NOSS.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a DBCMS23LEM11-Service Contract for Mass Spec & Chromatography Systems, Base Year plus three (3) option years of Preventative Maintenance Agreement (PMA), Sole Source, under Request for Quote FDA-RFQ- CDRH-2023-117752 ss.

Notice of Intent to Sole Source to: Thermo Electron North America LLC

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 Thermo Electron North America LLC., located at:

Thermo Electron North America LLC Attn: Jenifer Siegel, 1400 Northpoint Pkwy Ste 50 West Palm Beach, FL 33407-1976 Tel #: 513-338-3393 Jenifer.Siegel@thermofisher.com

FDA requires a Preventative Maintenance Agreement to cover the repair and maintenance of Mass Spec

& Chromatography Systems, Base Year plus three (3) option years of Preventative Maintenance

Agreement (PMA). This procurement request is for the purchase of an Annual Maintenance Service

Contract for 2 Thermo Fisher Scientific chemical analysis systems used by the Division of Biology, Chemistry and Materials Science (DBCMS) in the Office of Science and Engineering Laboratories

(OSEL), in the Center for Devices and Radiological Health (CDRH). The two systems are located at the

FDA Federal White Oak Research Campus located in Silver Spring Maryland 20993.

Scope

The two systems assist the CDRH in its mission by enabling research on improved methods in analytical methods which will reduce use of animals in biocompatibility testing and provide identification and quantitative information to assess toxicological risk. Increased regulatory science research capabilities in analytical chemistry are needed at FDA to improve consensus standards, increase review efficiency and reduction of data burden. The systems help devise methods for improved regulatory science mission of our office. The research supported by this equipment is included in the

Biocompatibility and Toxicology Program charter of OSEL. The research is integral to the modernization of biocompatibility testing, one of CDRH strategic priorities where chemical characterization and analysis is used to address several biocompatibility endpoints.

The purchase of an Annual Maintenance will help ensure that the systems operate properly. In order to ensure performance and not violate the warranty provided by the manufacturing company, each instrument must be covered by a service agreement, provided by the Vendor., and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

In a Sole Source justification letter submitted, the Vendor noted that “Thermo Fisher Scientific is the sole source equipment manufacturer and service provider for all Thermo Fisher Scientific instruments, parts, training, technical support, field service support, and software. The instruments and any attached peripherals use a technologically advanced method to analyze chemicals and to identify unknown samples. Thermo Fisher Scientific has proprietary rights to the design and software utilized in this instrument. Thermo Fisher Scientific is the only company with access to performance verified component parts, spare parts, software, technical support, upgrades and engineering resources to maintain the original operating specifications for your Thermo Fisher Scientific instrument. Thermo

Fisher Scientific Field Service Engineers (FSE’s) are the only certified and factory trained engineers available to service the instrument and are part of an organization that is ISO certified.

In a JOFOC submitted by the Program Office, the COR noted that FDA is seeking a new contract with

Thermo Electron North America LLC. Thermo Fisher Scientific Ultimate 3000RD UHPLC System was purchased in 2018, PO HHSF223201810137G. Thermo Fisher Scientific High-Resolution Mass

Spectrometer was purchased in 2019, PO 75F40119F80465.

FDA had a similar maintenance contract in 2021, PO 75F40121P00210 that was for a higher level of maintenance. To reduce cost of the annual maintenance, DBCMS has been asked to purchase a lower level of coverage on the two systems. Thermo Fisher is the sole source of maintenance service for Q

Exactive HF, Vanquish LC system, and Ultimate 3000 LC system. See sole source letter from Thermo

Fisher.

The associated NAICS for this procurement is: 811219 Laboratory instrument repair and maintenance services. Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation.

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 Fisher North America LLC., 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 04/20/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov