NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Required)

The National Institutes of Health (NIH), a component of the United States Department of Health and Human Services, is the primary federal agency responsible for conducting and supporting medical research. The NIH comprises numerous Institutes and Centers (ICs) focused on various aspects of health research, including NEI, NHLBI, NHGRI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIEHS, NIMH, NINR, NIMHD, NLM, NCCIH, NCI, and ORWH. Through its Small Business Technology Transfer (STTR) program, the NIH aims to foster collaboration between small businesses and research institutions, supporting the commercialization of innovative technologies that align with its research priorities. The NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Required), opportunity number FOR-OD-26-004, is a forecasted discretionary grant focused on supporting United States small business concerns (SBCs) that meet the criteria established by the Small Business Administration (SBA). The grant specifically targets projects that require clinical trials and encourages applications in a wide range of health-related research and technology fields, including but not limited to environmental health, genome research, communication disorders, complementary health, sleep disorders, mental health, addiction research, cancer, cardiovascular diseases, lung diseases, child health, aging, vision, and medical library science. This funding opportunity is designed for Phase I, Phase II, Fast-Track, and Phase IIB STTR projects and will utilize the R41 and R42 activity codes. It is intended to stimulate technological innovation, strengthen the role of small businesses in meeting federal research and development needs, and facilitate the transfer of research advancements into the marketplace. NIH encourages collaborative projects that combine expertise from multiple investigators or organizations. Acceptable spending includes costs directly associated with research and development leading to the commercialization of new health technologies, provided the projects require a clinical trial. Eligibility for this opportunity is limited to United States small business concerns as defined by the SBA, which must demonstrate both the research capabilities and technological expertise needed to contribute to NIH's research and development missions. The applicant must be a small business concern, and further details on SBA eligibility are available through the provided resources. As of now, the opportunity is only forecasted and not yet open for applications. The anticipated post date for the Notice of Funding Opportunity (NOFO) is October 1, 2025, with an estimated application due date of January 5, 2026. Award notifications are expected around June 1, 2026, with the project start date anticipated for July 1, 2026. The forecast date for this opportunity is June 10, 2025, and the most recent update was June 18, 2025. The official solicitation and final application details are contingent upon the reauthorization and extension of the federal STTR program. Potential applicants are advised to monitor for updates and begin preparing responsive projects and collaborations as appropriate. There are currently no specifics available regarding the award ceiling, award floor, total program funding, or the expected number of awards. Similarly, no cost-sharing or matching is required for this opportunity. Interested applicants may seek additional information or ask questions by contacting NIH SEED (Small business Education and Entrepreneurial Development), Office of Extramural Research, at 301-827-8595 or SEEDinfo@nih.gov. The opportunity is available to eligible small businesses nationwide, and further guidance and updates will be provided when the NOFO is officially published.