NIH Updates

The NIH Guide for Grants and Contracts is the official publication for NIH medical and behavioral research Grant Policies, Guidelines and Funding Opportunities.

In an effort to provide a mechanism to locate specific NIH guide notices that are relevant to UCSF faculty and staff, this page was developed with a library of current relevant NIH policy and guide notices that can be located by searching for key words/topic. While on the page strike CTRL-F and enter a key word or topic of the Notice.  Each month the page will be updated. If a notice is not listed that you would like to keep for reference, please email a request to post the guide notice (NOT-OD-18-XXX) on the OSR NIH UPDATES page.

Below is a list of Notices that are relevant to UCSF faculty and staff:

2024:

January, February, March

2023:

January, February, March, April, May, June, July, August, September, October, November, December

2022:
January, February, March, April, May, June, July, August, September, October, November, December

2021:
January, February, March, April, MayJune, July, August, SeptemberOctober, November, December

2020:
January, February, March, April, May, June, July, August, September, October, November, December

2019:
January,  FebruaryMarchAprilMayJuneJulyAugustSeptemberOctoberNovemberDecember

2018:
JuneJulySeptember, OctoberNovemberDecember

March 2024

 

GUIDANCE FOR VIDEOS SUBMITTED AS NIH APPLICATION MATERIALS: NOT-OD-24-067 updates the policy and guidance for submitting videos to accompany NIH applications. This guidance replaces the Video formats instructions in Guide Notices NOT-OD-12-141 and NOT-OD-20-061. It also revises the related portion of Guide Notice NOT-OD-19-083 on post-submission materials and is updated in NIH GPS 2.3.7.

Application Requirements:

  • Videos will only be accepted as digital files, submitted via email. Use of CD/DVD as an electronic format is no longer an allowable option for submitting video materials. This also applies for audio files.
  • At the time of submission, applications must indicate that a video will be submitted subsequently as post-submission materials.
  • Key images/“stills” and a brief description of each video must be included within the page limits of the Research Strategy. Descriptions should provide an understanding of the information presented in the video, as not all reviewers may be able to access the video due to technological constraints.
  • A cover letter that includes information of the intent to submit a video should be submitted with the application.

Submitting Videos as Post-Submission Materials

  • Post-submission video files should be sent via email as a digital file for upload to the grant application folder by the SRO. Acceptable digital formats are WMV, AVI, MOV, and MP4.
  • Digital files should not be embedded in another file format, e.g., PDF.
  • Concurrence from the Authorized Organization Representative (AOR) is required, merely cc’ing the AOR will not be accepted.
  • When human subjects or personal identifiable information is represented in a video, the AOR is certifying acceptance of the institution’s responsibility to ensure that human subjects have consented and are protected appropriately.

Please see the Notice for additional information and details on video formats and content, and where to direct inquiries.

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-24-073 announced that the Department of Health and Human Services (HHS), including National Institutes of Health (NIH), operates under the Extension of Continuing Appropriations and Other Matters Act, 2024 (Public Law 118-40) signed by President Biden on March 1, 2024. This Act (CR) continues government operations through March 22, 2024, at the Fiscal Year (FY) 2023 enacted level, with no reduction.

As practiced during Fiscal Years 2006-2023, NIH Institutes/Centers (ICs) may, at their discretion, issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments will be considered after FY 2024 appropriations are enacted. Recipients are expected to monitor expenditures carefully during this period.

Please see the Notice for details on where to direct inquiries.

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February 2024

 

NIH GUIDANCE ON MARKING CHANGES IN RESUBMISSION APPLICATIONS: NOT-OD-24-061 informs applicants that this Notice supersedes prior guidance on marking changes in Resubmission applications, effective May 25, 2024.  

The use of any markups such as bracketing, indenting, highlighting, bolding, italicizing, underlining, etc. should not be used to identify changes in Resubmission applications. Changes should only be outlined in the Introduction attachment. The Introduction must include a summary of substantial additions, deletions, and changes to the application. It must also include a response to weaknesses raised in the Summary Statement and, unless otherwise noted in the Table of Page Limits, may not exceed one page.  

Please see the Notice for additional details and where to direct inquiries. 

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AHRQ GUIDANCE ON SALARY LIMITATION FOR GRANTS, COOPERATIVE AGREEMENTS, AND R&D CONTRACTS – FY 2024:  NOT-HS-24-006 provides information regarding the salary limitation for grants, cooperative agreements, and extramural research and development contracts from the Agency for Healthcare Research & Quality (AHRQ).

AHRQ is operating under a Continuing Resolution, the "Further Continuing Appropriations and Other Extensions Act, 2024 (Public Law 118-22)”, that applies the terms and conditions of the Consolidated Appropriations Act, 2023, restricting the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management released new salary levels for the Executive Pay Scale. Effective January 1, 2024, the salary limitation for Executive Level II is $221,900.

Committed levels of funding for grants and contracts made in prior fiscal years that were restricted to Executive Level II will not be adjusted for the FY 2024 salary cap. Grantees may re-budget funds to accommodate the new salary cap if it is consistent with the institutional base salary, adequate funds are available, and re-budgeting will not negatively impact the aims of the project. No additional funds will be provided for grant awards and total estimated costs of contracts will not be modified.

UCSF implementation of the new salary cap, please see the UCSF Controller’s webpage: Salary Cap Changes Effective January 1, 2024.

Please see the Notice for additional details and where to direct inquiries.

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NIH GUIDANCE ON SALARY LIMITATION FOR GRANTS, COOPERATIVE AGREEMENTS, AND R&D CONTRACTS – FY 2024: NOT-OD-24-057 provides information regarding the salary limitation for NIH grants, cooperative agreements, and extramural research and development contracts.

NIH is operating under a Continuing Resolution, the "Further Continuing Appropriations and Other Extensions Act, 2024 (Public Law 118-22)”, that applies the terms and conditions of the Consolidated Appropriations Act, 2023, restricting the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management recently released new salary levels for the Executive Pay Scale. Effective January 1, 2024, the salary limitation for Executive Level II is $221,900.

On January 18, 2024 the Office of Sponsored Research implemented use of the new salary limitation for Executive Level II (salary cap) for all new, renewal, supplement, and resubmission NIH proposals. To do so, eProposal was updated to include the new salary cap option: $221,900 – FY 2024 NIH Salary Cap 01/01/2024 – Forward.

For active awards, including awards that have been issued during FY 2024 (continuation and new) that were restricted to Executive Level II, if adequate funds are available, and if the salary cap increase is consistent with the institutional base salary, recipients may rebudget funds to accommodate the new salary cap. For additional guidance on UCSF implementation of the new salary cap, please see the UCSF Controller’s webpage: Salary Cap Changes Effective January 1, 2024.

Please see the Notice for additional details and where to direct inquiries.

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January 2024

 

NIH ENFORCEMENT OF UNILATERAL CLOSEOUT REPORTING IN THE SYSTEM OF AWARD MANAGEMENT RESPONSIBILITY/QUALIFICATION: NOT-OD-24-055 alerts the NIH extramural community that NIH will report all unilateral closeouts of NIH awards as a Responsibility/Qualification (formerly FAPIIS, federal database serving as a government-wide source of information on prior performance of federal procurement contractors, grantees and cooperative agreement holders since 2010 ) record in the institution’s information in SAM.gov beginning with all unilateral closeout actions taken since January 1, 2023.

Per NIH GPS 8.6 NIH recipients must submit a Final Federal Financial Report (FFR), Final Research Performance Progress Report (F-RPPR), and Final Invention Statement and Certification (FIS) within 120 calendar days of the end of the period of performance. Reports become overdue the day after the 120 calendar day period ends.

NIH may initiate unilateral closeout if a recipient does not:

  • Provide timely, accurate closeout reports
  • Respond timely to NIH requests to reconcile discrepancies in grant records

If a recipient does not submit all required closeout reports within the 120-calendar day reporting period, NIH will unilaterally closeout the award and report the recipient’s failure to comply with the terms and conditions of award as a Responsibility/Qualification in SAM.gov.

Additionally, failure to correct recurring reporting problems may cause NIH to initiate one or more remedies for noncompliance or enforcement actions (per NIH GPS 8.5.2).

Timely submission of all final reports (e.g., F-RPPR, Final invention Statements, Final Federal Financial Reprots, etc.) will keep the university's record in good standing as a responsible recipient of federal funds.

Please see the Notice for complete details and where to direct inquiries.

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December 2023

 

REMINDER FOR NIH CLOSEOUT REPORTING REQUIREMENTS AND CLOSEOUT EMAIL NOTIFICATIONS: NOT-OD-24-047 reminds recipients of existing closeout requirements and provides an update to closeout reminder email notifications.

Per NIH GPS 8.6 recipients are required to submit a Final Federal Financial Report (FFR), Final Research Performance Progress Report (F-RPPR), and Final Invention Statement and Certification (FIS) within 120 calendar days of the end of the period of performance (project period).

Currently, NIH sends reminder emails to recipients 10, 120, and 150 days after the project period end date. Starting January 2024, NIH will begin to send an additional email reminder 90 days after the project period end date. As with the 120- and 150-day reminders, recipients will only receive this notification if at least one required closeout report has not been submitted as of the date of the notification.

Please see the Notice for details and where to direct inquiries.

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eRA COMMONS ID REQUIREMENT FOR ALL PERSONNEL ON THE R&R SENIOR/KEY PERSON PROFILE: NOT-OD-24-042 serves as a reminder and update to the requirement of an eRA Commons ID for all senior key personnel and other significant contributors listed on the R&R Senior/Key Person form.

Currently, applicants encounter an eRA system warning if the “Credential, e.g. agency login” field is blank or does not contain a valid eRA Commons ID. The validation will be updated from a warning to an error mid-January 2024. The change will affect application submissions for the January 25, 2024 due date and forward. Errors must be corrected in order to successfully submit the application.

Applicants are strongly encouraged to check that their Commons account is active well before applicable due dates.

Please see the Notice for details and where to direct inquiries.

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-24-039 announced that the Department of Health and Human Services (HHS), including NIH, operates under the Further Continuing Appropriations and Other Extensions Act 2024 (Public Law 118-22) signed on November 16, 2023. The Act (CR) continues government operations through February 2, 2024 at the FY 2023 enacted level, with no reduction.

As practiced during Fiscal Years 2006-2023, NIH Institutes/Centers (ICs) may, at their discretion, issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments will be considered after FY 2024 appropriations are enacted. Recipients are expected to monitor expenditures carefully during this period.

Please see the Notice for details.

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November 2023

October 2023

 

SIMPLIFIED REVIEW FRAMEWORK FOR NIH RESEARCH PROJECT GRANT (RPG) APPLICATIONS: NOT-OD-24-010 announces a new framework for peer review of most RPG applications beginning with submissions due on or after January 25, 2025 (please see the Notice for affected activity codes).

The simplified review framework reorganizes the five regulatory criteria, significance, investigators, innovation, approach, and environment (42 CFR Part 52h.8) into three factors that will be considered in arriving at the overall impact score:

  • Factor 1: Importance of the Research (Significance, Innovation), scored 1-9
  • Factor 2: Rigor and Feasibility (Approach), scored 1-9
  • Factor 3: Expertise and Resources (Investigator, Environment), evaluated with selection from a drop-down menu (e.g., Appropriate or briefly address specific gaps in expertise or resources)

Additional Changes:

  1. Certain clinical trials and inclusion criteria will be integrated within Factor 2: Rigor and Feasibility
  2. Additional Review Considerations for applications from foreign organizations, select agents, and resource sharing plans will be administratively reviewed by NIH prior to funding.

Please see the Notice for complete details and where to direct inquiries.

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-24-007 announces that the Department of Health and Human Services (HHS), including National Institutes of Health (NIH), operates under the Continuing Appropriations Act, 2024 and Other Extensions Act (Public Law 118-015), signed September 30, 2023. The Act (CR) continues government operations through November 17, 2023 at the FY 2023 enacted level, with no reduction.

Consistent with prior CRs, NIH ICs may at their discretion, issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments to awarded levels will be considered after FY 2024 appropriations are enacted. NIH expects institutions to monitor expenditures carefully during this period.

Please see the Notice for further details and where to direct inquiries.

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September 2023

 

PRIOR APPROVAL REQUESTS FOR REVISIONS TO APPROVED DMS PLAN MUST BE SUBMITTED USING THE PRIOR APPROVAL MODULE: NOT-OD-23-185 reminds researchers that any changes to an approved Data Management and Sharing Plan (DMS Plan), for funded awards subject to the Final NIH Policy for Data Management and Sharing (DMS Policy) requires the recipient to submit a timely formal prior approval request to the funding NIH IC.

Effective October 12, 2023, the Prior Approval Module in eRA Commons will include a function, Prior Approval – Other Request, to be used exclusively to submit prior approval requests to change an approved DMS Plan. As of this date emails and other communications will not be accepted.  Requests must be submitted by an Authorized Organization Representative (AOR). This individual would be your Grants Officer in the Office of Sponsored Research.

Please see the Notice for procedures to use the Prior Approval Module and where to direct inquiries.

 

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RECRUITMENT AND RETENTION MONITORING AND REPORTING OF CLINICAL RESEARCH: NOT-DA-23-033 summarizes the National Institute on Drug Abuse (NIDA) policy and effort related to the monitoring and reporting of recruitment and retention in clinical research throughout the award life cycle for identified clinical research projects and/or clinical research studies supported by NIDA.

The policy ensures that PIs work with their program official or contracting officer’s representative to establish recruitment and retention milestones and establish that progress must be reported based on the identified need throughout the course of the award.

The policy requires certain information regarding research that involves human subjects. The terms outlined in the Notice are in addition to and not in lieu of other NIH policies.

Please see the Notice for details and where to direct inquiries.

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NIH FINAL UPDATED POLICY GUIDANCE FOR SUBAWARD/CONSORTIUM WRITTEN AGREEMENTS: NOT-OD-23-182 announces updates made to enforce the requirements of Section 15.2 (Consortium Agreements) of the NIH Grants Policy Statement that take effect January 1, 2024. Notable updates are reflected in the following additional terms:

  • NIH will not support any agreement that does not meet the minimum requirements outlined in the written agreement section 15.2.1
  • NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed. Failure to provide requested documentation may lead to remedies for noncompliance.
  • NIH expects recipients to ask potential subrecipients, at the application stage, to submit language in their letters of support indicating their awareness of these requirements and willingness to abide by all requirements should an award be issued.
  • For foreign subrecipients, a provision requiring the foreign subrecipient to provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report to the primary recipient, no less than once per year, in alignment with the timing requirements of the RPPR. Such access may be entirely electronic.

Research Policy Analysis and Coordination (RPAC) in the UC Office of the President is developing guidance for the campuses and the UCSF Office of Sponsored Research (OSR) is partnering with IT Security to develop guidance and support solutions. Also, OSR is working on template language to communicate the requirement to subrecipients.  More information will be communicated to the campus as it becomes available.

Please see the Notice for details and where to direct inquiries regarding NIH Guidance and Policy. All other inquiries may be directed to [email protected].

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CONSOLIDATED NOTICE ON NIMH CLINICAL TRIALS POLICIES: NOT-MH-23-375 replaces NOT-MH-20-105 and provides clarification and guidance for National Institute of Mental Health (NIMH) supported  clinical trials involving preventive, therapeutic, and services interventions.

Please see the Notice for details and where to direct inquiries.

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August 2023

 

NIH APPLICATION INSTRUCTION UPDATES – DATA MANAGEMENT AND SHARING (DMS) COSTS: NOT-OD-23-161 announces updates to the NIH application instructions for submitting requests for DMS costs in a single line item. Effective for applications submitted for due dates on or after October 5, 2023, NIH will no longer require use of the single DMS cost line item on proposal budgets. DMS costs must be requested in the appropriate cost category, e.g. Personnel, Equipment, Supplies, Other Direct Costs, Consortium and Contractual Costs.

NIH expects applicants to specify estimated DMS cost details in the budget justification. OSR Staff are instructed to budget costs in appropriate cost categories and describe DMS cost estimates in the justification of the affected category. DMS cost estimates are compiled and itemized in a budget justification category for DMS Costs, which points-out the categories where costs are budgeted.

Please see the Notice for details and where to direct inquiries.

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July 2023

 

2023 NIH LOAN REPAYMENT PROGRAMS: The NIH Loan Repayment Programs are a set of programs established by Congress to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. The programs repay up to $50,000 annually of the qualified educational debt for successful applicants. In return, awardees commit to engage in NIH-mission relevant research. The applications to the following RFPs will be accepted from September 1, 2023 until 5PM (Pacific) November 16, 2023:

NOT-OD-23-142 LRP for Clinical Researchers

NOT-OD-12-143 LRP for Pediatric Research

NOT-OD-12-144 LRP for Health Disparities Research

NOT-OD-12-145 LRP for Research in Emerging Areas Critical to Human Health

NOT-OD-12-146 LRP for Individuals from Disadvantaged Backgrounds

NOT-OD-12-147 LRP for Contraception and Infertility Research

  • NIH LRP applications do not go through the UCSF Office of Sponsored Research (OSR).
  • Eligible applicants must have an eRA Commons ID to prepare and submit their applications using the Application Submission System & Interface for Submission Tracking (ASSIST).
  • The Institutional Business Official (IBO) is an official at the department level who is qualified to certify that:
    • The applicant is a U.S. citizen, U.S. national, or permanent resident of the U.S.
    • The applicant is not a federal or for-profit employee.
    • The applicant is employed to conduct research for an average of at least 20 hours per week per quarter (13 weeks) by a domestic, non-profit organization.
    • The applicant has protected research time for the length of the award.
    • The research is not prohibited by Federal law.
  • IBOs must have an eRA Commons account and should contact the eRA Helpdesk at (866) 504-9552 for assistance if they do not have an eRA Commons ID.
  • IBOs should contact the LRP Information Center at (866) 849-4047 if they need assistance with the certification process.

Please see the appropriate Notice for full details and where to direct inquiries.

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June 2023

 

USE OF GENERATIVE ARTIFICIAL INTELLIGENCE TECHNOLOGIES PROHIBITED FOR THE NIH PEER REVIEW PROCESS: NOT-OD-23-149 serves to clarify NOT-OD-22-044 on maintaining security and confidentiality in NIH peer review process and informs the extramural community that NIH prohibits NIH scientific peer reviewers from using natural language processors, large language models, or other generative Artificial Intelligence (AI) technologies for analyzing and formulating peer review critiques. To provide clarification and inform reviewers of this prohibition, NIH is revising the Security, Confidentiality, and Nondisclosure Agreements for Peer Reviewers.

As part of the standard pre-meeting certifications, all NIH Peer Reviewers will be required to sign and submit a modified Security, Confidentiality, and Nondisclosure Agreement certifying full understanding and compliance with the confidential nature of the review process. This includes the prohibition on uploading or sharing content or original concepts from an NIH grant application, R&D contract proposal, or critique to online generative AI tools. Members of NIH National Advisory Councils and Boards will be required to certify to similar Security, Confidentiality, and Nondisclosure agreements.

Please see the Notice for details and where to direct inquiries.

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May 2023

 

UPDATES TO NIH GENOMIC DATA SHARING POLICY INSTITUTIONAL CERTIFICATION FORMS: NOT-OD-23-132 notifies the research community of minor updates to the Institutional Certification forms required under the NIH Genomic Data Sharing Policy.

  • Added clarifying questions requesting additional information related to applicability of Certificates of Confidentiality (CoC) to data described on the form.
  • Updated Institutional Certification forms are marked with OMB approval is marked Ver. 03/23 with an expiration date of March 31, 2026.
  • Effective July 1, 2023 and forward, JIT submissions should use the updated forms (Ver. 03/23) any request using the prior forms will be rejected.
  • The Institutional Certification form must be submitted and accepted before an award can be issued.
  • The Institutional Certification form submission process has not been changed.

Note: Institutional Certification forms (Ver. 03/23) are coming soon to the Completing an Institutional Certification Form webpage of the Genomic Data Sharing Policy website.

Please see the Notice for details and where to direct inquiries.

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NOTICE REGARDING THE DATA MANAGEMENT AND SHARING PLAN FOR APPLICATIONS SUBMITTED TO PAR-20-299 OR PAR-20-300, “TRANSLATIONAL RESEARCH IN MATERNAL AND PEDIATRIC PHARMACOLOGY AND THERAPEUTICS”: NOT-HD-23-014 informs applicants who submitted applications due April 11, to either PAR-20-299 or PAR-20-300, that DMS plans and applicable budget and budget justifications will be collected during the Just-In-Time (JIT) process. This exception is being made due to an issue with the prior announcements which prevented applicants from submitting DMS Plans with their applications.

Please see the Notice for details and where to direct inquiries.

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NHLBI SUPPLEMENT TO THE NIH POLICY FOR DATA MANAGEMENT & SHARING: NOT-HL-23-070 announces the new NHLBI Supplement to the NIH Policy for Data Management and Sharing effective for competing applications or for ancillary studies to NHLBI parent studies on or after May 25, 2023.

The NHLBI supplement is intended to harmonize NHLBI Policy with the Final NIH Policy for Data Management and Sharing as well as establish additional expectations for NHLBI-supported researchers subject to the NIH DMS Policy. Additional expectations include special compliance timelines, data repositories, and ancillary studies.

Please see National Heart, Lung, and Blood Institute Supplement to the NIH Policy for Data Management and Sharing (NHLBI Supplement)  for details about the NHLBI Supplement and additional expectations.

Please see the Notice for where to direct inquiries.

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NOTICE OF REVISED AWARD ADMINISTRATION INFORMATION FOR X01 NOTICES OF FUNDING OPPORTUNITIES: NOT-OD-23-120, updates the Award Administration information for X01 NOFOs. The Notice informs applicants that the NIH resources access programs (X01) do not result in NIH grant funding, a Notice of Award (NoA) will not be issued to recipients, and there are no reporting requirements. NIH IC-specific language may vary slightly depending on the purpose of the NOFO.

Selected applicants will receive instructions as well as any requirements outlined within relevant data access, submission, or use agreements.

Please see the Notice of details and where to direct inquiries.

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April 2023

 

NEW SUFFIX ADDED TO NIH GRANT NUMBER: Effective April 26, 2023 eRA Commons started appending the letter “D” to the grant number of withdrawn applications after a subsequent version of the application was submitted. This allows NIH staff to assign the original grant number of the withdrawn application to the subsequent version and preserve information related to the withdrawn application in eRA. 

Applicants will see the withdrawn application listed on the Status Information screen (aka, Grant Folder) with D1, D2, D3 (as appropriate) appended to the end of the grant number. For example: 1R01CA12345-01D1. The Status will state “Application withdrawn.” 

Please direct inquiries to [email protected]

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PILOT FOR IMPROVING DATA ABOUT NIH R&D CONTRACTS: NOT-OD-23-115 announces that from May through October 2023, NIH will conduct a pilot with a small group of contract vendors to improve the quality, accuracy, and transparency of R&D contract project data displayed to the public through RePORTER and on the Categorical Spending page to promote the highest level of public accountability.

Please see the Notice for details and where to direct inquiries.

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UPDATE TO POLICY AND PROCEDURE FOR REPORTING HUMAN SUBJECTS ENROLLMENT DATA FOR NIA CLINICAL RESEARCH TRIALS/STUDIES: On June 17, 2021 the National Institute on Aging (NIA) announced a policy and procedures for reporting enrollment data for Clinical Research Trials/Studies (NOT-AG-21-029). The policy impacted NIA grants, contracts, and cooperative agreements that were active as of July 1, 2021.

NOT-AG-23-017 provides the research community updates and clarification of the NIA policy and procedures for reporting enrollment data for NIA supported clinical research trials/studies using NIA’s Clinical Research Operations & Management System (CROMS). Details and FAQs are posted on the NIA CROMS website.

NIA reminds the research community that the policy and procedures are a term and condition of award and non-compliance may result in enforcement action (e.g. disallowed costs, withholding awards, suspension of an award, etc.).

Please see the Notice for details and where to direct inquiries.

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REMINDER-NIH POLICIES FOR NRSA STIPENDS, COMPENSATIONAND OTHER INCOME: NOT-OD-23-111 reminds recipients of the policies surrounding stipends, compensation and other income for trainees and fellows supported on NRSA awards.

Per 42 CFR Part 66, NRSA fellows and trainees receive stipend as a subsistence allowance to help defray living expenses during their research training experience.

Stipends are not provided as a condition of employment with either the Federal government or the sponsoring institution (See NIH Grants Policy Statement 11.2.9.2 and 11.3.8.2).

For more information on NRSA training and fellowship programs see NIHGPS Chapter 11 and visit https://researchtraining.nih.gov/programs.

Please see the Notice for details and where to direct inquiries.

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UPDATES TO FUNDING OPPORTUNITY TERMINOLOGY: NOT-OD-23-109 informs the research community that effective immediately, NIH will replace the term Funding Opportunity Announcements (FOAs) with the term Notice of Funding Opportunity (NOFO) to align with terminology used by the Uniform Administrative Requirements in 2 CFR Part 200. The full definition can be found in the NIH Grants & Funding Glossary. NIH is currently updating websites, documents, and other resources to reflect the new terminology. 

Please see the Notice for details and where to direct inquiries.

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March 2023

 

REVISION OF THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY: NOT-OD-23-106 announces that with the termination of the Public Health Emergency on May 11, 2023, the special exception for post-submission material will end for applications submitted for the May 25 deadline and beyond.

However, for applications submitted for the May 25, 2023 receipt date and beyond, NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, if the NOFO used for submission allows preliminary data in the application.

Post-submission materials will not be accepted for emergency competitive revisions and urgent competitive revisions because they undergo expedited review.

Please see the Notice for full details and where to direct inquiries.

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NIH CAN NO LONGER GRANT COMMON RULE EXCEPTIONS TO THE USE OF A SINGLE IRB FOR MULTI-SITE RESEARCH AFTER THE COVID-19 PUBLIC HEALTH EMERGENCY EXPIRATION DATE OF MAY 11, 2023: NOT-OD-23-097 is a reminder that with the expiration of the federal public health emergency for COVID-19 on May 11, 2023, NIH will no longer be able to grant single IRB (sIRB) exceptions for multi-site research subject to the revised Common Rule.

NIH suggests submitting new exception requests (per process outlined in NOT-OD-21-006) no later than March 31, 2023  to ensure the request can be reviewed and a determination made before May 11, 2023.

Please see the Notice for full details and where to direct inquiries.

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EXPIRATION OF THE COVID-19 PUBLIC HEALTH EMERGENCY: NOT-OD-23-095 announces the termination of the HHS declared public health emergency for COVID-19 on May 11, 2023.

Effective May 12, 2023, NIH will no longer issue Emergency Notices of Funding Opportunities related to COVID-19. Ongoing emergency awards will not be impacted.

Please direct inquiries related to specific FOAs or Notices of Award to the Program and Grants Management Officials listed on the FOA/NoA.

Please see the Notice for full details.

Note: After May 11, 2023, OSR will continue to send weekly NIH policy and guidance updates and any OSR updates will replace COVID updates.

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February 2023

 

NIH REDESIGN OF XTRAIN MODULE IN ERA COMMONS: NOT-OD-23-094 announces the anticipated March 30, 2023 release of the updated xTrain module, commonly used to process training appointments, reappointments and terminations. The updated version will adopt the visual appearance of the other eRA modules with enhanced security and stability.

Significant changes, general:

  • Trainees will be required to sign reappointment and amendments as they do initial appointments
  • New functionality will require the PD/PI to provide explanation if trainee is unavailable to sign
  • Agency Staff will no longer have the ability to delete records submitted by the recipient organization

 Significant changes Change of Recipient Organization (Ts, Ks and Rs):

  • Relinquishing organization maintains access to work on appointments and terminations until award is transferred
  • After transfer occurs, only the relinquishing BO maintains access to modify records/forms associated with the transferred award that reflect the time the grant was active at the former organization
  • Relinquishing organization must complete all actions (appointments and terminations) in xTrain before the Type 7 may be awarded to the new recipient organization.
  • New organization officials have access to manage appointments, terminations, etc. after change has occurred
  • New organization will not have access to records/forms prior to the date of transfer
  • Any trainees who move to the new organization must have new appointments created

Significant changes Change of Recipient Organization (Fs):

  • Relinquishing organization need not take action in xTrain
  • The appointment will stay active as is in xTrain
  • New organization is responsible for continuing to manage xTrain forms and performing termination when the fellowship ends

Please see the Notice for full details and where to direct inquiries.

CLINICAL TRIALS RESULTS INFORMATION SUBMISSION: GOOD CAUSE EXTENSION REQUEST PROCESS AND CRITERIA DOCUMENT POSTED ON CLINICALTRIALS.GOV: NOT-OD-23-080 informs investigators of the “Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria” that provides information for requesting a good cause extension of the submission deadline for clinical trial results (Good Cause Extension Request). The process will be implemented beginning February 15. 2023.

Please see the Notice for full details and where to direct inquiries.

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RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPENDS, TUITION/FEES AND OTHER BUDGETARY LEVELS EFFEDTIVE FOR FISCAL YEAR 2023: NOT-OD-23-076 establishes the stipend and other budgetary levels for FY 2023 Kirschstein-NRSA awards (e.g. NIH F and T series) for undergraduate, predoctoral and postdoctoral trainees and fellows made on or after October 1, 2022, and supersedes NOT-OD-22-132.

The FY 2023 stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications. They will be administratively applied to all applications currently in the review process.

As a reminder:

  1. NRSA support is limited to 5 years for predoctoral trainees (6 years for dual-degree) and 3 years for postdoctoral fellows.
  2. As described in the NIH Grants Policy Statement 2.3.7.9, the maximum amount NIH will award to support the compensation package (e.g. salary, benefits, tuition remission) for a graduate student research assistant remains at the zero-level postdoctoral stipend in effect at the time of award.

Please see the Notice for details and where to direct inquiries.

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NIH ENCOURAGES THE USE OF THE ARRIVE ESSENTIAL 10 CHECKLIST IN ALL PUBLICATIONS REPORTING ON THE RESULTS OF VERTEBRATE ANIMAL AND CEPHALOPOD RESEARCH: NOT-OD-23-057 encourages investigators who work on NIH-supported animal and cephalopod based research to use the ARRIVE guidelines when reporting their results in publications.

Please see the Notice for details and where to direct inquiries.

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NOTICE OF LEGISLATIVE MANDATES IN EFFECT FOR FY 2023: NOT-OD-23-072 provides the current requirements outlined in the FY 2023 Legislative Mandates:

Division H, Title II – Department of Health and Human Services

  • Salary Limitation (Section 202)
  • Gun Control (Section 210)
  • Indirect Costs (Section 224)

Division H, Title V – General Provisions, Departments of Labor, Health and Human Services, and Education

  • Anti-Lobbying (Section 503)
  • Acknowledgement of Federal Funding (Section 505)
  • Restriction on Abortions (Section 506)
  • Exceptions to Restriction on Abortions (Section 507)
  • Ban on Funding Human Embryo Research (Section 508)
  • Limitation on Use of Funds for Promotion of Legalization of Controlled Substances (Section 509)
  • Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory Committee Candidates (Section 515(a))
  • Dissemination of False or Misleading Information (Section 515(b))
  • Restriction of Pornography on Computer Networks (Section 520)
  • Restriction on distribution of sterile Needles (Section 526)

Please see Notice for details and where to direct inquiries.

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NOTICE OF FISCAL POLICIES IN EFFECT FOR FY 2023: NOT-OD-23-071 provides guidance on NIH Fiscal Operations for FY 2023 and implements the Consolidated Appropriations Act, 2023 (Public Law 117-328).

FY 2023 Funding Levels: Non-competing continuation awards will generally be issued at the commitment level indicated on the Notice of Award. Subsequent budget periods are funded based on the availability of appropriations, satisfactory performance, compliance with the terms and conditions of the award, and continued best interest of the Federal government.

Ruth L . Kirschstein National Research Service Awards (NRSA): the NIH will increase NRSA stipends by approximately 3% for predocs and 3% for postdocs.

Salary Limits: Effective January 1, 2023 the salary limitation for Executive Level II is $212,100.

Please see the Notice for details and where to direct inquiries.

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CLARIFICATION AND GUIDANCE FOR APPLICANTS PREPARING APPLICATIONS FOR THE SPRING 2023 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-23-067 extends the following guidance provided for applicants preparing applications for the August/October 2023 Council round, starting with the January 25, 2023 due dates.

NIH grant applications should not include contingency or recovery plans for problems resulting from the COVID-19 pandemic. Reviewers will continue to receive instructions to assume that constraints arising from the COVID-19 pandemic will be resolved during the project period and thus should not affect their scores.

Effects on productivity due to the pandemic or other scoreable issues may be addressed in the Personal Statement in the NIH Biosketch. Reviewers will take these pandemic-related circumstances into account when assessing productivity and other score-driving factors.

Please see Notice for other details and where to direct inquiries.

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EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID PANDEMIC: NOT-OD-23-066 extends the special exception for post-submission material to applications submitted for the August/October 2023 Council rounds (beginning with applications submitted for the January 25, 2023 due date).

A one-page update with preliminary data will be accepted, ONLY if the Funding Opportunity Announcement used for the submission allowed preliminary date in the application. For a multi-component application, one page for each component will be accepted.

Please see the Notice for details and where to direct inquiries.

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January 2023

 

DATA SHARING INFORMATION FOR HUMAN SUBJECTS GRANTS RESEARCH FUNDED BY THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) [5TH REVISION]: NOT-AA-23-002 revises and replaces current NIAAA data sharing requirements published in NOT-AA-22-011 to align with the NIH Data Management and Sharing (DMS) Policy published in NOT-OD-21-013.

Though applications proposing to generate scientific data, listed on the current List of Activity Codes Applicable to DMS Policy, must abide by the NIH DMS Policy, Small Business STTR (R41/R44, U41/U44) and SBIR (R43/R44, U43/U44) are not required to deposit data into the NIAAADA specifically, but are welcome to do so (Note: R25 Education applications are not subject to the NIH DMS Policy).

NOT-AA-22-011 will continue to be in effect for all NIAAA applications due on or before January 24, 2023.

Please see the Notice for details and where to direct inquiries.

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GUIDANCE FOR DATA MANAGEMENT AND SHARING (DMS) PLANS FOR THE NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM (NIAAA): NOT-AA-23-001 informs researchers that NIAAA expects specific information in the DMS plans to be included in NIAAA grant applications in compliance with the

2023 NIH DMS Policy. Going forward these instructions will be included in all NIAAA Funding Opportunity Announcements (FOAs) in addition to guidance provided in NOT-OD-21-014 and the NIH DMS Plan format page).

Please see the Notice for NIAAA-specific requirements for DMS plan elements, Data Type, Standards, and Data Preservation, Access, and Associated Timelines and where to direct inquiries.

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December 2022

 

GUIDANCE ON SALARY LIMITATION FOR GRANTS AND COOPERATIVE AGREEMENTS FY 2023: NOT-OD-23-056 provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards.

The Consolidated Appropriations Act, 2023 (P.L. 117-328) restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management released new salary levels for the Executive Pay scale effective January 1, 2023. The salary limitation for Executive Level II is $212,100.

NIH Proposals

Effective January 6, 2023, OSR staff started applying (at the discretion of the PI) the FY 2023 salary cap on NIH new, renewal, revision, transfer-in, and respective resubmission application budgets.

  • If NIH implements the new cap, new award totals will not be adjusted to accommodate the new cap if it was not requested in the approved budget; however, NIH will allow institutions to rebudget.
  • If NIH does not implement the new cap at award and the proposal budget applies the new cap, NIH will adjust the budget to meet the current cap.

NIH Awards

Active awards, including awards issued in FY 2022 (continuation and new) may rebudget to accommodate the current Executive Level II salary level, if funds are available; however, no additional funds will be provided by the sponsor. 

More information and details are posted at News from the Controller’s Office

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-23-050 announces that the Department of Health and Human Services (DHHS), including NIH, operates under the Continuing Appropriations and Ukraine Supplemental Appropriations Act (Public Law 117-229) signed by President Biden on December 16, 2022.

The Act continues procedures identified under NOT-OD-22-105. NIH institutes and/or Centers may issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments to award levels will be considered after FY 2023 appropriations are enacted. NIH expects institutions to monitor expenditures carefully during this period.

All legislative mandates in effect FY 2022 (NOT-OD-22-117) remain in effect under this CR, as well as the salary limitation at Executive Level II (NOT-OD-22-076) and the Ruth L. Kirschstein National Research Service Award pre-postdoctoral stipend levels and tuition/fees (NOT-OD-22-132).

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UPDATES TO THE NON-DISCRIMINATION LEGAL REQUIREMENTS FOR NIH RECIPIENTS: NOT-OD-23-047 announces that effective December 23, 2022, NIH updated and implemented HHS language on the Non-Discrimination Legal Requirements for Recipients of Federal financial Assistance in all Notices of Funding Opportunities/Funding Opportunity Announcements (FOAs) and Section III of Notices of Award (NoAs).

Annually, OSR completes HHS Form 690 Assurance to comply with Federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex, and disability and compliance to Federal conscience laws where applicable, including accessibility to persons with limited English proficiency, and ensuring effective communications with persons with disabilities.

Please see the Notice for complete details and where to direct inquiries.

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PUBLICATION OF THE UPDATED NIH GRANTS POLICY STATEMENT (REV. DECEMBER 2022) FOR FISCAL YEAR 2023: NOT-OD-23-045 announces the publication of the updated NIH Grants Policy Statement (NIHGPS, rev. December 2022).

This update applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2022 and supersedes the NIHGPS dated December 2021. Previous versions remain applicable as standard terms and conditions for NIH grants and cooperative agreements awarded prior to October 1, 2022.

The current version of the NIHGPS and summary of significant changes are available on the NIH Grants Policy website.

NEW INBOX FOR INQUIRIES RELATED TO FEDERAL FINANCIAL REPORTS (FFRs) AND FINANCIAL CLOSEOUT: NOT-OD-23-035 informs NIH recipients of the creation of a central email inbox for inquiries related to the submission and processing of Federal Financial Reports (FFRs) and financial closeout.

Effective as of December 5, 2022 FFR and financial closeout inquiries to the Office of Policy for Extramural Research Administration (OPERA) FFR Reconciliation and Financial Closeout Support Center at [email protected].

Please see the Notice for details and where to direct inquiries.

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November 2022

 

REMINDER TO AHRQ GRANTEES – FY2018 FUNDS WILL EXPIRE ON SEPTEMBER 30, 2023: NOT-HS-23-002 reminds AHRQ grantees with awards issued out of the FY2018 fixed year appropriation accounts that FY2018 funds will expire September 30, 2023. All undrawn award funding falling under the M-Account condition will no longer be available for program expenditures, obligations or payment requests.

AHRQ grant recipients who received grant funding from AHRQ in Fiscal Year 2018 (10/1/2017-9/20/2018) are reminded to check the Program Support Center (PSC) Payment Management System (PMS) website for information regarding the last day to draw funds on awards issued using FY2018 fixed appropriation funds.

Please see the Notice for details and where to direct inquiries.

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October 2022

 

FORMS-H GRANT APPLICATION FORMS & INSTRUCTIONS MUST BE USED FOR DUE DATES ON OR AFTER JANUARY 25, 2023 – FORMS-H INSTRUCTIONS NOW AVAILABLE: NOT-OD-23-012 reminds applicants to use FORMS-H grant application forms and instructions for applications due on or after January 25, 2023. All applications with due dates on or before January 24, 2023 must use FORMS-G. Please see the Notice for other considerations for use of FORMS-H and FORMS-G.

FORMS-H IMPLEMENTATION UPDATES:

  • CDC Implementation: For CDC, please follow the instructions in the published notice of funding opportunity that describe the CDC Data Management Plan (DMP) format and placement in the application.

Please see the Notice for details and where to direct inquiries.

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ABILITY TO BYPASS 2-BUSINESS DAY APPLICATION VIEWING WINDOW AS AN OPTION FOR ADMINISTRATIVE SUPPLEMENTS: NOT-OD-23-011 announces that beginning October 27, 2022, NIH will offer an option to bypass the full standard 2-business day application viewing window that occurs after an error-free application submission. This function is available to expedite processing of eligible electronic administrative supplement requests.

Users with the SO role will have access to the optional “Verify” action in the eRA Commons Status module beginning October 27, 2022. The Verify action moves an administrative supplement application forward for agency processing without waiting for the application viewing window to expire.

Note: once the bypass option is used, the organization forfeits its ability to reject or make further changes to the application. Ensure that applications have been reviewed thoroughly before using the Verify action to avoid the need for resubmissions.

This action is only for use to expedite the processing of eligible electronic administrative supplement requests. Principal Investigators who wish to bypass the viewing window for their electronic administrative supplement request should email a written request to their Proposals and Grants Officer.

Please see the Notice for details and where to direct inquiries.

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CLARIFICATION AND GUIDANCE FOR APPLICANTS PREPARING APPLICATIONS FOR THE FALL 2022 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-23-008 extends guidance in NOT-OD-22-112 for applications for the May 2023 Council round, beginning with the September 25, 2022 due dates.

Applications should not include contingency or recovery plans for problems resulting from the pandemic; however, applicants may address effects on productivity due to the pandemic or other scoreable issues in the Personal Statement of the NIH Biosketch. Reviewers will be instructed to take these pandemic-related circumstances into account when assessing applicants’ productivity and other score-driving factors.

If needed, NIH staff will request and assess plans to resolve specific problems arising from the pandemic prior to funding.

Please see the Notice for details and where to direct inquiries.

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EXTENDING SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC: MAY 2023 COUNCILS: NOT-OD-23-006 extends special exception for post submission material to applications submitted for the May 2023 Council round beginning with applications submitted for the September 25, 2022 due date.

Only if the FOA used for the submission allowed preliminary data in the application, can one-page of preliminary data be accepted for a single component application or one page for each component of a multiple-component application.

All post-submission materials, including preliminary data, must be submitted 30 days before the study section meeting. Post submission materials will not be accepted for applications for emergency competitive revisions and urgent competitive revisions that undergo expedited review.

Please see the Notice for details and where to direct inquiries.

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-23-005 announces that the Department of Health and Human Services (DHHS), including NIH, operates under the Continuing Appropriations and Ukraine Supplemental Appropriations Act (Public Law 117-180) signed by President Biden on September 30, 2022.

The Act continues procedures identified under NOT-OD-22-045. NIH institutes and/or Centers may issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustments to award levels will be considered after FY 2023 appropriations are enacted. NIH expects institutions to monitor expenditures carefully during this period.

All legislative mandates in effect FY 2022 (NOT-OD-22-117) remain in effect under this CR, as well as the salary limitation at Executive Level II (NOT-OD-22-076) and the Ruth L. Kirschstein National Research Service Award pre-postdoctoral stipend levels and tuition/fees (NOT-OD-22-132).

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NIH DATA MANAGEMENT AND SHARING POLICY - RESOURCES ARE NOW AVAILABLE

Got questions? We’ve got you covered! 

NIH 2023 Data Management and Sharing Policy 

Effective January 25, 2023, prospective NIH grant and contract applications will be required to include a two-page data management and sharing plan outlining how scientific data will be managed and shared. The NIH is hosting a webinar series about the new policy; visit https://sharing.nih.gov/news-events to register.  

A multi-stakeholder workgroup formed by the UCSF Library and Office of Sponsored Research has been working to provide the UCSF community with resources to help researchers and research staff comply with the new policy. The below resources are available now to assist teams in preparing to apply for NIH grants beginning in January 2023: 

For questions about the new policy, contact Data Services Librarian Ariel Deardorff. 

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NIH DATA MANAGEMENT AND SHARING WEBINARS #1 AND #2 RECORDINGS AND MATERIALS ARE AVAILABLE: Recordings and materials for the NIH Data Management and Sharing Webinars #1 and #2 are available on the Sharing.NIH.gov website at: https://sharing.nih.gov/about/learning.

 

September 2022

 

NIH FINAL FEDERAL FINANCIAL REPORTS (FFRs) WILL NO LONGER BE CONVERTED TO INTERIM ANNUAL REPORTS IN THE PAYMENT MANAGEMENT SYSTEM (PMS): NOT-OD-22-215 serves to rescind NOT-OD-21-138 and provides an update to NIH recipients who need to submit an SF-425 Federal Financial Report (FFR). Effective October 1, 2022, PMS will no longer be converting NIH Final FFRs to Interim Annual FFRs in accordance with NOT-OD-22-099, which notified NIH recipients that they are no longer required to submit quarterly cash transaction reports 30 days after the end of each calendar quarter.

Please see the Notice for full details and where to direct inquiries.

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SUPPLEMENTAL INFORMATION TO THE NIH DMS POLICY – RESPONSIBLE MANAGEMENT AND SHARING OF AMERICAN INDIAN/ALASKA NATIVE PARTICIPANT DATA: NOT-OD-22-214 provides considerations for all researchers that are subject to the DMS Policy prior to conducting NIH-supported research projects, working with American Indian/Alaska Native (AI/AN) Tribes.

Considerations for Researchers Working with Tribal Nations

  • Recognize Tribal Sovereignty throughout the research process
  • Developing partnerships that align with Tribal research laws, regulations, policies, preferences, and processes
  • Awareness of past research abuses perpetrated against AI/AN Tribes
  • Facilitate understanding of health disparities, protective health factors, and health outcomes of AI/AN communities through data disaggregation and analyses of AI/AN data, while respecting Tribal sovereignty

Best Practices for Researchers

  • Proactively engage AI/AN Tribes in planning for data management and sharing
  • Establish mutual understandings of goals for data management and sharing
  • Incorporate AI/AN data management and sharing practices and preferences in Plans
  • Consider additional protections and appropriate limitations to future data sharing
  • Incorporate data management and sharing plans in the informed consent process
  • Safeguard against future risks

Please see the Notice for full details and where to direct inquiries.

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SUPPLEMENTAL INFORMATION TO NIH DMS POLICY – PROTECTING PRIVACY WHEN SHARING HUMAN RESEARCH PARTICIPANT DATA: NOT-OD-22-213 provides for consideration, a set of operational principles and best practices for protecting participant privacy when sharing scientific data, and points to consider for choosing whether to designate scientific data for controlled access. This Notice represents that this information is intended to assist in creating a robust framework for protecting the privacy of research participants when sharing data and not to provide a guide for compliance with regulatory requirements or establishing binding rules for NIH awardees.

NIH recommends that these operational principles, best practices, and points to consider be incorporated as early as possible into the research process to facilitate research planning and communication of plans to participants. These operational principles, best practices and points to consider may be updated in response to changes in laws, regulations, policies, technology, science, and other factors. DMS Plans can be updated with NIH prior approval and NIH encourages coordination and communication with NIH Program Officers.

Operational Principles:

  • Proactive assessment of protections
  • Clear communication of data sharing and use in consent forms
  • Consideration of justifiable limitations to sharing data
  • Institutional review of the conditions for data sharing
  • Protections for all data used in research
  • Remaining vigilant regarding data misuse

Best Practices:

  • Apply appropriate de-identification
  • Establish scientific data sharing and use agreements
  • Understand and communicate legal protections against disclosure and misuse

Points to Consider for Choosing Whether to Designate Scientific Data for Controlled Access:

  • If data has explicit limitations on subsequent use
  • If data could be considered sensitive
  • If data cannot be de-identified to established standards
  • If data, due to previously unanticipated approaches or technologies become known

Factors to considers when choosing whether to share data openly:

  • Participants explicitly consent to share scientific data without restrictions
  • Scientific data are de-identified and institutional review determined that they pose very low risk when shared or used, including risks posed by the presence of information that can allow inferences to be made about a participant’s identity when combined with other information

Please see the Notice for full details, references, and where to direct inquiries.

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NOTICE OF CHANGE TO THE NINDS POLICY ON SPECIAL COUNCIL REVIEW OF RESEARCH APPLICATIONS: NOT-NS-22-115 announces modifications to the Special Council Review (SCR) policy which pertains to well-funded PD/PIs submitting applications to the National Institute of Neurological Disorders and Stroke (NINDS). The policy change sets the NIH funding threshold at $2 million total costs, from $1 million or more direct costs, and sets a more stringent payline for pending applications that cause a PD/PI to exceed this threshold.

Please see the Notice for full details and where to direct inquiries.

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FINANCIAL CONFLICT OF INTEREST (FCOI) AND OTHER SUPPORT REMINDERS: NOT-OD-22-210 serves to provide the NIH extramural research community the following two reminders (in brief, please see the Notice for full details):

  1. The longstanding FCOI requirements provided in 42 CFR Part 50 Subpart F Promoting Objectivity in Research, also included in NIH Grants Policy Statement 4.1.10 Financial Conflict of Interest, which serves as a term and condition of NIH grant awards
  • Applies to all NIH grant and cooperative agreement awards including Phase II SBIR/STTR applications or awards, conference grants, and training grants
  • Investigators must disclose their significant financial interests (SFI) and those of their spouse and dependent children that appear to be related to the investigator’s research responsibilities
  • Institutions must provide FCOI training to each investigator prior to engaging in NIH-funded research at least every 4 years and immediately under certain circumstances, e.g.  FCOI policy changes, investigator is new to institution, or investigator is found out of compliance to FCOI policy or management plan
  • Investigators are required to disclose all foreign and domestic SFIs that are related to the investigator’s institutional responsibilities
  1. The requirement to submit complete and accurate Other Support Information (NOT-OD-21-073 and NOT-OD-21-110)
  • Under JIT procedures or in Progress Reports, other support for identified senior/key personnel must include all resources made available in support of and/or related to their research endeavors regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant, which includes resources and/or financial support from all foreign and domestic entities
  • NIH requires supporting documentation, which includes copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution for ALL foreign activities and resources reported in the Other Support

Please see the Notice for full details and where to direct inquiries.

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OLAW WAIVERS TO CONDUCT SEMIANNUAL FACILITY INSPECTIONS DUE TO COVID-19 WILL EXPIRE OCTOBER 1, 2022: NOT-OD-22-207 informs Assured Institutions that effective October 1, 2022, the Office of Laboratory Animal Welfare (OLAW) will no longer accept requests to temporarily waive the facility inspection (at least once every 6 months) requirement under Public Health Service (PHS), Humane Care and Use of Laboratory Animals Policy IV.B.2 due to COVID-19.

Assured Institutions, including those with expiring waivers, will be expected to conduct semiannual facility inspections as scheduled and required by the PHS Policy.

Please see the Notice for complete details and where to direct inquiries.

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NIH LOAN REPAYMENT PROGRAM APPLICATION PERIOD SEPTEMBER 1, 2022 - NOVEMBER 17, 2022: The NIH Loan Repayment Program (LRP) is a set of programs established by Congress designed to recruit and retain highly qualified biomedical and biobehavioral researchers. These programs help to counteract a researcher’s financial pressures by repaying up to $50,000 annually of their qualified educational debt for a commitment to engage in NIH mission-relevant research.

Please note that LRP payments are made directly to researcher’s lending institution(s) and not the University.

  1. There are six (6) extramural programs (also see NOT-OD-22-149).
  2. Application Submission Period:September 1, 2022 – November 17, 2022
  3. Applicants use ASSIST to prepare and submit their applications (see Apply)
  • UCSF is already registered in eRA Commons
  1. Applicants need an eRA Commons account – please contact [email protected]
  2. The Institutional Business Official (IBO) will receive an email with instructions to certify applicant’s salary and eligibility
  • IBO can be the Department Chair of their Delegate
  • Department Administrators acting as IBO need an eRA Commons account with the BO role – please contact the [email protected]
  • For assistance with the certification process, please contact the LRP Information Center at (866) 849-4047

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August 2022

 

CONTINUED EXTENSION OF CERTAIN FLEXIBILITIES FOR PROSPECTIVE BASIC EXPERIMENTAL STUDIES WITH HUMAN PARTICIPANTS: NOT-OD-22-205 replaces NOT-OD-21-088 to further extend flexibilities regarding registration and results reporting for a subset of NIH-funded research where the primary purpose is basic experimental studies with humans (BESH) submitted in response to BESH Funding Opportunity Announcements (FOAs). These studies defined as basic research also meet the NIH definition of a “clinical trial.”

The additional extension will delay the enforcement of registration and results reporting through September 24, 2024, while NIH continues to explore solutions to facilitate the dissemination of information in ways that are useful to other researchers and members of the public, while maintaining NIH’s commitment to stewardship and increasing transparency.

  • During the extension period, NIH expects registration and results reporting for BESH studies on alternative publicly available platforms. Plans to meet NIH expectations using alternative platforms should be described at the time of application in the Dissemination Plan attachment.
  • Funded awardees of BESH-specific FOAs who are not using ClinicalTrials.gov, should provide in their annual reports the unique identifier assigned by the alternative platform, if available and a link to the report in the alternative platform.

Please see the Notice for complete details and where to direct inquiries.

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IMPLEMENTATION CHANGES FOR GENOMIC DATA SHARING PLANS INCLUDED WITH APPLICATIONS DUE ON OR AFTER JANUARY 25, 2023: NOT-OD-22-198 announces implementation changes that apply to all applications submitted to NIH requesting support for research subject to the GDS policy (NOT-OD-14-124) beginning with receipt dates on or after January 25, 2023.

  • Consistent with changes described in NOT-OD-22-189, plans for sharing genomic data as expected by the GDS Policy are to be described in the DMS Plan submitted at the time of application and not as a separate plan or at Just-In-Time. There will be one data sharing plan subject to both the GDS and DMS Policies. GDS Plans will no longer be reviewed by peer reviewers (see NOT-OD-14-111). 
  • For studies subject to the GDS Policy, applicants should complete the DMS Plan anticipating sharing according to the criteria in the Institutional Certification. Institutional Certifications are expected for human genomic data subject to the GDS Policy and/or Genomic Summary Results (GSR) and may be submitted with the application (see NOT-OD-19-023); however, the Institutional Certification, or in some cases, a provisional certification, must be submitted and accepted at Just-in-Time before an award can be issued. See About Institutional Certifications for more information.

Please see the Notice for complete details of the changes and where to direct inquiries.

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NHGRI IMPLEMENTATION OF NIH POLICY ON ACCEPTANCE OF APPLICATIONS REQUESTING $500,000 OR MORE DIRECT CCOSTS IN A SINGLE YEAR: NOT-HG-22-033 describes NHGRI’s implementation of the NIH policy on the acceptance for review of unsolicited applications that request $500,000 or more in direct costs in a single year.

  • NHGRI strongly encourages applicants to submit their requests to a NHGRI Program Director at least eight (8) weeks prior to the anticipated submission date.
  • NHGRI will notify the applicant of acceptance or rejection in writing within 10-20 business days of receipt of the letter of request. This timeframe can be delayed if requests fail to supply adequate information.
  • If accepted, the written NHGRI acceptance should be submitted in a cover letter along with the application.

Please see the Notice for complete details to prepare requests and where to direct inquiries.

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NEW NIH “FORMS-H GRANT APPLICATION FORMS AND INSTRUCTIONS COMING FOR DUE DATES ON OR AFTER JANUARY 25, 2023: NOT-OD-22-195 informs NIH/AHRQ/FDA applicants and recipients of changes to FORMS-H for competing applications due on or after January 25, 2023. The Notice provides a High-Level Summary of Form Changes in FORMS-H Application Packages, which includes changes to accommodate Data Management and Sharing Policy requirements detailed in NOT-OD-22-189.

Use FORMS-G

Applications for intended due dates on or before January 24, 2023, including submission under NIH Late Policy 2 week window and continuous submissions submitted by February 1 for the January 7 AIDS deadline.

Use FORMS-H

Applications (New, Renewal, Resubmission, Revision) for intended due dates on or after January 25, 2023 (includes applications due January 25, 2023 that are submitted early).

Availability of FORMS-H

  • Beginning October 25, 2022, new funding opportunities (FOAs) will be posted.
  • New FOAs posted before October 25 for the January 25, 2023 deadline will be posted without application forms. FORMS-H packages will be added by November 25, 2022.
  • Between October 25 and November 25, FORMS-H will be added to parent and IC-issued FOAs with due dates on or after January 25, 2023.
  • All application forms packages will be posted 30 calendar days or more prior to receipt dates.

Please see the Notice for details, resources, and where to direct inquiries.

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ADJUSTMENTS TO NIH AND AHRQ GRANT APPLICATION DUE DATES BETWEEN SEPTEMBER 22 AND SEPTEMBE 30, 2022: NOT-OD-22-190 announces NIH and AHRQ application due date adjustments to accommodate scheduled Grants.gov downtime, Friday, September 23, 2022 at 12:01 AM ET to Thursday, September 29, 2022 at 11:59 PM ET (see Grants.gov calendar).

NIH and AHRQ due dates that fall on or between September 22 and September 30, 2022 will move to October 3, 2022.

The Notice serves as notification of due date change for impacted funding opportunities. Edits to due dates within the text of individual funding opportunities will not be made.

Please see the Notice for caveats and considerations that may affect your application submission and where to direct inquiries.

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IMPLEMENTATION DETAILS FOR THE NIH DATA MANAGEMENT AND SHARING POLICY: NOT-OD-22-189 provides implementation details for the NIH Policy for Data Management and Sharing (DMS Policy) that apply to NIH grant and cooperative agreement applications due on or after January 25, 2023. Detailed application instructions will be released in application forms packages with Competition ID FOMRS-H, targeted for release during Fall 2022.

The DMS Policy applies to all NIH research (funded whole or in part by NIH) that generates scientific data. The policy does not apply to research and other activities that do not generate scientific data, e.g. individual fellowships, research training awards, infrastructure development awards, and non-research activities.

Research and Development (R&D) Contracts and other funding agreements, e.g. Other Transactions are also subject to the DMS Policy. Please check applicable Requests for Proposals or Research Opportunity Announcements for implementation details.

Plans for grants and cooperative agreements covered in this Notice:

Implementation Updates

Beginning with receipt dates on or after January 25, 2023, competing NIH grant and cooperative agreement applications that are subject to the DMS Policy are required to submit a DMS Plan at the time of application. The following updates will be implemented in Competition ID FORMS-H application forms packages to accommodate the DMS Plan:

  1. The “Resource Sharing Plan(s)” field will no longer be used to submit data sharing plans and genomic data sharing plans.
  2. FORMS-H will have instructions to prepare a single PDF Data Management and Sharing Plan attachment with the Elements of a DMS Plan, which will be uploaded to a new “Other Plan(s)” field, located in the following application forms sections:
    1. PHS 398 Research Plan
    2. PHS 398 Career Development Award Supplemental Form
  3. An optional Data Management and Sharing Plan format page is available to assist applicants to prepare the DMS Plan attachment. A final fillable version will be included in the FORMS-H application forms package. Use of the format page is recommended; however, DMS Plans generated using other approaches will be accepted.
  4. Costs to support the activities proposed in the DMS Plan must be labeled “Data Management and Sharing Costs” and included in the:
    1. R&R Budget Form, Section F Other Direct Costs as a single line item, or
    2. PHS 398 Modular Budget Form: as text embedded within the Additional Narrative Justification
  5. Budget justifications should include an Other Direct Cost item for “Data Management and Sharing Costs,” providing a brief summary of the DMS Plan and description of requested DMS costs. Justifications are included in the:
    1. R&R Budget Form, Section L Budget Justification attachment, or
    2. PHS 398 Modular Budget Form, embedded as part of the Additional Narrative Justification

Back to List of Plans

Assessment of DMS Plan and Budget

  1. NIH IC program staff will assess DMS Plans to ensure the Elements of a DMS Plan have been addressed and are reasonable
  2. Peer reviewers will not be asked to comment on DMS Plans
  3. Peer reviewers may comment on the reasonableness of budgets and will use information in the budget justification to determine whether budgeted costs are reasonable
  4. DMS Plans will not be factored into the overall impact score, unless the FOA specifically states that sharing data is integral to the project design:
    1. NIH program staff will assess if data sharing is integral to project design and tied to a scored review criterion
    2. Peer reviewers will have access to DMS Plan attachment to factor that information into the score

Back to List of Plans

Pre-award Process for DMS Plan Revision

  • If the DMS Plan provide in the application cannot be approved, the PI will be notified and additional information requested as part of the Just-In-Time process (see NIH GPS 2.5.1 JIT Procedures).
  • Applicants are expected to communicate with their Program Officer or Grants Management Specialist to resolve issues

Back to List of Plans

Post-award Process for DMS Plan Revision

  • Following award, recipients must comply with the approved DMS Plan
  • DMS Plans may be updated during regular reporting intervals as part of the RPPR process (see NIH GPS 8.4.1 Reporting).
  • Changes to the DMS Plan must be approved by the funding NIH IC

Please see the Notice for detailed information and where to direct inquiries.

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July 2022

 

eRA RETIREMENT OF ALL APPLICATION FORM VERSIONS PRIOR TO FORMS-E: NOT-OD-22-182 announces that eRA will no longer support application forms prior to FORMS-E by the end of August 2022. Changes in FORMS-E set the framework to build web applications in eRA.

Regardless of the submission method (e.g. eRA ASSIST, Grants.gov Workspace, or S2S provider) applicants cannot submit forms that contain fields for the DUNS number. Only applications with valid Unique Entity Identifiers (UEI) will be processed by the eRA systems.

Following retirement of forms versions prior to FORMS-E, applicants using eRA ASSIST will not be able to copy information from an application prepared with a retired form set to an active FORMS-G Funding Opportunity Announcement.

Applicants who anticipate a need to copy information from a form set prior to FORMS-E should copy their application data to a FORMS-G application package to preserve the ability to reuse it in the future.

Please see the Notice for full details and where to direct inquiries.

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June 2022

 

GUIDANCE FOR SURGEON EFFORT LEVEL ON AHRQ INDIVIDUAL MENTORED K AWARDS: NOT-HS-22-018 announced a change to the minimum effort requirements for surgeons with active surgical duties applying for individual mentored K awards funded by the Agency for Healthcare Research and Quality (AHRQ).

Effective for individual mentored K applications (new and resubmission) submitted for or after the June 12, 2022 submission due date, AHRQ will allow surgeons to devote less than the minimum 75% of full-time professional effort but no less than 50% of full-time professional effort. Applicants proposing less than 75% effort but no less than 50% effort must provide adequate justification and reference NOT-HS-22-018 in the budget justification section. The Primary Mentor’s letter and Institutional Commitment letter both must mention concurrence with the applicant’s justification.

Current surgeon recipients of AHRQ individual mentored K awards may indicate a change in their level of effort but must request prior approval with adequate justification to reduce their level of effort no less than 50% during the course of their award. Note that a reduction in effort on K08 awards will result in a recalculation of the salary provided.

Please see the Notice for full details and where to direct inquiries.

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iEDISON TO TRANSITION FROM NIH eRA TO NIST; DOWNTIME AND ACTIION ITEMS IN PREPARATION FOR AUGUST 9 LAUNCH: NOT-OD-22-158 informs iEdison system users that the system will be unavailable from August 2-8, 2022 in preparation for the transition from NIH eRA to the National Institute of Standards and Technology (NIST) and the proposed launch on August 9.

iEdison is the system used by the Office of Technology Management (OTM) at UCSF to report inventions and patents resulting from federally-funded research. During July until the August 9 launch, OTM will be preparing to use the new system.

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May 2022

 

JUNE 2022 UPDATED eRA RPPR MODULE AND INSTRUCTION GUIDE: ACTION REQUIRED FOR IN PROGRESS BUDGET FORMS: NOT-OD-22-130 announces upgrades to the Research Performance Progress Report (RPPR) module in eRA Commons expected to be released on June 23, 2022.

Upgrades include addition of the Unique Entity Identifier (UEI) fields and required FORMS-G changes, including updated budget forms. With the upgrade release on June 23, 2022, NIH will publish an updated Instruction Guide.

Action Required for Budget Forms

Non-SNAP budget forms will be updated to a new format, as a result, users with in-progress RPPR forms will be required to re-enter budget form data if the in-progress RPPR is submitted on or after June 23, the date of the release. RPPRs submitted on or before June 22 will reflect the FORMS-F budget forms. Submission due dates remain unchanged.

