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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) is sponsored by 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.
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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) Department of Health and Human Services Food and Drug Administration Document Type:Grants Notice Funding Opportunity Number:RFA-FD-25-017 Funding Opportunity Title:Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) Opportunity Category:Discretionary Opportunity Category Explanation: Funding Instrument Type:Grant Category of Funding Activity:Agriculture Expected Number of Awards: Assistance Listings:93.
103 -- Food and Drug Administration Research Cost Sharing or Matching Requirement:No Last Updated Date:Jul 11, 2025 Original Closing Date for Applications:Feb 08, 2028 Current Closing Date for Applications:Feb 08, 2028 Archive Date:Mar 09, 2028 Estimated Total Program Funding: Eligible Applicants:Others (see text field entitled "Additional Information on Eligibility" for clarification) Additional Information on 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.
## Additional Information Agency Name:Food and Drug Administration 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.
Link to Additional Information:RFA-FD-25-017 Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) Grantor Contact Information:If you have difficulty accessing the full announcement electronically, please contact: Chief Grants Management Officer ## Similar Opportunities (identified by AI)
According to the current listing, eligibility includes: Eligible applicants: Others (see text field entitled Additional Information on Eligibility for clarification). Confirm the full requirements in the official notice before applying.
The current listing shows up to $600K per award. Verify award ceilings, matching requirements, and allowable costs in the official notice.
Applications for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) are due February 8, 2028. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
Yes — Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) is offered by Food and Drug Administration and this listing comes from Grants.gov, an official U.S. federal source. Federal applications generally require registrations (for example SAM.gov or an agency submission portal), so allow extra lead time.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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