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 Food and Drug Administration (FDA), specifically the FDA Office of Acquisition and Grant Services, has issued an Intent to Sole Source a bridge contract to Acumen LLC for the Biologics Effectiveness and Safety (BEST) Initiative Coordinating Center. This 12-month bridge contract, valued at approximately $6 million, is required to ensure continuity of critical public health operations from September 30, 2026, to September 29, 2027. The purpose is to prevent service disruption during the transition to Sentinel 3.0 and fulfill statutory obligations.
Purpose & Context
This acquisition aims to:
- Ensure uninterrupted management and coordination of activities across the BEST distributed data network and multiple data partners.
- Maintain analytic capacity for surveillance queries, safety signal detection, and follow-up analysis.
- Avoid costly delays and disruptions in mission-critical operations, including fulfilling Congressional mandates from the FDA Amendments Act 2007, 21st Centuries Cures Act, and the Prescription Drug User Fee Act (PDUFA VII). The BEST Initiative is a major component of the FDA’s active postmarket safety surveillance, essential for implementing the 21st Century Cures Act and the FDA Amendments Act of 2007.
Scope of Work
The incumbent, Acumen LLC, serves as the BEST Coordinating Center. This center plays a central role in executing the BEST Initiative's objectives by:
- Maintaining data and analytical infrastructure, expertise, and partnerships.
- Monitoring, refining, and identifying safety signals.
- Informing regulatory decisions and fulfilling FDA’s statutory obligations for biologic product surveillance.
- Managing task orders, coordinating data partners, project tracking, timeline oversight, and quality control.
- Providing program management, technical infrastructure, analytical capabilities, scientific support, and administrative oversight. All work is governed by a Statement of Work, ensuring continuity across projects, knowledge management, and technical infrastructure for standardized data transformation and querying.
Contract Details
- Opportunity Type: Special Notice (Intent to Sole Source)
- Incumbent: Acumen LLC (under IDIQ: HHSF223201810020I and Task Order: HHSF223201810020I / 75F40123F19005)
- Current Contract End: September 29, 2026
- Bridge Contract Duration: 12 months (September 30, 2026 – September 29, 2027)
- Estimated Value: Approximately $6,000,000
- Set-Aside: Not specified (Intent to Sole Source)
- Product Service Code: B537 - Medical And Health Studies
- Place of Performance: Silver Spring, MD 20993, United States
Rationale for Sole Source
A sole-source bridge is pursued to prevent delays, inefficiencies, and impacts on FDA statutory obligations that would arise from transitioning work to a new entity. The incumbent's business systems, including data infrastructure, analytical capabilities, staffing, data coordination, and communication processes, are deeply embedded in ongoing projects. Onboarding a new contractor would result in duplicative costs, loss of institutional knowledge, and disruption to time-sensitive public health surveillance deliverables.
Response & Contacts
- Response Date (for objections/comments): May 1, 2026, 7:00 PM EDT
- Primary Contact: Howard S. Yablon, howard.yablon@fda.hhs.gov
- Secondary Contact: Ian Weiss, Ian.Weiss@fda.hhs.gov, 301-796-5728