Key Dates

Related Announcements

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:

• FORMS-H Grant Application Instructions are now posted on the How to Apply - Application Guide page. All significant changes to form instructions are listed at: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/general/g.120-significant-changes.htm.
• FORMS-H application packages are currently being posted to all active funding opportunity announcements (FOAs). We expect to complete this process by late December 2022.
• All FORMS-G application forms packages will be updated with a close date of January 24, 2023.
• NOTE: Application due dates remain unchanged. Applicants must refer to the FOA for key date information.

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).

Applications submitted using the incorrect application package for their due date will be withdrawn and removed from funding consideration.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

• AHRQ Implementation: AHRQ applicants are reminded to follow the instructions in NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy, not the guidance for the NIH Policy for Data Management and Sharing.

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

• High-level Summary of Form Changes in FORMS-H Application Packages
• Do I Have the Right Form Version For My Application?
• Application Forms, Form Updates, and Choosing the Correct Forms FAQs

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