Opportunity Information: Apply for PAR 21 178
The Drug Development Tools Research Grants (U01) Clinical Trial Optional opportunity (PAR 21 178) is a cooperative agreement program run by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). Its main aim is to fund research that moves specific drug development tools forward toward formal qualification through an FDA drug development tool qualification program housed in either CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research). A key requirement is that the proposed tool must already be in the FDA qualification pipeline with an accepted Letter of Intent (LOI). In other words, this funding is meant to accelerate and strengthen tools that are already recognized by FDA as candidates for qualification, rather than support brand-new tool concepts that have not entered the qualification process.
The program focuses on developing tools that can make drug development more efficient, more reliable, and better aligned with public health needs. The funded work is intended to generate the evidence, validation, and supporting data needed for a tool to meet FDA qualification standards. Once a tool is qualified, it is expected to be made publicly available so it can be broadly used across the research and development community, helping address unmet needs in drug development rather than benefiting only a single sponsor or proprietary pipeline. The FOA is described as "Clinical Trial Optional," meaning applicants may propose projects that include clinical trial elements if they are necessary for tool development and validation, but a clinical trial is not automatically required.
This opportunity uses the U01 mechanism, which is a cooperative agreement. That matters because it typically involves substantial FDA involvement during the life of the award compared with a standard research grant. In practice, that can include coordination, feedback, and collaborative oversight to help ensure the proposed activities remain aligned with the qualification program expectations and the broader goal of producing a qualified, publicly usable tool. The funding instrument is categorized under discretionary funding, with activity areas spanning consumer protection, food and nutrition, science and technology, and other research and development. The program is listed under CFDA number 93.103.
Eligibility is broad and includes many types of organizations that are capable of conducting this kind of applied, translational research. 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 (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities as allowed under the FOA's additional eligibility language. This wide eligibility reflects the reality that drug development tool work can be performed by academic groups, nonprofits, consortia, government entities, and industry partners, as long as the work supports the public, precompetitive goal of a qualified and publicly available tool.
In terms of timing and scale, the FOA was created on February 18, 2021, with application due dates on May 25, 2021; May 3, 2022; and May 3, 2023 (each by 11:59 PM Eastern Time). The original closing date was May 3, 2023. The award ceiling is $250,000, and the opportunity anticipated making about 30 awards. Overall, the program is designed to support multiple projects that collectively strengthen the ecosystem of qualified drug development tools by funding the focused research and validation activities needed to complete the pathway from accepted LOI to eventual qualification and broad public availability.Apply for PAR 21 178
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Drug Development Tools Research Grants (U01) Clinical Trial 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 Feb 18, 2021.
- Applicants must submit their applications by May 03, 2023 Application Due Date(s)May 25, 2021 by 1159 PM Eastern Time May 3, 2022 by 1159 PM Eastern TimeMay 3, 2023 by 1159 PM Eastern Time. (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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 30 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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| Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Clinical Trials Not Allowed Apply for RFA FD 21 026 Funding Number: RFA FD 21 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $600,000 |
| SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under PASI (Pediatric Anesthesia Safety Initiative) (U01) Clinical Trials Not Allowed Apply for RFA FD 21 025 Funding Number: RFA FD 21 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Pediatric and Perinatal COVID-19 Registry (U18) Clinical Trials Optional Apply for RFA FD 21 035 Funding Number: RFA FD 21 035 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional Apply for RFA FD 22 003 Funding Number: RFA FD 22 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed) Apply for RFA FD 22 022 Funding Number: RFA FD 22 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $350,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed Apply for RFA FD 23 002 Funding Number: RFA FD 23 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $400,000 |
| Centers of Excellence in Regulatory Science and Innovation (CERSI) Apply for RFA FD 23 004 Funding Number: RFA FD 23 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
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