Agency: | HEALTH AND HUMAN SERVICES, DEPARTMENT OF |
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State: | Maryland |
Type of Government: | Federal |
FSC Category: |
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NAICS Category: |
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Posted Date: | Mar 27, 2024 |
Due Date: | Apr 5, 2024 |
Solicitation No: | FDARFI03252024 |
Bid Source: | Please Login to View Page |
Contact information: | Please Login to View Page |
Bid Documents: | Please Login to View Page |
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Amendment 01- Removed Appendix A refrences for submission.
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:
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:
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:
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:
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. Interested companies must submit responses to the questions limited to 15 pages.. 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.
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.
Mar 25, 2024 | [Sources Sought (Original)] Request for Information Sentinel System 3.0: Program Management & Business Informatics Support |
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