NIH Grants Policy Statement

INTRODUCTION

The

National Institutes of Health Grants Policy Statement

(NIHGPS) is intended to make available to

NIH recipients, in a single document, the policy requirements that serve as the terms and conditions of

NIH grant awards. These terms and conditions apply not only to the recipients of NIH Grant Awards, but

also flow down to any subawards as well as to subrecipients unless specified otherwise in the regulation

or the terms and conditions of the specific NIH award (see "Consortium Agreements" on page IIB-109).

This document also is designed to be useful to those interested in NIH grants by providing information

about NIH, its organization, its staff and its grants process. The NIHGPS is available

online

. This ver-

sion includes many links within the document as well as links to some web resources outside of this doc-

ument. Users are strongly encouraged to use the on-line version of this document to benefit from these

links.

NIHGPS ORGANIZATION

The NIHGPS has three parts, which allows general information, application information, and other types

of reference material to be separated from legally binding terms and conditions:

Part I: NIH Grants General Information.

Part I (chapters 1 and 2) contains a glossary defining

commonly used terms and abbreviations used throughout the document; describes NIH and its

relationship to other organizations within the Department of Health and Human Services (HHS);

specifies recipient, NIH, and other HHS staff responsibilities and outlines the grant application

and review processes.

Part II: Terms and Conditions of NIH Grant Awards.

Part II (chapters 3-19) includes generally

applicable terms and conditions (Part IIA). This part also specifies the terms and conditions that

apply to particular types of grants, recipients, and activities that differ from, supplement, or elab-

orate on the standard terms and conditions (Part IIB). These requirements, in separate chapters,

pertain to multiple PD/PI applications and awards; construction, modernization and major alter-

ation and renovation grants; research training grants and fellowships; career development

awards; modular applications and awards; conference grants, consortium agreements; grants to

foreign and international organizations (and grants with substantial foreign components awarded

to domestic organizations), grants to Federal institutions and payments to Federal employees;

grants to for-profit organizations; and research patient care activities.

Part III: Points of Contact.

Part III (chapter 20) lists pertinent offices with their contact inform-

ation.

CONVENTIONS

Certain conventions are followed throughout this document. The term “grant” is used to mean both

grants and cooperative agreements; however, for clarity, certain sections mention both grants and cooper-

ative agreements. The term “recipient” generally is used to refer to recipients of grants and cooperative

agreements. “NIH” may be used in this document to refer to the entire organization or to its component

organizations, or else to contrast an action by NIH, including actions by its ICs, with an action by a recip-

ient or other organization. A reference to “Part II (IIA or IIB)” or “Part III” without further elaboration

means the corresponding part of the NIHGPS.

SUPERSESSION

NIH Grants Policy Statement

This version of the Grants Policy Statement includes policies and requirements that have been published

via Guide Notices in effect as of March 17. 2026. The updates published in this version of the GPS con-

solidate all such Guide Notices and supersede the April 2024 version of the NIHGPS.

ADDITIONAL INFORMATION

The Office of Policy for Extramural Research Administration (OPERA) develops and maintains this doc-

ument. Changes in statutes, regulations, or policies that take effect before the next revision of the

NIHGPS will be published separately in the

NIH Guide for Grants and Contracts

. Recipients are respons-

ible for reviewing the

NIH Guide for Grants and Contracts

for changes and for implementing them, as

appropriate. Subscribe to the

NIH Guide for Grants and Contracts

Listserv at

https://-

grants.nih.gov/funding/nih-guide-for-grants-and-contracts/subscribe

iii

NIH Grants Policy Statement

TABLE OF CONTENTS

1 GLOSSARY

I-1

1.1 Abbreviations

I-1

1.2 Definition of Terms

I-7

2 THE NATIONAL INSTITUTES OF HEALTH AS A GRANT-MAKING

ORGANIZATION

I-48

2.1 Roles and Responsibilities

I-48

2.1.1 NIH and HHS Staff

I-48

2.1.2 Recipient Staff

I-49

2.2 eRA Commons

I-51

2.2.1 eRA Commons Registration

I-51

2.2.1.1 eRA Commons Registration for the Organization

I-52

2.2.1.2 eRA Commons Registration for the PD/PI

I-52

2.2.1.3 eRA Commons Registration for Other Individuals Participating in NIH

Application and Research Performance Progress Reports

I-52

2.3 Application Information and Processes

I-53

2.3.1 Support Mechanisms

I-53

2.3.2 Eligibility

I-54

2.3.3 Types of Award Instruments

I-54

2.3.4 Types of Applications

I-54

2.3.5 Types of Notices of Funding Opportunities (NOFOs)

I-55

2.3.5.1 Other Funding-Related Notices

I-56

2.3.6 Legal Implications of Applications

I-57

2.3.7 Policies Affecting Applications

I-57

2.3.7.1 Direct Cost Limitations for Applications That Include Con-

sortium/Contractual Indirect Costs

I-58

2.3.7.2 Resubmission of Unfunded RFA Applications

I-58

2.3.7.3 Resubmission of an Unfunded Application

I-58

2.3.7.4 New Investigators and Early Stage Investigators

I-59

2.3.7.5 Program Director/Principal Investigator, Individual Fellowship and Sponsor

Assurance

I-60

2.3.7.6 Post-Submission Grant Application Materials

I-60

2.3.7.7 SAM Registration and Unique Entity Identifier (UEI) Requirements

I-64

2.3.7.8 Graduate Student Compensation

I-64

2.3.7.9 NIH Data Management and Sharing and Genomic Data Sharing

I-65

2.3.7.10 Human Fetal Tissue from elective abortions

I-65

2.3.7.11 Biographical Sketches (Biosketches)

I-65

2.3.7.12 NIH Application Submission Limits

I-65

2.3.7.13 Appropriate Use of Artificial Intelligence (AI)

I-66

2.3.8 Application Forms

I-66

2.3.9 Application Receipt Information and Deadlines

I-66

2.3.9.1 Electronic Submission Requirements

I-67

2.3.9.2 Late Applications

I-67

2.3.9.3 Continuous Submission for Appointed Members of NIH Federal Advisory

Committees

I-68

2.3.9.4 Similar, Essentially Identical, or Identical Applications

I-68

2.3.9.5 Application Non-conformity

I-69

2.3.9.6 Natural Disasters and Other Emergencies

I-69

2.3.10 Fraud, Waste and Abuse of NIH Grant Funds

I-70

NIH Grants Policy Statement

2.3.11 Availability and Confidentiality of Information

I-71

2.3.11.1 Availability of Information

I-71

2.3.11.2 Confidentiality of Information

I-71

2.3.12 Protecting Sensitive Data and Information Used in Research

I-74

2.4 The Peer Review Process

I-74

2.4.1 Initial Review

I-75

2.4.1.1 Responsibilities

I-75

2.4.1.2 Overall Impact

I-75

2.4.1.3 Standard Scored Review Criteria (Non SRF-applicable activity codes)

I-76

2.4.1.4 Standard Additional Review Criteria (Non SRF-applicable activity codes)

I-76

2.4.1.5 Standard Additional Review Considerations (Non SRF-applicable activity

codes)

I-76

2.4.1.6 Simplified Review Framework (SRF)

I-77

2.4.2 Appeals of Initial Scientific Review

I-78

2.4.3 National Advisory Council or Board Review

I-80

2.4.4 Disposition of Applications

I-80

2.5 Completing the Pre-Award Process

I-81

2.5.1 Just-in-Time Procedures

I-81

2.5.2 Submitting Revised Project Summary/Abstracts, Specific Aims, and/or Public

Health Relevance Statement

I-84

2.5.3 Determining Applicant Organization Eligibility

I-85

2.5.4 Determining Eligibility of Individuals

I-86

2.5.5 Cost Analysis and Assessment of Management Systems

I-86

3 OVERVIEW OF TERMS AND CONDITIONS

IIA-1

3.1 Federalwide Standard Terms and Conditions for Research Grants

IIA-2

4 PUBLIC POLICY REQUIREMENTS, OBJECTIVES AND OTHER

APPROPRIATION MANDATES

IIA-3

4.1 Public Policy Requirements and Objectives

IIA-3

4.1.1 Animal Welfare Requirements

IIA-11

4.1.1.1 Animal Welfare Assurance Requirements

IIA-12

4.1.1.2 Verification of IACUC Approval

IIA-12

4.1.1.3 Consortiums

IIA-13

4.1.1.4 Foreign Recipients and Foreign Performance Sites

IIA-13

4.1.1.5 Reporting to OLAW

IIA-13

4.1.2 Civil Rights Protections

IIA-14

4.1.2.1 Civil Rights Act of 1964

IIA-14

4.1.2.2 Educational Amendments of 1972

IIA-15

4.1.2.3 Rehabilitation Act of 1973

IIA-15

4.1.2.4 Age Discrimination Act of 1975

IIA-15

4.1.2.5 Limited English Proficiency

IIA-15

4.1.2.6 Nondiscrimination in Health Programs or Activities

IIA-15

4.1.3 Clinical Trials Registration and Reporting in ClinicalTrials.gov Requirement

IIA-15

4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

IIA-15

4.1.3.2 Food and Drug Administration Amendments Act (FDAAA)

IIA-17

4.1.3.3 Good Cause Extension (GCE) Request Requirements

IIA-17

4.1.4 Confidentiality

IIA-19

4.1.4.1 Certificates of Confidentiality

IIA-19

4.1.4.2 Confidentiality of Alcohol and Substance Use Patient Records

IIA-21

4.1.4.3 Confidentiality of Patient Records: Health Insurance Portability and

IIA-22

NIH Grants Policy Statement

Accountability Act

4.1.5 Controlled Substances

IIA-22

4.1.6 Debarment and Suspension

IIA-22

4.1.7 Drug-Free Workplace

IIA-23

4.1.8 Federal Funding Accountability and Transparency Act (FFATA)

IIA-24

4.1.9 Federal Information Security Management Act

IIA-24

4.1.10 Financial Conflict of Interest

IIA-24

4.1.11 Fly America Act

IIA-27

4.1.12 Health and Safety Regulations and Guidelines

IIA-28

4.1.13 Human Biospecimens Security Measures

IIA-29

4.1.14 Human Stem Cell Research

IIA-30

4.1.14.1 Human Pluripotent Stem Cell Research Prohibited with NIH Funding

IIA-30

4.1.15 Human Fetal Tissue Research

IIA-31

4.1.15.1 Research on Transplantation of Human Fetal Tissue

IIA-31

4.1.15.2 Non-Transplantation Research on Human Fetal Tissue from Elective

Abortions

IIA-32

4.1.16 Human Subjects Protections

IIA-33

4.1.16.1 Federalwide Assurance Requirements

IIA-35

4.1.16.2 Certification of IRB Approval

IIA-36

4.1.16.3 Reporting to Funding Agency and OHRP

IIA-36

4.1.16.4 OHRP Oversight

IIA-37

4.1.16.5 Education in the Protection of Human Research Participants

IIA-37

4.1.16.6 Data and Safety Monitoring

IIA-37

4.1.16.7 Inclusion of Individuals Across the Lifespan as Participants in Research

Involving Human Subjects

IIA-38

4.1.16.8 Inclusion of Women and Members of Racial and/or Ethnic Minority

Groups in Clinical Research

IIA-39

4.1.16.9 Good Clinical Practice Training for NIH Recipients Involved in NIH-fun-

ded Clinical Trials

IIA-39

4.1.16.10 NIH Policy on the Use of a Single Institutional Review Board for Multi-

Site Research

IIA-40

4.1.17 Investigational New Drug Applications/Investigational Device Exceptions

IIA-41

4.1.18 Lobbying Prohibition

IIA-42

4.1.19 Metric System

IIA-43

4.1.20 Military Recruiting and Reserve Officer Training Corps Program Access to

Institutions of Higher Education

IIA-43

4.1.21 National Environmental Policy Act

IIA-43

4.1.22 Nondelinquency on Federal Debt

IIA-44

4.1.23 President's Emergency Plan for AIDS Relief (PEPFAR) Program

IIA-44

4.1.23.1 PEPFAR Agreements

IIA-44

4.1.23.2 PEPFAR Agreements Between the U.S. Government and Foreign Non-

Governmental Organizations (NGOs)

IIA-45

4.1.24 Pro-Children Act of 1994

IIA-46

4.1.25 Public Health Security

IIA-47

4.1.25.1 Public Health Security and Bioterrorism Preparedness and Response Act

(Select Agents)

IIA-47

4.1.25.1.1.1 Select Agent Awards to U.S. Institutions

IIA-47

4.1.25.1.1.2 Select Agent Awards to Foreign Organizations and Inter-

national Organizations

IIA-47

NIH Grants Policy Statement

4.1.25.1.1.3 Select Agent Awards to U.S. Institutions with Foreign Sub-

components

IIA-48

4.1.25.2 Dual Use Research of Concern

IIA-48

4.1.25.3 Agents Regulated Under the Chemical Weapons Convention

IIA-49

4.1.25.4 Procurement of Synthetic Nucleic Acids and Benchtop Nucleic Acid Syn-

thesis Equipment

IIA-49

4.1.26 Reporting and Assurance Requirements for Institutions Receiving Awards for

Training of Graduate Students for Doctoral Degrees

IIA-49

4.1.27 Research Involving Recombinant or Synthetic Nucleic Acid Molecules

IIA-50

4.1.27.1 Scope and Availability

IIA-50

4.1.27.2 Institutional Biosafety Committee

IIA-51

4.1.27.3 Investigators and Institutional Staff

IIA-51

4.1.28 Research Misconduct

IIA-51

4.1.29 Seat Belt Use

IIA-53

4.1.30 Smoke-Free Workplace

IIA-53

4.1.31 Standards of Conduct

IIA-53

4.1.32 Text Messaging While Driving

IIA-54

4.1.33 Trafficking in Persons

IIA-54

4.1.34 USA Patriot Act

IIA-54

4.1.35 Responsibility/Qualification Information in SAM.gov

IIA-55

4.1.36 Mandatory Disclosures

IIA-55

4.1.37 Never Contract with the Enemy

IIA-56

4.1.38 Prohibition on Certain Telecommunications and Video Surveillance Equipment

or Services

IIA-56

4.1.39 Whistleblower Protections

IIA-57

4.2 Appropriation Mandates

IIA-57

4.2.1 Acknowledgment of Federal Funding

IIA-57

4.2.2 Dissemination of False or Deliberately Misleading Information

IIA-57

4.2.3 Gun Control

IIA-57

4.2.4 Human Embryo Research and Cloning Ban

IIA-57

4.2.5 Lobbying—Appropriation Prohibition

IIA-58

4.2.6 Promotion or Legalization of Controlled Substances

IIA-58

4.2.7 Restriction on Abortion Funding

IIA-58

4.2.7.1 Exceptions to Restrictions on Abortions

IIA-59

4.2.8 Restriction on Distribution of Sterile Needles

IIA-59

4.2.9 Salary Cap/Salary Limitation

IIA-59

4.2.10 Restriction of Pornography on Computer Networks

IIA-60

4.2.11 Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory

Committee Candidates

IIA-60

5 THE NOTICE OF AWARD

IIA-61

5.1 Notice of Award Notification

IIA-63

5.2 Associated Applications and/or Awards

IIA-63

5.3 Funding

IIA-63

5.4 Budget

IIA-64

5.5 Additional Terms and Conditions

IIA-65

6 PAYMENT

IIA-66

6.1 NIH Payment Review Process

IIA-66

6.2 Smartlink II/ACH

IIA-66

vii

NIH Grants Policy Statement

6.3 Cash Request

IIA-66

6.4 Interest Earned on Advances of Grant Funds

IIA-67

6.5 Improper Payments Elimination and Recovery Improvement Act

IIA-67

7 COST CONSIDERATION

IIA-68

7.1 General

IIA-68

7.2 The Cost Principles

IIA-68

7.3 Direct Costs and Indirect Costs

IIA-69

7.4 Reimbursement of Indirect Costs

IIA-70

7.5 Cost Transfers, Overruns, and Accelerated and Delayed Expenditures

IIA-73

7.6 Allocation of Costs and Closely Related Work

IIA-74

7.7 Applicable Credits

IIA-74

7.8 Services Provided by Affiliated Organizations

IIA-74

7.9 Allowability of Costs/Activities

IIA-75

7.9.1 Selected Items of Cost

IIA-75

8 ADMINISTRATIVE REQUIREMENTS

IIA-106

8.1 Changes in Project and Budget

IIA-106

8.1.1 NIH Standard Terms of Award

IIA-106

8.1.1.1 Carryover of Unobligated Balances from One Budget Period to Any Sub-

sequent Budget Period

IIA-107

8.1.1.2 Cost-Related Prior Approvals

IIA-108

8.1.1.3 Extension of Final Budget Period of a Previously Approved Project

Period without Additional NIH Funds

IIA-109

8.1.1.4 Transfer of the Performance of Substantive Programmatic Work to a

Third Party by Means of a Consortium Agreement

IIA-110

8.1.1.5 Direct Charging Salaries of Administrative and Clerical Staff

IIA-110

8.1.1.6 Supplemental Compensation under Written Institutional Policy for IHEs

IIA-110

8.1.1.7 Intra-IHE Faculty Consulting that Exceed a Faculty Member's Base

Salary, Under Certain Conditions.

IIA-110

8.1.2 Prior Approval Requirements

IIA-110

8.1.2.1 Additional No-cost Extension or Extension Greater Than 12 Months or

Late Notification of Initial No-Cost Extension

IIA-112

8.1.2.2 Alterations and Renovations

IIA-112

8.1.2.3 Capital Expenditures

IIA-112

8.1.2.4 Carryover of Unobligated Balances

IIA-112

8.1.2.5 Change in Scope

IIA-113

8.1.2.6 Change in Status, Including Absence of PD/PI and Other Senior/Key Per-

sonnel Named in the NoA

IIA-115

8.1.2.7 Change of Recipient Organization

IIA-116

8.1.2.8 Change in Recipient Organizational Status

IIA-120

8.1.2.9 Deviation from Award Terms and Conditions, including Restrictions in

the NoA

IIA-121

8.1.2.10 Foreign Component Added to a Grant to a Domestic or Foreign Organ-

ization

IIA-122

8.1.2.11 Provide Subawards Based on Fixed Amounts

IIA-122

8.1.2.12 Need for Additional NIH Funding without Extension of Budget and Pro-

ject Period

IIA-123

8.1.2.13 Need for Additional NIH Funding with Extension of the Final Budget

Period of a Project Period

IIA-123

8.1.2.14 Pre-Award Costs

IIA-124

viii

NIH Grants Policy Statement

8.1.2.15 Rebudgeting of Funds from Trainee Costs

IIA-124

8.1.2.16 Rebudgeting of Funds Between Construction and Non-construction

Work

IIA-124

8.1.2.17 Retention of Research Grant Funds When a Career Development Award

is Issued

IIA-124

8.1.3 Requests for Prior Approval

IIA-124

8.2 Availability of Research Results: Publications, Intellectual Property Rights, and

Sharing Research Resources

IIA-125

8.2.1 Rights in Data (Publication and Copyrighting)

IIA-126

8.2.2 NIH Public Access Policy

IIA-127

8.2.3 Sharing Research Resources

IIA-127

8.2.3.1 Operational and Security Standards for Controlled-Access Repositories

IIA-128

8.2.3.2 Policy for Data Management and Sharing (DMS Policy)

IIA-129

8.2.3.3 Genomic Data Sharing (GDS) Policy

IIA-130

8.2.3.4 Sharing Model Organisms

IIA-132

8.2.4 Inventions and Patents

IIA-132

8.2.5 Interim Research Products

IIA-140

8.3 Management Systems and Procedures

IIA-141

8.3.1 Financial Management System Standards

IIA-141

8.3.2 Program Income

IIA-142

8.3.2.1 Reporting Program Income

IIA-142

8.3.2.2 Sale of Real Property, Equipment, and Supplies

IIA-143

8.3.2.3 Royalties and Licensing Fees from Copyrights, Inventions, and Patents

IIA-144

8.3.3 Property Management System Standards

IIA-144

8.3.3.1 Real Property

IIA-145

8.3.3.2 Equipment and Supplies

IIA-145

8.3.4 Procurement System Standards and Requirements

IIA-147

8.3.4.1 General

IIA-147

8.3.4.2 Approval Requirements

IIA-147

8.3.4.3 Contracting with Small Businesses, Minority-Owned Firms, Women's

Business Enterprises, and Veteran-Owned Businesses

IIA-148

8.3.4.4 Domestic Preferences for Procurements

IIA-148

8.4 Monitoring

IIA-148

8.4.1 Reporting

IIA-149

8.4.1.1 Non-Competing Continuation Progress Reports

IIA-149

8.4.1.2 Streamlined Non-Competing Award Process

IIA-150

8.4.1.3 Progress Reports for Multiyear Funded Awards

IIA-152

8.4.1.4 Final Research Performance Progress Report (F-RPPR)

IIA-152

8.4.1.5 Financial Reports

IIA-152

8.4.1.6 Invention Reporting

IIA-155

8.4.1.7 Financial Conflict of Interest Reports

IIA-156

8.4.1.8 Research Securities

IIA-156

8.4.1.9 NIH Disclosure Requirements

IIA-156

8.4.1.10 Malign Foreign Talent Recruitment Program

IIA-156

8.4.1.11 Research Security Training

IIA-156

8.4.2 Record Retention and Access

IIA-156

8.4.3 Audit

IIA-157

8.5 Specific Award Conditions and remedies for noncompliance (specific award con-

ditions and Enforcement Actions)

IIA-160

8.5.1 Specific Award Conditions: Modification of the Terms of Award

IIA-160

NIH Grants Policy Statement

8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Ter-

mination, and Withholding of Support

IIA-160

8.5.3 Other Enforcement Actions

IIA-162

8.5.4 Recovery of Funds

IIA-162

8.5.5 Debt Collection

IIA-163

8.6 Closeout

IIA-163

8.6.1 Final Federal Financial Report

IIA-164

8.6.2 Final Research Performance Progress Report

IIA-164

8.6.3 Final Invention Statement and Certification

IIA-165

8.6.4 Submission of Closeout Documents

IIA-165

8.7 Grant Appeals Procedures

IIA-165

8.8 Alignment with Program Goals and Agency Priorities

IIA-166

9 MULTIPLE PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR

APPLICATIONS AND AWARDS

IIB-2

9.1 General

IIB-2

9.2 Applicability

IIB-2

9.3 Application Requirements

IIB-2

9.4 Application Review and Award

IIB-4

9.5 Post-Award Administration

IIB-4

10 CONSTRUCTION, MODERNIZATION, OR MAJOR ALTERATION AND

RENOVATION OF RESEARCH FACILITIES

IIB-6

10.1 General

IIB-6

10.1.1 Eligibility

IIB-7

10.1.2 Notices of Funding Opportunity

IIB-7

10.1.3 Application Review and Award

IIB-7

10.1.4 Title to Site

IIB-8

10.1.5 Matching Requirement

IIB-8

10.2 Procurement Requirements for Construction Services

IIB-9

10.2.1 General

IIB-9

10.2.2 Liquidated Damages

IIB-10

10.3 Contracting Methods

IIB-10

10.3.1 Design-Bid-Build

IIB-10

10.3.2 Alternate Contracting Methods

IIB-10

10.3.2.1 Construction Manager

IIB-10

10.3.2.2 Design-Build Services

IIB-11

10.3.2.3 Guaranteed Maximum Price

IIB-12

10.4 Design Documentation Requirements

IIB-12

10.4.1 Minimum Design Requirements for Construction, Modernization and Major

A&R

IIB-13

10.5 Equal Opportunity and Labor Standards

IIB-13

10.5.1 Equal Employment Opportunity

IIB-14

10.5.2 Labor Standards

IIB-14

10.5.2.1 Contract Work Hours and Safety Standards

IIB-14

10.5.2.2 Disposition of Unclaimed Wages

IIB-14

10.6 Real Property Management Standards

IIB-15

10.6.1 General

IIB-15

10.6.2 Notice of Federal Interest

IIB-15

10.6.3 Insurance Requirements

IIB-16

NIH Grants Policy Statement

10.6.4 Use of Facility and Disposition

IIB-17

10.6.5 Real Estate Appraisals

IIB-17

10.7 Allowable and Unallowable Costs and Activities

IIB-18

10.8 Administrative Requirements

IIB-20

10.8.1 Prior Approval Requirements

IIB-20

10.8.2 Alteration and Renovation Projects Under Non-construction Grants

IIB-20

10.9 Closeout

IIB-21

10.10 Public Policy Requirements

IIB-22

10.10.1 Executive Orders

IIB-25

11 RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS

IIB-30

11.1 General

IIB-30

11.1.1 Background

IIB-30

11.1.2 Nondiscrimination

IIB-30

11.2 Individual Fellowships

IIB-30

11.2.1 General

IIB-30

11.2.2 Eligibility

IIB-31

11.2.2.1 Research Areas

IIB-31

11.2.2.2 Research Training Program

IIB-31

11.2.2.3 Degree Requirements

IIB-31

11.2.2.4 Citizenship

IIB-32

11.2.2.5 Sponsorship

IIB-32

11.2.2.6 NIH Employees & Other Federal Sponsorship (Federal Fellows)

IIB-33

11.2.2.7 Individuals on Active Military Duty

IIB-33

11.2.3 Application Requirements and Due Dates

IIB-34

11.2.3.1 Application

IIB-34

11.2.3.2 eRA Commons Registration

IIB-34

11.2.3.3 ORCID iDs

IIB-34

11.2.3.4 Letters of Reference

IIB-34

11.2.3.5 Responsible Conduct of Research

IIB-35

11.2.3.6 Concurrent Applications

IIB-37

11.2.3.7 Receipt Dates

IIB-37

11.2.4 Review

IIB-37

11.2.4.1 Overall Impact

IIB-37

11.2.4.2 Scored Review Criteria

IIB-37

11.2.4.3 Additional Review Criteria

IIB-38

11.2.4.4 Additional Review Considerations

IIB-38

11.2.4.5 Secondary Level of Review

IIB-38

11.2.5 Notification of Action

IIB-38

11.2.6 Period of Support

IIB-39

11.2.7 Full-Time and Part-Time Training

IIB-39

11.2.8 Initiation of Support

IIB-40

11.2.8.1 Process

IIB-40

11.2.8.2 Payment

IIB-41

11.2.9 Allowable and Unallowable Costs

IIB-41

11.2.9.1 Pre-award Costs

IIB-41

11.2.9.2 Stipends

IIB-41

11.2.9.3 Stipend Levels

IIB-41

11.2.9.4 Institutional Allowance

IIB-42

11.2.9.5 Tuition and Fees

IIB-43

11.2.9.6 Travel to Foreign Training Sites

IIB-44

NIH Grants Policy Statement

11.2.9.7 Childcare Costs

IIB-44

11.2.9.8 Employee Benefits

IIB-44

11.2.9.9 Rebudgeting of Funds

IIB-44

11.2.10 Supplementation of Stipends, Compensation, and Other Income

IIB-45

11.2.10.1 Stipend Supplementation

IIB-45

11.2.10.2 Compensation

IIB-45

11.2.10.3 Other Income: Concurrent Benefits

IIB-46

11.2.10.4 Other Income: Educational Loans or GI Bill

IIB-46

11.2.10.5 Other Income: NIH Loan Repayment Program

IIB-46

11.2.10.6 Taxability of Stipends

IIB-46

11.2.10.7 Form 1099

IIB-46

11.2.11 Reporting Requirements

IIB-47

11.2.11.1 Activation Notice

IIB-47

11.2.11.2 Payback Agreement

IIB-47

11.2.11.3 Termination Notice

IIB-47

11.2.11.4 Consecutive Support

IIB-48

11.2.11.5 Progress Reports

IIB-48

11.2.11.6 Financial Reporting

IIB-48

11.2.12 Changes in the Project

IIB-48

11.2.13 Other Terms and Conditions

IIB-49

11.2.13.1 Leave

IIB-49

11.2.13.2 Termination

IIB-49

11.2.13.3 Publications and Sharing of Research Results

IIB-50

11.2.13.4 Copyright

IIB-50

11.2.13.5 Inventions and Patents

IIB-50

11.2.13.6 Disposition of Professional Fees

IIB-50

11.2.13.7 Public Policy Requirements and Objectives

IIB-51

11.2.13.8 Applicability of NIH Standard Terms of Award

IIB-51

11.3 Institutional Research Training Grants

IIB-52

11.3.1 General

IIB-52

11.3.2 Eligibility

IIB-52

11.3.2.1 Applicant Eligibility

IIB-52

11.3.2.2 Research Areas

IIB-52

11.3.2.3 Training Program Director/Principal Investigator(s)

IIB-52

11.3.2.4 Research Training Program

IIB-53

11.3.2.5 Degree Requirements

IIB-53

11.3.2.6 Citizenship

IIB-55

11.3.3 Application Requirements and Due Dates

IIB-56

11.3.3.1 Application

IIB-56

11.3.3.2 Due Dates

IIB-56

11.3.3.3 Special Program Considerations

IIB-56

11.3.3.4 Training in the Responsible Conduct of Research

IIB-57

11.3.4 Review

IIB-58

11.3.4.1 Overall

IIB-58

11.3.4.2 Overall Impact

IIB-58

11.3.4.3 Scored Review Criteria

IIB-59

11.3.4.4 Additional Review Criteria

IIB-59

11.3.4.5 Additional Review Considerations

IIB-59

11.3.4.6 National Advisory Council Review

IIB-59

11.3.5 Notification of Action

IIB-60

11.3.6 Period of Support

IIB-60

xii

NIH Grants Policy Statement

11.3.6.1 Training Grants

IIB-60

11.3.6.2 Trainees

IIB-60

11.3.6.3 Kirschstein-NRSA Limitations

IIB-61

11.3.7 Initiation of Support

IIB-61

11.3.8 Allowable and Unallowable Costs

IIB-62

11.3.8.1 Pre-Award Costs

IIB-62

11.3.8.2 Stipends

IIB-62

11.3.8.3 Trainee Tuition and Fees

IIB-63

11.3.8.4 Training-Related Expenses

IIB-63

11.3.8.5 Trainee Travel Costs

IIB-64

11.3.8.6 Short-Term Training Costs

IIB-64

11.3.8.7 Employee Benefits

IIB-64

11.3.8.8 Indirect Costs

IIB-65

11.3.8.9 Childcare Costs

IIB-65

11.3.9 Rebudgeting of Funds

IIB-65

11.3.10 Stipend Supplementation, Compensation, and Other Income

IIB-65

11.3.10.1 Stipend Supplementation

IIB-65

11.3.10.2 Compensation

IIB-66

11.3.10.3 Other Income: Concurrent Benefits

IIB-66

11.3.10.4 Other Income: Educational Loans or GI Bill

IIB-66

11.3.10.5 Other Income: NIH Loan Repayment Program

IIB-66

11.3.10.6 Taxability of Stipends

IIB-66

11.3.10.7 Form 1099

IIB-67

11.3.11 Carryover Authority

IIB-67

11.3.12 Program Income

IIB-67

11.3.13 Reporting Requirements

IIB-67

11.3.13.1 Statement of Appointment (Form PHS 2271)

IIB-67

11.3.13.2 Payback Agreement (Form PHS 6031)

IIB-68

11.3.13.3 Termination Notice (Form PHS 416-7)

IIB-68

11.3.13.4 Research Performance Progress Reports

IIB-69

11.3.13.5 Federal Financial Report (FFR)

IIB-69

11.3.14 Closeout

IIB-69

11.3.15 Changes in the Project

IIB-69

11.3.16 Other Terms and Conditions

IIB-70

11.3.16.1 Leave

IIB-70

11.3.16.2 Termination

IIB-71

11.3.16.3 Publications and Sharing of Research Results

IIB-71

11.3.16.4 Copyright

IIB-71

11.3.16.5 Inventions and Patents

IIB-71

11.3.16.6 Disposition of Professional Fees

IIB-72

11.3.16.7 Public Policy Requirements and Objectives

IIB-72

11.4 Payback Requirements

IIB-73

11.4.1 General

IIB-73

11.4.2 Implementation

IIB-73

11.4.3 Payback

IIB-73

11.4.3.1 Service Payback

IIB-74

11.4.3.2 Financial Payback

IIB-75

11.4.3.3 Extensions of Payback

IIB-76

11.4.3.4 Waiver

IIB-76

11.4.4 Certification of Payback Activities

IIB-77

11.4.4.1 Annual Payback Activities Certification (Form PHS 6031-1)

IIB-77

xiii

NIH Grants Policy Statement

11.4.4.2 Annual Certification

IIB-77

11.4.4.3 Change of Address

IIB-77

11.4.4.4 Breaks in Kirschstein-NRSA Support

IIB-77

11.4.4.5 National Health Service Corps

IIB-78

12 RESEARCH CAREER DEVELOPMENT ("K") AWARDS

IIB-79

12.1 General

IIB-79

12.1.1 Background

IIB-79

12.2 Types of Career Development Awards

IIB-79

12.2.1 General

IIB-79

12.2.2 Individual Mentored Career Development Awards

IIB-79

12.2.2.1 Mentor

IIB-80

12.2.3 Career Transition Awards

IIB-80

12.2.3.1 K22 Phase

IIB-80

12.2.3.2 Pathway to Independence Award (K99/R00)

IIB-80

12.2.4 Individual Non-mentored (Independent) Career Development Awards

IIB-82

12.2.5 Institutional Scientist Development Programs

IIB-82

12.3 Eligibility

IIB-82

12.3.1 Eligible Institutions

IIB-83

12.3.2 Eligible Individuals

IIB-83

12.3.3 Degree Requirements

IIB-83

12.3.4 Citizenship

IIB-83

12.3.5 Type of Appointment

IIB-84

12.3.5.1 Temporary Adjustments to the Full-Time Institutional Appointment

Requirement

IIB-84

12.3.6 Level of Effort

IIB-85

12.3.6.1 Mentored CDAs

IIB-85

12.3.6.2 Concurrent Support

IIB-86

12.3.6.3 Non-mentored CDAs

IIB-87

12.3.6.4 Temporary Adjustments to the Percent Effort Requirement

IIB-87

12.3.7 Prior Research Support

IIB-87

12.4 Application Requirements and Due Dates

IIB-88

12.4.1 Application

IIB-88

12.4.1.1 Letters of Reference

IIB-89

12.4.1.2 Concurrent Applications

IIB-89

12.4.1.3 Environment and Institutional Commitment to the Candidate

IIB-89

12.4.1.4 Training in the Responsible Conduct of Research

IIB-90

12.4.1.5 Budget

IIB-91

12.4.1.6 Submission Dates

IIB-92

12.5 Review

IIB-92

12.5.1 Overall Impact

IIB-92

12.5.2 Scored Review Criteria

IIB-92

12.5.3 Additional Review Criteria

IIB-92

12.5.4 Additional Review Considerations

IIB-93

12.6 Notification of Action

IIB-93

12.7 Period of Support

IIB-93

12.8 Allowable and Unallowable Costs

IIB-94

12.8.1 Salaries and Fringe Benefits

IIB-94

12.8.2 Research Development Support Costs

IIB-95

12.8.3 Proposal Preparation Costs

IIB-95

xiv

NIH Grants Policy Statement

12.8.4 Indirect Costs

IIB-95

12.9 Rebudgeting of Funds

IIB-95

12.10 Carryover Authority

IIB-95

12.11 Reporting Requirements

IIB-95

12.11.1 Progress Reports

IIB-96

12.11.2 Federal Financial Report

IIB-96

12.11.3 Closeout

IIB-96

12.11.4 Post Closeout Evaluation

IIB-96

12.12 Changes in the Project

IIB-96

12.12.1 Temporary Off-Site Career Development Experience

IIB-97

12.13 Other Terms and Conditions

IIB-97

12.13.1 Leave

IIB-97

12.13.1.1 Unpaid Leave

IIB-98

12.13.2 Statement of Appointment—Institutional CDAs Only

IIB-98

12.13.3 Early Termination

IIB-98

12.13.4 Other Income: Generation and Disposition of Professional Fees

IIB-99

13 MODULAR APPLICATIONS AND AWARDS

IIB-100

13.1 General

IIB-100

13.2 Applicability

IIB-100

13.3 Application Requirements

IIB-100

13.3.1 Budget

IIB-100

13.4 Application Review and Award

IIB-101

13.5 Post-Award Administration

IIB-101

14 SUPPORT OF SCIENTIFIC MEETINGS (CONFERENCE GRANTS)

IIB-102

14.1 General

IIB-102

14.2 Applicability

IIB-102

14.3 Definitions

IIB-102

14.4 Eligibility

IIB-102

14.5 Application Requirements

IIB-103

14.6 Public Policy Requirements and Objectives

IIB-103

14.6.1 The United States Hotel and Motel Fire Safety Act of 1990

IIB-103

14.6.2 Plans to Promote Safe Environments at Conferences

IIB-103

14.7 Application Review

IIB-104

14.8 Funding

IIB-104

14.9 Acknowledgment of Funding Source and Disclaimer

IIB-105

14.10 Allowable and Unallowable Costs

IIB-105

14.10.1 Allowable Costs

IIB-105

14.10.2 Unallowable Costs

IIB-106

14.11 Administrative Requirements

IIB-107

14.11.1 Intellectual Property: Publications, Copyright, and Public Disclosure

IIB-107

14.11.2 Reporting and Record Retention

IIB-107

14.11.2.1 Progress/Final Report

IIB-107

14.11.2.2 Federal Financial Report

IIB-108

15 CONSORTIUM AGREEMENTS

IIB-109

15.1 General

IIB-109

15.2 Administrative and Other Requirements

IIB-110

15.2.1 Written Agreement

IIB-110

15.2.2 Public Policy Requirements and Objectives

IIB-112

NIH Grants Policy Statement

15.2.3 Allowable and Unallowable Costs

IIB-113

15.2.4 Approval Authorities

IIB-113

15.2.5 Tangible Personal Property

IIB-113

15.2.5.1 Exempt Property

IIB-113

15.2.5.2 Nonexempt Property

IIB-114

15.2.6 Audit

IIB-114

16 GRANTS TO FOREIGN ORGANIZATIONS, INTERNATIONAL

ORGANIZATIONS, DOMESTIC GRANTS WITH FOREIGN COMPONENTS AND

COLLABORATIVE INTERNATIONAL RESEARCH AWARDS

IIB-115

16.1 General

IIB-115

16.2 Eligibility

IIB-115

16.3 Application Review

IIB-116

16.4 Public Policy Requirements and Objectives

IIB-116

16.5 Funding and Payment

IIB-117

16.6 Allowable and Unallowable Costs

IIB-118

16.7 Administrative Requirements

IIB-119

16.7.1 Changes in Project and Budget

IIB-119

16.7.2 Change in Scope

IIB-119

16.7.3 Change of Recipient Organization

IIB-119

16.7.4 Audit

IIB-119

16.7.5 Reporting and Record Retention

IIB-120

16.8 Collaborative International Research Awards

IIB-120

16.8.1 General

IIB-120

16.8.2 Collaborative International Research Award Structure

IIB-120

16.8.3 Applicability

IIB-121

16.8.4 Application Review and Award

IIB-121

16.8.5 Public Policy Requirements

IIB-121

16.8.6 Allowable and Unallowable Costs

IIB-121

16.8.7 Administrative Requirements

IIB-121

17 GRANTS TO FEDERAL INSTITUTIONS AND PAYMENTS TO FEDERAL

EMPLOYEES UNDER GRANTS

IIB-123

17.1 General

IIB-123

17.2 Eligibility

IIB-123

17.3 VA-University Affiliations

IIB-123

17.4 Public Policy Requirements and Objectives

IIB-124

17.5 Payment

IIB-124

17.6 Allowable and Unallowable Costs

IIB-124

17.7 Administrative Requirements

IIB-127

17.7.1 Equipment Accountability

IIB-127

17.7.2 Procurement Requirements

IIB-127

17.7.3 Intellectual Property

IIB-127

17.7.4 Reporting Requirements

IIB-127

18 GRANTS TO FOR-PROFIT ORGANIZATIONS

IIB-128

18.1 General

IIB-128

18.2 Eligibility

IIB-128

18.3 Allowable and Unallowable Costs

IIB-128

18.3.1 Cost Principles

IIB-128

18.3.2 Indirect Costs

IIB-128

xvi

NIH Grants Policy Statement

18.3.3 Profit or Fee

IIB-128

18.4 Administrative Requirements

IIB-128

18.4.1 Equipment Accountability

IIB-129

18.4.2 Intellectual Property

IIB-129

18.4.3 Program Income

IIB-129

18.4.4 Operating Authorities

IIB-129

18.4.5 Audit

IIB-129

18.4.6 Labor Distribution Requirements for For-Profit Organizations

IIB-130

18.5 Small Business Innovation Research and Small Business Technology Transfer

Programs

IIB-130

18.5.1 NIH Fast-Track Application Process

IIB-132

18.5.2 Eligibility

IIB-133

18.5.2.1 Place of Performance

IIB-134

18.5.2.2 Change in Organization Size & Change of Recipient Institution Actions

IIB-134

18.5.2.3 Minimum Level of Effort

IIB-135

18.5.2.4 Multiple Program Director/Principal Investigator Applications and

Awards

IIB-135

18.5.3 Public Policy Requirements and Objectives

IIB-136

18.5.3.1 Required Disclosures of Foreign Affiliations or Relationships to Foreign

Countries

IIB-136

18.5.4 Allowable Costs and Fee

IIB-137

18.5.4.1 Program Levels (Total Costs)

IIB-137

18.5.4.2 Profit or Fee

IIB-137

18.5.4.3 Indirect Costs

IIB-138

18.5.5 Administrative Requirements

IIB-138

18.5.5.1 Market Research

IIB-139

18.5.5.2 Intellectual Property

IIB-139

18.5.5.3 Data Sharing

IIB-142

18.5.5.4 SBIR Life Cycle Certification

IIB-142

18.5.5.5 STTR Life Cycle Certification

IIB-144

18.5.5.6 Prior Approval of New Subawards

IIB-146

18.5.5.7 Monitoring Requirements for Relationships with Foreign Countries of

Concern Post-Award

IIB-146

18.5.5.8 Final RPPR

IIB-147

18.5.5.9 Phase II Data Collection Requirement for Government SBIR Reporting

Database

IIB-147

19 RESEARCH PATIENT CARE COSTS

IIB-149

19.1 General

IIB-149

19.2 Definitions

IIB-149

19.3 Policy

IIB-150

19.4 Allowable Costs

IIB-150

19.4.1 Computing Research Patient Care Costs

IIB-151

19.4.2 Indirect Costs

IIB-151

19.4.3 Special Procedures for Certain Hospitals

IIB-151

19.4.3.1 Recipients

IIB-151

19.4.3.2 Consortium Participants/Contractors under Grants

IIB-152

19.4.4 Financial Responsibilities

IIB-152

19.5 Program Requirements

IIB-152

19.6 Post-Award Requirements

IIB-153

xvii

NIH Grants Policy Statement

20 INSTITUTES AND CENTERS

III-1

20.1 Other NIH Offices

III-5

20.2 Other HHS Government Offices

III-10

xviii

Part I: NIH Grants - General Information

1 Glossary

PART I: NIH GRANTS—GENERAL INFORMATION

This part contains a glossary defining terms and abbreviations commonly used throughout the NIHGPS;

describes NIH and its relationship to other organizations within HHS; specifies recipient, NIH, and other

HHS staff responsibilities; and outlines the grant application and review processes.

1 GLOSSARY

The glossary lists acronyms and other abbreviations used in the NIHGPS. The glossary also defines

terms commonly used throughout the NIHGPS. The definitions may be amplified and additional defin-

itions may be found throughout this document and in source documents, such as applicable statutes and

grants administration regulations. This is the only location in the NIHGPS where these terms are defined.

If an abbreviation used in the NIHGPS is unfamiliar, the reader should consult this list for its meaning.

1.1 ABBREVIATIONS

Exhibit 1: Abbreviation and full language of acronyms used in the Grants Policy State-

ment

Abbreviation

Full Meaning of Abbreviation

A&R

Alteration and Renovation

ACF

Administration for Children and Families

ACH

Automated Clearinghouse

ACL

Administration for Community Living

AHRQ

Agency for Healthcare Research and Quality

AIA

American Institute of Architects

AoA

Administration on Aging

AOR

Authorized Organization Representative

APAC

Annual Payback Activities Certification

AREA

Academic Research and Enhancement Award

ASHRAE

American Society of Heating, Refrigeration and Air Conditioning Engineers

BSO

Biological Safety Officer

CAS

Cost Allocation Services

CDA

Career Development Award

CDC

Centers for Disease Control and Prevention

Common Form (previously known as Standard Form)

CFR

Code of Federal Regulations

I-1

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

CGMO

Chief Grants Management Officer

Construction Manager

CMS

Centers for Medicare and Medicaid Services

CoC

Certificate of Confidentiality

COR

Career Opportunities in Research Education and Training Program

CSR

Center for Scientific Review

DAB

Departmental Appeals Board

DCGP

Division of Central Grants Processing, OER, NIH

DCIS

Departmental Contracts Information System

DEA

Drug Enforcement Administration

DES

Department of Engineering Services, NIH

DFAS

Division of Financial Advisory Services, NIH

DGCO

Division of Grants Compliance and Oversight, OPERA, OER, NIH

DGP

Division of Grants Policy, OPERA, OER, NIH

DGSI

Division of Grant Systems Integration, OPERA, OER, NIH

DNA

Deoxyribonucleic acid

DoC

Department of Commerce

DoD

Department of Defense

DoL

Department of Labor

DPI

Division of Program Integrity, OMA, NIH

DRR

Division of Receipt and Referral, CSR

DSMB

Data and Safety Monitoring Board

Environmental Assessment

FFR

Federal Financial Report

EIN

Entity Identification Number

EIS

Environmental Impact Statement

Executive Order

eRA

Electronic Research Administration

ESI

Early Stage Investigator

eSNAP

Electronic Streamlined Non-competing Award Process

I-2

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

F&A

Facilities and Administrative (costs)

FAC

Federal Audit Clearinghouse

FAIN

Federal Award Identification Number

FAR

Federal Acquisition Regulation

FCOI

Financial Conflict of Interest

FDA

Food and Drug Administration

FDAAA

Food and Drug Administration Amendments Act of 2007

FDP

Federal Demonstration Partnership

FEMA

Federal Emergency Management Agency

FFATA

Federal Funding Accountability and Transparency Act

FFR

Federal Financial Report (SF425)

FIC

Fogarty International Center

FICA

Federal Insurance Contributions Act

FOI

Freedom of Information

FOIA

Freedom of Information Act

FTR

Federal Travel Regulation

FWA

Federalwide Assurance

GAAP

Generally Accepted Accounting Principles

GAGAS

Generally Accepted Government Accounting Standards

GeMCRIS

Genetic Modification Clinical Research Information System

GMO

Grants Management Officer

GMP

Guaranteed Maximum Price

GMS

Grants Management Specialist

GPO

Government Printing Office

GSA

General Services Administration

GWAS

Genome-wide Association Studies

hESC

Human Embryonic Stem Cells

HHS

U.S. Department of Health and Human Services

HIPAA

Health Insurance Portability and Accountability Act

HPSL

Health Professional Student Loan

I-3

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

HRSA

Health Resources and Services Administration

HVAC

Heating, Ventilating, and Air Conditioning

IACUC

Institutional Animal Care and Use Committee

IBC

Institutional Biosafety Committee

IBS

Institutional Base Salary

Institute or Center

IDE

Investigational Device Exception

IHE

Institutions of Higher Education

IHS

Indian Health Service

IND

Investigational New Drug

IPA

Intergovernmental Personnel Act

IPF

Institutional Profile File

IR&D

Independent Research and Development

IRB

Institutional Review Board

IRG

Integrated Review Group

IRS

Internal Revenue Service

IVF

In vitro Fertilization

K award

Career Award

Kirschstein-

NRSA

Ruth L. Kirschstein National Research Service Award

LWOP

Leave Without Pay

MARC-

U*STAR

Maximizing Access to Research Careers Undergraduate Student Training in Academic

Research Program

MOU

Memorandum of Understanding

MTDC

Modified Total Direct Cost

NCATS

National Center for Advancing Translational Sciences

NCT

National Clinical Trial

Not Discussed

NEARC

National External Audit Review Center, OIG

NEI

National Eye Institute

NEPA

National Environmental Policy Act

I-4

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

NFI

Notice of Federal Interest

NFPA

National Fire Protection Association

NHSC

National Health Service Corps

NICHD

Eunice Kennedy Shriver

National Institute for Child Health and Human Development

NIDCR

National Institute of Dental and Craniofacial Research

NIGMS

National Institute of General Medical Sciences

NIH

National Institutes of Health

NIH MSID

NIH manuscript submission reference number

NIHGPS

National Institutes of Health Grants Policy Statement

NIMH

National Institute of Mental Health

NINR

National Institute on Nursing Research

NLM

National Library of Medicine

NoA

Notice of Award

NOFO

Notice of Funding Opportunity

NTIS

National Technical Information Service

OASH

Office of the Assistant Secretary for Health

OCR

Office for Civil Rights, HHS

OER

Office of Extramural Research, NIH

OFCCP

Office of Federal Contract Compliance Programs, DoL

OFM

Office of Financial Management, NIH

OHRP

Office for Human Research Protections, HHS

OIG

Office of the Inspector General

OIR

Office of Intramural Research, NIH

OLAW

Office of Laboratory Animal Welfare, NIH

OMA

Office of Management Assessment, NIH

OMB

Office of Management and Budget

ONR

Office of Naval Research

OPERA

Office of Policy for Extramural Research Administration, OER, NIH

ORI

Office of Research Integrity, HHS

OSC

Other Significant Contributor

I-5

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

P.L.

Public Law

Program Announcement

PAR

Program Announcement with Special Review Criteria and/or Special Receipt Dates

PD/PI

Program Director/Principal Investigator

PDF

Portable Document Format

PHS

Public Health Service

PII

Personally Identifiable Information

PMC

PubMed Central

PMCID

PubMed Central Identification/reference number

PMS

Payment Management System, Payment Management Service, HHS

Program Official

PSC

Payback Service Center, NIH, or Program Support Center, HHS

PTE

Pass-through Entity

R&D

Research and Development

R&R

Research and Related

RePORT

Research Portfolio Online Reporting Tool

RFA

Request for Applications

RFP

Request for Proposals

ROTC

Reserve Officer Training Corps

RPPR

Research Performance Progress Report

S&W

Salaries and Wages

SAM

System for Award Management

SAMHSA

Substance Abuse and Mental Health Services Administration

SBA

Small Business Administration

SBC

Small Business Concern

SBIR

Small Business Innovation Research Program

SEP

Special Emphasis Panel

SEVIS

Student and Exchange Visitor Information System

Standard Form

SF424(R&R)

Standard Form 424 for Research and Research-Related (R&R)

I-6

Part I: NIH Grants - General Information

1 Glossary

Abbreviation

Full Meaning of Abbreviation

SII

Successor-In-Interest

SNAP

Streamlined Non-competing Award Process

Signing Official

SPOC

State Single Point of Contact

SRG

Scientific Review Group

SRO

Scientific Review Officer

STTR

Small Business Technology Transfer Program

TVPA

Trafficking Victims Protection Act

U.S.

United States

U.S.C.

United States Code

USCIS

United States Citizenship and Immigration Services

USDA

United States Department of Agriculture

USPS

United States Postal Service

Department of Veterans Affairs

VAMC

VA Medical Center

VANPC

VA-Affiliated Non-Profit research Corporation

VAT

Value Added Tax

VHA

Veterans Health Administration

WIC

Women, Infants and Children

1.2 DEFINITION OF TERMS

Exhibit 2: Definitions of terms used in the Grants Policy Statement

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Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Acquisition cost

The total cost of the asset including the cost to ready the asset for its intended

use. For example, acquisition cost for equipment, means the net invoice price of

the equipment, including the cost of any modifications, attachments, accessories,

or auxiliary apparatus necessary to make it usable for the purpose for which it is

acquired. Acquisition costs for software include those development costs cap-

italized in accordance with generally accepted accounting principles (GAAP).

Ancillary charges, such as taxes, duty, protective in transit insurance, freight, and

installation may be included in or excluded from the acquisition cost in accord-

ance with the recipient's or subrecipient’s regular accounting practices.

Activity code

A 3-character code used to identify a specific category of extramural research

activity, applied to financial assistance mechanisms. NIH uses three funding

mechanisms for extramural research awards: grants, cooperative agreements

and contracts. Within each funding mechanism, NIH uses 3-character activity

codes (e.g., F32, K08, P01, R01, T32, etc.) to differentiate the wide variety of

research-related programs NIH supports. A comprehensive list of activity codes

is on the

Activity Code Search Results webpage

Additive alternative

A use of program income earned during or after the project period that permits

income that is generated under a grant to be added to funds committed to the pro-

ject by the Federal awarding agency and recipient and used to further eligible pro-

ject or program objectives. (See definitions for

deductive alternative

and

cost

sharing or matching alternative

and

Administrative Requirements—Management

Systems and Procedures—Program Income

Administrative

supplement

A request for (or the award of) additional funds during a current project period to

provide for an increase in costs due to unforeseen circumstances. All additional

costs must be within the current scope of the peer reviewed and approved pro-

ject. Administrative supplements do not require peer review.

Advance payment

A payment that a Federal agency or pass through entity makes by any appro-

priate payment mechanism and payment method, before the recipient or sub-

recipient disburses the funds for program purposes.

Allocation

The process of assigning a cost, or a group of costs, to one or more cost object-

ive(s), in reasonable proportion to the benefit provided or other equitable rela-

tionship. The process may entail assigning a cost(s) directly to a final cost

objective or through one or more intermediate cost objectives. For additional

information, see

Cost Considerations—The Cost Principles

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Term

Definition

Allowable cost

A cost incurred by a recipient that is: (1) reasonable for the performance of the

award; (2) allocable; (3) in conformance with any limitations or exclusions set

forth in the Federal cost principles applicable to the organization incurring the

cost or in the NoA as to the type or amount of cost; (4) consistent with reg-

ulations, policies, and procedures of the recipient that are applied uniformly to

both federally supported and other activities of the organization; (5) accorded con-

sistent treatment as a direct or indirect cost; (6) determined in accordance with

generally accepted accounting principles; and (7) not included as a cost in any

other federally supported award (unless specifically authorized by statute).

For additional information on each, see

Cost Considerations—The Cost Prin-

ciples

Alteration and

renovation

Alteration and renovation (A&R) activities are considered as modernization activ-

ities and are typically supported under research grants where the primary pur-

pose for the grant is other than construction or modernization. The determination

of whether proposed A&R is major or minor is made by the NIH Program Official.

See definition for

Modernization

Applicable clinical trial

Applicable clinical trial is the term used in Title VIII of the Food and Drug Admin-

istration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope

of clinical trials that may be subject to the registration and results reporting

requirements in FDAAA.

Animal Welfare

Assurance

The Animal Welfare Assurance is part of the required documentation to receive

an award for organizations involved in live, vertebrate animal activity conducted

or supported by the Public Health Service (PHS). The Animal Welfare Assurance

enumerates the organization’s commitment to compliance with the PHS Policy

on Humane Care and Use of Laboratory Animals and other incorporated laws

and policies.

Applicable credit

Those receipts that offset or reduce direct or indirect costs. Typical examples of

such transactions include purchase discounts, rebates, or allowances; recov-

eries or indemnities on losses, insurance refunds; and adjustments of over-

payments or erroneous charges.

Application

A request for financial support of a project or activity submitted to NIH on spe-

cified forms and in accordance with NIH instructions. (See

Application Inform-

ation and Processes

for detailed information about the application process,

including an explanation of the types of applications).

Application type code

A single-digit code identifying the type of application received and processed.

Application type codes include the following: 1=New; 2=Renewal; 3=Revision;

4=Extension; 5=Non-Competing Continuation; 6=Change of Organization Status

(Successor-In-Interest); 7=Change of Recipient or Training Institution; 8=Change

of Institute or Division (Type 5 transfer to another NIH IC); 9=Change of Institute

or Division (Type 2 transfer to another NIH IC).

Appropriation Act

The statute that provides the authority for Federal agencies to incur obligations to

and make payments out of the U.S. treasury for specified purposes.

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Term

Definition

Assistance listing

number

A unique number assigned to identify an Assistance Listing.

Assistance listing

program title

The title that corresponds to the Assistance Listing Number.

Assurance

A certification by an applicant, normally included with the application or State

plan, indicating that the entity is in compliance with, or that it will abide by, a par-

ticular requirement if awarded a Federal grant.

Audit finding

Deficiencies which an auditor is required to report in the schedule of findings and

questioned costs. (See 2 CFR Part 200.516(a)).

Audit resolution

The process of resolving audit findings, including those related to management

and systems deficiencies and monetary findings (that is, questioned costs).

Authorized

organization

representative

The individual, named by the applicant organization, who is authorized to act for

the applicant and to assume the obligations imposed by the Federal laws, reg-

ulations, requirements, and conditions that apply to grant applications or grant

awards. This individual is equivalent to the signing official in the eRA Commons,

i.e., holds the SO Role.

Award

The provision of funds by NIH, based on an approved application and budget or

progress report, to an organizational entity or an individual to carry out a project

or activity.

Awarding IC

NIH IC responsible for the award, administration, and monitoring of grant sup-

ported activities.

Budget

The financial plan for the project or program that the Federal agency or pass-

through entity approves during the Federal award process or in subsequent

amendments to the Federal award. It may include the Federal and non-Federal

share or only the Federal share, as determined by the Federal agency or pass

through entity. The approved budget specified in the NoA may be shown in

detailed budget categories or as total costs without a categorical breakout.

Expenditures charged to an approved budget that consists of both Federal and

non-Federal shares are deemed to be borne by the recipient in the same pro-

portion as the percentage of Federal/non-Federal participation in the overall

budget.

Budget period

The time interval from the start date of a funded portion of an award to the end

date of that funded portion (usually 12 months) during which recipients and sub-

recipients are authorized to incur financial obligations of the funds awarded,

including any funds carried forward or other revisions. NIH award project periods

(periods of performance) are typically divided by budget periods for budgetary

and funding purposes. See

Project Period

. See

Period of Performance

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Term

Definition

Capital assets

Tangible or intangible assets used in operations having a useful life of more than

one year which are capitalized in accordance with GAAP. Capital assets include:

(1) Land, buildings (facilities), equipment, and intellectual property (including soft-

ware) whether acquired by purchase, construction, manufacture, lease-pur-

chase, exchange, or through capital leases; and (2) Additions, improvements,

modifications, replacements, rearrangements, reinstallations, renovations or

alterations to capital assets that materially increase their value or useful life (not

ordinary repairs and maintenance).

Capital expenditures

Expenditures to acquire capital assets or expenditures to make additions,

improvements, modifications, replacements, rearrangements, reinstallations,

renovations, or alterations to capital assets that materially increase their value or

useful life. (See

Administrative Requirements—Changes in Project and Budget—

Prior Approval Requirements—Capital Expenditures

Carryover

Unobligated Federal funds remaining at the end of any budget period that, with

the approval of the GMO or under an automatic authority, may be carried forward

to another budget period to cover allowable costs of that budget period (whether

as an offset or additional authorization). Obligated, but unliquidated, funds are

not considered carryover.

Change in scope

An activity whereby the objectives or specific aims identified in the approved

grant application are significantly changed by the recipient after award. GMO

prior approval is required for a change in scope to be allowable under an award.

See

Administrative Requirements—Changes in Project and Budget—Prior

Approval Requirements—Change of Scope

for additional information.

Change of PD/PI

A process, usually initiated by the recipient, whereby the federally approved

PD/PI is replaced by another individual, with the approval of the GMO.

Change of recipient

organization

Transfer of the legal and administrative responsibility for a grant-supported pro-

ject or activity from one legal entity to another before the completion date of the

approved project period (competitive segment).

Chief Grants

Management Officer

The Grants Management Officer within an awarding agency who is the principal

Grants Officer in the Institute or Center. The Chief Grants Management Officer

provides leadership to an organizational component that is responsible for the

business and fiscal management of an IC’s grant portfolio. Generally, the CGMO

will have the authority to appoint and exercise line authority over one or more

GMOs. At NIH each IC has a CGMO.

Claim

Depending on the context, either: (1) A written demand or assertion by one of the

parties to a Federal award seeking as a matter of right: (i) The payment of money;

(ii) The adjustment or interpretation of the terms and conditions of the Federal

award; or (iii) Other relief arising under or relating to a Federal award. (2) A

request for payment not in dispute when submitted.

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Term

Definition

Clinical research

Research with human subjects that is:

1) Patient-oriented research. Research conducted with human subjects (or on

material of human origin such as tissues, specimens, and cognitive phenomena)

for which an investigator (or colleague) directly interacts with human subjects.

Excluded from this definition are in vitro studies that utilize human tissues that

cannot be linked to a living individual. It includes: (a) mechanisms of human dis-

ease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new

technologies.

2) Epidemiological and behavioral studies.

3) Outcomes research and health services research

Studies falling under 45 CFR Part 46.101(b)(4) (the “Common Rule” prior to July

19, 2018 and 45 CFR Part 46.104(d)

4) (the “Revised Common Rule” effective July 19, 2018, Exemption 4) are not

considered clinical research by this definition.

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Term

Definition

Clinical trial

A research study in which one or more human subjects are prospectively

assigned to one or more interventions (which may include placebo or other con-

trol) to evaluate the effects of those interventions on health-related biomedical or

behavioral outcomes.

See 45 CFR Part 46, Subpart A, referred to as the “Revised Common

Rule" definition of research at 45 CFR Part 46.102(l). Pre-2018, see 45

CFR Part 46, Subpart A, referred to as the “Common Rule” definition of

research at 45 CFR Part 46.102(d)

See Revised Common Rule definition of human subject at 45 CFR Part

46.102(e)(1). See Common Rule definition of human subject at 45 CFR

Part 46.102(f)

The term “prospectively assigned” refers to a pre-defined process (e.g.,

randomization) specified in an approved protocol that stipulates the

assignment of research subjects (individually or in clusters) to one or

more arms (e.g., intervention, placebo or other control) of the clinical

trial.

intervention

is defined as a manipulation of the subject or subject’s

environment for the purpose of modifying one or more health-related pro-

cesses and/or endpoints. Examples include, but are not limited, to: drug-

s/small molecules/compounds, biologics, devices; procedures (e.g.,

surgical techniques); delivery systems (e.g., telemedicine, face-to-face);

strategies to change health-related behavior (e.g., diet, cognitive ther-

apy, exercise, development of new habits); and treatment, prevention,

and diagnostic strategies.

health-related biomedical or behavioral outcome

is defined as the pre-

specified effect of an intervention on the study subjects. Examples

include positive or negative changes to physiological or biological para-

meters (e.g., improvement of lung capacity, gene expression); psy-

chological or neurodevelopmental parameters (e.g., mood management

intervention for smokers; reading comprehension and/or information

retention); disease processes; health-related behavior; and well-being or

quality of life.

Biomedical clinical trials of an experimental drug, treatment, device, or behavioral

intervention may proceed through four phases:

Phase I. Tests a new biomedical intervention in a small group of people (e.g., 20-

80) for the first time to determine efficacy and evaluate safety (e.g., determine a

safe dosage range and identify side effects).

Phase II. Study the biomedical or behavioral intervention in a larger group of

people (several hundred) to determine efficacy and further evaluate safety.

Phase III. Study to determine efficacy of the biomedical or behavioral intervention

in large groups of people (from several hundred to several thousand) by com-

paring the intervention to other standard or experimental interventions as well as

to monitor adverse effects, and to collect information that will allow the inter-

ventions to be used safely.

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Term

Definition

Phase IV. Studies conducted after the intervention has been marketed. These

studies are designed to monitor the effectiveness of the approved intervention in

the general population and to collect information about any adverse effects asso-

ciated with widespread use.

Closeout

The process by which the Federal agency or pass-through entity determines that

all applicable administrative actions and all required work of the Federal award

have been completed and takes actions as described in 2 CFR Part 200.344.

Cluster of programs

A grouping of closely related programs that share common compliance require-

ments. The types of clusters of programs are research and development (R&D),

student financial aid (SFA), and other clusters. “Other clusters” are defined by

OMB in the compliance supplement or designated by a state for Federal awards

the state provides to its subrecipients that meet the definition of a cluster of pro-

grams. When designating “other clusters,” a state must identify the Federal

awards included in the cluster and advise the subrecipients of compliance

requirements applicable to the cluster, consistent with 2 CFR Part 200.332. A

cluster of programs must be considered one program when determining major

programs as described in 2 CFR Part 200.518 and with the exception of R&D as

described in 2 CFR Part 200.501(d), whether a program-specific audit may be

elected.

Code of Federal

Regulations

The codified regulations of the Federal government based on the final agency

regulations published in the Federal Register.

Cognizant agency for

audit

The Federal agency designated to carry out the responsibilities as described in 2

CFR Part 200.513. The cognizant agency for audit is not necessarily the same as

the cognizant agency for indirect costs. A list of Federal agency Single Audit con-

tacts may be found at the FAC web site.

Cognizant agency for

indirect costs

The Federal agency responsible for reviewing, negotiating, and approving cost

allocation plans or indirect cost proposals on behalf of all Federal agencies. The

cognizant agency for indirect cost is not necessarily the same as the cognizant

agency for audit. For assignments of cognizant agencies see the following: (1)

For IHEs: 2 CFR Part 200, Appendix III, C.11. (2) For nonprofit organizations: 2

CFR Part 200, Appendix IV, C.2. (3) For state and local governments: 2 CFR Pt

200, Appendix V, F.1. (4) For Indian Tribes: 2 CFR Pt 200, Appendix VII, D.1.

Co-Investigator

An individual involved with the PD/PI in the scientific development or execution of

a project. The Co-Investigator (collaborator) may be employed by, or be affiliated

with, the applicant/recipient organization or another organization participating in

the project under a consortium agreement. A Co-Investigator typically devotes a

specified percentage of time to the project and is considered

senior/key per-

sonnel

. The designation of a Co-Investigator, if applicable, does not affect the

PD/PI’s roles and responsibilities as specified in the NIHGPS, nor is it a role

implying multiple PD/PI.

Competitive revision

A request for (or the award of) additional funds during a current project period to

support new or additional activities which are not identified in the current award

that reflect an expansion of the scope of the grant-approved activities. Com-

petitive revisions require peer review.

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Term

Definition

Competitive segment

The initial project period recommended for support (up to 5 years) or each exten-

sion of a project period resulting from a renewal award.

Compliance

Supplement

Appendix XI to 2 CFR Part 200. See Section 93 for HHS Agency Program

Requirements.

Component

For the purposes of applications and progress reports, a component is a distinct,

reviewable part of a multi-project application or progress report for which there is

a business need to gather detailed information identified in the Notice of Funding

Opportunity (NOFO). Components typically include general information (com-

ponent organization, project period, project title, etc.), performance sites, per-

sonnel, and budget. The NOFO defines the construction and naming convention

for the application; the funded application defines the construction and naming

convention for the progress report. Components may also be referred to as

“cores” or “projects.” Note, for RPPR Question G.9, the term “foreign component”

is distinct from “component” as defined here. However, a “

foreign component

”

may also be a “component” in the RPPR. (See definition of

foreign component

for

more information).

Computing devices

Machines that acquire, store, analyze, process, and publish data and other

information electronically, including accessories (or ‘‘peripherals’’) for printing,

transmitting and receiving, or storing electronic information. See also “supplies”

and “information technology systems.”

Conference (domestic

or international)

A symposium, seminar, workshop, or any other organized and formal meeting,

whether conducted face-to-face or via the Internet, where individuals assemble

(or meet virtually) to exchange information and views or explore or clarify a

defined subject, problem, or area of knowledge, whether or not a published report

results from such meeting.

Conference grant

A grant whose purpose is to support activities related to the conduct of a con-

ference(s) or defined set of conference-related activities.

Conflict of interest

Conflict of Interest is a cross-cutting issue that affects many policy areas such as

peer review, financial conflict of interest, and responsible conduct of research.

There are different uses of this term throughout this document. It generally

means that a competing personal interest could affect, or could appear to affect,

an individual’s judgment or could cause the individual’s impartiality to be ques-

tioned. Conflicts of Interest (actual or potential) may arise in the objective review

process or in other activities or phases of the financial assistance process. See

also

Financial Conflict of Interest

for a specific definition covering that policy area.

Consortium

agreement

A formalized agreement whereby a research project is carried out by the recipient

and one or more other organizations that are separate legal entities. Under the

agreement, the recipient must perform a substantive role in the conduct of the

planned research and not merely serve as a conduit of funds to another party or

parties. These agreements typically involve a specific level of effort from the con-

sortium organization’s PD/PI and a categorical breakdown of costs, such as per-

sonnel, supplies, and other allowable expenses, including indirect costs. The

relationship between the recipient and the collaborating organizations is con-

sidered a subaward relationship. (See

Consortium Agreements

chapter in IIB).

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Term

Definition

Construction

Construction of a new building, structure or facility, including the installation of

fixed equipment, which provides space not presently available. It excludes the

purchase of land and ancillary improvements, for example, parking lots, roads or

fencing. The construction of shell space is not allowable as a construction activity

since shell space does not provide usable space for research activities.) See

Con-

struction

chapter in IIB.

Consultant

An individual who provides professional advice or services for a fee, but normally

not as an employee of the engaging party. In unusual situations, an individual

may be both a consultant and an employee of the same party, receiving com-

pensation for some services as a consultant and for other work as a salaried

employee. To prevent apparent or actual conflicts of interest, recipients and con-

sultants must establish written guidelines indicating the conditions of payment of

consulting fees. Consultants also include firms that provide professional advice

or services. (See

Cost Considerations—Allowability of Costs/Activities—Selec-

ted Items of Cost—Consultant Services

Contact PD/PI

When multiple PD/PIs are designated, NIH requires that the applicant organ-

ization identify one of the PD/PIs as the Contact PD/PI to serve as a primary point

of contact. Serving as Contact PD/PI confers no special authorities or respons-

ibilities within the project team. The Contact PD/PI must meet all eligibility require-

ments for PD/PI status. However, as with the single PD/PI model, if the Contact

PD/PI is not an employee, the applicant organization must have a formal written

agreement with the Contact PD/PI that specifies an official relationship between

the parties. See

Multiple PI

chapter in IIB for additional information.

Continuation funding

The second or subsequent budget period within an identified period of per-

formance. See

non-competing continuation application/award

Contract

A legal instrument by which a recipient or subrecipient conducts procurement

transactions under a Federal award. The term as used in 2 CFR Part 200 does

not include a legal instrument, even if the recipient or subrecipient considers it a

contract, when the substance of the transaction meets the definition of a Federal

award or subaward. See

Subaward

Contractor

An entity that receives a contract. See

contract.

Cooperative

agreement

See

grant or cooperative agreement

Cost allocation plan

Central service or public assistance cost allocation plan.

Cost objective

A program, function, activity, award, organizational subdivision, contract, or work

unit for which cost data are desired and for which provision is made to accu-

mulate and measure the cost of processes, products, jobs and capital projects. A

cost objective may be a major function of the recipient or subrecipient, a par-

ticular service or project, a Federal award, or an indirect cost activity, as

described in 2 CFR Part 200, Subpart E—Cost Principles.

Cost overrun

Any amount charged in excess of the Federal share of costs for the project period

(competitive segment).

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Term

Definition

Cost principles

The government-wide principles established under 2 CFR Part 200 for determ-

ining the allowable costs incurred by non-Federal entities under Federal awards.

The principles are for the purpose of cost determination and are not intended to

identify the circumstances or dictate the extent of Federal Government par-

ticipation in the financing of a particular program or project. The principles are

designed to provide that Federal awards bear their fair share of cost recognized

under these principles except where restricted or prohibited by statute. In the

case of hospitals, they follow the cost principles in 2 CFR Part 200, Appendix IX,

“Hospital Cost Principles.” In the case of for-profit organizations, there are no

cost principles specifically applicable; the cost principles for for-profit organ-

izations are set forth in the FAR (48 CFR Part 31.2). See

Cost Considerations—

The Cost Principles

for additional details.

Cost sharing

The portion of project costs not paid by Federal funds or contributions (unless

authorized by Federal statute). This term includes matching, which refers to

required levels of cost share that must be provided. See 2 CFR Part 200.306.

Cost sharing or

matching alternative

An alternative use of program income whereby income accrued during the period

of grant support may be used to satisfy a cost sharing or matching requirement.

(See also definitions for

additive alternative

and

deductive alternative

and

Admin-

istrative Requirements—Management Systems and Procedures—Program

Income

Cost-type contract

A contract or subcontract under a grant in which the contractor or subcontractor

is paid on the basis of the allowable costs it incurs, with or without a fee.

Data and safety

monitoring plan

For each NIH-supported clinical trial, NIH requires a data and safety monitoring

plan that will provide oversight and monitoring to ensure the safety of participants

and the validity and integrity of the data. The level of monitoring should be com-

mensurate with the risks and the size and complexity of the clinical trial. A

detailed data and safety monitoring plan must be submitted to the applicant’s IRB

and subsequently to the awarding IC for approval prior to the accrual of human

subjects.

Data Management

The process of validating, organizing, protecting, maintaining, and processing sci-

entific data to ensure the accessibility, reliability, and quality of the scientific data

for its users.

Data Management

and Sharing Plan

(DMS Plan)

A plan describing the data management, preservation, and sharing of scientific

data and accompanying metadata.

Data Sharing

The act of making scientific data available for use by others (e.g., the larger

research community, institutions, the broader public), for example, via an estab-

lished repository.

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Term

Definition

Debarment and

suspension

The actions taken by a debarring official in accordance with OMB guidance at 2

CFR Part 180, “Non-procurement Debarment and Suspension,” as implemented

by HHS in 2 CFR Part 376, to exclude a person or organization from participating

in grants and other non-procurement awards government-wide. If debarred or

suspended, the person or organization may not receive financial assistance

(under a grant, cooperative agreement, or subaward, or contract under a grant)

for a specified period of time. Debarments and suspensions carried out pursuant

to 2 CFR Part 376 are distinct from post-award suspension action by an awarding

agency. (See also

Public Policy Requirements and Objectives—Debarment and

Suspension

Debt collection

The process of collecting funds owed by recipients to the Federal government,

which, under grants, generally are owed as a result of formal cost disallowances.

Debt instrument

A document used to record a legal obligation of one party to pay a financial oblig-

ation to another in accordance with predetermined terms and conditions.

Deductive alternative

An alternative for the use of program income earned during the period of grant

support under which allowable costs of the project or program to be paid by the

Federal government are offset by the amount of the program income. (See also

definitions for

additive alternative

and

cost sharing or matching alternative

and

Administrative Requirements—Management Systems and Procedures—Pro-

gram Income

Departmental Grants

Appeals Board

The independent office established in the Office of the Secretary with delegated

authority from the Secretary to review and decide certain disputes between recip-

ients of HHS funds and HHS awarding agencies under 45 CFR Part 16 and to per-

form other review, adjudication and mediation services as assigned.

Deviation

A departure on a single-case or class basis from a regulatory or policy require-

ment. A single-case deviation represents a request for waiver or exception

sought for one grant only that arises on a case-by-case basis. A class deviation

involves more than one grant for which the same type of deviation action is being

requested.

Direct costs

Costs that can be identified specifically with a particular sponsored project, an

instructional activity, or any other institutional activity, or that can be directly

assigned to such activities relatively easily with a high degree of accuracy.

Disallowed costs

Charges to a Federal award that the Federal agency or pass-through entity

determines to be unallowable, in accordance with the applicable Federal stat-

utes, regulations, provisions of 2 CFR Part 200, or the terms and conditions of the

Federal award.

Discretionary Award

An award in which NIH, in keeping with its statutory authority to exercises judge-

ment (“discretion”), selects the recipient or the amount of funding through a com-

petitive process. Generally, NIH awards are discretionary. See

Non-

Discretionary Award

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1 Glossary

Term

Definition

Domestic

organization

A public (including a State or other governmental agency) or private non-profit or

for-profit organization that is located in the United States or its territories, is sub-

ject to U.S. laws, and assumes legal and financial accountability for awarded

funds and for the performance of the grant-supported activities.

Early Stage

Investigator

An individual who is classified as a New Investigator and is within 10 years of

completing their terminal research degree or is within 10 years of completing

medical residency (or the equivalent) is considered an Early Stage Investigator

(ESI). See definition of

New Investigator

Entity Identification

Number

A three-part coding scheme of 12 characters used in PMS to identify organ-

izations and individuals. The first character identifies the recipient as an organ-

ization or an individual. The next nine characters are the Employer Identification

Number. The last two characters are a suffix to provide distinction between organ-

izational entities that are assigned a single EIN and those that have more than

one. (Also known as Payment System Identifier.)

Equipment

Tangible personal property (including information technology systems) having a

useful life of more than one year and a per-unit acquisition cost that equals or

exceeds the lesser of the capitalization level established by the recipient or sub-

recipient for financial statement purposes, or $10,000. (See also

capital assets

computing devices

general purpose equipment

information technology

systems

special purpose equipment

, and

supplies

eRA Commons

The Electronic Research Administration (eRA) Commons is a virtual meeting

place where NIH extramural recipient organizations, recipients, and the public

can receive and transmit information about the administration of biomedical and

behavioral research. The eRA Commons is divided into both unrestricted and

restricted portions that provide for public and confidential information, respect-

ively.

Expanded authorities

A standard term of all NIH awards to allow recipients several flexibilities to waive

the requirement for prior approval for specified actions. NIH extended expanded

authorities to all NIH awards except for the provision to automatically carry over

unobligated balances for certain awards. (see

Administrative Requirements—

Changes in Project and Budget—NIH Standard Terms of Award

Expenditure report

Means: (1) For non-construction grants, the SF-425 Federal Financial Report

(FFR) (or other OMB-approved equivalent report); (2) for construction grants, the

SF-271 “Outlay Report and Request for Reimbursement” (or other OMB-

approved equivalent report)

I-19

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Expenditures

Charges made by a recipient or subrecipient to a project or program for which a

Federal award is received.

1. The charges may be reported on a cash or accrual basis, as long as the

methodology is disclosed and consistently applied.

2. For reports prepared on a cash basis, expenditures are the sum of:

i. Cash disbursements for direct charges for property and services;

ii. The amount of indirect expense charged;

iii. The value of third-party in-kind contributions applied; and

iv. The amount of cash advance payments and payments made to

subrecipients.

3. For reports prepared on an accrual basis, expenditures are the sum of:

i. Cash disbursements for direct charges for property and services;

ii. The amount of indirect expense incurred;

iii. The value of third-party in-kind contributions applied; and

iv. The net increase or decrease in the amounts owed by the recip-

ient and subrecipient for:

A. Goods and other property received;

B. Services performed by employees, contractors, sub-

recipients, and other payees; and

C. Programs for which no current services or performance are

required such as annuities, insurance claims, or other

benefit payments.

Facilities and

Administrative (F&A)

costs (or indirect

costs)

See definition of "

indirect costs

Federal agency

An ‘‘agency’’ as defined at 5 U.S.C. 551(1), which outlines what is not an agency,

and further clarified by 5 U.S.C. 552(f), which outlines what is an agency. The

term generally refers to the agency that provides a Federal award directly to a

recipient unless the context indicates otherwise. See also definitions of Federal

award and recipient.

Federal Audit

Clearinghouse (FAC)

The repository of record designated by OMB where non-Federal entities must

transmit the reporting packages required by Subpart F—Audit Requirements of 2

CFR Part 200 Subpart F – Audit Requirements. The mailing address of the FAC

is Federal Audit Clearinghouse, Bureau of the Census, 1201 E. 10th Street, Jef-

fersonville, IN 47132. Any future updates to the location of the FAC may be found

at the

Federal Audit Clearinghouse web site

I-20

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Federal award

Depending on the context, in either paragraph (1) or (2) of this section:

(1)(i) The Federal financial assistance that a recipient receives directly from a

Federal agency or indirectly from a pass-through entity, as described in 2 CFR

Part 200.101; or

(ii) The cost-reimbursement contract under the Federal Acquisition Regulation

that a non-Federal entity receives directly from a Federal agency or indirectly

from a pass-through entity, as described in 2 CFR Part 200.101.

(2) The instrument setting forth the terms and conditions. The instrument is the

grant agreement, cooperative agreement, other agreement for assistance

covered in paragraph (2) of

Federal financial assistance

, or the cost-reim-

bursement contract awarded under the Federal Acquisition Regulations.

(3) Federal award does not include other contracts that a Federal agency uses to

buy goods or services from a contractor or a contract to operate government-

owned, contractor-operated (GOCOs) facilities.

(4) See also definitions of

Federal financial assistance

grant agreement

, and

cooperative agreement

Federal award date

The date when the authorized official of the Federal agency signed (physically or

digitally) the Federal award or when an alternative, consistent with the require-

ments of 31 U.S.C. 1501, is reached with the recipient. The Federal award date is

distinct from the budget start date.

Federal Award

Identification Number

A unique number assigned to a financial assistance award to assist recipients in

correctly reporting subawards. The public can use the FAIN and the Assistance

listing number together to find one accurate result when searching online in such

databases as USASpending.gov. The FAIN can be found on the notice of award.

NIH implements the FAIN by deriving it from the core elements of the grant num-

ber. For example, the FAIN for 1R0lHL654321-01 would be R01HL654321.

Federal awarding

agency

The Federal agency that provides a Federal award directly to another entity. See

also

Awarding IC

Federal

Demonstration

Partnership

A cooperative initiative among some Federal agencies, including NIH, selected

organizations receiving Federal funding for research, and certain professional

associations. Its efforts include demonstration projects intended to simplify and

standardize Federal requirements in order to increase research productivity and

reduce administrative costs.

I-21

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Federal financial

assistance

1. Federal financial assistance means assistance that non-Federal entities

receive or administer in the form of:

i. Grants;

ii. Cooperative agreements;

iii. Non-cash contributions or donations of property (including

donated surplus property);

iv. Direct appropriations;

v. Food commodities; and

vi. Other financial assistance (except assistance listed in paragraph

(b) of this section).

2. For 2 CFR Part 200.202 and 2 CFR Part 200 Subpart F, federal financial

assistance also includes assistance that non-Federal entities receive or

administer in the form of:

i. Loans;

ii. Loan Guarantees;

iii. Interest subsidies; and

iv. Insurance.

3. Federal financial assistance does not include amounts received as reim-

bursement for services rendered to individuals as described in 2 CFR

Part 200.502(h) and (i).

Federal institution

A Cabinet-level department or independent agency of the executive branch of the

Federal government or any component organization of such a department or

agency. For the purposes of this document, this term is used in the context of a

Federal institution as a recipient. See also

Awarding IC

Federal interest

For purposes 2 CFR Part 200.330 or when used in connection with the acquis-

ition or improvement of real property, equipment, or supplies under a Federal

award, the dollar amount that is the product of the: (1) Federal share of total pro-

ject costs; and (2) Current fair market value of the property, improvements, or

both, to the extent the costs of acquiring or improving the property were included

as project costs.

Federal program

1. All Federal awards which are assigned a single number in the Assistance

listings.

2. When no Assistance listing number is assigned, all Federal awards to

non- Federal entities from the same agency made for the same purpose

should be combined and considered one program.

3. Notwithstanding paragraphs (1) and (2) of this definition, a cluster of pro-

grams. The types of clusters of programs are:

i. Research and development (R&D);

ii. Student financial aid (SFA); and

iii. ‘‘Other clusters,’’ as described in the definition of Cluster of Pro-

grams.

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Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Federal share

The portion of the total project costs that are paid by Federal funds.

Federalwide

Assurance

The Federalwide Assurance is the only type of assurance of compliance accep-

ted and approved by OHRP for institutions

engaged

in nonexempt research

involving human subjects conducted or supported by HHS. Under a FWA, an

institution commits to HHS that it will comply with the requirements set forth in

CFR Part 46

, as well as the

terms of assurance

Fee

An amount, in addition to actual, allowable costs, paid to an organization provid-

ing goods or services consistent with normal commercial practice. This payment

also is referred to as profit. (See

Grants to For-Profit Organizations—Small Busi-

ness Innovation Research and Small Business Technology Transfer Programs—

Allowable Costs and Fee—Profit or Fee

Financial conflict of

interest

A financial conflict of interest exists when the recipient’s designated official(s)

reasonably determines that an investigator’s significant financial interest could

directly and significantly affect the design, conduct, or reporting of the PHS-fun-

ded research. See

42 CFR Part 50, Subpart F, Responsibility of Applicants for

Promoting Objectivity in Research

for which PHS funding is sought and

Public

Policy Requirements and Objectives—Financial Conflict of Interest

Fixed Award Amount

A type of grant or cooperative agreement pursuant to which NIH or a pass-

through entity provides a specific amount of funding without regard to actual

costs incurred under the Federal award.

Foreign component

The performance of any significant scientific element or segment of a project out-

side of the United States, either by the recipient or by a researcher employed by a

foreign organization, whether or not grant funds are expended. Activities that

would meet this definition include, but are not limited to, (1) the involvement of

human subjects or animals at a foreign site, (2) extensive foreign travel by recip-

ient project staff for the purpose of data collection, surveying, sampling, and sim-

ilar activities, or (3) any activity of the recipient that may have an impact on U.S.

foreign policy through involvement in the affairs or environment of a foreign coun-

try. Examples of other grant-related activities that may be significant are:

collaborations with investigators at a foreign site anticipated to result in

co-authorship;

use of facilities or instrumentation at a foreign site; or

receipt of financial support or resources from a foreign entity.

Foreign travel for consultation is not considered a foreign component. (See

Grants to Foreign Organizations, International Organizations, and Domestic

Grants with Foreign Components

chapter in IIB).

I-23

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Foreign organization

An entity that is:

1. A public or private organization located in a country other than the United

States and its territories that is subject to the laws of the country in which

it is located, irrespective of the citizenship of project staff or place of per-

formance;

2. A private nongovernmental organization located in a country other than

the United States that solicits and receives cash contributions from the

general public;

3. A charitable organization located in a country other than the United

States that is nonprofit and tax-exempt under the laws of the country

where it is registered and is not a university, college, accredited degree

granting institution of education, private foundation, hospital, an organ-

ization engaged exclusively in research or scientific activities, church,

synagogue, mosque or other similar entities organized primarily for reli-

gious purposes; or

4. An organization located in a country other than the United States not

recognized as a

Foreign Public Entity

Foreign public entity

(1) A foreign government or foreign governmental entity; (2) A public international

organization, which is an organization entitled to enjoy privileges, exemptions,

and immunities as an international organization under the International Organ-

izations Immunities Act (22 U.S.C. 288–288f); (3) An entity owned (in whole or in

part) or controlled by a foreign government; or (4) Any other entity consisting

wholly or partially of one or more foreign governments or foreign governmental

entities.

For-profit organization

An organization or entity organized for the purpose of earning a profit, including

but not limited to, an “S” corporation incorporated under subchapter S of the

Internal Revenue Code, a corporation incorporated under another authority, a

partnership, a limited liability company or partnership, and a sole proprietorship. .

A for-profit organization is considered to be a small business if it is independently

owned and operated, if it is not dominant in the field in which research is pro-

posed, and if it employs no more than 500 persons. (Also see definition for

small

business concern

Full-time appointment

The number of days per week and/or months per year representing full-time effort

at the applicant/recipient organization, as specified in organizational policy. The

organization’s policy must be applied consistently regardless of the source of sup-

port.

General purpose

equipment

Equipment that is not limited to research, medical, scientific, or other technical

activities. Examples include office equipment and furnishings, modular offices,

telephone networks, information technology equipment and systems, air con-

ditioning equipment, reproduction and printing equipment, and motor vehicles.

See also the definition of

Early Stage Investigator

No-cost extension

An extension of time to a project period and/or budget period to complete the

work of the grant under that period, without additional Federal funds or com-

petition. See

NIH Standard Terms of Award

and

Prior Approval Requirements

Non-competing

continuation

application/award

A financial assistance request (in the form of an application or progress report) or

resulting award for a subsequent budget period within a previously approved pro-

ject period for which a recipient does not have to compete with other applicants.

Non-Discretionary

Award

An award made by NIH to specific recipients in accordance with statutory, eli-

gibility and compliance requirements, in which NIH cannot exercise judgment.

The award amount could be specifically determined or by formula. NIH does not

typically make non-discretionary awards. See "Discretionary Award" on page I-

18.

Non-Federal entity

A state, local government, Indian tribe, institution of higher education (IHE), or

nonprofit organization that carries out a Federal award as a recipient or sub-

recipient.

Non-Federal share

When cost sharing or matching is required as a condition of an award, the portion

of allowable project/program costs not borne by the Federal government.

Non-profit

organization

Any organization that: (1) Is operated primarily for scientific, educational, service,

charitable, or similar purposes in the public interest; (2) Is not organized primarily

for profit; (3) Uses net proceeds to maintain, improve, or expand the organ-

ization's operations, and (4) is not an IHE.

I-36

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Notice of Award

The official, legally binding document, signed (or the electronic equivalent of sig-

nature) by a Grants Management Officer that outlines the budgetary information

as well as standard and specific award conditions. Generally, the NoA:

1. notifies the recipient of the award of a grant / cooperative agreement;

2. contains or references all the terms and conditions of the grant including

any specific conditions, and Federal funding limits and obligations; and,

3. documents the basis for recording the obligation of Federal funds in the

NIH accounting system.

Notice of Funding

Opportunity (NOFO)

A publicly available document by which a Federal Agency makes known its inten-

tions to award discretionary grants or cooperative agreements, usually as a result

of competition for funds. NIH Notices of Funding Opportunities may also be

known as program announcements, requests for applications, notices of funding

availability, solicitations, or other names as described in 2 CFR 200.204,) depend-

ing on the Agency and type of program. Notices of Funding Opportunities can be

found at

Grants.gov

Obligations

When used in connection with a non- Federal entity’s utilization of funds under a

Federal award, obligations means orders placed for property and services, con-

tracts and subawards made, and similar transactions during a given period that

require payment by the non- Federal entity during the same or a future period.

Office of Management

and Budget (OMB)

The Executive Office of the President, Office of Management and Budget.

Offset

IC or awarding agency approval/authorization of the use of unobligated grant

funds remaining from a prior budget period to support grant activities of the cur-

rent budget period. An offset does not change the current budget period author-

ized amount of funding but does reduce the amount of current fiscal year funds

provided to support the authorized award amount.

Open Researcher and

Contributor Identifiers

(ORCID iDs)

Unique, persistent digital identifiers that distinguish individual investigators and

can be used to connect researchers with their contributions to science over time

and across changes of name, location, and institutional affiliation. These free

identifiers are assigned and maintained by the non-profit organization ORCID.

Organization

A generic term used to refer to an

Institution of Higher Education

or other entity,

including an individual, which applies for or receives an NIH grant or cooperative

agreement.

Other Significant

Contributors

Individuals who have committed to contribute to the scientific development or exe-

cution of the project, but are not committing any specified measurable effort (i.e.,

person months) to the project. These individuals are typically presented at "effort

of zero person months” or "as needed." Individuals with measurable effort may

not be listed as Other Significant Contributors (OSCs). Consultants should be

included if they meet this definition.

I-37

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Other support

Includes all resources made available to researcher or senior key personnel in

support of and/or related to all of their research endeavors, regardless of

whether or not they have monetary value and regardless of whether they are

based at the institution the researcher identifies for the current grant. Other sup-

port does not include training awards, prizes, start-up support from the US

based institution, or gifts.

Note:

Gifts are resources provided where there is no expectation of anything

(e.g., time, services, specific research activities, money, etc.) in return.

Monetary donations given to institutions or directly to senior/key per-

sonnel that support research activities related to an individual are given

with an expectation and therefore, such donations must be reported as

other support

Oversight agency for

audit

The Federal agency that provides the predominant amount of funding directly (dir-

ect funding) (as listed on the schedule of expenditures of Federal awards, see 2

CFR Part 200.510(b)) to a recipient or subrecipient unless OMB designates a

specific cognizant agency for audit. When the direct funding represents less than

25 per-cent of the total Federal expenditures (as direct and subawards) by the

recipient or subrecipient, then the Federal agency that is the predominant

amount of total funding (direct and subawards) is the designated cognizant

agency. When there is no direct funding, the Federal agency which is the pre-

dominant source of pass-through funding must assume the oversight respons-

ibilities. The duties of the oversight agency for audit and the process for any

reassignments are described in 2 CFR Part 200.513(b).

Parent announcement

Broad NOFO enabling applicants to electronically submit an

investigator-initiated

grant application for a specific activity code, e.g.,

Research Project Grant (Parent

R01)

Participant support

costs

Direct costs that support participants and their involvement in a Federal award

such as stipends, subsistence allowances, travel allowances, registration fees,

temporary dependent care, and per diem paid directly to or on behalf of par-

ticipants. For the purposes of Kirschstein-NRSA programs and Education Grants

(e.g., R25), this term does not apply. NIH will continue to use the terms trainees,

trainee-related expenses, and trainee travel for those programs.

Pass-through entity

A non- Federal entity that provides a subaward to a subrecipient (including lower

tier subrecipients) to carry out part of a Federal program (see

2 CFR 200.1

). The

authority of the pass-through entity under this part flows through the subaward

agreement between the pass-through entity and subrecipient.

I-38

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Payback

Requirement that the recipient of a NRSA postdoctoral fellowship engage in qual-

ified health-related research, health-related research training, or health-related

teaching activities for a length of time equal to the period of NRSA support

received. Only the first year of training incurs a payback obligation. In general,

payback activity must involve at least 20 hours per week and be conducted over

12 consecutive months; special exceptions may be considered on a case-by-

case basis. See

Ruth L. Kirschstein National Research Service Awards—Pay-

back

for additional information.

Payment

Management System

The HHS centralized grants payment system operated by the Payment Man-

agement Service, Program Support Center. Most HHS (and some other Federal

government agencies') recipients receive grant payments through this system.

Peer review

The two-stage process that involves the consistent application of standards and

procedures that produce fair, equitable, timely, and objective examinations of

applications based on an evaluation of scientific or technical merit or other rel-

evant aspects of the application. The review is performed by experts (Peer

Reviewers) in the field of endeavor for which support is requested. Peer review is

intended to provide guidance and recommendations to the NIH individuals

responsible for making award decisions.

Period of performance

The time interval between the start and end date of a Federal award, which may

include one or more budget periods. Identification of the period of performance

(project period) in the Federal award does not commit the Federal agency to fund

the award beyond the currently approved budget period. The period of per-

formance for NIH awards is noted on the Notice of Award. See "Project period"

on page I-41 as well as "Budget period" on page I-10.

Person months

The metric for expressing the effort (amount of time) PD/PI(s), faculty and other

senior/key personnel devote to a specific project. The effort is based on the type

of appointment of the individual with the organization; e.g., calendar year, aca-

demic year, and/or summer term; and the organization's definition of such. For

instance, some institutions define the academic year as a 9-month appointment

while others define it as a 10-month appointment.

Personal property

Property of any kind except real property. It may be tangible, or intangible, such

as copyrights, patents, or securities.

Personally Identifiable

Information (PII)

Information that can be used to distinguish or trace an individual’s identity, either

alone or when combined with other personal or identifying information that is

linked or linkable to a specific individual. Some PII is available in public sources

such as telephone books, web sites, and university listings. The definition of PII is

not attached to any single category of information or technology. Instead, it

requires a case-by-case assessment of the specific risk that an individual can be

identified. Non-PII can become PII whenever additional information is made pub-

licly available, in any medium and from any source, that could be used to identify

an individual when combined with other available information.

I-39

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Phase III clinical trial

As defined by NIH, a broadly based prospective Phase III clinical investigation

(usually involving several hundred or more human subjects) to evaluate an exper-

imental intervention in comparison with a standard or control intervention or to

compare two or more existing treatments. The definition includes pharmacologic,

non-pharmacologic, and behavioral interventions given for disease prevention,

prophylaxis, diagnosis, or therapy. Community trials and other population-based

intervention trials also are included. (See

clinical trial

definition).

Pre-award costs

Any cost incurred prior to the beginning date of the project period or the initial

budget period of a competitive segment (under a multi-year award), in anti-

cipation of the award and at the applicant’s own risk, for otherwise allowable

costs.

Prior approval

Written approval obtained in advance by an authorized official of a Federal

agency or pass-through entity of certain costs or programmatic decisions (see

Administrative Requirements—Changes in Project and Budget—Prior Approval

Requirements

Profit

See definition for

fee

Program

A coherent assembly of plans, project activities, and supporting resources con-

tained within an administrative framework, the purpose of which is to implement

an organization’s mission or some specific program-related aspect of that mis-

sion. For the NIHGPS, “program” refers to those NIH programs that carry out

their missions through the award of grants or cooperative agreements to other

organizations.

Program

Director/Principal

Investigator

The individual(s) designated by the applicant organization/recipient to have the

appropriate level of authority and responsibility to direct the project or program to

be supported by the award. The applicant organization may designate multiple

individuals as program directors/principal investigators (PD/PIs) who share the

authority and responsibility for leading and directing the project, intellectually and

logistically. When multiple PD/PIs are named, each is responsible and account-

able to the official(s) at the applicant organization/recipient, or as appropriate, to

a collaborating organization for the proper conduct of the project, program, or

activity including the submission of all required reports. The presence of more

than one PD/PI on an application or award diminishes neither the responsibility

nor the accountability of any individual PD/PI.

I-40

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Program income

Gross income earned by the recipient or subrecipient that is directly generated by

a supported activity or earned as a result of the Federal award during the period

of performance except as provided in 2 CFR Part 200.307(f). (See

Period of per-

formance

.) Program income includes but is not limited to income from fees for ser-

vices performed, the use or rental or real or personal property acquired under

Federal awards, the sale of commodities or items fabricated under a Federal

award, license fees and royalties on patents and copyrights, and principal and

interest on loans made with Federal award funds. Interest earned on advances of

Federal funds is not program income. Except as otherwise provided in Federal

statutes, regulations, or the terms and conditions of the Federal award, program

income does not include rebates, credits, discounts, and interest earned on any

of them. See 2 CFR Part 200.307, 45 CFR Part 200.307, 2 CFR Part 200.407

and 35 USC §§ 200-212 for inventions made under Federal awards. (See

Admin-

istrative Requirements—Management Systems and Procedures—Program

Income

Program

Official/Program

Officer/Project Officer

The NIH official responsible for the programmatic, scientific, and/or technical

aspects of a grant or cooperative agreement.

Progress report

Periodic, usually annual, report submitted by the recipient and used by NIH to

assess progress and, except for the final progress report of a project period, to

determine whether to provide funding for the budget period subsequent to that

covered by the report. This report may also be called the non-competing con-

tinuation progress report.

Project period

The total time for which Federal support of a project has been programmatically

approved as shown in the NoA; however, it does not constitute a commitment by

the Federal government to fund the entire period. The total project period com-

prises the initial competitive segment, any subsequent competitive segments res-

ulting from a renewal award(s), and extensions. See "Period of performance" on

page I-39. Also see "Budget period" on page I-10.

Project/performance

site

Location(s) of where the work described in the research plan will be conducted.

Property

Real property or personal property.

Protected Personally

Identifiable

Information

(Protected PII)

PII (see Personally Identifiable Information (PII)), except for PII that must be dis-

closed by law. Examples of PII include, but are not limited to, social security num-

ber; passport number; credit card numbers; clearances; bank numbers;

biometrics; date and place of birth; mother’s maiden name; criminal; medical and

financial records; and educational transcripts.

I-41

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Questioned cost

Has the meaning given in paragraphs (1) through (3):

1. 1.

Questioned cost

means an amount, expended or received from a

Federal award, that in the auditor’s judgment:

i. Is noncompliant or suspected noncompliant with Federal stat-

utes, regulations, or the terms and conditions of the Federal

award;

ii. At the time of the audit, lacked adequate documentation to

support compliance; or

iii. Appeared unreasonable and did not reflect the actions a

prudent person would take in the circumstances.

2. The questioned cost amount under (1)(ii) is calculated as if the portion of

a transaction that lacked adequate documentation were confirmed non-

compliant.

3. There is no questioned cost solely because of:

i. Deficiencies in internal control; or

ii. Noncompliance with the reporting type of compliance require-

ment (described in the compliance supplement) if this non-

compliance does not affect the amount expended or received

from the Federal award

Known questioned cost

means a questioned cost specifically identified

by the auditor. Known questioned costs are a subset of likely ques-

tioned costs. Where the costs incurred appear unreasonable and do not

reflect the actions a prudent person would take in the circumstances.

Likely questioned cost

means the auditor’s best estimate of total ques-

tioned costs, not just the known questioned costs. Likely questioned

costs are developed by extrapolating from audit evidence obtained, for

example, by projecting known questioned costs identified in an audit

sample to the entire population from which the sample was drawn. In

evaluating the effect of questioned costs on the opinion on compliance,

the auditor considers the likely questioned costs.

6. Questioned costs are not improper payments until reviewed and con-

firmed to be improper payments as defined in OMB Circular A–123

Appendix C.

Real property

Land, including land improvements, structures and appurtenances thereto, and

legal interests in land, including fee interest, licenses, rights of way, and ease-

ments. Real property excludes moveable machinery and equipment.

Recipient

An entity that receives a Federal award directly from a Federal agency to carry

out an activity under a Federal program. The term recipient does not include sub-

recipients, consortiums or individuals that are participants or beneficiaries of the

award. See

Non-Federal entity

I-42

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Renewal application

An application requesting additional funding for a period subsequent to that

provided by a current award. Renewal applications compete for funds with all

other peer reviewed applications, and must be developed as fully as though the

applicant is applying for the first time. The previous NIH term was “competing con-

tinuation.”

Renewal award

A Federal award for which the start date is contiguous with, or closely follows, the

end of the expiring Federal award. The start date of a renewal award begins a

new and distinct period of performance.

Research &

Development (R&D)

All basic and applied research activities, and all development activities performed

by HHS award recipients. The term research also includes activities involving the

training of individuals in research techniques where such activities use the same

facilities as other research and development activities and where such activities

are not included in the instruction function. ‘‘Research’’ is the systematic study dir-

ected toward fuller scientific knowledge or understanding of the subject studied.

‘‘Development’’ is the systematic use of knowledge and understanding gained

from research to produce useful materials, devices, systems, or methods, includ-

ing designing and developing prototypes and processes.

Research

Administrator

The Research Administrator acts as a local agent of the AOR and/or PD/PIs

providing day-to-day grant-related support. See also Roles and Respons-

ibilities—Recipient Staff.

Research misconduct

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing

research, or in reporting research results.

1. Fabrication is making up data or results and recording or reporting them.

2. Falsification is manipulating research materials, equipment, or pro-

cesses, or changing or omitting data or results such that research is not

accurately represented in the research record.

3. Plagiarism is the appropriation of another person’s ideas, processes, res-

ults, or words without giving appropriate credit.

4. Research misconduct does not include honest error or honest dif-

ferences of opinion.

Research patient care

costs

Costs of routine and ancillary services provided by hospitals to participants in

research protocols.

Responsible party

Responsible party is the term used in Title VIII of the Food and Drug Admin-

istration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to refer to the entity or

individual who is responsible under FDAAA for registering a clinical trial and sub-

mitting clinical trial information to

ClinicalTrials.gov

I-43

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Resubmission

application

An application that has been previously submitted, but was not funded, and is

being resubmitted for new consideration. Applicants must make significant

changes to the application and can only resubmit once the summary statement is

available from review of the first submission. Applicants must apply and undergo

peer review. Additional policies on resubmissions can be found in the applicable

Application Instruction Guide. The previous NIH term was "revision." A resub-

mission has a suffix in its application identification number, e.g., A1.

Revision application

As defined in the Federalwide SF424 (R&R): An application that proposes a

change in 1) the Federal Government’s financial obligations or contingent liability

from an existing obligation, or 2) any other change in the terms and conditions of

the existing award. Note in general for NIH applicants, #2 would not require the

submission of another application. NIH recipients use revision applications to

request an increase in support in a current budget period for expansion of the pro-

ject’s approved scope or research protocol. Applicants must apply and undergo

peer review. The previous NIH term was "competing supplemental." NOTE: The

former NIH term "revision," is now “resubmission”. A revision has a suffix in its

application identification number; e.g., S1.

Scientific Data

The recorded factual material commonly accepted in the scientific community as

of sufficient quality to validate and replicate research findings, regardless of

whether the data are used to support scholarly publications. Scientific data do not

include laboratory notebooks, preliminary analyses, completed case report

forms, drafts of scientific papers, plans for future research, peer reviews, com-

munications with colleagues, or physical objects, such as laboratory specimens.

Scientific Review

Group (SRG)

A peer review committee group of primarily non-government experts (peer

reviewers), qualified by training or experience in particular scientific or technical

fields, or as authorities knowledgeable in the various disciplines and fields related

to the applications under review, to evaluate and give expert advice on the sci-

entific and technical merit of the applications. No more than one-fourth of the

members of any SRG may be Federal employees, as noted in 42 CFR Part 52(h).

Scientific Review

Officer (SRO)

The NIH official who serves as the designated Federal officer having legal

responsibility for managing the peer review meeting, the procedures for eval-

uating the applications assigned to the SRG and the determinations and man-

agement of conflicts of interest, as noted in 42 CFR Part 52(h).

Scope of work

The aims, objectives, and purposes of a grant; as well as the methodology,

approach, analyses or other activities; and the tools, technologies, and time-

frames needed to meet the grant’s objectives. This includes the research or train-

ing plan included with the original grant application, along with any approved

modifications.

