CONTRACEPTIVE EFFICACY TESTING NIH GUIDE, Volume 25, Number 16, May 17, 1996 SOURCES SOUGHT: SS-NICHD-96-01 P.T. 34 Keywords: Contraceptives Biomaterials National Institute of Child Health and Human Development The announcement for Contraceptive Efficacy Testing published in the NIH Guide, Vol. 25, No. 12, April 19, 1996 is hereby amended as follows: The Contraceptive Development Branch of the Center for Population Research, National Institute of Child Health and Human Development (NICHD), is establishing a Contraceptive Clinical Trials Network to evaluate new devices and drugs plans to initiate contraceptive efficacy testing of synthetic, new material condoms in August 1996. Interested companies with condoms appropriate for this testing must submit documentation that they have the capability to manufacture approximately 41,000 condoms of each new condom type over a period of 18 months with incremental supply (actual number will be adjusted depending on study drop out rates and enrollment factors) as follows: supply 13,000 condoms by startup of study (for initial start up); supply an additional 9,000 by the 5th month of the study; supply an additional 7,000 by the 8th month of the study; supply an additional 6,000 by the 11th month of the study; and supply an additional 6,000 by the 14th month of the study. Documentation must also be provided supporting the ability to package according to specifications for masked studies. Additionally, documentation must support that these synthetic, new material condoms; 1) currently have a cleared FDA premarket notification or 2) will have undergone sufficient in vitro and clinical testing to have an FDA investigational device exemption (21 CFR part 812) for contraceptive efficacy testing by August 1996. An original and four copies of the requested documentation must be submitted by May 30, 1996, to: Paul J. Duska Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07 Bethesda, MD 20892 .
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