The Office of Clinical Pharmacology (or Center for Drug Evaluation and Research), FDA intends to issue solicitation Number FDA-SOL-06-00258 to award a noncompetitive contract to Kaiser Research Foundation Institute in Oakland, CA. to study the value of pharmacogenetics in determining the proper dose, efficacy, and safety of warfarin therapy. The amount of this contract shall not exceed $139,000 on the part of the FDA. Kaiser will be providing in kind services in part for patient management, genotyping facilities and the assay management. The contractor will specifically compare a "CYP2C9 and VKORC1-genotype-based" dosing algorithm and a “standard-of-care” dosing algorithm in effective anticoagulation after warfarin therapy. Kaiser is the only domestic source qualified to perform the needed studies by virtue of its access to a large number of specific patient populations (required for this study) via a network of well-established anticoagulation centers, its unique laboratory capability to analyze the VKORC1 gene via a newly established and complex technology, in addition to the simultaneous analysis of CYP2C9 gene, to obtain accurately and expeditiously genotyping information of both genes (within 24 hours after initiation of warfarin treatment- required for this study), its extensive experience in managing patients across all anticoagulation centers within its network, and its capability to perform research involving human subjects in compliance with OHRP regulations and guidelines. It will cost the government additional time and effort to duplicate what Kaiser has pre-worked on their own to establish its network of anticoagulation centers with trained pharmacists and well-established anticoagulation protocols. All of the above factors, taken together, makes Kaiser uniquely qualified for carrying out this study. The proposed contract action is for services for which the Goverment intends to solicit and negotiate with only one source under the authority of FDA 6.302. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty five days after the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered soley for the purpose of determining whether to conduct a competitive procurement.

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