Notice Number: NOT-OD-25-155
Release Date: September 12, 2025
Related Announcements
- May 1, 2025 – Updated NIH Policy on Foreign Subawards. See NOT-OD-25-104.
Issued by NATIONAL INSTITUTES OF HEALTH (NIH)
Background
NIH defines a foreign component as the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended.
As described in NOT-OD-25-104, NIH has recognized that current application and award structures for subawards have failed to meet federal reporting and oversight needs. This has raised concerns for national security, especially as it pertains to tracking the expenditure of federal funds at foreign components. To address these needs, NIH announced that it will no longer be accepting new applications that request funds for foreign components using the traditional grant subaward/consortium structure. The purpose of this Notice is to announce a new application and award structure for applications that request funding for foreign component organizations.
Policy
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.
NIH continues to support international collaborations. Of note, foreign components other than those previously supported by subawards or consortia agreements (e.g., foreign consultants, international travel) may continue to be supported through other activity codes unless otherwise indicated in the NOFO.
Implications for Applications
The new structure will leverage NIH’s multi-component or complex application package. At a minimum, PF5/UF5 applicants will be expected to provide an Overall Component that addresses the project’s overall objectives as a collaboration, a Research Project component that addresses the scientific and technical directions of the project, and an International Project component that addresses the foreign collaborator’s role on the project. Each funded foreign component should have a unique International Project component; therefore, an application with multiple foreign collaborators at different institutions would submit an application with multiple International Project components. NIH intends to issue a Parent NOFO for the PF5/UF5 activity codes with this basic structure that will provide specific guidance on the application components required for the Overall, Research Project, and International Project component types. Moving forward, NIH may also use the PF5/UF5 activity codes when issuing funding opportunities for specialized purposes that include other types of components (e.g., Cores) in combination with the International Project component type.
The primary applicant organization must be domestic (located in the U.S.). The leadership structure for the PF5 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 disaggregated Linked International Research Project award (see Implications for Awards section below).
Implications for Review
The technical merit review will be conducted consistent with the process for other multi-component application reviews. Reviewers will provide an Overall Impact score for the project as a whole and be asked to comment on the specific review criteria for each of the individual components. For the International Project components, the Evaluation Criteria in NIHGPS 16.3 will be applied, i.e., reviewers will be asked to evaluate:
- Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States 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 for significantly advancing the health sciences in the United States.
All International Collaboration (PF5/UF5) applications will be brought to the relevant National Advisory Council or Board for review, consistent with current procedures for reviewing applications from foreign (non-U.S.) organizations.
Implications for Awards
Following 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, and 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 Linked International Research Project Grant (RF2) or Linked International Cooperative Agreement (UL2).
Just-in-Time Information (e.g., IRB Approvals, IACUC Approvals, Current and Pending (Other) Support for key personnel), will be requested from both the PF5/UF5 and RF2/UL2 organizations independently. At this point in the process, if not already completed, the RF2/UL2 applicant must verify registration in SAM.gov, grants.gov, and eRA Commons, to ensure accurate awarding information moving forward.
Should a project be selected for funding, NIH will issue a PF5 or UF5 award to the domestic organization and an RF2 or UL2 award to the foreign organizations. Each organization will be responsible for ensuring the terms and conditions of their Notices of Award are met.
Note that the system disaggregation of a PF5 or UF5 application should not be considered a commitment to funding. The NIH has the ability to fund all, none, or some of the components of the PF5/UF5 application, based on the assessment of the technical merit, materials submitted through the JIT process, and agency priorities.
Implications for Reporting
For performance reporting, NIH recognizes the importance of coordination of all partners in international collaboration projects, and is currently reviewing progress reporting mechanisms (e.g., RPPR) that will 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 that will be 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 will be developing and posting resources, including FAQs, as well as planning training on the new activity codes and application structure. More details will be forthcoming.
Inquiries
Please direct all inquiries to:
NIH Office of Policy for Extramural Research Administration