Notice of Intent to Sole Source – Werfen USA, LLC

SOL #: NOI-CC-26-000442Special NoticeSole Source

Overview

Buyer

Health And Human Services
National Institutes Of Health
NATIONAL INSTITUTES OF HEALTH - CC
BETHESDA, MD, 20892, United States

Place of Performance

Bethesda, MD

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

Medical And Surgical Instruments, Equipment, And Supplies (6515)

Set Aside

No set aside specified

Timeline

1
Posted
Dec 16, 2025

Qualification Details

Fit reasons
  • NAICS alignment with historical contract wins in similar service areas.
  • Scope strongly matches core technical capabilities and delivery model.
Risks
  • Past performance thresholds may require one additional teaming partner.
  • Potential clarification needed on staffing minimums before bid/no-bid.
Next steps

Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.

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.

People

Points of Contact

Chris Ryssa NixPRIMARY

Files

Files

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Special Notice
Posted: Dec 16, 2025
Notice of Intent to Sole Source – Werfen USA, LLC | GovScope