Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional | RFA FD 23 025

Opportunity Information: Apply for RFA FD 23 025

The FDA funding opportunity titled "Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional" (Funding Opportunity Number RFA-FD-23-025) is a discretionary research and development grant that uses a cooperative agreement mechanism (U01). Its central aim is to support work that advances the FDA Real-World Evidence (RWE) Program by exploring, testing, and demonstrating how real-world data (RWD) can be used to generate reliable real-world evidence that the FDA can consider in regulatory decision-making. In practical terms, the opportunity is designed to help the FDA evaluate when and how data generated outside traditional randomized clinical trials can be transformed into evidence strong enough to inform regulatory questions, such as product safety, effectiveness, or use in specific populations, depending on the study design and regulatory context.

A key feature of this announcement is the emphasis on the FDA being able to "assess the potential utility" of RWD for RWE purposes. That framing signals that projects should not only use real-world sources of data, but also directly address the methodological and operational challenges that determine whether those data can credibly support regulatory conclusions. Examples of the kinds of underlying issues this type of program commonly targets include data quality and completeness, outcome and exposure definition, bias and confounding control, missing data, record linkage, reproducibility, validation approaches, and transparency in analytic decision-making. Because the award is a cooperative agreement, applicants should expect substantial FDA involvement during the project period, such as collaboration on project direction, milestones, deliverables, and coordination to ensure the outputs are useful for the agency's learning objectives.

The eligible applicant pool is broad and includes higher education institutions (public/state-controlled and private), nonprofits (with or without 501(c)(3) status, excluding institutions of higher education in those categories), for-profit organizations (including small businesses and other for-profits), and many levels of government and quasi-governmental entities. Eligible government applicants include state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, U.S. territories or possessions, and Indian/Native American tribal governments (federally recognized and other than federally recognized), as well as Native American tribal organizations that are not federally recognized tribal governments. The announcement also explicitly encourages applications from institutions that are often underrepresented in federal funding, including Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also allows faith-based or community-based organizations and regional organizations, reflecting an interest in diverse settings where real-world data are generated and maintained.

From an administrative standpoint, the opportunity is run by the Food and Drug Administration under CFDA number 93.103, categorized under science and technology and other research and development. The FOA was created on 2022-12-13, with an original closing date of 2023-02-28. The instrument type is a cooperative agreement rather than a standard grant, which generally means the FDA anticipates being an active partner rather than a hands-off funder. The listing notes an award ceiling of $6,750,000, indicating that projects could be funded at a relatively substantial scale, potentially supporting multi-site collaborations, major data infrastructure work, or large analytic efforts, depending on how an individual application is scoped. The posting also indicates expected awards are not specified in the excerpt provided.

Finally, the "Clinical Trials Optional" designation means that proposed studies may include clinical trial components if scientifically justified, but they do not have to. That flexibility fits the RWE focus, since many RWE efforts rely on observational designs using sources like electronic health records, claims and billing data, registries, pharmacy data, device data, or other routinely collected information. Overall, the opportunity is best understood as a way to fund rigorous, regulator-relevant demonstrations and methodological work that help clarify when real-world data can be trusted to support real-world evidence for FDA decisions, and what standards, practices, and validation steps are needed to make those approaches credible and repeatable.

• The Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) 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 2022-12-13.
• Applicants must submit their applications by 2023-02-28. (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 $6,750,000.00 in funding.
• 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.

Apply for RFA FD 23 025

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