NOS 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 CDER-2024-123839- Microfluidic Equipment for Organ-on-a-Chip Studies, Sole Source, under Request for Quote FDA-

RFQ- CDER-2024-123839.

Notice of Intent to Sole Source to: Alomone Labs 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 Fluigent, Inc., located at:

Fluigent, Inc.

73 Princeton St., Suite 310 N. Chelmsford, MA 01863 Phone (978) 269-0347 Email: fluigentinc@fl uigent.com

FDA requires a Microfluidic Equipment for Organ-on-a-Chip Studies, Sole Source, under Request for Quote FDA-RFQ- CDER-2024-123839. This is a request for the procurement of CDER-2024-123839- Microfluidic Equipment for Organ-on-a-Chip Studies, and the items are solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

This vendor is the sole manufacturer and supplier for this instrument, which is best technically acceptable for FDA’s needs. The equipment is similar and fully compatible with equipment and software previously purchased. This purchase will expand the maximum throughput of organ-on-a-chip systems. Fluigent is the only manufacturer of this class of equipment that satisfies the specifications outlined in the SOW. Additionally, this is the only microfluidic supplier with US distribution. Other available vendors require purchase and shipping from outside the United States.

In a sole source letter provided to FDA the manufacturer notes:

“We hereby certify by this written letter that “FLUIGENT” is a company which develops, manufactures, and commercializes instruments for microfluidic, as a result of our internal research projects, mobilizing scientists and engineers’ teams in order to design instruments warranting optimum results for our instrument users. The range of the product “Line Up Flow-EZ” allows to control flow inside the Microfluidics based devices by pressure actuation with the unique features Up-to-now, these equipment with the algorithm are the only products available on the market of laboratory equipment fulfilling above indicated features. Fluigent is the only company which designs, manufactures and sales those patented products exclusively.”

The associated NAICS: 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 Fluigent, 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 05/27/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov