NIH GUIDE, Volume 24, Number 6, February 17, 1995


P.T. 34



  Clinical Medicine, General 

National Institute of Child Health and Human Development

The Contraceptive Development 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 into which of these groups they would like to be

placed.  The proposed team for each clinical trial will include at

least one qualified obstetrician - gynecologist, one study

coordinator, and one data/research manager.  For phase III and IV

clinical trials, personnel with graduate degree in epidemiology or

statistics and clinical trials experience will 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 that

will 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 or FAX request to:

Paul J. Duska

Contracts Management Branch

National Institute of Child Health and Human Development

Executive Building, Suite 7A-07

6100 Executive Boulevard MSC 5710

Bethesda, MD 20892-7510

FAX:  (301) 402-3676


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