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NIH Announces New Application Structure for NIH-Funded International Collaborations That Eliminates Foreign Subawards

September 26, 2025

Authored by Patti Kavee Melick, Katherine “Katie” Rubino, Samantha Scheer, and Madiha M. Malik

On September 12, 2025, the National Institutes of Health (“NIH”) issued NOT-OD-25-155, announcing significant changes to the application and award structure for NIH-funded international research collaborations. This update expands on the previously-released Updated NIH Policy on Foreign Subawards (NOT-OD-25-104), published on May 1, 2025, which previewed the new award framework.

Effective as of September 30, 2025, NIH will no longer accept new applications that include foreign subawards under the traditional subaward/consortium model. Instead, ex-U.S. collaborators will receive separate funding as direct awardees under NIH’s new activity codes, as further explained below.

What’s New

Elimination of foreign subawards. Any “foreign component” defined as an entity performing significant scientific work outside the U.S. must now be submitted through a new multi-component or complex application. There are exceptions for direct foreign awards.
New Activity Codes (PF5/UF5). Applications involving foreign collaborators for a Notice of Funding Opportunity (NOFO) that supports NIH’s new PF5 Activity Code (grants) or UF5 Activity Code (cooperative agreements) must, at a minimum, include the following:
- An Overall Component, addressing the project’s overall objectives as a collaboration,
- A Research Project component, addressing the scientific and technical directions of the project, and
- An International Project component, addressing the foreign collaborator’s role on the project.
Application review: Technical merit reviewers will assess applications from foreign institutions through the NIH Grants Policy Statement 16.3 Evaluation Criteria, which considers whether the project (i) offers special opportunities for advancing research programs through means that are not readily available in the U.S. or augments existing U.S. resources, (ii) is relevant to the mission and objectives of the NIH Institute or Center, and (iii) has the potential to significantly advance U.S. health sciences.
Separate awards to foreign partners. If funded, NIH will issue separate awards to each domestic and foreign organization. The U.S. lead will receive the PF5/UF5 award and each approved foreign institution will receive a separate RF2/UL2 award that is linked to the primary domestic applicant’s project.

Implications

Administrative readiness: Foreign institutions will now be direct NIH recipients, required to register in U.S. federal systems (eRA Commons, SAM.gov, etc.) and comply with NIH’s financial and reporting requirements.
Increased compliance obligations: Each foreign grant recipient will be responsible for ensuring compliance with the terms and conditions of their Notices of Award.
Increased reporting obligations: Each foreign partner will be responsible for their own financial reporting, as outlined in NIH Grants Policy Statement 8.4.1.

Recommended Actions

Assess foreign partners’ capacity. For grants requesting NIH funding for one or more foreign components, confirm that the foreign affiliated company or any other international collaborator can meet NIH’s registration, reporting and audit standards.
Plan applications early. Build in time to complete registrations and prepare budgets and compliance plans.
Monitor upcoming guidance. Watch for NIH’s release of a Parent NOFO for the PF5/UF5 activity codes, which will provide guidance on the required components of NIH’s multi-component or complex application. NIH is also expected to provide additional resources, including FAQs and trainings on the new activity codes and application structure.

Looking Ahead

The new award structure aims to enhance transparency and oversight of U.S. taxpayer funds spent abroad. While this change will likely increase administrative complexity for foreign organizations, it could raise the profile of non-U.S. life sciences companies in NIH-funded projects.

Wiggin and Dana’s Life Sciences Practice Group and Emerging Companies and Venture Capital Practice Group will be working with new and existing clients on adapting their grant strategies and collaboration agreements to comply with this new framework. Please reach out to our team for guidance on compliance, contracting, and structuring international research collaborations.

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