Notices of NIH Policy Changes

Policy notices published in the NIH Guide for Grants and Contracts supersede information in the NIH Grants Policy Statement. Compliance with these policy updates become a term and condition of award. NIH incorporates these notices into the annual update of the NIH Grants Policy Statement.  Below is a listing of selected policy notices.
 
Search the NIH Guide for Grants and Contracts for all notices.
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Previous Years: 

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December 2018

December 12 Advance Notice: Streamlining the Certifications and Representations Process and Phasing out the SF-424B
December 7 Request for Information (RFI): Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research
December 3 Notice: Changes to the NIH Academic Research Enhancement Award (AREA)/R15 Program

November 2018

November 27 Notice of Fiscal Policies in Effect for FY 2019
November 27 Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2019
November 21 Reminder: Annual Reports to the Office of Laboratory Animal Welfare due January 31, 2019
November 16 NIH to Host Second Informational Webinar on Proposed Key Provisions for a Future Draft Data Management and Sharing Policy
November 9 Notice of Legislative Mandates in Effect for FY 2019
November 7 Harasment and Discrimination Protections in NIH Training Applications

October 2018

October 29 Update to NIH Management of Genomic Summary Results Access
October 29 Notice of Change to Activity Codes allowed for NIH Administrative Supplements to Recover Losses Due to Hurricanes Harvey, Irma, and Maria Under the Bipartisan Budget Act of 2018 - Non- Construction (Admin Supp Clinical Trial Optional) PA-18-936
October 29 Revised Process for SBIR/STTR Life Cycle Certifications
October 23 Publication of the Revised NIH Grants Policy Statement (Rev. October 2018) for FY 2019
October 22 Reminder: NIH Natural Disaster Policy - Hurricane Michael
October 17 Responsibilities of Recipient Institutions in Communicating Research Misconduct to the NIH
October 15 Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations
October 12 Notice of Change to Activity Codes allowed for Administrative Supplements to Promote Diversity in Research and Development Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed) PA-18-837
October 12 New NIH Peer Review Videos for Applicants

September 2018

September 24 Notice Regarding 2018 Bayh-Dole Act Final Rule - Rights to Federally Funded Inventions and Licensing of Government Owned Inventions
September 24 Update on NIH Extension Policy for Early Stage Investigator Status (ESI)
September 24 Review of the Accuracy of Grants Information for Fiscal Year 2018
September 14 NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Career Development Award Applications
September 14 NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications
September 14 NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Fellowship Award Applications
September 13 NIH Natural Disaster Policy - Hurricane Florence
September 6 Clarification: Fixed Amount Award Definition and Implementation for Clinical Trials
September 4 Additional Awards Eligible for PA-18-906 “Research Supplements to Promote Diversity in Health-Related Research” (Admin Supp)

August 2018

August 28 Protecting Human Research Participants (PHRP) Online Tutorial No Longer Available as of September 26, 2018
August 28 Notice of Increases to the Simplified Acquisition and Micro-purchase Thresholds by the Office of Management and Budget
August 27 NIH Request for Public Comment on Draft Protocol Template for Behavioral and Social Sciences Clinical Trials
August 16 Notice of the Publication of an NIH Proposal to Amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to Streamline Oversight of Human Gene Transfer Protocols
August 10 Request for Information (RFI): Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants
August 1 Update - NIH Response to Registration Issues in Sam.gov

July 2018

July 26 NIH Offers Assistance to Phase II HHS SBIR and STTR Awardees through the NIH Commercialization Accelerator Program (CAP) 2018-2019
July 26 Update on NIHs Next Generation Researchers Initiative (NGRI) Policy on Early Established Investigators (EEIs)
July 23 NIH/AHRQ Application Submission/Resubmission Policy
July 20 Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
July 18 NIH Implementation of the Burden-Reducing Provisions of the 2018 Common Rule
July 16 Updated Notice of NIH's Interest in Diversity
July 3 NIH Synchronizes Institutional Delegations and Now Allows Decimals in Effort Reporting Field in Research Performance Progress Reports (RPPR)

