66 -- Bot Tox Bio Threat alert kit & Abrin ELISA kits 64

The FDA intends to award a sole source procurement to Tetracore, Inc located at 9901 Belward Campus Drive, Rockville MD 20850. Government intends to solicit and negotiate with only one source under the authority of FAR 6.302.An award will be made nine(9) calendar days from the date of this notice. Description of Acquisition: (1) TC-8005-005 Bot Tox Bio Threat alert kit (2) TC-8011-025 Abrin ELISA kits 64 Background: The CFSAN/ FERN scientists under strict and CDC approved protocols use the various kits or reagents requested by the above mentioned vendor to develop methods used for training and the detection of foodborne contaminates which maybe a result of acts of terrorism or natural occurring events that effect our nations food source. The knowledge and information obtained regarding this method for detecting foodborne disease and associated phenomena will enhance CFSAN?s ability to protect and enhance the safety of the food supply. The FDA has a critical need for kits and reagents used to detect the characterization of foodborne pathogens. Sole Source Justification: TETRACORE is the sole manufacturer of the bio threat alert kits and supplies and accessories. No other method has been approved by CDC for the detection program submitted by FDA-CFSAN under the select agent registered program and there are no potential substitutes. There are no other vendors that can provide the capability required for FDA/CFSAN?s research program. There are no approved substitutes and there are no similar instruments. The methods used in the detection program make reproducibility and ease of use the ?gold standard?, and this can only be conducted using known and proven methods that have been approved by CDC for all labs in the USA to measure and detect microbial phenotypes. As the only known standard kits capable of providing the capability necessary, the bio threat alert test kit provides uniformity with the de facto international standard for research and rapid response. To select any other kits and reagents would place FDA/CFSAN research in this area out of step with the research community and would reduce both the capability and credibility of research in this critical scientific arena. NO REQUEST FOR QUOTE (RFQ) IS AVAILABLE. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by September 4, 2007. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. This announcement does not bind the government to any particular acquisition approach. All responses or questions regarding this posting must be in writing and can be sent via email to Dominique.Malone@fda.hhs.gov. No phone calls will be accepted. This sole source procurement will be awarded using a Simplified Acquisition Procedures in accordance with FAR Part 13. All contractors doing business with the Federal Government must be registered in the Central Contractor Registration (CCR) database. The website for registration is www.ccr.gov.