The Centers for Disease Control and Prevention (CDC), National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCZVED)/Division of Foodborne, Bacterial and Mycotic Diseases (DFBMD) intends to procure items for the performance evaluation of botulinum toxin gene real-time PCR on the Lightcycler 480 platform on a sole source basis from Roche Diagnostics Corporation, Indianapolis, Indiana 46256. The North American Industry Classification System (NAICS) code for this requirement is 334516, Analytical Laboratory Instrument Manufacturing, and the Small Business Standard Size is 500 employees.

The Government intends to procure from only one source under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The Botulism Public Health Research Unit is validating a multiplex real-time PCR assay for the detection and identification of botulinum toxin genes A through G. The assay is designed to use the Roche Lightcycler platform. No other vendor offers the Lightcycler 480 system or the Lightcycler reagents required.

This is not a request for competitive proposals, nor is a solicitation available. Any firm that believes it can furnish the items described above is encouraged to give written notification to the Contracting Officer within 15 days of the date of this synopsis. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed action, based on responses to this notice, is solely within the discretion of the Government.