Intent to sole source for BEST 1 Bridge Contract to Acumen, LLC
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The FDA Office of Acquisition & Grant Services intends to award a sole source bridge contract to Acumen, LLC for the BEST 1 Coordinating Center. This action is critical to ensure uninterrupted management and coordination of the Biologics Effectiveness and Safety (BEST) Initiative, maintain analytic capabilities, and fulfill federal mandates. The estimated value for the new contract is approximately $38.4M. Interested parties must submit capabilities by June 23, 2026, 6:00 PM ET.
Purpose & Justification
This bridge contract is necessary to prevent costly delays and disruptions in mission-critical operations, including completing in-progress surveillance projects and fulfilling Congressional mandates from the FDA Amendments Act 2007, 21st Century Cures Act, and PDUFA VII. The ongoing PDUFA demonstration project faces significant risk without immediate contract continuity. Acumen, LLC, the incumbent, currently serves as the BEST Coordinating Center under IDIQ HHSF223201810020I. The justification for sole source is based on Acumen's deeply embedded business systems, data infrastructure, analytical capabilities, and institutional knowledge, which would be costly and disruptive to replicate or transition to a new contractor.
Scope of Work
The BEST Coordinating Center, supported by this contract, serves as the central hub for managing all aspects of the program. This includes administration of task orders, coordination of data partners, project tracking, timeline oversight, and quality control across active surveillance activities. The center provides program management, technical infrastructure, analytical capabilities, scientific support, and administrative oversight to ensure timely and consistent execution of surveillance studies. It also ensures continuity across projects, supports knowledge management, and maintains the technical infrastructure for standardized data transformation and querying through the common data model, meeting CBER’s regulatory needs.
Contract Details
- Type: Intent to Award Sole Source Bridge Contract (Special Notice)
- Incumbent: Acumen, LLC
- New Contract Structure: One base year (September 30, 2026 – September 29, 2027) plus two one-year option periods.
- Estimated Value: Approximately $38.4M
- Set-Aside: Not Applicable (Sole Source)
- Place of Performance: Silver Spring, MD
Timeline & Response
- Published Date: June 8, 2026
- Response Due: June 23, 2026, 6:00 PM ET
- Action: This is an intent to award a sole source contract. All responsible sources who believe they can meet the requirement must submit a capabilities statement to the primary contact by the response date.