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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) intends to issue a sole source bridge contract to Acumen, LLC to maintain the Biologics Effectiveness and Safety (BEST) Initiative Coordinating Center. This bridge action ensures the uninterrupted management of the BEST distributed data network and the analytic capacity required to conduct surveillance queries and safety signal detection across millions of person-records. The acquisition is necessary to fulfill statutory mandates under the FDA Amendments Act of 2007, the 21st Century Cures Act, and the Prescription Drug User Fee Act (PDUFA VII) while the agency transitions to Sentinel 3.0. Performance will take place in Silver Spring, Maryland, under PSC B537 for Special Studies/Analysis- Medical/Health and NAICS code 541611 for Administrative Management and General Management Consulting Services.
Acumen, LLC currently serves as the incumbent coordinating center, providing program management, technical infrastructure, and administrative oversight for active surveillance activities. The bridge contract is structured with a one-year base period running from September 30, 2026, to September 29, 2027, followed by two one-year option periods, reaching an estimated total value of $38.4 million. This continuation of services aims to prevent the loss of institutional knowledge and duplicative costs associated with onboarding a new contractor during time-sensitive public health surveillance deliverables and ongoing regulatory projects.
This special notice, identified by solicitation number FDAINTENTSOLESOURCEBEST1ACUMEN, carries no set-aside (NONE/NONE). The coordinating center will continue to manage task orders, oversee project timelines, and maintain the common data model used for standardized data transformation. Interested parties must submit responses by the deadline of June 23, 2026. Howard S. Yablon is the designated point of contact for this requirement.
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