Request for Information Sentinel System 3.0: Program Management & Business Informatics Support

Request for Information Sentinel System 3.0: Program Management & Business Informatics Support 1.0 Purpose and Background This Request for Information (RFI) is being issued by the Food and Drug Administration (FDA) in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the FDA or its Centers. The goal of the Sentinel System 3.0 program is to continue meeting or exceeding the legislative requirements, promote efficiency and support the anticipated needs of each of the distinctive underlying requirement (e.g., Active Postmarket Risk Identification and Analysis (ARIA) system[1]), and ensure sufficient flexibility to address emerging safety issues and rapidly changing public health needs (e.g., public health emergencies). The Sentinel System 3.0 program will be a multi-vendor program and requiring comprehensive and

efficient coordination and integration of input and work products supported by a robust business informatics platform. The purpose of this RFI is to explore market capabilities to support Sentinel System 3.0 program management and business informatics requirements in the following areas: (1) Program and Project Management Services, (2) Business Informatics Support, (3) Website Management. Notice to Small Businesses: One purpose of this RFI/Sources Sought Notice is to seek declarations of technical capabilities and various information, data, and materials from qualified small business concerns [including 8A Businesses, Small Disadvantaged Businesses (SDB), Woman?owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, Veteran? Owned Small Businesses (VOSB), and Service?Disabled Veteran?owned Small Businesses (SDVOSB)]. FDA intends to provide maximum practicable opportunities in its acquisitions to small business, veteran?owned small business, service?disabled veteran?owned small business, HUBZone small business, and small disadvantaged business. Previous RFIs related to the Sentinel System 3.0 can be found at the following links: FDA CDER requests public comments to inform the future organization of the Sentinel System (SAM.gov) Proposed New Contracting Approach for Sentinel System 3.0 (SAM.gov) 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. Current Sentinel website:https://www.sentinelinitiative.org/sentinel/about 2.0 Information Requested In response to the input received through previous RFIs listed above, FDA seeks information to help shape the solicitation or Request for Proposal (RFP) for a stand-alone requirement that encompasses Program Management and Business Informatics capabilities to support the Sentinel System 3.0 program. Interested organizations are requested to respond to the following items: Describe your company’s relevant capabilities and experience performing functions similar to those described under Task Areas 1, 2, and 3 above. For example, has your company worked on projects that involved similar scope and that performed a similar function, or were of a similar scope and scale? Does your company have experience managing complex projects and engaging with multiple stakeholders? 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? 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? What would be the approximate cost of providing the services described under Tasks Areas 1, 2, and 3 above? 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: DUNS Number Company Name Company Address Company Point of Contact, phone number and email address 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. Please provide a cost estimate in accordance with FAR Part 10 or a copy of your commercial price catalog as market research. 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: FDARFI04252024 RFI release date: March 25, 2024 RFI response date: April 05, 2024, by 11:59 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.