MessageFrom: Walsh, Maria R Sent: Monday, January 10, 2005 10:32 AM To: Butler, Jennie C Subject: FW: Docket No 2004N-0432 Importance: High Jennie, Per Dr. Garner's request, I saved his document without revisions showing (attached). This is the version he wishes to be posted to docket 2004N-0432. Please post this attachment and not the attachment in Dr. Garner's e-mail dated January 6, 2005 below. Thanks. Maria -----Original Message----- From: Colin Garner [mailto:Colin.Garner@xceleron.co.uk] Sent: Monday, January 10, 2005 9:34 AM To: 'Walsh, Maria R' Subject: RE: Docket No 2004N-0432 Importance: High Dear Maria Thanks for your email. The version that should be posted should not contain any strikeouts or revisions. Could you please turn off track changes, save the document without revisions and then post it. If this is not possible please let me know and I will do it at this end. Thanks for pointing this out to me. With kind regards Colin Professor Colin Garner Chief Executive Officer ----------------------------------- https://www.fastweb.co.uk/meetingvoice.co.uk/securereg.htm Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Switchboard: +44(0)1904 561561 Direct line: +44(0)1904 561568 FAX: +44(0)1904 561560 Email: colin.garner@xceleron.co.uk Why not visit our Web site http://www.xceleron.co.uk Important Notice: The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. -------------------------------------------------------------------------------- From: Walsh, Maria R [mailto:WALSH@cder.fda.gov] Sent: 10 January 2005 14:24 To: 'Colin Garner' Subject: RE: Docket No 2004N-0432 Dr. Garner, I just noticed that your attachment contains underline and strikeout revisions. Is this the version you wish to appear on the docket? Maria -----Original Message----- From: Colin Garner [mailto:Colin.Garner@xceleron.co.uk] Sent: Thursday, January 06, 2005 1:31 PM To: 'Walsh, Maria R' Cc: 'jstarrant62@hotmail.com' Subject: RE: Docket No 2004N-0432 Importance: High Dear Maria Happy New Year to you! I wonder if you can do me a favour. I would like the attached to be lodged as our contribution to the debate on the revision of 21 CFR Part 361 under the above Docket Number. Can you please do this for me as I am unclear how to lodge such a document. Please can you also confirm that you received this email and that our contribution has been posted on the FDA site. Many thanks With kind regards Colin Garner Professor Colin Garner Chief Executive Officer ----------------------------------- https://www.fastweb.co.uk/meetingvoice.co.uk/securereg.htm Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Switchboard: +44(0)1904 561561 Direct line: +44(0)1904 561568 FAX: +44(0)1904 561560 Email: colin.garner@xceleron.co.uk Why not visit our Web site http://www.xceleron.co.uk Important Notice: The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. ------------------------------------------------------------------------------ From: Walsh, Maria R [mailto:WALSH@cder.fda.gov] Sent: 02 November 2004 19:17 To: 'Colin Garner'; Walsh, Maria R Cc: Gill Pilgrim Subject: RE: Docket No 2004N-0432 Dr. Garner, I received your final presentation for the November 16th RDRC public meeting (PowerPoint and pdf file). Thank you. Maria Maria R. Walsh, RN, MS Project Management Officer FDA/CDER/OND Office of Drug Evaluation III Immediate Office (HFD-103) 5600 Fishers Lane Rockville, Maryland 20857 Phone: (301) 827-3139 Fax: (301) 480-3761 e-mail: walsh@cder.fda.gov -----Original Message----- From: Colin Garner [mailto:Colin.Garner@xceleron.co.uk] Sent: Tuesday, November 02, 2004 1:28 PM To: 'Walsh, Maria R' Cc: Gill Pilgrim Subject: RE: Docket No 2004N-0432 Importance: High Dear Maria Please find attached a copy of my PowerPoint presentation for the upcoming meeting on 16th November 2004. Please can you confirm receipt. With kind regards Colin Garner Professor Colin Garner BPharm PhD DSc FRCPath Chief Executive Officer ----------------------------------- Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Switchboard: +44(0)1904 561561 Direct line: +44(0)1904 561568 FAX: +44(0)1904 561560 Email: colin.garner@xceleron.co.uk Why not visit our Web site http://www.xceleron.co.uk Important Notice: The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. -----Original Message----- From: Walsh, Maria R [mailto:WALSH@cder.fda.gov] Sent: 01 November 2004 14:04 To: 'Gill Pilgrim'; Walsh, Maria R Cc: Colin Garner Subject: RE: Docket No 2004N-0432 Dear Gill, Just a reminder...if Professor Garner plans to use an electronic presentation at the November 16, 2004 public meeting (e.g. PowerPoint