Opportunity Overview
The U.S. Food and Drug Administration has issued FDASSOC136354, a notice of intent to award a sole-source, firm-fixed-price contract to the Reagan-Udall Foundation for the FDA to support regulatory-science and public-health work across 16 project areas.
Deadline
Capability information is due September 21, 2026 at 1:30 PM Eastern Time.
Scope
The contemplated work supports FDA’s Pathways for Regulatory Innovation and Strategic Modernization activities through independent stakeholder engagement, scientific convening, landscape and evidence research, interviews, surveys, workshops, listening sessions, analysis, and development of reports, white papers, toolkits, dashboards, meeting summaries, and regulatory roadmaps.
Project areas described in the federal materials span public-health and regulatory-science priorities including neurotechnology safety, rare-disease diagnostics, real-world evidence for medical devices, generic-drug quality, cosmetics safety and inspection modernization, food inspection modernization, nicotine-use-disorder treatment, medication for opioid-use disorder, cannabis-related public-health communications, and drug repurposing.
Competition and Classification
This is a special notice and notice of intent to sole source, not a request for competitive proposals. FDA identifies the Reagan-Udall Foundation for the FDA as the intended source. Responsible parties that believe they can meet the Government’s requirements may submit written capability information for FDA’s consideration in determining whether a competitive procurement should be pursued.
The notice is classified under NAICS 541618, Other Management Consulting Services, and PSC R799, Support – Management: Other.
Period of Performance
The draft federal materials describe an anticipated period of performance from September 30, 2026 through September 29, 2027.
Funding / Contract Value
No fixed maximum contract value is stated in the public notice.
Qualification Guidance
Potential respondents should rely on the current SAM.gov notice and attachments. Any capability submission should demonstrate the independent scientific-convening, regulatory-science, stakeholder-engagement, public-health research, evidence-development, accessibility, and information-security capabilities required by the federal materials. The notice does not create a general competitive bidding opportunity.