Opportunity Information: Apply for FOR FD 20 007
Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional (Funding Opportunity Number: FOR FD 20 007) is a discretionary federal funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It is offered as a cooperative agreement under the U01 mechanism, which generally means the FDA expects to have substantial involvement during the project period, such as providing scientific input, coordinating activities, or helping guide milestones, rather than operating purely as a hands-off grantmaker. The program sits within the broad activity areas of agriculture, consumer protection, and food and nutrition (CFDA 93.103), reflecting FDA's mission and regulatory role. The opportunity was created on May 25, 2021, and the original closing date is listed as an archiving forecast, indicating the posting is not presented as a standard open-and-close cycle in the information provided.
The central purpose of the funding is to support research that advances how real-world data (RWD) can be analyzed and translated into real-world evidence (RWE) that is credible and useful in FDA regulatory decision-making. In practical terms, this means projects should focus on the kinds of data generated outside traditional randomized controlled trials, such as electronic health records, medical claims and billing data, pharmacy and dispensing records, registries, pragmatic data collected in routine care, and data captured through digital health tools. The emphasis is not simply on collecting large datasets, but on rigorously addressing the scientific, methodological, and operational challenges that determine whether evidence derived from those datasets can be trusted for regulatory uses, such as evaluating product safety, effectiveness, or performance in real-world populations.
The announcement highlights several topic areas the FDA is interested in, including data analytics, the use of digital health tools, and innovative trial designs that operate within healthcare settings. This points toward work that could include improved methods for linking and curating disparate healthcare datasets, developing approaches to control bias and confounding in observational analyses, validating algorithms that define exposures and outcomes, and assessing data quality, completeness, and provenance. It also suggests interest in technology-enabled data capture, such as wearables, remote monitoring, mobile apps, and other digital measures, especially where these tools can complement or enhance routine clinical data. On the design side, the mention of innovative trials in healthcare settings aligns with pragmatic and hybrid designs that embed research into clinical workflow, potentially combining elements of randomization with real-world practice data to answer questions efficiently while maintaining interpretability for regulatory decisions.
Clinical trials are listed as optional, which signals that applicants may propose projects that are purely observational and method-focused, projects that use pragmatic or embedded trial approaches, or mixed programs that include a clinical study component when it is necessary to test a method, validate a digital endpoint, or evaluate an RWE approach in a realistic setting. The key is that the research should be geared toward generating lessons, frameworks, tools, or validated methods that help FDA and stakeholders determine when and how RWD-derived evidence is fit for purpose in a regulatory context.
Eligibility is broad and includes many types of organizations that can contribute meaningfully to RWD/RWE research. Eligible applicants include state, county, city, township, and 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; other Native American tribal organizations; public housing authorities and 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; small businesses; and other entities as clarified in the opportunity's eligibility text. This broad eligibility reflects the interdisciplinary nature of RWE work, which often requires partnerships among academic researchers, health systems, data networks, technology developers, and public-sector entities.
The opportunity anticipates making about two awards, indicating a relatively selective program likely focused on high-impact projects with strong methodological rigor, clear relevance to FDA decision-making needs, and feasible plans for execution under a cooperative agreement model. The award ceiling is listed as 0 in the provided summary, which typically means the ceiling is not specified in the excerpted fields rather than implying no funding; applicants usually need to consult the full announcement for budget guidance, expectations, and any project period constraints. Overall, the program is designed to push forward the science and practice of using real-world healthcare data and digital tools to produce evidence that meets the standards needed for regulatory evaluation, with the FDA actively engaged as a partner through the cooperative agreement structure.Apply for FOR FD 20 007
- 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 May 25, 2021.
- Applicants must submit their applications by Archiving forecast. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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| Drug Development Science Support (U01) Apply for FOR FD 20 010 Funding Number: FOR FD 20 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
| Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed Apply for FOR FD 21 004 Funding Number: FOR FD 21 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: Case Dependent |
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| Renewal - Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition, JIFSAN (U01) Clinical Trial Not Allowed Apply for RFA FD 22 004 Funding Number: RFA FD 22 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Conformance with the Egg Regulatory Program Standards (U2F) (Clinical Trial Not Allowed) Apply for RFA FD 22 006 Funding Number: RFA FD 22 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Research to support the development of alternatives to antimicrobials for use in food-producing animals Apply for PAR 22 087 Funding Number: PAR 22 087 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
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| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 22 009 Funding Number: RFA FD 22 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Revision Applications - Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 019 Funding Number: RFA FD 22 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| Retail Food Safety Regulatory Association Collaboration (U18) (Clinical Trial Not Allowed) Apply for RFA FD 22 008 Funding Number: RFA FD 22 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
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| Renewal- Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trail Not Allowed Apply for RFA FD 22 024 Funding Number: RFA FD 22 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
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| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Optional Apply for RFA FD 22 020 Funding Number: RFA FD 22 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
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| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Clinical Trials Not Allowed Apply for RFA FD 23 020 Funding Number: RFA FD 23 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
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