I-44

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Senior/Key Personnel

The PD/PI and other individuals who contribute to the scientific development or

execution of a project in a substantive, measurable way, whether or not they

receive salaries or compensation under the grant. Typically, these individuals

have doctoral or other professional degrees, although individuals at the masters

or baccalaureate level may be considered senior/key personnel if their involve-

ment meets this definition. Consultants and those with a postdoctoral role also

may be considered senior/key personnel if they meet this definition. Senior/key

personnel must devote measurable effort to the project whether or not salaries or

compensation are requested. "Zero percent" effort or "as needed" are not accept-

able levels of involvement for those designated as Senior/Key Personnel.

Significant

rebudgeting

A threshold that is reached when expenditures in a single direct cost budget cat-

egory deviate (increase or decrease) from the categorical commitment level

established for the budget period by more than 25 percent of the total costs awar-

ded. Significant rebudgeting is one indicator of change in scope.

Simplified acquisition

threshold

The dollar amount below which a recipient or subrecipient may purchase prop-

erty or services using small purchase methods. Recipients and subrecipients

adopt small purchase procedures in order to expedite the purchase of items cost-

ing less than the simplified acquisition threshold. The simplified acquisition

threshold is set by the Federal Acquisition Regulation at 48 CFR Subpart 2.1.

(See also

Micro-purchase

Small business

concern

A business that is independently owned and operated and not dominant in its

field of operation; has its principal place of business in the United States and is

organized for profit; is at least 51 percent owned, or in the case of a publicly

owned business, at least 51 percent of its voting stock is owned by U.S. citizens

or lawfully admitted permanent resident aliens; has, including its affiliates, not

more than 500 employees; and meets other regulatory requirements established

by the SBA at 13 CFR Part 121.

Special purpose

equipment

Equipment that is used only for research, medical, scientific, or other similar tech-

nical activities. Examples of special purpose equipment include microscopes, x-

ray machines, surgical instruments, spectrometers and associated software. See

also

Equipment

and

General purpose equipment

State

Any state of the United States, the District of Columbia, the Commonwealth of

Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Com-

monwealth of the Northern Mariana Islands, and any agency or instrumentality

thereof exclusive of local governments.

State government

The government of any State of the United States, the District of Columbia, the

Commonwealth of Puerto Rico, any U.S. territory or possession, or any agency

or instrumentality of a State exclusive of local governments. For purposes of NIH

grants, federally recognized Indian tribal governments generally are considered

State governments. State institutions of higher education and State hospitals are

not considered State governments for HHS’s general administrative require-

ments for grants and the NIHGPS.

I-45

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Stipend

A payment made to an individual under a fellowship or training grant in accord-

ance with pre-established levels to provide for the individual’s living expenses

during the period of training. A stipend is not considered compensation for the ser-

vices expected of an employee.

Subaward

An award provided by a pass-through entity to a subrecipient for the subrecipient

to contribute to the goals and objectives of the project by carrying out part of a

Federal award received by the pass-through entity. It does not include payments

to a contractor, beneficiary or participant. A subaward may be provided through

any form of legal agreement consistent with criteria in 2 CFR Part 200.331, includ-

ing an agreement the pass-through entity considers a contract. The term includes

consortium agreements. The recipient must enter into a formal written agree-

ment, signed and agreed to by both parties, with each consortium par-

ticipant/subrecipient (see

Chapter 15

Subrecipient

A non-Federal entity that receives a subaward from a pass-through entity to carry

out part of a Federal award. The term subrecipient does not include a beneficiary

or participant. A subrecipient may also be a recipient of other Federal awards dir-

ectly from a Federal agency. The term includes consortium participants.

Subsidiary

An entity in which more than 50 percent of the entity is owned or controlled dir-

ectly by a parent corporation or through another subsidiary of a parent cor-

poration.

Successor-in-interest

Process whereby the rights to and obligations under an NIH grant(s) are acquired

incidental to the transfer of all of the assets of the recipient or the transfer of that

part of the assets involved in the performance of the grant(s). A SII may result

from legislative or other legal action, such as a merger or other corporate change.

Supply

All tangible personal property other than those described in Equipment. A com-

puting device is a supply if the acquisition cost is below the lesser of the cap-

italization level established by the recipient or subrecipient for financial statement

purposes or $10,000, regardless of the length of its useful life. See

Computing

devices

and

Equipment

Suspension of award

activities

An action by the NIH awarding IC requiring the recipient to cease all activities on

the award pending corrective action by the recipient. It is a separate action from

suspension under HHS regulations (2 CFR Part 376) implementing Executive

Orders 12549 and 12689. (See

Public Policy Requirements and Objectives—

Debarment and Suspension

and

Administrative Requirements—Enforcement

Actions

Termination

The action a Federal agency or pass-through entity takes to discontinue a

Federal award, in whole or in part, at any time before the planned end date of the

period of performance. Termination does not include discontinuing a Federal

award due to a lack of available funds.

I-46

Part I: NIH Grants - General Information

1 Glossary

Term

Definition

Terms and conditions

of award

All legal requirements imposed on a grant by NIH, whether based on statute, reg-

ulation, policy, or other document referenced in the grant award, or specified by

the grant award document itself. The NoA may include both standard and specific

award conditions that are considered necessary to attain the grant’s objectives,

facilitate post-award administration of the grant, conserve grant funds, or oth-

erwise protect the Federal government’s interests.

Third-party in-kind

contributions

The value of non-cash contributions (meaning, property or services) that: (1)

Benefit a project or program funded by a Federal award; and (2) Are contributed

by non-Federal third parties, without charge, to a non- Federal entity under a

Federal award.

Total costs

The total allowable costs (both direct costs and indirect costs) incurred by the

recipient to carry out a grant-supported project or activity. Total project costs

include costs charged to the NIH grant and costs borne by the recipient to satisfy

a matching or cost-sharing requirement.

Uniform

Administrative

Requirements

(“Uniform Guidance”)

The administrative requirements, cost principles and audit requirements for

Federal awards to non-Federal entities as set forth in Part 200 of CFR Title 2

(Federal Financial Assistance), also referred to as “Uniform Guidance”.

Unique Entity

Identifier (UEI)

The identifier assigned by the System for Award Management (SAM) to uniquely

identify business entities.

United States

The 50 States, territories, and possessions of the United States, the Com-

monwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the Dis-

trict of Columbia.

Unliquidated

obligations

Financial obligations incurred by the recipient or subrecipient but not paid (liquid-

ated) for financial reports prepared on a cash basis. For reports prepared on an

accrual basis, these are obligations incurred by the recipient or subrecipient but

for which expenditures have not been recorded.

Unobligated balance

The amount of funds authorized under a Federal award that the recipient or sub-

recipient has not obligated. The amount is computed by subtracting the cumu-

lative amount of the recipient's or subrecipient's unliquidated obligations and

expenditures under the Federal award from the cumulative amount of funds the

Federal agency or pass-through entity authorized the recipient or subrecipient to

obligate.

U.S. Person

As defined under 28 CFR § 202.256, any United States citizen, national, or lawful

permanent resident; any individual admitted to the United States as a refugee

under 8 U.S.C. 1157 or granted asylum under 8 U.S.C. 1158; any entity organ-

ized solely under the laws of the United States or any jurisdiction within the

United States (including foreign branches); or any person in the United States.

Withholding of

support

A decision by NIH not to make a non-competing continuation award within the cur-

rent competitive segment.

I-47

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

2 THE NATIONAL INSTITUTES OF HEALTH AS A

GRANT-MAKING ORGANIZATION

NIH is the steward of medical and behavioral research for the Nation. Its

mission

is to seek fundamental

knowledge about the nature and behavior of living systems and the application of that knowledge to

enhance health, lengthen life, and reduce illness and disability. NIH operates under the general policy

guidance of the Department in carrying out its mission, which is accomplished through the conduct and

support of biomedical and behavioral research, research training, research infrastructure, and com-

munications. These efforts take place intramurally (primarily at NIH) and extramurally (through grants,

cooperative agreements, and contracts awarded to institutions of higher education, governmental organ-

izations, non-profit research organizations, for-profit organizations, and individuals). NIH also works

closely with other HHS components and other Federal departments and agencies. HHS components

include SAMHSA, FDA, CDC, IHS, AHRQ, HRSA, ACF, ACL, OASH, and CMS, among others.

The rules that govern grants and cooperative agreements detailed at 2 CFR Part 200, and in certain cases

further codified through HHS regulation, provide the framework for the terms and conditions of NIH

awards, as specified in "Part II: Terms and Conditions of NIH Grant Awards" on page IIA-1.

NIH is organized into ICs, which have their own mission and functions, separate appropriations, and stat-

utory authorities. The ICs that award grants and their points of contact are listed in

Part III

. Although the

ICs operate under the same general grant process and requirements, applicants and recipients need to be

aware of differences that may exist. This information may be obtained from NIH IC staff. The policies

generally applicable to NIH grants are set forth in the NIHGPS.

2.1 ROLES AND RESPONSIBILITIES

NIH, as a Federal grantor agency, is responsible to Congress and the U.S. taxpayer for carrying out its

mission in a manner that not only facilitates research but does so cost-effectively and in compliance with

applicable rules and regulations. NIH seeks to ensure integrity and accountability in its grant award and

administration processes by relying on a system of checks and balances and separation of responsibilities

within its own staff and by establishing a similar set of expectations for recipient organizations.

The following subsections highlight the major functions and areas of responsibility of Federal and recip-

ient staffs. NIH recognizes that additional staff members in a number of different organizations may be

involved in grant-related activities; however, this section details only the major participants representing

the Federal government and the recipient. The responsibilities of CSR and IC staff members, who are

involved only in the initial review phase of the peer review process, are described in

The Peer Review

Process—Initial Review—Responsibilities

. The responsibilities of other offices, such as OHRP, are

described in Part II as applicable.

2.1.1 NIH and HHS Staff

The roles and responsibilities of NIH and HHS participants are as follows:

I-48

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

Grants Management Officer.

The GMO whose name appears in the NoA is the NIH official

responsible for the business management and other non-programmatic aspects of the award.

These activities include, but are not limited to, evaluating grant applications for administrative

content and compliance with statutes, regulations, and guidelines; negotiating grants; providing

consultation and technical assistance to applicants and recipients, including interpretation of

grants administration policies and provisions; and administering and closing out grants. The

GMO works closely with their counterparts in other NIH ICs and with the designated PO. The

GMO is the focal point for receiving and acting on requests for NIH prior approval or for

changes in the terms and conditions of award, and is the only NIH official authorized to obligate

NIH to the expenditure of Federal funds or to change the funding, duration, or other terms and

conditions of award. A Chief Grants Management Officer is the principal GMO who provides

leadership to an organizational component that is responsible for the business and fiscal man-

agement of the ICs grant portfolio. Generally, the CGMO will have the authority to appoint and

exercise line authority over one or more GMOs. At NIH each awarding component has a

CGMO.

Grants Management Specialist.

The GMS whose name appears in the NoA is an agent of the

GMO and is assigned responsibility for the day-to-day management of a portfolio of grants.

Program Official.

The PO is responsible for the programmatic, scientific, and/or technical

aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited

to, development of research and research training programs to meet the IC’s mission; coordin-

ation with CSR/IC SROs; and post-award administration, including review of progress reports,

participation in site visits, and other activities complementary to those of the GMO. The PO and

the GMO work as a team on many of these activities.

Scientific Review Officer.

SROs are health science administrators who manage the activities of

SRGs, including CSR study sections. The SRO is responsible for conduct of the SRG in accord-

ance with applicable laws, regulations, and policies. For the SRG for which they are responsible,

the SRO reviews applications for completeness and conformity to requirements, ensures that

adequate numbers of reviewers with appropriate expertise are available for application review,

assigns applications to individual reviewers as discussion leaders and for preparation of written

critiques, manages conflicts of interest and confidentiality, and serves as the overall point of con-

tact with applicants during the initial phase of the peer review process, i.e., until the conclusion

of the SRG meeting.

Other NIH, HHS and Federal Agency Staff.

In addition to the GMO and PO, the recipient may

be required to interact with other NIH or HHS staff members or offices with respect to its organ-

ization-wide systems and/or individual transactions. These include the office responsible for

negotiating indirect costs and research patient care rates, typically the cognizant CAS office,

ONR, or DFAS; OIG; OHRP; ORI; OLAW; and OPERA. Staff members in these offices gen-

erally coordinate with the GMO, but they are responsible for discrete areas of specialization and

are not required to channel their communications with the recipient through the GMO. Part III

includes a list of these organizations and their addresses and telephone numbers. ONR is the cog-

nizant agency for negotiation of indirect costs for some NIH recipients.

2.1.2 Recipient Staff

Overall responsibility for successfully implementing an NIH grant is a shared responsibility of the PD/PI

(s), the AOR, and the Research Administrator. As key members of the grant team, they respectively lead

the scientific and administrative aspects of the grant. While communications can be conducted with

Research Administrators and other institutional staff, NIH staff members conduct official business only

I-49

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

with the designated PD/PI(s) and AORs. The roles and responsibilities of recipient participants are as fol-

lows:

Authorized Organization Representative

. The AOR is the designated representative of the recip-

ient organization in matters related to the award and administration of its NIH grants, including

those that require NIH approval. The AOR should ascertain and assure that the materials the

applicant organization are submitting on behalf of the PD/PI are the original work of the PD/PI

and have not been used by other individuals in the preparation and submission of a similar grant

application. In signing a grant application, this individual certifies that the applicant organization

will comply with all applicable assurances and certifications referenced in the application. This

individual’s signature on the grant application further certifies that the applicant organization

will be accountable both for the appropriate use of funds awarded and for the performance of the

grant-supported project or activities resulting from the application. (Also see

Legal Implications

of Applications

.) This individual also is responsible to NIH for ensuring that the organization

complies with applicable Federal laws and regulations, including required certifications and

assurances, its application, and the terms and conditions of individual awards. For applications

submitted electronically through Grants.gov, the signature of the AOR is documented as part of

the electronic submission process and is authenticated through the Grants.gov registration pro-

cess. In the eRA Commons, this individual holds the Signing Official role. Although NIH

requires that the recipient organization designate such an official, NIH does not specify the

organizational location or full set of responsibilities for this official.

Program Director/Principal Investigator.

A PD/PI is an individual designated by the applicant

organization to have the appropriate level of authority and responsibility to direct the project or

program supported by the award. The applicant organization may designate multiple individuals

as PD/PIs who share the authority and responsibility for leading and directing the project, intel-

lectually and logistically. Each PD/PI is responsible and accountable to the recipient organization

or, as appropriate, to a collaborating organization, for the proper conduct of the project or pro-

gram, including the submission of all required reports. The presence of more than one identified

PD/PI on an application diminishes neither the responsibility nor the accountability of any indi-

vidual PD/PI.

When a single PD/PI is designated, that individual is not required to be an employee of the

applicant organization. However, because the grant, if awarded, is made to the organization, the

applicant organization must have a formal written agreement with the PD/PI that specifies an offi-

cial relationship between the parties even if the relationship does not involve a salary or other

form of remuneration. If the PD/PI is not an employee of the applicant organization, NIH will

assess whether the arrangement will result in the organization being able to fulfill its respons-

ibilities under the grant, if awarded.

When multiple PD/PIs are designated, NIH requires identification of one PD/PI who will be des-

ignated as the Contact PD/PI. This person is responsible for communication between the PD/PIs

and NIH. Serving as Contact PD/PI confers no special authorities or responsibilities within the

project team. The Contact PD/PI must meet all eligibility requirements for PD/PI status. They are

not required to be an employee of the applicant organization. However, as with the single PD/PI

model, if the Contact PD/PI is not an employee, the applicant organization must have a formal

written agreement with the Contact PD/PI that specifies an official relationship between the

parties. This same principle applies to all PD/PIs at the applicant organization; e.g., they need not

be employees; however, the applicant organization must have a formal written agreement in

place.

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Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

When multiple PD/PIs are involved at different organizations, only the Contact PD/PI is required

to have the official relationship with the applicant organization. PD/PIs in the leadership team at

other organizations must have a documented relationship with a consortium organization, but

need not be employees. Any consortium agreement must address the unique aspects to these indi-

viduals holding the PD/PI role. For additional information, see

NIHGPS Section 9

Multiple Pro-

gram Director/Principal Investigator Applications and Awards.

PD/PIs are members of the recipient team responsible for ensuring compliance with the financial

and administrative aspects of the award. They work closely with designated officials within the

recipient organization to create and maintain necessary documentation, including both technical

and administrative reports; prepare justifications; appropriately acknowledge Federal support of

research findings in publications, announcements, news programs, and other media; and ensure

compliance with other Federal and organizational requirements. NIH encourages PD/PIs to main-

tain contact with the NIH PO with respect to the scientific aspects of the project and the

GMO/GMS concerning the business and administrative aspects of the award. The

NIH staff con-

tacts list

includes contact information for NIH grants management and program staff at each IC.

Research Administrator

. The Research Administrator acts as a local agent of the AOR and/or

PD/PIs providing day-to-day grant-related support. Depending on the structure of the organ-

ization, this individual can be located centrally or within an organizational component such as a

Department.

2.2 ERA COMMONS

eRA Commons is an online interface where grant applicants, recipients and Federal staff at NIH and

grantor agencies can conduct their research administration business electronically as well as access and

share administrative information relating to research grants. While applicants use Grants.gov to find and

apply for grants; the eRA Commons retrieves the application or proposal information from Grants.gov,

compiles it into a consistent application format and then makes it available to applicants and NIH staff

for electronic research administration purposes.

Access to the eRA Commons is vital for all steps in the NIH grant administration process. Following

application submission, the eRA Commons becomes the primary site for accessing grant information

such as Institute/Center assignments, review outcomes, Summary Statements, and Notices of Award. The

eRA Commons also provides electronic business processes such as Internet Assisted Review, submission

of Just-In-Time material, submission of Research Performance Progress Reports (RPPRs), submission of

notification of extensions without funds, and submission of Closeout documents. Appropriate user roles

are assigned to registered individuals depending on the responsibilities assigned to them by the recipient

organization.

2.2.1 eRA Commons Registration

An organization and PD/PI(s) must complete a

one-time

registration in the Commons. Insti-

tutional/organizational officials are responsible for registering PD/PI(s) in the eRA Commons. PD/PI(s)

should work with their AOR (also known as the Signing Official in the eRA Commons) to determine

their institutional/organizational process for registration.

IMPORTANT: Organizations registering in the eRA Commons for the first time should allow 2-4 weeks

to complete the registration process.

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Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

2.2.1.1 eRA Commons Registration for the Organization

Prospective applicant organizations should also see

Legal Implications of Applications

before beginning

the eRA Commons registration process.

To register an Organization in the eRA Commons an AOR should follow the procedures found on the

Once an organization is registered, information in the Institutional Profile can be maintained through the

Commons.

During this registration process, NIH may make a preliminary assessment of applicant organization eli-

gibility. Applicants should be prepared to establish their eligibility to receive and administer all awards

(that are applied for), and NIH may deny registration if an organization is determined ineligible. Note,

acceptance of an organization’s registration in the Commons does not mean an organization is an accept-

able recipient for a particular program. That assessment will be made by the NIH awarding component

prior as part of the pre-award process. See

Determining Applicant Organization Eligibility

for additional

information.

Foundations that represent already existing recipient organizations, or a newly formed consortium where

the consortium members are already individually recognized as NIH recipient organizations present

unique and complex situations and should contact the

Systems Policy Branch, Division of Grants Sys-

tems Integration, OPERA

before attempting to separately register as a new applicant organization.

2.2.1.2 eRA Commons Registration for the PD/PI

The individual(s) designated as the PD/PI(s) on the application must also be registered in the eRA Com-

mons. The PD/PI(s) must hold a PI eRA Commons role

and

be affiliated with the applicant organization.

The initial registration must be done by an AOR who has the SO role in the eRA Commons or

other authorized accounts administrators at the organization

. However, after the initial registration

process is complete, it becomes the responsibility of each individual to maintain the information in their

personal profile.

Designating the PI role in the eRA Commons provides the individual with the administrative authority

needed to see pertinent information regarding an application (e.g., summary statements, scores, elec-

tronic submission status, etc.). The PI role within the eRA Commons is necessary to complete the grant

application process, to view the impact score and summary statement (the SO role also has this cap-

ability), and if an award is made, to complete required post-award actions such as submission of a pro-

gress report. The PD/PI may delegate certain authorities to other individuals.

Users should only have one PD/PI eRA Commons account. If the PD/PI has already been registered in

eRA Commons by an organization other than the organization submitting an application, a separate eRA

Commons registration with the submitting organization is not necessary. However, the submitting organ-

ization must take steps to affiliate the individual with that organization so that the individual can view

and access data records for those applications.

For more information on the features of the eRA Commons, including links to resources such as user

guides and frequently asked questions, see the

eRA Commons webpage

2.2.1.3 eRA Commons Registration for Other Individuals Participating in NIH

Application and Research Performance Progress Reports

Any individual with an Undergraduate, Graduate Student, and/or Postdoctoral Role who participates in a

NIH-funded project for at least one person month or more should also be registered in the eRA Com-

mons and should verify that all Personal Information located within the Personal Profile tab in the eRA

I-52

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

Commons System is accurate. This is required regardless of whether salary is actually charged to the pro-

ject. For graduate students supported on a particular research grant, this could include project roles of

graduate research assistant or graduate student. For postdoctoral individuals supported on a particular

research grant, this could include project roles such as Postdoctoral Associate and other similar Postdoc-

toral positions.

When an individual is assigned the Undergraduate, Graduate Student, or Postdoctoral Role in the Com-

mons, responses to certain data items in the Personal Profile tab will be required to meet NIH reporting

requirements to Congress included in the NIH Reform Act, P.L. 109-482. The Commons user name ID

for those with an Undergraduate, Graduate Student, or Postdoctoral Role is not required at the time of

application submission, but will be required as part of the Research Performance Progress Report

(RPPR).

For individuals at the postdoctoral level, this requirement is already in effect and progress reports will

not be accepted if the Commons ID is not provided. For individuals at the undergraduate and graduate

student levels, a Commons ID is required with RPPRs. The Undergraduate and Graduate Student Roles

have been added to the Commons to accommodate this requirement; recipients are encouraged to begin

registering these individuals now.

Note, the Graduate Student and Postdoctoral eRA Commons Roles should NOT be used for individuals

submitting Individual Fellowships; the PD/PI role is used for those submissions. Nor should they be used

for individuals supported on institutional training grants and reported using xTrain; the Trainee Role

must continue to be used for those individuals.

In addition to the above roles, a Commons ID is required at the time of submission for sponsors in fel-

lowship applications, component leads on multi-project applications, and primary mentors on career

development applications. A Commons ID is also required at the time of application submission for all

individuals listed on the R & R Senior / Key Person Profile (Expanded) Form; the requirement applies to

Senior/Key Personnel as defined in NIHGPS Section 1.2 as well as Other Significant Contributors

(OSCs). For other roles a Commons ID is strongly encouraged, but currently optional, for all other pro-

ject personnel. A general Commons Role of Project Personnel is available for those not assigned other

Commons Roles.

2.3 APPLICATION INFORMATION AND PROCESSES

This section provides an overview of NIH’s grant support mechanisms, types of entities eligible to

receive grants, types of applications, types of funding opportunities, legal implications of applications,

policies affecting application preparation and submission, application forms, application receipt inform-

ation and deadlines, fraud, waste and abuse of NIH grant funds, and availability and confidentiality of

application information.

2.3.1 Support Mechanisms

NIH ICs award grants under multiple programs and subprogram initiatives and use a variety of support

mechanisms. NIH grants may be distinguished by purpose, type of recipient, amount, or other char-

acteristics. One method NIH uses to differentiate the various support mechanisms is an activity coding

that indicates the category and specific form of support (e.g., R01, F32, P01, R43). The applicability of

requirements may vary for different activity codes. Some of the distinctions also are significant for pur-

poses of applying Part II. NIH ICs may vary in the way they use specific activity codes; not all ICs

accept applications for all types of grant programs and may apply specialized eligibility criteria. See a

comprehensive list of activity codes

on NIH's web site.

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2.3.2 Eligibility

In general, NIH grants may be awarded to organizations that are domestic or foreign, public or private,

or non-profit or for-profit. Eligible organizations include governments, including Federal institutions,

institutions of higher education, other non-profit organizations, hospitals, and, in rare occasions, indi-

viduals (see

Completing the Pre-Award Process—Determining Applicant Organization Eligibility

). Any

special criteria for applicant eligibility or requirements concerning the qualifications of the PD/PI or

other staff or participants will be specified in the NOFO, program guidelines, or other publicly available

documents. Part IIB includes information on fellow and trainee eligibility.

2.3.3 Types of Award Instruments

NIH uses several different extramural award instruments in support of its mission. The Federal Grant and

Cooperative Agreement Act of 1977 (P.L. 95-224) distinguishes financial assistance between contracts,

cooperative agreements and grants. The NIHGPS requirements apply to grants and cooperative agree-

ments. Both grants and cooperative agreements are financial assistance instruments.

The grant instrument is used to administer awards that do not require NIH involvement beyond standard

agency monitoring and stewardship. Under a cooperative agreement, NIH expects to be substantially

involved in carrying out the project. Grants are used both for investigator-initiated research and for more

targeted research. Cooperative agreements generally do not result from investigator-initiated applic-

ations. However, NIH may apply terms and conditions that differ from those in the NIHGPS consistent

with the nature of its involvement under cooperative agreements.

2.3.4 Types of Applications

In the NIH grants process, five types of applications are used most frequently. The first four application

types described below are considered “competing” because, through the peer review process, the applic-

ation must compete for available funding with other applications.

New Application (Type 1).

A request for financial assistance for a project or activity that is not

currently receiving NIH support and must compete for support. A new application is being sub-

mitted for the first time.

Renewal (Type 2).

A request for additional funding for a period subsequent to that provided by a

current award. A renewal application competes with all other applications and must be fully

developed as though the applicant is applying for the first time.

Competitive Revision (Type 3).

A request for an increase in support in a current project period

for expansion of the project’s approved scope or research protocol. The request may specify

budgetary changes required for the remainder of the project period as well as for the current

budget period. Applications for competitive revisions are not appropriate when the sole purpose

is to restore awards to the full SRG-recommended level if they were administratively reduced by

the funding agency. A competitive revision application should not be submitted until after the ori-

ginal application has been awarded and generally, a revision may not extend beyond the term of

the current award period without a strong justification (e.g., urgent or emergency revision). A

revision application must have the same title as the currently funded grant. Competitive revisions

require peer review.

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Administrative Supplement (Type 3.

A request for additional funds during a current project

period to provide for an increase in costs due to unforeseen circumstances. All additional costs

must be within the current scope of the peer reviewed and approved project, and may not extend

beyond the term of the current award. Administrative supplements do not require peer review.

[see Administrative Requirements—Changes in Project and Budget—Prior Approval Require-

ments—Need for Additional NIH Funding without Extension of Budget and Project Period.]).

Resubmission (suffix -A1).

An unfunded application that the applicant has modified following

initial review and resubmitted for new consideration. Before a resubmission application can be

submitted, the PD/PI must have received the summary statement from the previous review. A

resubmission application may be submitted for any of the three preceding types of applications

provided an appropriate NOFO is available. See

Application Information and Processes—

Policies Affecting Applications

for other policies affecting Resubmissions. NIH allows only one

resubmission application.

Non-Competing Continuation Progress Report (Type 5).

A non-competing progress report is

required to continue support of a PHS grant for the second or subsequent budget period within

an approved competitive segment (see

Administrative Requirements—Monitoring—Reporting—

Non-Competing Continuation Progress Reports

In addition to the list above, NIH periodically uses a pre-application (also known as a “white paper” or

“précis”) to facilitate certain approaches or economies, such as reducing burden on the applicant com-

munity, for a funding opportunity. Pre-applications are generally used in combination with a competing

application in a 2-phase process. Pre-applications do not result in an award; the end result is the oppor-

tunity to submit to the subsequent phase of a particular program. Successful applicants to the pre-applic-

ation phase are notified of the opportunity to submit to the subsequent phase. In addition to the pre-

application, NIH may use an application process for prospective applicants to request access to an NIH

research resource. This process also does not result in an award; the end result is permission to access a

resource. NIH uses the numbers shown in parentheses as prefixes to distinguish the application types and

any resulting awards (e.g., 5R0198765-02 is a non-competing continuation progress report).

2.3.5 Types of Notices of Funding Opportunities (NOFOs)

Most applications submitted to NIH under the categories of research and research training (including fel-

lowships) are investigator-initiated. NIH accepts applications on the application due dates noted on the

submission schedule. NIH generally reviews applications in three review cycles per year; however any

variations in schedule will be noted in the NOFO. Some ICs review applications for Institutional

National Research Service Awards (T32) only once a year; such information is generally found in a par-

ticular NOFO. The schedules for submission, review, and award of investigator-initiated applications are

available on

the NIH standard due dates web page

Notice of Notice of Funding Opportunity (NOFO).

In accordance with 2 CFR 200.204, NOFO is an

umbrella term for a publicly available document in which NIH makes known its intentions to award "Dis-

cretionary Award" on page I-18, usually as a result of competition for funds. Each NOFO includes a soli-

citation identifier, will outline the program goals and objectives, and will include information to allow

prospective applicants to determine whether the entity is eligible to apply. All applications must be elec-

tronically submitted in response to a NOFO.

NIH NOFOs primarily fall into the categories of Program Announcements, (PAs), which include Parent

Announcements, and Requests for Applications (RFAs). While individual announcements will continue

to carry an announcement number reference to

RFA

, all announcements are

NOFOs

. NOFO is the

general term is used to reference any type of funding announcement. NIH uses the PA and RFA ref-

erences in the actual announcement number to distinguish between the various types of announcements.

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Parent Announcement.

Electronic submission of applications requires that applications must be

associated with a specific NOFO. Therefore, NIH omnibus broad parent announcements are

provided for applicants to submit investigator-initiated (unsolicited) applications. Responding to

such an omnibus or umbrella parent NOFO ensures that the correct application package is used

and enables NIH to receive the application from

Grants.gov

. This process in no way diminishes

the interest of

NIH ICs

in investigator-initiated, unsolicited research grant applications. Parent

announcements are NIH-wide, but some ICs may limit their participation; therefore, prospective

applicants should check the announcement to determine IC participation. For institute-specific

opportunities in a particular area of science, visit the

NIH Highlighted Topics page

Program Announcement (PA).

A PA is a formal statement about a new or ongoing extramural

activity or program. It may serve as a reminder of continuing interest in a research area, describe

modification in an activity or program, and/or invite applications for grant support. Most applic-

ations in response to PAs may be submitted to a standing submission date and are reviewed with

all other applications received at that time using standard peer review processes. NIH may also

make funds available through PARs (PAs with special receipt, referral, and/or review con-

siderations) and PASs (PAs with set-aside funds).

ICOs issuing PARs or PASs may now choose to describe within the NOFO criteria that would make an

application non-responsive to the PAR/PAS. Only applications to PARs and PASs that include non-

responsive criteria will be evaluated by the ICOs upon receipt for non-responsiveness. These non-

responsive criteria will be listed in the Funding Opportunity Description section (Part 2, Section 1).

Those applications that are deemed non-responsive will be withdrawn from review.

PAs may be used for any support mechanism other than construction awards. Unless otherwise

specified in the PA, new applications (and associated renewal and revision applications) sub-

mitted in response to PAs are treated as investigator-initiated. PAs also are used to annually soli-

cit applications for the SBIR and STTR programs. Those applications must be received by the

dates specified in the PA.

Request for Applications (RFA).

An RFA is a formal statement that solicits grant or cooperative

agreement applications in a well-defined scientific area to accomplish specific program object-

ives. An RFA indicates the estimated amount of funds set aside for the competition, the estim-

ated number of awards to be made, whether cost sharing is required, and the application

submission date(s). For cooperative agreements, the RFA will describe the responsibilities and

obligations of NIH and recipients as well as joint responsibilities and obligations. Applications

submitted in response to an RFA are usually reviewed by an SRG specially convened by the

awarding component that issued the RFA.

All applications involving one or more clinical trials must be submitted through a NOFO specifically

designed for clinical trials. NIH will not process applications that propose one or more clinical trials if

the NOFO (Part 2, Section 2) indicates clinical trials are “Not Allowed.” Applications that propose clin-

ical trials, including applications with a mix of trial and non-trial aims or a combination of clinical and

non-clinical studies, must be submitted to NOFOs designated as clinical trial “Optional” or “Required".

All NIH NOFOs are forecasted on Grants.gov prior to publication and published on

Grants.gov

under

Search Grants

. NIH may also develop and publicize areas of highlighted topics to stimulate submission

of applications in those areas.

2.3.5.1 Other Funding-Related Notices

Request for Information (RFI)

. The purpose of an RFI is to alert the extramural research community to

a request for comments on a specific issue. A RFI does not include reminders, extensions, or

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clarifications to RFIs.

2.3.6 Legal Implications of Applications

An applicant must be an eligible entity and must submit a complete application in accordance with estab-

lished receipt (deadline) dates in order to be considered for support. The signature of an AOR on the

application certifies that the organization will comply with all applicable assurances and certifications ref-

erenced in the application. The applicant organization is responsible for verifying conformity with the

most current guidelines for all administrative, fiscal, and scientific information in the application, includ-

ing the indirect cost rate. The AOR’s signature further certifies that the applicant organization has the

ability to provide appropriate administrative and scientific oversight of the project and agrees to be fully

accountable for the appropriate use of any funds awarded and for the performance of the grant-supported

project or activities resulting from the application. NIH will not accept forms or other documentation

bearing generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored

Research). All forms and documentation submitted to NIH must reflect the name of the individual, elec-

tronic or otherwise, with the appropriate institutional authority to submit such information.

Applicants for and recipients of NIH grant funds, whether such funds are received through a grant, indir-

ectly under a contract or consortium agreement, or by a fiscal agent acting on another organization’s

behalf, or as student assistance under a training grant, are responsible for and must adhere to all applic-

able Federal statutes, regulations, and policies, including income tax regulations. Questions concerning

the applicability of income tax regulations to grant funds should be directed to the IRS. The applicant

also is expected to be in compliance with applicable State and local laws and ordinances.

Applicants may be required to provide proof of organizational eligibility (such as proof of non-profit

status), trainee or fellow eligibility and citizenship, or other eligibility information. Applications also

must demonstrate compliance (or intent to comply), through certification or other means, with a number

of public policy requirements. The more significant of the public policy requirements for the purpose of

peer review are those concerning research involving human subjects; inclusion of women, members of

racial and/or ethnic minority groups, and individuals across the lifespan in clinical research; and research

involving live vertebrate animals. Part II details public policy requirements and cost and administrative

policies.

Affiliate organizations and other similar administrative organizations

There are times when an institution desires to use an affiliate organization, such as a Foundation or other

similar organization to provide administrative services for NIH grants. These situations are often com-

plex and each situation is unique when determining which organization is the appropriate applicant insti-

tution. Foundations, particularly those associated with institutions already recognized as NIH recipient

organizations, should contact the

Division of Grants Systems Integration, OPERA

before attempting to

separately register as an applicant organization.

Similarly, when new consortiums are formed where the consortium members are already separately

recognized as NIH recipient organizations, DGSI/OPERA should be contacted before attempting to sep-

arately register as a new applicant organization.

See NIHGPS Section 7.8 Services Provided by Affil-

iated Organizations

2.3.7 Policies Affecting Applications

Application information to be submitted typically includes a project description, budget and budget jus-

tification, biographical sketches of senior/key personnel, and other information specified in the applic-

ation instructions, in the announcement, and/or in program guidelines, if any. Applicants should consult

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the cost principles and general administrative requirements for grants pertaining to their organizational

type in order to prepare the budget and complete other parts of the application. This section describes

NIH policies that affect application preparation and/or submission. Specific details on application content

are addressed in application instructions and specific NOFOs. Any significant change to the application

post-submission must be reported immediately to the appropriate NIH official.

2.3.7.1 Direct Cost Limitations for Applications That Include Con-

sortium/Contractual Indirect Costs

For NOFOs that include a direct cost limit, NIH policy excludes consortium/contractual indirect costs

when determining if an applicant is in compliance with the direct cost limitation. This policy extends to

all solicited and investigator-initiated applications and to all active announcements (Request for Applic-

ations and Program Announcements), involving consortium/contractual indirect costs, regardless of

budget amount or budget format (e.g., modular and non-modular). While consortium indirect costs may

be requested and awarded, applicants should not consider these costs when determining if a budget

exceeds a direct cost limit.

This policy impacts eligibility to submit a modular budget. The modular budget format is used for applic-

ations requesting $250,000 or less in direct costs per year. Consortium/contractual indirect costs are not

factored into this direct cost limit; however, they may be requested in addition to the $250,000.

This policy does not affect any specific NOFO that includes a total cost limit.

This policy does not affect the SBIR and STTR programs since the statutory budget guidelines are based

on total costs, not direct costs.

2.3.7.2 Resubmission of Unfunded RFA Applications

This policy applies to all activity codes that might be solicited via an RFA and to instances where there

is a change in activity code. Unless a particular NOFO states that resubmissions from an RFA may be

submitted, unfunded applications should be submitted as

new

applications if the grant applications fall

into the following categories:

1. Applications that were originally submitted in response to an RFA and now submitted as an

investigator-initiated application.

2. Applications that were originally submitted as investigator-initiated applications and sub-

sequently submitted in response to an RFA.

3. Applications that were originally submitted using one grant activity code and subsequently sub-

mitted using a different grant activity code (for example, an application that was originally an

R01 and is now submitted as an R21).

The new application must be submitted on the scheduled due dates for new applications and follow all

instructions that apply to new applications. Do not include an Introduction describing the changes and

improvements made; do not mark text to indicate the changes and do not mention prior review anywhere

in the application (including the cover letter). In these cases the reviewers will not be provided with the

previous summary statement.

2.3.7.3 Resubmission of an Unfunded Application

An unfunded competing application (A0) may be resubmitted for future funding opportunities. These

applications are referred to as a resubmission application (A1). NIH will only accept a single resub-

mission (A1) application. NIH will accept a new (A0) application following an unsuccessful resub-

mission (A1) application or a prior A0 application. The subsequent new application need not

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demonstrate substantial changes in scientific direction compared to previously reviewed submissions,

and must not contain an introduction to respond to the critiques from the previous review. NIH's policy

for accepting overlapping applications remains in effect: NIH will not accept duplicate or highly over-

lapping applications under review at the same time. This means that NIH will not review:

1. a new (A0) application that is submitted before issuance of the summary statement from the

review of an overlapping new (A0) or resubmission (A1) application.

2. a resubmission (A1) application that is submitted before issuance of the summary statement from

the review of the previous new (A0) application.

3. an application that has substantial overlap with another application pending appeal of initial peer

review (see Section

2.3.9.4

below)

NIH policy allows a 37 month window for one resubmission (A1) following the submission of a new,

renewal, or revision application (A0 application). The initial submission of a new, renewal or revision

application constitutes the starting point for the 37 month policy. After 37 months, NIH views a sub-

mission as a new application, regardless of whether an unsuccessful resubmission (A1) was submitted

during the 37 month period.

Submission to a different NOFO under review at the same time is not sufficient to make an application

new. (There are exceptions for applications following an RFA or changing activity code. See

Resub-

mission of Unfunded RFA Applications

above). The new application must be submitted on the

scheduled

due dates for new applications

. It must not include an Introduction describing the changes and improve-

ments made; and the text must not be marked to indicate the changes.

2.3.7.4 New Investigators and Early Stage Investigators

The NIH is committed to identifying and attracting new biomedical researchers and will continue to

explore novel ways to encourage early transition to independence. NIH has implemented a number of

policies specific to New Investigators, and in particular the category of New Investigator called Early

Stage Investigator.

New Investigator.

In general, a PD/PI is considered a New Investigator if they have not previously com-

peted successfully as PD/PI for a substantial NIH independent research award. For example, a PD/PI

who has previously received a competing NIH R01 research grant is no longer considered a New

Investigator. See definitions section for additional information and references.

Early Stage Investigator (ESI).

An ESI is a New Investigator who has completed their terminal research

degree or end of post-graduate clinical training (i.e., completing medical residency, whichever is later,

within the past 10 years at the time of application submission and who has not previously competed suc-

cessfully as a PD/PI for a substantial NIH independent research award. Extensions of the end of ESI eli-

gibility date may be requested following the procedures documented on the Early Stage Investigator

Extensions page on the NIH Grants & Funding website. Please note an investigator will retain their ESI

status if they receive smaller research grants, training, infrastructure, and career awards appearing on this

list.

The NIH intends to support New Investigators at success rates comparable to those for established invest-

igators submitting new applications. ESIs should comprise a majority of the New Investigators sup-

ported. Where possible, New Investigator applications will be clustered during review. The applications

will be given special consideration during peer review and at the time of funding. Peer reviewers will be

instructed to focus more on the proposed approach than on the track record, and to expect less pre-

liminary data than would be provided by an established investigator.

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NIH New Investigator policies are limited to applications for traditional research project grant (R01) sup-

port. Accordingly, NIH strongly encourages New Investigators, particularly ESIs, to apply for R01

grants when seeking first-time NIH funding. To determine New Investigator and ESI status, NIH relies

on the data entered by the individual in their eRA Commons Profile, therefore it is important that PD/PIs

verify the accuracy of their personal profiles. Particularly key for ESIs are the terminal research degree

and end date of residency data fields. ESI status and end of eligibility date also appear in the eRA Com-

mons profile for the individual.

2.3.7.5 Program Director/Principal Investigator, Individual Fellowship and Sponsor

Assurance

The applicant organization is required to secure and retain a unique signature and dated assurance from

the PD/PI for each submitted application, prior to submitting an application to the NIH. This assurance

must be available to the NIH or other authorized DHHS or Federal officials upon request. Such an assur-

ance must include at least the following certifications: 1) that the information submitted within the applic-

ation is true, complete and accurate to the best of the PI’s knowledge; 2) that any false, fictitious, or

fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalties; and 3)

that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the

required progress reports if a grant is awarded as a result of the application. If multiple PIs are proposed

in an application, this assurance must be retained for all named PIs.

For individual Fellowship applications, this assurance requirement applies to the individual fellow and

the sponsor. Such an assurance must include at least the follow certifications: (1) that the information

submitted within the application is true, complete and accurate to the best of the Fellow’s and Sponsor’s

knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the Fellow and

Sponsor to criminal, civil, or administrative penalties; (3) that the Sponsor will provide appropriate train-

ing, adequate facilities, and supervision if a grant is awarded as a result of the application; (4) that the

Fellow has read the

Ruth L. Kirschstein National Research Service Award Payback

and will abide by the

Assurance if an award is made; and (5) that the award will not support residency training. NIH will not

accept forms or other documentation bearing generic departmental signatures or their electronic equi-

valent (e.g., Department of Sponsored Research). All forms and documentation submitted to the NIH

must reflect the name of the individual, electronic or otherwise, with the appropriate institutional author-

ity to submit such information.

2.3.7.6 Post-Submission Grant Application Materials

Post-submission of application materials is not required. Adding materials to reviewer workload may be

counterproductive, so applicants should carefully consider the need to send post-submission materials.

For materials that are submitted after the initial grant application submission but prior to initial peer

review, NIH will only accept such materials resulting from unforeseen administrative issues. This policy

does not modify the Just-in-Time requirements or any other requests for additional information after the

initial peer review.

Allowable Post-Submission Materials for All Applications

For all research and research-related applications, individual fellowship, and individual career devel-

opment awards, acceptable materials include:

Citations of issued patents

Revised budget page(s) (e.g., due to new funding or institutional acquisition of equipment)

Biographical sketches (e.g., due to the hiring, replacement, or loss of an investigator)

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Letters of support or collaboration due to the hiring, replacement or loss of an investigator

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution [e.g., Program Director/Principal Investigator

(PD/PI) moves to another university]

News of professional promotion or positive tenure decision for any PD/PI or Senior/Key Per-

sonnel

Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of

the application

Video and audio files, within defined limits, that demonstrate devices and experimental data with

a temporal element, which refers to the need to show how something functions or occurs over

time, or demonstrates movement or change. Special submission procedures are required (See

‘

Non-Traditional Application Materials

’).

Other post-submission materials specified in the NOFO for which the application was submitted

or in a special Guide Notice.

News of an article accepted for publication since submission of the application, which must

include only

List of authors and institutional affiliations

Title of the article

Journal or citation (if available)

Copies of articles, links to articles, or any other materials related to an article accepted for publication

will not be accepted as post-submission materials, unless specified in the Notice of Funding Opportunity

(NOFO) for which the application was submitted or a special Guide Notice.

Additional Materials for Certain Applications

Preliminary Data NIH will accept preliminary data as post-submission material for Type 1 R01, R21, or

R03 applications, including resubmissions, if the NOFO used for submission allows preliminary data in

the application.

Institutional Training and Training-related Grants

(e.g., T32, T34, T35, T90, TU2, T15, D43, K12,

KM1, UR2): in addition to the materials for All Applications above, news—since the training grant

application was submitted—of:

A trainee's or former trainee's graduation, employment, promotion, funding, or publications;

A faculty member's promotion, funding, or publications; and

The addition or removal of any faculty member who will be involved in the training program

(mentors or senior/key persons).

Lists of publications for Training Grant are allowed. Follow the page limits in the NIH Table of

Page Limits.

Individual Fellowship (F-Series) and Individual Career Development Award (K-series) Applic-

ations

: in addition to the materials for All Applications listed above:

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New information on the Sponsor/Mentor funding, limited to the project title, funding source

(e.g., NIH grant number), a brief description of specific aims, and relevance to the fellowship or

career development application under review.

News of change in Mentor(s) or other Senior/Key Persons specified in the original application.

Applications submitted to Requests for Applications (RFAs)

: the same post-submission materials as

other applications (see "All Applications" above), for all due dates in the RFA.

Conference Grant Applications (R13, U13)

: a one-page explanation of all speakers who accepted invit-

ations to participate in the proposed conference after the application was submitted, plus a one-page

explanation of all speakers who declined such invitations after the application was submitted. Altern-

atively, the PD/PI may consider submitting a one-page explanation for each plenary slot on the agenda.

Any other types of post-submission materials are not likely to be accepted.

Requirements for Submitting Post-Submission Materials

All post-submission materials must conform to NIH policies on font size, margins, and paper size as ref-

erenced in the applicable application instructions.

Any specified formats (e.g., budgets, biographical sketches) and page limits referenced in the

applicable application instructions apply.

If post-submission material is not required on a specific format page and does not have a spe-

cified page limit, each explanation or letter is limited to one page.

If the application has multiple components (subprojects or cores), each subproject or core is

allowed explanations or letters, but each explanation or letter is limited to one page.

Post-submission materials must be received by the NIH Scientific Review Officer (SRO) no later than 30

calendar days prior to the peer review meeting. Post-submission materials will not be accepted if fewer

than 30 calendar days remain before the peer review meeting, unless specifically stated otherwise in the

NOFO for which the application was submitted or in a special Guide Notice.

Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is

required. Although the post-submission materials may originate from the PD/PI, Contact PD/PI, or organ-

izational officials, the AOR must send the materials directly to the SRO or must send their concurrence

to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the

PD/PI only or with a copy to the AOR will not be accepted.

Post-submission materials

can only

be submitted as a PDF attachment, except for video submissions.

The SRO is responsible for uploading acceptable materials into the official electronic grant file main-

tained in the eRA Commons. The PD/PI can check their application via the Commons to see these mater-

ials in the section titled "Additions for Review". This procedure provides the information to reviewers in

a secure manner.

Non-traditional Application Materials

NIH will accept only video and audio files as digital files submitted via email, non-traditional application

materials. No devices or other media will be accepted unless specified in the Notice of Funding Oppor-

tunity (NOFO). These guidelines may be superseded by instructions in specific NOFOs.

Acceptable video content.

The only acceptable content for videos is demonstrations of devices and exper-

imental data with a temporal element, which refers to the need to show how something functions or

occurs over time; or demonstrates movement or change. No demonstrations of data that could be feasibly

presented in figures or tables will be accepted.

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Examples of acceptable content include: unusual interventions or surgical procedures, prototype

model use, visualization of 3-D structures or structural changes in molecules or cells, temporal

changes in cell migration or interactions, demonstrations of interventions on animal behavior or

kinetic physiopathology, software, database or mobile app demonstrations, educational materials

or video games.

Examples of unacceptable content include virtual tours of laboratories, equipment in place, plat-

form presentations, testimonials, advertisements, or commercials, research or outreach present-

ations [unless requested by the Scientific Review Officer (SRO) in lieu of a site visit].

Application requirements.

The application must be structured at the time of submission to indicate that a

video will be submitted subsequently as post-submission materials. Key images/“stills” and a brief

description of each video must be included within the page limits of the research strategy. Sufficient

descriptive information must be provided within the research strategy to understand the information

presented in the video, as not all reviewers may be able to access the video, depending on technological

constraints. A cover letter that includes information about the intent to submit a video should also be sub-

mitted with the application.

When human subjects or personally identifiable information is represented in a video, the applicant

organization is responsible for ensuring that human subjects have consented and are protected appro-

priately. Submission through the Authorized Organizational Representative (AOR) certifies acceptance

of this responsibility.

Video formats.

Multiple videos may be submitted per application but their aggregate length (at normal

speed) must not exceed 2 minutes for single-project applications and 5 minutes for multi-component

applications. The maximum file size for all videos combined is 35 MB. Closed captioning is recom-

mended as an optional component of the video to assist reviewers evaluating the application.

Video submission.

Post-submission video files should be sent via email as a digital file for upload to the

application grant folder by the SRO. Acceptable digital formats are WMV, AVI, MOV, and MP4. To

avoid technical issues, digital files should not be embedded in another file format, e.g., PDF.

As with all other post-submission materials, videos must be received by the SRO one month (30 calendar

days) prior to the peer review meeting. Videos will not be accepted if fewer than 30 calendar days

remain before the peer review meeting.

Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is

required. The AOR must send the materials directly to the SRO, or must send their concurrence to the

PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI

only or with a “cc” to the AOR will not be accepted.

Video files containing unacceptable content or exceeding the time or size limits will not be accepted.

Applications submitted with hypertext (e.g., hyperlinks and URLs) to videos or with videos embedded in

the research strategy will be considered in violation of page limits and may be withdrawn before review.

Additional information on post-submission videos can be found on the NIH Format Attachments

webpage.

Note: Due to technological constraints, the NIH cannot guarantee that reviewers will be able to view

videos.

The opportunity to submit additional materials should not be a means of circumventing submission dead-

lines, page limitations, or content requirements and should not substantially enhance, alter or add to the

originally submitted application.

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After the initial peer review phase is completed, the Chief GMO of the IC is the NIH official responsible

for accepting additional materials. Most of the material submitted after peer review can be submitted as

part of the Just-in-Time process.

2.3.7.7 SAM Registration and Unique Entity Identifier (UEI) Requirements

All applicant organizations must register in the System for Award Management (SAM), in accordance

with Appendix I to 2 CFR Part 200(D.)(3.), and always maintain a current and active registration at all

times during which such organizations have an application under consideration for funding by NIH and,

if an award is made, until a final financial report is submitted or the final payment is received, whichever

is later. The applicant organization or recipient must review and update its information in SAM.gov annu-

ally from the date of initial registration or subsequent updates to ensure it is current, accurate, and com-

plete. If applicable, this includes identifying the applicant’s or recipient’s immediate and highest-level

owner and subsidiaries, as well as providing information on all predecessors that have received a Federal

award or contract within the last three years. SAM is the primary registrant database for the Federal gov-

ernment and is the repository into which an entity must provide information required for the conduct of

business as a recipient. SAM is the central repository for common government-wide certifications and

representations required of NIH applicants and recipients. Additional information about registration pro-

cedures may be found at the

SAM.gov internet site

A Unique Entity Identifier (UEI) is issued as part of the SAM.gov registration process. The UEI must be

provided on application forms; the same UEI must be used for all registrations, as well as on the grant

application.

2.3.7.8 Graduate Student Compensation

The maximum amount NIH will award for the support of a graduate student on a research grant or

cooperative agreement is tied to the National Research Service Award (NRSA) zero-level stipend for

postdoctoral fellows in effect at the time the grant award is issued on the Federal award date. Stipend

levels are updated periodically in conjunction with an NIH annual appropriation and are published in the

NIH Guide for Grants and Contracts. Consistent with cost principles for Institutions of Higher Education

(IHEs) described in

2 CFR Part 200.431(j)

and

200.466

, the compensation of graduate students sup-

ported by research grants must be reasonable. The amount provided for compensation includes salary or

wages, fringe benefits, and tuition remission.

These guidelines apply to graduate students at the recipient institution who are supported by NIH

research grants and cooperative agreements and not to individuals supported by NRSA training grants

and fellowships. NIH has separate appropriations to support research training under the NRSA author-

ization at Section 487 of the Public Health Service Act.

The stipends provided to recipients of NRSA support offset the cost-of-living during the period of train-

ing and are not considered equivalent to salaries or other forms of compensation provided to individuals

supported on research grants. Nevertheless, the entry-level postdoctoral NRSA stipend provides a useful

benchmark for an award amount that approximates a reasonable rate of compensation for graduate stu-

dents. Expected future increases in NRSA stipends, to adjust for inflation, should permit annual increases

in the maximum award for such individuals.

For all new and competing grant and cooperative agreement awards, the NIH will provide reasonable

amounts for graduate compensation, consistent with the requested budget for the position(s) and up to

the currently effective NRSA zero postdoctoral stipend level. NIH staff will review the compensation

requested for graduate students on competing and cooperative agreement applications for which a

detailed budget is submitted. NIH will neither request nor accept budgets for those applications using a

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modular budget format solely for the purpose of reviewing graduate student compensation. However,

applicants should use this policy when estimating the number of modules.

When submitting detailed budgets that request support for a graduate student, recipients are reminded to

request actual institutional-based compensation and to provide information justifying the requested com-

pensation level. If this information is not provided, NIH staff will obtain this information from the insti-

tution's business office for any request that appears excessive.

NIH Institutes and Centers will review the requested compensation level and, if considered reasonable,

will award the actual amount requested, up to a maximum equal to the NRSA zero level postdoctoral sti-

pend. Revised budgets submitted solely to adjust requested levels for graduate students will not be accep-

ted.

Institutions may continue to rebudget funds to charge more than the awarded amount provided that OMB

cost principles requiring reasonable compensation are observed. In general, graduate student com-

pensation will not be considered reasonable if in excess of the amount paid to a first-year postdoctoral

scientist at the same institution performing comparable work.

2.3.7.9 NIH Data Management and Sharing and Genomic Data Sharing

NIH issued the Data Management and Sharing (DMS) policy to promote the sharing of scientific data.

Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of

research results, providing accessibility to high-value datasets, and promoting data reuse for future

research studies. Applicant projects that generate scientific data are subject to the DMS Policy. Addi-

tionally, if applicable, genomic data sharing considerations must be submitted with the application.

Please refer to Section 8.2.3.1 Policy for Data Management and Sharing (DMS Policy) for more inform-

ation.

2.3.7.10 Human Fetal Tissue from elective abortions

Effective January 22, 2026, NIH funds are not permitted for research using Human Fetal Tissue (HFT)

from elective abortions. For ongoing projects as of January 22, organizations may rebudget released

funds to support research under the same project that is not unallowable under this policy.

2.3.7.11 Biographical Sketches (Biosketches)

NIH requires submission of a biographical sketch (also referred to as biosketch) for each proposed seni-

or/key personnel and other significant contributor.

Applicants and recipients are required to submit biosketches in 1) competing applications for all types of

grant programs; 2) in progress reports when new senior/key personnel or other significant contributors

are identified; and 3) to support prior approval requests for changes in senior/key personnel status and

changes of recipient organization.

NIH staff and peer reviewers utilize the biosketch to ensure that individuals included on the applications

are equipped with the skills, knowledge, and resources necessary to carry out the proposed research.

Applications containing one or more biosketches that do not conform to the required format may be with-

drawn.

See the

NIH Biosketch page

for format pages, instructions and the

NIH disclosure table.

2.3.7.12 NIH Application Submission Limits

NIH will only accept six new, renewal, resubmission, or revision applications from an individual Prin-

cipal Investigator/Program Director or Multiple Principal Investigator for all council rounds in a calendar

year beginning with applications submitted for the September 25, 2025 due date. This policy applies to

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all activity codes with the exception of T (Training grants), R25 (Research Education Grants) and R13

(Conference Grants). See FAQs for more information on the process.

2.3.7.13 Appropriate Use of Artificial Intelligence (AI)

While NIH recognizes that AI tools may be appropriate to assist in

limited aspects of application pre-

paration

, researchers should be aware that using AI comes with its own risks: AI use may result in pla-

giarism or possibly other kinds of research misconduct. NIH will not consider applications that are either

substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of

applicants. If NIH identifies evidence of plagiarism, fabrication, or falsification, NIH will refer the mat-

ter to the HHS Office of Research Integrity for review.

2.3.8 Application Forms

Exhibit 3 lists the required application forms for competing applications, which vary by support mech-

anism. These forms and associated instructions are available on the

NIH Forms and Format Pages.

Exhibit 3. Required Forms for Competing Applications

Application Title

Form Number

Use

SF424 (R&R) Application

Guide for NIH and Other

PHS Agencies

SF424 (R&R)

The SF424 (R&R) form set, combined with PHS

398 components, is used for electronic sub-

mission.

SF424 (R&R) Individual

Fellowship Application

Guide for NIH and AHRQ

SF424 (R&R)

and

PHS 416-1

The SF424 (R&R) form set, combined with a PHS

Fellowship Supplemental form component, is used

for electronic submission of individual fellowship

applications. The PHS 416-1 may be used for e-

mail form submissions of a change of sponsoring

recipient organization application.

Application for a Public

Health Service Grant

PHS 398

Form PHS 398 is used for paper submission for

those programs that have not yet transitioned to

electronic submission.

The NIH competing applications now require electronic application submission. Questions about applic-

ation forms and instructions may be directed to

DGSI/OPERA, OER, NIH;

see Part III for contact

information.

2.3.9 Application Receipt Information and Deadlines

The NIH generally requires electronic submission of all competing and administrative supplement applic-

ations. Applicants should carefully read instructions in the NOFO and the application guide to determine

submission requirements. The NOFO will either provide unique application deadlines or refer to NIH’s

standard due dates

NIH expects all applications to be submitted on time. Permission is not granted in advance for sub-

mission of a late application. Late applications are accepted only in extenuating circumstances and lim-

ited to two weeks past the due date. If an application is submitted late, a cover letter explaining the

reasons for the delay must be included with the signed, completed application. Late applications are eval-

uated on an individual basis considering the reasons provided. Only DRR, CSR has the authority to

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accept a late application; however, contacting DRR in advance will not influence the acceptance of a late

application. The NIH policy on late applications is stated in the applicable application instructions. Also

see Late Applications below.

2.3.9.1 Electronic Submission Requirements

NIH requires electronic submission of:

• All competing (Type 1, Type 2) and administrative supplement (Type 3) applications;

• All Research Performance Progress Reports (RPPRs), including interim and final RPPRs (submitted

electronically through the eRA Commons RPPR module);

• Change of recipient organization (Type 7) and successor-in-interest (Type 6) applications (may be sub-

mitted electronically via email).

All applications, regardless of the NOFO type, must be successfully submitted electronically to Grant-

s.gov on or before 5:00 p.m. local time (of the applicant organization) on the appropriate date listed in

the funding opportunity.

If an application due date falls on a weekend, it will be extended to the following Monday; any time the

date falls on a Federal holiday, the due date will be extended to the following business day. The applic-

ation will be on time if it is submitted on or before the following business day.

Questions about application forms and instructions may be directed to DGSI/OPERA, OER, NIH; see

Part III for contact information.

2.3.9.2 Late Applications

There is a two-week window of consideration after the application due date, during which time NIH

might consider accepting a late application (see details below). When the application due date falls on a

weekend or Federal holiday, and is extended to the next business day, the window of consideration for

late submission of applications will be calculated from that business day. Acceptance of late applications

will be made on a case-by-case basis, dependent upon the explanation provided in a cover letter sub-

mitted with the application.

Generally, when an applicant organization is closed due to natural disaster or other emergency situation,

applications must include a cover letter indicating the reasons for the delay. In general, the delay should

not exceed the time period that the applicant organization is closed, unless otherwise notified by the

agency. Additional information can be found on the

NIH Extramural Response to Natural Disasters and

Other Emergencies webpage

NIH will not consider accepting late applications under the following circumstances:

Submissions to RFAs that must be reviewed on a compressed timeline and that have declared, in

the Application Due Date field, “No late applications will be accepted for this Funding Oppor-

tunity”.

Submissions to any NOFOs (RFAs, PAs, PARs, PASs) after the two-week window of con-

sideration.

Please be aware that any reasons for late submission must be in relation to the individual(s) with the

PD/PI role on the application. For multiple PD/PI (MPI) applications, the reasons may apply to any or all

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of the PD/PIs. This accommodation does not apply to co-Investigators, project leaders in a multi-com-

ponent application, or other Key Persons listed in an application (unless they also have MPI status).

Examples of acceptable and unacceptable reasons for submission of a late application can be found in

the

NIH Submission Policies

web page.

The windows of time for consideration of late applications have been carefully chosen so that the late

applications can be processed with the cohort of on-time applications.

Late applications are evaluated on an individual basis considering the reasons provided. Contacting the

Division of Receipt and Referral, Center for Scientific Review (CSR)

, NIH in advance will not influence

the acceptance of a late application. Additional information on submission of electronic applications can

be found in the applicable SF424 (R&R) Application Guide.

2.3.9.3 Continuous Submission for Appointed Members of NIH Federal Advisory

Committees

Continuous Submission allows eligible members of NIH Federal Advisory Committees to submit applic-

ations for certain grant activity codes after the standard due date, until last day of the receipt period for

each Advisory Council Round.

PD/PI individuals serving as appointed members of the following categories of NIH Federal Advisory

Committees are eligible:

Chartered NIH Initial / Integrated Review Groups (IRGs),

NIH Boards of Scientific Counselors,

NIH Advisory Boards or Councils,

NIH Program Advisory Committees.

Eligibility begins on the date the appointment becomes active and continues for six weeks after the offi-

cial date of retirement from appointed committee service. Thus, if retirement from appointed service

occurs on June 30, continuous submission is permitted until August 16th of that year.

Continuous submission eligibility can be viewed in the reviewer's eRA Commons Personal Profile, in the

Reviewer Information section.

eRA Commons users with account administration roles (e.g., SO – Signing Official, AO – Admin-

istrative Official, AA – Account Administrator, BO – Business Official) can check an investigator’s eli-

gibility using the Advanced Search feature in the Admin module.

Under Continuous Submission, applications received after the Advisory Council Round continuous sub-

mission period end dates will be assigned to the next Advisory Council Round, as described on the NIH

Continuous Submission website. Please direct any continuous submission issues, including Grants.gov

rejection messages, to the eRA Service Desk.

See

NIH Continuous Submission website for details and procedures.

2.3.9.4 Similar, Essentially Identical, or Identical Applications

Simultaneous submissions of identical applications to one or more components of the PHS are not

allowed, and the NIH will not accept similar grant applications with essentially the same research focus

from the same applicant organization for the same receipt date. This includes derivative or multiple

applications that propose to develop a single product, process, or service that, with non-substantive modi-

fications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applic-

ations submitted by different applicant organizations will not be accepted for the same receipt date.

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Applicant organizations should ascertain and assure that the materials they are submitting on behalf of

the principal investigator are the original work of the principal investigator and have not been used else-

where in the preparation and submission of a similar grant application. Applications to the NIH are

grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or

disease state. The reviewers can thus easily identify multiple grant applications for essentially the same

project. In these cases, application processing may be delayed, or the application(s) may not be

reviewed.

Essentially identical applications will not be reviewed except for: 1) individuals submitting an applic-

ation for an Independent Scientist Award (K02) proposing essentially identical research in an application

for an individual research project; or 2) individuals submitting an individual research project identical to

a subproject that is part of a program project or center grant application.

2.3.9.5 Application Non-conformity

Applicants are reminded that non-conformity with application requirements can have serious con-

sequences. NIH may withdraw any application identified during the receipt, referral and review process

that does not conform with the instructions in the SF424 (R&R) Application Guide, the Notice of Fund-

ing Opportunity, and relevant NIH Guide Notices.

Some

examples

of how this policy is applied to NIH applications

include but are not limited to

Applications containing biosketches that do not conform to the required format may be with-

drawn.

Applications that do not conform to the page limit requirements because inappropriate materials

have been included in other parts of the application may be withdrawn.

Applications submitted as new but containing elements of a resubmission or renewal application

that do not conform with the resubmission policy and may be withdrawn.

Applications submitted after 5 PM local (applicant organization) time on the application due date

may be withdrawn.

It is important to remember that these are just examples, and that all requirements specified in the SF424

(R&R) Application Guide, the Notice of Funding Opportunity, and relevant NIH Guide Notices are to be

followed. Questions about application requirements can be directed to NIH "

Grants Info

" or the

Division

of Receipt and Referral

If an application is withdrawn because it does not conform to the application preparation and submission

instructions, a letter will be placed in the eRA Commons Status page for that application.

2.3.9.6 Natural Disasters and Other Emergencies

For major disasters impacting many organizations, NIH will coordinate with other HHS components and

Federal agencies (such as FEMA and OMB), as well as with state, local, and institutional rep-

resentatives, to develop any additional response. NIH will consider such issues as whether a Federal

Disaster is declared; the severity of damage inflicted; the length of time an organization may be required

to close or that is required for recovery; the impact on investigators, human research subjects, and animal

subjects; and the overall impact on the community.

Late applications due to natural disasters or other emergency situations are subject to the late application

policy found in NIHGPS Section 2.3.9.2.1.

NIH responses to specific events will be issued in the form of an NIH Guide Notice published in the

NIH Guide for Grants and Contracts.

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2.3.10 Fraud, Waste and Abuse of NIH Grant Funds

Any individual who becomes aware of the existence (or apparent existence) of fraud, waste, or abuse

related to NIH grants or grant funds should consider contact:

Your institution’s Office of Sponsored Research, Compliance Office, or other responsible office,

The NIH CGMO listed in the NoA for the IC that funded the grant,

The

DGCO/OPERA/OER

In addition, allegations of criminal offenses should be reported to the Department of Health and Human

Services,

OIG Hotline

The OIG has authority within HHS to conduct criminal investigations. The HHS OIG maintains a post

office box and a toll-free hotline for receiving information from individuals concerning fraud, waste, or

abuse under HHS grants and cooperative agreements. The identity of the caller is kept confidential, and

callers are not required to give their names. The address and telephone number of the

OIG

and the

OIG

hotline

are included in Part III.

Further allegations of non-criminal misuse of grant funds, and recipient conflict of interest should be

reported to the

NIH OMA

OMA provides a centralized management survey and review capability to promote program integrity,

conducts appraisals of alleged incidents of waste, fraud, and abuse and has lead responsibility for cases

received through the Office of Inspector General (OIG) Hotline that are referred to NIH for action. OMA

has no authority to undertake criminal investigations. OMA refers all allegations of criminal offenses to

the OIG for investigation. The address and telephone number for the

OMA, DPI

are included in Part III.

False statements involving falsified, fabricated, or plagiarized information identified during research mis-

conduct proceedings should be reported to the

NIH Extramural Research Integrity Officer

Examples of fraud, waste, and abuse that should be reported include, but are not limited to, embez-

zlement, misuse, or misappropriation of grant funds or property, and false statements, whether by organ-

izations or individuals. Other examples include theft of grant funds for personal use; using funds for non-

grant-related purposes; theft of federally owned property or property acquired or leased under a grant;

charging the Federal government for the services of “ghost” individuals; charging inflated building rental

fees for a building owned by the recipient; submitting false financial reports; and submitting false fin-

ancial data in bids submitted to the recipient (for eventual payment under the grant).

The Federal government may pursue administrative, civil, or criminal action under a variety of statutes

relating to fraud and making false statement or claims. Part II includes administrative and other remedies

the Federal government may use if a recipient deliberately withholds information or submits fraudulent

information or does not comply with applicable requirements. Even if a grant is not awarded, the applic-

ant may be subject to penalties if the information contained in or submitted as part of an application,

including its certifications and assurances, is found to be false, fictitious, or fraudulent.

The Program Fraud Civil Remedies Act of 1986, 31 U.S.C. 3801 et seq., provides for the administrative

imposition by HHS of civil penalties and assessments against any person who knowingly makes false,

fictitious, or fraudulent claims to the Federal government for money, including money representing

grants, loans, or benefits. A civil penalty of not more than $5,500 may be assessed for each such claim.

If a grant is awarded and payment is made on a false or fraudulent claim, an assessment of not more than

twice the amount of the claim, up to $150,000, may be made in lieu of damages. Regulations established

by HHS at 45 CFR Part 79 specify the review process for imposing civil penalties and assessments,

including hearing and appeal rights.

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The Criminal False Claims Act, 18 U.S.C. 287, and 18 U.S.C. 1001, provides for criminal prosecution of

a person who knowingly makes or presents any false, fictitious, or fraudulent statements or rep-

resentations or claims against the United States. Violations of these statutes carry a maximum sentence

of five and eight years imprisonment, respectively.

The Civil False Claims Act, 31 U.S.C. 3729(a), provides for imposition of penalties and damages by the

United States, through civil litigation, against any person who knowingly makes a false or fraudulent

claim for payment, makes or uses a false record or false statement to get a false claim paid or approved,

or conspires to defraud the Federal government to get a false claim paid. A “claim” includes any request

or demand for money or property made to the United States or to a contractor, recipient, or other recip-

ient, if the Federal government provides or will reimburse any portion of the funds claimed. Civil pen-

alties of $5,500 to $11,000 may be imposed for each false claim, plus damages of up to three times the

amount of the damages the government sustains because of the violation, and the costs of any civil

action brought to recover such penalties and damages.

NIH also may administratively recover misspent grant funds pursuant to the authorities contained in 2

CFR Part 200.

2.3.11 Availability and Confidentiality of Information

2.3.11.1 Availability of Information

Except for certain types of information that may be considered proprietary or private information that

cannot be released, most grant-related information submitted to NIH by the applicant or recipient in the

application or in the post-award phase is considered public information and, once an award is made, is

subject to possible release to individuals or organizations outside NIH. The statutes and policies that

require this information to be made public are intended to foster an open system of government and

accountability for governmental programs and expenditures and, in the case of research, to provide

information about federally funded activities.

NIH routinely places information about awarded grants, including project title, the name of the PD/PI,

and the project description, on the

RePORT Web site

. For funded research grant applications, NIH also

sends the project description provided by an applicant to the DoC’s NTIS. NTIS disseminates scientific

information for classification and program analysis. The public may obtain the project descriptions from

RePORT or request them from NTIS. Other information may be released case by case as described in

this subsection.

Several policies require acknowledgment of support and a disclaimer for publications, inventions, and

other research products, as provided in

Administrative Requirements—Availability of Research Results:

Publications, Intellectual Property Rights, and Sharing Research Resources

and elsewhere in the

NIHGPS.

2.3.11.2 Confidentiality of Information

Applicants are discouraged from submitting information considered proprietary unless it is deemed essen-

tial for proper evaluation of the application. However, if the application contains information that the

applicant organization considers to be trade secrets, information that is commercial or financial, or

information that is privileged or confidential, the pages containing that information should be identified

as specified in the application instructions.

When such information is included in the application, it is furnished to the Federal government in con-

fidence, with the understanding that the information will be used or disclosed only for evaluation of the

application. The information contained in an application will be protected by NIH from unauthorized

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disclosure, consistent with the need for peer review of the application (including the agreement by peer

reviewers and Advisory Council members to the NIH confidentiality and nondisclosure rules); and the

requirements of the FOIA and Privacy Act (5 U.S.C. 552 as discussed below). However, if a grant is

awarded as a result of or in connection with an application, the Federal government has the right to use

or disclose the information to the extent authorized by law. This restriction does not limit the Federal

government’s right to use the information if it is obtained without restriction from another source.

2.3.11.2.1 Privacy Act

The Privacy Act of 1974, 5 U.S.C. 552a (as amended), and its implementing regulations (45 CFR Part

5b) provide certain safeguards for information about individuals maintained in a system of records (i.e.,

information may be retrieved by the individual’s name or other identifying information). These safe-

guards include the rights of individuals to know what information about them is maintained in Federal

agencies’ files (hard copy or electronic) and how it is used, how they may obtain access to their records,

and how to correct, amend, or request deletion of information in their records that is factually incorrect.

The NIH maintains application and grant records as part of a system of records as defined by the

Privacy

Act: NIH 09-25-0225

This system of record provides guidance on requirements for the management of applicable grant records

in NIH’s possession and include appropriate routine uses of such information. It also includes require-

ments for safeguarding the records and for record retention and disposal.

Parties other than PD/PIs may request the release of Privacy Act grant records. Such requests are pro-

cessed under FOIA. For example, information requested by co-investigators in grant applications is

released to them only when required under FOIA because they have no right of access under the Privacy

Act. When releasing information about an individual to a party other than the subject of the file, NIH

will balance the individual’s right to privacy with the public’s right to know as provided by the FOIA.

Records maintained by recipients ordinarily are not subject to the requirements of 45 CFR Part 5b.

2.3.11.2.2 The Freedom of Information Act

The Freedom of Information Act, 5 U.S.C. 552, and implementing HHS regulations (45 CFR Part 5)

require NIH to release certain grant documents and records requested by members of the public, regard-

less of the intended use of the information. These policies and regulations apply to information in the

possession of NIH. Generally, NIH cannot require recipients or contractors under grants to permit public

access to their records. An exception related to certain research data is described in this subsection.

NIH generally will release the following types of records pursuant to a FOIA request:

Funded applications and funded progress reports, including award data.

Final reports that have been transmitted to the recipient organization of any audit, survey,

review, or evaluation of recipient performance.

NIH generally will withhold the following types of records or information in response to a FOIA

request:

Pending competing grant applications

Unfunded new, renewal, and revision applications

Financial information pertaining to project personnel, such as institutional base salary inform-

ation

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Information pertaining to an individual, the disclosure of which would constitute a clearly unwar-

ranted invasion of personal privacy

Predecisional opinions in interagency or intraagency memorandums or letters expressed by

Federal government officers, employees, or consultants

Evaluative portions of site visit reports and peer review summary statements, including impact

scores

Trade secrets and commercial, financial, and otherwise intrinsically valuable items of inform-

ation that are obtained from a person or organization and are privileged or confidential

Information which, if released, would adversely affect the competitive position of the person or

organization

Patent or other valuable commercial rights of the person or organization

Applicants are instructed to identify proprietary information at the time of submission of an application.

If, after receiving a FOIA request, NIH has substantial reason to believe that information in its records

could reasonably be considered exempt from release, the appropriate NIH FOI office will notify the

applicant or recipient, through the PD/PI, before the information is released. In the case of multiple

PD/PI’s the Contact PD/PI will be notified and is responsible for coordinating any response to the notice.

Multiple responses to the notice will not be accepted. If an applicant fails to identify proprietary inform-

ation at the time of submission as instructed in the application guide, a significant substantive jus-

tification will be required to withhold the information if requested under FOIA. The PD/PI will be given

five (5) working days to identify potentially patentable or commercially valuable information that the

PD/PI believes should not be disclosed. Any such submission must be specific as to the nature and type

of commercial harm that will result if the requested information is released. Submissions that merely

state in general terms that the grant application or portions should not be released will not be honored. If

the PD/PI does not respond within that time period, the grant will be prepared for release in accordance

with applicable FOIA policies and released to the requester. If the PD/PI does identify commercial or

proprietary information an NIH official will review that response. After NIH consideration of the

response, the PD/PI and recipient will be informed if NIH does not agree with the PD/PI’s position. If a

document contains both disclosable and non-disclosable information, the non-disclosable information

will be redacted and the balance of the document will be disclosed.

The HHS regulations implementing FOIA provide that only the NIH FOI Officer may deny requests for

information. Requests for information, the release of which is believed to be exempt under FOIA, are

referred to the NIH FOI Officer along with written documentation of the rationale for nondisclosure. If

the NIH FOI Officer determines that the requested information is exempt from release under FOIA, the

requester may appeal that determination to the Deputy Assistant Secretary for Public Affairs (Media),

HHS. Additional information on the FOIA process is available at the

NIH FOI Office Web site

2.3.11.2.3 Release of Research Data

NIH handles requests for the release of research data by certain types of recipients as FOIA requests.

The term “research data” is defined as the recorded factual material commonly accepted in the scientific

community as necessary to validate research findings. It does not include preliminary analyses; drafts of

scientific papers; plans for future research; peer reviews; communications with colleagues; physical

objects (e.g., laboratory samples, audio or video tapes); trade secrets; commercial information; materials

necessary to be held confidential by a researcher until publication in a peer-reviewed journal; inform-

ation that is protected under the law (e.g., intellectual property); personnel and medical files and similar

files, the disclosure of which would constitute an unwarranted invasion of personal privacy; or inform-

ation that could be used to identify a particular person in a research study.

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As required by 2 CFR Part 200.315, recipients that are institutions of higher education, hospitals, or non-

profit organizations must release research data first produced in a project supported in whole or in part

with Federal funds that are cited publicly and officially by a Federal agency in support of an action that

has the force and effect of law (i.e., regulations and administrative orders). If the data are publicly avail-

able, NIH directs the requester to the public source. Otherwise, the IC FOI coordinator handles the

request, consulting with the affected recipient and the PD/PI. This requirement also provides for assess-

ment of a reasonable fee to cover recipient costs and (separately) the NIH costs of responding.

This requirement to release research data does not apply to for-profit organizations or to research data

produced by State or local governments. However, if a State or local governmental recipient contracts

with an IHE, hospital, or non-profit organization, and the contract results in covered research data, those

data are subject to the disclosure requirement.

Additional information is available on the

Data Management & Sharing Policy Overview

web page.

(Also see

Administrative Requirements—Availability of Research Results: Publications, Intellectual

Property Rights, and Sharing Research Resources

2.3.12 Protecting Sensitive Data and Information Used in Research

Recipients of NIH funds have a vital responsibility to protect sensitive and confidential data as part of

proper stewardship of federally funded research, and take all reasonable and appropriate cybersecurity

and other actions to prevent the inadvertent disclosure, release or loss of sensitive personal information.

NIH advises that personally identifiable, sensitive, and confidential information about NIH-supported

research or research participants not be housed on portable electronic devices. If portable electronic

devices must be used, they should be encrypted to safeguard data and information. These devices include

laptops, tablets, mobile devices, CDs, disc drives, flash drives, etc. Researchers and institutions also

should limit access to personally identifiable information through proper access controls such as pass-

word protection and other means. Research data should be transmitted only when the security of the

recipient’s systems is known and is satisfactory to the transmitter. See also

Public Policy Requirements

and Objectives—Federal Information Security Management Act

2.4 THE PEER REVIEW PROCESS

NIH policy is intended to ensure that applications for funding submitted to NIH are evaluated on the

basis of a process that is fair, timely, and conducted in a manner that strives to eliminate bias. Competing

applications for NIH grants and cooperative agreements, including renewals and revisions, are subject to

peer review as required by sections 406 and 492 of the PHS Act, as amended by the NIH Reform Act of

2006 and 21

Century Cures Act. The peer review system used by NIH, often referred to as the “dual

review system,” is based on two sequential levels of review for each application—initial review for sci-

entific and technical merit by NIH’s Center for Scientific Review (CSR), and a second level of review

for mission relevance by the IC National Advisory Council / Board.

The NIH peer review process has evolved over the years to accommodate increasingly collaborative and

multi-disciplinary research, changes in workload, resource constraints, and recommendations of various

scientific and professional groups. However, the underlying basis for the system—to provide a fair and

objective review process in the overall interest of science—has not changed. Information concerning

NIH's peer review process may be found at NIH's web site or Peer Review Policies and Practices on the

NIH

Grants & Funding web site

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2.4.1 Initial Review

2.4.1.1 Responsibilities

The Division of Receipt and Referral (DRR) within the CSR receives all competing grant applications

submitted to NIH.

CSR centrally reviews the application for completeness and responsiveness to the NOFO, as applicable,

conducts the initial technical review for scientific merit and prepares the summary statements.

CSR Referral Officers, who are senior health scientist administrators with both research and scientific

review experience, assign each application to one or more ICs for potential funding and to a specific

study section for initial review of the scientific merit of the application. These assignments are made on

the basis of the application’s contents and referral guidelines.

CSR's study sections are organized into Review Branches by scientific discipline or current research

areas and are managed by health scientist administrators functioning as SROs. Generally, study sections

are chartered groups composed of formally appointed members serving multiyear terms, to which the

SRO often adds temporary members or other additional reviewers. Ad hoc Special Emphasis Panels

(SEPs) are formed to review applications that cannot be reviewed by a standing review group or study

section because they require special expertise or involve other special circumstances.

SRGs, whether study sections or SEPs, are primarily composed of non-federal scientists who have expert-

ise in relevant scientific disciplines and are actively engaged in research. NIH’s conflict-of-interest and

confidentiality of information requirements for reviewers are intended to promote an unbiased review

process by minimizing even the appearance of a conflict of interest and by restricting the use of priv-

ileged application information.

Applicants are notified by e-mail that their application has been received and that they can find inform-

ation about the application's SRO, SRG, and IC assignments in eRA Commons. At this time, applicants

may request reconsideration of the SRG and IC assignment. Applicants also are notified by e-mail to

check eRA Commons for any change in the application’s SRG or IC assignment, as well as a change in

Council date. Once the assignment process is completed, the SRO, not the PO, is the primary contact for

communication with the applicant until the summary statement is released. An applicant organization

may withdraw an application from consideration at any time during the review process. A request to

withdraw an application must be signed by the PD/PI and an AOR, and submitted to the SRO.

In preparation for the initial review, SROs review applications to determine whether they are complete

and conform to administrative requirements. For each reviewable application, they then assign (from

among the standing and temporary members) at least three reviewers to write a critique of the applic-

ation, provide initial scores, and to be prepared to discuss the application in detail.

Following the initial review, the SRO prepares a summary statement for most applications reviewed. The

summary statement includes the reviewers’ written comments, and, for scored applications, a summary

of the discussion, and an overall impact score. Summary statements are then provided to the IC’s Advis-

ory Councils, the PD(s)/PI(s), and applicant institution's Authorized Organization Representative.

2.4.1.2 Overall Impact

Reviewers assess overall impact in the determination of scientific and technical merit; overall impact is

defined based on the different types of applications. When considering applications for research grants

and cooperative agreements, reviewers will provide an overall impact score to reflect their assessment of

the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in

consideration of the five scored review criteria, and additional review criteria (as applicable for the

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project proposed). These criteria are evaluated and scored in accordance with the applicable peer review

framework (standard or Simplified Review Framework (SRF.)

NIH utilizes SRF for the peer review of the majority of competing research project grants (applications

under the following activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4,

RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the

following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33).

All other research project grant applications utilize the standard peer review criteria.

2.4.1.3 Standard Scored Review Criteria (Non SRF-applicable activity codes)

The goals of NIH-supported research are to advance the understanding of biological systems, improve

the control of disease, enhance health, and reduce illness and disability. For research grant applications,

and most other types of applications, reviewers evaluate the overall impact of the proposed project based

on five regulatory criteria: Significance, Investigator(s), Innovation, Approach, and Environment.

For non SRF-applicable activity codes, reviewers will consider each of the five criteria below in the

determination of scientific and technical merit, and determine a separate score for each. An application

does not need to be strong in all categories to be evaluated likely to have a major scientific impact. For

example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Investigator(s)

Innovation

Approach

Environment

The NOFO should be consulted for additional information describing each of the scored review criteria.

2.4.1.4 Standard Additional Review Criteria (Non SRF-applicable activity codes)

As applicable for the project proposed, reviewers will consider the following additional items in the

determination of scientific and technical merit, and in providing an overall impact score, but will not

give separate scores for these items.

Protections for Human Subjects

Inclusion of Human Subjects, Policies

Vertebrate Animals

Biohazards

Resubmission /Renewal / Revision Applications

The NOFO should be consulted for additional information describing each of the relevant additional

review criteria.

2.4.1.5 Standard Additional Review Considerations (Non SRF-applicable activity

codes)

As applicable for the project proposed, reviewers will consider each of the following items, but will not

give scores for these items and should not consider them in providing an overall impact score.

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Provision of Family Care Facilities (for Conference Grant Applications)

Select Agent Research

Resource Sharing Plans

Authentication of Key Biological and/or Chemical Resources

Budget and Period of Support

The NOFO should be consulted for additional information describing each of the relevant additional

review considerations.

Although these review criteria are intended for use primarily with investigator-initiated research project

grant applications (e.g., R24 and P01), including those in response to PAs, to the extent reasonable, the

criteria also will form the basis of the review of solicited applications and research related activities.

However, for some activities (e.g., construction grants and research project grants subject to the Sim-

plified Review Framework), the use of these criteria may not be feasible. Applications also may be

reviewed against other pertinent factors as stated in NOFOs.

2.4.1.6 Simplified Review Framework (SRF)

Due to the inherent complexity of the peer review process, NIH utilizes the Simplified Review Frame-

work (SRF) for the peer review of the majority of competing research project grants (applications under

the following activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1,

RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the fol-

lowing phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33). The SRF enables peer reviewers to

better focus on the central questions necessary to assess the scientific and technical merit of a proposed

research project: the importance of the proposed research, whether the proposed research methods are rig-

orous and feasible, and whether the investigators and institution have the expertise and resources neces-

sary to carry out the project as proposed. Additionally, the use of the SRF aids NIH in mitigating the

effect of reputational bias by refocusing the evaluation of the investigator/environment to within the con-

text of the proposed and research and also reduces burden on the reviewer by shifting policy compliance

activities to NIH staff.

SRF Review Criteria

The SRF reorganizes the five regulatory criteria into three factors as listed below. Each factor is eval-

uated by the Reviewer in the determination of scientific merit, and in providing an overall impact score.

Factors 1 and 2 will each receive a separate criterion score; Factor 3 will be evaluated for sufficiency.

An application does not need to be strong in all categories to be judged likely to have major scientific

impact.

Factor 1. Importance of the Research (scored 1-9):

Significance

Innovation

Factor 2. Rigor and Feasibility (Scored 1-9)

Approach (also includes Inclusion and Clinical Trial Study Timeline)

Factor 3. Expertise and Resources (considered in overall impact: no individual score provided)

Investigator(s), Environment

o

Evaluated as 'appropriate' or 'gaps identified'

o

Reviewer is required to provide further explanation, if gaps are defined.

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SRF Additional Review Criteria (can affect overall impact score)

As applicable for the project proposed, reviewers will consider the following additional items in the

determination of scientific and technical merit, and in providing an overall impact score, but will not

give separate scores for these items:

Protections for Human Subjects

Vertebrate Animals

Biohazards

Resubmission / Renewal / Revision Applications

The NOFO should be consulted for additional information describing each of the relevant additional

review criteria.

SRF Additional Review Considerations (No effect on overall impact score)

As applicable for the project proposed, reviewers will consider each of the following items, but will not

give scores for these items, and should not consider them in providing an overall impact score.

Authentication of Key Biological and/or Chemical Resources

Budget and Period of Support

2.4.2 Appeals of Initial Scientific Review

To preserve and underscore the fairness of the NIH peer review process, NIH has established a peer

review appeal system to provide applicants the opportunity to seek reconsideration of the initial review

results if, after consideration of the summary statement, they believe the review process was pro-

cedurally flawed. The NIH policy for appeals of initial peer review does not apply to appeals of the tech-

nical evaluation of Research and Development contract projects through the NIH peer review process,

appeals of NIH funding decisions, or appeals of decisions concerning extensions of MERIT awards. In

addition, NIH will not review a resubmission application when an appeal of initial peer review is

pending on the original application. As stated in the Notice of Funding Opportunity, appeals of initial

peer review outcome will not be accepted for applications in response to an RFA.

An appeal is a written communication from a Program Director/Principal Investigator (PD/PI) and/or

applicant institution that meets the following four criteria: 1) is received after issuance of the summary

statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or per-

ceived flaw in the review process for a particular application, 3) is based on one or more of four allow-

able issues (described below), and 4) displays concurrence from the Authorized Organization

Representative (AOR).

An applicant who is concerned about procedural aspects related to the completed initial peer review of

their application first should consider the comments in the summary statement, and then should contact

the appropriate NIH Program Official (PO). Following discussion of concerns with the PO, if the PD/PI

and/or an official of the applicant organization wishes to appeal the outcome of the initial peer review

process, an appeal letter must be submitted, either in hard copy or electronically, to the PO. The appeal

letter must display concurrence from the AOR of the applicant organization for the application. Although

the content of the appeal letter may originate from the PD/PI, Contact PD/PI for multiple PD/PI applic-

ations, or an organizational official(s) (not necessarily the AOR), the AOR must send the letter directly

to the PO, or must send their concurrence to the PD/PI who will forward the materials and AOR con-

currence to the PO. A communication from the PD/PI or official of the applicant organization (other than

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the AOR) only or with a “cc” to the AOR will not be accepted. The PO will send the PD/PI and/or insti-

tutional official, and AOR, an acknowledgement letter within 10 days of receipt of the appeal letter.

An appeal letter will be accepted only if the letter 1) describes the flaws in the review process for the

application in question, 2) explains the reasons for the appeal, and 3) is based on one or more of the fol-

lowing issues related to the process of the initial peer review:

Evidence of bias on the part of one or more peer reviewers.

Conflict of interest, as specified in regulation at

42 CFR Part 52h.5 “Scientific Peer Review of

Research Grant Applications and Research and Development Contract Projects”

, on the part of

one or more non-Federal peer reviewers.

Lack of appropriate expertise within the SRG.

Factual error(s) made by one or more reviewers that could have altered the outcome of review

substantially.

Appeal letters based solely on differences of scientific opinion will not be accepted. A letter that does

not meet these criteria and/or does not include the concurrence of the AOR will not be considered an

appeal letter, but rather a grievance. The IC will handle grievances according to IC-specific procedures.

If review staff and program staff do not support the appeal, or do not agree on its merit, the PD/PI and/or

an institutional official (not necessarily the AOR) may elect to withdraw the appeal letter. The request to

withdraw an appeal letter must be submitted either in hard copy or electronically to the PO, and must dis-

play concurrence from the AOR of the applicant organization for the application. Although the content

of the request may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organ-

izational official(s) (not necessarily the AOR), the AOR must send the request directly to the PO, or

must send their concurrence to the PD/PI who will forward the materials and their concurrence to the

PO. A communication from the PD/PI or institutional official (other than the AOR) only or with a “cc”

to the AOR will not be accepted.

If review staff and program staff do not support the appeal, or do not agree on its merit, and the appeal

letter is not withdrawn, the appeal letter will be made available to Council. The IC may not deny the

PD/PI or applicant organization the opportunity to have an appeal letter made available to Council. Only

two outcomes are possible following consideration of an appeal letter by Council:

The Council may concur with the appeal, and recommend that the application be re-reviewed.

The Council may concur with the SRG's recommendation and deny the appeal. Although factual

errors or other issues may be evident, the Council may determine that these factors were unlikely

to alter the final outcome of the SRG and deny the appeal. No action by the Council is equi-

valent to concurrence with the SRG’s recommendation and denial of the appeal.

The recommendation of Council concerning resolution of an appeal is final and will not be considered

again by the NIH through this or another process.

The Executive Secretary for the Council will communicate the Council recommendation concerning an

appeal to the PD/PI, AOR, and NIH staff with a need to know. If the appeal letter was received by the IC

deadline, the PD/PI and AOR will receive a written explanation of the resolution no later than 30 cal-

endar days after the Council meeting. If the appeal letter was received after the IC deadline, the Exec-

utive Secretary will provide, no more than 30 calendar days after the date when the appeal letter was

received, a written explanation of the IC’s plan for making the appeal available to Council.

If the Council recommended that the application be re-reviewed, the original application will be re-

reviewed without additional materials or modifications. The application may be re-reviewed by the same

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or a different SRG, depending on the flaws in the original review process that led to the appeal. In most

cases, the re-review will entail re-assignment to a subsequent review round and delay in the final funding

decision. The outcome of the re-review is final and cannot be appealed again.

On occasion, and for specific circumstances, the NIH may suspend temporarily the policy and process

for handling appeals of NIH initial peer review. Such decisions will be announced in NIH Guide Notices

and/or the relevant Notice of Funding Opportunity.

2.4.3 National Advisory Council or Board Review

The IC National Advisory Council or Board (hereafter “Council”) provides the second level peer review

of applications for grants and cooperative agreements. The Council members review the summary state-

ment and are asked to concur with the initial peer review for scientific and technical merit, as judged by

the SRG, and to consider relevance to the IC’s programs and priorities. Council members include senior

scientists with broad experience and members of the public with general knowledge of, and interest in,

the IC’s mission. The Council may concur with the SRG’s recommendation, may decide not to recom-

mend an application on the basis of program or policy considerations, or may recommend deferral of an

application and refer it back to the SRG for re-review.

In addition, Council members will receive a list of competing applications that will be considered for

funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who

currently receive $2 million or more in total costs (inclusive of direct and indirect) per year of NIH fund-

ing to support Research Project Grants. Council members will be asked to recommend consideration of

funding for applications that afford a unique opportunity to advance research which is both highly prom-

ising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH

funding.

With very limited exception, an application may not be considered for funding unless it has received a

favorable recommendation by both the SRG and the Council. For some applications (e.g., Kirschstein

NRSA Fellowship applications) the second level of review is conducted by senior level IC staff.

2.4.4 Disposition of Applications

Consistent with 2 CFR 200.204 and 200.205, all incomplete applications, non-compliant applications,

and applications determined to be nonresponsive to NOFO requirements will not be reviewed. If the

NOFO remains open with subsequent submission dates, the applicant may resubmit a corrected or com-

plete version of an investigator-initiated application for consideration in the next review cycle. An applic-

ation may resubmit one application may be submitted for an appropriate due date up to 37 months after

the application due date of the initial application, provided the NOFO allows resubmission applications.

Any application on the same topic proposed as a resubmission more than 37 months from the initial

receipt date will not be accepted; it must be formatted and submitted as a new application.

For complete, compliant and responsive applications, following the initial scientific peer review, the sum-

mary statement will be available to the PD/PI and AORs of the applicant organization with the Signing

Official (SO) user role in the eRA Commons. Applicants just receiving their summary statements should

consult the NIH Next Steps page for detailed guidance. If an application does not result in funding, there

may be an opportunity to respond to the reviewers’ comments and resubmit the application, provided the

NOFO allows resubmission applications. Applicants seeking advice beyond that available online may

want to contact the NIH Program Officer listed at the top of the summary statement.

The IC Director or designee is the official who has the authority to make final award decisions from

among those applications receiving a favorable initial review and Council recommendation. If an

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application has been recommended for further consideration but is not expected to be funded in the cur-

rent cycle, the application may be held by NIH for one or more additional cycles and will compete with

other applications submitted for that cycle. If an application is unsuccessful, the applicant may sub-

sequently submit one revised version of the application (referred to as a resubmission) for review in a

future cycle.

Some of the ICs publish paylines as part of their

funding strategies

to guide applicants on their like-

lihood of receiving funding. Application scores can only be compared against the payline for the fiscal

year when the application will be considered for funding, which is not necessarily the year when it was

submitted. At the beginning of fiscal years when the agency awaits an actual budget, there may be a

delay of several months to determine paylines. If the application is assigned to an IC that does not

announce a payline, the Program Officer listed at the top of the summary statement may be able to

provide guidance on the likelihood of funding.

Successful applicants will be notified of additional information that may be required or other actions lead-

ing to an award. The process leading to an award, including the business management review performed

by the GMO, is described in

Completing the Pre-Award Process

below.

For unsuccessful applicants, the NIH will send a centralized, automated correspondence to the applicant

organizations to notify them of NIH's intent not to fund the indicated applications.

The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is

not subject to appeal to any NIH or HHS official or board.

2.5 COMPLETING THE PRE-AWARD PROCESS

Following the peer review process, applications that an IC may fund are reviewed for a number of other

considerations. These include, as applicable, alignment with NIH’s funding principles, review of the pro-

ject budget, assessment of the applicant’s management systems, determination of applicant eligibility,

and compliance with public policy requirements. The applicant may be asked to submit additional

information (such as other support or verification of IACUC approval) or to undertake certain activities

(such as negotiation of an indirect cost rate) in anticipation of an award. However, such requests by NIH

do not guarantee that an award will be made. Following review of all applicable information, the IC will

determine whether an award can be made, if specific award conditions are required, and what level of

funding is appropriate.

Although these reviews and determinations occur before NIH makes a new award, recipients must con-

tinue to comply with eligibility and public policy requirements and maintain adequate management sys-

tems throughout the period of support. The pre-award process for non-competing continuation awards is

a streamlined version of this process, including an assessment of progress (see

Administrative Require-

ments—Monitoring—Reporting—Non-Competing Continuation Progress Reports

2.5.1 Just-in-Time Procedures

NIH uses Just-in-Time procedures for certain programs and award mechanisms (each NOFO will include

specific guidance on the use). These procedures allow certain elements of an application to be submitted

later in the application process, after review when the application is under consideration for funding. The

standard application elements include other support information (both active and pending) for senior/key

personnel; certification of IRB approval of the project’s proposed use of human subjects; verification of

IACUC approval of the project’s proposed use of live vertebrate animals; and evidence of compliance

with the education in the protection of human research participants requirement. Other program-specific

information may also be requested using this procedure. (Applications in response to RFAs also may be

subject to these procedures. The RFA will specify the timing and nature of required submissions.)

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Applicants will be notified (primarily by e-mail) when Just-in-Time information is needed. This noti-

fication is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Applicants should only submit this information when requested. Information must be submitted elec-

tronically using the Just-in-Time feature in the eRA Commons. In some circumstances the GMO may

ask for information in addition to the descriptions below, e.g., if the application involves hESCs and the

applicant did not identify a hESC from the NIH Registry in the application.

The requirement for applicants to verify the accuracy and validity of all administrative, fiscal, and pro-

grammatic information extends to information submitted through the Just-in-Time process. Applicants

are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-

Time information up to the time of award. This includes items such as Other Support changes that could

lead to budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for

the PD/PI(s) or any Senior/Key Personnel; or any changes in the use or approval of vertebrate animals or

human subjects. Similar to the NIH public policy requirements, applicants are responsible for estab-

lishing and maintaining the necessary processes to monitor its compliance and informing NIH of any

problems or concerns. Failure to address changes to Just-in-Time submissions prior to award does not

diminish the applicant’s responsibility to address changes post-award by submitting a prior approval

request to NIH in accord with Administrative Requirements—Changes in Project and Budget—NIH

Standard Terms of Award.

Other Support.

Information on other active and pending support will be requested as part of the Just-in-

Time procedures. Other support includes all resources made available to a researcher in support of and/or

related to all of their research endeavors, regardless of whether or not they have monetary value and

regardless of whether they are based at the institution the researcher identifies for the current grant. This

includes:

Resources and/or financial support from all foreign and domestic entities that are available to the

researcher. This includes but not limited to, financial support for laboratory personnel, and pro-

vision of high-value materials that are not freely available (e.g., biologics, chemical, model sys-

tems, technology, etc.). Institutional resources, such as core facilities or shared equipment that is

made broadly available, should not be included in Other Support, but rather listed under Facil-

ities and Other Resources.

Consulting agreements, when the PD/PI or other senior/key personnel will be conducting

research as part of the consulting activities and the activities fall outside of their appointment at

the applicant or recipient institution.

In-kind contributions, e.g., office/laboratory space, equipment, supplies, or employees or stu-

dents supported by an outside source. If the time commitment or dollar value of the in-kind con-

tribution is not readily ascertainable, the recipient must provide reasonable estimates.

Other support does not include training awards, prizes, or gifts. Gifts are resources provided where there

is no expectation of anything (e.g., time, services, specific research activities, money, etc.) in return. An

item or service given with the expectation of an associated time commitment is not a gift and is instead

an in-kind contribution and must be reported as Other Support.

Reporting of other support is required for all individuals designated in an application as senior/key per-

sonnel—those devoting measurable effort to a project. Each PD/PI or other senior/key personnel must

electronically sign their respective Other Support form prior to submission. This signature certifies that

the statements are true, complete, and accurate. Information on Other Support is not specifically reques-

ted for Program Directors, training faculty, and other individuals involved in the oversight of training

grants since applicable information is collected in other sections of a training grant application. It is also

not requested for individuals categorized as Other Significant Contributors.

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To promote compliance with all Other Support requirements, NIH requires recipients to establish and

maintain effective internal controls (e.g. policies, trainings, and procedures) to ensure that individuals

designated in applications as senior/key personnel fully disclose all Other Support information to their

institution as soon as it becomes known.

For Other Support submissions that include foreign activities and resources, recipients are required to

submit copies of contracts, grants, or any other agreement specific to senior/key personnel foreign

appointments and/or employment with a foreign institution as supporting documentation. If they are not

in English, recipients must provide translated copies. This does not include personal service contracts, or

employment contracts for fellows supported by foreign entities.

The supporting documentation must be provided as part of the Other Support PDF following the Other

Support Format page. See NIH Other Support page for forms, instructions, and other resources.

IC scientific program and grants management staff will review this information before award to ensure

the following:

Sufficient levels of effort are committed to the project.

There is no scientific, budgetary, or commitment overlap.

o

Scientific overlap occurs when (1) substantially the same research is proposed in more

than one application or is submitted to two or more funding sources for review and fund-

ing consideration or (2) a specific research objective and the research design for accom-

plishing the objective are the same or closely related in two or more applications or

awards, regardless of the funding source.

o

Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equip-

ment, salaries) are requested in an application but already are provided by another

source.

o

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent

(i.e., 12 person months), whether or not salary support is requested in the application.

o

Overlap, whether scientific, budgetary, or commitment of an individual’s effort greater

than 100 percent, is not permitted. Any overlap will be resolved by the IC with the

applicant and the PD/PI at the time of award

Only funds necessary for the approved project are included in the award.

Any foreign resources that meet the definition of a non-monetary foreign component have

received appropriate prior approval.

See

NIH Other Support

for format page, instructions and the

NIH disclosure table

Certification of IRB Approval.

If the proposed project involves human subjects research, a certification

to NIH that all non-exempt research involving human subjects has been reviewed and approved by an

appropriate IRB must be submitted. Pending or expired approvals are not acceptable. See Public Policy

Requirements/Human Subjects for additional information.

Verification of IACUC Approval.

If the proposed project involves research with live vertebrate animals,

verification of the date of IACUC approval of those sections of the application that involve use of ver-

tebrate animals along with any IACUC-imposed changes must be submitted. Pending or out-of-date

approvals are not acceptable. See Public Policy Requirements/Animal Welfare for additional inform-

ation.

Human Subjects Research Education Requirement.

If the proposed project involves human subjects

research, certification that any person identified as senior/key personnel involved in human subjects

I-83

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

research has completed an education program in the protection of human subjects must be submitted. See

Public Policy Requirements/Human Subjects/Education in the Protection of Human Research Par-

ticipants for additional information.

Human Embryonic Stem Cells (hESCs).

If the proposed project involves hESCs and the applicant did

not identify a hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line

(s) should be included in the Just-in-Time submission.

Genomic Data Sharing Institutional Certification

. If the proposed project involves research subject to

the Genomic Data Sharing policy for the generation of human genomic data (including within the Data

Management and Sharing Plan, as applicable), investigators must submit an Institutional Certification,

or, in some cases, a Provisional Institutional Certification. Institutional certification forms and directions

for completing them are available on the NIH GDS Data Sharing website. This certification must be sub-

mitted as a “Genome Data Sharing Certification” filein the eRA Commons Just-in-Time module.

SBIR / STTR Foreign Disclosure Form

For SBIR and STTR competing applications, applicants must

submit the Required Disclosure of Foreign Affiliations or Relationships to Foreign Countries form. See

NIH SBIR and STTR Foreign Disclosure requirements for more information. This form must be sub-

mitted as an “SBIR STTR Foreign Disclosure Form” file in the eRA Commons Just-in-Time module.

SBIR Funding Agreement Certification

For SBIR applicants, provide only upon request the SBIR

Funding Agreement Certification described in Section 2.18 of the Supplemental Grant Application

Instructions. The certification is available in fillable formats at:

https://grants.nih.gov/grants-pro-

cess/write-application/forms-directory/sbir-funding-agreement-certification

. This should be submitted as

an “Other Upload” in the eRA Commons Just-in-Time module.

STTR Funding Agreement Certification

For STTR applicants, provide only upon request the STTR

Funding Agreement Certification described in Section 2.19 of the Supplemental Grant Application

Instructions. The certification is available in fillable formats at:

https://grants.nih.gov/grants-pro-

cess/write-application/forms-directory/sttr-funding-agreement-certification

. This should be submitted as

an “Other Upload” in the eRA Commons Just-in-Time module.

My Bibliography Report of Publications.

For renewal applicants to research training programs, a My

Bibliography Report of Publications arising from work conducted by trainees while supported by the

training grant will be collected in the Interim/Final Research Performance Progress Report.

Other Information Requested by the Awarding IC.

NIH IC’s may also request additional Just-in-Time

information on a case-by-case basis, such as revised budgets or changes to the human subjects or ver-

tebrate animals sections of the application. If required, these changes must be submitted as an “Other

Upload” file in the eRA Commons Just-In-Time module.

