NIH and CDC Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Required)

The National Institutes of Health (NIH), a division within the U.S. Department of Health and Human Services, is collaborating with the Centers for Disease Control and Prevention (CDC) to announce a forthcoming funding opportunity titled “NIH and CDC Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Required).” This opportunity is specifically aimed at U.S.-based small business concerns (SBCs) as defined by the U.S. Small Business Administration (SBA). It falls under the Small Business Innovation Research (SBIR) program, which is a key mechanism for fostering technological innovation and supporting research aligned with public health missions. The notice is being issued in advance of the official solicitation to give potential applicants ample time to prepare collaborative and competitive proposals. The purpose of this SBIR grant is to support small businesses in conducting research and development that aligns with the missions of participating NIH Institutes and Centers and the CDC. These projects must include clinical trials and utilize the R43/R44 funding mechanisms. Applicants may submit proposals for Phase I, Phase II, Direct-to-Phase II (NIH only), Fast-Track (NIH only), and Phase IIB (NIH only). The solicitation of applications is contingent upon the reauthorization and extension of the SBIR program by Congress. Funding may be used for a broad range of health-related research areas, as reflected in the extensive list of applicable assistance listings. These include environmental health, hazardous waste training, human genome research, mental health, cancer detection and treatment, cardiovascular and lung disease research, and many others. Spending must be consistent with the specific guidelines of the SBIR program and the NIH and CDC’s research priorities. A detailed breakdown of eligible activity codes and research areas is provided in the forecast documentation. Eligibility for this funding opportunity is restricted to U.S. small business concerns that meet the SBA’s eligibility criteria. No other applicant types are accepted. The opportunity is forecasted, and applications are not currently being accepted. However, the estimated post date is October 1, 2025, with an application due date of January 5, 2026. The expected award date is June 1, 2026, with projects beginning by July 1, 2026. There is no cost-sharing or matching requirement for this grant. The anticipated number of awards has not yet been disclosed, nor have the award ceiling, floor, or total program funding. These will likely be provided once the full Notice of Funding Opportunity (NOFO) is released. Despite these unknowns, the forecast provides substantial insight into the type and scope of research sought. For further information, applicants are advised to contact NIH SEED (Small business Education and Entrepreneurial Development) at the Office of Extramural Research. They can be reached by phone at 301-827-8595 or via email at SEEDinfo@nih.gov. Interested applicants are encouraged to begin preparing their research plans and collaborations in anticipation of the official NOFO release later this year.