Find Your Funding Opportunity
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Service
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Source |
Final Application Due Date |
Funding Available
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Match Required
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|---|---|---|---|---|
| Health Care |
Federal
HHS |
05-16-2028 | N/A | No Match Required |
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Service
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Source
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Final Application Due Date
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Funding Available
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Match Required
Status
- Opportunity Type Discretionary
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CFDA
93.103 -- Food and Drug Administration Research
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions.Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
Eligibility
- IHE
- Local Government
- Non-Profit
- Other
- State Government
- Tribal Government
Additional Eligibility Information
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.
Key Date(s)
- July 11, 2025: Last Updated Date
- July 11, 2025: Posted Date
- May 16, 2028: Current Closing Date for Applications
- May 16, 2028: Application Due Date
- June 15, 2028: Application Archive Date
Contact Information
Kimberly Pendleton
Chief Grants Management Officer