Food and Drug Administration · Department of Health and Human Services
Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Key facts
- Deadline
- Forecast — no date yet
- Award size
- Up to $400K
- 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.
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Official notice: https://simpler.grants.gov/opportunity/aeb92aa0-a323-4b96-aa21-0250c6c37a24 · Printed from grantme.click/grants/e717b1bb-4c27-4497-884a-12ba9b95c520
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About this grant
The purpose of this notice of funding opportunity (NOFO) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
Eligibility (from the notice)
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
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)
Federal Governments
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 Organizations)
Foreign Organizations
Non-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.