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02/19/15 11:56 AM

#46427 RE: tjshooker #46425

"Since that time, several comments from Regenesis' industry have been posted to the regulations.gov website; but Regenesis' comment has not. 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" This whole statement is confusing.