NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

The NIH, CDC, and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Not Allowed) is a forecasted grant opportunity led by the National Institutes of Health, in partnership with the Centers for Disease Control and Prevention, and the Food and Drug Administration. This initiative is supported by a range of NIH Institutes and Centers including NEI, NHLBI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NINDS, NINR, NIMHD, NLM, NCCIH, NCATS, ORIP, NCI, and ORWH. The opportunity is designed to advance research and development in health and biomedical innovation through the Small Business Innovation Research (SBIR) program. The primary objective of this grant opportunity is to stimulate technological innovation and foster the involvement of small businesses in federal research and development. This is achieved by encouraging United States small business concerns (SBCs), as defined by the Small Business Administration, to propose projects that contribute to the research missions of the NIH, CDC, and FDA. The grant supports a variety of research areas related to health, disease prevention, environmental health, public health preparedness, and biomedical research, as indicated by the broad list of Assistance Listings covering chronic diseases, environmental health, mental health, cancer, cardiovascular diseases, drug use, and many other biomedical domains. Funding is delivered in the form of grants, with specific attention to the R43/R44 activity code. The opportunity is discretionary in nature and categorized under health-related funding activities. While the exact award ceiling, floor, and total available program funding are not specified in the forecast notice, the grant anticipates support for multiple awards that collectively address diverse research priorities across NIH, CDC, and FDA interests. Applicants are expected to utilize funds for research and development projects that do not involve clinical trials, in line with the “Clinical Trial Not Allowed” stipulation. Cost sharing or matching is not required for this opportunity. Eligible applicants are exclusively United States small business concerns (SBCs) that meet SBA criteria, ensuring that only organizations fitting this definition may apply. While the eligibility statement references “Others (see text field entitled ‘Additional Information on Eligibility’ for clarification),” the text confirms that only SBCs are eligible. Projects must demonstrate strong research capabilities and technological expertise aligned with the awarding agencies’ missions. The opportunity encourages collaborative investigations that combine expertise from multiple investigators or entities, particularly those that can contribute to responsive and innovative projects. The application process for this funding opportunity has not yet opened. The forecasted date for the official Notice of Funding Opportunity is June 18, 2025, with an estimated posting date of October 1, 2025. Applications are expected to be due by January 5, 2026, with awards anticipated in June 2026 and project start dates commencing in July 2026. As a forecasted opportunity, no applications are being accepted at this time, but advance notice is provided to allow interested applicants ample time to prepare and form collaborations. Applicants seeking additional information are directed to NIH SEED (Small business Education and Entrepreneurial Development), Office of Extramural Research (OER), with contact available via phone at 301-827-8595 or by email at SEEDinfo@nih.gov. The notice emphasizes the importance of monitoring the opportunity for updates regarding program reauthorization and the official publication of the solicitation. Applicants should check the NIH or Grants.gov website for the most current details as the timeline progresses.