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COMMERCE BUSINESS DAILY ISSUE OF MAY 8,1996 PSA#1590Contracts 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)
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