2.5.2 Submitting Revised Project Summary/Abstracts, Specific Aims,

and/or Public Health Relevance Statement

When requested by NIH as part of the pre-award process, PD/PIs and the AOR should discuss potential

changes in scope with NIH PO and revise the Project Summary/Abstract, Specific Aims, and/or Public

Health Relevance sections of their application as appropriate. Once all issues are resolved, applicants

should e-mail a document with final versions of the revised sections to the IC-designated e-mail address

(normally a Program Official, Grants Management Official, or centralized e-mail box) as a single

Microsoft Word file only. Be reminded that all revised application information submitted to the NIH

must be approved by an AOR. Applicants should use

this template

. The template includes specific head-

ings that must be used for each section. All three headings must be included in the document that is sub-

mitted even if a particular section had no changes from the previous submission. If there are no changes

I-84

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

for a section include the header but leave the text area blank to ensure appropriate processing of this

information by NIH’s electronic systems.

2.5.3 Determining Applicant Organization Eligibility

All applicant organizations must complete the one-time eRA Commons registration process (

see

NIHGPS 2.2.1 eRA Commons Registration

) prior to submitting any application (paper or electronic) to

the NIH. During the registration process, NIH may make a preliminary assessment of applicant organ-

ization eligibility. In an effort to streamline the registration requirements and reduce the administrative

burden (i.e., time between registration submission and NIH’s final determination), NIH urges potential

applicants to consider the following eligibility considerations:

What is the nature of the research and business that your organization performs and how does

that fit within the NIH mission?

Is your organization professionally responsible for the research?

How many people are in your organization?

Are the researchers employed by your organization?

Where will the proposed research physically be conducted?

Can you identify a Notice of Funding Opportunity that you would apply for?

Has your organization applied to and/or been directly funded by any other Federal agency?

Applicants should be prepared to establish their eligibility to receive and administer all awards (that are

applied for), and NIH reserves the right to deny registration if an organization is determined not to be an

appropriate applicant for a particular NOFO. NIH will not accept forms or other documentation bearing

generic departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research).

All forms and documentation submitted to the NIH must reflect the name of the individual, electronic or

otherwise, with the appropriate institutional authority to submit such information.

NIH awards may be made only to eligible applicants. Continued funding is dependent on the recipient’s

continued eligibility. In general, domestic or foreign, public or private, non-profit or for-profit organ-

izations and individuals are eligible to receive NIH grants. However, on the basis of statutory, reg-

ulatory, or published policy limitations, under certain programs or types of awards, NIH may limit

eligibility to, or exclude from eligibility, classes or types of entities. Examples are limitations on the par-

ticipation of foreign entities, and programs under which only small businesses are eligible applicants.

The determination of eligibility includes verification of the applicant’s status. The applicant may be

required to provide proof of its status by submitting documentation; otherwise, the AOR’s signature on

the application certifies that the applicant is eligible to apply for and receive an award (e.g., a small busi-

ness applying under the SBIR or STTR programs).

In addition to reviewing organizational eligibility, NIH may consider other factors relating to the applic-

ant’s ability to responsibly handle and account for Federal funds and to carry out the project. These

factors include the applicant’s intended role in the project, the location where the project will be per-

formed, the role of the PD/PI in the project, and the PD/PI’s employment and citizenship status.

Although some of these same considerations are reviewed as part of the peer review, NIH’s concern at

this stage in the process is making an award to a legal entity that will be accountable for both the per-

formance of the approved project or activity and the appropriate expenditure of funds. NIH will not

make an award to an applicant that does not have a substantive role in the project and would simply

serve as a conduit for another entity.

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Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

2.5.4 Determining Eligibility of Individuals

It is the responsibility of the applicant organization to select the individuals who have the appropriate

expertise to manage the scientific and administrative aspects of the project. The eligibility of these indi-

viduals to complete the project will be evaluated during peer review and at the IC level by grants man-

agement and program staff.

The GMO will verify whether the proposed PD/PI or other senior/key personnel are debarred or sus-

pended from participation in Federal assistance programs (see

Public Policy Requirements and Object-

ives—Debarment and Suspension

for certification requirements).

Generally, PD/PIs and other personnel supported by NIH research grants are not required to hold any par-

ticular educational degree, and are not required to be U.S. citizens. However, some NIH pro-

grams/mechanisms have a citizenship requirement. Any citizenship requirement will be stated in the

NOFO. In these cases, individuals are required to have the appropriate citizenship status when the award

is made rather than when the application is submitted. For example, under most career development

awards or Kirschstein-NRSA individual fellowships, the individual to be trained must be a citizen or a

non-citizen national of the United States or have been lawfully admitted for permanent residence at the

time of award.

NIH requires the applicant to determine that individuals’ visas will allow them to remain in this country

long enough for them to be productive on the research project, but NIH does not provide guidance on or

assess the different types of visas. NIH expects recipient organizations to have policies, consistently

applied regardless of the source of funds, to address this area. If a grant is awarded and an individual’s

visa will not allow a long enough stay to be productive on the project, NIH may terminate the grant (see

Administrative Requirements—Changes in Project and Budget

and

Administrative Requirements—

Enforcement Actions—Suspension, Termination, and Withholding of Support

The eligibility requirements for trainees and additional eligibility requirements for fellows are addressed

Ruth L. Kirschstein National Research Service Awards

chapter in IIB.

In the post-award phase, NIH monitors changes in recipient and project status to ensure they meet legal

and programmatic requirements and takes actions necessary to protect the Federal government’s

interests.

2.5.5 Cost Analysis and Assessment of Management Systems

The GMO will ensure that a cost analysis is performed on any application that requires a detailed budget.

Cost analysis involves obtaining cost breakdowns, validating cost data, evaluating specific elements of

cost, and examining data to determine the necessity for, and the reasonableness and allowability of, the

costs included in the application budget. The extent of cost analysis will depend on the type of funding

instrument and award mechanism, the complexity of the project, prior experience with the applicant, and

other factors. Information on the applicable cost principles and on allowable and unallowable costs under

NIH grants is provided in the

Cost Considerations

chapter.

The amount of NIH funding is based on reasonable and allowable costs consistent with the principles of

sound cost management, considering IC priorities (e.g., program relevance), constraints on the growth of

average grant costs, and available funds.

In addition to considering the specific information provided in the application, the GMO determines the

adequacy of the applicant’s financial and business management systems that will support the expenditure

of and accountability for NIH funds. When an applicant has had no prior Federal grants or cost-reim-

bursement contracts, the GMO may review the applicant’s financial management and other management

I-86

Part I: NIH Grants - General Information

2 The National Institutes of Health as a Grant-Making Organization

systems before award, or within a reasonable time after award, to determine their adequacy and accept-

ability. For an applicant with prior NIH or other Federal cost-reimbursement awards, the GMO may

review recent audit reports and other relevant available information to determine whether the applicant’s

management systems meet the standards established in 2 CFR Part 200. The GMO will advise the applic-

ant if additional information is required. Based on the results of the review results, the GMO will determ-

ine the need for any corrective action and may impose specific award conditions on the award.

I-87

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

3 Overview of Terms and Conditions

PART II: TERMS AND CONDITIONS OF NIH GRANT

AWARDS

Subpart A: General

3 OVERVIEW OF TERMS AND CONDITIONS

Part II includes the terms and conditions of NIH grants and cooperative agreements and is incorporated

by reference in all NIH grant and cooperative agreement awards. Subpart A (IIA) includes those terms

and conditions that apply, in general, to NIH awards. Subpart B (IIB) either expands on IIA coverage or

specifies additional or alternate terms and conditions for particular types of awards, recipients, or activ-

ities.

These terms and conditions are not intended to be all-inclusive. All awards or a specified subset of

awards also may be subject to additional requirements, such as those included in executive orders and

appropriations acts.

NIH recipients are responsible for complying with all requirements of the Federal award.

NIH grants

awards are based on the application submitted to, and approved by, the NIH and are subject to the terms

and conditions incorporated either directly or by reference in the following:

The grant program legislation and program regulation cited in the NoA.

The NIH Grants Policy Statement, including addenda in effect as of the beginning date of the

budget period.

Conditions on activities and expenditure of funds in other statutory requirements, such as those

included in

appropriations acts

. This also includes any recent legislation.

2 CFR Part 200.

The NoA including all terms and conditions cited on the document or attachments.

Notice of requirements not specified in the NIHGPS generally will be provided in the NoA, but such

notice is not required for the award to be subject to the requirements of pertinent statutes and regulations.

An individual award also may contain award-specific terms and conditions. For example, the GMO may

include terms or conditions necessary to address concerns about an applicant’s management systems.

Program and administrative policies and the terms and conditions of individual awards are intended to

supplement, rather than substitute for, governing statutory and regulatory requirements. Thus, the require-

ments of the NIHGPS apply in addition to governing statutory and regulatory requirements not cited

herein, and award-specific terms apply in addition to the requirements of the NIHGPS.

This NIHGPS is an aid to the interpretation of statutory and regulatory requirements. These terms and

conditions are intended to be compliant with governing statutes and the requirements of 2 CFR Part 200,

as modified by previously approved waivers and deviations. However, in the case of a conflict, the stat-

utes and regulations govern.

If there is a perceived conflict between or among these three categories of requirements—statutory and

regulatory requirements, the terms and conditions in the NIHGPS, and award-specific terms and con-

ditions—or if the recipient has other questions concerning award terms and conditions, the recipient

IIA-1

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

3 Overview of Terms and Conditions

should request written clarification from the GMO. This may be done at any time; however, if the inclu-

sion of the term or condition would cause the recipient not to accept the award or to be unable to com-

ply, the question should be raised before funds are requested from the HHS payment system. By drawing

funds from the HHS payment system, the recipient agrees to the terms and conditions of the award.

3.1 FEDERALWIDE STANDARD TERMS AND CONDITIONS

FOR RESEARCH GRANTS

In order to create greater consistency in the administration of Federal research awards, all Federal

research agencies now utilize a standard core set of administrative terms and conditions on research and

research-related awards that are subject to 2 CFR Part 200, to the extent practicable. The core set of

administrative requirements for participating Federal research agencies and other pertinent documents

are posted on the

National Science Foundation's web site

. Recipients are encouraged to review the com-

panion documents which include a Prior Approval Matrix, National Policy Requirement Matrix,

Subaward Requirement Matrix, and Agency-Specific Requirements. NIH implementation of these Feder-

alwide research terms and conditions is also known as the "NIH Standard Terms of Award".

See

Administrative Requirements—Changes in Project and Budget—NIH Standard Terms of Award

for

more details.

IIA-2

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4 PUBLIC POLICY REQUIREMENTS, OBJECTIVES

AND OTHER APPROPRIATION MANDATES

NIH grants are subject to requirements intended to ensure that recipient organizations handle their

Federal awards responsibly. Recipients are required to adopt and enforce policies that minimize the

opportunity for improper financial gain on the part of the organization, its employees, and organizations

and individuals whom they may collaborate, and that limit the potential for research results to be tainted

by possible financial or other gain. In addition, NIH recipients are expected to provide safe and healthful

working conditions for their employees and foster work environments conducive to high-quality

research.

This chapter addresses public policy requirements, objectives, and other appropriation mandates applic-

able to NIH awards. The term “public policy” indicates that the requirement is based on social, eco-

nomic, or other objectives or considerations that may be attached to the expenditure of Federal funds by

recipients, subrecipients, and contractors, in general, or may relate to the expenditure of Federal funds

for research or other specified activities.

In addition to cross-cutting requirements that some or all Federal agencies must apply to their grant pro-

grams, NIH recipients and subrecipients are subject to requirements contained in the HHS annual appro-

priations act that apply to the use of NIH grant funds, applicable provisions in other Federal agencies’

appropriations acts, including Treasury, and other Federal statutes. Some of those requirements are

included here in a separate section titled Appropriation Mandates since they have been included in the

appropriations acts for several years with little or no change. Those requirements may be changed or

other requirements may be added in the future.

The public policy requirements, objectives, and appropriation mandates listed in Exhibit 4 apply to all

NIH awards with exceptions as noted.

4.1 PUBLIC POLICY REQUIREMENTS AND OBJECTIVES

NIH intends to uphold high ethical, health, and safety standards in both the conduct of the research it

funds and the expenditure of public funds by its recipients. The public policy requirements specified in

this section set many of those standards. NIH will not accept forms or other documentation bearing gen-

eric departmental signatures or their electronic equivalent (e.g., Department of Sponsored Research). All

forms and documentation submitted to NIH must reflect the name of the individual, electronic or oth-

erwise, with the appropriate institutional authority to submit such information. The signature of the AOR

on the application certifies that the organization complies, or intends to comply, with all applicable

policies, certifications and assurances referenced (and, in some cases, included) in the application instruc-

tions. The policies, certifications and assurances listed in this section may or may not be applicable to

the project, program, or type of applicant organization. Requirements / objectives are listed in alpha-

betical order.

As noted in this section, some requirements may necessitate the submission of a separate document (e.g.,

human subjects assurance, certification of IRB approval or institutional exemption, civil rights assur-

ance). Applicants and recipients should take particular note of these requirements (for example, see spe-

cific sections on

Human Subjects Protections

and

Civil Rights Protections

), the absence or inadequacy of

which may delay an award or render an applicant ineligible for award.

IIA-3

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The recipient is responsible for: 1) establishing and maintaining the necessary processes to monitor its

compliance and that of its employees, consortium participants, and contractors with these requirements;

2) taking appropriate action to meet the stated objectives; and, 3) informing NIH of any problems or con-

cerns.

If a grant is awarded on the basis of false or misrepresented information, or if a recipient does not com-

ply with these public policy requirements, NIH may take any necessary and appropriate action, including

using any of the remedies described in

Administrative Requirements—Enforcement Actions

or other

available legal remedies.

Exhibit 4 contains information to help the recipient determine what public policy requirements, object-

ives and appropriations mandates apply to its activities and whether a requirement should be included in

a consortium agreement or a contract for routine goods or services under the grant (see

Glossary

in Part I

for definitions). The exhibit distinguishes between these types of transactions under a grant and indicates

(by “Y” for Yes or “NA” for Not Applicable) whether a given requirement normally would apply.

However, even if the exhibit indicates that a requirement is not applicable that requirement potentially

could be applicable in a specific situation, e.g., if a contract under a grant involves research activity.

Therefore, this exhibit should be used as general guidance only. The recipient should consult the terms

and conditions of its award and should contact the GMO if it has any question concerning the applic-

ability of a particular public policy requirement or objective.

Exhibit 4 also indicates where, in the NIHGPS, the individual public policy requirements, objectives and

appropriation mandates are covered in more detail. The recipient should also consult its attorney, as

appropriate, regarding particular questions about the governing statute or regulation as applied to its spe-

cific circumstances. Other cited policies or documents may provide additional information.

Foreign direct recipients or those under a collaborative international award structure, must follow the

recipient requirements in Exhibit 4, except when noted as not applicable to foreign awards, awards under

a collaborative international award structure nor foreign component. Additional guidance on public

policy requirements and objectives and their applicability to foreign awards is covered in NIHGPS

Chapter 16.4

In addition to the requirements addressed in this section, there are applicable NIH administrative require-

ments outlined in the

Administrative Requirements

chapter.

Some programs may have special requirements and are covered in IIB.

Exhibit 4. Public Policy Requirements, Objectives and Appropriation Mandates *

IIA-4

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

Military Recruiting and ROTC Pro-

gram Access to Institutions of

Higher Education

4.1.19

Seat Belt Use

4.1.28

Labor Standards under Federally

Assisted Construction

10.5.3

(Construction Grants

and major A&R Con-

tracts Exceeding

$100,000)

Smoke-Free Workplace

4.1.29

Drug-Free Workplace

4.1.7

Flood Disaster Protection Act of

1973 –- Flood Insurance

10.10.1

(Construction grants

only)

National Environmental Policy Act

of 1969 (including Public Dis-

closure)

4.1.20

and

10.10.1

Intergovernmental Review of

Federal Programs under EO 12372

10.10.1

(Construction grants

only)

Uniform Relocation Assistance and

Real Property Acquisition Policies

Act of 1970

10.10.1

Standards of Conduct

4.1.30

Federal Funding Accountability

and Transparency Act (FFATA)

4.1.8

and

8.4.1.5.5

If under $30,000

President’s Emergency Plan for

AIDS Relief (PEPFAR Program

4.1.22

Nondelinquency on Federal Debt

4.1.21

IIA-5

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

National Historic Preservation Act

of 1966 — Archaeological and His-

toric Preservation Act of 1974

10.10.1

(Construction Grants;

any award involving

major or minor A&R,

or any work resulting

in physical changes to

real property)

Lead-Based Paint Poisoning Pre-

vention Act

10.10.1

(Construction grants

only)

Investigational New Drug Applic-

ations/Investigational Device

Exceptions

4.1.16

Inclusion of Women/Minorities as

Subjects in Clinical Research

4.1.15.8

Metric System

4.1.18

and

10.10

Lobbying (Appropriation Mandate)

4.2.6

Limited English Proficiency

4.1.2.5

Pro-Children Act of 1994

4.1.23

Safe Drinking Water Act

10.10.1

(Construction grants

only)

Salary Limitation/Cap (Appro-

priation Mandate)

4.2.10

Restriction on Distribution of Sterile

Needles (Appropriation Mandate)

4.2.9

Select Agents (see Public Health

Security & Bioterrorism Pre-

paredness and Response Act)

4.1.24.1.1

USA Patriot Act

4.1.33

U.S. Flag Air Carriers

7.9.1

IIA-6

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

Text Messaging While Driving

4.1.31

Restriction on Abortions & Excep-

tions (Appropriation Mandates)

4.2.8

4.2.8.1

Wild and Scenic Rivers Act of 1968

10.10.1

(Construction grants

only)

Protection of Wetlands (EO 11990)

10.10.1

(Construction grants

only)

Promotion or Legalization of Con-

trolled Substances (Appropriation

Mandate)

4.2.7

Public Health Security and Bio-

terrorism Preparedness and

Response Act (Select Agents)

4.1.24.1.1

Research Misconduct

4.1.27

Research Involving Recombinant

or Synthetic Nucleic Acid

Molecules

4.1.26

Reporting and Assurance Require-

ments for Institutions Receiving

Awards for Training of Graduate

Students for Doctoral Degrees

4.1.25

Inclusion of Individuals Across the

Lifespan as Participants in

Research

4.1.15.7

Copeland Act, when required by

statute

10.10.1

(Construction grants

only)

Controlled Substances

4.1.5

IIA-7

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

Conservation of Petroleum and

Natural Gas (EO 12185)

10.10.1

(Construction grants

only)

Data and Safety Monitoring

4.1.15.6

Dual Use Research of Concern

4.1.24.2

Dissemination of False or Delib-

erately Misleading Information

(Appropriation Mandate)

4.2.3

Davis-Bacon Act, when required by

statute

10.10.1

(Construction grants

only)

Confidentiality of Alcohol and Drug

Abuse Patient/Client Records

4.1.4.2

Architectural Barriers Act of 1968

10.10

(Construction grants

and any grant

involving major A&R)

Animal Welfare

4.1.1

Acknowledgment of Federal

Funding (Appropriation Man-

date)

4.2.1

Certificates of Confidentiality

4.1.4.1

Coastal Zone Management Act of

1972

10.10

(Construction grants

only)

Clinical Trials.gov

4.1.3

Clean Air and Clean Water Act

10.10.1

(Construction grants

only); for contracts

exceeding $100,000

IIA-8

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

Earthquake Hazards Reduction

Act of 1977 and Seismic Safety of

Federal and Federally Assisted or

Regulated New Building Con-

struction (EO 12699)

10.10

(Construction grants

only)

Human Subjects Protections

4.1.15

Gun Control

4.2.4

Fly America Act

4.1.11

Hotel and Motel Fire Safety Act of

1990

14.6.1

(Conference Grants

Only)

Human Fetal Tissue Research

(Including Transplantation

Research)

4.1.14

Human Stem Cell Research

4.1.13

Human Embryo Research and

Cloning Ban (Appropriation Man-

date)

4.2.5

Health and Safety Regulations and

Guidelines

4.1.12

Endangered Species Act of 1973

10.10.1

(Construction grants

only)

Equal Employment Opportunity

10.5

(Construction grants

and any grant

involving major A&R)

If under $10,000

Financial Conflict of Interest

4.1.10

(NA to Phase I of the

SBIR/STTR programs

and to Federal insti-

tutions)

Federal Information System Secur-

ity Management Act

4.1.9

IIA-9

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Requirement, Objective, or

Appropriation Mandate

Recipient

Domestic

Subaward / Subre-

cipient

Contractor under

Grant (routine good-

s/services)

Age Discrimination Act of 1975

4.1.2.4

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

Civil Rights Act of 1964 (Title VI)

4.1.2.1

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

Health Insurance Portability and

Accountability Act (HIPAA)

4.1.4.3

(if a covered entity)

Debarment and Suspension

4.1.6

(NA to certain foreign

organizations)

(NA to certain for-

eign organizations)

If contract equals or

exceeds $25,000 (NA

to certain foreign

organizations)

Education Amendments of 1972

(Title IX)

4.1.2.2

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

Rehabilitation Act of 1973 (section

504)

4.1.2.3

and

10.10.1

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

(NA to foreign and

international organ-

izations)

Lobbying (Federalwide Cer-

tification)

4.1.17

(Certification required

if total costs expected

to exceed $100,000)

(Certification

required if greater

than $100,000 only)

(Certification required

on contracts greater

than $100,000 only)

Trafficking in Persons

4.1.32

(Private entities)

Never Contract with the Enemy

4.1.36

Prohibition on Certain Tele-

communications and Video Sur-

veillance Services or Equipment

4.1.37

IIA-10

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

* NA: A designation of NA in this table indicates that a particular requirement does not apply to an

otherwise eligible recipient, consortium participant, or contractor or may not apply because the type

of activity covered is one not normally performed by such an entity.

Please note that the core set of National Policy Requirements for participating Federal research agencies

is maintained by the National Science Foundation and is

posted on Research Terms and Conditions web-

site

4.1.1 Animal Welfare Requirements

The

Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

(PHS Policy)

requires that an approved Animal Welfare Assurance be on file with the Office of Laboratory Animal

Welfare (OLAW) at the time of award for all organizations involved in PHS-conducted or supported

activities involving live vertebrate animals. This requirement includes organizations that are award recip-

ients and organizations that serve as performance sites where animal activities will be conducted. Recip-

ient organizations must establish appropriate policies and procedures to ensure the humane care and use

of animals and bear ultimate responsibility for compliance with the PHS Policy in all PHS supported

activities.

The PHS Policy incorporates the

U.S. Government Principles for the Utilization and Care of Vertebrate

Animals used in Testing, Research, and Training

, and requires the recipient to maintain an animal care

and use program based on the Guide for the Care and Use of Laboratory Animals. An Institutional

Animal Care and Use Committee (IACUC) appointed by the Chief Executive Officer or designee, is fed-

erally mandated to oversee the organization’s animal program, facilities, and procedures (Public Law 99-

158, Sec. 495). Organizations in foreign countries must also comply with the PHS Policy on Humane

Care and Use of Laboratory Animals or may provide evidence to the PHS (i.e. NIH) that acceptable

standards for the humane care and use of the animals in PHS-conducted or supported activities will be

met per Section II of the PHS Policy.

The PHS Policy defines “animal” as any live, vertebrate animal used or intended for use in research,

research training, experimentation, biological testing or related purposes.

Applications from organizations proposing the use of animals are incomplete if they do not thoroughly

address the use of vertebrate animals required in the Research Plan of the application. If the involvement

of animals is not yet known and cannot be described in the application at the time of application, the

applicant should provide an explanation and indicate when it is anticipated that animals will be used. If

an award is made, prior to conducting any animal activities the recipient must submit to the NIH award-

ing IC for prior approval the detailed information about the use of animals as required in the Research

Plan of the application and meet the Assurance and IACUC approval requirements of the PHS Policy.

Noncompeting and competing awards are prohibited from using NIH funds to procure cats from USDA

Class B dealers. The procurement of cats may only be from USDA Class A dealers or other approved

legal sources.

NIH funds may not be used to procure or support the use of dogs from Class B dealers. Dogs used in

NIH-supported research may only be from USDA Class A dealers or other approved legal sources. Any

costs incurred in violation of this policy are unallowable and will be subject to a cost disallowance.

No activities with live vertebrate animals may begin and no costs for activities with live vertebrate anim-

als may be charged to NIH if there is not a valid Animal Welfare Assurance and IACUC approval of the

activity.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The PHS Policy does not supersede applicable State or local laws or regulations that impose more strin-

gent standards for the care and use of animals in research. All recipient organizations are required to

comply, as applicable, with the regulations (9 CFR, Subpart A) issued by the U.S. Department of Agri-

culture under the Animal Welfare Act, as amended, 7 U.S.C. 2131 et seq., and other Federal statutes and

regulations relating to animals.

4.1.1.1 Animal Welfare Assurance Requirements

An Animal Welfare Assurance is the document submitted by an institution assuring institutional com-

pliance with the PHS Policy. OLAW is responsible for requesting, negotiating, approving or dis-

approving, and, as necessary, restricting or withdrawing approval of Assurances.

When an applicant institution does not have an Animal Welfare Assurance, the Authorized Organization

Representative's signature on the application constitutes declaration that the institution will submit an

Assurance when requested by OLAW. Upon such request, the institution shall prepare the Assurance as

instructed by OLAW and in accordance with the PHS Policy, and the authorized IACUC shall review

those components of the application related to the care and use of animals. Except in certain cir-

cumstances, the Assurance must be submitted to and approved by OLAW in order for the IC to award

the grant. No activities with live vertebrate animals may be conducted and no costs for activities with

live vertebrate animals may be charged to NIH grants in the absence of a valid Assurance on file with

OLAW.

Organizations where live, vertebrate animal work is performed onsite (i.e., serve as an animal per-

formance site) must have an approved Domestic or Foreign Assurance. If the pass-through entity does

not have an approved Domestic or Foreign Assurance and the animal activities will be conducted at an

Assured institution named as a performance site, the recipient must obtain an Interinstitutional Assurance

from OLAW. Under the Interinstitutional Assurance, the recipient and performance site agree that the

research will be conducted under the auspices and program of animal care and use of the performance

site's Assurance.

4.1.1.2 Verification of IACUC Approval

NIH will delay an award for research involving live vertebrate animals until the recipient organization

and all performance sites are operating in accordance with approved Animal Welfare Assurances and the

recipient has provided verification of IACUC approval of those sections of the application that involve

use of vertebrate animals. IACUC approval must have been granted not more than three years prior to

the budget period start date to be valid; however, IACUCs may determine that continuing review on a

more frequent basis is appropriate.

Verification of IACUC approval may be filed at any time before award in accord with Just-in-Time pro-

cedures, unless required earlier by the IC. Therefore, following peer review and notification of impact

score/percentile, applicant organizations with approved Assurances may wish to proceed with IACUC

review for those applications that have not yet received IACUC approval and that appear to be in a fund-

able range.

It is an institutional responsibility to ensure that the research described in the application is congruent

with any corresponding protocols approved by the IACUC. The applicant verifies that there is con-

gruence between the application and the IACUC-approved protocol when it provides the IACUC

approval date.

No costs for activities with live vertebrate animals may be charged to NIH grants if there is not a valid

IACUC approval.

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1.1.3 Consortiums

Under consortium (subaward) agreements in which the recipient collaborates with one or more other

organizations, the recipient, as the direct and primary recipient of NIH grant funds, is accountable for the

performance of the project, the appropriate expenditure of grant funds by all parties, and all other oblig-

ations of the recipient as specified in the NIHGPS (see

Consortium Agreements

chapter in IIB). The

animal welfare requirements that apply to recipients also apply to consortium participants and sub-

projects.

The primary recipient is responsible for including these requirements in its agreements with col-

laborating organizations, and for ensuring that all sites engaged in research involving the use of live ver-

tebrate animals have an approved Animal Welfare Assurance and that the activity has valid IACUC

approval. The approval of more than one IACUC is not required if the recipient and performance site(s)

have Assurances; the institutions may exercise discretion in determining which IACUC reviews research

protocols and under which institutional program the research will be conducted.

The recipient is further responsible for complying with NIH prior approval requirements related to the

addition of sites not included in the approved application (see

Administrative Requirements—Changes in

Project and Budget—Prior Approval Requirements

The list of domestic and foreign organizations with a PHS approved animal welfare assurance is avail-

able on OLAW’s

website

4.1.1.4 Foreign Recipients and Foreign Performance Sites

Foreign recipients that will perform live, vertebrate animal activity onsite must provide OLAW with an

Animal Welfare Assurance for Foreign Institutions. This constitutes institutional assurance and cer-

tification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which

the research will be conducted, and a commitment to follow the

International Guiding Principles for

Biomedical Research Involving Animals

. IACUC approval is not required of foreign recipients; how-

ever, OLAW encourages foreign recipients to use the standards in the

Guide for the Care and Use of

Laboratory Animals

When the recipient is a domestic institution and animal performance sites are foreign, the IACUC

approval requirement applies. Accordingly, the domestic recipient remains responsible for animal activ-

ities conducted at the foreign site and must provide verification of IACUC approval (i.e., certification

that the activities as conducted at the foreign performance site are acceptable to the recipient). The recip-

ient IACUC may accept, as its own, the approval of a foreign organization's animal welfare committee or

oversight body; however, the domestic recipient IACUC remains responsible for the review. Addi-

tionally, the foreign animal performance site must obtain an Animal Welfare Assurance for Foreign Insti-

tutions as described in the preceding paragraph.

4.1.1.5 Reporting to OLAW

Reporting requirements under the PHS Policy include an annual report to OLAW describing any change

in the institution's program for animal care and use as described in the Assurance, changes in IACUC

membership, and the dates the IACUC conducted its semiannual evaluations of the institution's program

and facilities. The IACUC, through the institutional official signing the Assurance, must promptly report

any serious or continuing noncompliance with the PHS Policy, serious deviations from the Guide for the

Care and Use of Laboratory Animals, and any IACUC suspensions.

Charges to NIH grant awards for the conduct of live vertebrate animal activities during periods of time

that the terms and conditions of the grant award are not upheld are not allowable. Specific situations

under which charges are not allowable are:

IIA-13

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

1. The conduct of animal activities in the absence of a valid Animal Welfare Assurance on file with

OLAW.

2. The conduct of animal activities in the absence of a valid IACUC approval of the activities.

Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or sus-

pension of IACUC approval.

Instances of serious noncompliance with section IV.F.3. of the PHS Policy, such as those mentioned

above, are to be reported to OLAW and the IC supporting the grant award. In cases where charges have

been made for unauthorized animal activities, appropriate adjustments must be made to the grant to

remove those charges. NIH requires that reports contain a certification that no unallowable costs were

charged to NIH grant funds during a period of noncompliance. If such a certification cannot be made, a

detailed accounting of unallowable charges made to each affected grant should be included with the

report. If a detailed accounting has not been completed at the time of reporting, a date when it will be

provided should be included.

NIH expects recipients to continue to maintain and care for animals during periods when animal activ-

ities are conducted in the absence of a valid Animal Welfare Assurance and/or IACUC approval. ICs

may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis.

Consultation with the IC is encouraged regarding questions concerning allowable costs.

Information about the PHS Policy, Animal Welfare Assurances, and other relevant topics is available on

the OLAW

website

4.1.2 Civil Rights Protections

Recipients are required to administer NIH-funded projects in compliance with federal civil rights laws

that prohibit discrimination on the basis of race, color, national origin, disability, age, and sex, which

includes discrimination on the basis of pregnancy, and comply with applicable conscience protections.

Before NIH may make an award to a domestic organization, the AOR must certify, by means of the sig-

nature on the application, that the organization has on file with the HHS OCR a one-time Assurance of

Compliance with the statutes described in this subsection. The Assurance, HHS Form 690, is filed for the

organization and is not required for each application. If the application has been recommended for fund-

ing and the applicant organization does not have an Assurance of Compliance on file, it will receive the

required form and instructions for completion and submission from the awarding IC. The HHS Form 690

also is available from

GrantsInfo@nih.gov

or by telephone at 301-435-0714.

Domestic organizations that receive funding from recipients (including consortium participants and con-

tractors under grants) rather than directly from NIH, also are required to file an HHS 690. The applic-

ant/recipient is responsible for determining whether those organizations have the required Assurance on

file and, if not, ensuring that it is filed with OCR. This includes ensuring that entities take meaningful

steps to ensure effective communication with all persons, including those with disabilities. The HHS

Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.

4.1.2.1 Civil Rights Act of 1964

Title VI of the Civil Rights Act of 1964 provides that no person in the United States shall, on the

grounds of race, color, or national origin, be excluded from participation in, be denied the benefits of, or

be subjected to discrimination under any program or activity receiving Federal financial assistance. The

HHS implementing regulations are codified at 45 CFR Part 80.

IIA-14

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1.2.2 Educational Amendments of 1972

Title IX of the Education Amendments of 1972 provides that no person in the United States shall, on the

basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to dis-

crimination under any educational program or activity receiving Federal financial assistance. The HHS

implementing regulations are codified at 45 CFR Part 86.

4.1.2.3 Rehabilitation Act of 1973

Section 504 of the Rehabilitation Act of 1973, as amended, provides that no otherwise qualified han-

dicapped individual in the United States shall, solely by reason of the physical or mental impairment, be

excluded from participation in, be denied the benefits of, or be subjected to discrimination under any pro-

gram or activity receiving Federal financial assistance. These requirements pertain to the provision of

benefits or services as well as to employment. The HHS implementing regulations are codified at 45

CFR Parts 84 and 85.

4.1.2.4 Age Discrimination Act of 1975

The Age Discrimination Act of 1975 prohibits discrimination on the basis of age in any program or activ-

ity receiving Federal financial assistance. The HHS implementing regulations are codified at 45 CFR

Part 91.

4.1.2.5 Limited English Proficiency

HHS provides guidance on the obligations of recipients to provide meaningful access to health and social

services on the

Limited English Proficiency (LEP) page of the HHS website.

A program of language

assistance should provide for effective communication between the service provider and the person with

limited English proficiency to facilitate participation in, and meaningful access to, services.

4.1.2.6 Nondiscrimination in Health Programs or Activities

The Patient Protection and Affordable Care Act (ACA) (42 U.S.C. 18116) prohibits discrimination on

the basis of race, color, national origin, sex, age, and disability in certain health programs and activities.

Section 1557 provides that, except as otherwise provided in title I of the ACA, an individual shall not, on

the grounds prohibited under title VI of the Civil Rights Act of 1964, title IX of the Education Amend-

ments of 1972, the Age Discrimination Act of 1975, or section 504 of the Rehabilitation Act of 1973, be

excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any

health program or activity, any part of which is receiving Federal financial assistance, including credits,

subsidies, or contracts of insurance, or under any program or activity that is administered by an exec-

utive agency or any entity established under title I of the ACA. This applies to health programs or activ-

ities administered by recipients of Federal financial assistance from NIH. The HHS implementing

regulations are codified at 45 CFR Part 92.

4.1.3 Clinical Trials Registration and Reporting in ClinicalTrials.gov

Requirement

4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

For grant applications that request support for the conduct of a clinical trial, the NIH Policy on Dis-

semination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded

recipients and investigators conducting clinical trials, funded in whole or in part by NIH, will ensure that

their clinical trials are registered at, and that summary results information is submitted to, Clin-

icalTrials.gov for public posting. The purpose of the policy is to promote broad and responsible

IIA-15

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Disseminating

this information supports the NIH mission to advance the translation of research results into knowledge,

products, and procedures that improve human health.

Effective May 25, 2026, Basic Experimental Studies in Humans (BESH) are no longer considered clin-

ical trials by the NIH. BESH studies must follow all other applicable clinical research laws, regulations,

and policies, including, but not limited to human subjects protections and the NIH Data Management and

Sharing Policy.

This policy is complementary to requirements in the Clinical Trial Registration and Results Information

Submission regulation at 42 CFR Part 11, hereinafter referred to as the regulation.

This policy applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or

whether they are subject to the regulation. For example, NIH-funded phase 1 clinical trials of an FDA-

regulated product are covered by this policy as are clinical trials studying interventions not regulated by

the FDA, such as behavioral interventions. As such, the policy encompasses all NIH-funded clinical tri-

als, including applicable clinical trials subject to the regulation. All NIH-funded clinical trials will be

expected to register and submit results information to ClinicalTrials.gov according to the timelines

described in the regulation.

This policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive

NIH funds to support its conduct.

Applicants seeking NIH funding for clinical trials will be required to submit a plan that will address how

the expectations of this policy will be met. Recipients and investigators conducting clinical trials funded

in whole or in part by NIH are required to comply with all terms and conditions of award, including fol-

lowing their plan for the dissemination of NIH-funded clinical trial information.

The signature of the AOR on the grant application or progress report form certifies that, for any clinical

trials funded under the NIH award, the recipient and all investigators are in compliance with the recip-

ient’s clinical trial information dissemination plan.

Responsibilities of recipients and investigators will fall within one of the following three categories:

1. If the NIH-funded clinical trial is an applicable clinical trial under the regulation and the recip-

ient is the responsible party, the recipient will ensure that all regulatory requirements are met.

2. If the NIH-funded clinical trial is an applicable clinical trial under the regulation but the recip-

ient is not the responsible party, the recipient will coordinate with the responsible party to ensure

that all regulatory requirements are met.

3. If the NIH-funded clinical trial is not an applicable clinical trial under the regulation, the recip-

ient will be responsible for carrying out the tasks and meeting the timelines described in reg-

ulation. Such tasks include registering the clinical trial in ClinicalTrials.gov and submitting

results information to ClinicalTrials.gov.

Recipients of NIH funding conducting non-exempt research involving human subjects research subject to

the revised Common Rule and conducting a clinical trial as defined in 45 CFR Part 46.102(b) should be

aware that for each funded trial, one IRB-approved consent form must be posted on a designated public

federal website in accordance with 45 CFR Part 46.116(h). The forms must be posted on a designated

public federal website after recruitment closes and no later than 60 days after the last study visit by any

subject, as required by the protocol. More information about these requirements is available

on Posting

Clinical Trial Informed Consent Forms webpage.

NIH-funded recipients using an English-language informed consent form to enroll par-

ticipants may either:

IIA-16

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Submit an IRB-approved English-language informed consent form to ClinicalTrials.gov. Documents

that are uploaded to ClinicalTrials.gov should be uploaded in accordance with

these instructions

. Clin-

icalTrials.gov does not currently support upload of non-English documents. Or:

Submit an IRB-approved informed consent form to Regulations.gov following the instructions in the

paragraph below. NIH recipients submitting informed consent forms to Regulations.gov must main-

tain a copy of their Regulations.gov receipt and tracking number and make it available to NIH upon

request.

NIH-funded recipients using only non-English informed consent forms to enroll par-

ticipants:

Submit an IRB-approved informed consent form to Docket ID: HHS-OPHS-2018-0021 on the Regu-

lations.gov website in accordance with

guidance issued by the Office for Human Research Pro-

tections

. NIH recipients submitting informed consent forms to Regulations.gov must maintain a copy

of their Regulations.gov receipt and tracking number and make it available to NIH upon request.

Institutions submitting documents to either ClinicalTrials.gov or Regulations.gov must protect participant

privacy in accordance with applicable federal, state, and local laws and regulations (e.g., the HIPAA Pri-

vacy Rule, Certificates of Confidentiality) and any applicable terms of their NIH award.

Each NIH-funded clinical trial should have only one entry in ClinicalTrials.gov that contains its regis-

tration and results information. Recipients need not and should not create a separate record of the applic-

able clinical trial to comply with this policy.

4.1.3.2 Food and Drug Administration Amendments Act (FDAAA)

Applicants and recipients should familiarize themselves with the requirements of 42 U.S.C. 282(j), also

known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA), as imple-

mented in regulation by 42 CFR Part 11, with respect to registration and results, information submission

requirements that apply to certain clinical trials. Of particular note is that, in general, results information

of applicable clinical trials are due not later than 12 months after the primary completion date. If this

date occurs after the period of performance has ended, results information submission is still required in

accordance with FDAAA and the terms and conditions of grant award.

The signature of the AOR on the grant or progress report form certifies that, for applicable clinical trials

funded in whole or part by the award, the responsible party has made all registration and results sub-

missions required by 42 CFR Part 11.

4.1.3.3 Good Cause Extension (GCE) Request Requirements

Section 402(j) of the Public Health Service Act (PHS Act) and the Final Rule for Clinical Trials Regis-

tration and Results Information Submission establish requirements and deadlines for the submission of

clinical trial results information for Applicable Clinical Trials (ACTs). In general, the standard sub-

mission deadline for clinical trials results information is no later than 1 year after the primary completion

date. However, in rare instances, a good cause extension (GCE) request may be sought for the following

categories of trials:

ACTs that are subject to the Final Rule (42 CFR 11.42).

NIH Clinical trials subject to the complementary policy in Section 4.1.3.1.

Therefore, GCE requests must be submitted through the ClinicalTrials.gov Protocol Registration and Res-

ults System (PRS) prior to (i.e., the day before) the standard submission deadline or granted extended

deadline. Late submissions, or requests submitted outside of the PRS, will not be accepted. If NIH

IIA-17

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

determines the request does not constitute “good cause,” the GCE request will be denied. If the request is

denied, the responsible party must either (1) submit clinical trial results information by the later of the

date on which clinical trial results information would otherwise be due, or 30 calendar days after the date

that the PRS GCE denial notification was issued by NIH; or (2) submit an appeal.

Special Considerations for NIH Recipients

For NIH-funded and supported clinical trials, recipients should be aware that any GCE request could

impact other aspects of the grant award. Therefore, the submission of a “Request for an Extension for

Good Cause” does not constitute a prior approval request submission (e.g., No Cost Extension and Carry-

over).

Each GCE request must include

1. a complete description of the reason(s) why clinical trial results information cannot be provided

according to the deadline, with sufficient detail to justify good cause for the extension and to

allow for the evaluation of the request; and

2. an estimated date on which the clinical trial results information will be submitted.

Extension requests will be evaluated on a case-by-case basis using the following general criteria to sup-

port a determination of "good cause." These include, but are not limited to:

General Criteria:

1. The circumstances and their impact leading to the GCE request, including steps the responsible

party is taking to mitigate the impact of those circumstances.

2. The extent to which the factors underlying the GCE request are outside of the responsible party’s

control.

3. What steps will be taken during the requested extension, why they are necessary to mitigate the

circumstances leading to the GCE request, and whether the requested submission date is com-

mensurate with the explanation provided in the request.

4. Whether information is internally consistent with relevant data element definitions and is con-

sistent with information provided in other sections of the study record.

5. The number of, and explanations for, previous GCE request(s), and the proposed reporting dead-

line in previous requests.

General Formatting Criteria and Considerations:

1. The request must be in English.

2. Acronyms and abbreviations should be spelled out, with the acronym or abbreviation provided in

parentheses immediately after, at least the first time they are used in the request.

3. The responsible party should not include specific personal health information in the request.

Sufficient detail should be provided, including the steps that will be taken to meet the estimated sub-

mission date, a description of mitigating steps to avoid future delay, and any other information needed to

address the criteria listed above. Requests that do not provide sufficient information may be denied.

More than one GCE request may be submitted for the same ACT or NIH Clinical Trial after a previous

GCE request was granted. When a GCE is granted, the results submission deadline is updated to align

with the approved extension. Any subsequent GCE request must be submitted prior to the granted exten-

ded deadline.

Appeals

IIA-18

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Responsible parties or Recipients, as appropriate, may appeal denied GCE requests or the NIH-identified

earlier deadline specified in a granted extension request. An appeal must provide an explanation of the

reason(s) why the initial decision to deny the GCE request or grant the GCE request with a shorter dead-

line than requested should be overturned or revised, with sufficient detail to allow for the evaluation of

the appeal. Responsible parties or Recipients, as appropriate, should provide further elaboration of the

grounds for the request or highlight factors that justify an extension. The appeal should only address why

the initial decision was incorrect; new bases for an extension request should not be presented for the first

time in an appeal and will not be considered.

Only one appeal may be submitted for a denied GCE request. The appeal must be submitted via the PRS

not later than 30 calendar days after the date that the PRS notification was issued by NIH. NIH will

provide an electronic notification to the responsible party or recipient, as appropriate, communicating the

determination of whether the appeal is granted or denied.

If the appeal is granted, the responsible party or recipient, as appropriate, has until the extended date spe-

cified in the electronic notification to submit clinical trial results information. If NIH denies the appeal of

a denied GCE request, the responsible party or recipient, as appropriate, must submit clinical trial results

information by the later of the date on which clinical trial results information would otherwise be due, or

30 calendar days after the electronic notification denying the appeal was sent by NIH.

The GCE request process and criteria can be found in the ClinicalTrials.gov

NIH Good Cause Extension

FAQs

4.1.4 Confidentiality

4.1.4.1 Certificates of Confidentiality

In keeping with Section 301(d) of the PHS Act, as amended by Section 2012 of the 21st Century Cures

Act, P.L. 114-255, and as enacted December 13, 2016 Certificates of Confidentiality (Certificates) are

issued automatically to any NIH funded investigators or institutions engaged in biomedical, behavioral,

clinical, or other research activities in which identifiable, sensitive information is collected or used.

At the time of enactment, all NIH-funded and conducted research that was commenced or ongoing on or

after December 13, 2016 was deemed to be issued a Certificate and was therefore required to protect the

privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the

Public Health Service Act. Per the PHS Act, subsection 301(d)(1), the Certificates protect identifiable,

sensitive information collected and all copies, in perpetuity.

Institutions and their investigators are responsible for determining whether research they conduct is sub-

ject to the requirement and therefore issued a Certificate. Certificates issued in this manner will not be

issued as a separate document.

For the purposes of this Policy, NIH considers research in which identifiable, sensitive information is col-

lected or used, to include:

Human subjects research as defined in the Federal Policy for the Protection of Human Subjects

(45 CFR Part 46), including exempt research except for human subjects research that is determ-

ined to be exempt from all or some of the requirements of 45 CFR Part 46 if the information

obtained is recorded in such a manner that human subjects cannot be identified or the identity of

the human subjects cannot readily be ascertained, directly or through identifiers linked to the sub-

jects;

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Research involving the collection or use of biospecimens that are identifiable to an individual or

for which there is at least a very small risk that some combination of the biospecimen, a request

for the biospecimen, and other available data sources could be used to deduce the identity of an

individual;

Research that involves the generation of individual level, human genomic data from bio-

specimens, or the use of such data, regardless of whether the data is recorded in such a manner

that human subjects can be identified or the identity of the human subjects can readily be ascer-

tained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR Part 46);

Any other research that involves information about an individual for which there is at least a

very small risk, as determined by current scientific practices or statistical methods, that some

combination of the information, a request for the information, and other available data sources

could be used to deduce the identity of an individual, as defined in subsection 301(d) of the

Public Health Service Act.

Recipient Responsibilities

To determine if the requirement applies to research conducted or supported by NIH, investigators will

need to ask, and answer the following question:

Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then

investigators will need to answer the following questions:

Does the research involve Human Subjects as defined by 45 CFR Part 46?

Are you collecting or using biospecimens that are identifiable to an individual as part of the

research?

If collecting or using biospecimens as part of the research, is there a small risk that some com-

bination of the biospecimen, a request for the biospecimen, and other available data sources

could be used to deduce the identity of an individual?

Does the research involve the generation of individual level, human genomic data?

If the answer to any one of these questions is yes, then the requirement will apply to the research and

therefore, in accordance with subsection 301(d) of the Public Health Service Act, the recipient of the Cer-

tificate shall not:

Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or

other proceeding, the name of such individual or any such information, document, or bio-

specimen that contains identifiable, sensitive information about the individual and that was cre-

ated or compiled for purposes of the research, unless such disclosure or use is made with the

consent of the individual to whom the information, document, or biospecimen pertains; or

Disclose or provide to any other person not connected with the research the name of such an indi-

vidual or any information, document, or biospecimen that contains identifiable, sensitive inform-

ation about such an individual and that was created or compiled for purposes of the research.

Disclosure is permitted only when:

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cos-

metic Act, or state laws requiring the reporting of communicable diseases to State and local

health departments), excluding instances of disclosure in any Federal, State, or local civil, crim-

inal, administrative, legislative, or other proceeding;

Necessary for the medical treatment of the individual to whom the information, document, or bio-

specimen pertains and made with the consent of such individual;

Made with the consent of the individual to whom the information, document, or biospecimen per-

tains; or

Made for the purposes of other scientific research that is in compliance with applicable Federal

regulations governing the protection of human subjects in research.

As set forth in

NIHGPS Chapter 8.3

, recipients conducting NIH supported research applicable to the

Policy are required to establish and maintain effective internal controls (e.g., policies and procedures)

that provide reasonable assurance that the award is managed in compliance with Federal statutes, reg-

ulations, and the terms and conditions of award.

Recipients of Certificates are required to ensure that any investigator or institution not funded by NIH

who receives a copy of identifiable, sensitive information protected by a Certificate issued by the Policy,

understand they are also subject to the requirements of subsection 301(d) of the Public Health Service

Act. In accordance with

NIHGPS Chapter 15.2.1

, recipients are also responsible for ensuring that any

subrecipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sens-

itive information protected by a Certificate issued by the Policy understand they are also subject to sub-

section 301(d) of the Public Health Service Act.

For studies in which informed consent is sought, NIH expects investigators to inform research par-

ticipants of the protections and the limits to protections provided by a Certificate issued by the Policy.

Information on CoCs is available on the NIH Web site at Grants and Funding’s Certificates of Con-

fidentiality (CoC) webpage.

4.1.4.2 Confidentiality of Alcohol and Substance Use Patient Records

Section 543 of the PHS Act, as implemented in 42 CFR Part 2, requires that records of substance abuse

patients be kept confidential except under specific circumstances and purposes. These protections differ

from those available to patients under HIPAA and are intended to ensure that a patient in a substance or

alcohol use program is not made more vulnerable than a similar patient who does not seek treatment.

The covered records are any information, written or not, of a patient who has applied for or been given

diagnosis or treatment for substance or drug use at a federally assisted program and includes any indi-

vidual who, after arrest on a criminal charge, is identified as a substance or drug user in order to determ-

ine that individual’s eligibility to participate in a program. This includes records of the identity,

diagnosis, or treatment of any patient which are maintained in connection with the performance of any

program or activity relating to substance abuse education, training, treatment, rehabilitation, or research,

which is conducted under an NIH grant. Except as authorized under a court order, no patient record may

be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation

of a patient. The regulations also describe procedures to allow for nonvoluntary disclosure of certain

information by persons engaged in research on mental health, including research on the use and effect of

alcohol and other psychoactive substances.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1.4.3 Confidentiality of Patient Records: Health Insurance Portability and

Accountability Act

HHS issued the final version of the “Standards for Privacy of Individually Identifiable Health Inform-

ation”—the Privacy Rule—on August 14, 2002. The Privacy Rule is a Federal regulation under the

Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of indi-

vidually identifiable health information. It is administered and enforced by OCR, HHS.

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the

recipient organization. The

OCR web site

provides information on the Privacy Rule, including the com-

plete text of the regulation and a set of decision tools for determining whether a particular entity is sub-

ject to the rule. An educational booklet, Protecting Heath Information in Research: Understanding the

HIPAA Privacy Rule, is available through OCR’s web site. That web site also includes other educational

materials including information specific to grants.

4.1.5 Controlled Substances

If controlled substances are proposed to be administered as part of a research protocol or if research is to

be conducted on the substances themselves, applicants/recipient must ensure that the DEA requirements,

including registration, inspection, and certification, as applicable, are met. Regional DEA offices can sup-

ply forms and information concerning the type of registration required for a particular substance for

research use. The main registration office in Washington, DC may be reached at 800-882-9539. Inform-

ation also is available from the National Institute on Drug Abuse at 301-443-6441.

4.1.6 Debarment and Suspension

HHS regulations published in 2 CFR Part 376 implement the government-wide debarment and sus-

pension system guidance (2 CFR Part 180) for HHS’ non-procurement programs and activities. “Non-

procurement transactions” include, among other things, grants, cooperative agreements, scholarships, fel-

lowships, and loans. NIH implements the HHS Debarment and Suspension regulations as a term and con-

dition of award. Accordingly, recipients of NIH grants (“primary covered transactions”), including

sponsoring institutions for Kirschstein-NRSA individual fellowships, are required to determine whether

it or any of its principals (as defined in

2 CFR Part 180.995

and

2 CFR Part 376.995

) is excluded or dis-

qualified from participating in a covered transaction (i.e., grant or cooperative agreement) prior to enter-

ing into the covered transaction, i.e., prior to the drawdown of funds which signals acceptance of the

grant award. Recipients may decide the method and frequency by which this determination is made and

may check excluded parties in

SAM

, although checking SAM is not required.

Prior to the drawdown of funds for each grant award, recipients must report to the funding IC if the recip-

ient or any of its principals:

Are presently excluded or disqualified;

Have been convicted within the preceding three years of any of the offenses listed in 2 CFR Part

180.800(a) or had a civil judgment for one of those offenses within that time period;

Are presently indicted for or otherwise criminally or civilly charged by a governmental entity

(Federal, State, or local) with commission of any of the offenses listed in 2 CFR Part 180.800(a);

Have had one or more public transactions (Federal, State, or local) terminated within the pre-

ceding three years or default.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Disclosure of unfavorable information by recipients under this requirement will not necessarily cause

NIH to deny participation in the grant. NIH will consider the information when determining whether to

enter into the covered transaction. NIH will also consider any additional information or explanation that

recipients elect to submit with the disclosed information. However, if it is later determined that a recip-

ient failed to disclose information that it knew at the time it accepted the NIH grant award, NIH may (a)

terminate the transaction for material failure to comply with the terms and conditions of the award or (b)

pursue any other available remedies, including suspension and debarment.

Recipients must immediately report to the NIH funding IC if at any time during the project period,

including periods of no-cost extension, they discover that they (a) failed to disclose information prior to

the drawdown of funds or (b) due to changed circumstances the recipient or any of its principals for the

grant now meet the reporting criteria.

“Lower tier” transactions (e.g., consortiums, subcontracts, consultants, collaborators, and contractors that

require the provision of goods or services that will equal or exceed $25,000) also are subject to the HHS

regulations. Prior to entering into a lower tier covered transaction with a participant (as defined in

2 CFR

Part 180.980

), recipients must verify that the person (as defined in

2 CFR Part 180.985

) is not excluded

or disqualified. Recipients may not enter into any transaction with a person who is disqualified from that

transaction unless an exception under the disqualifying statue, Executive Order, or regulation has been

obtained from HHS.

Recipients must require participants at the next lower tier to (a) comply with the HHS Debarment and

Suspension regulations as a condition of participation in the transaction and (b) pass the requirement to

comply with the HHS Debarment and Suspension regulations to each person involved in the covered

transaction at the next lower tier. Likewise, before entering into such a transaction lower tier participants

and contractors under grants (where the contract requires the provision of goods or services that will

equal or exceed $25,000) must report to the recipient if it or any participants are presently excluded or

disqualified.

Recipients also are required to assure compliance for each trainee under a Kirschstein-NRSA insti-

tutional research training grant, or other similar NIH-supported institutional training grant, before their

appointment.

Organizations or individuals that are suspended, debarred, or voluntarily excluded from eligibility cannot

receive NIH grants, be paid from NIH grant funds, whether under a primary or lower-tier transaction

(including trainees on NIH-supported training grants), or otherwise participate during the period of sus-

pension, debarment, or exclusion. Because individuals who have been debarred, suspended, declared

ineligible, or voluntarily excluded from covered transactions may not receive Federal funds for a spe-

cified period, charges made to NIH grants for such individuals (e.g., salary) are unallowable.

4.1.7 Drug-Free Workplace

The Drug-Free Workplace Act of 1988 (41 U.S.C. § 701 et seq.) requires that all organizations receiving

grants from any Federal agency agree to maintain a drug-free workplace. By signing the application, the

AOR agrees that the recipient will provide a drug-free workplace and will comply with the requirement

to notify NIH if an employee is convicted of violating a criminal drug statute. Failure to comply with

these requirements may be cause for debarment. Government wide requirements for Drug-Free Work-

place for Financial Assistance are found in 2 CFR Part 182; HHS implementing regulations are set forth

in 2 CFR Part 382.400. All recipients of NIH grant funds must comply with the requirements in Subpart

B (or Subpart C if the recipient is an individual) of Part 382. Foreign applicants and recipients may be

exempted from the drug-free workplace requirements of 2 CFR Part 182 based on a documented finding

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

by the NIH awarding IC that application of those requirements is inconsistent with U.S. international

obligations or the laws and regulations of a foreign government.

4.1.8 Federal Funding Accountability and Transparency Act (FFATA)

Public Law 109-282, the

Federal Funding Accountability and Transparency Act of 2006

as amended

(FFATA), requires full disclosure of all entities and organizations receiving Federal funds including

grants, contracts, loans and other assistance and payments through a single publicly accessible web site,

USASpending.gov

. The Web site includes information on each Federal financial assistance award and

contract over $30,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including

FAIN

, transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements

of the law require information to be collected and reported by recipients: 1) information on executive

compensation when not already reported through the Central Contractor Registry; and 2) similar inform-

ation on all subawards/subcontracts/consortiums over $30,000. Information on the recipient reporting

requirement for this law can be found in

Monitoring—Reporting—Financial Reports—Recipient Report-

ing of Subrecipient Data for FFATA

Full text of the award term is available at

2 CFR Part 170

4.1.9 Federal Information Security Management Act

All information systems, electronic or hard copy which contain Federal data need to be protected from

unauthorized access. This also applies to information associated with NIH grants and contracts. Congress

and the OMB have instituted laws, policies and directives that govern the creation and implementation of

federal information security practices that pertain specifically to grants and contracts. The current reg-

ulations are pursuant to the Federal Information Security Management Act (FISMA), 44 U.S.C. 3541 et

seq. The applicability of FISMA to NIH recipients applies only when recipients collect, store, process,

transmit or use information on behalf of HHS or any of its component organizations. In all other cases,

FISMA is not applicable to recipients of grants, including cooperative agreements. The recipient retains

the original data and intellectual property, and is responsible for the security of this data, subject to all

applicable laws protecting security, privacy, and research. If and when information collected by a recip-

ient is provided to HHS, responsibility for the protection of the HHS copy of the information is trans-

ferred to HHS and it becomes the agency’s responsibility to protect that information and any derivative

copies as required by FISMA.

4.1.10 Financial Conflict of Interest

NIH requires recipient institutions (except Phase I SBIR/STTR applicants and recipients) to comply with

the requirements of 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity

in Research for which PHS Funding is Sought.” (FCOI Regulation), as implemented in the 2011 Final

Rule for grants and cooperative agreements. FCOI requirements are aligned with

42 CFR Part 50

--Sub-

part F and the overarching goal for reporting is to promote and encourage transparency in order to avoid

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

distorting NIH funding decisions; NIH staff consider reports in light of other disclosures, e.g. other sup-

port, biographical sketch data, and foreign components, etc., and provide a holistic approach to award

and risk management principles.

The requirements under the 2011 revised regulation promote objectivity in research by establishing stand-

ards that provide a reasonable expectation that the design, conduct, or reporting of research funded under

PHS grants or cooperative agreements will be free from bias by any conflicting financial interest of an

Investigator, defined as the PD/PI and any other person, regardless of title or position, who is responsible

for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which

may include, for example, collaborators or consultants. These requirements do not apply to Federal

employees or Federal agencies. Federal agencies have their own set of rules governing FCOI for employ-

ees. When submitting a grant application, the signature of the AOR certifies the applicant Institution’s

compliance with the requirements of the FCOI regulations, including that:

1. There is in effect at the Institution an up-to-date, written and enforced administrative process to

identify and manage FCOI with respect to all research projects for which NIH funding is sought

or received;

2. The Institution shall promote and enforce Investigator compliance with the regulation’s require-

ments including those pertaining to disclosure of Significant Financial Interests (SFI);

a. Institutions must review an Investigator’s SFI to determine if the SFI is related to the

NIH-funded research (i.e., could the SFI be affected by the research or is the SFI in an

entity whose financial interest could be affected by the research). A FCOI exists when

the institution, through its designated official(s), reasonably determines that the SFI

could directly and significantly affect the design, conduct, or reporting of the NIH-fun-

ded research.

3. The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to

NIH;

4. When requested, the Institution will promptly make information available to the NIH/HHS relat-

ing to any Investigator disclosure of financial interests and the Institution’s review of, and

response to, such disclosure, whether or not the disclosure resulted in the Institution’s determ-

ination of an FCOI;

5. The Institution must fully comply with the requirements of the regulation.

When the Institution determines that an FCOI exists, the Institution must report to the NIH awarding IC

through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module.

The initial FCOI report will include the following information:

Grant number and PD/PI or Contact PD/PI if the grant is awarded under the multiple PI model;

Name of Investigator (if different from the PD/PI) with the FCOI;

Name of the entity with which the Investigator has an FCOI;

Nature of the FCOI (e.g., consulting fees, honoraria, paid authorship, equity interest, intellectual

property rights and interests, and reimbursed or sponsored travel);

Value of the financial interest $0-4,999; $5,000-9,999; $10,000-19,999; amounts between

$20,000-100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000

or a statement that a value cannot be readily determined;

A description how the financial interest relates to NIH-funded research and the basis for the Insti-

tution’s determination that the financial interest conflicts with such research; and

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Key elements of the Institution’s management plan, including:

1. Role and principal duties of the conflicted Investigator in the research project;

2. Conditions of the management plan;

3. How the management plan is designed to safeguard objectivity in the research project;

4. Confirmation of the Investigator’s agreement to the management plan;

5. How the management plan will be monitored to ensure Investigator compliance; and

6. Other information as needed.

The annual FCOI report must be submitted to NIH through the eRA Commons FCOI Module each year

within a competitive segment or until the Institution reports that the FCOI no longer exists. The annual

FCOI report will include the following information:

Status of the FCOI

Changes to the management plan, if applicable

The Institution must enter into a formal written agreement, signed and agreed to by the recipient and

each consortium participant and/or subrecipient. The agreement must establish whether the FCOI policy

of the recipient Institution or that of the subrecipient will apply to subrecipient Investigators and in either

case, the agreement must include required significant financial interest disclosure, review, and FCOI

reporting timelines to ensure compliance with the FCOI regulations. Subrecipient Institutions who rely

on their FCOI policy must report identified FCOIs to the recipient Institution in sufficient time to allow

the recipient Institution to report the FCOI to NIH to meet its reporting obligations. (See

Consortium

Agreements, 15.2.1 Written Agreement

NIH will not support any agreement that does not meet the minimum requirements. If a subrecipient is

unwilling to accept the requirements of the written agreement by signing the agreement, then the agree-

ment cannot be issued. NIH reserves the right to request copies of the written agreement and relevant

supporting documentation as needed as part of its oversight responsibilities. Failure to provide requested

documentation may lead to remedies for noncompliance and potential enforcement actions (See 8.5, Spe-

cific Award Conditions and remedies for noncompliance).

The Institution will make certain information available concerning identified FCOI held by senior/key

personnel as defined in the regulation via a publicly accessible web site or by a written response to any

requestor within five business days of a request and update such information as specified in the reg-

ulation.

Each Institution shall maintain an up-to-date, written, enforced policy on FCOI that complies with the

regulation, and make the policy available via a publicly accessible web site. NIH funded recipients are

required to submit their publicly accessible FCOI policy to NIH via the eRA Commons Institution Pro-

file (IPF) Module (IPF Module). The information is provided on an institutional level as part of an insti-

tution’s IPF, rather than on a grant-specific level, so it is not necessary to submit the FCOI policy with

each grant application.

The Institution must require each Investigator to disclose their (and their spouse and dependent children)

domestic and foreign SFIs that are related to their Institutional responsibilities to the Institution’s des-

ignated official(s).

Investigators must disclose all foreign financial interests (which includes income from seminars, lectures,

or teaching engagements, income from service on advisory committees or review panels, and reimbursed

or sponsored travel) received from any foreign entity, including foreign Institutions of higher education

and foreign governments (which includes local, provincial, or equivalent governments of another

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000). Insti-

tutions are strongly encouraged to review their FCOI policy and make any necessary changes to ensure

Investigators fully understand their disclosure responsibilities.

The Institution must require each Investigator (including subrecipient Investigators) to complete training

prior to engaging in NIH-supported research and at least every four years, and immediately under the des-

ignated circumstances:

Institutional FCOI policies change in a manner that affects Investigator requirements

An Investigator is new to an Institution

An Institution finds an Investigator noncompliant with the Institution’s FCOI policy or man-

agement plan.

As described in the regulation, examples of how FCOIs might be managed include but are not limited to,

the following:

Public disclosure of FCOI (e.g., when presenting or publishing the research);

Disclosure of FCOI directly to human subjects research participants;

Monitoring of research by independent reviewer(s);

Modification of the research plan;

Change of personnel or personnel responsibilities, or disqualification of personnel from par-

ticipation in all or a portion of the research;

Reduction or elimination of SFIs (e.g., sale of an equity interest)

Severance of relationships that create FCOIs.

The information above is only a sample of the regulatory requirements found in 42 CFR Part 50--Sub-

part F. Applicants and recipients must review the regulation in its entirety to ensure compliance with all

of the requirements. Resources applicable to FCOI, including Frequently Asked Questions, etc. can be

found on

the NIH Financial Conflict of Interest website

4.1.11 Fly America Act

The Fly America Act (49 U.S.C. 40118) generally provides that foreign air travel funded by Federal gov-

ernment money may only be conducted on U.S. flag air carriers. A “U.S. flag air carrier” is an air carrier

that holds a certificate under 49 U.S.C. 41102 but does not include a foreign air carrier operating under a

permit. There are limited circumstances under which use of a foreign-flag air carrier is permissible.

These circumstances are outlined below:

Airline "Open Skies" Agreement.

A foreign flag air carrier may be used if the transportation is

provided under an air transportation agreement between the United States and a foreign gov-

ernment, which the Department of Transportation has determined meets the requirements of the

Fly America Act. For example, in 2008, the U.S. entered into an "Open Skies" Agreement with

the European Union (EU). This Agreement gives European Community airlines (airlines of Mem-

ber States) the right to transport passengers and cargo on flights funded by the U.S. government,

when the transportation is between a point in the United States and any point in a Member State

or between any two points outside the United States.

The U.S.-EU Open Skies Agreement was

amended

effective June 24, 2010. GSA issued

Guid-

ance

October 6, 2010. Pursuant to the amendment, federal contractors and recipients (not U.S.

Government employees) need not be concerned about city-pair contract fares. However,

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

contractors and recipients must check with the airline to ensure that the airline is covered by the

U.S.-EU Open Skies agreement which may change periodically.

Additionally, pursuant to the amendment, EU airlines are no longer limited to flying passengers

between points in the United States and points in the EU. Instead, EU airlines are authorized to

transport passengers between points in the United States and points outside the EU if the EU air-

line is authorized to serve the route under the U.S.-EU Open Skies Agreement. This includes

flights that originate, arrive, or stop in the European Union. For additional information, please

see

GSA Bulletin FTR 11-02

. For information on other "open skies" agreements in which the

United States has entered, refer to the

Fly America Act page

on GSA’s website

Involuntary Rerouting.

Travel on a foreign-flag carrier is permitted if a U.S.-flag air carrier

involuntarily reroutes the traveler via a foreign-flag air carrier, notwithstanding the availability

of alternative U.S.-flag air carrier service.

Travel To and From the U.S.

Use of a foreign-flag air carrier is permissible if the airport abroad

is: (a) the traveler's origin or destination airport, and use of U.S.-flag air carrier service would

extend the time in a travel status by at least 24 hours more than travel by a foreign-flag air car-

rier; or (b) an interchange point, and use of U.S.-flag air carrier service would increase the num-

ber of aircraft changes the traveler must make outside of the U.S. by two or more, would require

the traveler to wait four hours or more to make connections at that point, or would extend the

time in a travel status by at least six hours more than travel by a foreign-flag air carrier.

Travel Between Points Outside the U.S.

Use of a foreign-flag air carrier is permissible if: (a)

travel by a foreign-flag air carrier would eliminate two or more aircraft changes en route; (b)

travel by a U.S.-flag air carrier would require a connecting time of four hours or more at an over-

seas interchange point; or (c) the travel is not part of the trip to or from the U.S., and use of a

U.S.-flag air carrier would extend the time in a travel status by at least six hours more than travel

by a foreign-flag air carrier.

Short Distance Travel.

For all short distance travel, regardless of origin and destination, use of a

foreign-flag air carrier is permissible if the elapsed travel time on a scheduled flight from origin

to destination airport by a foreign-flag air carrier is three hours or less and service by a U.S.-flag

air carrier would double the travel time.

4.1.12 Health and Safety Regulations and Guidelines

Recipients are responsible for meeting applicable Federal, State, and local health and safety standards

and for establishing and implementing necessary measures to minimize their employees’ risk of injury or

illness in activities related to NIH grants. In addition to applicable Federal, State, and local laws and reg-

ulations, the following regulations must be followed when developing and implementing health and

safety operating procedures and practices for both personnel and facilities:

29 CFR Part 1910.1030, Blood borne pathogens; 29 CFR Part 1910.1450, Occupational expos-

ure to hazardous chemicals in laboratories; and other applicable occupational health and safety

standards issued by the Occupational Health and Safety Administration (OSHA) and included in

29 CFR Part 1910

Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reor-

ganization Act of 1974 (42 U.S.C. 5801 et seq.). Copies may be obtained from the U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001.

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The following guidelines are recommended for use in developing and implementing health and safety

operating procedures and practices for both personnel and facilities:

Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS. This pub-

lication is available at on

CDC’s Strengthening Lab Safety webpage.

Prudent Practices for Safety in Laboratories (2011), National Research Council, National

Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055 (ISBN 978-0-

309-13864-2).

Recipient organizations are not required to submit documented assurance of their compliance with or

implementation of these regulations and guidelines. However, if requested by the awarding IC, recipients

should be able to provide evidence that applicable Federal, State, and local health and safety standards

have been considered and have been put into practice.

4.1.13 Human Biospecimens Security Measures

As of October 24, 2025, NIH recipients must comply with the NIH Policy on Enhancing Security Meas-

ures for Human Biospecimens (“NIH Biospecimens Security Policy”).

The NIH Biospecimens Security Policy applies to ongoing or new NIH funding instruments (for the pur-

poses of the NIH GPS grants and cooperative agreements) regardless of NIH funding level, used to

obtain human clinical and research biospecimens from U.S. persons (regardless of identifiability) that are

collected, obtained, stored, used, or distributed. Note that for the purposes of this policy. The NIH Bio-

specimens Security Policy does not apply to cell derivative products or cell lines derived from human

biospecimens of U.S. persons collected, obtained, stored, used, or distributed using on-going or new NIH

funds that are commercially or publicly available prior to October 24, 2025.

The entity (e.g., biorepository, institution, investigator) that holds human biospecimens of U.S. persons

collected, obtained, stored, used, or distributed using ongoing or new NIH funds are prohibited from dir-

ectly or indirectly distributing the human biospecimens to institutions or parties located in countries of

concern. For the purposes of the NIH Biospecimens Security Policy, countries of concern are defined as

those determined under

28 CFR § 202.601 (Subpart F: Determination of Countries of Concern)

. NIH

expects the research community to recognize the risks posed by the sharing or distribution of U.S. per-

sons biospecimens that were collected, obtained, stored, used, or distributed with previous NIH funds or

support with countries of concern.

In limited circumstances, the human biospecimens may be shared or distributed to countries of concern

only if use of the human biospecimens is:

1. to meet transactions required or authorized by Federal law or international agreements, including

Global health, or necessary for compliance with Federal law; or

2. needed in rare and compelling circumstances where the facility and personnel in the country of

concern possess needed capabilities and/or expertise not available elsewhere, the use of the bio-

specimen cannot be delayed to a time when capability and/or expertise is available elsewhere,

and done with the consent of the individual from whom the biospecimen was collected; or

3. at the request of the individual whose biospecimen was collected, obtained, or stored using NIH-

funds; for purposes of diagnosis, prevention or treatment of that individual; and in compliance

with applicable Federal laws, regulations, and policies.

As a reminder, the export of human biospecimens must follow all applicable

export administration reg-

ulations

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NIH requires all recipients to retain documentation related to sharing or distributing biospecimens to

countries of concern under one of the allowable limited circumstances and further document the quantity

and content of the biospecimen material that was shared or distributed. In accordance with 2 C.F.R. Part

200.337, Access to Records, recipients are required to provide these records to NIH upon request.

4.1.14 Human Stem Cell Research

Under Executive Order 13505 NIH may support and conduct responsible, scientifically worthy human

stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by

law.

NIH Guidelines on Human Stem Cell Research

, implement the Executive Order. The Guidelines

apply to the expenditure of NIH funds for research using hESCs and certain uses of induced pluripotent

stem cells.

For the purpose of NIH Guidelines, "human embryonic stem cells (hESCs)" are cells that are derived

from the inner cell mass of blastocyst stage human embryos, are capable of dividing without dif-

ferentiating for a prolonged period in culture and are known to develop into cells and tissues of the three

primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves

human embryos.

NIH recipients may use hESCs that have been approved by NIH in accord with NIH Guidelines and are

posted on the

NIH Human Embryonic Stem Cell Registry

, or may establish eligibility of specific cell

lines for NIH funding by submitting a

Request for Human Embryonic Stem Cell Line to be Approved

for Use in NIH Funded Research

(NIH Form 2890). Prior to the use of NIH funds, applicants and recip-

ients must provide assurances, when endorsing applications and progress reports submitted to NIH for

projects using hESCs, that the hESCs to be used are listed on the NIH Registry and will be used in

accordance with any restrictions associated with the line as cited on the Registry. If a specific line from

the NIH Registry cannot be identified at the time of submission, the applicant/recipient must provide a

strong justification why one cannot be identified at that time and a certification that one from the NIH

Registry will be used.

DHHS regulations for Protection of Human Subjects,

45 CFR Part 46

, Subpart A, establish safeguards

for individuals who are the sources of many human tissues used in research, including non-embryonic

human adult stem cells and human induced pluripotent stem cells. When research involving human adult

stem cells or induced pluripotent stem cells constitutes human subject research, Institutional Review

Board review may be required and informed consent may need to be obtained per the requirements

detailed in 45 CFR Part 46, Subpart A.

In addition, 45 CFR Part 46, Subpart A, may apply to certain research using hESCs. This regulation

applies, among other things, to research involving individually identifiable private information about a

living individual, 45 CFR Part 46.102(f). The HHS

Office for Human Research Protections

(OHRP) con-

siders biological material, such as cells derived from human embryos, to be individually identifiable

when they can be linked to specific living individuals by the investigators either directly or indirectly

through coding systems. Thus, in certain circumstances, IRB review may be required, in addition to com-

pliance with these Guidelines. Applicant institutions are urged to consult

OHRP guidance

4.1.14.1 Human Pluripotent Stem Cell Research Prohibited with NIH Funding

The following uses of hESCs, even if derived from embryos donated in accordance with NIH Guidelines

and listed on the NIH Registry, or human induced pluripotent stem cells, are prohibited:

Research in which hESCs or human induced pluripotent stem cells are introduced into non-

human primate blastocysts.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Research involving the breeding of animals where the introduction of hESCs or human induced

pluripotent stem cells may contribute to the germ line.

In addition, the derivation of stem cells from human embryos is prohibited in NIH funded research by

the annual appropriations ban on funding of human embryo research known as the Dickey Wicker

Amendment. NIH funding for research using hESCs derived from other sources, including somatic cell

nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is also prohibited.

NIH will also not fund research in which human pluripotent cells are introduced into non-human ver-

tebrate animal pre-gastrulation stage embryos.

4.1.15 Human Fetal Tissue Research

Human fetal tissue is defined as tissue or cells obtained from a dead human embryo or fetus after a spon-

taneous or induced abortion or stillbirth. This definition does not include established human fetal cell

lines.

Sections 498A and 498B of the PHS Act (42 U.S.C. 289g-1 and 289g-2) set forth specific requirements

and prohibitions on research involving human fetal tissue. Research involving human fetal tissue is also

subject to the HHS Regulations for the Protection of Human Subjects. 45 C.F.R. 46.204 and 46.206 may

be specifically relevant.

The scientific and ethical challenges associated with research utilizing human fetal tissue make it imper-

ative that researchers and their organizations be fully aware of and in compliance with the Federal

requirements. When an application involving human fetal tissue research is submitted to NIH, the AOR’s

signature certifies that researchers using these tissues are in compliance with the PHS Act. The statute

specifically prohibits any person from knowingly acquiring, receiving, or transferring any human fetal tis-

sue for valuable consideration. The term “valuable consideration” is a concept similar to profit and does

not include reasonable payment for costs associated with the collection, processing, preservation, stor-

age, quality control, or transportation of these tissues. Violation of this statute carries criminal penalties

that apply to both those that supply and those that acquire human fetal tissue.

Current federal laws and regulations require informed consent for research involving the transplantation

of human fetal tissue and for research with human fetal material associated with information that can

identify a living individual. Most states require informed consent for the use of fetal tissue in research.

Accordingly, NIH expects informed consent to have been obtained from the donor for any NIH-funded

research using human fetal tissue.

When obtaining primary human fetal tissue for research purposes, NIH expects recipients to maintain

appropriate documentation.

4.1.15.1 Research on Transplantation of Human Fetal Tissue

Sections 498A and 498B contain additional requirements for research on the transplantation of human

fetal tissue for therapeutic purposes conducted or supported by NIH. Research involving the trans-

plantation of human fetal tissue must be conducted in accordance with applicable Federal, State and local

laws as well as the following NIH guidance.

Under section 498A, the official who signs the application is certifying that the research on trans-

plantation of human fetal tissue will adhere to the following provisions:

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The woman who donates the fetal tissue must sign a statement declaring that the donation is

being made:

o

for therapeutic transplantation research,

o

without any restriction regarding the identity of individuals who may receive the trans-

plantation, and

o

without the donor knowing the identity of the recipient.

The attending physician must sign a statement that they have:

o

obtained the tissue in accordance with the donor’s signed statement and

o

fully disclosed to the donor their intent, if any, to use the tissue in research and any

known medical risks to the donor or risks to her privacy associated with the donation

that are in addition to risks associated with the woman’s medical care.

In the case of tissue obtained pursuant to an induced abortion, the physician’s statement also

must state that they:

o

obtained the woman’s consent for the abortion before requesting or obtaining consent for

the tissue to be used;

o

did not alter the timing, method, or procedures used to terminate the pregnancy solely

for the purpose of obtaining the tissue for research; and

o

performed the abortion in accordance with applicable State and local laws.

The PD/PI must sign a statement certifying that they are aware that the tissue is human fetal tis-

sue obtained in a spontaneous or induced abortion, or pursuant to a stillbirth and that the tissue

was donated for research purposes. The PD/PI also must certify that this information has been

shared with others who have responsibilities regarding the research and, before eliciting

informed consent from the transplantation recipient, will obtain written acknowledgment that the

patient is aware of the aforementioned information.

The PD/PI must certify in writing that they have had no part in any decisions as to the timing,

method, or procedures used to terminate the pregnancy.

In submitting an application to NIH, the AOR that signs the application is certifying that, if research on

the transplantation of human fetal tissue is conducted under the grant-supported project, the organization

will make available for audit by the HHS Secretary or designee, the physician statements, the PD/PI’s

statements, and informed consents required by subsections 498A(b)(2) and (c) of the PHS Act or will

ensure HHS access to those records, if maintained by an entity other than the recipient. This requirement

is in addition to the requirements concerning human subjects in research.

In addition, FDA has jurisdiction over fetal cells and tissues intended for use in humans and requests that

investigators contact them to determine whether any planned or ongoing clinical research would require

submission of an IND application. Additional information and FDA contact information is available on

FDA’s Safety & Availability (Biologics)

webpage.

4.1.15.2 Non-Transplantation Research on Human Fetal Tissue from Elective Abor-

tions

For the purposes of this section, HFT from elective abortions is defined as research involving the study,

analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures obtained

from elective abortions and includes the following:

• human fetal primary or secondary cell cultures, whether derived by the investigator or obtained from a

vendor.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

• animal models incorporating HFT from elective abortions, including obtaining such models from a

vendor.

• derivative products from elective abortion tissues or cells such as protein or nucleic acid extracts.

• any human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amni-

otic fluid, and chorionic villi, if obtained from the process of elective abortion.

The definition of research involving HFT from elective abortions does not include

the following:

human fetal primary or secondary cell cultures, if cells were not derived

from an elective abortion

already-established (as of June 5, 2019) human fetal cell lines (e.g.,

induced pluripotent stem cell lines from human fetal tissue, immortalized

cell lines, differentiated cell lines).

derivative products from human fetal tissue or cells (e.g., DNA, RNA, pro-

tein) if not derived from elective abortion.

human extra-embryonic cells and tissue, including, but not limited to,

umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic

villi if not derived from elective abortion.

human fetal cells present in maternal blood or other maternal sources

human embryonic stem cells or human embryonic cell lines.

research on transplantation of HFT for therapeutic purposes (because of the

statutory provision(s) addressing such research).”

Effective January 22, 2026, NIH funds are not permitted for research using HFT from elective abortions.

4.1.16 Human Subjects Protections

The HHS regulations for the protection of human subjects, in 45 CFR Part 46, implement Section 491(a)

of the PHS Act and provide a framework, based on established, internationally recognized ethical prin-

ciples, to safeguard the rights and welfare of individuals who participate as subjects in research activities

supported or conducted by NIH or other HHS components.

The HHS regulations state that institutions (whether domestic or foreign) that are engaged in nonexempt

research involving human subjects and institutional boards (IRBs) reviewing research that is subject to

the HHS regulations must comply with the regulations at 45 CFR 46 (Revised Common Rule §46.101(a)

and Pre-2018 Common Rule §46.101(a)). Recipient institutions "engaged" in human subjects research

must provide written assurance that it will comply with the regulatory requirements (Revised Common

Rule §46.103(a) and Pre-2018 Common Rule §46.103(a)). The recipient institution provides written

assurance by obtaining a Federalwide Assurance (FWA) with the HHS Office for Human Research Pro-

tections (OHRP) and establishing appropriate policies and procedures for the protection of human sub-

jects (Revised Common Rule §46.108(a)(3) & (4) and Pre-2018 Common Rule §46.103(b)(4) & (5)). An

institution is engaged in human subjects research if:

1. the institution's employees or agents intervene or interact with human subjects for research pur-

poses;

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

2. the institution's employees or agents obtain individually identifiable private information or iden-

tifiable biospecimens about human subjects for research purposes; or

3. the institution receives a direct HHS award to conduct human subjects research, even where all

activities involving human subjects are carried out by a subcontractor or collaborator.

The OHRP's document entitled

Engagement of Institutions in Human Subjects Research

provides addi-

tional guidance on "engagement".

The HHS regulations at Subparts B, C, and D include additional protections for specific populations as

follows:

1. pregnant women, human fetuses and neonates (45 CFR Part 46, Subpart B);

2. prisoners (45 CFR Part 46, Subpart C); and

3. children (45 CFR Part 46, Subpart D).

Certain research activities are exempt from regulatory requirements for an FWA and IRB oversight

(Revised Common Rule 46.104(d) and Pre-2018 Common Rule 46.101(b).

OHRP guidance

states that

institutions must adopt clear procedures under which the IRB (or some authority other than the invest-

igator) determines whether proposed research is exempt from the human subjects regulations. NIH will

review the materials submitted by the institution, including the PHS Human Subjects Clinical Trails

Information Form of the application, to determine if it can concur with the institution that the proposed

activities are covered by the regulations or are in one or more exempt category. For research potentially

subject to an exemption, this includes reviewing which category of exemption applies. NIH's review

does not relieve the institution of any of its regulatory responsibility to accurately make and implement

correct determinations about the research for the entirety of the project or otherwise speak for regulatory

entities within HHS.

Unless all research activities meet the criteria for one or more exemptions from 45 CFR Part 46, research

involving human subjects may only be conducted under an HHS award if the organization has a current

OHRP approved FWA and provides certification that an Institutional Review Board (IRB) registered

with OHRP has reviewed and approved the proposed activity in accordance with the HHS regulations.

In accepting an award that supports human subjects research, the recipient institution assumes respons-

ibility for all research conducted under the award, including protection of human subjects at all par-

ticipating and consortium sites. The recipient institution also assumes responsibility for ensuring that all

institutions under the award engaged in nonexempt research involving human subjects have a current,

approved FWA and must obtain certification of approval by an IRB registered with OHRP, of all nonex-

empt research involving human subjects before research may begin. When consultants are performing

research involving human subjects on NIH-funded projects, the consultant’s institution must obtain an

FWA.

The

Human Subjects Research page of the NIH Grants & Funding website

contains additional inform-

ation and Frequently Asked Questions that are available to help investigators understand how these

Federal requirements apply to their research.

Applications will be considered incomplete if they do not address the involvement of human subjects in

the PHS Human Subjects and Clinical Trials Information Form of the application. If human subjects

research is anticipated within the period of the award but definite plans for involvement of human sub-

jects cannot be described in the application (referred to as “delayed onset human subjects research” in

the NIH grant application instructions), applicants must provide a detailed explanation of why it is not

possible to develop definite plans. Prior to the involvement of human subjects the recipient must submit

to the NIH awarding IC for prior approval either (1) detailed information as required in the PHS Human

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

Subjects and Clinical Trials Information Form of the application, and meet the FWA and IRB cer-

tification requirements, or (2) if all of the research meets the criteria for one or more exemptions, iden-

tification of which exemptions(s) is/are applicable to the research, and a justification for the exemption

with sufficient information about the involvement of human subjects to allow a determination that the

claimed exemption is appropriate. Typically, recipients that are part of large clinical research networks

or consortia that plan to add new protocols after the award must follow the awarding IC’s procedures for

approval of new protocols. Institutions with award mechanisms that allow them to select new projects,

typically small future research projects (e.g., pilot projects), for support by their NIH award are respons-

ible for ensuring that the selected projects follow all relevant regulations and policies including those

governing the involvement of human subjects in research, including prior approval from the IRB if

applicable. They must follow the awarding IC’s procedures for prior approval of new protocols and

updating the IC on the status of funded projects in annual progress reports which are typically described

in the NOFO and/or NoA.

Recipients may not draw funds from the payment system, request funds from the paying office, or make

obligations against Federal funds for research involving human subjects at any site engaged in nonex-

empt research for any period not covered by both an FWA and IRB approval consistent with 45 CFR

Part 46. Costs associated with IRB review of human research protocols are not allowable as direct

charges to NIH-funded research unless such costs are not covered by the organization’s indirect cost rate.

The use of autopsy materials is governed by applicable State and local law and is not regulated by 45

CFR Part 46.

4.1.16.1 Federalwide Assurance Requirements

The Federalwide Assurance (FWA) commits the organization to compliance with the requirements set

forth in 45 CFR Part 46, and the Terms of Assurance. Each institution that is engaged in HHS supported

human subjects research must be covered by an FWA approved by OHRP.

When an applicant organization proposes nonexempt research involving human subjects and does not

have an FWA, the AOR signature on the application constitutes declaration that the organization will

comply with 45 CFR Part 46 and proceed to obtain an FWA. The NIH awarding component will place a

restriction in the NoA so that no human subjects research may be conducted under the award until the

FWA and certification of IRB review and approval (or certification of institutional determination of

exemption, if applicable) have been obtained and accepted by NIH.

Each recipient institution must file its own FWA even if the organization does not operate its own IRB

and designates another IRB for that purpose. IRBs must be registered with OHRP before the IRB may be

designated on an FWA as reviewing proposed research for the FWA-holding institution.

Organizations that will serve as additional performance sites that are engaged in nonexempt research

involving human subjects under the award must obtain an FWA, or, under specified circumstance, may

be covered by the recipient's FWA in accordance with the OHRP's Guidance on Extension of an FWA to

Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement.

It is the recipient organization’s responsibility to ensure that all sites engaged in research involving

human subjects are covered by an appropriate FWA and have IRB approval consistent with 45 CFR Part

46. It also is the recipient’s responsibility to comply with NIH prior approval requirements related to the

addition of sites not included in the approved application (see

Administrative Requirements—Changes in

Project and Budget—Prior Approval Requirements

). A list of organizations with approved assurances is

available at the

OHRP web site

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No individual may receive NIH grant funds for nonexempt research involving human subjects unless the

individual is affiliated with or sponsored by an organization that assumes responsibility for the research

under an FWA or the individual makes other arrangements with OHRP.

Detailed information concerning FWAs is available on the

OHRP web site

4.1.16.2 Certification of IRB Approval

Recipients must provide a certification to NIH that all nonexempt research involving human subjects has

been reviewed and approved by an appropriate IRB, consistent with 45 CFR Part 46 and OHRP guid-

ance. NIH-funded sites in the United States cannot rely on a non-US IRB; therefore, NIH will not accept

an approval from a non-US IRB. The date of final IRB approval is the date that all protocols in the pro-

posed research application received IRB review and approval (i.e., the date of the last protocol approval).

When human subjects research is anticipated within the period of the award but definite plans for

involvement of human subjects cannot be described in the application or proposal (referred to as

"delayed onset human subjects research"), prior to the involvement of human subjects in nonexempt

research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as

required in the Human Subjects and Clinical Trials Information Form of the application, as well as the

certification and date of final IRB approval. Note that NIH requires the date of final IRB approval; con-

ditional IRB approval is not sufficient. According to OHRP, in the case of IRB approval with conditions,

IRB approval only becomes effective when the IRB has approved all information submitted in response

to their conditions.

Certification of IRB approval may be filed at any time before award in accord with Just-in-Time pro-

cedures, unless required earlier by the IC. Therefore, following peer review and notification of impact

score/percentile, applicant organizations with OHRP FWAs may wish to proceed with IRB review for

those protocols that have not yet received IRB approval and that apply to applications in a fundable

range.

Under no circumstances may NIH-supported nonexempt research involving human subjects be initiated

prior to obtaining IRB approval and providing the final IRB approval date to NIH. NIH will not allow

any funds to be used by recipients where a certification and an IRB approval date has not been provided

to the funding IC.

Recipients are also reminded that any changes to study protocols that have been subject to peer review,

as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute

or Center consistent with

Section 8.1.2.5

of the NIHGPS. Such requirements are also generally described

in the Notice of Funding Opportunity and/or the Notice of Award.

4.1.16.3 Reporting to Funding Agency and OHRP

Under the HHS regulations, recipient institutions must establish and follow written procedures for ensur-

ing prompt reporting to the IRB, appropriate institutional officials, and NIH of any unanticipated prob-

lem involving risks to subjects or others or any serious or continuing noncompliance with 45 CFR Part

46 or IRB requirements or determinations; and any suspension or termination of IRB approval(revised

Common Rule 45 CFR Part 46.108(a)(4) and pre-2018 Common Rule 45 CFR Part 46.103(b)(5)). Any

IRB suspension or termination of approval must include a statement of the reasons for the IRB's action

and must be reported promptly to the investigator, appropriate institutional officials, and NIH (45 CFR

Part 46.113). Recipient institutions must also file incident reports promptly with OHRP of unanticipated

problems involving risks to subjects or others, serious or continuing noncompliance with 45 CFR Part 46

or with the requirements or determinations of the IRB, and suspension or termination of IRB approval.

See

OHRP's website

, Guidance on Reporting Incidents to OHRP for more information.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1.16.4 OHRP Oversight

OHRP has regulatory responsibility for oversight of recipient compliance with the HHS human subjects

regulations. In carrying out this responsibility, OHRP evaluates all written allegations or indications of

non-compliance with the HHS regulations it receives from any source. All compliance oversight eval-

uations are predicated on the HHS regulations and the organization’s assurance of compliance. Any cor-

rective actions imposed as a result of a compliance oversight evaluation are intended to remedy

identified non-compliance and prevent reoccurrence. Because each case is different, OHRP tailors cor-

rective actions to foster the best interest of human research subjects and, to the extent possible, of the

organization, research community, and HHS. Most compliance oversight evaluations and resultant cor-

rective actions are resolved at the OHRP level. However, OHRP may recommend actions to be taken by

other HHS officials.

Information about the FWA submission process and about OHRP activities related to oversight and com-

pliance, as well as copies of the human subjects regulations, may be obtained from OHRP at the address

shown in Part III or from the

OHRP home page

4.1.16.5 Education in the Protection of Human Research Participants

Before funds are awarded for competing applications involving human subjects, applicants must submit

documentation that all senior/key personnel involved in human subjects research have received training

in the protection of human subjects. Senior/key personnel include all individuals responsible for the

design or conduct of the study, including senior/key personnel of all sites involved in research activities.

This documentation should be included in the cover letter signed by the AOR that accompanies the

description of other support, IRB and IACUC approval, and other information submitted prior to funding

in accordance with Just-in-Time procedures. For non-competing continuation awards, the description of

education for new senior/key personnel should be part of the progress report submitted as a prerequisite

to award. Additional information about this education requirement is available on the

Training &

Resources – Human Subjects page of the NIH Grants & Funding website

4.1.16.6 Data and Safety Monitoring

The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted

or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety

of participants and the validity and integrity of the data. NIH policies on data and safety monitoring spe-

cify that the level and frequency of monitoring should be commensurate with the risks, nature, size, and

complexity of the clinical trial, and are in addition to any monitoring requirements imposed by FDA.

There are a number of options for monitoring clinical trials including, but not limited to, monitoring by

a/an:

PD/PI (required),

IRB (required),

Independent individual/safety officer,

Designated medical/research monitor,

Internal committee or board with explicit guidelines,

DSMB (required for multi-site trials).

Applications that include clinical trials must include a general description of the data and safety mon-

itoring plan. The description of the data and safety monitoring plan in competing applications will be

reviewed by the SRG. A general description of a monitoring plan establishes the overall framework for

data and safety monitoring. It must describe the entity that will be responsible for monitoring how

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

adverse events will be reported to the IRB and NIH and, when appropriate, how NIH Guidelines and

FDA regulations for INDs and IDEs will be satisfied.

A detailed monitoring plan must be included as part of the research protocol, be submitted to the IRB,

and be reviewed and approved by the NIH awarding IC prior to the accrual of human subjects. The

awarding IC may specify the reporting requirements for adverse events, which are in addition to the

annual report to the IRB. The clinical trial monitoring function is above and beyond that traditionally

provided by IRBs; however, the IRB must be cognizant of the procedures used by clinical trial mon-

itoring entities and the monitor must provide periodic reports to investigators for transmittal to the IRB.

NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving inter-

ventions that entail potential risk to the participants, and generally for Phase III clinical trials. Although

Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this over-

sight format, and alternative monitoring plans may be appropriate.

For multi-site Phase I and II trials, investigators should organize a central reporting entity that will be

responsible for preparing timely summary reports of adverse events for distribution among sites and the

IRBs of participating sites. The frequency of summary reports will depend on the nature of the trial.

Organizations with a large number of clinical trials may develop standard monitoring plans for Phase I

and II clinical trials. However, such plans always should be evaluated for appropriateness for the par-

ticular investigation.

All multi-site trials with DSMBs are expected to forward summary reports of adverse events to each

responsible IRB so they can address as appropriate to their responsibility reports related to the site.

Recipients should address questions on this subject to the NIH PO.

Further information concerning these requirements is found on the

NIH Human Subjects Research web-

site

and in the SF424 (R&R) application instructions,

see section G.500 – PHS Human Subjects and Clin-

ical Trials Information

4.1.16.7 Inclusion of Individuals Across the Lifespan as Participants in Research

Involving Human Subjects

For all competing grant applications, individuals of all ages, including children (i.e. individuals under the

age of 18) and older adults (i.e., individuals 65 years of age or older), must be included in all human sub-

jects research, conducted or supported by NIH, unless there are scientific or ethical reasons not to

include them. The inclusion of individuals across the lifespan as subjects in research must be in com-

pliance with all applicable subparts of 45 CFR Part 46 as well as with other pertinent federal laws and

regulations.

Applications or proposals for research involving human subjects must address the age-appropriate inclu-

sion or exclusion of individuals in the proposed research project. Applications must include a description

of plans for including individuals across the lifespan, including a rationale for selecting the specific age

range justified in the context of the scientific question proposed. If individuals will be excluded from the

research based on age, the recipient / offeror must provide an acceptable justification for the exclusion.

Scientific review groups at NIH will assess each application as being "acceptable" or "unacceptable"

with regard to the age-appropriate inclusion or exclusion of individuals in the research project, in addi-

tion to evaluating the plans for conducting the research in accord with these provisions. NIH staff will

monitor implementation of this policy during the development, review, award and conduct of research;

and manage the NIH research portfolio to comply with the policy.

NIH recipients must submit data on participant age at enrollment in progress reports. Investigators plan-

ning to conduct research involving human subjects should design their studies in such a way that de-

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

identified individual-level participant data on sex, race, ethnicity, and age at enrollment may be provided

to NIH in progress reports.

4.1.16.8 Inclusion of Women and Members of Racial and/or Ethnic Minority

Groups in Clinical Research

In accordance with Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2, All NIH-funded or sup-

ported clinical research projects must address the inclusion of women and members of racial and/or eth-

nic minority groups and their subgroups developing a research design appropriate to the scientific

objectives of the study. The research plan/proposal should describe the composition of the proposed

study populations in terms of sex and race and/or ethnicity groups and provide a rationale for selection

of such participants. Investigators should also plan for appropriate outreach programs and activities to

recruit the proposed study population consistent with the purposes of the research project. This policy

applies to research participants of all ages in all NIH-supported clinical research studies (see definition

of clinical research).

Exceptions to this inclusion requirement may be granted the relevant NIH Institute / Center / Office

(IC/ICO) Director if a clear rationale and compelling justification establishes that inclusion is inap-

propriate with respect to the health of the participants or the purpose of the research. Exclusion under

other circumstances may be made by the NIH Director, upon the recommendation of an IC/ICO Director

based on a compelling rationale and justification.

Cost is not an acceptable reason for exclusion, except when inclusion would duplicate existing data from

other sources. Women of childbearing potential should not be routinely excluded from participation in

clinical research. The policy applies to research subjects of all ages in NIH-supported clinical research

studies (see definition of clinical research). The inclusion of individuals on the basis of sex, race, and eth-

nicity must be addressed in developing a research design appropriate to the scientific objectives of the

study. A proposed outreach program for recruiting should also be included.

If the proposed research project includes an NIH-defined Phase III clinical trial, investigators must com-

ply with the special considerations related to the application / proposal, progress reports, and registering

and reporting in ClinicalTrials.gov requirements and consider whether clinically important sex, racial,

and/or ethnic differences in the intervention effect are to be expected and plan the research accordingly.

When registering in Clincialtrials.gov, applicable clinical trials as defined in 42 C.F.R. Part 11, that are

also NIH-defined Phase III clinical trials must specify outcomes on sex and race and/or ethnicity, as

required based on prior evidence, and as explained in the

Inclusion of Women and Members of Racial

and/or Ethnic Minority Groups in Clinical Research topic page

. For applicable clinical trials that are also

NIH-defined Phase III clinical trials, submissions of results to Clinicaltrials.gov must include results of

valid analyses by sex and/or ethnicity, as required based on prior evidence.

Investigators must also collect and annually report information on sex, race, and ethnicity in clinical

research studies. The OMB minimum standards for maintaining, collecting, and presenting data on race

and ethnicity for all grant projects are described in

OMB Directive No. 15

update.

For more information on policies and procedures related to inclusion:

Inclusion Procedures

4.1.16.9 Good Clinical Practice Training for NIH Recipients Involved in NIH-funded

Clinical Trials

NIH expects that all NIH-funded investigators and staff who are involved in the conduct, oversight, or

management of clinical trials to be trained in Good Clinical Practice (GCP), consistent with principles of

the

International Conference on Harmonization (ICH) E6 (R3)

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a

standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and report-

ing (e.g., safety data, accrual reports, study status, protocol deviations, or final data), and outline the

responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. GCP

addresses elements related to the design, conduct and reporting of clinical trials.

GCP principles constitute an international ethical and scientific quality standard for designing, con-

ducting, recording, and reporting clinical trials. The principles were developed in 1996 by the ICH in col-

laboration with representatives from the European Union, Japan, and the United States. The U.S. Food

and Drug Administration (FDA) requires GCP compliance for studies conducted under an investigational

new drug application or investigational device exemption.

GCP describes the responsibilities of investigators, sponsors, monitors and IRBs in the conduct of clin-

ical trials. Compliance with GCP provides assurance that the rights, safety and well-being of human sub-

jects are protected, that clinical trials are conducted in accordance with approved plans with rigor and

integrity, and that data derived from clinical trials are reliable.

GCP training complements other required training on protections for human research participants. Since

June 2000, the NIH Extramural Research Program has required training on protections for human

research participants for all NIH-funded investigators and individuals responsible for the design or con-

duct of NIH funded research involving human subjects.

The GCP policy applies to NIH-funded investigators and clinical trial site staff who are responsible for

the conduct, management and oversight of

NIH-funded clinical trials

. GCP training includes the Prin-

ciples of ICH GCP found in Section 2 of ICH E6. GCP training may be achieved through a class or

course, academic training program, or certification from a recognized clinical research professional

organization. See the

NIH Grants & Funding Good Clinical Practice Training

page for examples of

acceptable GCP courses. Completion of GCP training will demonstrate that individuals have attained the

fundamental knowledge of clinical trial quality standards for designing, conducting, recording and report-

ing trials that involve human research participants. GCP training should be refreshed at least every three

years in order remain current with regulations, standards and guidelines. Recipients of GCP training are

expected to retain documentation of their training, and make it available to NIH upon request.

For purposes of Good Clinical Practice training the following definitions apply:

Investigator

: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical

trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the

team and may be called the principal investigator.

Clinical trial staff

: Individuals, identified by the investigator, who are responsible for study coordin-

ation, data collection and data management. The central focus of clinical trial staff is to manage par-

ticipant recruitment and enrollment, to maintain consistent study implementation, data management, and

to ensure integrity and compliance with regulatory and reporting requirements. These individuals may

also seek informed consent from prospective participants, enroll and meet with research participants, and

collect and record information from research participants. Clinical trial staff may also be called the

research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

4.1.16.10 NIH Policy on the Use of a Single Institutional Review Board for Multi-

Site Research

NIH requires sites located in the United States engaged in NIH-funded, multi-site research conducted at

more than one domestic site to rely upon approval by a single Institutional Review Board (sIRB) as

required by the Revised Common Rule (rCR) at 45 CFR Part 46.114 and NIH sIRB Policy, including

projects supported by career development (K) and fellowship (F) awards with initial IRB approval on or

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

after January 20, 2020. NIH expects the domestic sites in NIH-funded, multi-site studies to rely on a US

sIRB (located in the United States). Foreign sites participating in NIH-funded, multi-site studies will not

be expected to use a single IRB. This includes collaborative international research projects

NIH applicants whose research is subject to the sIRB requirements must provide the name of the sIRB

during the Just-in-Time period, before the award is issued. If, in delayed-onset research, an sIRB has not

yet been identified, the recipient will provide the name of the sIRB to the funding NIH Institute/Center

(IC) prior to initiating the multi-site research study/project.

The applicant may request direct cost funding for the additional costs associated with the establishment

and review of the multi-site study/project by the sIRB, with appropriate justification; all such costs must

be reasonable and consistent with cost principles, as described in Chapter 7 (Cost Consideration) and in

case of for-profit organizations the Federal Acquisition Regulation (FAR) 31.302 (Direct Costs) and

FAR 31.203 (Indirect Costs).

Recipients are responsible for ensuring that authorization agreements are in place. Copies of author-

ization agreements and other necessary documentation should be maintained to document compliance, as

needed. As appropriate, recipients are responsible for ensuring that a mechanism for communication

between the sIRB and participating sites is established.

All sites participating in multi-site research studies/projects subject to the sIRB requirements are expec-

ted to rely on an sIRB to carry out the functions that are required for institutional compliance with IRB

review set forth in the HHS regulations at 45 CFR Part 46. Participating sites are responsible for meeting

all other regulatory obligations.

NIH sIRB policy does not prohibit participating sites from also reviewing the research under the applic-

able regulatory framework. This additional review, even if performed by the institution's IRB, is not the

regulatory review of the research as that responsibility still remains with the sIRB. If this approach is

taken, NIH funds may not be used to pay for the cost of the duplicate review

4.1.17 Investigational New Drug Applications/Investigational Device

Exceptions

To be eligible for NIH funding, all clinical research involving investigational drugs and devices, or other

products regulated by the FDA, must comply with all applicable FDA requirements, including those for

INDs, IDEs, and human subjects protections. Among other provisions, FDA regulations for human sub-

jects protections are published in 21 CFR Parts 50 and 56 with additional standards found in Parts 312

and 812.

When applicable, the sponsor of the IND/IDE, whether NIH, a recipient, or a third party, is legally

responsible for meeting the FDA requirements for sponsors. If the sponsor is also the PI, then the spon-

sor will need to satisfy FDA’s requirements for sponsor-investigators. If the IND/IDE sponsor is a third

party, such as a pharmaceutical company or research organization under contract to a recipient or to a

pharmaceutical company, the legal responsibility for monitoring the clinical trial and reporting to FDA

rests with the sponsor rather than the recipient. This generally will be the case for larger, multi-site clin-

ical trials. If the recipient is the IND/IDE holder, commonly referred to as an “investigator-initiated

IND/IDE,” the recipient or the investigator serves as the sponsor and assumes the legal responsibility. In

any case, the recipient is ultimately responsible to NIH for ensuring compliance with the applicable

requirements for protection of human subjects, including compliance with FDA’s requirements.

