CONTRACEPTIVE EFFICACY TESTING NIH GUIDE, Volume 25, Number 12, April 19, 1996 SOURCES SOUGHT: SS-NICHD-96-01 P.T. 34 Keywords: Contraceptives Biomaterials National Institute of Child Health and Human Development 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 premarket 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 four copies of the requested documentation must be submitted, by May 10, 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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