NIH Grants Policy Statement (10/11) - Table of Contents
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Grants and Funding
Grants Policy
Policy & Guidance
Compliance & Oversight
Research Involving Human Subjects
Office of Laboratory Animal Welfare (OLAW)
Animals in Research
Peer Review Policies & Practices
Intellectual Property Policy
Acknowledging NIH Funding
Invention Reporting (iEdison)
NIH Public Access
Research Integrity

NIH Grants Policy Statement

(10/11)

Table of Contents


NIH Grants Policy Statement (10/1/2011) - Effective for all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2011. See 10/1/2010 NIHGPS for prior budget periods. See NOT-OD-12-003 for description and notable changes since the 2010 version.  See also the Significant Changes document (MS Word - 75 KB) which summarizes the significant changes in this revision of the NIH GPS.

Download PDF File – A PDF file containing the NIHGPS is available for viewing, searching and/or printing. You may download the Complete NIHGPS in a Single File (PDF - 3 MB).


Introduction

Part I: NIH Grants—General Information

1 Glossary

1.1 Abbreviations

1.2 Definitions 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 Grantee Staff

2.2 eRA Commons

2.2.1 eRA Commons Registration

2.2.1.1 eRA Commons Registration for the Organization

2.2.1.2 eRA Commons Registration for the PD/PI

2.2.1.3 eRA Commons Registration for Individuals Serving in a Postdoctoral Role

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

2.3.7.1 Applications That Include Consortium/Contractual F&A Costs

2.3.7.2 Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Costs

2.3.7.3 Resubmission of Unfunded RFA Applications

2.3.7.4 Submission of Resubmission Application

2.3.7.5 New Investigators and Early Stage Investigators

2.3.7.6 Program Director/Principal Investigator, Individual Fellowship and Sponsor Assurance

2.3.7.7 Post-Submission Grant Application Materials

2.3.7.8 DUNS Number and CCR Registration Requirements

2.3.8 Application Forms

2.3.9 Application Receipt Information and Deadlines

2.3.9.1 Paper Applications

2.3.9.2 Electronically Submitted Applications

2.3.9.3 Modified Submission Policy for Appointed Members of NIH Review and Advisory Group and Reviewers with Recent Substantial Service

2.3.9.4 Similar, Essentially Identical, or Identical Applications

2.3.10 Fraud, Waste and Abuse of NIH Grant Funds

2.3.11 Availability and Confidentiality of Information

2.3.11.1 Availability of Information

2.3.11.2 Confidentiality of Information

2.3.12 Protecting Sensitive Data and Information Used in Research

2.4 The Peer Review Process

2.4.1 Initial Review

2.4.1.1 Responsibilities

2.4.1.2 Overall Impact

2.4.1.3 Scored Review Criteria

2.4.1.4 Additional Review Criteria

2.4.1.5 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
Subpart A: General

3 Overview of Terms and Conditions

3.1 Federalwide Standard Terms and Conditions for Research Grants

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

4.1.1.1 Animal Welfare Assurance Requirements

4.1.1.2 Verification of IACUC Approval

4.1.1.3 Consortiums

4.1.1.4 Foreign Grantees and Foreign Performance Sites

4.1.1.5 Reporting to OLAW

4.1.2 Civil Rights Protections

4.1.2.1 Civil Rights Act of 1964

4.1.2.2 Education Amendments of 1972

4.1.2.3 Rehabilitation Act of 1973

4.1.2.4 Age Discrimination Act of 1975

4.1.2.5 Limited English Proficiency

4.1.3 ClinicalTrials.gov Requirement

4.1.4 Confidentiality

4.1.4.1 Certificates of Confidentiality

4.1.4.2 Confidentiality of Alcohol and Drug Abuse Patient Records

4.1.4.3 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

4.1.13.1 hESC Research Prohibited with NIH Funding

4.1.14 Human Fetal Tissue Research

4.1.14.1 Research on Transplantation of Human Fetal Tissue

4.1.15 Human Subjects Protections

4.1.15.1 Federalwide Assurance Requirements

4.1.15.2 Certification of IRB Approval

4.1.15.3 Reporting to Funding Agency and OHRP

4.1.15.4 OHRP Oversight

4.1.15.5 Education in the Protection of Human Research Participants

4.1.15.6 Data and Safety Monitoring

4.1.15.7 Inclusion of Children as Subjects in Clinical Research

4.1.15.8 Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender and Racial Ethnic Participation

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 Pro-Children Act of 1994

4.1.23 Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents)

4.1.23.1 Select Agents

4.1.24 Recombinant DNA Molecules, Research Involving (including Human Gene Transfer Research)

4.1.24.1 Scope and Applicability

4.1.24.2 Institutional Biosafety Committee

4.1.24.3 Investigators and Institutional Staff

4.1.24.4 Safety and Annual Reporting

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

4.1.26 Research Misconduct

4.1.27 Seat Belt Use

4.1.28 Smoke-Free Workplace

4.1.29 Standards of Conduct

4.1.30 Text Messaging While Driving

4.1.31 Trafficking in Persons

4.1.32 USA Patriot Act

4.2 Appropriation Mandates

4.2.1 Acknowledgment of Federal Funding

4.2.2 Certification of Filing and Payment of Taxes

4.2.3 Dissemination of False or Deliberately Misleading Scientific Information

4.2.4 Human Embryo Research and Cloning Ban

4.2.5 Lobbying—Appropriation Prohibition

4.2.6 Promotion or Legalization of Controlled Substances

4.2.7 Restriction on Abortion Funding

4.2.7.1 Exceptions to Restrictions on Abortions

4.2.8 Restriction on Distribution of Sterile Needles

4.2.9 Salary Cap/Salary Limitation

5 The 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

7 Cost Considerations

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

8.1.1.1 Carryover of Unobligated Balances from One Budget Period to Any Subsequent Budget Period

8.1.1.2 Cost-Related Prior Approvals

8.1.1.3 Extension of Final Budget Period of a Previously Approved Project Period without Additional NIH Funds

8.1.1.4 Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Agreement

8.1.2 Prior Approval Requirements

8.1.2.1 Additional No-cost Extension or Extension Greater Than 12 Months or Late Notification of Initial No-Cost Extension

8.1.2.2 Alterations and Renovations

8.1.2.3 Capital Expenditures

8.1.2.4 Carryover of Unobligated Balances

8.1.2.5 Change in Scope

8.1.2.6 Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA

8.1.2.7 Change of Grantee Organization

8.1.2.8 Change in Grantee Organizational Status

8.1.2.9 Deviation from Award Terms and Conditions, including Restrictions in the NoA

8.1.2.10 Foreign Component Added to a Grant to a Domestic or Foreign Organization

8.1.2.11 Need for Additional NIH Funding without Extension of Budget and Project Period

8.1.2.12 Need for Additional NIH Funding with Extension of the Final Budget Period of a Project Period

8.1.2.13 Pre-Award Costs

8.1.2.14 Rebudgeting of Funds from Trainee Costs

8.1.2.15 Rebudgeting of Funds Between Construction and Non-construction Work

8.1.2.16 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

8.2.3.1 Data Sharing Policy

8.2.3.2 Sharing Model Organisms

8.2.3.3 Policy for Genome-Wide Association Studies (GWAS)

8.2.4 Inventions and Patents

8.3 Management Systems and Procedures

8.3.1 Financial Management System Standards

8.3.2 Program Income

8.3.2.1 Reporting Program Income

8.3.2.2 Sale of Real Property, Equipment, and Supplies

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

8.3.3 Property Management System Standards

8.3.3.1 Real Property

8.3.3.2 Equipment and Supplies

8.3.4 Procurement System Standards and Requirements

8.3.4.1 General

8.3.4.2 Approval Requirements

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

8.4 Monitoring

8.4.1 Reporting

8.4.1.1 Non-Competing Continuation Progress Reports

8.4.1.2 Streamlined Non-Competing Award Process

8.4.1.3 Progress Reports for Multiyear Funded Awards

8.4.1.4 Final Progress Reports

8.4.1.5 Financial Reports

8.4.1.6 Invention Reporting

8.4.2 Record Retention and Access

8.4.3 Audit

8.5 Special Award Conditions and Enforcement Actions

8.5.1 Modification of the Terms of Award

8.5.2 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
Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

