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ACCEPTING APPLICATIONS · GRANT

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 · Food and Nutrition

Accepting applications. The agency is taking applications now through Grants.gov.
Deadline
Feb 8, 2028 (472 days left)
Who can apply
Others
Award range
$0 to $600,000
Expected awards
Not stated
Total program funding
Not stated
Your own money required
No cost sharing or matching required
Opportunity number
RFA-FD-25-017
Posted
Jul 11, 2025
Assistance listing
93.103

More on who can apply

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal

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

  1. Open the official notice on Grants.gov and download the full announcement (the NOFO) and any attachments.
  2. Check you can apply: the eligible applicants above, and any detail in the notice's eligibility section.
  3. Register your organization in SAM.gov (choose "all awards") and create a Grants.gov account; allow several weeks the first time.
  4. Apply through Grants.gov exactly as the notice says, before Feb 8, 2028. Late applications are usually not accepted.

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.

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