Critical Path Public Private Partnerships Clinical Trials Optional | RFA FD 24 027

Opportunity Information: Apply for RFA FD 24 027

The funding opportunity titled "Critical Path Public Private Partnerships Clinical Trials Optional" (RFA-FD-24-027) is a discretionary cooperative agreement offered by the U.S. Food and Drug Administration (FDA) to support the continued operation of public-private partnership consortia originally convened and established by the Critical Path Institute (C-Path). This announcement is specifically framed as a renewal of an existing cooperative agreement, #5U18FD005320, and it sits within the broader FDA Critical Path Initiative, which was authorized in Section 566 of the Federal Food, Drug, and Cosmetic Act. In practical terms, the FDA is looking for an applicant capable of maintaining and managing the current network of consortia groups and continuing their collaborative work rather than creating an entirely new program from scratch.

The central purpose of the award is to sustain and advance collaborative projects that help modernize and speed up the development of medical products by improving the tools, methods, and evidence-generation approaches used across the product lifecycle. The scope described emphasizes research, education, and outreach activities designed to foster drug product innovation and to enable faster and more efficient development, manufacturing, and translational therapeutics. The work is also intended to strengthen the foundations of regulatory science by enhancing the safety, efficacy, quality, and overall performance of drug products. Although the title references "Clinical Trials Optional," the description is broader than clinical trials alone and points to a range of activities that can support development and evaluation, including coordination of multi-stakeholder consortia and development of innovative approaches that can be shared across industry, academia, and regulators.

This opportunity uses the cooperative agreement mechanism, meaning FDA anticipates substantial involvement in the funded effort compared to a more hands-off grant. The activity category is listed under agriculture/consumer protection/food and nutrition (CFDA 93.103), reflecting FDA's broader public health mission and regulatory responsibilities. Eligibility is categorized as "Others," and the announcement indicates an expectation of a single award, which aligns with the renewal nature of the effort and the focus on continuing work tied to C-Path-established consortia.

Key logistics included in the notice are a creation date of January 4, 2024, and an original closing date of March 4, 2024. The award ceiling is up to $20,000,000, with one expected award, and the agency notes that actual support is dependent on the availability of FDA funding. Overall, the grant is designed to keep established consortia functioning effectively, continue cross-sector coordination, and produce collaborative outputs that help accelerate therapeutic innovation while improving evidence quality and public health protections.

• The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Critical Path Public Private Partnerships Clinical Trials Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on 2024-01-04.
• Applicants must submit their applications by 2024-03-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $20,000,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Others.

Apply for RFA FD 24 027

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