June 2018

June 22 Clarification: Assignment Deadlines for Applications Submitted Under the NIH Continuous Submission Policy
June 20 Notice of Availability of Administrative Supplements for NIH Grants Focused on Down Syndrome to Address Specific Down Syndrome Research Objectives
June 20 Notice of Availability of Administrative Supplements for NIH Grants that are NOT Focused on Down Syndrome to Address Specific Down Syndrome Research Objectives
June 14 Request for Information (RFI): Input on Report from Council of Councils on Assessing the Safety of Relocating At-Risk Chimpanzees
June 14 Early Registration Ends June 29 for Fall 2018 NIH Regional Seminar in San Francisco, CA
June 8 Updates to Registration Process Changes in SAM.gov
June 5 Request for Information on the Development of the FY 2021-2023 Trans-NIH Plan for HIV-Related Research

May 2018

May 16 Notice of Fiscal Policies in Effect for FY 2018
May 16 Notice of Legislative Mandates in Effect for FY 2018
May 11 Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018
May 9 Additional Awards Eligible for PA-18-586 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
May 9 Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2018
May 1 Clarification of NIHs Policy Regarding a Change in Program Directors/Principal Investigators Status

April 2018

April 30 Update on Additional Awards that Permit Eligibility for K01, K08, K23, and K25 Career Development Awards
April 10 Career Award (K) Policy Update: Temporary Adjustments to Percent Effort or Part-Time Institutional Appointment
April 6 Career Award (K) Policy Update: Concurrent Support from a Mentored K Award and a Research Grant

March 2018

March 30 Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests
March 29 Registration Process Changes in SAM.gov
March 26 Summary of Leave, Part-Time and Extension Policies Available to Ruth L. Kirschstein National Research Service Awards (NRSA) Trainees and Fellows
March 9 Register Today - Space is Limited and Savings End Soon for the NIH Regional Seminar on Program Funding & Grants Administration: Washington, D.C. - May 2-4, 2018
March 7 Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2018

February 2018

February 20 Advance Notice of Transition to the xTRACT System for Preparing Research Training Data Tables
February 8 NIH Operates Under a Continuing Resolution Through February 8, 2018
February 2 Notice of ORIP’s Interest to Highlight Resource-Related Research Projects for Development of Animal Models and Related materials that Address High Priority HIV/AIDS-related Research

January 2018

January 31 Request for Information (RFI): Research Questions to Inform Development of the All of Us Research Program
January 23 Grant Application Due Dates Following the Recent Lapse in Appropriations
January 18 Grant Application Instruction Corrections for Training Grants with Human Subjects Involvement
January 16 HHS issues Four (4) PHS 2018-2 SBIR and STTR Omnibus/Parent Grant Solicitations with FORMS-E and Clinical Trials Policy Updates
January 12 NIH Operates Under a Continuing Resolution Through January 19, 2018
January 12 Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018

December 2017

December 22 Maintaining Integrity in NIH Peer Review: Responsibilities and Consequences
December 19 Revision: NIH Policy and Guidelines on the Inclusion of Individuals across the Lifespan as Participants in Research Involving Human subjects
December 19 NIH Operates Under a Continuing Resolution Through December 22, 2017
December 14 Reminder: Annual Reports to OLAW due January 31, 2018
December 12 Additional Short-Term Administrative Relief to Institutions Impacted by Hurricane Harvey, Irma, and Maria
December 7 Notice of Requirement for Electronic Submission of Research Supplements to Promote Diversity in Health-Related Research and Upcoming System Validation
December 1 Revision: The NIH Announces Additional Review Criteria for Career Development Award Applications Involving Clinical Trials
December 1 Notice of Intent to Revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

November 2017

November 30 Standards for Documentation of Personnel Expenses
November 30 NIH Enforcement of Closeout Policies
November 30 Reminder: Policy on Finding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018
November 28 Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
November 27 Revision: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
November 17 2018 NIH Regional Seminar on Program Funding & Grants Administration - Early Registration Rates Available Now
November 16 NIH will Make the Project Outcomes Section of all Interim and Final RPPR’s Submitted on or After October 1, 2017 Available via the NIH RePORTER
November 3 Statement on Article Publication Resulting from NIH Funded Research

