The National Institutes of Health (NIH) has issued guide notice NOT-OD-25-130 that further addresses the implementation of the NIH Policy on Foreign Subawards (See NOT-OD-25-104), that was implemented on May 1, 2025. Taking into consideration concerns for patient safety risks for ongoing projects, NIH recognized the need to identify an alternative approach for removing foreign subawards under existing grants and cooperative agreements involving human subjects research (e.g., clinical trials and clinical research) at the foreign site.

Scope & Applicability

Applications submitted before May 1, 2025, and projects active on or before May 1, 2025 that include foreign subawards involving human subjects research (clinical trials and clinical research).

New Administrative Supplement (Type 3) Option

NIH may renegotiate the award structure with a recipient such that foreign subawards are financially removed from the primary award and awarded as an administrative supplement (Type 3) award.
Each foreign supplement will only include funds allocated for a single foreign entity, allowing NIH to better track obligations to foreign entities.

Financial Reporting & Award Management

  • Both the primary award and foreign supplement(s) will be removed from the streamlined non-competing award process (SNAP) and automatic carryover authority.

  • Each will be issued with a distinct document number and will need to submit separate annual Federal Financial Reports (FFRs). 

  • No rebudgeting is allowed between the primary award and supplements within the budget period, however, the annual RPPR process may be utilized to request a reallocation of future year commitments between the primary and foreign supplement awards

Important Notes

  • This supplemental option is in addition to, and not in lieu of, the other options outlined in NOT-OD-25-104.

  • This option is meant to be a short-term solution, permitted only for the current competitive segment, and it does not replace the new award structure that NIH expects to release in September 2025. 

Next Steps

  • Any investigators with a pending or active NIH award that involves foreign subaward(s) with human subjects research should reach out to their assigned OSRA Specialist. Proactive outreach to the NIH GMS and PO to discuss the foreign subawards and options for the Administrative Supplement for the foreign site(s) conducting human subjects research is highly recommended.

  • Please be sure to refer to OSRA's prior notice regarding NOT-OD-25-104, which still applies to foreign subawards on NIH awards that are not conducting human subjects research.

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