# Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)

Source: https://welltoldgrants.com/grants/rfa-tr-23-016-preclinical-proof-of-concept-studies-for-rare-diseases/  
Official notice: https://www.grants.gov/search-results-detail/349107

> National Institutes of Health offered grants of up to $275,000 to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on March 25, 2024.

| Field | Value |
|---|---|
| Opportunity number | RFA-TR-23-016 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | March 25, 2024 |
| Award ceiling | $275,000 |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.242, 93.350 |

## Who can apply

- 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)

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 Institutions) 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.

## What the grant funds

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 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.

## Questions people ask

### Is RFA-TR-23-016 still open?

No. It closed on March 25, 2024. A newer notice is open: RFA-TR-25-002, closes July 2, 2027 (237 days left).

### Who can apply for Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)?

National Institutes of Health 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 Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)?

Closed March 25, 2024. 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 $275,000 each.

### Who has been funded under RFA-TR-23-016?

NIH RePORTER lists 4 projects funded under RFA-TR-23-016 in fiscal 2024 to 2025, at 4 institutions. The most were at Duke University, Myogene Bio, LLC, University of Texas at Austin.

### Who has won Mental Health Research Grants grants before?

The largest recipients over five fiscal years were Yale Univ, University of Pittsburgh - of the Commonwealth System of Higher Education, University of California, Los Angeles. The program made 6,785 awards worth $8.8 billion in that time.