NIH GUIDE, Volume 25, Number 12, April 19, 1996




P.T. 34





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,



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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