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 REGULATORY OPERATIONS CENTER SOL N01-AI-65275 DUE 042400 POC Nancy Hershey; phone (301) 496-0193; fax (301) 480-5253 E-MAIL: Nancy Hershey, nhershey@niaid.nih.gov. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to negotiate with Social & Scientific Systems, Inc. for additional efforts and costs associated with international monitoring required under the contract. The contract currently provides regulatory support services for the Regulatory Affairs Branch, (RAB), Division of AIDS, (DAIDS), NIH, NIAID. The negotiated modification will provide continuity in the support of the Division for an expansive international trial referred to as the ESPRIT Study. As many as 225 institutions may participate in this collaborative trial. This modification shall support: site management, site registration, training, informed consent review, IND preparation and amendment; and receipt and management of serious adverse events. Social and Scientific Systems, Inc. is the only known source for meeting the requirements of 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 03/10/00 (W-SN433173). (0070)

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