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http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-1120-0002

 

Excerpt from the draft guidance document (emphasis added):

 

Quote:
Sexual transmission accounts for the majority of HIV infections both in the United States and globally. Behavior change through counseling, male and female condoms, antiretroviral therapy for the infected partner, voluntary male medical circumcision, and treatment of STIs can reduce the risk of HIV acquisition. However, despite these prevention methods, HIV incidence in the United States has not declined and remains stable at 56,300 new infections annually (Hall, Song, et al. 2008). Worldwide, the annual incidence is estimated to be about 2.7 million infections

 

There is a 2000 character limit in the comment web form, but you can upload larger documents.

You may want to center comments around the notion that vaginal microbicides are intended to be a "female controlled" anti-HIV measure, but that male circumcision (purportedly) makes it more difficult to insist on condom use or refuse sex, and that some analyses suggest a higher rate of male-to-female HIV transmission when men are circumcised.

 

We have several articles archived at foreskin-restoration.net which readers might find helpful in researching and drafting responses:

 

http://www.foreskin-restoration.net/forum/forumdisplay.php?f=22