Part I: NIH Grants - General information

1 Glossary

1.1 Abbreviations

1.2 Definition of Terms

2 The National Institutes of Health as a Grant-Making Organization

2.1 Roles and Responsibilities

2.1.1 NIH and HHS Staff

2.1.2 Recipient Staff

2.2 eRA Commons

2.2.1 eRA Commons Registration eRA Commons Registration for the Organization eRA Commons Registration for the PD/PI eRA Commons Registration for Other Individuals Participating in NIH Progress Reports

2.3 Application Information and Processes

2.3.1 Support Mechanisms

2.3.2 Eligibility

2.3.3 Types of Award Instruments

2.3.4 Types of Applications

2.3.5 Types of Funding Opportunity Announcements (FOAs)

2.3.6 Legal Implications of Applications

2.3.7 Policies Affecting Applications Applications That Include Consortium/Contractual F&A Costs Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Costs Resubmission of Unfunded RFA Applications Submission of Resubmission Application New Investigators and Early Stage Investigators Program Director/Principal Investigator, Individual Fellowship and Sponsor Assurance Post-Submission Grant Application Materials DUNS Number and SAM Registration Requirements Graduate Student Compensation NIH Genomic Data Sharing

2.3.8 Application Forms

2.3.9 Application Receipt Information and Deadlines Paper Applications Electronically Submitted Applications Modified Submission Policy for Appointed Members of NIH Review and Advisory Group and Reviewers with Recent Substantial Service Similar, Essentially Identical, or Identical Applications Application Non-confirmity

2.3.10 Fraud, Waste and Abuse of NIH Grant Funds

2.3.11 Availability and Confidentiality of Information Availability of Information Confidentiality of Information Privacy Act The Freedom of Information Act Access to Research Data

2.3.12 Protecting Sensitive Data and Information Used in Research

2.4 The Peer Review Process

2.4.1 Initial Review Responsibilities Overall Impact Scored Review Criteria Additional Review Criteria Additional Review Considerations

2.4.2 Appeals of Initial Scientific Review

2.4.3 National Advisory Council or Board Review

2.4.4 Disposition of Applications

2.5 Completing the Pre-Award Process

2.5.1 Just-in-Time Procedures

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

2.5.3 Determining Applicant Organization Eligibility

2.5.4 Determining Eligibility of Individuals

2.5.5 Cost Analysis and Assessment of Management Systems

Part II: Terms and Conditions of NIH Grant Awards

3 Overview of Terms and Conditions

3.1 Federalwide Standard Terms and Conditions

3.2 NIH Standard Terms of Award

4 Public Policy Requirements, Objectives and Other Appropriation Mandates

4.1 Public Policy Requirements and Objectives

4.1.1 Animal Welfare Requirements Animal Welfare Assurance Requirements Verification of IACUC Approval Consortiums Foreign Recipients and Foreign Performance Sites Reporting to OLAW

4.1.2 Civil Rights Protections Civil Rights Act of 1964 Educational Amendments of 1972 Rehabilitation Act of 1973 Age Discrimination Act of 1975 Limited English Proficiency

4.1.3 Clinical Trials Registration and Reporting in Requirement NIH Policy on Dissemination of NIH-Funded Clinical Trial Information Food and Drug Administration Amendments Act (FDAAA)

4.1.4 Confidentiality Certificates of Confidentiality Confidentiality of Alcohol and Drug Abuse Patient Records Confidentiality of Patient Records: Health Insurance Portability and Accountability Act