RPPR Instruction Guide Critical Updates

An interim RPPR Instruction Guide (dated May 13, 2022) has been published to include the following critical updates:

Please see the Notice for details and where to direct inquiries.

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NOTICE OF LEGISLATIVE MANDATES IN EFFECT FOR FY 2022: NOT-OD-22-117 provides the statutory provisions under the Consolidated Appropriations Act 2022 (P.L. 117-103) that limit or conditions  the use of funds on NIH grants, cooperative agreements, and contract awards for FY 2022.

  • Salary Limitation (Section 202)
  • Indirect Costs (Section 224)
  • Anti-Harassment (Section 239)
  • Anti-Lobbying (Section 503)                                                                                                
  • Acknowledgment of Federal Funds (Section 505)
  • Restriction on Abortions (Section 506)
  • Exceptions to Restriction on Abortions (Section 507)
  • Ban on Funding Human Embryo Research (Section 508)
  • Limitation on Use of Funds for Promotion of Legalization of Controlled Substances (Section 509)
  • Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory Committee Candidates (Section 515(a))
  • Dissemination of False of Misleading Information (Section 515(b))
  • Restriction of Pornography on Computer Networks (Section 520)
  • Restriction on Distribution of Sterile Needles (Section 527)

Please see the Notice for details and where to direct inquiries.

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CLARIFICAITON AND GUIDANCE FOR APPLICANTS PERPARING APPLICATIONS FOR THE SUMMER 2022 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-22-112 extends the guidance provided in NOT-OD-22-046 for applications for the January 2023 Council round, beginning with the May 25, 2022 due date. Reviewers will receive instruction to continue to assume that constraints arising from the COVID-19 pandemic will be resolved during the project period and should not affect their scores.

Applications should not include contingency or recovery plans for problems resulting from the pandemic; however, applicants may address effects on productivity due to the pandemic or other scoreable issues in the Personal Statement of the NIH Biosketch. Reviewers will be instructed to take these pandemic-related circumstances into account when assessing applicants’ productivity and other score-driving factors.

As previously instructed, NIH staff will request and assess plans to resolve specific problems arising from the pandemic prior to funding.

Please see the Notice for details and where to direct inquiries.

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CORRECTION TO STIPEND LEVELS FOR RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPENDS, TUITION/FEES AND OTHER BUDGETARY LEVELS EFFECTIVE FOR FY 2022: NOT-OD-22-132 corrects stipend levels and replaces NOT-OD-22-108.

The UC Postdoctoral salary scales will be available online on the Academic Personnel and Programs website.

Please see Notice for corrections in bold italics and where to direct inquiries. 

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UPDATED REQUIREMENTS FOR NIH NOTIFICATION OF REMOVAL OR DISCIPLINARY ACTION INVOLVING PROGRAM DIRECTORS/PRINCIPAL INVESTIGATORS OR OTHER SENIOR/KEY PERSONNEL: NOT-OD-22-129 announces an update to the requirement that NIH be notified when a Program Director/Principal Investigator (PD/PI) or other Senior Key personnel named on the Notice of Award is removed or disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions.

NIH recipient organizations will be required to notify NIH when individuals identified as PD/PI or Senior/Key personnel named in the NIH Notice of Award are removed from their position or otherwise disciplined due to concerns about harassment, bullying, retaliation or hostile working conditions. Notification must be provided within 30 days of the removal or disciplinary action. If determined that concerns will impact the individual’s ability to continue as scientific lead of the project, NIH will require prior approval to replace the PD/PI or Senior/Key official.

UCSF Reporting Procedures: Immediately upon knowledge of removal or disciplinary action involving the PD/PI or Senior Key Personnel named on the NIH Notice of Award, email the UCSF Point of Contact (POC) for NIH reporting. The UCSF POC will complete and submit the report and coordinate any resulting administrative requirements.

Please see the Notice for details and where to direct inquiries.

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April 2022

NIH RESPONSE TO REGISTRATION ISSUES IN SAM.GOV: NOT-OD-22-119 provides updated guidance to NIH applicants regarding the registration and renewal process in the System for Award Management (SAM.gov).

Due to high demands, the General Service Administration (GSA) experienced delays in the SAM.gov process to update or renew an entity registration. Organizations that do not have an active SAM.gov registration cannot be issued an NIH award. Due to the scope of these challenges, NIH is making an exception to the Late Application Policy until the issue is resolved. NIH will send notification when the issue is resolved and exceptions to the Late Application Policy will no longer be made for this reason.

Effective immediately, if an entity does not have a current SAM.gov registration or renewal at the time of the application submission due date, NIH will accept late applications within the two-week late window as long as the entity has submitted all SAM.gov registration or renewal documentation at least two weeks prior to the application due date and all other aspects of the application are compliant and consistent with the funding opportunity announcement requirements.

To be considered for this special accommodation, the entity’s application Cover Letter must include documentation, e.g. a confirmation email or screenshot, demonstrating that the SAM.gov registration or renewal request was submitted at least two weeks prior to the application due date.

Requests for accommodation beyond the two-week window will be considered on a case-by-case basis; however, permission to submit late will not be given in advance. The Cover Letter and documentation attached must demonstrate a good faith attempt to resolve the SAM.gov issues ahead of time and include relevant correspondence with GSA.

Please work with your OSR Staff if your collaborating entities are experiencing issues registering or renewing their registration in SAM.gov.

Please see the Notice for details and where to direct inquiries.

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AHRQ ANNOUNCEMENT OF CHILDCARE COST ALLOWANCE FOR RUTH L. KIRSCHSTEIN NRSA INSTITUTIONAL RESEARCH TRAINING AWARDS (T32) BEGINNING IN FY2022: NOT-HS-22-014 announces that beginning October 1, 2022, the Agency for Healthcare Research and Quality (AHRQ) will begin providing $2,500 per budget period as an allowance for childcare costs based on appointment slots (for eligible trainees) awarded on an AHRQ Institutional Research Training award (new, renewal, or continuation).

Eligibility:

  • Only applies to full-time AHRQ NRSA research trainee appointment slots awarded
  • Trainees must be appointed to the training award prior to use of childcare costs
  • Costs for childcare must be provided by a licensed (regulated by state or local authorities) childcare provider/service.
  • Covers dependent children living in the eligible fellow’s home from birth under the age of 13, or children who are disabled and under age 18.

Restrictions:

  • Childcare costs do not apply to elder or non-child dependent care costs.
  • Childcare costs are not tied to payback obligations, nor should it be reported as such.
  • When awarded, childcare costs are restricted to be used for that purpose only at a maximum of
  • $2,500 per eligible full-time NRSA trainee appointed to the award.
  • Unused funds must be reported as an unobligated balance on the Federal Financial Report (FFR)
  • AHRQ will utilize unused funds as an offset to a future year award ow will recover the funds as part of the closeout process, as appropriate.

Application/Continuation Process:

  • Childcare costs will be provided based on the number of full-time trainee slots awarded. No action is required at the time of application to request these funds.
  • Following issuance of an award that includes childcare costs, Section G.1 of the subsequent RPPR, must include a PDF attachment titled: Childcare_Costs.pdf, that specifies the number of trainees who used childcare support during the reporting period.

Please refer to the UCSF Controller’s webpage for the NIH NRSA Childcare Reimbursement Process.

Please see the Notice for details regarding applicability of childcare support on AHRQ NRSA institutional research training awards and where to direct inquiries.

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AHRQ ANNOUNCEMENT OF CHILDCARE COSTS ALLOWANCE FOR RUTH L. KIRSCHSTEIN NRSA INDIVIDUAL FELLOWSHIPS: NOT-HS-22-013 announces that the Agency for Healthcare Research and Quality (AHRQ) will begin providing $2,500 per budget period as an allowance for childcare costs to eligible recipients of new and continuation AHRQ Kirschstein National Research Service Award (NRSA) individual fellowships awarded after October 1, 2021.

Eligibility:

  • Only applies to full-time AHRQ NRSA-supported individual fellowship positions.
  • Costs for childcare must be provided by a licensed (regulated by state or local authorities) childcare provider/service.
  • Covers dependent children living in the eligible fellow’s home from birth under the age of 13, or children who are disabled and under age 18.

Restrictions:

  • Childcare allowance is not determined by the number of children.
  • Childcare costs do not apply to elder or non-child dependent care costs.
  • Childcare costs are not tied to payback obligations, nor should it be reported as such.
  • When awarded, childcare costs are restricted and unused funds may not be re-budgeted for any purpose.
  • In cases of early termination or in cases where a child ages-out during the covered budget period, the unused portion must remain unobligated for recovery by the agency as part of the closeout process.

Please refer to the UCSF Controller’s webpage for the NIH NRSA Childcare Reimbursement Process.

Please see the Notice for application instructions (e.g. new, continuation, and administrative supplement) to request childcare costs and where to direct inquiries.

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EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC: JANUARY 2023 COUNCILS: NOT-OD-22-113 extends the special exception for post-submission materials to applications submitted for the January 2023 council rounds.

Beginning with applications submitted for the May 25, 2022 due date, NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the Funding Opportunity Announcement used for the submission allowed preliminary data in the application. One page of preliminary data will be accepted for single component applications or for each component of a multi-component application.

The deadline for submitting all post-submission materials remains 30 days before the study section meeting.

Post-submission materials will not be accepted for applications for emergency competitive revisions and urgent competitive revisions that undergo expedited review.

Please see the Notice for details and where to direct inquiries.

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NOTICE OF FISCAL POLICIES IN EFFECT FOR FY 2022: NOT-OD-22-105 provides guidance about NIH fiscal Operations for Fiscal Year 2022 and implements the Consolidated Appropriations Act, 2021 (Public Law 117-103) signed into law on March 15, 2022.

The Notice summarizes Fiscal Policies instituted in FY 2022:

Please direct inquiries to: [email protected]

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MODIFICATIONS TO THE NIMH SPECIAL COUNCIL REVIEW PROCEDURES: NOT-MH-22-190 replaces NOT-MH-22-030 and updates guidance from the National Institute of Mental Health (NIMH) on  procedures for conducting Special Council Review (SCR).

NIMH is updating the dollar threshold for SCR to align with the revised NIH threshold of $2 million total costs (NOT-OD-22-049). SCR pertains to well-funded PD/PIs submitting applications to NIMH. The new procedure requires that additional consideration be applied to applications requiring special review by the National Advisory Mental Health Council (NAMHC).

Please see NOT-MH-22-190 for details on updated guidance and where to direct inquiries.

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NIDCR TO INCLUDE ADDITIONAL APPLICATION DUE DATES FOR DUAL DEGREE DENTIST SCIENTIST PATHWAY TO INDEPENDENCE AWARD (K99/R00): NOT-DE-22-007 announces the addition of application due dates and review and award cycles to the National Institute of Dental and Craniofacial Research (NIDCR) Dual Degree Dentist Scientist Pathway to Independence Award Programs.

Please see the Notice to view the modifications and where to direct inquiries.

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FINAL NIH POLICY FOR DATA MANAGEMENT AND SHARING: NOT-OD-21-013 announced the Final Policy for Data Management and Sharing, which applies to all research funded by NIH that results in the generation of scientific data. Effective January 25, 2023 prospective grant and contract applications will be required to include a data management and sharing plan outlining how scientific data will be managed and shared. Adherence to the plan will become a term and condition of the award.

NIH recently posted their Scientific Data Sharing website, home for the Final Data Management and Sharing Policy, Genomic Data Sharing Policy, Other Sharing Policies, and resources for Accessing Data. 

The UCSF Library and the Office of Sponsored Research have joined forces to provide guidance and resources on the UCSF NIH DMS Policy webpage. Check out our website for updated guidance FAQs, and examples.

We will also be engaging stakeholders from both the research and administrative communities to review current data management and sharing procedures and ensure consistency in practices and compliance with the final policy. Stay tuned for more outreach and training opportunities later this year.

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March 2022

IEDISON TO TRANSITION FROM NIH ERA TO NIST IN SUMMER 2022, ACTION REQUIRED BY USERS: NOT-OD-22-100 announces plans to transition iEdison from NIH eRA to Department of Commerce, National Institute of Standards and Technology, DOC NIST, Summer 2022. The Notices advised users to subscribe to NIST and Link to their Login.gov account to ensure smooth transition.

The UCSF Office of Technology Management acknowledges that they are prepared for the transition.

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SALARY LIMITATION ON AHRQ FY2022 GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS: NOT-HS-22-012 informs Agency for Healthcare Research and Quality (AHRQ) applicants, grantees, and contractors of the salary cap limitation imposed for Fiscal Year 2022.

Per the Consolidated Appropriations Act, 2022, (P.L. 117-103) signed into law on March 15, 2022, the amount of salary that may be paid to an individual under an HHS grant, cooperative agreement, or applicable contract is limited to Executive Level II of the Federal Executive Pay Scale, effective January 2, 2022, at $203,700.

Committed levels of funding for grant and contract awards made in prior fiscal years that were restricted to Executive Level II will NOT be adjusted to the new salary cap rate; however, if adequate funds are available and the salary cap limitation is consistent with the institutional base salary, grantees may re-budget funds to accommodate the FY2022 salary cap. It is expected that such re-budgeting will not negatively impact the aims of the project. No additional funds will be provided for grants and the total estimated costs of contracts will not be modified.

Please see the Notice for details and where to direct inquiries.

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CHANGES TO THE FEDERAL FINANCIAL REPORT (FFR) – APRIL 1, 2022: NOT-OD-22-099 informs NIH and AHRQ grant recipients that beginning April 1, 2022, recipients will no longer be required to submit quarterly cash transaction reports, 30 days after the end of each calendar quarter.

Instead, the HHS Payment Management System (PMS) will pre-populate cash transaction section using real-time cash expenses information from PMS and adjust recipient-reported disbursements to equal cash advance drawdowns on all non-closed sub-accounts (PMS type P). Recipients will be required to certify at the time of each drawdown.

The NIH Grants Policy Statement will be updated at the time of its next publication to remove this reporting requirement.

Please see the Notice for details.

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NOTICE OF NIAAA DATA-SHARING GUIDANCE FOR HUMAN SUBJECTS GRANTS RESEARCH FUNDED BY THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) [4TH Revision]: NOT-AA-22-011 replaces NOT-AA-18-009, NOT-AA-18-010, NOT-AA-19-020, and NOT-AA-22-003.

  1. The Notice informs prospective applicants of the expectation that investigators and their institutions provide in the Resource Sharing Plan section of applications a plan to submit grant-related human subjects data to a NIAAA-sponsored data repository. Applicants are encouraged to use the NIAAADA DSP template. Plans must include:
    1. A brief summary of the assessment schedule
    2. A listing of proposed data collection instruments (assessments) that do not currently exist in the NDA
    3. The proposed schedule for running the data validation tool once data collection begins
  1. Costs associated with submitting data to the NIAAADA should be included in grant applications. Researchers should use the cost estimation tool for this purpose when preparing applications to NIAAA.
  1. Institutional certification for sharing human data should be included with Just-In-Time material and compliance with the plan will become a special term and condition of the award.
  1. This requirement applies to all NIAAA grant applications (new and resubmissions) that include human subjects research and all FOAs in which NIAAA participates.
  1. This policy mandates that the NIAAADA serve as the repository for all genomic data funded by NIAAA unless otherwise agreed to by NIAAA. This does not supersede the general NIH Genome Data Sharing Policy. NIAAA awardees collecting human genomic data will register in dbGaP and add the link to the NIAAADA collection to the dbGaP registration.
  1. Grant applicants are strongly encouraged to review the NIAAADA website before submitting a human subjects grant application to NIAAA. The DSP Template and Cost Estimation Tool can be found by clicking on the Pre-Award tab and then the Application link.
  2. The UCSF Library will be adding a page with specific Institute/Center guidance at UCSF Library NIH 2023 DMS Policy.

Excluded from this requirement are applications for

  • Fellowships (F)
  • Training Awards (T)
  • Education (R25)
  • Conferences (R13/U13)
  • Small Business (SBIR/STTR and cooperative agreements)

Please see the Notice for additional information on data, data sharing, and where to direct inquiries.

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NIDDK NOTICE OF CONTINUATION OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) DURING THE COVID-19 PANDEMIC: NOT-DK-22-016 informs the extramural community that due to ongoing disruptions caused by the COVID-19 pandemic, NIDDK will provide a one-receipt cycle extension of eligibility for prospective applicants meeting the requirements for submission of a K01 application from the period covered by the February/March 2022 and June/July 2022 due dates. These individuals will be permitted to submit applications up to the June/July 2022 and October/November 2022, respectively.

Please see the Notice for details and where to direct inquiries.

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February 2022

PLANS TO PROMOTE SAFE ENVIRONMENTS AT CONFERENCES SUPPORTED BY NIH GRANTS AND COOPERATIVE AGREEMENTS: NOT-OD-22-074 informs applicants for NIH support of conferences and scientific meetings (R13/U13) that a Plan to Promote Safe Environments (Safety Plan) will be required at Just-In-Time (JIT).

Effective with R13/U13 applications due April 12, 2022 that are recommended for funding, NIH will require that the Safety Plan and Communications Strategy be included as part of the JIT materials.

If awarded, it is strongly recommended that Conference Organizers contact UCSF Interim Title IX Officer, Tracey Tsugawa, before making plans for your conference to ensure proper adherence to the Safety Plan and Communications Strategies.

The template Letter to Conference Participants reflects the lanugage used for the Safety Plan. The completed template letter must be included with conference registration materials and/or participant information packages. Templates reside on the OSR Public Webpage, Respond to Just-In-Time Requests.

Please see the Notice for details and where to direct inquiries.

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FY 2022 UPDATED GUIDNCE ON THE REQUIREMENT FOR INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH: NOT-OD-22-055 provides new recommendations on the format, frequency, and timing of instruction in the Responsible Conduct of Research (RCR) made by NIH, AHRQ, and HRSA.

Institutions are expected to begin to incorporate the changes described in this Notice into plans for RCR instruction for the 2022-2023 academic year and in new and renewal applications for research training, career development, research education and dissertation research grants beginning with the September 25, 2022 due dates.

As long as the COVID public health emergency continues, flexibilities allowing RCR training be completed online remain in place.

Please see the Notice for details on the updates and where to direct inquiries.

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NOTICE OF CHANGE TO NIH POLICY ON SPECIAL COUNCIL REVIEW OF RESEARCH APPLICATIONS: NOT-OD-22-049 announces the update of the threshold to require Special Council Review (SCR) to determine if additional funds should be provided to already well-supported investigators.  

To align SCR policy with updated Other Support disclosure requirements, the $1 million direct costs per year threshold has been updated to $2 million total costs (inclusive of direct and indirect costs) per year for all active NIH awards.

All other elements of the policy remain unchanged from NOT-OD-12-140, including the types of support that contribute to the threshold, applications excluded from the requirement, and provisions for IC-specific variations.

Please see the Notice for complete details and where to direct inquiries.

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GUIDANCE ON SALARY LIMITATION FOR GRANTS AND COOPERATIVE AGREEMENTS: NOT-OD-22-076 provides information on the salary limitation for NIH grant and cooperative agreement awards and research and development contract awards.

The Continuing Appropriations Act, 2022 (P.L. 117-70) applies the terms and conditions of the Consolidated Appropriations Act 2021 which restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management released new salary levels for the Executive Pay scale effective January 2, 2022. The salary limitation for Executive Level II is $203,700.

Active awards, including awards issued in FY 2022 (continuation and new) may rebudget to accommodate the current Executive Level II salary level, if funds are available; however, no additional funds will be provided by the sponsor.

For more information, please also see the February 2022 issue of News from the Controller’s Office.

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FURTHER CONTINUATION OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIH K99/R00 PATHWAY TO INDEPENDENCE AWARD DURING THE COVID-19 PANDEMIC: NOT-OD-22-062 announces continued extension of eligibility for prospective K99/R00 applicants due to ongoing disruptions caused by the COVID-19 pandemic.

Individuals whose final due date for eligibility is February/March 2022 and June/July 2022 will be granted a two-receipt cycle extension. Individuals who have previously received the two-cycle extension are not eligible for an additional extension.

Please see Notice for details and where to send inquiries.

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January 2022

NOTICE TO EXTEND ELIGIBILITY OF NIAMS K99/R00 PATHWAY TO INDEPENDENCE AWARD APPLICATIONS DUE TO COVID-19 DISRUPTIONS: NOT-AR-21-029 announces that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will extend eligibility for submission of K99/R00 applications due to COVID-related disruptions. Subject to future updates, NIAMS will provide a 2-receipt cycle extension of eligibility for individuals who were in postdoctoral training during the COVID public health emergency. The extension applies to AIDS and non-AIDS applications

Please see the Notice for details and where to direct inquiries.

TEMPORARY EXTENSION OF ELIGIBILITY FOR NHLBI K24 APPLICANTS DUE TO COVID-19: NOT-HL-22.007 announces a temporary change in National Heart Lung and Blood Institute (NHLBI) specific eligibility requirements for the Midcareer Investigator Award in Patient-Oriented Research (K24) FOAs PA-20-186 and PA-20-193 for due dates February 12, 2022 through November 12, 2023 (and any reissues published before November 12, 2023).

Due to disruptions in professional pursuits and personal lives experienced during the COVID-19 pandemic, NHLBI will temporarily extend the period of individual eligibility from 10 years to 12 years beyond an applicant’s appointment as an associate professor.

Please see the Notice for details and where to direct inquires.

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NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF PATHWAY TO INDEPENDENCE AWARD APPLICATIONS (K99/R00) TO NIDCR DUE TO COVID-19 DISRUPTIONS: NOT-DE-21-021 announces that due to disruptions caused by the COVID-19 pandemic, the National Institute of Dental and Craniofacial Research (NIDCR) will extend eligibility to apply for the NIH Pathway to Independence or NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00). Individuals whose eligibility window will end either February/March 2022 or June/July 2022 will have a 1 cycle extension to June/July 2022 and October/November 2022, respectively. Individuals who previously received the 2 cycle COVID-based eligibility extension for K99 submission are not eligible for an additional extension.

Please see the Notice for details and where to direct inquiries.

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PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT FOR FISCAL YEAR 2022: NOT-OD-22-050 announces the publication of the Revised NIH Grants Policy Statement (Rev. December 2021) for Fiscal Year 2022.

The updated NIH Grants Policy Statement (NIHGPS) incorporates new and modified requirements, clarifications, changes, and policies implemented since the previous version dated April 2021. The December 2021 NIHGPS applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2021 and supersedes the NIHGPS dated April 2021.

Previous versions of the NIHGPS remain applicable as standard terms and conditions of award for all grants and cooperative agreements with budget periods that begin prior to October 1, 2021.

Please see the Notice for details and where to send inquiries.

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December 2021

EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC: AUGUST/OCTOBER 2022 COUNCILS: NOT-OD-22-047 extends special exception for post-submission material to applications submitted for the August/October 2022 Council.

NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. One page of preliminary data will be accepted for single component applications or for each component of a multi-component application.

Please see the Notice for details and where to send inquiries.

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CLARIFICATION AND GUIDANCE FOR APPLICANTS PREPARING APPLICATIONS FOR THE SPRING 2022 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-22-046 extends guidance provided in NOT-OD-21-180 to applications for the August/October 2022 Council round, beginning with the January 25, 2022 due date.

  • Reviewers will continue to understand that constraints arising from the COVID-19 pandemic will be resolved during the project period and should not affect the score.
  • Applications should NOT include contingency or recovery plans for problems resulting from the COVID-19 pandemic.
  • Effects on productivity due to the pandemic or other scoreable issues may be included in the Personal Statement of the NIH Biosketch.
  • Reviewers will take pandemic-related circumstances into account when assessing applicants' productivity and other score-driving factors.
  • NIH staff may request and assess plans to resolve specific problems arising from the COVID-19 pandemic prior to funding.

Please see the Notice for details and where to send inquiries.

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MAINTAINING SECURITY AND CONFIDENTIALITY IN NIH PEER REVIEW: RULES, RESPONSIBILITIES AND POSSIBLE CONSEQUENCES: NOT-OD-22-044 reminds all participants and stakeholders in the NIH peer review process of federal sttutes, regulations, and NIH policies regarding peer review security and confidentiality, the responsibilities for abiding by these rules, and possible actions that NIH (in coordination with other offices) may take and consequences that may result from a violation of the rules. Participants and stakeholders include but are not limited to: 

  • Project Directors/Principal Investigators, Key Personnel, and officials of applicant organizations and offers, and other operating on their behalf
  • Peer reviewers (temporary and appointed) and NIH National Advisory Council (NAC) members (temporary and appointed)

This Notice replaces NIH Guide Notices NOT-OD-14-073, NOT-OD-15-106, and NOT-OD-18-115.

Please see the Notice for details and where to direct inquiries.

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NOTICE OF NIAAA DATA-SHARING GUIDANCE FOR HUMAN SUBJECTS GRANTS RESEARCH [3RD REVISION]: NOT-AA-22-003 replaces NOT-AA-18-009, NOT-AA-18-010, and NOT-AA-19-020 HAVE BEEN RESCINDED and REPLACED BY NOT-AA-22-011 (see March Notices)

Informed applicants of NIAAA’s expectation and policy that investigators and their institutions provide plans for submitting grant-related human subjects data to a NIAAA-sponsored data repository, the NIAAA Data Archive (NIAAADA).

Notable Points

Excluded from the policy are:

  • Fellowships (F)
  • Training (T)
  • Small Business (SBIR/STTR and cooperative agreements)
  • Education (R25)
  • Conference (R13/U13)

The following applies to applications (new and resubmissions) that include human subjects research and all FOAs in which NIAAA participates, regardless of amount of direct cost requested in any year, starting with the 2022 Cycle I due date (January 25 – March 16, 2022) and forward:

1. Plans should be included in the Resource Sharing Section of grant applications

2. Applicants are strongly encouraged to use the NIAAADA DSP template.

3. The portion of the plan dealing with data must include:

-A brief summary of the assessment schedule

-A listing of proposed data collection instruments (assessments) that do not currently exist in the NDA (if applicable)

4. The proposed schedule for running the data validation tool once data collection begins

5. Costs associated with submitting data to the NIAAADA should be included in application budgets using the cost estimation tool

6. Compliance with the NIAAADA DSP will become a special term and condition of the award

7/ The Institutional Certification (for sharing human data) should also be provided at JIT prior to award

Applicable Data for submission to NIAADA

Only electronic, de-identified data from human subjects studies

-including clinical trials, epidemiological surveys, human laboratory investigations

-excludes studies that meet the human subjects research exemption criteria defined by NIH

This policy mandates that the NIAAADA serve as the repository for all genomic data funded by NIAAA unless otherwise agreed to by NIAAA. Awardees collecting human genomic data will register in dbGaP and add the link to the NIAAADA collection to the dbGaP registration.

Please see Notice for details and additional information on:

  • Data Sharing Procedures
  • NIMH Data Archive (NDA) Sharing

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-22-045 announces that the Department of Health and Human Services (DHHS), including NIH operates under the Further Extending Government Funding Act (Public Law 117-70) signed by President Biden on December 3, 2021, which continues government operations through February 18, 2022.

The Act continues procedures identified under NOT-OD-21-058. NIH Institutes and Centers may, issue non-competing research awards at a level below that of the most recent Notice of Award. Upward adjustments to awarded levels will be considered after FY 2022 appropriations are enacted. NIH expects institutions to monitor their expenditures carefully during this period.

Legislative mandates (NOT-OD-21-056), salary limitations set at Executive Level II (NOT-OD-21-057), and Ruth Kirschstein NRSA pre and postdoctoral stipend and tuition/fees levels (NOT-OD-21-049) remain in effect under this CR.

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NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF MOSAIC K99/R00 APPLICATIONS TO NIGMS: NOT-GM-22-020 announces that due to continued disruptions caused by the COVID-19 pandemic, the National Institute of General Medical Sciences (NIGMS) is providing extensions in eligibility to prospective candidates for MOSAIC K99/R00 applications.

Applicants whose 48-month eligibility window will end February/March/May 2022 will receive a two-receipt cycle extension.

Applicants whose 48-month eligibility window will end June/July/September 2022 will receive a one-receipt cycle extension.

Individuals whose 48-month eligibility window ended October/November 2021 were provided an extension to apply in February/March 2022 per NOT-GM-21-057. These individuals will not be eligible for additional extensions.

Please see the Notice for more details and where to direct inquiries.

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NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF K99/R00 APPLICATIONS TO NIA: NOT-AG-22-003 announces that due to continued disruptions caused by the COVID-19 pandemic, the National Institute of Aging (NIA) is providing extensions in eligibility for prospective applicants to NIH Pathway to Independence Award FOAs PA-21-220, PA-20-187, PA-20-188, and PA-20-189.

NIA will now provide a 2-receipt cycle extension of eligibility for individuals who were eligible to apply between June/July/September 2021 and those whose eligibility window will end February/March/May 2022.

NIA will also provide a 1-receipt cycle extension of eligibility for those whose eligibility window will end June/July/September 2022.

Multiple extensions of K99/R00 eligibility is not permitted.

Please see the Notice for more details and where to direct inquiries.

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GUIDANCE: NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF NIGMS APPLICATIONS TO PA-20-188 (PARENT K99/R00 INDEPENDENT CLINICAL TRIAL NOT ALLOWED) DUE TO COVID RELATED DISRUPTIONS: NOT-GM-22-018 announces that due to continued disruptions caused by the COVID-19 pandemic, the National Institute of General Medical Sciences (NIGMS) is providing extensions in eligibility for prospective applicants to PA-20-188 - NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Not Allowed).

Applicants whose 48-month eligibility window will end with the February/March 2022 and June/July 2022 receipt dates will receive a two-receipt cycle extension.

Individuals whose 48-month eligibility window ended October/November 2021 were provided an extension to apply in February/March 2022 through NOT-OD-21-106. These individuals will not be eligible for additional extensions.

Please see the Notice for more details and where to direct inquiries.

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November 2021

REMINDER TO AHRQ GRANTEES THAT FY2017 FUNDS WILL EXPIRE ON SEPTEMBER 30, 2022: NOT-HS-22-009 reminds AHRQ grantees that federal agencies are required to close fixed year appropriation accounts by September 30 of the 5th fiscal year after the period of availability.  

AHRQ recipients who received awards funded by FY 2017 fixed appropriations should check the Program Support Center (PSC) Payment Management System (PMS) website for information regarding the last day to draw funds. Please plan to closeout early as the last day is often earlier than September 30.

Please direct inquiries to: [email protected].

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October 2021

REMINDER: FORMS-G GRANT APPLICATION FORM & INSTRUCTIONS MUST BE USED FOR DUE DATES ON OR AFTER JANUARY 25, 2022: NOT-0D-22-018 reminds the applicant community thatFORMS-G application packages must be used for due dates on or after January 25, 2022.

Updates:

FORMS-F Application Package will be used for:

  • Applications with due dates on or before January 24, 2022
  • Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before January 24, 2022
  • Applications submitted by February 1, 2022 under the NIH Continuous Submission Policy for the January 7, 2022 AIDS intended due date

FORMS-G Application Package will be used for:

  • Applications with due dates on or after January 25, 2022
  • All application types (New, Resubmission, Renewal, Revision) with due dates on or after January 25, 2022
  • Applications submitted early for intended due dates on or after January 25, 2022

For full details on the implementation of FORMS-G and where to direct inquiries, please see NOT-OD-22-008.

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GUIDANCE: ELECTRONIC RESEARCH ADMINISTRATION (eRA) RPPR SUBMISSION VALIDATIONS FOR CLINICAL TRIAL REGISTRATION AND RESULTS REPORTING: NOT-OD-22-008 provides notification of the implementation of updated eRA Research Performance Progress Report (RPPR) submission system validations for clinical trial registration and results reporting that will impact the ability to submit the RPPR.

NIH grants and cooperative agreements conducting clinical trials are subject to the clinical trial registration and results reporting requirements per 42 CFR Part 11 and NIH GPS 4.1.3.1.

Registration:

Recipients must ensure that NIH funded clinical trials are registered at ClinicalTrials.gov no later than 21 days after enrollment of the first participant (see RPPR Instructions Section G.4.c to report clinical trial registration – NCT number). If more than 30 days have passed since enrollment of the first participant and no NCT number is entered an error will prevent submission of the RPPR.

