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 Preventative Maintenance for Conviron Growth Chambers, plus two (2) option years of Preventative Maintenance Agreement (PMA), Sole Source, under Request for Quote FDA-RFQ-CFSAN-2023-116504..

Notice of Intent to Sole Source to: Thermo Fisher Scientific 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 Controlled Environments Inc./Conviron, Inc., located at:

ATTN: Jennifer Hodgson Controlled Environments Inc./Conviron, Inc #2 – 572 S 5th Street, PO Box 347 Pembina, ND, 58271, USA tel: +1.701.280.9635, toll free: +1.800.363.6451 fax: +1.204.786.7736. Email: info@conviron.com

FDA requires a Preventative Maintenance for Conviron Growth Chambers, plus two (2) option years of Preventative Maintenance Agreement (PMA), Sole Source, under Request for Quote FDA-RFQ- CFSAN-2023-116504. The purpose of this requirement is to purchase a Conviron GroGuardian preventative maintenance service plan, as well as the extended warranty coverage for six (6) CONVIRON Model GEN1000 (Serial No. 200201, 202, 203, 204, 205, 206) chambers that simulate real-life growing conditions of covered produce and the survival on the soil, their transfer to the edible portion of the crop, and the interaction of foodborne pathogens with their environment, instead of using surrogate organisms to provide science-based answers that drive the agency policy on produce safety.

The initial 24-month warranty that came with the purchase of the instruments is expiring on March 11, 2023. Conviron offers another three (3) more option years for the preventative maintenance service and extended warranty coverage that the Program office would like to utilize. Since Conviron is the manufacturer of the growth chambers and has been servicing the instruments for the past 2 years, the program office is requesting to extend the preventative maintenance service and the extended warranty coverage so that the vendor can continue to provide the annual maintenance of the instruments

3.3.1. Objectives

i. The focus of this work has been to generate data that represents real-life growing conditions of covered produce (as defined on the Produce Safety Rule) and their interaction with human pathogens of concern (bacteria, virus, and parasites) to be used by the CFSAN Program Offices to support policy.

ii. Purchase of GroGuardian Preventative Maintenance Service and the Extended Warranty Package for three (3) years for (6) CONVIRON Model GEN1000 Chambers, Serial No. 200201, 202, 203, 204, 205, 206

iii. The preventative maintenance service and the extended warranty package is needed to keep the instruments properly serviced and under warranty with regular maintenance.

The Contractor shall deliver annual maintenance, which consists of a multi-point inspection, tuning, and cleaning of the critical systems of the chambers, and the extended warranty package for the instruments, which includes annual preventative maintenance service per year of additional warranty on the six (6) GEN1000 Growth Chambers (Serial No. 200201, 202, 203, 204, 205, 206) was purchased in FY20 under PO 75F40120P00102.

This is a request for the preventative maintenance service and the extended warranty coverage for six growth chambers that OARSA currently has at FDA, Mod1. The instruments have been under a initial warranty, through Conviron, that is now expiring, and Program would like to continue the next three years of service and warranty coverage through the same company that makes the instrument and that has been servicing the instruments during the initial period, and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

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 Horiba Scientific 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 06/02/2022. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov