From: Allison Travis [allison.travis@sqa.org] Sent: Tuesday, January 04, 2005 5:11 PM To: Dockets, FDA Cc: patricia.miller@biogenidec.com; kathleen.l.reed@usa.dupont.com; Allison.travis@sqa.org; kevin.yount.b@bayer.com; krista.kerr@bms.com; siconolfi.rm@pg.com Subject: SQA Submission for Docket Number 2004D-0040 Please see the attached Docket Submission for Docket Number 2004D-0040 from the Society of Quality Assurance Clinical Specialty Section and Computer Validation Initiative Committee.