HIVE Infrastructure

The HIVE Infrastructure project seeks to address the urgent need for hardware modernization and system expansion to support the growing demands of the FDA’s enterprise-level computing environment. Designed to sustain uninterrupted operation for over 200 active users across multiple FDA agencies, the HIVE system has been in continuous use for four years to advance regulatory research and development. Due to high-volume usage and natural system degradation, current hardware is nearing the limit of its reliability and capacity, risking data accessibility and operational stability. The procurement aims to replace aging components with newer, more robust infrastructure to enhance system endurance, accommodate expanding algorithms and data volumes, and ensure long-term system integrity for critical regulatory functions. This initiative is forecasted by the Food and Drug Administration under NAICS code 423430, with no set-aside provision indicated. The opportunity is publicly listed to allow industry stakeholders to prepare for future solicitation, though no formal solicitation number or contract award timeline has been announced. Primary point of contact for program inquiries is the CBER Acquisition Liaison, with the Contracting Officer position yet to be filled. All performance will occur within FDA’s operational environment, and the system’s upgrade is not merely an enhancement but a necessary step to preserve mission-critical data availability, support continued user growth, and uphold the agency’s commitment to stable, secure, and scalable computational resources for regulatory science.