This program funds U.S. small business concerns to transition NIH-funded SBIR/STTR projects from late-stage development to commercialization. It supports activities not typically covered by Phase II/IIB awards, including replication studies, IND/IDE-enabling studies, clinical trials, manufacturing scale-up, and regulatory assistance. Subcontracting is allowed to meet project goals. Foreign entities are ineligible, and applicants must comply with NIH eligibility requirements.
Eligible applicants include U.S.-based small business concerns as defined by the SBA. Foreign organizations and non-domestic components are not eligible. Various government, nonprofit, and educational entities are listed but only SBCs may submit applications.
