Draft Request for Proposal_Sentinel 3 . 0_Tiers 1 - 6

2026-11-03

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 .

Maryland

2026-04-08