Intent to sole source for BEST 1 Bridge Contract to Acumen, LLC

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 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 post market safety surveillance capabilities within the Sentinel Systems (Initiative) which include HHS and the FDA Product office CDER and CDRH 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 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.