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

A -- CONTRACEPTIVE EFFICACY TESTING Due 053096. Contact Karlene Ruddy, Contract Specialist, 301-496-4611. This is a correction to the notice published 4/29/96 due to typos and a line omitted. The announcement for Contraceptive Efficacy Testing published in the CBD on April 5, 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 and is planning 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 condoms by the 5th month of the study; supply an additional 7,000 condoms by the 8th month of the study; supply an additional 6,000 condoms by the 11th month of the study; and supply an additional 6,000 condoms 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 4 copies of written documentation is due by May 30, 1996 at the address listed above. (127)

Loren Data Corp. http://www.ld.com (SYN# 0002 19960507\A-0002.SOL)