Intent to Sole Source for Sentinel 2.0 Bridge Contract to Harvard Pilgrim Health Care Inc.

SOL #: FDAINTENTTOSOLESOURCESENTINEL2Special NoticeSole Source

Overview

Buyer

Health And Human Services
Food And Drug Administration
FDA CENTER FOR DRUG EVALUATION AND RESEARCH
Silver Spring, MD, 20993, United States

Place of Performance

Silver Spring, MD

NAICS

Professional, Scientific, and Technical Services (541)

PSC

Medical And Health Studies (B537)

Set Aside

No set aside specified

Timeline

1
Posted
Jan 23, 2026
2
Action Date
Feb 6, 2026, 7:00 PM

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) intends to award a sole source bridge contract to Harvard Pilgrim Health Care Inc. for the continuation of Sentinel 2.0 operations. This contract aims to ensure uninterrupted service for the critical Sentinel system, which includes the ARIA System, RWE Claims-EHR linked data, and program management. Interested parties believing they can fulfill the requirements must submit their capabilities by February 6, 2026.

Scope of Work

This bridge contract will maintain the operational continuity of the Sentinel system, encompassing:

  • ARIA System: Active Post-market Risk Identification and Analysis system.
  • RWE Claims-EHR linked data: Real-World Evidence data integration.
  • Leadership and Program Management: Oversight and coordination.
  • Atlassian Access and Supporting FISMA Compliance: Technical and security support.

Contract & Timeline

  • Type: Intent to Award Sole Source Bridge Contract
  • Incumbent: Harvard Pilgrim Health Care Inc.
  • Period of Performance:
    • Base Period: March 29, 2026 – September 28, 2026 (6 months)
    • Option Period 1: September 29, 2026 – March 28, 2027 (6 months)
    • Option Period 2: March 29, 2027 – September 28, 2027 (6 months)
  • Response Due: February 6, 2026 (15 calendar days from publication)
  • Published Date: January 23, 2026

Justification & Background

The FDA's intent to sole source to Harvard Pilgrim Health Care Inc. is based on their status as the incumbent contractor, possessing the necessary expertise to ensure continuity of operations. This temporary measure is crucial to prevent a lapse in critical services until a competitive follow-on contract (Sentinel 3.0) can be awarded.

The Sentinel System is a Congressionally mandated program (FDAAA 2007) designed to modernize safety surveillance by leveraging electronic healthcare data, advancing epidemiological methods, and expanding FDA's capabilities. It includes the ARIA system (100M+ individuals) and responds to the Real-World Evidence Medical Data Enterprise (10M+ lives), aligning with the 21st Century Cures Act.

Response to Notice

This is not a request for competitive proposals. However, firms that believe they can successfully fulfill all stated requirements are invited to identify their interest and capabilities. Submissions must clearly demonstrate this ability and be sent via email to Howard Yablon (howard.yablon@fda.hhs.gov). The Government will review responses to determine if a competitive procurement process is feasible. All costs associated with responding are the responsibility of the submitting party.

People

Points of Contact

Howard S. YablonPRIMARY
Ian WeissSECONDARY

Files

Files

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Versions

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Special Notice
Posted: Jan 23, 2026
Intent to Sole Source for Sentinel 2.0 Bridge Contract to Harvard Pilgrim Health Care Inc. | GovScope