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
    Title
    Type
    NTELX Perpetual License, Software Maintenance & Support
    Currently viewing
    Sources Sought
    Similar Opportunities
    FY25 CTP Docker Desktop Software Licenses
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking quotes for the procurement of 99 Docker Desktop software licenses for its Center for Tobacco Products (CTP). This requirement is part of a firm-fixed-price contract, which will commence on January 15, 2025, and run through January 14, 2026, with options for two additional one-year extensions. The software licenses are essential for enhancing operational efficiency within the CTP, and vendors must comply with Federal Acquisition Regulation (FAR) guidelines, including accessibility standards under Section 508 of the Rehabilitation Act. Interested vendors should submit their quotes by January 13, 2025, and can direct inquiries to Terina Hicks at terina.hicks@fda.hhs.gov or Roosevelt Walker at roosevelt.walker@fda.hhs.gov.
    FDA Regulated Products Sampling Services
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking qualified vendors to provide Sampling Services for FDA-regulated products through a Sources Sought Notice (Ref No. 75F40125R00032). The primary objective of this procurement is to identify capable businesses that can collect physical samples of food, drugs, medical devices, and other products for laboratory analysis, ensuring safety and verifying labeling accuracy. This initiative is crucial for the FDA's regulatory oversight, as it supports the monitoring of product safety and quality, which may include both domestic and imported goods. Interested parties must submit their responses by January 9, 2025, and can contact Amanda Lusk at Amanda.Lusk@fda.hhs.gov or Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov for further information.
    Food Applications Regulatory Management (FARM) System
    Active
    Health And Human Services, Department Of
    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking information from small businesses capable of providing information technology support services for the Food Applications Regulatory Management (FARM) System as part of its Human Foods Program (HFP). The objective of this Request for Information (RFI) is to identify potential vendors who can enhance ongoing operations, maintenance, and development of various IT systems, ensuring improved workflows, data quality, and comprehensive management of IT operations related to food safety and nutrition. Interested parties are encouraged to submit detailed capability statements that address their relevant experience and solutions by January 13, 2025, and must be appropriately registered to qualify for consideration. For further inquiries, vendors can contact Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov or by phone at 301-796-7376.
    Access to Outpatient Longitudinal Drug Utilization Data
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide access to outpatient longitudinal drug utilization data through a Sources Sought notice. The primary objective is to acquire existing, HIPAA-compliant data resources that will enhance drug safety evaluations, support post-market surveillance, and inform regulatory decisions, rather than developing new databases. This initiative is crucial for monitoring medication utilization trends, particularly in areas such as opioid surveillance, and aims to improve public health outcomes through rigorous analyses of drug safety data. Interested firms must submit their responses by January 23, 2025, including their business size status and DUNS number, and can direct inquiries to Telisha Wilson at telisha.wilson@fda.hhs.gov.
    Safe Medication Use
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is conducting a Request for Information (RFI) to identify potential sources capable of providing medication error reports, an analytics platform, and related services aimed at preventing and analyzing medication errors. This initiative, led by the FDA's Center for Drug Evaluation and Research, seeks organizations that can supply nationwide data from healthcare providers, consumers, and patient safety organizations, emphasizing the importance of robust reporting, data analysis, and training in enhancing medication safety protocols. Interested parties, particularly small businesses, are encouraged to submit their capability statements by January 6th, 2025, and should note that responses are voluntary and do not imply a commitment for a contract. For further inquiries, contact Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov or call 301-796-7376.
    Annual Maintenance and Support (Hardware, Software, & Licenses)
    Active
    Justice, Department Of
    The Department of Justice, specifically the Drug Enforcement Administration (DEA), is planning a sole source procurement for annual maintenance and support of hardware, software, and licenses from Pen-Link Limited. This procurement is essential for ensuring the continued functionality and compliance of the DEA's communication equipment, which falls under the NAICS code 334290. Interested vendors are invited to submit capability statements by January 13, 2025, at 10:00 AM EST, although the DEA retains discretion over whether to seek additional competition. Submissions should be directed electronically to Robert A. Jones at robert.a.jonesjr@usdoj.gov.
    MRC Biosafety Cabinet Evaluation
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking qualified small businesses to provide engineering evaluation services for biological safety cabinets (BSCs) at its Center for Veterinary Medicine. The primary objective of this procurement is to assess existing BSCs that are failing to meet certification standards, particularly focusing on their associated HVAC and control systems, and to provide recommendations for replacements. This evaluation is crucial for maintaining laboratory safety and operational efficiency, ensuring compliance with federal safety standards. Interested parties must attend a mandatory site visit on December 17, 2024, and submit their quotations by January 8, 2025, to the contracting officer, Sheneil Green, at Sheneil.Green@fda.hhs.gov.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting proposals through the FY25 Broad Agency Announcement (BAA) aimed at advancing regulatory science and innovation. This opportunity invites organizations, particularly small businesses, to submit research and development proposals that address critical areas such as alternative drug development methods, advanced manufacturing technologies, and predictive toxicology, with a strong emphasis on including diverse populations in research. Proposals must be submitted by February 24, 2025, and will undergo a two-tier evaluation process, with the potential for multiple contracts awarded based on proposal quality and funding availability. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    NIH-NIAID docuBridge Upgrade
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), intends to award a sole source contract for the upgrade of the LORENZ docuBridge system from version 21.1 to version 24.2. This upgrade is crucial for maintaining regulatory compliance, adhering to industry standards, and minimizing security vulnerabilities associated with the NIAID Electronic Common Technical Document (eCTD) system, which was initially implemented using commercial off-the-shelf software from LORENZ International, LLC. The contract will include services such as system configuration, role-based training for staff, and maintaining compliance with 21 CFR Part 11 regulations, with an estimated performance period from January 20, 2025, to September 29, 2025. Interested vendors may submit their capabilities statements to Tamara McDermott at tamara.mcdermott@nih.gov within 18 days of this notice, although the government plans to proceed with a sole source award within 25 days.
    Solicitation: Tobacco Retailer Inspections - 75F40125R00018
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is soliciting proposals for an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to conduct tobacco retailer inspections across multiple regions in the United States. The primary objective of this procurement is to ensure compliance with federal laws regarding the sale and advertising of tobacco products, particularly focusing on preventing youth access to these products. This initiative is critical for enhancing the FDA's enforcement capabilities and protecting public health by reducing tobacco use among minors. Interested contractors should contact Janice Heard at janice.heard@fda.hhs.gov or Brandon Rafus at brandon.rafus@fda.hhs.gov for further details, with the contract period spanning five years and specific funding amounts to be determined for each region.