Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
Notice Number:
NOT-OD-23-012

Key Dates

Release Date:

October 26, 2022

Related Announcements

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RFA-DK-22-017 - NIDDK Information Network Coordinating Unit: dkNET-CU (U24 Clinical Trial Not Allowed)

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RFA-HD-24-006 - Using Archived Data and Specimen Collections to Advance Maternal and Pediatric HIV/AIDS Research (R21 - Clinical Trial Not Allowed)

RFA-MH-23-310 - Social Drivers of Mental Illnesses in Low- and Middle-Income Countries: Mechanisms and Pathways of Interventions for Youth (R01 Clinical Trial Optional)

PAR-23-051 - Mechanistic links between diet, lipid metabolism, and tumor growth and progression (U01 Clinical Trial Not Allowed)

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PAR-23-047 - Engineering Next-Generation Human Nervous System Microphysiological Systems (R21 Clinical Trials Not Allowed)

PAR-23-046 - Engineering Next-Generation Human Nervous System Microphysiological Systems (R01 Clinical Trials Not Allowed)

November 8, 2022 - Transformative Educational Advancement and Mentoring Network (TEAM) (R25 Clinical Trial Not Allowed). See Notice RFA-CA-23-013

November 8, 2022 - Investigating the Effects of Addictive Substances on Brain Developmental Trajectories Using Innovative Scalable Methods for Quantification of Cell Identity, Lineage and Connectivity (R01 - Clinical Trial Not Allowed). See Notice RFA-DA-23-036

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PAR-22-252 - Early Stage Investigator HIV/AIDS Research Using Nonhuman Primate (NHP) Models (R21 Clinical Trial Not Allowed)

PAR-23-040 - Development of Resources and Technologies for Enhancing Rigor, Reproducibility, and Translatability of Animal Models in Biomedical Research (R01))

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PAR-22-248 - HIV/AIDS Scholars Using Nonhuman Primate (NHP) Models Program (K01 Independent Clinical Trial Not Allowed).

NOT-OD-22-198– Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

NOT-OD-22-195– New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-189- Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-21-013- Final NIH Policy for Data Management and Sharing

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Centers for Disease Control and Prevention (CDC)

Agency for Healthcare Research and Quality (AHRQ)

U.S. Food and Drug Administration (FDA)

Purpose

This Notice reminds the applicant and recipient community that applicants must use FORMS-H application packages for due dates on or after January 25, 2023 and must use FORMS-G application packages for due dates on or before January 24, 2023 (see NOT-OD-22-195 for details).

Applicants are encouraged to submit early to allow time to work through any unforeseen issues. Also, applicants are encouraged to use the contact information below to address questions and challenges.

Additional Updates:

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

If the intended due date is...

You must use...

On or before January 24, 2023, including:

  • Applications submitted for due dates on or before January 24, 2023
  • Applications submitted under NIH Late Policy 2-week window of consideration for intended due dates on or before January 24, 2023
  • Applications submitted by February 1, 2023 under NIH Continuous Submission Policy for the January 7, 2023 AIDS intended due date
FORMS-G application package

On or after January 25, 2023, including:

  • Applications submitted for due dates on or after January 25, 2023
  • All application types (New, Resubmission, Renewal, Revision)
  • Applications submitted early for intended due dates on or after January 25, 2023
FORMS-H application package

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

Additional Implementation Details

For NIH, as part of the implementation of the 2023 NIH Data Management and Sharing (DMS) Policy, a new “Other Plan(s)” attachment field has been added to the PHS 398 Research Plan Form and the PHS 398 Career Development Award Supplemental Form. Applicants must attach the required Data Management and Sharing Plan in this new field in FORMS-H applications. See NOT-OD-21-013 and NOT-OD-22-189 for more information. Note: Although the 2023 NIH Data Management and Sharing Policy is not applicable to fellowship and institutional training grant applications, the new attachment field was added for potential future use with other plans. Refer to the FOA and the list of NIH activity codes subject to the DMS Policy for information on whether your application must address a DMS Plan.

  • 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.

Updates to NIH FOAs

NIH is in the process of updating all active FOAs with due dates on or after January 25, 2023, to include information regarding DMS Plan requirements in Sections IV, V, and VI. These updates are expected to be completed by December 25, 2022.

Examples of the DMS policy language that will be included in NIH FOAs with receipt dates on or after January 25, 2023 are provided below for your information. Some language may vary depending on the type of FOA and activity. Refer to the FOA for specific information and contact the Scientific/Research Contact(s) in Section VII. Agency Contacts with any programmatic questions.

  • Section IV. Application and Submission Information will be updated to specify if the application must address a DMS Plan and include a note regarding the effective date.
    • Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
  • Section V. Application Review Information will be updated to reflect that the separate Data Sharing Plan and Genomic Data Sharing Plan that was previously provided in the Resource Sharing Plans attachment will no longer be evaluated at the time of review.
    • Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
  • Section VI. Award Administration Information will be updated to address Data Management and Sharing.
    • Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Resources

Inquiries

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 FDA inquiries to:

OAGS Grants Policy
Email: oagsgrantspolicy@fda.hhs.gov

Please direct all AHRQ inquiries to:

Kathryn Marron, Ph.D.
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1554
Email: Kathryn.Marron@ahrq.hhs.gov

Please direct all CDC inquiries to:

CDC Office of Grant Services (OGS)
Policy, Risk, Information and Systems Management (PRISM) Branch
Email: PRISM@cdc.gov