NTELX Perpetual License, Software Maintenance & Support
ID: FDA-RFI-11-01-2024Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF REGULATORY AFFAIRSSilver Spring, MD, 20993, USA

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/984ebd487b884a6b8c28af1239e60dec/view
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is seeking small business sources to provide a perpetual license, maintenance, and support for NTELX software, specifically for the Office of Regulatory Affairs (ORA). This procurement aims to ensure continuous operational support for mission-critical applications used by ORA staff, which are vital for optimizing import inspections and public health compliance under the Bioterrorism Act of 2002. The NTELX software, including key modules such as PREDICT, FDanalyzer, FDfusion, FDmonitor, and FDauditor, processes approximately 50 million lines of import data annually, making it essential for risk assessment and compliance targeting. Interested small businesses must submit their capability statements by November 14, 2024, and can contact Robert Waite at robert.waite@fda.hhs.gov for further information.

    Point(s) of Contact
    Robert Waite
    robert.waite@fda.hhs.gov
    Files
    Title
    Posted
    SSNT.pdf
    The U.S. Food and Drug Administration (FDA) is conducting market research to identify small business sources capable of providing NTELX software licensing, maintenance, and support for the Office of Regulatory Affairs (ORA). The FDA's mission includes optimizing import inspections and ensuring public health, particularly under the Bioterrorism Act of 2002. The NTELX software, specifically the PREDICT application, is essential for risk assessment and compliance targeting of import entries, processing approximately 50 million lines annually. Key modules include FDanalyzer for data analysis, FDfusion for execution of rules, FDmonitor for business process oversight, and FDauditor for audit tracking. The FDA seeks technical support that includes Level 1 assistance, timely software updates, and potential future upgrades to ensure operational continuity. Interested small businesses are encouraged to respond with capability statements detailing their qualifications and previous experiences. Responses are due by November 14, 2024. This notice, while not a solicitation, aims to inform the FDA's upcoming contracting decisions and does not obligate the government to award any contracts. Confidentiality of proprietary information is emphasized throughout the communication.
    Lifecycle
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    Type
    NTELX Perpetual License, Software Maintenance & Support
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