Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a service contract- Preventative Maintenance Agreement (PMA) for Malvern Panalytical Epsilon 5 Energy Dispersive X- Ray Fluorescence Spectrometer, for a base year (12 Months) and 1 (0ne) (12 Months) option period, under Request for Quote CFSAN-2024-123768.

Notice of Intent to Sole Source to: Malvern PANalytical 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 Malvern PANalytical Inc., located at:

Malvern PANalytical Inc.

2400 Computer Drive Westborough, MA 01581, USA

TPOC: Maryann Tognazzi Sales Representative Telephone number: +1 413-459-9272 Email address: Maryann.tognazzi@malvernpanalytical.com.

FDA requires a Preventative Maintenance Agreement (PMA) for Malvern Panalytical Epsilon 5 Energy Dispersive X-Ray Fluorescence Spectrometer, for a base year (12 Months) and 1 (0ne) (12 Months) option period, under Request for Quote CFSAN-2024-123768. The purpose of this request is to acquire a new service agreement contract for the Epsilon 5 Energy Dispersive X-Ray Fluorescence Spectrometer (ED-XRF), which is solely manufactured by Malvern PANalytical. The proposed request includes (1) at least one annual preventative maintenance (PM), (2) base year of service, and (3) four additional option years of service. The Contractor will provide the following: Malvern PANalytical authorized service technicians only. No technicians without Malvern PANalytical’s authorization are permitted to operate on the ED-XRF Spectrometer and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

Only Malvern PANalytical certified replacement parts will be used for servicing the ED-XRF. No substitute parts shall be accepted for servicing Malvern PANalytical equipment. Repair parts shall be provided at no cost and covered under the contract for future replacement if necessary. Repair part shall be genuine Malvern PANalytical and be installed within two (2) days of the service visit. Malvern PANalytical-certified parts shall be used in the equipment only and the equipment shall be restored to operating specifications and performance after service visits.

mailto:Maryann.tognazzi@malvernpanalytical.com

There was an original contract (Order No # 75F40119P10523) associated with the Malvern PANalytical ED-XRF spectrometer. However, this contract will expire in September 2024. Thus, the purpose of this acquisition is to obtain a new service maintenance contract for the Malvern PANalytical ED-XRF spectrometer.

In a sole source letter, the subject Vendor notified FDA that, that Malvern Panalytical is the sole source provider of factory parts, training, and services for the all Malvern Panalytical (formerly known as Malvern Instruments, PANalytical, ASD, and/or Claisse) systems in the United States and Canada. This includes all service, preventive maintenance, parts, and calibration procedures developed by Malvern Panalytical. Malvern Panalytical has an experienced and certified staff of customer support engineers as well as in-house design engineers to ensure that all Malvern Panalytical Products meet the highest standards of quality required by our customers and evidenced by our ISO Certification.

The associated NAICS Code 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 Illumina, 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 06/18/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov