CBER BEST Initiative 3 - Data Sources for Surveillance of Biologics

The CBER BEST Initiative 3 Master IDIQ contract vehicle supports the Food and Drug Administration's Center for Biologics Evaluation and Research in conducting post-market surveillance of biological products through access to comprehensive healthcare data sources. Under this $75 million shared ceiling vehicle, prime contractors provide large-scale, longitudinal United States healthcare data covering tens of millions of patients, including administrative claims data and electronic health records accessible through distributed data networks. Contractors must serve as primary data sources—such as health insurers, payers, or healthcare providers—and furnish full medical charts for patient data review, abstraction, and adjudication activities related to biologic product surveillance. The contract vehicle was established through full and open competition without set-aside designations and maintains an ordering period extending through September 29, 2029.

Task orders issued under this vehicle have ranged from approximately $1.4 million to $8.3 million in ceiling value, with performance periods typically concluding between September 2025 and September 2026. All awarded delivery orders utilize time and materials pricing structures and are performed without set-aside designations, indicating continued full and open competition among contractors. The primary awardees include CVS Healthspire Payor & Life Sciences LLC (a CVS Health subsidiary), IQVIA Government Solutions Inc., and The Lewin Group Inc. (a UnitedHealth Group subsidiary), each bringing established healthcare data infrastructure and analytics capabilities to support the FDA's regulatory mission. Task order awards are issued by the FDA's Center for Biologics Evaluation and Research with obligated funding ranging from approximately $1.4 million to $8.3 million per delivery order, with performance locations including Falls Church, Virginia and other operational centers.