SYNOPSIS - SENTINEL 9 24 2025.pdf

TYPE OF NOTICE: SYNOPSIS

SOLICITATION NUMBER: 75F40126R00003

AGENCY: Department of Health and Human Services (DHHS), Food and Drug Administration

(FDA)

OFFICE: Office of Acquisition and Grants Services

CLASSIFICATION

PSC: B537: Special Studies/Analysis/Medical/Health NAICS CODE: 518210, Computer Infrastructure Providers, Data Processing, Web Hosting, and Related Services SIZE STANDARD: $40 million SET-ASIDE: Unrestricted

Description

Title: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) – Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract

This is a pre-solicitation notice/synopsis, and NOT a solicitation for proposals. The related solicitation is expected to be posted to SAM.gov on or about 10/09/2025. Interested parties should monitor SAM.gov for the complete solicitation. This synopsis complies with FAR 5.207 and is posted in accordance with FAR 5.101 publicizing requirements.

The FDA intends to procure commercial support services in support of the Sentinel 3.0 program/initiative. This acquisition is being conducted in accordance with FAR Part 12, Acquisition of Commercial Products and Commercial Services.

The Government intends to award a multiple award, Indefinite-Delivery, Indefinite-Quantity (IDIQ), Contract for the services specified and effective for the stated period of performance as contained in this notice. The services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. All resultant task orders will be subject to the terms and conditions in the IDIQ base contract.

At its discretion, the Government may use any combination of contract types when issuing task orders under this IDIQ contract to meet its needs, including Firm-Fixed Price (FFP), Time and Materials (TM), or Labor Hour (LH) or hybrid of the mix.

This acquisition is being procured unrestricted; however, set-aside decisions per task or at the Task Order level, if any, will be addressed per the solicitation. This procurement will be awarded using a Tradeoff type Source Selection using combined technical/risk ratings, requiring the submission of a technical proposal with selected non-price factors. Price/Cost proposal submissions will also be required.

Ordering Periods/Periods of Performance The anticipated period of performance (subject to change) consists of one (1), 12-month base period and four (4), 12-month option periods, as follows:

• Base Period: November 30, 2025, through November 29, 2026

• Option Period: November 30, 2026, through November 29, 2027

• Option Period: November 30, 2027, through November 29, 2028

• Option Period: November 30, 2028, through November 29, 2029

• Option Period: November 30, 2029, through November 29, 2030

Background

The Sentinel Initiative was created as the result of a 2007 congressional mandate to strengthen post-market surveillance of medical products. In 2008, the Secretary of Health and Human Services (HHS) and FDA’s Commissioner announced the Sentinel Initiative, a long-term effort to create a national electronic system for monitoring FDA-regulated medical product safety in alignment with FDA’s mission to protect the public health.

The goal of the next Sentinel 3.0 System contract is to continue meeting or exceeding the legislative requirements, promote program efficiency, support the anticipated needs of each of the distinctive underlying Sentinel 3.0 components (e.g., Active Postmarket Risk Identification and Analysis (ARIA) system), and ensure sufficient flexibility to address emerging safety issues and rapidly changing public health needs (e.g., public health emergencies).

The Sentinel 3.0 Initiative fulfills the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Sec 905) requirement for an active postmarket risk identification and analysis system. FDAAA requires that FDA access disparate data sources to link and analyze safety data to cover at least 100 million U.S. patients. CDER, CBER, and CDRH developed various approaches to conduct complementary postmarket safety surveillance activities utilizing population-based data sources tailored to the regulated products under the purview of each center. The FDA is consolidating postmarket safety surveillance activities utilizing population-based data sources conducted through the Sentinel 3.0 System, CBER Biologics Effectiveness and Safety (BEST) Initiative, and CDRH under the new Sentinel 3.0. The proposed new system will provide a collaborative, central framework for active surveillance activities for CDER, CBER and CDRH.

The purpose of this procurement is to establish a contract to support the Sentinel 3.0 System.

SCOPE:

The Sentinel 3.0 will include the following components:

(1) FDA Sentinel Coordinating Center (SCC): The SCC will be managed by the Sentinel 3.0 Core Team (SCT) in CDER’s Office of Surveillance and Epidemiology (OSE), in the Office of Biologics Product Review’s (OBPV) Surveillance Program Staff (CSPS), in CDRH’s Office of Clinical Evidence and Analysis (OCEA), and Office of the Commissioner (OC).

(2) Sentinel Program Management Organization (PMO): The PMO, via a contract awarded in September 2024, provides program/project management and business informatics support services (e.g., Collaboration Platform that operates outside of FDA in a Federal Risk and Authorization Management Program (FedRAMP) cloud-based environment).

