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Notice of Intent to Sole Source – Werfen USA, LLC

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NOI-CC-26-000442Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The National Institutes of Health (NIH) Clinical Center intends to enter into a sole source, firm-fixed-price contract with Werfen USA, LLC for reagent kits specific to the ACL TOP 350 and 750 coagulation analyzers. This procurement covers a base year plus two one-year options, spanning from January 1, 2026, through December 31, 2028, with an estimated total value of $570,000. Werfen USA, LLC is uniquely positioned as the sole supplier because their reagents are the only validated products compatible with the existing NIH instrumentation, a requirement critical to maintaining uninterrupted patient care testing and research capabilities. Due to this exclusive validation, competition requirements are waived under FAR 6.302-1, and acquisition is conducted under FAR Part 13 – Simplified Acquisition Procedures, allowing for streamlined procurement processes focused on efficiency and minimal administrative burden. The contract’s scope requires delivery of reagents and consumables that meet strict quality and compatibility standards, including a minimum one-year expiration date on key assays such as Protein C, Protein S, dRVVT, and Antithrombin III. Deliveries will be made to NIH’s Bethesda laboratory, where inspection and acceptance will occur. Despite the precise technical specifications and critical nature of the supplies, no formal evaluation factors or clause sets typical of competitive contracts are present, reflecting the sole source justification. Contract administration includes designated government representatives for oversight and technical liaison, while packaging and marking requirements align with maintaining reagent integrity and traceability without referencing military or federal packaging standards. Responses to the notice are due electronically by December 23, 2025, directed to the NIH Contract Specialist. Overall, this acquisition emphasizes uninterrupted clinical testing operations by securing a validated supply of essential reagents exclusively available from a single vendor.

General Info

NIH sole source contract with Werfen USA for ACL TOP reagent kits, $570K, 2026-2028.

Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

Blanket Purchase Order Statement of Work for ACL TOP 750 Reagents

sow

High

Justification for Other than Full and Open Competition for ACL TOP 750 Reagents

justification-and-authorization

High

NOI-CC-26-000442 Notice of Intent to Sole Source - Werfen USA, LLC

notice-of-intent

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PostedDec 16

special-notice

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Contacts1 person available

OfficeBETHESDA, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Office AddressBETHESDA, MD, 20892, USA

Contacts

Chris Ryssa Nix

contact@example.gov

Full 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 contact@example.gov by close date.