Opportunity Information: Apply for RFA FD 20 030
The grant opportunity "Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional" (Funding Opportunity Number RFA-FD-20-030) is a discretionary funding program from the U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA). It uses a cooperative agreement mechanism (U01), which generally means the FDA expects to have substantial involvement during the project period rather than operating as a hands-off funder. The overall focus is on advancing how real-world data (RWD) can be turned into real-world evidence (RWE) that is reliable enough to inform regulatory decision-making.
At its core, this FOA is looking to fund research projects that test and refine the scientific and practical foundations of using data generated outside traditional randomized clinical trials. That includes data from routine healthcare delivery and other real-life sources, with an emphasis on understanding what makes RWD "fit for purpose" and how it can be analyzed to produce evidence that regulators can trust. The announcement also highlights several connected areas of interest, including modern data analytics approaches, the use of digital health tools (for example, technologies that capture health-related measures remotely or continuously), and innovative clinical trial designs that leverage healthcare settings. The "Clinical Trials Optional" label indicates that applicants may propose clinical trial components if they are appropriate to the research questions, but a clinical trial is not required.
Funding is offered under CFDA number 93.103 and falls within the activity category areas of agriculture, consumer protection, and food and nutrition, reflecting the FDA context and its public health regulatory mission. The program anticipated making a small number of relatively large awards: the expected number of awards was 2, with an award ceiling of $12,000,000. In practical terms, that structure suggests the FDA was aiming for a limited set of substantial, high-impact projects rather than many smaller exploratory studies.
Eligibility is broad and includes many types of organizations that might be positioned to work with healthcare data at scale or develop new evidence-generation methods. Eligible applicants include 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; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with a note to consult additional eligibility details in the full announcement, which is typical when an agency wants flexibility for certain applicant types or partnerships.
The timing information in the source data indicates the FOA was created on March 16, 2020, with an original closing date of May 11, 2020. While those dates place the opportunity in a specific historical window, the content reflects ongoing FDA and broader public health priorities: figuring out when and how RWD and RWE can complement or, in some cases, substitute for more traditional evidence sources, and building better methods for analyzing complex observational data. In sum, this funding opportunity was designed to accelerate the development and evaluation of tools, data strategies, and study designs that can transform routine health information and digitally captured measures into regulatory-grade evidence.Apply for RFA FD 20 030
- 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 16, 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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| Funding Opportunity |
|---|
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support FDA Land and Water Initiative (U01) Clinical Trial Not Allowed Apply for RFA FD 20 034 Funding Number: RFA FD 20 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Drug Development Science Support (U01) Clinical Trials Optional Apply for RFA FD 20 033 Funding Number: RFA FD 20 033 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed Apply for RFA FD 20 032 Funding Number: RFA FD 20 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Renewal - Federal and University Partnership to Improve the Safety of Seafood from the Gulf of Mexico (U19) Clinical Trials Not Allowed Apply for RFA FD 21 009 Funding Number: RFA FD 21 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $125,000 |
| Renewal - Cooperative Agreement to Support Shellfish Assistance Project (U01) Clinical Trial Not Allowed Apply for RFA FD 21 006 Funding Number: RFA FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Research, Education, and Outreach on Botanical Natural Products (U01) Clinical Trial Not Allowed Apply for RFA FD 21 010 Funding Number: RFA FD 21 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal - Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U50 Clinical Trial Not Allowed Apply for RFA FD 21 011 Funding Number: RFA FD 21 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| National Food and Nutrient Analysis Program (U01) Clinical Trial Not Applicable Apply for RFA FD 21 023 Funding Number: RFA FD 21 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U2F) Clinical Trials Not Allowed Apply for RFA FD 21 028 Funding Number: RFA FD 21 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Training Alliance to Enhance Produce Safety and FDA Food Safety Modernization Act Compliance (U2F) Clinical Trial Not Allowed Apply for RFA FD 21 024 Funding Number: RFA FD 21 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 21 179 Funding Number: PAR 21 179 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Alliance to Support Integrated Public Health System Activities (U2F) Clinical Trials Not Allowed Apply for RFA FD 21 029 Funding Number: RFA FD 21 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed Apply for PAR 21 174 Funding Number: PAR 21 174 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,500,000 |
| Data Standards for Tobacco Research and Scientific Review Program (U24) Clinical Trial Not Allowed Apply for RFA FD 22 002 Funding Number: RFA FD 22 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases (R01) Clinical Trials Not Allowed Apply for RFA FD 21 033 Funding Number: RFA FD 21 033 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Strategies that Support Global Food Safety (U01) Clinical Trial Not Allowed Apply for RFA FD 21 030 Funding Number: RFA FD 21 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| AAV Vector manufacturing for diseases affecting very small populations (R01) Clinical Trials Not Allowed Apply for RFA FD 21 034 Funding Number: RFA FD 21 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Collaboration in Regulatory Systems Strengthening and Standardization Activities to Increase Global Access to Safe and Effective Biological Products (U01) Clinical Trials Not Allowed Apply for RFA FD 21 031 Funding Number: RFA FD 21 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
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