Results Reporting:

Results information must be submitted to ClinicalTrials.gov no later than one year after the primary completion date with limited exceptions. If results are not submitted in ClinicalTrials.gov, an error will prevent submission of the RPPR. To address this error the applicant will need to submit the trial results to ClinicalTrials.gov.

BESH Studies:

Basic Experimental Studies in Humans (BESH), responsive to BESH FOAs, have flexibility to report results in platforms other than ClinicalTrials.gov (NOT-OD-21-088). The validation changes do not apply to BESH award responsive to BESH FOAs.

Please see the Notice for more details, resources, and where to direct inquiries.

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MODIFICATIONS TO NIMH SPECIAL COUNCIL REVIEW PROCEDURES: NOT-MH-22-190 REPLACES NOT-MH-22-030 that announced modifications to the National Institute of Mental Health (NIMH) procedures for conducting Special Council Review (SCR) pertaining to well-funded PD/PIs submitting applications to NIMH. These procedures require additional considerations be applied to applications requiring special review by the National Advisory Mental Health Council (NAMHC).

Please see NOT-MH-22-190 for modified updates. Inquiries may be directed to Tracy Waldeck, Ph.D (NIMH). Email: [email protected].

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-22-009 announces that on September 30, 2021, President Biden signed the Extending Government Funding and Delivery Emergency Assistance Act (Public Law 117-43), which continues government operations through December 3, 2021 at the FY 2021 enacted level, with no reductions. 

NIH institutes and/or centers may, at their discretion, issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award. Upward adjustment to the awarded levels will be considered after FY 2022 appropriations are enacted. NIH expects institutions to monitor expenditures carefully during this period. 

All legislative mandates that were in effect in FY 2021 (see NOT-OD-21-056) remain in effect this Continuing Resolution, as well as the salary limitation set at Executive Level II of the Federal Pay Scale (see NOT-OD-21-057) and the Ruth L. Kirschstein National Research Service Award predoctoral and postdoctoral stipend levels and tuition/fees as described in NOT-OD-21-049

Questions regarding adjustments applied to individual grant awards may be directed to the Grants Management Specialist identified in the Notice of Award.

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NIH IMPLEMENTATION OF THE REVISED COMMON RULE PROVISION REGARDING PUBLIC HEALTH SURVEILLANCE ACTIVITIES DEEMED NOT TO BE RESEARCH: NOT-OD-22-001 announces NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research.

All requests for NIH-funded research - whether conducted or supported - including competing applications submitted for due dates on or after January 25, 2022, contract solicitations issued on or after January 25, 2022, applications for awards issued under Other Transactions Authorities (OTAs) on or after January 25, 2022 - must receive approval by NIH to be considered as a public health surveillance activity deemed not to be research under 45 CFR Part 46.102(k), 46.102(l)(2).

NIH will not consider NIH-defined clinical trials or studies that contain activities that do not meet the requirements of the exclusion, including the intent to store specimens and/or data for future use.

Prior approval requests for determination must contain a compelling justification, which must include all of the following:

  1. The proposed activity is limited to that necessary for NIH to identify, monitor, assess, or investigate:
  2. The activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. The activities will directly inform NIH public health decision making or action.
  • Grant applicants should notify their NIH Program Official/Director of their intention to submit the request and submit the request with justification during the just-in-time period following just-in-time procedures.
  • Offerors for contracts should follow instructions in the Request for Proposal (RFP).
  • Applicants for awards issued under Other Transactions Authorities (OTAs) shall follow instructions in the Research Opportunity Announcement (ROA).

Applicants, offerors, and recipients should not assume approval of use of the exclusion will be granted:

  • Applicants, offerors, and recipients must complete the PHS Human Subjects and Clinical Trials Information Form following instructions in the Application Guide, solicitation or opportunity announcement. 
  • The proposed budget in the application or proposal must reflect all necessary costs for conducting research involving human subjects without approval of the exclusion.

NIH applicants, offerors, and recipients will be notified of the final decision by the NIH grants specialist, agreements officer, or contracting officer prior to award.

Please see the Notice for full details and where to direct inquiries.

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September 2021

ANNOUNCEMENT OF CHILDCARE COSTS FOR RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARD (NRSA) INSTITUTUIONAL RESEARCH TRAINING AWARDS: NOT-OD-21-177 announces NIH plans to provide childcare cost support to full-time pre and postdoctoral trainees appointed on NRSA Institutional Research Training Awards.

  • NIH will provide $2,500 per each full-time predoctoral or postdoctoral NRSA trainee appointment slot at the time the new, renewal, or continuation award is made.
  • For childcare costs to be considered allowable, eligible full-time predoctoral or postdoctoral NRSA trainees must be appointed to the NRSA institutional training award prior to use of childcare costs.
  • Childcare costs will be provided unless otherwise specified on the Notice of Award base d on the number of trainee slots awarded.
  • At a minimum, recipients must obtain and retain documentation verifying that a childcare provider is licensed and/o9r regulated by state and/or local authorities and must document that the trainee and dependents meet eligibility requirements.
  • Frequently Asked Questions are available at: https://grants.nih.gov/faqs#/funding_programs_childcare_costs.htm?anchor=alphaHeader4240

Reporting for Continuation Applications

In Section G.1 of the RPPR, recipients must upload a PDF named: Childcare_Costs.pdf. The attachment must specify the number of trainees who used childcare costs in the reporting period.

For more information, please see the UCSF Controller’s Office webpage for  NIH NRSA Childcare Reimbursement Process and scroll down to Training Grants.

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August 2021

CLARIFICATION AND GUIDANCE FOR APPLICANTS PREPARING APPLICATIONS FOR THE FALL 2021 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-21-180 clarifies guidance provided in NOT-OD-21-026 for applicants preparing applications for the May 2022 Council round beginning with the September 25, 2021 due date.

Reviewers are instructed to assume that constraints arising from COVID-19 pandemic will be resolved during the project period and should not affect scoring.

Applicants should NOT include contingency or recovery plans for problems resulting from the COVID-19 pandemic; however, applicants may address effects of the pandemic on productivity or other scoreable issues in the Personal Statement of their biosketch. These circumstances will be taken into account in the assessment of applicant’s productivity and other score-driving factors.

If needed, NIH staff will request and assess plans to resolve specific problems arising from the COVID-19 pandemic prior to funding.

Please direct inquiries to [email protected].

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EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC: MAY 2022 COUNCIL: NOT-OD-21-179 extends the special exception for post submission material to applications submitted for the May 2022 Council round, beginning with the September 25, 2021 application due date.

Only if the FOA used for the submission allowed preliminary data in the application, can one page of preliminary data will be accepted for a single component application or one page for each component of a multiple-component application.

All post-submission materials, including preliminary data, must be submitted 30 days before the study section meeting. Post submission materials will not be accepted for applications for emergency competitive revisions and urgent competitive revisions that undergo expedited review.

Please see the notice for details and where to direct inquiries.

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REMINDER OF GUIDANCE ON REQUIREMENT FOR NIH SINGLE INSTITUTIONAL REVIEW BOARD (IRB) PLAN: NOT-OD-21-174 informs applicants of the change in FORMS-F instructions, that NIH applications proposing multi-site studies involving non-exempt human subjects research are no longer required to include the sIRB Plan attachment (NOT-OD-16-094). NIH will require a statement providing the name of the sIRB as part of the Just-in-Time (JIT) process prior to award to fulfill this requirement.

This change in NIH forms instructions does not preclude the Office of Sponsored Research (OSR) recommendation that the applicant PI consult with the UCSF IRB early in the proposal preparation process to confirm if there is a need to include sIRB fees in the proposal budget.

Please direct all inquiries concerning the sIRB policy to: [email protected]. Please consult with your OSR Staff concerning proposal preparation.

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NOTICE OF INFORMATINAL WEBINAR ON THE NIH MAXIMIZING OPPORTUNITIES FOR SCIENTIFIC AND ACADEMIC INDEPENDENT CAREERS (MOSAIC) PROGRAM FUNDING OPPORTUNITY ANNOUNCEMENTS (K99/R00 AND UE5): NOT-GM-21-061 informs potential applications of the upcoming webinar on planning submissions to the NIH Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Program Funding Opportunity Announcements, K99/R00 (PAR-21-271PAR-21-272, and PAR-21-273) and UE5 (PAR-21-277).

Webinar Information

Topic:    Preparing an Application to the NIH Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Program

Date:     Tuesday, September 7, 2PM EST

During this webinar, you will learn about the MOSAIC program and the process for writing a UE5 or K99/R00 application.

Please click the link below to join the webinar:

https://nih.zoomgov.com/j/1606371760?pwd=VWpsVy9WN01LVkdSbEl4NlVJTjIxZz09

Or One tap mobile:

US: +16692545252,,1606371760#,,,,*108423#  or +16468287666,,1606371760#,,,,*108423#

Or Telephone:

Dial (for higher quality, dial a number based on your current location):

US: +1 669 254 5252  or +1 646 828 7666  or +1 551 285 1373  or +1 669 216 1590

International numbers available: https://nih.zoomgov.com/u/acNEymvPCQ

Webinar ID: 160 637 1760

Passcode: 108423

Participants requiring sign language interpretation and/or other reasonable accommodations should email [email protected] or call the Federal Relay Service at 800-877-8339 at least 3 days prior to the event.

Please direct inquiries to Kenneth D. Gibbs, Jr., Ph.D., MPH at [email protected].

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CONTINUATION OF TEMPORARY EXTENSION OF APPLICANT ELIGIBILITY IN “MAXIMIZING OPPORTUNITIES FOR SCIENTIFIC AND ACADEMIC INDEPENDENT CAREERS (MOSAIC) POSTDOCTORAL CAREER TRANSITION AWARD TO PROMOTE DIVERSITY (K99/R00)” FOAs: NOT-GM-21-057 extends the temporary extension of the 48 month eligibility requirement through the October/November 2021 due dates for the following FOAs in addition to PAR-19-343 (NOT-GM-21-037):

PAR-21-271 - Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Clinical Trial Not Allowed)

PAR-21-272 - Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Clinical Trial Required)

PAR-21-273 - Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Basic Experimental Studies with Humans Required (BESH))

Please direct inquiries to Kenneth D. Gibbs, Jr., Ph.D., MPH at [email protected].

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ADJUSTED TIMELINE FOR REQUIRING TWO-FACTOR AUTHENTICATION TO ACCESS eRA MODULES USING LOGIN.GOV OR INCOMMON FEDERATED ACCOUNTS: NOT-OD-21-172 announces an adjustment of the timeline for eRA Commons users to transition to two-factor authentication using Login.gov. All single account holders are expected to transition by September 15, 2021 (see Step-by-Step Instructions).

All users with a scientific role should plan to transition to two-factor authentication using Login.gov now.

Please note that a triggering event has been established requiring Principal Investigators and Key Personnel associated with an application or RPPR, to transition within 45 days after submission of their competing application (Type 1 or 2) or RPPR. 45 days after the triggering event, users will not be able to access eRA systems until they setup and use a two-factor authentication provider, e.g. Login.gov.

Users with a scientific account and administrative account should transition their scientific account now and delay transitioning the administrative account until early FY 2022.

Users with more than one administrative account will not be required to transition to two-factor authentication until early FY 2022.

All external eRA Commons users are expected to maintain their eRA Commons username and password for the time being. eRA is planning to switch from use of passwords to passphrases (e.g. a set of random words or sentence at least 15 characters long) effective the end of 2021. 

If you have a technical and eRA Commons question, please submit a ticket to: https://era.nih.gov/register-accounts/access-modules-with-federated-account.htm

Please direct all other inquiries to [email protected].

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NOTIFICATION OF UPCOMING CHANGE IN FEDERAL-WIDE UNIQUE ENTITY IDENTIFIER REQUIREMENTS: NOT-OD-21-170 provides an update on the implementation of the transition from the DUNS number to the Unique Entity Identifier (UEI) to uniquely identify entities registered in the System for Award Management (SAM). 

Already registered in SAM, UCSF was automatically issued UEI KMH5K9V7S518, mid-FY2021.

Commencing October 2021, eRA Commons Institutional Profile File (IPF) will reflect the UEI, Page One of the NoA will reflect the UEI, and for applications due on or after January 25, 2022 applicants will be required to have a UEI.

Please see the Notice for the detailed policy change, resources and where to send inquiries by agency.

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NEW NIH FORMS-G GRANT APPLICATION FORMS AND INSTRUCTIONS COMING FOR DUE DATES ON OR AFTER JANUDARY 25, 2021: NOT-OD-21-169 introduces the new FORMS-G grant application forms and application guide instructions for due dates on or after January 25, 2022.

Key Changes:

  • Transition from requirement of the DUNS number to requirement of the government-owned Unique Entity Identifier (UEI). The System for Award Management (SAM) will be the central repository for the UEI, which will be incorporated into an institution’s SAM registration. Although agencies are not required to fully transition until April 2022, NIH, AHRQ, and FDA will transition for due dates on or after January 25, 2022 to align with standard application and review cycles.
  • NIH will require the use of the updated Biographical Sketch and Other Support format pages for submissions on or after January 25, 2022 as announced in NOT-OD-21-073NOT-OD-21-110 and NOT-OD-21-122.
  • All Senior/Key personnel listed on the R&R Senior/Key Person Profile (Expanded) form will be required to have an eRA Commons username (Commons ID).

The Notice provide a full list of form changes in a High-level Summary of Form Changes in FORMS-G Application Packages. Participating agencies will communicate if additional changes are needed.

See NOT-OD-21-169 for availability and implementation plan for the new FORMS-G application guides and packages, resources and where to direct inquiries by agency.

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GUIDANCE ON FLEXIBILITIES FOR CONDUCTING SEMIANNUAL INSPECTIONS OF ANIMAL FACILITIES: NOT-OD-21-164 highlights flexibilities that are available to IACUCs when conducting semiannual inspections. The flexibilities outlined in the Notice may be used alone or in combination to meet institutional needs and circumstances, provided that animal welfare and the quality and rigor of the inspection are not compromised. Please see the Notice for the list of flexibilities reviewed and agreed to by the USDA Animal and Plant Health Inspection Service.

Please direct inquiries to: [email protected].

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EXTENSION OF COVID FLEXIBILITIES FOR INSTRUCTION IN THE RESPONSIBLE CONDUCT OF RESEARCH: NOT-OD-21-152 announces that NIH, AHRQ, and HRSA will extend the flexibility permitting online training in responsible conduct of research through December 31, 2021 even if the declared public health emergency is rescinded before then.

This flexibility applies to all awards requiring instruction in the responsible conduct of research, including research training grants (e.g., T32, T34, T35), individual fellowships (e.g., F30, F31, F32), institutional career development awards (e.g., K01, K08, K12/KL2, K23), and research education awards (e.g., R25).

Please check Funding Opportunity Announcements (FOAs) to see if a specific award is required to provide training in responsible conduct of research.

Please direct inquiries to: [email protected].

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July 2021

UPDATED POLICY FOR FAMILY LEAVE AND UNPAID LEAVE FOR EXTRAMURAL LOAN REPAYMENT PROGRAM RECIPIENTS: NOT-OD-21-153 announces updates to the NIH Loan Repayment Program (LRP) policies regarding Family Leave and Unpaid Leave for LRP recipients.

Recipients of LRP awards are employees at their institutions and all leave requests and decisions (paid/unpaid) are between the LRP recipient and their employer. Any unpaid leave, even if covered by FMLA, results in a reduction (loss) of quarterly LRP payment. The updated policy focuses on how an extended period of unpaid leave might impact an LRP payment or LRP recipient’s ability to continue participation. Effective October 1, 2021, the Award policy will include the following updates:

Family Leave

LRP recipients can take family leave for certain family and medical needs. Recipients must notify the Division of Loan Repayment (DLR) at [email protected] if planning to take family leave at their research institution.

Unpaid Leave

LRP recipients requesting greater than 15 calendar days of unpaid sick leave/60 calendar days of unpaid family leave from their research institution, must request approval from DLR at [email protected] to continue LRP participation. Requests must be signed by the recipient and research supervisor prior to the leave period.

 If approved the leave period may not exceed 12 months, will not reduce the total months of LRP support and LRP award will be extended by the period of unpaid leave. No LRP payments will be made during the leave period and recipients must keep their loan accounts in good standing. Unpaid leave requests that are not approved may reduce the number of quarterly payments or result in a termination of the award.

 Please see the Notice for the full policy updates and where to send inquiries.

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REMINDER REGARDING RECIPIENT AND APPPLICANT GRANTS POLICY RELATED INQUIRIES: NOT-OD-21-151 reminds the extramural research community of best practices when submitting inquiries on grants policies to NIH.

Inquiries concerning the new Biosketch and Other Support guidance from the NIH Office of Policy for Extramural Research Administration (OPERA) should be routed to [email protected]. This is a change from guidance provided in NOT-OD-21-122. Please do not reach out directly to [email protected].

Inquiries concerning administrative management of an award should be directed to OSR Staff supporting the award. If needed, the AOR for the award will direct the question to Grants Management contact listed on the award.

Inquiries concerning scientific considerations that might change the scope of an award should be routed your AOR for review and if needed, a prior approval request should be routed to the Grants Management with a copy to the Program Official by your AOR.

Inquiries concerning the FOA should be directed to the NIH contacts listed in the FOA; scientific questions to the Program Officials and administrative questions to the Grants Management Specialist

Inquiries concerning unclear information in NIH Notices should be directed to the contact listed on the Notice. If the Notice is from OPERA, please do not send inquiries directly to [email protected]. Please route the inquiry to your AOR for review and response or to be routed to OPERA.

 Please direct inquiries to [email protected].

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UPDATED PROCESS FOR REQUESTING DRAWDOWNS OUTSIDE OF THE LIQUIDATION PERIOD: NOT-OD-21-149 updates NOT-OD-21-102 and provides the process for requesting payment from the HHS Payment Management System after the 120-day liquidation period.

NIH expects recipients to request payment within the 120-day liquidation period; however, there may be circumstances that prevent timely drawdown. In these instances, a prior approval request must be submitted to the GMS named on the Notice of Award.

Departments should coordinate preparation of prior approval requests with Contracts and Grants Accounting (CGA). More information to follow from CGA under separate cover. NIH GMS will review requests on a case-by-case basis. NIH GMS will accept requests from the AOR and that include:

  1. The PMS subaccount number
  2. NIH grant number
  3. Amount of funds requested
  4. Justification for the late payment request
  5. Description of action being taken to preclude similar situations in the future

 Please check award end dates. If an award ends September 30, 2021, and it is anticipated that time is needed beyond the 120-day liquidation period in order to achieve orderly closeout of the award, a no-cost extension (NCE) may be necessary. All requests for NCEs should be submitted to OSR 30-60 days prior to the award end date.

Inquiries should be directed through the AOR to [email protected].

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June 2021

 

NIH LOAN REPAYMENT PROGRAM (LRP) 2021: The NIH Loan Repayment Program (LRP) is a set of programs established by Congress designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. The LRPs counteract financial pressure by repaying up to $50,000 annually of a researcher’s qualified educational debt for a commitment to engage in NIH mission-relevant research. 

Application Facts

  • Applications will be accepted from September 1 until November 18, 2021.
  • LRP applications must be submitted electronically using the Application Submission System & Interface for Submission Tracking (ASSIST), https://public.era.nih.gov/assist/.
  • Applications are submitted directly to the LRP by the Applicant as an Individual
  • Applicants will need to have an eRA Commons I.D. 
  • The IBO may be the Chair's administrative delegate, authorized to act on behalf of the Chair

For more details please see the related RFP listed below: 

  • NOT-OD-21-139 Extramural Loan Repayment Program for Clinical Researchers (LRP-CR)
  • NOT-OD-21-140 Extramural Loan Repayment Program for Pediatric Research (LRP-PR)
  • NOT-OD-21-141 Extramural Loan Repayment Program for Health Disparities Research (LRP-HDR)
  • NOT-OD-21-142 Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (LRP-IDB)
  • NOT-OD-21-143 Extramural Loan Repayment Program for Contraception and Infertility Research (LRP-CIR)
  • NOT-OD-21-144 Extramural Loan Repayment Program for Research in Emerging Areas Critical to Human Health (LRP-REACH) 

Please direct all inquiries to NIH LRP Information Center: [email protected] or (866)849-4047.

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NOTICE INFORMING THE COMMUNITY OF APPLICATION FORM ISSUE WITH RFA-RM-21-016 NIH DIRECTOR’S NEW INNOVATOR AWARD PROGRAM (DP2 CLINICAL TRIAL OPTIONAL): NOT-RM-21-030 warns the research community that the forms package for RFA-RM-21-016 did not include Budget forms. To correct this, a new application forms package was posted in Grants.gov, under Competition ID: FORMS-F-REVISED. Users that used the original forms package under Competition ID: FORMS-F will need to transfer information to FORMS-F-REVISED. Please see the notice for complete guidance.

Please direct all inquiries to: [email protected].

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UPDATED NIGMS GUIDELINES FOR FUNDING INVESTIGATORS WITH SUBSTANTIAL OTHER RESEARCH SUPPORT: NOT-GM-21-053 announces updated guidance from the National Institute of General Medical Sciences (NIGMS) on NIGMS Funding for Investigators with Substantial Research Support

This guidance will be used in making funding decisions for research grants to investigators with high levels of research funding from all sources. For the purpose of the guidance NIGMS considers funding from all sources in excess of $1,500,000 in annual total costs to be a high level of research support. Applications under funding consideration for PD/PIs with such funding will require Council review and approval. 

The updated guidance will go into effect for applications under funding consideration at the September 2021 National Advisory General Medical Sciences (NAGMS) Council meeting. 

Please direct all inquiries to Darren Sledjeski, PhD at [email protected].

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NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION TO PAR-19-371 NIAID CAREER TRANSITION AWARD (K22 INDEPENDENT CLINICAL TRIAL NOT ALLOWED) DUE TO COVID-RELATED DISRUPTIONS: NOT-AI-21-062 announces that NIAID will extend eligibility to apply for NIAID K22 Career Transition Award to Promote Award two-receipt cycles (roughly 8 months) for individuals whose eligibility expires between June/July 2021 and February/March 2022 due to COVID-related disruptions. Additionally, individuals who would have been eligible to apply for the June/July 2022 receipt date will have a one-receipt cycle extension (roughly 4 months). 

Please direct all inquiries to Deborah Philip, PhD at [email protected]  

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NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF K99/R00 PATHWAY TO INDEPENDENCE AWARD APPLICATIONS (AND PHYSICIAN-SCIENTIST K99/R00) DUE TO COVID-RELATED DISRUPTIONS: NOT-AI-21-061 announces that announces that NIAID will extend eligibility to apply for NIAID K99/R00 two-receipt cycles (roughly 8 months) for individuals whose eligibility expires between June/July 2021 and February/March 2022 due to COVID-related disruptions. Additionally, individuals who would have been eligible to apply for the June/July 2022 receipt date will have a one-receipt cycle extension (roughly 4 months).

Please direct all inquiries to Deborah Philip, PhD at [email protected]  

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NIA ANNOUNCES NEW POLICY AND PROCEDURES FOR THE REPORTING OF HUMAN SUBJECTS ENROLLMENT DATA FOR NIA CLINICAL RESEARCH TRIALS/STUDIES: NOT-AG-21-029 announces new National Institute on Aging (NIA) policy and procedures that will apply to all NIA supported grants contracts and cooperative agreements that are active as of July 1, 2021 and supports human subjects research as defined by NIH.

New Policy:

In addition to NIH reporting requirements for study enrollment, NIA investigators will be required, on a monthly basis, to electronically submit participant enrollment data into the secure NIA Clinical Research Operations & Management System (CROMS) for all human subjects enrolled in their trials/studies. All new Funding Opportunity Announcements (FOAs), Notices of Award (NoA), and Terms of Agreement (ToAs) will include information about CROMS and NIA’s expectation that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of CROMS as necessary.

Investigators will have the following three options for transferring enrollment data into NIA’s CROMS:

  1. File transfer (one-time Excel template setup and subsequent monthly upload using the Excel file)
  2. Web portal entry (manually enter data monthly through a secure NIA CROMS web portal)
  3. System-to-system transfer (one-time setup with investigator/organization system to push data automatically to CROMS)

NIA will rollout enrollment data entry for clinical trials (per NIH definition for clinical trial) and clinical research (per NIH definition for clinical research)  in CROMS, in three Stages, each Stage will have two Waves:

Stage 1: investigators with awards supporting Alzheimer’s and other dementias (AD/ADRD) clinical trials – communications were sent to investigators on June 15, 2021

  • Wave 1 will begin on July 1, 2021
  • Wave 2 will begin on September 1, 2021

Stage 2: investigators with awards that support non-AD/ADRD clinical trials  

  • Communication of policy and timeframe will be sent to investigators on September 1, 2021
  • Enrollment data entry in CROMS will commence on November 1, 2021

Stage 3: investigators with awards that support all other clinical studies that enroll human subjects

  • Communication of policy and timeframe will be sent to investigators on January 1, 2022
  • Enrollment data entry in CROMS will commence on March 1, 2022 

Please note that the terms outlined here are in addition to and not in lieu of other NIH policies, including the Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the SF424 Application Guide and the Research Performance Progress Report (RPPR). CROMS has the capabilities to allow investigators to generate reports and inclusion enrollment reports to meet requirements for annual NIH/NIA reporting. 

Please direct all inquires to Holly Massette at: [email protected].

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UPDATED AHRQ POLICY FOR LATE APPLICATION SUBMISSION FOR ACTIVE PEER REVIEW OR NATIONAL ADVISORY COUNCIL SERVICE: NOT-HS-21-016 modifies the time requirements for submission and referral of research grant applications from the Agency for Healthcare Research and Quality (AHRQ) advisory groups beginning with applications submitted on or after September 25, 2021.

There is a two-week window of consideration for late submission of grant applications to AHRQ based on the following criteria:

  • A PD/PI is currently an active member of the AHRQ and/or NIH Initial Review Group or study section
  • Review service of a PD/PI on an AHRQ advisory group during the two months preceding or the two months following the application standard due date. Qualifying services include participation in an AHRQ study section as a temporary reviewer, service on an active AHRQ Special Emphasis Panel (SEP), or AHRQ National Advisory Council.
  • Late submission applies only to the individuals with the PD/PI role on the application. For multiple PD/PI applications, it applies to any or all PD/PIs.

 Applications will not be accepted late if the following criteria apply:

  • Applications submitted for non-standard, specific receipt dates (RFAs and some PARs) or activity codes other than R01, R18, R21/R33.
  • Applications for which members have a role other than PD/PI, including appointed members serving as sponsors for fellowship applications or mentors for career award applications, co-investigators, or other key personnel in the application.
  • Review service on NIH review panels as temporary, ad hoc, SEP reviewers and NIH Advisory Council and Boards
  • Late submission due to personal or computer issues

 Please note:

  • Applications must include a cover letter, indicating application of the policy guidance under NOT-HS-21-016 and include the name of the study section or SEP, and the date of the active service.
  • AHRQ does not provide advance permission to submit a late application

 Please direct inquires to Kathryn Roberts Marron, PhD at: [email protected]. 

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May 2021

NIDDK NOTICE OF CONTINUATION OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) AWARD DURING THE COVID-19 PANDEMIC: NOT-DK-21-019 informs the extramural community that due to on-going disruptions caused by the COVID-19 pandemic, the NIDDK will extend the two-receipt cycle extension of eligibility for prospective applicants meeting the requirements for submission of a K01 application from the time period covered by the June/July 2021 due dates through the October/November 2021 due dates. These individuals will be permitted to submit applications up to the February/March, 2022 and June/July, 2022 due dates, respectively. 

The eligibility under this Notice applies only to applicants for a K01 award under PA-20-176: Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required), and PA-20-190: Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed). 

Please see NOT-DK-21-019 for details and examples. 

Inquiries should be directed to Tracy L. Rankin, PhD, MPH at [email protected].

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NIDA EXTENSIONS FOR NRSA FELLOWSHIPS AND CAREER DEVELOPMENT AWARD RECIPIENTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY AFFECTED BY COVID-19: NOT-DA-21-046 clarifies eligibility and application details for NIDA recipients who apply for supplements due to COVID -19 related delays. NIDA recipients considering applying for an extension are strongly encouraged to contact their Program Officer prior to beginning their application. 

Application Criteria

  • Currently funded NIDA F30, F31, F32, K99, K01, K08, K23, or K25 in the final year
  • Funded extensions must be within the scope of the parent grant and cannot exceed 12 months
  • Funded extensions must apply using PA-20-272
  • Recipients who have successfully competed as a PD/PI for a research project grant (RPG) with direct costs of ≥ $100,000 per year are not eligible 

Program Priorities

  • Projects where the entire investment is at-risk, including
    • Human subjects studies in which completion of data collection are critical for project success
    • Longitudinal cohort studies
  • PIs who have been affected by the COVID-19 pandemic beyond the universally experienced disruptions
  • PIs whose grants are ending and the PI does not have any additional funding to support continued research 

Please see NOT-DA-21-046 for detailed application and submission information. 

Inquiries should be directed to Lindsey Friend, PhD at [email protected].

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NEW INBOX FOR INQUIRIES RELATED TO CHANGES TO BIOGRAPHICAL SKETCH AND OTHER SUPPORT FORMAT PAGES: NOT-OD-21-122 informs the research community of a central email inbox created for inquiries related to changes to the biographical sketch and other support.

Effective as of May 18, 2021, please send inquiries related to changes to the biographical sketch and other support templates to [email protected].

NIH encourages the research community to review the currently available resources:

Please direct all inquiries to: [email protected].

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AHRQ POLICY ON THE INCLUSION OF PRIORITY POPULATIONS IN RESEARCH: NOT-HS-21-015 announces that the Agency for Healthcare Research and Quality (AHRQ) is revising its policy on the inclusion of priority populations in research to ensure that all individuals are included in health services research so that the knowledge gained from AHRQ-funded research is equally applicable to all populations.

AHRQ is also expanding its definition of Priority Population to include members of underserved communities described in Section 2(a) of Executive Order 139895 (Advancing Racial Equity and Support of Underserved Communities Through the Federal Government), issued January 20, 2021.

Please see NOT-HS-21-015 for a detailed description of the policy and how it will affect research applications for AHRQ support and the review of those applications.

Please direct all inquiries to Ms. Brenda Harding at: [email protected].

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NOTICE OF INFORMATION: ESTABLISHMENT OF A STANDARD THC UNIT TO BE USED IN RESEARCH: NOT-DA-21-049 informs the research community of a new requirement to measure and report results using a standard THC unit in all applicable human subjects research on cannabis or THC beginning May 7, 2021. 

A standard THC unit is defined as any formulation of cannabis plant material or extract that contains 5 milligrams of THC. 

The goal of this Notice is to increase the comparability of cannabis research studies by establishing a standard unit that can be used to quantify THC exposure, a goal that is a high priority of NIDA leadership and the National Advisory Council on Drug Abuse. It is not the intent of this Notice to prescribe the quantity of THC that is permissible for use in research projects. 

This guidance will apply to applications where THC is a focus of the research and applicants are responsible for determining if use of this standard unit is applicable to their research and the best approach to applying it in their research applications. A justification should be provided for research that does not propose the use of the standard unit. 

Please direct inquiries to Susan Weiss, PhD at: [email protected].

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NIAID FUNDED EXTENSIONS FOR FELLOWSHIP AWARD RECIPIENTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY IMPACTED BY COVID-19: NOT-AI-21-052 provides NIAID specific guidance in addition to NOT-OD-21-052, which provided general guidance for currently funded NIAID Fellowship (F30, F31, F32) award recipients significantly impacted by COVID-19.

NIAID seeks to support F award recipients in the last year of their award for whom an NIAID-supported cost extension will be most impactful toward subsequent funding and transition to independent investigation. 

