The Food and Drug Administration, Office of Acquisitions and Grant Services, Facility Support Branch intends to award a firm fixed price purchase order to Knauer Wissen Schaftliche Gerare Gmbh, Berlin, Germany 14163 for the purchase of a NanoScaler, impingement jet mixing system inclusive of eluent heater for the Center for Drug Evaluation and Research (CDER).

Knauer is the only company that provides direct control eluent temperature via the two channel eluent heater. This is unique for both bench scale and pilot or production scale instruments. The flow rate range (1-50 mL/min) also allows scalable experiments with the ability to make low volume batches (~10s mL) up to pilot scale batches (liters per hour). This system has also been demonstrated to produce lipid nanoparticles of very controlled size (50-200nm) with very narrow variation in size (polydispersity index below 0.2) this meets the requirement for comparative analysis of performance (e.g., particles need to be extremely mono-dispersed).

This procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows the Contracting Officer to solicit from one source. The North American Classification System Code is 334516, Analytical Laboratory Instrument Manufacturing and Product Service Code, 6640 Laboratory Equipment and Supplies.

This notice is being distributed solely via the General Services Administration’s System for Awards Management website (www.SAM.gov). As Knauer is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to Contracting Officer, Sheneil Green, at Sheneil.Green@fda.hhs.gov no later than 10:00 AM EST on March 15, 2024. Responses sent utilizing other means will not be considered.

Information received will be used solely to determine whether to conduct a competitive procurement. A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government.

All responses must include the following business information:

1. Unique Entity Identification (UEI) Number
2. Company Name, address, primary point of contact and their email and phone number
3. Type of company (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.) as validated in SAM.gov.

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