Beginning with applications submitted for due dates on or after September 5, 2023, NIAID will require small business innovation research (SBIR) and small business technology transfer (STTR) applicants to provide a “Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries” form before issuing a grant award. The disclosure form will allow NIH to better assess and mitigate risks to national security.

Before an Award Is Made

The form will be submitted as part of the Just-in-Time process, after an application has been peer reviewed and is within the range of possible funding—not at the time of initial application submission.

On the form, small business concerns (SBCs) will share the following information:

• The identity of all owners and covered individuals of the SBC who are a party to any malign foreign talent recruitment program.
• The existence of any parent company, joint venture, or subsidiary of the SBC that is based in or receives funding from, any foreign country of concern.
• Any current or pending contractual or financial obligation or other agreement specific to a business arrangement, or joint venture-like arrangement with an enterprise owned by a foreign state or any foreign entity.
• Whether the SBC is wholly owned in a foreign country.
• Any venture capital or institutional investment and if the investing entity has a general partner or any other individual holding a leadership role who has a foreign affiliation with any foreign country of concern.
• Any technology licensing or intellectual property sales or transfers to a foreign country of concern during the 5-year period preceding submission of the proposal.
• Any foreign business entity, offshore entity, or entity outside the United States related to the SBC.
• Any owners, officers, or covered individuals that have a foreign affiliation with a research institution located in a foreign country of concern.
• Information technology and information safeguarding plans.

Note that “covered individual” is defined as all senior key personnel that were identified by the SBC in its grant application.

The disclosure form pertains to both funded and unfunded relationships alike.

Foreign countries of concern include: the People’s Republic of China, the Democratic People’s Republic of North Korea, the Russian Federation, the Islamic Republic of Iran, or any other country determined to be a country of concern by the U.S. Secretary of State. The Small Business Administration will maintain an updated list of countries of concern at Required Disclosures of Foreign Affiliations or Relationships.

The new form supplements existing disclosure requirements for Other Support, rather than replaces them. You’ll recall, for Other Support, an applicant reports all resources made available to senior/key personnel in support of their research endeavors (with certain roles excluded). SBCs will submit the new disclosure form electronically using the Just-in-Time feature in eRA Commons.

During the Award Period

Recipient SBCs must submit an updated disclosure form to report any of the following throughout the duration of an award:

• Any change to a disclosure on the disclosure form.
• Any material misstatement that poses a risk to national security.
• Any change of ownership, change to entity structure, or other substantial change in circumstances that poses a risk to national security.

SBCs must submit an updated disclosure form within 30 days of any change in ownership, entity structure, covered individual, or other substantive changes in circumstance. Further, regular updates are required at the time of annual, interim, and final Research Performance Progress Report (RPPR) submission.

The Additional Materials tool in eRA Commons will facilitate SBC submission of updated disclosures.

Implications, Ramifications

These procedural changes are mandated by law, specifically the SBIR and STTR Extension Act of 2022.

Also by law, NIH, CDC, and FDA have established a Due Diligence Program to assess security risks posed by SBC applicants; specifically, the program will conduct cybersecurity assessments, patent analysis, employee analysis, and foreign ownership review of SBCs, including financial ties and obligations to foreign countries, persons, or entities.

Disclosing foreign relationships does not disqualify an SBC from grant award eligibility. Rather, the Due Diligence Program will determine whether foreign involvement may:

• Interfere with the capacity for activities to be carried out.
• Create duplication with activities.
• Present concerns about conflicts of interest.
• Violate federal law or agency terms and conditions.
• Pose a risk to national security.

Should a foreign relationship prompt any of the above concerns, then the Due Diligence Program will work with the SBC to resolve the risk. If a risk cannot be resolved, NIAID will not consider funding the award.

Lastly: If an SBC makes a material misstatement that poses a risk to national security (i.e., information in your disclosure form was substantially inaccurate) or undergoes a change in ownership, entity structure, or other substantial change that poses a risk to national security, NIAID may take noncompliance and enforcement actions to include required repayment of grant funds.

Read the June 12, 2023 Guide notice for complete details. Direct questions to NIH’s Small Business Education and Entrepreneurial Development (SEED) program at SEEDinfo@nih.gov.

Are you an international investigator in a resource-constrained country? Can you propose high-priority, regionally relevant infectious diseases research? If so, consider applying to the notice of funding opportunity (NOFO) International Research in Infectious Diseases (R01, Clinical Trial Not Allowed), which continues our longstanding committment to infectious diseases research abroad.

Applicant organizations must be headquartered in foreign (non-U.S.) resource-constrained countries (i.e., low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank Classification). Eligibility status of applicant organizations will be determined by the World Bank Classification list at the time of application submission.

You may propose studies on any aspect of infectious disease research (except clinical trials), including but not limited to: basic biological studies of pathogens and vectors; the epidemiology, natural history, pathogenesis, immunopathogenesis of infectious diseases; epidemiologic studies to define the incidence, clinical presentations, and outcomes of diseases; identification of resistance mechanisms and patterns; characterization of susceptible cohorts for a particular pathogen; pilot and feasibility studies in preparation for larger studies; and studies focused on the effects of climate change on the incidence, prevalence, and severity of infectious diseases.

Further Details

The scientific scope of this NOFO is sufficiently broad to cover the full range of infectious diseases research prioritized by NIAID’s Division of Microbiology and Infectious Diseases (DMID) and Division of AIDS (DAIDS), with the exception of clinical trials. Note that HIV/AIDS studies must address NIAID priorities as described in the Division of AIDS Overview.

While the program is open to institutions located in any foreign, resource-constrained country, we especially encourage applications from institutions located in countries classified as low- and lower-middle-income economies.

We encourage potential applicants to build collaborations, whether with U.S. institutions or other institutions within the host country or region, although this is not a requirement for funding.

To be eligible, a principal investigator must not have had (or currently have) an R01-equivalent award other than a current or expiring International Research in Infectious Diseases award.

NIAID will hold a virtual program kick-off meeting for award recipients in early 2024 and annual meetings thereafter to facilitate communication and collaboration.

Application Requirements

There is one receipt date per year: August 2, 2023; August 2, 2024; and August 1, 2025. All applications submitted in response to the first receipt date (August 2, 2023) must be new applications; resubmission or competitive renewals are not allowed.

Application budgets should not exceed $125,000 in annual direct costs and should reflect the actual needs of the project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. 

Additional Resources

Frequently asked questions concerning this NOFO are available at Questions and Answers for RFA-AI-23-023.

NIAID staff will host an informational webinar on July 7, 2023. Registration details will be listed on the Questions and Answers page linked above.

If you are interested in applying, we strongly encourage you to contact one of NIAID’s scientific/research contacts to discuss our research priority areas: Dr. Glen McGugan, Jr., DMID, at gm233g@nih.gov or 240-627-3314; Melanie Bacon, DAIDS, at mbacon@niaid.nih.gov or 240-627-3215; or Dr. David McDonald, DAIDS, at david.mcdonald@nih.gov or 301-761-7815. Direct questions related to application review to NIAID’s peer review contact Dr. Soheyla Saadi at saadisoh@nih.gov or 240-669-5178.