4.1.5 Controlled Substances

4.1.6 Debarment and Suspension

4.1.7 Drug-Free Workplace

4.1.8 Federal Funding Accountability and Transparency Act (FFATA)

4.1.9 Federal Information Security Management Act

4.1.10 Financial Conflict of Interest

4.1.11 Fly America Act

4.1.12 Health and Safety Regulations and Guidelines

4.1.13 Human Stem Cell Research Human Pluripotent Stem Cell Research Prohibited with NIH Funding

4.1.14 Human Fetal Tissue Research Research on Transplantation of Human Fetal Tissue

4.1.15 Human Subjects Protections Federalwide Assurance Requirements Certification of IRB Approval Reporting to Funding Agency and OHRP OHRP Oversight Education in the Protection of Human Research Participants Data and Safety Monitoring Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender, Racial, and Ethnic Participation Informed Consent for Research on Dried Blood Spots Obtained Through Newborn Screening Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

4.1.16 Investigational New Drug Applications/Investigational Device Exceptions

4.1.17 Lobbying Prohibition

4.1.18 Metric System

4.1.19 Military Recruiting and Reserve Officer Training Corps Program Access to Institutions of Higher Education

4.1.20 National Environmental Policy Act

4.1.21 Nondelinquency on Federal Debt

4.1.22 President's Emergency Plan for AIDS Relief (PEPFAR) Program PEPFAR Agreements PEPFAR Agreements Between the U.S. Government and Foreign Non-Governmental Organizations (NGOs)

4.1.23 Pro-Children Act of 1994

4.1.24 Public Health Security Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents) Select Agents Select Agent Awards to U.S. Institutions Select Agent Awards to Foreign Organizations and International Organzations Select Agent Awards to U.S. Institutions with Foreign Subcomponents Dual Use Research of Concern Agents Regulated Under the Chemical Weapons Convention

4.1.25 Reporting and Assurance Requirements for Institutions Receiving Awards for Training of Graduate Students for Doctoral Degrees

4.1.26 Research Involving Recombinant or Synthetic Nucleic Acid Molecules (including Human Gene Transfer Research) Scope and Availability Institutional Biosafety Committee Investigators and Institutional Staff Safety and Annual Reporting

4.1.27 Research Misconduct

4.1.28 Seat Belt Use

4.1.29 Smoke-Free Workplace

4.1.30 Standards of Conduct

4.1.31 Text Messaging While Driving

4.1.32 Trafficking in Persons

4.1.33 USA Patriot Act

4.1.34 Federal Awardee Performance and Integrity Information System (FAPIIS)

4.1.35 Mandatory Disclosures

4.2 Appropriation Mandates

4.2.1 Acknowledgment of Federal Funding

4.2.3 Dissemination of False or Deliberately Misleading Information

4.2.4 Gun Control

4.2.5 Human Embryo Research and Cloning Ban

4.2.6 Lobbying-Appropriation Prohibition

4.2.7 Promotion or Legalization of Controlled Substances

4.2.8 Restriction on Abortion Funding Exceptions to Restrictions on Abortions

4.2.9 Restriction on Distribution of Sterile Needles

4.2.10 Salary Cap/Salary Limitation

4.2.11 Restriction of Pornography on Computer Networks

4.2.12 Restriction on Disclosure of Political Affiliation of Federal Scientific Advisory Committee Candidates

5 Notice of Award

5.1 Notice of Award Notification

5.2 Associated Applications and/or Awards

5.3 Funding

5.4 Budget

5.5 Additional Terms and Conditions

6 Payment

6.1 Smartlink II/ACH

6.2 Cash Request

6.3 Interest Earned on Advances of Grant Funds

6.4 Improper Payments Elimination and Recovery Improvement Act

7 Cost Consideration

7.1 General

7.2 The Cost Principles

7.3 Direct Costs and Facilities and Administrative Costs

7.4 Reimbursement of Facilities and Administrative Costs

7.5 Cost Transfers, Overruns, and Accelerated and Delayed Expenditures

7.6 Allocation of Costs and Closely Related Work

7.7 Applicable Credits

7.8 Services Provided by Affiliated Organizations

7.9 Allowability of Costs/Activities

7.9.1 Selected Items of Cost

8 Administrative Requirements

8.1 Changes in Project and Budget

8.1.1 NIH Standard Terms of Award Carryover of Unobligated Balances from One Budget Period to Any Subsequent Budget Period Cost-Related Prior Approvals Extension of Final Budget Period of a Previously Approved Project Period without Additional NIH Funds Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Agreement Direct Charging Salaries of Administrative and Clerical Staff Supplemental Compensation under Written Institutional Policy for IHEs Intra-IHE Faculty Consulting that Exceed a Faculty Member's Base Salary, Under Certain Conditions.

