For-profit, for profit, sbir, sttr, public policy requirements and objectives, place of performance, change in organization status and change of recipient institution actions, minimum level of effort, multiple program director/principal investigator applications and awards, small business

18.5.3 Public Policy Requirements and Objectives

For-profit organizations receiving SBIR/STTR awards generally are subject to the same public policy requirements as non-profit organizations. However, the requirements concerning reporting of financial conflicts of interest (see Public Policy Requirements, Objectives, and Other Appropriation Mandates—Financial Conflict of Interest in IIA) do not apply to applications or awards under Phase I of the SBIR/STTR programs. The requirements do, however, apply to Phase II, Phase IIB and CRP applications and awards.

Consistent with SBA program policy directives and NIH's omnibus NOFOs for SBIR and STTR, when purchasing equipment or a product under the SBIR/STTR award, the small business concern should purchase only American-made items whenever possible.

18.5.3.1 Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries

As required under the SBIR and STTR Extension Act of 2022, NIH has implemented a due diligence program designed to assess security risks and deny funding of an award when foreign relationships or commitments with countries of concern pose a significant risk. The due diligence program assesses the cybersecurity practices, patent analysis, employee analysis, and foreign ownership of an SBC seeking an award, including the financial ties and obligations of the SBC and employees of the SBC to a foreign country, foreign person, or foreign entity. Applicants to the SBIR/STTR programs, as well as active SBIR/STTR awards, are subject to review under this due diligence program.

Each SBC applying for SBIR/STTR awards is required to disclose all funded and unfunded relationships with foreign countries for all owners and covered individuals. A covered individual is defined as all senior key personnel identified by the SBC in the application (i.e., individuals who contribute to the scientific development or execution of a project in a substantive, measurable way). Upon request, applicants will submit the completed Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form via the Just-In-Time (JIT) process described in NIHGPS section 2.5.1 Just-in-Time Procedures . Prior to issuing an award, NIH will assess the application, including JIT elements and the disclosure form. Based on the outcomes of the assessment, , NIH may request additional documentation (e.g., copy of contractual or financial obligation or other agreement) specific to an arrangement with an enterprise owned by a foreign state or any foreign entity in effect during the 5-year period (calendar year) preceding submission of the proposal. Based on the security risks identified during the assessment, NIH may decline to move forward with an award. Generally, SBC applicants will not have the opportunity to address any identified security risks prior to award.

Recipients with active SBIR/STTR 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 a 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 (see NIHGPS Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support) .

For additional information on the due diligence program, see the Foreign Disclosure and Risk Management webpage , which contains foreign risk review areas and foreign risk case studies.