Following the filing of an IND, FDA has a 30-day period in which to review it. FDA may allow the IND

to proceed or may defer approval of the IND until changes it deems acceptable are made. FDA also may

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

order a clinical trial to be suspended or terminated, at any time, based on information it receives about

that clinical trial.

When NIH funds any part of a clinical study involving an IND or an IDE, NIH must be knowledgeable

about any significant communications with FDA concerning the study. The recipient organization must

report certain types of FDA communications to the NIH awarding IC within 72 hours of receiving a

copy of, or upon being informed of, the FDA communication (through the PD/PI or another person act-

ing on behalf of the recipient), whichever occurs first. This notification requirement applies to any of the

following communications from FDA with the sponsor of the IND or IDE:

Warning letters (whether sent to the recipient or to the for-profit sponsor)

Notices of Initiation of Disqualification Proceedings and Opportunity to Explain

Notice of Opportunity for Hearing

Notice of Disqualification

Consent Agreements

Clinical hold letters that pertain to breaches of good manufacturing practices, good clinical prac-

tices, or other major issue requiring significant changes in the protocol.

The notification should be made in writing, but also may be done by telephone if a written notice would

delay the notification. It should include a statement of the action taken or contemplated and the assist-

ance needed to resolve the situation. These requirements apply to the recipient even if the recipient or the

NIH-funded PD/PI is the sponsor. Failure to comply with this requirement may result in NIH imposing a

corrective and/or enforcement action (see

Administrative Requirements—Enforcement Actions

). FDA

communications are considered grant-related records for purposes of retention and access (see

Admin-

istrative Requirements—Monitoring—Record Retention and Access

4.1.18 Lobbying Prohibition

Recipients of Federal grants, cooperative agreements, contracts, and loans are prohibited by 31 U.S.C.

1352, “Limitation on use of appropriated funds to influence certain Federal contracting and financial

transactions,” from using appropriated Federal funds to pay any person for influencing or attempting to

influence any officer or employee of an agency, a Member of Congress, an officer or employee of Con-

gress, or an employee of a Member of Congress with respect to the award, continuation, renewal, amend-

ment, or modification of any of these instruments. These requirements are implemented for HHS in 45

CFR Part 93, which also describes types of activities, such as legislative liaison activities and pro-

fessional and technical services, which are not subject to this prohibition under certain circumstances.

Applicants for NIH awards are required to certify and disclose that they:

have not made, and will not make, such a prohibited payment;

used or will use non-appropriated funds if they have made or agreed to make such payment; and

will include these requirements in consortium agreements and contracts under grants that will

exceed $100,000 and obtain necessary certifications from those consortium participants and con-

tractors.

Certifications and disclosures must be filed at the times prescribed in the regulations based on the expec-

ted total costs.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

The signature of the AOR on the application serves as the required certification of compliance for the

applicant organization. Disclosure reporting is addressed in

Administrative Requirements—Monitoring—

Reporting

See also Appropriation Public Policy Requirements Mandates

Lobbying—Appropriation Prohibition

for

additional restrictions.

4.1.19 Metric System

Consistent with EO 12770 (July 25, 1991), Metric Usage in Federal Government Programs, meas-

urement values in applications and recipient-prepared reports, publications, and other grant-related doc-

uments should be in metric. See

Construction Grants

chapter in IIB for requirements for metric usage in

construction activities.

4.1.20 Military Recruiting and Reserve Officer Training Corps Program

Access to Institutions of Higher Education

Section 588 of the National Defense Authorization Act of 1995, amended (10 U.S.C. §983), precludes

NIH grant awards to institutions of higher education that DoD determines have an anti-Reserve Officer

Training Corps (ROTC) policy or practice (regardless of when implemented) that either prohibits or, in

effect, prevents the Secretary of Defense from gaining entry to campuses or access to students or inform-

ation for military recruiting. DoD publishes each determination of ineligibility in the Federal Register as

well as publishing, once every 6 months, a list of all currently ineligible schools. If DoD determines that

an institution is ineligible during an ongoing project period, NIH will suspend support of current and

future grant awards as provided in

Administrative Requirements—Enforcement Actions—Suspension,

Termination, and Withholding of Support

. Funding eligibility may be restored on the basis of new

information provided by DoD.

4.1.21 National Environmental Policy Act

All NIH grants, whether or not they include construction or major A&R activities, are subject to the

requirements of the National Environmental Policy Act (NEPA) of 1969, as amended. This Act requires

Federal agencies to consider the reasonably foreseeable environmental consequences of all grant-sup-

ported activities. As part of NIH’s implementation of this Act, recipients are required to promptly notify

NIH of any reasonably foreseeable impacts on the environment from grant-supported activities, or certify

that no such impacts will arise upon receipt of a grant award. In addition, NIH has determined that most

NIH research grants are not expected to individually or cumulatively have a significant effect on the

environment unless any part of the proposed research and/or project includes one or more of the fol-

lowing categorical exclusions listed below:

1. The potential environmental impacts of the proposed research may be of greater scope or size

than other actions included within a category.

2. The proposed research threatens to violate a Federal, State, or local law established for the pro-

tection of the environment or for public health and safety.

3. Potential effects of the proposed research are unique or highly uncertain.

4. Use of especially hazardous substances or processes is proposed for which adequate and accep-

ted controls and safeguards are unknown or not available.

5. The proposed research may overload existing waste treatment plants due to new loads (volume,

chemicals, toxicity, additional hazardous wasted, etc.)

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

6. The proposed research may have a possible impact on endangered or threatened species.

7. The proposed research may introduce new sources of hazardous/toxic wastes or require storage

of wastes pending new technology for safe disposal.

8. The proposed research may introduce new sources of radiation or radioactive materials.

9. Substantial and reasonable controversy exists about the environmental effects of the proposed

research.

This requirement is in addition to other public policy requirements for grants for construction and alter-

ation and renovation activities discussed more fully in the Construction chapter —

Construction, Modern-

ization, or Major Alteration and Renovation of Research Facilities—Public Policy Requirements

4.1.22 Nondelinquency on Federal Debt

The Federal Debt Collection Procedures Act of 1990 (Act), 28 U.S.C. 3201(e), provides that an organ-

ization or individual that is indebted to the United States, and has a judgment lien filed against it, is

ineligible to receive a Federal grant. NIH cannot award a grant unless the AOR of the applicant organ-

ization (or individual in the case of a Kirschstein-NRSA individual fellowship) certifies, by means of

their signature on the application, that the organization (or individual) is not delinquent in repaying any

Federal debt. If the applicant discloses delinquency on a debt owed to the Federal government, NIH may

not award the grant until the debt is satisfied or satisfactory arrangements are made with the agency to

which the debt is owed. In addition, once the debt is repaid or satisfactory arrangements made, NIH will

take that delinquency into account when determining whether the applicant would be a responsible NIH

grant recipient.

Anyone who has been judged to be in default on a Federal debt and who has had a judgment lien filed

against them should not be listed as a participant in an application for an NIH grant until the judgment is

paid in full or is otherwise satisfied. No funds may be used for or rebudgeted following an award to pay

such an individual. NIH will disallow costs charged to awards that provide funds to individuals in viol-

ation of this Act.

These requirements apply to all types of organizations and awards, including foreign grants.

4.1.23 President's Emergency Plan for AIDS Relief (PEPFAR) Program

4.1.23.1 PEPFAR Agreements

Specific terms and conditions concerning prostitution and sex trafficking apply to all grants awarded

under the U.S. President’s Emergency Plan for AIDs Relief (PEPFAR) program. These are:

A. The U.S. Government is opposed to prostitution and related activities, which are inherently harm-

ful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the

funds made available under this agreement may be used to promote or advocate the legalization

or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be con-

strued to preclude the provision to individuals of palliative care, treatment, or post-exposure phar-

maceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits,

condoms, and, when proven effective, microbicides.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

B. The following definitions apply for purposes of this provision:

1. “Commercial sex act” means any sex act on account of which anything of value is given

to or received by any person.

2. “Prostitution” means procuring or providing any commercial sex act and the “practice of

prostitution” has the same meaning.

3. “Sex trafficking” means the recruitment, harboring, transportation, provision, or obtain-

ing of a person for the purpose of a commercial sex act.

C. The Recipient must insert this provision, which is a standard provision, in all subawards or sub-

contracts.

D. This provision includes express terms and conditions of the award and any violation of it is

grounds for unilateral termination of the award by NIH prior to the end of its term.

4.1.23.2 PEPFAR Agreements Between the U.S. Government and Foreign Non-

Governmental Organizations (NGOs)

Additional requirements regarding the opposition to prostitution and sex trafficking may be applied to

grants awarded under PEPFAR and issued to foreign Non-Governmental Organizations (NGOs) directly

supported by or subrecipients of U.S. public or private NGOs. Subject to the United States Supreme

Court’s decision in Agency for International Development, et al., v. Alliance for Open Society Inter-

national, Inc., et al., 133 S. Ct. 2321 (2013) and subsequent proceedings, the terms and conditions for

such agreements with foreign NGOs may include the following:

A. The U.S. Government is opposed to prostitution and related activities, which are inherently harm-

ful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the

funds made available under this agreement may be used to promote or advocate the legalization

or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be con-

strued to preclude the provision to individuals of palliative care, treatment, or post-exposure phar-

maceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits,

condoms, and, when proven effective, microbicides.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

1. Except as provided in (B)(2) and (B)(3), by accepting this award or any subaward, a

non-governmental organization or public international organization recipient / sub-

recipient agrees that it is opposed to the practices of prostitution and sex trafficking

because of the psychological and physical risks they pose for women, men, and children.

Any enforcement of this clause is subject to

Agency for International Development, et

al., v. Alliance for Open Society International, Inc., et al.

, 133 S. Ct. 2321 (2013) and

subsequent proceedings.

2. The following organizations are exempt from (B)(1): the Global Fund to Fight AIDS,

Tuberculosis and Malaria; the World Health Organization; the International AIDS Vac-

cine Initiative; and any United Nations agency.

3. Contractors and subcontractors are exempt from (B)(1) if the contract or subcontract is

for commercial items and services as defined in FAR 2.101, such as pharmaceuticals,

medical supplies, logistics support, data management, and freight forwarding.

4. Notwithstanding section (B)(3), not exempt from (B)(1) are recipients, subrecipients,

contractors, and subcontractors that implement HIV/AIDS programs under this assist-

ance award, any subaward, or procurement contract or subcontract by:

i. Providing supplies or services directly to the final populations receiving such sup-

plies or services in host countries;

ii. Providing technical assistance and training directly to host country individuals or

entities on the provision of supplies or services to the final populations receiving

such supplies and services; or

iii. Providing the types of services listed in FAR 37.203(b)(1)-(6) that involve giving

advice about substantive policies of a recipient, giving advice regarding the activ-

ities referenced in (i) and (ii), or making decisions or functioning in a recipient’s

chain of command (e.g., providing managerial or supervisory services approving

financial transactions, personnel actions).

C. The following definitions apply for purposes of this provision:

1. “Commercial sex act” means any sex act on account of which anything of value is given

to or received by any person.

2. “Prostitution” means procuring or providing any commercial sex act and the “practice of

prostitution” has the same meaning.

3. “Sex trafficking” means the recruitment, harboring, transportation, provision, or obtaining

of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).

D. The recipient shall insert this provision, which is a standard provision, in all subawards, pro-

curement contracts or subcontracts.

E. This provision includes express terms and conditions of the award and any violation of it shall

be grounds for termination of the award by NIH prior to the end of its term.

4.1.24 Pro-Children Act of 1994

Public Law 103-227, Title X, Part C, Environmental Tobacco Smoke, also known as the Pro-Children

Act of 1994, imposes restrictions on smoking in facilities where federally funded children’s services are

provided. NIH grants are subject to these requirements only if they meet the Act’s specified coverage.

The Act specifies that smoking is prohibited in any indoor facility (owned, leased, or contracted for)

used for the routine or regular provision of kindergarten, elementary, or secondary education or library

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

services to children under the age of 18. In addition, smoking is prohibited in any indoor facility or por-

tion of a facility (owned, leased, or contracted for) used for the routine or regular provision of federally

funded health care, day care, or early childhood development (Head Start) services to children under the

age of 18. The statutory prohibition also applies if such facilities are constructed, operated, or maintained

with Federal funds. The statute does not apply to children’s services provided in private residences, facil-

ities funded solely by Medicare or Medicaid funds, portions of facilities used for inpatient substance or

alcohol treatment, or facilities where Women, Infants and Children (WIC) coupons are redeemed. Failure

to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up

to $1,000 per violation and/or the imposition of an administrative compliance order on the responsible

entity.

Because of the nature of NIH programs and funding, individual transactions, rather than entire programs,

may be subject to these requirements. The signature of the AOR will indicate the intent to comply. Any

questions concerning the applicability of these provisions to an NIH grant should be directed to the

GMO.

4.1.25 Public Health Security

4.1.25.1 Public Health Security and Bioterrorism Preparedness and Response Act

(Select Agents)

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 42 U.S.C. 201, is

designed to provide protection against misuse of select agents and toxins whether inadvertent or the res-

ult of terrorist acts against the U.S. homeland or other criminal acts. The Act was implemented, in part,

through regulations published by HHS and USDA at 42 CFR Part 73, 9 CFR Part 121 and 7 CFR Part

331 or commonly referred to as “Select Agent Regulations.” Copies of these regulations are available

here

, or can be obtained from CDC, 1600 Clifton Road, MS A-46, Atlanta, GA 30333; telephone: 404-

718-2000.

Research involving select agents and recombinant or synthetic nucleic acid molecules also is subject to

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH

Guidelines)

NIH Guidelines

apply to all research projects (NIH-funded and non-NIH-funded) that

involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organ-

ization that receives NIH support for recombinant or synthetic nucleic acid molecule research.

4.1.25.1.1 Select Agents

4.1.25.1.1.1 Select Agent Awards to U.S. Institutions

Domestic recipients who conduct research involving select agents or toxins (see Section 3 and 4 of 42

CFR Part 73 and 9 CFR Part 121 and Section 3 of 7 CFR Part 331) must maintain a registration with

CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research

involving select agents or toxins if the registration certificate maintained by CDC or USDA is suspended

or revoked.

4.1.25.1.1.2 Select Agent Awards to Foreign Organizations and International Organ-

izations

Foreign Organizations and International Organizations who conduct research involving select agents (see

42 CFR Part 73 for the select agent list; and 7 CFR Part 331 and 9 CFR Part 121 for the relevant animal

and plant pathogens) must provide information satisfactory to NIH that a process equivalent to that

described in 42 CFR Part 73 for U.S. institutions is in place and will be administered on behalf of all

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

select agent work sponsored by NIH funds before using these funds for any work directly involving

select agents. Recipients must be willing to address the following key elements appropriate for their insti-

tutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals

have access to the select agents, and any applicable laws, regulations and policies equivalent to 42 CFR

Part 73. If this work will not, in fact, involve select agents (e.g. excluded strains), and you provide doc-

umentation satisfactory to NIH that your work does not now nor will it in the future (i.e. throughout the

life of the award) involve select agents, no further action will be necessary.

4.1.25.1.1.3 Select Agent Awards to U.S. Institutions with Foreign Subcomponents

Recipients who conduct research involving select agents (see 42 CFR Part 73 for the select agent list;

and 7 CFR Part 331 and 9 CFR Part 121 for the relevant animal and plant pathogens) must complete

registration with CDC (or USDA, depending on the agent) before using NIH funds for any work directly

involving the select agent at the U.S. institution. No funds can be used for research involving select

agents if the final registration certificate is denied. Before using NIH funds for any work directly

involving the select agents at a foreign subrecipient, the U.S. recipient must provide information from

the foreign organization satisfactory to NIH that a process equivalent to that described in 42 CFR Part 73

for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by

these funds. Recipients must be willing to address the following key elements appropriate for the foreign

organization: safety, security, training, procedures for ensuring that only approved/appropriate indi-

viduals have access to the select agents, and any applicable laws, regulations and policies equivalent to

42 CFR Part 73 are followed. If this work will not, in fact, involve select agents (e.g. excluded strains),

and you provide documentation satisfactory to NIH that your work does not now nor will it in the future

(i.e. throughout the life of the award) involve select agents, no further action will be necessary.

4.1.25.2 Dual Use Research of Concern

On September 24, 2014, the Federal government issued a policy for the oversight of life sciences

“Dual

Use Research of Concern” (DURC)

. DURC is defined as life sciences research that, based on current

understanding, can be reasonably anticipated to provide knowledge, information, products, or tech-

nologies that could be directly misapplied to pose a significant threat with broad potential consequences

to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or

national security.

The DURC policy applies to recipient institutions and its investigators in the United States that receive

Federal funding for life sciences research and that conduct or sponsor research involving one or more of

the 15 agents or toxins listed in the policy and to foreign recipients that receive Federal funding to con-

duct or sponsor research involving one of these 15 agents or toxins. Institutions must establish an Insti-

tutional Review Entity (IRE) which must review research involving these agents or toxins to determine if

it involves one or more of the listed experimental effects and if so, whether it meets the definition of

DURC. Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR), as

required by the U.S. Government’s DURC Policy, to serve as an internal resource for issues regarding

compliance with and implementation of the requirements for the oversight of research that falls within

the scope of the DURC policy role. The award recipient must maintain records of institutional DURC

reviews and completed risk mitigation plans for the term of the research grant or contract plus three

years after its completion, but no less than eight years, unless a shorter period is required by law or reg-

ulation.

For research that may be considered DURC, NIH will work collaboratively with the institution and

investigators to develop a risk mitigation plan, which may be implemented through a term of award and

that NIH must approve.

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4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1.25.3 Agents Regulated Under the Chemical Weapons Convention

The United States is one of 175 States Parties to the Chemical Weapons Convention (CWC), which pro-

hibits the development, production, stockpiling, and use of chemical weapons (CW). The CWC does not

prohibit production, processing, consumption, or trade of related chemicals for peaceful purposes, but it

does establish a verification regime to ensure such activities are consistent with the object and purpose of

the treaty.

NIH researchers engaged in activities involving these chemicals, especially Schedule 1 chemicals, may

be required to submit declarations and/or reports to the Bureau of Industry and Security (BIS) and may

be subject to inspection by the Organization for the Prohibition of Chemical Weapons, which administers

the CWC. In addition, trade in certain chemicals with States not Party to the CWC may be prohibited or

subject to an export license and or end-use certificate.

Schedule 1 chemicals include, but are not limited to, the toxic chemicals sarin, soman, tabun, VX, sulfur

mustards, Lewisites, saxitoxin, ricin, and nitrogen mustards. More information about the U.S. CWC,

including complete lists of Schedule 1, 2, and 3 chemicals under the CWC may be found at on the

U.S.

Chemical Weapons Convention website

. Federal regulations that apply to the CWC are 15 CFR

CHAPTER VII, SUBCHAPTER B, PARTS 710-722, SUBCHAPTER C, PARTS 730-774; 22 CFR

CHAPTER I, PART 103, PARTS 120-130. These CRFs and other applicable safety standards issued by

the Department of Commerce and Department of State are available on the

Chemical Weapons Con-

ventions Regulations webpage.

4.1.25.4 Procurement of Synthetic Nucleic Acids and Benchtop Nucleic Acid Syn-

thesis Equipment

Effective April 26, 2025, NIH funds may only be used to procure synthetic nucleic acids or benchtop

nucleic acid synthesis equipment from sources adhering to the 2024 OSTP Framework for Nucleic Acid

Synthesis Screening (Framework), or successor frameworks. NIH requires recipients to maintain appro-

priate documentation at the time of procurement in accordance with record retention requirements (See 2

CFR 200.334). Supporting documentation must be made available to NIH upon request, in accordance

with 2 CFR 200.337. For more information, and definitions for synthetic nucleic acids and benchtop nuc-

leic acid synthesis equipment subject to these requirements, see the Framework or successor frameworks.

Further guidance can be found in the

HHS 2023 Screening Framework Guidance for Providers and Users

of Synthetic Nucleic Acids and Companion Guide

4.1.26 Reporting and Assurance Requirements for Institutions Receiv-

ing Awards for Training of Graduate Students for Doctoral Degrees

As required by Section 403C of the Public Health Service Act, each institution receiving an NIH award

for the training of graduate students for doctoral degrees must provide information on completion rates

and time to degree to all applicants to doctoral programs supported by NIH training awards. Specifically,

institutions must provide applicants with the following information for the programs to which they

apply:

The percentage of students admitted for study who successfully attain a doctoral degree, and

The average time (not including any leaves of absence) between the beginning of graduate study

and the receipt of a doctoral degree.

Institutions

affected

by this Assurance and information disclosure requirement are doctoral degree grant-

ing institutions that receive any of the following institutional training grant awards or cooperative agree-

ments from NIH for the doctoral training of graduate students:

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D43, TU2, T15, T32, T37, T90, U2R, U90, and U54/TL1

Institutions are

not affected

by this requirement if they:

Receive only individual NIH fellowship awards.

Provide training only to undergraduate or master’s level students supported through one of the

activity codes listed above.

Provide only short-term training to doctoral-level health professional students through one of the

activity codes listed above.

Receive an award for one or more of the activity codes for doctoral training of graduate students,

but do not confer doctoral degrees themselves (e.g., teaching hospitals).

Receive an institutional training grant award for doctoral training of graduate students from a

Public Health Service Agency other than NIH.

In complying with this Assurance and information disclosure requirement, institutions may decide how

best to present the required information to applicants and may wish to consider consolidating data by

department or broad program to which candidates apply, or providing additional information in order to

provide context.

Recipients with awards for any of the activity codes listed above are also required to provide cor-

responding information on trainees supported by each of their awards when submitting a renewal applic-

ation or RPPR.

4.1.27 Research Involving Recombinant or Synthetic Nucleic Acid

Molecules

4.1.27.1 Scope and Availability

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH

Guidelines)

(April 2024 or latest revision) apply to all research projects (NIH-funded and non-NIH-fun-

ded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by

an organization that receives NIH support for recombinant or synthetic nucleic acid molecules.

According to

NIH Guidelines

, recombinant and synthetic nucleic acid molecules are defined as (1)

molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell,

i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means syn-

thesized or amplified, including those that are chemically or otherwise modified but can base pair with

naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or (3)molecules that result from

the replication of those described in (1) or (2).

NIH Guidelines

apply to both basic and clinical research

studies.

Failure to comply with these requirements may result in suspension or termination of an award for recom-

binant or synthetic nucleic acid molecule research at the organization, or a requirement for NIH prior

approval of any or all recombinant or synthetic nucleic acid molecule projects at the organization. The

recipient should carefully review

NIH Guidelines

in its entirety to ensure compliance with all of the

requirements for projects involving recombinant or synthetic nucleic acid molecules.

Research involving recombinant or synthetic nucleic acid molecules and select agents also is subject to

pertinent CDC and USDA regulations, 42 CFR Part 73, Select Agents and Toxins; and 7 CFR Part 331

and 9 CFR Part 121, Possession, Use, and Transfer of Biological Agents and Toxins.

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4.1.27.2 Institutional Biosafety Committee

Each organization that conducts research involving recombinant or synthetic nucleic acid molecules,

including contractors under grants, must have policies and procedures to ensure compliance with NIH

Guidelines and must establish a standing IBC. The IBC is required to review experiments involving

recombinant or synthetic nucleic acid molecules to ensure that the procedures, project, personnel, and

facilities are adequate and in compliance with NIH Guidelines. All IBC minutes resulting from meetings

taking place on or after June 1, 2025, must be posted on a public-facing institutional website imme-

diately after approval and once all appropriate and allowable redactions have been made. Section IV of

NIH Guidelines specifies the composition of IBCs. A roster of the IBC members and biosketches for

each member must be submitted to NIH. At a minimum, the roster should indicate the name of each IBC

member, as well as which IBC members are serving as the chairperson, contact person, and, as applic-

able, experts in biosafety or plant, animal, or human experimentation. Biosketches should include a

description of the occupation and professional qualifications of each member. Organizations can register

their IBC with NIH on-line by utilizing the

IBC Registration Management System (RMS)

4.1.27.3 Investigators and Institutional Staff

Section IV of

NIH Guidelines

also specifies the roles and responsibilities of PIs, biological safety

officers (BSOs) and recipient institutions with respect to the safe conduct and oversight of recombinant

or synthetic nucleic acid molecules. Investigators, laboratory staff, BSOs, and institutional officials are

strongly encouraged to review and comply with these requirements, as described by the

NIH Guidelines

for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

4.1.28 Research Misconduct

Title 42 CFR Part 93, PHS Policies on Research Misconduct (the “PHS regulation”), Subpart C,

“Responsibilities of Institutions” specifies recipient responsibilities to have written policies and pro-

cedures for addressing allegations of research misconduct, to file an Assurance of Compliance with the

HHS Office of Research Integrity (ORI), and take all reasonable and practical steps to foster research

integrity. Research misconduct is defined by Subpart A of 42 CFR Part 93 as fabrication, falsification, or

plagiarism in proposing, performing, or reviewing research, or in reporting research results. Subpart D,

“Responsibilities of the U.S. Department of Health and Human Services,” specifies that

ORI

has respons-

ibility for addressing research integrity and misconduct, monitors institutional investigations of research

misconduct and facilitates the responsible conduct of research through education, preventive, and reg-

ulatory activities.

To be eligible for PHS funding, domestic and foreign institutions must have approved assurances and

required renewals on file with ORI. The responsible institutional official must assure on behalf of the

institution that the institution (1) has written policies and procedures in compliance with 42 CFR Part 93

for inquiring into and investigating allegations of research misconduct in PHS-supported research and (2)

complies with its own policies and procedures and the requirements of 42 CFR Part 93. In addition,

recipient institutions must foster a research environment that promotes the responsible conduct of

research. Domestic subrecipient institutions and institutions funded through linked international research

projects must also maintain an assurance by submitting form PHS-6315 to ORI. An institution estab-

lishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant applic-

ation form or when the institution files a separate assurance form. Once established, institutions maintain

their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and

April 30 each year), submitting their policy for responding to allegations of research misconduct for

review when requested by ORI, revising their policy when requested by ORI to bring the policy into

compliance with the PHS regulation, and complying with the PHS regulation.

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As stated throughout the NIHGPS, the recipient has primary responsibility for ensuring that it is con-

ducting its NIH-funded project in accordance with the approved application and budget and the terms

and conditions of the award. The recipient must carry out its responsibilities with extra care where

research misconduct has been found or where a research misconduct investigation has been initiated, as

specified in 42 CFR Part 93, Subpart C. The recipient must report promptly to ORI any decision to ini-

tiate an investigation of research misconduct.

The regulations specify the timing of an institutional investigation, related reporting to ORI, notice to the

respondent, custody of records, documentation, opportunity for respondent to comment on the report,

and the components on a final institutional investigative report.

If a misconduct investigation is initiated, the recipient must take any necessary steps, in addition to its

normal and ongoing responsibilities under the grant, to protect the scientific integrity of the project, pro-

tect human subjects and live vertebrate animals, provide reports to ORI, and ensure the proper expendit-

ure of funds and continuation of the project during the investigation, if appropriate. ORI staff members

are available to provide technical assistance to any institution that is responding to an allegation of

research misconduct involving PHS funds. NIH IC staff members are available to provide guidance and

to work with recipient institutions to protect funded projects from the adverse effects of research mis-

conduct.

The recipient institution’s engagement with ORI as provided in 42 CFR Part 93 does not substitute for

its engagement with NIH to ensure ongoing compliance with the terms and conditions of award. When

the recipient institution finds, learns of, or suspects research misconduct that impacts or might impact the

conduct or performance of an NIH-supported project(s), whether at the recipient organization or at a

third-party subrecipient organization, the recipient must work with NIH to assess the effect on the ability

to continue the project, as originally approved by NIH. If the recipient institution determines that a

change of scope or a change of PD/PI or other senior/key personnel is required, the institution must

promptly obtain approval from the NIH funding Institute or Center Grants Management Officer. When a

recipient institution finds, learns, or suspects that falsified, fabricated, or plagiarized information has

affected the integrity of NIH-supported research, including but not limited to, applications for funding

and progress reports, or published research or research products supported by NIH funds, NIH has a

need to know this information, and the institution must immediately provide information on the affected

research to the

NIH Office of Extramural Research – Research Integrity

(OER-RI), in a manner con-

sistent with the ORI confidentiality provision at, 42 CFR Part 93.108. The final institutional invest-

igation report must be submitted to ORI, as outlined in Subpart C of 42 CFR Part 93.

NIH retains the authority to provide oversight regarding the management of grants and cooperative agree-

ments. Accordingly, NIH may take action(s) to protect the health and safety of the public, including

research participants, to promote the integrity of the PHS supported research and research process, and to

conserve public funds. When a recipient fails to comply with the terms and conditions of award, NIH

may take one or more enforcement actions including disallowance of costs, withholding of further sup-

port, or suspension or termination of the grant. These actions are described in

Administrative Require-

ments—Enforcement Actions

Where research misconduct has affected data validity or reliability, ORI or NIH may request that the

recipient and its employee/collaborator authors submit a correction or retraction of the data to a journal,

publish the corrected data, or both. If the recipient does not comply, NIH may invoke its rights, under 2

CFR Part 200.315, to access the data (including copyrightable material developed under the award), and

may then have the data reviewed, and notify the journal.

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4.1.29 Seat Belt Use

Pursuant to EO 13043 (April 16, 1997), Increasing the Use of Seat Belts in the United States, NIH

encourages recipients to adopt and enforce on-the-job seat belt policies and programs for their employees

when operating vehicles, whether organizationally owned or rented or personally owned.

4.1.30 Smoke-Free Workplace

NIH strongly encourages recipients to provide smoke-free workplaces and to promote the nonuse of

tobacco products. NIH defines the term “workplace” to mean office space (including private offices and

other workspace), conference or meeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias, and

other public spaces.

4.1.31 Standards of Conduct

NIH requires recipients to establish safeguards to prevent employees, consultants, members of governing

bodies, and others who may be involved in grant-supported activities from using their positions for pur-

poses that are, or give the appearance of being, motivated by a desire for private financial gain for them-

selves or others, such as those with whom they have family, business, or other ties. These safeguards

must be reflected in written standards of conduct. Except as provided below, NIH does not require a

recipient to establish separate standards of conduct if it maintains such standards for its non-grant-sup-

ported activities, as long as those standards are consistent with State and local laws and cover, at a min-

imum, expected conduct in regard to financial interests, gifts, gratuities and favors, nepotism, and such

other areas as political participation and bribery. The standards also must do the following:

Address the conditions under which outside activities, relationships, or financial interests are

proper or improper.

Provide for advance notification of outside activities, relationships, or financial interests to a

responsible organizational official.

Include a process for notification and review by the responsible official of potential or actual

violations of the standards.

Specify the nature of penalties that the recipient may impose. These penalties would be in addi-

tion to any penalties that NIH or a cognizant Federal agency may impose for infractions that also

violate the terms or conditions of award.

The recipient is not required to submit its general standards of conduct to NIH for review or approval.

However, a copy must be made available to each of its officers, each employee and consultant working

on the grant-supported project or activity, each member of the governing board, if applicable, and, upon

request, to NIH. The recipient is responsible for enforcing its standards of conduct, taking appropriate

action on individual infractions, and, in the case of financial conflict of interest, the recipient is required

to notify the NIH of an identified financial conflict of interest (FCOI) by submitting the FCOI report to

NIH via the eRA Commons FCOI Module (see 4.1.10, Financial Conflict of Interest). If a suspension or

separation action is taken by a recipient against a PD/PI or other senior/key personnel under an NIH

grant, the recipient must request prior approval of the proposed replacement as specified in

Admin-

istrative Requirements—Changes in Project and Budget—Prior Approval Requirements

The recipient must promptly report issues involving potential criminal violations, such as mis-

appropriation of Federal funds, to the

HHS OIG

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4.1.32 Text Messaging While Driving

Executive Order 13513 (E.O. 13513) requires each Federal agency to encourage contractors, sub-

contractors, and grant and cooperative agreement recipients and subrecipients to adopt and enforce

policies that ban text messaging while driving company-owned or -rented vehicles or Government

Owned Vehicles, or while driving Personally Owned Vehicles when on official Government business or

when performing any work for or on behalf of the Government.

To further the requirement of encouraging such policies, NIH encourages recipients to consider new

rules and programs, reevaluate existing programs to prohibit text messaging while driving, and conduct

education, awareness, and other outreach for employees about the risks associated with texting while

driving. These initiatives should encourage voluntary compliance with the recipient agency’s text mes-

saging policy while off duty.

For the purposes of this policy and pursuant to E.O. 13513, the following definitions apply:

a. ‘‘Texting’’ or ‘‘Text Messaging’’ means reading from or entering data into any handheld or

other electronic device, including for the purpose of SMS texting, e-mailing, instant messaging,

obtaining navigational information, or engaging in any other form of electronic data retrieval or

electronic data communication.

b. ‘‘Driving’’ means operating a motor vehicle on an active roadway with the motor running,

including while temporarily stationary because of traffic, a traffic light or stop sign, or otherwise.

It does not include operating a motor vehicle with or without the motor running when one has

pulled over to the side of, or off, an active roadway and has halted in a location where one can

safely remain stationary.

4.1.33 Trafficking in Persons

This government-wide award term implements Section 106 (g) of the Trafficking Victims Protection Act

(TVPA) of 2000, as amended (

22 U.S.C. 7104

), located at

2 CFR Part 175.A

Final Notice is expected to

be issued in the future; however, HHS agencies have implemented this award term based on the Interim

Final Guidance.

In accordance with the statutory requirement, in each agency award under which funding is provided to a

private entity, section 106(g) of the TVPA, as amended, requires the agency to include a condition that

authorizes the agency to terminate the award, without penalty, if the recipient or a subrecipient —

a. Engages in severe forms of trafficking in persons during the period of time that the award is in

effect;

b. Procures a commercial sex act during the period of time that the award is in effect; or

c. Uses forced labor in the performance of the award or subawards under the award.

4.1.34 USA Patriot Act

The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and

Obstruct Terrorism Act (USA PATRIOT Act) (P.L. 107-56) amends 18 U.S.C. 10 and provides criminal

penalties for possession of any biological agent, toxin, or delivery system of a type or in a quantity that

is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose.

The Act also establishes restrictions on access to specified materials. “Restricted persons,” as defined by

the Act, may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select

agent (see

Public Health Security and Bioterrorism Preparedness and Response Act

in this section).

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4.1.35 Responsibility/Qualification Information in SAM.gov

NIH award recipients are subject to the reporting requirements established by Public Law 112-239,

National Defense Authorization Act for Fiscal Year 2013 and provided in Appendix XII to 2 CFR Part

200, NIH recipients that have currently active Federal grants, cooperative agreements, and procurement

contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000

must report and maintain information in the System for Award Management (SAM) about civil, crim-

inal, and administrative proceedings in connection with the award or performance of a Federal award

that reached final disposition within the most recent five-year period. The recipient must also make semi-

annual disclosures regarding such proceedings. Proceedings information will be made publicly available

in the designated integrity and performance system. Full reporting requirements and procedures are

found in Appendix XII to 2 CFR Part 200.

4.1.36 Mandatory Disclosures

Consistent with 2 CFR Part 200.113, NIH applicants, recipients, or subrecipients must promptly disclose

in writing to the NIH awarding IC, the HHS Office of Inspector General (OIG), and the pass-through

entity (if applicable) whenever, in connection with the Federal award (including any activities or sub-

awards), it has credible evidence of the commission of a violation of Federal criminal law involving

fraud, conflict of interest, bribery, or gratuity violations found in Title 18 of the United States Code or a

violation of the civil False Claims Act (31 U.S.C. 3729–3733). Disclosures must be sent in writing to the

NIH awarding IC and to the HHS OIG at the following address:

NIH CGMO listed on the NoA for the IC that funded the grant (See

Part III: Points of Contact 20

INSTITUTES AND CENTERS

)

AND

Office of Counsel to the Inspector General

Office of Inspector General

U.S. Department of Health and Human Services

Grant Self-Disclosure

330 Independence Avenue, SW, Cohen Building

Room 5527

Washington, DC 20201

URL:

https://oig.hhs.gov/compliance/self-disclosure-info/hhs-oig-grant-self-disclosure-program/

Email:

grantdisclosures@oig.hhs.gov

Failure to make required disclosures can result in any of the remedies described in 2 CFR Part 200.339.

Remedies for noncompliance and

Administrative Requirements – Enforcement Actions

, including

sus-

pension or debarment

(See 2 CFR Part 180 and 376, 31 U.S.C.3321 and

Public Policy Requirements and

Objectives— Debarment and Suspension

), as necessary and appropriate.

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4.1.37 Never Contract with the Enemy

Federal awarding agencies and recipients are subject to the regulations implementing Never Contract

with the Enemy in 2 CFR Part 183. The regulations in 2 CFR Part 183 affect covered contracts, grants

and cooperative agreements that are expected to exceed $50,000 within the period of performance, are

performed outside the United States and its territories, and are in support of a contingency operation in

which members of the Armed Forces are actively engaged in hostilities.

4.1.38 Prohibition on Certain Telecommunications and Video Sur-

veillance Equipment or Services

Recipients and subrecipients are prohibited from expending loan or grant funds to: (1) Procure or obtain

covered telecommunications equipment or services; (2) Extend or renew a contract to procure or obtain

covered telecommunications equipment or services; or (3) Enter into a contract (or extend or renew a

contract) to procure or obtain covered telecommunications equipment or services.

As described in section 889 of Public Law 115-232, “covered telecommunications equipment or ser-

vices” means any of the following:

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation

(or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of government facilities, physical security surveillance of

critical infrastructure, and other national security purposes, video surveillance and telecommunications

equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology

Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

(3) Telecommunications or video surveillance services provided by such entities or using such equip-

ment;

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity

that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Dir-

ector of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by,

or otherwise connected to, the government of a covered foreign country.

COVERED FOREIGN COUNTRY means the People’s Republic of China.

For the purposes of this section, “covered telecommunications equipment or services” also include sys-

tems that use covered telecommunications equipment or services as a substantial or essential component

of any system, or as critical technology as part of any system.

In implementing the prohibition under section 889 of Public Law 115-232, heads of executive agencies

administering loan, grant, or subsidy programs must prioritize available funding and technical support to

assist affected businesses, institutions, and organizations as is reasonably necessary for those affected

entities to transition from covered telecommunications equipment or services, to procure replacement

equipment or services, and to ensure that communications service to users and customers is sustained.

When the recipient or subrecipient accepts a loan or grant, it is certifying that it will comply with the pro-

hibition on covered telecommunications equipment and services in this section. The recipient or sub-

recipient is not required to certify that funds will not be expended on covered telecommunications

equipment or services beyond the certification provided upon accepting the loan or grant and those

provided upon submitting payment requests and financial reports.

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4.1.39 Whistleblower Protections

An employee of a recipient or subrecipient must not be discharged, demoted, or otherwise discriminated

against as a reprisal for disclosing to a person or body described in paragraph (a)(2) of 41 U.S.C. 4712

information that the employee reasonably believes is evidence of gross mismanagement of a Federal con-

tract or grant, a gross waste of Federal funds, an abuse of authority relating to a Federal contract or

grant, a substantial and specific danger to public health or safety, or a violation of law, rule, or regulation

related to a Federal contract (including the competition for or negotiation of a contract) or grant. The

recipient and subrecipient must inform their employees in writing of employee whistleblower rights and

protections under 41 U.S.C. 4712. See statutory requirements for whistleblower protections at 10 U.S.C.

4701, 41 U.S.C. 4712, 41 U.S.C. 4304, and 10 U.S.C. 4310.

4.2 APPROPRIATION MANDATES

The following statutory provisions limit the use of funds on NIH grants, cooperative agreements, and

contract awards. These are provided separately in this section since they are subject to change annually

based on specific appropriation language that restricts the use of grant funds. References to “Act” in

these sections refer to the governing HHS annual appropriation Act. A list of Appropriation Mandates

applicable to each fiscal year can be found on the

NIH Fiscal Policies page

4.2.1 Acknowledgment of Federal Funding

In accordance with

the Steven's Amendment

, all HHS recipients must acknowledge Federal funding

when issuing statements, press releases, requests for proposals, bid invitations, and other documents

describing projects or programs funded in whole or in part with Federal money. Recipients are required

to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal

money and (2) the dollar amount of the total costs financed by nongovernmental sources.

4.2.2 Dissemination of False or Deliberately Misleading Information

None of the funds made available in the governing appropriations Act may be used to disseminate

information that is deliberately false or misleading.

4.2.3 Gun Control

NIH funds may not be used, in whole or in part, to advocate or promote gun control.

4.2.4 Human Embryo Research and Cloning Ban

NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or

(2) for research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected

to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR Part

46.204(b) and subsection 498(b) of the PHS Act (42 U.S.C. 289g(b)). The term “human embryo or

embryos” includes any organism not protected as a human subject under 45 CFR Part 46, as of the date

of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, clon-

ing, or any other means from one or more human gametes or human diploid cells. Furthermore, per the

NIH Director’s Statement of April 28, 2015, NIH will not fund any use of gene-editing technologies in

human embryos.

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In addition to the statutory restrictions on human fetal research under subsection 498(b) of the PHS Act,

by Presidential memorandum of March 4, 1997, NIH is prohibited from using Federal funds for cloning

of human beings.

4.2.5 Lobbying—Appropriation Prohibition

NIH appropriated funds may not be used, other than for normal and recognized executive-legislative rela-

tionships for publicity or propaganda purposes, for the preparation, distribution, or use of a kit, pamphlet,

booklet, publication, electronic communication, radio, television, or video presentation designed to sup-

port or defeat the enactment of legislation before the Congress or any State or local legislature or legis-

lative body, except in presentation to the Congress or any State legislature or local legislature itself or

designed to support or defeat any proposed or pending regulation administrative action, or order issued

by the executive branch of any State or local government, except in presentation to the executive branch

of any State or local government itself. No part of any governing appropriation act shall be used to pay

the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any

activity designed to influence the enactment of legislation, appropriations, regulation, administrative

action, or Executive Order proposed or pending before the Congress or any State government, State legis-

lature or local legislature or legislative body other than for normal and recognized executive-legislative

relationships or participation by an agency or officer of a State, local or tribal government in poli-

cymaking and administrative processes within the executive branch of that government. No part of any

governing appropriation Act shall be used for any activity to advocate or promote any proposed, pending

or future Federal, State or local tax increase, or any proposed, pending, or future requirement or restric-

tion on any legal consumer product, including its sale or marketing, including but not limited to the

advocacy or promotion of gun control, except as described above. Also see

Public Policy Requirements

and Objectives—Lobbying Prohibition

Appropriation Mandates—Gun Control

and

Cost Con-

siderations—Allowability of Costs and Activities

4.2.6 Promotion or Legalization of Controlled Substances

Recipients are prohibited from knowingly using appropriated funds to support activities that promote the

legalization of any drug or other substance included in Schedule I of the schedules of controlled sub-

stances established by section 202 of the Controlled Substances Act, 21 U.S.C. 812 except for normal

and recognized executive-congressional communications. This limitation does not apply if the recipient

notifies the GMO that there is significant medical evidence of a therapeutic advantage to the use of such

drug or other substance or that federally sponsored clinical trials are being conducted to determine thera-

peutic advantage (see also

4.1.5 Controlled Substances

4.2.7 Restriction on Abortion Funding

NIH appropriated funds and funds in any trust fund to which funds are appropriated in the governing

appropriation Act may not be spent for any abortion. None of the funds appropriated in the governing

appropriation Act, and none of the funds in any trust fund to which funds are appropriated in this Act,

shall be expended for health benefits coverage that includes coverage of abortion. The term ‘‘health bene-

fits coverage’’ means the package of services covered by a managed care provider or organization pur-

suant to a contract or other arrangement.

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.2.7.1 Exceptions to Restrictions on Abortions

A. The limitations established in the preceding section shall not apply to an abortion —

1. If the pregnancy is the result of an act of rape or incest; or

2. In the case where a woman suffers from a physical disorder, physical injury, or physical

illness, including a life endangering physical condition caused by or arising from the

pregnancy itself, that would, as certified by a physician, place the woman in danger of

death unless an abortion is performed.

B. Nothing in the preceding section shall be construed as prohibiting the expenditure by a State, loc-

ality, entity, or private person of State, local, or private funds (other than a State’s or locality’s

contribution of Medicaid matching funds).

C. Nothing in the preceding section shall be construed as restricting the ability of any managed care

provider from offering abortion coverage or the ability of a State or locality to contract sep-

arately with such a provider for such coverage with State funds (other than a State’s or locality’s

contribution of Medicaid matching funds).

1. None of the funds appropriated to NIH may be made available to a Federal agency or

program, or to a State or local government, if such agency, program, or government sub-

jects any institutional or individual health care entity to discrimination on the basis that

the health care entity does not provide, pay for, provide coverage of, or refer for abor-

tions.

2. In this subsection, the term ‘‘health care entity’’ includes an individual physician or

other health care professional, a hospital, a provider-sponsored organization, a health

maintenance organization, a health insurance plan, or any other kind of health care facil-

ity, organization, or plan.

4.2.8 Restriction on Distribution of Sterile Needles

NIH appropriated funds may not be used to carry out any program of distributing sterile needles or syr-

inges for the hypodermic injection of any illegal drug. However, this limitation does not apply to the use

of funds for elements of a program other than making such purchases if the relevant State or local health

department, in consultation with the Centers for Disease Control and Prevention, determines that the

State or local jurisdiction, as applicable, is experiencing, or is at risk for, a significant increase in hep-

atitis infections or an HIV outbreak due to injection drug use, and such program is operating in accord-

ance with State and local law

4.2.9 Salary Cap/Salary Limitation

None of the funds appropriated in the governing appropriation Act for NIH (the Act), shall be used to

pay direct salaries (individuals working directly on NIH projects) or indirect salaries (executive salaries

in various uncapped cost pools) through a grant or other extramural mechanism at a rate in excess of that

prescribed in the Act. Applications and proposals reflecting salaries of individuals in excess of the rate

prescribed in the Act will be adjusted in accordance with the legislative salary limitation. Recipients may

not draw down funds, whether direct or indirect, to pay salaries above the salary rate limitation, and

recipients must have established policies and procedures that are consistently applied regardless of the

source of funds. Current and historical information on the applicable salary cap for each fiscal year is on

the

Salary Cap Summary

page of the NIH Grants & Funding website.

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.2.10 Restriction of Pornography on Computer Networks

“(a) None of the funds made available in this Act may be used to maintain or establish a computer net-

work unless such network blocks the viewing, downloading, and exchanging of pornography.

(b) Nothing in subsection (a) shall limit the use of funds necessary for any Federal, State, tribal, or local

law enforcement agency or any other entity carrying out criminal investigations, prosecution, or adju-

dication activities.”

4.2.11 Restriction on Disclosure of Political Affiliation for Federal

Scientific Advisory Committee Candidates

Section 515 of the FY2014 Consolidated Appropriations Act included an additional legislative mandate

regarding this requirement:

“None of the funds made available in this Act may be used to request that a candidate for appointment to

a Federal scientific advisory committee disclose the political affiliation or voting history of the candidate

or the position that the candidate holds with respect to political issues not directly related to and neces-

sary for the work of the committee involved.”

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

5 The Notice of Award

5 THE NOTICE OF AWARD

The Notice of Award (NoA) is the legal document issued to notify the recipient that an award has been

made and that funds may be requested from the designated HHS payment system or office. The NoA is

issued for the initial budget period and each subsequent budget period in the approved project period.

The NoA reflects any future-year commitments. A revised NoA may be issued during a budget period to

affect an action resulting in a change in the period or amount of support or other change in the terms and

conditions of award. NIH will not issue a revised NoA to reflect a recipient’s post-award rebudgeting.

Until an IC has issued the NoA for the initial award, any costs incurred by the applicant for the project

are incurred at its own risk (see

Cost Considerations—Allowability of Costs/Activities—Selected Items

of Cost—Pre-Award (Pre-Agreement) Costs

for NIH policy on the allowability of pre-award costs).

Notice of Award Page One

HHS implemented a standardized page one of the NoA that serves as the first page of every HHS NoA

for all discretionary awards. The standardized page one incorporates the following data elements:

o

HHS Operating Division

o

Federal Award Identification Number

o

Federal Award Date

Recipient Information

Recipient Name

Congressional District of Recipient

Payment System Identifier (also known as Entity Identification Number)

Employer Identification Number

Data Universal Numbering System

Recipient’s Unique Entity Identifier

Project Director or Principal Investigator

Authorized Official

Federal Agency Information

Awarding Agency Contact Information

Program Official Contact Information

Federal Award Information

Award Number

Unique Federal Award Identification Number

Statutory Authority

Federal Award Project Title

Assistance Listing Number (formerly / also known as CFDA Number)

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

5 The Notice of Award

Assistance Listing Program Title (formerly / also known as CFDA program title)

Name

Award Action Type

Is this Award R&D?

Summary Federal Award Financial Information

Budget Period Start and End Date

Total Amount of Federal Funds Obligated by this Action

Direct Cost Amount

Indirect Cost Amount

Authorized Carryover

Offset

Total Amount of Federal Funds Obligated this Budget Period

Total Approved Cost Sharing or Matching, where applicable

Total Federal and Non-Federal Approved this Budget Period

Project Period Start and End Date

Total Amount of the Federal Award, including Approved Cost Shar-

ing or Matching, this Project Period

Authorized Treatment of Program Income

Grants Management Officer Signature

Remarks

Remainder of the NIH NoA

Additionally, the remainder of the NIH NoA sets forth pertinent information about the grant in Section I

(Award Data), Section II (Payment Information), and Sections III and IV (Applicable Terms and Condi-

tions of Award). This additional information, includes, but not limited to, the following:

Cumulative budget approved by the NIH awarding IC

Amount of anticipated future-year commitments (if applicable)

Names of the cognizant IC PO, GMO, and GMS

Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45

CFR Part 75.414)

Applicable terms and conditions of award, either by reference or inclusion

Federal award performance goals (as required by the periodic report in the RPPR or in the final

RPPR when applicable)

Any restriction on the use of funds

Note: If applicable, section III of the NoA will also reference an institution’s participation in the current

phase of the Federal Demonstration Partnership (FDP).

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

5 The Notice of Award

As specified in the NoA, all awards issued by the National Institutes of Health (NIH) meet the definition

of “Research and Development” at 2 CFR Part 200. As such, auditees should identify NIH awards as

part of the R&D cluster on the Schedule of Expenditures of Federal Awards (SEFA). The auditor should

test NIH awards for compliance as instructed in Part V, Clusters of Programs. NIH recognizes that some

awards may have another classification for purposes of indirect costs. The auditor is not required to

report the disconnect (i.e., the award is classified as R&D for Federal Audit Requirement purposes but

non-research for indirect cost rate purposes), unless the auditee is charging indirect costs at a rate other

than the rate(s) specified in the award document(s).

A recipient indicates acceptance of an NIH award and its associated terms and conditions by drawing or

requesting funds from the designated HHS payment system or office. If the recipient cannot accept the

award, including the legal obligation to perform in accordance with its provisions, it should notify the

GMO immediately upon receipt of the NoA. If resolution cannot be reached, the GMO will void the

grant. NIH’s determination of applicable terms and conditions of award or a GMO’s denial of a request

to change the terms and conditions is discretionary and not subject to appeal (post-award appeal rights

are discussed in

Administrative Requirements—Grant Appeals Procedures

). Once the award is accepted

by the recipient, the contents of the NoA are binding on the recipient unless and until modified by a

revised NoA signed by the GMO.

5.1 NOTICE OF AWARD NOTIFICATION

NIH notifies the recipient organization via e-mail when an award has been issued-i.e., on the Federal

award date. In order to allow for the e-mail notification of the NoA, recipient organizations must register

a valid e-mail address in the NoA E-mail field in the eRA Commons Institutional Profile once the initial

eRA Commons registration process is complete. Organizations are encouraged to use a unique e-mail

address that is not specific to an individual in order to avoid communication problems when personnel

change. It is the responsibility of the recipient organization to maintain a current and accurate e-mail

address for NoAs. NIH will not distribute NoAs other than through this system-generated e-mail noti-

fication process. Recipients that do not maintain a current NoA notification e-mail address will be

responsible for accessing NoAs via the eRA Commons.

On the Federal award date, the NoA is made available to recipient officials and corresponding PD/PIs in

the eRA Commons through the Status module. The eRA Commons is the official repository for the NoA

document.

5.2 ASSOCIATED APPLICATIONS AND/OR AWARDS

For some special initiatives a project or program may be funded by multiple awards that are associated

with the others through specific terms and conditions. These terms include any reporting requirements

that would need to be coordinated in future years. When multiple awards are issued for a particular pro-

ject/program at different institutions, the coordination required among the recipient institutions admin-

istering the awards will be documented in the specific terms and conditions.

5.3 FUNDING

For most grants, NIH uses the project period system of funding. Under this system, projects are pro-

grammatically approved for support in their entirety but are funded in annual increments called budget

periods. The length of an initial project period (competitive segment) or of any subsequent competitive

segment is determined by the NIH awarding IC based on:

any statutory or regulatory requirements,

the length of time requested by the applicant to complete the project,

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

5 The Notice of Award

limitation on the length of the project period recommended by the peer reviewers,

the awarding IC’s programmatic determination of the frequency of competitive review desirable

for managing the project, and

NIH funding principles.

The total project period consists of the initial competitive segment, any additional competitive segments

authorized by approval of a competing continuation application, and any non-competing extensions. NIH

policy limits each competitive segment to a maximum of 5 years (exclusive of non-competing exten-

sions). A single award covering the entire period of support generally is used only if the project is solely

for construction or modernization of real property, if the total planned period of support will be less than

18 months, or if the project is awarded under a special support mechanism.

The initial NoA provides funds for the project during the first budget period. Budget periods usually are

12 months long; however, shorter or longer budget periods may be established for compelling pro-

grammatic or administrative reasons. The NoA that documents approval of a project period that extends

beyond the budget period for which funds are provided (including anticipated levels of future support)

expresses NIH’s intention to provide continued financial support for the project. The amounts shown for

subsequent years represent projections of future funding levels based on the information available at the

time of the initial award. Such projected levels of future support are contingent on satisfactory progress,

the availability of funds, and the continued best interests of the Federal government. They are not guar-

antees by NIH that the project will be funded or will be funded at those levels and create no legal oblig-

ation to provide funding beyond the ending date of the current budget period as shown in the NoA.

Recipients are required to submit an annual progress report as a prerequisite to NIH approval and fund-

ing of each subsequent budget period (non-competing continuation award) within an approved project

period (see

Administrative Requirements—Monitoring—Reporting—Non-Competing Continuation Pro-

gress Report

). A decision to fund the next budget period will be formalized by the issuance of the NoA

indicating the new budget period and the amount of new funding. The NoA also will reflect any remain-

ing future-year commitments. NIH may decide to withhold support for one or more of the reasons cited

Administrative Requirements—Enforcement Actions—Suspension, Termination, and Withholding of

Support

. A recipient may appeal this decision only if the withholding was for the recipient’s failure to

comply with the terms and conditions of a previous award (see

Administrative Requirements—Grant

Appeals Procedures

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and

cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability

unless otherwise authorized by Congress. In order for NIH to meet its obligation to close these accounts

and cancel any remaining balances by September 30, recipients must report disbursements on the FFR no

later than August 31 of the fifth fiscal year after the year of availability. This provision may limit the

availability of funds for carryover. It may also limit or eliminate the authority to extend the final budget

period when an entire project period is funded by a single award (e.g., multiyear funded awards).

5.4 BUDGET

Each NoA sets forth the amount of funds awarded. The amount may be shown either as a categorical

(line item) budget or as an amount for total direct costs (not broken down by category) and an amount

for indirect costs, if applicable. Modular awards represent a type of award made without a categorical

budget (see

Modular Applications and Awards

chapter in IIB). The recipient has certain rebudgeting flex-

ibility within the overall amount awarded (see

Administrative Requirements—Changes in Project and

Budget

). The recipient may be required to provide matching funds under construction awards as spe-

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

5 The Notice of Award

cified in

Construction Grants—Matching

in IIB as well as under other NIH programs or awards if spe-

cified in the Notice of Funding Opportunity.

5.5 ADDITIONAL TERMS AND CONDITIONS

In addition to, or in lieu of, the standard terms and conditions of award specified in the NIHGPS, NIH

may use terms and conditions for program-specific or award-specific reasons. For example, if, on the

basis of a recipient’s application or other available information, the GMO finds—at the time of award or

at any time subsequent to award—that the recipient’s management systems and practices are not

adequate to ensure the appropriate stewardship of NIH funds or to achieve the objectives of the award,

the GMO may impose special, more restrictive terms and conditions on the award in accordance with

applicable regulations including 42 CFR Part 52.9 and 2 CFR Part 200.339 and 45 CFR Part 75.371. For

example, NIH could require a recipient to obtain prior approval for expenditures that ordinarily do not

require such approval or to provide more frequent reports. In addition to closer monitoring, NIH may

assist the recipient in taking any necessary corrective action.

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

6 Payment

6 PAYMENT

The PMS is a centralized grants payment and cash management system, operated by HHS PSC, PMS.

HHS grant payments may be made by one of several advance payment methods, including

SMARTLINK II/ACH, cash request, or by cash request on a reimbursement basis, as specified in the

NoA and as described in this chapter. Payments under NIH grants generally are made as advance pay-

ments. NIH grant payments are made by PMS, operated by PSC, in accordance with Department of the

Treasury and OMB requirements, as implemented by 2 CFR Part 200.305. These requirements are inten-

ded to minimize the time elapsing between the transfer of funds from the Federal government and dis-

bursement by a recipient. Therefore, although the grant may be financed by advance payments, the intent

is that recipients draw funds on an as-needed basis—specifically, no more than 3 business days before

the funds are needed.

All Federal funds deposited by PMS in a recipient’s bank account as an unrestricted advance payment

should be fully disbursed (checks written, signed, and issued to the payees) by the close of business the

next workday after receipt of the funds. The potential for excessive Federal cash on hand exists each

time a recipient does not disburse Federal funds in this manner. The recipient is responsible for determ-

ining when the Federal funds have been deposited into its bank account for each drawdown, ensuring

that the funds are fully disbursed by the close of business the next workday after they are received, and

immediately returning all undisbursed Federal funds to PMS.

The Treasury and OMB policies also establish accountability for interest earned on advances of grant

funds and provide for use of the reimbursement method if cash management requirements are not met.

Advances made by recipients to consortium participants and contractors under grants must conform to

substantially the same standards of timing and amount that govern advances to the recipient.

Operational guidance for recipients is provided through a training CD from PSC. Inquiries regarding

drawdown requests, cash management rules, and the disbursement of funds through the Federal Financial

Report (SF 425) should be directed to

PSC/PMS

(see Part III).

6.1 NIH PAYMENT REVIEW PROCESS

As part of the implementation of

Executive Order 14222 - Implementing the President's "Department of

Government Efficiency" Cost Efficiency Initiative

, to enhance transparency and accountability and

reduce waste, fraud and abuse. NIH grant recipients are required to include a detailed justification

explaining why the funds are being drawn and how the funds are being used during the period of per-

formance when submitting payment requests to PMS in order for

NIH staff to conduct a timely review

and approval within the Defend the Spend (DTS) system.

6.2 SMARTLINK II/ACH

The SMARTLINK II/ACH method of advance payment makes direct deposit of funds to a recipient’s

bank account and requires recipients to have Internet access to submit a request for funds to PMS.

SMARTLINK II/ACH provides funds the day following the request with direct deposit using the Federal

Reserve Bank’s (Richmond, Virginia) ACH process.

6.3 CASH REQUEST

Recipients not eligible for an unrestricted advance of funds by SMARTLINK II/ACH must submit a

cash request, usually monthly. The cash request may be on either an advance or reimbursement basis, as

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

6 Payment

specified by the NIH awarding IC. Cash requests are used when a recipient’s cash management must be

closely monitored (for example, recipients whose financial management systems do not meet the stand-

ards specified in 2 CFR Part 200.302) or under programs where reimbursement financing is appropriate.

A recipient also may be converted from an unrestricted advance payment method to a cash request basis

if, during post-award administration, the GMO determines that a recipient is not complying with the cash

management requirements or other requirements of the award, including the submission of complete and

timely reports (see

Administrative Requirements—Monitoring—Reporting

and

Administrative Require-

ments—Enforcement Actions—Modification of the Terms of Award

If the cash request is for an advance payment, the recipient may request grant funds from PMS monthly

on the basis of expected disbursements during the succeeding month and the amount of Federal funds

already on hand. A request for reimbursement may be submitted more often, if authorized. For timely

receipt of cash, a recipient must submit the request through the awarding IC early enough for it to be for-

warded to PMS at least 2 weeks before the cash is needed. PMS makes payment to the recipient elec-

tronically through the ACH process upon receipt of the approved payment request from the awarding IC.

6.4 INTEREST EARNED ON ADVANCES OF GRANT FUNDS

Except as provided in 2 CFR Part 200.305(b)(8), any NIH recipient subject to the requirements of 2 CFR

Part 200 that receives advance payments must maintain those advances in an interest-bearing account.

Recipients are expected to promptly return any funds not spent within three business days. As provided

in 2 CFR Part 200.305(b)(9) subject to the requirements of 2 CFR Part 200 and to the extent required by

law, interest earned on Federal advance payments deposited in interest-bearing accounts must be remit-

ted annually to the Department of Health and Human Services, Payment Management System, Rockville,

MD 20852. Interest amounts up to $500 per year may be retained by the recipient or subrecipient for

administrative expense.

6.5 IMPROPER PAYMENTS ELIMINATION AND RECOVERY

IMPROVEMENT ACT

The Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA) (PL 112-248),

signed into law on January 10, 2013, established the Do Not Pay Initiative to reduce improper payments

or awards. Improper payments occur when funds go to the wrong recipient, the recipient receives the

incorrect amount of funds (including overpayments and underpayments), documentation is not available

to support a payment, or the recipient uses funds in an improper manner. Incorrect amounts are over-

payments or underpayments that are made to eligible recipients (including inappropriate denials of pay-

ment or service, any payment that does not account for credit for applicable discounts, payments that are

for an incorrect amount, and duplicate payments). When an agency’s review is unable to discern whether

a payment was proper as a result of insufficient or lack of documentation, this payment should also be

considered an improper payment. When establishing documentation requirements for payments, agencies

should ensure that all documentation requirements are necessary and should refrain from imposing addi-

tional burdensome documentation requirements. Interest or other fees that may result from an under-

payment by an agency are not considered an improper payment if the interest was paid correctly. These

payments are generally separate transactions and may be necessary under certain statutory, contractual,

administrative, or other legally applicable requirements.

HHS has implemented provisions of IPERIA through integrating use of the Do Not Pay system

into the current payment processes managed by the PMS, HHS.

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7 Cost Consideration

7 COST CONSIDERATION

7.1 GENERAL

Cost considerations are critical throughout the life cycle of a grant. An applicant’s budget request is

reviewed for compliance with the governing cost principles and other requirements and policies applic-

able to the type of recipient and the type of award. Any resulting award will include a budget that is con-

sistent with these requirements.

NIH anticipates that, because of the nature of research, the recipient may need to modify its award

budget during performance to accomplish the award’s programmatic objectives. Therefore, NIH provides

some flexibility for recipients to deviate from the award budget, depending on the deviation’s sig-

nificance to the project or activity. More significant post-award changes require NIH prior approval.

Prior approval requirements and authorities are discussed in

Administrative Requirements—Changes in

Project and Budget

During post-award administration, the GMO, or a GMO designee, monitors expenditures for con-

formance with cost policies. The GMO’s monitoring includes, among other things, responding to prior

approval requests and reviewing progress reports, audit reports, and other periodic reports. The GMO

also may use audit findings as the basis for final cost adjustments (see

Administrative Requirements—

Closeout

This chapter addresses the general principles underlying the allowability of costs, differentiates direct

costs from indirect costs, and highlights a number of specific costs and categories of cost for NIH applic-

ants and recipients. It is not intended to be all-inclusive and should be used as a supplement to the applic-

able cost principles.

7.2 THE COST PRINCIPLES

In general, NIH grant awards provide for reimbursement of actual, allowable costs incurred and are sub-

ject to Federal cost principles. The cost principles establish standards for the allowability of costs,

provide detailed guidance on the cost accounting treatment of costs as direct or indirect costs, and set

forth allowability and allocability principles for selected items of cost. Applicability of a particular set of

cost principles depends on the type of organization (regardless whether domestic or foreign) making the

expenditure. For example, a for-profit organization collaborating with a university recipient would be

subject to the cost principles for for-profit organizations, while the university would be subject to the

cost principles for Institutions of Higher Educations (IHEs).

The cost principles are set forth in HHS regulations at 2 CFR Part 200, Subpart E. For-profit organ-

izations are subject to the cost principles located at 48 CFR Part 31.2 Federal Acquisition Regulation.

The cost principles apply to all NIH award instruments, award mechanisms, and special programs and

authorities, including modular awards and awards under SNAP with one exception: they do not apply to

Kirschstein-NRSA individual fellowship awards. The allowable use of funds under those awards is

included in

Ruth L. Kirschstein National Research Service Awards

in IIB.

Recipients may use their own accounting systems, policies, and procedures to implement the cost prin-

ciple requirements as long as they meet the standards prescribed in 2 CFR Part 200.302 for financial

management systems.

The cost principles address four tests to determine the allowability of costs. The tests are as follows:

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Part II: Terms and Conditions of NIH Grant Awards - Subpart A

7 Cost Consideration

Reasonableness (Including Necessity).

A cost may be considered reasonable if it does not

exceed an amount that a prudent person would incur under the circumstances prevailing when

the decision to incur the cost was made. The cost principles elaborate on this concept and

address considerations such as whether the cost is generally necessary for the organization’s oper-

ations or the grant’s performance, whether the recipient complied with its established organ-

izational policies in incurring the cost or charge, and whether the individuals responsible for the

expenditure acted with due prudence in carrying out their responsibilities to the Federal gov-

ernment and the public at large as well as to the organization.

Allocability.

A cost is allocable to a specific grant, function, department, or other component,

known as a cost objective, if the cost is assignable to that cost objective in accordance with the

relative benefits received or other equitable relationship. A cost is allocable to a grant if it is

incurred solely in order to advance work under the grant; it benefits both the grant and other

work of the institution, including other grant-supported projects; or it is necessary to the overall

operation of the organization and is deemed to be assignable, at least in part, to the grant. A cost

is allocable as a direct cost to a grant if it is incurred solely in order to advance work under the

grant or meets the criteria for closely related projects determination (see

Cost Considerations—

Allocation of Costs and Closely Related Work

Consistency.

Recipients must be consistent in assigning costs to cost objectives. Costs may be

charged as either direct costs or indirect costs, depending on their identifiable benefit to a par-

ticular project or program, but all costs must be treated consistently for all work of the organ-

ization under similar circumstances, regardless of the source of funding.

Conformance.

This test of allowability—conformance with limitations and exclusions as con-

tained in the terms and conditions of award, including those in the cost principles—varies by the

type of activity, the type of recipient, and other characteristics of individual awards.

Cost Con-

siderations—Allowability of Costs/Activities

provides information common to most NIH grants

and, where appropriate, specifies some of the distinctions if there is a different treatment based

on the type of grant or recipient. IIB contains additional information on allowability of costs for

particular types of grants, recipients, and activities.

These four tests apply regardless of whether the particular category of costs is one specified in the cost

principles or one governed by other terms and conditions of an award. These tests also apply regardless

of treatment as a direct cost or an indirect cost. The fact that a proposed cost is awarded as requested by

an applicant does not indicate a determination of allowability.

7.3 DIRECT COSTS AND INDIRECT COSTS

Direct costs are any cost that can be identified specifically with a particular sponsored project, an instruc-

tional activity, or any other institutional activity, or that can be directly assigned (allocated) to such activ-

ities relatively easily with a high degree of accuracy. Direct costs may include, but are not limited to,

salaries, travel, equipment, and supplies directly supporting or benefiting the grant-supported project or

activity. If directly related to a specific award, certain costs that otherwise would be treated as indirect

costs may also be considered direct costs.

Most organizations also incur costs for common or joint objectives that cannot be readily identified with

an individual project or program. These are referred to as indirect costs, also called Facilities and Admin-

istrative costs (F&A). Facilities operation and maintenance costs, depreciation, and administrative

expenses are examples of costs that usually are treated as indirect costs. The organization is responsible

for the management and accounting of costs consistently and must not include costs associated with its

indirect costs rate as direct costs. Note, the term

indirect costs

and the term

facilities and administrative

costs

may be used interchangeably to determine applicable policies. For NIH purposes, including the

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7 Cost Consideration

NIHGPS, these costs will be referred to as indirect costs; however, other documents or non-NIH entities

may refer to them as

facilities and administrative

costs.

Project costs consist of the allowable direct costs directly related to the performance of the grant plus the

allocable portion of the allowable indirect costs of the organization, less applicable credits (as described

below and in the cost principles).

The amount NIH awards for each budget period will reflect the total approved budget for the grant,

including direct costs and, if applicable, indirect costs. (SBIR and STTR awards also may include a fee

as specified in

Grants to For-Profit Organizations—Small Business Innovation Research and Small Busi-

ness Technology Transfer Programs

in IIB.) If a recipient waives reimbursement of full indirect costs,

NIH will either not award indirect costs or will award only partial indirect costs, as appropriate. The NIH

award amount shown in the NoA constitutes NIH’s maximum financial obligation to the recipient under

that award.

7.4 REIMBURSEMENT OF INDIRECT COSTS

Under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224),

the provisions relating to indirect costs in 45 CFR 75, including with respect to the approval of devi-

ations from negotiated rates, apply to NIH awards. For grant programs that can provide indirect cost

reimbursement, NIH will generally not provide indirect costs unless the recipient has established an indir-

ect cost rate covering the applicable activities and period of time, except for awards under which indirect

costs are reimbursed at a fixed rate.

In addition, NIH will not require a recipient to establish indirect cost rate if the organization’s total oper-

ations consist of a single grant-supported project or if the organization appropriately and consistently

treats all costs as direct costs to projects and accounts for them as such. In the latter case, the GMO must

be satisfied that the organization’s accounting system can adequately identify and support all costs as dir-

ect costs to the project. This includes being able to identify and segregate costs on the basis of a process

that assigns costs commensurate with the benefits provided to individual projects (see

Administrative

Requirements—Management Systems and Procedures—Financial Management System Standards

Indirect cost rates are negotiated by CAS, DFAS in the Office of Acquisition Management and Policy,

NIH (responsible for negotiating indirect cost rates for for-profit entities receiving awards from HHS), or

other agency with cognizance for indirect cost rate (and other special rate) negotiation. If an applicant is

advised by the GMO of the need to establish a rate, the GMO will indicate the responsible office to be

contacted.

Indirect cost proposals must be prepared in accordance with the applicable cost principles and guidance

provided by the cognizant office or agency for indirect costs and must conform to cost policies in the

NIHGPS. Further information concerning the establishment of indirect rates and the reimbursement of

indirect costs may be obtained from

DFAS

(see Part III).

Consistent with 45 CFR 75.414(f), recipients and subrecipients that do not have a current Federal nego-

tiated (including provisional) indirect cost rate, may elect to charge a de minimis rate of 10% of mod-

ified total direct costs (MTDC). Federal agencies and pass-through entities may not require recipients

and subrecipients to use a de minimis rate lower than the negotiated indirect cost rate or the de minimis

rate elected unless required by Federal statue or regulation. Recipients and subrecipients are not required

to use the de minimis rate. When applying the de minimis rate, costs must be consistently charged as

either direct or indirect costs but may not be double charged or inconsistently charged as both. The de

minimis rate does not require documentation to justify its use and may be used indefinitely. Once elec-

ted, the recipient or subrecipient must use the de minimis rate for all Federal awards until the recipient

and subrecipient chooses to receive a negotiated rate.

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If a subrecipient already has a negotiated indirect cost rate established with their cognizant agency for

indirect cost, the pass-through entity must accept the negotiated rate. If no approved rate exists, the pass-

through entity must determine the appropriate rate in collaboration with the subrecipient, which is either:

the negotiated indirect cost rate between the pass-through entity and the subrecipient; which can be

based on a prior negotiated rate between a different PTE and the same subrecipient. If basing the rate on

a previously negotiated rate, the pass-through entity is not required to collect information justifying this

rate but may elect to do so; or the de minimis indirect cost rate. The pass-through entity must not require

use of a de minimis indirect cost rate if the subrecipient has a Federally approved rate. Subrecipients can

elect to use the cost allocation method to account for indirect costs. The cost principles are designed to

provide that Federal awards bear their fair share of costs recognized under these principles. (See 45 CFR

75.100. Pass-through entities may, but are not required, to negotiate a rate with a proposed subrecipient

that asks to do so. If the consortium is with a for-profit entity, such as a small business, the organization

must have an established indirect cost rate before they can charge indirect costs. The default small busi-

ness rate of 40 percent is only applicable to SBIR and STTR applications.

Regardless of the type of recipient, the rate(s) in effect at the beginning of the competitive segment will

be used to determine the amount budgeted for indirect costs for each year of the competitive segment. If

the rate agreement does not extend to the end of the project period, the last rate in effect will be used to

establish the total cost commitment for any remaining future years. NIH generally will not award addi-

tional indirect costs beyond those calculated in the approved budget.

Indirect costs awarded may be subject to upward or downward adjustment, depending on the type of rate

negotiated and recipient type. Generally, recipients may rebudget between direct and indirect costs (in

either direction) without NIH prior approval, provided there is no change in the scope of the approved

project. indirect cost reimbursement on grants to IHEs is based on the rates used in the award, which are

not subject to adjustment in reimbursement except for the establishment of permanent rates when a pro-

visional rate was used for funding (See 45 CFR 75 Appendix III Section C(7)(b)). Therefore per 45

CFR 75 Appendix III, IHEs may not rebudget from direct costs to accommodate a rate increase if the

indirect costs provided for a period were based on negotiated (final, fixed or predetermined) rates rather

than provisional rates (See 45 CFR 75 Appendix III Section C(7)(a)).For recipients other than IHEs,

Indirect cost reimbursement is based on the negotiated indirect rate agreement consistent with the time

period when the cost is incurred, except if indirect costs were limited or not provided. Indirect costs are

subject to downward adjustment if the proposal that served as the basis for the negotiation included unal-

lowable costs.

Some grants require negotiation of project costs annually, e.g., clinical trials. For these awards, the

policies pertain to each year of support rather than to a multiyear competitive segment.

Once NIH awards a grant, it is not obligated to make any supplemental or other award for additional

indirect costs or for any other purpose. There are limited circumstances under which the GMO may

award indirect costs where none were previously awarded or may increase the amount previously awar-

ded. If an award does not include an amount for indirect costs because the applicant or recipient did not

submit a timely indirect cost proposal and the recipient subsequently establishes a rate, the GMO may

amend the award to provide an appropriate amount for indirect costs if the amendment can be made

using funds from the same Federal fiscal year in which the award was made. However, the amount will

be limited to the indirect costs applicable to the period after the date of the recipient’s indirect cost pro-

posal submission. This provision does not affect local governmental agencies that are not required to sub-

mit their indirect cost proposals to the Federal government. They may charge indirect costs to NIH

grants based on the rate computations they prepare and keep on file for subsequent Federal review.

If funds are available, a GMO may amend an award to provide additional funds for indirect costs, but

only under the following circumstances:

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NIH made an error in computing the award. This includes situations in which a higher rate than

the rate used in the grant award is negotiated and the date of the rate agreement for the higher

rate is before 1 calendar month prior to the beginning date of the grant budget period.

NIH restores funds previously recaptured as part of a recipient’s unobligated balance.

The recipient is eligible for additional indirect costs associated with additional direct costs awar-

ded for the supplementation or extension of a project.

NIH may use a rate different from the negotiated rate for a class of Federal awards or a single award

only when required by Federal statute or regulation, or when approved by the agency head or delegate

based on documented justification.

NIH does not reimburse indirect costs under the following classes of awards:

Fellowships.

Indirect costs will not be provided on Kirschstein-NRSA individual fellowships or

similar awards for which NIH funding is in the form of fixed amounts or is determined by the

normal published tuition rates of an institution and for which the recipient is not required to

account on an actual cost basis.

Construction and Modernization.

Indirect costs will not be provided on construction or mod-

ernization grants.

Grants to Individuals.

Indirect costs will not be provided on awards to individuals.

Grants to Federal Institutions.

Indirect costs will not be provided on grants to Federal insti-

tutions.

Grants in Support of Scientific Meetings (Conference Grants).

Indirect costs will not be

provided under grants in support of scientific meetings.

Endowment Grants.

Indirect costs will not be provided for endowment grants.

NIH limits the amounts included in the indirect cost base for the following type of costs:

Genomic Arrays (GA)

are a high-throughput genetic analysis technology which enables the

study of genetic variation and gene expression at high resolution. Approaches such as genome-

wide association and gene expression profiling often depend upon manufactured products known

as microarrays or bead arrays. These tools are exceptional among laboratory supplies in that they

are almost always procured from a commercial source; have a relatively high unit cost and are

often utilized in large numbers. The treatment of the costs for purchase of GA as “supplies” in

these specialized award budgets at high levels of usage would result in the application of indirect

cost recovery that is disproportionate to the actual administrative burden associated with the rel-

atively high cost of the procurement of these GA. Accordingly, for purposes of budgeting for

and award of high volume purchases of GA in excess of $50,000 per year, the standard treatment

of these resources as supplies in determining the indirect base of an award will be non-applic-

able. Instead, the requested and reimbursed costs for GA will utilize as a surrogate the concept

of subcontracts (consortium/contractual cost). Therefore, for each budget year, the first $50,000

of GA will be treated as “supplies”, and any GA in excess of $50,000 (for high volume require-

ments) will use as a surrogate the budgeting and reimbursement concept utilized for subcontracts

(consortium/contractual cost), providing consistent budgeting, accounting and reimbursement of

these costs.

NIH provides indirect costs without the need for a negotiated rate under the following classes of awards:

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Research Training and Education Grants (e.g., R25), and K Awards.

Indirect costs under

Kirschstein-NRSA institutional research training grants, educational and K awards will be

budgeted and reimbursed at a rate of 8 percent of modified total direct costs, exclusive of tuition

and fees, expenditures for equipment, and consortiums in excess of $25,000. State, local, and

Indian tribes (or "federally recognized Indian tribes") may receive full indirect cost reim-

bursement under NIH Kirschstein-NRSA institutional research training grants and K awards. For

this policy, State universities or hospitals are not considered governmental agencies.

Grants to Foreign Organizations and International Organizations.

With the exception of the

American University of Beirut and the World Health Organization, which are eligible for full

indirect cost reimbursement, indirect costs under grants to foreign and international organ-

izations, including collaborative international research projects, will be funded at a fixed rate of

8 percent of modified total direct costs, exclusive of tuition and related fees, direct expenditures

for equipment, and subawards in excess of $25,000. These funds are paid to support the costs of

compliance with federal requirements. Some examples of NIH compliance requirements are the

protection of human subjects (including the required education in the protection of human

research participants), animal welfare, invention reporting, other post-award reporting require-

ments, financial conflict of interest and research misconduct. Note, these are just a few rep-

resentative examples of compliance requirement; this list is not all inclusive. NIH will not

support the acquisition of or provide for depreciation on any capital expenses (facilities) or the

normal general operations of foreign and international organizations. Therefore, these expenses

may not be requested as a direct cost; however, equipment is an allowable direct cost.

Other

items normally treated as indirect costs (e.g., rent) may be requested as direct costs and will be

evaluated by NIH for allowability.

7.5 COST TRANSFERS, OVERRUNS, AND ACCELERATED

AND DELAYED EXPENDITURES

Cost transfers to NIH grants by recipients, consortium participants, or contractors under grants that rep-

resent corrections of clerical or bookkeeping errors should be accomplished within 90 days of when the

error was discovered. The transfers must be supported by documentation that fully explains how the

error occurred and a certification of the correctness of the new charge by a responsible organizational

official of the recipient, consortium participant, or contractor. An explanation merely stating that the

transfer was made “to correct error” or “to transfer to correct project” is not sufficient. Transfers of costs

from one project to another or from one competitive segment to the next solely to cover cost overruns

are not allowable.

Recipients must maintain documentation of cost transfers, pursuant to 2 CFR Part 200.337, and must

make it available for audit or other review (see

Administrative Requirements—Monitoring—Record

Retention and Access

). The recipient should have systems in place to detect such errors within a reas-

onable time frame; untimely discovery of errors could be an indication of poor internal controls. Fre-

quent errors in recording costs may indicate the need for accounting system improvements, enhanced

internal controls, or both. If such errors occur, recipients are encouraged to evaluate the need for

improvements and to make whatever improvements are deemed necessary to prevent reoccurrence. NIH

also may require a recipient to take corrective action by imposing additional terms and conditions on an

award(s).

The GMO monitors recipient expenditure rates under individual grants within each budget period and

within the overall project period. The funding that NIH provides for each budget period is based on an

assessment of the effort to be performed during that period and the recipient’s associated budget, includ-

ing the availability of unobligated balances. Although NIH allows recipients certain flexibilities with

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respect to rebudgeting (see

Administrative Requirements—Changes in Project and Budget

), NIH expects

the rate and types of expenditures to be consistent with the approved project and budget and may ques-

tion or restrict expenditures that appear inconsistent with these expectations.

The GMO may review recipient cash drawdowns to determine whether they indicate any pattern of accel-

erated or delayed expenditures. Expenditure patterns are of particular concern because they may indicate

a deficiency in the recipient’s financial management system or internal controls. Accelerated or delayed

expenditures may result in a recipient’s inability to complete the approved project within the approved

budget and period of performance. In these situations, the GMO may seek additional information from

the recipient and may make any necessary and appropriate adjustments.

7.6 ALLOCATION OF COSTS AND CLOSELY RELATED

WORK

When salaries or other activities are supported by two or more sources, issues arise as to how the direct

costs should be allocated among the sources of support. In general, a cost that benefits two or more pro-

jects or activities in proportions that can be determined without undue effort or cost should be allocated

to the projects on the basis of the proportional benefit. A cost that benefits two or more projects or activ-

ities in proportions that cannot be determined because of the interrelationship of the work involved may

be allocated or transferred to the benefiting projects on any reasonable basis as long as the costs charged

are allowable, allocable, and reasonable under the applicable cost principles and the recipient’s financial

management system includes adequate internal controls (for example, no one person has complete con-

trol over all aspects of a financial transaction).

7.7 APPLICABLE CREDITS

The term

applicable credits

refers to transactions that operate to offset or reduce direct or indirect cost

items. Typical examples are purchase discounts, rebates or allowances, recoveries or indemnities on

losses, and adjustments for overpayments or erroneous charges. Additional information concerning

applicable credits is included in the cost principles.

Applicable credits to direct charges made to NIH grants must be treated as an adjustment on the recip-

ient’s FFR, whether those credits accrue during or after the period of grant support. (See

Administrative

Requirements—Monitoring—Reporting

and

Administrative Requirements—Closeout—Final Federal Fin-

ancial Reports

.) The NIH awarding IC will notify the recipient of any additional actions that may be

necessary.

7.8 SERVICES PROVIDED BY AFFILIATED ORGANIZATIONS

A number of universities and other organizations have established closely affiliated, but separately incor-

porated, organizations to facilitate the administration of research and other programs supported by

Federal funds. Such legally independent entities are often referred to as “foundations,” although this term

does not necessarily appear in the name of the organization. Sometimes, the parent organization provides

considerable support services, in the form of administration, facilities, equipment, accounting, and other

services, to its foundation, and the latter, acting in its own right as an NIH recipient, includes the cost of

these services in its indirect proposal.

Costs incurred by an affiliated, but separate, legal entity in support of a recipient foundation are allow-

able for reimbursement under NIH grants only if at least one of the following conditions is met:

The affiliated organization is charged for, and is legally obligated to pay for, the services

provided by the parent organization.

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The affiliated organizations are subject to State or local law that prescribes how Federal reim-

bursement for the costs of the parent organization’s services will be expended and requires that a

State or local official acting in their official capacity approves such expenditures.

There is a valid written agreement between the affiliated organizations whereby the parent organ-

ization agrees that the recipient foundation may retain Federal reimbursement of parent organ-

ization costs. The parent organization may either direct how the funds will be used or permit the

recipient foundation that discretion.

If none of the above conditions are met, the costs of the services provided by the parent organization to

the recipient foundation are not allowable for reimbursement under an NIH grant. However, the services

may be acceptable for cost-sharing (matching) purposes.

Foundations that represent already existing recipient organizations should contact

DGP, OPERA

before

attempting to become a separately recognized applicant organization.

7.9 ALLOWABILITY OF COSTS/ACTIVITIES

The governing cost principles address selected items of cost, some of which are mentioned in this section

for emphasis. This section is not intended to be all-inclusive. The cost principles should be consulted for

the complete explanation of whether or not a cost is allowed.

This section also includes NIH-specific requirements concerning costs and activities. The allowability of

costs under specific NIH awards may be subject to other requirements specified in the program legis-

lation, regulations, or the specific terms and conditions of an award, which take precedence over the gen-

eral discussion provided here. Specific program requirement may also be covered in other sections of the

NIHGPS. Applicants or recipients that have questions concerning the allowability of particular costs

should contact the GMO.

If a cost is allowable, it is allocable as either a direct cost or an indirect cost, depending on the recip-

ient’s accounting system. For some costs addressed in this section, the text specifies whether the cost is

usually a direct cost or an indirect cost.

Unless otherwise indicated in the NoA, an award based on an application that includes specific inform-

ation concerning any costs or activities that require NIH prior approval constitutes the prior approval for

those costs or activities. The recipient is not required to obtain any additional approval for those cost-

s/activities. Post-award requests to incur costs or undertake activities requiring prior approval that are not

described in the approved application are subject to the requirements in

Administrative Requirements—

Changes in Project and Budget

Consortium participants and contractors under grants are subject to the requirements of the cost prin-

ciples otherwise applicable to their type of organization and to any requirements placed on them by the

recipient to be able to comply with the terms and conditions of the NIH grant.

The cost principles do not address profit or fee. NIH policy allows the payment of fee on SBIR/STTR

grants (see

Grants to For-Profit Organizations

chapter in IIB) but NIH will not provide profit or fee to

any other type of recipient under any other grant program or support mechanism. A fee may not be paid

by a recipient to a consortium participant, including a for-profit organization. However, a fee (profit)

may be paid to a contractor providing routine goods or services under a grant in accordance with normal

commercial practice.

7.9.1 Selected Items of Cost

Exhibit 5: Selected Items of Cost

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The table presents specific items that may or may not be included in the cost portion of grants

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7 Cost Consideration

Items

Explanation of Allowable Costs

Advertising and Public

Relations

1. The term advertising costs means the costs of advertising media and

corollary administrative costs. Advertising media include magazines,

newspapers, radio and television, direct mail, exhibits, electronic or

computer transmittals, and the like.

2. The only allowable advertising costs are those which are solely for:

a. The recruitment of personnel required by the recipient or

subrecipient for performance of a Federal award (See also 2 CFR

Part 200.463);

b. The procurement of goods and services for the performance of a

Federal award;

c. The disposal of scrap or surplus materials acquired in the

performance of a Federal award except when non-Federal

entities are reimbursed for disposal costs at a predetermined

amount; or

d. Program outreach and other specific purposes necessary to meet

the requirements of the Federal award.

3. The term ‘‘public relations’’ includes community relations and means

those activities dedicated to maintaining the image of the recipient or

subrecipient or maintaining or relations with the community or public at

large or any segment of the public.

4. The only allowable public relations costs are:

a. Costs specifically required by the Federal award;

b. Costs of communicating with the public and press pertaining to

specific activities or accomplishments which result from

performance of the Federal award (these costs are considered

necessary as part of the outreach effort for the Federal award); or

c. Costs of conducting general liaison with news media and

government public relations officers, to the extent that such

activities are limited to communication and liaison necessary to

keep the public informed on matters of public concern, such as

notices of funding opportunities, financial matters, etc.

5. Unallowable advertising and public relations costs include the following:

a. All advertising and public relations costs other than as specified in

paragraphs (2) and (4) of this section;

b. Costs of meetings, conventions, convocations, or other events

related to other activities of the entity (see also 2 CFR

Part 200.432), including:

i. Costs of displays, demonstrations, and exhibits;

ii. Costs of meeting rooms, hospitality suites, and other

special facilities used in conjunction with shows and other

special events; and

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Items

Explanation of Allowable Costs

iii. Salaries and wages of employees engaged in setting up

and displaying exhibits, making demonstrations, and

providing briefings;

c. Costs of promotional items and memorabilia, including models,

gifts, and souvenirs;

d. Costs of advertising and public relations designed solely to

promote the recipient or subrecipient

Alcoholic Beverages

Unallowable as an entertainment expense, but allowable if within the scope of an

approved research project.

Alteration and

Renovation

Individual A&R projects that are treated as direct costs and that are determined

to be minor are subject to the A&R policies specified in this exhibit and in the

Construction Grants

chapter, as applicable. Individual A&R projects determined

to be major A&R will be subject to the requirements specified in the

Construction

Grants

chapter.

Routine maintenance and repair of the organization’s physical plant or

equipment, which is allowable and is ordinarily treated as an indirect cost, is not

considered A&R for purposes of applying this policy. Certain allowable costs of

installing equipment, such as the temporary removal and replacement of wall

sections and door frames to place equipment in its permanent location, or the

costs of connecting utility lines, replacing finishes and furnishings, and installing

any accessory devices required for the equipment’s proper and safe utilization,

may be considered either equipment costs or A&R costs, depending on the

recipient's accounting system.

A&R costs are not allowable under grants to individuals, and grants in support of

scientific meetings (conference grants). In all other cases, these costs are

allowable unless the program legislation, implementing regulations, program

guidelines, or other terms and conditions of the award specifically exclude such

activity.

The A&R must be consistent with the following criteria and documentation

requirements:

The building has a useful life consistent with program purposes and is

architecturally and structurally suitable for conversion to the type of

space required.

The A&R is essential to the purpose of the grant-supported project.

The space involved will be occupied by the project.

The space is suitable for human occupancy before A&R work is started

except where the purpose of the A&R is to make the space suitable for

some purpose other than human occupancy, such as storage.

If the space is rented, evidence is provided that the terms of the lease

are compatible with the A&R proposed and cover the duration of the

project period.

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Items

Explanation of Allowable Costs

If the A&R will affect a site listed in (or eligible for inclusion in) the

National Register of Historic Places, the requirements specified in

“Preservation of Cultural and Historic Resources” have been followed.

Work necessary to obtain an initial occupancy permit for the intended use is not

an allowable A&R cost.

A recipient may rebudget up to 25 percent of the total approved budget for a

budget period into A&R costs without NIH prior approval unless such

rebudgeting would result in a change in scope. If the rebudgeting will result in the

addition of a major A&R project, NIH will consider the rebudgeting to be a change

in scope, and the recipient must submit to the NIH awarding IC the

documentation specified in the

Construction Grants

chapter for prior approval of

A&R projects above that dollar level.

Under foreign grants or foreign components under domestic grants, major A&R

is unallowable. Minor A&R is generally allowable on grants made to foreign

organizations or to the foreign component of a domestic grant, unless prohibited

by the governing statute or implementing program regulations.

Animals

Allowable for the acquisition, care, use and rehoming / retirement of

experimental animals, contingent upon compliance with the applicable

requirements of the PHS Policy on Humane Care and Use of Laboratory Animals

(see

Public Policy Requirements and Objectives—Animal Welfare

). If the

recipient operates an animal resource facility, charges for use of the facility

should be determined in accordance with the

Cost Analysis and Rate Setting

Manual for Animal Resource Facilities

(PDF, 32 MB) — May 2000.

Audiovisual Activities

Allowable for the production of an audiovisual. “Audiovisual” means any product

containing visual imagery, sound, or both, such as motion pictures, films,

videotapes, live or recorded radio or television programs or public service

announcements, slide shows, filmstrips, audio recordings, multimedia

presentations, or exhibits where visual imagery, sound, or both are an integral

part. “Production” refers to the steps and techniques used to create a finished

audiovisual product including, but not limited to, design, layout, scriptwriting,

filming or taping, fabrication, sound recording, and editing.

A recipient with in-house production capability must determine whether it would

be more efficient and economical to use that capability or to contract for the

production of an audiovisual.

If an audiovisual intended for members of the general public (i.e., people who are

not researchers or health professions personnel or who are not directly involved

in project activities as employees, trainees, or participants such as volunteers or

patients) is produced under an NIH grant-supported project, the recipient must

submit two copies of the finished product along with its annual or final progress

report (see

Administrative Requirements—Monitoring—Reporting

and

Administrative Requirements—Closeout

). The costs of such copies are

allowable project costs.

Audiovisuals produced under an NIH grant-supported project must bear an

acknowledgment and disclaimer, such as the following:

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Items

Explanation of Allowable Costs

The production of this [type of audiovisual (motion picture, television

program, etc.)] was supported by Grant No.____________ from [name of

NIH awarding IC]. Its contents are solely the responsibility of [name of

recipient organization] and do not necessarily represent the official views of

[name of NIH awarding IC].

Audit Services

1. A reasonably proportionate share of the costs of audits required by, and

performed in accordance with the Single Audit Act Amendments of 1996

(31 U.S.C. 7501-7507) and the requirements of 2 CFR Part 200, are

allowable. However, the following audit costs are unallowable:

a. Any costs when audits required by the Single Audit Act and

Subpart F— Audit Requirements of 2 CFR Part 200 have not

been conducted or have been conducted but not in accordance

with the requirements; and

b. Any costs of auditing a non- federal entity that is exempted from

having an audit conducted under the Single Audit Act and

Subpart F—Audit Requirements of 2 CFR Part 200 because its

expenditures under Federal awards are less than $1,000,000

during its fiscal year.

2. The costs of a financial statement audit of a recipient or subrecipient that

does not currently have a Federal award may be included in the indirect

cost pool for a cost allocation plan or indirect cost proposal.

3. Pass-through entities may charge Federal awards for the cost of agreed-

upon-procedures engagements to monitor subrecipients (in accordance

with Subpart D of 2 CFR Part 200.331 through 200.333) exempt from the

requirements of the Single Audit Act and Subpart F of 2 CFR Part 200.

This cost is allowable only if the agreed-upon-procedures engagements

are:

a. Conducted in accordance with GAGAS or applicable international

attestation standards, as appropriate;

b. Paid for and arranged by the pass-through entity; and

c. Limited in scope to one or more of the following types of

compliance requirements: activities allowed or unallowed;

allowable costs/cost principles; eligibility; and reporting.

Bad Debts

Bad debts (debts which have been determined to be uncollectable), including

losses (whether actual or estimated) arising from uncollectable accounts and

other claims, are unallowable. Related collection costs, and related legal costs,

arising from such debts after they have been determined to be uncollectable are

also unallowable. (See also 2 CFR Part 200.428).

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Items

Explanation of Allowable Costs

Bonding

1. Bonding costs arise when the Federal awarding agency requires

assurance against financial loss to itself or others by reason of the act or

default of the recipient or subrecipient. They arise also in instances

where the recipient or subrecipient requires similar assurance, including:

bonds as bid, performance, payment, advance payment, infringement,

and fidelity bonds for employees and officials.

2. Costs of bonding required pursuant to the terms and conditions of the

Federal award are allowable.

3. Costs of bonding required by the recipient or subrecipient in the general

conduct of its operations are allowable as an indirect cost to the extent

that such bonding is in accordance with sound business practice and the

rates and premiums are reasonable under the circumstances.

Books and Journals

Allowable. If an organization has a library, books and journals generally should

be provided as part of normal library services and treated as indirect costs.

Building Acquisition

Unallowable unless building acquisition or construction is specifically authorized

by program legislation and is provided for in the NoA. For real property acquired

with NIH grant support, the cost of title insurance may be charged to the grant in

proportion to the Federal share of the acquisition cost. Filing fees for recording

the Federal interest in the real property in appropriate records of the applicable

jurisdiction also may be charged to the grant. (Also see

Construction Grants—

Allowable and Unallowable Costs and Activities

in IIB).

Capital Expenditures

See

Equipment and Other Capital Expenditures.

Childcare Costs

Allowable if incurred to assist individuals to participate as subjects in research

projects. Such costs also may be allowable as a fringe benefit for individuals

working on a grant-supported project (see

Fringe Benefits

and

Travel Costs

this exhibit). NRSA Fellowship Grants may also be allowed to incur these costs

(see 11.2.9.7 and 11.3.8.9 for specific eligibility criteria).

Closeout Costs

Administrative costs specifically associated with closeout activities of an award

are allowable (for example, salaries of personnel preparing final reports,

publication and printing costs, costs associated with the disposition of equipment

and property, and related indirect costs), without NIH prior approval, and may be

incurred until the due date of the final report(s). Incurred costs must be liquidated

before the due date of the final report(s) and charged to the final budget period of

the award unless otherwise specified by NIH.

Collection of Improper

Payments

The costs incurred by a recipient or subrecipient to recover improper payments

are allowable as either direct or indirect costs, as appropriate. Amounts collected

may be used by the recipient or subrecipient in accordance with cash

management standards set forth in 2 CFR Part 200.305. (See

Improper

Payment

Communications

Allowable. Such costs include local and long-distance telephone calls, express

mail, and postage, and usually are treated as indirect costs.

Conference Grant

See

Support of Scientific Meetings (Conference Grants)

chapter in IIB for

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Costs

allowability of costs for scientific meetings (conferences).

Consortium

Agreements/

Contracts under

Grants

Allowable to carry out a portion of the programmatic effort or for the acquisition of

routine goods or services under the grant. Such arrangements may require NIH

approval as specified in

Administrative Requirements—Changes in Project and

Budget

. (See also

Administrative Requirements—Management Systems and

Procedures—Procurement System Standards and Requirements

for policies

that apply to the acquisition of routine goods and services and the

Consortium

Agreements

chapter in IIB for policies that apply to recipient collaboration with

other organizations in carrying out the grant-supported research).

Construction

Allowable only when program legislation specifically authorizes new

construction, modernization, or major A&R, and NIH specifically authorizes such

costs in the NoA. When authorized, construction activities may include

construction of a new facility or projects in an existing building that are

considered to be construction, such as relocation of exterior walls, roofs, and

floors; attachment of fire escapes; or completion of unfinished shell space to

make it suitable for human occupancy (see

Construction Grants

chapter in IIB).

Consultant Services

See

Professional Services and Salaries

and

Wages/Intra-IHE Consulting

Contingency

Provisions

Unallowable. Payments made by the NIH awarding IC to the recipient or

subrecipient's “contingency reserve” or any similar payment made for events the

occurrence of which cannot be foretold with certainty as to the time or intensity,

or with an assurance of their happening, are unallowable under non-construction

grants. Contingency funds do not include pension funds, self-insurance funds,

and normal accruals (also see

Reserve Funds

in this exhibit). (See also

Construction Grants—Allowable and Unallowable Costs and Activities

in IIB

concerning contingency funds under construction grants).

Customs and Import

Duties

Allowable under grants to domestic organizations when performance will take

place entirely within the United States, its possessions, or its territories, or when

foreign involvement in the project is incidental to the overall grant-supported

project. Charges may include consular fees, customs surtaxes, value-added

taxes, and other related charges. (See

Taxes

in this exhibit).

Depreciation or Use

Allowances

Allowable. Such costs usually are treated as indirect costs. Depreciation or use

charges on equipment or buildings acquired under a federally supported project

are not allowable.

Donor Costs

Allowable as payment to volunteers or research subjects who contribute blood,

urine samples, and other body fluids or tissues that are specifically project-

related. Donor costs are not considered a research patient care expense (see

the

Research Patient Care Costs

chapter in IIB). Also see

Incentive Costs

in this

exhibit.

Drugs

Allowable if within the scope of an approved research project.

Project funds may not be used to purchase drugs classified by FDA as

“ineffective” or “possibly effective” except in approved clinical research projects

or in cases where there is no alternative other than therapy with “possibly

effective” drugs.

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Dues or Membership

Fees

Allowable as an indirect cost for organizational membership in business,

professional, or technical organizations or societies.

Payment of dues or membership fees for an individual’s membership in a

professional or technical organization is allowable as a fringe benefit or an

employee development cost, if paid according to an established organizational

policy consistently applied regardless of the source of funds.

See also

Reserve Funds.

The cost of insuring equipment, whether purchased with project funds or

furnished as federally owned property, normally should be included in indirect

costs but may be allowable as a direct cost if this manner of charging is the

normal organizational policy.

Health insurance for

trainees

and

fellows

is addressed in the

Ruth L. Kirschstein

National Research Service Awards

chapter in IIB.

Fringe Benefits/Leave

The cost of fringe benefits in the form of regular compensation paid to

employees during periods of authorized leave (absences) from the job, such as

for annual, family-related, sick, holidays, court, military, administrative, and

other similar benefits, are allowable if all of the following criteria are met:

1. They are provided under established written leave policies;

2. The costs are equitably allocated to all related activities, including

Federal awards; and

3. The accounting basis (cash or accrual) selected for costing each type

of leave is consistently followed by the recipient or subrecipient or a

specified group of employees.

See Ruth L. Kirschstein National Research Service Awards—Individual

Fellowships—Other Terms and Conditions—Leave and Ruth L. Kirschstein

National Research Service Awards—Institutional Research Training Grants—

Other Terms and Conditions—Leave in IIB for NIH policy on leave for

fellows and trainees.

Fringe Benefits /

Pension Plan Costs

Pension plan costs which are incurred in accordance with the established written

policies of the recipient or subrecipient are allowable, provided that:

1. Such policies meet the test of reasonableness.

2. The methods of cost allocation are not discriminatory.

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3. For recipients using accrual-based accounting, the cost assigned to

each fiscal year is determined in accordance with GAAP.

4. The costs assigned to a given fiscal year are funded for all plan

participants within six months after the end of that year. However,

increases to normal and past service pension costs caused by a delay in

funding the actuarial liability beyond 30 calendar days after each quarter

of the year to which such costs are assignable are unallowable. The

recipients or subrecipient may elect to follow the ‘‘Cost Accounting

Standard for Composition and Measurement of Pension Costs’’ (48 CFR

Part 9904.412).

5. Premiums for pension plan termination insurance that are paid pursuant

to the Employee Retirement Income Security Act (ERISA) of 1974 (29

U.S.C. 1301–1461) are allowable. Late payment charges on such

premiums are unallowable. Excise taxes on accumulated funding

deficiencies and other penalties imposed under ERISA are unallowable.

6. Pension plan costs may be computed using a pay-as-you-go method or

an actuarial cost method recognized by GAAP and following the

recipient’s or subrecipient’s established written policies.

a. For pension plans financed on a pay-as-you-go method,

allowable costs will be limited to those representing actual

payments to retirees or their beneficiaries.

b. Pension costs calculated using an actuarial cost-based method

recognized by GAAP are allowable for a given fiscal year if they

are funded for that year within six months after the end of that

year. Costs funded after six months (or a later period agreed to by

the cognizant agency for indirect costs) are allowable in the year

funded. The cognizant agency for indirect costs may agree to an

extension if an appropriate adjustment is made to compensate for

the timing of the charges to the Federal government and related

Federal reimbursement and the recipient's or subrecipient’s

contribution to the pension fund. Adjustments may be made by

cash refund or other equitable procedures to compensate the

Federal government for the time value of Federal

reimbursements in excess of contributions to the pension fund.

c. Amounts funded by the recipient or subrecipient in excess of the

actuarially determined amount for a fiscal year may be used as

the recipient's or subrecipient’s contribution in future periods.

d. When a recipient or subrecipient establishes or converts to an

acceptable actuarial cost method, as defined by GAAP, and

funds pension costs in accordance with this method, the

unfunded liability at the time of conversion is allowable if

amortized over a period of years in accordance with GAAP.

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e. Payments for unfunded pension costs must be charged in

accordance with the allocation principles of 2 CFR 200.431.

Specifically, the recipient or subrecipient may not charge

unfunded pension costs directly to a Federal award if those

unfunded pension costs are not allocable to that award.

f. The recipient or subrecipient must provide the Federal

government an equitable share of any previously allowed pension

costs (including subsequent earnings) that revert or inure to the

recipient or subrecipient through a refund, withdrawal, or other

credit.

Fringe Benefits /

Severance Pay

1. Severance pay, also commonly referred to as dismissal wages, is a

payment in addition to regular salaries and wages, by non-Federal

entities to workers whose employment is being terminated. Costs of

severance pay are allowable only to the extent that in each case, it is

required by:

a. law,

b. employer-employee agreement,

c. established policy that constitutes, in effect, an implied

agreement on the non- Federal entity’s part, or

d. circumstances of the particular employment.

2. Costs of severance payments are divided into two categories as follows:

a. Actual normal turnover severance payments must be allocated to

all activities; or, where the recipient or subrecipient provides for a

reserve for normal severances, such method will be acceptable if

the charge to current operations is reasonable in light of

payments actually made for normal severances over a

representative past period, and if amounts charged are allocated

to all activities of the recipient or subrecipient.

b. Measuring the costs of abnormal or mass severance pay by

means of an accrual method will not achieve equity for both

parties. Therefore, accruals are not allowable. However, the

Federal government recognizes its responsibility to contribute its

fair share toward a specific payment. Prior approval by the

Federal agency or cognizant agency for indirect cost, as

appropriate, is required.

