SAM #FDASSOC136354

FDA Sole Source Contract for Regulatory Science Support Services (16 Project Areas)

This opportunity is a sole source contract from the FDA to the Reagan-Udall Foundation for regulatory science support across 16 project areas. - Agency: U.S. Food and Drug Administration (FDA) - Vendor: Reagan-Udall Foundation for the FDA (RUF) - Contract Type: Sole source, firm fixed price - Scope: Regulatory science and public health support services - Structured stakeholder engagement, scientific convening, and landscape research - 16 distinct project areas including: - Transcranial ultrasound safety and reporting - Rare disease diagnostics - Medical device real-world evidence - Neurological innovation - Cosmetics safety and inspection planning - Generic drug quality testing - Nicotine and alcohol use disorder initiatives - Drug repurposing accelerator - Pediatric exposure prevention messaging - Cannabis public health messaging - Deliverables: Workshops, roundtables, surveys, reports, white papers, educational materials, toolkits, dashboards - Unique Requirements: Scientific foundation, stakeholder input, evidence infrastructure, not available from other sources - Period of Performance: September 30, 2026 – September 29, 2027 (deliverables scheduled throughout) - No specific products or part numbers; all requirements are specialized services - Estimated contract value: $2,000,000 – $5,000,000

Potential Commercial Opportunities: - Similar regulatory science support services for other agencies - Competing vendors could offer stakeholder engagement, scientific convening, and research services - Related products: Workshop facilitation platforms, survey tools, educational content development

Key Requirements: - Ability to convene stakeholders and experts - Experience in regulatory science and public health - Capacity to deliver reports, workshops, and educational materials on diverse topics - Proven track record in supporting FDA or similar agencies

Description

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its congressionally mandated regulatory mission across 16 project areas addressing high-priority regulatory science gaps and public health challenges. The work — spanning structured stakeholder engagement, independent scientific convening, and landscape research — is a prerequisite to FDA's ability to develop sound regulatory frameworks and fulfill statutory obligations.

Each project area targets a specific gap where FDA cannot act without the scientific foundation, stakeholder input, or evidence infrastructure this contract provides. The contract is framed as a high-value investment: the cost of inaction — measured in delayed regulatory frameworks, preventable harm, and eroded public trust — exceeds the cost of the engagement.

See Attachment for Intent to Sole Source Posting 

See Attachment for Draft Statement of Work

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