The National Institutes of Health (NIH) is preparing to release a Notice of Funding Opportunity (NOFO) for the R61/R33 grant program, aimed at supporting investigator-initiated single-site clinical trials. This initiative encourages applications that focus on various types of clinical trials, including efficacy, comparative effectiveness, and implementation research, particularly those employing innovative trial designs such as adaptive and Bayesian methods. The trials must align with the research mission of the National Heart, Lung, and Blood Institute (NHLBI) and adhere to the NIH definition of a clinical trial. Interested small businesses are advised to begin developing collaborative projects in anticipation of the application period, which is expected to open following the estimated synopsis post date of July 11, 2025, with applications due by October 13, 2025. For further inquiries, potential applicants can contact Dr. Yves Rosenberg at rosenbey@nhlbi.nih.gov or by phone at 301-435-1292.