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

The National Institutes of Health, within the U.S. Department of Health and Human Services, is preparing to release a Notice of Funding Opportunity for the Small Business Technology Transfer program using the R41 and R42 activity codes. This forecasted opportunity is intended to support research and development collaborations between eligible United States small business concerns and research institutions. The program is part of NIH’s broader effort to stimulate technological innovation, strengthen the role of small businesses in meeting federal research needs, and increase commercialization of federally funded research. Multiple NIH Institutes and Centers are expected to participate, covering a wide range of biomedical, behavioral, and health-related research domains. The primary purpose of this opportunity is to encourage small businesses with strong research and development capabilities to engage in cooperative projects that advance scientific knowledge and improve human health outcomes. The STTR mechanism specifically requires collaboration between small businesses and nonprofit research institutions, enabling the transfer of technology from academic or research settings into commercial applications. The funding will support various project phases, including Phase I for feasibility studies, Phase II for full research and development, Fast-Track for combined phases, and Phase IIB for continued development toward commercialization. Although detailed funding amounts, award ceilings, and total program funding have not yet been specified in the forecast notice, the program is expected to follow standard NIH STTR structures, which typically include defined project periods and staged funding tied to milestone achievement. Cost sharing or matching is explicitly not required for this opportunity. Allowable uses of funds generally include personnel, research supplies, equipment, and subcontracting costs associated with the collaborating research institution, though final allowable cost categories will be defined in the official Notice of Funding Opportunity upon release. Eligibility is limited to United States small business concerns as defined by the Small Business Administration. These entities must meet specific size and ownership requirements and are expected to demonstrate the technical capability to conduct the proposed research. The program strongly encourages collaborative arrangements, meaning applicants must establish formal partnerships with nonprofit research institutions. Additional eligibility details, including requirements for principal investigator employment and allocation of research effort between the small business and the partner institution, will be clarified in the final solicitation. The submission process will be conducted through standard NIH application systems, likely including Grants.gov and associated NIH submission portals. Applicants should anticipate preparing comprehensive proposals that include research plans, commercialization strategies, budgets, and documentation of the collaborative relationship. While applications are not yet being accepted, this forecast is intended to give potential applicants time to develop partnerships and prepare competitive proposals in advance of the official release. The estimated timeline indicates that the opportunity is expected to be posted on October 1, with an application due date of January 5 of the following cycle. Awards are anticipated around June, with project start dates projected for July. Because this is a forecasted notice, all dates remain subject to change and are contingent upon reauthorization of the STTR program. Interested applicants are encouraged to monitor updates and begin early planning activities, including identifying collaborators and refining project concepts. For additional information, applicants may contact the NIH Small Business Education and Entrepreneurial Development office within the Office of Extramural Research. This office provides guidance on small business programs and can assist applicants in understanding requirements and preparing for submission once the funding opportunity is officially released.