From: Thomas Quinn [tquinn@hollisgroup.com] Sent: Friday, December 20, 2002 11:56 AM To: FDA Dockets Cc: Anthony B. Cunningham; Paul Motise Subject: Fw: Submission for Docket 00D-1539 Dear Dockets Management Branch, Federal Register / Vol. 67, No. 172 / Thursday, September 5, 2002, 56848-56849 announced the availability of DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Draft Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance of Electronic Records. The Notice also announced the opening of Docket 00D-1539 to accept public comments regarding the Draft Guidance. The Notice indicated that 00D-1539 would remain open until 04 DEC 2002. On 15 OCT 2002, I submitted the attached two files for inclusion in 00D-1539. Since these are the training materials that were presented to the 21 CFR 11 Industry Coalition e-Archiving Subcommittee, they are an important resource for any person wishing to comment on the Draft Guidance. It is unfortunate that the files, or any references to the files, have not yet been posted to the 00D-1539 docket page on the FDA website. Even though the Docket Closure date has passed, I believe that the files will be of value to persons interested in commenting on the Draft Guidance. Could you, please, post the files on the 00D-1539 page? Thank you. Thomas Quinn, CISSP, AAA President, The Hollis Group, Inc. tquinn@hollisgroup.com v: 610-889-7350 f: 610-296-2339 "More freedom there, not less freedom here!" tquinnİ20010911 This message is copyrighted tquinnİ2002 ----- Original Message ----- From: Thomas Quinn To: fdadockets@oc.fda.gov Cc: Jennifer Thomas ; Paul Motise ; Barbara Meserve ; James McCormack Sent: Tuesday, October 15, 2002 10:21 AM Subject: Submission for Docket 00D-1539 Sirs, Please accept the attached presentations as submissions for docket 00D-1539, Electronic Records & Electronic Signatures, Retention of Electronic Records. The Hollis Group, Inc. hereby grants FDA an unlimited right to copy and distribute the work, or any portion thereof, as long as the attribution to The Hollis Group, Inc.as the original author is included in and prominently displayed upon such copies or distributions. Thank you. Sincerely, Thomas Quinn, CISSP, AAA President, The Hollis Group, Inc. tquinn@hollisgroup.com v: 610-889-7350 f: 610-296-2339 "More freedom there, not less freedom here!" tquinnİ20010911 This message is copyrighted tquinnİ2002