RFA-FD-23-026: Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials 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 2023.
Food and Drug Administration offered grants of up to $2.0 million (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on April 26, 2023.
From the official notice on Grants.gov, last changed February 16, 2023. Checked November 7, 2026.
- Award ceiling$2.0 million
- Award floor$50,000
- Cost sharingNot required
- Funding typeCooperative Agreement
Other notices with this title
| Notice | Posted | Deadline | Status |
|---|---|---|---|
| RFA-FD-22-026 | March 4, 2022 | Closed May 9, 2022 | Closed |
Key dates
| Posted | February 16, 2023 |
|---|---|
| Deadline | April 26, 2023 |
| Archived by Grants.gov | May 26, 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 Organizations Higher Education Institutions Public/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 Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State 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 Other Independent 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 Non-domestic (non-U.S.) Entities (Foreign Institutions)
Is this a realistic fit?
- Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $2.0 million 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 projects that enhance biosimilar and interchangeable product development and regulatory science.
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 RFA-FD-23-026 still open?
No. It closed on April 26, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for Biosimilar User Fee Act (BsUFA) Research Grant (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 Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional?
Closed April 26, 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 $2.0 million 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.