Opportunity Information: Apply for RFA FD 20 031
This funding opportunity, titled "Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional," is a cooperative agreement from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). It was released under Funding Opportunity Number RFA-FD-20-031 and was created on March 11, 2020, with an original application deadline of May 11, 2020. The award mechanism is a U01 cooperative agreement, which generally means the FDA expects to be actively involved in the project through substantial programmatic collaboration, rather than operating strictly as a hands-off grantmaker.
The central aim of the announcement is to support research that advances how real-world data (RWD) can be translated into real-world evidence (RWE) that is credible and usable in regulatory decision-making. In practical terms, the FDA is interested in studies that help clarify when and how data generated outside traditional randomized clinical trials can reliably answer regulatory questions about medical products, public health interventions, or related outcomes. The opportunity explicitly calls out several connected areas of interest: data analytics approaches suited to complex real-world datasets, the use of digital health tools (such as sensors, apps, wearables, or remote monitoring technologies) to generate or augment RWD, and innovative trial designs that are embedded in healthcare settings. The "clinical trials optional" label indicates applicants may propose clinical trial components if appropriate, but they are not required to do so to be responsive.
Projects supported under this FOA are expected to examine the practical and scientific challenges of working with RWD and generating RWE, including issues like data quality, completeness, standardization, bias, confounding, endpoint definition, and generalizability. The research focus is not simply to analyze a dataset, but to produce insights, methods, or demonstrations that help show what is feasible and reliable for regulatory-grade evidence. This can include evaluating different analytical methods, comparing RWE approaches to more traditional evidence sources, testing whether digital health technologies can capture outcomes or exposures accurately enough for regulatory use, and exploring hybrid or pragmatic designs that leverage routine healthcare delivery environments.
Funding details indicate a very large maximum award size, with an award ceiling of $12,000,000, and the FDA anticipated making 2 awards. The activity category is listed under areas that include agriculture, consumer protection, and food and nutrition, and the CFDA number provided is 93.103. While the category language can reflect FDA program structures, the substance of the FOA is clearly centered on methodological and applied research related to RWD/RWE and their use in decision-making contexts.
Eligibility is broad and includes a wide range of potential applicants: state, county, and city or township 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; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding higher education institutions in those lines); for-profit organizations other than small businesses; small businesses; and other entities as described in the additional eligibility text referenced in the full announcement. This wide eligibility suggests the FDA is open to proposals from academic research groups, health systems, data organizations, technology developers, and cross-sector consortia, as long as the work aligns with the goal of producing actionable knowledge about RWD and RWE in regulatory contexts.
Overall, the opportunity is aimed at strengthening the scientific foundation for using real-world sources of information to support regulatory decisions. The FDA is seeking projects that can move the field beyond general enthusiasm for RWD and toward practical, well-validated approaches for generating evidence that meets regulatory needs, especially in real healthcare environments and with modern digital data collection tools.Apply for RFA FD 20 031
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Exploring 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 Mar 11, 2020.
- Applicants must submit their applications by May 11, 2020. (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 $12,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 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).
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