Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF APRIL 5,1996 PSA#1567

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 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)


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