Description

Intent to Award a Sole Source Contract: 4/17/2026 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, a nd conduct follow-up analysis on detected safety signals across millions of person-records included in the databases of multiple data partners. 3. Avoid costly delays and/or disruptions in mission-critical operations by completing in-progress surveillance projects and requirements by federal law – i.e., fulfilling Congressional mandates from the FDA Amendments Act 2007, 21st Centuries Cures Act, and the Prescription Drug User Fee Act (PDUFA VII) – during the transition to Sentinel 3.0. The ongoing PDUFA demonstration project faces significant risk of missing critical regulatory timelines without immediate contract continuity measures. Coordination of the BEST Initiative is a major component of the FDA's active postmarket safety surveillance capabilities and is an essential and necessary part of the agency's implementation of the 21st Century Cures Act and the FDA Amendments Act of 2007 to use electronic healthcare data to evaluate the safety and effectiveness of biologics. The Coordinating Center plays a central role in executing the BEST Initiative's objectives by maintaining the data and analytical infrastructure, expertise, and partnerships needed to monitor, refine and identify safety signals, inform regulatory decisions, and fulfill FDA's statutory obligations for biologic product surveillance. This 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 follow-on acquisition is already in progress, but due to procurement timelines, a limited-duration extension is necessary to prevent a lapse in service. A sole-source bridge is being pursued because any transition of work to a new entity at this stage would introduce delays and inefficiencies, and such transition would also risk impacting system processes necessary for fulfilling FDA statutory obligations. The incumbent's business systems including data infrastructure, analytical capabilities, staffing, data coordination, and communication processes are deeply embedded in ongoing projects. Restarting or onboarding 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 …

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