Key Dates

Related Announcements

• December 12, 2024 – NIH Requires Mandatory Use of the eRA Prior Approval Module for the Submission of Prior Approval Requests for all SBIR and STTR Awards Beginning January 27, 2025. See Notice NOT-OD-25-040.
• November 14, 2023 – Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029.
• June 12, 2023 – Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-23-139.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

This guidance serves as notice for the extramural community on recent policy changes made for the Small Business Innovation Research (SBIR) Program and the Small Business Technology Transfer (STTR) Program. This notice implements a change in policy for domestic subawards.

The National Institutes of Health Grants Policy Statement (NIHGPS) Sections 8.1.3 Requests for Prior Approval, 15.2.4 Approval Authorities, and 18.5 Small Business Innovation Research and Small Business Technology Transfer Programs will be updated to reflect this policy requirement.

Applicability

This guidance applies to all recipients under the SBIR and STTR Programs.

Background

Prior to the passing of the SBIR and STTR Reauthorization Act 2022, NIH did not require prior approval (refer to NIHGPS Section 8.1.2 Prior Approval Requirements) for recipients seeking to add a new domestic subaward to a new entity post-award. Following the enactment of the SBIR and STTR Reauthorization Act of 2022 (hereafter referred to as the “Reauthorization Act”), NIH implemented the Due Diligence Program which involves performing a foreign risk assessment to ensure federal funding is not awarded to small business concerns (SBCs) found to have prohibited relationships with foreign countries of concern. In order to ensure compliance with the requirements of the Reauthorization Act, NIH must assess the foreign relationships of domestic subawards that are added to a project post-award.

The new prior approval requirement is intended to support recipients in monitoring their relationships with countries of concern and will help avoid security risk findings for subawards post-award.

Policy Update

SBIR and STTR recipients are now required to seek prior approval when adding a new domestic subaward to a project.post award, where the arrangement was not originally a part of the peer reviewed and approved application. NIH continues to require prior approval when adding a foreign subaward to the project.

A foreign risk assessment is required for the entity selected for the subaward when a recipient submits a prior approval request (refer to NIHGPS Section 8.1.3 Requests for Prior Approval) to add a new domestic subaward post-award. Recipients are required to submit an updated SBIR STTR Foreign Disclosure Form via the “SBIR STTR Foreign Disclosure Request for Additional Materials” (RAM) feature in eRA Commons. The recipient must receive official written approval notification from the NIH Grants Management Official prior to signing a subaward agreement.

It is important for recipients to monitor their subaward relationships with foreign entities in order to avoid project disruptions. An SBC will be required to repay all amounts received from NIH, CDC, and FDA under the award if either of the following determinations are made upon assessment of a change to their disclosure:

• the SBC makes a material misstatement that NIH, CDC, and FDA determine poses a risk to national security; or
• there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.

As a general reminder, SBIR and STTR recipients are strongly encouraged to consult with their designated Grants Management Official identified on the Notice of Award as early as possible when considering changes to the project that require prior approval as outlined in NIHGPS Section 8.1.2. Prior Approval Requirements.

Inquiries

For all inquiries concerning the NIH SBIR and STTR Program requirements please contact:

SEED (Small business Education and Entrepreneurial Development)
Office of Extramural Research
[email protected]

For general NIH grants policy-related inquiries, please contact:

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