From: Paul G. King [drking@gti.net] Sent: Friday, April 30, 2004 2:18 PM To: jbutler1@oc.fda.gov Cc: sherwoodt@cder.fda.gov Subject: Re: Public Docket 2003D-0493 Ms. Butler, Re: Draft Guidance For Industry on Drug Product: Chemistry, Manufacturing, and Controls Information [Docket No. 03D-0493] Please post the attached file to public docket: 2003D-0493 and link it to the e-Docket. This file are being submitted because Ted Sherwood (who is copied) and other FDA personnel have expressed an interest in reading my review of the formal commenters' comments to this docket. Since the PDA comments were only submitted recently (about a month after the docket closed) and only postedthis week, my review of said comments will, of necessity, be submitted at a later date (currently targeted for 6 May 2004). Should you have any problem with this file, then I should be available Monday, 3 May 2004 after 07:00 AM EDT. Thank you for your assistance in this matter. Respectfully, Dr. King FAME Systems