Synopsis -Sentinel 3. 0 - The FDA intends to procure services in support of the Sentinel 3. 0 program/initiative.
Closed Pre-Solicitation Posted
- Solicitation number
- 75F40126R00003SYNOPSIS
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 518210 Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration seeks commercial support services for the Sentinel 3.0 program through a multiple-award Indefinite Delivery, Indefinite Quantity (IDIQ) contract structure. The Sentinel 3.0 initiative aims to establish a national electronic system for monitoring the safety of FDA-regulated medical products, requiring comprehensive data management and analytical capabilities across eight distinct service tiers. These tiers encompass data partners, platform management, and scientific support services, including healthcare insurance claims data, electronic health records, registry data, and AI-enabled analytics capabilities. The procurement falls under NAICS code 518210 for computing infrastructure and data processing services, with a focus on medical and health analysis as indicated by PSC code B537. The pre-solicitation notice was posted on September 24, 2025, with the full solicitation expected on October 9, 2025, and responses due within 15 days of the synopsis issue date.
This procurement is designated as an unrestricted set-aside with no small business designation, establishing a $40 million size standard for eligible contractors. Current incumbent contractors providing similar services include Harvard Pilgrim Health Care Inc. and Deloitte Consulting L.L.P., indicating the scope and complexity of existing operations. The anticipated contract performance period spans five years beginning November 30, 2025, structured with one 12-month base period followed by four 12-month option periods. The government reserves the right to issue task orders under various contract types including Firm-Fixed Price, Time and Materials, or Labor Hour arrangements, providing flexibility in procurement execution. Interested parties must monitor SAM.gov for the forthcoming full solicitation and should prepare responses according to the established timeline requirements.
Notice text
See synopsis attachment
Files
| File | Type | Posted |
|---|---|---|
| SYNOPSIS - SENTINEL 9 24 2025.pdf |
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