Sentinel Initiative: Request for Information Purpose The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) requests public comments to inform the future organization of the Sentinel System. FDA seeks information that will assist in the exploration of alternative approaches to meet FDA’s legal requirements and fulfill its public health mission by adding value to the Sentinel System. Specifically, FDA is interested in organizational capabilities that will support the development of an efficient and economical product safety surveillance system that is not limited to the use of a common data model and a distributed data partners network and instead leverages multiple technical approaches. The following factors are particularly pertinent to this Request for Information (RFI): 1) the technical capability to provide administrative healthcare claims data with established linkages to electronic health record (EHR) data with the rigor to address regulatory questions, and 2) fully developed advanced analytic capabilities. FDA further seeks information on capabilities to offer flexible, iterative collaboration with FDA scientists in designing studies to address safety questions, to optimize speed from the time of identifying a potential safety concern to generating actionable study results available for FDA consideration, and to promote efficient use of resources. This RFI offers the public (e.g., healthcare research organizations, pharmaceutical industry, and academic medical centers) the opportunity to share with FDA important information regarding technical and organizational capabilities available in the marketplace to inform the development of future contract(s) to support activities related to FDA’s Sentinel System. The RFI process will consist of a 45-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. Background Contractual Arrangement In 2007, Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) which called for the development of an Active Postmarket Risk Identification and Analysis (ARIA) system using linked data from public and private sources. FDAAA set goals that FDA’s new safety monitoring system must be able to access data from 25 million patients by July 2010 and 100 million patients by July 2012. 1 FDA established the Sentinel Initiative in 2008, met the FDAAA goal for access to patients’ electronic healthcare data on schedule in 2010 and 2012, completed the Mini-Sentinel Pilot in 2014, and officially announced the activation of the Sentinel System in 2016. In 2019, FDA established a multiple award 1 (Section 905(a) (3) (B) (i) – (ii) (II)). Indefinite Delivery/Indefinite Quantity (IDIQ) contract with the focus to achieve the 2019 Sentinel FiveYear Strategy 2 . FDA accomplished this via three major contract vehicles: • • • HHSF223200910006I, Mini-Sentinel Pilot IDIQ contract, 2009 to 2014 HHSF223201400030I, Sentinel IDIQ contract award, 2015 to 2019 75F40119D10037 and 75F40119D10038, Sentinel multiple award IDIQ contract, 2019 to 2024 To continue to meet the congressional mandate in FDAAA and maintain ongoing operations of the Sentinel System, FDA plans to award a fourth five-year Sentinel System contract by September 2024. See the Sentinel Initiative website to learn more about the current Sentinel System and the Assessment Report in Support of the Sentinel System. 3,4 Information Requested FDA seeks information to help shape the next solicitation or Request for Proposal (RFP) for the Sentinel System. The goal of the next Sentinel contract(s) will be to continue meeting or exceeding the legislative requirements, promote efficiency and support the anticipated needs of each of the distinctive underlying Sentinel components (e.g., Active Postmarket Risk Identification and Analysis (ARIA) system 5 , FDA-Catalyst 6 ), and ensure sufficient flexibility to address emerging safety issues and rapidly changing public health needs (e.g., public health emergencies). Interested organizations are requested to respond to the following items: 1. How would your organization provide a Sentinel System comprised of disparate and complementary data resources that cover at a minimum 100 million U.S. patients across claims data and 10 million U.S. patients with medical claims and electronic health record (EHR) linked data? 7 A high proportion of claims-EHR linked data is preferred. • Completion of the Data Resource Information Table (Appendix A) in table format is requested when responding to this RFI. 2. How does your organization perform analyses using Centers for Medicare and Medicaid Services (CMS) data? 3. How does your organization obtain and analyze data with established mother-and-infant-linked records to facilitate evaluating potential adverse events in neonates and infants following drug exposure during pregnancy? 4. What is your organization’s capacity (e.g., number of epidemiologists, statisticians, data analysts) to conduct multiple concurrent studies that range in complexity from descriptive Sentinel 5-year Strategy: https://www.fda.gov/media/120333/download See Sentinel website for further details: https://www.sentinelinitiative.org/sentinel/about 4 Assessment Report in Support of the Sentinel System: https://www.fda.gov/media/161944/download 5 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 6 More information about FDA-Catalyst can be found at: https://www.sentinelinitiative.org/methods-data-tools/fda-catalyst-proje cts 7 The 21st Century Cures Act (Cures Act) was enacted in 2016 to accelerate medical product development and bring new innovations faster to patients who need them. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act 2 3 studies of drug utilization or assessing outcome background rates to inferential exposureoutcome studies with confounding control to help evaluate causality between medical products and adverse events? • What is your organization’s capacity to sustain a core collaborative team of investigators with statistical and epidemiologic expertise with the ability to expand resources in response to FDA’s regulatory and public health needs? 5. What is your organization’s approach for conducting safety signal identification using medical claims and EHR data to offer a robust system that can identify adverse events and potential drug safety signals? 6. How would your organization conduct protocol-based pharmacoepidemiology assessments? 8 7. How would your organization support FDA Catalyst6 projects that involve interactions with patients and/or providers? 8. How would your organization maintain the Sentinel Initiative public website, systems and contents hosted in a Federal Information Security Modernization Act (FISMA) and Section 508 compliant environment used for critical communications with industry and the public to meet transparency mandates associated with FDA policy objectives and user fee commitments? 9. How would your organization maintain a business informatics environment to support program operations and scientific workflow tracking and reporting and comply with FDA’s records management requirements? Business Information: Responders to this RFI may include commercial or not-for-profit organizations and consider teaming arrangements/partnerships or joint ventures. Please provide the following Business information: a. DUNS Number and Unique Entity Identification 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 http://www.sam.gov/index.asp. 8 Typically, an investigation designed by a study team that adheres to the specifications of a study protocol that includes the study design, objectives, methodology and overall organization to be carried out. RFI Submission Instructions Responses shall be submitted to Howard Yablon, Contract Specialist, via email at howard.yablon@fda.hhs.gov, and to Ian Weiss 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. Appendix A provides a Data Resource Information Table that interested parties are requested to complete when responding to this RFI. 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: FDARFI10282022 RFI release date: November 01, 2022 RFI response date: December 12, 2022, by 2:00 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 in 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.
