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 intends to award a firm fixed price sole source contract to the Reagan-Udall Foundation for the FDA (RUF) for the period of September 30, 2026, through September 29, 2027. This engagement is designed to support the FDA's congressionally mandated regulatory mission across 16 project areas, utilizing the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) framework. The scope of work includes independent stakeholder convening, scientific engagement, operational evaluation, and landscape research to address critical regulatory science gaps and public health challenges. Key focus areas include emerging neurotechnologies, rare disease diagnostics, real-world evidence for medical devices, generic drug quality, cosmetovigilance under MoCRA, food inspection modernization, and nicotine use disorder treatment. The RUF will operate as an independent private nonprofit partner and is strictly prohibited from participating in FDA regulatory decision-making or providing advice on specific regulatory policy matters. Deliverables include publicly available or agency-facing reports, white papers, and the facilitation of workshops and expert panels. All work must adhere to strict cybersecurity standards, including NIST SP 800-53 or 800-171, and comply with Executive Order 13556 regarding controlled unclassified information. The contract is justified as a sole source based on the foundation's statutory mandate under the FDAAA of 2007. Performance will take place at the contractor's facility, with the FDA's Contracting Officer's Representative overseeing the inspection and acceptance of all deliverables.