slides), the final presentation must be submitted to me by close of business November 2, 2004. Thanks. Maria -----Original Message----- From: Gill Pilgrim [mailto:gill.pilgrim@xceleron.co.uk] Sent: Monday, November 01, 2004 5:52 AM To: WALSH@cder.fda.gov Cc: Colin Garner Subject: FW: Docket No 2004N-0432 Dear Maria Please find attached edit by Professor Colin Garner to his submission for presentation at the November 16th RDRC public meeting during the 2.45 - 4.00pm public presentation period. With kind regards. Gill ------------------------------------------------------- Gill Pilgrim Administrative Secretary/Archivist ------------------------------------------------------ Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Tel No: +44(0)1904 561561 Fax No: +44(0)1904 561560 Email: gill.pilgrim@xceleron.co.uk Visit our Web site at http://www.xceleron.co.uk Important Notice The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. ---------------------------------------------------------------------------- From: Colin Garner Sent: 01 November 2004 09:04 To: Gill Pilgrim Subject: RE: Docket No 2004N-0432 Please see attached for edits. I think I sent my original to the wrong address. However please send this to Maria Walsh. Many thanks Colin ---------------------------------------------------------------------------- From: Gill Pilgrim Sent: 01 November 2004 08:39 To: Colin Garner Subject: FW: Docket No 2004N-0432 Importance: High Colin Do you have any edits re your presentation, if so they must be in by end of today. Gill ------------------------------------------------------- Gill Pilgrim Administrative Secretary/Archivist ------------------------------------------------------ Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Tel No: +44(0)1904 561561 Fax No: +44(0)1904 561560 Email: gill.pilgrim@xceleron.co.uk Visit our Web site at http://www.xceleron.co.uk Important Notice The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. ---------------------------------------------------------------------------- From: Colin Garner Sent: 26 October 2004 18:14 To: Gill Pilgrim; June Garner; Andrew Davidson Subject: FW: Docket No 2004N-0432 Importance: High Professor Colin Garner BPharm PhD DSc FRCPath Chief Executive Officer ----------------------------------- Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Switchboard: +44(0)1904 561561 Direct line: +44(0)1904 561568 FAX: +44(0)1904 561560 Email: colin.garner@xceleron.co.uk Why not visit our Web site http://www.xceleron.co.uk Important Notice: The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation. -----Original Message----- From: Walsh, Maria R [mailto:WALSH@cder.fda.gov] Sent: 26 October 2004 18:06 To: 'Colin.Garner@xceleron.co.uk' Subject: FW: Docket No 2004N-0432 Importance: High Dr. Garner, You are scheduled to present at the November 16th RDRC public meeting during the 2:45 - 4:00 pm public presentation period. Your name will appear on the agenda as follows: Colin Garner, PhD, DSc, FRCPath, CEO, Xceleron Ltd., U.K. Please let me know if you have any edits by close of business November 1, 2004. Thank you. Maria Maria R. Walsh, RN, MS Project Management Officer FDA/CDER/OND Office of Drug Evaluation III Immediate Office (HFD-103) 5600 Fishers Lane Rockville, Maryland 20857 Phone: (301) 827-3139 Fax: (301) 480-3761 e-mail: walsh@cder.fda.gov -----Original Message----- From: Colin Garner [mailto:Colin.Garner@xceleron.co.uk] Sent: Wednesday, October 13, 2004 8:31 AM To: 'fdadockets@oc.fda.gov' Subject: Docket No 2004N-0432 Importance: High <<21 CFR Part 361 submission VO1 Garner Xceleron 16 November 2004.doc>> Please find attached a request to attend and to present at the Public Meeting concerning 21 CFR Part 361 on 16th November 2004. Could you kindly acknowledge receipt of this email and let me know if my attendance will be possible? Yours sincerely Professor Colin Garner BPharm PhD DSc FRCPath Chief Executive Officer ----------------------------------- Xceleron Ltd York Biocentre Innovation Way Heslington York YO10 5NY United Kingdom Switchboard: +44(0)1904 561561 Direct line: +44(0)1904 561568 FAX: +44(0)1904 561560 Email: colin.garner@xceleron.co.uk Why not visit our Web site http://www.xceleron.co.uk Important Notice: The information contained in this message may include privileged, proprietary or confidential information. Please treat it with the same respect that you would expect for your own information. If you have received it in error, we apologise, and ask that you contact the sender immediately and erase it from your computer. Thank you for your co-operation.