Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act | RFA FD 23 023

Opportunity Information: Apply for RFA FD 23 023

The Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act (Funding Opportunity Number RFA-FD-23-023) is a discretionary federal funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It is structured as a cooperative agreement, which typically means the FDA expects to be substantially involved in the work as it progresses (for example, helping shape priorities, coordinating with the recipient, and ensuring the work aligns with FDA program goals), rather than functioning like a more hands-off grant.

The core purpose of the project is to strengthen and inform FDA regulatory science initiatives connected to the agency commitments made under the 2022 reauthorization of the Prescription Drug User Fee Act, commonly referred to as PDUFA VII, as well as the Biosimilars User Fee Act, BsUFA III. In practical terms, this opportunity is aimed at generating and organizing the kinds of evidence, analysis, and expert input that can support how FDA develops, refines, and implements regulatory approaches affecting prescription drugs and biosimilars. The stated objective is not simply to fund general biomedical research, but to fund supporting research and structured expert engagement that help the FDA identify key issues and make progress on major regulatory science priorities tied to these user fee commitments.

A central element of the work is convening appropriate subject matter experts. That means the recipient is expected to bring together relevant expertise (which could span scientific, clinical, methodological, statistical, policy, and other specialized areas depending on the topic) to examine important questions and emerging challenges. These expert convenings are meant to help surface consensus views, highlight uncertainties or evidence gaps, and outline feasible paths forward for FDA-related regulatory science initiatives. Alongside convenings, the award supports research and issue identification, suggesting an emphasis on activities like targeted analyses, literature and landscape reviews, data-driven evaluations, and other structured work products that can be directly useful to FDA decision-making and program implementation under PDUFA VII and BsUFA III.

The opportunity sits within the broad activity area of Food and Nutrition, Science and Technology, and other Research and Development, and it is listed under CFDA number 93.103. While that category is broad, the scope described here is clearly focused on regulatory science as it relates to prescription drug and biosimilar oversight and the modernization or enhancement commitments FDA makes through these user fee programs. Because PDUFA and BsUFA reauthorizations often include time-bound performance goals and programmatic enhancements, the work supported by this cooperative agreement is designed to be aligned with those commitments, helping FDA implement or advance initiatives that may require additional external research support and cross-sector expert input.

Eligibility is expansive and includes a wide range of potential applicants: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities); for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility text. This wide eligibility suggests the FDA was open to partnering with many kinds of organizations capable of conducting credible regulatory science support work and managing expert convenings, such as universities, research institutes, policy organizations, professional societies, or other qualified entities with the infrastructure to coordinate multi-stakeholder input.

In terms of funding and competition details, FDA anticipated making a single award under this announcement, with an award ceiling of $4,500,000. The opportunity was created on December 1, 2022, and the original application closing date was March 13, 2023. With only one expected award and a relatively high ceiling, the intent appears to have been to select one lead organization to serve as a central partner capable of executing a coordinated body of work, rather than distributing smaller awards across multiple recipients.

Overall, this cooperative agreement is best understood as an FDA-supported effort to build an evidence base, clarify priority regulatory science issues, and create structured forums for expert input, all in service of FDA commitments under PDUFA VII and BsUFA III. The focus is on actionable support for regulatory science initiatives tied to those user fee reauthorizations, rather than open-ended investigator-driven research, with the cooperative agreement mechanism signaling an ongoing, collaborative relationship between FDA and the awardee throughout the project.

• 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 RFA FD 23 023

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