Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
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.
Eligibility
See official grant page for eligibility requirements
Industry Tags
About This Grant
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.
Funding Information
- Award Ceiling
- $600,000
Eligibility Overview
This opportunity from Food and Drug Administration is open to eligible applicants nationwide. Organizations working in Federal are especially encouraged to review the requirements.
Federal grant opportunities like this one are typically open to a range of applicant types. Common eligible organizations include:
- Nonprofits and 501(c)(3) organizations
- Small businesses and startups (especially for SBIR/STTR programs)
- State, local, and tribal governments
- Colleges, universities, and research institutions
- Individuals (for select programs in education, arts, and research)
Eligibility requirements vary by opportunity. Always review the official listing before investing time in an application.
How to Apply
- 1
Review the full opportunity
Read the complete Notice of Funding Opportunity (NOFO) for this Food and Drug Administration program on its official page (https://www.grants.gov/search-results-detail/360007).
- 2
Confirm eligibility
Check that your organization meets every requirement set by Food and Drug Administration — applicant type, location, registration status, and any prior-award restrictions.
- 3
Prepare required documents
Gather your budget narrative, needs statement, organizational details, SAM.gov registration, and any required certifications.
- 4
Submit before the deadline
This opportunity closes on February 8, 2028. Submit at least 48 hours early — portal systems are often slow near closing time.
Grant Writing Tips
Proposals for federal programs such as those from Food and Drug Administration are competitive — these tips can strengthen your application:
- ✓Start your application at least 4 weeks before the deadline — rushed proposals score lower.
- ✓Tailor your needs statement to match the funder's stated priorities, using their exact language where possible.
- ✓Have a colleague outside your team review your budget narrative before submitting — fresh eyes catch errors reviewers penalize.
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Frequently Asked Questions
Who is eligible for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)?
This opportunity from Food and Drug Administration is open to eligible applicants nationwide. Organizations working in Federal are especially encouraged to review the requirements. Always confirm the full eligibility criteria on the official listing before applying.
How much funding does Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) provide?
Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) provides awards of up to $600,000.
When is the deadline for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)?
The application deadline for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) is February 8, 2028. Submit at least 48 hours early to avoid last-minute portal issues.
How do I apply for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)?
Apply for Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) through the official grant page (https://www.grants.gov/search-results-detail/360007). Confirm your eligibility and prepare your application materials before the deadline.
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