Draft Request for Proposal_Sentinel 3.0_Tiers 1-6

Solicitation / RFP / RFQ

This document is a DRAFT Request for Proposal (RFP) from the U.S. Food and Drug Administration (FDA) for Sentinel 3.0 Data Broker Services. The FDA is seeking to understand the market's capability to support Tiers 1-6 of the Sentinel 3.0 program, which involves acquiring, licensing, governing, and providing access to various types of healthcare data. This notice is for market research and planning purposes; no award will result from it.

The FDA anticipates needing a Data Broker-led acquisition model where a prime contractor is responsible for acquiring, licensing, governing, and providing access to healthcare data across Tiers 1-6. This includes coordinating with third-party data providers. The services may also involve coordinating with and managing third-party data providers.

The document outlines three potential contract structures:

• Contract 1: Sentinel 3.0 - Data Broker (Tiers 1-6) for acquiring and providing access to healthcare data.
• Contract 2: Sentinel 3.0 - Government-Owned, Contractor-Operated (GOCO) platform (Tier 7) for data repository and informatics.
• Contract 3: Sentinel 3.0 - Studies-As-A-Service (Tier 8) for scientific services and data analytics.

The FDA contemplates utilizing North American Industry Classification System (NAICS) code 518210.

Interested parties are invited to submit responses to specific questions regarding data availability, pricing constructs, data delivery, licensing, DUAs, resource models, and fee structures. They are also asked to provide recommendations for optimizing requirements in the draft attachments (Pricing Table, PWS, Agency Requirements, Clauses).

Key submission requirements include:

• Company profile (UEI, Tax ID, CAGE, size, classification)
• Contact information
• Applicable schedule contract vehicles (if any)
• Capability statement proving technical experience
• Confirmation of interest in a subsequent solicitation
• Description of the anticipated team structure (prime or subcontractor)

Responses are due no later than 10:00 am EST March 23, 2026, and should be submitted to Narissa Charles at Narissa.charles@fda.hhs.gov. The total response length is limited to 10 pages.

Respondents should include their business size and classification (small, small-disadvantaged, SBA Certified 8(a), HUBZone, service-disabled veteran-owned, women-owned, other than small, etc.).

Attachments provided include:

• Section B - Draft Pricing Table
• Section C - Draft Performance Work Statement (PWS) – Data Broker Services Tiers 1-6
• Section H - Draft Agency Requirements
• Section I - Draft Clauses

Respondents should assume Task Orders under the Data Broker IDIQ will be Firm-Fixed-Price (FFP).

Form / Attachment / Pricing Sheet

This document is a draft pricing table, likely intended to be used by bidders to propose pricing for various data tiers and services. It outlines line items (LI) with corresponding descriptions, quantities, and pricing structures.

• Tiers of Data: Includes "Tiers 1-4 Data" (Commercial Claims Data, Commercial Claims Aggregator Data, Healthcare Insurance Claims-EHR Linked Data, Specialty and Registry Data), "Tier 5 CMS Data" (with user interface), and "Tier 6 Outpatient Prescription Data" (with user interface).
• Data Brokerage Services: A separate line item for brokerage services.
• Quantity: Generally listed as '1' for each item.
• Pricing Structure: Indicated as 'FFP' (Firm-Fixed-Price) for all listed items.
• Years: The table is structured by year (1 through 5), with different line items associated with each year.

This pricing table is crucial for bidders to understand the structure of potential costs associated with the opportunity. Bidders will need to use this as a basis for developing their own detailed pricing proposals, ensuring they align with the government's defined data tiers and services, and the specified pricing structure.

Other / Unclassified

This document, titled "Section H - Draft Agency Requirements," outlines various contractual and administrative requirements for potential bidders. It covers critical aspects such as packing, marking, and shipping of materials, prohibited packaging materials, and inspection/acceptance procedures. It also details government personnel roles (Contracting Officer, Contract Specialist, Contracting Officer's Representative), emphasizing the limitations of the COR's authority. Key sections address contractor performance assessment reports (CPARS), travel cost policies (including restrictions for the Washington D.C. metro area), additional labor categories, tobacco-free facility policies, and occupational safety and health terms and conditions. Furthermore, it specifies personnel security clearance standards, background investigations, and the process for obtaining Personal Identity Verification (PIV) cards. Insurance requirements (Worker's Compensation, General Liability, Automobile Liability) are also outlined. The document clarifies that services are non-personal, addresses conflicts of interest and confidentiality, and details procedures for data disclosure. It also designates an Ombudsman for Task Order/Delivery Order contracts and outlines government use of data and incumbent phase-out procedures.

