Sentinel: Sentinel System Data Platform BPA
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $13,000,000 to $20,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- 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 forecasting a new requirement for the Sentinel System 3.0 Data Hub, a single multiple-award, tiered contract designed to provide FDA access to a broad range of data sources and associated analytic support services. This procurement directly supports the FDA's mandate under the FDA Amendments Act (FDAAA) to establish an Active Postmarket Risk Identification and Analysis (ARIA) system, requiring the development of methods to obtain access to disparate data sources and validated approaches for linking and analyzing safety data from multiple sources. The solicitation is estimated to release on September 1, 2025, with an anticipated award date of March 1, 2026.
The estimated award value ranges from $13 million to $20 million under NAICS code 541690 (Other Scientific and Technical Consulting Services) with no set-aside restrictions. This contract will leverage Real-World Data to support investigations across all Center for Drug Evaluation and Research (CDER) medical products, with funding sourced from multiple appropriations including Budget Authority, Real-World Evidence funding, PDUFA, GDUFA, BSUFA, and 21st Century CURES RWE funds. Interested parties should direct inquiries to the FDA's CDER Acquisitions Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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.
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