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Priority review Notice Amended Final

NIH Requires Prior Approval for Domestic Subaward Changes

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Published June 1st, 2026
Detected March 25th, 2026
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Summary

The National Institutes of Health (NIH) is implementing a new policy requiring prior approval for all changes to domestic subawards on NIH grants and cooperative agreements, effective June 1, 2026. This change aims to improve tracking and oversight of subaward activities to ensure compliance with federal reporting requirements.

What changed

The National Institutes of Health (NIH) has issued a notice requiring prime recipients of NIH grants and cooperative agreements to obtain prior approval before adding any new domestic subawards to an ongoing project, effective June 1, 2026. This policy reverses NIH's previous stance of not requiring prior approval for domestic subawards and is intended to enhance NIH's ability to track subaward activities and ensure compliance with the Federal Funding Accountability and Transparency Act (FFATA).

Prime recipients must now submit requests for new domestic subawards through the eRA Commons Prior Approval Module using the 'Other Request' type. This change necessitates an update to internal grant management and compliance procedures for any organization that utilizes domestic subawards on NIH-funded projects. Failure to obtain prior approval could lead to non-compliance with NIH grant terms and conditions.

What to do next

  1. Update internal policies to require prior approval for all new domestic subawards.
  2. Submit requests for new domestic subawards via the eRA Commons Prior Approval Module.
  3. Ensure awareness of FFATA reporting requirements related to subawards.

Source document (simplified)

Prior Approval Requirement for Changes to Domestic Subawards Notice Number: NOT-OD-26-062

Key Dates

Release Date: March 25, 2026

Related Announcements

  • January 21, 2026. NIH Requires Use of the eRA Prior Approval Module for the Submission of ALL Prior Approval Requests. See NOT-OD-26-026.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This guide notice updates the NIH requirements for obtaining prior approval for changes to domestic subawards on all NIH grants and cooperative agreements. NIH has a longstanding policy of not requiring prior approval for the addition of domestic subawards to ongoing projects. This makes tracking and oversight of subawards challenging, and NIH needs to be aware of all subawards in order to effectively track compliance with the Federal Funding Accountability and Transparency Act (see NIH Grants Policy Statement 4.1.8).

Effective June 1, 2026, all prime recipients are required to obtain NIH prior approval when adding a new domestic subaward to a project post-award, when the arrangement was not originally a part of the peer-reviewed and approved application.

The new prior approval requirement is intended to ensure that NIH is aware of all subaward activities for each NIH project, so that NIH can monitor the prime recipient and ensure compliance with subaward monitoring and reporting requirements.

Requests must be submitted in the eRA Commons Prior Approval Module using the “Other Request” type.

As a reminder, effective May 1, 2025, NIH no longer recognizes foreign subawards. Recipients seeking to initiate a new international collaboration must utilize the new application structure for NIH-funded international collaborations (PF5/UF5).

Inquiries

Please direct all inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration (OPERA)
[email protected]

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Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
NIH
Published
June 1st, 2026
Compliance deadline
June 1st, 2026 (68 days)
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
NOT-OD-26-062

Who this affects

Applies to
Employers
Industry sector
6111 Higher Education 6211 Healthcare Providers 9211 Government & Public Administration
Activity scope
Grant Management Subaward Oversight
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Grant Management Research Funding Compliance

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