Opportunity Information: Apply for FOR FD 20 010
The Drug Development Science Support (U01) opportunity (Funding Opportunity Number FOR-FD-20-010) is a discretionary federal grant from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It is administered jointly through the FDA Office of the Chief Scientist (OCS) and the FDA Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). The core purpose is to protect and promote public health by supporting work that generates practical, applied scientific knowledge and deliverables that help FDA and the broader drug development ecosystem evaluate medical products more effectively, more predictably, and more efficiently. In plain terms, the focus is on strengthening the science behind drug development and regulatory decision-making by creating or improving tools, standards, methods, and approaches that can be used to assess products and evidence with greater confidence and consistency.
This funding is offered as a cooperative agreement under the U01 activity, which typically means FDA expects substantial involvement during the project rather than a hands-off, standard grant relationship. Projects supported under cooperative agreements commonly involve active coordination with agency scientists and staff, shared planning around aims and deliverables, and ongoing collaboration to ensure the outputs are useful for regulatory science needs. The program sits within the broad activity category of Agriculture, Consumer Protection, Food and Nutrition, and it is associated with CFDA number 93.103.
Eligibility is broad and includes many types of organizations: 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those specific nonprofit categories); for-profit entities other than small businesses; small businesses; and additional entities as clarified in the opportunity’s eligibility text. This wide eligibility suggests FDA is interested in drawing from universities, research organizations, industry, and government partners who can contribute applied drug development and regulatory science expertise.
The forecast indicates an expectation of about five awards. The listing shows an award ceiling of 0, which generally signals that a specific maximum dollar amount is not provided in the summarized record and that applicants should rely on the full announcement or FDA guidance for budget expectations and constraints. The opportunity record was created May 25, 2021, and the original closing date is shown as “Archiving forecast,” implying it may have been posted as a forecast/intent notice and later archived rather than presented as an active open competition with a standard due date in this summary view.
Overall, the opportunity is best understood as FDA-supported, applied research and development in drug development science and regulatory science: efforts that produce usable methods and standards, improve evaluation efficiency and predictability, and ultimately strengthen how evidence is generated and assessed for drug products in ways that support public health.Apply for FOR FD 20 010
- 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 "Drug Development Science Support (U01)" 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 5 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 |
|---|
| 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 |
| AAV Vector manufacturing for diseases affecting very small populations Apply for FOR FD 21 007 Funding Number: FOR FD 21 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Enhancing Innovations in Advanced Manufacturing Technologies for Vaccines against Influenza and Emerging Infectious Diseases Apply for FOR FD 21 006 Funding Number: FOR 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 - 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 |
| Innovative ways to provide education on antimicrobial stewardship practices in animals. Apply for PAR 22 108 Funding Number: PAR 22 108 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Revision Applications - Development and Maintenance of the Animal Feed Regulatory Program Standards Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) (Clinical Trials Not Allowed) Apply for RFA FD 22 010 Funding Number: RFA FD 22 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000 |
| 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 |
| Renewal - Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 22 025 Funding Number: RFA FD 22 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| 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 |
| Funding Opportunity Title Innovation Award: Minority Health and Health Equity (U01) Clinical Trials Optional Apply for RFA FD 22 005 Funding Number: RFA FD 22 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| 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 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Clinical Trials Not Allowed Apply for RFA FD 23 003 Funding Number: RFA FD 23 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| 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 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 027 Funding Number: RFA FD 23 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $565,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 23 019 Funding Number: RFA FD 23 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Renewal-Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 23 032 Funding Number: RFA FD 23 032 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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