Eligibility

Applicants meeting the following requirement s may be eligible for a 4-month funded extension using PA-20-272 Administrative Supplement to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional):

  • Must be a currently funded NIAID F30, F31, F32 award recipient
  • Must be in the last year of their award
  • Must have experienced a minimum of a 12-week lab closure or clinical research interruption due to COVID-19 

Funding Criteria

  • Funded extensions provide stipend support and a prorated institutional allowance only
  • Recipients who successfully competed as PD/PI for a research project grant with direct costs of at least $100,000 per year are not eligible 

Please see the Notice for application instructions. Please direct inquiries to: [email protected]

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NIAID FUNDED EXTENSIONS FOR CAREER AWARD RECIPIENTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY IMPACTED BY COVID-19:  NOT-AI-21-051 provides NIAID specific guidance in addition to NOT-OD-21-052, which provided general guidance for early career scientists affected by COVID-19 to request no-cost extensions or funded extensions.  

NIAID is providing an opportunity for K01, K08, K23, K25 and K99 award recipients to apply for a funded extension to support their career development to facilitate successful transition to research independence.

Eligibility

Applicants meeting the following requirement s may be eligible for a 4-month funded extension using PA-20-272 Administrative Supplement to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional):

  • Must be a currently funded NIAID K01, K08, K23, K25 and K99 award recipient
  • Must be in the last year of their award or in a no-cost extension
  • Must have experienced a minimum of a 12-week lab closure or clinical research interruption due to COVID-19
  • K99 recipients in a no-cost extension have additional administrative requirements and are encouraged to contact the grants management specialist 

Funding Criteria

  • Funded extensions provide salary support for the PI only
  • Awards with an unobligated balance equivalent to 1-year of funding or more are not eligible
  • Recipients who successfully competed as PD/PI for a research project grant with direct costs of at least $100,000 per year are not eligible  

Please see the Notice for application instructions. Please direct inquiries to: [email protected]

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April 2021

TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NINDS F32 AWARD DUE TO THE COVID-19 PANDEMIC: NOT-NS-21-059 updates the eligibility requirements specific to PAR-21-032 NINDS Ruth L. Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32 Clinical Trial Not Allowed), under which applicants are only eligible to apply before beginning or within the first 12 months of joining the lab in which the fellowship will be active. 

Due to the impact of the COVID-19 pandemic on newly appointed postdoctoral fellows, NINDS is providing a 1-receipt cycle extension of eligibility to individuals who started in their new laboratory between February 1 and May 30 of 2020. These individuals will be able to apply for the June 2021 due date. 

There is no change to the eligibility window for Individuals who started in their postdoctoral positions before February 1, 2020 or after May 30, 2020. 

Please direct questions to Michael Tennekoon, Ph.D. at [email protected].

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GUIDANCE REGARDING REDUCTION OF EFFORT FOR SURGEONS ON NIA INDIVIDUAL MENTORED K AWARDS: NOT-AG-21-019 announces a change in minimum effort requirement for surgeons on individual mentored career development (K) awards funded by the National Institute for Aging (NIA). 

Effective immediately for surgeons who are applicants for or recipients of NIA individual mentored K mechanisms (including K01, K08, K23, K76, and K99), NIA will allow surgeons to devote less than 75% of full-time professional effort, but no less than 50% of full-time professional effort in all years of the award for the purpose of maintaining clinical competency.

For the purposes of this policy, a surgeon is a physician who is clinically active in one of the 14 surgical subspecialties recognized by the American College of Surgeons . Applicants proposing to reduce their effort below nine person months of effort must provide adequate justification for such reduction.

  • Applicants must include the justification in the budget justification of the application.
  • Current and pending awardees must contact their program officer to confirm eligibility and if eligible, submit a formal request through their Authorized Organizational Representative (AOR), which references this Notice and includes an updated budget and justification. 

Inquiries may be directed to [email protected].

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NOTICE OF SPECIAL INTEREST (NOSI): AVAILABILITY OF FUNDS TO DEFRAY CHILDCARE COSTS FOR NCI, NIA, NIDCR, NIDDK, AND NIH BLUEPRINT PREDOCTORAL TO POSTDOCTORAL FELLOW TRANSITION PROGRAMS F99 AWARDEES: NOT-CA-21-053 announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award. 

  • Eligible individuals must be planning an F99/K00 application or have an active F99/K00 award (still in the F99 phase), from NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN)
  • See the Notice for a listing of eligible FOAs
  • Eligible applicants/recipients may request $2,500 per budget period for the cost of childcare provided by a licensed childcare provider
  • Costs are permitted for dependent children living in the eligible fellow’s home from birth until the age of 13 years, or disabled children under the age of 18 years
  • Elder or non-child dependent care are not covered
  • Follow NOT-OD-21-074 for instructions to request in new (Type 1) or continuation (Type 5) applications
  • Follow NOT-OD-21-075 for instructions to request in administrative supplements (Type3) to existing F99 awards using PA-20-272 

Consult the NOSI for specific instructions and contacts for inquirie

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CONTINUATION OF TEMPORARY EXTENSION OF APPLICANT ELIGIBILITY IN PAR-19-343 “MAXIMIZING OPPORTINITIES FOR SCIENTIFIC AND ACADEMIC INDEPENDENT CAREERS (MOSAIC) POSTDOCTORAL CAREER TRANSITION AWARD TO PROMOTE DIVERSITY (K99/R00): NOT-GM-21-037 announces that NIGMS will be extending the two receipt cycle extension of the eligibility for prospective eligible candidates for a MOSAIC K99/R00 application who experienced delays due to disruptions caused by the COVID-19 pandemic. 

Individuals whose final eligible due dates are June/July 2021 or October/November 2021 will have a 2-cycle eligibility extension to February/March 2022 or June/July 2022, respectively. 

The Notice provides examples to aid potential candidates in determining whether they are eligible for an extension. 

Inquiries may be directed to Kenneth D. Gibbs, Jr., Ph.D., MPH at [email protected]

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CONTINUATION OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIDCR DUAL DEGREE DENTIST SCIENTIST PATHWAY TO INDEPENDENCE AWARD (K99/R00) DURING THE COVID-19 PENDEMIC: NOT-DE-21-003 announces that NIDCR will be extending the two receipt cycle extension of the eligibility for prospective eligible candidates for an NIDCR Dual Degree Dentist Scientist K99/R00 application who experienced delays due to disruptions caused by the COVID-19 pandemic. 

Individuals whose final eligible due dates are June/July 2021 or October/November 2021 will have a 2-cycle eligibility extension to February/March 2022 or June/July 2022, respectively. 

The Notice provides examples to aid potential candidates in determining whether they are eligible for an extension. 

Inquiries may be directed to Leslie A. Frieden, PhD at [email protected].

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UPDATE ON CHANGES TO NIH REQUIREMENTS REGARDING PROPOSED HUMAN FETAL TISSUE RESEARCH: NOT-OD-21-111 announces that HHS is reversing its decision (NOT-OD-20-053) that all research applications for NIH grants proposing the use of human fetal tissue from elective abortions be reviewed by an Ethics Advisory Board. HHS/NIH will not convene another NIH Human Fetal Tissue Research Ethics Advisory Board. All other requirements described in NOT-OD-19-128 and NOT-OD-19-137 for extramural research remain unchanged.

NIH also reminds the research community of expectations to obtain consent from the donor for any NIH-funded research using human fetal tissue (NOT-OD-16-033), and continue to conduct such research in accordance with applicable Federal, State, and local laws and regulations, including prohibitions on the payment of valuable consideration for human fetal tissue.

Please direct all inquiries to: [email protected].

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IMPLEMENTATION OF UPDATED BIOGRAPHICAL SKETCH AND OTHER SUPPORT FORMAT PAGES: NOT-OD-21-110 describes the implementation of the updated Other Support and Biosketch format and instructions outlined in NOT-OD-21-073.

NIH expects applicants and recipients to use the updated other support and biosketch format for applications, Just-In-Time (JIT) reports, and Research Performance Progress Reports (RPPRs) commencing May 25, 2021. If applicants and recipients choose not to use the updated format pages at this time, they must still capture all the necessary information.

Beginning with due dates on or after January 25, 2022, failure to follow the appropriate formats may cause NIH to withdrawal applications from or delay consideration for funding.

Please direct inquiries to [email protected].

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EXPANDING REQUIREMENT FOR eRA COMMONS IDs TO ALL SENIOR/KEY PERSONNEL: NOT-OD-21-109 informs the research community that effective with applications due on or after January 25, 2022, Senior/Key Personnel (as defined in NIH GPS 1.2) who are listed on the R&R Senior/Key Person Profile (Expanded) form including Other Significant Contributors, must enter their eRA Commons ID in the “Credential, e.g. agency login” field. This applies to the individual components in addition to the Overall component of multiple-component applications. If your collaborators are experiencing problems, please work with your OSR Staff to resolve the problem.

It is important to note that commencing late April, applicants will encounter an eRA validation if the “Credential, e.g. agency login” field does not contain a valid eRA Commons ID. The validation will serve as a warning for at 2 council rounds before it is escalated to an error that will STOP the application until it is corrected. It is strongly recommended that eRA Commons IDs be entered for all individuals listed on the Senior/Key Person Profile to avoid future errors. 

As a reminder, all individuals with a scientific role should have only one eRA Commons ID for the life of their research career. 

For inquiries, please see the Notice.

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PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. APRIL 2021) FOR FISCAL YEAR 2021: NOT-OD-21-107 announces the publication of the NIH Grants Policy Statement (NIH GPS Rev. April 2021). The revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2020. Previous versions of the NIH GPS remain applicable as the standard terms and conditions of award for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2020. 

A document outlining notable policy changes and clarifications is posted with the current NIH GPS. Please note that this document does not include modifications to application instructions. 

Please direct inquiries to [email protected].

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CONTINUATION OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIH K99/R00 PATHWAY TO INDEPENDENCE AWARD DURING THE COVID-19 PANDEMIC: NOT-OD-21-106 announces that due to disruptions caused by COVID-19 NIH will continue the two-receipt cycle extension (roughly eight additional months) of eligibility for prospective, eligible candidates for a K99/R00 application. Individuals whose final due date eligibility based on a 48-month eligibility window was either the June/July 2021 or October/November 2021 will have a 2-cycle extension of eligibility (to February/March 2022 and June/July, 2022, respectively). 

Please see the Notice for the detailed implementation plan. Prospective applicants should direct inquiries related to their specific circumstances to the NIH Institute or Center to which their application will be submitted. 

Please direct inquiries to [email protected].

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REMINDER: REQUIRED USE OF FORMS-F APPLICATION FORMS FOR APPLICATION SUBMISSION: NOT-OD-21-104 reminds the research community that NIH has extended some late submission windows and allowed FORMS-E application forms to provide flexibility to applicants during the COVID-19 Pandemic. This flexibility has ended and all grant applications must use FORMS-F. Effective April 19, 2021, any remaining FORMS-E forms packages will be closed.

Additionally, the Notice lists FORMS-F options for competing revision FOAs and non-competing parent FOAs.

Please direct inquiries to [email protected].

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UPDATED NCI GUIDANCE CONCERNING THE MENTORED CLINICAL SCIENTIST RESEARCH CAREER DEVELOPMENT AWARD: PERCENT EFFORT OF SURGEON-SCIENTISTS FOR K08 AWARDS FROM NCI: NOT-CA-21-054 announces that the National Cancer Institute (NCI) will make the following changes to K08 applications submitted to NCI for due dates on or after June 12, 2021. 

    NCI will allow U.S.-licensed surgeon-scientists with active surgical duties to request less than the required 9 person months (75%) of full-time effort under a K08 award for the specific purpose of maintaining specialty clinical competency.
  • Applicants may not request less than 6 person months (50%) of full-time professional effort devoted to research and career development
  • Applicants must include a justification that clearly states the reason(s) for the effort reduction in:
  • the Candidate’s Plan for Career Development/Training Activities During Award Period
  • the Mentor’s letter
  • the Institutional commitment letter
  • Applicants must upload a copy of their current U.S. clinical license (and board certification, if applicable) as Other Attachments in the application
  • Applicants must include all relevant information, e.g. surgical training, clinical license, expiration date, board certification in their NIH Biosketch 
  • Please direct inquiries to Susan Lim, PhD at: [email protected].

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    CHANGES TO NINDS ADMINISTRATIVE REDUCTION POLICY FOR MODULAR R01 AWARDS: NOT-NS-21-053 announces that NINDS will no longer apply administrative reductions to modular investigator-initiated R01 grants as of the September 2020 NANDS Council round.

    NINDS will continue to apply the 17.5% administrative reduction to non-modular R01 awards. Please see the Notice for NINDS Funding Strategy and budget development guidance.

    Please direct inquiries to David Owens, PhD at: [email protected],

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    REMINDER OF NIH POLICIES RELATED TO CLOSEOUT: NOT-OD-21-102 reminds NIH recipients of the deadlines for drawing funds from the Payment Management System (PMS). A recipient may draw funds up to the date that its Final Federal Financial Report (FFR) is due to NIH or up to 120 days past the period of performance end date. 

    Recipients must submit a final FFR, Final Research Performance Progress Report (RPPR), and Final Invention Statement and Certification within 120 calendar days of the end of the period of performance.

    In the event that additional time is needed to fulfill the closeout requirements (e.g. prepare, revise, or amend financial reports), a no-cost extension should be requested. 

    If a recipient needs to revise or amend previously submitted expenditures more than 120 days past the period of performance end date in order to revise a previously submitted FFR,the AOR must notify the IC Grants Management Specialist listed in the NoA for additional guidance.  

    Grants policy questions should be directed to [email protected].

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    March 2021

    EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICYT DURING THE COVID-19 PANDEMIC: JANUARY 2022 COUNCIL:  NOT-OD-21-095 extends special exception for preliminary data as post-submission material (see NOT-OD-20-123NOT-OD-20-163; and NOT-OD-20-179) to applications submitted for the January 2022 Council round. 

    Beginning with applications submitted for the May 25, 2021 due date for the Fall 2021 review meetings, the NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. One page of preliminary data will be accepted for single component applications or for each component of a multi-component application. 

    Please see the Notice for details and where to send inquiries.

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    CONTINUED EXTENSION OF CERTAIN FLEXIBILITIES FOR PROSPECTIVE BASIC EXPERIMENTAL STUDIES WITH HUMAN PARTICIPANTS: NOT-OD-21-088 rescinds NOT-OD-19-126 and extends flexibilities regarding registration and results reporting (in clinicaltrials.gov) for some types of basic experimental studies with humans (BESH), referred to as “prospective basic science studies involving human participants,” which meets the Federal definition of basic science (see NOT-OD-18-212). 

    Registering and results reporting in clinicaltrial.gov poses a challenge for some types of BESH projects:

    • NIH expects that these projects use alternate publicly available platforms, which should be described by applicants in the Dissemination Plan attachment of their NIH application.
    • Awardees of BESH FOAs that are not using clinicaltrials.gov should provide in the RPPR, the unique identifier assigned by the alternative platform and if possible a link to the results report in the alternative platform 

    This additional extension will last through September 24, 2023, allowing NIH to continue to work with the BESH community to explore solutions that allow dissemination of information, while maintaining transparency and NIH commitment to stewardship. 

    Additionally, NIH reminds BESH applicants and recipients of the following expectations:

    • Continued Good Clinical Practice (GCP) training per NOT-OD-16-148
    • Posting of informed Consent forms per NOT-OD-19-110
    • Continued requirement for completion of the PHS Human Subjects and Clinical Trials Information (HSCTI) form in applications, which will be evaluated using the clinical trial review criteria 

    Inquiries should be directed to: [email protected].

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    UPDATED REPORTING REQUIREMENTS FOR RADx-rad GRANT RECIPIENTS: NOT-OD-21-084 updates the reporting requirements of awards issued in response to RFAs and NOSIs under the RADX Radical (rad) initiative. Please see the Notice for specific RFA and NOSI numbers. 

    In addition to the annual RPPR, recipients of subject awards are required to submit an interim progress report every six months, outlining key milestones met. Reports for the first year of the award(s) are due on June 30, 2021 and should be uploaded using the Additional Materials (AM) tool in eRA.  Please see the Notice for specific instructions and details. 

    Questions regarding the specific grant awards should be directed to the Grants Management Specialist identified in the Notice of Award. 

    Grants policy questions should be directed to [email protected].

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    CORRECTED ANNOUNCEMENT OF CHILDCARE SUPPORT FOR NRSA INDIVIDUAL FELLOWS: NOT-OD-21-074 rescinds NOT-OD-21-069 the announcement of Childcare Costs for Kirschstein NRSA Individual Fellows issued on March 1, 2021 and corrects the instructions for new and administrative supplement applications. 

    Per the corrected instructions, applicants must include the childcare cost request for the first year (i.e. $2,500 for 12 months) on the PHS Fellowship Supplemental Form and enter NIH as the Source. Any additional years requested must be included in an attachment uploaded in the Other Attachments section of the R&R Other Project Information form. 

    Please see NOT-OD-21-074 for detailed instructions to request childcare costs on new applications, administrative supplement applications, and continuations (RPPR). 

    Also see Frequently Asked Questions: https://grants.nih.gov/faqs#/funding_programs_childcare_costs.htm 

    Please direct inquiries on policy to [email protected].

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    UPCOMING CHANGES TO THE NIH BIOGRAPHICAL SKETCH AND OTHER SUPPORT FORMAT PAGES: NOT-OD-21-073 announces changes to NIH Biographical Sketch and Other Support forms and instructions. The new forms and instructions apply to applications and RPPRs submitted for due dates on or after May 25, 2021.  

    NIH BIOSKETCH:  NIH Biosketch webpage for forms/instructions/Samples/FAQs 

    Please note that during the transition to the new Biosketch format, NIH will not withdraw applications that include the previous Biosketch format. Beginning with applications submitted on or after January 25, 2022 failure to follow the updated Biosketch format may cause NIH to withdraw the application from consideration.  Please review the updated Biosketch format and instructions for complete details. 

    Notable changes to the NIH Biosketch

  1. Section A Personal Statement – will include ongoing and completed research projects from the past three years that you want to draw attention to (previously captured under Section D. Research Support).
  2. Section B Positions, Scientific Appointments, and Honors – in reverse chronological order, list all positions and scientific appointments both foreign and domestic, including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
  3. Section D Research Support
    • Non-Fellowship Biosketch Template – Removed entirely
    • Fellowship Biosketch Templates – changed to Scholastic Performance 

Researchers may wish to consider transitioning to the updated NIH Biosketch template when it becomes available in SciENcv. Using SciENcv eliminates the need to repeatedly enter data on a Word document. Researchers will also be able to leverage their information from the eRA Commons, Research.gov, ORCID, and NCBI. 

NIH OTHER SUPPORT: NIH Other Support webpage for forms/instructions/sample/FAQs 

The new format and instructions apply to applications and RPPRs submitted for due dates on or after May 25, 2021.  

Notable changes to the NIH Other Support: 

  • Re-organized entire format (see Other Support sample)
  • Effort is projected for each budget period for the entire project period
  • Separation of funded projects from in-kind contributions
  • Signature block added for PD/PI or Senior/Key Personnel certification of accuracy of information – each PD/PI or Senior/Key Personnel must electronically sign their respective Other Support section prior to submission
  • Requirement of support documentation - Other Support submissions that include foreign activities and resources must include copies of contracts, grants, or any other agreement specific to Senior/Key Personnel foreign appointments and/or employment with a foreign institution as part of the Other Support. All supporting documents must be in English
  • When a recipient organization discovers that the PI or other Senior/Key Personnel failed to disclose outside of JIT or the RPPR, they must submit an updated Other Support as soon as it becomes know  

NIH is finalizing the template to accommodate Other Support requirement updates in SciENcv and anticipates that it will be available beginning in FY 2022. Until the SciENcv template is available, the Interim Process must be followed for the May 25, 2021 due date and forward: 

  • Applicants and recipients must use Word Format page to prepare Other Support
  • Forms must be converted to PDF
  • PDF forms must be electronically signed prior to submission 

The Office of Sponsored Research is conducting training for the campus to complete the Word Other Support Template and Interim Process to accommodate Other Support updates.

Please note that the updates do not change the policies.

Please direct systems/forms inquiries to: [email protected] 

Please direct grant policy inquiries to: [email protected] 

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UPDATED NOTICE OF INFORMATION: NHLBI EXTENSIONS FOR CAREER DEVELOPMENT AWARD (K01,K08,K23,K25) RECIPIENTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY IMPACTED BY COVID-19: NOT-HL-21-009 updates instructions provided in NOT-HL-21-005 to submit applications using PA-20-272 instead of submitting a direct request to the Grants Management Specialist and Program Official named in the Notice of Award. 

Please see the Notice for detailed updated application instructions. 

Inquiries should be directed to: 

Roya Kalantari, Ph.D. at [email protected]

Wayne Wang, Ph.D. at [email protected]

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NHLBI EXTENSIONS FOR CAREER DEVELOPMENT AWARD (K01, K08, K23, K25) RECIPIENTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY IMPACTED BY COVID-19NOT-HL-21-005 provides NHLBI-specific guidance in addition to NOT-OD-21-052, which provided general guidance for early career scientists affected by COVID-19 to request no-cost extensions or funded extensions. 

NHLBI is providing an opportunity for select K recipients (K01, K08, K23, K25) to apply for a funded extension to support their career development and successful transition to research independence. Successful applicants may receive a 4-month funded extension. Successful clinician applicants who had experienced increased clinical duties due to COVID-19 may receive an additional 2-month extension (or a total of 6 months). 

Eligibility Criteria:

  1. Currently a funded NHLBI K01, K08, K23 or K25 recipient
  2. Award is in the final year or no-cost extension
  3. A minimum of 12-week lab closure or clinical research interruption experienced due to COVID-19
  4. Awards with unobligated balances equivalent to 1 year or more of funding are not eligible
  5. Individuals who successfully competed as PD/PI for a Research Project Grant with direct costs equal to $100,000 per year are not eligible

If eligible, please see NOT-HL-21-009 for specific, detailed instructions to apply for a funded extension using PA-20-272. Please also note: 

  1. All application packages must be submitted by the Authorized Organization Representative (AOR) Signing Official (SO) to the GMS and PO named in the Notice of Award
  2. Applicants are encouraged to consult with their Program Official prior to submission
  3. Application packages must be received by the following due dates
    • April 15, 2021
    • June 25, 2021
    • May 17, 2021
  4. Though not eligible, NHLBI individual fellowship (F series) and K99 recipients may contact their respective Program Officer to discuss the effects of COVID-19 on their awards. 

Please direct all inquiries to Roya Kalantari, PhD at [email protected] or Wayne Wang, PhD at [email protected]

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UPDATED NHLBI GUIDANCE CONCERNING MENTORED CAREER DEVELOPMENT (K08 AND K23) AWARDS PERCENT EFFORT: NOT-HL-21-003 acknowledges that individuals in medical specialties that require significant clinical activity in order to maintain specialty clinical competency skills may be unable to devote the required minimum 75% of full-time professional effort required by K awards. 

NHLBI will allow cardiothoracic vascular and trauma surgeons, interventional cardiologists, and electrophysiology cardiologists to request less than the required 75% effort to specifically to maintain their specialty clinical competency skills. Individuals in these specialties may request a minimum of 50% effort on competing NHLBI K08/K23 applications on or after June 12, 2021. A clear justification for the reduced level of effort must be included in the application. 

NHLBI K08/K23 awardees who did not originally request a reduced level of effort in their applications may request consideration of the reduction of effort in the last two years of their awards regardless of whether they receive a subsequent NIH research award or equivalent per NOT-OD-08-065

NHLBI will adjust the total salary support committed to the K award consistent with the adjusted level of effort. 

Please direct inquires to contacts listed on the Notice.

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NHGRI GUIDANCE FOR THIRD-PARTY INVOLVEMENT IN EXTRAMURAL RESEARCH: NOT-HG-21-023 announces that the National Human Genome Research Institute (NHGRI) is open to third-party involvement in NHGRI-supported studies and contracts, so long as the primary purpose of the studies and contracts is not compromised and NHGRI policies are followed. Please see Guidance for Third-party Involvement in NHGRI-Supported Extramural Projects

Please direct inquiries to: [email protected].

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ANNOUNCEMENT OF CHILDCARE COSTS FOR RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARD (NRSA) INDIVIDUAL FELLOWS: NOT-OD-21-069  rescinded and replaced by NOT-OD-21-075 announced that NIH will begin providing childcare support to recipients of NRSA fellowships (F series), on or after April 8, 2021. Phase II of this initiative will provide a similar cost for NRSA-supported trainees. Look for implementation and guidance in early FY 2022. 

Highlights:

  • Applies to full-time NIH-NRSA-supported fellowship positions
  • Each fellow is eligible to receive $2,500 per budget period for costs for childcare provided by a licensed childcare provider
  • Childcare costs are permitted for dependent children living in the eligible fellow’s home from birth under the age of 13, or children who are disabled and under age 18.
  • Childcare costs do not apply to elder or non-child dependent care costs.
  • Childcare costs are not tied to payback obligations, nor should it be reported as such.
  • Include in New applications for the April 8, 2021 due date and forward
  • Existing awards can request in the RPPR or through Administrative Supplement NOT-OD-21-070.

NOTE: When awarded, childcare costs are generally restricted and cannot be rebudgeted without prior written approval from the NIH awarding IC. In cases of early termination, recipients may not use any unused portion of the childcare costs. It will remain unobligated and will be adjusted by the agency as part of the closeout process. 

Please see NOT-OD-21-075  NOT-OD-21-069 for specific application instructions and FAQs.

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February 2021

NATIONAL HUMAN GENOME RESEARCH INSTITUTE’S (NHGRI) EXPECTATION FOR SHARING QUALITY METADATA AND PHENOTYPIC DATA: NOT-HG-21-022 announces NHGRI’s efforts to improve the availability and quality of ‘relevant associated data’ as it is referred to in the NIH Genomic Data Sharing (GDS) Policy (e.g., metadata and phenotypic data). 

Effective June 5, 2021, this Notice applies to projects subject to NHGRI implementation of the NIH Data Sharing Policies, including the NIH Genomic Data Sharing Policy and the NIH Data Management and Sharing Policy

NHGRI-funded and supported researchers are expected to:

  • Share the metadata and phenotypic data associated with the study
  • Use standardized data collection protocols and survey instruments for capturing data, as appropriate
  • Use standardized notation for metadata (e.g. controlled vocabularies or ontologies) to enable the harmonization of data sets for secondary research analyses 

When preparing grant proposals for NHGRI funds, applicants should include in their budget the cost of activities that are necessary to support data sharing, including the sharing of comprehensive and standardized metadata and phenotypic data. Metadata and phenotypic data are to be shared on the same timeline as genomic data (see NHGRI Data Standards page for data submission and release guidance). 

Please see the Notice for recommended Resources and where to direct inquiries.

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NIBIB GUIDANCE FOR SUPPORT OF CLINICAL TRIAL APPLICATIONS: NOT-EB-21-005 informs National Iinstitute of Biomedical Imaging and Bioengineering (NIBIB) applicants of the process for support of clinical trials for individuals who plan to submit applications involving clinical trials.

Effective for applications for the April 5, 2021 receipt date and forward, NIBIB will only support early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials that inform early stage technology development, for applications submitted using the NIH Parent funding opportunity announcements (FOAs) and their subsequent reissuances. Under these announcements, NIBIB will not support applications proposing pivotal, Phase II, III, IV or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. 

In advance of submitting a clinical trial application, NIBIB strongly encourages applicants to consult with the Scientific/Research contacts listed in NOT-EB-21-005

Please direct inquiries to appropriate contact listed in the Notice.

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POLICY ON PROTECTING LIFE IN GLOBAL HEALTH ASSISTANCE IS REVOKED: NOT-OD-21-063 rescinds previously issued notices concerning NIH’s implementation of the requirements for Protecting Life in Global Health Assistance (PLGHA) policy (NOT-OD-17-083 and NOT-OD-19-079).

On January 28, 2021, President Biden issued a Presidential Memorandum (“Memorandum on Protecting Women's Health at Home and Abroad”) revoking the “Protecting Life in Global Health Assistance” (PLGHA) policy.

Effective immediately, implementation and enforcement of the PLGHA standard provisions are waived for all current National Institutes of Health grant and cooperative agreement awards.

Please direct inquiries to: [email protected]

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NOTICE OF CHANGES IN THE REVIEW CRITERIA FOR APPLICATIONS SUBMITTED FOR NIH SUPPORT FOR SCIENTIFIC CONFERENCES (R13/U13): NOT-OD-21-055 announces changes to the review criteria for applications submitted for NIH support of Scientific Conferences (R13 and U13) related to the implementation of guidelines announced in NOT-OD-21-053.  All changes take effect for R13/U13 applications submitted for the April 12, 2021 application due date and subsequent receipt dates.

  •  Applications are required to include a Diversity Plan, which reviewers will evaluate plan demonstrate efforts to enhance diversity by increasing the participation of individuals from diverse backgrounds, including those from underrepresented groups, in the planning and implementation, and participation in the proposed conference. The Diversity Plan will be considered in determining the scientific and technical merit of the application, and in providing an overall impact score.
  • Applicants should describe past experiences with enhancing diversity by increasing the participation of individuals from diverse backgrounds, including those from underrepresented groups, in biomedical sciences when preparing the Personal Statement of their Biographical Sketches. Reviewers will evaluate if the applicant and key personnel are suited to fulfill the goals of the conference and qualified to perform their roles in the conference.

 Please direct inquiries to: [email protected].

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REQUESTING EXTENSIONS FOR EARLY CAREER SCIENTISTS WHOSE CAREER TRAJECTORIES HAVE BEEN SIGNIFICANTLY IMPACTED BY COVID-19: NOT-OD-21-052 informs recipients of NIH individual fellowships (F series) and NIH career development awards (K series) that NIH is providing an opportunity to request extensions to those whose career tracks have been impacted by COVID-19.

No-Cost Extension

Most NIH award recipient may extend the final budget period up to 12 months without prior approval. Recipients of individual fellowships and some career development awards, e.g. K99 may submit requests for extension. Recipients may also submit prior approval requests for a second no-cost extension. Requests will be considered by ICs on a case-by-case bases. Recipients should work with their OSR Staff.

Funded Extension

Requests for funded extensions from recipients of individual fellowships (F) and career development awards (K) will be considered on a case-by-case basis by each IC. Recipients should work with their OSR Staff.

All requests must include a justification outlining the impact of COVID-19 on the recipient’s training or career development activities.

See the Notice for details and where to send inquiries.

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January 2021

NOTICE OF FISCAL POLICIES IN EFFECT FOR FY 2021: NOT-OD-21-058 provides information on NIH Fiscal Operations for FY 2021 and implements the Consolidated Appropriations Act 2021 (PL 116-260) signed into law on December 27, 2020.

The Notice summarizes Fiscal Policies instituted in FY 2021, listed below:

  • FY 2021 Funding Levels
  • Ruth L. Kirschstein National Research Service Awards (NRSA) – NOT-OD-21-049 information oncampus implementation to follow in an OSR Announcement
  • Next Generation Researchers Initiative Policy – NOT-OD-17-101
  • Salary Limits – NOT-OD-21-057 information on campus implementation to follow in an OSR Announcement
  • Other Legislative Mandates – NOT-OD-21-056

 Please direct inquiries to: [email protected]

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NOTICE OF LEGISLATIVE MANDATES IN EFFECT FOR FY 2021: NOT-OD-21-056 provides the current statutory provision that limits or conditions the use of funds on NIH grants, cooperative agreements, and contract awards for FY 2021.

FY 2021 Mandates

  • Salary Limitation
  • Gun Control
  • Anti-Lobbying
  • Acknowledgement of Federal Funding
  • Restriction on Abortions
  • Exceptions to Restriction on Abortions
  • Ban on Funding Human Embryo Research
  • Limitation on Use of Funds for Promotion of Legalization of Controlled Substances
  • Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory Committee Candidates
  • Dissemination of False or Misleading Information
  • Restriction of Pornography on Computer Networks
  • Restriction on Distribution of Sterile Needles

 Please see NOT-OD-21-056 for details in each area.

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GUIDANCE ON SALARY LIMITATION FOR GRANTS AND COOPERATIVE AGREEMENTS FY 2021: NOT-OD-21-057 provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards.

Effective January 3, 2021, the salary limitation for Executive Level II is $199,300.

