September 12 Updated Implementation Guidance: NIH Policy on Foreign Subawards

On May 1, 2025, the National Institutes of Health (NIH) released NOT-OD-25-104, "Updated Policy on Foreign Subawards", stating it will not issue awards that include a subaward to a foreign entity until the details of its new foreign collaboration structure are released.

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The original policy states:

Effective with the date of this notice and until the details of the new foreign collaboration award structure are released, NIH will not issue awards to domestic or foreign entities (new, renewal or non-competing continuation), that include a subaward to a foreign entity. Additionally, NIH will no longer accept prior approval requests to add a new foreign component or subaward to an ongoing project. In all cases, NIH will allow Institutes, Centers and Offices (ICOs) to renegotiate awards, whether new, renewal or non-competing, to remove subawards to foreign entities and, where the work can be performed domestically, allow the funds to be rebudgeted for use by the prime recipient (domestic or foreign) or a domestic subrecipient. 

According to the notice, existing awards will not be revised to remove foreign subawards at this time. NIH will no longer accept prior approval requests to add a new foreign component or subaward to an ongoing project.

The policy will apply to all "monetary foreign collaborations" but will not apply to funds provided to "support foreign consultants", or to "purchasing equipment or supplies from foreign vendors".

icon  The University has received advice that proposals with foreign subawards, submitted on or after May 1, will be administratively withdrawn and not considered. It may be advisable to submit proposals without foreign subawards or postpone proposals involving foreign subawards until NIH releases new, to-be-developed NOFOs.

For now, we suggest that researchers discuss proposals with foreign subawards with their Program Officer and, at PI discretion, submit proposals with foreign subawards as planned. 

On May 7, 2025, NIH released a follow-up announcement: New NIH Foreign Subaward Structure Enhances Integrity, Accountability, Oversight, and National Security of NIH Funded Research.

According to the May 7 announcement, NIH will:

• Not issue awards that include a foreign subaward
  • This is a temporary pause for foreign subawards, while NIH finalizes the implementation of the new award structure (expected no later than September 30, 2025).
• No longer accept prior approval requests to add a new foreign component or subaward to an ongoing project.
• Renegotiate new, renewal or non-competing awards to remove subawards to foreign entities, and allow the funds to be rebudgetd for use by the prime recipient when the work can be performed domestically.
• Work with the recipient to negotiate a bilateral termination if a project is no longer viable without the foreign subaward, taking into consideration any need to support participant safety and/or animal welfare.

OSP will continue adding clarification on this topic as we have updates from NIH.

On July 18, 2025, NIH released NOT-OD-25-130: Updated Implementation Guidance of NIH Policy on Foreign Subawards for Active Projects. 

Taking into consideration concerns for patient safety risks for ongoing projects, NIH recognized the need to identify an alternative approach for removing the foreign subawards from existing grants and cooperative agreements involving human subjects research at foreign sites.

NIH Notice NOT-OD-25-130 applies to applications submitted before May 1, 2025, and projects active on or before May 1, 2025. Below are key aspects of the policy:

• Applies to existing grants and cooperative agreements involving human subjects research.
• NIH Institutes, Centers, and Offices (ICOs) will have the option to renegotiate the award structure with a recipient such that foreign subawards are removed from the primary award and reissued as an administrative supplement (i.e., Type 3).
• Each supplement will be for a single foreign entity.
• SNAP and automatic carry-forward authority will be removed from the primary award and the foreign supplement.
• The primary award and each foreign supplement will have distinct document numbers and will require separate Federal Financial Reports (FFR, SF-245).
• Rebudgeting is not allowed between the primary award and the supplement within a budget period. However, the RPPR may be used to request reallocation for future year commitments.

This supplement option is meant to be a short-term solution and is not the new award structure. 

NIH has clarified in public forums that proposals submitted on or after May 1, 2025, involving foreign subawards will not be accepted until the new structure is implemented. Applicants have been advised to hold these submissions.

Update: On September 12, 2025, NIH released: New Application Structure for NIH-Funded International Collaborations, detailing its new foreign collaboration structure.

The NIH notice NOT-OD-25-155 announces a major change in how international collaborations are structured in NIH grant applications. 

New structure for foreign components: Effective September 25, 2025, NIH will no longer accept applications with foreign components using the traditional subaward/consortium model. Instead, applicants must use new activity codes:

• PF5 for grants
• UF5 for cooperative agreements

Application Requirements:

• Must include three components:
  • Overall Component: Describe the collaborative project's goals
  • Research Project Component: Covers scientific and technical details
  • International Project Component: Detail the foreign collaborator's role
• Each foreign institution must have its own International Project component

Eligibility:

• The primary applicant must be a U.S. based organization
• Each foreign collaborator will be listed as a PD/PI on a separate linked award

Review Process:

• Applicants will be reviewed for technical merit and relevance to NIH's mission
• International components will be evaluated for their unique contributions and potential impact on U.S. health sciences

Award Disaggregation:

If selected for funding, NIH will issue separate awards:

• PF5/UF5 to the U.S. institution
• RF2/UL2 to each foreign collaborator

Reporting & Oversight:

• NIH is revising progress reporting to streamline collaboration while maintaining accountability
• Each organization will handle its own financial reporting

This shift is designed to enhance transparency, oversight, and national security in NIH-funded international research.

Researchers should contact OSP to perform restricted party screening whenever projects involve foreign entities and non-U.S. nationals.