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

May 18, 2026 (Letter of Intent) | June 15, 2026 (Full application, all applicants)

Up to $500,000 per year for up to 3 years; total program funding up to $1,500,000; 1–3 awards expected.

Supports innovative approaches to advance therapeutic development for ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers.

--- ## Description This opportunity from the FDA Oncology Center of Excellence (OCE) seeks to fund new methods, tools, and strategies to facilitate the development of therapies for ultra-rare cancers. Ultra-rare cancers are defined for this program as those with an annual U.S. incidence of 300–400 people or less, a more stringent criterion than the Orphan Drug Act. The program encourages projects that address barriers in drug development for these cancers, such as difficulties in patient recruitment, limited financial incentives, and gaps in disease understanding. Areas of interest include infrastructure for data sharing, novel endpoints for clinical studies, leveraging real-world data, drug repurposing, pragmatic trial design, and innovative delivery technologies. Both pediatric and adult ultra-rare cancers are within scope, including molecularly-defined subsets of more common cancers. --- ## Due Dates - **Letter of Intent Deadline:** May 18, 2026 - **Full Application Deadline:** June 15, 2026 (due by 11:59 PM local time of applicant organization) *No late applications will be accepted for this funding opportunity.* --- ## Funding Amount - **Award Ceiling:** $500,000 per year (direct + indirect costs) - **Project Duration:** Up to 3 years - **Estimated Total Program Funding:** $1,500,000 - **Expected Number of Awards:** 1–3 - **Cost Sharing:** Not required --- ## Eligibility Eligible applicants include: - Public and State controlled institutions of higher education - Private institutions of higher education - Nonprofits with or without 501(c)(3) IRS status (excluding higher education institutions) - For-profit organizations (including small businesses) - State, county, city/township, and special district governments - Independent school districts - Native American tribal governments (federally recognized and other) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than federally recognized) - Faith-based or community-based organizations - Regional organizations **Note:** - Non-domestic (non-U.S.) entities and components of U.S. organizations are not eligible. - Individuals with the appropriate skills, knowledge, and resources are encouraged to apply as PD/PI. - Applications proposing clinical trials are not allowed (observational studies or innovations to support interventional trials are permitted). --- ## Application Process - **Letter of Intent:** Strongly encouraged but not required. Should include project title, PD/PI and key personnel details, participating institutions, and the funding opportunity number/title. Email to Patrick Johnson ([patrick.johnson@fda.hhs.gov](mailto:patrick.johnson@fda.hhs.gov)) by May 18, 2026. - **Application Submission:** All applications must be submitted electronically via [Grants.gov](https://www.grants.gov/search-results-detail/362217) by June 15, 2026. - **Required Registrations:** Applicant organizations must be registered with SAM, eRA Commons, and Grants.gov. PDs/PIs must have an eRA Commons account. - **Page Limit:** Research Strategy section is limited to 30 pages. - **Other Requirements:** Include a Data Management and Sharing Plan and comply with all instructions in the NOFO and the Application Guide. --- ## Additional Information - Clinical trials are not allowed under this NOFO. - The primary goal should not be development of a specific therapeutic product, but rather approaches broadly applicable to the field. - Projects must address ultra-rare cancers as defined by the program. - Multiple applications from the same organization are allowed if scientifically distinct. - All research involving human or animal subjects must secure appropriate approvals before funds can be used for active research. - Semi-annual progress reports and a grant closeout report are required. --- ## External Links - [FDA Oncology Center of Excellence](https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence) - [Grants.gov Listing & Application Portal](https://www.grants.gov/search-results-detail/362217) - [Full Funding Announcement (PDF)](https://api.atomgrants.com/storage/v1/object/public/grants3-sources/RFA-FD-26-004.pdf) - [FDA Project Catalyst](https://www.fda.gov/about-fda/oncology-center-excellence/project-catalyst) - [Ultra-Rare Cancer Treatment Advancement Program (ULTRA)](https://fnih.org/our-programs/ultra-rare-cancer-treatment-advancement/) --- ## Contact Information | Role | Name/Email | |------------------------------|-------------------------------------------------| | Scientific/Research Contact | Rebekah Zinn, PhD
[Rebekah.Zinn@fda.hhs.gov](mailto:Rebekah.Zinn@fda.hhs.gov) | | Financial/Grants Management | Patrick Johnson
[patrick.johnson@fda.hhs.gov](mailto:patrick.johnson@fda.hhs.gov) | | Grants.gov Support | [support@grants.gov](mailto:support@grants.gov) | | eRA Commons Support | [eRA Service Desk](https://www.era.nih.gov/need-help) | ---

Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers

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