Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers
Closed Posted
- Opportunity number
- RFA-FD-26-004
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $500,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Tribal Organizations (Not Federally Recognized)
- City/Township Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- Public or Indian Housing Auth.
- Higher Education Inst. (Private)
- Tribal Governments (Federally Recognized)
- Small Businesses
- Special District Governments
- Independent School Districts
- County Governments
- State Governments
- For Profit Organizations
- 501(c)(3) Nonprofits
Opportunity details come from Grants.gov. Updated .
About this opportunity
The FDA Oncology Center of Excellence seeks innovative research proposals to support therapeutic development in ultra-rare cancers through cooperative agreement funding (RFA-FD-26-004). Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, and other domestic entities that can advance new tools, methods, or therapeutic approaches for ultra-rare pediatric and adult cancers, defined as those with approximately 300-400 or fewer annual incidences in the U.S. Proposed research may not involve clinical trials but may include observational studies or implementation approaches, and the primary research goal must not focus on developing a specific therapeutic product. Applications will be evaluated using FDA objective review criteria across five dimensions: significance (20 points), investigator qualifications (20 points), approach and innovation (30 points), program alignment (20 points), and environment (10 points). The letter of intent deadline is May 18, 2026, with full applications due electronically by June 15, 2026.
The FDA intends to commit up to $1,500,000 in FY 2026 funding to support 1-3 awards, with each award providing $500,000 per year for up to three years, contingent upon appropriations and satisfactory performance. Award recipients must submit annual Research Performance Progress Reports and semi-annual progress reports, comply with FDA data management and sharing requirements, and provide FDA review of co-authored publications prior to submission. Performance locations include recipient institutions and multi-site research collaborations distributed across the United States. Applicants must register in SAM, eRA Commons, and Grants.gov before proposal submission.
Synopsis
Background
The FDA Oncology Center of Excellence (OCE) aims to advance the development and regulation of oncology products for patients with cancer. The Pediatric Oncology Program and Rare Cancers Program were established to facilitate and expedite drug development for pediatric and other rare cancers. OCE's Project Catalyst connects scientific knowledge, creative insight, and medical professionals to foster early-stage product innovation, which is particularly important to address the challenges related to product development for ultra-rare cancers. In collaboration with the National Institutes of Health (NIH) and the OCE, the Foundation for the National Institutes of Health (FNIH) recently launched the design phase of the Ultra-Rare Cancer Treatment Advancement Program (ULTRA), a new public-private partnership dedicated to accelerating the development of innovative ultra-rare cancer treatments.
For the purposes of this NOFO, the FDA OCE refers to cancers with an approximate annual incidence in the U.S. of 300 to 400 people or less as ultra-rare (a more stringent criterion compared to the threshold for a rare disease specified in the Orphan Drug Act based on a U.S. prevalence of
Files
| File | Type | Posted |
|---|---|---|
| RFA-FD-26-004.pdf |
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