Draft Request for Proposal_Sentinel 3. 0_Tiers 1-6

The U.S. Food and Drug Administration (FDA) Office of Acquisition and Grant Services has issued a Draft Request for Proposal (RFP) for Sentinel 3.0 Data Broker Services covering Tiers 1-6, which seeks a prime contractor to acquire, license, govern, and provide access to multiple types of healthcare data to support the agency's postmarket safety surveillance program. The contractor will bear full contractual, legal, and compliance responsibility for all data delivered across six tiers, ranging from commercial healthcare insurance claims data (100 million patient lives) to specialty registries, EHR-linked datasets, CMS data subscriptions, and outpatient prescription drug utilization data. Key requirements include ensuring all datasets are compatible with the FDA's Government-owned platform, enabling privacy-preserving record linkage, providing medical records access at the patient level, and maintaining a minimum of ten years of historical data with multiple delivery formats (Excel, SAS, R, CSV, and tab-separated files). This is a market research notice intended to inform acquisition planning rather than a binding solicitation, and responses are limited to 10 pages and must be submitted by March 23, 2026, at 10:00 am EST to Contracting Officer Narissa Charles at Narissa.charles@fda.hhs.gov. Respondents must address six primary questions covering data capability, tier-specific pricing constructs for commercial and government clients, data delivery mechanisms, subscription pricing models, and resource requirements.

This procurement carries no set-aside designation and identifies no incumbent contractors in the notice materials. The contract will be structured as a Firm-Fixed-Price (FFP) Indefinite-Delivery, Indefinite-Quantity (IDIQ) vehicle with task orders issued over a five-year performance period, with anticipated pricing based on annual line items for Tiers 1-4 data, Tier 5 CMS data subscriptions, Tier 6 outpatient prescription data, and data brokerage services. Task Area 3 permits optional additional dataset acquisitions through up to five separate task orders per year, each not exceeding $25 million in total value over the contract period. The FDA uses NAICS code 518210 (Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services) for this acquisition, and all data delivered will be Government-owned or Government-controlled with unrestricted use consistent with Sentinel 3.0 objectives. Contractors must comply with extensive administrative requirements including OSHA compliance, Personal Identity Verification (PIV) card requirements for on-site personnel, FDA confidentiality agreements, and annual performance evaluations through the Contractor Performance Assessment Reporting System (CPARS).