NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required) | PAR 24 099

Opportunity Information: Apply for PAR 24 099

The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required), Funding Opportunity Number PAR-24-099, is a National Institutes of Health discretionary funding program designed to help U.S. small business concerns move into the actual implementation of an investigator-initiated clinical trial that aligns with the research mission of the National Institute of Allergy and Infectious Diseases (NIAID). It uses a cooperative agreement mechanism (U44), which generally means the project will be carried out with substantial NIH/NIAID involvement compared with a traditional grant, reflecting the hands-on nature of running a clinical trial and the need for close coordination around trial conduct, milestones, and oversight.

At its core, the opportunity is aimed at hypothesis-driven clinical trials that are also milestone-driven, meaning applicants should be prepared to define clear, measurable objectives and go/no-go decision points that show whether the study is progressing as planned. The NOFO supports clinical trial implementation rather than purely planning or exploratory work, and it emphasizes disciplined execution: strong rationale, well-defined endpoints, operational readiness, and a trial design that can generate interpretable results tied to the stated hypothesis. In addition to the main clinical outcomes, the program also welcomes mechanistic studies, which can be included to help explain how an intervention works, identify biological correlates, or clarify pathways that relate to efficacy, safety, or immune responses, as long as they are appropriately integrated with the clinical trial.

A notable feature of this NOFO is its explicit encouragement of higher-risk clinical studies, but with an important clarification about what "high-risk" means in this context. It is not referring to elevated risk to human participants; instead, it refers to scientific or operational novelty and uncertainty. Examples include studies that involve non-routine interventions, administration of an unlicensed product, or use of a licensed product for an unapproved indication. In other words, NIAID is signaling interest in trials that may carry greater development or translation uncertainty because they test something new, unconventional, or not yet established in the intended clinical setting, while still requiring appropriate participant protections and regulatory compliance.

Eligibility is limited to small businesses, consistent with the SBIR program’s purpose of supporting innovation and commercialization-oriented R&D within U.S. small business concerns. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply as part of the project. However, foreign components as defined by the NIH Grants Policy Statement may be allowed in some circumstances, which typically means that certain limited, well-justified activities could be performed outside the U.S. if they are necessary for the project and meet NIH policy requirements.

Key administrative details provided include the sponsoring agency (National Institutes of Health), the health-related activity category, and the CFDA number 93.855. The opportunity was created on January 29, 2024, and lists an original closing date of January 13, 2027. While the provided source text does not specify an award ceiling or expected number of awards, the central takeaway is that this is a Phase II SBIR pathway specifically focused on executing a clinical trial under a cooperative agreement structure, with strong emphasis on milestone-based progress and openness to scientifically bold trial concepts that fit within NIAID’s mission areas.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2024-01-29.
• Applicants must submit their applications by 2027-01-13.
• Eligible applicants include: Small businesses.

Apply for PAR 24 099

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