RFI_SENTINEL 3.0 5 30 2025.pdf

Sentinel Initiative: Request for Information

Sentinel 3.0 Data Hub and Scientific Support Services

Purpose

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH) request public comments to inform the future organization of the Sentinel System.

FDA seeks information that will assist in the development of new approaches to meet FDA’s legal requirements, fulfill its public health mission, and add value to the Sentinel System. This information will also help to shape the next solicitation or Request for Proposal (RFP) for the Sentinel System.

Specifically, FDA is interested in obtaining input from the public on the proposed Sentinel 3.0 Data Hub and Scientific Support Services structure and operations. The goal of the next Sentinel System contract is to continue meeting or exceeding the legislative requirements, promote program’s efficiency, support the anticipated needs of each of the distinctive underlying Sentinel components (e.g., Active Postmarket Risk Identification and Analysis (ARIA) system1), and ensure sufficient flexibility to address emerging safety issues and rapidly changing public health needs (e.g., public health emergencies).

Background The Sentinel 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 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 Sentinel 3.0 will include the following components:

(1) FDA Sentinel Coordinating Center (SCC): The SCC will be managed by the Sentinel Core Team (SCT) in CDER’s Office of Surveillance and Epidemiology (OSE), staff from CBER’s Office of Biostatistics and Pharmacovigilance (OBPV) BEST initiative and select staff from CDRH’s Office of Clinical Evidence and Analysis (OCEA).

(2) Sentinel Program Management Organization (PMO): The PMO, via a contract awarded in September 2024 2, 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).

1 An explanation of the ARIA system and how it is used within the Sentinel System can be found on the Sentinel Initiative website. https://www.sentinelinitiative.org/studies/drugs 2 Sam.gov at the following link: https://sam.gov/opp/685973fab70e492c83dc33e7f76dfc0c/view https://www.sentinelinitiative.org/studies/drugs https://sam.gov/opp/685973fab70e492c83dc33e7f76dfc0c/view

(3) Data Hub and Scientific Support Services: The Data Hub and Scientific Support Services (via a new contract) will provide access to:

a. Data Partners (a component of the Data Hub): Provide health care data (e.g., commercial and Centers for Medicare & Medicaid Services (CMS)) claims data, commercial claims aggregators data, claims data linked to electronic health records (EHR) data, specialty EHR Data (e.g., oncology, pediatrics, geriatrics, hospital intensive care unit (ICU)), disease or product registry or registry network data, and Health Information Exchange (HIE) Data). Data sources with the ability to link health care data to Immunization Information Systems (IIS) across the country to supplement vaccine exposure data for all vaccines and/or have access to medical device utilization data (e.g., Unique Device Identifier (UDI)) are of high importance to FDA.

b. Data Platform (a component of the Data Hub): Provides artificial intelligence (AI) enabled data repository services and informatics tools and capabilities (e.g., facilitates data analysis by providing tools and terminologies to translate clinical definitions to operational definitions). The Data Platform is a contractor-operated, FedRAMP cloud-based, multi-tenant environment.

c. Scientific Support Services: Provide scientific services including data analytics support (e.g., capability to conduct complex pharmacoepidemiology and pharmacovigilance studies, and advanced analytics).

To continue to meet the congressional mandate in FDAAA and maintain ongoing operations of the Sentinel System, FDA plans to award a five-year Sentinel System contract by December 2025. The planned contract vehicle is a multiple award, tiered Indefinite Delivery Indefinite Quantity (IDIQ) contract. The IDIQ will be awarded by Tiers as follows:

Tier 1: Commercial Healthcare Insurance Claims Data

Tier 2: Commercial Healthcare Insurance Claims Data from Third-Party Aggregator(s) (access to medical records is not required)

Tier 3: Healthcare Insurance Claims-EHR Linked Data

Tier 4: Specialty EHR Data (e.g., 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: Centers for Medicare and Medicaid Services (CMS) Data

Tier 6: Data Platform – This platform is setup and managed by the Contractor

Tier 7: Scientific Support Services – These services are managed by Contractor

Data Partners (Tiers 1-5) and the Data Platform (Tier 6) are the two components of the Data Hub.