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 Alternate Contracting Methods

10.3.1 Guaranteed Maximum Price

10.3.2 Construction Manager as Agent

10.3.3 Construction Manager-at-Risk

10.3.4 Design-Build Services

10.4 Design Documentation Requirements

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

10.5 Equal Employment Opportunity and Labor Standards

10.5.1 Equal Employment Opportunity

10.5.2 Nonsegregated Facilities

10.5.3 Labor Standards

10.5.3.1 Contract Work Hours and Safety Standards

10.5.3.2 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

11.2.2.1 Research Areas

11.2.2.2 Research Training Program

11.2.2.3 Degree Requirements

11.2.2.4 Citizenship

11.2.2.5 Sponsorship

11.2.2.6 NIH Employees & Other Federal Sponsorship (Federal Fellows)

11.2.2.7 Individuals on Active Military Duty

11.2.3 Application Requirements and Receipt Dates

11.2.3.1 Application

11.2.3.2 eRA Commons Registration

11.2.3.3 Letters of Reference

11.2.3.4 Responsible Conduct of Research

11.2.3.5 Concurrent applications

11.2.3.6 Receipt Dates

11.2.4 Review

11.2.4.1 Overall Impact

11.2.4.2 Scored Review Criteria

11.2.4.3 Additional Review Criteria

11.2.4.4 Additional Review Considerations

11.2.4.5 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

11.2.8.1 Process

11.2.8.2 Payment

11.2.9 Allowable and Unallowable Costs

11.2.9.1 Pre-award Costs

11.2.9.2 Stipends

11.2.9.3 Stipend Levels

11.2.9.4 Institutional Allowance

11.2.9.5 Tuition and Fees

11.2.9.6 Travel to Foreign Training Sites

11.2.9.7 Employee Benefits

11.2.9.8 Rebudgeting of Funds

11.2.10 Supplementation of Stipends, Compensation, and Other Income

11.2.10.1 Stipend Supplementation

11.2.10.2 Compensation

11.2.10.3 Other Income: Concurrent Benefits

11.2.10.4 Other Income: Educational Loans or GI Bill

11.2.10.5 Other Income: NIH Loan Repayment Program

11.2.10.6 Taxability of Stipends

11.2.10.7 Form 1099

11.2.11 Reporting Requirements

11.2.11.1 Activation Notice

11.2.11.2 Payback Agreement

11.2.11.3 Termination Notice

11.2.11.4 Consecutive Support

11.2.11.5 Progress Reports

11.2.11.6 Financial Reporting

11.2.12 Changes in the Project

11.2.13 Other Terms and Conditions

11.2.13.1 Leave

11.2.13.2 Termination

11.2.13.3 Publications and Sharing of Research Results

11.2.13.4 Copyright

11.2.13.5 Inventions and Patents

11.2.13.6 Disposition of Professional Fees

11.2.13.7 Public Policy Requirements and Objectives

11.2.13.8 Applicability of NIH Standard Terms of Award

11.3 Institutional Research Training Grants

11.3.1 General

11.3.2 Eligibility

11.3.2.1 Applicant Eligibility

11.3.2.2 Research Areas

11.3.2.3 Training Program Director/Principal Investigator(s)

11.3.2.4 Research Training Program

11.3.2.5 Degree Requirements

11.3.2.6 Citizenship

11.3.3 Application Requirements and Receipt Dates

11.3.3.1 Application

11.3.3.2 Receipt Dates

11.3.3.3 Special Program Considerations

11.3.3.4 Recruitment and Retention Plan to Enhance Diversity

11.3.3.5 Training in the Responsible Conduct of Research

11.3.4 Review

11.3.4.1 Overall

11.3.4.2 Overall Impact

11.3.4.3 Review Criteria

11.3.4.4 Additional Review Criteria

11.3.4.5 Additional Review Considerations

11.3.4.6 National Advisory Council Review

11.3.5 Notification of Action

11.3.6 Period of Support

11.3.6.1 Training Grants

11.3.6.2 Trainees

11.3.6.3 Kirschstein-NRSA Limitations

11.3.7 Initiation of Support

11.3.8 Allowable and Unallowable Costs

11.3.8.1 Pre-Award Costs

11.3.8.2 Stipends

11.3.8.3 Trainee Tuition and Fees

11.3.8.4 Training-Related Expenses