October 2017

October 25 NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements
October 24 Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018
October 12 Publication of the Revised NIH Grants Policy Statement (Rev. October 2017) for FY 2018
October 11 Guidance on Exceptions to the NIH Single IRB Policy
October 11 Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
October 6 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials
October 6 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials
October 6 The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials
October 4 NIH Offers Assistance to Active Phase I HHS SBIR and STTR Awardees through the Niche Assessment Program 2017-2018
October 3 Application and Report Submission Flexibilities Available to Institutions Impacted by Hurricane Maria
October 2 NIH Operates Under a Continuing Resolution Through December 8, 2017

September 2017

September 25 New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018
September 21 The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials
September 20 Request for Comment: Proposal to Update Data Management of Genomic Summary Results Under the NIH Genomic Data Sharing Policy
September 20 Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018
September 20 Review the Accuracy of Grants Information for Fiscal Year 2017
September 19 NIH Peer Review Online Briefings for AREA (R15) and SBIR/STTR Grant Applicants
September 14 Reminder: NIH Natural Disaster Policy – Hurricane Irma
September 12 Reminder: NIH Applications Must Be Complete and Compliant With NIH Policy and Application Instructions At Time of Submission
September 11 Notice of Assistance Available to Institutions Impacted by Hurricane Harvey
September 1 Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality

August 2017

August 31 Policy Supporting the Next Generation Researchers Initiative
August 30 Notice to Extend the Response Date for NOT-OD-17-090 “Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol
August 28 Reminder: NIH Natural Disaster Policy – Hurricane Harvey
August 15 Notice of Correction to NOT-OD-17-090 “Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol”
August 14 Request for Information (RFI): Infrastructure for Research in Nonhuman Primates
August 10 Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol
August 3 NIH Offers Assistance to Phase II HHS SBIR and STTR Awardees through the NIH Commercialization Accelerator Program (CAP) 2017-2018
August 2 Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications submitted to Due Dates on or After January 25, 2018

July 2017

July 24 Additional Guidance on “Full-Time Training” for Ruth L. Kirschstein National Research Service Awards
July 24 Clarification and Update: Salary Supplementation and Compensation on Research Caree Development (“K”) Awards
July 10 NIH Implementation of Final Research Performance Progress Reports (Final RPPR) for Small Business and Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grants and Cooperative Agreements
July 3 Revision: Guidance on Salary Limitation for Grants and Cooperative Agreements

June 2017

June 30 NIH Fiscal Policy for Grant Awards – FY 2017
June 27 Revision: Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017
June 23 Protecting Life in Global Health Assistance
June 22 RESCINDED Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017
June 16 Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institution Review Board for Multi-Site Research
June 9 Notice of Legislative Mandates in Effect for FY 2017
June 5 NIH Reminds Recipients to Submit Complete , Timely and Accurate Progress and Financial Reports
June 5 HHS Issues PHS 2017-2 SBIR and STTR Onmibus Grant Solicitations

May 2017

May 31 Reminder: Authentication of Key Biological and/or Chemical Resources
May 30 NIH Offering Fall Seminar on Program Funding & Grants Administratoin in Baltimore, MD Early Registration Ends June 9
May 30 Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials
May 11 Interagency Edison Requests for Extensions of Time to Retain Title to a Subject Invention or to File an Initial Patent Application under NIH Funding Agreements
May 2 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials

April 2017

April 27 New “FORMS-E” Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018
April 26 Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan
April 14 Guidance for Adjustments to Appointment Records in xTrain to Reflect Stipend Level Increases for Postdoctoral Trainees on Institutional Ruth L. Kirschstein National Research Service Awards (NRSA)
April 12 Notice of Form Correction for PA-16-268 “Successor-in-Interest (Type 6 Parent)”
April 11 Request for Information on the Development of the FY 2019 Trans-NIH Plan for HIV-Related Research
April 3 Change to NIH Method of Payment for Award to Federal Institutions and Individual Fellowships at Federal Sponsoring Institutions

March 2017

March 24 Reporting Preprints and Other Interim Research Products
March 17 Interim Guidance on Salary Limitation for Grants and Cooperative Agreements