Contracts Management Branch, NICHD, National Institute of Health, PHS, Executive Building, Suite 7A-07, 6100 Executive Blvd., MSC 7510, Bethesda, Maryland 20892-7510

A -- MASTER AGREEMENT FOR CLINICAL SITES FOR THE CLINICAL NETWORK FOR CONTRACEPTIVE RESEARCH SOL MAA-NICHD-CD-95-O2. DUE 050395. Contact Karlene Ruddy, Contract Specialist, 301/496-4611. The Contraceptive Deveopment Branch and the Contraceptive and Reproductive Evaluation Branch of the Center for Population Research of the National Institute of Child Health and Human Development (NICHD) will sponsor clinical trials necessary for FDA approval of new contraceptive drugs and devices and further evaluation of existing drugs and devices. The NICHD anticipates initiating evaluation of as many as seven spermicides, four male condoms, three female devices, and two other contraceptive drugs between 1995 and 1999. This solicitation is a Master Agreement Announcement (MAA). Through this MAA, three pools of sites will be established to conduct phase I, II, and III studies, or phase IV studies, or phase I, II, III, and IV clinical trials. Each offeror must designate clearly in their proposal in which of these groups they would like to be placed. The proposed team for each clinical trial shall include at least one qualified obstetrician-gynecologist, study coordinator, and data/research manager. For phase III and IV clinical trials, personnel with graduate degree in epidemiology or statistics and clinical trials experience shall also be included. all offerors must demonstrate the ability to recruit women or couples of reproductive age who are at low risk of genital tract infections including 200 couples per year for a contraceptive efficacy study of barrier methods. All responsible sources may submit an offer which shall be considered by the agency. It is anticipated that all sites found technically acceptable will become holders of Master Agreements, eligible to compete for clinical trials for a period of five years, beginning September 30, 1995. It is also anticipated that several clinical trials will be initiated as Master Agreement Orders (MAOs) beginning September 30, 1995. This Master Agreement Announcement is a new competition. This notice is not the Master Agreement Announcement. MAA-NICHD-CD-95-02 will be issued on or about February 15, 1995. Proposals will be due approximately 75 days thereafter. Copies of the MAA may be obtained by sending a written request to the address listed above. Please enclose a self-addressed label. Requests may also be made by FAX telephone (301) 496-3676. (026)

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