Sentinel: Sentinel System Studies Order

Department of Health and Human Services

Forecast Overview

NAICS
541690
Performance end
3/2026

Support program continuity. The Sentinel System 3.0 (OY1) includes a single, multiple-award, tiered contract for a new 'Data Hub' to allow FDA access to a broad range of data sources and associated analytic support services. FDAAA mandated FDA to establish an Active Postmarket Risk Identification and Analysis (ARIA) and requires the FDA to develop methods to obtain access to disparate data sources and validated methods for the establishment of a system to link and analyze safety data from multiple sources. The 'Data Hub' will address these FDAAA requirements. Fund Type Rationale: ARIA relies on the use of Real-World Data to support investigations for all CDER medical products. Therefore, this request includes BA, BA RWE, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds.

Source

Source
HHS SBCX Forecast Export
Source file
Forecast.csv
Official source
Agency forecast source
Last verified
2026-08-31

Agency-published contact: · TBD@fda.hhs.gov

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