Key Dates

Related Announcements

• 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

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this notice is to inform active Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) recipients of a change in Post-Award Reporting requirements for active awards that did not undergo foreign risk assessment at the time of their original application submission. This serves as notification of a modification to NIH’s due diligence program to assess security risks and denial of award when foreign relationships or commitments with countries of concern pose a significant risk as provided in the SBIR and STTR Extension Act of 2022 under these programs. 

Effective immediately the SBIR and STTR Foreign Disclosure and Risk Management Requirements described in NOT-OD-23-139 and NOT-OD-24-029 may be applied to all active SBIR and STTR awards regardless of the due date the competing application was submitted. Recipients with active awards that did not undergo foreign risk assessment at the time of their original application may be required to disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries Form. If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding NIH may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support and 15 U.S.C. 638(g)(15); (o)(19) for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award. Small businesses seeking to participate in the SBIR and STTR programs should review the Foreign Disclosure and Risk Management webpage, which contains the foreign risk review areas and case studies, and resolve any foreign security risks.

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]

For NIH system related inquiries, please contact:

Systems Policy Branch, Division of Grants Systems Integration
OPERA
[email protected]