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

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

• NAICS541618
• PSCR799

• Intent to Sole Source DRAFT 9 14 2026 1152 AM.pdf

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• STATEMENT OF WORK DRAFT 9 14 2026.pdf

  .pdf486 KBNot yet available

• Ian Weiss
  ian.weiss@fda.hhs.gov3017965728
• Howard Yablon
  howard.yablon@fda.hhs.gov