NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

The NIH Small Business Innovation Research Phase IIB Strategic Breakthrough Award is administered by the National Institutes of Health within the U.S. Department of Health and Human Services. This funding opportunity is part of the broader SBIR and STTR programs, which aim to stimulate technological innovation among U.S. small businesses while supporting research and development aligned with national health priorities. The Phase IIB Strategic Breakthrough Award specifically addresses the critical funding gap that often occurs between the conclusion of a Phase II project and the transition to commercialization. By providing additional support at this later stage, the program enables small businesses to further develop promising biomedical and health-related technologies that have already demonstrated feasibility and early-stage success. The primary purpose of this funding opportunity is to accelerate the translation of previously funded SBIR or STTR Phase II projects into commercially viable products, services, or technologies. The award supports advanced research and development activities that are necessary to move innovations closer to market readiness. These activities may include scaling up production, conducting additional preclinical or clinical studies, refining prototypes, and preparing for regulatory approval. The program allows for clinical trials but does not require them, giving applicants flexibility depending on the nature of their project. The overall scope is focused on high-impact innovations that address significant health challenges across a wide range of NIH mission areas, including cancer, cardiovascular disease, mental health, infectious diseases, and more. Funding provided under this opportunity is discretionary and issued as a grant. While specific award ceilings, floors, and total program funding levels are not explicitly stated in the summary, the opportunity includes a cost-sharing or matching requirement, indicating that applicants must contribute non-federal resources to support the project. This requirement underscores the program’s emphasis on commercialization readiness and leveraging private or other funding sources. The funding instrument supports later-stage development, meaning that applicants are expected to have already achieved key milestones under a prior Phase II award and be positioned for continued advancement toward market entry. Eligibility for this opportunity is restricted to U.S.-based small business concerns that have previously received an NIH SBIR or STTR Phase II award. Applicants must be submitting a renewal or resubmission Type 2 application within the first six due dates following the expiration of their Phase II budget period. Only one Phase IIB Strategic Breakthrough award is permitted per project, and non-U.S. entities or components are not eligible to apply. However, unfunded international collaborations may be allowed under NIH policy. This targeted eligibility ensures that the program supports projects with demonstrated progress and a clear pathway toward commercialization. The application process is conducted through standard NIH submission systems and follows established grant application procedures. Applicants must prepare and submit a complete application package, including detailed research plans, commercialization strategies, budgets, and supporting documentation. While specific application components are not fully detailed in the summary, NIH applications typically require rigorous scientific and technical justification, as well as evidence of market potential and commercialization feasibility. Evaluation criteria are expected to include scientific merit, innovation, significance, investigator capability, and commercialization potential, consistent with NIH review standards. The funding opportunity was posted on May 28, 2026, with the most recent update on June 1, 2026. Applications are accepted through a recurring schedule with a final closing date of April 5, 2029. This extended timeline reflects NIH’s standard omnibus submission cycles, which typically include multiple due dates per year. Applicants are encouraged to plan submissions according to these cycles and ensure compliance with all eligibility and timing requirements. For assistance, applicants may contact NIH SEED, the Small Business Education and Entrepreneurial Development office, via email. The program represents a strategic investment in advancing innovative health technologies from development to commercialization, supporting both public health outcomes and economic growth.