Intent to Sole Source FDA_NCTR-2025-126233_75F40125Q00026.pdf

Preventive Maintenance Agreement for a Nikon Inverted Confocal Microscope Nikon Instruments Inc Intent to Sole Source

FDA_NCTR-2025-126233_75F40125Q00026

Date Posted: November 4, 2024 Response Date: November 18, 2024, 12:00 PM CST

Classification Code: J066 – Maint/Repair/Rebuild Of Equipment- Instruments

And Laboratory Equipment

NAICS Code: 811210 – Other Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $30 Million

The U.S. Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR) intends to award a sole source, firm fixed price purchase order to Nikon Instruments Inc, 1300 Walt Whitman Road, Melville, NY 11747-3064, under the authority of FAR 13.106-1(b)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The FDA/NCTR has a requirement for a Preventive Maintenance Agreement for a Nikon Inverted Confocal Microscope (Serial Number: 542932) with 2 (1-year Maintenance Option periods). The Division of Neurotoxicology purchased a Nikon Inverted Confocal Microscope in 2020 for live-cell and fixed-tissue imaging. The microscope is receiving regular use and live-cell imaging for functional assays is a developing area within the division. To enhance the live-cell capabilities of the microscope imaging over long periods of time, and increase throughput of imaging, the system needs a Service Agreement to maintain optimal capability, better resolution and image analysis, leading to improved and reliable microscopy results. The microscope is currently covered by a one-year preventative maintenance service agreement that will expire on 12/31/2024.

Nikon Instruments Inc is the sole source authorized service provider for Nikon Confocal and Super Resolution systems using highly skilled and factory trained personnel. This system involves proprietary components and must be fully compatible with the existing system. Due to the highly specialized nature of this instrument and in an effort to not invalidate existing warranties or service coverage on the microscope, the Preventive Maintenance service can only be performed by the original equipment manufacturer, Nikon Instruments Inc.

This service is critical for maintaining optimal capability, better resolution and image analysis, leading to improved and reliable microscopy results. This vendor is the only company that can provide the Preventive Maintenance service and support for this product. The service is offered exclusively by Nikon Instruments Inc. There are no substitutes available.

Competing this requirement would result in significant detrimental delays in fulfilling the agency’s requirement. In an effort to maintain continuity and consistency, FDA/NCTR will purchase the Preventive Maintenance Service from Nikon Instruments Inc. Attempting to introduce another vendor at this time could impact the entire research program within the Division of Neurotoxicology.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1).

This notice of intent is not a request for competitive proposals. Interested parties that believes it can meet the requirement, may submit a capability statement to Mrs. Yolanda Rankin at yolanda.rankin@fda.hhs.gov before November 18, 2024, at 12:00 pm Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to Nikon Instruments Inc.

mailto:yolanda.rankin@fda.hhs.gov