The US Department of Health and Human Services, Food and Drug Administration has a continuing requirement for a contractor to support the Sentinel Initiative.

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 Indefinite Delivery/Indefinite Quantity (IDIQ) contract with the focus to achieve the 2019 Sentinel FiveYear Strategy

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 Systemcontract 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

• Task Area 1:  Program and Project Management Support Services: Provide program and project management support services to the FDA Sentinel System 3.0 program including interactions between the FDA Sentinel Program Team and multiple contractors under a proposed Multiple Award IDIQ, Tiered contract (SAM.gov). Provide end-to-end program and regulatory operations support including:
  • Providing skilled and experienced project management support for scientific research (e.g., routine safety surveillance, emerging safety issues, and public health emergencies) and methods development projects
  • Development of a communication plan to support collaborations between Sentinel System 3.0 program staff, FDA staff, multiple contractors, and other key stakeholders
  • Maintaining operational and workload information trackers that would support rapid and efficient response to information requests and comply with FDA Records Management requirements
  • Meeting coordination (e.g., governance, leadership, internal and external meetings with Sentinel Stakeholders).
  • Systematic collection, analyses and reporting of program performance metrics
  • Preparation of meeting agenda, slides, documentation of minutes, tracking action items, archiving meeting documentation and materials
  • Triaging and facilitating responses to routine and ad hoc information requests
  • Providing project management support in planning for the Sentinel Annual Public Workshop, and FDA training, and clearance of various documents and slides generated for the program.
  • Identifying areas for program management improvement
  • Assistance with the planning and execution of tasks and projects
  • Provide detailed transition-in services from the incumbent contractor; and transition-in services for new contractors under the proposed Sentinel System 3.0 to ensure program continuity and the minimal reduction or degradation in services
• Task Area 2: Business Informatics Support Services
  • Implement, operate, and maintain a secure information exchange portal to allow secure data exchange between FDA and other contractors in the Sentinel System 3.0 program ecosystem. Implement and maintain workflow and document management systems compliant with FDA records management requirements and Federal Information Security Management Act (FISMA)
  • Provide subject matter expertise in business informatics systems support, including support of Multi-Factor Authentication (MFA) access to the exchange portal in compliance with FDA cybersecurity requirements
• Task Area 3: Website Management
  • Development and operations/maintenance of the Sentinel Initiative website to support FDA’s commitment to transparency. Manage website content provided by FDA Sentinel System 3.0 program staff and its contractors including analytic packages, study results, resources, upcoming events and other program documents or activities. Provide support in coordinating time sensitive posting for associated documents during sponsor notification, advisory committees, and public conferences. Maintain an environment compliant with Section 508.