3. Costs incurred in certain severance pay packages that are in excess of

the standard severance pay provided by the recipient or subrecipient to

an employee upon termination of employment and that are paid to the

employee contingent upon a change in management control over, or

ownership of, the recipient's or subrecipient’s assets, are unallowable.

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4. Severance payments to foreign nationals employed by the recipient or

subrecipient outside the United States, to the extent that the amount

exceeds the customary or prevailing practices for the recipient or

subrecipient in the United States, are unallowable, unless they are

required by applicable foreign law necessary for the performance of

Federal programs and approved by the NIH awarding IC.

5. Severance payments to foreign nationals employed by the recipient or

subrecipient outside the United States due to the termination of the

foreign national as a result of the closing of, or curtailment of activities

by, the recipient or subrecipient in that country, are unallowable, unless

they are required by applicable foreign law or necessary for the

performance of Federal programs and approved by the NIH awarding

IC.

Fundraising and

Investment

Management Costs

1. Costs of organized fund raising, including financial campaigns,

endowment drives, solicitation of gifts and bequests, and similar

expenses incurred to raise capital or obtain contributions are

unallowable. Fund raising costs for the purposes of meeting the Federal

program objectives are allowable with prior written approval from the

Federal awarding agency. (See also

Proposal Costs

2. Costs of investment counsel and staff and similar expenses incurred to

enhance income from investments are unallowable except when

associated with investments covering pension, self-insurance, or other

funds which include Federal participation allowed by 2 CFR Part 200.

3. Costs related to the physical custody and control of monies and

securities are allowable.

4. Both allowable and unallowable fund raising and investment activities

must be allocated as an appropriate share of indirect costs under the

conditions described in 2 CFR Part 200.413.

Genomic Arrays

Allowable as a direct cost, but with specialized treatment of indirect cost

reimbursement for costs exceeding $50,000 in each budget year. See

Cost

Considerations-Reimbursement of Indirect Costs

for more information.

Hazardous Waste

Disposal

Allowable; usually treated as an indirect cost.

Honoraria

Unallowable when the primary intent is to confer distinction on, or to symbolize

respect, esteem, or admiration for, the recipient of the honorarium. A payment for

services rendered, such as a speaker’s fee under a conference grant, is

allowable.

Hospitalization

See

Research Patient Care

in this exhibit.

Incentive Costs

Incentive payments to volunteers or patients participating in a grant-supported

project or program are allowable. Incentive payments to individuals to motivate

them to take advantage of grant-supported health care or other services are

allowable if within the scope of an approved project. See

Salaries and

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Wages/Incentive Compensation

in this exhibit for incentive payments to

employees.

Indemnification

Absent express statutory authority, unallowable if the indemnification would

result in liability that is indefinite, indeterminate or potentially unlimited. In those

rare cases where authority does allow this cost, it would be reflected in the NoA.

Independent

Research and

Development Costs

Independent research and development is research and development which is

conducted by an organization, and which is not sponsored by Federal or non-

Federal awards, contracts, or other agreements. Independent research and

development shall be allocated its proportionate share of indirect costs on the

same basis as the allocation of indirect costs to sponsored research and

development. The cost of independent research and development, including

their proportionate share of indirect costs, are unallowable.

Intellectual Property

(Invention, Copyright,

Patent, or Licensing

Costs)

Unallowable as a direct cost unless specifically authorized on the grant award.

May be allowable as indirect costs, provided they are in accordance with 2 CFR

Part 200.448 and are included in the negotiation of indirect cost rates.

Interest

Allowable as an indirect cost for certain assets as specified in

2 CFR

Part 200.449

. Unallowable for hospitals.

(2 CFR Part 200, Appendix IX

, I.o.).

(See

Payment—Interest Earned on Advances of Grant Funds

IRB or IACUC Costs

Costs associated with IRB review of human research protocols, or IACUC review

of animal research protocols, are not allowable as direct charges to NIH-funded

research unless such costs are not covered by the organization’s indirect cost

rate.

Laboratory Directed

Research &

Development

NIH awards to DOE laboratories will not include the proportionate share of

indirect costs for Laboratory Directed Research & Development (LDRD) in

accordance with the MOU with the Department of Energy dated June 18, 1998,

although NIH will not restrict the DOE laboratory contractors from recovering

LDRD costs within the total funding included in an award. In addition, DOE has

agreed to waive the Overhead Rate on all NIH grant awards to DOE laboratory

contractors.

Legal Services

Allowable. Generally treated as an indirect cost but, subject to the limitations

described in the applicable cost principles, may be treated as a direct cost for

legal services provided by individuals who are not employees of the recipient

organization. Before a recipient incurs legal costs that are extraordinary or

unusual in nature, the recipient should make an advance agreement regarding

the appropriateness and reasonableness of such costs with the GMO.

Legal costs incurred in defending or prosecuting claims, whether equitable or

monetary, including administrative grant appeals, are generally unallowable

charges to NIH grant-supported projects, except as expressly permitted in the 2

CFR Part 200.

Library Services

General library support is not allowable as a direct cost but may be included in

the recipient’s indirect cost pool. However, such services are allowable as a

direct cost when specifically required for the conduct of the project and when

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identifiable as an integral part of the grant-supported activity (e.g., in those

programs designed to develop and support such services).

Lobbying

Generally unallowable, in accordance with 2 CFR Part 200.450, including costs

of lobbying activities to influence the introduction, enactment, or modification of

legislation by the U.S. Congress or a State legislature. Under certain

circumstances, costs associated with activities that might otherwise be

considered “lobbying” that are directly related to the performance of a grant may

be allowable. The recipient should obtain an advance understanding with the

GMO if it intends to engage in these activities. Unallowable for State and Local

governments and for-profit organizations. (Also see

Public Policy Requirements

and Objectives—Lobbying Prohibition

Appropriation Mandates – Lobbying –

Appropriation Prohibition

, and

Administrative Requirements—Monitoring—

Reporting

concerning lobbying restrictions, the required certification, and

reporting).

Maintenance and

Repair Costs

Costs incurred for utilities, insurance, security, necessary maintenance, janitorial

services, repair, or upkeep of buildings and equipment (including Federal

property unless otherwise provided for) which neither add to the permanent

value of the property nor appreciably prolong its intended life, but keep it in an

efficient operating condition, are allowable. Costs incurred for improvements

which add to the permanent value of the buildings and equipment or appreciably

prolong their intended life must be treated as capital expenditures (see 2 CFR

Part 200.439 and 45 CFR Part 75.439). These costs are only allowable to the

extent that they are not paid through rental or other agreements.

Materials and

Supplies Costs,

including Costs of

Computing Devices.

1. Costs incurred for materials, supplies, and fabricated parts necessary to

carry out a Federal award are allowable.

2. Purchased materials and supplies must be charged at their actual

prices, net of applicable credits. Withdrawals from general stores or

stockrooms should be charged at their actual net cost under any

recognized method of pricing inventory withdrawals, consistently

applied. Incoming transportation charges are a proper part of materials

and supplies costs.

3. Materials and supplies used for the performance of a Federal award may

be charged as direct costs. In the specific case of computing devices,

charging as direct costs is allowable for devices that are essential and

allocable, but not solely dedicated, to the performance of a Federal

award.

4. Where federally-donated or furnished materials are used in performing

the Federal award, such materials will be used without charge.

Meals

Allowable for subjects and patients under study, or where specifically approved

as part of the project activity, provided that such charges are not duplicated in

participants’ per diem or subsistence allowances, if any.

When certain meals are an integral and necessary part of a meeting or

conference (i.e., a working meal where business is transacted), grant funds may

be used for such meals only when consistent with terms of award.

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Recurring business meetings, such as staff meetings, should not be broadly

considered as meetings for the primary purpose of disseminating technical

information in order to justify charging meals or refreshment costs to grants.

Membership,

Subscription, and

Professional Activity

Costs

1. Costs of the recipient's or subrecipient’s membership in business,

technical, and professional organizations are allowable as an indirect

cost.

2. Costs of the recipient's or subrecipient’s subscriptions to business,

professional, and technical periodicals are allowable.

3. Costs of membership in any civic or community organization are

allowable if the costs are used to support research and development

activities and do not support advocacy or lobbying.

4. Costs of membership in any country club or social or dining club or

organization are unallowable.

5. Costs of membership in organizations whose primary purpose is

lobbying are unallowable. See also

Lobbying

6. Payment of dues or membership fees for an individual’s membership in

a professional or technical organization is allowable as a fringe benefit or

an employee development cost, if paid according to an established

organizational policy consistently applied regardless of the source of

funds.

Moving

See

Recruitment Costs

Relocation Costs

, and

Transportation Costs

in this

exhibit.

Nursery Items

Allowable for the purchase of items such as toys and games to allow patients to

participate in research protocols.

Overtime

See

Salaries and Wages/Extra Service Pay (Overtime)

in this exhibit.

Participant Support

Costs

Participant support costs are allowable without NIH prior approval if

additional cost categories are not requested (i.e. souvenirs, t-shirts,

memorabilia). The classification of items as participant support costs must be

documented in the recipient’s or subrecipient’s written policies and procedures

and treated consistently across all Federal awards.

Pre-Award (Pre-

Agreement) Costs

Allowable. A recipient may, at its own risk and without NIH prior approval, incur

obligations and expenditures to cover costs up to 90 days before the beginning

date of the initial budget period of a new or renewal award if such costs:

are necessary to conduct the project, and

would be allowable under the grant, if awarded, without NIH prior

approval.

If specific expenditures would otherwise require prior approval, the recipient

must obtain NIH approval before incurring the cost. NIH prior approval is

required for any costs to be incurred more than 90 days before the beginning

date of the initial budget period of a new or competing continuation award. Pre-

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award costs must be charged to the initial budget period of the award, unless

otherwise specified by NIH.

Recipients may incur pre-award costs before the beginning date of a non-

competing continuation award without regard to the time parameters stated

above.

The incurrence of pre-award costs in anticipation of a competing or non-

competing award imposes no obligation on NIH either to make the award or to

increase the amount of the approved budget if an award is made for less than the

amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the recipient to be fully aware that pre-award costs result in

borrowing against future support and that such borrowing must not impair the

recipient’s ability to accomplish the project objectives in the approved time frame

or in any way adversely affect the conduct of the project.

Pre-Award Costs are generally not applicable to training grants or fellowships.

See respective sections for Individual Fellowships and Institutional Training

Grants in the Ruth L. Kirschstein National Research Service Award chapter in IIB

for additional information.

Prizes or Challenges

Allowable, without NIH prior approval, if they have a specific and direct

programmatic purpose and are included in the Federal award.

Professional Services

Costs

1. Costs of professional and consultant services rendered by persons who

are members of a particular profession or possess a special skill, and

who are not officers or employees of the recipient or subrecipient, are

allowable, subject to paragraphs (b) and (c) below when reasonable in

relation to the services rendered and when not contingent upon recovery

of the costs from the Federal government. In addition, legal and related

services are limited under 2 CFR Part 200.435.

2. In determining the allowability of costs in a particular case, no single

factor or any special combination of factors is necessarily determinative.

However, the following factors are relevant:

a. The nature and scope of the service rendered in relation to the

service required.

b. The necessity of contracting for the service, considering the

recipient's or subrecipient’s capability in the particular area.

c. The past pattern of such costs, particularly in the years prior to

Federal awards.

d. The impact of Federal awards on the recipient's or subrecipient’s

business (i.e., what new problems have arisen).

e. Whether the proportion of Federal work to the recipient's or

subrecipient’s total business is such as to influence the recipient

or subrecipient in favor of incurring the cost, particularly where

the services rendered are not of a continuing nature and have

little relationship to work under Federal awards.

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f. Whether the service can be performed more economically by

direct employment rather than contracting.

g. The qualifications of the individual or concern rendering the

service and the customary fees charged, especially on non-

federally funded activities.

h. Adequacy of the contractual agreement for the service (e.g.,

description of the service, estimate of time required, rate of

compensation, and termination provisions).

3. In addition to the factors in paragraph (b) above, to be allowable, retainer

fees must be supported by evidence of bona fide services available or

rendered.

Recipients, consortium participants, and contractors under grants are

encouraged to obtain written reports from consultants unless such a report is not

feasible given the nature of the consultation or would not be useful.

Documentation maintained by the receiving organization should include the

name of the consulting firm or individual consultant; the nature of the services

rendered and their relevance to the grant-supported activities, if not otherwise

apparent from the nature of the services; the period of service; the basis for

calculating the fee paid (e.g., rate per day or hour worked or rate per unit of

service rendered); and the amount paid. This information may be included in the

consultant’s invoice, in the report, or in another document. See Grants to Federal

Institutions and Payments to Federal Employees under Grants chapter in IIB for

allowable costs associated with consultant payments to Federal employees and

the circumstances of allowability. See

Salaries and Wages/Intra-IHE Consulting.

Profit or Fee

Except for grants awarded under the SBIR / STTR programs, under an NIH

grant, no profit or fee will be provided to a for-profit organization, whether as a

recipient or as a consortium participant. A profit or fee under a grant is not a cost,

but is an amount in excess of actual allowable direct and indirect costs. In

accordance with normal commercial practice, a profit / fee may be paid to a

contractor under an NIH grant providing routine goods or services to the

recipient.

Proposal Costs

Proposal costs are the costs of preparing bids, proposals, or applications on

potential Federal and non-Federal awards or projects, including the development

of data necessary to support the recipient's or subrecipient’s bids or proposals.

Proposal costs of the current accounting period of both successful and

unsuccessful bids and proposals normally should be treated as indirect costs

and allocated currently to all activities of the recipient or subrecipient. No

proposal costs of past accounting periods will be allocable to the current period.

Public Relations

Costs

See

Advertising and Public Relations

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Publication and

Printing Costs

1. Publication costs for electronic and print media, including distribution,

promotion, and general handling are allowable. These costs should be

allocated as indirect costs to all benefiting activities of the recipient or

subrecipient if they are not identifiable with a particular cost objective.

2. Page charges, article processing charges (APCs) or similar fees such as

open access fees for professional journal publications and other peer-

reviewed publications resulting from a Federal award are allowable

where:

a. The publications report work supported by an NIH-funded project;

and

b. The charges are levied impartially on all items published by the

journal, whether or not under an NIH-funded project.

c. The recipient or subrecipient may charge the NIH award as

closeout costs for the costs of publication or sharing of research

results if the costs were not incurred during the period of

performance (prior to the final year of the award) unless the terms

and conditions do not allow for such costs under a specific

project.

Publications and journal articles produced under an NIH grant-supported project

must bear an acknowledgment and disclaimer, as appropriate, as provided in

Section 8.2,

Administrative Requirements—Availability of Research Results:

Publications, Intellectual Property Rights, and Sharing Research Resources

Rearrangement and

Reconversion Costs

See

Alteration and Renovation costs

Recruiting Costs

1. Subject to paragraphs (2) and (3) of this section, and provided that the

size of the staff recruited and maintained is in keeping with workload

requirements, costs of ‘‘help wanted’’ advertising, operating costs of an

employment office necessary to secure and maintain an adequate staff,

costs of operating an aptitude and educational testing program, travel

costs of employees while engaged in recruiting personnel, travel costs of

applicants for interviews for prospective employment, and relocation

costs incurred incident to recruitment of new employees, are allowable

to the extent that such costs are incurred pursuant to the recipient's or

subrecipient’s standard recruitment program. Where the recipient or

subrecipient uses employment agencies, costs not in excess of standard

commercial rates for such services are allowable.

2. Special emoluments, fringe benefits, and salary allowances incurred to

attract professional personnel that do not meet the test of

reasonableness or do not conform with the established practices of the

recipient or subrecipient, are unallowable.

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3. Where relocation costs incurred incident to recruitment of a new

employee have been funded in whole or in part as a direct cost to a

Federal award, and the newly hired employee resigns for reasons within

the employee's control within 12 months after hire, the recipient or

subrecipient will be required to refund or credit the Federal share of such

relocation costs to the Federal government. See also

Relocation Costs

of Employees

4. Short-term, travel visa costs (as opposed to longer-term, immigration

visas) are generally allowable expenses that may be proposed as a

direct cost. Since short-term visas are issued for a specific period and

purpose, they can be clearly identified as directly connected to work

performed on a Federal award. For these costs to be directly charged to

a Federal award, they must:

a. Be critical and necessary to conduct the project;

b. Be allowable under the applicable cost principles;

c. Be consistent with the recipient's or subrecipient’s cost

accounting practices and established written policy; and

d. Meet the definition of ‘‘direct cost’’ as described in the applicable

cost principles.

Project funds may not be used for a prospective trainee’s travel costs to or from

the recipient organization for the purpose of recruitment. However, other costs

incurred in connection with recruitment under training programs, such as

advertising, may be allocated to a grant-supported project according to the

provisions of the applicable cost principles (also see

Travel

Relocation Costs

and

Visa Costs

in this exhibit).

Registration Fees (for

Symposiums and

Seminars)

Allowable if necessary to accomplish project objectives.

Relocation Costs of

Employees

Allowable—in other than change of recipient organization situations—when such

costs are incurred incidental to a permanent change of duty assignment (for an

indefinite period or for a stated period of no less than 12 months) for an existing

employee working on a grant-supported project, or when a new employee is

recruited for work on the project, provided that the move is for the recipient’s

benefit rather than the individual’s and that payment is made according to

established organizational policies consistently applied regardless of the source

of funds. Relocation costs may include the cost of transporting the employee and

their family, dependents, and household goods to the new location and certain

expenses associated with the sale of the former home. If relocation costs have

been incurred in connection with the recruitment of a new employee, whether as

a direct cost or an indirect cost, and the employee resigns for reasons within their

control within 12 months after hire, the recipient must credit the grant account for

the full cost of the relocation charged to the grant.

When there is a change in the recipient organization, the personal relocation

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expenses of the PD/PI and others moving from the original recipient to the new

recipient are not allowable charges to NIH grants (see

Administrative

Requirements—Changes in Project and Budget—Prior Approval Requirements

Rental or Lease of

Facilities and

Equipment

Allowable subject to the limitations below. Rental costs are allowable to the

extent that the rates are reasonable at the time of the decision to lease in light of

such factors as rental costs of comparable property, if any; market conditions in

the area; the type, life expectancy, condition, and value of the property leased;

and available alternatives. Because of the complexity involved in determining the

allowable amount under certain types of leases, recipients are encouraged to

consult the GMO before entering into leases that will result in direct charges to

the grant project.

In general, the rental costs for facilities and equipment applicable to each budget

period should be charged to that period. However, see

Administrative

Requirements—Management Systems and Procedures—Procurement System

Standards and Requirements

for an exception to this general rule.

Rental costs under leases that create a material equity in the leased property, as

defined in 2 CFR Part 200 Subpart E, are allowable only up to the amount that

would be allowed had the recipient purchased the property on the date the lease

agreement was executed. This would include depreciation or use allowances,

maintenance, taxes, and insurance, but would exclude unallowable costs.

When a recipient transfers property to a third party through sale, lease, or

otherwise, and then leases the property back from that third party, the lease

costs that may be charged to NIH projects generally may not exceed the amount

that would be allowed if the recipient continued to own the property.

Rental costs under “less-than-arms-length” leases are allowable only up to the

amount that would be allowed under 2 CFR Part 200, Subpart E had title to the

property been vested in the recipient. A less-than-arms-length lease is one in

which one party to the lease agreement is able to control or substantially

influence the actions of the other. Such leases include, but are not limited to,

those between divisions of an organization; between organizations under

common control through common officers, directors, or members; and between

an organization and its directors, trustees, officers, or key employees (or the

families of these individuals), directly or through corporations, trusts, or similar

arrangements in which they hold a controlling interest.

Research Patient

Care

The costs of routine and ancillary services provided by hospitals to individuals,

including patients and volunteers, participating in research programs are

allowable. Incurrence of patient care costs if not previously approved by NIH and

rebudgeting additional funds into, or rebudgeting approved amounts out of, the

research patient care costs category may be considered a change in scope and

require prior approval by the NIH awarding IC.

Routine services

include the regular room services, minor medical and surgical

supplies, and the use of equipment and facilities for which a separate charge is

not customarily made.

Ancillary services

are those special services for which

charges customarily are made in addition to routine services, e.g., x-ray,

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Explanation of Allowable Costs

operating room, laboratory, pharmacy, blood bank, and pathology. See the

Research Patient Care Costs

chapter in IIB for NIH policy concerning

reimbursement of these costs.

The following otherwise allowable costs are not classified as research patient

care costs: items of personal expense such as patient travel; consulting

physician fees; and any other direct payments to individuals, including inpatients,

outpatients, subjects, volunteers, and donors. Such costs should be included in

the “Other Expenses” category of the grant budget.

Reserve Funds

Contributions to a reserve fund for self-insurance are allowable as specified in

the governing cost principles (also see

Fringe Benefits/Insurance

and

Contingency Provisions

in this exhibit).

Salaries and Wages /

IHEs — Part-time

faculty

Charges for work performed on Federal awards by faculty members having only

part-time appointments will be determined at a rate not in excess of that regularly

paid for part-time assignments.

Salaries and Wages /

IHEs — Periods

outside the academic

year

1. Except as specified for teaching activity in paragraph (2) below, charges

for work performed by faculty members on Federal awards during

periods not included in the base salary period will be at a rate not in

excess of the IBS.

2. Charges for teaching activities performed by faculty members on

Federal awards during periods not included in IBS period will be based

on the normal written policy of the IHE governing compensation to

faculty members for teaching assignments during such periods.

Salaries and Wages /

IHEs — Sabbatical

Leave Costs

Sabbatical leave costs may be included in a fringe benefit rate or in the

organization’s indirect cost rate. Salary may be charged directly to a project for

services rendered to the project by individuals while they are on sabbatical leave,

provided the salary is proportional to the service rendered and is paid according

to established organizational policies applicable to all employees regardless of

the source of funds. Sabbatical leave paid by an individual’s employer, in

combination with other compensation (e.g., partial salary from an NIH grant),

may not exceed 100 percent of that individual’s regular salary from their

organization.

Salaries and Wages /

Standards for

Documentation of

Personnel Expenses

Salary and wage amounts charged to grant-supported projects for personal

services must be based on an adequate payroll distribution system that

documents such distribution in accordance with Federal Cost Principles and

consistently applied institutional policy and practices. See 2 CFR Part 200.430(i).

Salaries and Wages

Allowable. Compensation for personal services covers all amounts, including

fringe benefits, paid currently or accrued by the organization for employee

services rendered to the grant-supported project. Compensation costs are

allowable to the extent that they are reasonable, conform to the established

policy of the organization consistently applied regardless of the source of funds,

and reasonably reflect the percentage of time actually devoted to the NIH-funded

project. Direct salary is exclusive of fringe benefits and indirect costs. This salary

guidance does not apply to consultant payments or to contracts for routine goods

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Explanation of Allowable Costs

and services but it does apply to consortium participants (see the

Consortium

Agreements

chapter in IIB). Salaries of federal employees with permanent

appointments are unallowable except in certain circumstances (see the

Grants

to Federal Institutions and Payments to Federal Employees Under Grants

chapter in IIB).

Salaries and Wages /

Extra Service Pay

(Overtime)

Extra Service Pay normally represents overload compensation, subject to

institutional compensation policies for services above and beyond IBS. Where

extra service pay is a result of Intra-IHE consulting, it is subject to the

reasonableness standards for

Salaries and Wages

above. It is allowable if all of

the following conditions are met:

1. The IHE establishes consistent written policies which apply uniformly to

all faculty members, not just those working on Federal awards.

2. The IHE establishes a consistent written definition of work covered by

IBS which is specific enough to determine conclusively when work

beyond that level has occurred. This may be described in appointment

letters or other documentations.

3. The supplementation amount paid is commensurate with the IBS rate of

pay and the amount of additional work performed.

4. The salaries, as supplemented, fall within the salary structure and pay

ranges established by and documented in writing or otherwise

applicable to the IHE.

5. The total salaries charged to Federal awards including extra service pay

are subject to the Standards of Documentation as described in

Salaries

and Wages / IHEs

Salaries and Wages /

Institutions of higher

education (IHEs)

Certain conditions require special consideration and possible limitations in

determining allowable personnel compensation costs under Federal awards.

Allowable activities: Charges to Federal awards may include reasonable

amounts for activities contributing and directly related to work under an

agreement, such as delivering special lectures about specific aspects of the

ongoing activity, writing reports and articles, developing and maintaining

protocols (human, animals, etc.), managing substances/chemicals, managing

and securing project-specific data, coordinating research subjects, participating

in appropriate seminars, consulting with colleagues and graduate students, and

attending meetings and conferences.

Salaries and Wages /

Intra-IHE Consulting

Intra-IHE consulting by faculty is assumed to be undertaken as an IHE obligation

requiring no compensation in addition to IBS. However, in unusual cases where

consultation is across departmental lines or involves a separate or remote

operation, and the work performed by the faculty member is in addition to their

regular responsibilities, any charges for such work representing additional

compensation above IBS are allowable provided that such consulting

arrangements are specifically provided for in the Federal award or approved in

writing by the NIH awarding IC.

Recipients, consortium participants, and contractors under grants that want to be

IIA-98

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able to charge employee consulting costs to grant-supported projects must

establish written guidelines permitting such payments regardless of the source of

funding and indicating the conditions under which the payment of consulting fees

to employees is proper. Under no circumstances may an individual be paid as a

consultant and an employee under the same NIH grant.

Authorization for consulting fees paid to individuals serving as both employees

and consultants of the same party must be documented in writing, on a case-by-

case basis, by the head of the organization (or their designee) incurring the costs

– i.e., the recipient organization, consortium participant, or contractor. If the

designee is personally involved in the project, the authorization may be given

only by the head of the recipient organization, consortium participant, or

contractor. This authorization must include a determination that the required

conditions are present and that there is no apparent or actual conflict of interest.

Salaries and Wages /

Nonprofit

Organizations

For compensation to members of nonprofit organizations, trustees, directors,

associates, officers, or the immediate families thereof, determination should be

made that such compensation is reasonable for the actual personal services

rendered rather than a distribution of earnings in excess of costs. This may

include director’s and executive committee member’s fees, incentive awards,

allowances for off-site pay, incentive pay, location allowances, hardship pay, and

cost-of-living differentials.

Salaries and Wages /

Professional Activities

outside of the

Recipient or

Subrecipient

Unless an arrangement is specifically authorized by an NIH awarding IC, a

recipient or subrecipient must follow its written policies and practices concerning

the permissible extent of professional services that can be provided outside the

recipient or subrecipient for non-organizational compensation. Where such

written policies do not exist or do not adequately define the permissible extent of

consulting or other non-organizational activities undertaken for extra outside

pay, the Federal government may require that the effort of professional staff

working on Federal awards be allocated between:

1. Recipient or subrecipient activities, and

2. Non-organizational professional activities. If the NIH awarding IC

considers the extent of non-organizational professional effort excessive

or inconsistent with the conflicts-of-interest terms and conditions of the

Federal award, appropriate arrangements governing compensation will

be negotiated on a case-by-case basis.

Salaries and Wages /

Special

Considerations

Special considerations in determining allowability of compensation will be given

to any change in a recipient or subrecipient’s compensation policy resulting in a

substantial increase in its employees’ level of compensation (particularly when

the change was concurrent with an increase in the ratio of Federal awards to

other activities) or any change in the treatment of allowability of specific types of

compensation due to changes in Federal policy.

Salaries and Wages /

Unallowable Costs

1. Costs which are unallowable under other sections of these principles

must not be allowable under this section solely on the basis that they

constitute personnel compensation.

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Explanation of Allowable Costs

2. The allowable compensation for certain employees is subject to a ceiling

in accordance with statute. For the amount of the ceiling for cost

reimbursement contracts, the covered compensation subject to the

ceiling, the covered employees, and other relevant provisions, see 10

U.S.C. 2324(e)(1)(P), and 41 U.S.C. 1127 and 4304(a)(16). For other

types of Federal awards, other statutory ceilings may apply.

Salaries and Wages

Incentive

Compensation

Incentive compensation to employees based on cost reduction, or efficient

performance, suggestion awards, safety awards, etc., is allowable to the extent

that the overall compensation is determined to be reasonable and such costs are

paid or accrued pursuant to an agreement entered into in good faith between the

recipient or subrecipient and the employees before the services were rendered,

or pursuant to an established plan followed by the recipient or subrecipient so

consistently as to imply, in effect, an agreement to make such payment.

Salaries and Wages

Overtime Premiums

Premiums for overtime generally are allowable; however, such payments are not

allowable for faculty members at institutions of higher education. If overtime

premiums are allowable, the categories or classifications of employees eligible to

receive overtime premiums should be determined according to the formally

established policies of the organization consistently applied regardless of the

source of funds.

Salaries and Wages

Payments for Dual

Appointments

For investigators receiving compensation from the institution

(recipient/contractor) and separately organized clinical practice plans,

compensation from such sources may be included in the institutional base salary

(IBS) budgeted and charged to NIH sponsored agreements if all of the following

criteria are met:

Clinical practice compensation must be set by the institution. *

Clinical practice activity must be shown on the institution's payroll or

salary appointment forms and records approved by the institution.

Clinical practice compensation must be paid through or at the direction

of the institution.

Clinical practice activity must be included and accounted for in the

institution's effort reporting and/or payroll distribution system.

The institution must assure that all financial reports and supporting

documents associated with the combined IBS and resulting charges to

NIH grants are retained and made available to Federal officials or their

duly authorized representatives consistent with the requirements of 2

CFR Part 200.430.

* “Set by the institution” means the recipient/contractor institution must be in a

position to document and certify that the specified amount of clinical practice

compensation is being paid in essentially the same manner as other specified

amounts of the committed IBS (compensation) of the investigator. Further, this

requires that the IBS not vary based on the specific clinical services provided by

investigator within the periods for which total IBS is certified by the recipient

institution.

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Salaries and Wages

Support from Multiple

Grants

See

Cost Considerations—Allocation of Costs and Closely Related Work

Selling and Marketing

Costs

Costs of selling and marketing any products or services of the recipient or

subrecipient (unless allowed under 2 CFR Part 200.421) are generally not

allowable, except as direct costs, with prior approval by the NIH awarding IC

when necessary for the performance of the Federal award.

Service Charge

Allowable. The costs to a user of organizational services and central facilities

owned by the recipient organization, such as central laboratory, technology

infrastructure fees, computer services and next generation

computing/communication costs, are allowable provided that they are not

covered by indirect costs. They must be based on organizational fee schedules

consistently applied regardless of the source of funds.

Specialized Service

Facilities

1. The costs of services provided by highly complex or specialized facilities

operated by the recipient or subrecipient, such as computing facilities,

wind tunnels, and reactors are allowable, provided the charges for the

services meet the conditions of either paragraphs (b) or (c) of this

section, and, in addition, take into account any items of income or

Federal financing that qualify as applicable credits under 2 CFR Part

200.406.

2. The costs of such services, when material, must be charged directly to

applicable awards based on actual usage of the services on the basis of

a schedule of rates or established methodology that:

a. Does not discriminate between activities under Federal awards

and other activities of the recipient or subrecipient, including

usage by the recipient or subrecipient for internal purposes, and

b. Is designed to recover only the aggregate costs of the services.

The costs of each service must consist normally of both its direct

costs and its allocable share of all indirect costs. Rates must be

adjusted at least biennially and must take into consideration over

/ under applied costs of the previous period(s).

c. Where the costs incurred for a service are not material, they may

be allocated as indirect costs.

d. Under some extraordinary circumstances, where it is in the best

interest of the Federal government and the recipient or

subrecipient to establish alternative costing arrangements, such

arrangements may be worked out with the Federal cognizant

agency for indirect costs.

Stipends

Allowable as cost-of-living allowances for trainees and fellows only under

Kirschstein-NRSA individual fellowships and institutional research training

grants. These payments are made according to a preestablished schedule

based on the individual’s experience and level of training. A stipend is not a fee-

for-service payment and is not subject to the cost accounting requirements of the

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cost principles. Additional information, including NIH policy on stipend

supplementation, is included in

Ruth L. Kirschstein National Research Service

Awards—Individual Fellowships—Supplementation of Stipends, Compensation,

and Other Income—Stipend Supplementation

and

Ruth L. Kirschstein National

Research Service Awards—Institutional Research Training Grants—Stipend

Supplementation, Compensation, and Other Income—Stipend Supplementation

in IIB. Stipends are not allowable under research grants even when they appear

to benefit the research project. See

Fringe Benefits / IHE Tuition/Tuition

Remission

in this exhibit.

Subject Costs

See

Research Patient Care

and

Donor Costs

in this exhibit.

Taxes

For nonprofit organizations and IHEs:

1. In general, taxes which the recipient or subrecipient is required to pay

and which are paid or accrued in accordance with GAAP, and payments

made to local governments in lieu of taxes which are commensurate with

the local government services received are allowable, except for:

a. Taxes from which exemptions are available to the recipient or

subrecipient directly or which are available to the recipient and

subrecipient based on an exemption afforded the Federal

government and, in the latter case, when the NIH awarding IC

makes available the necessary exemption certificates,

b. Special assessments on land which represent capital

improvements, and

c. Federal income taxes.

2. Any refund of taxes, and any payment to the recipient or subrecipient of

interest thereon, which were allowed as Federal award costs, will be

credited either as a cost reduction or cash refund, as appropriate, to the

Federal government. However, any interest actually paid or credited to a

recipient or subrecipient incident to a refund of tax, interest, and penalty

will be paid or credited to the Federal government only to the extent that

such interest accrued over the period during which the recipient or

subrecipient has been reimbursed by the Federal government for the

taxes, interest, and penalties.

Termination or

Suspension Costs

Termination of a Federal award may lead to the incurrence of additional costs by

the recipient or subrecipient, or the need for special treatment of costs, which

would not have arisen had the NIH award not been terminated. Cost principles

covering the allowability of termination costs are set forth in 2 CFR 200.472.

They must be used in conjunction with termination requirements outlined in

Section 8.5.2, Administrative Requirements—Enforcement Actions—

Suspension, Termination, and Withholding of Support.

If a grant is terminated or suspended, the recipient may not incur new obligations

that are not directly associated with the termination after the effective date of the

termination or suspension and must cancel as many outstanding obligations as

possible (see

Administrative Requirements—Enforcement Actions—

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Suspension, Termination, and Withholding of Support

). NIH will allow full credit

to the recipient for the Federal share of otherwise allowable costs if the

obligations were properly incurred by the recipient before suspension or

termination—and not in anticipation of it—and, in the case of termination, are not

cancelable.

Trailers and Modular

Units

Allowable only if considered equipment as provided below. A “trailer” is defined

as a portable vehicle built on a chassis that is designed to be hauled from one

site to another by a separate means of propulsion and that serves, wherever

parked, as a dwelling or place of business. A “modular unit” is a prefabricated

portable unit designed to be moved to a site and assembled on a foundation to

serve as a dwelling or a place of business. The determination of whether costs to

acquire trailers or modular units are allowable charges to NIH grant-supported

projects depends on whether such units are classified as real property or

equipment. The classification will depend on whether the recipient’s intended

use of the property is permanent or temporary.

A trailer or modular unit is considered real property when the unit and its

installation are designed or planned to be installed permanently at a given

location so as to seem fixed to the land as a permanent structure or

appurtenance thereto. Units classified as real property may not be charged to an

NIH grant-supported project unless authorizing legislation permits construction

or acquisition of real property and the specific purchase is approved by the NIH

awarding IC.

A trailer or modular unit is considered equipment when the unit and its

installation are designed or planned to be used at any given location for a limited

time only. Units classified as equipment may be charged to NIH grant-supported

projects only if the terms and conditions of the award do not prohibit the

purchase of equipment and NIH prior approval is obtained, as appropriate.

A trailer or modular unit properly classified as real property or as equipment at

the time of acquisition retains that classification for the life of the item, thereby

determining the appropriate accountability requirements under 2 CFR Part

200.439 or 200.465, as applicable.

Trainee Costs

Allowable only under predoctoral and postdoctoral training grants. (See

Ruth L.

Kirschstein National Research Service Awards—Institutional Research Training

Grants—Allowable and Unallowable Costs

in IIB for detailed information).

Transportation Costs

Costs incurred for freight, express, cartage, postage, and other transportation

services relating either to goods purchased, in process, or delivered, are

allowable. When such costs can readily be identified with the items involved,

they may be charged directly as transportation costs or added to the cost of such

items. Where identification with the materials received cannot readily be made,

inbound transportation cost may be charged to the appropriate indirect cost

accounts if the recipient or subrecipient follows a consistent, equitable procedure

in this respect. Outbound freight, if reimbursable under the terms and conditions

of the Federal award, should be treated as a direct cost.

Travel

Allowable as a direct cost where such travel will provide direct benefit to the

project.

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Travel/

Employees

Consistent with the organization’s established travel policy, these costs for

employees working on the grant-supported project may include associated per

diem or subsistence allowances and other travel-related expenses, such as

mileage allowances if travel is by personal automobile.

Domestic travel is travel performed within the recipient’s own country. For U.S.

and Canadian recipients, it includes travel within and between any of the 50

States of the United States and its possessions and territories and also travel

between the United States and Canada and within Canada.

Foreign travel is defined as any travel outside of Canada and the United States

and its territories and possessions. However, for an organization located outside

Canada and the United States and its territories and possessions, foreign travel

means travel outside that country.

In all cases, travel costs are limited to those allowed by formally established

organizational policy and, in the case of air travel, the lowest reasonable

commercial airfares must be used. For-profit recipients’ allowable travel costs

may not exceed those established by the FTR, issued by GSA, including the

maximum per diem and subsistence rates prescribed in those regulations. This

information is available at

http://www.gsa.gov

. If a recipient organization has no

established travel policy, those regulations will be used to determine the amount

that may be charged for travel costs.

Recipients are strongly encouraged to take advantage of discount fares for

airline travel through advance purchase of tickets if travel schedules can be

planned in advance (such as for national meetings and other scheduled events).

Recipients must comply with the requirements of the Fly America Act (49 U.S.C.

40118) which generally provides that foreign air travel funded by Federal funds

may only be conducted on U.S. flag air carriers and under applicable Open Skies

Agreements. For additional information regarding the Fly America Act and its

exceptions, see

Public Policy Requirements and Objectives—Fly America Act

Applicants and recipients should consult application instructions to determine

how to budget for travel costs under specific mechanisms and for certain types of

travelers, because they are not all required to be budgeted as travel (e.g.,

research subjects).

Travel/

Research

Patients

If research patient care is an approved activity of the grant-supported project, the

costs of transporting individuals participating in the research protocol to the site

where services are being provided, including costs of public transportation, are

allowable. The purchase of motor vehicles for this purpose also may be

allowable. (See also

Research Patient Care

in this exhibit).

Value Added Tax

(VAT)

Foreign taxes charged for the purchase of goods or services that a recipient or

subrecipient is legally required to pay in country is an allowable expense under

Federal awards. Foreign tax refunds or applicable credits under Federal awards

refer to receipts, or reduction of expenditures, which operate to offset or reduce

expense items that are allocable to Federal awards as direct or indirect costs. To

the extent that such credits accrued or received by the recipient or subrecipient

relate to allowable cost, these costs must be credited to the NIH awarding IC

either as costs or cash refunds. If the costs are credited back to the Federal

IIA-104

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Explanation of Allowable Costs

award, the recipient or subrecipient may reduce the Federal share of costs by the

amount of the foreign tax reimbursement, or where Federal award has not

expired, use the foreign government tax refund for approved activities under the

Federal award with prior approval of the NIH awarding IC. For many countries an

exemption of this tax for research exists. Consequently, requesting this cost

should be unallowable for research grants involving such countries as a

performance site.

Visa Costs (including

short-term travel visa

costs)

Generally, allowable direct cost as part of recruiting costs on an NIH grant, as

long as the institution has an employee/employer relationship with the individual.

Visa costs may also be allowable when identified in specific NOFOs or when

within the scope of an approved research project.

Visa renewal costs for employees is not a recruiting cost and would not be an

allowable charge to a grant. Expedited processing fees are generally

unallowable unless and until they become part of standard processing fees.

Fraud prevention and detection fees are allowable if they are required fees.

Department of Homeland Security SEVIS Form I-901 is a required fee and is

allowable. See also

Recruiting Costs

in this exhibit.

IIA-105

Part II: Terms and Conditions of NIH Grant Awards - Subpart A

8 Administrative Requirements

8 ADMINISTRATIVE REQUIREMENTS

8.1 CHANGES IN PROJECT AND BUDGET

In general, NIH recipients are allowed a certain degree of latitude to rebudget within and between budget

categories to meet unanticipated needs and to make other types of post-award changes. Some changes

may be made at the recipient’s discretion as long as they are within the limits established by NIH. In

other cases, NIH prior written approval may be required before a recipient makes certain budget modi-

fications or undertakes particular activities. The recipient-initiated changes that may be made under the

recipient’s authority and the changes that require NIH approval are outlined below and, with respect to

particular types of awards, activities, or recipients, in Subpart IIB. In addition, individual awards may

restrict recipients’ authorities to make budget and project changes without NIH prior approval. If NIH

approval is required, it must be requested of, and obtained in writing from, the awarding IC GMO in

advance of the change or obligation of funds as specified later in this chapter under

Requests for Prior

Approval

Recipients are required to notify NIH of developments that have a significant impact on the award-sup-

ported activities as soon as they become known. This includes significant changes to Other Support (e.g.

new appointments or affiliations) that occur during the award. Also, notification shall be given in the

case of problems, delays, or adverse conditions which materially impair the ability to meet the objectives

of the award. This notification shall include a statement of the action taken or contemplated, and any

assistance needed to resolve the situation.

Changes in project or budget resulting from NIH-initiated actions are discussed in other sections of this

chapter.

8.1.1 NIH Standard Terms of Award

Federal administrative requirements allow agencies to waive certain cost-related and administrative prior

approvals; these are known as expanded authorities. In 2001, NIH extended expanded authorities to all

NIH awards except for the provision to automatically carry over unobligated balances. Certain award

instruments, grant programs, and types of recipients are routinely excluded from the authority to auto-

matically carry over unobligated balances. This includes centers (P50, P60, P30, and others); cooperative

agreements (U); Kirschstein-NRSA institutional research training grants (T); non-Fast Track Phase 1

SBIR and STTR awards (R43 and R41); clinical trials (regardless of activity code); and awards to indi-

viduals.

One or more of these authorities may be overridden by a specific term or condition of the award. Recip-

ients must review the NoA to determine if a particular authority is withheld for a specific grant.

Recipients must exercise proper stewardship over Federal funds and ensure that costs charged to awards

are allowable, allocable, reasonable, necessary, and consistently applied regardless of the source of

funds. NIH may disallow the costs if it determines, through audit or otherwise, that the costs do not meet

the tests of allowability, allocability, reasonableness, necessity, and consistency.

Several authorities have specific deadlines for submission of reports or for timely notification to the NIH

awarding IC. Recipients should be aware that any consistent pattern of failure to adhere to those dead-

lines for reporting or notification will be grounds for excluding that recipient from a specific authority.

Exhibit 6. Summary of NIH Standard Terms of Award

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Recipient Authorities as NIH Standard Terms of

Award

Exceptions

Carryover of unobligated balances from one budget

period to any subsequent period

Centers (P50, P60, P30 and others), cooperative

agreements (U), Kirschstein-NRSA institutional

research training grants (T), non-Fast Track Phase

I SBIR and STTR awards (R43 and R41), clinical

trials, and awards to individuals, or if the NoA

indicates otherwise.

Cost-related prior approval changes, including

research patient care costs and equipment

The cost would result in a change of scope.

Extension of final budget period of a project period

without additional NIH funds (no-cost extension)

The recipient has already exercised its one-time

authority to extend the award for up to 12 months;

the NIH awarding IC has previously extended the

project period; and/or a project is multi-year for 5

years (i.e., the entire 5-year project period is funded

by a single award).

Transfer of performance of substantive

programmatic work to a third party (by consortium

agreement)

SBIR and STTR awards or the transfer would be to

a foreign component that does not result in an

international collaboration (formerly known as a

foreign subaward) or it would result in a change in

scope.

Direct charge the salaries of administrative and

clerical staff if conditions in 2 CFR Part 200.413 are

met and the charges also meet the criteria for

allowable costs described in 2 CFR Part 200.403.

Direct charge payments of Incidental activities for

which supplemental compensation is allowable

under written institutional policy (at a rate not to

exceed the institutional base salary) 2 CFR

Part 200.430. Such activities must be specifically

provided for in the Federal award budget.

Include charges for Intra-IHE faculty consulting on

sponsored agreements that exceed a faculty

member’s base salary, but only in unusual cases

where: (a) consultation is across departmental lines

or involves a separate or remote operation; and (b)

the consulting work is in addition to the faculty

member’s regular departmental load.

8.1.1.1 Carryover of Unobligated Balances from One Budget Period to Any Sub-

sequent Budget Period

Recipients should be aware that there is a difference between unliquidated obligations and unobligated

balances. Unliquidated obligations are commitments of the recipient and are considered to be obligations

and, therefore, should not be reported as unobligated balances.

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The NoA will include a term and condition to indicate the disposition of unobligated balances. The term

and condition will state whether the recipient has automatic carryover authority, or if prior approval is

required by the NIH awarding IC. Note the authority to automatically carry over unobligated balances

includes the authority to carryover from one competitive segment to another.

Automatic carryover of unobligated balances applies to all awards except centers (P50, P60, P30, other),

cooperative agreements (U), Kirschstein-NRSA institutional research training grants (T), non-Fast Track

Phase I SBIR and STTR awards (R43 and R41), clinical trials (regardless of activity code), and awards

to individuals. For these grants, carryover of unobligated balances requires NIH awarding IC prior

approval unless otherwise noted in the NoA. Other awards may be excluded from this authority through

a specific term or condition in the NoA.

For awards under SNAP (see

Administrative Requirements—Monitoring—Reporting—Streamlined

Non-Competing Award Process

for applicability), funds are automatically carried over to the subsequent

budget period. However, the recipient will be required to indicate, as part of the grant’s progress report,

whether any estimated unobligated balance (including prior-year carryover) is expected to be greater

than 25 percent of the current year’s total approved budget. The total approved budget amount includes

current year and any carryover from prior years of the project period. If the unobligated balance is

greater than 25 percent of the total approved budget, the recipient must provide an explanation and indic-

ate plans for expenditure of those funds within the current budget year.

For awards that require an annual FFR, the amount to be carried over must be specified under item 12,

“Remarks.”

For both SNAP and non-SNAP, when a recipient reports a balance of unobligated funds in excess of 25

percent of the total amount awarded for the budget period, plus any approved carryover of funds from a

prior year(s), the GMO will review the circumstances resulting in the balance to ensure that these funds

are necessary to complete the project, and may request additional information from the recipient, includ-

ing a revised budget, as part of the review.

If the GMO determines that some or all of the unobligated funds are not necessary to complete the pro-

ject, the GMO may restrict the recipient’s authority to automatically carry over unobligated balances in

the future, use the balance to reduce or offset NIH funding for a subsequent budget period, or use a com-

bination of these actions. The GMO also may indicate whether the balance may be carried forward to a

budget period other than the succeeding one. The GMO’s decision about the disposition of the reported

unobligated balance will be reflected in the terms and conditions of the NoA.

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and

cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability,

unless otherwise authorized by Congress. In order for NIH to meet its obligation to close these accounts

and cancel any remaining balances by September 30

, recipients must report disbursements on the FFR

no later than August 31

of the fifth fiscal year after the year of availability. At the end of five years, the

funds are cancelled and returned to the Treasury. This provision may limit the availability of funds for

carryover.

8.1.1.2 Cost-Related Prior Approvals

NIH prior approval is not required to rebudget funds for any direct cost item that the applicable cost prin-

ciples identify as requiring the Federal awarding agency’s prior approval, unless the incurrence of costs

is associated with or is considered to be a change in scope.

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8.1.1.3 Extension of Final Budget Period of a Previously Approved Project Period

without Additional NIH Funds

The recipient may extend the final budget period of the previously approved project period one time for

a period of up to 12 months beyond the original completion date shown in the NoA if:

no term of award specifically prohibits the extension,

no additional funds are required to be obligated by the NIH awarding IC, and

the project’s originally approved scope will not change.

Such an action affirms that additional work remains to be completed on the project and that resources are

available to continue to support the project, or that additional time is needed to provide for an orderly

closeout. The fact that funds remain at the completion date of the grant is not, in itself, sufficient jus-

tification for an extension without additional funds.

With the exception of grant programs that have an effort requirement, or where terms and conditions pro-

hibit such reductions, NIH will not require prior approval for the reduction in effort for Senior/Key per-

sonnel named in the NOA. The recipient is reminded that active awards must have a measurable level of

effort.

Recipients must use the eRA Commons No-Cost Extension feature to electronically notify NIH that they

are exercising their one-time authority to extend without funds the completion date of an award. This

extension feature becomes available to the recipient 90 days before the project period end date. Exten-

sions may be up to 12 months beyond the final budget period end date. In the eRA Commons, this noti-

fication can be made up to the last day of the current project end date. An e-mail notification is

automatically sent to the GMO. No further action by the recipient is required.

Notifications may not be submitted via e-mail or fax. If a no-cost extension notification is submitted late,

the eRA Commons No-Cost Extension feature cannot be used. Instead, the extension notification

becomes a request and that requires the approval of the IC GMO. Recipients who miss the window (or

opportunity) to extend the grant in eRA Commons must submit a written prior approval request to the

NIH awarding IC for consideration. (See

Administrative Requirements—Prior Approval Requirements

for extension requiring additional funds.)

In extending the final budget period of the project period through this process, the recipient agrees to

update all required certifications and assurances, including but not limited to those pertaining to human

subjects and vertebrate animals, in accordance with applicable regulations and policies. Recipients are

reminded that all terms and conditions of the award apply during the extension period.

Recipients may not extend project periods that were previously extended by the NIH awarding IC. Any

additional project period extension requires NIH prior approval. (See

Administrative Requirements—

Prior Approval Requirements

for extensions requiring additional funds.)

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and

cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability. In

order for NIH to meet its obligation to close these accounts and cancel any remaining balances by

September 30, recipients must report disbursements on the quarterly cash transaction report (using the

FFR) no later than August 31

of the fifth fiscal year after the year of availability. At the end of five

years, the funds are cancelled and returned to the Treasury. This provision may limit or eliminate this

authority to extend the final budget period when an entire project period is funded by a single award

(e.g., multiyear funded awards).

The provisions in this subsection do not apply to fellowship awards.

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8.1.1.4 Transfer of the Performance of Substantive Programmatic Work to a Third

Party by Means of a Consortium Agreement

Prior approval by the NIH awarding IC is not required to transfer the performance of already peer

reviewed programmatic work unless the activity constitutes a change in scope or results in the transfer of

substantive programmatic work to a foreign component. NIH no longer recognizes foreign subawards.

Collaborative international research projects will only be considered in competing applications. New

international collaborations may not be requested post-award.

8.1.1.5 Direct Charging Salaries of Administrative and Clerical Staff

The salaries of administrative and clerical staff should normally be treated as indirect costs. Direct char-

ging of these costs may be appropriate only if all of the following conditions are met:

1. Administrative or clerical services are integral to a project or activity;

2. Individuals involved can be specifically identified with the project or activity;

3. Such costs are explicitly included in the budget; and

4. The costs are not also recovered as indirect costs.

Such charges must also meet the criteria for allowable costs described in 2 CFR Part 200.403.

NIH prior approval is not required to rebudget funds for this direct cost item post-award. Prior approval

is only required when additional funds are being requested for such a position.

8.1.1.6 Supplemental Compensation under Written Institutional Policy for IHEs

IHEs may direct charge payments of incidental activities for which supplemental compensation is allow-

able under written institutional policy (at a rate not to exceed the institutional base salary) and not

include them in the records described in 2 CFR Part 200.430. Such activities must be specifically

provided for in the Federal award budget.

8.1.1.7 Intra-IHE Faculty Consulting that Exceed a Faculty Member's Base Salary,

Under Certain Conditions.

IHEs may include charges for Intra-IHE faculty consulting on sponsored agreements that exceed a fac-

ulty member’s base salary, but only in unusual cases where: (a) consultation is across departmental lines

or involves a separate or remote operation; and (b) the consulting work is in addition to the faculty mem-

ber’s regular departmental load.

8.1.2 Prior Approval Requirements

This section describes the activities and/or expenditures that require NIH prior approval. NIH prior

approval requirements are summarized in Exhibit 7, which is provided for guidance only. For the prior

approval requirements specified in the exhibit, approval is required whether or not the change has a

budgetary impact. The circumstances under which prior approval is required also are summarized in the

exhibit.

Recipients also should consult Subpart IIB for prior approval requirements that apply to specific mech-

anisms, types of grants, and types of recipients.

Any question about the need for prior approval for an activity or cost under a specific NIH award should

be directed to the GMO.

Exhibit 7. Summary of Actions Requiring NIH Prior Approval

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NIH prior approval is required

for

Under the following circumstances

Additional no-cost extension,

extension greater than 12

months, or late notification of ini-

tial no-cost extension (

8.1.2.1

)

All instances.

A&R (

8.1.2.2

)

Rebudgeting into A&R costs that would exceed 25 percent of the total

approved budget for a budget period.

If rebudgeting would not meet this threshold but would result in a

change in scope.

Addition of a Major single A&R project.

Capital expenditures (con-

struction, land, or building

acquisition) (

8.1.2.3

)

All instances. Also, any proposals to convey, transfer, assign, mort-

gage, lease, or in any other manner encumber real property acquired

with NIH grant funds.

Carryover of unobligated bal-

ances (

8.1.2.4

)

If the NoA indicates that the recipient does not have the authority to

automatically carry over unobligated balances.

Change in scope (

8.1.2.5

)

All instances.

Change in status of the PD/PI

or senior/key personnel named

in the NoA (

8.1.2.6

)

A significant change in the status including but not limited to withdrawal

from the project; absence for any continuous period of 3 months or

more; reduction of the level of time or effort devoted to project by 25 per-

cent or more from what was approved in the initial competing year

award.

Change of recipient organ-

ization (

8.1.2.7

)

All instances.

Change of recipient organ-

ization status (

8.1.2.8

)

All instances.

Deviation from award terms

and conditions (

8.1.2.9

)

All instances. Includes undertaking any activities disapproved or restric-

ted as a condition of the award.

Foreign component added to a

grant to a domestic or foreign

organization (

8.1.2.10

)

All instances.

Make subawards based on

fixed amounts (

8.1.2.11

)

All instances

Need for additional NIH funding

(

8.1.2.12

and

8.1.2.13

)

All instances, including extension of a final budget period of a project

period with additional funds.

Pre-award costs (

8.1.2.14

)

More than 90 days before effective date of the initial budget period of a

new or competing continuation award; always at the recipient’s own

risk.

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NIH prior approval is required

for

Under the following circumstances

Rebudgeting funds from trainee

costs (

8.1.2.15

)

All instances.

Rebudgeting of funds between

construction and non-con-

struction work (

8.1.2.16

)

All instances.

Retention of research grant

funds when CDA awarded

(

8.1.2.17

)

All instances.

8.1.2.1 Additional No-cost Extension or Extension Greater Than 12 Months or Late

Notification of Initial No-Cost Extension

The

NIH Standard Terms of Award

provide the recipient the authority to extend the final budget period

of a previously approved project period one time for a period of up to 12 months beyond the original

completion date down in the NoA. Any additional project period extension beyond the initial extension

of up to 12 months requires NIH prior approval. The request should include a description of the project

activities that require support during the extension and a statement about the funds available to support

the extension. Further any late notification of the initial no-cost extension provided by the NIH Standard

Terms of Award also requires prior approval.

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and

cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability,

unless otherwise authorized by Congress. In order for NIH to meet its obligation to close these accounts

and cancel any remaining balances by September 30, recipients must report disbursements on the FFR no

later than August 31

of the fifth fiscal year after the year of availability. At the end of five years, the

funds are cancelled and returned to the Treasury. This provision may limit NIH’s ability to further

extend the final budget period.

8.1.2.2 Alterations and Renovations

NIH prior approval is required if a recipient wishes to rebudget more than 25 percent of the total

approved budget for a budget period into A&R costs. NIH prior approval also is required for lesser

rebudgeting into A &R costs if the rebudgeting would result in a change in scope. If rebudgeting results

in the addition of a Major A&R project, NIH will consider the rebudgeting to be a change in scope. (See

the

Construction Grants

chapter in IIB for documentation requirements for Major A&R projects).

8.1.2.3 Capital Expenditures

Capital expenditures for land or buildings require NIH prior approval. In addition, real property acquired

with NIH grant funds may not be conveyed, transferred, assigned, mortgaged, leased, or in any other

manner encumbered by the recipient without the written prior approval of the NIH awarding IC or its suc-

cessor organization.

8.1.2.4 Carryover of Unobligated Balances

The NoA will include a term and condition to indicate the disposition of unobligated balances. The term

and condition will state whether the recipient has automatic carryover authority or if prior approval is

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required by the NIH awarding IC. When NIH prior approval is required, the AOR should submit a

request to the GMO that includes at a minimum the following information:

A detailed budget by direct cost category with the indirect cost information (base and rate) for

the proposed use of the carryover funds. If personnel costs are requested, include a detailed

breakdown of personnel costs, including base salary, salary requested and effort to be spent on

the project during the extension. In general, carryover action requiring prior approval will be

approved using the indirect rate that was in effect at the time the initial funds were awarded for

the year to which the funds are being carried over. For example, if the carryover is approved

from year -01 to year -03, the indirect cost rate used to calculate the revised -03 year award will

be the rate used to initially calculate year -03. However, actual expenditures will still be based

on the rate applicable when the cost is incurred.

A scientific justification for the use of funds.

The reason for the unobligated balance.

8.1.2.5 Change in Scope

In general, the PD/PI may make changes in the methodology, approach, or other aspects of the project

objectives. However, the recipient must obtain prior approval from the NIH awarding IC for a change in

scope. A change in scope is a change in the direction, aims, objectives, purposes, or type of research

training, identified in the approved project. The recipient must make the initial determination of the sig-

nificance of a change and should consult with the GMO as necessary.

Potential indicators of a change in scope include, but are not limited to, the following:

Change in the specific aims approved at the time of award.

Substitution of one animal model for another.

Change from the approved use of live vertebrate animals.

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Change from the approved involvement of human subjects that would result in an increased risk.

This includes:

o

An addition or change that would result in changing the overall human subjects or clin-

ical trial designation of the award;

From non-human subjects research to research involving human subjects

(exempt or non-exempt);

From exempt to non-exempt research involving human subjects; or

From “No Clinical Trial” to “Includes a Clinical Trial.” Requests for this change

must be submitted to a clinical trial NOFO as a competitive revision. See NIH

definition of

clinical trial

and

2.3.5 — Types of Notices of Funding Opportunity

o

The new inclusion of subject populations that are covered by additional regulatory pro-

tections under 45 CFR Part 46 subparts B, C or D (pregnant women, human fetuses, and

neonates; prisoners; or children).

o

Any change to the study protocol that would increase the risk level for subjects includ-

ing physical, psychological, financial, legal or other risks. This could include the addi-

tion of a new study population that would be at higher risk from existing research

procedures, the addition of new study procedures that are greater than minimal risk, any

modification of existing study procedures that would increase overall risk, or the addi-

tion of a new clinical study or a new clinical trial intervention arm not originally pro-

posed that is greater than minimal risk.

o

New information indicating a higher level of risk to participants than previously recog-

nized for a study intervention, procedure, or pharmacological treatment.

Shift of the research emphasis from one disease area to another.

A clinical hold by FDA under a study involving an IND or an IDE.

Application of a new technology, e.g., changing assays from those approved to a different type

of assay.

Transfer of the performance of substantive programmatic work to a third party through a con-

sortium agreement, by contract, or any other means. If the third party is a foreign component that

does not result in a foreign subaward, NIH prior approval is always required. NIH no longer

recognizes foreign subawards. Collaborative international research projects will only be con-

sidered in competing applications. NIH will not approve post-award requests for international

collaborations that were not reviewed and approved as part of the competing application.

Change in other senior/key personnel not specifically named in the NoA (see

Change in Status,

Including Absence, of PD/PI and Other Senior/Key Personnel Named in the NoA

below for

requirements for NIH approval of alternate arrangements for or replacement of named senior/key

personnel).

Significant rebudgeting

, whether or not the particular expenditure(s) require prior approval. Sig-

nificant rebudgeting occurs when expenditures in a single direct cost budget category deviate

(increase or decrease) from the categorical commitment level established for the budget period

by 25 percent or more of the total costs awarded. For example, if the award budget for total costs

is $200,000, any rebudgeting that would result in an increase or decrease of more than $50,000

in a budget category is considered significant rebudgeting. The base used for determining sig-

nificant rebudgeting excludes the effects of prior-year carryover balances but includes competing

and non-competing supplements. Significant rebudgeting does not apply to modular grants.

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Incurrence of research patient care costs if costs in that category were not previously approved

by NIH or if a recipient desires to rebudget additional funds beyond those approved into or

rebudget funds out of the research patient care category.

Purchase of a unit of equipment exceeding $25,000.

8.1.2.6 Change in Status, Including Absence of PD/PI and Other Senior/Key Per-

sonnel Named in the NoA

The recipient is required to submit a prior approval request to the GMO if:

There is a significant change in the status of the PD/PI or other Senior/Key Personnel spe-

cifically named in the NoA including but not limited to withdrawing from the project entirely,

being absent from the project during any continuous period of 3 months or more, or reducing

time and effort devoted to the project by 25 percent or more from the level that was approved at

the time of initial competing year award (for example, a proposed change from 40 percent effort

to 30 percent or less effort or in calendar months a change from 4.8 to 3.6 calendar months).

Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive

reductions that total 25% or more. Once agency approval has been given for a significant change

in the level of effort, then all subsequent reductions are measured against the approved adjusted

level. Selecting

Yes

in the RPPR constitutes a prior approval request to the agency and the issu-

ance of a subsequent year of funding constitutes agency approval of the request.

There is a change from a multiple PD/PI model to a single PD/PI model.

There is a change from a single PD/PI model to a multiple PD/PI model.

There is a change in the number or makeup of the PD/PIs on a multiple PD/PI award.

NIH must approve any alternate arrangement proposed by the recipient, including any replacement of the

PD/PI or senior/key personnel named in the NoA, and the addition of any new PD/PIs.

The request for prior approval of any additional or substitute PD/PIs or Senior/Key Personnel named in

the NoA, or change from a multiple PD/PI model to a single PD/PI model, must be submitted promptly,

and must be accompanied by a strong scientific justification related to the scientific project, including

any proposed changes in scope, the biographical sketch of any new individuals proposed and other

sources of support, and any budget changes resulting from the proposed change. A new or revised Lead-

ership Plan is required if the request is to change from a single PD/PI model to a multiple PD/PI model,

or to change the number or makeup of the PD/PIs on a multiple PD/PI award. The Commons ID must be

provided for any new PD/PIs.

In addition, because NIH recipients are expected to provide safe and healthful working conditions for

their employees and foster work environments conducive to high-quality research, the request for

approval should include mention as to whether change(s) in PD/PI or Senior/Key Personnel is related to

concerns about safety and/or work environments (bullying, retaliation, or hostile working conditions).

NIH recipient institutions are required to notify NIH when individuals identified as PD/PI or other Seni-

or/Key personnel in an NIH notice of award are removed from their position or are otherwise disciplined

by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working con-

ditions. Notification must be provided by the Authorized Organization Representative within 30 days of

the removal or disciplinary action and must be submitted to NIH through the dedicated web form,

Inform

NIH About Harassment or Discrimination Concerns

.. All required notifications must include, at a min-

imum, the name of the Authorized Organization Representative submitting the notification, the name of

the individual of concern, a description of the concerns, the action(s) taken, and any anticipated impact

on the NIH-funded award(s). If it is determined that the concerns shared with NIH will impact the PD/PI

or senior key personnel's ability to continue as the scientific lead of the project, NIH will require prior

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approval for a replacement PD/PI or senior key official. NIH will, in turn, be better positioned to enable

informed grant-stewardship decisions regarding matters including, but not limited to, substitute personnel

and institutional management and oversight.

When NIH receives information related to concerns about safety and/or work environments regarding

any PD/PI or Senior/Key Personnel identified in the NIH NOA or RPPR and if, during the course of the

investigation the individual leaves their current position, and is no longer employed by the institution,

the NIH Director may decline transfer of an ongoing extramural award to a different institution if con-

cerns about harassment, bullying, hostile work environment, or other professional misconduct have not

been resolved to the NIH's satisfaction. NIH has full authority to share investigation reports, conclusions,

and the results of any investigation related to harassment, bullying, retaliation, or hostile working con-

ditions on an as needed basis with any institution that receives a grant, cooperative agreement or any

other extramural (e.g. Other Transactions) award. In order to continue to receive NIH funding, recipient

institutions must complete any investigation undertaken due to concerns about harassment, bullying

retaliation, or hostile working conditions regarding any individual identified as a principal investigator or

key personnel in an NIH notice of award or progress report even if during the course of the investigation

the individual under investigation leaves their current position and is no longer employed by the insti-

tution.

If the arrangements proposed by the recipient, including the qualifications of any proposed replacement,

are not acceptable to the NIH awarding IC, the grant may be suspended or terminated. If the recipient

wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the

GMO, in writing, of its wish to terminate, and NIH will forward closeout instructions.

The requirement to obtain NIH prior approval for a change in status pertains only to those personnel

NIH designates in the NoA regardless of whether the applicant organization designates others as seni-

or/key personnel for its own purposes.

8.1.2.7 Change of Recipient Organization

NIH prior approval is required for the transfer of the legal and administrative responsibility for a grant-

supported project or activity from one legal entity to another before the completion date of the approved

project period (competitive segment). A change of recipient organization may be accomplished under

most NIH grants if any of the following conditions are met:

The original recipient has agreed to relinquish responsibility for an active project before the com-

pletion date of the approved project period. This includes any proposed change of recipient as a

result of a PD/PI on a research project transferring from one organization to another organ-

ization. The project under the same PD/PI may be supported at a new organization for a period

up to the remainder of the previously approved project period in an amount not to exceed that

previously recommended for direct costs (plus applicable indirect costs) for the remaining

period.

A non-competing continuation award that is within an approved project period has been withheld

because of the recipient’s actions (see

Administrative Requirements—Enforcement Actions—

Suspension, Termination, and Withholding of Support

A request for change of recipient organization should include mention as to whether the change in recip-

ient organization is related to concerns about safety and/or work environments (e.g. due to concerns

about harassment, bullying, retaliation, or hostile working conditions) involving the PD/PI. NIH recipient

organizations are required to notify NIH when individuals identified as PD/PI or other Senior/Key per-

sonnel in an NIH notice of award are removed from their position or are otherwise disciplined by the

recipient organization due to concerns about harassment, bullying, retaliation or hostile working con-

ditions. Notification must be provided by the Authorized Organization Representative within 30 days of

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the removal or disciplinary action and must be submitted to NIH through a dedicated web form. All

required notifications must include, at a minimum, the name of the Authorized Organization Rep-

resentative submitting the notification, the name of the individual of concern, a description of the con-

cerns, the action(s) taken, and any anticipated impact on the NIH-funded award(s). If it is determined

that the concerns shared with NIH will impact the PD/PI or senior key personnel's ability to continue as

the scientific lead of the project, NIH will require prior approval for a replacement PD/PI or senior key

official.

NIH will, in turn, be better positioned to enable informed grant-stewardship decisions regarding matters

including, but not limited to, substitute personnel and organizational management and oversight.

NIH expects both the relinquishing and applicant organizations to disclose whether a Change of Recip-

ient Organization is occurring within the context of an ongoing or recent investigation of misconduct of

any kind, including but not limited to professional misconduct or research misconduct.

A change of recipient that involves the transfer of a grant to or between foreign organizations or inter-

national organizations also must be approved by the IC’s Advisory Council or Board. A change of recip-

ient for a

linked international research project

is not allowed.

A grant to an individual may not be transferred.

A successor-in-interest or a name change is not considered a change of recipient (see

Change in Recip-

ient Organizational Status

below).

A change of recipient organization may involve the transfer of equipment purchased with grant funds.

The transfer may be accomplished as part of the original recipient’s relinquishment of the grant; oth-

erwise, NIH reserves the right to transfer title to equipment to the new organization as indicated in

Administrative Requirements—Management Systems and Procedures—Property Management System

Standards

A change of recipient request normally will be permitted only when all of the permanent benefits attrib-

utable to the original grant can be transferred, including equipment purchased in whole or in part with

grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued

need for the grant-supported project or activity and the impact of any proposed changes in the scope of

the project. NIH will also consider the length of time, the percentage of funds, and the amount of work

remaining in the project period. A change may be made without peer review, provided the PD/PI plans

no significant change in research objectives and the facilities and resources at the new organization will

allow for successful performance of the project. If these conditions or other programmatic or admin-

istrative requirements are not met, the NIH awarding IC may require peer review or may disapprove the

request and, if appropriate, terminate the award.

A change of recipient organization request must be made before the anticipated start date at the new

organization and preferably several months in advance. Failure to provide timely notification may result

in disapproval of the request or significant delays in processing. Recipients are encouraged to discuss

any potential issues with the awarding IC(s) prior to submitting a change of recipient organization

request. If requesting a transfer in the middle of a budget period or at the end of the Federal fiscal year,

recipients should contact the awarding IC for IC-specific guidance on the timing and preparation of the

change of institution application.

A request for a change of recipient organization must be submitted to the GMO. The original institution

must include an Official Statement Relinquishing Interests and Rights in a Public Health Service

Research Grant (PHS 3734) (relinquishing statement). The relinquishing statement may be submitted in

paper or electronically via the eRA Commons. Final FFR Expenditure Data and a Final Invention State-

ment are due to NIH from the relinquishing organization no later than 120 days after the end of NIH

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support of the project. Final FFR Expenditure Data should not be submitted until the original institution

has received a revised NoA for the relinquished grant.

The proposed new recipient organization must provide the GMO with a change of institution application

which may be submitted using the PHS 398 or PHS 416-1 paper application forms, or electronically via

Grants.gov using the

Parent Announcement

. If the original award was the result of a modular application

and the recipient will submit a paper change of institution application, the modular procedures apply to

the request for change of recipient. If the original award was the result of a modular application and the

recipient will submit an electronic change of institution application, the recipient may submit a detailed

budget or streamlined-detailed budget (as described in the NOFO).

The paper application from the proposed new recipient organization should include, at a minimum, the

following:

PHS 398 Face page

Budget pages (current and future years). (Under awards resulting from modular applications, the

application should include narrative budget information for the current budget period, including

total direct cost and the basis for computing indirect costs and, if applicable, future budget peri-

ods.) Budgets should not exceed the direct costs (plus applicable indirect costs) previously

recommended for any budget period. For transfers in the middle of a budget period, the budget

for the initial year may be based on the total costs relinquished only if the recipient has been

instructed to do so by the awarding IC. For these applications, recipients will also need to

include the Other Project Information and the Senior/Key Personnel components.

Updated biographical sketches for the PD/PI and existing senior/key personnel and biographical

sketches for any proposed new senior/key personnel.

If transferring on the anniversary date, include the progress report for the current year including

a statement regarding the goals for the upcoming year. For all transfer applications include also a

statement indicating whether the overall research plans/aims have changed from the original sub-

mission, and, if so, provide updated information.

Updated “other support” page(s), if necessary.

Resources page, including probable effect of the move on the project.

Checklist page

Certification of IRB/IACUC approval, including OHRP and OLAW assurance numbers, if applic-

able.

Detailed list of any equipment purchased with grant funds to be transferred to the new organ-

ization (inclusion of this list in the transfer application from the new organization indicates its

acceptance of title to that equipment).

The electronic application from the proposed recipient organization should include, at a minimum, the

following:

SF 424 (R&R) Cover Component

SF 424 (R&R) Project Performance Site Location(s)

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SF 424 (R&R) Other Project Information:

o

Certification of IRB/IACUC approval, including OHRP and OLAW assurance numbers,

if applicable.

o

Facilities and Other Resources, including probable effect of the move on the project.

o

Detailed list of any equipment purchased with grant funds to be transferred to the new

organization (inclusion of the list in the transfer application from the new organization

indicates its acceptance of title to that equipment).

SF 424 (R&R) Senior/Key Person Profile:

o

Updated biographical sketches for the PD/PI and existing senior/key personnel and bio-

graphical sketches for any proposed new senior/key personnel, and updated “other sup-

port” page(s) as necessary.

Budget pages applicable for activity code (current and future years). If the budget for the original

award was submitted in a modular format, use the R&R Detailed Budget form for all electronic

applications. Recipients may either complete all of the fields in the R&R Detailed Budget as

appropriate or complete only the costs for the PD/PI (Section A), and include the remainder of

the direct costs under Section F (Other Direct Costs) Items 8-17, and Section H (Indirect Costs).

(For awards resulting from modular applications, include narrative budget information for the

current budget period, including total direct cost and the basis for computing indirect costs and,

if applicable, future budget periods.) Budgets should not exceed the direct costs previously

recommended for direct costs (plus applicable indirect costs) for any budget period. For transfers

during the course of a budget period, the budget for the initial year may be based on the total

costs relinquished only if the recipient has been instructed to do so by the awarding IC.

PHS 398 Research Plan

o

If transferring on the anniversary date, include the progress report for the current year

including a statement regarding the goals for the upcoming year. For all transfer applic-

ations include also a statement indicating whether the overall research plans/aims have

changed from the original submission, and, if so, provide updated information.

PHS 398 Cover Page Supplement

PHS 398 Checklist

And, as applicable:

PHS Training Budget Form

PHS 398 Career Development Award Supplemental Form

PHS 398 Research Training Program Form

PHS Human Subjects and Clinical Trial Information Form

SBIR/STTR Information

NIH may request additional information necessary to accomplish its review of the request. Acceptance of

a relinquishing statement by NIH does not guarantee approval of a transfer application for the continued

funding of a project.

NIH will accomplish a change of recipient organization by issuing a revised NoA to the original recip-

ient reflecting the revised budget/project period end dates, deletion of any future-year support, and deo-

bligation of remaining funds, if applicable. (A deobligation of funds will be based on the estimated grant

expenditures through the relinquishment date, as determined from the relinquishing statement or the

available balance in PMS, whichever is less.)

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Concurrently, the new recipient will receive the NoA reflecting the direct cost balance reported on the

relinquishing statement plus applicable indirect costs, if funds are available. If the change of recipient

organization occurs on the anniversary date of the project, the NoA to the new recipient will reflect the

previously committed direct cost level plus applicable indirect costs if funds are available. If the change

of recipient organization occurs during the course of the budget period, the policy of the awarding IC

will determine if the NoA to the new recipient will reflect the direct cost relinquished by the former

recipient plus applicable indirect costs or the total costs relinquished by the former recipient. This

amount is subject to change as a result of the closeout of the original grant and may be adjusted down-

ward.

A recipient may, at its own risk and without NIH prior approval, incur obligations and expenditures to

cover costs before the beginning date of a transfer award. The recipient may do so only if those costs are

necessary to conduct the project and would not require prior approval if incurred under an awarded

grant. For the purposes of pre-award costs, transfers are treated like non-competing continuation awards.

Therefore, the pre-award costs incurred are not limited to 90 days prior to the beginning date of the ini-

tial budget period of that transferred award to the new recipient organization.

8.1.2.8 Change in Recipient Organizational Status

Recipients must give NIH advance notice of the following types of change in organizational status (not a

change of recipient organization

as described above):

Merger.

Legal action resulting in the unification of two or more legal entities. When such an

action involves the transfer of NIH grants, the procedures for recognizing a successor-in-interest

will apply. When the action does not involve the transfer of NIH grants, the procedures for recog-

nizing a name change normally will apply.

Successor-in-Interest (SII).

Process whereby the rights to and obligations under an NIH grant(s)

are acquired incidental to the transfer of all of the assets of the recipient or the transfer of that

part of the assets involved in the performance of the grant(s). A SII may result from legislative

or other legal action, such as a merger or other corporate change.

Name Change.

Action whereby the name of an organization is changed without otherwise affect-

ing the rights and obligations of that organization as a recipient.

Advance notification is required to ensure that the recipient remains able to meet its legal and admin-

istrative obligations to NIH, and payments are not interrupted.

Recipients are encouraged to contact the GMO of the lead NIH awarding IC to explain the nature of the

change in organizational status and receive guidance on whether it will be treated as a name change or

SII. The lead awarding IC ordinarily will be the IC with which the organization has the most NIH grants.

NIH reserves the right to review the material provided, seek clarification or additional information, and

make an independent determination.

A recipient’s formal request for a change in organizational status should be submitted to NIH as soon as

possible so that NIH can determine whether the organization will continue to meet the grant program’s

eligibility requirements and take the necessary action to reflect the change in advance of the change in

status.

For a SII, a letter signed by the AORs of the current recipient (transferor) and the successor-in-interest

(transferee) must be sent to the lead NIH awarding IC, following consultation with the GMO of that

awarding IC. The letter must include the following:

Stipulate that the transfer will be properly affected in accordance with applicable law.

Indicate that the transferor relinquishes all rights and interests in all of the affected grants.

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Request that the awarding IC(s) modify its (their) records to reflect the transferee as the recipient

of record.

State the effective date of the transfer.

Provide the transferee’s EIN. If EIN is new, include completed Form W-9.

Include verification of the transferee’s compliance with applicable requirements (e.g., research

misconduct assurance of compliance).

Include a list of all affected NIH grants (active and pending) with the following information for

each:

o

Complete grant number (e.g., 5 R01 GM 12345-04).

o

Name(s) of PD/PI(s).

o

Current budget period and project period.

o

The total direct costs (as originally recommended) plus applicable indirect costs for each

remaining budget period. If the SII will occur during a budget period rather than on the

anniversary date, the transferor also must provide estimated levels of current-year direct

and indirect costs remaining as of the SII effective date. The estimate may be reported

on the PHS 3734 (Official Statement Relinquishing Interests and Rights in a Public

Health Service Research Grant), which may be submitted via e-mail or electronically

through the eRA Commons, or may be itemized by grant number as an attachment to the

letter. When an SII occurs during a budget period, the deobligation of funds will be

based on the estimated grant expenditures through the relinquishment date, as reported

on the relinquishing statement or the available balance in PMS, whichever is less.

Include a complete face page (PHS 398) for each affected grant showing the transferee as the

applicant organization. Each face page must be signed by an AOR at the transferee organization.

Include a copy of the current negotiated indirect cost rate agreement for the transferee.

Recipients may choose to submit an electronic application for a successor-in-interest request to satisfy

the requirement for the face page(s), confirmation of the transferee’s EIN, verification of the transferee’s

compliance with applicable requirements (e.g., research misconduct assurance of compliance), and Relin-

quishing Statement. The electronic application is submitted via Grants.gov using the

Parent Announce-

ment

In order to be recognized as the SII, the “new” (transferee) organization must meet each grant program’s

eligibility requirements; except for grants awarded under the SBIR/STTR programs. See

Small Business

Innovation Research and Small Business Technology Transfer Programs—Eligibility

in IIB for addi-

tional guidance. Upon review and acceptance of this information, NIH will revise the NoA(s) to show

the transferee as the recipient of record.

For name changes, the recipient’s written notification to the lead NIH awarding IC must include the

effective date of the change. Revised face pages are not required for name changes because name

changes are reported and processed with the next award action (e.g., non-competing continuation award).

8.1.2.9 Deviation from Award Terms and Conditions, including Restrictions in the

NoA

NIH prior approval is required for any deviation from terms or conditions stated or referenced in the

NoA, including those in the NIHGPS. This includes undertaking any activities disapproved or restricted

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as a condition of the award.

8.1.2.10 Foreign Component Added to a Grant to a Domestic or Foreign Organ-

ization

Adding a non-monetary foreign component under a grant to a domestic or foreign organization requires

NIH prior approval. NIH will not accept nor approve requests to add a foreign subaward to an ongoing

project.

8.1.2.11 Provide Subawards Based on Fixed Amounts

With NIH prior approval, a pass-through entity may provide subawards based on fixed amounts (as

defined in 2 CFR Part 200.201), up to $500,000, to which the following conditions apply:

1. Fixed amount subawards are negotiated using the cost principles (or other pricing information)

as a guide. The pass-through entity may use fixed amount subawards if the project scope has spe-

cific measurable goals and objectives and if accurate cost, historical, or unit pricing data is avail-

able to establish a fixed budget based on a reasonable estimate of actual costs. Budgets for fixed

amount awards are negotiated with the subrecipient and the total amount of Federal funding is

determined in accordance with the subrecipient’s proposal, available pricing data, and using the

cost principles as a model for establishing the fixed amount. Accountability for fixed amount

awards is based on performance and results, which can be communicated to the recipient or

pass-through entity using the reporting tool identified in the written subaward agreement, and to

NIH by the direct recipient or pass-through entity in the annual RPPR. There is no expected

routine monitoring of the actual costs incurred by the recipient or subrecipient under the sub-

award. Therefore, subrecipients are not required to submit Federal Financial Reports. This does

not absolve the subrecipient from the record retention requirements contained in 2 CFR Part

200.334 through 200.338; nor does it absolve the subrecipient of the responsibilities of making

records available for review during an audit. Payments must be based on meeting specific

requirements of the Federal award. Some of the ways in which the fixed amount subaward may

be paid include, but are not limited to:

a. In several partial payments, the amount of each payment as well as the “milestone” or

event triggering the payment should be agreed to in advance, and included in the sub-

award;

b. On a unit price basis, the defined unit(s), or price(s) should be agreed to in advance and

set included in the subaward; or

c. In one payment at the completion of the subaward.

2. A fixed amount subaward must not be used in programs that require cost sharing, whether man-

datory or administrative.

3. A fixed amount award may generate and use program income in accordance with the terms and

conditions of the Federal award; however, the requirements for the use of program income

(deduction, addition or cost-sharing) do not apply. (see Administrative Requirements—Man-

agement Systems and Procedures—Program Income).

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4. At the end of a fixed amount award, the subrecipient must certify in writing to the pass-through

entity that the project was completed as agreed to in the Federal award, or identify those activ-

ities that were not completed, and that all expenditures were incurred in accordance with 2 CFR

Part 200.403. When the required activities were not carried out, including fixed amount awards

paid on a unit price basis under 2 CFR Part 200.201(b)(1)(ii), the amount of the Federal award

must be reduced by the amount that reflects the activities that were not completed in accordance

with the Federal award. When the required activities were completed in accordance with the

terms and conditions of the Federal award, the subrecipient is entitled to any unexpended funds.

5. Periodic reports may be established for each fixed amount subaward.

6. Prior approval requirements that apply to fixed amount awards are found at 2 CFR Part 200.308

(f) (paragraphs 1 through 3, 6 through 8, and 10) and § 200.333.

When considering the use of a fix amount subaward, note the distinction between a fixed-amount sub-

award and a fixed-rate agreement.

In a fixed amount subaward, the total value of the award is negotiated upfront. This requires the pass-

through entity to know both the unit price and the total number of units that will be provided. In a fixed-

rate agreement, while there is a negotiated cost per unit, e.g. per patient cost in a clinical trial (or par-

ticipant in a non-Clinical Trial Human Subjects Study), the total amount of the award may be unknown

when the agreement is created. Since this type of agreement is based on a “fixed rate” as opposed to a

“fixed amount” as defined by 2 CFR Part 200.201, prior approval is not required to enter into this type

of agreement provided there are no other factors that would require NIH prior approval consistent with

Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Con-

sortium Agreement

8.1.2.12 Need for Additional NIH Funding without Extension of Budget and Project

Period

A request for additional funding for a current budget period to meet increased costs that are within the

scope of the approved application, but that were unforeseen when the new or renewal application or

grant progress report for non-competing continuation support was submitted, is a non-competing sup-

plemental application. Such requests must be submitted electronically, for both single and multi-project

awards, and are not required to compete with other applications for funding. Other recipient-initiated

requests for supplemental funding during a current budget period are considered to change the scope of

the approved project and may be required to compete for funding with other applications. When cal-

culating the award for additional funds, NIH will 1) prorate funding if the requested budget is adjusted at

the time of award, and 2) use the institution’s current indirect cost rate; i.e., the rate in effect when the

new funding is provided.

8.1.2.13 Need for Additional NIH Funding with Extension of the Final Budget

Period of a Project Period

A request for a non-competing extension of the final budget period of a project period with a minimal

amount of additional funds should be submitted to the GMO, in writing, at least 30 days before the pro-

ject period is scheduled to expire. Such requests usually are for a period of up to 12 months and must be

either for work that remains to be completed on the project or to permit orderly phase-out of project

activities for which there will be no further NIH support. Resources must be available to continue to sup-

port the project. The request must specify the proposed revised ending date and must include justification

for both the extension and the additional funds requested. Special justification will be required for an

extension that would exceed 12 months. NIH will not approve such requests if the primary purpose of

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the proposed extension is to permit the use of unobligated balances of funds. All terms and conditions of

the award apply during the extended period.

All Federal agencies are required by 31 U.S.C. §1552(a) to close fixed year appropriation accounts and

cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability,

unless otherwise authorized by Congress. For NIH to meet its obligation to close these accounts and can-

cel any remaining balances by September 30, recipients must report disbursements on the FFR no later

than August 31

of the fifth fiscal year after the year of availability. At the end of five years, the funds

are cancelled and returned to the Treasury. This provision may limit NIH’s ability to further extend the

final budget period with funding.

8.1.2.14 Pre-Award Costs

See

Cost Considerations—Selected Items of Cost—Pre-Award (Pre-Agreement) Costs

8.1.2.15 Rebudgeting of Funds from Trainee Costs

The rebudgeting of amounts previously awarded for trainee costs (stipends, tuition, and fees) to other cat-

egories of expense requires NIH prior approval. This excludes trainee travel, which NIH does not con-

sider to be a trainee cost, and training-related expenses (see

Ruth L. Kirschstein National Research

Service Awards—Institutional Research Training Grants—Rebudgeting of Funds

in IIB).

8.1.2.16 Rebudgeting of Funds Between Construction and Non-construction Work

Under awards that provide for both construction and non-construction work, NIH prior approval is

required to transfer funds between the two types of work.

8.1.2.17 Retention of Research Grant Funds When a Career Development Award is

Issued

Funds budgeted under an NIH grant for an individual’s salary and fringe benefits, but available as a res-

ult of receiving a K award for that individual, may not be used for any other purpose without NIH prior

approval.

8.1.3 Requests for Prior Approval

Most requests for NIH awarding IC prior approval must be made in writing (including submission by e-

mail) to the GMO no later than 30 days before the proposed change, and signed by the AOR. If the

request is e-mailed, it must provide evidence of the AOR’s approval; a cc to the AOR is not acceptable.

SBIR and STTR recipients are required to submit all prior approval requests through the eRA Commons

Prior Approval Module. A request by a subrecipient for prior approval will be addressed in writing to the

recipient. The recipient will promptly review such request and shall approve or disapprove the request in

writing. A recipient will not approve any budget or project revision which is inconsistent with the pur-

pose or terms and conditions of the Federal-award to the recipient. If the revision, requested by the sub-

recipient would result in a change to the recipient's approved project which requires Federal prior

approval, the recipient will obtain the awarding IC’s approval before approving the subrecipient's

request. Failure to obtain required prior approval from the appropriate awarding IC may result in the dis-

allowance of costs, termination of the award, or other enforcement action within NIH’s authority. While

the PD/PI signature is no longer required as part of the submission to NIH, the recipient must secure and

retain such a signature for each prior approval request and make it available to NIH or other authorized

DHHS or Federal officials upon request. When multiple PD/PIs are recognized for a particular grant, this

requirement applies to all PD/PIs. (See

Policies Affecting Applications-Program Director/Principal

Investigator, Individual Fellowship and Sponsor Assurance

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E-mail requests must be clearly identified as prior approval requests, must reflect the complete grant

number in the subject line, and should be sent by the AOR to the GMO that signed the NoA. Contact

information is provided on each NoA and is also available in the eRA Commons. E-mail addresses for

NIH staff can be also obtained from the

NIH Enterprise Directory

. E-mail requests must include the

name of the recipient, the name of the initiating PD/PI, the PD/PI’s telephone number, fax number, and

e-mail address, and comparable identifying information for the AOR.

The GMO will review the request and provide a response to the AOR indicating the final disposition of

the request, with copies to the PD/PI and to the cognizant NIH PO. Only responses provided by the

GMO are considered valid. Recipients that proceed on the basis of actions by unauthorized officials do

so at their own risk, and NIH is not bound by such responses.

Whenever recipients contemplate rebudgeting or other post-award changes and are uncertain about the

need for prior approval, they are strongly encouraged to consult, in advance, with the GMO.

Under a consortium agreement or contract, the prior approval authority usually is the pass-through entity.

However, the pass-through entity may not approve any action or cost that is inconsistent with the pur-

pose or terms and conditions of the NIH grant. If an action by a consortium participant will result in a

change in the overall grant project or budget requiring NIH approval, the pass-through entity must obtain

that approval from NIH before giving its approval to the consortium participant.

SBIR and STTR recipients are required to seek prior approval when adding a new domestic subaward to

a project post-award, where the arrangement was not originally a part of the peer reviewed and approved

application. A foreign risk assessment is required for the entity selected for the subaward when the prior

approval request is submitted through submission of an updated SBIR STTR Foreign Disclosure Form

via the “SBIR STTR Foreign Disclosure Request for Additional Materials” (RAM) feature in eRA Com-

mons. The recipient must receive official written approval notification from the NIH Grants Management

Official prior to signing a subaward agreement.

8.2 AVAILABILITY OF RESEARCH RESULTS:

PUBLICATIONS, INTELLECTUAL PROPERTY RIGHTS, AND

SHARING RESEARCH RESOURCES

It is NIH policy that the results and accomplishments of the activities that it funds should be made avail-

able to the public. PD/PIs and recipient organizations are expected to make the results and accom-

plishments of their activities available to the research community and to the public at large. (See also

Availability and Confidentiality of Information—Confidentiality of Information—Access to Research

Data

in Part I for policies related to providing access to certain research data at public request.) If the out-

comes of the research result in inventions, the provisions of the Bayh-Dole Act of 1980, as implemented

in 37 CFR Part 401, apply.

As long as recipients abide by the provisions of the Bayh-Dole Act, as amended by the Technology

Transfer Commercialization Act of 2000 (P.L. 106-404), and 37 CFR Part 401, they have the right to

retain title to any invention conceived or first actually reduced to practice using NIH grant funds. The

principal objectives of these laws and the implementing regulation are to promote commercialization of

federally funded inventions, while ensuring that inventions are used in a manner that promotes free com-

petition and enterprise without unduly encumbering future research and discovery.

The regulation requires the recipient to use patent and licensing processes to transfer grant-supported

technology to industry for development. Alternatively, unpatented research products or resources

“research tools” may be made available through licensing to vendors or other investigators. Sharing of

copyrightable outcomes of research may be in the form of journal articles or other publications.

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The importance of each of these outcomes of funded research is reflected in the specific policies per-

taining to rights in data, sharing of research data and unique research resources, and inventions and pat-

ents described in the following subsections.

8.2.1 Rights in Data (Publication and Copyrighting)

In general, recipients own the rights in data resulting from a grant-supported project. Specific terms and

conditions of the award may indicate alternative rights, e.g., under a cooperative agreement or based on

specific programmatic considerations as stated in the applicable RFA. Except as otherwise provided in

the terms and conditions of the award, any publications, data, or other copyrightable works developed

under an NIH grant may be copyrighted without NIH approval. For this purpose, “data” means recorded

information, regardless of the form or media on which it may be recorded, and includes writings, films,

sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural

manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or com-

puter programs (software), statistical records, and other technical research data.

Rights in data also extend to students, fellows, or trainees under awards whose primary purpose is edu-

cational, with the authors free to copyright works without NIH approval. In all cases, NIH must be given

a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or

otherwise use the material and to authorize others to do so for Federal purposes. Data developed by a

consortium participant also is subject to this policy.

As a means of sharing knowledge, NIH encourages recipients to arrange for publication of NIH-sup-

ported original research in primary scientific journals. Recipients also should assert copyright in sci-

entific and technical articles based on data produced under the grant where necessary to effect journal

publication or inclusion in proceedings associated with professional activities.

Journal or other copyright practices are acceptable unless the copyright policy prevents the recipient

from making copies for its own use (as provided in 2 CFR Part 200.315) or prevents the recipient from

being able to comply with NIH policies, including the 2024 NIH Public Access Policy. The disposition

of royalties and other income earned from a copyrighted work is addressed in

Administrative Require-

ments—Management Systems and Procedures—Program Income

All recipients must acknowledge Federal funding when issuing statements, press releases, requests for

proposals, bid invitations, and other documents describing projects or programs funded in whole or in

part with Federal money. In accordance with the

Stevens Amendment

,each publication, press release, or

other document about research supported by an NIH grant must include both:

An acknowledgment of NIH grant support clearly stating the percentage and dollar amount of

the total costs of the program or project funded with federal money, and the percentage and dol-

lar amount of the total costs of the project or program funded by non-governmental sources. For

example:

“Research reported in this [publication, release] was supported by [name of the Institute, Center,

or other funding component] of the National Institutes of Health under grant number [specific

NIH grant number in this format: R01GM012345]." A total of $[amount], or [percentage] per-

cent of [research/project/program] [is/was] financed with federal funds. A total of $[amount], or

[percentage] percent of [research/project/program] [is/was] financed with non-governmental

funds (if applicable)", and

A disclaimer that says:

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“The content is solely the responsibility of the authors and does not necessarily represent the offi-

cial views of the National Institutes of Health.”

If the recipient plans to issue a press release about research supported by an NIH grant, it should notify

the NIH funding component in advance to allow for coordination. See

Media Inquiries

for media contact

information.

Publications resulting from work performed under an NIH grant-supported project must be included as

part of the annual or final progress report submitted to the NIH awarding IC (see

Administrative Require-

ments—Monitoring—Reporting—Non-Competing Continuation Progress Reports

and

Administrative

Requirements—Closeout—Final Reports—Final Progress Report

). When publications are available elec-

tronically, the URL or the PMCID number must be provided. If not available electronically, one copy of

the publication may be provided along with the progress report. See also

NIH Public Access Policy

below for additional requirements for publications resulting from NIH funded research.

8.2.2 NIH Public Access Policy

The 2024 NIH Public Access Policy implements Division F, Section 217 of

PL 111-8 (Omnibus Appro-

priations Act, 2009)

. The policy ensures that the public has access to the published results of NIH funded

research at the

NIH NLM PMC

, a free digital archive of full-text biomedical and life sciences journal lit-

erature. Under the Policy NIH-funded investigators are required to submit (or have submitted for them)

to PMC an electronic version of the final, peer-reviewed manuscript upon acceptance for publication, to

be made publicly available without embargo upon the Official Date of Publication, as defined in the

Policy. The Author Accepted Manuscript is defined as the author's final version that has been accepted

for journal publication, and includes all revisions resulting from the peer review process, including all

associated tables, graphics and supplemental material. This policy applies to any Author Accepted

Manuscript accepted for publication in a journal, on or after July 1, 2025, that is the result of funding by

NIH in whole or in part, through grants and cooperative agreements (including training grants), con-

tracts, Other Transactions, NIH intramural research, and the official work of an NIH employee.

Institutions and investigators are responsible for ensuring compliance with this Policy. Applicants citing

articles in NIH applications, proposals, and progress reports that fall under the Policy, were authored or

co-authored by the applicant and result from NIH support must include the PMCID or NIHMS ID.

More details may be found at:

https://grants.nih.gov/faqs#/public-access-policy

and

https://-

grants.nih.gov/policy-and-compliance/policy-topics/public-access

8.2.3 Sharing Research Resources

Investigators conducting biomedical research frequently develop unique research resources. NIH con-

siders the sharing of such unique research resources (also called research tools) an important means to

enhance the value of NIH-sponsored research. Restricting the availability of unique resources can

impede the advancement of further research. Therefore, when these resources are developed with NIH

funds and the associated research findings have been accepted for publication, or after they have been

provided to NIH, it is important that they be made readily available for research purposes to qualified

individuals within the scientific community. At the same time NIH recognizes the rights of recipients

and contractors to elect and retain title to subject inventions developed with federal funding pursuant to

the Bayh-Dole Act. See the

Office of Extramural Research, Division of Extramural Inventions & Tech-

nology Resources (DEITR), Intellectual Property Policy page

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Program staff are responsible for overseeing resource sharing policies and for assessing the appro-

priateness and adequacy of any proposed resource sharing plans.

NIH has published a set of principles and guidelines known as the NIH Research Tools Policy for fund-

ing recipients and the biomedical community. These serve as a reference for identifying an appropriate

strategy for disseminating and sharing research tools. The NIH Research Tools Policy webpage explains

these principles and guidelines in more detail and provides suggestions on implementation.

For recipients working with biological materials, NIH has a policy for allowing NIH funding recipients

to retain and license biological materials for which patent protection might not be pursued. To learn

more, read "NIH Procedures for Handling Non-election of Title to Patentable Biological Materials".

The terms of those agreements also must reflect the objectives of the Bayh-Dole Act and the Technology

Transfer Commercialization Act of 2000 to ensure that inventions made are used in a manner to promote

free competition and enterprise without unduly encumbering future research and discovery.

In addition to sharing research resources with the research community, upon request of the NIH award-

ing IC, the recipient also must provide a copy of documents or a sample of any material developed under

an NIH grant award. The recipient may charge a nominal fee to cover shipping costs for providing this

material. Income earned from these charges must be treated as program income (see

Administrative

Requirements—Management Systems and Procedures—Program Income

To facilitate the availability of unique or novel materials and resources developed with NIH funds, invest-

igators may distribute the materials through their own laboratory or organization or submit them, if

appropriate, to entities such as the American Type Culture Collection or other repositories and should

ensure that those entities distribute them in a way that is consistent with the above referenced

NIH

Research Tools Policy webpage

. Investigators are expected to submit unique biological information,

such as DNA sequences or crystallographic coordinates, to the appropriate data banks so that they can be

made available to the broad scientific community. When distributing unique resources, investigators are

to include pertinent information on the nature, quality, or characterization of the materials.

8.2.3.1 Operational and Security Standards for Controlled-Access Repositories

The Required Security and Operational Standards for NIH Controlled-Access Data Repositories apply to

grants and cooperative agreements, for the purposes of the NIH GPS, and other funding mechanisms not

covered by the NIH GPS (e.g. intramural contracts and Other Transactions), regardless of the activity

code, that support NIH controlled-access data repositories and access management systems (hereafter

NIH CADRs) that meet all the following criteria:

Are supported by an NIH funding mechanism (e.g. grants and cooperative agreements);

Provide long-term storage for, or provide access to, data for research purposes (hereafter,

"data");

Control access to data by prospective review of data access requests or partner with access sys-

tems that control access via prospective review of requests; and

Use federal employees to conduct reviews and authorize access, or partner with access systems

that use federal employees for those purposes.

NIH will determine which repositories are subject to these requirements and will maintain a public list of

NIH CADRs, which can be found here. NIH will periodically update this list as needed.

Repositories and access management systems that control access to data, but do not meet the criteria of

an NIH CADR as described above, will not be subject to these requirements. Repositories that only facil-

itate direct sharing between investigator teams, cloud workspaces that only temporarily store data, data

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coordinating centers, and similar activities that do not manage data sharing beyond specific programs or

initiatives, will not be considered an NIH CADR.

To meet the requirements, NIH CADRs must follow the NIH Controlled-Access Data Repository Guide-

book to Adhere to “Required Security and Operational Standards for NIH Controlled-Access Data Repos-

itories” (NIH CADR Guidebook), including all relevant effective dates listed in the Guidebook.

8.2.3.2 Policy for Data Management and Sharing (DMS Policy)

The NIH Policy for Data Management and Sharing (DMS Policy) applies to all research, funded or con-

ducted in whole or in part by NIH, that results in the generation of scientific data. This includes research

funded or conducted by extramural grants or other funding agreements regardless of NIH funding level

or funding mechanism. The DMS Policy does not apply to research and other activities that do not gen-

erate scientific data, including training, infrastructure development, and non-research activities. A list of

NIH activity codes subject to the DMS Policy is available on the NIH website, and the applicability of

the DMS Policy will be specified in each NIH NOFO.

Applicants must submit a DMS Plan in each competitive grant application, and outline DMS costs in the

appropriate cost categories in the budget (see NIH Application Guide for detailed instructions). DMS

Plans should explain how scientific data generated by research projects will be managed and which of

these scientific data and accompanying metadata will be shared. If DMS Plan revisions are necessary

(e.g., new scientific direction, a different data repository, or a timeline revision), DMS Plans should be

updated by researchers and reviewed by the NIH ICO during regular reporting intervals or sooner. DMS

Plans from NIH-funded or conducted research may be made publicly available and should not include

proprietary or private information. Costs associated with data management and data sharing are subject

to Federal cost principles for the reimbursement of actual costs that are allowable, allocable, reasonable,

and consistently treated as described in NIHGPS Section 7.2 The Cost Principles.

Under the NIH DMS Policy, NIH expects researchers will maximize the appropriate sharing of scientific

data, acknowledging certain factors (i.e., legal, ethical, or technical) that may limit data sharing to some

extent. Per the supplemental information “Elements of an NIH Data Management Sharing Plan,” a com-

pelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH.

Shared scientific data must be made accessible as soon as possible, and no later than the time of an asso-

ciated publication, or the end of performance period, whichever comes first.

Consistent with 2 CFR 200.403 and the NIHGPS Section 7.4

, budget requests must not include infra-

structure costs that are included in institutional overhead (e.g., indirect costs) or costs associated with the

routine conduct of research. Costs associated with collecting or otherwise gaining access to research data

(e.g., data access fees) are considered costs of doing research and should not be included in scientific

data management and sharing budgets. Costs may not be double charged or inconsistently charged as

both direct and indirect costs.

Applicants may request data management and sharing costs that are allowable and reasonable when asso-

ciated with (1) Curating data and developing supporting documentation, including formatting data accord-

ing to accepted community standards; de-identifying data; preparing metadata to foster discoverability,

interpretation, and reuse; and formatting data for transmission to and storage at a selected repository for

long-term preservation and access. (2) Local data management considerations, such as unique and spe-

cialized information infrastructure necessary to provide local management and preservation (e.g., before

deposit into an established repository). (3) Preserving and sharing data through established repositories,

such as data deposit fees necessary for making data available and accessible. For example, if a DMS

Plan proposes preserving and sharing scientific data for 10 years in an established repository with a

deposition fee, the cost for the entire 10-year period must be paid prior to the end of the period of

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performance. If the DMS Plan proposes deposition to multiple repositories, costs associated with each

proposed repository may be included.

Generally, DMS Plans are not considered during peer review, unless the NOFO identifies data sharing as

integral to the project. DMS Plans will undergo programmatic assessment by NIH staff following peer

review. ICs may request additional information at Just-in-Time in order to meet expectations for data

management and data sharing in support of programmatic priorities or to expand the utility of the sci-

entific data generated from the research.

Once approved, the DMS Plan will become a Term and Condition of the NOA, and failure to comply

may result in an enforcement action, including additional special terms and conditions or termination of

the award, and may affect future funding decisions. In accordance with NIHGPS Section 8.1.1 NIH

Standard Terms of Award, recipients must obtain prior approval to make changes to the previously

approved DMS Plan (e.g. change in scientific direction, change in repository, or change in the timeline).

All prior approval requests must be submitted in the eRA Prior Approval Module (see NIH Application

Guide).

All allowable Data Management and Sharing costs in budget requests must be incurred (e.g., curation

fees, data repository fees) during the performance period, even for scientific data and metadata preserved

and shared beyond the award period.

Recipients are required to provide updates on the activities described in the DMS plan as part of the

annual RPPR, and the IC will use this information to assess compliance with the previously approved

DMS Plan.

For additional information and resources,

see the grants policy website on the Data Management and

Sharing Policy.

8.2.3.3 Genomic Data Sharing (GDS) Policy

The NIH Genomic Data Sharing (GDS) Policy applies to all NIH-funded research that generates large-

scale human or non-human genomic data, as well as the use of these data for subsequent research. For

the purposes of the GDS Policy, the genome is the entire set of genetic instructions found in a cell and

large-scale genomic data include genome-wide association studies (GWAS), single nucleotide poly-

morphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene

expression data. The grants policy website on Genomic Data Sharing Policy Overview provides

examples of genomic research projects that are subject to the Policy and the timeline for submission and

sharing of data from such projects.

All applications, regardless of the amount requested, proposing research that will generate large-scale

genomic data, are expected to describe plans for sharing genomic data in the Data Management and Shar-

ing (DMS) Plan submitted with the application as described in 8.2.3.2 Policy for Data Management and

Sharing. For guidance on developing a DMS plan that meets the requirements of the DMS and GDS

policies, refer to the grants policy website on

Writing a Data Management & Sharing Plan

. Once

approved, the DMS Plan will become a Term and Condition of the NOA and compliance and enforce-

ment will be handled as described in 8.2.3.2 Policy for Data Management and Sharing.

PD / PIs should register all studies with human genomic data that fall within the scope of the GDS

Policy in the NIH database of Genotypes and Phenotypes (dbGaP) by the time that data cleaning and

quality control measures begin. After registration in dbGaP, PD / PIs, through the recipient institution,

should submit large-scale human genomic data as well as relevant associated data (e.g., phenotype and

exposure data) to an NIH-designated data repository in a timely manner, consistent with their NIH-

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approved DMS Plan. PD / PIs should also submit any information necessary to interpret the submitted

genomic data, such as study protocols, data instruments, and survey tools.

