Opportunity

Simpler Grants.gov #RFA-FD-25-017

FDA Grant for Innovative Natural History Studies in Rare Diseases

Buyer

Food and Drug Administration

Posted

July 11, 2025

Respond By

February 08, 2028

Identifier

RFA-FD-25-017

NAICS

541715

This opportunity is a grant solicitation from the Food and Drug Administration (FDA) to support innovative natural history studies in rare diseases: - Government Buyer: - U.S. Department of Health and Human Services, Food and Drug Administration (FDA) - Products/Services Requested: - Research services to conduct efficient and innovative natural history studies for rare diseases or conditions with unmet needs - May include clinical trials as part of the research - Eligibility and Funding: - Open to higher education institutions, nonprofits, for-profit organizations, government entities, and foreign organizations - Minimum award amount is $600,000 - No cost sharing or matching required - Unique/Notable Requirements: - Focus on generating high quality, interpretable data to address knowledge gaps in rare disease research - Aims to remove barriers and facilitate medical product development for rare diseases - Supports studies for specific rare diseases or multiple diseases with similar pathophysiology - No specific OEMs or vendors are named, as this is a research grant opportunity - Place of performance and contracting office is the Food and Drug Administration

Description

This funding opportunity supports efficient and innovative natural history studies aimed at advancing medical product development for rare diseases with unmet needs. The goal is to generate high quality and interpretable data to address critical knowledge gaps and remove barriers in rare disease research. The studies are expected to have a significant impact on specific rare diseases or multiple diseases with similar pathophysiology, facilitating product development. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit organizations, government entities, and foreign organizations. The award minimum is $600,000, and the funding instrument is a grant.

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