Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act | FOR FD 23 025

Opportunity Information: Apply for FOR FD 23 025

The Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act (Funding Opportunity Number FOR FD 23 025) is a discretionary grant opportunity offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It is structured as a cooperative agreement, which generally means the FDA expects to have substantial involvement during the project period, not just provide funding and step back. The program sits within a research and development focus area (Food and Nutrition, Science and Technology, and other R and D) and is listed under CFDA 93.103.

The main purpose of the award is to strengthen the scientific and policy groundwork behind FDA regulatory science priorities tied to the 2022 reauthorization of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilars User Fee Act (BsUFA III). In practical terms, the project is meant to generate supporting research, surface and clarify key regulatory or scientific issues, and bring together the right experts to help the FDA shape and execute major initiatives that it committed to under these user fee agreements. Rather than funding product-specific development, the emphasis is on cross-cutting regulatory science work that can inform FDA decision-making, improve review processes, and support the agency's broader commitments under PDUFA VII and BsUFA III.

A key feature of the opportunity is its convening and coordination role. The recipient is expected not only to conduct or commission research, but also to identify emerging or high-impact questions and organize engagement with subject matter experts. That can include workshops, expert panels, structured consultations, and other mechanisms for gathering technical input. The overall aim is to ensure that FDA initiatives under the user fee programs are informed by current evidence and informed expert perspectives, particularly in areas where science, regulation, and implementation challenges intersect.

The opportunity was created on December 1, 2022, with an original application closing date of March 13, 2023. The funding level reflects a single, sizable award: the expected number of awards is one, with an award ceiling of $4,500,000. This setup signals that the FDA was looking for one lead organization capable of acting as a central hub for research support and expert convening across multiple topics relevant to PDUFA VII and BsUFA III commitments.

Eligibility is broad and includes many categories of public and private entities: state, county, city, and township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; and small businesses. The listing also references an "Others" category with additional eligibility clarification in the full announcement, suggesting the FDA was open to applicants that can credibly perform the research coordination and expert-convening functions.

In summary, this cooperative agreement is designed to fund a single organization to help the FDA deliver on user fee reauthorization commitments by producing targeted regulatory science support, identifying and framing priority issues, and organizing expert input that can guide major FDA regulatory initiatives connected to prescription drugs and biosimilars under PDUFA VII and BsUFA III.

• The Department of Health and Human Services, Food and Drug Administration in the food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act" 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 Dec 01, 2022.
• Applicants must submit their applications by Mar 13, 2023. (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 $4,500,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for FOR FD 23 025

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