BEST Initiative - Data Tools and Infrastructure for Surveillance of Biologics

The FDA Food and Drug Administration awarded this Master IDIQ to expand and enhance Center for Biologics Evaluation and Research (CBER) surveillance capabilities for vaccines, blood products, tissues, and advanced therapeutics, with ordering closed as of September 5, 2023 — this vehicle is no longer accepting new task orders.

The IDIQ established September 7, 2018, executed 11 task orders over five years through September 2023, declining in frequency from three orders annually in 2018–2019 to one order in 2023. The combined potential value across all task orders is $105.8 million, with $97.1 million obligated (92% of potential value). The most recent order, awarded September 27, 2023, to Acumen LLC carried a ceiling of $22.1 million and extended through September 2025, representing the vehicle's single largest delivery order.

Work spans surveillance activities, epidemiological studies, and development of electronic health data sources, infrastructure, methods, and tools to assure the safety and effectiveness of biologic products. All 11 task orders are unrestricted competitive procurements with Time and Materials pricing. Task orders range from $2.7 million to $22.1 million in ceiling value, with durations typically spanning 12–24 months from award date to ultimate completion.

Competition is heavily concentrated: Acumen LLC holds 5 orders representing $70.1 million combined potential value (66% of the IDIQ's total), International Business Machines Corporation holds 4 orders valued at $24.5 million (23%), and Iqvia Government Solutions Inc. holds the remaining 2 orders at $11.2 million (11%). All task orders funded FDA Center for Biologics Evaluation and Research priorities with no interagency activity. Because the ordering period closed in September 2023, this vehicle is not available for new work pursuit.

The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. The primary goal of the contract is to expand and enhance the current CBER capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiological studies that promote CBER's Office of Biostatistics and Epidemiology's (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics.