CONTRACEPTIVE EFFICACY TESTING 

NIH GUIDE, Volume 25, Number 16, May 17, 1996

 

SOURCES SOUGHT:  SS-NICHD-96-01

 

P.T. 34



Keywords:

  Contraceptives 

  Biomaterials 

 

National Institute of Child Health and Human Development

 

The announcement for Contraceptive Efficacy Testing published in the

NIH Guide, Vol. 25, No. 12, April 19, 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 plans 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 by the 5th month of the study; supply an

additional 7,000 by the 8th month of the study; supply an additional

6,000 by the 11th month of the study; and supply an additional 6,000

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 four copies of the requested documentation must be

submitted by May 30, 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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