National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- NIAID CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER SOL N01-AI-85352 DUE 051500 POC Nancy M. Hershey, Contracting Officer; Phone (301)496-0193; Fax (301) 480-5253 WEB: NIAID Home Page, http://www.niaid.nih.gov/. E-MAIL: Nancy M. Hershey, nh11x@nih.gov. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate with McKesson BioServices, Inc., for additional effort and costs associated with international monitoring required under this contract. This contract currently provides regulatory support services for the Regulatory Affairs Branch (RAB), Division of AIDS (DAIDS), NIAID, NIH. The resultant modification will expand the support of the Division by providing for an expansive international trial referred to as the ESPRIT Study. As many as 225 institutions may participate in this collaborative trial. This modification will provide continued and additional support for training, product management and distribution in the U.S. and foreign sites, management of pharmacy related issues and site monitoring issues and maintain records for all products distributed for the study. McKesson BioServices, Inc. is currently providing this service for meeting the requirements of this highly specializedwork; therefore, seeking full and open competition would result in delays in fulfulling the requirements of the NIAID and unnecessary duplication of cost to the Government. Authority for this action is 41 USC 253(c)(1), as set forth in FAR 6.302-1(a)(2)(ii). See Numbered Note 22. All responses to this notice must be submitted in writing. Collect calls will not be accepted. Posted 03/31/00 (W-SN440241). (0091)

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