From: Razzaghi, Frederick [FRazzaghi@chpa-info.org] Sent: Friday, June 04, 2004 5:00 PM To: Henig, Anne M; fdadockets@oc.fda.gov Subject: 2004N-0133 Anne, Mary should have sent you the presenation. I am sending it to you just in case. Frank and I will be representing the Part 11 Coalition. Regards Fred Razzaghi -----Original Message----- From: Henig, Anne M [mailto:HENIGA@cder.fda.gov] Sent: Mon 5/24/2004 3:40 PM To: 'Frank.sena@phrma.com'; Razzaghi, Frederick Cc: McDonald, Mary Subject: Part 11 meeting Frank and Fred, Thank you for registering to speak at the Food and Drug Administration (FDA's) public meeting to discuss various topics concerning our regulations on electronic records and electronic signatures in Part 11 (21 CFR Part 11). The goal of this meeting is for FDA to consider public input as we evaluate potential changes to Part 11. Your registration indicates that Frank will speak and Fred will be the backup speaker. Will Frank be representing CHPA? Due to the number of registrants, all presentations are strictly limited to 10 minutes each. Please introduce yourself and your affiliation. You are scheduled to speak at 10:20 a.m. Attached for your information is the DRAFT agenda. You will be seated in the order of presentation as indicated on the agenda. If you plan to present slides as part of your presentation, please use Microsoft PowerPoint. Please submit your presentation electronically, including the docket number 2004N-0133 in the subject line of your email message, to both Anne Henig at heniga@cder.fda.gov and to FDA Dockets at fdadockets@oc.fda.gov by close of business on June 4, 2004. In addition, please bring a copy of your presentation on a floppy disk the day of the meeting. The public meeting will be held on June 11, 2004 from 8:00 a.m. to 4:30 p.m. at the National Transportation Safety Board (NTSB) Boardroom and Conference Center, located at 429 L'Enfant Plaza, SW, in Washington, DC. We recommend that you arrive to NTSB no later than 7:45 a.m. Directions to the NTSB Boardroom and Conference Center are as follows: The street entrance is located on Lower 10th Street just below the L'Enfant Plaza Promenade running between D Street and Frontage Road, SW (next to the public garage entrance). The NTSB Boardroom and Conference Center can also be reached by Metro, using the L'Enfant Plaza station on the green, yellow, blue or orange lines. From the L'Enfant Plaza Metro, take the 9th and D Street exit, walk through the shopping plaza towards CVS and take the escalator down to the lower level. The NTSB Boardroom and Conference Center will be to the left. Directions from the local airports will be provided upon request. Please feel free to contact me on 301-443-5576 if you have any questions or concerns. I will look forward to seeing you on June 11th! <> Anne M. Henig FDA/Center for Drug Evaluation and Research Executive Operations Staff 301-443-5576 heniga@cder.fda.gov