December 16, 2021: New NIH “FORMS-G” Grant Application Forms and Instructions Coming for Due Dates on or after January 25,2022

New NIH “FORMS-G” Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

Notice Number: NOT-OD-21-169

Release Date: August 5, 2021

Related Announcements: RFA-AT-22-006 – NIH-DOD-VA Pain Management Collaboratory Pragmatic and/or Implementation Science Demonstration Projects ((UG3/UH3) Clinical Trial Required); NOT-OD-21-170 RFA-EB-21-001-Technology Development to Reduce Health Disparities (R01 Clinical Trial Optional); RFA-RM-22-007 – Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed); RFA-HG-22-001-Supporting Talented Early Career Researchers in Genomics (R01 Clinical Trial Optional); PAR-22-068– Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement (UH3 Clinical Trial Required); RFA-HD-23-020 – Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Scientific Leadership Center (UM2 Clinical Trial Optional); RFA-HD-23-021 – Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional); PAR-21-356 – Limited Competition: Research Resource for the National Swine Resource and Research Center (U42 Clinical Trial Not Allowed); NOT-OD-22-018 – Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 – New Grant Application Instructions Now Available; NOT-OD-21-073 – Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021; NOT-OD-21-109 – Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel; >NOT-OD-21-110 – Implementation of Changes to the Biographical Sketch and Other Support Format Page; NOT-OD-21-122 – Announcing New Inbox for Inquiries Related to Changes to Biographical Sketch and Other Support Format Page; NOT-OD-21-170 – Updates: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements.

Issued by: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ)

Purpose: This notice informs the applicant and recipient communities of changes to grant application forms and application guide instructions for due dates on or after January 25, 2022.

The following application forms include substantive form changes (i.e., new/deleted/modified fields). All other forms include only an OMB expiration date change.

  • SF424 R&R
  • R&R Senior/Key Person Profile (Expanded)
  • R&R Budget and Associated Subaward Budget Attachment(s) Form
  • Project/Performance Site Location(s)
  • PHS 398 Training Budget and Associated Subaward Budget Attachment(s) Form
  • PHS Additional Indirect Costs
  • PHS Fellowship Supplemental Form
  • PHS Human Subjects and Clinical Trials Information
  • SBIR/STTR Information

Key changes:

  • As part of the federal-wide transition from the DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number to the new government-owned Unique Entity Identifier (UEI), applicants will be required to have a UEI to apply for federal grants or cooperative agreements. The System for Award Management (SAM) will become the central repository for the new UEI that 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. See NOT-OD-21-170 for more information.
  • NIH will require the use of the updated Biographical Sketch and Other Support format pages for submissions on or after January 25, 2022. See NOT-OD-21-073, NOT-OD-21-110, and NOT-OD-21-122 for more information.
  • Targeting due dates on or after January 25, 2022, 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). Extension of the existing eRA Commons ID requirement to include all senior/key personnel will facilitate better data collection for individuals contributing to federally funded research as well as assist in disambiguating data on applications and facilitating the identification of conflicts of interest in peer review. See NOT-OD-21-109 for more information.

See High-level Summary of Form Changes in FORMS-G Application Packages for a full list of form changes. Participating agencies will notify the community if it is determined additional changes are needed. These changes will be implemented with application form packages identified with a Competition ID of “FORMS-G” and associated application guide instructions. Additional guidance and confirmation of implementation plans will be provided in Fall 2021.

Effective Date
Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022. Applications submitted using the wrong forms for their intended due date may be withdrawn and removed from funding consideration.

Availability of FORMS-G Application Guides
Application guides for FORMS-G application packages will be posted to the How to Apply – Application Guide page no later than October 25, 2021.

Availability of FORMS-G Application Packages
FORMS-G application packages will be posted as follows

  • New funding opportunity announcements (FOAs) will be posted with FORMS-G application packages beginning October 25, 2021.
  • New FOAs posted before October 25, 2021 with initial due dates on or after January 25, 2022 will be posted without application forms until updated forms are available. Application packages will be added to these FOAs by November 25, 2021.
  • All active Parent and IC-issued FOAs with due dates on or after January 25, 2022 will be updated to add FORMS-G application packages between October 25, 2021 and November 25, 2021.

For a transition period, both FORMS-F and FORMS-G application packages will be active simultaneously. Applicants must choose the appropriate application package for their due date when presented with both FORMS-F and FORMS-G application packages on the same FOA (see table below).

If your intended due date is… You must use…
On or before January 24, 2022, including:

Applications submitted for 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 January24, 2022

Applications submitted by February 1, 2022 under NIH Continuous Submission Policy for the January 7, 2022 AIDS intended due date

 FORMS-F application package
On or after January 25, 2022, including:

Applications submitted for due dates on or after January 25, 2022

All application types (New, Resubmission, Renewal, Revision)

Applications submitted early for intended due dates on or after January 25, 2022

 FORMS-G application package

Applications submitted using the incorrect application package for their due date may be withdrawn and removed from funding consideration.

Resources:

Please direct all NIH inquiries to:
NIH Office of Policy for Extramural Research Administration (OPERA)
Systems Policy Branch
Email: OPERAsystemspolicy@nih.gov

Please direct all AHRQ inquiries to:
Division for Policy, Coordination and Analysis
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality, HHS
Email: Grant_Queries@ahrq.hhs.gov

Please direct all FDA inquiries to:
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services (OAGS)
Grants Management Branch
Email: OAGSGrantsPolicy@fda.hhs.gov

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