Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
The summary for the Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) grant is detailed below.
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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): 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.
| Federal Grant Title: | Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) |
| Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
| Grant Categories: | Agriculture, Consumer Protection, Food and Nutrition |
| Type of Opportunity: | Discretionary |
| Funding Opportunity Number: | RFA-FD-25-017 |
| Type of Funding: | Grant |
| CFDA Numbers: | 93.103 |
| CFDA Descriptions: | Information not provided |
| Current Application Deadline: | February 8th, 2028 |
| Original Application Deadline: | February 8th, 2028 |
| Posted Date: | July 11th, 2025 |
| Creation Date: | July 11th, 2025 |
| Archive Date: | March 9th, 2028 |
| Total Program Funding: | |
| Maximum Federal Grant Award: | $600,000 |
| Minimum Federal Grant Award: | $0 |
| Expected Number of Awards: | |
| Cost Sharing or Matching: | No |
| Last Updated: | July 11th, 2025 |
- Applicants Eligible for this Grant
- 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.
- Link to Full Grant Announcement
- 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)
- Grant Announcement Contact
- Kimberly Pendleton
Chief Grants Management Officer
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