Published September 12, 2025, via Research News
On September 12, 2025, the National Institutes of Health (NIH) issued NOT-OD-25-155: New Application Structure for NIH-Funded International Collaborations.
As referenced in NOT-OD-25-104, NIH recognized that current application and award structures for subawards have failed to meet federal reporting and oversight needs. Therefore, NIH has announced it will no longer be accepting new applications that request funds for foreign components using the traditional grant subaward/consortium structure.
For grants requesting NIH funding for one or more foreign components, NIH will require that competing applications submit applications to a Notice of Funding Opportunity (NOFO) that supports the new PF5 Activity Code for grants, new UF5 Activity Code for cooperative agreements, or another complex mechanism activity code that supports the International Project component type.
Application Structure Requirements
The new structure must follow NIH’s multi-component or complex application package. NIH plans to issue a Parent NOFO for PF5/UF5 activity codes that will provide more detailed guidance on the required components, but a minimum, PF5/UF5 applicants will be expected to provide:
- An Overall Component that addresses the collaborative project’s overall objectives
- A Research Project Component that addresses the project’s scientific and technical direction
- An International Project Component that details the role of each foreign collaborator
Each funded foreign collaborator must be represented by a separate International Project Component. If an application involves multiple foreign collaborators, it must include multiple International Components.
The primary applicant organization must also be in the U.S. The PF5 leadership must include:
- At least one PD/PI from the primary applicant organization, and
- At least one individual from each of the International Projects, who will serve as the PD/PI of the corresponding Linked International Research Project award (see “Implications for Awards” section).
Review Process
The technical merit review will follow the standard process for other multi-component application reviews. Reviewers will:
- Provide an Overall Impact score for the project as a whole
- Comment on the specific review criteria for each individual component
For International Project Components, the evaluation will follow the criteria outlined in NIHGPS 16.3. Reviewers will evaluate:
- Whether the project presents special opportunities for advancing research programs with unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources.
- Whether the proposed project has specific relevance to the mission and objectives of the IC and has the potential to significantly advance health sciences in the U.S.
All International Collaboration (PF5/UF5) applications will be reviewed by the appropriate National Advisory Council or Board, consistent with current procedures for reviewing applications from foreign (non-U.S.) organizations.
Award Process
After merit review, PF5/UF5 applications identified by an NIH Institute or Center for funding consideration will be disaggregated. The International Project Components will be pulled from the PF5/UF5 application. Each will be provided a distinct grant number with an RF2 or UL2 activity code. The foreign organization will be considered the applicant/ recipient of the RF2 or UL2 award.
Just-in-Time (JIT) information (e.g., IRB approvals, IACUC approvals, and Current and Pending (Other) Support for key personnel) will be requested from both the PF5/UF5 and the RF2/UL2 organizations independently. If not already completed, the RF2/UL2 applicant must also verify registration in SAM.gov, Grants.gov, and eRA Commons.
If a project is selected for funding, NIH will issue the PF5 or UF5 award to the domestic organization and an RF2 or UL2 award to foreign organizations. Each organization is responsible for complying with the terms and conditions of their respective Notice of Awards.
Note: Disaggregating a PF5 or UF5 application is not a funding guarantee. NIH may fund all, some, or none of the components of the application based on:
- The technical merit
- Materials submitted through the JIT process, and
- Agency priorities
Reporting Requirements
NIH is currently reviewing progress reporting mechanisms (e.g., RPPR) to allow all funded collaborators to demonstrate their progress towards meeting the scientific aims of the overall project while reducing the administrative burden of duplicative reporting. Additional details, including updated progress reporting instructions incorporated into the terms and conditions of the Notice of Award, will be forthcoming. Each recipient organization will be responsible for their own financial reporting (NIHGPS 8.4.1) moving forward.
Resources Coming Soon
NIH is developing resources, including FAQs, as well as planning training on the new activity codes and application structure. More details on these resources will be shared as they become available.