Opportunity

Simpler Grants.gov #RFA-FD-26-004

FDA Solicitation for Research and Infrastructure to Advance Therapeutics in Ultra-Rare Cancers

Buyer

Food and Drug Administration

Posted

May 04, 2026

Respond By

June 15, 2026

Identifier

RFA-FD-26-004

NAICS

541715, 541714, 541713

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence is seeking proposals to advance therapeutic development for ultra-rare pediatric and adult cancers. - Government Buyer: - U.S. Food and Drug Administration (FDA), Oncology Center of Excellence (OCE) - OEMs and Vendors: - No specific Original Equipment Manufacturers (OEMs) or vendors are named in the solicitation - Products/Services Requested: - Research and development services to support novel approaches in therapeutic development for ultra-rare cancers - Infrastructure for coordination networks and data repositories - Validation of novel clinical endpoints - Collaborative efforts leveraging real-world data - Innovative drug repurposing strategies - Novel delivery methods for therapeutics, including nanoparticle-based delivery for nucleic acids - Telemedicine integration and molecular characterization studies - No clinical trials are permitted under this opportunity - Unique or Notable Requirements: - Focus on ultra-rare cancers (≤300-400 cases annually in the U.S.), including molecularly-defined subsets of more common cancers - Open to a wide range of eligible applicants: higher education institutions, nonprofits, small businesses, for-profit organizations, and government entities - Compliance with federal anti-discrimination laws and restrictions on funding activities that promote racial preferences, denial of the sex binary, harm reduction, illegal immigration, or anti-American values - Maximum project period of three years, with annual budgets not to exceed $500,000 and total funding up to $1,500,000 for 1-3 awards

Description

This funding opportunity from the Food and Drug Administration (FDA) aims to support new approaches to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers. The scope includes development of infrastructure for coordination networks and data repositories, validation of novel clinical endpoints, collaborative efforts leveraging real-world data, innovative drug repurposing strategies, and novel delivery methods for therapeutics. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, small businesses, for-profit organizations, and various government entities. The award provides up to $1,500,000 in funding for 1-3 awards with a project period of up to three years.

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