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NIH, CDC, FDA Implement Disclosure Requirements for SBIR/STTR Programs with International Relationships

June 29, 2023

Pre- and Post-Award Requirements. Due dates on or after 9/23/2023

NIH FDA CDCNOT-OD-23-139 introduced a due diligence program to the small business innovation research (SBIR) and Small Business Technology Transfer (STTR) programs under the National Institutes for Health (NIH), the Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA).

It requires applicants to disclose all funded and unfunded relationships or commitments with international entities.

  • NIH - Upon request, applicants will submit the completed disclosure form via the Just-in-Time (JIT)  feature in the eRA Commons.
  • CDC, FDA - Applicants will follow each agency’s policies for submitting additional documents.

NIH, CDC, and FDA will assess security risks posed by applicants and foreign countries of concern (FCOC) regarding cybersecurity practices, patent analysis, employee analysis, and obligations.

Applicants not submitting disclosure materials will not be considered for funding.