# Drug Development Tools Research Grants (U01) Clinical Trials Optional

Source: https://welltoldgrants.com/grants/rfa-fd-24-030-drug-development-tools-research-grants-u01-clinical-trials/  
Official notice: https://www.grants.gov/search-results-detail/352224

> Food and Drug Administration offered grants of up to $500,000 (at least $500,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 6 awards worth $6 in total. Applications closed on May 13, 2025.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-24-030 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | May 13, 2025 |
| Award ceiling | $500,000 |
| Award floor | $500,000 |
| Expected awards | 6 |
| Total funding | $6 |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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)

These grants will be used to provide funding to developers of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a CDER/CBER's Drug Development Tool Qualification Program and are working towards their qualification plan (QP) or full qualification package (FQP).If you received DDT research grant support from FDA-CDER/CBER in previous years, you are eligible to apply provided that you have successfully progressed to the next submission milestone (e.g., Accepted LOI to Accepted QP) and are requesting additional funding for new DDT project needs addressing different aspects of the project.

## What the grant funds

The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted or a reviewable Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER. The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development.

## Questions people ask

### Is RFA-FD-24-030 still open?

No. It closed on May 13, 2025. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Drug Development Tools Research Grants (U01) Clinical Trials Optional?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Drug Development Tools Research Grants (U01) Clinical Trials Optional?

Closed May 13, 2025. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $500,000 each. About $6 in total across about 6 awards.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.