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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

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 eleme

Funding
Varies
Category
Agriculture & Food
Status
OPEN
Deadline
2/9/2028

About

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.

Eligibility

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.

Applicant types

Grants.gov eligibility code 25
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Notice-specific evidence check

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

Applicant evidence

  • Applicant type: Other eligible applicants

Opportunity boundaries

  • Recorded funding: Up to USD 600,000
  • Recorded deadline: February 9, 2028; confirm time zone and submission system.
  • Recorded focus: Agriculture
  • Recorded focus: Consumer protection
  • Recorded focus: Food and nutrition
Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

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

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

  • • Applicant types: Grants.gov eligibility code 25.
  • • Geographic scope is not structured in this record.
  • • Notice summary: 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.

Focus areas: AG, CP, FN

Recorded deadline

February 8, 2028 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

  1. 1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
  2. 2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
  3. 3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
  4. 4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Open official notice →

Last directory verification: Sep 13, 2026.