Brand Name Only Det_75F40124Q00113.pdf

BRAND-NAME ONLY DETERMINATION

For actions above the micro-purchase threshold but not exceeding the Simplified Acquisition Threshold

Date: __________________ Procurement Title: ________________________________________________________

1. Nature and/or description of the item/service being procured:

2. Brand-Name Only Determination Rationale in accordance with FAR 13.106-1(b)(1)(i) and (ii):

3. It is anticipated that multiple quotations will be received for this solicitation. Therefore, in accordance with FAR Part 13.106-3(a)(1) price will be determined fair and reasonable based on comparison of competitive quotations received. If only one response is received, pricing will be determined fair and reasonable utilizing one or more of the price analysis techniques described at FAR Part 13.106-3(a)(2).

4. Technical/Requirements Personnel Certification:

I certify that this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for the Brand-Name Only Determination, is accurate and complete.

Requirements Office Representative Signature Date

5. Contract Specialist Concurrence:

I concur the circumstances described herein exist and that the information is accurate and complete to the best of my knowledge:

Contract Specialist Signature Date

6. Contracting Officer Certification/Approval:

I hereby certify that the brand-name only justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer Signature Date

Emulate, a developer of MPS, has designed a liver MPS. This microfluidic system contains two channels composed of polydimethylsiloxane (PDMS) where hepatocytes can be seeded into the apical channel other cells found in the liver can be seeded in the basolateral channel. To culture cells on the chip, the FDA requires the purchase of the Emulate Zoe and Orb. This hardware regulates the flow of media through the chip and is required to grow the cells.

Text2: Explain how the brand-name requested is an item peculiar to only one manufacturer. Provide support why the particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs.

The FDA requires the Emulate Zoe and Orb Organ-On-A-Chip culture systems for implantation into liver microphysiological systems (MPS). The Emulate Zoe will be used to conduct further testing and research with liver MPS system. This allows the FDA to understand adverse events associated with small and large molecule drugs to better predict drug safety.

For the past two years the FDA has been using the proprietary Emulate Zoe culture system to study liver MPS under a Cooperative Research and Development Agreement (CRADA) with Emulate Inc. Over the past two years the FDA has generated vast amounts of data and has become highly proficient in culturing cells for MPS studies using the Emulate Zoe system. The CRADA agreement will end in September 2024 and the FDA must return the culture equipment to Emulate. Accordingly, the FDA requires the purchase of new culture modules to replace those the FDA is returning.

The Emulate Zoe and Orb are required to culture cells on the chip that Emulate manufactures. If the office had to switch to another system, two years’ worth of data would be lost and the office would have to repeat all the experiments previously completed on the existing Emulate system.