This solicitation for commercial item is prepared in accordance with the format in FAR Subpart 12.6, in conjunction with FAR Part 13.5, as applicable and as supplemented with additional information included in the notice. This announcement constitutes the only solicitation; proposals that are being requested and a written solicitation will not be issued. The solicitation number FDA-SOL-0800542. The solicitation is issued as a Request for Quotation (RFQ). The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing. Small Business Size Standard 500 Employees. The Food & Drug Administration is soliciting a Sole Source basis from Distek, Inc. 121 North Center Drive, North Brunswick, NJ 08902 for the following item: Distek Automated Dissolution System, Model 6100 Evolution 6100 Bathless Dissolution System. Includes six spindles with six each of the following, 316 SS paddle blades and shafts, serialized 1L Premiere glass vessels, vessel covers and back light kit; Basket and Basket adapter, 40 mesh, evolution style; VisiChek for Enhanced Visual Perspective and Observation of solid dosage form for 5100/6100; Upgrade Kit 5100 to 6100 includes boards, power supply, cable, cover, transformer; front cover and PC104; Performance qualification for 6100 series; product training and familiarization; Media Degasser and Dispenser preheats up to 45C; Remote Dispensing Nozzle; Mobile Cart for ezfill 4500; UV-Vis Chemstation Software Upgrade; Dissolution Software System for two Baths; Sample probe, 900ml & 500ml; Communication driver for Agilent 8453 UV/Vis; Cable ? RS-232; OQ/PV Standard Kit; Cell Passivating and Cleaning Fluid; Caffeine sample solution; Multicell Transport; Flow Cell, quartz 2mm, 5mm & 10mm; Deuterium Lamp; Tungsten Lamp; UV/Vis Software Security Pack IQ & OQ/PV; Training on UV/Vis Dissolution Specific Application; Installation; Operations Qualification; Travel An official authorized to bind the offer must sign the terms and conditions of the offer. Offerors that fail to furnish required representation and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.. Contract Type: Commercial Item ? Firm Fixed Price. Simplified procurement procedures will be utilized. FOB Destination: FOB Point of Delivery for Services and Supplies will be the following: FDA 300 River Place Detroit, MI 48207 The provision as FAR 52.212-1 Instructions to Offerors ? Commercial Items applied to this solicitation. The following addenda have been attached to this provision: None An award will be made in fifteen (15) days from the date of this notice. Sources may submit a quote, which fully demonstrate their capabilities, which will be considered by the agency. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5. The government is not responsible for locating or securing any information, which is not identified in your quote. To ensure information is available, vendors must furnish as part of their package all descriptive material necessary for the government to determine whether the product meets the above requirements. If the vendor proposes to modify a product so as to make it conform to the requirement of this solicitation the vendor shall include a clear description of such proposed modifications and clearly mark any descriptive materials to show modifications. The provision at FAR 52.212-3. Offeror Representations and Certifications - Commercial Items applies to this acquisition. If offerors are not registered via the ORCA website at http//orca.bpn.gov, offerors shall complete and return a copy of the provision at FAR 52.212-3 with their offer. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following agenda have been attached to the clause. None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders ? Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-1.52.225-13, 52.232-33 and 52.232-34 Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. All responsible sources may submit a quotation, which shall be considered. The quotation must reference solicitation number FDA-SOL-08-00542. The Offers are due in person, by mail or fax on or before 03/10/08 by 14:00 hours (Eastern Standard Time in Philadelphia, PA) at the Food and Drug Administration, 200 Chestnut Street, Rm. 900, Philadelphia, PA 19106. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. For information regarding this solicitation, please contact Janice Cooper at (215) 717-3093; or email [email protected].

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