Opportunity

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

FDA Solicitation for Innovative Research in Ultra-Rare Cancer Therapeutics

Buyer

Food and Drug Administration

Posted

January 01, 2026

Identifier

FOR-FD-26-004

NAICS

541715, 541714, 541713

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is inviting proposals for innovative research to support therapeutic development in ultra-rare pediatric and adult cancers. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are named in this solicitation - Products/Services Requested: - Research and development services focused on: - Infrastructure for data coordination networks - Validation of clinical endpoints for ultra-rare cancers - Collaborative real-world data generation - Innovative clinical development for discontinued drugs - Integration of telemedicine in clinical trials - Nanoparticle-based delivery of therapeutic nucleic acids - Comprehensive characterization of plasma-membrane protein expression in ultra-rare cancers - Unique or Notable Requirements: - Emphasis on ultra-rare cancers, including molecularly-defined subsets of common cancers - Encourages collaborative, multi-institutional, and innovative approaches - Focus on preserving drug availability and improving clinical trial design - Open to a broad range of applicants: educational institutions, government entities, nonprofits, and businesses - Funding provided via cooperative agreement; no cost sharing or matching required

Description

This program aims to support new approaches to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers. Areas of interest include developing infrastructure for data coordination, validating early clinical endpoints, supporting real-world data use, identifying new clinical development opportunities for drugs, preserving availability of discontinued drugs, incorporating telemedicine in trials, nanoparticle-based delivery for therapeutic nucleic acids, and characterizing plasma-membrane protein expression in ultra-rare cancers. Eligible applicants include educational institutions, government entities, nonprofits, and businesses. The funding instrument is a cooperative agreement with no cost sharing required.

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