This document is highly relevant to bidders as it defines many of the operational, administrative, and compliance requirements that will govern the contract. Understanding these sections is crucial for accurately estimating costs, planning logistics, ensuring personnel compliance, and preparing a compliant proposal. Key areas for bidders to note include:

• Personnel Security: Requirements for background investigations and PIV cards will impact hiring and onboarding timelines.
• Travel Costs: Specific limitations on travel reimbursement, particularly within the D.C. metro area, need to be factored into pricing.
• Safety and Health: Compliance with OSHA and site-specific safety plans is mandatory.
• Reporting: Requirements for performance assessments (CPARS) and incident reporting are detailed.
• Contract Administration: Understanding the roles of the CO, CS, and COR is essential for communication and contract management.
• Insurance: Minimum coverage amounts for various liability types must be met.
• Non-Personal Services & Conflicts of Interest: These sections clarify the nature of the relationship and ethical obligations.

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for the Sentinel 3.0 Data Broker Services, aiming to establish a real-time surveillance platform for the FDA. The goal is to provide governed, scalable access to healthcare data assets to support the Sentinel 3.0 platform operations and study execution, ensuring compliance with legislative requirements and adapting to emerging public health needs.

The Contractor will serve as the Data Broker, responsible for identifying, acquiring, licensing, governing, and providing FDA with access to healthcare data. This includes:

• Data Broker Services (Tiers 1-6): Providing access to diverse healthcare data sources such as commercial claims, EHR-linked data, specialty EHR data, registries, Health Information Exchange (HIE) data, Centers for Medicare & Medicaid Services (CMS) data, and outpatient prescription data. The Contractor must be able to link data using privacy-preserving record linkage methods.

• Optional Task Area 3: Identifying, acquiring, and licensing additional healthcare datasets or data access services to augment core data holdings, as authorized by the Government.

• Data must be acquired and prepared to support ingestion into the FDA Data Platform.

• Datasets must be compatible with the Sentinel 3.0 FDA data platform.

• Data acquisition activities must comply with applicable federal laws, regulations, and data use agreements.

• The Contractor must maintain access to applicable data resources throughout the period of performance.

• The document specifies a period of performance, but the exact dates are not defined in the provided text.

• Place of Performance is listed as "Contractor Site."

• Security and Privacy: Strict adherence to FDA and HHS policies for safeguarding government information and information systems, including PII and CUI, is required.

• IT Compliance: Compliance with all applicable federal IT laws, regulations, policies, and standards.

• Organizational Conflict of Interest (OCI): Contractors must identify and mitigate potential OCIs.

• Data Rights: The Government retains unlimited rights to all documents and materials produced under this contract.

• Training: Mandatory security, privacy, and records management training for all contractor staff.

Forms / Attachments / Pricing Sheets

This document, "Section I - Draft Clauses.pdf," lists clauses from the Federal Acquisition Regulation (FAR) and the HHS Acquisition Regulation (HHSAR) that are incorporated by reference into the contract. It provides the title and date of each clause and directs bidders to online resources for the full text.

• FAR Clauses: A list of FAR clauses with their titles and dates, including but not limited to:
  • FAR 52.204-9: Personal Identity Verification of Contractor Personnel (Jan 2011)
  • FAR 52.212-5: Contract Terms and Conditions Required To Implement Statutes or Executive Orders- Commercial Products and Commercial Services (OCT 2025)
  • FAR 52.237-3: Continuity of Services (Jan 1991)
• HHSAR Clauses: A list of HHSAR clauses with their titles and dates, including but not limited to:
  • HHSAR 352.203-70: Anti-Lobbying (Dec 2015)
  • HHSAR 352.239-71: Security Requirements for Information Technology Resources (Feb 2024) Deviation
  • HHSAR 352.239-72: Information Technology Security Plan and Accreditation (Feb 2024) Deviation
• Full Text Access: Links to https://www.acquisition.gov/far and https://www.acquisition.gov/hhsar for accessing the full text of referenced clauses.
• Specific Clause Text: The full text of HHSAR 352.203-70 (Anti-Lobbying) and HHSAR 352.208-70 (Printing and Duplication) are provided.
• Confidential Information: The full text of HHSAR 352.224-71 (Confidential Information) is provided, outlining restrictions on disclosure and use of government-furnished or contractor-generated confidential information.

Bidders must review these incorporated clauses to understand the contractual terms, conditions, and regulatory requirements that will govern the contract. Key areas of focus include personnel identity verification, contract terms for commercial products/services, continuity of services, anti-lobbying restrictions, information technology security, printing and duplication limitations, and the handling of confidential information. Understanding these clauses is crucial for accurate proposal preparation and compliance if awarded the contract.