Opportunity
Simpler Grants.gov #RFA-FD-26-007
FDA PRISM Cooperative Agreement for Regulatory Science Modernization
Buyer
Food and Drug Administration
Posted
March 31, 2026
Respond By
May 01, 2026
Identifier
RFA-FD-26-007
NAICS
541715
The U.S. Food and Drug Administration (FDA) is seeking to advance public health through the PRISM (Pathways for Regulatory Innovation and Strategic Modernization) cooperative agreement. - Government Buyer: - U.S. Food and Drug Administration (FDA), Department of Health and Human Services - Eligible Applicant: - Reagan-Udall Foundation for the FDA (sole eligible applicant) - Funding Details: - Up to $1,300,000 per year - Maximum project period of five years (one-year base, up to four option years) - Annual funding contingent on appropriations and satisfactory performance - Products/Services Requested: - Applied research and development of tools to modernize regulatory science - Stakeholder engagement, convenings, and workshops - Activities to enhance regulatory predictability, efficiency, and transparency - Emphasis on leveraging real-world data, real-world evidence, and artificial intelligence - Support for gold-standard, science-based approaches in regulatory science, food safety, and nutrition - Unique/Notable Requirements: - Focus on non-regulatory collaborations and modernization of regulatory oversight - No specific OEMs, products, or part numbers requested (research and modernization services only) - Supports FDA-regulated domains including medical products, diagnostics, foods, and digital health
Description
The PRISM cooperative agreement aims to advance public health by modernizing regulatory oversight in a rapidly evolving landscape. It supports non-regulatory collaborations aligned with strategic priorities to enhance regulatory predictability, efficiency, and transparency. The program focuses on leveraging expertise and real-world insights to bridge gaps between innovation and regulation, optimizing the uptake of emerging technologies and new evidence sources. The award provides funding for a single applicant to support these modernization efforts over a potential five-year period.