Food and Drug Administration · Department of Health and Human Services
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Key facts
- Deadline
- Due May 16, 2028 · 588 days left
- Award size
- Up to $900K
- Cost share / match
- Not required
- Who can apply
- Other (see eligibility)
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Grant-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No cost share required
- Tennessee recipients since 2023: 18
Tell us who you are to see whether you're eligible.
Read the official notice View on Grants.gov Add deadline to my calendar
About this grant
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
Eligibility (from the notice)
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits 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 BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Who in Tennessee has won this program
18 awards to Tennessee recipients in 5 counties since federal FY2023. Largest shown:
| Recipient | Where | Amount | FY |
|---|---|---|---|
| University Of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $2.4M | 2020 |
| University Of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.9M | 2020 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| University Of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department Of Health | Nashville, Davidson County | $1.3M | 2020 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2016 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.2M | 2025 |
Source: USAspending.gov. Past awards show who this program funds; they don't guarantee future awards.
About the program (93.103)
Food and Drug Administration Research — General Grant Funding
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Matching requirements
This program has no statutory formula.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Examples of funded projects
Not Applicable.