Sentinel: Sentinel System 3.0 IDIQ
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $100,000,000 or more
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is launching the Sentinel 3.0 System IDIQ in fiscal year 2026, a foundational surveillance program built on the FDA's experience with the Sentinel 2.0 System, BEST Initiative, and Medical Device Active Surveillance. The procurement draws on development work conducted from 2019 to 2025 and input from four Requests for Information and the 2024 16th Annual Sentinel 3.0 Initiative Public Workshop. Estimated solicitation release is September 1, 2026, with estimated award on March 1, 2027.
The award is valued at a minimum of $100 million. The Sentinel 3.0 System comprises three primary components: the Sentinel Coordinating Center managed by the Core Team across CDER's Office of Surveillance and Epidemiology, OBPV's Surveillance Program Staff, CDRH's Office of Clinical Evidence and Analysis, and the Office of the Commissioner; the Program Management Organization, which provides program and project management and business informatics support via a FedRAMP cloud-based environment; and the Data Hub with Data Partners and the Data Platform along with Scientific Support Services. Inquiries should be directed to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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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