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COMMERCE BUSINESS DAILY ISSUE OF APRIL 5,1996 PSA#1567Contracts 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 051096, contact Karlene Ruddy,
Contract Specialist, 301-496-4611. 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 supports
that they have the capability to produce 3000 synthetic, new material
condoms under good manufacturing practices and are planning to market
these condoms. Additionally, documentation must support that these
synthetic, new material condoms; 1) currently have a cleared FDA
pre-market notification or 2) have undergone sufficient in vitro and
clinical testing to have an FDA investigational device exemption (21CFR
part 812) for contraceptive efficacy testing. An original and 4 copies
of written documentation is due by May 10, 1996 at the address listed
above. (092) Loren Data Corp. http://www.ld.com (SYN# 0006 19960404\A-0006.SOL)
A - Research and Development Index Page
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