Draft Request for Sentinel 3.0 Support Services – Tiers 1 to 6

The U.S. Food and Drug Administration (FDA) issues this DRAFT Request for Proposal (RFP) as a means of expanding its understanding of the market place to inform acquisition planning in accordance with the Federal Acquisition Regulation (FAR) Parts 7 and 10. This notice is not a RFP, Request for Quotation (RFQ), or Invitation for Bid (IFB), and no award will result from this announcement. As part of an earlier market research effort, the FDA previously issued Notice FDARFI5302025. The operational framework described in that notice has since been revised. The FDA now anticipates supporting its Sentinel 3.0 programmatic

requirements with the following contract structure: Contract 1: Sentinel 3.0 – Data Broker (Tiers 1–6, previously Tiers 1–5) providing access to multiple types of healthcare data. The FDA is considering a Data Broker–led acquisition model in which a prime contractor is responsible for acquiring, licensing, governing, and providing access to healthcare data across Tiers 1–6, including coordination with third-party data providers. Respondents should assume a single prime contractor retains full contractual, legal, and compliance responsibility for all data delivered under this model. Contract 2: Sentinel 3.0 – Government-Owned, Contractor-Operated (GOCO) platform (Tier

7) serving as a data repository, enabling interoperability, and delivering informatics tools and capabilities. Uder this model, the Government will not require platform development, platform hosting, platform replacement, alternative architectures, or contractor-operated environments. All

pricing responses should assume data is delivered to, accessed through, or integrated with the existing Government platform. Contract 3: Sentinel 3.0 – Studies-As-A-Service (Tier 8). Provide scientific services including data analytics support (e.g., capability to conduct complex pharmacoepidemiology and pharmacovigilance studies, and advanced analytics). Specifically, through this notice, the Government seeks information to better understand the commercial market’s capability to support Tiers 1–6 under a Data Broker–led acquisition model for Sentinel 3.0. The Government anticipates requiring the expertise of a qualified service provider to acquire, aggregate, de-identify, govern, license, and facilitate access to healthcare data across multiple data types and sources. This effort may also involve coordinating with and managing third-party data providers, as described in the attached draft Performance Work Statement (PWS) – Data Broker Services Tiers 1-6. See attachment titled "Draft Request for Proposal (RFP)-Data Broker Services Tiers 1-6" for complete notice information. Narissa Charles to this opportunity. Draft Request for Proposal (RFP) - Data Broker Services Tiers 1-6.pdf Section B - Draft

Pricing Table.pdf Section C - Draft Performance Work Statement (PWS).pdf Section H - Draft Agency

Requirements.pdf