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.

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

Information about prior RFIs relevant Sentinel 3.0 can be accessed below:

1. The Food and Drug Administration (FDA), CDER requests public comments to inform the future organization of the Sentinel System (November 1, 2022, SAM.GOV);

2. Contract Approach for Sentinel 3.0 (December 5, 2023, SAM.GOV ); and

3. Request for Information Sentinel System 3.0: Program Management and Business Informatics

Support (April 20, 2024, SAM.GOV).

Proposed Sentinel 3.0 Operational Framework The Sentinel 3.0 will be led by the FDA SCC, which is staffed by the FDA. The Sentinel 3.0 will be supported by the PMO contractor, who will work in close collaboration with CDER, CBER and CDRH 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 1-5), serve as a data repository, and provide informatics tools and capabilities (Data Platform, Tier 6), and provide scientific support services (Tier 7). FDA envisions that other government organizations (e.g., Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH)) will leverage the Sentinel Data Hub (i.e., Data Platform (Tier 6) and the data provided by the participating Data Partners (Tiers 1-5)) to support the advancement of public health. The Scientific Support Services contractor(s) will provide scientific and technical support to the FDA program, including data analytics support by working in close collaboration with FDA SCC staff, the PMO contractor, and other FDA staff.

The Data Partners (Tiers 1-5) will provide all the data that will reside in the Data Platform (Tier 6). These data could include both individual-patient data as well as summarized and aggregated data. Data Partners (Tiers 1-5) will be awarded task order contracts to provide FDA the data according to the IDIQ Tier(s) awarded to the contractor. In addition, Data Partners (Tiers 1-5) 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 1-5) shall be able to manage the data use agreements with sub-contracted data partners and make those data available through the Data Platform (Tier 6).

The Data Platform (Tier 6), including a data repository component and informatics tools, will be on a FedRAMP cloud-based multi-tenant environment. The data provided by Data Partners (Tiers 1-5) will reside in the Data Platform (Tier 6) environment which provides the appropriate security controls and data accessibility rules. Though the multi-tenant environment will keep each Data Partners’ data separate from other Data Partners’ 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 6) contractor will grant access to the data relevant to individual FDA SCC staff, Scientific Support Services (Tier 7) staff, and other study team participant (i.e. FDA staff), as appropriate.

The Data Platform (Tier 6) 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 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.

https://sam.gov/opp/4ca6bfd7de07401d8d818d0bf337f472/view https://sam.gov/opp/e33882c0b5384497a34e39415e75a43e/view https://sam.gov/opp/b814f2c901194269873519fc12906f45/view

Data analysis and assessment will be conducted by the FDA Coordinating Center (FCC), Scientific Support Services contractors (Tier 7), and other FDA staff, with support from the PMO under a previously awarded contract. Additionally, the Scientific Support Services contractor (Tier 7) will lead efforts in data summarization, statistical analysis and analytics needed to carry out the study using the data repository and informatics tools.

The figure below shows how the different Sentinel 3.0 Data Hub and Scientific Support Services contract tiers are related to the FDA’s operational framework. This figure identifies those components in the operational framework by a that are to be fulfilled via this new Sentinel 3.0 contract.

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 services (e.g., scientific consultations, requests for data to address regulatory questions). The FDA SCC will work with CDER, CBER, and CDRH 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 7), will develop a strategy to address each service request, which may include consultation with Data Partners (Tiers 1-5), as tasked.

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

• The FDA SCC will work with CDER, CBER, and CDRH staff, Scientific Support Services contractor (Tier 7), and Data Partners (Tiers 1-5) 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).

• The Data Partners (Tiers 1-5) providing data to support a specific study are responsible for generating quality-checks and timely results in response to protocol implementation.