11.3.8.5 Trainee Travel Costs

11.3.8.6 Short-Term Training Costs

11.3.8.7 Employee Benefits

11.3.8.8 Facilities and Administrative Costs

11.3.9 Rebudgeting of Funds

11.3.10 Stipend Supplementation, Compensation, and Other Income

11.3.10.1 Stipend Supplementation

11.3.10.2 Compensation

11.3.10.3 Other Income: Concurrent Benefits

11.3.10.4 Other Income: Educational Loans or GI Bill

11.3.10.5 Other Income: NIH Loan Repayment Program

11.3.10.6 Taxability of Stipends

11.3.10.7 Form 1099

11.3.11 Carryover Authority

11.3.12 Program Income

11.3.13 Reporting Requirements

11.3.13.1 Statement of Appointment (Form PHS 2271)

11.3.13.2 Payback Agreement (Form PHS 6031)

11.3.13.3 Termination Notice (Form PHS 416-7)

11.3.13.4 Progress Reports

11.3.13.5 Federal Financial Report (FFR)

11.3.14 Closeout

11.3.15 Changes in the Project

11.3.16 Other Terms and Conditions

11.3.16.1 Leave

11.3.16.2 Termination

11.3.16.3 Publications and Sharing of Research Results

11.3.16.4 Copyright

11.3.16.5 Inventions and Patents

11.3.16.6 Disposition of Professional Fees

11.3.16.7 Public Policy Requirements and Objectives

11.4 Payback Requirements

11.4.1 General

11.4.2 Implementation

11.4.3 Payback

11.4.3.1 Service Payback

11.4.3.2 Financial Payback

11.4.3.3 Extensions of Payback

11.4.3.4 Waiver

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

11.4.4.3 Change of Address

11.4.4.4 Breaks in Kirschstein-NRSA Support

11.4.4.5 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

12.2.2.1 Mentor

12.2.3 Career Transition Awards

12.2.3.1 K22

12.2.3.2 Pathway to Independence Award (K99/R00)

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

12.3.5.1 Temporary Adjustments to the Full-Time Institutional Appointment Requirement

12.3.6 Level of Effort

12.3.6.1 Mentored CDAs

12.3.6.2 Concurrent Support

12.3.6.3 Non-mentored CDAs

12.3.6.4 Temporary Adjustments to the Percent Effort Requirement

12.3.7 Prior Research Support

12.4 Application Requirements and Submission Dates

12.4.1 Application

12.4.1.1 Letters of Reference

12.4.1.2 Concurrent applications

12.4.1.3 Environment and Institutional Commitment to the Candidate

12.4.1.4 Training in the Responsible Conduct of Research

12.4.1.5 Budget

12.4.1.6 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

12.13.1.1 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

14.11.2.1 Progress/Final Report

14.11.2.2 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

15.2.5.1 Exempt Property

15.2.5.2 Nonexempt Property

15.2.6 Audit

16 GRANTS TO FOREIGN INSTITUTIONS, 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 Grantee 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

18.5 Small Business Innovation Research and Small Business Technology Transfer Programs

18.5.1 NIH Fast-Track Application Process

18.5.2 Eligibility

18.5.2.1 Place of Performance

18.5.2.2 Change in Organization Status & Change of Grantee Institution Actions

18.5.2.3 Minimum Level of Effort

18.5.2.4 Multiple Program Director/Principal Investigator Applications and Awards

18.5.3 Public Policy Requirements and Objectives

18.5.4 Allowable Costs and Fee

18.5.4.1 Program Levels (Total Costs)

18.5.4.2 Profit or Fee

18.5.4.3 Facilities and Administrative Costs (Indirect Costs)

18.5.5 Administrative Requirements

18.5.5.1 Market Research

18.5.5.2 Intellectual Property

18.5.5.3 Data Sharing

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

19.4.3.1 Grantees

19.4.3.2 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 and Government Offices





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