Part I: NIH Grants - General information
2 The National Institutes of Health as a Grant-Making Organization
2.1 Roles and Responsibilities
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 Other Individuals Participating in NIH Progress Reports
2.3 Application Information and Processes
2.3.3 Types of Award Instruments
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
2.3.7.3 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 SAM Registration Requirements
2.3.7.9 Graduate Student Compensation
2.3.7.10 NIH Genomic Data Sharing
2.3.9 Application Receipt Information and Deadlines
2.3.9.2 Electronically Submitted Applications
2.3.9.4 Similar, Essentially Identical, or Identical Applications
2.3.9.5 Application Non-confirmity
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
2.3.11.2.2 The Freedom of Information Act
2.3.11.2.3 Access to Research Data
2.3.12 Protecting Sensitive Data and Information Used in Research
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
2.5.3 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
4.1.1.1 Animal Welfare Assurance Requirements
4.1.1.2 Verification of IACUC Approval
4.1.1.4 Foreign Recipients and Foreign Performance Sites
4.1.2 Civil Rights Protections
4.1.2.1 Civil Rights Act of 1964
4.1.2.2 Educational 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 Clinical Trials Registration and Reporting in ClinicalTrials.gov Requirement
4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
4.1.3.2 Food and Drug Administration Amendments Act (FDAAA)
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
4.1.6 Debarment and Suspension
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
4.1.12 Health and Safety Regulations and Guidelines
4.1.13 Human Stem Cell Research
4.1.13.1 Human Pluripotent Stem Cell 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
4.1.15.5 Education in the Protection of Human Research Participants
4.1.15.6 Data and Safety Monitoring
4.1.15.9 Informed Consent for Research on Dried Blood Spots Obtained Through Newborn Screening
4.1.15.10 Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
4.1.15.11 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
4.1.20 National Environmental Policy Act
4.1.21 Nondelinquency on Federal Debt
4.1.22 President's Emergency Plan for AIDS Relief (PEPFAR) Program
4.1.23 Pro-Children Act of 1994
4.1.24.1 Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents)
4.1.24.1.1.1 Select Agent Awards to U.S. Institutions
4.1.24.1.1.2 Select Agent Awards to Foreign Organizations and International Organzations
4.1.24.1.1.3 Select Agent Awards to U.S. Institutions with Foreign Subcomponents
4.1.24.2 Dual Use Research of Concern
4.1.24.3 Agents Regulated Under the Chemical Weapons Convention
4.1.26.1 Scope and Availability
4.1.26.2 Institutional Biosafety Committee
4.1.26.3 Investigators and Institutional Staff
4.1.26.4 Safety and Annual Reporting
4.1.31 Text Messaging While Driving
4.1.34 Federal Awardee Performance and Integrity Information System (FAPIIS)
4.2.1 Acknowledgment of Federal Funding
4.2.3 Dissemination of False or Deliberately Misleading Information
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
4.2.8.1 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
5.1 Notice of Award Notification
5.2 Associated Applications and/or Awards
5.5 Additional Terms and Conditions
6.3 Interest Earned on Advances of Grant Funds
6.4 Improper Payments Elimination and Recovery Improvement Act
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
7.8 Services Provided by Affiliated Organizations
7.9 Allowability of Costs/Activities
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
8.1.1.5 Direct Charging Salaries of Administrative and Clerical Staff
8.1.1.6 Supplemental Compensation under Written Institutional Policy for IHEs
8.1.2 Prior Approval Requirements
8.1.2.2 Alterations and Renovations
8.1.2.4 Carryover of Unobligated Balances
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 Recipient Organization
8.1.2.8 Change in Recipient 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 Provide Subaward Based on Fixed Amounts
8.1.2.12 Need for Additional NIH Funding without Extension of Budget and Project Period
8.1.2.15 Rebudgeting of Funds from Trainee Costs
