The Center for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH), Division of Laboratory Sciences intends to award a sole source purchase order to Bachem, Inc., 3132 Kashiwa St., Torrance, California, 90505-4087.

The authority for this sole source is FAR Part 13.106-1(b)(1). The NAICS code is 325411, Medicinal and Botanical Manufacturing. The requirement for this award is to acquire the following custom synthesized octapeptides: 

     • Quantity (200 mg) of N-(2-Carbamoyl-ethyl)-[13C5; 15N] Val-His-Leu-Thr-Pro-Glu-Glu-Lys-OH trifluoroacetate salt, with a minimum 90 percent purity or greater guaranteed with 95 percent targeted - {AA IS Octapeptide}, and 

     • Quantity (200 mg) of item number 4074988, N-[(RS)-2-Carbamoyl-2-hydroxyethyl) - [13C5; 15N]Val-His-Leu-Thr-Pro-Glu-Glu-Lys-OH trifluoroacetate salt; with a minimum 90 percent purity or greater guaranteed with 95 percent targeted for both diastomers, with lead-time within12 weeks -{GA IS Octapeptide}.

Bachem is the only source available to provide these custom synthesized octapeptides. These octapeptides are utilized as part of an ongoing testing and analysis project. The project requires that all analysis methods be validated in order to ensure accurate results. The analysis methods using these custom synthesized octapeptides produced by Bachem have already undergone a stringent validation process based on CLIA regulations for method verification and validation. Changing to an octapeptide that has been synthesized by a different source would require a new validation process. Undergoing a new validation process during the course of this project would cause unreasonable delay and expense to the government. Therefore Bachem is the only source available.

As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to Bachem. However, all responsible sources that believe they can meet these requirements may submit their capabilities/qualifications statement to provide the services to David Serwitz VIA EMAIL ONLY at [email protected] with the solicitation number 2013-Q-15411 referenced in the subject line NO LATER THAN February 20, 2013. The Contracting Officer will not respond to verbal requests. All requests must be in writing.

A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

 

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