Notice of Intent to Limiting sources for Preventative Maintenance and Qualification Service) for Thermo Q-Exactive Mass Spectrometer

Food and Drug Administration (FDA)

Notice of Intent to Limiting sources

Subject: System Service (Preventative Maintenance and Qualification Service) for Thermo Q-Exactive Mass Spectrometer System.

Notice of Intent to Limiting sources to: Thermo Electron North America LLC.

Pursuant to the authority of Federal Acquisition Regulation (FAR) Subpart 8.405-6 (a)(i)(1)(B), (only one source is capable of providing the supplies required at the level of quality required because the supplies are highly specialized), the Food and Drug Administration (FDA) intends to award a delivery order to Thermo Electron North America LLC.

Thermo Electron North America LLC

1400 Northpoint Pkwy Ste 50

West Palm Beach, FL 33407-197676

FDA has a requirement to obtain Preventative Maintenance and Qualification Service) for Thermo Q-Exactive Mass Spectrometer System.

Thermo Electron North America LLC, which operates under Unity Laboratory Services is the sole-source􀀁 provider for maintenance and repair on the current system, Thermo Q-Exactive Mass Spectrometer System. Thermo Electron North America LLC is also the only provider that can provide validated OEM parts necessary for replacement or repair on the system.  There are no authorized third-party providers to support this procurement action. Thermo Electron North America LLC is the OEM, maintains OEM parts, and has the trained technicians to perform repairs, maintenance, and qualifications to ensure ISO/IEC 17025 accreditation. Thermo Electron North America LLC does not train other technicians outside the company to perform OEM services, there are no authorized third-party providers.

The NAICS Code for this procurement is: 541990.  - All Other Professional, Scientific, and Technical Services.

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 Thermo Electron North America LLC within approximately fifteen (15) days after the closing date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 3:00 p.m. EST 09/10/2024. Please email responses to Elena Tatarov at Elena.Tatarov@fda.hhs.gov.