National Institutes of Health · Department of Health and Human Services
Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
Key facts
- Deadline
- Due Jul 2, 2027 · 267 days left
- Award size
- Not stated: see the official notice
- Match ?
- Not required · Work out your budget and match
- Who can apply
- City or town government, Larger business, School district, Special district (utility, fire, etc.), Tribal government, Nonprofit without 501(c)(3), County government, Small business, Tribal organization, Private college or university, State government, Public college or university, Nonprofit with 501(c)(3), and others named in the official notice
- 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. Get-ready checklist
How this fits you
- Available in Shelby County (nationwide program)
- No match required
- Past Tennessee awards on file: 54 — including your county
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/99e43e8c-dfd4-4e00-9930-081ca0dd9eae · Printed from grantme.click/grants/18b0ad4b-9711-4cbe-81c3-9f896a1fa193
View on Grants.gov Add deadline to my calendar
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About this grant
This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.
Who can apply, from the official notice
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Your schedule, working back from the deadline
- Oct8
Check that your SAM.gov registration is active (or start it now)
Grants.gov: allow up to 10 business days for SAM registration, weeks or months if information isn't verified. It must be renewed every year. Grants.gov - Jun11
Ask partners for letters of support or commitment
Suggested: partners need about three weeks to write and sign letters. - Jun25
Finish a complete draft for a final review
Suggested: leave about a week for someone else to read the draft. - Jun30
Submit
Grants.gov: submit at least 24–48 hours before the deadline: uploads fail, systems slow down, errors need fixing. Grants.gov blog - Jul2
Deadline
From the funder.
Save this grant to put these dates in My grants and your private calendar.
Writing the need statement? Shelby County facts with citations.
Who in Tennessee has won this program
20 awards to Tennessee groups in 2 counties since 2016 · 2 in Shelby County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | $118.6M | 2017 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $31.4M | 2016 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $24.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $20.9M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $19.9M | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $9.3M | 2017 |
| Vanderbilt University | Nashville, Davidson County | $7.6M | 2018 |
| Vanderbilt University | Nashville, Davidson County | $4.6M | 2020 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $4.6M | 2017 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $3M | 2018 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.8M | 2026 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $448K | 2021 |
Source: USAspending.gov; Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 34 pass-through grants on file · 2 in Shelby County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Davidson County | Duke Clinical Research Institute | $1.7M spent that year | 2025 |
| Ut-Battelle LLC | Oak Ridge | Georgetown University | $1.4M | 2024 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $798K spent that year | 2025 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $486K | 2026 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $486K | 2024 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $486K | 2026 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $486K | 2023 |
| Meharry Medical College | Nashville, Davidson County | Vumc | $473K spent that year | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Duke University | $387K | 2023 |
| Meharry Medical College | Nashville, Davidson County | Vanderbilt University Medical Center | $372K | 2024 |
| Vanderbilt University | Nashville | Vanderbilt University Medical Center | $367K spent that year | 2025 |
| Vanderbilt University | Nashville, Davidson County | Vanderbilt University Medical Center | $308K | 2024 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
National Center for Advancing Translational Sciences, also called “NCATS”
Program number 93.350 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, National Institutes of Health · Cooperative agreement (a grant with close agency involvement)
How applications are judged
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives and (7) the availability of funds.
Match
None required (federal program listing).