Sentinel 3.0_2026 Updated Market Research

Solicitation / RFP / RFQ

This notice is a means for the U.S. Food and Drug Administration (FDA) to conduct market research for acquisition planning related to the Sentinel 3.0 program. It is not a Request for Proposal (RFP), Request for Quotation (RFQ), or Invitation for Bid (IFB), and no award will result from this announcement. The FDA is seeking information to understand the commercial market's capabilities to support Tiers 1-6 of Sentinel 3.0 under a Data Broker-led acquisition model. This model involves acquiring, aggregating, de-identifying, governing, licensing, and facilitating access to healthcare data across multiple data types and sources, potentially including coordination with third-party data providers.

• The FDA is seeking expertise in acquiring, aggregating, de-identifying, governing, licensing, and facilitating access to healthcare data.

• The scope includes multiple data types and sources, with potential coordination of third-party data providers.

• The document outlines a proposed contract structure involving three contracts:

  • Contract 1: Data Partners (Tiers 1-6) providing access to healthcare data.
  • Contract 2: Government-Owned, Contractor-Operated (GOCO) platform (Tier 7) for data repository and informatics.
  • Contract 3: Scientific Support Services (Tier 8) for data analytics.

• Specific data tiers mentioned include Commercial Claims Data, Commercial Claims Aggregator Data, Healthcare Insurance Claims-EHR Linked Data, Specialty and Registry Data, CMS Data, and Outpatient Prescription Data.

• The FDA anticipates utilizing North American Industry Classification System (NAICS) code 518210 (Computing Infrastructure Providers, Data Processing, Web Hosting, And Related Services).

• Task Orders under the anticipated Data Broker IDIQ are expected to be Firm-Fixed-Price (FFP).

• Interested parties are invited to submit responses to specific questions regarding data availability, tier-specific pricing constructs, data licensing/access preferences, user-based subscription pricing, and data broker service resource models.

• Responses should also include a company profile, contact information, existing contract information (if applicable), a capability statement, and confirmation of interest in a subsequent solicitation.

• Recommendations for optimizing requirements in draft attachments (Pricing Structure, PWS, Agency Requirements, Terms and Conditions) are also requested.

• Submission deadline: March 23, 2026, by 10:00 pm EST.

• Submission contact: Narissa Charles, Contracting Officer at Narissa.charles@fda.hhs.gov.

• Not explicitly stated in this market research notice, but respondents are asked to provide their business size and classification (small, small-disadvantaged, SBA Certified 8(a), HUBZone, service-disabled veteran-owned, women-owned, other than small, etc.).

• This notice supersedes a previous market research notice (FDARFI5302025).

• Draft attachments are provided for context and feedback: Draft Pricing Structure, Draft Performance Work Statement (PWS), Draft Solicitation Agency Requirements, and Draft Solicitation Terms and Conditions.

• Responses are limited to 10 pages for capability statements and answers to questions 1-5. Recommendations for draft attachments have no page limit.

Form / Attachment / Pricing Sheet

This document, "DRAFT Data Characteristics Table - Attachment H.xlsx", is an Excel spreadsheet containing Appendix H, the Data Resource Information Table. It is designed to guide potential bidders in providing detailed information about the data sources they propose to support the Sentinel Program. Bidders must complete this table as applicable to their proposed data sources.

The table outlines numerous data points and characteristics that bidders must address, including:

• Data Source Description: Brief description of proposed data sources.
• Population Characteristics: Size, patient enrollment (current and cumulative), person-time, demographic distribution, geographic diversity, representation of special populations, and comparison to larger geographic populations.
• Data Availability & Quality: Total and validated years of data, observation time, patient visits, lag time for data availability, data collection start date, data dictionary availability, missing data extent and handling procedures, and data refresh methods.
• Patient-Specific Data: Mother-infant linkage, geographic distribution, patient demographics (age, gender/sex, race/ethnicity), unique patient IDs, drug/biologic therapy information (generic name, strength, dose, dates, prescriber specialty, indication, etc.), and ability to verify dispensed vs. prescribed status.
• Medical Information: Diagnoses and procedures (ambulatory, hospitalizations), laboratory tests and results, tobacco/alcohol/cannabis use, BMI, blood pressure, medical history, family history, pregnancy outcomes, cancer diagnoses, and linkages to registries.
• EHR Data Specifics: Patient lives represented, linkage methods between EHR and claims data, pediatric patient data, overlapping observation time, patient encounters per year, and availability of specific data elements (coded data, clinical concepts from notes, clinical notes, lab values, vital signs, death data, imaging, pathology, radiology, demographics, medical history, allergies, immunizations, provider orders, procedure notes, intraoperative exposures, dialysis).
• Data Standards & Tools: Terminologies used (NDC, RXNORM, ICD-10, SNOMED-CT, etc.), capabilities for drug utilization inquiry, adverse event analysis, prevalence/incidence rates, propensity score analysis, IPTW, signal identification, and use of AI/ML/NLP tools.
• Data Quality & Privacy: Data quality control processes, patient privacy protection (HIPAA compliance), data error correction procedures, and data completeness/consistency/accuracy measures.

This attachment is critical for bidders to detail the characteristics and quality of their proposed data resources. It directly informs the government's assessment of the suitability and capabilities of the data to support the Sentinel Program's objectives. Completing this table accurately and thoroughly is essential for a compliant and competitive proposal.

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

This Performance Work Statement (PWS) outlines the requirements for Data Broker Services for the FDA Sentinel 3.0 program. The objective is to provide governed, scalable access to healthcare data to support FDA's postmarket safety surveillance activities, ensuring compliance with legislative requirements and addressing emerging public health needs.

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

• Data Broker Services (Tiers 1-6): Providing access to diverse healthcare data sources such as commercial claims, EHR-linked data, registry data, CMS data, and outpatient prescription data.

• Optional Dataset Acquisition: Identifying, acquiring, and licensing additional healthcare datasets or data access services to augment core data holdings.

• Data Acquisition: Procuring and preparing commercial claims, EHR-linked data, registry data, CMS data, and outpatient prescription data.

• Data Management: Ensuring acquired datasets are compatible with the FDA Sentinel 3.0 data platform and can be linked using privacy-preserving record linkage methods.

• Data Access: Providing access through user-friendly interfaces and ensuring data is available in open, machine-readable formats (CSV, JSON, Parquet) with documented APIs.

• Reporting: Providing monthly progress and financial reports, data onboarding roadmaps, and maintaining data characteristics tables.

• Security and Privacy: Adhering to strict security and privacy requirements, including data de-identification, encryption, and compliance with federal regulations.

Not specified in this document excerpt, but the document is dated March 02, 2026.

• Contractual: Contractor retains full contractual, legal, and compliance responsibility for all data assets.
• Coordination: Close coordination with FDA and other Sentinel 3.0 support contractors is required.
• Data Rights: FDA retains unlimited rights to all documents and materials produced under this contract.
• Training: Mandatory HHS-mandated contractor training is required annually.