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