November 14, 2023
- July 3, 2024 - Prior Approval Requirement for Changes to Domestic Subawards for the SBIR and STTR Programs. See Notice NOT-OD-24-149
- June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See NOT-OD-23-139.
NATIONAL INSTITUTES OF HEALTH (NIH)
The purpose of this Notice is to provide clarification regarding findings of foreign involvement with countries of concern related to grants and cooperative agreements. The specific changes implemented in NOT-OD-23-139 and clarified in the current Notice apply to all competing applications for funding under the NIH, CDC, and FDA SBIR and STTR programs submitted for due dates on or after September 5, 2023.
Clarification of Specific Changes to Competing Application Instructions
NIH has revised the guidance to outline the fact that generally, for competing applications submitted for funding under the NIH, CDC, and FDA SBIR and STTR programs for due dates on or after September 5, 2023, NIH, CDC, and FDA will not mitigate security risks identified as part of the due diligence program.
Therefore, the sections regarding risk mitigation have been modified to read as follows (changes in bold italics). All other portions of NOT-OD-23-139 remain applicable.
Denial of Awards
Applicants and recipients are encouraged to consider whether their entity’s relationships with foreign countries of concern will pose a security risk. Prior to issuing an award, NIH, CDC, and FDA will determine whether the SBC submitting the application:
- has an owner or covered individual that is party to a malign foreign talent recruitment program;
- has a business entity, parent company, or subsidiary located in the People’s Republic of China or another foreign country of concern; or
- has an owner or covered individual that has a foreign affiliation with a research institution located in the People’s Republic of China or another foreign country of concern.
A finding of foreign involvement with countries of concern will not necessarily disqualify an applicant. Final award determinations will be based on the above finding of foreign involvement and whether the applicant’s involvement falls within any of the following risk criteria, per the Act:
- interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;
- create duplication with activities supported by NIH, CDC, or FDA;
- present concerns about conflicts of interest;
- were not appropriately disclosed to NIH, CDC, or FDA;
- violate Federal law or terms and conditions of NIH, CDC, or FDA; or
- pose a risk to national security.
Generally, NIH, CDC, and FDA will not provide SBC applicants the opportunity to address any identified security risks prior to award. NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered relationship with a foreign country of concern identified in this guidance is determined to fall under any of the above criteria provided.
Post-Award Reporting Requirements
Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated disclosure form to report any of the following changes to NIH, CDC, and FDA throughout the duration of the award:
- any change to a disclosure on the disclosure form;
- any material misstatement that poses a risk to national security; and
- any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.
Regular, annual updates are required at the time of all SBIR/STTR annual, interim, and final Research Performance Progress Reports (RPPRs). For changes that occur between RPPR submissions, updated disclosure forms are required within 30 days of any change in ownership, entity structure, covered individual, or other substantive changes in circumstance, as described above. Recipients will be required to upload these updated disclosures using the Additional Materials (AM) tool in eRA Commons. System enhancements to facilitate these uploads are underway, with an anticipated deployment in calendar year 2024.The RPPR Instruction Guide will be updated to reflect this process.
If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this guidance, NIH, CDC, and FDA 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 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.
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]
For inquiries concerning CDC’s SBIR and STTR program requirements, please contact:
CDC Office of Grants Services, Office of Financial Resources
[email protected]
For inquiries concerning FDA’s SBIR and STTR program requirements, please contact:
Kimberly Pendleton
CGMO/Director
Office of Finance, Budget, Acquisitions, and Planning
[email protected]
and Human Services (HHS)
