Grants / Department of Health and Human Services / Food and Drug Administration

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

Open Closes February 8, 2028 (465 days left) Opportunity RFA-FD-25-017

• Award ceiling$600,000
• Award floornot stated
• Expected awardsnot stated
• Total fundingnot stated
• Cost sharingNot required
• Funding typeGrant

Key dates

Add the deadline to your calendar

Who can apply

This opportunity is open to the applicants described in the notice.

• Others (see text field entitled "Additional Information on Eligibility" for clarification)

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 Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant 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.

Category: Agriculture, Consumer Protection, Food and Nutrition.

How to apply

1. Read the full notice and attachments on Grants.gov and the agency's announcement. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Stephanie Bogan, Grantor, Kimberly.Pendleton@fda.hhs.gov, 3018276802.

Open the official notice