From: Madeleine Kennedy [KENNEDY_MADELEINE@LILLY.COM] Sent: Friday, June 04, 2004 12:57 PM To: fdadockets@oc.fda.gov; heniga@cder.fda.gov Cc: Madeleine Kennedy; Michael L Rutherford Subject: Docket Number 2004N-0133 Attached is the presentation that will be delivered on June 11 by representatives of Eli Lilly and Company (see Contact Information below). Contact Information Madeleine Kennedy, Ph.D. Director, Computer Systems Quality Assurance, Lilly Research Labs Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 email: mmk@lilly.com Phone: (317)277-1734 Michael Rutherford Global Quality System Manager - Computer Systems Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 email: ml.rutherford@lilly.com Phone: (317)276-1473