Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of an Automated Upright Microscope as a Sole Source acquisition to Nikon Instruments Inc., under Request for Quote FDA-

RFQ-CFSAN-2022-112859.

Notice of Intent to Sole Source to: Nikon Instruments Inc.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source, and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Purchase Order Type to Nikon Instruments Inc., located at:

1300 Walt Whitman Road, Melville, NY 11747-3064 Tel: (631) 547-8500 Fax: (631) 944-9370 www.nikoninstruments.com

ATTN: Laura Kelehan 240.401.3383 Laura.Kelehan@nikon.com

Nikon Instruments Inc., is the exclusive provider of the requested instrument. The FDA-CFSAN laboratory currently uses a Nikon Ni-U manual microscope for imaging fluorescence, phase contrast and Brightfield slides. FDA’s needs have evolved to the automate image acquisition including the tiling of large images with the use of an encoded motorized stage, automated z-focus and the automation of multichannel fluorescence. It is imperative that this new microscope, the automated Nikon Ni-E, be compatible with the old Ni-U system for continuity of imaging, analysis and the compatibility of all components. In a letter to FDA, Nikon Instruments Inc., the requested research-grade Nikon NiE Upright Motorized Microscope, as well as other research products, are sold and supported exclusively by Nikon Instruments, Inc., in the Maryland area. Nikon Instruments, Inc., does not offer these products for research institutions in this area through dealers, distributors or resellers. This support includes on-site installation and training services as well as long-term technical support at no additional charge.

Nikon Instruments Inc., certifies, that it is the only supplier of the requested instruments and that all instruments and related instrument/service bundles are solely distributed by the manufacturer, with no thirty party re-sellers.

http://www.nikoninstruments.com/ mailto:Laura.Kelehan@nikon.com

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Nikon Instruments, Inc., within approximately fifteen

(15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 05/27/2022. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov