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 CFSAN-2023-119435 ss BioRad CFX Opus Deepwell Real-Time PCR System, Sole Source, under Request for Quote FDA-

CFSAN-2023-119435.

Notice of Intent to Sole Source to: PerkinElmer Health Sciences 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 Bio-Rad Laboratories, Inc., located at:

ATTN: Bryan Edoria Bio-Rad 2000 Alfred Nobel Drive, Hercules, CA 94547

Email: bryan_edoria@bio-rad.com

FDA requires a CFSAN-2023-119435 ss BioRad CFX Opus Deepwell Real-Time PCR System, Sole Source, under Request for Quote FDA- CFSAN-2023-119435. This is a request for the procurement of a BioRad CFX Opus Deepwell Real-Time PCR System, Sole Source, under Request for Quote FDA- CFSAN-2023-119435, and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. The CFX Opus 96 deepwell real-time PCR system is the newest real-time PCR system specifically designed for larger reaction volumes. It can analyze 96 wells with reaction volumes up to 125 μL which is the most advantage feature for our qPCR method development for tough food matrices and environmental samples since most of real-time PCR is only designed for up to 50 μL reaction volume. CFX Opus 96 deepwell real-time PCR system not only has a fast mode using honey-comb design to heat up and down very quickly, but it also uses reliable shuttle optical scan system to eliminate routine passive dye and all other dyes calibration which are required for most of other real-time PCR systems and cost more for preventive maintenance each year. CFX Opus 96 deepwell real-time PCR system has five-color channels and plus FRET (Fluorescence Resonance Energy Transfer) channel. It provides quite flexibility for our method development using multiplex channels or FRET technology. The instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. Bio-Rad is the sole distributor to the CFX Opus Deepwell Real-time system in the USA. Bio-Rad does not allow others to distribute this item on their behalf.

mailto:bryan_edoria@bio-rad.com

The associated NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing. 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 Bio-Rad Laboratories, 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 08/22/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov