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 -- SUPPORT FOR CLINICAL AND REGULATOR AFFAIRS PROGRAM SOL Contract N01-AI-55267 DUE 110199 POC Nancy M. Hershey, Contract Specialist, ph (301)496-0193; fax (301)480-5253 E-MAIL: Nancy M. Hershey, Nhershey@niaid.nih.gov. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate with McKesson BioServices, Inc. (Contract N01-AI-55267) for additional efforts and costs associated with international monitoring required under the contract. The contract currently provides regulatory support services for the Clinical and Regulatory Affairs Branch, (CRAB), Division of Microbiology and Infectious Diseases (DMID), NIH, NIAID. The negotiated modification will provide continuity in the support of the Division for on-going projects in order to remain in compliance with federal law governing the use of Investigational New Drugs; provide funding for the labeling and shipping of vaccine for a large phase three efficacy trial in the Gambia project that is being funded by several international agencies including DMID through the World Health Organization (WHO) that is scheduled to start the first of the year 2000; provide for international monitoring of tropical disease centers; provide funds for the special packaging of investigational drug for use by potentially impaired participants and to upgrade the tracking databases to be compliant with NIAID requirements, to be compatible with NIAID software changes and to take advantage of new technical advancement for rapid data retrieval. McKesson BioServices is the only known source for meeting the requirements of this highly specialized work; therefore seeking full and open competition would only result in unacceptable delays in fulfulling the requirements of the NIAID. Authority for this action is 41 USC 253 (c)(1), as set forth in FAR 6.302-1(a)(2)(ii). Inherent duplication of cost to the Government and risks associated make competition unfeasible for this period. See Numbered Note 22. All responses to this notice must be submitted in writing. Collect calls will not be accepted. Posted 09/17/99 (W-SN381326). (0260)

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