8.1.2 Prior Approval Requirements Additional No-cost Extension or Extension Greater Than 12 Months or Late Notification of Initial No-Cost Extension Alterations and Renovations Capital Expenditures Carryover of Unobligated Balances Change in Scope Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA Change of Recipient Organization Change in Recipient Organizational Status Deviation from Award Terms and Conditions, including Restrictions in the NoA Foreign Component Added to a Grant to a Domestic or Foreign Organization Provide Subaward Based on Fixed Amounts Need for Additional NIH Funding without Extension of Budget and Project Period Need for Additional NIH Funding with Extension of the Final Budget Period of a Project Period Pre-Award Costs Rebudgeting of Funds from Trainee Costs Rebudgeting of Funds Between Construction and Non-construction Work Retention of Research Grant Funds When a Career Development Award is Issued

8.1.3 Requests for Prior Approval

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

8.2.1 Rights in Data (Publication and Copyrighting)

8.2.2 NIH Public Access Policy

8.2.3 Sharing Research Resources Data Sharing Policy Sharing Model Organisms Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS)

8.2.4 Inventions and Patents

8.2.5 Interim Research Products

8.3 Management Systems and Procedures

8.3.1 Financial Management System Standards

8.3.2 Program Income Reporting Program Income Sale of Real Property, Equipment, and Supplies Royalties and Licensing Fees from Copyrights, Inventions, and Patents

8.3.3 Property Management System Standards Real Property Equipment and Supplies Exempt Property Nonexempt Property Revocable License

8.3.4 Procurement System Standards and Requirements General Approval Requirements Contracting with Small Businesses, Minority-Owned Firms, and Women's Business Enterprises

8.4 Monitoring

8.4.1 Reporting Non-Competing Continuation Progress Reports Requirement for Commons ID Expectation for Institutions to Develop Individual Development Plans for Graduate Students and Postdoctoral Researchers Streamlined Non-Competing Award Process Modified Annual Progress Reports Modified NoAs Modified Financial Reporting Requirements Submitting SNAP Progress Reports Progress Reports for Multiyear Funded Awards Final Research Performance Progress Report (F-RPPR) Financial Reports Cash Transaction Reports Financial Expenditure Reports Revised Financial Reports and Expenditures Unobligated Balances and Actual Expenditures Recipient Reporting of Subrecipient Data and Executive Compensation Information for Federal Funding Accountability and Transparency Act (FFATA) Invention Reporting Financial Conflict of Interest Reports NIH Disclosure Requirements

8.4.2 Record Retention and Access

8.4.3 Audit

8.5 Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions

8.5.1 Specific or Special Award Conditions: Modification of the Terms of Award

8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

8.5.3 Other Enforcement Actions

8.5.4 Recovery of Funds

8.5.5 Debt Collection

8.6 Closeout

8.6.1 Final Federal Financial Report

8.6.2 Final Progress Report

8.6.3 Final Invention Statement and Certification

8.6.4 Submission of Closeout Documents

8.7 Grant Appeals Procedures

Part II: Terms and Conditions of NIH Grant Awards

9 Multiple Program Director/Principal Investigator Applications and Awards

9.1 General

9.2 Applicability

9.3 Application Requirements

9.4 Application Review and Award

9.5 Post-Award Administration

10 Construction, Modernization, or Major Alteration and Renovation of Research Facilities

10.1 General

10.1.1 Eligibility

10.1.2 Funding Opportunity Announcements

10.1.3 Application Review and Award

10.1.4 Title to Site

10.1.5 Matching Requirement

10.2 Procurement Requirements for Construction Services

10.2.1 General

10.2.2 Liquidated Damages

10.3 Contracting Methods

10.3.1 Design-Bid-Build

10.3.2 Alternate Contracting Methods Construction Manager Construction Manager as Agent Construction Manager-at-Risk Design-Build Services Guaranteed Maximum Price

