Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Food and Drug Administration · Other Federal · RFA-FD-25-017
Source: Grants.gov · View original posting ↗
- AwardWhat a single award can be worth — the funder's published per-award amount or floor–ceiling range.
- Up to $600K
- DeadlineFinal application due date.
- Feb 8, 2028
- Letter of intentDue date for the letter of intent (a short pre-application some funders require or request before the full proposal).
- —
- MechanismNIH activity code — the grant type (R01 research project, R21 exploratory, K series career development, F series fellowship, …).
- R01
- DurationMaximum project period for a single award.
- —
- Expected awardsHow many awards the funder anticipates making under this opportunity.
- —
- Funding cycleHow often the program accepts applications (annual, multiple cycles per year, rolling, or one-time).
- One-time
- Open dateWhen applications open (or opened).
- Jul 11, 2025
- Total fundingThe overall pool the funder expects to commit across ALL awards under this opportunity — not what one project receives.
- —
- Clinical trialWhether proposed projects must, may, or must not include a clinical trial.
- Optional / allowed
Research areas
Auto-classified from the title and description (keyword-based) — may be imperfect.
Description
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.