Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Open Posted
- Opportunity number
- RFA-FD-25-017
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $600,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Other
- Points of contact
-
- Kimberly Pendleton kimberly.pendleton@fda.hhs.gov (240) 402-7610
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is soliciting applications for efficient and innovative natural history studies addressing unmet needs in rare diseases, with applications due February 8, 2028. The opportunity funds R01 clinical trials optional grants to advance medical product development through high-quality natural history data that closes critical knowledge gaps and facilitates rare disease product development.
Eligible applicants include higher education institutions (public and private), nonprofits with and without 501(c)(3) status, for-profit organizations including small businesses, state and local governments, Indian tribes (federally recognized and other), faith-based and community-based organizations, independent school districts, regional organizations, and non-domestic entities. Foreign organizations and non-domestic components of U.S. organizations are eligible to apply; foreign components as defined in the NIH Grants Policy Statement are allowed.
The NOFO expects natural history studies to address critical knowledge gaps, remove major barriers to progress in the field, and exert significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology. The program seeks studies with high quality and interpretable data elements that facilitate medical product development in rare diseases or conditions.
Applicants must use the SF424 (R&R) Application Package with forms including the PHS 398 Cover Page Supplement, R&R Budget Form, R&R Senior/Key Person Profile (Expanded) Form, and PHS 398 Research Plan Form. Applications must comply with NIH submission standards regarding sensitive information, page limits, formatting requirements, and human subjects and vertebrate animal considerations.
The opportunity is assigned to CFDA 93.103 (Food and Drug Administration Research). This is a reissue of RFA-FD-22-001 with an updated agency contact.
Synopsis
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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00291182.pdf |
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