8.1.2.16 Rebudgeting of Funds Between Construction and Non-construction Work
8.1.2.17 Retention of Research Grant Funds When a Career Development Award is Issued
8.1.3 Requests for Prior Approval
8.2.1 Rights in Data (Publication and Copyrighting)
8.2.2 NIH Public Access Policy
8.2.3 Sharing Research Resources
8.2.3.2 Sharing Model Organisms
8.2.3.3 Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS)
8.2.5 Interim Research Products
8.3 Management Systems and Procedures
8.3.1 Financial Management System Standards
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
8.3.3.2 Equipment and Supplies
8.3.4 Procurement System Standards and Requirements
8.3.4.3 Contracting with Small Businesses, Minority-Owned Firms, and Women's Business Enterprises
8.4.1.1 Non-Competing Continuation Progress Reports
8.4.1.1.1 Requirement for Commons ID
8.4.1.2 Streamlined Non-Competing Award Process
8.4.1.2.1 Modified Annual Progress Reports
8.4.1.2.3 Modified Financial Reporting Requirements
8.4.1.2.4 Submitting SNAP Progress Reports
8.4.1.3 Progress Reports for Multiyear Funded Awards
8.4.1.4 Final Research Performance Progress Report (F-RPPR)
8.4.1.5.1 Cash Transaction Reports
8.4.1.5.2 Financial Expenditure Reports
8.4.1.5.3 Revised Financial Reports and Expenditures
8.4.1.5.4 Unobligated Balances and Actual Expenditures
8.4.1.7 Financial Conflict of Interest Reports
8.4.1.8 NIH Disclosure Requirements
8.4.2 Record Retention and Access
8.5.1 Specific or Special Award Conditions: Modification of the Terms of Award
8.5.3 Other Enforcement Actions
8.6.1 Final Federal Financial Report
8.6.3 Final Invention Statement and Certification
8.6.4 Submission of Closeout Documents
Part II: Terms and Conditions of NIH Grant Awards
9 Multiple Program Director/Principal Investigator Applications and Awards
9.4 Application Review and Award
10 Construction, Modernization, or Major Alteration and Renovation of Research Facilities
10.1.2 Funding Opportunity Announcements
10.1.3 Application Review and Award
10.2 Procurement Requirements for Construction Services
10.3.2 Alternate Contracting Methods
10.3.2.1.1 Construction Manager as Agent
10.3.2.1.2 Construction Manager-at-Risk
10.3.2.2 Design-Build Services
10.3.2.3 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
10.5.3.1 Contract Work Hours and Safety Standards
10.5.3.2 Disposition of Unclaimed Wages
10.6 Real Property Management Standards
10.6.2 Notice of Federal Interest
10.6.4 Use of Facility and Disposition
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
10.10 Public Policy Requirements
11 Ruth L. Kirschstein National Research Service Awards
11.2.2.2 Research Training Program
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
11.2.3.2 eRA Commons Registration
11.2.3.4 Responsible Conduct of Research
11.2.3.5 Concurrent Applications
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
11.2.7 Full-Time and Part-Time Training
11.2.9 Allowable and Unallowable Costs
11.2.9.4 Institutional Allowance
11.2.9.6 Travel to Foreign Training Sites
11.2.10 Supplementation of Stipends, Compensation, and Other Income
11.2.10.1 Stipend Supplementation
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
11.2.11 Reporting Requirements
11.2.12 Changes in the Project
11.2.13 Other Terms and Conditions
11.2.13.3 Publications and Sharing of Research Results
11.2.13.5 Inventions and Patents
11.2.13.6 Disposition of Professional Fees
11.2.13.7 Public Policy Requirements and Objectives
11.2.13.7.2 Vertebrate Animals
11.2.13.8 Applicability of NIH Standard Terms of Award
11.3 Institutional Research Training Grants
11.3.2.1 Applicant Eligibility
11.3.2.3 Training Program Director/Principal Investigator(s)
11.3.2.4 Research Training Program
11.3.2.5.1 Predoctoral Training
11.3.2.5.2 Postdoctoral Training
11.3.2.5.3 Short-Term Research Training
11.3.2.5.4 Pre-baccalaureate Training
11.3.3 Application Requirements and Receipt Dates
11.3.3.3 Special Program Considerations
11.3.3.4 Recruitment Plan to Enhance Diversity
11.3.3.5 Training in the Responsible Conduct of Research
11.3.4.3 Scored Review Criteria
11.3.4.4 Additional Review Criteria
11.3.4.5 Additional Review Considerations
11.3.4.6 National Advisory Council Review
