Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
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
See official grant page for eligibility requirements
Industry Tags
About This Grant
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.
Funding Information
- Award Ceiling
- $900,000
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/360008).
- 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 May 16, 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.
More Grants from Food and Drug Administration
- Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed →
- Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) →
- Minor Use Minor Species Development of Drugs (R01) →
- View all 8 grants from Food and Drug Administration →
Frequently Asked Questions
Who is eligible for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?
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-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) provide?
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) provides awards of up to $900,000.
When is the deadline for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?
The application deadline for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is May 16, 2028. Submit at least 48 hours early to avoid last-minute portal issues.
How do I apply for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?
Apply for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) through the official grant page (https://www.grants.gov/search-results-detail/360008). Confirm your eligibility and prepare your application materials before the deadline.
Helpful Resources
Need help writing your grant application?
Try Instrumentl — Grant Writing Software →Starting a nonprofit to apply for grants?
Launch your nonprofit with Swyft Filings →GrantLocate may earn a commission from qualifying purchases. This does not affect our grant listings.