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Intent to sole source for BEST 1 Bridge Contract to Acumen, LLC
Contact and place of performance
Howard S. Yablon
Silver Spring, MD 20993
USA
Intent to Award a Sole Source Contract: 6/8/2026 The purpose of this acquisition is to: 1. Ensure uninterrupted management and coordination of activities across the BEST distributed data network and multiple data partners. 2. Maintain analytic capacity and capabilities to run surveillance queries, generate population-based estimates, detect safety signals, and conduct follow-up analysis on detected safety signals acr...
View moreThis bridge action is a continuation of services currently being performed under IDIQ: HHSF223201810020I and Task Order: HHSF223201810020I / 75F40123F19005, awarded to Acumen, LLC, which serves as the BEST Coordinating Center. The current period of performance ends on 9/29/2026 with approximately $8,000,000.00 obligated to date. The incumbent was competitively awarded the contract.
The incumbent’s business systems including data infrastructure, analytical capabilities, staffing, data coordination, and communication processes are deeply embedded in ongoing projects. Restarting or on-boarding a new contractor would result in duplicative costs, loss of institutional knowledge, and disruption to time-sensitive public health surveillance deliverables.
This contract supports the coordinating center for the Biologics Effectiveness and Safety (BEST) Initiative. The coordinating center serves as the central hub for managing all aspects of the program, including the administration of task orders, coordination of data partners, project tracking, timeline oversight, and quality control across active surveillance activities. The coordinating center provides program management, technical infrastructure, analytical capabili-
ties, scientific support, and administrative oversight to ensure the timely and consistent execution of surveillance studies conducted through separate contracts with data partners.
All work is governed by the Statement of Work and organized into infrastructure and study-related tasks. The coordinating center ensures continuity across projects, supports knowledge management, and maintains the technical infrastructure needed to support standardized data transformation and querying through the common data model, enabling timely and efficient delivery of safety surveillance outputs to meet CBER’s regulatory needs. BEST 1 is also instrumental in the effectiveness, usage and function of BEST 3 Data Partners contract.
A new base contract and 2 option periods best suited to bring proper continuity to the surveillance systems for CBER and its partners. This contract action is required to ensure the protection of Public Health The base action would run from 9/30/2026 – 09/29/2027 and 2 additional one year option periods for a total contract value approximately of $38.4M.
The Food and Drug Administration (FDA) has issued special notice FDAINTENTSOLESOURCEBEST1ACUMEN indicating its intent to award a sole source bridge contract to Acumen, LLC. This acquisition ensures the uninterrupted management of the Biologics Effectiveness and Safety (BEST) Initiative distributed data network and its various data partners. The contract provides the necessary infrastructure and analytical capabilities to run surveillance queries and conduct follow-up analysis on millions of person-records to meet mandates established by the FDA Amendments Act of 2007, the 21st Century Cures Act, and the Prescription Drug User Fee Act. As the BEST Coordinating Center, the contractor maintains the technical infrastructure for standardized data transformation and querying to support regulatory decisions for the Center for Biologics Evaluation and Research (CBER).
This bridge action continues services currently performed under contract HHSF223201810020I and is classified under PSC B537 for medical and health special studies and analysis and NAICS 541990 for all other professional, scientific, and technical services. The requirement includes a base performance period from September 30, 2026, to September 29, 2027, with two additional one-year option periods for a total estimated contract value of $38.4 million. The work will be performed in Silver Spring, Maryland, and no set-aside has been designated for this action.
The bridge contract is intended to avoid costly disruptions during the transition to Sentinel 3.0 and to prevent delays in mission-critical surveillance projects. The coordinating center serves as a central hub for task order administration, project tracking, quality control, and scientific support. By maintaining existing data infrastructure and communication processes, the agency aims to prevent the loss of institutional knowledge and duplicative costs associated with onboarding a new contractor. Responses to this notice are due by June 23, 2026.
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