Upon further review, we have noted that the comment submitted to FDA stated "CONFIDENTIAL" in the footer. We do this as a matter of habit with extemal communications and this was done in error. We apologize for any confusion this may have caused. The comments submitted to FDA are not confidential and we are requesting that Regenesis' comment noted under FDA-2012-N-0378-DRAFT-0315 be posted to the regulations.gov website.