Information on campus implementation will follow in an OSR Announcement.

For a historical record of the salary cap, including effective dates see: https://grants.nih.gov/grants/policy/salcap_summary.htm

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RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPENDS, TUITION/FEES AND OTHER BUDGETARY LEVELS EFFECTIVE FOR FISCAL YEAR 2021: NOT-OD-21-049 supersedes NOT-OD-20-070 and provides the FY 2021 stipend levels for Kirschstein NRSA awards for undergraduate, predoctoral, and postdoctoral trainees/fellows, effective for awards made on or after October 1, 2020.

  • Calculation of tuition and fees remains unchanged.
  • Training Related Expenses on Institutional Training Grants remains unchanged
  • Institutional Allowance for Individual Fellows remains unchanged

 Information on campus implementation to follow in an OSR Announcement.

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FDA GRANTS/COOPERATIVE AGREEMENTS – CLINICAL TRIAL INSURANCE REQUIREMENTS: NOT-FDA-21-005 notifies the FDA applicants and recipients of the requirement to acquire Clinical Trial Insurance on FDA grants/cooperative agreements involving clinical trials. 

Clinical Trial liability insurance should cover all liabilities, damages, losses, injuries, complaints and/or claims arising from the trial, including but not limited to malpractice and/or negligence. 

Applicants should include the cost of this insurance in the budget and will be responsible for maintaining a certificate of insurance that satisfies relevant regulations/guidance/policies including local requirements. 

Please direct inquiries to: [email protected]

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UPDATED GUIDELINES FOR ENHANCING DIVERSITY AND CREATING SAFE ENVIRONMENT IN CONFERENCES SUPPORTED BY NIH GRANTS AND COOPERATIVE AGREEMENTS: NOT-OD-21-053 updates the guidance on enhancing the diversity of conferences supported by NIH under R13 and U13 activity codes and replaces guidance in NOT-OD-03-066.

 The Notice updates the policy for NIH-supported conferences/scientific meetings to include:

  • Plans to enhance Diversity are included in the application (see NOT-OD-20-031 NIH Interest in Diversity)
  • Strategies that seek to prevent or mitigate the effects of discrimination and harassment, sexual and otherwise (see NOT-OD-15-152 Civil Rights Protections)
  • Accessibility as outlined by Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act of 1990.

 Please see NOT-OD-21-053  for details in each area.

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FDA-MANDATORY SUBMISSION OF THE FEDERAL FINANCIAL REPORT (FFR) IN THE PAYMENT MANAGEMENT SYSTEM BEGINNING JANUARY 1, 2021:  NOT-FD-21-004 announces that in alignment with HHS, the Food and Drug Administration (FDA) is implementing the requirement to submit Federal Financial Reports (FFRs) using the Payment Management System (PMS) effective January 1, 2021.

This change the will not affect the FFR submission timeline. FFR due dates outlined in the Notice of Award remain unchanged.

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December 2020

REMINDER-MANDATORY SUBMISSION OF THE FEDERAL FINANCIAL REPORT (FFR) IN THE PAYMENT MANAGEMENT SYSTEM BEGINNING JANUARY 1, 2021: NOT-OD-21-046 reminds NIH award recipients that Federal Financial Reports (FFRs) submitted on or after January 1, 2021 must be submitted in the Payment Management System (PMS).

The Notice provides implementation details (e.g. direct access to the PMS using the new Manage FFR button in the eRA Commons) and system changes resulting from the transition to PMS (e.g. Indirect Expense Section 11 of the FFR form is now limited to ten F&A rates).

Training sessions offered by PMS for recipients will be posted at this link as they become available: https://pms.psc.gov/training/grant-recipient-training.html

Please direct all systems policy inquiries to:

NIH Office of Policy for Extramural Research Administration (OPERA)

Systems Policy Branch
Email: [email protected]

Please direct all eRA systems-related inquiries to:

eRA Service Desk
Submit a web ticket: https://grants.nih.gov/support/index.html
Toll-free: 1-866-504-9552
Phone: 301-402-7469

Please direct all PMS systems-related inquiries to:

ONE-DHHS Help Desk
Self-Help Web Portal: https://postprod.ams.hhs.gov/amsApp/help/genericContactHelpdesk.html 
Email: [email protected]
Toll-free: 1-877-614-5533

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REQUIRED USE OF TWO-FACTOR AUTHENTICATION USING LOGIN.GOV FOR ERA’s MODULES IN 2021: NOT-OD-21-040 informs the research community that by September 15, 2021, NIH eRA users will be required to use Login.gov to access external eRA modules, e.g. Commons, Commons Mobile, Internet Assisted Review (IAR) and ASSIST. Login.gov is a shared service, 2-factor authentication provider managed by General Services Administration (GSA).

eRA will rollout the requirement to associate eRA accounts to Login.gov stating with users of the IAR module. The new requirement will be phased in for reviewers meeting by meeting starting with the February 1, 2021 meeting and forward.

eRA Commons and ASSIST users should plan to associate their eRA Commons and Login.gov accounts any time before the mandatory implementation deadline of September 15, 2021.

Users can only have one eRA account associated to one Login.gov account. If you have more than one eRA account please consult the FAQs: https://era.nih.gov/faqs.htm#XXIV11

Once a user has transitioned to Login.gov, they should not use their eRA credentials and password to access NIH eRA modules.

See step-by-step instructions, FAQs, video tutorials and more at: https://era.nih.gov/register-accounts/access-era-modules-via-login-gov.htm

Direct all inquiries to the eRA Service Desk: https://grants.nih.gov/support/index.html

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REMINDER - EXPIRING FUNDS ALERT TO AHRQ GRANT RECIPIENTS WHO RECEIVED MULTI-YEAR-FUNDED AWARDS: NOT-HS-21-004 reminds recip;ients of AHRQ multi-year-funded (MYF) or awards funded by fixed year appropriations in Fiscal Year 2016, that the 2016 fixed appropriations will expire on September 30, 2021 Upon expiration, funds will no longer be available to the grantee or AHRQ.

The deadline to drawdown funds is generally a few days before September 30. Please check the Program Support Center (PSC) Payment Management System (PMS) website for information regarding the last day to draw funds: https://pms.psc.gov/grant-recipients/cancelled-awards.html.

Please direct inquiries to [email protected].

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UPDATED INSTRUCTIONS ON INTERIM REPORTING AND CARRYOVER FOR RADx-UP RECIPIENTS: NOT-OD-21-038 updates the terms and conditions of award for recipients of competitive revisions under the RADx Underserved Populations (RADx-UP) initiative. This Notice applies only to awards for the following NOSIs:

  • NOT-OD-20-121 NOSI: Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing Among Underserved and/or Vulnerable Populations
  • NOT-OD-20-120 NOSI: Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing Among Underserved and/or Vulnerable Populations
  • NOT-OD-20-119 NOSI: Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing Among Underserved and/or Vulnerable Populations

Multiple PD/PI Requirements

Competitive revisions to parent awards with multiple PD/PIs (MPIs) must align with PD/PIs on the parent. Members may be added to the leadership team to provide expertise for the supplement; however, the contact PD/PI and MPIs may not differ for the parent award. Any changes to contact and MPIs must be submitted in a prior approval request with an updated leadership plan.

Interim Reports

In addition to the annual RPPR, an interim progress report is due every six months for each competitive revision supplement outlining key milestones that have been met. Due Dates: for awards issued September 2020 interim reports are due March 31, 2021; for awards issued November 2020, interim reports are due May 31, 2021

Beginning March 31, 2021 interim reports must be uploaded using the Additional Materials (AM) tool in the eRA Commons. The AOR will be required to submit reports to the GMO named on the NoA.

The interim progress report must outline:

  • A brief summary of major activities, significant results, and key outcomes or other achievements for each specific aim.
  • Funds obligated how much are unliquidated obligations and how much are unobligated.
  • If recipient is on track to meet the 75% milestone, if not, provide a justification.

Annual Reports

Competitive revision supplement information will be reported in the annual RPPR, Section G.1 as directed in the current term of award and must include updates to the information provided in the interim report. For parent awards in an extension, recipients must upload the annual report including budget information for the next year using the AM tool in the eRA Commons.

Carryover

Recipients of competitive revision supplements are expected to complete 75% of their milestones along with the accompanying budget within the first 12 months of the project. Recipients maintain authority for automatic carryover of unobligated balances; however, NIH staff will monitor drawdowns in the PMS for large unobligated balances. NIH may offset where performance and expenditure milestones have not been met.

Please direct inquiries to [email protected].

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November 2020

ROLLOUT OF REDESIGNED eRA COMMONS HOME AND LANDING SCREENS IN JANUARY 2021: NOT-0D-21-028 announces the redesign of the home screen (log-in screen) and the landing screen (screen once logged in). A significant change will be that once logged in, the eRA modules will be accessed through an application menu that will be located at the top-left of the screen.

eRA has posted a Take A Peak webpage where users can preview the new home screen and landing screen.

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EXTENDED GUIDANCE FOR APPLICANTS PREPARING APPLICATIONS DURING THE COVID-19 PANDEMIC: NOT-OD-21-026 informs NIH applicants that the guidance for applicants preparing applications during the COVID-19 pandemic (NOT-OD-20-122) is extended until further notice.

NIH grant applications should not include contingency plans outlining “steps needed to recover from temporary, emergency situations, or institutional return-to-the-workplace plans, resulting from the COVID-19 pandemic”. Such contingency plans will not be reviewed during the peer review process. If necessary, NIH staff will review the requested COVID-19 contingency plans carefully before funding.

Temporary, emergency situations due to the COVID-19 Pandemic will not affect review scores. Example situations include, but are not limited to:

  • Temporary declines in productivity
  • Availability of key personnel
  • Proposed patient populations
  • Animal facility shutdowns

Please direct all inquiries to: [email protected]

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AHRQ GUIDE NOTICE ON EXCEPTION TO THE USE OF THE SINGLE IRB REVIEW REQUIREMENTS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY: NOT-HS-21-002 provides information regarding the Agency for Healthcare Research and Quality (AHRQ)’s implementation of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) determination of Exception to the Single IRB Review Requirements for Certain HHS-conducted or Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

This exception represents an effort to prioritize the health and safety of both research subjects and investigators, and provides flexibility to institutions in seeking IRB review due to the unique challenges created by the COVID-19 outbreak and is appropriate for cooperative research:

  1. That is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of Health and Human Services at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx;
  2. Where reliance on a single IRB would not be practical; and
  3. For which the HHS division supporting or conducting the research approves of the use of this exception.

 AHRQ Exception Request Content Requirements

  • Justification as to why the study meets the exception criteria defined by OHRP
  • Include the name of the site(s) for which an IRB other than the single IRB of record is proposed to review the study for the site(s)

 Pre-Award Exception Requests (for Federal Contracts follow instruction outlined in the RFP)

 Post-Award Exception Requests

  • Submit a prior approval request in writing to the Grants Management Officer (GMO) for grants or to the Contracting Officer (CO) for contracts
  • Requests must include appropriate justification as to why the study meets the exception criteria defined by OHRP
  • Requests must be submitted no later than 30 days prior to the proposed change
  • Requests must be signed by the Authorized Organization Representative (AOR), please work with your assigned OSR Staff to expedite these requests

 Please direct all inquiries to: [email protected]

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NOTICE OF OFFICE OF LABORATORY ANIMAL WELFARE STATEMENT ON OVERSIGHT OF NIH-OWNED CHIMPANZEES: NOT-OD-21-022 announces a statement from the Director, Office of Laboratory Animal Welfare (OLAW) regarding the restricted transportation of significantly compromised NIH-owned chimpanzees.

Summary:

All facilities that house, care for, or are engaged in the transport of NIH-owned chimpanzees are subject to the Animal Welfare Act (AWA) and implementing regulations and policies.

The Alamogordo Primate Facility is a government-owned, contractor-operated federal facility, conducting non-invasive sample collection and observational behavioral studies. In the case of Federal research facilities, the head of the Federal agency conducting the research shall be responsible for all corrective action to be taken at the facility and the granting of all exceptions to inspection protocols.

Animal Welfare Regulations prohibit a research facility, including a Federal research facility, from delivering a nonhuman primate to any intermediate handler or carrier for transportation unless the nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian, certifying the nonhuman primate [must have] appeared to be free of any infectious disease or physical abnormality that would endanger the animal(s) or other animals or endanger public health. Further, if a nonhuman primate is obviously ill, injured, or in physical distress, it must not be transported and in doing so would be a violation of AWA regulations and PHS Policy.

It is the OLAW Director’s determination that the frailest chimpanzees must remain in their current location in keeping with the regulatory requirements.

Please see the Notice for the complete statement and details and direct all inquiries to [email protected]

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October 2020

NOTICE OF CLARIFICATION: POLICY FOR MANAGING CONFLICT OF INTEREST IN NIH PEER REVIEW: NOT-OD-21-019 clarifies Section IIB.4 “Professional Associates (NOT-OD-13-010); Section IIB.2 “May Serve with a Waiver” (NOT-OD-14-069); and NOT-OD-18-115 “Maintaining Integrity in NIH Peer Review Responsibilities and Consequences.”

Policy: NIH considers involvement in the preparation of an NIH grant application/contract proposal as a professional association that creates a conflict of interest with any other individual with a major professional role on that application, whether:

  • The application is funded
  • The individual involved in the preparation was listed as having a major professional role
  • Compensation was provided to the individual involved in the preparation of the application/proposal

 Management of such conflicts is outlined in NOT-OD-13-010 and NOT-OD-14-069.

Failure of a Scientific Review Group member to declare any conflict of interests, known to the reviewer, is considered a breach in the integrity of the NIH peer review process. Applicable consequences are outlined in NOT-OD-18-115.

Please refer to the Notices for full details and direct inquiries to: [email protected].

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NOTICE OF POLICY REVISION: MANAGING CONFLICTS OF INTEREST FOR REQUESTS FOR APPLICATIONS: NOT-OD-21-005 removes Section II.B.5 (entirely) from policy notice NOT-OD-13-010 Advance Notice: Revised Policy for Managing Conflict of Interest in the initial Peer Review of NIH Grant and Cooperative Agreemen

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-21-009 announces that the Department of Health and Human Services (HHS), including NIH, operates under the Continuing Appropriations Act, 2021 and Other Extensions Act (PL 116-159) signed on October 1, 2020, which continues government operations through December 11, 2020.

NIH will continue procedures outlined in NOT-OD-20-068 and issue non-competing research awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments will be considered after FY 2021 appropriations are enacted. All legislative mandates in effect for FY 2020 (NOT-OD-20-066) remain in effect, as well as salary the salary limitation (NOT-OD-20-065) and Kirschstein-NRSA pre- and postdoctoral stipend levels (NOT-OD-20-070)

Please direct inquires to the Grants Management Specialist identified in the Notice of Award.

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EXCEPTIONS TO THE USE OF A SINGLE IRB DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCYNOT-OD-21-006 provides information regarding NIH implementation of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) determination of Exception to the Single IRB Review Requirements for Certain HHS-conducted or Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

This exception represents an effort to prioritize the health and safety of both research subjects and investigators, and provides flexibility to institutions in seeking IRB review due to the unique challenges created by the COVID-19 outbreak.

Such an exception is appropriate for cooperative research:

  1. That is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19) public health emergency as declared by the Secretary of Health and Human Services at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx;
  2. Where reliance on a single IRB would not be practical* and
  3. For which the HHS division supporting or conducting the research approves of the use of this exception

*Scenarios for which OHRP anticipates it may not be practical to rely on use of a single IRB for multi-site, cooperative research trials during the ongoing COVID-19 pandemic include (but are not limited to):

  1. Trials for which timely administration of an intervention for the rapidly emerging COVID-19 outbreak is paramount, but:
    • research sites cannot be identified in advance due to the unpredictable nature of the exact location of the outbreak and patients cannot be moved to an existing trial site or to a newly established site without further increasing public health exposure risks; or
    • institutions lacking existing reliance agreements, especially those in underserved or under-resourced areas, may face delays in starting the trial and in administration of the intervention while reliance agreements are negotiated.
  2. Trials leveraging existing federally-supported trial networks to maximize access to appropriate patients, but where each network is operating under a different single IRB of record and negotiating reliance agreements between the networks and single IRBs could reduce the ability of qualified sites to access appropriate patients at the correct stage of disease.
  3. Trials in which a federal research agency wishes to participate as a research site with non-federal (but federally-supported) sites but is legally prohibited from agreeing to certain terms in reliance agreements required by the non-federal sites.
  4. A cooperative research study supporting the response to the COVID-19 outbreak in which the lead site is engaged in administration of an intervention and in addition is receiving study-wide identifiable samples and/or data for the purposes of determining risk factors linked to COVID-19 disease susceptibility, severity, outcome, or for developing potential diagnostics or therapeutics. The sites that would be engaged in the research may include institutions that do not have standing reliance agreements within a research network and establishing new reliance agreements would cause unacceptable delays as well as result in a lost opportunity to collect critical COVID-19 samples and data.
  5. Trials in which the lead site or IRB is unable to provide oversight due to disruption in operations caused by the COVID-19 public health emergency, but other sites can continue, and selecting another site as the IRB of record would require renegotiation of reliance agreements with a new IRB of record, and the study would otherwise be required to halt until such agreements were in place.

Note that this exception determination is only made for purposes of section 46.114(b)(2)(ii) - namely, for determining whether certain cooperative research may be excepted from the single IRB mandate. This exception determination does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements that would fall into the above category. HHS fully expects use of single IRB where possible even during the COVID-19 public health emergency. Approved use of the flexibilities provided under this exception do not change any other obligations under the 2018 Requirements.

NIH Exception Request Content Requirements

  • Justification as to why the study meets the exception criteria defined by OHRP
  • Include the name of the site(s) for which an IRB other than the single IRB of record is proposed to review the study for the site(s).

Pre-award Exception Requests (for Federal Contracts follow instruction outlined in the RFP)

  • Provide exception request and required justification in the Other Attachments section of the Research & Related Other Project Information form in the grant application
  • Name the PDF document “SIRBexceptionrequest.pdf and follow instruction in the NIH Application Guide
  • Proposed budget in the application or contract proposal should reflect all necessary single IRB costs. Applicants and offerors should not assume that an exception will be granted when considering costs to include in the budget

Post-Award Exception Requests

  • Submit a prior approval request in writing to the Grants Management Officer (GMO) for grants or to the Contracting Officer (CO) for contracts
  • Requests must include appropriate justification as to why the study meets the exception criteria defined by OHRP
  • Requests must be submitted no later than 30 days prior to the proposed change
  • Requests must be signed by the Authorized Organization Representative (AOR), please work with your assigned OSR Staff to expedite these requests

Please direct all inquiries to: [email protected]

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NOTICE OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE BRAIN INITIATIVE DIVERSITY K99/R00 CAREER TRANSITION AWARD DURING THE COVID-19 PANDEMIC: NOT-NS-21-004 announces that the BRAIN Initiative will be providing up to a two-receipt cycle extension of the eligibility for prospective applicants that meet the requirements to apply for the BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00).

  • For individuals whose eligibility would normally end with the October/November due dates, the temporary extension would allow them to apply in February/March 2021 or June/July 2021.
  • For individuals whose eligibility would normally end with the February/March 2021 due dates, the temporary extension would allow them to apply in June/July 2021 or October/November 2021.

For inquiries email: [email protected].

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EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC-AUGUST/OCTOBER 2021 COUNCILS: NOT-OD-20-179 extends the special exception for post-submission materials (NOT-OD-20-123 and NOT-OD-20-163) to applications submitted for the August/October 2021 council round.

NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the FOA used for submission allowed preliminary data in the application.

Contacts for inquiries are listed in NOT-OD-20-179.

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REQUIREMENT FOR TRAINEE DIVERSITY REPORT TO BE SUBMITTED ELECTRONICALLY FOR INSTITUTIONAL RESEARCH TRAINING, CAREER DEVELOPMENT, AND RESEARCH EDUCATION AWARDS BEGINNING IN EARLY FY 2021: NOT-OD-20-178 announces the requirement for recipients of institutional research training, career development, and research education awards to submit the Trainee Diversity Report, required with the Research Performance Progress Report (RPPR),  Interim Final RPPR, and Final RPPR, electronically using a new option that will be available in the xTrain module beginning October 30, 2020.

NIH will integrate the Trainee Diversity Report form into the xTrain module of the eRA Commons. The electronically generated report will leverage demographic data from appointed trainees’ Personal Profiles in the eRA Commons, minimizing the need for manual data entry.

Beginning October 30, 2020, the following activity codes will require an electronically generated Trainee Diversity Report with the RPPR, I-RPPR, and F-RPPR submission:

T15, T32, T34, T35, T37. T42, T90, TL1, TL4, TU2, K12/KL2, KM1, R25, R38, R90, RL5, RL9

For the specified activity codes, eRA will check RPPRs for an electronically generated Trainee Diversity Report. If the electronically generated report is missing, the RPPR will not be accepted. Please see NOT-OD-20-178 for special provision for K12/KL2, R25, KM1 and R90 activity codes.

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September 2020

REMINDER: NIH POLICY ON USE OF HYPERTEXT IN NIH GRANT APPLICATIONS: NOT-OD-20-174 reminds the NIH applicants about the guidance that restricts the use of hypertext (e.g. hyperlinks and URLs) in NIH grant applications.

Use of unallowable hyperlinks and URLs raise the following concerns:

  • Reviewer Confidentiality: Sophisticated web-based tracking systems may allow identification of reviewers who attempt to access the link
  • Overstuffing: All materials required for review must be contained within the page limits of the application. Linking out to additional information may exceed the content limitations of the application
  • Review Consistency: some reviewers may consider hyperlinked materials while others may not, which may create inconsistency among reviewers
  • Malware: The possibility exists for malware or other breaches to occur on the reviewer’s computer and/or system

Applicants are reminded of the guidance in the SF424 (R&R) Application Guide:

  • Hyperlinks and URLs are only allowed if specified in the funding opportunity announcement (FOA) and form field instructions where it is typically limited to citing relevant publications in biosketches and publication lists
  • It is highly unlikely for a FOA to allow links in Specific Aims, Research Strategy , and other page-limited attachments
  • Hyperlinks and URLs may not be used to provide information necessary to application review
  • Reviewers are instructed against viewing linked sites and are cautioned that they should not directly access a website unless the link was specifically requested in the application instructions
  • When allowed, the actual URL text should appear on the page rather than being hidden behind a word or phrase
  • Applications that do not follow this guidance may be withdrawn from review and funding consideration

 Direct inquiries to [email protected].

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NOTICE OF LIMITED AVAILABILITY OF RESEARCH NON-HUMAN PRIMATES: NOT-OD-20-173 informs researchers who are conducting or planning to conduct COVID-19 studies involving non-human primates (NHPs), housed at the National Primate Research Centers (P51) or P40 facilities supported by ORIP,  that access to and availability of NHPs will be limited and that specific programmatic priority settings will be implemented to minimize impact of the shortage.

All requestors seeking to utilize National Primate Research Center (NPRC) or ORIP-supported resources for COVID-19 studies must submit the information requested in the COVID-19 NHP Study Information Portal so that the urgency of the proposed research and its timeline for potential impact on public health can be assessed by the NIH COVID-19 Expert Panel (the “Expert Panel”). The Expert Panel will make recommendations on the urgency for a study to be conducted and the timeline for public health impact, which will be conveyed to the Research Advisory Committee at each NPRC or the NHP Facility Director.

All information submitted via the portal will be treated as confidential and proprietary to the submitter and will not be shared outside of NIH. NIH is only collecting information on studies that have secured funding, whether from government, private, or other sources.

Please see NOT-OD-20-173 for complete details.

Please direct all inquiries to: [email protected]

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NOTICE OF CHANGE TO THE ELIGIBILITY OF PRINCIPAL INVESTIGATORS IN PAR-20-042: NCMRR EARLY CAREER RESEARCH AWARD (R03 CLINICAL TRIAL OPTIONAL): NOT-HD-20-030 announces NICHD changes to the eligibility limit in PAR-20-042 to acknowledge productivity delays due to the COVID-19 pandemic and mitigation efforts.

 Original eligibility limit states that the PD/PI must be no more than 7 years beyond the date that the first professional, advanced professional, or terminal academic degree was awarded, whichever is most recent. This limit had been increased to 8 years.

 Please direct inquiries to Theresa Hayes Cruz, PhD at [email protected].

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August 2020

NOTICE TO EXTEND ELIGIBILITY FOR SUBMISSION OF NIAID K99/R00 PATHWAY TO INDEPENDENCE AWARD APPLICATIONS (AND PHYSICIAN SCIENTIST K99/R00) DUE TO COVID-RELATED DISRUPTIONS: NOT-AI-20-068 announces that the National Institute of Allergy and Infectious Diseases (NIAID) will extend the 48-month eligibility requirement for submission of K99/R00 applications due to COVID-related disruptions.

 Subject to future updates, NIAID will provide a 2-receipt cycle extension (roughly 8 additional months) of eligibility for individuals who were eligible to apply for the K99/R00, under normal eligibility rules, between June/July 2020 and February/March 2021 (inclusive of these dates). In addition, those who normally would have been eligible to apply for the June/July 2021 receipt date will have a 1-receipt cycle (roughly 4 months) extension.

 Examples:

  • Individuals whose eligibility ended with the June/July 12, 2020 submission dates, the extension would allow them to apply for the K99/R00 in October/November 2020 or February/March 2021.
  • Individuals whose eligibility would normally end with the February/March 12, 2021 due date, the extension would allow them to apply through the October/November 2021 due dates.
  • Individuals whose eligibility would normally end with June/July 12, 2021 due date, the extension would allow them to apply through the October/November 2021 due dates.

 Please Note:

  • If the final due date at which an individual could apply was for the February/March 12, 2020 due dates, this individual is no longer eligible for the K99/R00.
  • If an individual’s eligibility is good through the June/July 2020 due dates and the review of their February/March submission was not completed in time to be resubmitted at the June/July 2020 due date, the individual is no longer eligible to apply for the K99/R00 and may not receive an extension.
  • An individual who has applied twice for the K99/R00 is not eligible for an extension.

 Reminder:

  • K99 applicants who wish to receive non-COVID-related extensions, (e.g. for childbirth, adoption, family leave, etc.) must continue to provide relevant documentation.

Please direct inquiries to the [email protected]

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NOTICE OF TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIDCR DUAL DEGREE DENTIST SCIENTIST PATHWAY TO INDEPENDENCE AWARD (K99/R00): NOT-DE-20-031 announces that the National Institute of Dental and Craniofacial Research (NIDCR) will provide up to a two-receipt cycle extension (roughly 8 months) of eligibility to applicants for the Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) due to disruptions caused by the COVID-19 pandemic.

Applicants must have both a clinical dental (DDS/DMD) and research (PhD) degree and no more than 4 years of postdoctoral research experience since their most recent doctoral degree to meet submission requirements for this award during the period covered by the June/July 2020 due dates through the February/March 2021 due dates.

 Examples:

  • If an individual’s eligibility ended with the June/July 12, 2020 due dates, the extension would allow them to submit for the October/November 2020 or February/March 2021 due dates.
  • If an individual’s eligibility ends with the October/November 12, 2020 due dates, the extension will allow them to apply for the February/March 2021 or the June/July 2021 due dates.
  • If an individual’s eligibility will end with the February/March 12, 2021 due dates the extension will allow them to apply in June/July 2021 or October/November 2021.

 Reminders:

  • Individuals applying for the NIH Pathway to Independence (Parent K99/R00) should refer to NOT-OD-20-158.
  • K99 applicants who wish to receive non-COVID-related extensions, (e.g. for childbirth, adoption, family leave, etc.) must continue to provide relevant documentation.

 Please direct inquiries to Leslie A. Frieden, PhD at [email protected].

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EXTENDING THE SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERAIL POLICY DURING THE COVID-19 PANDEMIC: NOT-OD-20-163 extends the special exception for post-submission materials announced in NOT-OD-20-123, for the May 2021 Council round. Beginning with applications submitted for the September 25, 2020 due date. NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data for applications under all activity codes, ONLY if the Funding Opportunity Announcement (FOA) used for the submission allowed for preliminary data in the application.

All materials listed as acceptable in NOT-OD-19-083 and any preliminary data (per this exception) must be submitted no later than 30 days prior to the study section meeting.

Post-submission materials will not be accepted for those applications that undergo expedited review, such as emergency competitive revisions and urgent competitive revisions.

Please see NOT-OD-20-163 for details and where to direct inquiries.

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TEMPORARY EXTENSION OF ELIGIBILITY FOR THE NIH K99/R00 PATHWAY TO INDEPENDENCE AWARD DURING THE COVID-19 PANDEMIC: NOT-OD-20-158 announces that NIH will be providing up to a two-receipt cycle extension (roughly eight additional months) of eligibility for prospective K99/R00 applicants who have/will reach the 4 year eligibility threshold while experiencing delays in submitting an application due to disruptions caused by the COVID-19 pandemic. The extension will apply only to eligible applicants submitting new and resubmission K99/R00 applications under parent announcements PA-20-187PA-20-188, and PA-20-189, which will be automatically accepted by NIH. This extension is temporary and subject to change.

Examples:

  • Individuals whose eligibility ended with the June/July 12, 2020 due dates, the temporary extension would allow them to apply for the K99/R00 in October/November 2020 or February/March 2021.
  • Individuals whose eligibility would normally end with October/November 12, 2020 due dates, the temporary extension would allow them to apply in February/March 2021 or June/July 2021.
  • Individuals whose eligibility would normally end with February/March 12, 2021 due dates, the temporary extension would allow them to apply in June/July 2021 or October/November 2021.

 K99 applicants who wish to receive non-COVID-related extensions, (e.g. for childbirth, adoption, family leave, etc.) must continue to provide relevant documentation.

 Please direct inquiries to [email protected].

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NEW ONLINE TRAINING MODULE FOR THE VERTEBRATE ANIMALS SECTION (VAS) OF NIH APPLICATIONS:  NOT-OD-16-006 announced and described the changes implemented to simplify and remove redundancies in the Vertebrate Animals Section (VAS) for NIH grant, cooperative agreement, and contract applications. The Office of Laboratory Animal Welfare (OLAW) recently released an online training module for the VAS that can be completed in 20-30 minutes. The module provides:

  • An overview of the requirements
  • A checklist for applicants and reviewers
  • Detailed instructions

The VAS Training Module and more details can be found on the OLAW webpage for the Vertebrate Animals Section (VAS).

Please direct inquiries to OSRInfo.ucsf.edu.

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July 2020

UPCOMING CHANGES TO THE NOTICE OF AWARD (NoA) BEGINNING OCTOBER 1, 2020: NOT-OD-20-155 announces the upcoming changes to the format of the NIH Notice of Award (NoA). The Department of Health and Human Services (HHS) has developed a standard Page One to be used across HHS effective October 1, 2020.

The majority of the change will affect the appearance of Page One of the NoA. There will be four sections (see the NOT-OD-20-155 for details):

  • Award Data
  • Recipient Information
  • Federal Agency Information
  • Federal Award Information

NIH NoAs will continue to use the following sections, following Page One:

  • Section I – Award Data
  • Section II – Payment Information
  • Section III/IV – Terms and Conditions of Award

In the coming weeks, additional information and samples will be posted on the View Notice of Award webpage.

Please direct inquiries to OSRInfo.ucsf.edu.

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GRANTS & CONTRACT SUBMISSION REQUIREMENTS REGARDING THE UPDATED AVMA GUIDELINES FOR THE EUTHANASIA OF ANIMALS: 2020 EDITION: NOT-OD-20-143 provides guidance to assured institutions on the implementation of the AVMA guidelines for the Euthanasia of Animals: 2020 Edition.

After October 1, 2020, grant applications and contract proposals must be consistent with the 2020 Guidelines. Grant applications must continue to follow application form instructions in the How to Apply – Application Guide (see the Notice for complete details).

Please direct inquiries to: [email protected].

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GUIDANCE FOR APPLICATS PREPARING APPLICATIONS FOR THE FALL 2020 DUE DATES DURING THE COVID-19 PANDEMIC: NOT-OD-20-122 provides guidance for investigators and institutions preparing NIH grant applications for the May 2021 Council round, beginning with applications for the September 25, 2020 due date.

