Notice of Intent to Sole Source – Werfen USA, LLC

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Maryland
Type of Government: Federal
FSC Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
NAICS Category:
  • 325413 - In-Vitro Diagnostic Substance Manufacturing
Posted Date: Dec 16, 2025
Due Date:
Solicitation No: NOI-CC-26-000442
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Description

Follow
Notice of Intent to Sole Source – Werfen USA, LLC
Active
Contract Opportunity
Notice ID
NOI-CC-26-000442
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH - CC
General Information
  • Contract Opportunity Type: Special Notice (Original)
  • Original Published Date: Dec 16, 2025 11:17 am EST
  • Original Response Date:
  • Inactive Policy: Manual
  • Original Inactive Date: Jan 15, 2026
  • Initiative:
Classification
  • Original Set Aside:
  • Product Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES
  • NAICS Code:
    • 325413 - In-Vitro Diagnostic Substance Manufacturing
  • Place of Performance:
    Bethesda , MD 20892
    USA
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.


Attachments/Links
Contact Information
Contracting Office Address
  • 6707 DEMOCRACY BLVD, SUITE 106
  • BETHESDA , MD 20892
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Dec 16, 2025 11:17 am ESTSpecial Notice (Original)
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