• Data Platform (Tier 6) contractor provides a secure environment for Data Partners (Tiers 1-5), Scientific Support Services contractor (Tier 7), 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 7) is responsible for conducting a second quality check of the summary data provided by the Data Partners (Tiers 1-5) and for integrating the study results if analyses are based on data from multiple Data Partners.

This RFI offers the public (e.g., healthcare research organizations, pharmaceutical industry, and academic medical centers, and others) the opportunity to share with FDA input regarding the Agency’s planned technical and contractual mechanism to support activities related to FDA’s Sentinel System.

The RFI process will consist of a 20-day information solicitation phase. This information is being sought for planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the FDA.

Information Requested

Interested organizations are requested to respond to the following items:

1. Sentinel 3.0 Data Hub - Data Platform Component

a. Describe your organization’s proposed Data Platform (Tier 6) component for the Sentinel 3.0 Data Hub. Detail how this centralized system would manage data from multiple data partners, including its capabilities for organization, storage, processing, linkage, security, infrastructure, compliance, data privacy, and governance framework.

i. Describe the attributes of your proposed system including but not limited to:

(1) Scalability to accommodate increasing data volumes and adapt to evolving business requirements.

(2) Robust security measures to safeguard sensitive information.

(3) Comprehensive data governance framework to ensure data quality and adherence to system requirements.

(4) Real-time processing capabilities and user interfaces that enable authorized personnel to efficiently access and analyze data.

(5) Capability in managing diverse data formats from various sources and locations.

(6) Advanced data linkage capabilities to integrate information from disparate sources when necessary.

(7) Seamless interoperability with other components of the Sentinel 3.0.

b. Describe in brief how the Data Platform can incorporate advanced artificial intelligence (AI)-driven capabilities to optimize data processing and enhance data accessibility? Please provide specific examples of AI technologies or methodologies that may be utilized to improve efficiency and user experience within the Sentinel 3.0.

c. Describe your approach or methodology to logically linking multiple data sources, particularly claims data with EHR data, specifically on patient-level matching, data integration techniques, and how you address privacy, security, and scalability in the proposed Data Platform using AI, as needed. Highlight any innovative technologies and provide examples of successful implementations in similar environments.

d. Provide a breakdown of the cost structure (i.e., rough order of magnitude (ROM)) for a Data Platform, including but not limited to the following elements:

i. Expenses associated with handling multiple data sources.

ii. Storage costs, including any scalability considerations.

iii. Network infrastructure and data transfer costs.

iv. Costs related to the chosen architecture (e.g., cloud-based, on-premises, or hybrid solutions)

v. Also, include a) Initial implementation costs, b) Ongoing operational expenses, c) Any potential cost-saving measures or efficiencies.

e. Provide an architectural approach for a contractor-owned, contractor-operated (COCO) and/or public-private-partnership (PPP) model to address the Sentinel 3.0 Data Platform requirement.

Your description should encompass the following key elements:

i. Architectural Independence: Explain how your design ensures flexibility and autonomy.

ii. AI Compatibility: Describe how the architecture supports AI-driven data processing and analysis.

iii. Advanced Technical Features: Highlight innovative capabilities that set your platform apart.

iv. Data Integration and Application Programming Interface (API) Linkages: Detail your approach to seamless data integration and API-driven connections.

v. Security and Privacy: Outline robust measures to protect sensitive health data.

vi. Scalability and Performance: Explain how the architecture accommodates growth and ensures optimal performance.

vii. Accessibility: Describe how users can easily access data, tools, and services.

viii. Regulatory Compliance: Specify how the architecture adheres to relevant regulations and standards.