10.4 Design Documentation Requirements

10.4.1 Minimum Design Requirements for Construction, Modernization and Major A&R

10.5 Equal Opportunity and Labor Standards

10.5.1 Equal Employment Opportunity

10.5.2 Nonsegregated Facilities

10.5.3 Labor Standards Contract Work Hours and Safety Standards Disposition of Unclaimed Wages

10.6 Real Property Management Standards

10.6.1 General

10.6.2 Notice of Federal Interest

10.6.3 Insurance Requirements

10.6.4 Use of Facility and Disposition

10.6.5 Real Estate Appraisals

10.7 Allowable and Unallowable Costs and Activities

10.8 Administrative Requirements

10.8.1 Prior Approval Requirements

10.8.2 Alteration and Renovation Projects Under Non-construction Grants

10.9 Closeout

10.10 Public Policy Requirements

10.10.1 Executive Orders

11 Ruth L. Kirschstein National Research Service Awards

11.1 General

11.1.1 Background

11.1.2 Nondiscrimination

11.2 Individual Fellowships

11.2.1 General

11.2.2 Eligibility Research Areas Research Training Program Degree Requirements Citizenship Sponsorship NIH Employees & Other Federal Sponsorship (Federal Fellows) Individuals on Active Military Duty

11.2.3 Application Requirements and Receipt Dates Application eRA Commons Registration Letters of Reference Responsible Conduct of Research Concurrent Applications Receipt Dates

11.2.4 Review Overall Impact Scored Review Criteria Additional Review Criteria Additional Review Considerations Secondary Level of Review

11.2.5 Notification of Action

11.2.6 Period of Support

11.2.7 Full-Time and Part-Time Training

11.2.8 Initiation of Support Process Payment

11.2.9 Allowable and Unallowable Costs Pre-award Costs Stipends Stipend Levels Institutional Allowance Tuition and Fees Travel to Foreign Training Sites Employee Benefits Rebudgeting of Funds

11.2.10 Supplementation of Stipends, Compensation, and Other Income Stipend Supplementation Compensation Other Income: Concurrent Benefits Other Income: Educational Loans or GI Bill Other Income: NIH Loan Repayment Program Taxability of Stipends Form 1099

11.2.11 Reporting Requirements Activation Notice Payback Agreement Termination Notice Consecutive Support Progress Reports Financial Reporting

11.2.12 Changes in the Project

11.2.13 Other Terms and Conditions Leave Termination Publications and Sharing of Research Results Copyright Inventions and Patents Disposition of Professional Fees Public Policy Requirements and Objectives Human Subjects Vertebrate Animals Applicability of NIH Standard Terms of Award

11.3 Institutional Research Training Grants

11.3.1 General

11.3.2 Eligibility Applicant Eligibility Research Areas Training Program Director/Principal Investigator(s) Research Training Program Degree Requirements Predoctoral Training Postdoctoral Training Short-Term Research Training Pre-baccalaureate Training Citizenship

11.3.3 Application Requirements and Receipt Dates Application Receipt Dates Special Program Considerations Recruitment Plan to Enhance Diversity Training in the Responsible Conduct of Research

11.3.4 Review Overall Overall Impact Scored Review Criteria Additional Review Criteria Additional Review Considerations National Advisory Council Review

