Intent to Sole Source for Best 1 Bridge Contract Tender - 139724833

Procurement Summary

Country: USA

Summary: Intent to Sole Source for Best 1 Bridge Contract to Acumen Llc

Deadline: 01 May 2026

Posting Date: 18 Apr 2026

Other Information

Notice Type: Tender

TOT Ref.No.: 139724833

Document Ref. No.: FDAINTENTTOSOLESOURCEBRIDGECONTRACTBEST1

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

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, 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 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 $...
Notice ID: fdaintenttosolesourcebridgecontractbest1

Department/Ind. Agency: health and human services, department of

Sub-tier: food and drug administration

Office: fda office of acq grant svcs

Product Service Code: b537 - special studies/analysis- medical/health

NAICS Code: 541 - Professional, Scientific, and Technical Services

Inactive Dates: may 16, 2026

Inactive Policy: 15 days after response date

Documents

 Tender Notice