RFQ-HFP-2025-130317- Purchase of BioMerieux Service Agreement

In support of Project No: HFP-2025-130317

The U.S. Food and Drug Administration, Office of Acquisitions and Grants Services, Facilities Support Branch intends to award a firm fixed price purchase order to bioMerieux Inc., 1201 Normandy Place, Philadelphia, PA 19112 for the purchase of a bioMerieux Service Agreement for the Office of Applied Microbiology and Technology (OAMT) in College Park. This acquisition is to enable the continued functionality of the bioMérieux instrument, VITEK MS Plus, that is currently installed at OAMT. OAMT’s service contract, which is called a “Business Full Service”, is requested for the VITEK MS Plus.

BioMerieux Inc. is the manufacture and only source able to distribute the corresponding service agreement that will be used to continue functionality of the bioMérieux instrument, Vitek MS Plus, which is currently installed at FDA/OAMT in College Park. As the original equipment manufacturer (OEM) and authorized service provider, bioMérieux is the only source with direct access to equipment, propriety software, as well as certified and trained technicians to provide warranty service and technical support. Additionally, bioMérieux does not offer the required item through any distributors and only provides for direct sales.

This procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows for the Contracting Officer to solicit one source if only one source is reasonably available. The North American Industry Classification System Code (NAICS) is 811210- Electronic and Precision Equipment Repair and Maintenance. The Product Service Code (PSC), J066 – Maintenance, Repair, and Rebuilding of Equipment-Instruments and Laboratory Equipment.

This notice is being distributed solely System for Awards Management website (www.SAM.gov). As bioMérieux Inc. is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contracting Officer, Brandon Rafus, at brandon.rafus@fda.hhs.gov no later than 4:00 PM EST on September 15, 2025. The primary objective of this Notice of Intent is to inform potential contractors of the government's intent to proceed with a sole source procurement while providing an opportunity for other parties to demonstrate comparable capabilities. Although this is not a competitive solicitation and no formal solicitation document exists, interested parties may submit capability statements demonstrating their ability by the September 15, 2025 deadline. All capability statements must be submitted electronically via email to brandon.rafus@fda.hhs.gov in Microsoft Office Word, Excel, or Adobe PDF format. The government will consider all capability statements received by the closing date, though the final determination whether to compete the requirement remains at the government's sole discretion. This notice represents a standard pre-award transparency measure that allows the marketplace to respond before a sole source award is finalized.

Lastly, please note this requirement has not received final approval by HHS/FDA leadership for award. Accordingly, the Government may or may not proceed with an award under this solicitation.

All responses must include the following business information:

a.Unique Entity Identification (UEI) Number

b.Company Name, address, primary point of contact and their email and phone number

c.Type of company as validated in SAM.gov. All interested parties must be registered in

SAM.gov to receive consideration of government contracts. d. Technical capability to supply, install, and technically support one (1) bioMérieux Business Full-Service agreement as detailed in the attached Statement of Work (SOW).