INTENT TO SOLE SOURCE FOR SENTINEL 2.0 BRIDGE CONTRACT TO HARVARD PILGRIM HEALTH CARE INC.

SOL #: FDAINTENTTOSOLESOURCEBRIDGESENTINEL2Special 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 28, 2026
2
Action Date
Feb 4, 2026, 8:30 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 extension of Sentinel 2.0 operations. This action ensures uninterrupted service for the critical Sentinel system until a competitive Sentinel 3.0 contract is awarded. Responses from interested parties are due by February 4, 2026.

Scope of Work

This bridge contract will maintain the Sentinel system's capabilities, which include:

  • Active Risk Identification and Analysis System (ARIA)
  • Real World Claims (RWE)-Electronic Health Records (EHR) linked data
  • Leadership and Program Management
  • Atlassian Access and Supporting Federal Information Security Modernization Act (FISMA) Compliance

The Sentinel System is a Congressionally mandated program (FDAAA 2007) that modernizes safety surveillance by leveraging electronic healthcare data and advancing epidemiological methods. It also supports Real-World Evidence (RWE) initiatives as mandated by the 21st Century Cures Act.

Contract & Timeline

  • Type: Intent to Sole Source Bridge Contract
  • Awardee: Harvard Pilgrim Health Care Inc. (incumbent)
  • Period of Performance: 18 months total
    • 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)
  • Set-Aside: None (Sole Source)
  • Response Due: February 4, 2026 (7 calendar days from publication)
  • Published: January 28, 2026
  • Place of Performance: Silver Spring, MD

Justification & Response

The sole source justification is based on Harvard Pilgrim Health Care Inc.'s incumbent status and necessary expertise to ensure continuity of operations and prevent a lapse in critical services during the transition to Sentinel 3.0.

This notice is not a request for competitive proposals. However, firms believing they can fulfill the requirements may submit their interest and capabilities within 7 calendar days of publication. The Government will review submissions to determine if a competitive procurement process is feasible. All inquiries must be submitted via email to Howard Yablon (howard.yablon@fda.hhs.gov).

People

Points of Contact

Howard S. YablonPRIMARY
Ian WeissSECONDARY

Files

Files

No files attached to this opportunity

Versions

Version 1Viewing
Special Notice
Posted: Jan 28, 2026
INTENT TO SOLE SOURCE FOR SENTINEL 2.0 BRIDGE CONTRACT TO HARVARD PILGRIM HEALTH CARE INC. | GovScope