Sentinel: Sentinel System Studies Order
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- 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 seeking a single, multiple-award, tiered contract to establish a new 'Data Hub' component as part of the Sentinel System 3.0, 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 FDAAA to establish an Active Postmarket Risk Identification and Analysis (ARIA) system, which requires the development of methods to obtain access to disparate data sources and validated techniques for linking and analyzing safety data from multiple sources. The solicitation is expected to be released on October 1, 2025, with an estimated contract award date of March 1, 2026.
The estimated award value ranges between $3,000,000 and $7,000,000, classified under NAICS code 541690 (Other Scientific and Technical Consulting Services). Funding will be drawn from multiple sources including Budget Authority, Budget Authority Real-World Evidence, PDUFA, GDUFA, BSUFA, and 21st Century CURES Real-World Evidence funds, reflecting the contract's focus on leveraging real-world data to support product safety investigations across all Center for Drug Evaluation and Research medical products. Interested contractors should direct inquiries to the FDA Acquisition 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.
On GovTribe
Work this forecast
- Track it in your pipeline
- Find teaming partners
- Similar forecasts
- Ask GovTribe AI about this forecast