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

The National Institutes of Health, in coordination with the Centers for Disease Control and Prevention and the Food and Drug Administration, is preparing to release a Small Business Innovation Research funding opportunity designed to support research and development initiatives led by United States small business concerns. This program is part of the broader federal SBIR framework, which aims to stimulate technological innovation, strengthen the role of small businesses in meeting federal research and development needs, and increase commercialization of innovations derived from federally funded research. The participating agencies collectively represent a wide range of biomedical, public health, and regulatory missions, providing applicants with opportunities to align projects with diverse health-related priorities. The purpose of this funding opportunity is to encourage small businesses with strong research capabilities to propose innovative solutions that contribute to the missions of the NIH, CDC, and FDA. The program supports multiple project phases, including Phase I for feasibility studies, Phase II for expanded research and development, Direct to Phase II for more advanced projects, and Fast-Track mechanisms that combine Phase I and Phase II efforts. The inclusion of optional clinical trials indicates that applicants may propose projects involving human subjects when appropriate, expanding the scope to include translational and clinical research. Funding under this opportunity is expected to support a wide array of health-related research areas, including chronic disease prevention, environmental health, mental health, infectious diseases, biomedical technology, and health disparities. The program allows for flexibility in how funds are used, provided that expenditures directly support the proposed research and development activities. While specific funding amounts, award ceilings, and total program funding are not yet disclosed in the forecast, the structure of SBIR programs typically includes staged funding aligned with project milestones and deliverables. Eligibility is restricted to United States small business concerns as defined by the Small Business Administration. These entities must demonstrate the technical expertise and organizational capacity to carry out research and development activities. The program encourages collaborative efforts, allowing small businesses to partner with research institutions or other organizations to strengthen project proposals. Such collaborations are intended to enhance scientific rigor and increase the likelihood of successful outcomes. At this stage, the opportunity is in forecast status, meaning applications are not yet being accepted. The agencies have issued this notice to provide advance awareness and allow potential applicants time to prepare, form partnerships, and develop competitive proposals. The estimated application due date is September 5, 2026, with an anticipated award date of March 1, 2027, and project start date of April 1, 2027. No pre-application requirements such as letters of intent are specified at this time. Applications will be submitted through standard federal grant submission systems, likely including Grants.gov, once the official Notice of Funding Opportunity is released. Applicants should expect to provide detailed research plans, budgets, and supporting documentation demonstrating feasibility, innovation, and alignment with agency priorities. Evaluation criteria will likely focus on scientific merit, commercial potential, and the qualifications of the investigative team, consistent with standard SBIR review processes. For additional information, applicants may contact NIH SEED, the Small Business Education and Entrepreneurial Development office, which provides guidance and support for small businesses interested in NIH funding opportunities. The forecast nature of this announcement indicates that further details, including specific application instructions and evaluation criteria, will be released in the forthcoming official funding notice.