The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required), with funding opportunity number PAR-24-099, invites small business concerns (SBCs) to apply for support to conduct investigator-initiated clinical trials related to the research mission of the National Institute of Allergy and Infectious Diseases (NIAID). This funding opportunity aims to encourage hypothesis-driven, milestone-based clinical trials, including high-risk studies involving non-routine interventions, unlicensed products, or licensed products used for unapproved indications. Mechanistic studies associated with the trials may also be included. Applicants can propose new, renewal, or resubmission projects, including Fast-Track applications, which combine Phase I and II activities. However, only one clinical trial can be included in each application.

The award can cover a wide range of clinical trial-related costs, such as personnel training, recruitment, data management, regulatory activities, and safety monitoring. For Phase II trials, budgets may request up to $1,000,000 per year for a duration of up to three years. Fast-Track applications, which include a Phase I component, can request up to $300,000 annually for two years. All planning activities must be completed before application submission, and trials must be ready for implementation at the time of the award. NIAID may determine specific requirements regarding regulatory submissions, safety monitoring, and other trial resources.

Eligible applicants are U.S.-based small businesses, including those majority-owned by venture capital or private equity firms under certain conditions. Collaborations with federal laboratories and other organizations are permitted within specific subcontracting limits. Applicants must meet benchmarks for transitioning from Phase I to Phase II or for commercialization to remain eligible. The program excludes applications focused solely on trial planning, studies outside NIAID’s mission, or trials using existing NIAID-supported networks.

Applications will be reviewed for scientific merit, potential impact, and feasibility. The clinical trial design, regulatory compliance, and monitoring plans will be key evaluation factors. Pre-application consultation with NIAID is recommended to confirm the trial's alignment with the institute’s priorities. Successful applicants will have ongoing interactions with NIAID staff throughout the project, including progress reviews and potential protocol adjustments.