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.