Cytiva Xcellerex XDUO 100 J Jacketed Mixer and Accessories

NOTICE OF INTENT TO SOLE SOURCE In support of Project No: CDER-2024-123844 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 Global Life Sciences (Global Life Sciences) Solutions USA LLC, Marlborough, MA 01752-3078 for a Cytiva Xcellerex XDUO 100 L Jacketed Mixer (XDUO 100) and accessories for the Center for Drug Evaluation and Research (CDER) and the Office of Pharmaceutical Quality Research (OPQR).

Global Life Sciences is the manufacturer and only source able to distribute the XDUO 100. As the original equipment manufacturer (OEM) and authorized service provider, Cytiva is the only source with direct access to the equipment, propriety software, as well as certified and trained technicians to provide warranty service and technical support. Global Life Sciences 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 Classification System Code is 334516, Analytical Laboratory Instrument Manufacturing, and Product Service Code is 6640 – Laboratory Equipment and Supplies. This notice is being distributed solely via the System for Award Management website (www.SAM.gov).

As Global Life Sciences 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 capability in relation to this procurement electronically to the Contract Specialist, Iris Johnson, at Iris.Johnson1@fda.hhs.gov no later than 12:00 AM EST on August 27, 2024. Responses sent utilizing other means will not be considered. Information received will be used solely to determine whether to conduct a competitive procurement.

A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government. 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 (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.) 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) Cytiva Xcellerex XDUO 100 L Jacketed Mixer and accessories as detailed in the attached Statement of Work