Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers

The Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services (HHS), is forecasting a new funding opportunity titled “Novel approaches to support therapeutic development in ultra-rare cancers.” This initiative aligns with the FDA’s longstanding mission to protect public health by ensuring the safety and efficacy of medical products, and to promote the development of therapies where medical needs remain unmet. The opportunity falls under Assistance Listing 93.103, which supports FDA research priorities. This grant is a forecasted opportunity, meaning that while it is not currently open for applications, it is expected to be announced for formal submission in the near future. The primary goal of this funding opportunity is to explore and promote the development of innovative strategies that support therapeutic development in ultra-rare cancers. Due to the small patient populations and complex biological characteristics associated with these diseases, there is often limited commercial interest and insufficient data to drive traditional drug development. This grant will offer funding through cooperative agreements, enabling collaboration between the FDA and recipients to explore novel scientific, technological, or regulatory approaches that can reduce the challenges associated with therapeutic development for ultra-rare cancers. Although the specific award amounts have not yet been announced, the FDA anticipates making two awards under this opportunity. There are currently no publicly disclosed details about the estimated total program funding, minimum or maximum award thresholds, or the allowable uses of funds. However, because the funding mechanism is a cooperative agreement, recipients can expect substantial involvement from FDA staff in the form of technical collaboration and guidance. Cost-sharing or matching is not required for this opportunity. Eligibility for this grant is broad and includes a wide range of organizations. Eligible applicants are state governments, local governments (including city, township, county, and special district governments), public and private institutions of higher education, independent school districts, public and Indian housing authorities, small businesses, for-profit organizations other than small businesses, nonprofits with or without 501(c)(3) status (excluding institutions of higher education), and both federally recognized and other Native American tribal organizations. This broad eligibility underscores the FDA’s intent to attract diverse applicants capable of contributing to innovative solutions in a complex therapeutic area. As this is a forecasted opportunity, key dates such as the estimated application opening date, submission deadline, award announcement date, and project start date have not yet been finalized. The forecast was last updated on August 4, 2025, and it is projected to fall within the 2026 fiscal year. At this time, there is no indication that the opportunity is offered on a rolling or recurring basis. Additional guidance on deadlines, application questions, and evaluation criteria is expected to be released once the formal Notice of Funding Opportunity (NOFO) is published. Interested applicants are advised to monitor Grants.gov for updates and to reach out directly to the grant’s point of contact for additional information. The contact for this opportunity is Patrick Johnson, Grants Management Specialist at the FDA, who can be reached by phone at 301-796-0154. Once published, applicants are encouraged to review all eligibility, technical, and administrative requirements carefully to ensure compliance and maximize their competitiveness in securing funding.