11.3.5 Notification of Action

11.3.6 Period of Support Training Grants Trainees Kirschstein-NRSA Limitations

11.3.7 Initiation of Support

11.3.8 Allowable and Unallowable Costs Pre-Award Costs Stipends Trainee Tuition and Fees Training-related Expenses Trainee Travel Costs Short-Term Training Costs Employee Benefits Facilities and Administrative Costs

11.3.9 Rebudgeting of Funds

11.3.10 Stipend Supplementation, Compensation, and Other Income Stipend Supplementation Compensation Other Income: Concurrent Benefits Other Income: Educational Loans or GI Bill Other Income: NIH Loan Repayment Program Taxability of Stipends Form 1099

11.3.11 Carryover Authority

11.3.12 Program Income

11.3.13 Reporting Requirements Statement of Appointment (Form PHS 2271) Payback Agreement (Form PHS 6031) Termination Notice (Form PHS 416-7) Research Performance Progress Reports Federal Financial Report (FFR)

11.3.14 Closeout

11.3.15 Changes in the Project

11.3.16 Other Terms and Conditions Leave Termination Publication and Sharing of Research Results Copyright Inventions and Patents Disposition of Professional Fees Public Policy Requirements and Objectives Human Subjects Vertebrate Animals

11.4 Payback Requirements

11.4.1 General

11.4.2 Implementation

11.4.3 Payback Service Payback Definitions Time Commitment Initiation of Payback Service Source of Funding Timing of Service Obligation Financial Payback Policy and Principal Calculation Interest and Interest Rate Calculation Extensions of Payback Extensions of the 2-Year Period to Initiate Payback Basics for Extensions or Break in Service Waiver Policy Waiver Criteria

11.4.4 Certification of Payback Activities Annual Payback Activities Certification (Form PHS 6031-1) Annual Certification Change of Address Breaks in Kirschstein-NRSA Support National Health Service Corps

12 Research Career Development ("K") Awards

12.1 General

12.1.1 Background

12.2 Types of Career Development Awards

12.2.1 General

12.2.2 Individual Mentored Career Development Awards Mentor

12.2.3 Career Transition Awards K22 Pathway to Independence Award (K99/R00) Eligibility K99 Transition to the R00 Phase

12.2.4 Individual Non-mentored (Independent) Career Development Awards

12.2.5 Institutional Scientist Development Programs

12.3 Eligibility

12.3.1 Eligible Institutions

12.3.2 Eligible Individuals

12.3.3 Degree Requirements

12.3.4 Citizenship

12.3.5 Type of Appointment Temporary Adjustments to the Full-Time Institutional Appointment Requirement

12.3.6 Level of Effort Mentored CDAs Concurrent Support Non-mentored CDAs Temporary Adjustments to the Percent Effort Requirement

12.3.7 Prior Research Support

12.4 Application Requirements and Submission Dates

12.4.1 Application Letters of Reference Concurrent Applications Environment and Institutional Commitment to the Candidate Training in the Responsible Conduct of Research Budget Submission Dates

