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 ts congressionally mandated regulatory mission across 16 project areas
Closed Special Notice Posted
- Solicitation number
- FDASSOC136354
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541618 Other Management Consulting Services
- PSC
- R799 Support- Management: Other
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration issued a sole-source Intent to Award notice on September 14, 2026, announcing its plan to contract with the Reagan-Udall Foundation for the FDA (RUF) to support execution of FDA's congressionally mandated regulatory mission across 16 project areas addressing regulatory science gaps and public health challenges, with expressions of interest due by September 21, 2026.
RUF, established by Congress under the Food and Drug Administration Amendments Act of 2007, is authorized by federal law to receive FDA contracts. The FDA intends to use the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) framework, under which RUF has demonstrated capacity to recruit expert panels, facilitate workshops and roundtables, conduct landscape reviews, and produce white papers. Work spans the Center for Devices and Radiological Health, Center for Drug Evaluation and Research, Office of Chief Scientist, Office of Cosmetics and Colors, and Human Foods Program.
The contract period runs September 30, 2026 through September 29, 2027, on a Firm Fixed Price basis. Performance occurs at the contractor's Washington, D.C. facility, virtually, or as specified. Deliverables include stakeholder convening, scientific engagement, operational evaluation, research, and report preparation across 16 discrete projects addressing transcranial ultrasound, rare disease diagnostics, medical device real-world evidence, cosmetics adverse events, generic drug quality, food inspection systems, nicotine and alcohol use disorders, buprenorphine products, pediatric exposure, cannabis messaging, and drug repurposing.
Interested firms must submit written expressions of interest demonstrating ability to fulfill all requirements within five calendar days of publication to howard.yablon@fda.hhs.gov. The FDA reserves the right not to respond and will review submissions solely to determine whether to pursue competitive procurement.
Notice text
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
Files
| File | Type | Posted |
|---|---|---|
| STATEMENT OF WORK DRAFT 9 14 2026.pdf | ||
| Intent to Sole Source DRAFT 9 14 2026 1152 AM.pdf |
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