For research that falls within the scope of the GDS Policy, institutions submitting data, through their

Institutional Review Boards (IRBs), privacy boards, or equivalent bodies, are to review the informed con-

sent materials to determine whether it is appropriate for data to be shared for secondary research use. For

studies proposing to use genomic data from cell lines or clinical specimens that were created or collected

after the effective date of the GDS Policy, NIH expects that informed consent for future research use and

sharing will have been obtained even if the cell lines or clinical specimens are de-identified. The respons-

ible Institutional Signing Official of the submitting institution must provide an Institutional Certification

to the funding IC prior to award. For guidance on completing an Institutional Certification under the

GDS Policy, see the NIH Scientific Data Sharing website and section 2.3.7.10.

If there are compelling scientific reasons that necessitate the use of genomic data from cell lines or clin-

ical specimens that were created or collected after the effective date of this Policy and that lack consent

for research use and data sharing, investigators should provide a justification in the funding request for

their use. The funding IC will review the justification and decide whether to make an exception to the

consent expectation. In some instances, the funding IC may need to determine whether to grant an excep-

tion to the data submission expectation under the GDS Policy. Studies provided exceptions to data sub-

mission under the GDS Policy will still be expected to be registered in the NIH Database of Genotypes

and Phenotypes (dbGaP) for transparency.

Investigators approved to access data and their institution are responsible for maintaining the con-

fidentiality, integrity, and security of data accessed from a NIH-designated repository in accordance with

the NIH Security Best Practices for Users of Controlled-Access Data included in Data Use Certifications

(DUCs), or similar data use agreements, stipulating terms of access and the requirements of the Genomic

Data User Code of Conduct. Violating these terms and requirements is considered a data management

incident.

If an investigator plans to use a Cloud Service Provider (CSP) and/or a third-party IT system to store and

analyze controlled-access data, NIH expects the CSP and/or third party IT system to meet the same stand-

ards as outlined in the

NIH Security Best Practices for Users of Controlled-Access Data

The institution, not the CSP and/or third-party IT system, will be held responsible for any failure in the

oversight of controlled-access data.

NIH requires Lead Developers, and those they directly supervise, who seek access to controlled-access

human genomic data under the GDS Policy for developer work (e.g., testing platforms, pipelines, ana-

lysis tools, and user interfaces that store, manage, and interact with human genomic data; providing infra-

structure development and repository maintenance), to submit a request containing a Developer Use

Statement (DUS) to the NIH Developer Data Access Committee (DeveloperAccessDAC@od.nih.gov) no

later than at Just-in-Time (JIT) for grants and cooperative agreements. If a project has multiple Lead

Developers, (e.g., for multicomponent awards), each Lead Developer must submit a DUS. All Lead

Developers must be associated with an institution that is receiving or applying for NIH or other federal

support for the developer work with a funding mechanism that has incorporated the developer terms of

access. Once established, Lead Developers must follow the Developer Terms of Access.

Additional information about the GDS Policy can be found on NIH’s "

Genomic Data Sharing Policy

webpage.

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8.2.3.4 Sharing Model Organisms

All applications, regardless of amount requested, where the development of model organisms is anti-

cipated are expected to include a description of a specific plan for sharing and distributing unique model

organism research resources generated using NIH funding so that other researchers can benefit from

these resources, or state appropriate reasons why such sharing is restricted or not possible.

Model organisms include but are not restricted to mammalian models, such as the mouse and rat; and

non-mammalian models, such as budding yeast, social amoebae, round worm, Arabidopsis, fruit fly,

zebrafish, and frog. Research resources to be shared include, but are not limited to, genetically modified

organisms, mutant organisms, sperm, embryos, vectors, non-human embryonic stem cells, established

cell lines, protocols for genetic and phenotypic screens, mutagenesis protocols, genetic and phenotypic

data for all mutant strains.

For additional information on this policy, see the

NIH Scientific Data Sharing Model Organism Sharing

Policy website

8.2.4 Inventions and Patents

The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212; Executive Order 12591; 37 C.F.R.

401 et al; updated April 14, 2018.) provides NIH funding recipients incentives to promote the utilization

of inventions conceived or reduced to practice (Subject Invention) in the performance of federally sup-

ported research and development. Unless waived by NIH or the funding agreement is for educational pur-

poses, e.g. fellowships, training grants or certain types of career development awards, the Bayh-Dole Act

applies to all NIH research and development funding granted to for-profit organizations regardless of

size and all non-profit entities. (See 2 CFR Part 200 and 37 CFR Part 401.1(b)).

To retain rights and title to Subject Inventions, the NIH funding recipient must comply with the Bayh-

Dole statute and implementing regulations that ensure the Invention will be brought to practical applic-

ation while protecting certain rights of the Federal government. The compliance actions required by the

Bayh-Dole Act are summarized below at Exhibit 8.

Failure of the recipient to comply with any of the Bayh-Dole regulations cited at 37 CFR Part 401 or

other requirements may result in the loss of patent rights or the suspension, termination or withholding of

NIH funding support. See also

Section 8.5.2

for additional remedies for noncompliance of the Bayh-Dole

Act.

All Bayh-Dole compliance actions are required to be submitted to NIH by using the iEdison data base

(See 37 CFR Part 401.16). All issues or questions regarding extramural technology transfer policy and

reporting of inventions and their utilization should be referred to OPERA/OER at

edison@nih.gov

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Exhibit 8. Extramural Invention Reporting Compliance Responsibilities

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8 Administrative Requirements

Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Employee

Agreement to

Disclose All

Subject

Inventions

Recipient employees working

under a federal funding award

(other than clerical and

nontechnical employees) must

sign an agreement with the

recipient organization. This

agreement requires the Recipient

employee to: (1) disclose promptly

in writing to personnel identified as

responsible for the administration

of patent matters each Subject

Invention made under

NIH funding; (2) assign to the

Recipient the entire right, title and

interest in and to each Subject

Invention made under the funding

agreement; (3) execute all papers

necessary to file patent

applications on Subject

Inventions; and, (4) establish the

government's right in the Subject

Inventions.

Before a Recipient or a

consortium employee

participates in NIH-funded

research and development.

401.14(f)(2)

Consortium

Participant Rights

in Inventions

All consortium participants,

regardless of tier, for

experimental, developmental or

research work retain all rights and

obligations provided to the

Consortium Participant in the

NIH funding agreement.

At the time of issuance of a

consortium agreement,

recipient must include in all

consortium agreements,

regardless of tier, for

experimental,

development, or research

work 37 CFR Part 401

seq

suitably modified to

identify the parties and the

rights and obligations

awarded to the contractor.

401.14(g)(1)

401.14(g)(2)

401.14(g)(3)

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8 Administrative Requirements

Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Invention

Disclosure

The term "Subject

Invention"

means any invention

of a recipient/consortium

participant conceived or first

actually reduced to practice in the

performance of work under a

funding agreement.

The recipient must submit to NIH a

disclosure for all Subject

Inventions. There is no single

format for disclosing the invention

to NIH. However, the disclosure of

the Subject Invention must

include: a detailed technical

description of the invention

conveying a clear understanding

of the nature, purpose, operation,

and the physical, chemical,

biological, or electrical

characteristics of the Subject

Invention; the names of all

inventors; title of the Subject

Invention; all federal funding

agreement numbers; date of

disclosure of the Subject Invention

from the researcher or inventor to

the Recipient; and whether a

manuscript describing the

invention was submitted,

accepted and/or published.

Within 2 months of the

inventor’s disclosure to the

recipient organization.

401.14(a)(2)

401.14(c)(1)

Government

Assignment to

Recipient of

Rights in

Invention of

Government

Employee

Disclosure to NIH that a federal

employee is a co-inventor on a

Subject Invention.

Within 2 months of receipt

of the initial invention

report.

401.14(f)(2)

401.10

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8 Administrative Requirements

Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Acceptance of

Manuscript

following

Submission of

Initial Invention

Disclosure

The recipient needs to promptly

notify NIH of the acceptance of

any manuscript describing the

Subject Invention.

Promptly following the

acceptance of a

manuscript describing a

Subject Invention.

401.14(c)(1)

Election of Title to

a Subject

Invention

The recipient must notify NIH of its

decision to retain title to a Subject

Invention and any associated

patent rights.

Election of title is made before the

filing of an

Initial Patent

Application

Statutory Period

is defined as

the one-year period before the

effective filing date of a claimed

invention during which exceptions

to prior art exist per 35 U.S.C. 102

(b) as amended by the Leah-

Smith American Inventions Act,

Public Law 112-29.

Within 2 years of the

disclosure of the invention

to NIH.

In any case where a patent,

a printed publication, public

use, sale or other

availability to the public has

initiated the one-year

Statutory Period

wherein

valid patent protection can

still be obtained in the

United States, the period

for election of title is

shortened by NIH to a date

that is no more than 60

days prior to the end of the

statutory period.

401.14(b)

401.14(c)(2)

401.2(n)

Confirmatory

License

For each Subject Invention, the

recipient must provide a license to

NIH confirming the rights the

Government has throughout the

world in the Subject Invention.

When a confirmatory license is

filed on the

Initial Patent

Application

the license applies to

all subsequent patent applications

linked in the patent family.

When the

Initial Patent

Application

is filed.

401.14(f)(1)

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Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Government

Support Clause

The recipient must include, within

the specification of all United

States patent applications and any

patent issuing thereon covering a

Subject Invention, the following

statement, "This invention was

made with government support

under (grant number, including the

two-letter institute code and six-

digit serial number, e.g.,

CA012345) awarded by the

National Institutes of Health. The

government has certain rights in

the invention."

Must be included within the

specifications of any United

States patent applications

and any patent(s) issuing

thereon covering a Subject

Invention.

401.14(f)(4)

Patent

Applications and

Issued Patents

The recipient must inform NIH of

the filing date of its

Initial Patent

Application

, the

Initial Patent

Application

number and title and

all subsequently filed patent

applications.

Initial Patent Application

defined as the first provisional or

nonprovisional U.S. national

application for patent as defined in

37 CFR Part 1.9(a)(2) and (3),

respectively, the first international

application filed under the Patent

Cooperation Treaty as defined in

37 CFR Part 1.9(b) that

designates the United States, or

the first application for a Plan

Variety Protection certificate, as

applicable, a non-provisional U.S.

national application for patent as

defined in 37 CFR Part 1.9(a)(3).

Within 1 year after election

of title, or, if earlier, prior to

the end of any Statutory

Period wherein valid patent

protection can be obtained

in the United States after a

publication, on sale, or

public use, unless there is

an extension of time

granted by NIH.

401.14(c)(3)

401.14.(f)(6)

401.2(n)

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Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Notification to NIH

to Not to Continue

Prosecution

Notify NIH of any decision to: not

to continue the prosecution of a

non-provisional patent application;

not to pay a maintenance, annuity

or renewal fee; not to defend in a

reexamination or opposition

proceeding on a patent, in any

country; to request, be a part to, or

take action in a trial proceeding

before the Patent Trial and

Appeals Board of the U.S. Patent

and Trademark Office including

but not limited to post-grant

review, review of a business

method patent,

inter partes

review, and deviation proceeding;

or to request, be a part to, or take

action in a non-trial submission of

art or information at the U.S.

Patent and Trademark Office,

including but not limited to a pre-

issuance submission, a post-

issuance submission, and

supplemental examination.

Notify NIH no less than 60

days prior to taking any

action defined under

"Action Required."

401.14(f)(3)

Assignment of

Rights to Third

Party

If the recipient is a non-profit

organization, it must request

NIH prior approval to assign a

Subject Invention or U.S. patent

rights to any third party, including

the inventor(s).

Recipients that are for-profit

entities (including small

businesses) do not need to

request approval for the

assignment of a Subject Invention

or U.S. patent rights to any third

party.

Recipient must submit a

Third-Party Waiver

Request or an Inventor

Waiver Request and must

have NIH approval before

any rights of the recipient

are transferred or

assigned.

401.10

401.14(k)(1)

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Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Preference for

United States

Industry

Recipient cannot grant to any

person, unless approved by NIH in

advance, the exclusive right to use

or sell any Subject Invention in the

United States unless any such

product embodying the Subject

Invention or produced through the

use of the Subject Invention is

manufactured substantially in the

United States.

For a waiver of this

compliance requirement, a

request is required to NIH

providing specific details

and reasons why the

Subject Invention cannot

be substantially

manufactured in the United

States.

401.14(i)

Issued Patent

Recipient must notify NIH of the

date a patent is issued, patent

number, and the expiration date of

the issued patent.

When patent is issued.

401.5(f)(2)

Extension of Time

to Disclose a

Subject Invention

The recipient may request for

NIH's approval for an extension of

time to disclose a Subject

Invention.

Not less than 30 days in

advance of the 60-day

disclosure reporting

deadline.

401.14(c)(5)

Extension of Time

to Elect Title to a

Subject Invention

Recipient may request with

justification, NIH's approval of a

request for an extension of up to 2

years to elect title to a Subject

Invention.

As needed before the

expiration of the time

allowed.

401.14(c)(5)

Extension of Time

to File a Patent

Application

The recipient may request, subject

to NIH's approval, an extension

time up to 1 year to file a patent

application.

The request must include details

of why an extension is needed.

As needed before the

expiration of the time

allowed.

401.14(c)(5)

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Invention

Compliance

Reporting

Requirement

Action Required

When Compliance Action

Must Be Taken.

(All Compliance Actions are to

be Submitted to NIH through

iEdison)

37 CFR Part 401

Reference

Extension of Time

to File a Non-

provisional Patent

Application

following the

Filing of a

Provisional

Application as the

Initial Patent

Application

When a recipient requests an

extension of time for filing a non-

provisional application, after filing

a provisional application as an

Initial Patent Application

, a 1-

year extension will be granted

unless NIH notifies the recipient

within 60 days of receiving the

request.

Recipient must submit this request

citing an extension of time

pursuant to 401.14(c)(5). No

additional details for the request

are required.

As needed before the

expiration of the time

allowed.

401.14(c)(5)

Invention

Utilization Report

The recipient must submit an

annual utilization report with

information about the status of

commercialization of any Subject

Invention for which title has been

elected.

Annually, based on the

fiscal year of the recipient.

401.14(h)

Annual Invention

Statement

The recipient must indicate any

inventions made during the

previous budget period in Section

C of the Research Performance

Progress Report (RPPR).

Part of all competing

applications and non-

competing continuation

progress reports.

SF424, (R&R)

PHS 2590,

RPPR

Final Invention

Statement and

Certification

The recipient must submit to the

NIH awarding IC CGMO through

the eRA Closeout Module a

summary of all inventions made

during the entire term of each

grant award.

Within 120 days after the

project period (competitive

segment) ends.

401.14(f)(5)

8.2.5 Interim Research Products

Interim Research Products are complete, public research products that are not final. A common form is

the preprint, which is a complete and public draft of a scientific document. Interim research products are

effective ways for NIH funded scientists to speed dissemination, establish priority, obtain feedback, and

reduce bias. They may also be cited in applications for NIH funding.

NIH intends to maximize impact of interim research products that are developed with NIH funds. There-

fore, NIH expects recipients to ensure a high level of public access to NIH supported interim products.

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To facilitate text mining and other analysis of these products as data, NIH expects standardized terms of

use. NIH also expects recipients will adhere to other norms of responsible scientific communication.

Specifically, to claim an interim research product as a product of an NIH award, NIH expects that the

recipient will:

Make the product publicly available. To maximize the impact of an interim research product,

NIH strongly encourages recipients to select a Creative Commons Attribution (CC-BY) license

or dedicate their work to the public domain.

In the text of the document:

o

Acknowledge NIH funding in accordance with

NIH GPS Section 8.2.1

o

Clearly state that the work is not peer-reviewed

o

Declare any competing interests, as an author would do for any journal article

8.3 MANAGEMENT SYSTEMS AND PROCEDURES

Recipient organizations are expected to have systems, policies, and procedures in place by which they

manage funds and activities. Recipients may use their existing systems to manage NIH grant funds and

activities as long as they are consistently applied regardless of the source of funds and meet the stand-

ards and requirements set forth in 2 CFR Part 200 and the NIHGPS. NIH may review the adequacy of

those systems and may take appropriate action, as necessary, to protect the Federal government’s

interests, including, but not limited to, the use of specific terms and conditions. NIH also will oversee the

recipient’s systems as part of its routine post-award monitoring. The recipient’s systems also are subject

to audit (see

Administrative Requirements—Monitoring—Audit

NIH seeks to foster within recipient organizations an organizational culture that is committed to com-

pliance, leading to both exemplary research and exemplary supporting systems and use of resources to

underpin that research. Actions to achieve this result should include a clear delineation of the roles and

responsibilities of the organization’s staff, both programmatic and administrative; written policies and

procedures; training; performance assessment; administrative simplifications; information sharing; man-

agement controls and other internal controls.

Recipient organizations must establish and maintain effective internal controls to provide reasonable

assurance that they are in compliance with Federal statutes, regulations, and terms and conditions of

award (2 CFR 200.303(a) and (b)). They must evaluate and monitor their compliance with statutes, reg-

ulations, and terms and conditions (2 CFR 200.303(c)), and they must take prompt action when instances

of noncompliance are identified (2 CFR 200.303(d)).

Recipient organizations’ internal controls should be in compliance with guidance in “Standards for Con-

trol in the Federal Government.” (2 CFR 200.303(a)). Thus, recipient organizations are expected to estab-

lish codes of conduct which define expectations of integrity and ethical values and criteria of

competence of personnel involved in the work supported by NIH grant funds. Codes of conduct should

articulate expectations to assure compliance with terms and conditions of award, including but not lim-

ited to, providing true, complete, and accurate information on application documents (2.3.7.6); assuring

work environments are free of discriminatory harassment and are safe and conducive to high-quality

work (4); and meeting applicable public policy requirements (4.1).

8.3.1 Financial Management System Standards

Recipients are required to meet the standards and requirements for financial management systems set

forth or referenced in 2 CFR Part 200.302 as applicable. The standards and requirements for a financial

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management system are essential to the grant relationship. NIH cannot support the research unless it has

assurance that its funds will be used appropriately, adequate documentation of transactions will be main-

tained, and assets will be safeguarded.

Recipients must have in place accounting and internal control systems that provide for appropriate mon-

itoring of grant accounts to ensure that obligations and expenditures are reasonable, allocable, and allow-

able. In addition, the systems must be able to identify large unobligated balances, accelerated

expenditures, inappropriate cost transfers, and other inappropriate obligation and expenditure of funds.

Recipients must notify NIH when problems are identified.

A recipient’s failure to establish adequate control systems constitutes a material violation of the terms of

the award. Under these circumstances, NIH may include specific conditions on awards or take any of the

range of actions specified in

Administrative Requirements—Enforcement Actions

, as necessary and

appropriate.

8.3.2 Program Income

Program income is gross income—earned by a recipient, a consortium participant, or a contractor under

a grant—that was directly generated by the grant-supported activity or earned as a result of the award.

Program income includes, but is not limited to, income from fees for services performed; charges for the

use or rental of real property, equipment or supplies acquired under the grant; the sale of commodities or

items fabricated under an award; charges for research resources; registration fees for grant-supported con-

ferences, and license fees and royalties on patents and copyrights. (Note: Program income from license

fees and royalties from copyrighted material, patents, and inventions is exempt from reporting require-

ments unless otherwise specified in the terms and conditions of award.) The requirements for account-

ability for these various types of income under NIH grants are specified in this subsection.

Accountability refers to whether NIH will specify how the income is to be used and whether the income

needs to be reported to NIH and for what length of time. Unless otherwise specified in the terms and con-

ditions of the award, NIH recipients are not accountable for program income accrued after the period of

grant support.

NIH applies the additive alternative to all recipients, including for-profit entities, unless there is a con-

cern with the recipient or activity and NIH uses specific terms and conditions, or the program requires a

different program income alternative. NIH may require a different use of program income if a recipient

has deficient systems; if the PD/PI has a history of frequent, large annual unobligated balances on pre-

vious grants; or if the PD/PI has requested multiple extensions of the final budget period of the project

period. Regardless of the alternative applied, program income may be used only for allowable costs in

accordance with the applicable cost principles and the terms and conditions of the award. Each NoA will

indicate the allowable treatment of program income. Program income alternatives and their usage are

noted below in Exhibit 9.

Consortium agreements and contracts under grants are subject to the terms of the agreement or contract

with regard to the income generated by the activities, but the terms specified by the recipient must be

consistent with the requirements of the grant award. Program income must be reported by the recipient

as discussed in this subsection.

8.3.2.1 Reporting Program Income

The amount of program income earned and the amount expended must be reported on the appropriate

annual financial report, currently the FFR. Any costs associated with the generation of the gross amount

of program income that are not charged to the grant should be deducted from the gross program income

earned, and the net program income should be the amount reported. Program income must be reported in

the Program Income section of the FFR (lines 10 L – O). (See

Administrative Requirements—

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Monitoring—Reporting—Financial Reporting

.) For awards under SNAP, the amount of program income

earned must be reported in the non-competing continuation progress report.

Income resulting from royalties or licensing fees is generally exempt from reporting as program income.

When applicable, income earned from the sale of equipment must be reported on the FFR for the period

in which the proceeds are received in accordance with the reporting requirements for the program

income alternative specified. Amounts due NIH for unused supplies must be reflected as a credit to the

grant on the FFR using line 10 m.

Reporting requirements for accountable income accrued after grant support ends will be specified in the

NoA.

Exhibit 9. Use and Applicability of Program Income Alternatives

Program income

alternative

Use of program income

Applicability

Additive Alternative

Added to funds committed to the project or

program and used to further eligible

project or program objectives.

Applies to all NIH awards unless

there is a concern with the recipient

or activity or the program requires a

different alternative.

Deductive Alternative

Deducted from total allowable costs of the

project or program to determine the net

allowable costs on which the Federal

share of costs will be based.

Available for use by NIH programs

on an exception basis.

Combination

Alternative

Uses all program income up to (and

including) $25,000 as specified under the

additive alternative and any amount of

program income exceeding $25,000 under

the deductive alternative.

Available for use by NIH programs

on an exception basis.

Matching Alternative

Used to satisfy all or part of the non-

Federal share of a project or program.

Available for use by NIH programs

that require matching.

8.3.2.2 Sale of Real Property, Equipment, and Supplies

The requirements that apply to the sale of real property are addressed in the

Construction Grants

chapter.

For equipment and supplies purchased under NIH grants for basic or applied research by non-profit insti-

tutions of higher education or non-profit organizations whose principal purpose is the conduct of sci-

entific research, the recipient is exempt from any requirement to account to NIH for proceeds from the

sale of the equipment or supplies; however, NIH has certain rights with respect to such property as spe-

cified in

Administrative Requirements—Management Systems and Procedures—Property Management

System Standards

All other types of grants and recipients are subject to the requirements specified in 2 CFR Part 200.313 if

title to the equipment vests in the recipient rather than in NIH. If the grant-supported project or program

for which equipment was acquired is still receiving NIH funding at the time of sale, the recipient must

credit the NIH share of the proceeds to the grant and use that amount under the deductive alternative for

program income. If the recipient is no longer receiving NIH grant support, the amount due should be

paid in accordance with instructions from NIH. These grants and recipients also are subject to the

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requirements in 2 CFR Part 200.314 with respect to the use or sale of unused supplies. If the recipient

retains the supplies for use on other than federally sponsored activities, an amount is due NIH as if they

were sold.

8.3.2.3 Royalties and Licensing Fees from Copyrights, Inventions, and Patents

NIH recipients do not have to report program income resulting from royalties or licensing fees from sale

of copyrighted material unless specific terms and conditions of the award provide otherwise. The NoA

may include specific terms and conditions if commercialization of an invention is an anticipated outcome

of a research project.

However, the regulations implementing the Bayh-Dole Act (37 CFR Part 401.14(h)) require reporting of

income resulting from NIH-funded inventions and patents. Specifically, as part of the annual invention

utilization report, recipients must report income generated by all subject inventions to which title has

been elected and by inventions such as research tools that have been licensed but not patented (see

Administrative Requirements—Availability of Research Results: Publications, Intellectual Property

Rights, and Sharing Research Resources

and

Administrative Requirements—Monitoring—Reporting

8.3.3 Property Management System Standards

Generally, recipients may use their own property management policies and procedures for property pur-

chased, constructed, or fabricated as a direct cost using NIH grant funds, provided they observe the reg-

ulatory requirements in 2 CFR Parts 200.310 through 200.316, as applicable, and the following. State

governments will use, manage, and dispose of equipment acquired under a grant in accordance with state

laws and procedures as specified in 45 CFR Part 92.32.

The dollar threshold for determining the applicability of several of the requirements in those regulations

is based on the unit acquisition cost of an item of equipment. As defined in 2 CFR Part 200.1 , the

acquisition cost of an item of equipment to the recipient includes necessary modifications and attach-

ments that make it usable for the purpose for which it was acquired or fabricated. When such accessories

or attachments are acquired separately and serve to replace, enhance, supplement, or otherwise modify

the equipment’s capacity and they individually meet the definition of

equipment

(see Glossary in Part I),

any required NIH prior approval for equipment must be observed for each item. However, the aggregate

acquisition cost of an operating piece of equipment will be used to determine the applicable provisions

of 2 CFR Part 200.313. If property is fabricated from individual component parts, each component must

itself be classified as equipment if it meets the definition of equipment. In this case, the aggregate acquis-

ition cost of the resulting piece of equipment will determine the appropriate accountability requirements

in 2 CFR Part 200.313 .

Recipients are required to be prudent in the acquisition of property under a grant-supported project. It is

the recipient’s responsibility to conduct a prior review of each proposed property acquisition to ensure

that the property is needed and that the need cannot be met with property already in the possession of the

organization. If prior approval is required for the acquisition, the recipient must ensure that appropriate

approval is obtained in advance of the acquisition. The recipient also must follow appropriate pro-

curement procedures in acquiring property as specified in

Administrative Requirements—Management

Systems and Procedures—Procurement System Standards and Requirements

Recipients of NIH grants other than Federal institutions cannot be authorized to use Federal supply

sources.

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8.3.3.1 Real Property

See

Construction Grants—Real Property Management Standards

in IIB for requirements that apply to the

acquisition, use, and disposition of real property. Fixed equipment that is part of a construction grant is

subject to those requirements.

8.3.3.2 Equipment and Supplies

In general, title to equipment and supplies acquired by a recipient with NIH funds vests in the recipient

upon acquisition, subject to property management requirements of 2 CFR Parts 200.310, 2 CFR Part

200.316. Limited exceptions to these general rules are States, which may use, manage, and dispose of

equipment acquired under a grant in accordance with State laws and procedures, and certain research

grant recipients with exempt property (see 2 CFR Part 200.317). These requirements do not apply to

equipment for which only depreciation or use allowances are charged, donated equipment, or equipment

acquired primarily for sale or rental rather than for use.

8.3.3.2.1 Exempt Property

Under the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6306, NIH may permit non-profit

institutions of higher education and non-profit organizations whose primary purpose is the conduct of sci-

entific research to obtain title to equipment and supplies acquired under grants for support of basic or

applied scientific research without further obligation to the Federal government. However, there is one

exception: NIH has the right to require transfer of title to equipment with an acquisition cost of $10,000

or more to the Federal government or to an eligible third party named by the NIH awarding IC under the

conditions specified in 2 CFR Part 200.312. NIH may exercise this right within 120 days of the com-

pletion or termination of an award or within 120 days of receipt of an inventory, as provided in 2 CFR

Part 200.313, whichever is later.

8.3.3.2.2 Nonexempt Property

All other equipment and supplies acquired under all other NIH grant-supported projects by any other

type of recipient are subject to the full range of acquisition, use, management, and disposition require-

ments of 2 CFR Part 200.313 and 2 CFR Part 200.314. Property acquired or used under an NIH grant-

supported project, including any federally owned property, also is subject to the requirements for internal

control specified in 2 CFR Part 200.303. Equipment (and intangible property and debt instruments)

acquired with, or improved with, NIH funds must not be encumbered without NIH approval.

The recipient’s management system for equipment must meet the following requirements:

Records that adequately identify (according to the criteria specified in the regulations) items of

equipment owned or held by the recipient and state the current location of each item.

A physical inventory of the equipment, at least once every 2 years, to verify that the items in the

records exist and either are usable and needed or are surplus (a statistical sampling basis is

acceptable).

Control procedures and safeguards to prevent property loss, damage, and theft.

Regular maintenance procedures to ensure the property is in proper working condition.

Proper sales procedures when the recipient is authorized to sell the equipment.

For items of equipment having a unit acquisition cost of $10,000 or more, NIH has the right to require

transfer title to the equipment to the Federal government or to an eligible third party named by the NIH

awarding IC under the conditions specified in 2 CFR Part 200.313. Such transfer shall be subject to the

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following standards: (1) The equipment shall be appropriately identified in the award or otherwise made

known to the recipient in writing. (2) The awarding IC may require submission of a final inventory that

lists all equipment acquired with NIH funds and federally-owned equipment. (3) If the awarding IC fails

to issue disposition instructions within 120 calendar days after receipt of the inventory or if so instructed,

the recipient shall sell the equipment and reimburse the NIH an amount calculated by multiplying the per-

centage of NIH’s contribution towards the original purchase by the current market value or proceeds

from the sale. However, the recipient shall be permitted to retain from the NIH share $1,000.00 of the

proceeds, to cover expenses associated with the selling and handling of the equipment. If the recipient is

instructed to ship the equipment elsewhere, the recipient shall be reimbursed by the awarding IC an

amount which is computed by applying the percentage of the recipient’s share in the cost of the original

project or program to the current fair market value of the equipment, plus any reasonable shipping or

interim storage costs incurred. If the recipient is instructed to otherwise dispose of the equipment, the

recipient will be reimbursed by the NIH for such costs incurred in its disposition. If the recipient’s pro-

ject or program for which or under which the equipment was acquired is still receiving support from the

same NIH program, and if the NIH approves, the net amount due may be used for allowable costs of that

project or program. Otherwise the net amount must be remitted to the NIH by check. This right applies

to nonexempt property acquired by all types of recipients, including Federal institutions, under all types

of grants under the stipulated conditions. When included in the terms and conditions of the award, NIH

may permit the recipient to retain equipment, or authorize a pass-through entity to permit the sub-

recipient to retain equipment, with no further obligation to the NIH unless prohibited by Federal statute

or regulation.

If there is a residual inventory of unused supplies exceeding $10,000 in aggregate fair market value upon

termination or completion of the grant and if the supplies are not needed for other federally sponsored

programs or projects, the recipient may either retain them for use on other than federally sponsored activ-

ities or sell them, but, in either case, the recipient must compensate the NIH awarding IC for its share as

a credit to the grant.

Recipients of NIH grants must not use equipment acquired with grant funds to provide services for a fee

to compete unfairly with private companies that provide equivalent services, unless the terms and con-

ditions of the award provide otherwise.

8.3.3.2.3 Revocable License

As permitted under Federal property management statutes and regulations and NIH property man-

agement policies, federally owned tangible personal property may be made available to recipients under

a revocable license agreement. The revocable license agreement between NIH and the recipient provides

for the transfer of the equipment for the period of grant support under the following conditions:

Title to the property remains with the Federal government.

NIH reserves the right to require the property to be returned to the Federal government should it

be determined to be in the best interests of the Federal government to do so.

The use to which the recipient puts the property does not permanently damage it for Federal gov-

ernment use.

The property is controlled and maintained in accordance with the requirements of 48 CFR Part

45.5 (the FAR).

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8.3.4 Procurement System Standards and Requirements

8.3.4.1 General

Recipients may acquire a variety of goods or services in connection with a grant-supported project, ran-

ging from those that are routinely purchased goods or services to those that involve substantive pro-

grammatic work. States may follow the same policies and procedures they use for procurements from

non-Federal funds and ensure that every purchase order or other contract includes any clauses required

2 CFR Part 200.327

. All other recipients must follow the requirements in

2 CFR Part 200.318

through 200.327 for the purchase of goods or services through contracts under grants. The requirements

for third-party activities involving programmatic work are addressed under

Consortium Agreements

chapter in IIB.

A contract under a grant must be a written agreement between the recipient and the third party. The con-

tract must, as appropriate, state the activities to be performed; the time schedule; the policies and require-

ments that apply to the contractor, including those required by 2 CFR Part 200, Appendix II — Contract

Provisions for non-Federal Entity Contracts Under Federal Awards and other terms and conditions of the

grant (these may be incorporated by reference where feasible); the maximum amount of money for

which the recipient may become liable to the third party under the agreement; and the cost principles to

be used in determining allowable costs in the case of cost-type contracts. The contract must not affect the

recipient’s overall responsibility for the direction of the project and accountability to the Federal gov-

ernment. Therefore, the agreement must reserve sufficient rights and control to the recipient to enable it

to fulfill its responsibilities.

When a recipient enters into a service-type contract in which the term is not concurrent with the budget

period of the award, the recipient may charge the costs of the contract to the budget period in which the

contract is executed even though some of the services will be performed in a succeeding period if the fol-

lowing conditions are met:

The NIH awarding IC has been made aware of this situation either at the time of application or

through post-award notification.

The project has been recommended for a project period extending beyond the current year of sup-

port.

The recipient has a legal commitment to continue the contract for its full term.

However, costs will be allowable only to the extent that they are for services provided during the period

of NIH support. To limit liability if continued NIH funding is not forthcoming, it is recommended that

recipients insert a clause in such contracts of $100,000 or less stipulating that payment beyond the end of

the current budget period is contingent on continued Federal funding. The contract provisions prescribed

by 2 CFR Part 200, Appendix II — Contract Provisions for recipient and subrecipient Contracts Under

Federal Awards, paragraph B specify termination provisions for contracts in excess of $100,000.

8.3.4.2 Approval Requirements

The procurement standards in 2 CFR Part 200.325 allow NIH to require approval of specific pro-

curement transactions under the following circumstances (and provide a mechanism for governmental

recipients to be exempt from this type of review):

A recipient’s procurement procedures or operations do not comply with the procurement stand-

ards required by those regulations.

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The procurement is expected to exceed the “simplified acquisition threshold” (currently

$250,000 per

OMB memo M-18-18

) (formerly the “small purchase threshold”) established by

the Federal Property and Administrative Services Act, as amended, and is to be awarded without

competition or only one bid or proposal is received in response to a solicitation.

A procurement that will exceed the simplified acquisition threshold specifies a “brand name”

product.

A proposed award over the simplified acquisition threshold is to be awarded to other than the

apparent low bidder under a sealed-bid procurement.

A proposed contract modification changes the scope of a contract or increases the contract

amount by more than the amount considered to be a simplified acquisition.

When NIH prior approval is required, the recipient must make available sufficient information to enable

review. This may include, at NIH discretion, presolicitation technical specifications or documents, such

as requests for proposals or invitations for bids, or independent cost estimates. Approval may be deferred

pending submission of additional information by the applicant or recipient or may be conditioned on the

receipt of additional information. Any resulting NIH approval does not constitute a legal endorsement of

the business arrangement by the Federal government nor does such approval establish NIH as a party to

the contract or any of its provisions.

8.3.4.3 Contracting with Small Businesses, Minority-Owned Firms, Women's Busi-

ness Enterprises, and Veteran-Owned Businesses

Recipients must make positive efforts to use small businesses, minority-owned firms, women’s business

enterprises and veteran-owned businesses as sources of goods and services whenever possible. Recip-

ients should take the steps outlined in the applicable administrative requirements (2 CFR Part 200.321)

to implement this policy.

8.3.4.4 Domestic Preferences for Procurements

The recipient or subrecipient should, to the greatest extent practicable and consistent with law, provide a

preference for the purchase, acquisition, or use of goods, products, or materials produced in the United

States (including but not limited to iron, aluminum, steel, cement, and other manufactured products). The

requirements of this section must be included in all subawards, contracts, and purchase orders under

Federal awards. See 2 CFR Part 200.322.

8.4 MONITORING

Recipients are responsible for managing the day-to-day operations of grant-supported activities using

their established controls and policies, as long as they are consistent with NIH requirements. However, to

fulfill their role in regard to the stewardship of Federal funds, NIH awarding ICs monitor their grants to

identify potential problems and areas where technical assistance might be necessary. This active mon-

itoring is accomplished through review of reports and correspondence from the recipient, audit reports,

site visits, and other information available to NIH. The names and telephone numbers of the individuals

responsible for monitoring the programmatic and business management aspects of a project or activity

will be provided to the recipient at the time of award.

Monitoring of a project or activity will continue for as long as NIH retains a financial interest in the pro-

ject or activity as a result of property accountability, audit, and other requirements that may continue for

a period of time after the grant is administratively closed out and NIH is no longer providing active grant

support (see

Administrative Requirements—Closeout

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8.4.1 Reporting

NIH requires that recipients periodically submit financial and progress reports. Other required reports

may include annual invention utilization reports, lobbying disclosures, conflict of interest reports, audit

reports, reports to the appropriate payment points (in accordance with instructions received from the pay-

ment office), and specialized programmatic reports. Recipients also are expected to publish the results of

research in peer-reviewed journals and to provide information to the public on the objectives, meth-

odology, and findings of their NIH-supported research activities, as specified in

Administrative Require-

ments—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing

Research Resources

The GMO is the official receipt point for most required reports. However, NIH has centralized the sub-

mission of annual progress reports; details are provided below. In addition, electronic submission

through the eRA Commons is required for some annual progress reports and closeout documents (final

grant progress reports and final invention statements and certifications). When a paper non-competing

continuation progress report is submitted, only a signed original is required; no copies are required. Sub-

mission of these reports to an address other than the centralized one may result in delays in processing of

the non-competing continuation award or the submission being considered delinquent. FFRs must be

electronically submitted to NIH (see

Financial Reports

below) through PMS unless otherwise indicated

in the award’s terms and conditions.

Recipients are allowed a specified period of time to submit required financial and final progress reports

(see 2 CFR 200.328 and 2 CFR Part 200.329, and the discussion in this subsection). Failure to submit

complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result

in possible award delays or enforcement actions, including withholding, removal of certain NIH Stand-

ard Terms of Award, or conversion to a reimbursement payment method (also see

Administrative

Requirements—Enforcement Actions

). The schedule for submission of the non-competing continuation

progress report is discussed in the next subsection.

8.4.1.1 Non-Competing Continuation Progress Reports

Progress reports usually are required annually as part of the non-competing continuation award process.

NIH may require these reports more frequently. The Research Performance Progress Report (RPPR)

must be submitted to, and approved by, NIH to non-competitively fund each additional budget period

within a previously approved project period (competitive segment). Except for awards subject to SNAP,

the progress report includes an updated budget in addition to other required information.

NIH requires the use of the RPPR for all Type 5 progress reports, including accessing the Human Sub-

jects System link in the RPPR, if applicable, that will allow reporting of inclusion enrollment data.

Recipients may query eRA Commons Status and Research Performance Progress Report (RPPR) to view

a list their organization's pending grant progress reports and respective due dates. Late submission of a

grant progress report will result in delaying the issuance and funding of the non-competing continuation

award and may result in a reduced award amount.

Recipients also have an obligation to submit a complete and accurate progress report. NIH program or

grants management staff may require additional information to evaluate the project for continued fund-

ing. Failure to provide this information will result in a delayed award. Incomplete or inadequate progress

reports may result in a delay of continued support.

The progress report for the final budget period of a competitive segment for which a competing con-

tinuation application is submitted will be part of that application; however, if an award is not made or the

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recipient does not submit an application for continued support, a final RPPR is required (see

Final

Research Performance Progress Report

The NIH awarding IC will specify the requirements for progress reporting under construction grants or

grants supporting both construction activities, including acquisition or modernization, major alteration

and renovation, and non-construction activities.

8.4.1.1.1 Requirement for Commons ID

For progress reports using the RPPR, the Commons ID requirement is part of the Participants Section

and is required for the PD/PI(s) and those who worked on the project in a postdoctoral role. This could

include project roles such as Postdoctoral Associate and other similar Postdoctoral positions.

For undergraduate and graduate students supported on a particular research grant, a Commons ID is

required. Undergraduate and Graduate Student Roles have been added to the Commons to accommodate

this requirement; recipients are encouraged to begin registering these individuals now. For graduate stu-

dents, this could include project roles of graduate research assistant or graduate student.

When an individual is assigned the Undergraduate, Graduate Student, and/or Postdoctoral Role in the

Commons, responses to certain data items in the Personal Profile tab will be required to meet NIH report-

ing requirements to Congress included in the NIH Reform Act, P.L. 109-482.

Note, the Graduate Student and Postdoctoral eRA Commons Roles should NOT be used for individuals

submitting Individual Fellowships; the PD/PI role is used for those submissions. Nor should they be used

for individuals supported on institutional training grants and reported using xTrain; the Trainee Role

must continue to be used for those individuals.

A Commons ID is strongly encouraged, but currently optional, for all other project personnel. A general

Commons Role of Project Personnel is available for those not assigned other Commons Roles.

8.4.1.1.2 Expectation for Institutions to Develop Individual Development Plans for

Graduate Students and Postdoctoral Researchers

In an effort to assist graduate students and post-doctoral researchers in achieving their career goals and

become contributing members of the biomedical workforce, NIH encourages recipients to develop an

institutional policy requiring that an Individual Development Plan (IDP) be implemented for every gradu-

ate student and postdoctoral researcher supported by any NIH grant and reportable on the progress

report, regardless of the type of NIH grant that is used for support. This is an expectation that should be

broadly implemented by institutions for all graduate students and postdoctoral researchers supported by

NIH. The actual reporting of the implementation of this expectation is in the RPPR; recipients must

report in RPPR

Section B. Accomplishments

, Question B.4 the use of the IDP for graduate students

and/or postdoctoral researchers included in RPPR

Section D

. Participants or on a Statement of Appoint-

ment Form (PHS 2271). Do not include the actual IDP; instead include information to describe how

IDPs are used, if they are used, to help manage the training for those individuals.

8.4.1.2 Streamlined Non-Competing Award Process

SNAP includes a number of provisions that modify annual progress reports, NoAs, and financial reports.

The NoA will specify whether an award is subject to SNAP. Awards routinely included in SNAP are

“K” awards and “R” awards, except R35. Awards excluded from SNAP are those that generally do not

have the authority to automatically carry over unobligated balances (centers; cooperative agreements,

Kirschstein-NRSA institutional research training grants, non-Fast Track Phase I SBIR and STTR

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awards), clinical trials (regardless of activity code), P01, R35, and awards to individuals. However, these

grants can be included in SNAP on a grant-specific basis. In addition, specific awards may be excluded

from SNAP if:

they require close project monitoring or technical assistance, e.g., high-risk recipients, certain

large individual or multi-project grants, or grants with significant unobligated balances, or

the recipient has a consistent pattern of failure to adhere to appropriate reporting or notification

deadlines.

8.4.1.2.1 Modified Annual Progress Reports

While a modified, streamlined, progress report is still a feature of grants awarded under the SNAP author-

ities, a streamlined version of the RPPR has replaced the eSNAP module in the eRA Commons. For all

SNAP awards, the progress report is submitted using this streamlined version of the RPPR that does not

include detailed budget information.

8.4.1.2.2 Modified NoAs

Under SNAP, the GMO negotiates the direct costs for the entire competitive segment at the time of the

competing award or, in the case of modular awards, determines the applicable number of modules for

each budget period within the competitive segment. This eliminates the need for annual budget sub-

missions and any negotiations, and reduces the information NIH requires to review, approve, and mon-

itor non-competing continuation awards. SNAP NoAs are issued with only total direct and indirect costs

awarded for the budget period. While direct costs categorical breakdowns are not awarded, recipients are

required to allocate and account for costs by category in accordance with applicable cost principles.

Future year commitments on SNAP awards reflect total cost commitments (direct plus indirect costs).

8.4.1.2.3 Modified Financial Reporting Requirements

For awards under SNAP, an FFR is required only at the end of a competitive segment rather than annu-

ally. The FFR must be submitted within 120 days after the end of the competitive segment and must

report on the cumulative support awarded for the entire segment. An FFR must be submitted at this time

whether or not a competing continuation award is made. If no further award is made, this report will

serve as the final FFR (see

Administrative Requirements—Closeout

8.4.1.2.4 Submitting SNAP Progress Reports

All SNAP progress reports are due the 15th of the month preceding the month in which the budget

period ends (e.g., if the budget period ends 11/30, the due date is 10/15). If the 15th falls on a weekend

or Federal holiday, the due date is automatically extended to the next business day. Paper submissions

are not acceptable, will not be used for consideration for funding, and will not become part of the official

file. If a paper SNAP progress report is submitted, recipients will be required to resubmit the information

electronically.

The RPPR module in the eRA Commons allows recipients to electronically prepare and submit progress

reports and supporting documentation. The RPPR module provides the user with dedicated screens to col-

lect the required progress report information, including appropriate uploads for text documents. Data sub-

mitted through RPPR for Performance Sites and Participants is retained in the system to assist the

recipient in completion of future progress reports.

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The RPPR may be routed to authorizing officials at the applicant institution for review and approval

prior to submission to NIH. For SNAP awards, the RPPR module provides recipients with the option to

delegate to the PD/PI the authority to submit the progress report directly to NIH. This optional authority

is managed on a PD/PI basis in the eRA Commons; such authority can be rescinded at any time.

Guidance on RPPR submission is documented in the

RPPR Instruction Guide

8.4.1.3 Progress Reports for Multiyear Funded Awards

A limited number of NIH grant awards are multi-year funded, i.e., not funded in budget years but funded

in full at the start of the project period from a single fiscal year appropriation. The project period and the

budget period are the same in a multi-year funded (MYF) award and are longer than one year. Progress

reports for MYF awards are due annually on or before the anniversary of the budget/project period start

date of the award. A progress report is not required if the award is in a no-cost extension period unless

specifically required by the IC. The reporting period for a MYF progress report is the calendar year pre-

ceding the anniversary date of the award. For example, if an award is made on 04/01/2021, the MYF pro-

gress report is due on or before 04/01/2022, and should report on the activities performed under the

award between 04/01/2021 and 03/31/2022. For the subsequent year the MYF progress report will be

due 04/01/2023, and should report on the activities performed under the award between 04/01/2022 and

03/31/2023. Information on the content of a MYF progress report and instructions on how to submit the

report through the eRA Commons are posted at

NIH Instructions for Progress Reports for Multi-year

Funded (MYF) Awards

and

NIH RPPR Instruction Guide

. The multi-year research performance progress

report (MYRPPR) link to upload the report will be available two months before the anniversary date of

the award, on the eRA Commons Status search page in the folder “List of Applications/Grants” in the

“Action” column. Progress reports for MYF awards must be completed by the PD/PI, and then submitted

by a Signing Official (SO) or a PD/PI with delegated authority from the SO to submit a progress report.

Information about SO delegation of authority to a PD/PI to submit a progress report appears in the

eRA

Commons User Guide under Section 10.2 Delegations.

8.4.1.4 Final Research Performance Progress Report (F-RPPR)

The F-RPPR has replaced the Final Progress Report for closeout. NIH is no longer accepting Final Pro-

gress Reports. Generally, the F-RPPR format is the same as the current annual RPPR. As part of the F-

RPPR recipients will be required to report on Project Outcomes. This section will be made publicly avail-

able, allowing recipients the opportunity to provide the general public with a concise summary of the

cumulative outcome or findings of the project (analogous to the Project Summary/Abstract section of the

competing application).

NIH will not maintain its previous Type 2 policy which stated that “whether funded or not” the progress

report contained in the Type 2 application may serve in lieu of a separate final progress report. NIH now

requires that organizations submit an Interim-RPPR while their Type 2 is under consideration. In the

event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for

the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be

treated by NIH staff as the institution’s F-RPPR.

See the

F-RPPR Instructions

for more information. Recipients should also review the information found

Final Research Performance Progress Report

8.4.1.5 Financial Reports

PMS will pre-populate the cash transaction section (lines 10a through 10c) of the FFR using recipient

real-time cash advance information from PMS, and adjust recipient-reported disbursements to equal cash

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advance drawdowns on all non-closed sub-accounts. Recipients will be required to certify at the time of

each drawdown whether the cash drawdown request is for reimbursement of actual expenditures or is an

advance for immediate disbursement; recipients must assert that award funds, including those issued to

subrecipients, are used in compliance with all award conditions and federal statutory requirements.

8.4.1.5.1 Financial Expenditure Reports

Reports of expenditures are required as documentation of the financial status of grants according to the

official accounting records of the recipient organization. NIH requires all financial expenditure reports to

be submitted using the Payment Management System. This includes all initial FFRs being prepared for

submission and any revised FFRs being submitted or re-submitted to NIH. The eRA Commons and Pay-

ment Management systems allows participants to view information on currently due and late expenditure

reports and to submit these reports electronically to NIH through PMS. Paper expenditure reports are not

accepted. Expenditure data submitted to NIH is initially reviewed and accepted the FFR Reconciliation

and Financial Closeout Support Center (FFR-C) within the Office of Policy for Extramural Research

Administration (OPERA). NIH IC grants management staff also review these expenditure reports.

Except for awards under SNAP and awards that require more frequent reporting, the FFR is required on

an annual basis. When required on an annual basis, the report must be submitted for each budget period

no later than 90 days after the end of the calendar quarter in which the budget period ended. The report-

ing period for an annual FFR will be that of the budget period for the particular grant; however, the

actual submission date is based on the calendar quarter. Failure to submit timely reports may affect

future funding. The report also must cover any authorized extension in time of the budget period. If more

frequent reporting is required, the NoA will specify both the frequency and due date.

In lieu of the annual FFR expenditure data, NIH will monitor the financial aspects of grants under SNAP

by using the information submitted directly to PMS. The GMO may review the report for patterns of

cash expenditures, including accelerated or delayed drawdowns, and to assess whether performance or

financial management problems exist. For these SNAP awards, FFR expenditure data is required only at

the end of a competitive segment. It must be submitted within 120 days after the end of the competitive

segment and must report on the cumulative support awarded for the entire segment. An FFR must be sub-

mitted at this time whether or not a competing continuation award is made. If no further award is made,

this report will serve as the final FFR (see

Administrative Requirements—Closeout

Before submitting FFRs to NIH, recipients must ensure that the information submitted is accurate, com-

plete, and consistent with the recipient’s accounting system. When submitting the FFR through the Pay-

ment Management System, as applicable, the AOR or the individual designated to submit this report on

behalf of their institution, certifies that the information in the FFR is correct and complete and that all

outlays and obligations are for the purposes set forth in grant documents, and represents a claim to the

Federal government. Filing a false claim may result in the imposition of civil or criminal penalties.

8.4.1.5.2 Revised Financial Reports and Expenditures

Revisions for Indirect Cost Changes.

Each Federal Financial Report submitted by the recipient shall

reflect the proper amount of indirect costs applicable to the grant period. If a provisional or an earlier

period’s permanent rate is used in the report, a subsequent adjustment to the FFR is necessary if a lower

permanent rate(s) applicable to the grant is established, except for Institutions of Higher Education

(IHEs) subject to 2 CFR 200.

Revised Expenditure Reports.

NIH requires all financial expenditure reports (domestic and foreign) to

be submitted using the Payment Management System. This includes the initial FFR and any FFR

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revisions being submitted or re-submitted to NIH. In some cases the recipient may have to revise or

amend a previously submitted annual or final FFR. When the revision results in a balance of $20,000 or

greater due to NIH, the recipient must submit a revised report whenever the overcharge is discovered, no

matter how long the lapse of time since the original due date of the report, and post the refund to the

PMS document if the funds have not expired and are reconciled and closed in PMS. All refunds under

$20,000 on closed PMS documents should be sent directly to PMS with instruction to post the funds to

Miscellaneous Receipts. PMS refund instructions may be found on the

Program Support Center

webpage

. Revised expenditure reports representing additional expenditures by the recipient that were not

reported to NIH within the 90-day time frame may be submitted electronically with an explanation for

the revision. The explanation also should indicate why the revision is necessary and describe what action

is being taken by the recipient to preclude similar situations in the future. This should be done as

promptly as possible, but no later than one year from the due date of the original report for annual FFRs

and no later than 60 calendar days from the due date of the original report for final FFRs (i.e., 180 days

from the project end date).

8.4.1.5.3 Unobligated Balances and Actual Expenditures

Disposition of unobligated balances is determined in accordance with the terms and conditions of the

award. (See

Administrative Requirements—Changes in Project and Budget

for NIH approval authorities

for unobligated balances.) Using the principle of “first in-first out,” unobligated funds carried over are

expected to be used before newly awarded funds.

Upon receipt of the annual FFR for awards other than those with authority for the automatic carryover of

unobligated balances, the GMO will compare the total of any unobligated balance shown and the funds

awarded for the current budget period with the NIH share of the approved budget for the current budget

period. If the funds available exceed the NIH share of the approved budget for the current budget period,

the GMO may select one of the following options:

In response to a written request from the recipient, revise the current NoA to authorize the recip-

ient to spend the excess funds for additional approved purposes.

Offset the current award or a subsequent award by an amount representing some or all of the

excess.

8.4.1.5.4 Recipient Reporting of Subrecipient Data and Executive Compensation

Information for Federal Funding Accountability and Transparency Act (FFATA)

A component of Public Law 109-282, the

Federal Funding Accountability and Transparency Act of 2006

as amended (FFATA), requires most recipients of new Federal funds to report on sub-

awards/subcontracts/consortiums equal to or greater than $30,000. This includes awards that are initially

below $30,000 but subsequent grant modifications result in an award equal to or greater than $30,000.

Subaward reports are submitted in SAM.gov with subaward data ultimately distributed for publication

and display on

www.USASpending.gov

. Recipients are required to register with SAM.gov, collect the

necessary data from subrecipients, and file subaward reports by the end of the month following the

month in which the pass-through entity awards any subaward greater than $30,000.

FFATA specifies the data that should be captured for each pass-through entity and first-tier subrecipient

of Federal awards, regardless of award type. To promote data consistency and reduce reporting burdens,

existing agency data sources will be leveraged to pre-populate reports for pass-through entities as well as

for subrecipients when available. Recipients are responsible for confirming the pre-populated data and

providing any additional required information.

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Included in these requirements is the need to report the names and total compensation of the five most

highly compensated officers of the entity if the entity as part of their registration profile in SAM in the

preceding fiscal year: 1) received 80 percent or more of its annual gross revenues in Federal grants, sub-

awards, contracts, and subcontracts; and 2) received $25,000,000 or more in annual gross revenues from

Federal grants, subawards, contracts, and subcontracts; and 3) had gross income, from all sources, of

$300,000 or more; and 4) the public does not have access to this information about the compensation of

the senior executives of the entity through periodic reports filed under section 13(a) or 15(d) of the Secur-

ities Exchange Act of 1934 (15 U.S.C. §§ 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code

of 1986. See FFATA § 2(b)(1). Additionally, recipient organizations may be required to verify the fol-

lowing information in SAM.gov:

Organization UEI

Name and Address of organization

Parent UEI

Assistance listing number

FAIN

Federal Awarding Agency of the grant

8.4.1.6 Invention Reporting

A complete list of the reporting requirements under the Bayh-Dole Act can be found at 37 CFR 401.14.

The requirements also are specified in

Administrative Requirements—Availability of Research Results:

Publications, Intellectual Property Rights, and Sharing Research Resources

In addition to complying with Bayh-Dole-related regulations, each NIH competing grant application and

non-competing continuation progress report must indicate whether or not any subject inventions were

made during the preceding budget period. If inventions were made, the recipient must also indicate

whether they were reported.

The recipient also must submit an annual invention utilization report for all subject inventions to which

title has been elected and inventions that have been licensed but not patented (research tools). The util-

ization report provides a way to evaluate the extent of commercialization of subject inventions, con-

sistent with the objectives of the Bayh-Dole Act.

A recipient’s failure to comply with invention reporting requirements and/or associated NIH policies on

intellectual property and resource sharing may result in the loss of patent rights or a withholding of grant

funds or other enforcement actions, including the imposition of specific terms and conditions.

Bayh-Dole regulations allow recipients to report inventions electronically (37 CFR 401.16). NIH

requires electronic reporting through an Internet-based system,

Interagency Edison

. To meet the object-

ives of the Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107), recip-

ients are required to submit invention reports to NIH using iEdison. The system supports confidential

transmission of required information and provides a utility for generating reports and reminders of

pending reporting deadlines. Further information about the system, including instructions for creating an

account needed to submit reports electronically, are on the iEdison site. Recipients also may contact the

Division of Extramural Inventions and Technology Resources Branch, OPERA, OER

. See Part III for

contact information.

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8.4.1.7 Financial Conflict of Interest Reports

Information related to FCOI reporting requirements can be found within

Public Policy Requirements --

Financial Conflict of Interest

8.4.1.8 Research Securities

In alignment with the CHIPS and Science Act of 2022 (P.L. 117-167) and National Security Presidential

Memorandum-33 (NSPM-33), NIH has established a series of requirements to strengthen research secur-

ity across NIH-funded projects.

8.4.1.9 NIH Disclosure Requirements

As part of the application preparation and submission process, and annual progress report submission, all

individuals designated in an application as senior/key personnel are required to certify and submit inform-

ation to assist reviewers and NIH staff in making informed recommendations and funding decisions.

Details on all required disclosures can be found in the

NIH Disclosure Table

. It is vital that submission

of such disclosure information be taken seriously. Failure to comply with terms and conditions related to

disclosure requirements may cause NIH to take action(s) to remedy non-compliance, such as disallowing

costs, withholding of further awards, or wholly or partly suspending the grant, pending corrective action

(see Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding

of Support).. Further, violations that are potentially criminal will be referred to the NIH Office of Man-

agement Assessment for consultation with the HHS Office of Inspector General, the Department of

Justice, or other law enforcement agencies, as appropriate.

8.4.1.10 Malign Foreign Talent Recruitment Program

In accordance with the CHIPS and Science Act of 2022 (P.L. 117-167) , individuals who are a current

party to a Malign Foreign Talent Recruitment Program (MFTRP) are not eligible to serve as a senior/key

person on an NIH grant or cooperative agreement.

8.4.1.11 Research Security Training

In accordance with the CHIPS and Science Act of 2022 (P.L. 117-167), each senior/key personnel listed

on an NIH grant application must certify that they have completed Research Security Training (RST)

within 12 months of the date of application submission. This individual certification is required at the

time of the application submission, through the Biographical Sketch in SciENcv.

The Act also requires applicant institutions to certify that each covered individual who is employed by

the institution and listed on the application has completed RST. The AOR, via their signature on the face

page of the application, certifies the applicant institution’s compliance with this requirement.

Completion of RST and the individual and institutional certifications is required for applications sub-

mitted for due dates on or after May 25, 2026.

8.4.2 Record Retention and Access

Recipients generally must retain financial and programmatic records, supporting documents, statistical

records, and all other records that are required by the terms of a grant, or may reasonably be considered

pertinent to a grant, for a period of 3 years from the date the annual FFR is submitted. For awards under

SNAP (other than those to Federal institutions), the 3-year retention period will be calculated from the

date the FFR for the entire competitive segment is submitted. Those recipients must retain the records

pertinent to the entire competitive segment for 3 years from the date the FFR is submitted to NIH.

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Federal institutions must retain records for 3 years from the date of submission of the annual FFR to

NIH. See 2 CFR Part 200.334 for exceptions or qualifications to the 3-year retention requirement exist

(e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the

3-year period), the records must be retained until all litigation, claims, or audit findings involving the

records have been resolved and final action taken). Maintain the information for the retention period for

other types of grant-related records, including indirect cost proposals and property records. See 2 CFR

Part 200.334 and 2 CFR Part 200.337 for record retention and access requirements for contracts under

grants.

These record retention policies apply to both paper and electronic storage of applicable information,

including electronic storage of faxes, copies of paper document, images, and other electronic media. Insti-

tutions that rely on an electronic storage system must be able to assure such a system is stable, reliable,

and maintains the integrity of the information. When storing electronic images of paper documents, the

system must also assure a full, complete, and accurate representation of the original, including all official

approvals.

NIH, pass-through entities, Inspectors General, the Comptroller General of the United States, or any of

their authorized representatives, must have the right of access to any records of the recipient or sub-

recipient pertinent to the NIH award, to perform audits, execute site visits, or for any other official use.

This right also includes timely and reasonable access to the recipient's or subrecipient’s personnel for the

purpose of interview and discussion related to such documents or the NIH award in general. NIH's rights

of access are not limited to the required retention period of this part but lasts as long as the records are

retained. Pass-through entities must not impose any other access requirements upon subrecipients.

8.4.3 Audit

An audit is a systematic review or appraisal made to determine whether internal accounting and other

control systems provide reasonable assurance of the following:

Financial operations are properly conducted.

Financial reports are timely, fair, and accurately.

The entity has complied with applicable laws, regulations, and other grant terms.

Resources are managed and used economically and efficiently.

Desired results and objectives are being achieved effectively.

NIH recipients (other than Federal institutions) are subject to audit requirements in 2 CFR Part 200 Sub-

part F and in the NIHGPS (for types of organizations to which 2 CFR Part 200, Subpart F-Audit Require-

ments do not directly apply). In general, 2 CFR Part 200, Subpart F- Audit Requirements requires a State

government, local government, or non-profit organization (including institutions of higher education)

that expends $1,000,000 or more per year under Federal grants, cooperative agreements, and/or pro-

curement contracts are required to have an annual audit by a public accountant or a Federal, State, or

local governmental audit organization. The audit must meet the standards specified in generally accepted

government auditing standards (GAGAS). The audit requirements for foreign recipients and for-profit

recipients are addressed in the chapters of this NIHGPS that provide specific requirements for those

types of recipients. In accordance with 2 CFR 200.101(a)(2), HHS has established for-profit audit

requirements at 2 CFR 300.218. See NIHGPS 18.4.5 for details on NIH’s implementation of the for-

profit audit requirements.

As specified in the NoA, all awards issued by NIH meet the definition of “Research and Development”

at 2 CFR Part 200.1. As such, NIH grant awards are subject to the R&D cluster of program requirements

in the compliance supplement. NIH recognizes that some awards may have another classification for

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purposes of indirect costs. The auditor is not required to report the disconnect (i.e., the award is clas-

sified as R&D for Federal Audit Requirement purposes but non-research for indirect cost rate purposes),

unless the auditee is charging indirect costs at a rate other than the rate(s) specified in the award doc-

ument(s).

Exhibit 10. Summary of Audit Requirements

Recipient Type

Source of Audit Requirement

Where to Submit Audit Reports

State & Local

Governments

2 CFR 200.501

Federal Audit Clearinghouse

(See contact information in Part III)

Colleges &

Universities (IHEs)

2 CFR 200.501

Federal Audit Clearinghouse

(See contact information in Part III)

Non-Profits

2 CFR 200.501

Federal Audit Clearinghouse

(See contact information in Part III)

Hospitals

2 CFR 200.501

Federal Audit Clearinghouse

(See contact information in Part III)

For-Profits

NIH Grants Policy Statement

Audit Resolution Division

(See contact information in Part III)

Foreign

NIH Grants Policy Statement

(same as

For-Profits)

Audit Resolution Division

(See contact

information in Part III)

When a recipient procures audit services, the procurement must comply with the procurement standards

of 2 CFR Part 200, as applicable, including obtaining competition and making positive efforts to use

small businesses, minority-owned firms, women’s business enterprises, and veteran-owned enterprises.

Recipients should ensure that comprehensive solicitations made available to interested firms include all

audit requirements and specify the criteria to be used for selection of the firm. Recipients’ written agree-

ments with auditors must specify the rights and responsibilities of each party.

2 CFR Part 200, Subpart F-Audit Requirements explains in detail the scope, frequency, and other aspects

of the audit. Some highlights of this regulation are as follows:

Covered organizations expending $1,000,000 or more per year in Federal awards are required to

have an audit performed in accordance with the regulation. However, if the awards are under one

program, the organization can have either a single organization-wide audit or a program-specific

audit of the single program, subject to the provisions of 2 CFR Part 200.507. NIH identifies one

program as all awards funded by one IC. Prior to electing a program-specific audit, the recipient

must obtain written prior approval from the relevant NIH awarding IC. Covered organizations

expending less than $1,000,000 in any year are exempt from these audit requirements in that

year but must have their records available for review as required by

Administrative Require-

ments—Monitoring—Record Retention and Access

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The reporting package must contain the following:

o

Financial statements and schedule of expenditures of Federal awards.

o

Independent auditor’s report, including an opinion on the financial statements and the

schedule of expenditures of Federal awards, a report on compliance and internal control

over financial reporting, and a report on compliance with requirements applicable to

each major program and on internal control over such compliance requirements.

o

A schedule of findings and questioned costs.

o

If applicable, a summary of prior audit findings and a corrective action plan.

An audit under 2 CFR Part 200, Subpart F-Audit Requirements is in lieu of a financial audit of

individual Federal awards. However, Federal agencies may request additional audits necessary to

carry out their responsibilities under Federal law or regulation. Any additional audits will build

upon work performed by the independent auditor.

The data collection form (SF-SAC) and a copy of the Single Audit reporting package must be

submitted electronically to the

FAC

at the address provided in Part III.

A senior level representative of the auditee (e.g., state controller, director of finance, chief exec-

utive officer, or chief financial officer) must sign a statement to be included as part of the data

collection that says that the auditee complied with the requirements of this part, the data were

prepared in accordance with this part (and the instructions accompanying the form), the reporting

package does not include protected personally identifiable information, the information included

in its entirety is accurate and complete, and that the FAC is authorized to make the reporting

package and the form publicly available on a web site. Exception: An auditee that is an Indian

tribe or a tribal organization (as defined in the Indian Self- Determination, Education and Assist-

ance Act (ISDEAA), 25 U.S.C. 450b(l)) may opt not to authorize the FAC to make the reporting

package publicly available on a web site, by excluding the authorization for the FAC pub-

lication. If this option is exercised, the auditee becomes responsible for submitting the reporting

package directly to any pass-through entities through which it has received a Federal award and

to pass-through entities for which the summary schedule of prior audit findings reported the

status of any findings related to Federal awards that the pass-through entity provided. Unless

restricted by Federal statute or regulation, if the auditee opts not to authorize publication, it must

make copies of the reporting package available for public inspection.

If the schedule of findings and questioned costs discloses an audit finding related to an HHS or NIH

award or if the schedule of prior audit findings reports the status of any audit finding relating to an HHS

or NIH award, the FAC will provide copies of the audit report to NEARC, OIG, HHS. NEARC will, in

turn, distribute them within HHS for further action, as necessary. Audit reports should not be sent dir-

ectly to the GMO. The threshold for reporting questioned costs is described in 2 CFR Part 200.516.

Recipients must follow a systematic method for ensuring timely and appropriate resolution of audit find-

ings and recommendations, whether discovered as a result of a Federal audit or a recipient-initiated

audit. Recipients usually are allowed 30 days from the date of request to respond to the responsible audit

resolution official (Action Official) concerning audit findings. Failure to submit timely responses may

result in cost disallowance or other actions by NIH or HHS. At the completion of the audit resolution pro-

cess, the recipient will be notified of the Action Official’s final decision. The recipient may appeal this

decision if the adverse determination is of a type covered by NIH or HHS grant appeals procedures (see

Administrative Requirements—Grant Appeals Procedures

). Refunds owed to the Federal government as

a result of audit disallowances must be made in accordance with instructions issued by the Action Offi-

cial or OFM.

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It is imperative that recipients submit required 2 CFR Part 200, Subpart F audits within the time limits

specified in the regulation. If recipients are delinquent in complying with the provisions of the reg-

ulation, NIH will take one or more actions that may result in the loss of Federal funds. No audit costs

will be allowed either as indirect costs or direct costs to Federal awards if the required audits have not

been completed or have not been conducted in accordance with the provisions of 2 CFR Part 200, Sub-

part F.

See

Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost

for the allowability

of audit costs.

8.5 SPECIFIC AWARD CONDITIONS AND REMEDIES FOR

NONCOMPLIANCE (SPECIFIC AWARD CONDITIONS AND

ENFORCEMENT ACTIONS)

A recipient’s failure to comply with the terms and conditions of award, including confirmed instances of

research misconduct, may cause NIH to take one or more actions, depending on the severity and duration

of the non-compliance. NIH will undertake any such action in accordance with applicable statutes, reg-

ulations, and policies. NIH generally will afford the recipient an opportunity to correct the deficiencies

before taking action unless public health or welfare concerns require immediate action. However, even if

a recipient is taking corrective action, NIH may take proactive actions to protect the Federal gov-

ernment’s interests, including placing specific conditions on awards or precluding the recipient from

obtaining future awards for a specified period, or may take action designed to prevent future non-com-

pliance, such as closer monitoring.

8.5.1 Specific Award Conditions: Modification of the Terms of Award

During grant performance, the GMO may include specific award conditions in the grant award to require

correction of identified financial or administrative deficiencies as a means of protecting NIH’s interests

and effecting positive change in a recipient’s performance or compliance. When specific conditions are

imposed, the GMO will notify the recipient in writing of the nature of the conditions, the reason why

they are being imposed, the type of corrective action needed, the time allowed for completing corrective

actions, and the method for requesting reconsideration of the conditions. See 42 CFR Part 52.9 and 2

CFR Part 200.339.

The NIH awarding IC may withdraw approval of the PD/PI or other senior/key personnel specifically ref-

erenced in the NoA if there is a reasonable basis to conclude that the PD/PI and other such named seni-

or/key personnel are no longer qualified or competent to perform the research objectives. In that case,

the awarding IC may request that the recipient designate a new PD/PI or other named senior/key per-

sonnel.

Generally, the decision to modify the terms of an award (e.g., by imposing specific award conditions) is

discretionary on the part of the NIH awarding IC and is not appealable.

8.5.2 Remedies for Noncompliance or Enforcement Actions: Sus-

pension, Termination, and Withholding of Support

NIH may implement specific award conditions if a recipient or subrecipient fails to comply with the U.S.

Constitution, Federal statues, regulations, or the terms and conditions of award., When NIH determines

that noncompliance cannot be remedied by imposing specific conditions, NIH may take one or more of

the following actions:

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Temporarily withhold payments until the recipient or subrecipient takes corrective action.

Disallow costs for all or part of the activity associated with the noncompliance by the recipient

or subrecipient.

Suspend or terminate the Federal award in part or in its entirety.

Initiate suspension or debarment proceedings as authorized in 2 CFR Part 180.

Withhold further Federal funds (new awards or continuation funding) for the project or program

Pursue other legally available remedies in consultation with the HHS Office of General Counsel,

NIH Branch.

The regulatory procedures requirements that pertain to suspension and termination are specified in 2

CFR Parts 200.340 through 200.343.

An NIH award may be terminated in part or in its entirety as follows:

By NIH if the recipient fails to comply with the terms and conditions of the Federal award.

By NIH with the consent of the recipient (i.e. bilateral termination), in which case the two

parties must agree upon the termination conditions. These conditions include the effective date

and, in the case of partial termination, the portion to be terminated.

By the recipient upon sending NIH a written notification of the reasons for such termination, the

effective date, and, in the case of partial termination, the portion to be terminated. However, if

NIH determines that the remaining portion of the award will not accomplish the purposes for

which the award was made, NIH may terminate the Federal award in its entirety.

By NIH pursuant to the terms and conditions of the Federal award, including, to the extent

authorized by law, if the award no longer effectuates the program goals or agency priorities.

In accordance with the requirements outlined in 2 CFR Part 200.341, NIH must provide written noti-

fication of termination to the recipient. The written notice of termination will include the reasons for ter-

mination, the effective date, and the portion of the award to be terminated, if applicable.

If an NIH award is terminated due to the recipient's material failure to comply with the Federal award,

the notification must state that:

1. The termination decision will be reported to the OMB-designated integrity and performance sys-

tem accessible through SAM.gov.

2. The information will be available in SAM.gov for a period of five years from the date of the ter-

mination, then archived;

3. If NIH considers making a Federal award to the recipient during that five year period, NIH and

other Federal agencies must consider this information in judging whether the recipient is qual-

ified to receive the NIH award, when the NIH share of the award is expected to exceed the sim-

plified acquisition threshold over the period of performance;

4. The recipient may comment on any information in SAM.gov about the recipient for future con-

sideration by Federal awarding agencies. The recipient may submit comments in SAM.gov.

5. NIH may consider the recipient’s comments when determining whether the recipient is qualified

for a future NIH award.

Upon termination of an award, NIH will provide the information required by FFATA to USAspend-

ing.gov. In addition, NIH will update or notify any other relevant government-wide systems or entities of

any indications of poor performance as required by 41 U.S.C. 2313 and 31 U.S.C. 3321.

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When the recipient fails to comply with the terms and conditions of the award, NIH generally will sus-

pend (rather than immediately terminate) a grant and allow the recipient an opportunity to take appro-

priate corrective action before NIH makes a termination decision. However, NIH may decide to

terminate the grant if the recipient does not take appropriate corrective action during the period of sus-

pension. NIH may immediately terminate a grant when necessary, such as to protect the public health

and welfare from the effects of a serious deficiency. Termination due to the recipient’s failure to carry

out its approved project in accordance with the applicable law and the terms and conditions may be

appealed under NIH and HHS grant appeals procedures (see

Administrative Requirements—Grant

Appeals Procedures

A grant also may be terminated, partially or totally, by the recipient or by NIH with the consent of the

recipient (i.e., bilateral termination). If the recipient decides to terminate a portion of a grant, NIH may

determine that the remaining portion of the grant will not accomplish the purposes for which the grant

was originally awarded. In any such case, NIH will advise the recipient of the possibility of termination

of the entire grant and allow the recipient to withdraw its termination request. If the recipient does not

withdraw its request for partial termination, NIH may initiate procedures to terminate the entire grant.

See

Cost Considerations—Allowability of Costs/Activities—Selected Items of Cost

for the allowability

of termination costs. Allowability of these costs does not vary whether a grant is terminated by NIH, ter-

minated at the request of the recipient, or terminated by mutual agreement.

Withholding of support is a decision not to make a non-competing continuation award within the current

competitive segment. Support may be withheld for one or more of the following reasons:

Adequate Federal funds are not available to support the project.

A recipient failed to show satisfactory progress in achieving the objectives of the project.

A recipient failed to meet the terms and conditions of a previous award.

For whatever reason, continued funding would not be in the best interests of the Federal gov-

ernment.

The recipient may appeal NIH’s determination to deny (withhold) a non-competing continuation award

because the recipient failed to comply with the terms and conditions of a previous award.

8.5.3 Other Enforcement Actions

Depending on the nature of the deficiency, NIH may use other means of promoting recipient compliance.

Other options available to NIH include, but are not limited to conversion from an advance payment

method to a reimbursement method or disallow (deny) all or part of the cost of the activity or action not

in compliance. Other actions may include suspension or debarment of an organization or individual

under Government-wide Debarment and Suspension rules provided at 45 CFR Part 76, and other avail-

able legal remedies, such as civil action. Suspension under 45 CFR Part 76, implementing E.O.s 12549

and 12689, “Debarment and Suspension,” is a separate action from the “suspension” of an award as a

post-award remedy, as described in

Suspension, Termination, and Withholding of Support

above. The

subject of debarment and suspension as an eligibility criterion is addressed in

Completing the Pre-Award

Process—Determining Eligibility of Individuals

and

Public Policy Requirements and Objectives—

Debarment and Suspension

8.5.4 Recovery of Funds

NIH may identify and administratively recover funds paid to a recipient at any time during the life cycle

of a grant. Debts may result from cost disallowances, unobligated balances, unpaid share of any required

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matching or cost sharing, funds in the recipient’s account that exceed the final amount determined to be

allowable, or other circumstances. NIH guidance on the repayment of grant funds that are unrelated to

audit findings can be found on the

Grants Compliance and Oversight page

8.5.5 Debt Collection

The debt collection process is governed by the Federal Claims Collection Act, as amended (Public Law

[P.L.] 89-508, 80 Stat. 308, July 19, 1966); the Federal Debt Collection Act of 1982 (P.L. 97-365, 96

Stat. 1749, October 25, 1982); the Debt Collection Improvement Act (P. L.104-134, 110 Stat. 1321,

April 26, 1996); and, the Federal Claims Collection Standards (31 CFR Parts 900-904), which are imple-

mented for HHS in 45 CFR 30. NIH is required to collect debts due to the Federal government and,

except where prohibited by law, to charge interest on all delinquent debts owed to NIH by recipients.

When NIH determines the existence of a debt under a grant, written debt notification will be provided to

the recipient. Unless otherwise specified in law, regulation, or the terms and conditions of the award,

debts are considered delinquent if they are not paid within 30 days from the date the debt notification is

mailed to the recipient. Delinquent debts are subject to the assessment of interest, administrative cost

charges, and penalties. The interest on delinquent debts accrues on the amount due beginning on the date

the debt notification is mailed to the recipient.

If a recipient appeals an adverse monetary determination under 42 CFR Part 50, Subpart D, or 45 CFR

Part 16, interest will accrue but assessment will be deferred pending a final decision on the appeal. If the

appeal is not successful, interest will be charged beginning with the date the debt notification was mailed

to the recipient, not the date of the appeal decision. Interest charges will be computed using the pre-

vailing rate in effect on the date the debt notification is mailed, as specified by the Department of the

Treasury and 45 CFR Part 30.13(a)(2).

8.6 CLOSEOUT

The requirement for timely closeout is generally a recipient responsibility. However, NIH may initiate

unilateral closeout if a recipient does not provide timely accurate closeout reports or does not respond

timely to NIH requests to reconcile discrepancies in grant records. Recipients must submit a final FFR,

Final RPPR, and Final Invention Statement and Certification within 120 calendar days of the end of the

period of performance (i.e., project period end date). The reports become overdue on day 121. Note that

no-cost extensions update the project period end date and submission deadlines.

When recipients fail to submit timely reports, NIH will initiate unilateral closeout. If a recipient does not

submit all required closeout reports within a year of the project period end date, NIH will unilaterally

close the award and report the recipient’s failure to comply with the terms and conditions of award in

SAM.gov. In addition, failure to correct recurring reporting problems may cause NIH to take one or

more actions that may include, but are not limited to, corrective actions, withholding or further awards,

suspension or termination.

Failure to submit timely and accurate closeout documents may affect future funding to the organization.

NIH will close out a grant as soon as possible after the project period end date (no later than one year

after the project period end date in accordance with 2 CFR Part 200.344) if the grant will not be exten-

ded or after termination.

Closeout includes ensuring timely and accurate submission of all required reports and adjustments for

amounts due the recipient or NIH. Closeout of a grant does not automatically cancel any requirements

for property accountability, (see section

8.3.3.2.1 Exempt Property

and

8.3.3.2.2 Nonexempt Property

record retention, or financial accountability. Recipients generally must retain financial and programmatic

records, supporting documents, statistical records, and all other records that are required by the terms of

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the grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the

annual FFR is submitted. (See

8.4.2 Record Retention and Access

, for further information). Following

closeout, the recipient remains obligated to return funds due as a result of later refunds, corrections, or

other transactions, and the Federal government may recover amounts based on the results of an audit cov-

ering any part of the period of grant support.

A subrecipient must submit to the recipient, no later than 90 calendar days (or an earlier date as agreed

upon in the subaward agreement after the project period end date, all reports as required by the terms and

conditions of award.

8.6.1 Final Federal Financial Report

A final FFR is required for

any award that is terminated,

any award that is transferred to a new recipient, or

any award, including awards under SNAP, which will not be extended through award of a new

competitive segment.

Recipients are required to electronically submit the final FFR through the Payment Management System.

The final FFR must cover the entire competitive segment or as much of the competitive segment as has

been funded before termination. Final FFRs must indicate the exact balance of unobligated funds and

may not reflect any unliquidated obligations. There must be no discrepancies between the Federal share

of expenditures reported on the final FFR and the net cash disbursements reported in PMS on the Trans-

actions section of the FFR. It is the recipient’s responsibility to reconcile reports

prior

to submission to

PMS and to the NIH awarding IC. Withdrawal of the unobligated balance following completion date or

termination of a grant is not considered an adverse action and is not subject to appeal (see

Admin-

istrative Requirements—Enforcement Actions—Recovery of Funds

When the submission of a revised final FFR results in additional claims by the recipient, NIH will con-

sider the approval of such claims subject to the following minimum criteria:

The recipient must indicate why the revision is necessary and explain and implement internal

controls that will preclude similar occurrences in the future.

The charge must represent otherwise allowable costs under the provisions of the grant.

There must be an unobligated balance for the budget period sufficient to cover the claim.

The funds must still be available for use.

NIH must receive the revised final FFR within one year of its original due date.

8.6.2 Final Research Performance Progress Report

A Final RPPR required for any grant that is terminated and any award that will not be extended through

award of a new competitive segment. If a competitive renewal (Type 2) application has been submitted,

the recipient must submit an Interim-RPPR while their renewal application is under consideration. In the

event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for

the final year of the previous competitive segment. If the Type 2 is not funded, the Interim RPPR will be

treated by NIH staff as the institution’s Final RPPR.

A Final RPPR should be prepared in accordance with the requirements in the RPPR Instructions found

on the

NIH RPPR

web site and any specific requirements set forth in the terms and conditions of the

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8 Administrative Requirements

award. In addition to the standard requirements detailed in those Instructions, recipients should also

report additional information required by the awarding IC in program-specific final progress report

instructions.

Final RPPR Instructions for SBIR/STTR Phase II Reports are in Section 7.3. of the

RPPR Instructions

8.6.3 Final Invention Statement and Certification

The recipient must submit a Final Invention Statement and Certification (HHS 568), whether or not the

funded project results in any subject inventions, and whether or not inventions were previously reported.

The HHS 568 must list all inventions that were conceived or first actually reduced to practice during the

course of work under the project, and it must be signed by an AOR. The completed form should cover

the period from the original effective date of support through the completion date or termination of the

award, and it should be submitted to the NIH awarding IC. If there were no inventions, the form must

indicate “None.” For certain programs (activity codes = C06, , D42, D43, D71, DP7, G07, G08, G11,

G13, K12, K16, K30, P09, P40, P41, P51, R13, R25, R28, R30, R90, RL5, RL9, S10, S14, S15, U13,

U14, U41, U42, U45, UH4, UC6, UC7, UG4, UR2, X01, X02, Ts, and Fs), the Final Invention State-

ment and Certification is not currently required. For questions, the recipient should contact NIH award-

ing IC for specific instructions.

When invention reporting is required, the HHS 568 does not relieve the responsible party of the oblig-

ation to assure that all inventions are promptly and fully reported directly to NIH, as required by terms of

the award. Copies of the HHS 568 form are available on the iEdison web site at

http://iEdison.gov

and at

Forms Directory

8.6.4 Submission of Closeout Documents

All closeout documents must be submitted electronically via eRA Commons (Final RPPR and Final

Invention Statement) or PMS (Final FFR), as applicable. NIH no longer accepts paper or e-mail sub-

missions.

8.7 GRANT APPEALS PROCEDURES

HHS permits recipients to appeal certain post-award adverse administrative decisions made by HHS offi-

cials (see 45 CFR Part 16 and appendix to Part 16). NIH has established a first-level grant appeal pro-

cedure that must be exhausted before an appeal may be filed by the recipient with the Departmental

Appeals Board (DAB) (see 42 CFR Part 50, Subpart D). NIH will assume jurisdiction for the following

adverse determinations set forth in 42 CFR Part 50.404:

Termination, in whole or in part, of a grant for failure of the recipient to carry out its approved

project in accordance with the applicable law and the terms and conditions of award or for fail-

ure of the recipient otherwise to comply with any law, regulation, assurance, term, or condition

applicable to the grant.

Determination that an expenditure is not allowable under the grant has been charged to the grant

or that the recipient has otherwise failed to discharge its obligation to account for grant funds.

Denial (withholding) of a non-competing continuation award for failure to comply with the

terms of a previous award.

Determination that a grant is void (i.e., a decision that an award is invalid because it was not

authorized by statute or regulation or because it was fraudulently obtained).

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8 Administrative Requirements

The formal notification of an adverse determination will contain a statement of the recipient’s appeal

rights. In the first level appeal of an adverse determination, the recipient must submit a request for

review to the NIH official specified in the notification, detailing the nature of the disagreement with the

adverse determination and providing supporting documents in accordance with the procedures contained

in the notification.

“The request for review must include a copy of the adverse determination, must identify the issue(s) in

dispute, and must contain a full statement of the recipient’s position with respect to such issue(s) and the

pertinent facts and reasons in support of the recipient’s position. In addition to the required written state-

ment, the recipient shall provide copies of any documents supporting its claim.” 42 CFR Part 50.406(b).

The recipient’s request to NIH for review must be submitted no later than 30 days after the written noti-

fication of the adverse determination is received; however, an extension may be granted if the recipient

can show good cause why an extension is warranted (42 CFR Part 50.406(a)).

If the NIH decision on the appeal is adverse to the recipient or if a recipient’s request for review is rejec-

ted on jurisdictional grounds, the recipient then has the option of submitting a request to the DAB for a

further review of the case in accordance with the provisions of 45 CFR Part 16. A prospective appellant

must submit a notice of appeal to the DAB within 30 days after receiving the final NIH decision. “The

appellant must have exhausted any preliminary appeal process required by regulation.” 45 CFR Part 16.3

(c).

In addition to the adverse determinations indicated above, the DAB is the

single level of appeal

for dis-

putes related to the establishment of indirect cost rates, research patient care rates, and certain other cost

allocations used in determining amounts to be reimbursed under NIH grants (e.g., cost allocation plans

negotiated with State or local governments and computer, fringe benefit, and other special rates. The

determination leading to such disputes may be made by an HHS official other than the GMO and may

affect NIH grants as well as other HHS grants.

8.8 ALIGNMENT WITH PROGRAM GOALS AND AGENCY

PRIORITIES

As stewards of taxpayer funds, NIH is committed to delivering results that matter to the public, per a

Unified Strategy that aligns our priorities and funding approaches. See, e.g., Advancing NIH’s Mission

Through a Unified Strategy and its addenda. Therefore, NIH may terminate awards, to the extent author-

ized by law, if an award no longer effectuates the program goals or agency priorities. These termination

actions are not terminations for noncompliance with terms and conditions of award, and they are not

appealable under 2 CFR 200.342 or 42 CFR 50, subpart D.

When a recipient accepts an NIH award, they agree that continued funding for the award is contingent

upon the availability of appropriated funds, recipient satisfactory performance, compliance with the

Terms and Conditions of the award, and ongoing alignment with program goals or agency priorities.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

PART II: TERMS AND CONDITIONS OF NIH GRANT

AWARDS

Subpart B: Terms and Conditions for Specific Types of Grants,

Recipients, and Activities

This Subpart includes terms and conditions that vary from, are in addition to, elaborate on, or highlight

the standard requirements and terms and conditions in IIA because of the type of grant, recipient, or

grant-supported activity. Each chapter of IIB specifies how the coverage relates to that in IIA and must

be used in conjunction with IIA to determine all of the applicable terms and conditions of a covered type

of activity, recipient, or award.

This Subpart contains the following chapters:

Multiple Program Director/Principal Investigator Applications and Awards

Construction, Modernization, or Major Alteration and Renovation of Research Facilities (this

chapter also includes requirements for specified A&R activities under non-construction grants)

Individual Fellowships and Institutional Research Training Grants (also termed “fellowships”

and “training grants”) under the Kirschstein-NRSA program

Career Development Awards

Modular Applications and Awards

Support of Scientific Meetings (Conference Grants)

Consortium Agreements

Grants to Foreign Organizations, International Organizations, and Domestic Grants with a For-

eign Component

Grants to Federal Institutions and Payments to Federal Employees Under Grants

Grants to For-profit Organizations

Research Patient Care Costs.

IIB-1

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

9 Multiple Program Director/Principal Investigator Applications and Awards

9 MULTIPLE PROGRAM DIRECTOR/PRINCIPAL

INVESTIGATOR APPLICATIONS AND AWARDS

9.1 GENERAL

Multiple Program Director/Principal Investigator (multiple PD/PI) awards are an opportunity for mul-

tidisciplinary efforts and collaboration through a team of scientists under a single grant award. All

PD/PIs share equally the authority and responsibility for leading and directing the project, intellectually

and logistically. Each PD/PI is responsible and accountable to the applicant organization, or as appro-

priate to a collaborating organization, for the proper conduct of the project or program, including the sub-

mission of all required reports. The presence of more than one PD/PI on an application or award

diminishes neither the responsibility nor the accountability of any individual PD/PI. The applic-

ant/recipient organization is responsible for securing and retaining the required written assurance sig-

natures from each identified PD/PI on all applications, post-submission information, progress reports,

and post-award prior approval requests and must make these signatures available to NIH or other author-

ized DHHS or Federal officials upon request.

Additional information is available at the NIH Multiple

Principal Investigators website

9.2 APPLICABILITY

Applications submitted electronically through Grants.gov for most award mechanisms permit multiple

PD / PIs, with the exception of awards for which multiple PD / PIs would not be appropriate such as indi-

vidual fellowship and career awards, dissertations grants (R36), Pioneer Awards (DP1), Construction

Grants (C06 / UC6), Grants for Repair, Renovation and Modernization of Existing Research Facilities

(G20), and Shared Instrumentation Grants (S10). SBIR / STTR applicants may use the multiple PD / PI

option; refer to the SBIR / STTR multiple PD / PI section for specific requirements affecting small busi-

ness concerns. For active awards, changing from a multiple PD / PI model to a single PD / PI model or

changes in the number or makeup of the PD / PIs on a multiple PD / PI award requires the prior approval

of the funding IC (see

Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel

Named in the NoA

9.3 APPLICATION REQUIREMENTS

The decision to submit a multiple PD/PI application is that of the applicant organization and the PD/PIs,

and should be consistent with the scientific goals of the project. A single applicant organization may des-

ignate multiple PD/PIs from the applicant organization or may designate multiple PD/PIs from multiple

institutions. Multiple organizations may not submit the same multiple PD/PI application.

All PD/PIs must be qualified and have appropriate expertise to serve as a PD/PI and the appropriate level

of authority and responsibility to direct the project or program as part of the leadership team. Each PD/PI

must have a defined role on the project. There is no limit on the number of PD/PIs that may be des-

ignated, and no minimum person months requirement, except STTR applicants where each PD/PI must

commit a minimum of 1.2 calendar months (10%) effort (see

Grants to For-Profit Organizations—SBIR

and STTR Programs—Multiple PD/PI Applications and Awards

Contact PD/PI.

The applicant organization must designate one of the PD/PIs as the Contact PD/PI to

serve as a primary point of contact. The Contact PD/PI must be listed first on the application and must

be associated with the applicant organization. The Contact PD/PI is responsible for communication

between the PD/PIs and NIH, but has no special authorities or responsibilities within the leadership

team. Responsibilities of the Contact PD/PI may include communication between the leadership team

IIB-2

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

9 Multiple Program Director/Principal Investigator Applications and Awards

and NIH, assembly of the application materials, and coordination of progress reports. On complex pro-

jects the Contact PD/PI may request additional effort for coordination responsibilities if necessary.

eRA Commons Registration Required.

All PD/PIs must have established eRA Commons accounts with

a PI role prior to application submission. When multiple PD/PIs are at different organizations, all organ-

izations must also be registered in the eRA Commons. If the contact PD/PI is at a different institution

from the applicant organization, then the applicant organization must also affiliate the contact PD/PI with

their institution. Beyond the contact PD/PI, it is not necessary for all other PD/PIs to be affiliated with

the applicant organization.

Leadership Plan.

All multiple PD/PI applications are required to include a Leadership Plan. The purpose

of the Leadership Plan is to facilitate and enhance scientific productivity and establish a decision-making

process. The Plan must describe a rationale for choosing the multiple PD/PI approach. The governance

and organizational structure of the leadership team and the research project should be described, includ-

ing communication plans, process for making decisions on scientific direction, and procedures for resolv-

ing conflicts. The roles and administrative, technical, and scientific responsibilities for the project or

program should be delineated for the PD/PIs, including responsibilities for human subject studies or stud-

ies with vertebrate animals as appropriate.

New Investigators (Including Early Stage Investigators).

Multiple PD/PI applications may designate

senior and new investigators, including early stage investigators. However, the application will only be

considered a new investigator application when all of the PD/PIs meet the NIH definition of new invest-

igator, and will only be considered an early stage investigator application when all of the PD/PIs meet

the NIH definition of early stage investigator. For the purposes of classification as a new investigator,

serving as a PD/PI on a substantial independent PD/PI research award is equivalent to serving as a PD/PI

on a substantial independent PD/PI research award. Thus, if a new investigator successfully competes as

a PD/PI on a substantial independent multiple PD/PI grant, they no longer qualifies as a new (or early

stage) investigator on a substantial independent single PD/PI application. However, if a new investigator

is added as a PD/PI to an active substantial independent research award, the individual will retain their

new investigator status.

Multi-Project Applications.

Assuming the NOFO for Multi-project applications (e.g., P01, P30) spe-

cifically allows multiple PD/PIs, applications may include multiple lead investigators for subprojects as

well as multiple PD/PIs for the entire program. Do not confuse lead investigator(s) of a subproject or

component of a multi-project application with multiple PD/PIs of the entire program. Lead investigator

(s) of subprojects or components are not automatically considered to be PD/PIs of the entire application.

When a lead investigator of a subproject or component is also a PD/PI of the entire program, that indi-

vidual must specifically be designated as a PD/PI of the application.

Budgets.

In general, multiple PD/PI applications will submit a single budget for the entire project. This

applies to both modular and detailed budgets. When determining if a modular budget should be sub-

mitted, the $250,000 threshold is for the entire project, not per PD/PI. When multiple PD/PIs are at dif-

ferent institutions, the standard instructions for submitting consortium budgets apply. Applicants can

choose to include budget allocation information for specific PD/PIs as part of the Leadership Plan. In the

event of an award, the requested allocations may be reflected in a term in the NoA (see Leadership Plan

above).

Renewal or Resubmission Applications.

A renewal or resubmission application may change from a

single PD/PI to multiple PD/PIs or may change the number or makeup of the multiple PD/PIs. However,

the applicant must provide a rationale for the change in the renewal / resubmission application, and

include the required Leadership Plan. Likewise, a previously submitted multiple PD/PI application may

change to a single PD/PI application in a renewal or resubmission; the applicant must provide a rationale

for the change in the application.

IIB-3

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

9 Multiple Program Director/Principal Investigator Applications and Awards

Competing Revision Applications.

A competing revision application to an existing Multiple PD/PI grant

must be submitted using the same Contact PD/PI as the parent grant, and may propose changes in the

Leadership Plan or in the composition of the leadership (by adding or removing PD/PIs), and should

provide a rationale for any such changes. A competitive revision to a single PD/PI grant may be sub-

mitted proposing multiple PD/PIs provided a Leadership Plan is also included.

9.4 APPLICATION REVIEW AND AWARD

The review criteria applied to multiple PD/PI applications are the same criteria applied to single PD/PI

applications and each application will be evaluated on its own merit (see

The Peer Review Process

Part I). Peer reviewers will consider each PD/PI's qualifications and identified role in the project. The

leadership approach will be used to facilitate understanding of the complexities of the science and the

management of the project. The quality of the Leadership Plan will be considered as part of the assess-

ment of the overall approach and incorporated into the scientific and technical merit determination. Peer

reviewers will not recommend that individual PD/PIs be removed; however, reviewers may recommend

deletion of the specific aims and budget of a PD/PI, which would effectively remove the PD/PI's effort.

The SRG must evaluate the application in its entirety without dropping components.

All PD/PIs are listed on the Summary Statement, in the NoA, and in NIH databases.

9.5 POST-AWARD ADMINISTRATION

If multiple PD/PIs are from multiple organizations, NIH will issue the award to the applicant organ-

ization which will administer the award using consortium or subaward arrangements in accord with the

Consortium Agreements

chapter. Budgets, including indirect costs associated with subawards, will be

determined according to existing policy. Changes in the allocation and the size of subawards will be

handled in the same way as single PD/PI awards.

Responsibility for all required reports is shared by the PD/PIs and the recipient institution. Only one of

each required report should be submitted. Although all PD/PIs are responsible for the content of all

reports, only one PD/PI should upload information in the eRA Commons. As with most other Commons

features, only the recipient Signing Official may submit the reports to NIH, including closeout reports

(final invention statement, progress report and financial status report).

Requests for administrative supplements must be submitted from an authorized official at the recipient

organization and include the grant number and name of the Contact PD/PI in the request. For all applic-

ations, post-submission information, progress reports, and prior approval requests including requests to

add or drop a PI, the recipient organization remains responsible for securing and retaining the required

written assurance signatures from each identified PD/PI.

A change in Contact PD/PI may be designated in a non-competing continuation progress report; the

Contact PD/PI must be a member of the existing leadership team and associated with the recipient organ-

ization. Revision of the Leadership Plan during the project period may be accomplished through a joint

decision of the PD/PIs and reported in a non-competing continuation progress report.

All existing prior approval requirements apply to multiple PD/PI awards, including the change in status

of any one of the PD/PIs or the addition of a PD/PI; refer to

Administrative Requirements—Prior

Approval Requirements

in IIA. If a PD/PI withdraws from the grant or is no longer able to work on the

project, a revised Leadership Plan or description of the impact on the project of a change to a single

PD/PI award must be submitted as part of the prior approval request. NIH will evaluate the request con-

sidering the project as a whole, including the impact on the scope of work and budget.

IIB-4

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

9 Multiple Program Director/Principal Investigator Applications and Awards

If the Contact PD/PI changes institutions, the recipient institution will need to consider options. Since it

is required that the Contact PD/PI be affiliated with the recipient institution in the Commons, the insti-

tution may choose to designate another PD/PI as the Contact. Another option would be to relinquish the

grant and allow it to be transferred. Contact PD/PIs considering transferring should consult with the NIH

awarding IC early in the process to discuss options.

IIB-5

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

10 CONSTRUCTION, MODERNIZATION, OR MAJOR

ALTERATION AND RENOVATION OF RESEARCH

FACILITIES

10.1 GENERAL

The chapter uses the following definitions:

Construction.

Construction of a new building, structure or facility, including the installation of

fixed equipment, which provides space not presently available. It excludes the purchase of land

and ancillary improvement, for example parking lots, roads, or fencing. The construction of shell

space is not allowable as a construction activity since shell space does not provide usable space

for research activities.

Modernization.

Alteration, renovation, remodeling, improvement, expansion or repair of, or com-

pletion of shell space in an existing building (whether for storage or human occupancy) neces-

sary to make the building suitable for use for the purposes of a particular program.

Modernization is distinct from construction in that it leaves the existing structure in place. This

can range from updating flooring to replacing everything except for the existing mainframe and

foundations. When the primary purpose of the award is to modernize biomedical research facil-

ities, the grant cannot support the conduct of any research.

Alteration and Renovation (A&R) activities are considered as modernization activities and are typically

supported under research grants where the primary purpose of the grant is other than construction or mod-

ernization. The determination of whether proposed A&R is major, or minor is made by the NIH Program

Official. Major A&R is an unallowable activity or cost under foreign grants and foreign components in

domestic grants.

To issue awards with the primary purpose of construction or modernization, an IC must have specific

statutory authority allowing construction or modernization. Even if NIH has this authority, a recipient

may not incur costs for any of these activities unless NIH specifically authorizes such costs.

NIH generally requests applications, and makes awards, for construction or modernization under grants

or cooperative agreements specifically for that purpose. The recipient retains the primary responsibility

for the project, including all phases of design and construction. When needed, under cooperative agree-

ments, there is substantial scientific/programmatic staff involvement during the performance of the activ-

ity, which may include providing technical assistance in designing, constructing, and commissioning the

facility and coordinating collaboration with other IC funded construction activities.

In addition, an applicant/recipient may propose to undertake an A&R project(s) under a grant whose

primary purpose is other than construction or modernization. NIH characterizes these A&R projects as

“minor” or “major,” depending on the type of activity proposed (see definitions above). If a post-award

change would result in an A&R project that meets the definition of construction or Major A&R the recip-

ient must notify the GMO in order for the IC to determine whether it is construction and whether the IC

has the necessary statutory authority. The requirements that apply to minor A&R projects are addressed

in IIA. Minor A&R projects are not required to satisfy all of the requirements of this chapter. Major

A&R projects are subject to the requirements of this chapter as indicated.

Except where indicated, the requirements in this chapter apply to NIH grant-supported construction or

modernization in lieu of the requirements in IIA. For major A&R projects, this chapter applies to the

A&R activity only and IIA pertains to the other grant-supported activities under the same award, if any.

IIB-6

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

However, there may be areas of overlap (e.g., a post-award change that causes a minor A&R project to

become a major A&R project). See

Exhibit 11

for a summary of the requirements specified in this

chapter and their potential applicability to construction, modernization, or major A&R.

This chapter addresses all aspects of grant-supported construction, modernization, and major A&R from

application through closeout. Due to the size and complexity of these activities, this chapter describes in

detail requirements and recipient responsibilities related to procurement of construction services (see

Pro-

curement Requirements for Construction Services

below). Applicants and recipients also should refer to

the construction grant program regulations (42 CFR Part 52b), which, by their terms, apply to con-

struction and modernization grants as well as major A&R under a research grant mechanism; 2 CFR

Part 200; and applicable administrative regulations; and program guidelines. Questions concerning con-

struction or modernization grants or major A&R requirements or policies should be directed to the GMO

or other official designated in the NoA.

10.1.1 Eligibility

In addition to any program-specific eligibility criteria, only public or private non-profit entities located in

the United States or in U.S. territories or possessions are eligible to apply for construction or mod-

ernization grants. For-profit organizations and foreign organizations are not eligible to receive NIH con-

struction or modernization grants. Major A&R is an unallowable activity or cost under foreign grants and

foreign components in domestic grants.

10.1.2 Notices of Funding Opportunity

Construction grant applicants are required to apply in response to a specific NOFO. RFAs generally are

used to solicit construction or modernization grant applications. PAs also may be issued to solicit con-

struction or modernization grant applications for ongoing programs for which applications may be sub-

mitted under multiple cycles or years.

In addition to the NOFO, NIH awarding ICs also may develop program guidelines that include detailed

policy and procedural information applicable to specific construction and modernization grant pro-

grams/activities. Any program-specific requirements will be included in or referenced in the NOFO and

NoA. Applicants should consult the NOFO and program guidelines, if any, when applying for con-

struction or modernization grants.

10.1.3 Application Review and Award

Construction and modernization grant applications and applications requesting funding for a major A&R

project are subject to peer review. Specific review criteria are included in the NOFO.

Construction and modernization grants usually involve a single award, covering more than one year,

made on the basis of an application for the entire project. Incremental funding (budget periods) within a

project period normally is not used for construction or modernization grants and funding may be limited

by the requirements of Federal appropriations law (31 U.S.C. §1552(a)) which may limit NIH’s ability to

approve no-cost extensions. Recipients must consult with the GMO if it is expected that the construction

or modernization activity is unlikely to be concluded within the project period specified in the NoA.

Unlike other grants awarded by NIH, under which a recipient’s signature is not required to indicate

acceptance of an award, under construction and modernization grants, the AOR must sign the NoA and

return it to the GMO to indicate acceptance of the terms and conditions of award.

IIB-7

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

10.1.4 Title to Site

NIH expects that the applicant holds (or will hold) fee simple title (i.e., absolute ownership of real prop-

erty or absolute title to land, free of any claims against the title) to the property or other estate or interest

in the site (e.g., leasehold interest) on which the construction, modernization, or major A&R is per-

formed. NIH will determine whether an applicant meets this requirement as part of the administrative

review of an application.

The applicant must include with the application a legal opinion describing the interest the applicant has

in the performance site. The legal opinion should describe any mortgages or other foreclosable liens on

the property, including the principal amount of the mortgage (and rate of interest); the dates of the mort-

gage; the terms and conditions of repayment; the appraised value of the property; and any provisions

designed to protect the Federal interest in the property.

10.1.5 Matching Requirement

The requirements for recipients to share in the cost of the project are set forth in 42 CFR Part 52.b.6,

What is the rate of federal financial participation?

Unless otherwise specified by statute, the rate of fed-

eral financial participation in a construction project cannot be more than 50 percent of allowable con-

struction costs. NIH can waive this requirement; however, it is not automatic and must be requested from

the IC prior to application submission.

Matching may be in the form of allowable costs incurred by the recipient or a contractor under the grant.

NIH generally does not allow recipients to use the value of third party in-kind contributions as a source

to meet a matching requirement; however, the GMO may allow third party in-kind contributions

included in the application budget on an exception basis. Third party in-kind contributions are the value

of non-cash contributions provided by non-Federal third parties. Third party in-kind contributions may

be in the form of real property, equipment, supplies and other expendable property and the value of

goods and services directly benefiting and specifically identifiable to the project or program. To be allow-

able as matching, costs and in-kind contributions (if authorized) must meet allowability and doc-

umentation requirements of 2 CFR Part 200.306, as applicable. Costs and third party in-kind

contributions claimed as matching also are subject to the requirements in IIA that apply to the expendit-

ure of NIH funds.