12.5 Review

12.5.1 Overall Impact

12.5.2 Scored Review Criteria

12.5.3 Additional Review Criteria

12.5.4 Additional Review Considerations

12.6 Notification of Action

12.7 Period of Support

12.8 Allowable and Unallowable Costs

12.8.1 Salaries and Fringe Benefits

12.8.2 Research Development Support Costs

12.8.3 Proposal Preparation Costs

12.8.4 Facilities and Administrative Costs

12.9 Rebudgeting of Funds

12.10 Carryover Authority

12.11 Reporting Requirements

12.11.1 Progress Reports

12.11.2 Federal Financial Report

12.11.3 Closeout

12.11.4 Post Closeout Evaluation

12.12 Changes in the Project

12.12.1 Temporary Off-Site Training Experience

12.13 Other Terms and Conditions

12.13.1 Leave Unpaid Leave

12.13.2 Statement of Appointment-Institutional CDAs Only

12.13.3 Early Termination

12.13.4 Other Income: Generation and Disposition of Professional Fees

13 Modular Applications and Awards

13.1 General

13.2 Applicability

13.3 Application Requirements

13.3.1 Budget

13.4 Application Review and Award

13.5 Post-Award Administration

14 Support of Scientific Meetings (Conference Grants)

14.1 General

14.2 Applicability

14.3 Definitions

14.4 Eligibility

14.5 Application Requirements

14.6 Public Policy Requirements and Objectives

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

14.6.2 Guideline on the Inclusion of Women

14.7 Application Review

14.8 Funding

14.9 Acknowledgment of Funding Source and Disclaimer

14.10 Allowable and Unallowable Costs

14.10.1 Allowable Costs

14.10.2 Unallowable Costs

14.11 Administrative Requirements

14.11.1 Intellectual Property: Publications, Copyright, and Public Disclosure

14.11.2 Reporting and Record Retention Progress/Final Report Federal Financial Report

15 Consortium Agreements

15.1 General

15.2 Administrative and Other Requirements

15.2.1 Written Agreement

15.2.2 Public Policy Requirements and Objectives

15.2.3 Allowable and Unallowable Costs

15.2.4 Approval Authorities

15.2.5 Tangible Personal Property Exempt Property Nonexempt Property

15.2.6 Audit

16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components

16.1 General

16.2 Eligibility

16.3 Application Review

16.4 Public Policy Requirements and Objectives

16.5 Funding and Payment

16.6 Allowable and Unallowable Costs

16.7 Administrative Requirements

16.7.1 Changes in Project and Budget

16.7.2 Change in Scope

16.7.3 Change of Recipient Organization

16.7.4 Audit

16.7.5 Reporting and Record Retention

17 Grants to Federal Institutions and Payments to Federal Employees Under Grants

17.1 General

17.2 Eligibility

17.3 VA-University Affiliations

17.4 Public Policy Requirements and Objectives

17.5 Payment

17.6 Allowable and Unallowable Costs

17.7 Administrative Requirements

17.7.1 Equipment Accountability

17.7.2 Procurement Requirements

17.7.3 Intellectual Property

17.7.4 Reporting Requirements

18 Grants to For-Profit Organizations

18.1 General

18.2 Eligibility

18.3 Allowable and Unallowable Costs

18.3.1 Cost Principles

18.3.2 Independent Research and Development Costs

18.3.3 Facilities and Administrative Costs (Indirect Costs)

18.3.4 Profit or Fee

18.4 Administrative Requirements

18.4.1 Equipment Accountability

18.4.2 Intellectual Property

18.4.3 Program Income

18.4.4 Operating Authorities

18.4.5 Audit

18.4.6 Labor Distribution Requirements for For-Profit Organizations

18.5 Small Business Innovation Research and Small Business Technology Transfer Programs

18.5.1 NIH Fast-Track Application Process

18.5.2 Eligibility Place of Performance Change in Organization Status & Change of Recipient Institution Actions Minimum Level of Effort Multiple Program Director/Principal Investigator Applications and Awards

18.5.3 Public Policy Requirements and Objectives

18.5.4 Allowable Costs and Fee Program Levels (Total Costs) Profit or Fee Facilities and Administrative Costs (Indirect Costs)

18.5.5 Administrative Requirements Market Research Intellectual Property Data Sharing SBIR Life Cycle Certification STTR Life Cycle Certification

19 Research Patient Care Costs

19.1 General

19.2 Definitions

19.3 Policy

19.4 Allowable Costs

19.4.1 Computing Research Patient Care Costs

19.4.2 Facilities and Administrative Costs

19.4.3 Special Procedures for Certain Hospitals Recipients Consortium Participants/Contractors under Grants

19.4.4 Financial Responsibilities

19.5 Program Requirements

19.6 Post-Award Requirements

Part III: Points of Contact

20 Institutes and Centers

20.1 Other NIH Offices

20.2 Other HHS Government Offices