The National Institutes of Health (NIH) invites applications for the PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer (STTR) Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). This funding opportunity, issued under PA-24-248, encourages eligible U.S. small businesses to submit STTR grant applications for Phase I, Phase II, Fast-Track, or Phase IIB projects that include clinical trials. The aim is to support early-stage research and development with a strong potential for commercialization in alignment with the missions of various NIH institutes and centers.

The STTR program seeks to promote technology transfer through partnerships between small businesses and nonprofit research institutions. Applicants must propose clinical trials and align their projects with the scientific missions of one or more of the participating NIH Institutes and Centers (ICs). Notably, the announcement was reissued to align with updated agency priorities and extends participation to include new components such as the National Institute on Drug Abuse and the Office of Research on Women's Health.

Funding may support up to $306,872 for Phase I and $2,045,816 for Phase II, although these amounts may vary based on project specifics and participating IC guidelines. Phase IIB budgets must comply with IC-specific limitations. Award periods typically span up to 1 year for Phase I and 2 years for Phase II. The grant supports commercialization efforts and mandates that Fast-Track and Phase IIB applicants provide a commercialization strategy, which may include securing third-party investor funds.

Eligible applicants are U.S. small business concerns that meet specific ownership and operational criteria. Applicants must have appropriate business and research capacity and may submit applications only if scientifically distinct. Applications are reviewed based on criteria such as significance, innovation, approach, investigator qualifications, and commercial potential. Applicants are also evaluated on their ability to manage data, adhere to ethical research standards, and effectively implement and monitor clinical trials.

Applications are accepted on a rolling basis aligned with NIH standard due dates: September 5, 2024; January 5, 2025; April 5, 2025; and September 5, 2025. All applications are due by 5:00 PM local time of the applicant organization. The program is not subject to Executive Order 12372 and requires electronic submission through systems like ASSIST, Grants.gov Workspace, or institutional solutions.

Applicants must comply with several registrations (e.g., SAM, eRA Commons, SBA Company Registry) and submit a comprehensive application that adheres to the NIH's format and requirements. Detailed guidance is available in the NIH “How to Apply” Application Guide. Further information, including contacts for program-specific questions, is available through the NIH SEED office.