The source and amount of funds proposed by an applicant to meet a matching requirement must be iden-

tified in the application. The applicant also will be required to demonstrate that the funds are committed

or available at the time of, and for the duration of, the award. Exception to “cash on hand” will require

negotiation with NIH prior to award. This may take the form of an assurance, as specified by the NIH

awarding IC. The amount of NIH (Federal) funds awarded, combined with the non-Federal share, will

constitute the total approved budget as shown in the NoA. The prior approval and other dollar thresholds

contained in this chapter are based on the total approved budget unless otherwise specified. Downward

adjustments to the matching requirement after award are a prior approval action. If NIH approval is not

received in advance it is considered a violation of the terms and conditions of the construction award and

may warrant enforcement action.

In addition to sharing in the costs of a construction grant, the recipient must ensure the availability of suf-

ficient funds for operation (or continued operation) of the facility when construction or modernization is

completed to allow the effective use of the facility for the grant-supported purposes.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

10.2 PROCUREMENT REQUIREMENTS FOR CONSTRUCTION

SERVICES

10.2.1 General

Construction, modernization, and major A&R activity usually is carried out through one or more con-

tracts under the grant. Therefore, the circumstances of the procurement are critical to the successful com-

pletion of the grant-supported project. Recipient procurement must comply with the requirements

specified in 2 CFR Parts 200.317 through 200.327, as applicable. Recipients must use only those con-

tracting methods that will:

Ensure that all qualified contractors are given an opportunity to bid or propose and to have their

bids/proposals fairly considered.

Ensure that the contract(s) will result in the completion of a facility—ready for occupancy—that

conforms to the design and specifications approved by NIH (or any appropriate modification

thereof also approved by NIH), at a cost that is within the owner’s ability to pay.

Unless otherwise authorized by NIH, all work associated with NIH grant-supported construction, mod-

ernization, or major A&R must be procured by formal advertising, resulting in lump-sum, fixed-price

contracts using the

Design-Bid-Build

model. NIH may authorize other procurement methods and other

types of contracts when sealed bidding is impractical (see

Construction-Alternate Contracting Methods

The recipient must obtain NIH approval of final construction documents both before bids or proposals

are solicited and prior to the award of the contract. The recipient must ensure that the project is com-

pleted in accordance with the approved plans and specifications or secure NIH approval of any changes

that materially alter the scope or costs of the project, use of space, or functional layout.

The two basic means of ensuring that a contract can be awarded at, or very near, the budgeted amount

are accurate cost estimating and the use of bid alternates.

A precise description of the scope of work, specifications, materials, and construction techniques will

facilitate accurate cost estimating by the recipient and, ultimately, the responsive bidders. The descrip-

tion of the scope of work is especially important when multiple contracts will be awarded in support of

the same project, because each contractor must know exactly what is involved in the portions of the job

being bid.

Where practical, the recipient may request in the invitation for bids, alternates to the base bid which are

keyed to specified, and explicitly stated, changes in the project scope, materials, or construction tech-

niques. The invitation may contain either additive alternates (adjustments increasing the amount of the

base bid), or deductive alternates (adjustments reducing the amount of the base bid), or both. Additive

alternates will make it possible to incorporate necessary features that otherwise would not have been

included in the project as long as the features do not expand the scope of the peer reviewed and

approved project. Alternates that are selected may be included in determining the low aggregate bid.

If, notwithstanding the use of deductive alternates, all bids exceed the funds available, the recipient may:

Decline to award the contract(s) and instead, after NIH approval, issue a revised invitation for

bids containing changes in the bid documents or other factors affecting price.

Negotiate with the low bidder. All changes in design and specifications resulting from such nego-

tiations must be approved by NIH. If the low bidder refuses to negotiate, negotiations may be

entered into with the next lowest bidder. If efforts to negotiate are unsuccessful, all bids must be

cancelled and the project rebid.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

If the NIH-supported project is less than the entire facility or project, the recipient must obtain bids or

proposals that provide the costs for that portion of the total job that will be paid by NIH funds and any

required matching. This may be done in one of the following ways:

If the project consists of more than one building or site and can be divided for purposes of obtain-

ing a price or cost estimate and for carrying out the construction or modernization, showing the

cost for each building or site, or

If the project is a single site or contains common space and cannot be divided for pricing and

construction or modernization purposes, identifying or prorating the applicable costs or price.

10.2.2 Liquidated Damages

Invitations for bids must stipulate a time for completion of the project, expressed either in calendar days

or as a fixed date, for each prime contract to be awarded under the project.

At the option of the recipient, a liquidated damages provision may be included in the contract, allowing

for assessment of damages when the contractor has not completed the construction by the date specified

in the contract. Liquidated damages must be realistic and justified and must be approved by NIH before

solicitation. Where damages are assessed, any amounts paid belong to the recipient.

10.3 CONTRACTING METHODS

10.3.1 Design-Bid-Build

The traditional three-phase project delivery method in which the recipient contracts with separate entities

for each the design and construction phase of a project. It begins with a project design phase, followed

by the construction bid phase (including solicitation and selection of a construction contractor), and then

the active construction phase.

10.3.2 Alternate Contracting Methods

The use of a contracting method other than Design-Bid-Build, including the use of construction man-

agement services or design-build services as described below, may be authorized by NIH when cost,

time, and quality benefits will result. In making such determinations, NIH will consider the scope of the

project, estimated cost, and other factors deemed relevant. NIH approval must be received before the

recipient begins the process of using an alternate contracting method.

If a construction management firm is currently employed, the recipient may choose to authorize that firm

to perform the construction work. Such authorization requires NIH prior approval and the price for the

work involved must not exceed the GMP also approved by NIH.

10.3.2.1 Construction Manager

10.3.2.1.1 Construction Manager as Agent

Use of construction management services, under which the recipient contracts for technical consultation

during the design stage of a project and for organization and general project oversight of construction

activities during the construction phase, is considered professional services and, therefore, may be pro-

cured on a negotiated basis rather than by formal advertising. However, the services of CMs may be pro-

cured by formal advertising in those cases where State or local governments prohibit the award of

construction management contracts on a negotiated basis. Where bids are invited, the bidders should be

pre-qualified. Under this procedure, the CM, operating as a member of a recipient-architect-CM team, is

IIB-10

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

responsible for cost estimates during the design and construction as well as cost control, review of design

(s) with a view toward value engineering, consultation on construction techniques, construction coordin-

ation and scheduling, and oversight of all construction activities. The CM’s fee is considered an eligible

cost for the purpose of determining the total eligible cost of the project.

10.3.2.1.2 Construction Manager-at-Risk

A CM-at-Risk is considered a sole proprietorship, partnership, corporation, or other legal entity that

assumes the financial risk for construction, rehabilitation, alteration, or repair of a facility at a GMP (see

Construction-Alternate Contracting Methods-Guaranteed Maximum Price

). The CM-at-Risk serves as a

general contractor and provides consultation to the client during the design of the facility and through

construction. The terms of the CM’s employment must be such as to preclude any conflict of interest.

The recipient may authorize the CM as Agent to become the CM-at-Risk to perform the construction ser-

vices when authorized by NIH.

Under this procedure:

The construction management contract must place total financial responsibility on the CM to

complete construction of the project at or below a GMP. The CM is required to provide 100 per-

cent performance and payment bonds to ensure that the facility can be completed with the

amount of funds available.

The GMP must be obtained from the CM before NIH will authorize the award of the first con-

struction contract. This requirement applies whether or not phased construction techniques are

employed. Each portion of the work for which a separate contract is expected shall be separately

priced as an individual line item in the GMP contract.

10.3.2.2 Design-Build Services

Design-build is a method of project delivery in which one entity works under a single contract with the

project owner to provide design and construction services. In design-build contracting, construction firms

respond to a request for proposals by submitting building designs that meet the recipient’s performance

requirements within a GMP (see

Construction-Alternate Contracting Methods-Guaranteed Maximum

Price

) covering all architectural, engineering, and construction services required. The design-build firm

must be selected in a manner that will allow maximum feasible competition. Because of the nature of

design-build contracting, the following departures from formal advertising are authorized:

Cost will be treated as a competitive factor although the recipient may insert in the request for

proposals a specified maximum permissible figure.

A contract may be awarded regardless of the number of proposals received or the number of

firms determined to have met qualification standards.

The recipient may negotiate cost or design with one or any number of firms.

The selection of a design-build firm must be accomplished by a process that includes the following activ-

ities:

Preparation of a RFP describing the recipient’s design requirements, cost requirements, standards

for qualifying firms, and the criteria on which proposals will be judged.

Public announcement of the RFP.

Consideration of all proposals from firms that are determined to be qualified.

Selection of that firm that, in the recipient’s judgment, represents the best offer considering both

the firm’s qualifications and satisfaction of the criteria in the RFP.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

On all design-build projects, the recipient must:

Ensure a firm total cost by including in the contract a provision that extra costs resulting from

errors or omissions in the drawings or estimates will be the design-build firm’s responsibility.

Justify cost on the basis of comparability with similar construction.

10.3.2.3 Guaranteed Maximum Price

Under this procedure:

The Guaranteed Maximum Price (GMP) contracting method can be used in either Construction

Manager at Risk contracts or as part of Design-Build Services contracts. In either case, the pro-

ject must be completed at or below the GMP.

The recipient must transmit all GMP bids to the GMO, with its recommendation for award to the

lowest responsive, responsible bidder.

The GMP must be completely itemized, by trade, to include a separation of labor and materials,

all markups, and no contingency other than that which will cover change orders as approved by

the recipient.

After approval of the GMP, all GMP subcontracts must be competed, and there must be at least

three bidders to allow for an award.

o

Issue a “sources sought” announcement describing the nature of the construction work

required, the separate contracts to be awarded, and the standards for prequalification. It

must also describe the complete scope of work with sufficient specificity to ensure

response from all interested sources.

o

Pre-qualify all firms that respond to the announcement who are determined by the recip-

ient to meet the prequalification standards.

o

Establish bidder’s lists for each of the invitations to bid. The lists must include all firms

qualified on the basis of responses to the “sources sought” announcement and may also

include other qualified firms known to the recipient.

o

By written invitation, solicit bids from all firms on the bidders list.

o

Consider bids from any contractor who requests permission to bid and who is determ-

ined by the recipient to meet the prequalification standards.

o

If three bids cannot be obtained, the recipient must submit, in writing, to the GMO a

detailed explanation of why the GMP contractor is unable to comply, along with sup-

porting documentation for NIH consideration and approval of another alternate con-

tracting method.

o

Funds unexpended, due to lower construction costs than estimated in the GMP, must be

refunded or credited to the recipient by the contractor and by the recipient to NIH. All

costs in excess of the GMP are the responsibility of the GMP contractor.

o

All subcontract prices must be approved by the GMO before making individual awards.

The awards shall be made to the lowest-priced responsible, responsive bidders.

10.4 DESIGN DOCUMENTATION REQUIREMENTS

Unless otherwise specified in the NoA, following award acceptance for construction or modernization

grants or award of funds for a major A&R project, the recipient may begin the design phase of the

award, which includes the review, and approval of the design documents with the IC program or other

IIB-12

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

designated NIH staff. Funds for construction, modernization, or major A&R will not be released until the

final architectural drawings, specifications, construction schedule, and updated cost estimates are

reviewed and approved by the NIH IC unless otherwise indicated in the NoA. The release of funds is

accomplished by a revised NoA. The purpose of the NIH design review is to ensure that applicable

design standards, including, as applicable, the minimum requirements contained in 42 CFR Part 52b.12

(see

Minimum Requirements for Construction, Modernization, and Major A&R

below), have been incor-

porated into the working drawings and specifications to ensure that program requirements are met, and

that the facility will suitably accommodate the activities for which it is planned to be used.

Advertisement for bids may be initiated only after approval of the final construction documents by the

NIH awarding IC. The procurement methods to be employed, including any plans that involve a con-

struction management contract with a GMP clause, must be reviewed and approved by the NIH awarding

IC.

10.4.1 Minimum Design Requirements for Construction, Modernization

and Major A&R

The minimum design requirements for NIH grant-supported construction or modernization are set forth

in 42 CFR Part 52b.12. The

NIH Design Requirements Manual

incorporates the regulatory standards for

construction or modernization grants and those for major A&R projects.

Section 1.1.2 of the Design Requirements Manual provides the Required Codes and Standards for con-

struction. The recipient will be subject to the standards in effect at the time of design or construction

(modernization or A&R), as appropriate. Working drawings and specifications submitted for NIH

approval (see Design Documentation Requirements above) must conform to the minimum standards in

the NIH Design Requirements Manual. The NIH Design Requirements Manual also include policies,

design standards, and technical criteria for use in planning, designing, and constructing or altering /

renovating buildings owned or leased for use by NIH. Recipients are not subject to NIH site specific

requirements contained in the NIH Design Requirements Manual but should meet the intended design

objectives in such cases.

Recipients also must ensure that each project meets the requirements of the applicable State and local

codes and ordinances. Where State or local codes are proposed as a basis for facility design in lieu of

NIH design requirements, a prior determination must be made by the NIH awarding IC that the specific

State or local code is equivalent to, or exceeds, NIH requirements. If State and local codes or require-

ments exceed the design requirements set forth in NIH regulations, the

NIH Design Requirements

Manual

or program guidelines, the more stringent requirements will apply.

In planning and designing construction or modernization projects, recipients must consider that the facil-

ity is generally subject to an extended usage requirement, e.g., 10 or 20 years, after the date of occu-

pancy and it should be constructed accordingly.

NIH will monitor compliance with design requirements during the project’s design and construction

phase. Recipients (or applicants) with questions concerning the applicability of requirements contained in

the

NIH Design Requirements Manual

should consult with the NIH PO.

10.5 EQUAL OPPORTUNITY AND LABOR STANDARDS

Labor standards and equal employment opportunity requirements for federally assisted construction must

be specified in the information provided to potential bidders/offerors on contracts for construction ser-

vices under NIH construction and modernization grants and major A&R projects and must be included in

the resulting contract documents (see 2 CFR Part 200, Appendix II to Part 200-Contract Provisions for

IIB-13

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Non-Federal EntityContracts Under Federal Awards). NIH construction and modernization grants and

major A&R projects (and contracts under them) are not subject to the requirements of the Davis-Bacon

Act, unless the authorizing statute for the program/award specifically requires compliance.

10.5.1 Equal Employment Opportunity

Contracts (and subcontracts) for construction (including modernization or major A&R) are subject to 41

CFR Part 60-1 implemented by OFCCP, DoL.

Additional information is available at

http://www.dol.gov/ofccp/

10.5.2 Labor Standards

10.5.2.1 Contract Work Hours and Safety Standards

Contractors and subcontractors providing construction services under NIH construction or modernization

grants or major A&R projects with contracts or subcontracts exceeding $100,000 are subject to the

requirements of the Contract Work Hours and Safety Standards Act, 40 U.S.C. 3701, et seq., concerning

the payment of overtime and the maintenance of healthful and safe working conditions.

Wages paid any laborer or mechanic employed by the contractor or subcontractor must be computed on

the basis of a standard workweek of 40 hours. For all work in excess of the standard workweek, mech-

anics and laborers shall be compensated at a rate not less than one-and-a-half times the basic rate of pay.

If this requirement is violated, the contractor or subcontractor is liable to the employee for the unpaid

wages and may be liable to the Federal government for liquidated damages. NIH or the recipient may

withhold otherwise payable funds to satisfy any such liability. The statute also specifies penalties for

intentional violation of these requirements.

Further, pursuant to standards issued by the Secretary of Labor, no contractor or subcontractor under an

NIH grant shall require any laborer or mechanic employed in the performance of the contract to work in

surroundings or under working conditions that are unsanitary, hazardous, or dangerous to an individual’s

health or safety. Violation of these requirements may be cause for debarment from future Federal con-

tracts or financial assistance.

10.5.2.2 Disposition of Unclaimed Wages

During or after the period of performance of a contract for construction services under an NIH grant, if it

is discovered that an employee is entitled to wages but cannot be located for the purposes of payment (or

for some reason refuses to accept payment), the recipient may eventually have to repay the Federal gov-

ernment. Therefore, NIH suggests that the contractor be required to turn over any unclaimed wages to

the recipient.

The recipient should notify the GMO that an escrow account has been established in the affected

employee’s name and should maintain the account for 2 years (or longer if required by State or local

law) following the completion of the contract. Upon the expiration of this period, any amounts still

unclaimed will be disbursed by refunding to NIH either the entire amount, if the construction, mod-

ernization, or major A&R project was 100 percent funded by NIH, or an amount representing the per-

centage of NIH participation in the project. If the project was funded by more than one NIH or HHS

program at differing rates, the refund should be based on an average percentage calculated by weighting

each program’s rate of participation by the dollar amount of that program’s contribution.

If the contractor has made a reasonable effort to locate the employee by having mail forwarded and con-

tacting the employee’s union, the recipient need not repeat such attempts. If there is reason to believe

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10 Construction, Modernization, or Major Alteration and Renovation of Research

that the contractor’s efforts to locate employees that are due wages were not thorough, the recipient

should attempt to locate the employees. Doing so will reduce the likelihood of future claims against the

recipient.

If any wages held in escrow are paid to an employee or an employee’s legal representative while the

account is maintained, a complete report must be made to the GMO when the account is closed.

10.6 REAL PROPERTY MANAGEMENT STANDARDS

10.6.1 General

Unless alternate requirements are specified in the governing statute:

Construction, modernization and major A&R under research grants are subject to the require-

ments of 42 CFR Part 52b.

Major A&R under center grants or minor A&R under other types of grants/mechanisms is sub-

ject to the provisions of 2 CFR Part 200.310 through 200.316, as applicable, regarding use, trans-

fer of title, and disposition.

Statutory provisions may specify alternate requirements for the length of the recipient’s accountability

obligations, the Federal right of recovery, or waivers. To the extent statutory provisions differ from the

requirements of 42 CFR Part 52b and/or 2 CFR Part 200, including those described in this subsection,

the statutory provisions, as reflected in the terms and conditions of the award, apply.

Real property constructed, modernized, or otherwise altered as part of a major alteration with NIH grant

support may not be conveyed, transferred, assigned, mortgaged, leased, or in any other manner

encumbered by the recipient, except as expressly authorized in writing by NIH. If the recipient defaults

in any way on a mortgage, the recipient shall immediately notify the GMO by telephone and in writing.

If the mortgagor intends to foreclose, the recipient must notify the GMO in writing at least 30 days

before the foreclosure action is initiated.

The mortgage agreement must specifically allow, in the case of default, that NIH or its designee may

assume the role of mortgagor and continue to make payments. If NIH (or its designee) chooses not to

assume the role of mortgagor, the mortgagee (recipient) must pay NIH an amount equal to the share of

the sales proceeds otherwise due the recipient (mortgagor) times the Federal share in the property.

Any NIH assignment of the property and mortgage responsibilities to any party other than NIH shall be

subject to prior approval of the mortgagor.

10.6.2 Notice of Federal Interest

To protect the Federal interest in real property constructed, or where applicable, improved with NIH

grant funds, recipients shall record a NFI in the appropriate official records of the jurisdiction in which

the property is located as required by 2 CFR Part 200.316 and the NIHGPS. The NFI is required when

use and disposition conditions apply to the property as stated in the NoA. The time of recordation shall

be when construction begins. The recipient should consult with the GMO prior to recording the NFI, if

necessary, to determine if the NFI is required under the award. Fees charged for recording the NFI may

be charged to the grant (see

Allowable and Unallowable Costs and Activities

in this chapter). A copy of

the recorded NFI must be provided to the GMO within 10 days following the date of recordation. To

obtain a sample NFI, contact the GMO.

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10 Construction, Modernization, or Major Alteration and Renovation of Research

10.6.3 Insurance Requirements

Builder’s risk insurance is required at the time construction begins. The insurance must cover potential

losses after initiation, but before completion, of the construction or modernization caused by theft, fire,

vandalism, and other types of accidental loss or damage to the structure.

Immediately upon completion of construction, a nongovernmental recipient shall, at a minimum, provide

the same type of insurance coverage as it maintains for other property it owns, consistent with the min-

imum coverage specified below. “Completion of construction” means either the point at which the

builder turns a facility constructed with NIH grant support, or portion of a facility modernized or mod-

ified under a major A&R project, (that conforms to the design and specifications approved by NIH and is

available for occupancy) over to the recipient (i.e., the date of the final acceptance of the building or por-

tion of a building) or the date of beneficial occupancy, whichever comes first.

If title to real property constructed, modernized, or altered under a major A&R project under an NIH

grant vests (or will vest upon completion) in the recipient, the following minimum insurance coverage is

required:

Title insurance policy that insures the fee interest in the real property for an amount not less than

the full appraised value of the property. When the Federal participation covers only a portion of

a building, title insurance should cover the total cost of the facility to prevent liens on the unse-

cured portion from having an adverse impact on the portion with a Federal interest. In those

instances where the recipient already owns the land, such as a building being constructed in the

middle of a campus setting, in lieu of a title insurance policy, the recipient may provide evidence

satisfactory to the NIH awarding IC, such as legal or title opinion, that it has good and mer-

chantable title free of all mortgages or other foreclosable liens to all land, rights of way, and ease-

ments necessary for the project. In instances where a recipient is given land by the State, if the

State recently acquired the land in a land swap transaction, the recipient should obtain title insur-

ance. However, if the State has owned the land for a considerable period of time (i.e., 5 years or

more), title insurance would not be necessary; a copy of the State documents giving the land to

the recipient would be sufficient. If the recipient must buy the land on which to build, a legal

opinion would not be sufficient; title insurance must be obtained in order to protect the Federal

interest in the building to be constructed.

Physical destruction insurance policy that insures the full appraised value of the facility (whether

owned or leased by the recipient) from risk of partial and total physical destruction. When the

Federal participation covers only a portion of a building, the insurance should cover the total

cost of the facility, because any damage to the building could make the building unusable and

could thus affect the Federal interest. The insurance policy is to be maintained for the duration of

the Federal interest in the property (see

Real Property Management Standards—Use of Facility

and Disposition

in this chapter). The cost of insurance coverage after the period of grant support

must be borne by a source other than the grant that provided the funds for the grant-supported

project. The grant account will not remain active for this purpose.

Governmental recipients may follow their own insurance requirements. Federally owned property

provided to a recipient for use need not be insured by the recipient.

The NIH awarding IC may waive one or both requirements above if the recipient shows that it is effect-

ively self-insured against the risks involved. The term “effectively self-insured” means that the recipient

has sufficient funds to pay for any damage to the facility, including total replacement if necessary, or to

satisfy any liens placed against the facility. If the recipient claims self-insurance, the recipient must

provide to NIH assurance that it has sufficient funds available to replace or repair the facility or to sat-

IIB-16

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

isfy all liens. This assurance should state the source of the funds, such as the organization’s endowment

or other special funds set aside specifically for this purpose.

10.6.4 Use of Facility and Disposition

NIH construction grants require that the facility be used for biomedical or behavioral research for as long

as needed for that purpose for the period prescribed in the NoA. The date of beneficial occupancy is the

date that a facility constructed or modernized with NIH grant support conforming to the design and spe-

cifications approved by NIH are available for occupancy and fully operational to carry out all intended

facility/research activities. During that time, the recipient must use the facility for the originally author-

ized purpose unless it obtains prior approval from the NIH awarding IC to use the facility for an altern-

ate purpose. To ensure a recipient’s compliance with the facility usage requirement, the IC GMO will

periodically (e.g., at least every two years) survey the recipient throughout the usage period and request a

self-certification concerning continued use. NIH may also obtain the names of the investigator(s) occupy-

ing the space and an indication of their research interests. Most of the monitoring will be accomplished

in this manner. However, NIH staff may perform periodic site visits to observe the use of the grant-sup-

ported space throughout the usage period. After the required usage period, NIH will no longer directly

monitor the use of the space.

When use and disposition conditions apply to real property supported under an NIH award, the recipient

may not convey, transfer, assign, mortgage, lease, or in any other manner encumber such property

without the prior written approval from the awarding office. If the recipient decides that the grant-sup-

port space is no longer needed before the expiration of the period of Federal interest, the recipient must

request written disposition instruction from the awarding office. This action must be done prior to the

recipient’s making any irreversible commitment related to property disposition. In this case, NIH may

consider an alternate use of the facility or provide disposition instructions.

In determining whether to approve an alternate use of the facility, NIH will take into consideration the

extent to which the facility will be used for:

Other health-related purposes consistent with the authorizing legislation of the program.

Other health-related activities that are consistent with the mission of the IC; or

Training and instruction in health fields for health professionals or health-related information pro-

grams for the public.

The usage obligation may also be transferred to another facility with the prior approval of NIH. If

approved, the remaining usage obligation shall be released from the original facility constructed with

grant funds and transferred to the new facility. The recipient remains subject to all other requirements

imposed by the NoA or successor document (if the change occurs following the period of grant support).

For disposition of property acquired on an amortized acquisition basis, the computation of the Federal

share of real property acquired with long-term debt financing will be computed for each year of grant

support in which Federal funds are used to meet all or a portion of the down payment and/or principal on

the mortgage.

10.6.5 Real Estate Appraisals

If a real estate transaction funded in whole or in part by NIH requires the use of a real estate appraisal

(including, but not limited, to appraisals to determine the Federal share of real property and appraisals to

determine required insurance levels), the appraisal must be performed by appraisers certified or licensed

by the applicable State in accordance with the requirements established by Title XI of the Financial Insti-

tutions Reform, Recovery, and Enforcement Act of 1989, as amended (Public Law 101-73).

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10 Construction, Modernization, or Major Alteration and Renovation of Research

10.7 ALLOWABLE AND UNALLOWABLE COSTS AND

ACTIVITIES

The following lists indicate types of costs and activities generally allowable and unallowable under NIH

construction or modernization grants and major A&R projects unless otherwise noted in the NOFO. The

lists are not all-inclusive. Program guidelines, the NoA, and other terms and conditions of the award

should be consulted for the specific costs allowable under a particular program or grant.

Major A&R is unallowable under foreign grants and foreign components in domestic grants.

The allowability and unallowability of costs and activities applies to the use of Federal funds and funds

expended by the recipient to satisfy a matching requirement (see

Matching Requirement

in this chapter).

Allowable costs and activities include the following:

Acquisition and installation of fixed equipment.

Appraisals

Architectural and engineering services. Also see

Pre-award costs

below.

Bid advertising

Bid guarantees and performance and payment bonds. Bid guarantees and performance and pay-

ment bonds are allowable as provided in 2 CFR Part 200.326 and 2 CFR Part 200.427. A bid

guarantee is a form of security assuring that the bidder will not withdraw a bid within the period

specified for acceptance and will execute a written contract and furnish required bonds. Per-

formance bonds secure fulfillment of all the contractor’s obligations under the contract and pay-

ment bonds assure payment as required by law to all persons supplying labor and material in the

execution of the work provided for in the contract.

Contingency fund. To provide for unanticipated costs, applicants for construction grants may

include a project contingency amount with the initial total allowable cost estimates. Contingency

funds will be limited to 15 percent of the total allowable costs before bids are received and must

be reduced to 10 percent after a construction contract has been awarded. NIH may maintain con-

trol up to 3% of the total contingency for unanticipated program specific changes during the

course of the project.

Filing fees for recording the NFI. See

Real Property Management Standards—Notice of Federal

Interest

in this chapter.

Force Account Labor. If the recipient’s own construction and maintenance staffs are used in car-

rying out construction or modernization activities (i.e., force account), the associated costs are

allowable provided the recipient can document that a force account is less expensive than if the

project were competitively bid and can substantiate all costs with appropriate receipts for the pur-

chase of materials and certified pay records for the labor involved. This requires prior approval

by the NIH awarding IC.

General conditions (e.g. moveable site trailers, port-a-johns, hard hats, temporary or limited dur-

ation signage, security costs during construction).

Inspection and commissioning fees.

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Insurance. Costs of builders risk insurance, title insurance, physical destruction insurance, and

liability insurance are generally allowable. Physical destruction, and liability insurance usually

are treated as indirect costs but may be treated as direct costs in accordance with the established

policy of the recipient, consistently applied regardless of the source of funds. Builder’s risk insur-

ance and title insurance may be charged to the grant in proportion to the amount of NIH par-

ticipation in the property (see

Real Property Management Standards—Insurance Requirements

this chapter).

Legal fees. Legal fees related to obtaining a legal opinion regarding title to a site.

Pre-award costs. Costs incurred before award for architect’s fees, consultant’s fees and envir-

onmental analysis necessary to the planning and design of the project are allowable if the project

is subsequently approved and funded. Pre-award construction or modernization costs are gen-

erally unallowable unless NIH grants an exception.

Profit/fee for contractors/subcontractors. Allowable as part of the overall cost/price of a contract

consistent with commercial practice.

Project management.

Relocation expenses related to the

Uniform Relocation Assistance and Real Property Acquisition

Policies Act of 1970

(49 CFR Part 24).

Sidewalks necessary for use of facility.

Site survey and soil investigation.

Site clearance. Site clearance costs are allowable as long as they are reflected in the bid.

Threat-risk assessment. Costs incurred for a site-specific or project-specific assessment of secur-

ity risk by a qualified professional are allowable.

NEPA and historic preservation analysis. Costs associated with evaluation of the environmental

effects and historic preservation effects of proposed construction, modernization, or A&R activ-

ity and obtaining public input, producing the necessary studies, analysis, and resultant reports are

allowable. Also see

Pre-award costs

above.

Unallowable costs and activities include the following:

Bonus payments to contractors. Bonus payments other than earned incentive payments to con-

tractors under formal incentive arrangements are unallowable. An incentive arrangement is used

to motivate contractors to provide required supplies or services at lower costs and, in certain

instances, with improved delivery or technical performance, by relating the amount of profit or

fee payable under the contract to the contractor’s performance.

Construction of shell space designed for completion at a future date.

Consultant fees not related to actual construction.

Damage judgment suits.

Equipment purchased through a conditional sales contract. A conditional sale is a type of agree-

ment to sell under which the seller retains title to goods sold and delivered to a purchaser until

full payment has been made.

Fund-raising expenses.

Indirect costs.

Interior and exterior decorating fees (e.g. purchase of artwork, sculpture, etc.).

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Land acquisition.

Landscaping and irrigation costs.

Legal services not related to title certification.

Movable equipment.

Off-site improvements. Off-site improvements, such as parking lots, are not allowable.

10.8 ADMINISTRATIVE REQUIREMENTS

10.8.1 Prior Approval Requirements

Recipients must obtain written prior approval from the GMO for the following types of recipient-ini-

tiated project or budget changes:

Any applicable change as specified in

Administrative Requirements—Changes in Project and

Budget

in IIA.

Revision that would result in a change in scope of the project, change in project site and/or loc-

ation, including proposed modifications that would materially alter the costs of the project, space

utilization, or financial outlay (including Federal/non-Federal cost share adjustments), resulting

in changes in the previously approved procurement method or contract. Modifications that would

materially alter the costs include the transfer of funds between construction and non-construction

work.

Deviations from design requirements.

Alternate contracting methods.

Revision that would increase the amount of Federal funds needed to complete the project.

Extension of the project period with or without funds.

Change in the use of the facility (see

Real Property Standards—Use of Facility and Disposition

in this chapter).

Transfer of the remaining usage obligation to another facility.

The request for approval must include sufficient information to allow NIH review of the circumstance(s)

and need for the proposed change. For changes affecting construction contracts, if the recipient receives

written prior approval from the GMO, the recipient may make or authorize the approved modifications to

the construction contract. Minor modifications to construction contracts may be made without NIH

awarding IC prior approval. However, copies of all change orders to construction contracts must be

retained as grant-related records (see

Administrative Requirements—Monitoring—Record Retention and

Access

in IIA).

10.8.2 Alteration and Renovation Projects Under Non-construction

Grants

Two copies of each of the following documents must be submitted with each request for approval of

minor A&R projects whether proposed in the application or as a post-award rebudgeting request:

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Single-line drawing of the existing space and proposed alterations.

Narrative description of the proposed functional utilization of the space and equipment require-

ments prepared by the program and administrative managers who will use and be responsible for

the working space and, when appropriate, with input from architectural and engineering advisors.

Final drawings and specifications will be based on this description. The description must include

a detailed explanation of the need, character, and extent of the functions to be housed in the

space proposed for A&R, using the following headings, as appropriate:

o

General information

o

Description of the functions to be performed in the space

o

Space schedule (detailed description of floor space)

o

List of fixed equipment proposed for the facility

o

Cost estimate (see sample format in Exhibit 8)

o

Special design problems

o

Description of the existing and proposed utility systems for the modified space

o

Description of plans to provide accessibility for the physically handicapped

o

Provisions for meeting the requirements of the Life Safety Code

o

Length of the property lease if the space is rented

o

Other information required by program legislation or regulations.

When the proposed alteration is to occur in a building that is under construction or in an incomplete

structure, two copies of the following documentation also must be provided:

Detailed justification for the need to perform the work before the building is completed

Cost comparison between doing the work before and after the building is completed

Description of other specific benefits to be gained by doing the work before the building is com-

pleted.

Applicants/recipients undertaking major A&R projects are subject to the review, approval, and doc-

umentation requirements included or referenced in this chapter for construction grants.

10.9 CLOSEOUT

Immediately upon completion of construction, modernization, or alteration under a major A&R project

the recipient should contact the awarding IC GMO. Under construction grants, the recipient will gen-

erally be required to submit the following documents within 120 days following the completion of the

project as part of the closeout process:

A final tabulation of net assignable space supported under the award for each program activity.

The actual cost of construction per gross and net square foot/meter.

The actual total allowable project costs after construction per gross and net square foot/meter.

Actual date of beneficial occupancy of the facility.

A simplified floor plan or space assignment drawing in electronic format clearly marked to

identify the grant-supported space.

Final record as-built construction documents.

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Electronic submission of the FFR reflecting both the Federal and non-Federal share of outlays

when matching is required.

A written assurance signed by the AOR stating that the recipient has the required insurance cov-

erage and agrees to maintain the required insurance for the applicable duration of the Federal

interest in the property or an indication that the recipient is self-insured against the risks

involved and the source of funds.

10.10 PUBLIC POLICY REQUIREMENTS

In addition to the public policy requirements and objectives specified in IIA, grants for construction,

modernization or major A&R projects are subject to the public policy requirements in this section. These

requirements may be specified by statute, regulation, executive order, or policy, and apply regardless of

the type of recipient.

Exhibit 11

may be used as guidance; however, some of the requirements for con-

struction or modernization grants or major A&R activities may not be applicable to your project or pro-

gram. Specific questions about whether a particular requirement applies should be directed to the GMO

of the awarding IC. Recipients of construction or modernization grants and funding for major A&R pro-

jects also must require contractors and subcontractors providing construction services to comply with cer-

tain Federal labor standards. These labor standards are discussed in

Equal Employment Opportunity and

Labor Standards

in this chapter. Following are highlights of public policy requirements:

Architectural Barriers Act of 1968, as amended (42 U.S.C. §§ 4151 et seq.).

The Architectural

Barriers Act of 1968, as amended, the Federal Property Management Regulations 101-19.6 (41

CFR Part 101-19.6), and the Uniform Federal Accessibility Standards issued by the General Ser-

vices Administration (41 CFR Part 101-19.6, Appendix A) set forth requirements to make facil-

ities accessible to, and usable by, the physically handicapped and include minimum design

standards. All new facilities constructed with NIH grant support must comply with these require-

ments. These minimum standards must be included in the specifications for any NIH-funded new

construction unless the recipient proposes to substitute standards that meet or exceed these stand-

ards. Where NIH assistance is provided for alteration or renovation (including modernization) of

existing facilities, the altered facility (or part of the facility) must comply, including use of the

minimum standards in the specifications. The recipient will be responsible for conducting inspec-

tions to ensure compliance with these standards by any contractor performing construction ser-

vices under the grant.

Clean Air Act (42 U.S.C. 7401 et seq.), and Federal Water Pollution Control Act (Clean Water

Act), as amended (33 U.S.C. 1251 et seq.).

Provide for the protection and enhancement of the

quality of the nation’s air resources to promote public health and welfare, and for restoring and

maintaining the chemical, physical and biological integrity of the nation’s waters; for contracts

exceeding $100,000.

Coastal Zone Management Act of 1972 (16 U.S.C. §§1451 et seq.).

Assurance of project con-

sistency with the approved State management program developed under the Act.

Copeland Act (40 U.S.C. §276c and 18 U.S.C. §874).

When required by statute.

Davis-Bacon Act (40 U.S.C. §§276a to 276a-7).

When required by statute.

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10 Construction, Modernization, or Major Alteration and Renovation of Research

Earthquake Hazards Reduction Act of 1977, as amended (Public Law 95-124), and EO 12699,

Seismic Safety of Federal and Federally Assisted or Regulated New Building Construction

(January 5, 1990).

Apply to NIH-assisted construction located in the applicable geographic loc-

ation. The EO requires that new federally assisted or regulated buildings be designed and con-

structed using appropriate seismic standards compliant with State, country, or local jurisdictional

building ordinances. Where necessary, special structural and other features to protect life and

minimize damage to facilities from tornadoes also may be required.

Endangered Species Act of 1973, as amended (P.L. 93-205).

For the protection of endangered

species.

Flood Disaster Protection Act of 1973 — Flood Insurance — The Flood Disaster Protection

Act of 1973, as amended (Public Law 93-234).

Provides that no Federal financial assistance to

acquire, modernize, or construct property may be provided in identified flood-prone com-

munities in the United States, unless the community participates in the National Flood Insurance

Program and flood insurance is purchased within 1 year of the identification. Lists of flood-

prone areas that are eligible for flood insurance are published in the Federal Register by FEMA.

Lead-Based Paint Poisoning Prevention Act (42 U.S.C. §§4801 et seq.).

Prohibits the use of

lead-based paint in construction or rehabilitation of residence structures.

National Environmental Policy Act of 1969 — NEPA, as amended (Public Law 91-190).

Estab-

lishes national policy goals and procedures to protect and enhance the environment, including

protection against natural disasters. NEPA requires all Federal agencies to consider the reas-

onably foreseeable environmental consequences of any major Federal activity, including grant-

supported activities. If NIH determines that NEPA applies to grant-supported activities, NIH will

require that the environmental aspects of the activity be reviewed and evaluated by NIH tech-

nical staff before final action on the application. This determination also includes determinations

concerning floodplain management pursuant to

EO 11988

, Floodplain Management (May 24,

1977) (42 FR 26951, 3 CFR Part, 1977 Comp., p. 117) and

EO 11990

, Protection of Wetlands

(May 24, 1977) (42 FR 26961, 3 CFR, 1977 Comp., p. 121).

Because projects for construction, modernization, or major A&R activities have the potential to affect

the environment, NIH requires that applicants for this type of support provide information on anticipated

environmental impact as part of their just-in-time submission. Applicants may use the

Review of Envir-

onmental and Other Impacts document

to supply this information. An alternate format can be used as

long as equivalent environmental and other impacts information is provided.

NIH will review the Environmental and Other Impacts information contained in the application to assess

the level of environmental impact of the proposed project. It is the responsibility of NIH to determine

which of the following will apply to the proposed project:

Environmental Impact Statement (EIS).

A document required of federal agencies by the NEPA

for major projects or legislative proposals significantly affecting the environment. A tool for

decision making, it describes the positive and negative effects of the undertaking and considers

alternatives.

Environmental Assessment (EA).

An environmental analysis prepared pursuant to the NEPA to

determine whether a federal action would significantly affect the environment and thus require a

more detailed environmental impact statement.

No Further Action is Required.

If NIH determines that an EA or an EIS is required, the applicant (recipient) must conduct the appro-

priate environmental review and provide the necessary documentation to NIH for review, approval, and

IIB-23

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

processing. NIH will provide advice and assistance to the applicant (recipient), as necessary, concerning

review procedures; evaluate the results of the review; and make the final decision on environmental

impact as required by NEPA.

Applicants also must (1) provide a current listing and copies, as applicable, of all relevant licenses, per-

mits, and/or other approvals required including, but not limited to, the State and local air, water quality,

and zoning board reports, and (2) indicate the State, local, and regional planning authorities contacted or

consulted regarding the application and briefly discuss the proposed facility with respect to regional

development plans.

Applicants are not required to incur costs for extensive consultant services at the application stage; there-

fore, hiring of consultants to develop detailed data and elaborate presentations is discouraged and such

costs generally will not be allowable as pre-award costs.

Public Disclosure — Section 102 of NEPA and EO 11514.

Section 102 of NEPA and EO

11514 (March 5, 1970) provide for public comment and participation in the environmental

impact review process. When there is an environmental impact (in accord with NEPA), the

applicant must publicly disclose the project in a newspaper or other publicly available medium

and to describe any environmental impacts that affect the protection and enhancement of envir-

onmental quality concurrent with notification to the SPOC (see

Public Policy Requirements—

Executive Orders—Intergovernmental Review of Programs under Executive Order 12372

in this

chapter). An example of a sample disclosure statement follows:

"Notice is hereby given that the Uptown Medical School proposes to construct additional space,

partially utilizing Federal funds. The proposed construction project is the addition of 251 net

square meters connected to the existing Allen Building, which is located at 5333 Main Street,

Downtown, Ohio.

The Medical School has evaluated the environmental and community impact of the proposed con-

struction. There will be (appropriate text will describe impact). The Medical School anticipates

that no significant permanent environmental impacts are foreseen, however, this determination is

ultimately the responsibility of the awarding Federal agency. In accordance with Executive Order

11514 (March 5, 1970), which implements the National Environmental Policy Act of 1969, as

amended, any individual or group may comment on, or request information concerning, the envir-

onmental implications of the proposed project. Communications should be addressed to the

Office of Planning, Uptown Medical School, and must be received by (date). The Federal grant

application may be reviewed at the Office of the Dean, School of Medicine, 5333 Main Street,

during normal working hours."

National Historic Preservation Act of 1966 and Archaeological and Historic Preservation Act

of 1974.

Under the provisions of the National Historic Preservation Act, as amended (16 U.S.C.

470 et seq.), and the Archaeological and Historic Preservation Act of 1974, as amended (16

U.S.C. 469a-1 et seq.), the Secretary of the Interior has compiled a National Register of Historic

Places—sites and buildings of significant importance to U.S. history. These statutes require that,

before approval of a grant related activity, NIH take into account the effect on these sites of the

proposed activity. NIH is primarily responsible for determining whether activities will affect a

property listed in the National Register or one that meets the eligibility criteria for inclusion,

even if not included in the National Register at the time the application is submitted. The

National Register of Historic Places may be obtained from the State Liaison Officers designated

by their respective states to administer this program or from the

Advisory Council on Historic

Preservation

. The National Trust for Historic Preservation is at http://www.nationaltrust.org/.

IIB-24

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

If an eligible or potentially eligible historic property will be affected, the applicant must obtain

clearance from both the appropriate State Historic Preservation Office and

Tribal Historic Pre-

servation Office

before submitting the application. Failure to obtain this clearance will delay NIH

action on an application. The State Historic Preservation Liaison Officer or the National Trust for

Historic Preservation may be contacted for additional details.

Rehabilitation Act of 1973.

The HHS implementation of section 504 of the Rehabilitation Act of

1973 is found in 45 CFR Part 84, Nondiscrimination on the Basis of Handicap in Programs and

Activities Receiving Federal Financial Assistance. Section 504 is designed to eliminate dis-

crimination on the basis of handicap in any program or activity receiving Federal financial assist-

ance. Each facility or part of a facility constructed by, on behalf of, or for the use of a recipient

shall be designed and constructed in such manner that the facility or part of the facility is readily

accessible to and usable by handicapped persons. Furthermore, each facility or part of a facility

which is modernized or altered by, on behalf of, or for the use of a recipient in a manner that

affects or could affect the usability of the facility or part of the facility shall, to the maximum

extent feasible, be modernized or altered in such manner that the altered portion of the facility is

readily accessible to and usable by handicapped persons. Design, construction, or alteration of

buildings shall conform to the Federal Property Management Regulations at 41 CFR Part 102

subchapter C, Real Property, Part 102-76.

Safe Drinking Water Act (Title XIV of the Public Health Service Act, as amended).

For the

protection of underground sources of drinking water.

Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 (Uniform

Relocation Act).

HHS requirements for complying with the Uniform Relocation Act are set forth

in 49 CFR Part 24. Uniform relocation assistance and real property acquisition for Federal and

federally assisted programs. The Uniform Relocation Act, 42 U.S.C. 4601 et seq., applies to all

programs or projects undertaken by Federal agencies or with Federal financial assistance that

cause the displacement of any person. The HHS requirements for complying with the Uniform

Relocation Act are set forth in 45 CFR Part 15, which references 49 CFR Part 24. Those reg-

ulations provide policies and procedures for the acquisition of real property, including acquis-

ition by recipients, and require that displaced people be treated fairly. They encourage acquiring

entities to negotiate promptly and amicably with property owners so property owners’ interests

are protected and litigation can be avoided.

Wild and Scenic Rivers Act of 1968 (16 U.S.C. §§1271 et seq.).

Related to protecting com-

ponents or potential components of the national wild and scenic rivers system.

10.10.1 Executive Orders

Intergovernmental Review of Federal Programs (July 14, 1982), as amended, under Executive

Order 12372.

EO 12372 requires consultation with State and local officials on certain proposed

Federal assistance. For HHS, these requirements are the Intergovernmental Review of Depart-

ment of Health and Human Services Programs and Activities. NIH construction and mod-

ernization grants are subject to these requirements. Applicants from states that have chosen to

participate in the intergovernmental review process should contact their SPOC as early as pos-

sible to alert the SPOC to the planned application and to obtain necessary instruction on the

State process. Indian tribes (or "federally recognized Indian tribes") are not subject to these

requirements.

SPOCs are given 60 days to review applications. To accommodate this time frame and the NIH

review process, an applicant must provide a copy of the application to the SPOC no later than the

IIB-25

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

time the application is submitted to NIH. SPOC comments must be submitted to NIH with the

application, or the application must indicate the date on which the application was provided to

the SPOC for review. If SPOC comments are not submitted with the application, the applicant

must provide them upon receipt and may include its reaction to the comments, or it must notify

NIH that it did not receive any SPOC response.

Executive Order 11988

, Floodplain Management (May 24, 1977) (42 FR 26951, 3 CFR, 1977

Comp., p. 117).

Uneconomical, hazardous, or unnecessary use of flood plains for construction.

Executive Order 11990

, Protection of Wetlands (May 24, 1977).

See 42 FR 26961, 3 CFR,

1977 Comp., p. 121.

Executive Order 12185, Conservation of Petroleum and Natural Gas (Dec. 17, 1979).

See 44

FR 75093, 3 CFR, 1979 Comp., p. 474.

Executive Order 12699, Seismic Safety of Federal and Federally Assisted or Regulated New

Building Construction (January 5, 1990).

See 3 CFR, 1990 Comp., p. 269. See

Earthquake Haz-

ards Reduction Act

bullet in the Construction—Public Policy Requirements section.

Executive Order 12770 — Metric System.

Consistent with EO 12770 (July 25, 1991), Metric

Usage in Federal Government Programs. All construction, modernization, or A&R (major or

minor) supported by NIH grant funds must be designed using the metric system.

Exhibit 11. Summary of Requirements Applicable to Construction, Modernization, and

Major A&R Activities

Program Regulation

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

NIH Construction Grants

Regulations (42 CFR

Part 52b)

Applicable

Applicable to major A&R

under a research project

grant; does not apply to

minor A&R funded under

an NIH Center grant.

Public Policy Requirements

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Architectural Barriers

Act of 1968

Applicable

Clean Air and Clean

Water Act

Applicable

Coastal Zone

Management Act of

1972

Applicable

Copeland Act

As required by statute

Davis-Bacon Act

As required by statute

IIB-26

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Earthquake Hazards

Reduction Act of 1977

Applicable

N/A

Endangered Species

Act of 1973

Applicable

Flood Disaster

Protection Act of 1973

Applicable

N/A

Lead-Based Paint

Poisoning Prevention

Act

Applicable

National Environmental

Policy Act (NEPA) of

1969

Applicable

As specified by NIH

Public Disclosure —

Section 102 of NEPA

and EO 11514 (as

applicable for the

protection and

enhancement of

environmental quality)

Applicable when the

project involves an

environmental impact

Applicable when the

project involves an

environmental impact

Applicable when the

project involves an

environmental impact

Rehabilitation Act of

1973 (45 CFR Part 84)

Applicable

Safe Drinking Water Act

Applicable

Uniform Relocation Act

(49 CFR Part 24)

Applicable

N/A

Wild and Scenic Rivers

Act of 1968

Applicable

Executive Orders

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Executive Order 12372,

Intergovernmental

Review of Federal

Programs

Applicable

Specified in the NOFO

Applicable

Executive Order 11988,

Floodplain Management

Applicable

Executive Order 11990,

Protection of Wetlands

Applicable

IIB-27

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Executive Order 12185,

Conservation of

Petroleum and Natural

Gas

Applicable

Executive Order 12699,

Seismic Safety of

Federal and Federally

Assisted or Regulated

New Building

Construction

Applicable

N/A

Executive Order 12770,

Metric System

Applicable

Other Requirements

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Matching

Specified in the NOFO

and NoA

Specified in the NOFO

and NoA

N/A

NIH Design

Requirements Manual

Applicable

Specified in the NOFO

Applicable

Design Documentation

Requirements

Applicable

Procurement Requirement

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Liquidated Damages

Applicable

Equal Employment Opportunity and Labor Standards

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Equal Employment

Opportunity

Applicable

Contract Work Hours

and Safety Standards

Contracts exceeding

$100,000

Contracts exceeding

$100,000

Contracts exceeding

$100,000

Disposition of

Unclaimed Wages

Applicable

Real Property Standards

IIB-28

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

10 Construction, Modernization, or Major Alteration and Renovation of Research

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Real Property

Management Standards

Applicable

Notice of Federal

Interest

Applicable

Title Insurance

Applicable unless

waived

Applicable unless

waived

Applicable unless

waived

Physical Destruction

Insurance

Applicable unless

waived

Applicable unles waived

Applicable unless

waived

Use of Facility and

Disposition

Specified in the NOFO

and NoA

Specified in the NOFO

and NoA or 2 CFR

Part 200.311 and 45

CFR Part 75.318

As specified by NIH in

accordance with 2 CFR

Part 200.311 and 45

CFR Part 75.318

Closeout

Requirement

Type of Activity:

Construction Grant

Type of Activity:

Modernization Grant

Type of Activity: Major

A&R Project

Final Record As-built

Construction Documents

Applicable

N/A

IIB-29

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

11 RUTH L. KIRSCHSTEIN NATIONAL RESEARCH

SERVICE AWARDS

11.1 GENERAL

This chapter includes general information about Kirschstein-NRSA individual fellowships and insti-

tutional research training grants. Separate but all-inclusive sections are provided for each; therefore some

information may appear duplicative but is provided separately so that nuances between individual fel-

lowships and institutional training grants are covered. Many of the requirements of IIA also apply; this

chapter of IIB includes appropriate cross-references to IIA when applicable.

11.1.1 Background

Section 487 of the PHS Act (42 U.S.C. 288) provides authority for NIH to award Kirschstein-NRSA indi-

vidual fellowships to support predoctoral and postdoctoral training of individuals to undertake bio-

medical, behavioral, or clinical research at domestic and foreign, public and private institutions (profit

and non-profit). Section 487(a)(1)(B) authorizes Kirschstein-NRSA institutional research training grants

and limits institutional Kirschstein-NRSA support to training and research at domestic public and non-

profit private entities. The legislation requires postdoctoral NRSA recipients to pay back to the Federal

government their initial 12 months of Kirschstein-NRSA postdoctoral support by engaging in health-

related biomedical, behavioral and/or clinical research, health related research training, health-related

teaching, or any combination of these activities. (See

Payback Requirements

in this chapter.) The reg-

ulations at 42 CFR Part 66 apply to these awards.

11.1.2 Nondiscrimination

The Kirschstein-NRSA program is conducted in compliance with applicable laws that provide that no

person shall, on the grounds of race, color, national origin, handicap, or age, be excluded from par-

ticipation in, be denied the benefits of, or be subjected to discrimination under any program or activity

(or, on the basis of sex, with respect to any education program or activity) receiving Federal assistance.

Applicant organizations are required to have appropriate Assurance of Compliance forms filed with

HHS’s OCR before a grant may be made to that institution. The NIH awarding IC should be contacted if

there are any questions concerning compliance. (See

Public Policy Requirements and Objectives—Civil

Rights

in IIA for detailed requirements.)

11.2 INDIVIDUAL FELLOWSHIPS

11.2.1 General

The Kirschstein-NRSA program helps ensure that highly trained scientists are available in adequate num-

bers and in appropriate research areas to carry out the Nation’s biomedical, behavioral, and clinical

research agenda. Fellowship activities can be in basic biomedical or clinical sciences, in behavioral or

social sciences, in health services research, or in any other discipline relevant to the NIH mission. Under

this authority, NIH awards individual postdoctoral fellowships (F32) to promising applicants with the

potential to become productive, independent investigators in fields related to the mission of the NIH ICs.

Individual predoctoral fellowships for research doctoral dissertation training (F31), Individual pre-

doctoral fellowships for MD/PhD and other dual clinical / research doctoral training (F30), and Senior

IIB-30

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

Fellowships (F33), are also provided under this authority. For individual predoctoral fellowships, NIH

ICs have differing requirements; specific NOFOs should be consulted for guidance.

Kirschstein-NRSA fellowships are awarded as a result of national competition for research training in

specified health-related areas. All NIH ICs have authority to award Kirschstein-NRSA fellowships. FIC

and NLM also have unique funding authorities for fellowships that are not under the Kirschstein-NRSA

authority.

11.2.2 Eligibility

11.2.2.1 Research Areas

Kirschstein-NRSA fellowships may be made for research training in areas that fall within the missions of

the NIH ICs. Applications that do not address these areas will be returned. An increased emphasis has

been placed on the research training of physicians. The HHS Secretary is required by law, in taking into

account the overall national needs for biomedical research personnel, to give special consideration to

physicians who agree to undertake a minimum of 2 consecutive years of biomedical, behavioral, or clin-

ical research training. NIH recognizes the critical importance of training clinicians to become researchers

and encourages them to apply. For those who have a doctoral-level health professional degree, the pro-

posed training may be used to satisfy a portion of the degree requirements for a master’s degree, a doc-

toral degree, or any other advanced research degree program.

11.2.2.2 Research Training Program

The Kirschstein-NRSA fellowship must be used to support a program of research training. It may not

support studies leading to M.D., D.O., D.D.S., D.V.M., or other similar clinical, health professional

degrees except when those studies are part of a formal combined research degree program such as the

M.D./Ph.D. Similarly, Kirschstein-NRSA fellowships may not support the clinical portion of residency

training. Research fellows in clinical areas are expected to devote full time effort to the proposed

research training and to confine clinical duties to those that are part of the research training.

11.2.2.3 Degree Requirements

Predoctoral Training.

Individuals must have received, as of the activation date of their Kirschstein-

NRSA predoctoral fellowship award, a baccalaureate degree or equivalent and must be enrolled in and

training at the postbaccalaureate level in a program leading to the award of a Ph.D. or equivalent

research degree program (e.g., Eng.D., D.N.Sc., Dr.P.H., D.S.W., Pharm.D, Sc.D.), a formally combined

MD/PhD, or other combined professional/clinical and research doctoral program (eg., D.O./Ph.D.,

D.D.S./Ph.D., D.V.M./Ph.D.) in basic biomedical, behavioral, or clinical sciences, in behavioral or social

sciences or in health services research.

Postdoctoral Training.

Before a Kirschstein-NRSA postdoctoral fellowship award can be activated, indi-

viduals must have received a Ph.D., M.D., D.D.S, D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D.,

Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from

an accredited domestic or foreign organization. Also acceptable is a statement by an AOR of the degree-

granting institution that all degree requirements have been met. It is the responsibility of the sponsoring

institution, not NIH, to determine if a foreign degree is equivalent.

Senior Fellows.

As of the beginning date of their award, senior fellows must have a doctoral degree (as

specified in

Postdoctoral training

referenced above) and at least 7 subsequent years of relevant research

and professional experience. The senior fellowship is awarded to provide opportunities for experienced

scientists to make major changes in the direction of their research careers or to broaden their scientific

backgrounds by acquiring new research capabilities. In addition, these awards will enable individuals

IIB-31

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

who are beyond the new investigator stage to take time from regular professional responsibilities to

enhance their capabilities to engage in health-related research. Senior fellowships are made for full-time

research training. More information on the senior fellowship program can be found in the

NIH

Kirschstein-NRSA

Senior Fellows (F33) program announcement available on the NIH Research Training

and Career Development website.

11.2.2.4 Citizenship

The individual to be trained must be a citizen or a noncitizen national of the United States or have been

lawfully admitted for permanent residence by the time of award. Noncitizen nationals are individuals,

who, although not citizens of the United States, owe permanent allegiance to the United States. They gen-

erally are people born in outlying possessions of the United States (e.g., American Samoa and Swains

Island). Individuals who have been lawfully admitted for permanent residence must have a currently

valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For

example, if an individual has the proper validation on their passport, a notarized photocopy of the pass-

port could suffice. Because there is a 6-month limitation on this validation, it is the responsibility of the

sponsoring institution to follow up and ensure that the individual receives the I-551 before the 6-month

expiration date.

An individual expecting to be admitted as a permanent resident by the earliest possible award date listed

in the Kirschstein-NRSA individual fellowship program announcement may submit an application for a

fellowship. The submission of documentation concerning permanent residency is not required as part of

the initial application. Any fellowship applicant selected to receive an award must provide a notarized

statement of admission for permanent residence prior to award.

Fellowship applicants who have been lawfully admitted for permanent residence, i.e., have a Permanent

Resident Card or other legal verification of such status, should check the Permanent Resident box in the

citizenship section on the PHS Fellowship Supplemental Form of the fellowship application. Fellowship

applicants who have applied for and have not yet been granted admission as a permanent resident should

check the box indicating Permanent Resident of U.S. Pending.

Individuals with a Conditional Permanent Residency Status may still apply for individual fellowships.

However, in all cases when permanent residency status is involved, it is the responsibility of the spon-

soring institution to assure the individual remains eligible for NRSA support for the period of time of

any award.

Individuals with Asylum/Refugee status do not automatically hold a type of permanent residency status;

they have the opportunity to apply for permanent residency status once they have been in the U.S. for a

period of time. Therefore, individuals with Asylum/Refugee status should only submit an individual fel-

lowship application once they have applied for permanent residency status.

When an application involving Permanent Residency is selected to receive an award, prior to any award

being issued, a notarized statement will be required that documents that a licensed notary has seen the

individual’s valid Permanent Resident Card or other valid verification from the U.S. Immigration and

Naturalization Service of legal admission to the U.S.

Individuals on temporary or student visas are not eligible to apply for Kirschstein-NRSA individual fel-

lowships unless they have begun the process for becoming a permanent resident and expect to be admit-

ted as a permanent resident by the earliest possible award date.

11.2.2.5 Sponsorship

General.

Before submitting a Kirschstein-NRSA individual fellowship application, the fellowship applic-

ant must identify a sponsoring institution and an individual who will serve as a sponsor (also called

IIB-32

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

mentor or supervisor) and supervise the training and research experience. The sponsoring institution may

be domestic or foreign, public or private (for-profit or non-profit), including NIH intramural programs,

other Federal laboratories, and units of State and local governments. The sponsoring institution is legally

responsible for providing facilities for the applicant and financially responsible for the use and dis-

position of any funds awarded based on the application. The sponsor should be an active investigator in

the area of the proposed research who will directly supervise the fellow’s research. The sponsor must

document in the application the training plan for the applicant as well as the availability of staff, research

support, and facilities for high-quality research training. In most cases, postdoctoral fellowships support

research training experiences in new settings in order to maximize acquisition of new skills and know-

ledge. Therefore, postdoctoral fellowship applicants proposing training at their doctoral institution must

document thoroughly the opportunity for new training experiences designed to broaden their scientific

backgrounds. In addition, the application should propose research experiences that will allow the fellow

to acquire new knowledge and/or technical skills that will enhance their potential to become a pro-

ductive, independent investigator.

Foreign Sponsorship.

An individual may request support for training abroad. In such cases, the fel-

lowship applicant is required to provide detailed justification for the foreign training, including the reas-

ons why the facilities, the mentor, or other aspects of the proposed experience are more appropriate than

training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the

foreign training as compared to the training available domestically. Foreign training may require addi-

tional administrative reviews and will be considered for funding only when the scientific advantages are

clear.

11.2.2.6 NIH Employees & Other Federal Sponsorship (Federal Fellows)

Both civil service employees and PHS commissioned officers at NIH and other Federal laboratories are

permitted to compete for predoctoral and postdoctoral fellowships. The proposed training should be

primarily for career development rather than for the immediate research needs of NIH or the other

Federal laboratory. When at an NIH laboratory, the employee’s supervisor must disassociate themselves

from the review and award process.

An individual at NIH or another Federal laboratory who is supported under an individual fellowship may

not also hold an employee position with the Federal Government. Therefore, successful fellowship applic-

ants for predoctoral or postdoctoral awards must either resign from NIH or the other Federal laboratory

or take LWOP before activating the award. (There is no obligation or commitment by either the Federal

agency or the fellow for future employment upon termination of the fellowship.)

Support provided for Federal fellows is similar to those at non-Federal sponsoring institutions; stipends,

tuition (when applicable), and institutional allowance are provided. However, the administration and pay-

ment of these fellowships is unique. Specifics are noted in the applicable sections below. This require-

ment does not apply to employees of facilities that are Government-owned but Contract-operated, as they

are not considered Federal laboratories.

11.2.2.7 Individuals on Active Military Duty

NIH does not restrict career military personnel from applying for Kirschstein-NRSA individual fel-

lowship awards while on active military duty. At the time of application, the fellowship applicant’s

branch of the military service should submit a letter endorsing their application and indicating will-

ingness to continue normal active duty pay and allowances during the period of the requested fellowship.

If an award is made, the institutional allowance and necessary tuition and fees permitted on a postdoc-

toral program will be paid by NIH. However, stipends, health insurance, and travel allowances are not

allowable charges to a Kirschstein-NRSA individual fellowship for career military personnel. Payment of

concurrent benefits by NIH to active-duty career military recipients is not allowed.

IIB-33

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

11.2.3 Application Requirements and Due Dates

11.2.3.1 Application

Each fellowship applicant must submit an application based on the application package provided as part

of the NOFO. Individual fellowship applications are submitted electronically through Grants.gov using

an application package that combines form components from the SF424 (R&R) application with the PHS

Fellowship Supplemental Form.

The major emphasis of the application should be the research training experience and broadening of sci-

entific competence. The AOR of the sponsoring institution agrees to secure and retain, but need not sub-

mit to NIH, the assurance signatures of the fellowship applicant and sponsor. For postdoctoral fellowship

applicants, the assurance of the fellowship applicant includes certification that they have read the pay-

back information and will meet any payback provisions required under the law as a condition for accept-

ing the award.

Fellowship applicants and sponsoring institutions must comply with policies and procedures governing

such requirements as civil rights; the protection of human subjects, including data and safety monitoring

requirements; research misconduct; the humane care and use of live vertebrate animals; the inclusion of

women, minorities and individuals across the lifespan in study populations; human embryonic stem cells;

and research involving recombinant or synthetic nucleic molecules. (For a complete list of applicable

requirements, see

Exhibit 4, Public Policy Requirements, Objectives and Appropriation Mandates

IIA.)

11.2.3.2 eRA Commons Registration

All fellowship applicants and sponsoring institutions must be

registered in the eRA Commons

. The fel-

lowship applicant must be assigned the “PI Role” in the eRA Commons. Only the PI Role will provide

the fellowship applicant with the appropriate access in the eRA Commons to the application and review

information. When a prospective fellowship applicant is submitting an application through a sponsoring

institution that is different than their current institution, that individual must be affiliated with the spon-

soring institution.

11.2.3.3 ORCID iDs

The requirement for ORCID identifiers will be enforced at the time of application for individual fel-

lowship including the following: F05, F30, F31, F32, F33, F37, F38, F99/K00 and FI2.

eRA system validations will check whether applicants have ORCID iDs and applications will not be

accepted unless an ORCID iD is linked to the PD/PI's eRA Commons Personal Profile.

To either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them

back to the eRA Commons, prospective applicants for individual fellowship awards may follow the

ORCID link from their Personal Profiles in the eRA Commons.

11.2.3.4 Letters of Reference

As part of an application submission, at least three (but no more than five) letters of reference on behalf

the fellowship applicant also must be submitted. Electronic submission of the fellowship application

incorporates a separate, yet simultaneous electronic submission process for reference letters through the

eRA Commons. Reference letters are submitted directly by the referee through the eRA Commons and

not as part of the electronic application submitted through Grants.gov. Reference letters will be joined

with the electronic application within the eRA system once an application completes the submission pro-

cess. Applications that are missing the required letters may be delayed in the review process or not

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11 Ruth L. Kirschstein National Research Service Awards

accepted. Applicants must carefully follow the instructions provided in the

Individual Fellowship Applic-

ation Guide.

The Application Guide includes specific instructions to be sent to prospective referees.

11.2.3.5 Responsible Conduct of Research

All fellowship applicants must include a plan to obtain instruction in the responsible conduct of research.

This plan should document prior instruction in responsible conduct of research during the applicant’s cur-

rent career stage (including the dates of last occurrence) and propose a plan to receive instruction in

responsible conduct of research. The plan must address the five instructional components, format, subject

matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and

explained below. The plan may include career stage-appropriate, individualized instruction or inde-

pendent scholarly activities that will enhance the applicant’s understanding of ethical issues related to

their specific research activities and the societal impact of that research. The role of the sponsor/mentor

in responsible conduct of research instruction must be described. Applications lacking a plan for instruc-

tion in responsible conduct of research will be considered incomplete and may be delayed in the review

process. Further, applications with unacceptable plans will not be funded until the applicant provides an

acceptable, revised plan. For additional instructions, see the specific NOFO.

Format.

Discussion-based instruction in the responsible conduct of research is expected to

remain a key feature of RCR training and to include substantive face-to-face interaction among

participants and faculty. However, recognizing that advances in video conferencing now allow

for effective “face-to-face” discussions to occur electronically, institutions may wish to consider

incorporating video conferencing options into their RCR instruction, provided that those options

are utilized in a way that fosters discussion, active learning, engagement, and interaction among

the participants. At the same time, video conferencing should not be the sole means for meeting

the requirement for RCR instruction, and a plan that employs only video conferencing will not

be considered acceptable, except in special instances of short-term training programs or unusual

and well-justified circumstances.

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11 Ruth L. Kirschstein National Research Service Awards

Subject Matter.

Developments in the conduct of research and a growing understanding of the

impact of the broader research environment have led to a recognition that additional topics merit

inclusion in discussions of the responsible conduct of research, including below:

a. conflict of interest – personal, professional, and financial – and conflict of commitment,

in allocating time, effort, or other research resources

b. policies regarding human subjects, live vertebrate animal subjects in research, and safe

laboratory practices

c. mentor / mentee — responsibilities and relationships

d. safe research environments (e.g., those that are free of sexual, racial, ethnic, disability

and other forms of discriminatory harassment)

e. collaborative research including collaborations with industry and investigators and insti-

tutions in other countries

f. peer review, including the responsibility for maintaining confidentiality and security in

peer review

g. data acquisition and analysis; and laboratory tools (e.g., tools for analyzing data and cre-

ating or working with digital images); recordkeeping practices, including methods such

as electronic laboratory notebooks.

h. secure and ethical data use; data confidentiality, management, sharing, and ownership

i. research misconduct and policies for handling misconduct

j. responsible authorship and publication

k. the scientist as a responsible member of society, contemporary ethical issues in bio-

medical research, and the environmental and societal impacts of scientific research

Faculty Participation.

Sponsors and other appropriate faculty are highly encouraged to con-

tribute both to formal and informal instruction in responsible conduct of research. Informal

instruction occurs in the course of laboratory interactions and in other informal situations

throughout the year. Sponsors may contribute to formal instruction in responsible conduct of

research as discussion leaders, speakers, lecturers, and/or course directors.

Duration of Instruction.

Instruction should involve substantive contact hours between the fel-

low, sponsor and other appropriate faculty. Acceptable programs generally involve at least eight

contact hours. A semester-long series of seminars/programs may be more effective than a single

seminar or one-day workshop because it is expected that topics will then be considered in suf-

ficient depth, learning will be better consolidated, and the subject matter will be synthesized

within a broader conceptual framework.

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11 Ruth L. Kirschstein National Research Service Awards

Frequency of Instruction.

Existing policy and guidance call for RCR instruction to be under-

taken at least once during each career stage, and at a frequency of no less than once every four

years. As institutions consider how to optimize the timing and delivery of instruction in the

responsible conduct of research, they are encouraged to bear in mind the value of ongoing and

discipline-specific training as individuals progress in their research careers. For example, while

broad-based instruction in the responsible conduct of research is often appropriate early in gradu-

ate school; a more tailored, discipline-specific approach may better fit the needs of advanced

graduate students and those who have transitioned to postdoctoral status. If advanced students

and postdoctorates have been exposed to the full range of topics traditionally included in RCR

instruction early in their scientific training, it may make sense for their ongoing and/or sub-

sequent RCR training to focus on subjects most relevant to their fields, and institutions may wish

to consider this approach, where applicable.

Information on the nature of the instruction in the responsible conduct of research and the extent of fel-

low and faculty participation also must be provided in the annual progress report submitted as a pre-

requisite to receiving non-competing continuation support.

11.2.3.6 Concurrent Applications

An individual may not have two or more competing Kirschstein-NRSA individual fellowship applic-

ations pending review concurrently. In addition, CSR will not accept for review any application that is

essentially the same as one already reviewed.

11.2.3.7 Receipt Dates

Kirschstein-NRSA individual fellowship applications undergo a review process that takes 5 to 8 months.

The annual schedule for application receipt, review, and award can be found in a specific Notice of Fund-

ing Opportunity and on

NIH's Standard Due Dates website

11.2.4 Review

Each new and renewal application will be evaluated for scientific merit by an NIH SRG.

11.2.4.1 Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fel-

lowship will enhance the fellowship applicant’s potential for a productive independent scientific research

career in a health-related field, in consideration of the scored and additional review criteria (as applicable

for the project proposed).

Individual Fellowship programs are training awards and not research awards. Major considerations in the

review are the candidate’s potential for a productive career, the candidate’s need for the proposed train-

ing, and the degree to which the research training proposed, the sponsor, and the environment will satisfy

those needs.

11.2.4.2 Scored Review Criteria

Reviewers will consider each of the three review criteria below in the determination of scientific and

technical merit, and give a separate score for each. The following review criteria are applicable primarily

to F30, F31, F32, F33 and F99/K00 applications. For review criteria pertaining to other individual fel-

lowship applications (e.g., F05), please refer to the specific NOFO. The scored criteria are:

Candidate's Preparedness and Potential

Research Training Plan

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11 Ruth L. Kirschstein National Research Service Awards

Commitment to Candidate

The NOFO should be consulted for additional information describing each of the scored review criteria.

11.2.4.3 Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the

determination of scientific and technical merit but will not give separate scores for these items:

Protections for Human Subjects

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Vertebrate Animals

Biohazards

Resubmission Applications

Renewal Applications

The NOFO should be consulted for additional information describing each of the relevant additional

review criteria.

11.2.4.4 Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not

give scores for these items and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

Select Agents Research

Resource Sharing Plans

Authentication of Key Biological and/or Chemical Resources

Budget and Period Support

Foreign Sponsoring Institutions

The NOFO should be consulted for additional information describing each of the relevant additional

review considerations.

11.2.4.5 Secondary Level of Review

Kirschstein-NRSA individual fellowship applications receive a secondary level of review by IC staff. Cri-

teria used in making award decisions include the SRG’s recommendation concerning the overall merit of

the application, the relevance of the application to the IC’s research training priorities and program bal-

ance, and the availability of funds.

11.2.5 Notification of Action

Shortly after the initial review meeting, each fellowship applicant receives an e-mail indicating that the

SRG recommendation/impact score is available in the eRA Commons. The fellowship applicant is also

notified via an e-mail when the summary statement is available in the eRA Commons.

The PO may notify the fellowship applicant about the final review recommendation. All questions about

initial review recommendations and funding possibilities should be directed to the designated IC PO, not

to the SRO of the SRG. Name and contact information of the assigned PO is also available in the eRA

Commons. If the application is under consideration for funding, NIH will request any additional

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

necessary information from the applicant. After all program and administrative issues have been

resolved, the NoA will be issued for those selected for funding.

11.2.6 Period of Support

No individual may receive more than 5 years of aggregate Kirschstein-NRSA support at the predoctoral

level and 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any com-

bination of Kirschstein-NRSA support from institutional research training grants and individual fel-

lowships. For individual MD/PhD or other dual-doctoral degree fellowships (F30 only), individuals may

receive up to 6 years of aggregate NRSA support at the predoctoral level, including any combination of

support from institutional research training grants and individual fellowships. Over the total duration of

dual degree support, at least 50 percent of the award period must be devoted to graduate research train-

ing leading to the doctoral research degree. For F30 applications for dual-degree candidates other than

DDS/PhD, DMD/PhD, and AuD/PhD candidates, applicants must have matriculated into a dual-degree

program no more than 48 months prior to the due date of the initial (-01) application. For DDS/PhD,

DMD/PhD, and AuD/PhD degree candidates to be eligible, an applicant must have matriculated into a

dual-degree program and identified a dissertation research project and sponsor(s).

Any exception to the maximum period of support requires a waiver from the NIH awarding IC based on

review of a justification from the individual and sponsoring institution. The AOR of the sponsoring insti-

tution must make the request in writing to the NIH awarding IC on behalf of the fellow, and must secure

and retain, but need not submit to NIH, the fellow and sponsor’s signatures. The request must specify the

amount of additional support for which approval is sought. Individuals seeking additional support bey-

ond the third year of postdoctoral support are strongly advised to consult with their PO before submitting

a waiver request.

Some generally recognized categories under which NIH may grant exceptions include the following:

Physicians/Clinicians.

Individuals requiring additional time to complete training, either as par-

ticipants in a combined M.D./Ph.D. program or as clinicians (e.g., physicians, dentists, veter-

inarians) who are completing postdoctoral research training. An exception is contingent upon an

assurance of the recipient’s good academic standing and sufficient justification.

Interruptions (Break in Service).

Requests for additional time also will be considered if an

event unavoidably alters the planned course of the research training, if the interruption has sig-

nificantly detracted from the nature or quality of the planned research training, and if a short

extension would permit completion of the training as planned. Such events include sudden loss

of the preceptor’s services or an accident, illness, or other personal situation, which prevent a fel-

low from effectively pursuing research training for a significant period of time. Requests for

extension of support also will be considered if a short additional period would provide the fellow

an opportunity to use an exceptional training resource directly related to the approved research

training program.

Requests for additional time that do not arise from either of the above-described circumstances will be

considered only if they are accompanied by an exceptionally strong justification.

11.2.7 Full-Time and Part-Time Training

All fellows are required to pursue their research training full time. Full-time is generally defined as devot-

ing at least 40 hours per week to research training activities or as specified by the sponsoring institution

in accordance with its own policies.

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11 Ruth L. Kirschstein National Research Service Awards

Part-Time Training.

While NRSA fellows are required to pursue training full-time, under certain cir-

cumstances, a written request may be submitted to the NIH awarding IC to permit less than full-time

training.

Written requests for part-time training will be considered on a case-by-case basis and must be approved

by the NIH awarding IC in advance of each budget period. The circumstances requiring part-time train-

ing might include medical conditions, disability, or personal or family situations such as a child or elder

care. Part-time training will not be approved to accommodate other sources of funding, job opportunities,

clinical practice, clinical training, or responsibilities associated with the fellow’s position at the spon-

soring institution.

Each written request must be signed by the fellow, the AOR and the fellowship sponsor. The request for

part-time training must provide a justification of the need for a reduced level of effort and the expected

duration of the period of part-time training. The written request also must include an estimate of the

expected duration of the period of part-time training and assurances that the fellow intends to return to

full-time training when that becomes possible and intends to complete the proposed research training pro-

gram. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA support for less

than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must

take a leave of absence from Kirschstein-NRSA fellowship support.

NIH will issue a revised NoA with prorated stipend for the period of any approved part-time training.

Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral

fellows.

11.2.8 Initiation of Support

11.2.8.1 Process

The NIH IC will notify the fellowship applicant of the intention to make an award and confirm the plans

for the start of fellowship support. The individual may activate the fellowship on or after the Federal;

award date of the NoA up to the latest activation date shown in the NoA (generally 6 months after the

Federal award date). This timing allows the individual to make arrangements, such as the completion of

degree requirements, coordination with the sponsor, and, if necessary, a move to the sponsoring insti-

tution. The latest activation date may be extended in unusual circumstances. Written requests for exten-

sions should be submitted to the NIH awarding IC, by the AOR of the sponsoring institution. The

sponsoring institution must secure and retain, but need not submit to NIH, signatures of the fellowship

applicant and sponsor before the request is submitted to NIH.

The Activation Notice must be submitted to the NIH awarding IC as of the day the individual begins

training. A Payback Agreement also must be completed and submitted but only by postdoctoral fellows

in their first 12 months of Kirschstein-NRSA postdoctoral support. See

Reporting Requirements—Activ-

ation Notice

and

Reporting Requirements—Payback Agreement

in this chapter. A stipend may not be

paid until the forms are submitted and the fellow begins training. If necessary for payroll purposes, the

Activation Notice and Payback Agreement may be submitted up to 30 days before the start date.

However, any change in the planned activation start date must be reported immediately to the sponsoring

institution’s business office and to the NIH awarding IC. If an award is conditioned upon completion of

degree requirements, the fellow must submit, with the Activation Notice, proof of completion by the

degree-granting institution.

Generally, individual fellowship support is approved for consecutive years of training. The initial award

budget period is usually for 12 months. Subsequent periods of approved fellowship training are con-

secutive with the first year of support and are usually in 12-month increments (budget periods). Awards

for less than 12 months will be prorated accordingly. If a fellow decides not to activate the award, or to

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11 Ruth L. Kirschstein National Research Service Awards

terminate early, they must notify the institution’s business office, the sponsor, and the NIH awarding IC

immediately, in writing. NIH will make any necessary adjustments in the stipend and other costs, includ-

ing the institutional allowance.

11.2.8.2 Payment

Domestic.

Non-Federal sponsoring institutions receive an award for the stipend, institutional allowance,

and tuition and fees (when applicable). The institution directly pays the fellow and disburses all other

awarded costs.

Federal Laboratories.

Fellows training at Federal laboratories are paid stipends directly by the NIH

awarding IC through PMS. Reimbursement for appropriate expenditures is coordinated by the NIH

awarding IC; however, payment is through PMS. Note, if a fellow is training at a facility that is Govern-

ment-owned but Contract operated, this is not considered a Federal laboratory. As with other grants to

these types of facilities, the sponsoring institution would be the contractor.

Foreign.

Fellows training at foreign sites are paid stipends directly by the NIH awarding IC, through

PMS. However, the institutional allowance is awarded to and disbursed by the sponsoring institution.

11.2.9 Allowable and Unallowable Costs

11.2.9.1 Pre-award Costs

Pre-award costs to an individual fellowship are limited. Stipends and tuition and fees may not be charged

to a fellowship award until a fellow has actually activated the award and the appropriate paperwork sub-

mitted to NIH. Therefore, these costs may never be charged as pre-award to an individual fellowship.

There are rare occasions when costs associated with the institutional allowance may be allowable as pre-

award costs. Sponsoring institutions should consult with the NIH awarding IC when considering a pre-

award cost.

11.2.9.2 Stipends

A stipend is provided as a subsistence allowance for Kirschstein-NRSA fellows to help defray living

expenses during the research training experience. It is not provided as a condition of employment with

either the Federal government or the sponsoring institution. Stipends must be paid in accordance with sti-

pend levels established by NIH, which are based on a 12-month full-time training appointment. In the

event of early termination, the stipend will be prorated according to the amount of time spent in training.

The sponsoring institution will submit a Termination Notice reflecting the early termination and the NIH

awarding IC will issue a revised NoA to decrease approved funding. The sponsoring institution must

base its calculations on the applicable stipend level provided by NIH.

While stipends are not provided as a condition of employment, NIH policy is not intended to discourage

or otherwise prevent recipient organizations from hiring NRSA trainees and fellows as employees or

providing them with benefits consistent with what the organization provides other employees at similar

career stages.

11.2.9.3 Stipend Levels

Stipend levels are updated periodically in conjunction with an NIH annual appropriation. When increases

are approved, they are published in the

NIH Guide for Grants and Contracts

. Current levels are posted

on the

NIH Fiscal Policies page

. The NIH awarding IC will adjust fellowship awards on their

anniversary dates to include the currently applicable stipend amount.

General information related to stipends follows:

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11 Ruth L. Kirschstein National Research Service Awards

Predoctoral.

One stipend level is used for all predoctoral candidates, regardless of the level of

experience.

Postdoctoral.

The stipend level for the entire first year of support is determined by the number

of full years of relevant postdoctoral experience when the award is issued. Relevant experience

may include research experience (including industrial), teaching assistantship, internship, res-

idency, clinical duties, or other time spent in a health-related field beyond that of the qualifying

doctoral degree. Once the appropriate stipend level has been determined, the fellow must be paid

at that level for the entire grant year. The stipend for each additional year of Kirschstein-NRSA

support is the next currently available level in the stipend structure and does not change mid-

year.

Senior Fellows.

The stipend level must be commensurate with the base salary or remuneration

that would have been paid by the institution with which the individual is permanently affiliated

when the award is issued but cannot exceed the current Kirschstein-NRSA stipend limit set by

the NIH for those with 7 or more years of experience. The level of Kirschstein-NRSA support

will take into account concurrent salary support provided by the institution and the policy of the

sponsoring institution. NIH support does not provide fringe benefits for senior fellows.

11.2.9.4 Institutional Allowance

NIH awards an institutional allowance to help support the costs of training. The specific levels of allow-

ance for predoctoral and postdoctoral support, including those for individuals training at Federal labor-

atories, for-profit organizations, or foreign organizations, are published in the

NIH Guide for Grants and

Contracts

. They also are available on the

NIH Institutional Training Grants web site

The institutional allowance is a fixed amount. Expenditures under institutional allowances are not subject

to NIH prior approval requirements, and the institution is not required to account for these expenditures

on an actual cost basis. Allowable uses of the Institutional Allowance are described below.

Except for fellows at Federal training sites, consistent with NIH policy governing the type of expendit-

ures appropriate for the institutional allowance, the sponsoring institution authorizes the expenditure of

the institutional allowance on behalf of the fellow according to the institution’s policy. The institution is

entitled to expend up to the full institutional allowance upon official activation of the award. However, if

an individual fellow is not in a training status for more than 6 months of the award year, only one-half of

that year’s institutional allowance may be charged to the grant. The NoA will be revised and the stipend

and institutional allowance balances must be refunded to NIH.

For fellows at Federal training sites, the NIH awarding IC authorizes the expenditure of the allowance,

and payment is made through PMS.

The type of sponsoring institution dictates what costs may be charged to this category and how the funds

are to be administered:

Non-Federal Public and Private Non-Profit Institutions (Domestic and Foreign).

The allow-

ance is intended to defray expenses for the individual fellow such as research supplies, equip-

ment, travel to scientific meetings, and health insurance and to otherwise offset, insofar as

possible, appropriate administrative costs of training. Funds are paid directly to and administered

by the sponsoring institution.

Federal Laboratories.

The allowance is intended to cover the costs of scientific meeting travel,

health insurance, and books. Funds are administered by the NIH awarding IC and disbursed

through PMS.

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11 Ruth L. Kirschstein National Research Service Awards

For-Profit Institutions.

The allowance is intended to cover the costs of scientific meeting travel,

health insurance, and books. Funds are paid directly to the sponsoring institution for dis-

bursement to the fellow.

The following are guidelines for the use of the institutional allowance:

Travel.

Payment for travel to scientific meetings is appropriate when it is necessary for the indi-

vidual’s training and when the costs are incurred within the period of grant-supported training.

For fellows at Federal laboratories, reimbursement of travel costs must be in accordance with

applicable Federal travel regulations.

Funds may not be expended to cover the costs of travel between the fellow’s place of residence

and the domestic training institution, except that the sponsoring institution may authorize the cost

of a one-way travel allowance in an individual case of extreme hardship.

Health Insurance.

A fellow’s health insurance is an allowable cost only if applied consistently

to all individuals in a similar training status regardless of the source of support. Family health

insurance is an allowable cost for fellows who have families and are eligible for family health

insurance coverage at the sponsoring institution. Self-only health insurance is an allowable cost

for fellows without families. Health insurance can include coverage for costs such as vision

and/or dental care if consistent with organizational policy.

Medical Liability and Other Special Insurance.

Medical liability (malpractice) insurance or

other special insurance is an allowable cost to NRSA grants only if nature of the research train-

ing requires such special insurance. For instance, medical liability would be allowable if the

research training experience involves direct contact with patients or human subjects. In all cases,

for the cost to be charged to the NRSA grant, it must be consistently required for all in a similar

training status, regardless of the source of support. Special insurances that are routinely offered

as optional employee benefits (such as disability insurance, life insurance, or workman’s com-

pensation insurance), are not normally allowable charges (see separate section on Employee

Benefits) unless the nature of the research training requires such special insurance.

Extraordinary Costs.

Additional funds may be requested by the institution when the training of a

fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution

or accommodations for fellows who are disabled, as defined by the Americans with Disabilities

Act. The funds requested for extraordinary costs must be reasonable in relationship to the total

dollars awarded under a fellowship and must be directly related to the approved research training

project. Such additional funds shall be provided only in exceptional circumstances that are fully

justified and explained by the institution in the application or as part of a special written request.

11.2.9.5 Tuition and Fees

Tuition and fees are provided under the following policy:

For individual predoctoral fellowships (

F30 and F31

), an amount equal to 60% of the actual

tuition level at the applicant institution, up to $16,000 per year, will be provided. If the program

supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount

provided will be 60% of the actual tuition level, up to $21,000 per year. Note the new policy

moves health insurance into the Institutional Allowance budget category for predoctoral fel-

lowships. This is now consistent with the treatment of this cost for postdoctoral fellowships.

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11 Ruth L. Kirschstein National Research Service Awards

For individual postdoctoral fellowships (

F32

) and individual senior fellowships (

F33

), an

amount equal to 60% of the actual tuition level at the applicant institution, up to $4,500 per year,

will be provided. If the fellow is enrolled in a program that supports postdoctoral individuals in

formal degree-granting training, the amount provided will be 60% of the actual tuition level, up

to $16,000 per year. For postdoctoral fellows, costs associated with tuition and fees are allow-

able only if they are required for specific courses in support of the research training. Health insur-

ance is not included in this budget item because costs for it are to be charged as institutional

allowance.

11.2.9.6 Travel to Foreign Training Sites

For fellows at foreign training sites, in addition to the institutional allowance, awards may include a

single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air

carriers must be used to the maximum extent possible when commercial air transportation is the means

of travel between the United States and a foreign country or between foreign countries. This requirement

shall not be influenced by factors of cost, convenience, or personal travel preference. Any funds awarded

for travel to/from foreign training sites must be reported on the Termination Notice as part of the

“Amount of Stipend” column. For additional information regarding foreign travel, see

Cost Con-

siderations—Allowability of Costs/Activities-Selected Items of Cost-Travel/Employees

in IIA.

11.2.9.7 Childcare Costs

Childcare costs are allowable for full-time NRSA fellows and full-time recipients of Predoctoral to

Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award. Applic-

ants and recipients may request the NRSA costs as part of new applications, continuation applications

(Type 5), or as an administrative supplement request (Type 3). Childcare cost levels are updated peri-

odically. When increases are approved, they are published in the NIH Guide for Grants and Contracts.

Childcare must be provided by a licensed childcare provider. Recipients must maintain all supporting

documentation (e.g., proof provider is licensed) and make it available to NIH officials upon request. NIH

does not require recipients to submit this supporting documentation with each request.

The NRSA fellow childcare costs are not tied to payback obligations, nor should it be reported as such.

When childcare costs are awarded, they are generally restricted and cannot be re-budgeted without prior

written approval from the NIH awarding IC. In cases of early termination, recipients may not use any

unused portion of the childcare costs. It will remain unobligated and will be adjusted by the agency as

part of the closeout process.

11.2.9.8 Employee Benefits

Since Kirschstein-NRSA fellowships are not provided as a condition of employment with either the

Federal government or the sponsoring institution, institutions may not seek funds, or charge individual

fellowship awards, for costs that normally would be associated with employee benefits (for example,

Federal Insurance Contributions Act (FICA), which funds Social Security and Medicare, workman’s

compensation, life insurance, union dues, and unemployment insurance). Concerning union dues or other

similar costs otherwise paid personally by the fellow; if a fellow requests the institution deduct such a

cost from the stipend amount, the institution can provide the fellow such a service. However, in no case

can such a deduction from the stipend be made automatically without the approval of the fellow.

11.2.9.9 Rebudgeting of Funds

Individual fellowship awards are formula based, generally restricted for the specific budget category of

the award, and cannot be rebudgeted without prior written approval from the NIH awarding IC.

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11 Ruth L. Kirschstein National Research Service Awards

Stipends must be expended using the stipend level provided in the award; no funds can be

rebudgeted into the stipend category to accommodate a stipend level different from the estab-

lished NIH level. When a fellowship terminates early, any unexpended stipends must be returned

and cannot be rebudgeted into any other budget category.

Institutional allowance is a fixed amount of money with a number of allowable costs. In the rare

case where institutional allowance may be unexpended, it can only be rebudgeted into the tuition

and fees category when tuition and fees have been awarded.

When tuition and fees is awarded, it is generally restricted and cannot be rebudgeted without

prior written approval from the NIH awarding IC.

11.2.10 Supplementation of Stipends, Compensation, and Other

Income

11.2.10.1 Stipend Supplementation

Kirschstein-NRSA fellows receive stipends to defray living expenses. Stipends may be supplemented by

an institution from non-Federal funds provided this supplementation is without any additional obligation

for the fellow. An institution can determine the amount of stipend supplementation, if any, it will provide

according to its own formally established policies governing stipend support. These policies must be con-

sistently applied to all individuals in a similar status regardless of the source of funds. Federal funds may

not be used for stipend supplementation unless specifically authorized under the terms of the program

from which funds are derived. Under no circumstances may PHS funds be used for supplementation.

An individual may use Federal educational loan funds or VA benefits when permitted by those programs

as described in

Other Income: Educational Loans or GI Bill

in this chapter.

11.2.10.2 Compensation

NIH recognizes that Kirschstein-NRSA fellows may seek part-time employment incidental to their train-

ing program to offset further their expenses. Fellows and trainees may spend on average, an additional

25% of their time (e.g., 10 hours per week) in part time research, teaching, or clinical employment, so

long as those activities do not interfere with, or lengthen, the duration of their NRSA training. Funds

characterized as compensation may be paid to fellows only when there is an employer-employee rela-

tionship, the payments are for services rendered, and the situation otherwise meets the conditions for

compensation of students as detailed in

Cost Considerations—Selected Items of Cost—Fringe Benefits /

IHE Tuition/Tuition Remission

in IIA. In addition, compensation must be in accordance with organ-

izational policies applied consistently to both federally and non-federally supported activities and must

be supported by acceptable accounting records that reflect the employer-employee relationship. Under

these conditions, the funds provided as compensation (salary, fringe benefits, and/or tuition remission)

for services rendered, such as teaching or laboratory assistance, are not considered stipend sup-

plementation; they are allowable charges to Federal grants, including PHS research grants. However,

NIH expects that compensation from research grants will be for limited part-time employment apart from

the normal full-time training activities.

Compensation may not be paid from a research grant that supports the same research that is part of the

fellow’s planned training experience as approved in the Kirschstein-NRSA individual fellowship applic-

ation.

Stipend Supplementation & Compensation.

Under no circumstances may the conditions of stipend sup-

plementation or the services provided for compensation interfere with, detract from, or prolong the fel-

low’s approved Kirschstein-NRSA training program. Fellowship sponsors must approve all instances of

IIB-45

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

employment on research grants to verify that the circumstances will not detract from or prolong the

approved training program.

11.2.10.3 Other Income: Concurrent Benefits

A Kirschstein-NRSA individual fellowship may not be held concurrently with another federally

sponsored fellowship or similar Federal or non-Federal award that provides a stipend or otherwise duplic-

ates provisions of the Kirschstein-NRSA.

11.2.10.4 Other Income: Educational Loans or GI Bill

An individual may accept concurrent educational remuneration from the VA (GI Bill) and Federal edu-

cational loan funds. Such funds are not considered supplementation or compensation.

11.2.10.5 Other Income: NIH Loan Repayment Program

Postdoctoral fellows may also be eligible to participate in the

NIH Loan Repayment Program

11.2.10.6 Taxability of Stipends

Section 117 of the Internal Revenue Code (26 U.S.C. 117) applies to the tax treatment of scholarships

and fellowships. In general, degree candidates may exclude from gross income (for tax purposes) any

amount used for qualified tuition and related expenses such as fees, books, supplies, and equipment

required for courses of instruction at a qualified educational organization. Non-degree candidates are

required to report as gross income any monies paid on their behalf for stipends or any course tuition and

fees required for attendance.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedures 2005-11)

clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed

by a school, college, or university where the student is pursuing a course of study. NIH’s understanding

is that these final regulations do

not

apply to or impact Kirschstein-NRSA programs or awards.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA fellows and spon-

soring institutions. Kirschstein-NRSA stipends are not considered salaries. In addition, recipients of

Kirschstein-NRSA individual fellowships are not considered to be in an employee-employer relationship

with NIH or the sponsoring institution solely as a result of the Kirschstein-NRSA award. The inter-

pretation and implementation of the tax laws are the domain of the IRS and the courts. NIH takes no pos-

ition on what the status may be for a particular taxpayer, and it does not have the authority to dispense

tax advice. Individuals should consult their local IRS office about the applicability of the law to their situ-

ation and for information on their tax obligations.

11.2.10.7 Form 1099

Although stipends are not considered salaries, these funds are subject to Federal and, sometimes, State

income tax. Such income may be reported by the sponsoring institution on IRS Form 1099, Statement of

Miscellaneous Income. Normally, the business office of the sponsoring institution will be responsible for

annually preparing and issuing IRS Form 1099 for fellows paid through the institution (fellows at

domestic non-Federal institutions). Sponsoring institutions are not required to issue a Form 1099, but it

is a useful form of documentation of funds received and it serves as a reminder to the fellow that some

tax liability may exist. Fellows are reminded that, even if the sponsoring institution does not issue a

Form 1099, they still are required to report Kirschstein-NRSA stipends. For fellows training at a Federal

or foreign laboratory and receiving a stipend from NIH, PMS will issue a Form 1099.

IIB-46

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

11.2.11 Reporting Requirements

The submission of the forms described in this subsection is critical to establishing and paying stipends

and other costs and determining possible payback service. All of these forms are available

in PDF-fil-

lable and Word formats

. The NIH awarding IC may provide copies of applicable forms with the NoA or

reference the

NIH Forms Library website

in the NoA.

11.2.11.1 Activation Notice

The individual may activate the fellowship on or after the issue date of the NoA up to the latest activ-

ation date shown in the NoA (generally 6 months after the award issue date). Immediately upon the ini-

tiation of training, the individual must complete and sign the Ruth L. Kirschstein Individual Fellowship

Activation Notice (Form PHS 416-5), obtain the signature of the AOR, and forward the notice along

with the Payback Agreement (required only for postdoctoral fellows in their first 12 months of

Kirschstein-NRSA support) to the NIH awarding IC.

For Kirschstein-NRSA fellows paid directly by PMS (i.e., those sponsored by foreign or federal insti-

tutions) the Activation Notice is required for the initial year only and should be submitted immediately

prior to the initiation of training. For all other Kirschstein-NRSA fellows the form should not be sub-

mitted before the fellow actually begins training. Stipend checks are issued when both the Activation

Notice and the Payback Agreement (required only for postdoctoral fellows in their first 12 months of

Kirschstein-NRSA support) are received by the NIH awarding IC.

The Activation Notice is required for the initial year only. The Activation Notice may be submitted up

to 30 days before the individual begins training if necessary for payroll purposes. However, the insti-

tution must not release any funds until the individual has started their fellowship training. Furthermore, if

the individual does not begin research fellowship training on the day indicated, the institution must

notify the NIH awarding IC immediately. Competing continuation awards must be activated on the day

following the end of the last budget period of the previous award.

11.2.11.2 Payback Agreement

A Ruth L. Kirschstein National Research Service Award Payback Agreement (Form PHS 6031) that cov-

ers the initial 12 months of Kirschstein-NRSA postdoctoral support must be signed by each person who

is to receive an individual postdoctoral fellowship. This form is not required if the individual has already

received 12 months of postdoctoral Kirschstein-NRSA support under any Kirschstein-NRSA institutional

research training grant or fellowship award. For details on Kirschstein-NRSA payback, see

Payback

Reporting Requirements

in this chapter.

No Payback Agreement is required for predoctoral fellows.

11.2.11.3 Termination Notice

The Ruth L. Kirschstein National Research Service Award Termination Notice (Form PHS 416-7) (along

with the Activation Notice and the NoA) is the basis for validating the total period of Kirschstein-NRSA

support and establishing the amount of payback obligation for each Kirschstein-NRSA fellow. For indi-

vidual fellowships, a reminder of this reporting requirement may be sent to the fellow by the NIH award-

ing IC before the scheduled termination date. For early terminations, the completed form will be required

immediately upon receipt of notification from the fellow or an AOR.

For individual fellowships training at Foreign training sites, any funds awarded for travel to/from foreign

training sites must be reported on the Termination Notice as part of the “Amount of Stipend” column.

For individual fellowships training at Federal laboratories, this column should include all monies paid dir-

ectly to them through PMS (stipend, travel, etc. as awarded).

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

The termination notice must be submitted within 30 days of the termination date even if the fellow is not

available for signature. In most cases, the information on the form must be verified by the sponsor and

an institutional business official, however, in cases where the sponsor is not available to sign the Notice

within the required timeframe, the form may be verified by the institutional business official alone. The

lack of timely and accurate information on this form could adversely affect data collected associated

with aggregate NRSA support and the payback process. For additional information on early termination,

see

Changes in the Project

below. All Termination Notices for individual fellowships are required to be

submitted electronically using the eRA Commons xTrain application.

11.2.11.4 Consecutive Support

If a fellow switches from one Kirschstein-NRSA grant mechanism to another (e.g., from an institutional

research training grant to an individual fellowship or from one NIH IC to another), the requirement for

payback service incurred is deferred until the total period of Kirschstein-NRSA support is completed. All

fellowship applications are reviewed to determine if previous Kirschstein-NRSA support has been

provided.

11.2.11.5 Progress Reports

Annual progress reports must be submitted for non-competing continuation support. The Research Per-

formance Progress Report (RPPR), which is required for fellowship awards, can be accessed from the

eRA Commons. The IDP requirement described in

Non-Competing Continuation Progress Reports

applies to individual fellowships. Inadequate or incomplete progress reports may result in a delay of con-

tinued support. For Kirschstein-NRSA individual fellowship awards, the final progress report inform-

ation is required as part of the Termination Notice.

11.2.11.6 Financial Reporting

An annual or final FFR to report expenditure information is not required for Kirschstein-NRSA indi-

vidual fellowship awards.

11.2.12 Changes in the Project

Individual fellowship awards are made for training at a specific institution under the guidance of a par-

ticular sponsor. The approval of the NIH awarding IC is required for a transfer of the award to another

institution, a change in sponsor, or a project change. As part of the approval process, if a fellow

sponsored by a domestic non-Federal institution requests a transfer to another domestic non-Federal insti-

tution before the end of the current award year, the institutions are responsible for negotiating which

institution will pay the stipend until the end of the current year. Disposition of the institutional allowance

is also negotiable between the two sponsoring organizations. No Activation Notice is required from the

new sponsoring organization. The relinquishing sponsoring organization does not need to take any action

in xTrain when a Fellowship is being transferred via a Change of Recipient Organization. The appoint-

ment will stay active as it currently is in xTrain. The new sponsoring organization of the fellow is

responsible for continuing to manage the xTrain forms and performing the termination on behalf of all

grant years when the Fellowship award ends.. No Activation Notice is required from the new sponsoring

institution.

Transfers involving Federal or foreign sponsoring institutions require unique administrative procedures

and approvals. Because each transfer varies depending on individual circumstances, the sponsoring insti-

tution should contact the NIH awarding IC for specific guidance.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

Any proposed change in the individual’s specified area of research training must be reviewed and

approved in writing by the NIH awarding IC to ensure that the training continues to be within the sci-

entific scope of the original peer-reviewed application.

When the sponsor plans to be absent for a continuous period of more than 3 months, an interim sponsor

must be named by the institution and approved in writing by the NIH awarding IC.

11.2.13 Other Terms and Conditions

11.2.13.1 Leave

Vacations and Holidays.

Kirschstein-NRSA fellows may receive the same vacations and holidays avail-

able to individuals in comparable training positions at the sponsoring institution. Fellows shall continue

to receive stipends during vacations and holidays. At academic institutions, the time between semesters

or academic quarters generally is considered an active part of the training period and is not considered to

be a vacation or holiday.

Sick leave and Other Leave.

Kirschstein-NRSA fellows may continue to receive stipends for up to 15

calendar days of sick leave per year. Under exceptional circumstances, this period may be extended by

the NIH awarding IC in response to a written request from an AOR. Sick leave may be used for medical

conditions related to pregnancy and childbirth.

Parental Leave.

Kirschstein-NRSA fellows may receive stipends for up to

60 calendar days

(equivalent

to 8 work weeks) of parental leave per year for the adoption or the birth of each child. NRSA trainees

and fellows must provide advanced notification to the recipient institution prior to taking parental leave.

Notification of supervisors and others about plans to use leave must be consistent with the organization’s

policy and must be consistently applied regardless of the source of funds. Either parent is eligible for par-

ental leave. The use of parental leave requires approval by the sponsor.

Terminal Leave.

A period of terminal leave is not permitted, and payment may not be made from grant

funds for leave not taken.

Unpaid Leave.

Individuals requiring extended periods of time away from their research training exper-

ience, that is, more than 15 calendar days of sick leave or more than 60 calendar days of parental leave,

must seek approval from the NIH awarding IC for an unpaid leave of absence. A request letter signed by

the fellow and fellowship sponsor must be submitted by the AOR, and must advise the NIH awarding IC

of the dates of the leave of absence. Upon approval of the request, the NIH awarding IC will issue a

revised NoA extending the ending date of the current budget/project period by the appropriate number of

days or months of unpaid leave time. Recipients are precluded from spending award funds during the

leave of absence; although continued coverage of health insurance would be allowable if in accordance

with policy of the sponsoring institution.

During a leave of absence, documentation to suspend the award and/or the accrual of service for cal-

culating the payback obligation must be completed and retained by the sponsoring institution. When the

fellowship is eventually terminated, the leave of absence must be clearly documented on the Termination

Notice.

11.2.13.2 Termination

NIH may terminate a Kirschstein-NRSA individual fellowship before its scheduled completion date if it

determines that the recipient has materially failed to comply with the terms and conditions of the award

or to carry out the purpose for which it was made. If an award is terminated, NIH will notify the fellow

in writing of the determination, the reasons for the determination, the effective date, and the right to

appeal the decision.

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

NIH also may terminate an award at the request of the sponsoring institution or the individual fellow.

The NIH awarding IC must be notified immediately if a sponsoring institution wants to terminate an indi-

vidual fellow or the fellow decides to terminate training before the scheduled completion date.

If a fellow receives another NIH award, e.g., as a PD/PI on an R03, then the fellow is no longer eligible

for the fellowship and the sponsoring institution should contact the awarding IC concerning early ter-

mination.

If a Kirschstein-NRSA fellowship is terminated early, the stipend must be prorated according to the

amount of time spent in training, and the NoA will be revised downward. In addition, if the length of the

final budget period was 6 months or less, the balance of any institutional allowance (at least one-half)

must be refunded.

11.2.13.3 Publications and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded research. Therefore, recipients

of Kirschstein-NRSA fellowships should make the results and accomplishments of their activities avail-

able to the research community and to the public at large. The sponsoring institution should assist the fel-

low in such activities, including the further development of discoveries and inventions for furthering

research and benefiting the public. No restrictions should be placed on the publication of results.

Kirschstein-NRSA fellows are encouraged to submit reports of their findings to the journals of their

choice for publication. Responsibility for direction of the project should not be ascribed to NIH.

However, NIH awarding IC support must be acknowledged by a footnote in language similar to the fol-

lowing: “This research was supported by the National Institutes of Health under Ruth L. Kirschstein

National Research Service Award (number) from the (name of NIH IC).” In addition, Federal funding

must be acknowledged as provided in

Appropriation Mandates—Acknowledgment of Federal Funding

IIA.

The Public Access Policy requirements described in

Administrative Requirements—Availability of

Research Results—NIH Public Access Policy

in IIA apply to articles that are authored or co-authored by

NRSA fellows and arose from NIH Support. Information on publications is included as part of the

annual progress report.

11.2.13.4 Copyright

Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable

material is developed from work supported by NIH, the author is free to arrange for copyright without

approval of the NIH awarding IC. Any such copyrighted materials shall be subject to a royalty-free,

nonexclusive, and irrevocable right to the Federal agency to reproduce, publish, and otherwise use the

work for Federal purposes and to authorize others to do so.

