Opportunity Information: Apply for RFA FD 24 030
The Drug Development Tools Research Grants (U01) Clinical Trials Optional opportunity (RFA-FD-24-030) is a Food and Drug Administration (FDA) cooperative agreement intended to push forward specific drug development tools (DDTs) that are already in the FDA qualification pipeline. The program is focused on tools that have an accepted or reviewable Letter of Intent (LOI) in a Drug Development Tool Qualification Program housed in either CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research). In practical terms, this FOA is designed to fund the next stage of work needed to move a tool from an LOI position toward an accepted Qualification Plan (QP) and ultimately a Full Qualification Package (FQP), with the end goal of formal qualification.
A key feature of this opportunity is its public-benefit requirement: the supported tools are expected to become publicly available once qualified, so they can fill unmet needs across drug development rather than remain proprietary resources available to only a single sponsor. The FDA is using this funding to help developers generate the evidence, datasets, validation work, and other deliverables typically required to demonstrate that a tool is reliable and fit for a defined regulatory use. While clinical trials are listed as optional, the main emphasis is on research activities that strengthen the scientific foundation and usability of the tool so it can withstand regulatory review and be adopted broadly.
Because this is a cooperative agreement (U01), recipients should expect substantial FDA involvement compared with a standard grant. That usually means closer coordination with FDA staff on milestones, deliverables, and alignment with the tool qualification process, reflecting that the work is meant to integrate directly into a formal FDA program rather than operate as a stand-alone academic project.
The FOA also makes clear that prior recipients of FDA-CDER/CBER DDT research grant support can apply again, but only under specific conditions. Applicants must show they have successfully advanced to the next qualification submission milestone since their previous award (for example, moving from an accepted LOI to an accepted QP). In addition, the new request must cover additional funding needs tied to new aspects of the project, not simply a continuation of the same work without meaningful progression.
In terms of logistics and funding profile, the agency is FDA, the instrument is a discretionary cooperative agreement, and the activity category is listed under Agriculture, Consumer Protection, Food and Nutrition (CFDA 93.103). The application deadline is 2025-05-13. The award ceiling is $500,000, and FDA anticipates making about 6 awards under this announcement.
Eligibility is broad and includes many organization types: 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. Overall, the opportunity is best suited for teams that already have an LOI in the CDER/CBER DDT Qualification Program and are ready to produce the next set of qualification-ready evidence and documentation needed to reach QP and FQP milestones and, eventually, make a qualified tool available for broad use in drug development.Apply for RFA FD 24 030
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Drug Development Tools Research Grants (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 2024-02-12.
- Applicants must submit their applications by 2025-05-13. (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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 6 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.
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Applicants who have applied for this opportunity (RFA FD 24 030) also looked into and applied for these:
| Funding Opportunity |
|---|
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Apply for PAR 19 306 Funding Number: PAR 19 306 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed] Apply for RFA FD 22 021 Funding Number: RFA FD 22 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 24 216 Funding Number: PAR 24 216 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U18) - Clinical Trials Not Allowed Apply for RFA FD 24 017 Funding Number: RFA FD 24 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Animal and Veterinary Innovation Centers (U18) Apply for PAR 24 251 Funding Number: PAR 24 251 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,250,000 |
| Single Source Cooperative Agreement to Support HPAI H5N1 Research at Cornell University (U18) - Clinical Trails Not Allowed Apply for RFA FD 24 042 Funding Number: RFA FD 24 042 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,150,000 |
| Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required Apply for RFA FD 25 001 Funding Number: RFA FD 25 001 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $650,000 |
| Laboratory Flexible Funding Model (LFFM) Apply for RFA FD 25 007 Funding Number: RFA FD 25 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| A Research Study of Contaminants in School Meals (U18) Apply for RFA FD 25 024 Funding Number: RFA FD 25 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed Apply for PAR 25 003 Funding Number: PAR 25 003 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
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