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Sentinel: Sentinel System Data Platform BPA

Active

Federal

Contract Overview

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

AI Contract Overview

The contract involves the establishment of the Sentinel System Data Platform BPA, designed to support the FDA’s Sentinel System 3.0 through a tiered, multiple-award contract focused on developing a new 'Data Hub'. This hub will enable the FDA to access and analyze a wide range of data sources to meet the requirements under the FDA Amendments Act (FDAAA) for Active Postmarket Risk Identification and Analysis (ARIA). The Data Hub aims to provide validated methods to link and evaluate safety data from multiple sources, enhancing the FDA’s ability to monitor the safety of medical products post-market. Funding for this contract will be sourced from various appropriations, including Budget Authority (BA), Real-World Evidence (RWE) funds, and fees collected under programs such as PDUFA, GDUFA, BSUFA, and 21st Century CURES. The use of real-world data is essential, as ARIA depends on it to support investigations involving all CDER medical products. The contract relates to NAICS code 541690 and is managed by the FDA, with a designated program point of contact available via email. Specific contracting details and points of contact are noted, but some remain to be determined.

General Info

Establish Sentinel System Data Hub to support FDA postmarket risk analysis using real-world data.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

forecast

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food 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

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.