11.2.13.5 Inventions and Patents

Fellowships funded primarily for educational purposes are not subject to invention reporting require-

ments nor does NIH have any rights to inventions under those awards (as specified in 37 CFR Part 401.1

(b)). Kirschstein-NRSA fellows training at NIH represent an exception to this policy. Those fellows are

subject to the provisions of EO 10096 and NIH determines the disposition of rights to any invention con-

ceived or first actually reduced to practice during the period of the fellowship.

11.2.13.6 Disposition of Professional Fees

Fees resulting from clinical practice, professional consultation, or other comparable activities performed

pursuant to the purpose of the award must be assigned to the sponsoring institution for disposition in

accordance with established organizational policy. The term “professional fees” does not apply to

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

honoraria, fees for scholarly writing, delivery of occasional outside lectures, or service in an advisory

capacity to public or private non-profit organizations, which, if permitted by organizational policy, may

be retained by the fellow.

11.2.13.7 Public Policy Requirements and Objectives

All

Public Policy Requirements, Objectives, and Other Appropriation Mandates

discussed in IIA apply

to Individual Kirschstein-NRSA fellowships when appropriate. Applicants must comply with policies

and procedures governing such requirements as civil rights; the protection of human subjects, including

data and safety monitoring requirements and inclusion policies for women, minorities and individuals

across the lifespan; the humane care and use of live vertebrate animals; human embryonic stem cells;

and/or or synthetic nucleic acid research. See IIA for a complete list of applicable requirements.

It is the sponsoring institution’s responsibility to ensure that a fellow has received the proper train-

ing/education and is properly supervised particularly in the areas of human subjects research, vertebrate

animal research, and occupational safety programs.

Additional information and any application requirements can be found in the

Individual Fellowship

Application Guide

Information provided below is in addition to that provided in IIA where unique circumstances might

exist for individual fellowships.

11.2.13.7.1 Human Subjects

Indefinite Involvement.

If the sponsoring institution has an approved FWA on file with OHRP but, at

the time of application, plans for the involvement of human subjects are indefinite, the assurance number

should be provided in the application. If an award is made, human subjects may not be involved until a

certification of IRB approval or designation of exemption has been submitted.

If the applicant organization does not have an approved FWA with OHRP, one needs to be obtained

prior to IRB approval.

11.2.13.7.2 Vertebrate Animals

Indefinite Involvement.

If the sponsoring institution has an approved Animal Welfare Assurance on file

with OLAW but, at the time of application, its plans for the involvement of vertebrate animals are so

indefinite that IACUC review and approval are not feasible, the institution should indicate “Yes,” to the

involvement of Vertebrate Animals, include the Animal Welfare Assurance number, and indicate “Indef-

inite.” If an award is made, vertebrate animals may not be involved until verification of the IACUC

approval date has been submitted to the NIH awarding IC.

If the applicant organization does not have an approved Animal Welfare Assurance on file with OLAW

or for additional information on vertebrate animals, refer to the Individual Fellowship Application Guide

or contact

OLAW

(see Part III).

11.2.13.8 Applicability of NIH Standard Terms of Award

Individual Fellowships are awarded under the

NIH Standard Terms of Award

however the provisions to

extend the final budget period of a project period without additional funds and carryover of unobligated

balances do not apply.

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11 Ruth L. Kirschstein National Research Service Awards

11.3 INSTITUTIONAL RESEARCH TRAINING GRANTS

11.3.1 General

NIH will award Kirschstein-NRSA institutional research training grants (T32, TL2, T34, T35, T35 and

T90) to eligible institutions to develop or enhance research training opportunities for individuals, selec-

ted by the institution, who are training for careers in specified areas of biomedical, behavioral, and clin-

ical research. The purpose of the Kirschstein-NRSA program is to help ensure that a highly trained

workforce is available in adequate numbers and in the appropriate research areas and fields to carry out

the nation’s biomedical, behavioral, and clinical research agenda. Training activities can be in basic bio-

medical or clinical sciences, in behavioral or social sciences, in health services research, or in any other

discipline relevant to the NIH Mission. The Kirschstein-NRSA training programs support predoctoral,

postdoctoral, and short-term research training as well as limited specialized support at the pre-

baccalaureate level. All NIH ICs except FIC and NLM award Kirschstein-NRSA institutional research

training grants. FIC and NLM have unique funding authorities for training grants that are separate from

the Kirschstein-NRSA authority.

11.3.2 Eligibility

11.3.2.1 Applicant Eligibility

A domestic, non-profit public or private organization may apply for a grant to support a research training

program in a specified area(s) of research. Support for predoctoral, postdoctoral, or a combination of

trainees may be requested. (Specific program announcements should be consulted for IC guidelines.) Sup-

port for short-term training positions for students in health-professional degree programs also may be

requested as indicated in

Short-Term Research Training

in this subsection. Each applicant institution

must submit an application using the research training forms and instructions (see

Application Require-

ments and Due Dates

in this subsection).

11.3.2.2 Research Areas

Kirschstein-NRSA institutional research training grants may be made for research training in areas that

fall within the missions of the NIH ICs. Applications that do not address these areas will be returned. An

increased emphasis has been placed on the research training of physicians. The HHS Secretary is

required by law, in taking into account the overall national needs for biomedical research personnel, to

give special consideration to physicians who agree to undertake a minimum of 2 consecutive years of bio-

medical, behavioral, or clinical research training.

The applicant institution must have a strong research program in the areas proposed for research training

and must have the staff and facilities required to carry out the proposed program.

Trainees appointed to the training program must have the opportunity to carry out supervised biomedical,

behavioral, social or clinical research with the primary objective of developing or extending their

research skills and knowledge in preparation for a research career.

11.3.2.3 Training Program Director/Principal Investigator(s)

The Training PD/PI must be an individual with the skills, knowledge, and resources necessary to organ-

ize and implement a high-quality research training program at the recipient organization. The Training

PD/PI at the recipient organization will be responsible for the selection and appointment of trainees to

the Kirschstein-NRSA research training grant and for the overall direction, management, and admin-

istration of the training program, including program evaluation, and submission of all required forms in a

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Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

timely manner. In selecting trainees, the PD/PI must make certain that individuals receiving support meet

the eligibility requirements set forth in this subsection.

More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for training

programs that require a team approach and therefore, clearly do not fit the single-PD/PI model (e.g., inter-

disciplinary of multidisciplinary training). The decision to apply for a single PD/PI or multiple PD/PIs is

the responsibility of the investigators and applicant organizations, and should be determined and justified

by the goals of the training program. Applications for grants with multiple PD/PIs require additional

information, including the structure and governance of the PD/PI leadership team. In addition, the know-

ledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall

scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility

for leading and directing the training program, intellectually and logistically. Each PD/PI is responsible

and accountable to the recipient organization for the proper conduct of the program, including the sub-

mission of required reports.

Applications reflecting multiple PD/PIs must provide a Leadership Plan. The emphasis in the Leadership

Plan should be on how it will benefit the research training program and the trainees.

A single Contact PD/PI must be designated for the purpose of communicating with NIH, although other

individuals may contact NIH on behalf of the Contact PD/PI when necessary. Because training programs

are intended to be coherent, NIH will not allocate the budget or training positions between multiple

PD/PIs. Only a single award will be issued. Multiple PD/PI training programs should include reasonable

numbers of PD/PIs and each individual should be included for a specific purpose. Multiple-PD/PI applic-

ations should not include all mentors of the training grant as PD/PIs, except in unusual cases.

11.3.2.4 Research Training Program

A Kirschstein-NRSA institutional research training grant must be used to support a program of research

training. It may not support studies leading to the M.D., D.D.S., D.V.M., or other clinical, health pro-

fessional training except when those studies are a part of a formal combined research degree program,

such as the M.D./Ph.D. Similarly, trainees may not accept Kirschstein-NRSA support for clinical training

that is part of residency training leading to clinical certification in a medical or dental specialty or sub-

specialty. However, clinicians are permitted and encouraged to engage in Kirschstein-NRSA-supported

full-time, postdoctoral research training even when that experience is creditable toward certification by a

clinical specialty or subspecialty board.

Research trainees are expected to devote full time to the proposed research training. Full-time is gen-

erally defined as devoting at least 40 hours per week to the program or as specified by the sponsoring

institution in accordance with its own policies. In order to fulfill the full-time requirement, trainees who

also are training as clinicians must confine clinical duties to those that are an integral part of the research

training experience.

11.3.2.5 Degree Requirements

11.3.2.5.1 Predoctoral Training

Predoctoral research training is for individuals who have a baccalaureate degree or equivalent and are

enrolled in and training at the postbaccalaureate level in a program leading to either a Ph.D., a com-

parable research doctoral degree, or a combined clinical degree and Ph.D., such as M.D./Ph.D. Indi-

viduals who have Ph.D., M.D., D.D.S., D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.

P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited

domestic or foreign organization are not eligible for predoctoral training. Students enrolled in an integ-

rated dual degree program leading to any of the degrees described above are eligible for the predoctoral

IIB-53

Part II: Terms and Conditions of NIH Grant Awards- Subpart B

11 Ruth L. Kirschstein National Research Service Awards

training program. An integrated dual degree training program is a postgraduate program that leads to two

degrees that are pursued concurrently. The student maintains their predoctoral training status as long as

they remain enrolled in the dual degree program, regardless of whether the health professional degree

(M.D. D.D.S.) is awarded prior to the research doctoral degree. A student cannot possess both pre-

doctoral and postdoctoral statuses. A student that is not enrolled in a dual degree program and is pur-

suing both a research degree and health professions degree separately will not maintain their predoctoral

status if the student completes one degree prior to completing the other degree (e.g. student completes

the M.D. degree prior to completing their Ph.D.).

Students enrolled in health-professional programs that are not part of a formal, dual-degree program (i.e.,

M.D./Ph.D.), and who wish to postpone their professional studies to gain research experience, also may

be appointed to a Kirschstein-NRSA institutional research training grant. Predoctoral research training

must emphasize fundamental training in areas of basic biomedical, behavioral, and clinical sciences.

11.3.2.5.2 Postdoctoral Training

Postdoctoral research training is for individuals who have received a Ph.D., M.D., D.D.S., D.M.D., D.C.,

D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D.,

or equivalent doctoral degree from an accredited domestic or foreign organization. It is the responsibility

of the recipient institution, not NIH, to determine if a foreign degree is equivalent. Research training at

the postdoctoral level must emphasize specialized training to meet national research priorities in the bio-

medical, behavioral, or clinical sciences.

Kirschstein-NRSA institutional research training grants are a desirable mechanism for the postdoctoral

training of physicians and other health professionals who may have had extensive clinical training but

limited research experience. For such individuals, the training may be a part of a research degree pro-

gram. In all cases, health-professional postdoctoral trainees are to engage in at least two years of

research, research training, or comparable experiences beginning at the time of appointment.

11.3.2.5.3 Short-Term Research Training

Short-term research training includes the following:

Students in Health Professional Schools.

NIH offers two short-term training programs: those

that are part of a traditional institutional research training grant (T32) and those that exclusively

support short-term trainees (T35). Short-term research training experiences of 2 to 3 months are

available to students in health-professional schools under both mechanisms. All short-term train-

ing must be full time. Unless otherwise stated, the requirements that apply to institutional

research training grants also apply to short-term research training. Current stipend levels are pub-

lished in the

NIH Guide for Grants and Contracts

T32.

T32 (Kirschstein NRSA-Institutional Research Training Grant) applications may include a

request for short-term positions reserved specifically to provide full-time health-related research

training experiences during the summer or other “off-quarter” periods. Such positions are limited

to medical students, dental students, students in other health-professional programs, and graduate

students in the physical or quantitative sciences. Short-term appointments under institutional

research training grants are intended to provide health-professional students with opportunities to

participate in biomedical, behavioral, or clinical research in an effort to attract these individuals

into research careers.

To be eligible for short-term predoctoral research training positions, students must be enrolled and in

good standing and must have completed at least one quarter or semester in a program leading to a clin-

ical doctorate or doctorate degree in a quantitative science, such as physics, mathematics, or engineering,

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11 Ruth L. Kirschstein National Research Service Awards

before participating in the program. Individuals already matriculated in a formal research degree program

in the health sciences, holding a research doctorate or master’s degree, or a combined professional and

research doctorate normally are not eligible for short-term training positions. In schools of pharmacy,

only candidates for the Pharm. D. degree are eligible for short-term positions.

Short-term positions should be requested in the application. Short-term research training positions should

last at least 8, but no more than 12, weeks. Health-professional students and students in the quantitative

sciences selected for appointment should be encouraged to obtain multiple periods of short-term, health-

related research training during the years leading to their degrees. Such appointments may be con-

secutive or may be reserved for summers or other “off-quarter” periods.

Since some NIH ICs do not support short-term research training positions under the T32 or support them

on a limited basis only, applicants are urged to contact the appropriate NIH IC before requesting short-

term research training positions as part of a T32 application.

T35.

Several NIH ICs provide short-term research using a separate training grant mechanism (T35). The

program intent and student eligibility requirements are similar to those indicated for the T32. However,

since this Kirschstein-NRSA funding mechanism is used by only a few NIH ICs; interested applicants

are encouraged to contact specific ICs for details.

11.3.2.5.4 Pre-baccalaureate Training

NIH offers distinct programs for pre-baccalaureate training under the auspices of the Kirschstein-NRSA

undergraduate support mechanism (T34).

These programs are designed to support selected students at a variety of institutions, depending on the

specific program.

Information about the specific programs are available in the applicable NOFOs.

11.3.2.6 Citizenship

The individual to be trained must be a citizen or a noncitizen national of the United States or have been

lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are indi-

viduals who, although not citizens of the United States, owe permanent allegiance to the United States.

They generally are people born in outlying possessions of the United States (e.g., American Samoa and

Swains Island). Individuals who have been lawfully admitted for permanent residence must have a cur-

rently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For

example, if an individual has the proper validation on their passport, a notarized photocopy of the pass-

port could suffice. Because there is a 6-month limitation on this validation, it is the recipient’s respons-

ibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date.

A notarized statement verifying possession of permanent residency documentation must be submitted

with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Res-

ident status may be supported on Kirschstein-NRSA training grants; however, as with all types of Per-

manent Resident status it is the recipient’s responsibility to assure the individual remains eligible for

NRSA support for the period of time of any appointment. Individuals with Asylum/Refugee status do not

automatically hold a form of permanent residency status; they have the opportunity to apply for per-

manent residency status once they have been in the U.S. for a period of time. Therefore, individuals with

Asylum/Refugee status may not be appointed to a Kirschstein-NRSA training grant until they have also

secured permanent residency status. Individuals on temporary or student visas are not eligible for

Kirschstein-NRSA support.

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11 Ruth L. Kirschstein National Research Service Awards

11.3.3 Application Requirements and Due Dates

11.3.3.1 Application

All applications for Kirschstein-NRSA institutional research training grants are submitted electronically

through Grants.gov and use an application package that combines form components from the SF424

(R&R) application along with the PHS398 components. Application forms and instructions are provided

as part of each NOFO. Applicants should pay particular attention to the special instructions for insti-

tutional research training grants found in the SF424(R&R) Application Guide.

11.3.3.2 Due Dates

Several NIH ICs receive training grant applications three times each year; however, many ICs use only

one or two receipt dates. Information on

-specific receipt dates is available on Grants.gov in the NIH-

wide T32 and T35 NOFOs and NOFOs issued by the individual NIH ICs or by contacting the appro-

priate NIH

program official. For a list of the standard receipt dates and review cycle, see the

NIH

Standard Due Dates website

. (Also see

research training

Applicants are encouraged to contact the appropriate NIH staff before preparing and submitting an applic-

ation.

11.3.3.3 Special Program Considerations

The duration of training, the transition of trainees to individual support mechanisms, and their transition

to the next career stage are important considerations in institutional training programs. Studies have

shown that the length of the research training grant appointment of postdoctoral trainees with health-pro-

fessional degrees strongly correlates to subsequent application for and success in receiving independent

NIH research support. Therefore, Training PD/PIs should appoint only those individuals who are com-

mitted to a career in research and plan to remain on the training grant or in a non-Kirschstein-NRSA

research experience for a minimum of 2 years in the aggregate. It also has been shown that transition to

independent support is related to career success. Therefore, Training PD/PIs also should encourage and

provide training in the skills necessary for postdoctoral trainees to apply for subsequent support through

individual postdoctoral fellowships, mentored career development awards (K programs), or independent

research project grants. When reviewing Kirschstein-NRSA institutional research training grant applic-

ations, peer reviewers will examine the training record to determine the average duration of training

appointments for health-professional postdoctoral trainees and whether there is a history of transition to

individual support mechanisms.

Programs located in clinical departments that focus on research training for individuals with the M.D. or

other health-professional degrees should consider developing ties to basic science departments, or, if con-

sistent with the goals of the program, modifying the program to include individuals with research doc-

torates. In these cases, applications should describe the basic science department’s contribution to the

research training experience and also indicate whether both health professional trainees and trainees with

research doctorates will be included in the training program.

Training PD/PIs also must develop methods for ongoing evaluation of the quality and effectiveness of

the training program. This should include plans to obtain feedback from current and former trainees to

help identify weaknesses in the program and provide suggestions for program improvements as well as

plans for assessing trainee’s career development and progression, including publications, degree com-

pletion, and post-training positions. Evaluation results are to be included in competing continuation

(renewal) applications and as part of the Final RPPR.

Within the framework of the program’s longstanding commitment to excellence and projected need for

investigators in particular areas of research, attention must be given to recruiting prospective trainees

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11 Ruth L. Kirschstein National Research Service Awards

from all backgrounds in the biomedical, behavioral and clinical sciences. According to 42 USC 288 (a)

(4), this program must be carried out "in a manner that will result in the recruitment of women, and indi-

viduals from disadvantaged backgrounds (including racial and ethnic minorities), into fields of bio-

medical or behavioral research and in the provision of research training to women and such individuals."

Individuals of all backgrounds are encouraged to participate.

11.3.3.4 Training in the Responsible Conduct of Research

Every trainee supported by an NRSA training grant must receive instruction in the responsible conduct

of research. All applications must include a plan to provide such instruction. The plan must address the

five components listed below. Renewal (Type 2) applications must, in addition, describe changes in

formal instruction over the past project period and plans for the future to address any weaknesses in the

current instructional plan. All training faculty who served as course directors, speakers, lecturers, and/or

discussion leaders during the past project period must be named in the application. Applications lacking

a plan for instruction in responsible conduct of research will be considered incomplete and may be

delayed in the review process. Plans and past record will be rated as acceptable or unacceptable. Applic-

ations with unacceptable plans will not be funded until the applicant provides an acceptable, revised

plan. For additional instructions, see the specific NOFO.

Format.

Discussion-based instruction in the responsible conduct of research is expected to remain a

key feature of RCR training and to include substantive face-to-face interaction among participants and

faculty. However, recognizing that advances in video conferencing now allow for effective “face-to-

face” discussions to occur electronically, institutions may wish to consider incorporating video con-

ferencing options into their RCR instruction, provided that those options are utilized in a way that fosters

discussion, active learning, engagement, and interaction among the participants. At the same time, video

conferencing should not be the sole means for meeting the requirement for RCR instruction, and a plan

that employs only video conferencing will not be considered acceptable, except in special instances of

short-term training programs, or unusual and well-justified circumstances

Subject Matter.

Developments in the conduct of research and a growing understanding of the impact

of the broader research environment have led to a recognition that additional topics merit inclusion in dis-

cussions of the responsible conduct of research, including:

a. conflict of interest – personal, professional, and financial – and conflict of commitment, in alloc-

ating time, effort, or other research resources

b. policies regarding human subjects, live vertebrate animal subjects in research, and safe labor-

atory practices

c. mentor/trainee responsibilities and relationships.

d. safe research environments (e.g., those that are free of sexual, racial, ethnic, disability and other

forms of discriminatory harassment)

e. collaborative research including collaborations with industry and investigators and institutions in

other countries

f. peer review, including the responsibility for maintaining confidentiality and security in peer

review

g. data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or work-

ing with digital images); recordkeeping practices, including methods such as electronic labor-

atory notebooks;

h. secure and ethical data use; data confidentiality, management, sharing, and ownership

i. research misconduct and policies for handling misconduct

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11 Ruth L. Kirschstein National Research Service Awards

j. responsible authorship and publication

k. the scientist as a responsible member of society, contemporary ethical issues in biomedical

research, and the environmental and societal impacts of scientific research

Faculty Participation.

Training faculty and sponsors/mentors are highly encouraged to contribute both

to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the

course of laboratory interactions and in other informal situations throughout the year. Training faculty

may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers,

lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or dis-

cussion leaders may be a useful way to achieve the ideal of full faculty participation in formal respons-

ible conduct of research courses over a period of time.

Duration of Instruction.

Instruction should involve substantive contact hours between the trainees and

the participating faculty. Acceptable programs generally involve at least eight contact hours. A semester-

long series of seminars/programs may be more effective than a single seminar or one-day workshop

because it is expected that topics will then be considered in sufficient depth, learning will be better con-

solidated, and the subject matter will be synthesized within a broader conceptual framework.

Frequency of Instruction.

Existing policy and guidance call for RCR instruction to be undertaken at

least once during each career stage, and at a frequency of no less than once every four years. As insti-

tutions consider how to optimize the timing and delivery of instruction in the responsible conduct of

research, they are encouraged to bear in mind the value of ongoing and discipline-specific training as

individuals progress in their research careers. For example, while broad-based instruction in the respons-

ible conduct of research is often appropriate early in graduate school; a more tailored, discipline-specific

approach may better fit the needs of advanced graduate students and those who have transitioned to

postdoctoral status. If advanced students and postdoctorates have been exposed to the full range of topics

traditionally included in RCR instruction early in their scientific training, it may make sense for their

ongoing and/or subsequent RCR training to focus on subjects most relevant to their fields, and insti-

tutions may wish to consider this approach, where applicable.

Information on the nature of the instruction in the responsible conduct of research and the extent of

trainee and faculty participation also must be provided in the annual progress report submitted as a pre-

requisite to receiving non-competing continuation support.

11.3.4 Review

11.3.4.1 Overall

Each initial and competing continuation application will be evaluated for scientific merit by an NIH peer

review group. Kirschstein-NRSA institutional research training grant applications also must be reviewed

by the National Advisory Council or Board of the IC whose activities relate to the proposed research

training.

11.3.4.2 Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the

research training program to exert a sustained, powerful influence on the research field(s) involved. The

scored review criteria and additional review criteria (as applicable for the research training program pro-

posed) will be considered when determining the overall impact.

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11 Ruth L. Kirschstein National Research Service Awards

11.3.4.3 Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the scientific and tech-

nical merit, and give a separate score for each. An application does not need to be strong in all categories

to be judged likely to have major scientific merit.

Training Program and Environment

Training Program Director/Principal Investigator

Preceptor/Mentors

Trainees

Training Record

The NOFO should be consulted for additional information describing each of the scored review criteria.

Individual Institutes and Centers may have additional specialized review criteria appropriate for their spe-

cial initiatives and mission.

11.3.4.4 Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the

determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Vertebrate Animals

Biohazards

Training in Methods for Enhancing Reproducibility

Resubmission Applications

Renewal Applications

Revision Applications

The NOFO should be consulted for additional information describing each of the relevant addition

review criteria.

11.3.4.5 Additional Review Considerations

As applicable for the training program proposed, reviewers will address each of the following items, but

will not give scores for these items and should not consider them in providing the overall impact score:

Training in the Responsible Conduct of Research

Select Agents Research

Budget and Period of Support

The NOFO should be consulted for additional information describing each of the relevant addition

review considerations.

11.3.4.6 National Advisory Council Review

Following initial peer review, applications undergo a second-level review by the appropriate NIH IC’s

National Advisory Council or Board. In addition to the assessment of the scientific and educational merit

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11 Ruth L. Kirschstein National Research Service Awards

of the research training grant application, these advisory groups will consider the initial peer review

group’s comments on the plan for instruction in the responsible conduct of research.

11.3.5 Notification of Action

Shortly after the initial peer review meeting, the PD/PI will be sent an e-mail indicating that the SRG

recommendation/impact score is available in the eRA Commons. The PD/PI is also notified via an e-mail

when the summary statement is available in the eRA Commons. The PD/PI may be notified by the PO of

the final review recommendation. Once any and all administrative and programmatic issues have been

resolved, the NoA will be issued for applications selected for funding. Any questions concerning initial

review recommendations and funding possibilities should be directed to the named PO, not to the SRO

of the SRG. Name and contact information of the assigned PO is also available in the eRA Commons.

11.3.6 Period of Support

11.3.6.1 Training Grants

Kirschstein-NRSA institutional research training grants may be made for competitive segments of up to

5 years and are renewable. Awards within an approved competitive segment normally are made in 12-

month increments, referred to as budget periods; support for additional non-competitive years depends

on satisfactory progress, submission of all required trainee-related documents, and availability of funds.

11.3.6.2 Trainees

Trainees under Kirschstein-NRSA institutional research training grants generally are appointed for full-

time 12-month continuous periods. An appointment or reappointment period may begin any time during

a particular budget period but may not begin before the budget period start date of the grant year. An

appointment or reappointment may not exceed 12 months without prior approval by the NIH awarding

IC. All trainees are required to pursue their research training on a full-time basis. Full-time is generally

defined as devoting at least 40 hours per week to the program or as specified by the recipient institution

in accordance with its own policies. Unless the NIH awarding IC furnishes other instructions, the amount

of the stipend, tuition, and fees for each full period of appointment must be obligated by the recipient

from funds available when the individual begins training.

With the exception of specifically designated short-term research training positions, no trainee may be

appointed under a regular Kirschstein-NRSA institutional research training grant for less than 9 months

except with the prior written approval of the NIH awarding IC and then usually only to complete an

ongoing program of training. An initial appointment of less than 9 months may be allowed as long as an

assurance is included that the individual will be immediately reappointed in the subsequent year so that

the cumulative continuous training period is at least 9 months.

Part-Time Training.

While Kirschstein-NRSA trainees are required to pursue research training on a full-

time basis, under certain circumstances, a written request may be submitted to the NIH awarding IC to

change a trainee appointment to less than full time. All such requests must be signed by the trainee, the

AOR and the training grant PD/PI. The request for part-time training must provide a justification of the

need for a reduced level of effort and the expected duration of the period of part-time training. Such

requests will be considered case-by-case and must be approved by the awarding IC before the applicable

budget period. The circumstances requiring the part-time training might include medical conditions, dis-

ability, or personal or family situations such as a child or elder care. Part-time training will not be

approved to accommodate use of other sources of funding, job opportunities, clinical practice, clinical

training, or for other responsibilities associated with the trainee’s position at the organization. In each

case, the written request must be signed by an AOR and must include documentation supporting the need

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11 Ruth L. Kirschstein National Research Service Awards

for part-time training. Countersignatures of the trainee and program director must be secured and

retained by the recipient, but need not be submitted to NIH prior to submission to NIH. The written

request also must include an estimate of the expected duration of the period of part-time training and

assurances that the trainee intends to return to full-time training when that becomes possible and intends

to complete the research training program.

The stipend may be prorated in the grant award during the period of any approved part-time training.

Part-time training also may affect the rate of accrual or repayment of the service obligation for postdoc-

toral trainees. In no case will it be permissible for the trainee to be engaged in Kirschstein-NRSA-sup-

ported research for less than 50 percent effort. Individuals who must reduce their commitment to less

than 50 percent effort must take a leave-of-absence from a Kirschstein-NRSA training grant.

11.3.6.3 Kirschstein-NRSA Limitations

No individual trainee may receive more than 5 years of aggregate Kirschstein-NRSA support at the pre-

doctoral level and 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including

any combination of support from Kirschstein-NRSA institutional research training grants and individual

fellowships.

Any exception to the maximum period of support requires a waiver from the NIH awarding IC based on

review of a justification from the individual and the recipient organization. The AOR must make the

request in writing to the NIH awarding IC on behalf of the trainee. The endorsement of the trainee’s

PD/PI certifying the need for additional support is retained by the recipient institution. The request must

specify the amount and length of additional support for which approval is sought.

Some generally recognized categories under which NIH may grant exceptions include the following:

Physicians/Clinicians.

Individuals requiring additional time to complete training, either as par-

ticipants in a combined M.D./Ph.D. program or as clinicians (e.g., physicians, dentists, veter-

inarians) who are completing postdoctoral research training, may anticipate favorable

consideration of a request for waiver of the time limitation. This action is contingent upon an

assurance of the trainee’s good academic standing and justified need for the exception to this

policy.

Interruptions (Break in Service).

Requests for additional time also will be considered if an

event unavoidably has altered the planned course of the research training, if the interruption has

significantly detracted from the nature or quality of the planned research training, and if a short

extension would permit completion of the training as planned. Such events include sudden loss

of the preceptor’s services or an accident, illness, or other personal situation that prevents a

trainee from effectively pursuing research training for a significant period of time. Requests for

extension of support also will be considered if a short additional period would provide the

trainee an opportunity to use an exceptional training resource directly related to the approved

research training program.

Requests that arise from circumstances other than those described above will be considered only if they

are accompanied by an exceptionally strong justification.

11.3.7 Initiation of Support

The NoA is issued to the recipient organization, generally for a budget period of 12 months. A trainee

may be appointed any time during the budget period for an appointment period of 9 to 12 months,

without prior approval by the NIH awarding IC. A trainee appointment may not begin before the budget

period start date.

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11 Ruth L. Kirschstein National Research Service Awards

At the time of the initial appointment and subsequent reappointment of trainees, the Training PD/PI must

submit a Statement of Appointment for each trainee to the NIH awarding IC. In addition, a signed Pay-

back Agreement must be submitted for each postdoctoral trainee who is in their first 12 months of

Kirschstein-NRSA postdoctoral support. See

Reporting Requirements—Statement of Appointment (Form

PHS 2271)

and

Reporting Requirements—Payback Agreement (Form PHS 6031)

in this chapter for spe-

cific information on required forms. The Statement of Appointment includes biographical data on the

trainee and the stipend level for the period of appointment. The stipend is paid by the recipient organ-

ization directly to the trainee.

11.3.8 Allowable and Unallowable Costs

Policies included in the applicable cost principles in 2 CFR Part 200, Subpart E and the NIHGPS govern

the expenditure of all training grant funds, unless otherwise indicated in the NoA.

11.3.8.1 Pre-Award Costs

While some pre-award costs are allowable to a training grant, recipients should note that stipends and

tuition and fees may not be charged to a grant until a trainee has been officially appointed and the appro-

priate paperwork submitted to NIH. Therefore, these costs may not be charged as pre-award to an insti-

tutional training grant. There are rare occasions when costs associated with training related expenses

and/or trainee travel may be allowable as pre-award costs. Recipient institutions should consult with the

NIH awarding IC when considering a pre-award cost.

11.3.8.2 Stipends

Trainees generally are supported for 12-month full-time training appointments for which they receive a

stipend as a subsistence allowance to help defray living expenses during the research training experience.

The stipend is not “salary” and is not provided as a condition of employment with either the Federal gov-

ernment or the recipient organization.

While stipends are not provided as a condition of employment, NIH policy is not intended to discourage

or otherwise prevent recipient organizations from hiring NRSA trainees and fellows as employees or

providing them with benefits consistent with what the organization provides other employees at similar

career stages. Institutions should consult their local IRS office about the applicability of the law to their

situation and for information on their tax obligations.

Stipends must be paid in accordance with established stipend levels. No departure from the standard sti-

pend provided by NIH under the grant may be negotiated by the recipient organization with the trainee.

NIH stipend amounts may be adjusted only at the time of appointment or reappointment. For appoint-

ments of less than 12 months, the stipend will be prorated.

Stipend levels are updated almost every fiscal year. When increases are approved, they are published in

NIH Guide for Grants and Contracts

. Current levels also are posted on

NIH Fiscal Policies page

Stipend levels are as follows:

Prebaccalaureate.

One stipend level is provided for trainees.

Predoctoral.

One stipend level is used for all predoctoral trainees, regardless of the level of

experience.

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11 Ruth L. Kirschstein National Research Service Awards

Postdoctoral.

The stipend level for the entire first year of support is determined by the number

of full years of relevant postdoctoral experience at the time of appointment. Relevant experience

may include research experience (including industrial), teaching assistantship, internship, res-

idency, clinical duties, or other time spent in a health-related field beyond that of the qualifying

doctoral degree. Once the appropriate stipend level has been determined, the trainee must be

paid at that level for the entire grant year. The stipend for each additional year of Kirschstein-

NRSA support is the next level in the stipend structure and does not change mid-year.

11.3.8.3 Trainee Tuition and Fees

Tuition and fees are allowable trainee costs only if such charges are applied consistently to all indi-

viduals in a similar training status at the organization, without regard to their source of support.

Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved

training program and requires NIH awarding IC prior approval.

Tuition and fees are provided under the following policy:

For Predoctoral Trainees.

An amount equal to 60% of the actual tuition level at the applicant

institution, up to $16,000 per year, will be provided. If the program supports formally combined

dual-degree training (e.g., M.D.-Ph.D, D.D.S.-Ph.D.), the amount provided per trainee will be

60% of the actual tuition level, up to $21,000 per year.

For Postdoctoral Trainees.

An amount equal to 60% of the actual tuition level at the applicant

institution, up to $4,500 per year, will be provided. If the trainee is enrolled in a program that

supports postdoctoral individuals in formal degree-granting training, the amount provided per

trainee will be 60% of the actual tuition level, up to $16,000 per year.

Tuition and fees are awarded as a lump sum that can be allocated (without the prior approval of the NIH

awarding IC) based on recipient needs.

11.3.8.4 Training-Related Expenses

Funds are provided to defray costs such as staff salaries, consultant costs, equipment, research supplies,

staff travel, trainee health insurance (self-only or family as applicable), and other expenses directly

related to the training program. Funds are requested and awarded as a lump sum on the basis of the pre-

determined amount per predoctoral and postdoctoral trainee approved for support. Levels are published

in the

NIH Guide for Grants and Contracts

. Interested applicants should consult the program announce-

ment regarding the specific level for programs such as the short-term training program or the MARC pro-

gram. Many of the costs allowable under Training-Related Expenses may cover global costs for an

institutional training program where the Kirschstein-NRSA support covers only some of the participating

trainees. For these types of global costs, institutions should allocate the appropriate portion of such costs

to the training grant. Institutions are reminded that this budget category is a finite amount of money avail-

able to cover a variety of allowable costs. Institutions should be particularly mindful to apply core cost

principles of allocation and consistent treatment.

Health Insurance.

Health Insurance (self-only or family) are allowable trainee related expenses only if

such charges are applied consistently to all individuals in a similar training status at the organization,

without regard to their source of support. Health insurance can include coverage for costs such as vision

and/or dental care if consistent with organizational policy. Health insurance is awarded as part of the

Training Related Expenses category.

Medical Liability and Other Special Insurance.

Medical liability (malpractice) insurance or other spe-

cial insurance is an allowable cost to NRSA grants only if nature of the research training requires such

special insurance. For instance, medical liability would be allowable if the research training experience

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11 Ruth L. Kirschstein National Research Service Awards

involves direct contact with patients or human subjects. In all cases, for the cost to be charged to the

NRSA grant, it must be consistently required for all in a similar training status, regardless of the source

of support. Special insurances that are routinely offered as optional employee benefits (such as disability

insurance, life insurance, or workman’s compensation insurance), are not normally allowable charges

(see separate section on Employee Benefits) unless the nature of the research training requires such spe-

cial insurance.

Staff Salaries.

Institutions are reminded that applicable cost principles apply. Training programs may

qualify as a “major project” where administrative salaries are allowable as a training-related expense.

Speaker Fees.

When speakers are part of program required for NSRA-supported trainees, a portion of

such a cost could be charged as Training-related expenses.

Meals.

As stated in IIA, the

cost of meals

may be allowable if they are provided in conjunction with a

meeting considered an ancillary activity to the training grant. A portion of such a cost could be charged

as Training-related expenses. See

Cost Considerations—The Cost Principles

in IIA for specific guidance

on the need institutional policies on consistent treatment and reasonableness.

Extraordinary Costs.

Under exceptional circumstances, which can include accommodating the dis-

abilities of a trainee, it is possible to request organizational costs above the standard level. Requests for

additional costs must be explained in detail and justified in the application. Consultation with NIH pro-

gram staff in advance of such requests is strongly advised.

11.3.8.5 Trainee Travel Costs

If requested by the recipient, the NIH awarding IC may provide grant funds to cover the costs of trainee

travel, including attendance at scientific meetings, which the organization determines is necessary to the

individual’s training. Trainees must be appointed to the training grants at time of the actual travel for this

to be an allowable cost. Funds may not be expended to cover the costs of travel between the trainee’s

place of residence and the training institution, except that the recipient organization may authorize a one-

way travel allowance in an individual case of extreme hardship.

In addition, support for travel to a research training experience away from the recipient organization may

be permitted. Research training experiences away from the parent organization must be justified on the

basis of the type of opportunities for training available, the opportunities offered that are different from

those at the parent organization, and the relationship of the proposed experience to the trainee’s career

stage and career goals. This type of research training requires prior approval of the NIH awarding IC.

Letters requesting such training may be submitted to the NIH awarding IC at any time during the appoint-

ment period.

11.3.8.6 Short-Term Training Costs

The recipient may receive up to one-twelfth of the annual amount designated for training-related

expenses each month to offset the costs of tuition, fees, travel, supplies, and other expenses for each

short-term, health-professional research training position.

11.3.8.7 Employee Benefits

Because Kirschstein-NRSA awards are not provided as a condition of employment with either the

Federal government or the recipient, it is inappropriate and unallowable for organizations to seek funds,

or to charge Kirschstein-NRSA institutional research training grants, for costs that normally would be

associated with employee benefits (for example, FICA, workers compensation, life insurance, union

dues, and unemployment insurance). Concerning union dues or other similar costs otherwise paid per-

sonally by the trainee, if a trainee requests the institution deduct such a cost from the stipend amount, the

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11 Ruth L. Kirschstein National Research Service Awards

institution can provide the trainee such a service. However, in no case can such a deduction from the sti-

pend be made automatically without the approval of the trainee and institution.

11.3.8.8 Indirect Costs

Recipients, other than State, local, or Indian tribes (or ‘‘federally recognized Indian tribes”), will receive

indirect costs at 8 percent of modified total direct costs (exclusive of tuition and fees, childcare costs,

consortiums in excess of $25,000, and expenditures for equipment) rather than on the basis of a nego-

tiated rate agreement. State, local, and Indian tribe (or ‘‘federally recognized Indian tribes”) are eligible

for full indirect cost reimbursement. For this policy, State universities or hospitals are not considered

governmental agencies.

11.3.8.9 Childcare Costs

Childcare costs are allowable for full-time predoctoral or postdoctoral NRSA trainees appointed to the

NRSA institutional research training award prior to use of the childcare costs. NIH will provide childcare

costs at the time each new, renewal, or continuation award is made. Childcare cost levels are updated

periodically and published in the

NIH Guide for Grants and Contracts

The NRSA trainee childcare costs are not tied to payback obligations and should not be reported as such.

Childcare must be provided by a licensed childcare provider. Recipients must maintain all supporting

documentation (e.g., proof provider is licensed) and make it available to NIH officials upon request. NIH

does not require recipients to submit this supporting documentation with each request.

11.3.9 Rebudgeting of Funds

Funds may be rebudgeted only as follows:

Trainee-Related Expenses.

Rebudgeting of funds awarded in a lump sum for trainee-related

expenses does not require NIH awarding IC prior approval.

Trainee Costs.

For rebudgeting purposes, trainee costs include funds awarded in the stipends or

tuition/fees budget categories. These costs may not be used for other purposes except under

unusual circumstances and then only with the prior approval of the NIH awarding IC. Unless oth-

erwise restricted, rebudgeting into or within the stipends and tuition/fees is allowable without

prior approval of the NIH awarding IC.

Trainee Travel.

For rebudgeting purposes, trainee travel is not considered a trainee cost and,

therefore, may be rebudgeted into any other budget category without prior approval of the NIH

awarding IC.

11.3.10 Stipend Supplementation, Compensation, and Other Income

11.3.10.1 Stipend Supplementation

Recipients may supplement stipends from non-Federal funds provided the supplementation is without

any additional obligation for the trainee. An organization can determine what amount of stipend sup-

plementation, if any, will be provided according to its own formally established policies governing sti-

pend support. These policies must be consistently applied to all individuals in a similar training status

regardless of the source of funds. Federal funds may not be used for stipend supplementation unless spe-

cifically authorized under the terms of the program from which funds are derived. An individual may use

Federal educational loan funds or VA benefits when permitted by those programs as described in

Edu-

cational Loans or GI Bill

below. Under no circumstances may PHS funds be used for supplementation.

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11 Ruth L. Kirschstein National Research Service Awards

11.3.10.2 Compensation

NIH recognizes that student or postdoctoral trainees may seek part-time employment coincidental to

their training program to further offset their expenses. Fellows and trainees may spend on average, an

additional 25% of their time (e.g., 10 hours per week) in part time research, teaching, or clinical employ-

ment, so long as those activities do not interfere with, or lengthen, the duration of their NRSA training.

Funds characterized as compensation may be paid to trainees only when there is an employer-employee

relationship, the payments are for services rendered, and the situation otherwise meets the conditions of

the compensation of students as detailed in

Cost Considerations—Allowability of Costs/Activities—

Selected Items of Cost—Fringe Benefits / IHE Tuition/Tuition Remission

in IIA. In addition, com-

pensation must be in accordance with organizational policies consistently applied to both federally and

non-federally supported activities and must be supported by acceptable accounting records that reflect

the employer-employee relationship. Under these conditions, the funds provided as compensation (salary,

fringe benefits, and/or tuition remission) for services rendered, such as teaching, laboratory assistance, or

clinical duties are not considered stipend supplementation; they are allowable charges to Federal grants,

including PHS research grants. However, NIH expects that compensation from research grants will be

for limited part-time employment apart from the normal full-time training activities.

Compensation may not be paid from a research grant that supports the same research that is part of the

trainee’s planned training experience as approved in the Kirschstein-NRSA institutional research training

grant application.

Stipend Supplementation & Compensation.

Under no circumstances may the conditions of stipend sup-

plementation or the services provided for compensation interfere with, detract from, or prolong the

trainee’s approved Kirschstein-NRSA training program. Training PD/PIs must approve all instances of

employment on research grants to verify that the circumstances will not detract from or prolong the

approved training program.

11.3.10.3 Other Income: Concurrent Benefits

An individual may not receive support under a Kirschstein-NRSA institutional research training grant

concurrently with another federally sponsored fellowship or similar Federal or non-Federal award that

provides a stipend or otherwise duplicates provisions of the Kirschstein-NRSA award.

11.3.10.4 Other Income: Educational Loans or GI Bill

An individual may accept concurrent educational remuneration from the VA (GI Bill) and Federal edu-

cational loan funds. Such funds are not considered supplementation or compensation. In the case of the

MARC-U*STAR program, funds from a Pell grant may be accepted as well.

11.3.10.5 Other Income: NIH Loan Repayment Program

Postdoctoral trainees also may be eligible to participate in the

NIH Loan Repayment Program

11.3.10.6 Taxability of Stipends

Section 117 of the Internal Revenue Code (26 U.S.C. 117) applies to the tax treatment of scholarships

and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used

for qualified tuition and related expenses, such as fees, books, supplies, and equipment, required for

courses of instruction at a qualified educational organization. Nondegree candidates are required to

report as gross income any monies paid on their behalf for stipends or any course tuition and fees

required for attendance.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedures 2005-11)

clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed

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11 Ruth L. Kirschstein National Research Service Awards

by a school, college, or university where the student is pursuing a course of study. NIH’s understanding

is that these final regulations do

not

apply to or impact Kirschstein-NRSA programs or awards.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA trainees and recip-

ient organizations. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported

under Kirschstein-NRSA institutional research training grants are not considered to be in an employee-

employer relationship with NIH or the recipient organization solely as a result of the Kirschstein-NRSA

support. Interpretation and implementation of the tax laws are the domain of the IRS and the courts. NIH

takes no position on what the status may be for a particular taxpayer, and it does not have the authority

to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law

to their situation and for information on their tax obligations.

11.3.10.7 Form 1099

Although stipends are not considered salaries, the funds are subject to Federal and, sometimes, State

taxes. The recipient organization may report such funds on IRS Form 1099, Statement of Miscellaneous

Income. Normally, the business office of the recipient organization will be responsible for annually pre-

paring and issuing the IRS Form 1099 for trainees. Recipient organizations are not required to issue the

Form 1099, but it is a useful form of documentation of funding received and it serves as a reminder to

the trainee that some tax liability may exist. Even if the recipient organization does not issue the Form

1099, trainees are required to report Kirschstein-NRSA stipends as income.

11.3.11 Carryover Authority

NIH Standard Terms of Award apply to Kirschstein-NRSA institutional research training grants; how-

ever, in most cases, recipients must obtain awarding IC prior approval to carry over funds. Some NIH

awarding ICs have also waived this prior approval requirement for training grants. The NoA for a

Kirschstein-NRSA institutional research training grant will specify whether or not the recipient must

obtain the prior approval of the awarding IC to carry over funds.

11.3.12 Program Income

Applicants for NIH research grants, including Kirschstein-NRSA institutional research training grants,

are required to include in their grant applications an estimate of the amount and source of program

income expected to be generated as a result of the project for which support is being sought. See

Admin-

istrative Requirements—Management Systems and Procedures—Program Income

in IIA for policies that

govern the disposition and reporting of program income.

11.3.13 Reporting Requirements

The submission of the forms described in this subsection is critical to establishing the payment of sti-

pends and other costs and determining possible payback service. Failure to submit the required forms in

a timely manner may result in an expenditure disallowance or a delay in any continuation funding. All of

these forms are available in the

Forms Directory

11.3.13.1 Statement of Appointment (Form PHS 2271)

The recipient must submit a PHS 2271 to the NIH awarding IC before or at the start of each trainee’s

appointment or reappointment. The PHS 2271 cannot be submitted until after the NoA for the respective

budget period has been issued. Recipients are required to submit the PHS 2271 data electronically using

the eRA Commons xTrain application. See

xTrain

for more information. Trainees are required to sign

reappointments and amendments, just as they are required to sign the initial appointments.

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11 Ruth L. Kirschstein National Research Service Awards

The requirement for ORCID identifiers is incorporated into the appointment process for trainees, schol-

ars, and participants supported by institutional research training, career development, and research edu-

cation awards that require appointments through the xTrain system, including the following: T03, T15,

T32, T34, T35, T37, T42, T90/R90, TL1, TL4, TU2, K12/KL2, R25, R38, RL5, and RL9.

At the time of appointment, the xTrain system will check whether appointees have ORCID iDs and

appointments will not be accepted for agency review unless an ORCID iD is linked to the individual's

eRA Commons Personal Profile.

No stipend or other allowance may be paid until the appointment form has been submitted. If the support

covers the individual’s initial 12 months of postdoctoral support, a signed Payback Agreement also must

be submitted. The information on the Statement of Appointment (and the

Termination Notice

as dis-

cussed below) is the basis for determining the length or amount of an individual’s payback requirement.

The PD/PI and the organizations’ financial officials should coordinate the information reported on the

Statement of Appointment. It should be treated as a financial document for obligating funds (stipends),

which later are reflected on the Termination Notice and as part of the total costs in the FFR.

Interim Revisions.

Any changes or corrections involving a trainee appointment under a Kirschstein-

NRSA institutional research training grant, such as name, permanent mailing address, period of training,

or stipend support, must be reported by the Training PD/PI to the NIH awarding IC on an amended PHS

2271 at the time of the change, require the trainee signature, and be submitted through xTrain.

Consecutive Support.

If a trainee switches from one Kirschstein-NRSA mechanism to another (e.g.,

from an individual fellowship to a training grant) or from one NIH awarding IC to another, the require-

ment for payback service incurred is deferred until the total period of Kirschstein-NRSA support is com-

pleted. All Statement of Appointment forms are reviewed to determine if previous Kirschstein-NRSA

support has been provided.

11.3.13.2 Payback Agreement (Form PHS 6031)

A Payback Agreement that covers the initial 12 months of Kirschstein-NRSA postdoctoral support must

be signed by each postdoctoral trainee. If the individual has already received 12 months of postdoctoral

support under any Kirschstein-NRSA training grant or fellowship award, this form is not required. For

details on Kirschstein-NRSA payback, see

Payback Requirements

in this chapter.

No Payback Agreement is required for predoctoral or prebaccalaureate trainees.

11.3.13.3 Termination Notice (Form PHS 416-7)

The Termination Notice (along with the PHS 2271 Statement of Appointment form) is the basis for val-

idating the total period of Kirschstein-NRSA support and establishing the amount of payback obligation,

if any, for each Kirschstein-NRSA trainee. The PD/PI is responsible for submitting a Termination Notice

for each trainee within 30 days of the end of the total period of support even if the trainee is not avail-

able for signature. In most cases, the information on the form must be verified by the program director

and an institutional business official, however, in cases where the program director is not available to

sign the Notice within the required timeframe, the form may be verified by the institutional business offi-

cial alone. The lack of timely and accurate information on this form could adversely affect data collected

associated with aggregate NRSA support and the payback process. Recipients are required to submit the

PHS 416-7 data electronically using the xTrain application.

See

xTrain

for more information.

No Termination Notice is required for prebaccalaureate (T34) trainees.

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11 Ruth L. Kirschstein National Research Service Awards

11.3.13.4 Research Performance Progress Reports

RPPRs must be submitted for non-competing continuation support in accordance with the RPPR instruc-

tions. Report forms and instructions are available from the

Forms Directory

. Guidance for training grants

can be found in section 7.4 of the RPPR Instructions. Following completion or termination of a project

period, the recipient must submit a Final RPPR to the NIH awarding IC within 120 days after the end of

grant support.

The IDP provision described in

Non-Competing Continuation Progress Reports

applies to all trainees

reported on a Statement of Appointment Form (PHS2271). This information should be provided using

the instructions in

Non-Competing Continuation Progress Reports

11.3.13.5 Federal Financial Report (FFR)

An annual FFR is required for all Kirschstein-NRSA institutional research training grant awards no later

than 90 days after the end of the calendar quarter in which the budget period ended. This report will doc-

ument the financial status of the grant according to the official accounting records of the recipient organ-

ization. Trainee stipends and tuition are obligated for the full 12-month appointment from the budget

period in which the appointment is initiated. Portions of stipends, tuition, childcare costs, and applicable

indirect costs that extend beyond the budget period are reported as unliquidated obligations. The same

principal may apply to trainee health insurance when an institution cannot truly obligate the full amount

of health insurance at the start of the appointment.

If the report covers the final budget period of the project period, it must have no unliquidated oblig-

ations, must indicate the exact balance of unobligated funds, and is due within 120 days of the period of

performance end date (see

Administrative Requirements—Monitoring—Reporting—Financial Reports

and

Administrative Requirements—Closeout—Final Reports

in IIA).

11.3.14 Closeout

The Closeout requirements included in IIA apply (see

Administrative Requirements—Closeout—Final

Reports

). In addition, Termination Notices for all trainees are required.

11.3.15 Changes in the Project

Changes in the program objectives as they relate to the area of research training for which the grant was

approved require prior approval of the NIH awarding IC.

If the PD/PI is expected to be absent more than 3 months, plans for the conduct of the program during

their absence must be approved in writing by the NIH awarding IC. Any proposed change of PD/PI must

be requested by the recipient organization and be approved in writing by the NIH awarding IC following

review of the nominee’s qualifications and re-evaluation of the project in light of the proposed change.

Kirschstein-NRSA institutional research training grants may not be transferred from one domestic organ-

ization to another except under the most unusual circumstances. Such a change generally will be

approved by the NIH awarding IC only if all of the major benefits attributable to the original grant can

be transferred and there is no negative impact on trainees active in the program.

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11 Ruth L. Kirschstein National Research Service Awards

11.3.16 Other Terms and Conditions

11.3.16.1 Leave

Note: The leave durations stated below apply to full-time trainees. Short-term trainee leave must be pro-

portionally adjusted based depending on the duration of appointment.

In general, trainees may receive stipends during the normal periods of vacation and holidays observed by

individuals in comparable training positions at the sponsoring institution. For the purpose of these

awards, however, the period between the spring and fall semesters is considered to be an active time of

research and research training and is not considered to be a vacation or holiday. Trainees may receive sti-

pends for up to 15 calendar days of sick leave per year. Under exceptional circumstances, this period

may be extended by the NIH awarding IC in response to a written request from an AOR. Sick leave may

be used for the medical conditions related to pregnancy and childbirth. Trainees may receive stipends for

up to

60 calendar days (equivalent to 8 work weeks)

of parental leave per year for the adoption or the

birth of each child. Either parent is eligible for parental leave. Kirschstein-NRSA trainees and fellows

must provide advanced notification to the recipient institution prior to taking parental leave. Notification

of supervisors and others about plans to use leave must be consistent with the organization’s policy and

must be consistently applied regardless of the source of funds. A period of terminal leave is not per-

mitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring peri-

ods of time away from their research training experience longer than specified here, i.e., more than 15

calendar days of sick leave or more than 60 calendar days of parental leave, must seek approval from the

NIH awarding component for an unpaid leave of absence. Approval for a leave of absence must be

requested in advance by an AOR on behalf of the trainee. Trainees supported by academic institutions

should refer to the NIH Institutional NRSA training grant guidelines in the NIH Grants Policy Statement

for further guidance regarding vacations and requested leave.

Vacations and Holidays.

Trainees may receive the same vacations and holidays available to individuals

in comparable training positions at the recipient organization. Trainees will continue to receive stipends

during vacations and holidays. At academic institutions, the time between semesters or academic quar-

ters generally is considered an active part of the training period and is not considered to be a vacation or

holiday.

Sick Leave and Other Leave.

Trainees may continue to receive stipends for up to 15 calendar days of

sick leave per year. Under exceptional circumstances, this period may be extended by the NIH awarding

IC in response to a written request from an AOR. Sick leave may be used for the medical conditions

related to pregnancy and childbirth.

Parental Leave.

Trainees may receive stipends for up to 60 calendar days (equivalent to 8 work weeks)

of parental leave per year for the adoption or the birth of each child. Either parent is eligible for parental

leave. Kirschstein-NRSA trainees and fellows must provide advanced notification to the recipient insti-

tution prior to taking parental leave. Notification of supervisors and others about plans to use leave must

be consistent with the organization’s policy and must be consistently applied regardless of the source of

funds.

Terminal Leave.

A period of terminal leave is not permitted, and payment may not be made from grant

funds for leave not taken.

Unpaid Leave.

Individuals requiring extended periods of time away from their research training exper-

ience, that is, more than 15 calendar days of sick leave or more than 60 calendar days of parental leave,

must seek approval from the NIH awarding IC for an unpaid leave of absence. A request letter must be

submitted by the AOR, signed by the trainee as well as the training grant PD/PI.

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11 Ruth L. Kirschstein National Research Service Awards

During a leave of absence, documentation to suspend the period of appointment must be completed by

submitting an amended Statement of Appointment and a Termination Notice. These forms should be sub-

mitted to the NIH awarding IC at the beginning of the leave. Upon resumption of Kirschstein-NRSA sup-

port, the reappointment must be documented on another Statement of Appointment form.

11.3.16.2 Termination

NIH may terminate a Kirschstein-NRSA institutional research training grant before its normal com-

pletion date if it determines that the recipient has materially failed to comply with the terms and con-

ditions of the award or to carry out the purpose for which the award was made. If an award is

terminated, NIH will notify the recipient organization in writing of this determination, the reasons for the

determination, the effective date, and the right to appeal the decision. NIH also may terminate an award

at the request of the recipient.

An organization that wants to terminate a training grant before the scheduled termination date must

notify the NIH awarding IC immediately. In such cases, NIH will issue a revised NoA to specify the

changed period of support and to show prorated trainee stipends, depending on the amount of time spent

in training.

11.3.16.3 Publications and Sharing of Research Results

NIH supports the practical application and sharing of outcomes of funded research. Therefore, PD/PIs

and trainees should make the results and accomplishments of their Kirschstein-NRSA institutional train-

ing grant activities available to the research community and to the public at large. The recipient organ-

ization should assist trainees in these activities, including further development of discoveries and

inventions for furthering research and benefiting the public. No restrictions should be placed on the pub-

lication of results.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice.

Responsibility for direction of the project should not be ascribed to NIH. However, NIH IC support must

be acknowledged by a footnote in language similar to the following: “This investigation was supported

by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (num-

ber) from the (name of NIH IC).” In addition, Federal funding must be acknowledged as provided in

Appropriation Mandates—Acknowledgment of Federal Funding

in IIA.

The Public Access Policy requirements described in

Administrative Requirements—Availability of

Research Results—NIH Public Access Policy

in IIA apply to articles that are authored or co-authored by

NRSA trainees and arose from NIH Support. Information on trainee publications is included as part of

the annual progress report.

11.3.16.4 Copyright

Except as otherwise provided in the NoA, when a publication or similar copyrightable material is

developed from work supported by NIH, the author is free to arrange for copyright without the approval

of the NIH awarding IC. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive,

and irrevocable license to the Federal government to reproduce, translate, publish, and use and dispose of

such materials, and to authorize others to do so for Federal government purposes.

11.3.16.5 Inventions and Patents

All Kirschstein-NRSA institutional research training grants and other funding agreements awarded

primarily for educational purposes are not subject to invention reporting requirements nor does NIH have

any rights to inventions under those grants and agreements (as specified in 2 CFR 200.315 and in 37

CFR 401.1(b)).

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11 Ruth L. Kirschstein National Research Service Awards

11.3.16.6 Disposition of Professional Fees

Fees resulting from clinical practice, professional consultation, or other comparable activities performed

pursuant to the purpose of the award may not be retained by the trainee. Such fees must be assigned to

the recipient organization for disposition in accordance with NIH policy on program income (see

Admin-

istrative Requirements—Management Systems and Procedures—Program Income

in IIA). The term “pro-

fessional fees” does not apply to honoraria, fees for scholarly writing, delivery of occasional outside

lectures, or service in an advisory capacity to public or private non-profit organizations. If permitted by

organizational policy, these fees may be retained by the trainee.

11.3.16.7 Public Policy Requirements and Objectives

All

Public Policy Requirements, Objectives, and Other Appropriation Mandates

discussed in IIA apply

to Kirschstein-NRSA Institutional programs when appropriate. Applicants must comply with policies and

procedures governing such requirements as civil rights; the protection of human subjects, including data

and safety monitoring requirements and inclusion policies for women, minorities and individuals across

the lifespan; the humane care and use of live vertebrate animals; human embryonic stem cells; and/or

research involving recombinant or synthetic nucleic acid. See IIA for a complete list of applicable

requirements.

Additional information and any application requirements can be found in the SF424 (R&R), Section 8.

Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein-NRSA Applications.

Information provided below is in addition to that provided in IIA where unique circumstances might

exist for institutional training programs.

11.3.16.7.1 Human Subjects

Indefinite Involvement.

If the applicant organization has an approved FWA or other applicable assur-

ance on file with OHRP but, at the time of application, plans for the involvement of human subjects are

indefinite, the assurance number should be provided in the application. If an award is made, human sub-

jects may not be involved until a certification of IRB approval or designation of exemption has been sub-

mitted.

In many instances, trainees supported by Kirschstein-NRSA institutional research training grants will be

participating in research supported by research project grants for which the IRB review is already com-

pleted or an exemption is already designated. This review or exemption designation is sufficient,

provided the research would not be substantially modified by the participation of a trainee. The appro-

priate grants must be identified along with their IRB review dates or exemption designation. The recip-

ient institution must ensure that trainees have received the proper training/education in human subjects

research.

11.3.16.7.2 Vertebrate Animals

Indefinite Involvement.

If the applicant organization has an approved Animal Welfare Assurance on file

with OLAW but, at the time of application, its plans for the involvement of vertebrate animals are so

indefinite that IACUC review and approval are not feasible, the organization should indicate “Yes,” to

the involvement of Vertebrate Animals and include the Animal Welfare Assurance number. If an award

is made, vertebrate animals may not be involved until verification of the IACUC approval date has been

submitted to the NIH awarding IC.

In many instances, trainees supported by institutional research training grants will be participating in

research supported by research project grants for which the IACUC review already is completed. This

review is sufficient, provided the research would not be substantially modified by the participation of a

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11 Ruth L. Kirschstein National Research Service Awards

trainee. The appropriate grants must be identified along with their IACUC review dates. The institution

must ensure that trainees are enrolled in the institution’s animal welfare training and occupational health

and safety programs for personnel who have contact with animals, as appropriate. It is also the insti-

tution’s responsibility to ensure that trainees are properly supervised when working with live vertebrate

animals.

If the applicant organization does not have an approved Animal Welfare Assurance on file with OLAW

or for additional information on vertebrate animals, refer to the Application Guide or contact

OLAW

(see Part III).

11.4 PAYBACK REQUIREMENTS

11.4.1 General

The Kirschstein-NRSA legislation requires some recipients of support (post-doctoral fellows and train-

ees) to pay back the Federal government by engaging in health-related research, health-related research

training or health-related teaching (or any combination thereof). See

Payback—Service Payback—Defin-

itions

in this subsection for complete coverage of requirements.

11.4.2 Implementation

The incurrence of a payback obligation for an NRSA recipient is solely dependent upon when NRSA

support was received. This section reflects current Payback requirements for individuals.

Predoctoral Recipients.

For predoctoral trainees no payback obligation is incurred. Thus, a Payback

Agreement Form (PHS 6031) is not required.

Postdoctoral Recipients.

For individuals receiving postdoctoral support under individual fellowships or

institutional research training grants, a payback obligation is incurred for the first 12 months of

Kirschstein-NRSA support. However, the 13th and subsequent months of postdoctoral NRSA supported

research training serves to pay back this obligation month by month. A Payback Agreement (PHS 6031)

is required but only for the initial 12-month postdoctoral support period.

Short-Term Training.

Any individual receiving support for predoctoral short-term training does not

incur a payback obligation; however, postdoctoral short-term training does incur a payback obligation.

Support for short-term training accrues, along with any subsequent NRSA postdoctoral support, until the

first 12 months is established. At that point, the 13th and subsequent months of support serve to offset

the obligation month by month. If subsequent postdoctoral support is not received, the individual has an

obligation to pay back in the traditional manner.

11.4.3 Payback

Once a Termination Notice has been submitted and accepted, the NIH awarding IC determines if a pay-

back obligation exists. When a trainee or fellow must pay back, the Termination Notice and related doc-

uments are forwarded to the NIH Kirschstein-NRSA Payback Service Center (PSC). PSC personnel are

NIH’s experts in Kirschstein-NRSA payback requirements. The PSC administers the payback activities

of all NIH ICs. The authorities related to payback normally delegated to the IC are delegated to the

Chief, Kirschstein-NRSA PSC. The PSC retains all records until an obligation is satisfied, and then trans-

fers closed records to the Federal Records Center.

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11 Ruth L. Kirschstein National Research Service Awards

Most Kirschstein-NRSA recipients eventually fulfill their payback obligation by engaging in activities

that are determined to be acceptable service. Some recipients fulfill their obligation via financial pay-

back. On rare occasions, the payback obligation is waived.

As indicated in

Payback Reporting Requirements—Implementation

in this subsection, the amount of a

payback obligation incurred is solely dependent on the total period of support and the laws in effect

when the Kirschstein-NRSA support was received.

11.4.3.1 Service Payback

11.4.3.1.1 Definitions

For fulfilling the Kirschstein-NRSA service payback obligation, the following definitions apply:

Research.

Research is defined as an activity that involves designing experiments, developing pro-

tocols, and collecting and interpreting data. In addition, review of original research or admin-

istration of original research that includes providing scientific direction and guidance to research

may be acceptable if a doctoral degree and relevant research experience is required for indi-

viduals filling such positions. Such research can be conducted in an academic, government, for-

profit, or other environment in either a foreign or domestic setting. In addition, when consistent

with the cumulative amount, type, and frequency of research or research training experiences,

functions that involve analytic or other technical activities conducted in direct support of

research, as defined above, will also satisfy the service payback obligation.

Teaching.

Teaching is an instructional activity that takes place in an organized educational or

other instructional environment. Activities classified as teaching are generally carried out in a

formal didactic setting, but other activities will be considered if they are consistent with the cer-

tifying institution’s policy on the definition of teaching responsibilities. Such teaching can be

conducted at universities, professional schools, research institutes, teaching hospitals, primary

schools, secondary schools, or colleges. When calculating hours of teaching per week, it is per-

missible to include 3 hours of preparation time for each hour of direct instruction. Acceptable

teaching activities must have a biomedical or health-related relevance.

Health-Related .

“Health-related” means related to the description, diagnosis, prevention, or

treatment of disease. Fields other than those usually considered to be directly related to human

disease, such as agriculture, environmental sciences, biotechnology, and bioengineering, also

will be considered health-related.

11.4.3.1.2 Time Commitment

All acceptable activities must be undertaken for periods that average at least 20 hours per week. Total

employment in such activities averaging less than 20 hours per week cannot be counted toward fulfilling

the obligation except in cases of disability or other pressing personal or family circumstances, such as

childcare or elder care responsibilities. It is not permissible for individuals otherwise engaged in full-

time employment to engage in service payback activities at effort levels below 20 hours per week.

If less than 20 hours commitment per week is permitted, the total period of service obligation will be pro-

rated. For example, an individual who owes 12 months of service and can devote only 10 hours per week

to service payback activities due to a disability will be required to engage in such service for 24 months.

These exceptions are rare and must receive prior approval from the PSC.

11.4.3.1.3 Initiation of Payback Service

Service payback obligations for postdoctoral recipients may be discharged by

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11 Ruth L. Kirschstein National Research Service Awards

receiving an equal number of months of postdoctoral Kirschstein-NRSA support beginning in

the 13th month of such postdoctoral Kirschstein-NRSA support, or

engaging in an equal number of months of health-related research, health-related research train-

ing, or health-related teaching (or any combination thereof) that averages more than 20 hours per

week.

11.4.3.1.4 Source of Funding

There is no restriction on the source of funds supporting an individual’s service payback activity. An

individual could be supported by a PHS grant or any non-Kirschstein-NRSA Federal or non-Federal

source. Unpaid service also is permitted.

11.4.3.1.5 Timing of Service Obligation

An individual must begin to undertake the payback service requirement within 2 years after the ter-

mination date of the individual’s Kirschstein-NRSA support unless an extension of time to begin pay-

back has been approved by the PSC (see

Payback—Extensions of Payback—Extensions of the 2-Year

Period to Initiate Payback

below).

11.4.3.2 Financial Payback

11.4.3.2.1 Policy and Principal Calculation

If an individual does not perform payback service, the Federal government shall be entitled to recover

certain costs. The amount the United States is entitled to recover depends on when support was received.

Calculation formulas take into account the total amount paid the individual (see

Interest and Interest Rate

Calculation

below), less any obligation already fulfilled through service or legislative allowance when

applicable. The total paid an individual under an institutional research training grant or individual fel-

lowship award at a domestic, non-Federal sponsoring institution is considered to be the stipend only. The

total paid an individual under a fellowship award at a foreign sponsoring institution includes the payment

for the round-trip travel costs. The total paid an individual under a fellowship award at a Federal spon-

soring institution includes any money expended from the institutional allowance provided for such pur-

poses as health insurance, travel, tuition, and fees.

11.4.3.2.2 Interest and Interest Rate Calculation

NIH computes interest on the principal amount beginning on the date the United States became entitled

to recover stipends. The interest rate is the rate fixed by the Secretary of the Treasury after considering

prevailing consumer rates of interest. Accordingly, interest may accrue on any Kirschstein-NRSA oblig-

ation if the 2-year grace period has passed, if deferment has expired, or if service has terminated before

completion of the payback obligation. The Department of the Treasury certifies Kirschstein-NRSA

interest rates quarterly. Interest is computed on a 360 day-a-year basis and is applied through the date of

receipt. Any outstanding amount will continue to bear interest at the initial rate set by the Secretary of

the Treasury until financial payback is complete.

The date that sets the applicable rate of interest depends on the type of Kirschstein-NRSA account

received for collection. If financial payback is voluntary, the signature date of the notification of vol-

untary payback is the date that determines the interest rate as well as the initiation of the 3-year repay-

ment period. If financial payback is involuntary, the date that sets the interest rate and the 3-year

repayment period is the date of expiration of the 2-year period following the completion date or ter-

mination of Kirschstein-NRSA support. For example, if during June 2021, OFM received an account

reflecting January 31, 2019, as the termination date of NRSA support, the Federal government, lacking

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11 Ruth L. Kirschstein National Research Service Awards

any documentation to the contrary, becomes entitled to financial payback effective February 1, 2019.

The rate of interest applicable is determined based on the February 1, 2019, date, and the total NRSA

obligation is required to be fulfilled by January 31, 2022.

The amount to be recovered financially, as determined from the Termination Notice plus applicable

interest, shall be paid to the United States within the 3-year period following such date.

11.4.3.3 Extensions of Payback

The authorizing legislation and the implementing regulations (42 CFR Part 66) permit exceptions to cer-

tain requirements under the Act.

11.4.3.3.1 Extensions of the 2-Year Period to Initiate Payback

An extension of the 2-year period to initiate payback may be requested in the Annual Payback Activities

Certification form. Indication of valid plans to initiate payback soon after the 2-year grace period may be

good reason to grant an extension.

11.4.3.3.2 Basis for Extensions or Break in Service

The PSC may extend the period for undertaking payback service or permit breaks in continuous service.

These determinations are based on the following criteria:

An extension or break in service is necessary so the individual may complete their non-health

related research or clinical training.

An extension or break in service is necessary so the individual may participate in the NIH Loan

Repayment Program.

The individual is unable to complete the requirements within the specified period because of a

temporary disability.

Completion by the individual of the requirement within the specified period would involve sub-

stantial hardship to the individual, and failure to extend the period would be against equity and

good conscience.

Reasons for an extension or break in service include, for example, completing residency training where

clinical teaching or research are not an integral part of the training, or seeking employment that would

fulfill the payback requirements.

Participation in LRP will result in an automatic deferral of the NRSA obligation because concurrent pay-

back under both LRP and NRSA is not permissible. Payback service cannot begin until after LRP has

ended.

11.4.3.4 Waiver

11.4.3.4.1 Policy

The authorizing legislation and the implementing regulation (42 CFR Part 66) permit exceptions to cer-

tain requirements under the Act. NIH may waive, in whole or in part, the payback obligation, upon

determination that compliance by the individual is impossible or would involve substantial hardship.

11.4.3.4.2 Waiver Criteria

Requests for waivers should be made in writing to the PSC and should include an explanation of the

need for the waiver according to the following criteria:

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11 Ruth L. Kirschstein National Research Service Awards

Compliance by an individual will be deemed impossible if the individual is permanently, and

totally disabled.

In determining whether compliance would involve substantial hardship to the individual, the

PSC will consider the individual’s

o

financial resources and obligations at the time of request for a waiver and

o

estimated future financial resources and obligations.

In rare cases, the following also may be considered:

o

Reasons for the individual’s failure to complete the requirements within the prescribed

period, such as personal problems;

o

Extent to which the individual has engaged in payback activities;

o

Sufficiency of training to qualify the individual to perform such activities;

o

Lack of employment opportunities appropriate to the individual’s education and training;

o

Any other extenuating circumstances.

Any obligation of any individual toward payback will be canceled upon death of the individual.

11.4.4 Certification of Payback Activities

11.4.4.1 Annual Payback Activities Certification (Form PHS 6031-1)

11.4.4.2 Annual Certification

Payback service is certified through the use of the Kirschstein-NRSA APAC (PHS 6031-1). Individuals

with an outstanding payback obligation must complete an APAC annually until their payback obligation

is fulfilled.

If an individual has a payback obligation, an APAC is sent by the PSC approximately one year after the

completion of Kirschstein-NRSA support. Payback service may be initiated within the first 12 months of

termination even though trainees and fellows have up to 24 months to initiate payback. There is no pen-

alty to those individuals who do not initiate payback within the first 12 months; however, it is critical

that they complete an APAC form to ensure contact is maintained and addresses are current.

The individual will report on the APAC the activity in which they were engaged for the preceding 12

months, within the specified reporting period. These forms are to be returned within 30 days of the

reporting period end date to the address specified on the mailing label included with the form.

The PSC reviews the forms, determines acceptability of reported activities, and then informs the former

trainee or fellow of their status. This process will continue annually until the individual’s total payback

obligation is satisfied.

11.4.4.3 Change of Address

Any change in the mailing address of a Kirschstein-NRSA recipient must be reported promptly to the

PSC until the service obligation is fully discharged. Notification of changes can be made by letter, tele-

phone, fax, or e-mail to

NRSAPaybackCenter@mail.nih.gov

11.4.4.4 Breaks in Kirschstein-NRSA Support

Sometimes a trainee/fellow will have a period of non-Kirschstein-NRSA support between two

Kirschstein-NRSA awards. An appropriate activity performed during this period of time may count for

payback purposes toward the first Kirschstein-NRSA award. If the nonsupport period is 6 months or

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11 Ruth L. Kirschstein National Research Service Awards

longer, the individual receives an APAC form through the regular mechanism. However, if the break is

less than 6 months, an APAC will not be mailed automatically. If acceptable payback service was per-

formed during the break, the individual may complete an APAC, which can be obtained from the

NIH

web site

11.4.4.5 National Health Service Corps

A Kirschstein-NRSA recipient may have also been a National Health Service Corps (NHSC) scholar.

Kirschstein-NRSA recipients that also have been NHSC scholars are required to fulfill their NHSC ser-

vice commitment through direct clinical service to the underserved in accordance with NHSC policy.

Any Kirschstein-NRSA payback must be fulfilled separately through acceptable Kirschstein-NRSA pay-

back service.

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12 Research Career Development ("K") Awards

12 RESEARCH CAREER DEVELOPMENT ("K")

AWARDS

12.1 GENERAL

This chapter includes general information about research career development awards (CDAs), also

known as “K” awards. It supplements the general information found in IIA that applies to all NIH

awards.

The objective of NIH career development programs is to help ensure that highly trained scientists are

available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, beha-

vioral, and clinical research needs. Among NIH ICs, a variety of programs are available for scientists

who require additional mentored or independent experience in a productive scientific environment in

order to further develop their careers in independent biomedical, behavioral and clinical research.

For mentored programs, support is provided to cover protected time for supervised career development

experiences with a goal of leading to research independence. Independent (non-mentored) programs

foster the development of outstanding scientists and enable them to expand their potential to make sig-

nificant contributions to a field of research.

12.1.1 Background

The research CDA program was established in 1961 to enable investigators who have demonstrated

research potential to develop further their research careers. The program is authorized by sections 301,

402 and 405 of the PHS Act, 42 U.S.C. 241, 282 and 284. In general, CDAs provide up to five years of

salary support and guarantee substantial protected time to engage in research and related activities. The

award is available to persons who have demonstrated independent research accomplishments but need

additional experience to establish or sustain an independent research program.

12.2 TYPES OF CAREER DEVELOPMENT AWARDS

12.2.1 General

NIH offers a wide variety of CDAs: mentored awards to individuals, including unique career transition

programs; non-mentored awards to individuals (mid-career and senior stages), and institutional programs

that provide mentored experiences for multiple individuals who are selected by the institution. Some

CDAs are linked to other types of NIH awards. Applicants are encouraged to review the NOFO for

information about IC-specific utilization of the wide variety of CDAs. Specific questions may be dir-

ected to the appropriate NIH scientific/research staff or grants management staff named in the NOFO.

Further information about specific NIH CDAs is found at the

K Kiosk

12.2.2 Individual Mentored Career Development Awards

Individual mentored CDAs (e.g. K01, K07 (developmental), K08, K22, K23, K25, K99/R00) provide

support for a sustained period of “protected time” (generally three, four, or five years) for intensive

research career development under the guidance of an experienced mentor or sponsor in the biomedical,

behavioral, or clinical sciences. Through the sustained period of research career development and train-

ing provided by mentored CDAs, recipients are expected to gain the skills and experience necessary for

independent and productive research careers. Mentored CDAs are not renewable, nor are they

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12 Research Career Development ("K") Awards

transferable from one individual to another. No-cost extensions in time are permitted; however, all terms

and conditions, including appointment and minimum effort requirements, remain during the extension

period.

Generally, mentored CDA programs are covered by NIH-wide Parent NOFOs. In addition, some ICs

may issue IC-specific NOFOs for specialized programs. Specific program requirements for each ment-

ored CDA program are found in the NOFOs. Some programmatic information is provided below for pro-

grams with unique policies.

12.2.2.1 Mentor

Individual mentored CDA applications require the candidate to identify a mentor (sometimes referred to

as a sponsor) with extensive and appropriate research experience. The candidate must name a primary

mentor/sponsor, who, together with the candidate is responsible for the planning, direction, and exe-

cution of the program. The mentor should be recognized as an accomplished investigator in the proposed

research area; have a track record of success in training independent investigators; and should have suf-

ficient independent research support to cover any costs of the proposed research project in excess of the

allowable costs of the CDA award. Candidates may have co-mentors/sponsors as appropriate to the goals

of the program.

12.2.3 Career Transition Awards

In general, the career transition award programs (K22 and K99/R00) provides protected time through

salary and research support to facilitate the transition of postdoctoral individuals or junior faculty in

mentored positions to research independence.

12.2.3.1 K22 Phase

In general, the K22 program supports two phases of research: 1) a mentored phase (2 years); and, 2) an

independent phase (up to 3 years), for a total of up to 5 years of combined support. Some programs, how-

ever, support only the newly-independent phase of an investigator’s research career development. Applic-

ants for K22 programs need not be affiliated with an applicant institution, e.g., NIH intramural scientists.

Planning, direction, and execution of the proposed K22 award are the responsibility of the candidate.

Only a few ICs support K22 programs and each has specific eligibility criteria and award provisions.

There is no parent NOFO.

When the applicant is an intramural scientist, NIH issues a provisional award letter and the actual NoA is

issued after identifying a suitable position at an extramural research institution. The position may include

continuation of a postdoctoral segment.

12.2.3.2 Pathway to Independence Award (K99/R00)

The objective of the Pathway to Independence Award (K99/R00) is to assist postdoctoral investigators in

transitioning to a stable independent research position with independent research funding. The K99/R00

program offers a two-phase award, generally providing up to a total of 5 years of support. Phase I (K99)

provides support for up to 2 years of intensive, mentored research career development; Phase II (R00)

provides support for up to 3 years of independent research, contingent on securing an independent

research position. Phase II is also contingent upon an administrative review and approval by the award-

ing IC of a transition application.

12.2.3.2.1 Eligibility

The K99/R00 program has several unique eligibility criteria that are not generally applicable to other

CDA programs.

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12 Research Career Development ("K") Awards

U.S. citizens and non-U.S. citizens with the skills, knowledge and resources necessary to carry

out the proposed research and career development activities are eligible to apply.

K99/R00 applicants must not have more than 4 years of postdoctoral research training as of the

relevant application due date regardless of whether it is a new or resubmission application. NIH

will consider requests for extension of the K99 eligibility window for various reasons, including

medical concerns, disability, family care, extended periods of clinical training, natural disasters,

and active duty military service. Each of these requests is reviewed on a case by case basis. NIH

will approve an extension of one year for childbirth within the 4 year K99 eligibility window.

Applicants who will be PD/PIs on a K99 application must provide the child’s date of birth in the

extension request justification submitted to IC program officials and/or scientific/research con-

tacts listed in the NOFO at least 12 weeks before submitting an application.

NIH intramural scientists are eligible to apply. If selected for funding, the K99 phase is sup-

ported by the NIH IC intramural laboratory in which the candidate conducts research. The R00

phase is supported via an extramural award once an acceptable position at an extramural organ-

ization is secured.

It is expected that K99 recipients will benefit from no less than 12 months of mentored research

training and career development before transitioning to the R00 phase.

If an applicant achieves independence prior to initiating the K99 phase, neither the K99 nor the

R00 phase will be awarded.

12.2.3.2.2 K99 Phase

Generally, the K99 phase is for 2 years; however, award recipients may transition earlier than 2 years

when the recipient has been offered an acceptable position. It is expected that K99 recipients will receive

at least 12 months of career development support from the award before transitioning to the R00 phase.

If an applicant achieves independence prior to initiating the K99 phase, neither the K99 nor the R00

phase will be awarded. Recipients are advised to contact the awarding IC if early transition is being con-

sidered. In all cases, early transition is considered a prior approval request and therefore subject to the

approval of NIH in accordance with

Requests for Prior Approval

Since the K99 and R00 phases are awarded independently, a no-cost extension may be allowed should

additional time be needed to complete the goals of the K99 phase. However, no-cost extensions for K99

awards are not automatic and require prior approval by NIH. All terms and conditions of the K99/R00

award (including minimum effort requirements) remain in effect when the grant is in a no-cost extension.

In requesting a no-cost extension, K99 recipients wishing to continue to seek a tenure-track or equivalent

position should submit a plan for continued career development and a timely transition to an independent

position. If an application for the R00 Phase with a suitable position is not submitted within the one-year

period of the no-cost extension, the R00 will not be awarded. Those not continuing to seek to transition

to the R00 will be permitted to extend without additional funds, in order to permit an orderly phase-out

of the project.

Carryover of Funds: Carryover from the K99 phase to the R00 phase may be allowed provided the K99

phase was funded by extramural support. The K99 recipient should consult with the awarding IC as to its

practices regarding carryover.

12.2.3.2.3 Transition to the R00 Phase

The K99 award recipient is required to secure a tenure track, full-time assistant professor position or

equivalent in order to transition to the R00 independent phase. Transition to the R00 phase is not guar-

anteed. The transition application for the R00 phase is administratively reviewed by NIH staff and is not

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12 Research Career Development ("K") Awards

peer reviewed by a study section. There should not be any delay between the K99 phase and the R00

phase. R00 award recipients will be expected to compete successfully for independent R01 support from

NIH during the R00 phase of the award.

Additional information on the K99/R00 and the NOFO are found on the

New Investigators Program web

page

12.2.4 Individual Non-mentored (Independent) Career Development

Awards

Independent (non-mentored) CDAs (e.g. K02, K05, K07 leadership, K24) provide protected time for sci-

entists who can demonstrate the need for a period of intensive research focus as a means of enhancing

their research careers. Independent CDAs are intended to foster the development of outstanding scientists

and to enable them to expand their potential to make significant contributions to their field of research.

Some Independent CDAs also require the candidates to serve as research mentors for junior researchers.

Candidates for independent CDAs must have a doctoral degree and independent, peer-reviewed support

at the time the award is made. Some of the participating NIH ICs require candidates to have an NIH

research grant from their IC at the time of application. Other NIH ICs will accept candidates with peer-

reviewed, independent research support from other sources.

Planning, direction, and execution of the proposed career development program and research project are

the responsibility of the applicant and sponsoring institution. Independent CDAs are not transferable

from one PD/PI to another. Non-mentored awards are sometimes renewable.

12.2.5 Institutional Scientist Development Programs

The institutional mentored research scientist development program (K12 and KL2) provides support to

an institution for the development of independent basic or clinical scientists. The goal is to enhance

research career development for individuals (known as ‘scholars’) selected by the institution who are

training for careers in specified research areas. A specified number of scholar positions are awarded in a

K12. The K12 is solicited only by IC-specific NOFOs. Although the K12 is subject to NIH Standard

Terms of Award, the carryover of unobligated balances from one budget period to the next generally

requires prior written approval. K12 awards are generally not transferable to another institution. When

institutional mentored research development programs are incorporated as part of a Clinical and Trans-

lational Science Award Consortium the KL2 activity code is used.

The Clinical Research Curriculum Award (K30) is awarded to an institution to stimulate the inclusion of

high-quality, multidisciplinary, didactic training as part of the career development of clinical invest-

igators. It supports the development and/or improvement of core courses designed as in-depth instruction

in the fundamental skills, methodologies, and theories necessary for the well-trained, independent, clin-

ical researcher.

12.3 ELIGIBILITY

Eligibility can vary depending on the type of award and may even vary by NIH IC within a particular

program. However, there are some eligibility criteria which are consistent across all CDA programs and

these criteria are discussed in this section. Candidates are always strongly encouraged to carefully review

the eligibility criteria in a specific NOFO and to contact the scientific/research and/or grants man-

agement contacts in the relevant IC prior to preparing an application to discuss issues of eligibility.

These contacts are listed in the individual NOFO for each CDA.

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12 Research Career Development ("K") Awards

12.3.1 Eligible Institutions

Applications for CDAs may be submitted on behalf of the candidate by any domestic for-profit or non-

profit public or private institution/organization such as universities, colleges, hospitals, and laboratories

to support a research program in a specified area(s) of research. Foreign organizations are not eligible to

apply for CDAs, but

foreign components

may apply.

12.3.2 Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as

the candidate (called the PD/PI) is invited to work with their organization to develop an application for a

CDA program. Individuals from all backgrounds are always encouraged to apply for NIH programs. Mul-

tiple PD/PI applications are not accepted for individual CDAs; institutional CDAs should check the

NOFO for the allowability of Multiple PD/PIs.

For mentored CDA programs, candidates who are well-established in their fields are considered

ineligible. Some indications of having achieved this status are tenure or the equivalent, a substantial pub-

lication record or considerable research support that already requires commitment of a major part of the

candidate's time. Applicants who meet one or more of these criteria must provide justification in the

application that they are not already established in their field.

12.3.3 Degree Requirements

Degree requirements for CDAs are outlined in the specific NOFO. Applicants are generally required to

hold a research or health-professional doctoral degree or its equivalent; eligibility for some CDAs is lim-

ited to only applicants with health professional doctoral degrees.

12.3.4 Citizenship

For CDA programs other than the K99/R00 program, only U.S. citizens, non-citizen nationals or indi-

viduals lawfully admitted for permanent residence at the time an offer of an award is made, are eligible

for this award. Individuals on temporary or student visas are not eligible to apply for a CDA unless they

have begun the process for becoming a permanent resident and expect to be admitted as a permanent res-

ident by the earliest possible award date. In an application package, on the PHS398 Career Development

Award Supplemental Form, the option of selecting “Non-citizen with temporary visa” is applicable to

K99/R00 candidates only.

Noncitizen nationals are individuals who, although not citizens of the United States, owe permanent alle-

giance to the United States. They generally are born in outlying possessions of the United States (e.g.,

American Samoa and Swains Island).

Individuals who have been lawfully admitted for permanent residence must have a currently valid Per-

manent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an

individual has the proper validation on their passport, a notarized photocopy of the passport could suf-

fice. Because there is a 6-month limitation on this validation, it is the applicant organization’s respons-

ibility to follow up and ensure that the candidate receives the I-551 before the 6-month expiration date.

An individual expecting to be admitted as a permanent resident by the earliest possible award date listed

in the career award NOFO may submit an application recognizing that no award will be made until legal

verification of permanent resident status is provided to NIH. The submission of documentation con-

cerning permanent residency is not required as part of the initial application.

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12 Research Career Development ("K") Awards

Applicants who have been lawfully admitted for permanent residence, i.e., have a Permanent Resident

Card or other legal verification of such status, should check the Permanent Resident of U.S. box in Sec-

tion 3. Citizenship of the PHS398 Career Development Award Supplemental Form. Applicants who have

applied for and have not yet been granted admission as a permanent resident or have been granted Condi-

tional Permanent Residency Status should also check the same box.

If a candidate’s citizenship status changes after submission of an application, the new status should be

reported in the candidate’s Personal Profile in the eRA Commons.

In all cases involving any type of Permanent Residency status, when an application is selected to receive

an award, prior to any award being issued, a notarized statement will be required that documents that a

licensed notary has seen the candidate’s valid Permanent Resident Card or other valid verification from

the U.S. Immigration and Naturalization Service of legal admission to the U.S. In all cases where Per-

manent Residency status is involved, it is the responsibility of the recipient institution to assure the indi-

vidual remains eligible for the project period of the award.

12.3.5 Type of Appointment

By the time of award, all CDA recipients must have a full-time appointment at the applicant institution.

With prior approval from NIH, award recipients may hold part-time appointments for limited periods dur-

ing the course of their awards (see

Temporary Adjustments to the Full-Time Institutional Appointment

Requirement

below). Full-time or part-time is as defined by applicant institutional policy.

Candidates who hold additional appointments with an independent clinical practice plan, the VA or other

organizations should contact the scientific/research and/or grants management contact in the relevant IC

prior to preparing an application to discuss their eligibility. Responsibilities outside of the applicant

organization appointment are not restricted; however, these types of additional appointments cannot be

used to meet the full-time appointment requirement nor the effort requirement discussed below. If a can-

didate has a dual appointment, they must also have a full-time appointment at the applicant institution to

qualify for a CDA.

12.3.5.1 Temporary Adjustments to the Full-Time Institutional Appointment

Requirement

Temporary adjustment of the full-time requirement for awarded CDAs is allowed under certain cir-

cumstances. At the time of the award, the candidate must meet the full-time appointment requirement (as

well as any minimum effort requirement); however, recipients may request a temporary reduction in their

appointment to less than full-time (but not less than three-quarter time) for a period not to exceed 12 con-

tinuous months during the CDA award project period. Circumstances requiring such a change in appoint-

ment status might include personal or family situations such as parental leave, childcare, elder care,

medical conditions, or a disability. Permission to change appointment status will not be approved to

accommodate job opportunities, clinical practice, clinical training, or joint appointments.

When requesting approval to change to a part-time appointment status, the recipient must continue to

commit at least 75% effort (of the part-time appointment) to research and career development activities.

The recipient is encouraged to consider increasing their percent effort to greater than 75% (e.g., 85%) to

compensate for the anticipated effect of the part-time appointment on the recipient’s career progress.

On behalf of the K recipient, the recipient institution must submit a request and documentation to the

NIH awarding IC supporting the need for a reduced faculty appointment and assuring the institution’s

continuing commitment to the scientific and research career development of the recipient. The request

should justify reducing the appointment to less than full-time status and must describe the anticipated

impact of the requested change on their career progress during the remainder of the award period. In

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addition, the recipient must submit assurance of their intention to return to a full-time faculty appoint-

ment as soon as possible. The mentor must provide a revised mentoring plan and specifically describe

updated milestones for the recipient’s progression to independence. Lastly, a revised statement of insti-

tutional commitment to the recipient must ensure continued “protected time” and describe additional sup-

port that will assist the recipient to continue to make progress toward their goals during the requested

period of the reduced appointment. During the period of reduced appointment, the salary and other costs

supported by the award will be reduced accordingly. Requests must be submitted by the recipient insti-

tution to the awarding Institute or Center (IC) where they will be considered on a case-by-case basis.

For transition CDAs (K22 and K99/R00), because of the relatively short duration of the mentored phase

of the award, a request for reduction in the appointment must address the impact of this action on the

recipient’s ability to make sufficient progress to meet the goals of the program. For example, a K99 recip-

ient must describe how the request will affect the recipient’s ability to transition to the R00 phase of the

award.

This policy also allows recipients to temporarily reduce the level of effort devoted to the CDA award;

that policy is described below in

Level of Effort

. While these 2 policies are similar in overall goals, a

recipient may not simultaneously request a reduction in appointment status from full-time to part-time

AND a reduction in percent effort to less than 75%.

12.3.6 Level of Effort

In addition to the full-time appointment requirement described above, mentored and non-mentored CDA

recipients are required to devote and maintain a minimum level of effort to the award. During a no-cost

extension, the recipient is required to maintain any effort minimum and can only reduce their effort with

prior approval of the awarding IC.

CDA recipients who hold additional appointments with an independent clinical practice plan, the VA or

other organizations may not use these additional appointments to meet the minimum effort requirement.

Responsibilities outside of the applicant organization appointment are not restricted; however, they also

cannot be used to meet any minimum effort requirement. If a CDA recipient has a dual appointment,

they must also have a full-time appointment at the applicant institution and be able to meet the minimum

effort requirement as part of that full-time appointment in order to qualify for a CDA. Candidates are

strongly encouraged to contact the scientific/research and/or grants management contact in the relevant

IC prior to preparing an application to discuss their eligibility.

12.3.6.1 Mentored CDAs

Mentored CDA recipients are required to devote a minimum commitment equivalent of 9 calendar per-

son months (75% of their full-time appointment at the applicant institution) to the career development

and research objectives of the program specified in each NOFO. The remaining 3 person months (25%

effort), if applicable, can be divided among other research, clinical, and teaching activities only if these

activities are consistent with the goals of the mentored CDA, i.e., the recipient’s development into an

independent investigator. Some NIH ICs allow less than 75% (but not lower than 50%) effort for certain

clinical specialties (e.g., surgical and procedure-intensive specialties). Applicants must consult the

NOFO and also IC Program staff for this exception.

Mentored K recipients are encouraged to apply for additional research grants during the tenure of their K

award (see

Concurrent Support

below). Mentored CDA recipients are allowed to devote complementary

effort without salary support on other research grants that include related research between the CDA and

the research grant. In such cases where there is scientific overlap, the percent effort on the research grant

is subsumed within the required effort of the CDA. However, there should not be significant duplication

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of the scope of the research supported by the CDA. Further, the related research must be consistent with

the goals and objectives of the CDA.

12.3.6.2 Concurrent Support

Provided they remain in a mentored status, mentored CDA recipients in the final two years of their sup-

port period are permitted to reduce the level of effort required for the CDA when they have competed

successfully for peer-reviewed research awards from NIH or any Federal agency, if programmatic policy

of the other Federal agency allows such an arrangement, or non-Federal sources (e.g., foundations or pro-

fessional societies) of at least $100,000 in direct costs. Recipients are encouraged to obtain funding from

NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agree-

ment or as a project leader on a competing multi-project award.

Budgets for a competing research grant or a subproject on a multi-project grant should request appro-

priate amounts for the salary and associated costs for the CDA recipient’s effort. At the time the research

grant is awarded the effort required on the CDA may be reduced to no less than 6 person months (50%

full-time professional effort at the recipient organization) and replaced by effort and corresponding

salary from the research award so that the total level of research commitment remains at 9 person

months (75% full-time professional effort) or more for the duration of the mentored CDA. This policy

applies to the following mentored CDA activity codes: K01, K07 (developmental), K08, K22, K23, and

K25, as well as individuals mentored through institutional K12 or KL2 awards. To be eligible for salary

support from peer-reviewed research awards from any Federal agency:

The CDA recipient must be one of the named PD/PIs on a competing NIH research grant applic-

ation (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a

sub-project director on a competing multi-component research or center grant or cooperative

agreement application (P01, P50, U01, etc. or an equivalent application from another Federal

agency).

The CDA must be active when the competing research grant application is submitted.

The CDA must be in its final two years before the reduction in effort to 6 person months (50%

full-time professional effort) is permitted.

For submissions to NIH, a letter must accompany the research grant application from the chair of the

mentored award recipient’s department or other responsible institutional official providing: (1) evidence

that the recipient will continue to focus on the development of their research career; (2) will continue to

have access to their mentor; and (3) that the recipient’s total level of research effort will be maintained

and protected at a minimum of 9 person months (75% full-time professional effort). For submissions to

other Federal agencies, this type of institutional commitment letter is strongly encouraged; however,

applicants should check with that agency for guidance on the allowability of such a letter.

When a mentored CDA recipient obtains independent support, as described above, the NIH awarding IC

supporting the CDA will adjust the level of effort committed to the CDA to no less than 6 person months

(50% effort) consistent with maintaining total research effort at 9 person months or 75% or more of the

full-time appointment. NIH will adjust the total salary support committed to the K award consistent with

the adjusted level of effort. However, NIH will continue to provide full research development support

costs (i.e., Other Personnel, Equipment, Travel, Participant/Trainee Support, and Other Direct Costs

budget categories) as indicated on the original Notice of Award. If necessary, the K award may also be

adjusted to avoid any additional budget overlap.

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12.3.6.3 Non-mentored CDAs

Established investigators on independent (non-mentored) CDAs are generally required to devote a min-

imum of 3-6 person months (25-50% effort) conducting research and research career development

related activities during the period of the award. Some independent CDAs allow and may require more

than 6 person months (50% effort). For example, K02 recipients are required to devote 9 person months

(75% effort) to research.

Generally, an independent or leadership recipient may receive additional salary support from other

NIH/PHS grants for effort not committed to the CDA and there are no limitations to receiving other

salary support. Where applicable, specific policies are noted in the NOFO. The candidate must be able to

demonstrate that the requested period of salary support and protected time will foster their career and

capacity to contribute to the specified field.

12.3.6.4 Temporary Adjustments to the Percent Effort Requirement

At the time of the CDA award, the candidate must still meet the applicable effort requirement (as well as

the full-time appointment requirement); however, under certain circumstances, recipients may request a

temporary reduction in their effort for a period not to exceed 12 continuous months during the award pro-

ject period. For programs that require a 75% effort minimum (equivalent to 9 person months), a recipient

can request a reduction to no less than 50%. Circumstances requiring such a change in effort might

include personal or family situations such as parental leave, childcare, elder care, medical conditions, or

a disability. Permission to temporarily reduce effort will not be approved to accommodate job oppor-

tunities, clinical practice, clinical training, or joint appointments.

On behalf of the K recipient, the recipient institution must submit a request and documentation to the

NIH awarding IC supporting the need for reduced effort and assuring the institution’s continuing com-

mitment to the scientific and research career development of the recipient. The request should justify

reducing effort and must describe the anticipated impact of the requested change on their career progress

during the remainder of the award period. In addition, the recipient must submit assurance of their inten-

tion to return to 75% effort as soon as possible. The mentor must provide a revised mentoring plan and

specifically describe updated milestones for the recipient’s progression to independence. Lastly, a

revised statement of institutional commitment to the recipient must ensure continued “protected time”

and describe additional support that will assist the recipient to continue to make progress toward their

goals during the requested period of the reduced appointment. During the period of reduced effort, NIH

will adjust the total salary amount committed to the K award consistent with the adjusted level of effort.

However, NIH will continue to provide full research costs in other budget categories as indicated on the

original Notice of Award. In addition, the K recipient may request to extend the duration of the award to

account for the reduced effort. Requests must be submitted by the recipient institution to the awarding

Institute or Center (IC) where they will be considered on a case-by-case basis.

This option is not available for Independent CDAs that require only 25-50% effort; e.g., K07 leadership,

K05, and K24.

While this temporary adjustment in effort policy is similar to the policy described above allowing a tem-

porary adjustment in the full-time appointment requirement, recipient may not simultaneously request a

reduction in appointment status from full-time to part-time AND a reduction in percent effort to less than

75%.

12.3.7 Prior Research Support

For most mentored career development awards, individuals are eligible to apply if they have previously

served as the PD/PI of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Planning

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Grant (R34/U34), Dissertation Award (R36), SBIR/STTR Award, Transition Scholar Award (K38) or

been appointed to an institutional career development program (K12, KL2). The K99/R00 program, how-

ever, has different eligibility requirements related to prior research support and those are detailed in the

Notice of Funding Opportunity.

In general, for mentored CDAs, individuals are NOT eligible if they:

Are current and former PDs/PIs on NIH research project (R01), program project (P01), center

grants (P50), other major individual career development awards (e.g., DP5, K01, K07, K08,

K22, K23, K25, K76, K99/R00), or

Project Leads of program project (P01) or center grant (P50) sub-projects, or the equivalent.

Most independent (non-mentored) CDAs require that the applicant have independent, peer-reviewed sup-

port at the time the award is made. Some of the participating NIH ICs require the candidate to have an

NIH research grant at the time of application and that the support be from their IC. Other NIH ICs will

accept candidates with peer-reviewed, independent research support from other sources. Applicants must

check the NOFO for specific eligibility requirements.

12.4 APPLICATION REQUIREMENTS AND DUE DATES

12.4.1 Application

Before applying for a CDA, applicants should carefully review the guidelines in the NOFO for the spe-

cific career award(s) of interest, noting especially the eligibility requirements, award provisions, require-

ments for a mentor, and review criteria. The participating ICs may have distinctive guidelines,

requirements, and funding amounts for each NOFO in order to accommodate the career needs of

researchers working in fields related to their specific research missions. Candidates are therefore strongly

encouraged to contact the staff person in the relevant IC listed in the NOFO prior to preparing an applic-

ation to discuss any specific provisions of the award.

The specific NOFO provides links to the application forms package as well as the appropriate applic-

ation instruction guide. As with all NIH programs using electronic submission, a CDA application uses a

combination of SF424(R&R) and PHS398 forms. A separate section (Section I.7) of the SF424(R&R)

Application Guide is included that provides supplemental instructions for preparing a CDA application.

Further information is available from the

NIH Grants & Funding website

Applications must contain Candidate Information, Statements of Support, Environment and Institutional

Commitment to the Candidate, as well as a Research Plan. The Candidate Information section includes

required information about the candidate and must justify the need for the requested period of support,

be tailored to the prior research experience and career development needs of the candidate, and for ment-

ored CDAs be designed to move the candidate from a mentored phase to an independent status. The

research plan must have intrinsic research importance as well as serve as a suitable vehicle for learning

the methodology, theories, and skills necessary for a well-trained independent researcher. For mentored

award programs, the research plan must also include a description of the relationship between the

mentor’s research and the candidate’s proposed research plan.

Other than the K22 application from an unaffiliated candidate, all applications require documents describ-

ing the Environmental and Institutional commitment to the candidate.

For mentored award programs the career development application also must include Statement by

Mentor(s), Co-Mentor(s), Consultant(s) and Contributor(s) as well as a statement describing the insti-

tution’s commitment to the candidate’s development.

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The requirement for ORCID identifiers will be enforced at the time of application for individual career

development awards, including the following: K01, K02, K05, K07, K08, K18, K22, K23, K24, K25,

K26, K38, K43, K76, and K99/R00.

eRA system validations will check whether applicants have ORCID iDs and applications will not be

accepted unless an ORCID iD is linked to the PD/PI's eRA Commons Personal Profile.

To either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them

back to the eRA Commons. Prospective applicants for individual career development awards may follow

the ORCID link from their Personal Profiles in the eRA Commons.

12.4.1.1 Letters of Reference

At least three (but no more than five) letters of reference are required for all new and resubmission ment-

ored CDA applications. The letters should be from individuals not directly involved in the application,

but who are familiar with the candidate’s qualifications, training, and interests and include advisory com-

mittee members (if applicable). However, the candidate’s mentor(s) of the application must not submit a

separate letter of reference because a mentor’s statement is required as part of the application. The letters

of reference should address the candidate's competence and potential to develop into an independent bio-

medical, behavioral, or clinical investigator.

Electronic submission of CDA applications requires electronic submission of reference letters as well.

However, reference letters are submitted directly by the referee through the eRA Commons and not as

part of the electronic application that goes through Grants.gov. Reference letters will be joined with the

electronic application within the eRA system once an application completes the submission process.

Applications that are missing the required letters may be delayed in the review process or not accepted at

all. Complete instructions for candidates and referees are found in Part I, Section 7.3 of the SF424(R&R)

Application Guide for Adobe Applications.

12.4.1.2 Concurrent Applications

NIH will not accept any application in response to an NOFO that is essentially the same as one currently

pending initial review unless the applicant withdraws the pending application. NIH will not accept any

application that is essentially the same as one already reviewed. This does not preclude the submission of

a substantial resubmission of an application already reviewed, but such applications must include an

Introduction addressing the previous critique.

12.4.1.3 Environment and Institutional Commitment to the Candidate

The applicant organization must define and document a strong, well-established research and career

development program related to the candidate's area of interest, including a high-quality research envir-

onment with staff capable of productive collaboration with the candidate. The institution must provide a

statement of commitment to the candidate's development into a productive, independent investigator and

to meeting the requirements of the award. The institution should indicate how the necessary facilities and

other resources will be made available for career enhancement as well as the research proposed in the

application. The applicant should describe opportunities for intellectual interactions with other invest-

igators, including courses offered, journal clubs, seminars, and presentations.

The institution should provide a document on institutional letterhead that describes its commitment to the

candidate and the candidate’s career development. The document should include the institution’s agree-

ment to provide adequate time and support for the candidate to devote the proposed protected time to

research and career development for the entire period of the proposed award. The institution should

provide the equipment, facilities, and resources necessary for a structured research career development

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experience. It is essential to document the institution's commitment to the retention, development, and

advancement of the candidate during the period of the award.

Because of the diverse types of CDAs, applicants should contact the appropriate awarding IC sci-

entific/research contact named in the specific NOFO to determine the level of commitment required for

the application. Institutional commitment to the candidate may not be contingent upon the receipt of the

CDA.

Off-Site Training Experience.

A candidate may propose a career award experience that involves sites

beyond the applicant organization, provided that the goals of the total experience are encompassed and

supported under the appointment with the applicant organization.

12.4.1.4 Training in the Responsible Conduct of Research

All CDA applicants (mentored and non-mentored) must include a description of the formal and informal

activities related to instruction in the responsible conduct of research planned for the proposed research

program. Specifically, applicants must include a description of a plan for instruction in responsible con-

duct of research. This description should document prior instruction in or the nature of the applicant’s

participation in responsible conduct of research instruction (lecturer, discussion leader, etc.) during the

applicant’s current career stage (including the dates of last occurrence) and propose plans to receive or

participate in instruction in responsible conduct of research. Such plans must address the five instruc-

tional components, format, subject matter, faculty participation, duration of instruction, and frequency of

instruction, as outlined below. Applications lacking a plan for instruction or participation in responsible

conduct of research will be considered incomplete and may be delayed in the review process. Plans and

past record will be rated as

acceptable

unacceptable

and the summary statement will provide the con-

sensus rating of the review committee. Applications with unacceptable plans will not be funded until the

applicant provides an acceptable, revised plan. For additional information see the specific NOFO.