From: Rolando Perez - ADPEN Laboratories, Inc. [rp@adpen.com] Sent: Tuesday, June 01, 2004 4:32 PM To: fdadockets@oc.fda.gov Subject: Docket No. 2002N-0085 and RIN number 0910-AB96 FDA Dockets: The proposed rule is welcomed. Could you explain to whom would an LC/MS/MS confirming laboratory reports its confirmation data, will it need to send it to the FDA compliance officer or to the laboratory that did the initial testing using ELISA tests. I would appreciate any comments. Thanks, Rolando Perez Technical Director ADPEN Laboratories, Inc.