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-2023-118835- Particle Imaging Analysis System, Sole Source, under Request for Quote FDA-RFQ-CFSAN-2023- 118835.

Notice of Intent to Sole Source to: FlowCam Inc.

(Yokogawa Fluid Imaging Technologies, 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 FlowCam Inc., located at:

ATTN: John Yin

FlowCam Yokogawa Fluid Imaging Technology, Inc.

200 Enterprise Drive Scarborough, ME 04074 207 289-3200

Email: john.yin@fluidimaging.com Email: Orders@FluidImaging.com

FDA requires a CFSAN-2023-118835-Particle Imaging Analysis System, Sole Source, under Request for Quote FDA-RFQ- CFSAN-2023-118835. This is a request for the procurement of a CFSAN-2023- 118835-Particle Imaging Analysis System, and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. The proposed acquisition is to procure a CFSAN-2023-118835-Particle Imaging Analysis System. FlowCam Inc., is the sole manufacturer of the system, and no market equivalents exist. The following is a summary market research report of the particle imaging analysis system identified to meet the required technical specifications outlined in the Statement of Need:

FlowCam Inc Yokogawa Fluid Imaging Technologies, Inc Phone (207) 289-3200 200 Enterprise Drive Scarborough, ME 04074

USA

A sole source letter from the Vendor stated that “Yokogawa Fluid Imaging Technologies is the only vendor who can meet all our requirements outlined in the Statement of Need.

Yokogawa Fluid Imaging Technologies is the sole manufacturer and sole distributor of the FlowCam 8100® flow imaging microscopy instrument in the United States and Canada. There are no alternative authorized dealers. The FlowCam® is a unique digital imaging particle analyzer having technology protected by U.S. Patents #6,115,119 and #8,994,945, and #9,983,115”.

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 FlowCam 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 06/15/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov