PAR-21-178: Drug Development Tools Research Grants (U01) Clinical Trial Optional
Closed
This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2021.
Food and Drug Administration offered grants of up to $250,000 (at least $10,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 30 awards. Applications closed on May 3, 2023.
From the official notice on Grants.gov, last changed April 29, 2022. Checked November 7, 2026.
- Award ceiling$250,000
- Award floor$10,000
- Expected awards30
- Cost sharingNot required
- Funding typeCooperative Agreement
Other notices with this title
| Notice | Posted | Deadline | Status |
|---|---|---|---|
| FOR-FD-20-031 | May 25, 2021 | Closed | Closed |
Key dates
| Posted | February 18, 2021 |
|---|---|
| Deadline | May 3, 2023 |
| Archived by Grants.gov | June 2, 2023 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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)
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations
Is this a realistic fit?
- Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $250,000 per award.
- Most of the program's money (35% over five years) went to nonprofits.
- No cost sharing or match is required.
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 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.
Who has won Food and Drug Administration Research grants before
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Critical Path Institute | Arizona | 13 | $94.0 million |
| National Environmental Health Association | Colorado | 9 | $55.4 million |
| Association of Food & Drug Officials | Pennsylvania | 14 | $50.3 million |
| The Medical Device Innovation Consortium | Virginia | 1 | $48.6 million |
| Duke University | North Carolina | 11 | $35.6 million |
Applying now
This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is PAR-21-178 still open?
No. It closed on May 3, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for Drug Development Tools Research Grants (U01) Clinical Trial 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 Trial Optional?
Closed May 3, 2023. 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 $250,000 each.
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.