Sol_Brand Name Only Det_75F40124Q00325.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

5/14/2024 CDER-2024-123784: Operation parts and components for capilla

5/15/2024

Operational parts and components for capillary protein analysis system named Maurice by ProteinSimple.

A Maurice by ProteinSimple instrument is owned by the U.S. Food and Drug Administration (FDA) and operated by FDA Office of Product Quality and Research (OPQR) staff. Maurice is an item peculiar to one original equipment manufacturer (OEM - ProteinSimple) that has custom components to perform two different analytical procedures:

image capillary electrophoresis SDS and image capillary isoelectric focusing. These two analytical procedures use cartridges, kits, reagents, and standards that are specifically manufactured by ProteinSimple for the Maurice system to ensure system suitability and performance of the instrument. Purchasing alternatives to the OEM brand-name will introduce the risk for instrument damage or time and cost extensive optimization studies. Several companies distribute the cartridges, kits, and reagents that are manufactured by ProteinSimple for Maurice. To prevent instrument damage and delays in performing mission critical research, FDA OPQR requires the purchase of cartridges, kits, and reagents that are made specifically for the Maurice system and manufactured by ProteinSimple.

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

Benjamin J. Dorgan -S Digitally signed by Benjamin J.

Dorgan -S Date: 2024.05.16 15:58:53 -07'00'

05/16/2024