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Sentinel: Sentinel System 3.0 IDIQ

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Food and Drug Administration is launching the Sentinel 3.0 System in fiscal year 2026, an initiative developed from the experience of the Sentinel 2.0 System, the BEST Initiative, and Medical Device Active Surveillance. This new system integrates foundational work involving EHR and administrative claims data, guidance from CDER, CBER, and CDRH leadership, and extensive feedback from public workshops and Requests for Information. The operational structure consists of the Sentinel Coordinating Center, managed by a core team across various FDA offices, and a Program Management Organization that provides business informatics and project management via a FedRAMP cloud-based environment. Additionally, the system incorporates a Data Hub consisting of Data Partners and a Data Platform, supported by Scientific Support Services. This effort is organized as an IDIQ forecast under NAICS code 541714.

General Info

FDA is launching Sentinel 3.0 in 2026 via an IDIQ for system integration.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Organization / AgencyFood and Drug Administration → Food And Drug Administration
Office AddressN/A
Contacts
Cder Acquisition Liaison
contact@example.gov
To Be Determined To Be DeterminedContracting Officer

Full Description

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FDA is launching the new Sentinel 3.0 System in fiscal year 2026 based on 1) FDA's experience using the Sentinel 2.0 System, BEST Initiative, and Medical Device Active Surveillance, 2) the foundational work conducted by both the Sentinel 2.0 Innovation Center and BEST programmatic work using EHR data linked to administrative claims data during the 2019 to 2025 contract cycle, 3) the guidance provided by CDER, CBER, and CDRH Senior Leadership, 4) input received through responses to four Requests for Information (RFI) related to the Sentinel 3.0 System recompete,10 and 5) input received from the public through questions and comments received by FDA after the 2024 16th Annual Sentinel 3.0 Initiative Public Workshop.(1) FDA Sentinel Coordinating Center (SCC): The SCC will be managed by the Sentinel 3.0 Core Team (SCT) in CDER's OSE, in the OBPV's Surveillance Program Staff (CSPS), in CDRH's Office of Clinical Evidence and Analysis (OCEA), and Office of the Commissioner (OC).(2) Sentinel Program Management Organization (PMO): The PMO, via a contract awarded in September 202412, provides program/project management and business informatics support services (e.g., Collaboration Platform that operates outside of FDA in a Federal Risk and Authorization Management Program (FedRAMP) cloud-based environment).(3) Data Hub and Scientific Support Services: The Data Hub, comprising Data Partners and the Data Platform, along with Scientific Support Services

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