Preventive Maintenance and Repair for Thermo Orbitrap Exploris MS Instrument

This is a Sources Sought Notice (SSN) - a market survey designed to collect written information only.

This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. There is no RFQ, or other iteration of a solicitation associated with this Notice, and no telephone calls will be accepted requesting an RFQ package or solicitation. To protect the procurement integrity of any future acquisition that may arise from this announcement, information regarding a government technical

point of contact will not be given and no appointments for presentations will be made. The U.S. Food and Drug Administration (FDA), (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR), Division of Systems Biology (DSB), to determine the presence of small business sources capable providing a preventive maintenance-repair (PM/R) service agreement for a Thermo Scientific Orbitrap Exploris MS system, S/N: MM10285C, to include the following: Vanquish Split Sampler FT, S/N: 8330951; Vanquish Binary Pump, S/N: 8330828. The Division of Systems Biology (DSB) operates within the U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) to address mission-critical regulatory research needs, knowledge gaps, and emerging health threats using systems-biology approaches and innovative technologies in several areas. To conduct its research DSB relies heavily on the Thermo Scientific Orbitrap Exploris MS system described herein and is continuously employed for lipidomics and metabolomics analysis in the Center for Metabolomics also located at NCTR. With such a heavy workload, it’s critical that this system always operate optimally, so a PM/R agreement is essential to its continuing performance. This requirement is for a base year and 2 option periods of service. The system is currently covered through 8/27/2026. If your firm is considered a small business source under North American Industry System (NAICS) 811210 – Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $34 Million, and you believe that your firm would be able to provide the FDA with the service described below, please submit an email containing capability statement(s) to [email protected]. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all the following minimum performance

requirements. Minimum Technical

Requirements are as follows for preventive maintenance service for a Thermo Scientific Orbitrap Exploris MS system, S/N: MM10285C, to include a Vanquish Split Sampler FT, S/N: 8330951; and Vanquish Binary Pump, S/N: 8330828: One (1) planned on-site preventive maintenance visit for routine certification and/or calibration per contract year (standard PM kit included); Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Eastern Time; 10% discount on rates for engineer labor, travel, and factory-certified replacement parts for on-demand on-site corrective maintenance visits with a targeted response time of 5 business days; Priority status for technical support inquiries with a targeted immediate response time; shall include remote diagnosis and corrective maintenance procedures with latest digital remote support tools; Direct Access by the FDA Technical Representative (TR) and/or system operator personnel to the manufacturer’s call center (Unity Lab Services Online Knowledge Base) for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument; Software and firmware updates as required by the Original Equipment Manufacturer (OEM) either remotely or in conjunction with a scheduled preventive maintenance or corrective maintenance visit (updates are defined as changes of the existing software version that are intended to improve its performance); All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.; All preventive maintenance and/or repair service

pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventive maintenance visit, provide the end-user of the equipment and the