Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

In support of FDA Project No: CFSAN-2024-123768

The Food and Drug Administration, Office of Acquisitions and Grant Services, Facilities Support Branch intends to award a firm fixed price purchase order to Malvern PANalytical Inc., located at: Malvern PANalytical Inc., 2400 Computer Drive Westborough, MA 01581, USA, to procure a Preventative Maintenance Agreement (PMA) to cover a Malvern Panalytical Epsilon 5 Energy Dispersive X-Ray Fluorescence Spectrometer, for a base year (12 Months) and 1 (0ne) Year (12 Months) option period.

Malvern PANalytical Inc., is the only approved source for Malvern Panalytical Epsilon 5 Energy Dispersive X-Ray Fluorescence Spectrometer factory new or remanufactured repair parts.

Additionally, Malvern PANalytical Inc., is the only source authorized to provide service and installation for instrumentation manufactured and sold by Malvern PANalytical Inc., as the service team must consist of Malvern PANalytical Inc., factory trained/certified engineers. No technicians without Malvern PANalytical’s authorization are permitted to operate on the ED-XRF Spectrometer.

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.

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 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.

This procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows the Contracting Officer to solicit from one source. The North American Classification System Code is 811210, Other Electronic and Precision Equipment Repair and Maintenance and Product Service Code, J066 – Maintenance/Repair/Rebuild of Equipment – Instruments and Laboratory Equipment.

This notice is being distributed solely via the General Services Administration’s System for

Awards Management website (www.SAM.gov). As Malvern PANalytical Inc is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contracting Officer, Emmanuel T. Mbah, at Emmanuel.mbah@fda.hhs.gov no later than 12:00 PM EST on June 18, 2024. Responses sent utilizing other means will not be considered.

Information received will be used solely to determine whether to conduct a competitive procurement. A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government.

All responses must include the following business information:

a. Unique Entity Identification (UEI) Number

b. Company Name, address, primary point of contact and their email and phone number

c. Type of company (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.) as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.

d. Evidence of technical acceptability such as documents of OEM certified technicians to perform service.

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.