(3) Data Hub and Scientific Support Services: The Data Hub, comprising Data Partners and the Data Platform, along with Scientific Support Services, will provide access to:

a. Data Partners (a component of the Data Hub): Provides diverse healthcare data sources including commercial and CMS claims data, outpatient prescription data (subscription with user interface), claims aggregator data, and Healthcare Insurance Claims-EHR Linked Data (EHR).

Specialty EHR data encompasses oncology, pediatrics, geriatrics, and hospital intensive care unit records. Additional data types include disease and product registries, registry networks, and Health Information Exchange (HIE) data. The data sources with capabilities to link healthcare data to Immunization Information Systems (IIS) nationwide for vaccine exposure supplementation and access to medical device utilization data (including Unique Device Identifier information) are particularly valuable and important to FDA operations.

b. Data Platform (a component of the Data Hub): Provides AI-enabled data repository services and informatics tools that facilitate data analysis through standardized terminologies and clinical-to-operational translations capabilities. The Data Platform operates as a Contractor managed, FedRAMP authorized cloud environment supporting multiple tenants.

c. Scientific Support Services: Provide scientific services including data analytics support for complex pharmacoepidemiology and pharmacovigilance studies, as well as advanced AI-based analytics capabilities.

To continue to meet the congressional mandate in FDAAA and maintain ongoing operations of the Sentinel 3.0 System, FDA plans to award a five-year Sentinel 3.0 System contract. The planned contract vehicle is a multiple award, tiered five- year (5) indefinite Delivery Indefinite Quantity (IDIQ) contract. The IDIQ will be awarded by Tiers as follows:

Table 1: Sentinel 3.0 Scope

Tier 1 - Data Partner - Commercial Healthcare Insurance Claims Data Tier 2 – Data Partner - Commercial Healthcare Insurance Claims Data from Third-Party

Aggregator(s) (access to medical records is not required) Tier 3 – Data Partner - Healthcare Insurance Claims-EHR Linked Data Tier 4 – Data Partner - EHR Data (including oncology, pediatrics, geriatrics, inpatient settings of care), Registry or Registry Network Data (product or disease-based registries), and Health Information Exchange (HIE) Data Tier 5 – Data Partner - Centers for Medicare and Medicaid Services (CMS) Data Tier 6 – Data Partner - Outpatient Prescription Data (subscription with user interfaces and raw data) Tier 7 - Data Platform – This AI-enabled FedRAMP approved data, and advanced analytics platform is setup and managed by the Contractor.

Tier 8 - Scientific Support Services (SSS) - These services are managed by Contractor.

Data Partners (Tiers 1-6) and the Data Platform (Tier 7) are the two components of the Data Hub, refer to Table 1.

In a multi-tier IDIQ:

• An individual vendor does not have to meet requirements for all IDIQ tiers but could be awarded more than one tier in the IDIQ.

• Within a particular IDIQ tier, multiple vendors compete for and may be awarded task orders.

• It will be a requirement for all IDIQ awardees to coordinate with other awardees for interconnected work.

• The number of vendors awarded each IDIQ tier is contingent on program requirements and funding availability.

• The Government will give higher priority to vendors whose successful response covers multiple tiers.

The Sentinel 3.0 will be led by the FDA SCC. The Sentinel 3.0 will be supported by the Program Management Organization (PMO). Contractor, who will work in close collaboration with FDA Staff as needed.

A key element of the Sentinel 3.0 operational framework is the establishment of a flexible and cost-effective technical solution via a Data Hub and Scientific Support Services contract. This contract will allow access to multiple types of healthcare data (Data Partners, Tiers 1-6), serve as a data repository, provide informatics tools and capabilities (Data Platform, Tier 7), and provide Scientific Support Services (Tier 8) refer to Table 1. FDA envisions that other government organizations (e.g., Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH)) will leverage the Sentinel 3.0 Data Hub (i.e., Data Platform (Tier 7) and the data provided by the participating Data Partners (Tiers 1-6)) to support the advancement of public health. The Scientific Support Services Contractor(s) will provide scientific and technical support to the FDA SCC, including data analytics support by working in close collaboration with FDA SCC staff, the PMO Contractor, and other FDA staff.

The Data Partners (Tiers 1-6) will provide all the data that will be accessible in the Data Platform (Tier 7). Data Partners (Tiers 1-6) will be issued task orders to provide FDA with the required data, consistent with the IDIQ Tier(s) awarded to them. In addition, Data Partners (Tiers 1-6) will be capable of sub-contracting access to new, relevant data sources within the scope of the Tier(s) awarded to the Contractor. Each Data Partner (Tiers 1-6) shall be able to manage the Data Use Agreements (DUA) with sub-contracted data partners and make those data available through the Data Platform (Tier 7).

The Data Platform (Tier 7), including a data repository component, informatics tools, and data exchange capabilities, will be on a FedRAMP cloud-based multi-tenant environment. The data provided by Data Partners (Tiers 1-6) will be accessible in the Data Platform (Tier 7) environment which provides the appropriate security controls and data accessibility rules.

Though the multi-tenant environment will keep each Data Partner data separate from other Data Partner data, linkage of data partners data might be required for particular use cases as determined by FDA or other government agencies. Based on Data Platform user’s role and authorized level of access (i.e., user “persona”), the Data Platform (Tier 7) Contractor will grant access to the data relevant to individual FDA SCC staff, Scientific Support Services (Tier 8) staff, and other study team participant (i.e. FDA staff), as appropriate.

The Data Platform (Tier 7) is envisioned to integrate artificial intelligence (AI) and machine learning (ML) capabilities directly into the data management and analytics workflow, automating tasks and enhancing insights. They aim to simplify data processes and empower users with AI-driven functionalities, from data preparation to advanced analytics and AI model deployment. In addition to the data repository, the Data Platform (Tier 7) also includes informatics tools to perform data summarization, statistical analysis, and analytics necessary to conduct the study using the data in the data repository. It will have the flexibility to add more tools as necessary.

Data analyses and assessments will be conducted by the FDA Sentinel Coordinating Center (SCC), Scientific Support Services Contractors (Tier 8), and other FDA staff, with support from the PMO under a previously awarded contract. Additionally, the Scientific Support Services Contractor (Tier 8) will lead efforts in data summarization, statistical analysis and analytics needed to carry out the study using the data repository and informatics tools.

The IDIQ requires that all awardees coordinate and collaborate with other awardees on shared interconnected work. Sentinel 3.0 will rely on Contractors cooperating across and within Tiers to provide FDA with the capabilities and data needed to address Sentinel 3.0 work.

Following is a high-level description of key functions of Sentinel 3.0 components to manage a typical request for Sentinel 3.0 services (e.g., scientific consultations, requests for data to address regulatory questions). The FDA SCC will work with FDA staff to manage requests for Sentinel

3.0 services.

• The FDA SCC will receive requests for Sentinel 3.0 services (e.g., scientific questions, requests for information or consultation) from FDA staff. These requests will be triaged and, as appropriate, routed to the PMO for initiation of a new project and tracking. The SCC, in collaboration with the Scientific Support Services Contractor (Tier 8), will develop a strategy to address each service request, which may include consultation with Data Partners (Tiers 1-6), as tasked.

• The PMO Contractor provides support through scheduling meetings, managing study- or task-related documentation, conference presentations, publications, clearance support and helping track deliverables and program performance metrics. The PMO manages a Collaboration Platform and Sentinel 3.0 Initiative Website.

• The FDA SCC will work with FDA staff, Scientific Support Services Contractor (Tier 8), and Data Partners (Tiers 1-6) to identify the most appropriate data resources and scientific methods available to address the scientific question, develop a study protocol and methods, including a Statistical Analysis Plan (SAP) and programming specifications.

• The Data Partners (Tiers 1-6) providing data to support a specific study are responsible for generating quality-checks and timely results in response to protocol implementation.

• Data Platform (Tier 7) Contractor provides a secure environment for Data Partners (Tiers 1-6), Scientific Support Services Contractor (Tier 8), and FDA staff to exchange data readily available directly from the Data Partners (e.g., accessed via individual or enterprise-level licenses) or datasets generated as a result of specific queries to address safety surveillance questions.

• The Scientific Support Services Contractor (Tier 8) is responsible for conducting a second quality check of the summary data provided by the Data Partners (Tiers 1-6) and for integrating the study results if analyses are based on data from multiple Data Partners.

INCUMBENTS

Incumbent contractors and contract numbers for the current Sentinel 2.0 Contract are as follows:

HARVARD PILGRIM HEALTH CARE INC: Contract # 75F40119D10037

DELOITTE CONSULTING L. L. P.: Contract # 75F40119D10038

SYNOPSIS INFORMATION

SYNOPSIS ISSUE DATE: 9/24/25

RESPONSE DUE DATE: 15 DAYS – 10/09/25

POINTS OF CONTACT:

• Contracting Officer: Ian Weiss, ian.weiss@fda.hhs.gov

• Contract Specialist: Howard Yablon, howard.yablon@fda.hhs.gov