NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. Department of Health and Human Services' National Institutes of Health (NIH), is offering a funding opportunity under its Small Business Innovation Research (SBIR) Phase II Clinical Trial Implementation Cooperative Agreement (U44). This Notice of Funding Opportunity (NOFO), PAR-24-099, is designed to support hypothesis-driven, milestone-based clinical trials led by U.S.-based small business concerns (SBCs). These trials must align with the mission of NIAID, which encompasses improving prevention, diagnosis, and treatment of infectious, immunologic, and allergic diseases. The opportunity specifically encourages high-risk studies involving non-routine interventions or products used off-label or under investigational protocols, as well as mechanistic studies. Applicants must have completed all clinical trial planning activities prior to application submission unless applying under the Fast-Track mechanism. The NOFO supports only one clinical trial per application and excludes trials that are already integrated into NIAID-supported networks without prior approval. Proposed budgets for Phase II may request up to $1,000,000 in total costs per year for up to three years. Applications are expected to justify budget needs thoroughly and clearly outline milestones for trial execution, including data collection, product procurement, participant recruitment, safety oversight, and final analysis. Eligibility is restricted to U.S.-based small business concerns meeting specific ownership and operational criteria outlined by the Small Business Administration. This includes traditional SBCs as well as those majority-owned by multiple venture capital entities, provided no single entity holds over 50% ownership unless it too qualifies as an SBC. All research activities must occur within the U.S. or its territories. Applicants must also meet specific performance benchmarks regarding Phase I to Phase II transitions and commercialization rates. Applications must be submitted through authorized portals such as NIH ASSIST, Grants.gov Workspace, or institutional systems. Letters of intent are encouraged but not mandatory and should be submitted 30 days prior to the chosen application deadline. The NOFO supports multiple application cycles, with upcoming due dates on January 13, 2025, May 13, 2025, and September 15, 2025. Funding decisions follow a structured review process culminating in earliest start dates ranging from December 2024 to July 2027 depending on the cycle. Evaluation criteria include scientific merit, feasibility, appropriateness of the budget, and readiness to implement the trial. Applicants must adhere strictly to NIH and NIAID guidance, including protocol and consent templates, and are strongly encouraged to contact program officers for guidance prior to application. The scientific/research contact is Dr. Louis Rosenthal, who can be reached at louis.rosenthal@nih.gov or 240-669-5070.