FORECAST · GRANT
Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
- Expected deadline
- Not stated
- Who can apply
- Others
- Award range
- Up to $400,000
- Expected awards
- Not stated
- Total program funding
- Not stated
- Your own money required
- No cost sharing or matching required
- Opportunity number
- FOR-FD-25-017
- Posted
- Jul 11, 2025
- Assistance listing
- 93.103
More on who can apply
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 Governme
What it funds
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.
Open the official notice on Grants.gov ↗What to do next
- This is a forecast: the agency expects to post the full notice later. Open it on Grants.gov and subscribe there to be told when it posts.
- Get your SAM.gov registration ("all awards") and Grants.gov account active now; both take time.
- Use the forecast's award range and eligibility to decide whether to prepare.
- Watch for the notice; the dates here are estimates and can change.
New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: Kimberly.Pendleton@fda.hhs.gov
From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.