[Food and Drug Administration](https://www.fda.gov)

Forecasted: August 4, 2025

Expected 2 awards; award ceiling not yet specified; cooperative agreement.

Supports innovative approaches to accelerate therapeutic development for ultra-rare pediatric and adult cancers.

This is a forecasted opportunity; all dates and details are subject to change.

--- ## Description This grant program, offered by the FDA, seeks to fund novel strategies that facilitate therapeutic development in ultra-rare cancers, including specific molecular subtypes of more common cancers. The program encourages projects that address critical barriers in drug development for both pediatric and adult ultra-rare cancers. Areas of interest include building data infrastructure, developing and validating novel clinical endpoints, leveraging real-world data, repurposing discontinued drugs, using telemedicine and pragmatic trial designs, and advancing nanoparticle-based therapies. Special attention is given to research that enables regulatory decision-making, preserves access to promising therapies, and identifies unique molecular signatures in rare cancers. --- ## Due Dates - Forecasted application due date: August 4, 2025 *All dates are projected based on the annual cycle; check the program page for updates.* --- ## Funding Amount - Expected number of awards: 2 - Award ceiling and floor: Not yet specified (check program page for updates) - Funding instrument: Cooperative Agreement --- ## Eligibility Eligible applicants include: - State, county, city, or township governments - Special district governments - Independent school districts - Public and state-controlled institutions of higher education - Native American tribal governments (federally recognized and other tribal organizations) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (excluding institutions of higher education) - Private institutions of higher education - For-profit organizations (including small businesses, except those specifically excluded) --- ## Application Process - The opportunity is currently forecasted; the application package and detailed instructions will be available closer to the official posting date. - Monitor the [Grants.gov opportunity page](https://www.grants.gov/search-results-detail/360223) for updates, application materials, and official deadlines. - No cost sharing or matching is required. --- ## Additional Information - The program is open to both pediatric and adult cancer research. - Projects may focus on infrastructure, clinical endpoints, data registries, drug repurposing, telemedicine, trial design, advanced delivery methods, or molecular characterization. - Tumors of interest include, but are not limited to, Sclerosing epithelioid fibrosarcoma and atypical teratoid rhabdoid tumors (ATRT). --- ## External Links - [FDA Funder Page](https://www.fda.gov) - [Official Grants.gov Listing](https://www.grants.gov/search-results-detail/360223) --- ## Contact Information | Name | Title | Email | Phone | |--------------------|---------------------------|------------------------------------------|---------------| | Patrick Johnson | Grants Management Specialist | [patrick.johnson@fda.hhs.gov](mailto:patrick.johnson@fda.hhs.gov) | 301-796-0154 |

Novel approaches to support therapeutic development in ultra-rare cancers

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