The Food and Drug Administration intends to award a sole source purchase to Remel Inc, Shawnee Mission, KS. This is NOT a request for competitive quotes. The purchase order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures and 13.106 and Part 12. Sole source acquisitions for the following, Remel Inc. Description of Acquisition: (1) V. Choleras antisera set #679817, (2) V. Choleras antisera polyvalent #678831, (3) V. Cholera antisera Inaba # 679824. This purchase orders will provide 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. 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 Remel V. Cholera antiserum test kits 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. Remel, Inc. is the sole manufacturer of the V. Cholera antiserums 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 approved substitutes and there are no similar instruments. Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. The anticipated award date is 08/24/2007. The following FAR clauses apply to this RFQ. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), 52.217-9 Option to Extend the Term of the Contract (Mar 2000). All quotes received by 2:00pm EST on August 24, 2007 will be considered by the Government. All questions must be emailed no later than August 21, 2007 to
[email protected].