  • NIH grant applications should not include contingency plans that outline steps needed to recover from temporary emergency situations or institutional return-to-the-workplace plans resulting from the COVID-19 pandemic.
  • Contingency plans will not be considered in peer review.
  • Reviewers will be instructed to disregard situations due to the COVID-19 pandemic, e.g. temporary declines in productivity, availability of key personnel, proposed patient populations, animal facility shutdowns, etc.
  • Reviewers will continue to assume that temporary emergency problems arising from the COVID-19 pandemic will be resolved and complications related to COVID-19 should not affect their scores.

If needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding.

Please direct inquiries to [email protected].

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NIH EXTRAMURAL LOAN REPAYMENT PROGRAMS - 2020:

The NIH Loan Repayment Programs (LRPs) are a set of programs established by Congress and designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. LRP repays up to $50,000 annually of a researcher’s qualified educational debt in return for a commitment to engage in NIH mission-relevant research at a domestic, non-profit, or government entity. LRP applications are accepted annually from September 1 through November 20. LRP applications are not grant applications and can be submitted by the applicant’s department. Below are LRP application requests released this week:

  • NOT-OD-20-133  Extramural Loan Repayment Program for Clinical Researchers (LRP-CR)
  • NOT-OD-20-134 Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (LRP-IDB)
  • NOT-OD-20-135 Extramural Loan Repayment Program for Contraception and Infertility Research (LRP-CIR)
  • NOT-OD-20-136 Extramural Loan Repayment Program for Pediatric Research (LRP-PR)
  • NOT-OD-20-137 Extramural Loan Repayment Program for Health Disparities Research (LRP-HDR)

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June 2020

NOTICE OF REQUIREMENT FOR ELECTRONIC SUBMISSION OF ALL ADMINISTRATIVE SUPPLEMENTS: NOT-OD-20-128 announces three updates to NIH administrative supplement submission policies.

  1. Effective immediately, NIH will begin accepting administrative supplement applications for multi-project awards electronically using the single-project application form package for research grants and cooperative agreements (e.g. Competition ID = FORMS-F-ADMINSUPP-RESEARCH).
  2. Effective July 25, 2020, the streamlined submission method through the eRA Commons will be discontinued.
  3. Effective July 25, 2020, all supplement applications to existing single and multi-project awards must be submitted electronically through Grants.gov using NIH ASSIST, Grants.gov Workspace, or institutional system-to-system (S2S) solutions (e.g. eProposal).

NIH will reissue parent administrative supplement announcements PA-18-591 and PA-18-592. Any in-progress applications submitted through Grants.gov using these announcements must be completed by July 24, 2020. Applications submitted on or after July 25. 2020 must use the reissued announcements.

See the Notice for complete details.

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UPCOMING MANDATORY SUBMISSION OF THE FEDERAL FINANCIAL REPORT (FFR) IN THE PAYMENT MANAGEMENT SYSTEM BEGINNING JANUARY 1, 2021: NOT-0D-20-127 informs NIH recipients that beginning January 1, 2021, they will be required to submit the SF-425 Federal Financial Report (FFR) in the Payment Management System (PMS) as opposed to the eRA Commons/FFR Module.

FFRs submitted prior to January 1, 2021 will use the eRA Commons/FFR Module based on the previous requirements set forth by the agency (NIH Grants Policy Statement 8.4.1.5.2).

This change will not affect FFR due dates as outlined in the NIH Grants Policy Statement 8.4.1.5.2 and 8.6.1.

Please see the Notice for complete details.

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GUIDANCE REGARDING CHANGE IN STATUS, INCLUDING ABSENCE OF PD/PI AND OTHER KEY PERSONNEL NAMED IN THE NOTICE OF AWARD: NOT-OD-20-124 serves to clarify NIH expectations regarding administrative requirements for change in status and change of recipient organization.

  1. NIH recipients are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research and
  2. Prior approval requests regarding change in the status, of the PD/PI and Key Personnel named in the Notice of Award (NoA), and change of recipient organization should include mention as to whether the change is related to concerns about safety and/or work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions)
  3. Requests for prior approval of any additional or substitute PD/PIs or Senior/Key Personnel named in the NoA, or change from a multiple PD/PI model to a single PD/PI model, must be submitted promptly, and must be accompanied by a strong scientific justification related to the scientific project, including
    • Any proposed changes in scope
    • The biographical sketch of any new individuals proposed and other sources of support
    • Any budget changes resulting from the proposed change.
    • A new or revised Leadership Plan is required if the request is to change from a single PD/PI model to a multiple PD/PI model, or to change the number or makeup of the PD/PIs on a multiple PD/PI award
    • The Commons ID must be provided for any new PD/PIs. 
  4. NIH expects both relinquishing and applicant organizations to disclose whether a Change of Recipient Organization is occurring within the context of an ongoing or recent investigation of misconduct of any kind, including but not limited to professional misconduct or research misconduct.

Affected sections of the Grants Policy Statement are 8.1.2.6 Change in Status and 8.1.2.7 Change of Recipient Organization.

Please direct inquiries to [email protected].

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SPECIAL EXCEPTION TO THE NIH/AHRQ/NIOSH POST-SUBMISSION MATERIAL POLICY DURING THE COVID-19 PANDEMIC: NOT-OD-20-123 announces that NIH, AHRQ, and NIOSH understand that the emergency declaration related to Coronavirus Disease 2019 (COVID-19) can adversely affect the ability of many applicants to generate preliminary data in time for the submission of their grant applications.

This Notice provides an exception to the policy for post-submission materials (NOT-OD-19-083) for applications submitted for the January 2021 council (beginning with applications submitted for the May 25, 2020 due date for Fall 2020 review meetings). NIH, AHRQ, and NIOSH will accept a one-page update with preliminary data as post-submission materials for applications submitted under all activity codes, ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. One page of preliminary data will be accepted for single component applications or for each component of a multi-component application.

Please see the Notice for complete details and where to submit inquiries.

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AGENCY FOR HEALTHCARE RESEARCH AND QUALITY DATA MANAGEMENT PLAN POLICYNOT-HS-20-011 announces that effective immediately all new competing grants and research contract proposals to the Agency for Healthcare Research and Quality (AHRQ) are required to include a Data Management Plan (DMP) for managing, storing and disseminating primary data, samples, physical collections, and other supporting materials created or gathered in the course of research funded by AHRQ. This policy applies to AHRQ intramural researchers and extramural recipients of AHRQ grants and research contracts unless otherwise specified in the funding opportunity announcement (FOA) or request for proposals (RFP).

The DMP should be submitted under the Resource Sharing Plan section of a grant application or as an appendix for a research contract proposal. The plan will not count toward the page limit for grant applications or contract proposals.

AHRQ recognizes the time and costs required to prepare data for sharing. AHRQ will allow the inclusion of appropriate costs for data management and access in grant applications and research contract proposals. The appropriateness of requested funding levels for DMPs will be assessed on a case-by-case basis through scientific peer review and by program and grants or contracts management staff. Requests can be made only for costs that will be incurred while the award is active. Applicants must categorize these costs as either direct costs or as indirect costs as appropriate in accordance with federal and institutional policy.

Award recipients are expected to include updates on publicly released data in digital format resulting from their research in quarterly reports (if applicable), annual progress reports, and final reports, and will develop mechanisms to monitor such compliance.

  • Annual or quarterly reports should provide information on the progress of data management and public release of research products (could include citations of relevant publications, conference proceedings, and descriptions of other types of data sharing and dissemination).
  • Final reports are required to include a discussion on execution and any updating of the original DMP included in the original grant applications or research contract proposals.

Please see the Notice for complete details.

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May 2020

COVID-related notices or communications have been posted on the OSR COVID-19 webpages.

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April 2020

FLEXIBILITIES AVAILABLE TO AHRQ APPLIANTS AND RECIPIENTS IMPACTED BY COVID-19: NOT-HS-20-010 announces flexibilities allowed by the Agency for Healthcare Research & Quality (AHRQ) to applicants and recipients impacted by COVID-19 due to loss of operation.  A summary of flexibilities in the following areas are posted on the OSR COVID-19 webpage under Sponsor Specific Guidance. 

  • Late Application Submission Policy
  • Pre-award Costs
  • No-cost Extension
  • Delays in Research Progress/Reporting
  • Expenditures of Award Funds for Salaries, Stipends, and Other Project Activities
  • Travel Costs

 As the COVID-19 national emergency continues, recipients may identify the need for other cost related flexibilities. AHRQ will consider such requests on a case-by-case basis. Please work with your OSR Staff to contact the Grants Management Specialist named on the most recent Notice of Award.

 Please direct inquiries to [email protected].

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REMINDER – CHANGES TO FORMS & INSTRUCTIONS FOR RESEARCH TRAINING, FELLOWSHIP, & CAREER DEVELOPMENT AWARD APPLICATIONS DUE ON OR AFTER MAY 25, 2020NOT-OD-20-090 reminds the biomedical and health services research communities of changes to application forms and instructions for research training, fellowship, and career development award applications due on or after May 25, 2020. Changes to the following areas are described for:

  • Training in techniques for rigorous and reproducible research
  • Training in relevant quantitative and data science approaches
  • Training data tables
  • Progress reporting for renewal applications
  • Required letters for applications to selected programs

 Applicants are urged to consult FORMS-F Application Guides for detailed guidance. Research training data table modifications are expected to be incorporated into the xTRACT system on April 24, 2020.  Users who have prepared data tables in xTRACT will need to update selected data entry fields prior to finalizing their research training datasets.

Please direct inquires to [email protected].

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March 2020

REMINDER: FORMS-F GRANT APPLICATION FORMS & INSTRUCTIONS MUST BE USED FOR DUE DATES ON OR AFTER MAY 25, 2020 – NEW GRANT APPLICATION INSTRUCTIONS NOW AVAILABLENOT-OD-20-077 reminds NIH and AHRQ applicants that FORMS-F application packages must be used for due dates on or after May 25, 2020 and FORMS-E application packages for due dates on or before May 24, 2020.

Applicants are encouraged to submit early to work through any unforeseen issues. Applications submitted using the incorrect application package for their due date may be withdrawn and removed from funding consideration.

The notice also provides the following updates:

  1. FORMS-F instructions are now posted on the How to Apply – Application Guide page
  2. Significant changes to forms and instructions are listed at https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.120-significant-changes.htm
  3. FORMS-F application packages are being posted to active Funding Opportunity Announcements (expected completion by March 25, 2020)
  4. Parent announcements will be reissued with FORMS-F for due dates on or after May 25, 2020 (FORMS-F application packages will not be added to existing parent applications)

Please send questions and concerns to the NIH Office of Policy for Extramural Research Administration (OPERA) Systems Policy Branch at [email protected]

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NIH LATE APPLICATION POLICY DUE TO PUBLIC HEALTH EMERGENCY FOR U.S. FOR 2019 NOVEL CORONAVIRUS (COVID-19): NOT-OD-20-082 reiterates the late application policy that NIH will consider accepting late applications on a case by case basis when delays occur because the applicant or recipient organization is officially closed or unable to submit grant applications due to the effects of COVIS-19, in accordance with NIH Grants Policy Statement, Section 2.3.9, under the following circumstances:

  1. Institutions must submit applications or reports as soon as possible after reopening or resuming operations so that the time to submit does not exceed the number of days the institution was officially closed or unable to submit
  2. A cover letter must accompany the application with enough detail about the delay so that NIH staff can make a determination whether circumstances justify accepting the application late.
  3. Institutions need not request advance permission to submit late due to this declared emergency

Please see NIH Grants Policy Statement, Section 2.3.9 for the complete policy on late application submission.

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GENERAL FREQUENTLY ASKED QUESTIONS (FAQs) FOR PROPOSAL SUBMISSION & AWARD MANAGEMENT RELATED TO COVID-19NOT-OD-20-083 provides high-level questions associated with proposal submission and award management that may arise in relation to COVID-19.  As COVID-19 and associated impacts continue to evolve, applicants and award recipients are encouraged to monitor NIH weekly notices.

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FLEXIBILITIES AVAILABLE TO APPLICANTS AND RECIPIENTS OF FEDERAL FINANCIAL ASSISTANCE AFFECTED BY COVID-19NOT-OD-20-086 informs the research community of short-term administrative flexibilities identified that apply to NIH applicants and recipients conducting research activities related to or affected by COVID-19.

Some of the flexibilities include, but are not limited to:

  1. Pre-award costs
  2. Prior approvals waived for carryover of unobligated funds, no-cost extension of the final year up to 12 months, and rebudgeting
  3. Salaries
  4. Travel
  5. Delays in reporting (will still delay awards)
  6. Extension of closeout

Please see NOT-OD-20-086 for the complete list and details.  

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GUIDANCE FOR NIH-FUNDED CLINICAL TRIALS AND HUMAN SUBJECTS STUDIES AFFECTED BY COVID-19: NOT-OD-20-087 provides guidance outlining flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies that are impacted by the declared public health emergency for COVID-19.

At this time, NIH is encouraging recipients to consult with their IRBs about potential measures to protect participants and research staff. For example:

  1.  Limit study visits to those needed for participant safety or coincident with clinical care
  2. Virtual study visits
  3. Flexibility for laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
  4. Canceling large gatherings of 50 or more
  5. Limiting or suspending unnecessary travel

Delays to ongoing research due to the effects of COVID-19:

  1.  Recipients may submit late financial and progress reports
  2. Recipients may carryover unobligated balances on active grants without prior approval

Delays in research progress on NIH-funded clinical trials & human subjects research due to COVID-19:

  1. Recipients may extend the final budget period of approved projects on active grants one time for up to 12 months without prior approval (NIH GPS 8.1.1.3).
  2. Recipients should contact awarding Institute or Center (IC) and provide details on the effect of COVID-19 to request additional extensions including mid-project period extensions.
  3. NIH will allow clinical trial and other human subjects research to extend beyond the typical 7-year timeframe for extensions related to COVID-19.

Unanticipated costs incurred as a result of COVID-19:

  1. If unobligated balances are not available to rebudget, recipients may request administrative supplements from the awarding IC (PA-18-591). ICs will make funding decisions on a case by case basis to support the safety and welfare of participants and sustain research during delays.
  2. Examples of unanticipated costs:
    • Arrangements for participants to receive care at local sites or virtually, rather than at the study site
    • Supply chain disruptions
    • Personnel disruptions due to illness or closure of facilities
    • Additional lab testing (e.g. for COVID-19)
    • Increased transportation costs

Additional NIH resources are posted on the COVID-19 Information for NIH Applicants and Recipients webpage.  

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UPDATE: NIH LATE APPLICATION POLICY DUE TO PUBLIC HEALTH EMERGENCY FOR U.S. FOR COVID-19NOT-OD-20-091 informs the research community that NIH will accommodate late applications (prior permission and cover letter not required) for due dates between March 9, 2020 and May 1 through May 1, 2020.  Due dates after May 1, including the May 7, 2020 AIDS and AIDS-Related Research due dates will remain as posted and follow the usual late application policies and will require a cover letter.

  1. This applies to all relevant FOAs including those that indicate no late applications will be accepted and pertains to applications reviewed by CSR.
  2. This does not supersede the IC’s discretion or authorities to make decisions on a case-by-case basis.

NIH will extend the expiration date of FOAs that expire prior to May 1 for 90 days to accommodate submission of late applications. Grants.gov will be adjusted to allow NIH to receive these applications.

  1. Reference letters for Fellowships and Career Development Award applications submitted during this interval will be accepted through May 1, 2020.
  2. Non-AIDS applications eligible for continuous submission will also be accepted through May 1, 2020.
  3. Some IC reviewed FOAs with due dates during this time may accept applications beyond the May 1, 2020 deadline. Applicants must first contact the IC to confirm that a later deadline is possible.

 NIH cannot guarantee that all late applications submitted through May 1, 2020 will be reviewed in the council round to which they were submitted (e.g. August or October 2020).  Further extension of this flexibility creates multiple challenges for conducting review and applications submitted after May 1, 2020 may not be reviewed until meetings for the January 2021 council round (e.g. October-November 2020).

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February 2020

UPDATED GUIDANCE FOR VIDEOS SUBMITTED AS NIH APPLICATION MATERIALS: NOT-OD-20-061 provides an update of the video format instructions to maintain compatibility with NIH information systems.

Effective immediately, post-submission videos do not need to be embedded in PDF files. Acceptable formats are .mp4, .mov, .avi, and .wmv. File size limit remains at 25 MB.

Please remember that videos may only be submitted as post-submission materials and not embedded or linked from the application materials unless expressly instructed to do so in the FOA. The application cover letter must include information about the intent to submit the video as post submission materials. If this is not done the video will not be accepted (SF 424 R&R Application Instructions, Cover Letter Attachment).

If multiple videos are submitted for the same application the aggregate length cannot exceed 2 minutes for single-project applications and 5 minutes for mutli-component applications.

See details and references in NOT-OD-20-061.

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GUIDANCE ON SALARY LIMITATION FOR GRANTS AND COOPERATIVE AGREEMENTS FY20: NOT-OD-20-065 announces that effective January 5, 2020, the salary limitation for Executive Level II increased from $192,300 to $197,300. The salary limitation applies to NIH grants, cooperative agreements and extramural research and development contract awards.

The Office of Sponsored Research implemented the new higher cap on all new, renewal, and revision applications effective January 10, 2020. Existing awards may adopt the new salary cap through rebudgeting; however, no additional funds will be provided by the sponsor. For a historical record of the salary cap including effective dates, see the NIH Salary Cap Summary page.

University-specific guidance is available from Contracts and Grants Accounting.

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NOTICE OF LEGISLATIVE MANDATES IN EFFECT FOR FY 2020: NOT-OD-20-066 provides the current requirements that limit or conditions the use of funds on NIH grants, cooperative agreements and contract awards for FY 2020. The following mandates remain in effect for FY 2020:

Division A, Title II – Department of Health and Human Services

  1. Salary Limitation
  2. Gun Control
  3. Anti-Lobbying
  4. Acknowledgement of Federal Funding
  5. Restriction on Abortions
  6. Exceptions to Restrictions on Abortions
  7. Ban on Funding Human Embryo Research
  8. Limitation on Use of Funds for Promotion of Legalization of Controlled Substances
  9. Restriction on Disclosure of Political Affiliation for Federal Scientific Advisory Committee Candidates
  10. Dissemination of False or Misleading Information
  11. Restriction of Pornography on Computer Networks
  12. Restriction on Distribution of Sterile Needles

Please see NOT-OD-20-066 for complete details.

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Ruth L. Kirschstein National Research Service Award (NRSA) Stipend, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2020: NOT-OD-20-070 establishes the stipend and other budgetary levels for FY 2020 Kirschstein-NRSA awards for undergraduate, predoctoral and postdoctoral trainees and fellows made on or after October 1, 2019, and supersedes NOT-OD-19-036.

Current stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications. They will be administratively applied to all applications currently in the review process.

NRSA support is limited to 5 years (aggregate) for predoctoral trainees (6 years for dual-degree training) and 3 years (aggregate) for postdoctoral fellows. NIH provides 8 levels of postdoctoral stipends to accommodate individuals who complete other forms of health-related training prior to accepting a Kirschstein-NRSA supported position. Please note that the presence of 8 discrete levels of experience does not constitute an endorsement of extended periods of postdoctoral research training.

 Other NIH Budgetary Notes:

  1. FY 2020 Stipend for Predoctoral Fellows is $25,320.
  2. Please see NOT-OD-20-070 for FY 2020 stipend levels for Postdoctoral trainees and fellows.
  3. Calculation and thresholds for Tuition and Fees for all educational levels remain unchanged.
  4. Training-related Expenses and Institutional Allowance for Postdoctoral trainees and fellows have been increased by $1,000 from $10,850 to $11,850
  5. Training-related Expenses and Institutional Allowance for Predoctoral trainees remain unchanged.

Please see NOT-OD-20-070 for complete details. University-specific guidance is forthcoming from UCSF Human Resources.

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January 2020

NOTICE OF INFORMATION: NATIONAL DEATH INDEX LINKAGE ACCESS FOR NIH-SUPPORTED INVESTIGATORS: NOT-OD-20-057 announces that effective January 1, 2020 through an agreement between the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) National Center for Health Statistics (NCHS), NIH-supported investigators, who are actively funded to conduct research that requires their research data be linked to the National Death Index (NDI), will be able to do so at no cost. To be covered by this agreement:

  1. NIH-supported investigators will continue to submit applications for NDI linkage per current NDI procedures
  2. NDI will review and approve or disapprove these applications
  3. The NIH-supported investigator must be the owner or steward of the research data to be linked to the NDI data file
  4. Investigators are limited to no more than 4 linkage requests in a calendar year
  5. Any linkages exceeding $100,000 will require NIH prior approval

See NOT-OD-20-057 for full details.

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ADDITIONAL GUIDANCE ON THE NIH POLICY ON THE USE OF A SINGLE INSTITUTIONAL REVIEW BOARD FOR MULTI-SITE RESEARCH: NOT-OD-20-058 informs the research community that effective January 20, 2020, Career Development (K) and Fellowship (F) awards that obtain initial IRB approval on or after January 20, 2020 are subject to the sIRB policy.

  1. Not included are studies for which NIH approved an exception from the sIRB policy before January 20, 2020. Exempted studies conducted under ongoing, non-competing awards (with receipt dates prior to January 25, 2018) that received an initial IRB approval before January 20, 2020 will continue to use multiple IRBs for the duration of the exemption but no later than the next competing award.
  2. K and F applications submitted on or after January 20, 2020  must follow revised instructions to complete the PHS Human Subjects and Clinical Trials Information form, Section 3.2 is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one site?  
  3. K and F applications with studies approved on or after January 20, 2020 must select either “Yes” or “No” to indicate if it is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site.  “N/A” may not be used.

Please direct questions regarding the additional policy guidance to the Office of Policy for Extramural Research Administration at [email protected].

Questions regarding application forms and instructions should be directed to [email protected].

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UPDATE OF NIH CONTINUOUS SUBMISSION POLICY: CHANGE IN SUBMISSION DEADLINES AND END OF RECENT SUBSTANTIAL SERVICE OPTION: NOT-OD-20-060 supersedes NOT-OD-17-042 and NOT-OD-18-178 and alerts the research community of plans to discontinue the practice of granting one-year continuous submission status to reviewers with recent substantial review service. This change will be implemented as follows:

  1. Reviewers who are currently eligible for continuous submission through Recent Substantial Service will remain eligible through the end of their term on September 30, 2020
  2. Reviewers who earn eligibility for continuous submission through Recent Substantial Service during the period January 1, 2019 through June 30, 2020 will be eligible from August 1, 2020 through September 30, 2021
  3. No reviewers will subsequently earn or be granted continuous submission eligibility due to Recent Substantial Service

Effective February 8, 2020, the continuous submission deadlines for assignment to each council round have been moved back approximately one week (see Table 1 of NOT-OD-20-060). Continuous submission eligibility for appointed members of NIH committees and other terms/requirements of the overall policy have not changed with the exception of the deadlines for assignment to a given council round.

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December 2019

NIH/AHRQ CHANGES TO POLICIES, INSTRUCTIONS, & FORMS FOR RESEARCH TRAINING GRANT, FELLOWSHIP, & CAREER DEVELOPMENT APPLICATIONS: NOT-OD-20-033 provides additional information on the planned changes to forms and instructions affecting research training grant, fellowship, and career development applications as announced in NOT-OD-20-026.

Planned changes will affect the following areas:

  • Training in techniques for rigorous and reproducible research
  • Training in relevant quantitative and data science approaches
  • Progress reporting for renewal applications
  • Research training data tables
  • Extending requirements for rigor and transparency to fellowship research projects
  • Required letters for applications to diversity-related programs

Please see NOT-OD-20-033 for a detailed listing of the changes. 

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PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (NIHGPS Rev. December 2019) FOR FY 2020NOT-OD-20-043 announced the publication of the updated NIH Grants Policy Statement (NIHGPS, rev. December 2019). The updated GPS applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2019 and supersedes the NIH GPS, rev. October 2018 as a standard term and condition of award. Prior versions of the GPS will remain available as standard term and condition of NIH grants and cooperative agreements with budget periods that began before October 1, 2019.

Significant changes include, but are not limited to:

Section 2.3.5 Types of Funding Opportunity Announcements – introduction of Notices of Special Interest (NOSI), which highlights a specific topic of interest and directs applicants to one or more active FOAs (usually a parent announcement) to apply for the initiative described.

Sections 2.3.7.11 and 4.1.14.2 Human Fetal Tissue from Elective Abortions (HFT) – requires applicants proposing use of HFT to provide justification for the use of HFT, details regarding procurement and costs, information about how HFT will be used. Reiteration of Sections 498A and 498B of the PHS Act (42 U.S.C. 289g-1 and 289g-2) specific requirements and prohibitions on research involving human fetal tissue and how HHS Regulations for Protection of Human Subjects 45 CFR 46.204 and 46.206 may be specifically relevant to such research. Requirement expects grantees and contractors to maintain appropriate documentation and required informed consent and acknowledgement that human fetal tissue was not received or transferred for valuable consideration.

Section 4.1.3.1 Policy on Dissemination of NIH-Funded Clinical Trial Information – additional language requiring recipients of NIH funding conducting non-exempt human subjects research subject to the revised Common Rule and conducting a clinical trial as defined in 45 CFR 46.102(b) be award that for each trial one IRB-approved consent form must be posted on a designated public federal website in accordance with 45 CFR 46.116(h) after recruitment closes and no later than 60 days after the last study visit by any subject as required by the protocol.

Section 4.1.27 Research Misconduct – clarifies institution’s responsibilities in handling suspected or confirmed research misconduct in NIH-funded research and requirement for recipient and subrecipient institutions (foreign or domestic) to hold assurances with the HHS Office of Research Integrity (ORI) and follows procedure to communicate matters related to research misconduct proceedings to the NIH and ORI.

Section 4.2.1-12 Appropriations Mandates – updated per 2019 Appropriations.

Section 11.3.13.1 Statement of Appointment – the requirement of the Open Researcher and Contributor Identifiers (ORCID) is added to the appointment process for trainees, scholars, and participants supported by institutional research training, career development, and research education awards that require appointments through the xTrain system including: T03, T15, T32, T34, T37, T42, T90/R90, TL1, TL4, TU2, K12/KL2, R25, R38, RL5, and RL9. Appointments will not be accepted unless an ORCID is linked to an individual’s Personal Profile in the eRA Commons.

Section 12.4.1 Application – beginning with receipt dates on or after January 25, 2020, the requirement for an ORCID will be enforced at the time of application for individual fellowship (F series) and career development (K series) awards. eRA system validations will check for ORCIDs and applications will not be accepted unless an ORCID is linked to the PD/PI’s eRA Commons Personal Profile.

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NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-20-046 announces that the Department of Health and Human Services (HHS), including NIH, operates under the "Continuing Appropriations Act, 2020 and Health Extenders Act of 2019" (Public Law 116-69) signed by President Trump on November 21, 2019. The Continuing Resolution continues government operations through December 20, 2019 at 99.3209% of the FY 2019 enacted level.

Continuing the procedures under NOT-OD-19-131 and consistent with NIH practices during the Continuing Resolutions of FY 2006-2019, NIH will issue non-competing research awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments will be considered after FY 2020 appropriations are enacted.

All FY 2019 legislative mandates (NOT-OD-19-030), salary cap (NOT-OD-19-099), and predoctoral and postdoctoral stipend levels and tuition and fees (NOT-OD-19-036) remain in effect under this Continuing Resolution.

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November 2019

NEW NIH FORMS-F GRANT APPLICATION FORMS AND INSTRUCTIONS FOR APPLICATIONS DUE ON OR AFTER MAY 25, 2020: NOT-OD-20-026 announces NIH's plan to implement FORMS-F for grant applications due on or after May 25, 2020. Significant changes, e.g. new, deleted, or modified fields, will be made to the following application forms:

  • PHS 398 Career Development Award Supplemental form
  • PHS 398 Cover Page Supplement
  • PHS Assignment Request form
  • PHS Fellowship Supplemental form
  • PHS Human Subjects and Clinical Trials Information
  • SBIR/STTR Information

The Notice provides a High-level Summary of form changes and plan to transition from FORMS-E to FORMS-F (see NOT-OD-20-026 for details). 

  • FORMS-F will be available in new Funding Opportunity Announcement (FOA) application packages beginning February 25, 2020.
  • New FOAs published prior to February 25, 2020 with initial due dates on or after May 25, 2020, will be posted without application forms until the updated forms become available. Application packages will be added to these FOAs by March 25, 2020.
  • Previously issued active FOAs with submission due dates on or after May 25, 2020  (except Parent FOAs for administrative suppplements, change of institution, and successor-in-interest), will be updated to add FORMS-F between February 25, 2020 and March 25, 2020.
  • Administrative supplements, change of institution, and successor-in-interest parent announcements will be reissued with new FOA numbers and FORMS-F application packages and instructions on May 25, 2020. Applications started on or after May 25, must use the FORMS-F parent FOA.  FORMS-E parent applications will remain available until June 25, 2020 allowing applicants one month to complete applications initiated using FORMS-E.
  • Applications with due dates on or before May 24, 2020 mut use FORMS-E
  • Applications submitted under the NIH Late Policy 2-week consideration window that were submitted on or before May 24, 2020 must use FORMS-E
  • Applications submitted by June 7, 2020 under the NIH Continuous Submission Policy for the May 7, 2020 AIDS due date must use FORMS-E 

NIH plans to provide additional guidance and confirmation of implementation plans in early 2020.

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NOTICE OF NIH'S INTEREST IN DIVERSITY: NOT-OD-20-031 supersedes NOT-OD-18-210 and provides updated diversity language for existing Funding Opportunity Announcements (FOAs) effective immediately.  A noted significant change is the increase of criterion describing Disadvantaged Backgrouns. Please see the NOT-OD-20-031 for the current Diversity Statement and updated criterion for Disadvantaged Backgrounds.

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October 2019

NIH OPERATES UNDER A CONTINUING RESOLUTION: NOT-OD-20-003 announces that the Department of Health and Human Services (HHS), including NIH, operates under the "Continuing Appropriations Act, 2020 and Health Extenders Act of 2019" (Public Law 116-59) signed by President Trump on September 27, 2019. The Continuing Resolution continues government operations through November 21, 2019 at 99.3209% of the FY 2019 enacted level.

Continuing the procedures under NOT-OD-19-131 and consistent with NIH practices during the Continuing Resolutions of FY 2006-2019, NIH will issue non-competing research awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments will be considered after FY 2020 appropriations are enacted.

All FY 2019 legislative mandates (NOT-OD-19-030), salary cap (NOT-OD-19-099), and predoctoral and postdoctoral stipend levels and tuition and fees (NOT-OD-19-036) remain in effect under this Continuing Resolution.

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GUIDANCE ON POSTING INFORMED CONSENT FORMS FOR AHRQ-FUNDED CLINICAL TRIALS: NOT-HS-19-023 provides guidance to AHRQ grant applicants on posting clinical trial informed consent forms, as required by the Final Rule. The HHS Office of Human Research Protections (OHRP) has identified ClinicalTrials.gov and Regulations.gov as the publicly available federal websites that will satisfy the consent form posting requirement.

To fulfill the requirement, recipients conducting AHRQ-funded clinical trials must submit one IRB-approved version of a consent form that has been used to enroll participants to either ClinicalTrials.gov or Regulations.gov. AHRQ recipients submitting informed consent forms to Regulations.gov should maintain a copy of their receipt and tracking number. Additional instructions are available at: https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/.

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NIH EXTENDS EXLIGIBILITY WINDOW FOR PATHWAY TO INDEPENDENCE AWARDS (K99/R00): NOT-OD-20-011 serves to update the NIH extension policy on the eligibility window for PIs to apply for a K99/R00 Pathway to Independence Award.

Applicants for the K99 awards listed in the Notice must have no more than 4 years of postdoctoral research experience at the time of application. NIH considers requests for extension of the eligibility window on a case by case basis for reasons including medical concerns, disability, family care, extended periods of clinical training, natural disasters, and active duty military service.

Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), effective immediately, NIH will approve an extension of one year for childbirth within the 4 year K99 eligibility window. Applicants must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the FOA at least 12 weeks before submitting an application.

Recommended timeframe to submit extension requests for NIH Standard Due Dates:

  • For February 12, requests were due during the week of November 18, 2019
  • For March 12, requests should be received on or during the week of December 16, 2019
  • For June 12, requests should be received on or during the week of March 16, 2020
  • For July 12, requests should be received on or during the week of April 13, 2020
  • For November 12, requests should be received on or during the week of August 17, 2020

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September 2019

  (no policy/procedure changes to post)


August 2019

NIH ANNOUNCES NEW CENTRALIZED NOTIFICATIONS FOR UNFUNDED APPLICATIONS: NOT-OD-19-133 introduces a new centralized, streamlined process for official NIH notification of unfunded applications.

  •  NIH will begin sending centralized, automated notifications of unfunded applications via the eRA system approximately 14 months after the application’s council date
  • Notifications will be sent to the AOR/SO listed in the grant application and to the Notice of Award email address
  • PIs and individuals with privileges to view Status will also be able to see if an unfunded application notification has been sent for a specific application in eRA Commons
  • Funding decisions are specific to the applications included in the email and have no impact on subsequent submissions/resubmissions. There is no change to NIH’s application submission/resubmission policy as outlined in NOT-OD-18-197
  • More information is available in the FAQs and the eRA Online Help webpage.

 For technical assistance contact the eRA Service Desk.

Questions regarding this policy should be directed to [email protected].

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REPORT ON REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS: ANIMAL CARE AND USE IN RESEARCH: NOT-OD-19-136 announces the publication of Reducing Administrative Burden for Researchers: Animal Care and Use in Research, a report by NIH, USDA and FDA, resulting from Title II, Section 2034(d) of the 21st Century Cures Act (P.L. 114-255), enacted December 13, 2016. With regard to the regulations and policies for the care and use of laboratory animals in research, the Act instructs NIH to:

  1. Seek the input of experts
  2. Identify ways to ensure applicable regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative
  3. Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies
  4. Take other actions, as appropriate to improve the coordination or regulations and policies with respect to research with laboratory animals

Implementation of the planned changes in policies, guidance, or regulations are expected to begin within the next two years to accommodate time needed for the public engagement processes.

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CLARIFYING COMPETING APPLICATION INSTRUCTIONS AND NOTICE OF PUBLICATION OF FAQs REGARDING PROPOSED USE OF HFT IN RESEARCHNOT-OD-19-137 provides clarification of competing application instructions referenced in NOT-OD-19-128 and announces the publication of Frequently Asked Questions (FAQs) regarding the proposed use of human fetal tissue from elective abortions in extramural applications for grants, cooperative agreements, and R&D contracts.

Clarifications from this Notice have been incorporated into guidance provided on the Human Fetal Tissue Research (HFT) - NIH Requirements page of the OSR website.

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SEXUAL AND GENDER MINORITY PROPULATIONS IN NIH-SUPPORTED RESEARCH: NOT-OD-10-139 announces the revision of the definition of Sexual and Gender Minority (SGM) populations for research purposes at NIH. NIH is releasing the updated SGM definition to foster and expand inclusion of SGM individuals in health research. Please see the Notice for the full revised definition.

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July 2019

REQUIREMENT FOR ORCID iDs FOR INDIVIDUALS SUPPORTED BY RESEARCH TRAINING, FELLOWSHIP, RESEARCH EDUCATION, AND CAREER DEVELOPMENT AWARDS BEGINNING IN FY2020NOT-OD-19-109 announces the NIH/AHRQ/CDC requirement that individuals supported by research training, fellowship, research education, and career development awards, have an Open Researcher and Contributor Identifier (ORCID). The requirement will be implemented through the appointment process in the xTrain system commencing October 2019 and through the application process commencing with applications due January 25, 2020. Prospective applicants/appointees should follow the ORCID link from their Personal Profile in the eRA Commons to create and link or link the ORCID profile back to their eRA Commons Personal Profile. Please see NOT-OD-19-109 for details and specific activity codes affected.

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REMINDERS OF NIH POLICIES ON OTHER SUPPORT AND ON POLICIES RELATED TO FINANCIAL CONFLICTS OF INTEREST AND FOREIGN COMPONENTS: NOT-OD-19-114 reminds the extramural community of the need to report foreign activities through documentation of other support, foreign components, and financial conflict of interest. There is no change to the policies, the notice highlights several points summarized below:

Other Support:

Report all current projects and activities that involve senior/key personnel including all resources, funded or in-kind (e.g. lab space, equipment, supplies, employees) in support of and/or related to all of their research endeavors regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant.

Foreign Component:

NIH requires recipients to determine if supported activities include a foreign component, defined as: the existence of any “significant scientific element or segment of a project” outside of the United States. For example:

  • Work performed by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended
  • Work performed by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended

Conflict of Interest

FCOI regulation specifies the minimum requirements for investigators to disclose to their institution their significant financial interests including financial interests received from a foreign entity.

For details and FAQs, please refer to NOT-OD-19-114.

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NOTICE OF SYSTEM CHANGE AND PROCEDURE FOR REQUESTING AN EXTENSION TO EARLY STAGE INVESTIGATOR (ESI) STATUS: NOT-OD-19-125 serves to inform the extramural community of a change in the procedure for requesting an extension of early stage investigator (ESI) eligibility.

NIH defines ESI as a Program Director/Principal Investigator (PD/PI) who has completed their terminal research degree or post-graduate clinical training within the past 10 years who has not previously competed successfully as PD/PI for a substantial independent NIH research award. Some investigators may experience a lapse in their research/research training or less than full-time effort during the 10 year ESI period. NIH will consider requests for extension the ESI period for reasons such as family care responsibilities, medical concerns, disability, natural disasters, and active duty military service.

Effective August 22, 2019, the ESI Extension request button will be available in the Education section of the PD/PI’s Personal Profile in the eRA Commons. If selected, the system will provide text fields for justification of the extension request and the ability to upload PDFs of supporting documentation. If the request is approved after review by the ESI Extension Committee, a new ESI end date will appear in the Education section of the PD/PI’s Personal Profile.  With the introduction of the new ESI Extension process, the prior Extension Request form and portal will be retired.

Note: other aspects of the ESI Extension process remain unchanged. See Early Stage Investigator FAQs for more information.

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EXTENSION OF CERTAIN FLEXIBILITIES FOR PROSPECTIVE BASIC EXPERIMENTAL STUDIES WITH HUMAN PARTICIPANTS: NOT-OD-19-126 announces the delay of the enforcement of the NIH Policy on the Dissemination of NIH funded clinical trial information for Basic Experimental Studies with Human Subjects (BESH) through September 24, 2019.

Points to be considered:

NIH recognizes that registering and reporting results in ClinicalTrials.gov for BESH studies can pose a challenge

  • NIH is extending the delayed enforcement of this reporting requirement originally announced in NOT-OD-18-212 through September 24, 2019
  • This delayed enforcement is only applicable to BESH studies submitted to FOAs designated as “basic experimental studies with humans” in the title
  • During this time NIH expects registration and results reporting using alternative publicly available platforms
  • Plans for meeting NIH reporting expectations using an alternative platform should be described at the time of application in the Dissemination Plan Attachment
  • Funded awardees for applications to BESH-specific FOAs who are not using ClinicalTrials.gov, should provide in their annual progress reports the unique identifier assigned by the alternate platform (if available) and a link to the report (e.g. page or record) in the alternate platform

 NOTE:

  • NIH will not extend leniency for applications submitted to incorrect FOAs based on the study-type designation.
  • Commencing with due dates on or after September 25, 2019, applications submitted to an incorrect FOA based on study-type designation (e.g. clinical trial submitted to a “clinical trial not allowed” FOA) may be withdrawn.
  • See clinical trial-specific FAQs.

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CHANGES TO NIH REQUIREMENTS REGARDING PROPOSED HUMAN FETAL TISSUE RESEARCH: NOT-OD-19-128 announces the upcoming HHS requirements and review considerations for NIH research applications (e.g. grants, cooperative agreements, and R&D contracts) that involve the proposed use of human fetal tissue obtained from elective abortions (HFT). Changes will apply to competing grant applications submitted for due dates on or after September 25, 2019 and in response to R&D contract solicitations published on or after September 25, 2019.  Information on the changes are posted on the Human Fetal Tissue Research (HFT) - NIH Requirements page of the OSR website.

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June 2019

NIH EXPANDING USAGE OF NOTICES OF SPECIAL INTERESTNOT-OD-19-107 alerts the extramural community that NIH has been updating the format of the Weekly NIH Funding Opportunities and Notices to include a special section highlighting Notices of Special Interest (NOSI) since early May.

NOSIs highlight a specific topic of interest, e.g. a specific area of research or program and direct applicants to use one or more active Funding Opportunity Announcements (FOAs), often parent announcements, for submission of applications for the initiative described in the NOSI. These Notices of Special Interest will replace the non-parent announcements (PAs) that have standard submission and review requirements, which will be phased-out to streamline how NIH announces areas of interest.

NIH will continue to post full FOAs for Requests for Applications (RFAs), program announcements with special receipt/referral/review considerations (PARs), and program announcements with set-aside funds (PASs).

Applicants must always follow guidance found in the FOA used for submission and the How to Apply – Application Guide as well as any additional submission guidance described in the NOSI. Applicants are encouraged to contact the Program Official listed on the NOSI for clarification prior the submission. Applicants will be required to include the notice number in the Agency Routing Identifier field (4b) of the SF424 (R&R) form at the time of submission. 

For more information, please visit the Applying Electronically FAQs Section II Funding Opportunities.

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NOTICE OF INTENT TO PUBLISH FUNDING OPPORTUNITY ANNOUNCEMENT TO DEVELOP STATE-LEVEL CAPACITY FOR DISSEMINATION AND IMPLEMENTATION OF PATIENT-CENTERED OUTCOMES RESEARCH INTO PRIMARY CARENOT-HS-19-019 announces that the Agency for Healthcare Research and Quality (AHRQ) intends to publish a Request for Application (RFA) to disseminate and implement patient-centered outcome research (PCOR) findings into primary care practices, with a focus on improving heart health and developing sustainable, primary care quality improvement (QI) capacity within states.

Additionally, this notice is intended to inform potential applicants of the expectation to establish multi-organizational partnerships that will support AHRQ’s role to disseminate and implement patient-centered outcomes research.

 See NOT-HS-19-019 for more information.

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NOTICE OF DATA SHARING POLICY FOR THE NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH): NOT-MH-19-033 notifies the research community of NIMH’s Data Sharing Policy.

NIMH has established an informatics infrastructure to enable responsible sharing and use of data collected from and about human subjects by the research community. This data archive provides the infrastructure and support to enable mental health researchers to deposit their data and share that data with the research community. Consistent with the authorities under the 21st Century Cures Act, researchers funded by NIMH are required to deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from experiments involving human subjects into this infrastructure.

This policy applies to all grant applications that involve human subject research submitted to NIMH and FOAs that NIMH participates in after January 1, 2020. This policy does not apply to the following types of applications:

  • Fellowship (F)
  • Research Career Development (K)
  • Training (T)
  • Small Business (SBIR/STTR)
  • Small Grants (R03)
  • Education (R25)
  • Awards related to AIDS applications

 The NIMH Data Sharing Policy does not supersede the general NIH Genomic Data Sharing Policy (NOT-OD-14-124); however, it does mandate that the NIMH Data Archive (NDA) serve as the repository for genomic data resulting from NIMH funded research unless NIHM agrees to a different data archive during the negotiation of the award terms and conditions. Awardees who are measuring human genomic data will register with dbGaP. After registration, all data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) will be deposited in the NDA and a link to the NDA collection will be added to the dbGaP registration. Computational credits may be applied for to do facilitate the re-analysis of aggregated data in the single cloud based data archive. All data associated with new projects at the NIMH Repository and Genomics Resource will be deposited in the NDA and then appropriate data will be transmitted to the NIMH Repository and Genomics Resource.

See NOT-MH-19-033 for details and additional information concerning Proposal and Post Award requirements.

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May 2019

NIGMS-managed HIV/AIDS RESEARCH PORTFOLIO TRANSITIONING TO NIAID: NOT-GM-19-039 announces that effective immediately the National Institute of General Medical Sciences (NIGMS) is transferring its HIV/AIDS portfolio and associated funds to the National Institute of Allergy and Infectious Diseases (NIAID). This portfolio is funded from the HIV/AIDS budget, which is separate from the general NIGMS appropriations. The transfer will be coordinated by the NIH Office of AIDS Research (OAR). 

Also, effective immediately, HIV/AIDS applications will no longer be accepted by NIGMS. This applies to FOAs issued by NIGMS, FOAs in which NIGMS participates, and NIH Parent Announcements.

 Affected grantees will be contacted by NIGMS and NIAID staff with further information including Program Official and Grants Management Specialist assignment.

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NOTICE OF INTENT TO PUBLISH A FUNDING OPPORTUNITY ANNOUNCEMENT FOR MAXIMIZING TH SCIENTIFIC VALUE OF EXISTING BIOSPECIMEN COLLECTIONS: NOT-OD-19-100 announces the intent of the NIH Tobacco Regulatory Science Program (TRSP), participating NIH ICs, and FDA Center for Tobacco Products (CTP) to promote a new initiative through an R21 Funding Opportunity Announcement (FOA). The FOA will solicit applications for research that will stimulate exploratory research relevant to the mission of the FDA CTP using existing (publicly available) biospecimen currently stored in repositories in the United States. This will included (but not limited to) collections associated with:

  • Population Assessment of Tobacco and Health (PATH) Study
  • National Health and Nutrition Examination Survey (NHANES)
  • NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC)
  • Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial 

Short Turnaround:  Estimated FOA publication – August 1, 2019. First estimated Application due date – October 8, 2019.

Please see NOT-OD-19-100 for more information (please note estimated award and start dates).

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NOTICE OF INTENT TO PUBLISH A FUNDING OPPORTUNITY ANNOUNCEMENT FOR SECONDARY ANALSES OF EXISTING DATASETS OF TOBACCO USE AND HEALTH: NOT-OD-19-104 announces the intent of the NIH Tobacco Regulatory Science Program (TRSP), participating NIH ICs, and FDA Center for Tobacco Products (CTP) to promote a new initiative through an R21 Funding Opportunity Announcement (FOA). The FOA will solicit applications for research proposing innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the FED CTP.

Short Turnaround:  Estimated FOA publication – August 1, 2019. First estimated Application due date – October 8, 2019.

Please see NOT-OD-19-104 for more information (please note estimated award and start dates).

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REQUIRED USE OF THE xTRACT SYSTEM TO PREPARE DATA TABLES FOR TRAINING GRANT RPPRs IN FY 2020NOT-OD-19-108 announces the requirement to use the xTRACT feature in the eRA Commons to prepare the required data tables for Research Performance Progress Reports (RPPRs) of institutional research training awards (T15, T32, T90/R90, and TL1). Beginning with RPPRs due October 1, 2019, system validations in the RPPR module will check to ensure that the uploaded data tables were created using xTRACT.

This requirement is not mandatory for new and renewal institutional research training awards (T15, T32, T90/R90, and TL1) in FY 2020; however, this may become a requirement in future years.

Other types of predoctoral, postdoctoral, and career-level training, education, and career development awards that currently use training data tables (T37, R25, K12/KL2) will not be required to use xTRACT to prepare tables for RPPRs in FY 2020. Recipients of these awards may wish to wait for future editions of xTRACT, which are expected to include features and instructions tailored to these specific programs.

Please see NOT-OD-19-108 for more information and specific details.

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GUIDANCE ON POSTING INFORMED CONSENT FORMS FOR NIH-FUNDED CLINICAL TRIALS: NOT-OD-19-110 provides guidance regarding where to post clinical trial informed consent forms, as required by Section 46.116(h) of the Revised Common Rule (Subpart A of 45 CFR 46). The Revised Common Rule requires Federally-supported clinical trial (as defined in 45CFR46.102(b)) recipients to post an IRB-approved consent from on a public federal website designated for posting such consent forms.

NIH-funded recipients should submit IRB-approved English-language informed consent forms to ClinicalTrials.gov, following the instructions. Note: ClinicalTrails.gov does not support non-English documents.

NIH-funded recipients using only non-English informed consent forms to enroll participants should submit IRB-approved informed consent forms to Docket ID: HHS-OPHS-2018-0021 on the Regulations.gov website following the instructions provided by the Office for Human Research Protections.

See NOT-OD-19-110 for specific details.

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April 2019

NOTIFICATION OF CHANGE IN FEDERAL-WIDE UNIQUE ENTITY IDENTIFIER REQUIREMENTS: NOT-OD-19-098 alerts NIH recipients of the Federal-wide transition from the Data Universal Numbering System (DUNS) to a new Government-owned Unique Entity Identifier (UEI). Effective December 2020, the System for Award Management (SAM) will be the central repository for the new SAM Managed Identifier (SAMMI) that will be incorporated into an institution’s SAM registration and will not impact the Institutional Profile File (IPF) generated by the eRA Commons. Details related to full implementation will be provided to agencies by December 2020.

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FY 2019 SALARY LIMITATION FOR GRANTS & COOPERATIVE AGREEMENTS:  NOT-OD-19-099 announces that effective January 6, 2019, the salary limitation for Executive Level II increased from $189,600 to $192,300. The salary limitation applies to NIH grants, cooperative agreements and extramural research and development contract awards. Existing awards may adopt the new salary cap through rebudgeting; however, no additional funds will be provided by the sponsor. For a historical record of the salary cap including effective dates, see the NIH Salary Cap Summary page.

For University-specific guidance, please see the May 1, 2019 issue of the Controller's Newsletter.

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 PUBLICATION OF REVISED NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES: NOT-OD-19-106 announces the update of the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and describes  NIH’s efforts to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate.  The RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). Please see the Notice for links to the final revisions.

IMPORTANT NOTE: Though NIH is streamlining individual protocol reporting requirements, robust oversight over gene therapy trials will continue as Federal and local oversight must continue to review and approve these trials before any research with human participants can be initiated.

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March 2019

NOTICE OF SPECIAL INTEREST: DEVELOPMENT OF CRYOGENIC OR OTHER LONG-TERM PRESERVATION AND REVIVAL METHODS FOR DROSOPHILA AND ZEBRAFISH GENETIC STOCKS: NOT-OD-19-089 announces that the Office of Research Infrastructure Programs (ORIP) is interested in receiving grant applications for hypothesis-driven research projects through PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) aimed at developing or improving cryogenic or other long-term preservation and revival methods of either Drosophila or zebrafish genetic stocks. Submission should indicate that they are in response to NOT-OD-19-089 in Field 4.b. on the SF 424 form. Interested Principal Investigators are encouraged to contact scientific contacts listed on the Notice to be advised on the appropriateness of the intended research project, competitiveness of a potential application, and alignment with ORIP's program priorities. Please see the Notice for areas of high priority.

CLARIFICATION REGARDING THE SUBMISSION OF BIOSKETCHES FOR PA-18-906: NOT-OD-19-091 informs potential applicants using the eRA Commons for electronic-based submissions for PA-18-906 “Research Supplements to Promote Diversity in Health-Related Research (Admin Supp-Clinical Trial Not Allowed)” that biosketch information for the candidate, any mentors, and any senior or key persons directly involved in the activities related to the supplement should be included. Biosketches for mentors and other senior and key persons should provide evidence of past mentoring experience.

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February 2019

REVISED GUIDANCE ON PROTECTING LIFE IN GLOBAL HEALTH ASSISTANCT: NOT-OD-19-079 extends the applicability of the PLGHA policy (see NOT-OD-17-083) to the foreign non-governmental organizations (NGO) who are subrecipients (and their vendors) of US State or local governmental entities including state universities that receive US global health assistance from the President's Emergency Plan for AIDS Relief (PEPFAR). This requirement is effective January 3, 2019 for new awards and contracts and existing awards and contracts when amended to add new funding.  The term will appear in Section IV: Special Terms and Conditions of the Notice of Award, below is an example of the term:

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organizations (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award either as a prime recipient or subrecipient of a US NGO are strictly prohibited regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning or  engaging in any activity that promotes abortion as a method of family planning or to provide financial support to any other foreign NGO that conducts such activities. Please refer to the NOT-OD-19-083 for full provisions of the requirement. 

UPDATE TO NIH/AHRQ/NIOSH POLICY ON POST-SUBMISSION MATERIALS: NOT-OD-19-083 updates and clarifies the NIH, AHRQ, and NIOSH policy for post-submission materials for applications submitted on or after May 25, 2019. 

What will change for Training Grant (T series) applications submitted on or after May 25, 2019, a list of publications up to 3-pages will be accepted as post-submission materials. This replaces the former 1-page limit.

Clarifications: Preprints and Other Interim Research Products are not accepted as post-submission materials - they do not represent unforeseen events. Missing or corrected materials are not accepted unless specifically listed in this Notice as post-submission materials. Materials resulting from change of institution or change of PD/PI that occurs between application submission and peer review must first be sent to the SRO managing the review with a copy to the Division of Receipt and Referral ([email protected]), and after review materials should be sent to the Grants Management Specialist listed in eRA Commons for that application.

See the Notice for Allowable Post-Submission Materials for All Applications.

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January 2019

NIH IMPLEMENTATION OF THE FINAL RULE ON THE FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS (COMMON RULE): NOT-OD-19-050 announces the NIH implementation of the Final Rule amending the Federal Policy for the Protection of Human Subjects (Common Rule). Several provisions in the Revised Common Rule resulted in changes to NIH policies and procedures. From an application submission perspective, the most notable changes are: 1.) Changes to categories of research qualifying for exemptions (FAQs) and 2.) Use of new exemptions 7 and 8, when applicable.

UCSF HRPP hosted two Town Hall meetings on January 14-15, 2019, to discuss the changes to the federal policy for research involving Human Subjects.  The sessions were live-streamed and recorded.  See the HRPP Common Rule webpage for more information and resources.

NIH POLICY FOR REVIEW AND RESUBMISSION OF NEW INVESTIGATOR R01 APPLICATIONS: NOT-OD-19-053 provides an update of review and resubmission of New Investigator (NI) R01 applications, commencing with R01 applications submitted for due dates on or after January 25, 2019. NIH has prioritized funding of meritorious R01 applications (NOT-OD-17-101) and will continue to make a special accommodation for NI R01 applications by retaining clustered review and preferential release of summary statements.  The special NI deadline for next round resubmission of A1 R01 applications will be eliminated.

REMOVAL OF REQUIREMENT FOR IRB REVIEW OF NIH GRANT APPLICATIONS & CONTRACT PROPOSALS: NOT-OD-19-055 provides guidance on the implementation of revisions to the Final Rule on the Federal policy for the Protection of Human Subjects (Common Rule). Effective January 21, 2019 and forward, NIH will no longer require IRB review of the entire grant application or contract proposal. NIH will continue to require certification that all NIH-supported, non-exempt human subjects research protocols have been reviewed and approved by an IRB and the date of final IRB approval provided at Just-In-Time. The notice further provides a reminder that any changes to peer reviewed protocols or the addition of new study protocols require NIH prior approval (NIH GPS 8.1.2.5).

CLARIFICATION REGARDING HARASSMENT AND DISCRIMINATION PROTECTIONS IN NIH TRAINING (T) APPLICATIONS: NOT-OD-19-056 provides clarification that this policy allows for a single letter, on institutional letterhead, signed by a key institutional leader with institution-wide responsibilities.  The letter provides the institution's commitment to the planned program  and includes its commitment to prevent discriminatory harassment and other discriminatory practices through proper policies, procedures, and oversight; appropriately responding to such allegations; and following NIH prior approval procedures if there is a change in the status of NIH-supported Senior/Key Personnel as a result. 

Please note, UC has a separate campus-wide Letter of Support for the prevention of harassment and other discriminatory actions. The link to this letter is posted on the OSR webpage for Regulatory/Compliance Requirements.  The campus-wide letter and the program specific letter should be included in the single pdf for the Letters of Support on the PHS 398 Research Training Program Plan form for T applications due on or after January 25, 2019. Also, consult specific instructions provided by individual NIH Institutes and Centers.

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December 2018

REVISION: NIH POLICY AND GUIDELINES ON INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN IN RESEARCH INVOLVING HUMAN SUBJECTS: NOT-OD-18-116 replaces NOT-98-024 revising the NIH Policy and Guidelines on the Inclusion of Children. Now individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to include them. Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in the Inclusion of Women, Minorities, and Children section of the proposed research project.

CHANGES TO NIH ACADEMIC RESEARCH ENHANCEMENT AWARD R15 PROGRAM: NOT-OD-19-015 announces the rebranding of the "NIH Research Enhancement Award."  The R15 activity code will include two programs: 1.) Academic Research Enhancement Award (AREA) for Undergraduate-Focused institutions and 2.) Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools. The ineligible institution list will no longer be maintained, instead an institution letter verifying eligibility is required with criteria listed in the funding opportunity announcement.

ADVANCE NOTICE-STREAMLINING THE CERTIFICATIONS AND REPRESENTATIONS PROCESS AND PHASING OUT THE SF-424B: NOT-OD-19-043 announces that effective January 1, 2020, the System for Award Management (SAM) will become the central repository for common government-wide certifications and representations (assurances) required by NIH. This action will reduce the duplicative practice of Federal-awarding agencies requesting these assurances with the submission of each Federal financial assistance application and will phase-out the use of the SF-424B. 

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November 2018

UPDATE TO NIH MANAGEMENT OF GENOMIC SUMMARY RESULTS (GSR) ACCESS: NOT-OD-19-023 provides an update to the NIH Genomic Data Sharing (GDS) Policy, which implements data management procedures for GSR access. Investigators proposing to conduct GDS Policy applicable research will be expected to indicate in their genomic data sharing plans (in grant or contract proposals) if a study should be designated as "sensitive" for the purposes of access to GSR.

HARASSMENT AND DISCRIMINATION PROTECTIONS IN NIH TRAINING APPLICATIONS: NOT-OD-19-029 announces that NIH training (T) applications due on and after January 25, 2019 will require an additional letter of support describing the institutional commitment to prevent discriminatory harassment and other discriminatory practices. NOTE: Resources and guidance are under development for the January 25, 2019 due date.

LEGISLATIVE MANDATES IN EFFECT FOR FY 2019:  NOT-OD-19-030 provides current requirements that limit or conditions the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2019, under the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 (Public Law 115-245), signed into law on September 28, 2018.

NOTICE OF FISCAL POLICIES IN EFFECT FOR FY 2019: NOT-OD-19-031 summarizes NIH fiscal policies instituted in FY 2019:

  • FY 2019 Funding Levels - non-competing continuation awards will generally be issued at the commitment level indicated in the Notice of Award. Out-year commitments for continuation awards remain unchanged. NIH awarding ICs will post their individual fiscal policies on the NIH Funding Strategies webpage.
  • Kirschstein-NRSA - stipends will increase by approximately 2% on average (see NOT-OD-19-036).
  • Next Generation Researchers Initiative Policy - NIH will prioritize meritorious R01 - equivalent applications for Early Stage Investigators (ESI) per the policy established in FY 2017 (see NOT-OD-17-101).
  • Salary Limits - salaries paid through extramural mechanisms (e.g. grants) shall not exceed Executive Level II, currently $189,600.
  • Other Legislative Mandates - other statutory requirements are described in more detail in NOT-OD-19-030.
  • Additional Information - details on Fiscal Operations and IC-specific funding strategies will be posted on the NIH Funding Strategies webpage.

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KIRSCHSTEIN-NRSA STIPENDS AND OTHER BUDGETARY LEVELS (FY 2019): NOT-OD-19-036 establishes stipend levels for fiscal year (FY) 2019 Kirschstein-NRSA awards for predoctoral and postdoctoral trainees and fellows. Budgetary categories described in this notice apply only to Krischstein-NRSA awards made on or after October 1, 2018 with FY 2019 funds. All FY 2019 awards previously issued using budgetary levels published in NOT-OD-18-175 will be revised to adjust funding to the FY 2019 levels.

NOTE:  Additional information regarding UC scale from HR is forthcoming. OSR to concurrently release additional guidance.

CORRECTION-KIRSCHSTEIN-NRSA INDIVIDUAL PREDOCTORAL FELLOWSHIP TO PROMOTE DIVERSITY IN HEALTH-RELATED RESEARCH: NOT-OD-19-039 informs prospective applicants that the Certification Letter required in PA-18-666 should avoid revealing sensitive personal information, such as the candidate's specific racial/ethnic background or type of disability. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible. The letter should be uploaded to the "Other Attachments" section in the Research & Related Other Project Information Form.

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 October 2018

REINSTATEMENT OF NIH SBIR DIRECT-TO-PHASE II AUTHORITY: NOT-OD-19-019 announces the reinstatement of the NIH SBIR Direct Phase II provision through FIscal Year 2022. Please refer to the notice for exceptions.

COMMUNICATING RESEARCH MISCONDUCT TO NIH:  NOT-OD-19-020 reminds recipient institutions of their responsibilities in handling research misconduct (suspected or confirmed) in NIH-funded research. The notice also clarifies the requirement of recipient and subrecipient institutions (foreign or domestic) to hold assurances with HHS Office of Research Integrity (ORI) and outlines procedures to communicate matters related to research misconduct proceedings to the NIH and ORI.

REVISED NIH GRANTS POLICY STATEMENT (NIHGPS):  NOT-OD-19-021 announces publication of the revised NIH Grants Policy Statement (NIHGPS. Rev. October 2018). This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018 and supersedes, in its entirety, NIHGPS. Rev. October 2017 as a standard term and condition of award.

NEW FUNDING OPPORTUNITY ANNOUNCEMENTS (FOAs) TARGETING BASIC EXPERIMENTAL STUDIES WITH HUMANS: NOT-OD-19-024 announces the intent to publish new R01 Parent Announcements identified as Basic Experimental Studies with Humans, which focus on applications that propose clinical trials that also meet the definition of basic research. Pay close attention to participating Institutes and Centers and any restrictions posted in the Related Notices section of each FOA. Applications proposing basic experimental studies involving humans may also be submitted to opportunities which allow clinical trials.

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September 2018

2018 BAYH-DOLE ACT FINAL RULE:  NOT-OD-18-233 implements the new final regulations of the Bayh-Dole Act (rights to Federally-funded inventions and licensing of government-owned inventions), which applies to all NIH new (including renewals) and continuation awards beginning on or after October 1, 2018.

FIXED AMOUNT AWARDS:  NOT-OD-18-222 provides clarification of the definition of “fixed amount” subawards, specifically when used for human subject studies, e.g. clinical trials and other types. 

FELLOWSHIP APPLICATION UPDATES:  NOT-OD-18-227 announces planned updates to the application instructions and review criteria for fellowship grant applications for due dates on or after January 25, 2019.

RESEARCH APPLICATION UPDATES:  NOT-OD-18-228 announces planned updates to the application instructions and review criteria for research grant applications for due dates on or after January 25, 2019.

CAREER DEVELOPMENT AWARD APPLICATIONSNOT-OD-18-229 announces planned updates to the application instructions and review criteria for career development award applications for due dates on or after January 25, 2019.

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July 2018

SUBMISSION/RESUBMISSION POLICY:  NOT-OD-18-197 consolidates the policy onto one notice and rescinds prior notices. Use this notice when referring to the policy.

UPDATES TO RPPR:  NOT-OD-18-202 announces update to the delegation feature of the final and interim RPPR to align with the annual RPPR. Now, PIs can delegate initiation of any RPPR to the ASST role. Also, RPPR forms include decimals in the effort being reported.

2018 COMMON RULE:  NOT-OD-18-211 announces NIH implementation of the 3 burden reducing provisions during the 6 month delay. UCSF has decided not to implement to provisions and is working on campus-wide training materials for the January 21, 2019 compliance date.

BASIC SCIENCES HS STUDIES:  NOT-OD-18-212 announces delayed enforcement and short-term flexibilities for some requirements affecting Basic Science Studies with Human Participants.

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June 2018

CONTINUOUS SUBMISSION:  NOT-OD-18-178 is rescinded and replaced by NOT-OD-18-197.

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