October 26, 2022
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
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)
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:
|
FORMS-G application package |
On or after January 25, 2023, including:
|
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Applications submitted using the incorrect application package for their due date will be withdrawn and removed from funding consideration.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.
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.
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.
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Please direct all NIH inquiries to:
NIH Office of Policy for Extramural Research Administration (OPERA)
Systems Policy Branch
Email: [email protected]
Please direct all FDA inquiries to:
OAGS Grants Policy
Email: [email protected]
Please direct all AHRQ inquiries to:
Kathryn Marron, Ph.D.
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1554
Email: [email protected]
Please direct all CDC inquiries to:
CDC Office of Grant Services (OGS)
Policy, Risk, Information and Systems Management (PRISM) Branch
Email: [email protected]