The Office of Women’s Health, FDA intends to issue Solicitation Number FDA-SOL-05-00050 to award a noncompetitive contract to St. Jude Children’s Research Hospital, Inc. to study the influence of sex and ethnicity on cytochrome P450 2B6 activity, which affects metabolism of certain drugs of interest. St. Jude Children’s is the only domestic source qualified to perform the needed studies by virtue of its documented experience inresequencing the cytochrome P450 2B6 gene, its access to the required study population, and its capability to perform research involving human subjects in compliance with OHRP regulations and guidelines. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 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 solely for the purpose of determining whether to conduct a competitive procurement.

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