National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- CLINICAL STUDIES OF THERAPIES FOR VIRUS INFECTIONS POC Mr. Bruce E. Anderson, Contracting Officer, 301-496-8371 The National Institute of Allergy and Infectious Diseases plans to increase the level-of-effort for the University of Alabama at Birmingham (UAB) Contract No. N01-AI-65306, entitled "Clinical Studies of Therapies for Virus Infection" to perform more protocols than originally estimated. This contract is in year 3 of 7, and expires on June 30, 2003. The contract has been performed under the auspices of the NIAID Collaborative Antiviral Study Group (CASG), a clinical network that presently consists of more than one hundred clinical investigators throughout the U.S., in addition to two sites in Canada and one site in Mexico, one site in Sweden and one site in the United Kingdom. As the Central Unit of the CASG, the UAB: 1) coordinates and manages the performance of the multicenter clinical trials; 2) provides a central laboratory facility to conduct diagnostic and related immunological, biochemical and virological studies; and 3) provides support in the areas of data management and statistical analysis. The CASG has successfully undertaken and completed numerous important clinical trials (which generally resulted in FDA approval of an NDA for virus-caused diseases. The focus of this contract has traditionally been on therapies for severe herpesvirus infections. The current workscope includes all viral infections of importance to NIAID. The increase in number of opportunities as a result of the broader emphasis has resulted in a greater number of clinical trial protocols than originally anticipated. In order to complete the studies which have been initiated, the Government will need to increase the effort in this contract. The current requirement is for UAB to provide 8,225% effort over 7 years, which will be increased by 2,525%, to 10,750% effort over 7 years. The University of Alabama at Birmingham 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 fulfilling the requirements of the NIAID. See numbered Note 22. Posted 07/14/98 (W-SN222784). (0195)

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