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 sole source, firm fixed price 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, landscape research, and operational evaluation 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 contract requires the production of reports, white papers, and meeting summaries, as well as the facilitation of public workshops and expert panels. To maintain regulatory integrity, RUF must operate as an independent partner and is strictly prohibited from participating in FDA regulatory decision-making or providing advice on specific policy matters. All deliverables will be reviewed by the Contracting Officer's Representative for accuracy and professional quality, with a fifteen-working-day government review period. Additionally, the contractor must adhere to strict cybersecurity standards, including NIST SP 800-53 or 800-171, and report any privacy or security incidents to the FDA Cybersecurity and Infrastructure Operations Coordination Center within one hour of detection.