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FBO DAILY ISSUE OF JULY 05, 2002 FBO #0215
SOLICITATION NOTICE

66 -- 66-Robotic Sample Handling System

Notice Date
7/3/2002
 
Notice Type
Solicitation Notice
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
 
ZIP Code
20852
 
Solicitation Number
NCI-20052-NQ
 
Response Due
7/10/2002
 
Archive Date
7/25/2002
 
Point of Contact
Cynthia Brown, Purchasing Agent, Phone (301) 496-8608, Fax (301) 402-4513, - Caren Rasmussen, Lead Contract Specialist, Phone (301) 402-4509, Fax (301) 402-4513,
 
E-Mail Address
cb106x@nih.gov, rasmusc@mail.nih.gov
 
Description
The National Cancer Institute, Division of Clinical Sciences, Clinical Proteomics Reference Lab intends on entering into a sole source contract with Tecan US, 4022 Stirrup Creek Road, Suite 310, Durham, NC 207703 for a Robotic Sample Handling System with accessoriies. The primary focus of the Clinical Proteomics Reference Lab is the advancement of common research interests shared by CBER and NCI in the application and development of proteomic technology to the diagnosis and treatment of human cancer. The formation of Clinical Proteomics Reference Lab was approved with the goal of providing approved methods and specifications of utilizing proteomic patterns for diagnostic purposes. The use of proteomic pattern evaluation for the diagnosis of Ovarian Cancer was developed and published by CPRL. In order to bring this methodology to the public in as rapid a fashion as possible, CPRI intends to file a Pre-market Application(PMA) to the Food and Drug Administration for approval as a method for aid in the diagnosis of ovarian cancer in high risk populations. As part of the research effort to demonstate the method feasibility, a determination has been made that the consistency of sample and reagent application was critical to obtaining high quality results, therefore, it would be necessary to utilize instrumenttion for this purpose rather than depend on manual functions which are not reliable, reproducible or consistent. An instrument was obtained and modified in-house for this purpose and consistent results were obtained. However, it is necessary to develop and optimize the methodology under the mandate of design control (CFR Part 820). This requires an instrument that is flexible in design for the optimization and must be provided by a company that can provide a configuration which can be specified for performance as part of a PMA. The characteristics of such instrumentation are provided by a company whose focus is robotic instrumentation for serum handling and processing. Because of the PMA filing, the instrument must be developed and manufactured under design controls as mandated by 21 CFR Part 820. Tecan US is the only source known to the Government that can provide a system which can provide this service for this technique. However, if any interested party believes it can meet the above requirements,it may submit a statement of capabilities. The capability statement and any other furnished information must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can fully meet the requirements herein. Capability statements must be received in the contracting office no later than 1:30 PM EST on July 10, 2002. This action is pursuant to 41 USC 253(1) and under the authority of FAR 6.302-1. The requirement will be procured as a commercial item in accordance with FAR Part 12.102(c) under the test program. If you have any questions, please contact Cynthia Brown, Purchasing Agent(301) 402-4509. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. Information received shall be considered solely for the purpose of determining whether to conduct a competitive procurement. No collects calls will be accepted. The NAICS Code 334516.
 
Record
SN00110620-W 20020705/020704052234 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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