11.3.6.3 Kirschstein-NRSA Limitations
11.3.8 Allowable and Unallowable Costs
11.3.8.3 Trainee Tuition and Fees
11.3.8.4 Training-related Expenses
11.3.8.6 Short-Term Training Costs
11.3.8.8 Facilities and Administrative Costs
11.3.10 Stipend Supplementation, Compensation, and Other Income
11.3.10.1 Stipend Supplementation
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
11.3.13 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 Research Performance Progress Reports
11.3.13.5 Federal Financial Report (FFR)
11.3.15 Changes in the Project
11.3.16 Other Terms and Conditions
11.3.16.3 Publication and Sharing of Research Results
11.3.16.5 Inventions and Patents
11.3.16.6 Disposition of Professional Fees
11.3.16.7 Public Policy Requirements and Objectives
11.3.16.7.2 Vertebrate Animals
11.4.3.1.3 Initiation of Payback Service
11.4.3.1.5 Timing of Service Obligation
11.4.3.2.1 Policy and Principal Calculation
11.4.3.2.2 Interest and Interest Rate Calculation
11.4.3.3 Extensions of Payback
11.4.3.3.1 Extensions of the 2-Year Period to Initiate Payback
11.4.3.3.2 Basics for Extensions or Break in Service
11.4.4 Certification of Payback Activities
11.4.4.1 Annual Payback Activities Certification (Form PHS 6031-1)
11.4.4.4 Breaks in Kirschstein-NRSA Support
11.4.4.5 National Health Service Corps
12 Research Career Development ("K") Awards
12.2 Types of Career Development Awards
12.2.2 Individual Mentored Career Development Awards
12.2.3 Career Transition Awards
12.2.3.2 Pathway to Independence Award (K99/R00)
12.2.3.2.3 Transition to the R00 Phase
12.2.4 Individual Non-mentored (Independent) Career Development Awards
12.2.5 Institutional Scientist Development Programs
12.3.5.1 Temporary Adjustments to the Full-Time Institutional Appointment Requirement
12.3.6.4 Temporary Adjustments to the Percent Effort Requirement
12.4 Application Requirements and Submission Dates
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
12.5.3 Additional Review Criteria
12.5.4 Additional Review Considerations
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
12.11.2 Federal Financial Report
12.11.4 Post Closeout Evaluation
12.12.1 Temporary Off-Site Training Experience
12.13 Other Terms and Conditions
12.13.2 Statement of Appointment-Institutional CDAs Only
12.13.4 Other Income: Generation and Disposition of Professional Fees
13 Modular Applications and Awards
13.4 Application Review and Award
13.5 Post-Award Administration
14 Support of Scientific Meetings (Conference Grants)
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
14.9 Acknowledgment of Funding Source and Disclaimer
14.10 Allowable and 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
15.2 Administrative and Other Requirements
15.2.2 Public Policy Requirements and Objectives
15.2.3 Allowable and Unallowable Costs
15.2.5 Tangible Personal Property
16.4 Public Policy Requirements and Objectives
16.6 Allowable and Unallowable Costs
16.7 Administrative Requirements
16.7.1 Changes in Project and Budget
16.7.3 Change of Recipient Organization
16.7.5 Reporting and Record Retention
17 Grants to Federal Institutions and Payments to Federal Employees Under Grants
17.3 VA-University Affiliations
17.4 Public Policy Requirements and Objectives
17.6 Allowable and Unallowable Costs
17.7 Administrative Requirements
17.7.1 Equipment Accountability
17.7.2 Procurement Requirements
18 Grants to For-Profit Organizations
18.3 Allowable and Unallowable Costs
18.3.2 Independent Research and Development Costs
18.3.3 Facilities and Administrative Costs (Indirect Costs)
18.4 Administrative Requirements
18.4.1 Equipment Accountability
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
18.5.2.2 Change in Organization Status & Change of Recipient 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)
18.5.4.3 Facilities and Administrative Costs (Indirect Costs)
18.5.5 Administrative Requirements
18.5.5.2 Intellectual Property
18.5.5.4 SBIR Life Cycle Certification
18.5.5.5 STTR Life Cycle Certification
19 Research Patient Care Costs
19.4.1 Computing Research Patient Care Costs
19.4.2 Facilities and Administrative Costs
19.4.3 Special Procedures for Certain Hospitals
19.4.3.2 Consortium Participants/Contractors under Grants