2. Sentinel 3.0 Data Hub - Data Partners

a. FDA seeks data that could be housed in a Data Platform as described above.

i. Describe the types of data that your organization can provide via the Data Platform.

ii. Describe how your organization will handle data governance if your organization provides data to the Sentinel 3.0 Data Hub as a Data Partner. The data would be made available to analysts (e.g., FDA staff and Scientific Support Services (Tier 7) contractors) and personnel providing informatics support to address regulatory questions.

iii. Describe the approaches and requirements to allow ingestion of data provided by your organization into the Data Platform, including whether data would be provided in batches or in near-real-time/streaming.

iv. Describe the frequency at which your organization refreshes data and how you would implement the refreshes to maintain access to updated data in the Data Platform. Describe how the refreshes might affect the claims-EHR linkages (or need to re-link).

v. Would your organization’s position to consider data sharing differ based on the operator of the platform (e.g., federal government, academic institution, non-profit, private contractor)?

vi. Please describe any legal, regulatory, or contractual limitations your organization faces regarding sharing data provided by Data Partners with third parties (e.g., via Data Platform).

vii. What types of agreements (e.g., Data Use Agreements) would be required to facilitate data sharing?

viii. Are there specific privacy or compliance concerns (e.g., HIPAA, re-identification risks) that would limit your ability or willingness to participate?

ix. What restrictions or controls would be necessary for your organization to share data via the Data Platform (e.g., limits on data reuse, de-identification)?

x. Would your organization agree to store its data with data from other commercial vendors, assuming appropriate access controls are in place?

xi. Would your organization expect to have a role in the governance or oversight of the Data Platform? If so, what do you envision that role to be?

xii. FDA seeks availability of near real-time data with ready access to analysts to address FDA needs and with costs that are not anchored in number of studies completed or similar caps. Describe your cost structure (ROM) inclusive of access fees, data extraction needs, potential data license agreements, data cleaning/preprocessing cost break down, etc. Discuss if any data volume considerations apply.

b. FDA seeks data from specialty EHRs, registries and health information exchanges as described above.

i. Do you see any unique challenges with bringing specialty EHR or registry data into the data platform on an as needed, “just-in-time" basis?

ii. Do you envision any specific concerns with linking specialty EHR or registry data with other data types (e.g., claims) in the data platform?

iii. How would health information exchange data be brought into the data platform?

c. Are there models or previous government initiatives you believe could serve as helpful references?

Business Information:

Responders to this RFI may include commercial or not-for-profit organizations and may consider teaming arrangements/partnerships or joint ventures.

Please provide the following Business information:

a. DUNS Number

b. Company Name

c. Company Address

d. Company Point of Contact, phone number and email address

e. Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at https://www.sam.gov/ or https://www.sam.gov/entity-registration

RFI Submission Instructions

Responses shall be submitted to Howard Yablon, Contract Specialist, via email at howard.yablon@fda.hhs.gov, and to Ian Weiss, Contracting Officer, at ian.weiss@fda.hhs.gov. Please include the RFI number in the response. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested companies must submit responses to the questions limited to 15 pages, not including appendices. Other than the cover letter, the response document(s) shall have no watermarks, no header or footer notations, etc. identifying the organization. General Capabilities Statements will not be accepted.

Responses will not be returned and will not be accepted after the due date.

Note that FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems.

• RFI number: FDARFI5302025

• RFI release date: 05/30/2025]

• RFI response date: [06/11/2025]by 3:00 pm EST

• Point of Contract email: howard.yablon@fda.hhs.gov; email and attachments cannot be larger than 10MB

• Hardcopy address: DHHS/FDA/OAGS/DAO

• Contractors shall submit all electronic documents using the Microsoft Office Suite products without the use of “macros”. When submitting documents via email, DO NOT include any executable file types (e.g., .exe,. mso) that have the potential to trigger email security protections (i.e., email blocks, quarantine). If the contractor submits documents that contain macros, macro reference files, and/or executable files, the Government will not be able to view or open such documents.

FDA will not award a contract based on responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Information obtained because of this notice may be used by the FDA for program planning on a non-attribution basis.

Eligibility for participating in a future acquisition does not depend upon a response to this notice.

Responses will be reviewed only by FDA personnel and will be held in a confidential manner.

https://www.sam.gov/ mailto:howard.yablon@fda.hhs.gov mailto:ian.weiss@fda.hhs.gov mailto:howard.yablon@fda.hhs.gov