From: Paul G. King [drking@gti.net] Sent: Thursday, April 05, 2007 11:39 PM To: Dockets, FDA Cc: Shuren, Jeff; Swisher, Kathleen (CBER); Cliff Shoemaker Subject: Response to Docket 2004P-0349 Re FDA/CBER 'MAR 28 2007' Letter Attachments: 20070406_CoMeDReplyToFDA(CBER)LetterDate-Stamped'MAR_28_2007'-b.pdf; ATT17016.txt Jennie Butler, Division of Dockets Management The attached file is CoMeD's formal response to the FDA/CEBER's 'MAR 28 2007' letter to CoMeD. Please appropriately file this response letter in both FDA Public Dockets 2004P-0349 and 2006P-0535 as the FDA's letter addressed both dockets and CoMeD's attached response addresses and bears on matters addressed in both dockets, including 2004P-0349/ANS1, the FDA's official answer to 2004P-0340/PSA1 that effectively denied the 2004P-0349/PSA1 document's request for a stay of action. As always, let me thank you and your staff in advance for your ongoing efforts to appropriately post all submissions to the FDA Public Docket as expedictiously as your limited resources permit. Respectfully, Dr. King http://www.dr-king.com ++++++++++++++++++++++++++++++++++++++++