Effective for budget periods that began between 10/1/2010 and 9/30/2011.
See the 10/1/2011 NIH GPS for a more current version. |
NIH Grants Policy Statement
(10/10)
Table of Contents
NIH Grants Policy Statement (10/1/2010) - Effective for all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2010. See 12/03 NIHGPS for prior budget periods. See NOT-OD-11-003 for description and notable changes since the 2003 version. See also the Significant Changes document (MS Word - 252 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 - 2.8 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
2.3.10 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 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 Final Progress Reports
8.4.1.4 Financial Reports
8.4.1.5 Invention Reporting
8.4.2 Record Retention and Access
8.4.3 Audit
8.5 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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