Closed Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES

    NOTICE OF INTENT TO SOLE SOURCE – WERFEN USA, LLC

    Sol. NOI-CC-26-000442Special NoticeBETHESDA, MD
    Closed
    STATUS
    Closed
    POSTED
    Dec 16, 2025
    Publication date
    NAICS CODE
    325413
    Primary industry classification
    PSC CODE
    6515
    Product & service classification

    AI Summary

    The Department of Health and Human Services intends to award a sole source contract to Werfen USA, LLC for kits and reagents used in patient care testing. These supplies are specifically validated for use in ACL TOP 350 and 750 analyzers. This acquisition will follow FAR Part 13 Simplified Acquisition Procedures, allowing for a streamlined procurement process.

    Contract details

    Solicitation No.
    NOI-CC-26-000442
    Notice Type
    Special Notice
    Posted Date
    December 16, 2025
    Response Deadline
    NAICS Code
    325413AI guide
    PSC / Class Code
    6515
    Primary Contact
    Chris Ryssa Nix
    State
    MD
    ZIP Code
    20892
    AI Product/Service
    product

    Description

    This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

    This procurement is for one base year plus two option years contract to obtain kits and reagents used in patient care testing. These are the only supplies that are validated for use in the ACL TOP 350 and 750 analyzers we own. These reagents are specific for the existing instruments, and are the only ones that can meet the needs of this patient care testing.

    Werfen USA, LLC is the only supplier to fit the instrumentation validation and requirements.

    This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 –Simplified Acquisition Procedures, Subpart 13.5(a) This subpart authorizes the use of simplified procedures for the acquisition of supplies and services in amounts greater than the simplified acquisition threshold but not exceeding $9 million ($15 million for acquisitions as described in 13.500(c)), including options, if the contracting officer reasonably expects, based on the nature of the supplies or services sought, and on market research, that offers will include only commercial products or commercial services. Contracting officers may use any simplified acquisition procedure in this part, subject to any specific dollar limitation applicable to the particular procedure. The purpose of these simplified procedures is to vest contracting officers with additional procedural discretion and flexibility, so that commercial acquisitions in this dollar range may be solicited, offered, evaluated, and awarded in a simplified manner that maximizes efficiency and economy and minimizes burden and administrative costs for both the Government and industry. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

    Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Ryssa Nix, Contract Specialist via email to Ryssa.nix@nih.gov by close date.

    Key dates

    1. December 16, 2025Posted Date

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    Frequently asked questions

    NOTICE OF INTENT TO SOLE SOURCE – WERFEN USA, LLC is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.

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