Dockets Entered on December 6, 2006

Dockets Management



Dockets Entered On December 6, 2006 Table of Contents



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

2004P-0349	Action on Products containing added Mercury

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006E-0500	Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446

2006E-0501	Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870

2006E-0502	Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

2006N-0414	Suicidality Data from Adult Antidepressant Trials

2006N-0464	Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

1978N-0065	Skin Bleaching Drug Products

EC 104	Mr. David Scott	Vol #:	14

EC 105	A Center for Dermatology, PA	Vol #:	14

2004P-0349	Action on Products containing added Mercury

EC 27	American Dental Association	Vol #:	4

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases


EC 2639	Mr. Mark Kalpakgian	Vol #:	10

EC 2640	Mr. Philip McManamon	Vol #:	10

EC 2641	Mrs. Samar Salvino	Vol #:	10

EC 2642	Mrs. Victoria Richardson	Vol #:	10

EC 2643	Home	Vol #:	10

EC 2644	Mrs. Deborah Holcomb	Vol #:	10

EC 2645	Ms. Sue Schweizer	Vol #:	10

EC 2646	Mrs. Stacey Kinkel	Vol #:	10

EC 2647	Mrs. Tara Davis	Vol #:	10

EC 2648	Mrs. Rachelle Sauvageau	Vol #:	10

EC 2649	Miss. Mary Ann Rouse	Vol #:	10

EC 2650	Mr. Peter M. Richards	Vol #:	10

EC 2651	Mr. Larry Borelli II	Vol #:	10

EC 2652	Mrs. Colleen Bowen	Vol #:	10

EC 2653	Mrs. Heidi Darakjy	Vol #:	10

EC 2654	Mrs. Dianna Meinecke	Vol #:	10

EC 2655	Mrs. Mary Mormann	Vol #:	10

EC 2656	Mr. Daniel Gibbons	Vol #:	10



EC 2657	Mrs. EILEEN LLORET	Vol #:	10

EC 2658	Mrs. Martha Taylor	Vol #:	10

EC 2659	Morning Star Obstetrics and Gynecology	Vol #:	10

EC 2660	Mrs. Frances Thomas	Vol #:	10

EC 2661	Ms. Nicole Walcott	Vol #:	10

EC 2662	Mrs. Andrea Rice	Vol #:	10

EC 2663	Mr. Tim Shivers	Vol #:	10

EC 2664	private	Vol #:	10

EC 2665	Mr. Dean Lopata	Vol #:	10

EC 2666	Mr. Jason Pohlmeier	Vol #:	10

EC 2667	Mr. Andrew Schmiedicke	Vol #:	10

EC 2668	Mrs. Kathleen Miller	Vol #:	10

EC 2669	Mrs. Jenny Zilmer	Vol #:	10

EC 2670	Mrs. L.M. O'Brien	Vol #:	10

EC 2671	Mrs. Holly Craw	Vol #:	10

EC 2672	Mrs. Maureen Redmer	Vol #:	10

EC 2673	Mrs. Mary Kent	Vol #:	10

EC 2674	Mr. Edward Hallwood, Jr.	Vol #:	10

EC 2675	Mrs. Crystal Barnes	Vol #:	10

EC 2676	Mr. Robert Connelly	Vol #:	10

EC 2677	Dr. Rex Kochanski	Vol #:	10

EC 2678	Mr. Doug Ritter	Vol #:	10

EC 2679	Franciscan University	Vol #:	10

EC 2680	Mr. Burwell Downs	Vol #:	10

EC 2681	Mrs. Mary Forsman	Vol #:	10

EC 2682	Mrs. Adele Todd	Vol #:	10

EC 2683	U.S. TAXPAYER	Vol #:	10

EC 2684	Mr. Bob Adelman	Vol #:	10

EC 2685	Mr. DAVID ROSS	Vol #:	10

EC 2686	Mrs. Melanie Bettinelli	Vol #:	10

EC 2687	Miss. Sabitha Narendran	Vol #:	10

EC 2688	Mrs. Amanda Matysik	Vol #:	10

EC 2689	Bechtel-Bettis, Inc.	Vol #:	10

EC 2690	Ms. Jillian Everett	Vol #:	10

EC 2691	Mrs. Misty Campbell	Vol #:	10

EC 2692	Mrs. Kristine Witt	Vol #:	10

EC 2693	Mr. Vincent Uher	Vol #:	10



EC 2694	Mrs. Shana Buck	Vol #:	10

EC 2695	Mr. John Roche	Vol #:	10

EC 2696	Mrs. Cheryl Terrel	Vol #:	10

EC 2697	Mrs. Mickey Long	Vol #:	10

EC 2698	Ms. Madeline Ashley	Vol #:	10

2006E-0500	Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446

LET 1	U.S. Patent and Trademark Office	Vol #:	1

2006E-0501	Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870

APP 1	Merck & Co., Inc.	Vol #:	1

LET 1	U.S. Patent and Trademark Office	Vol #:	1

2006E-0502	Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775

APP 1	Johnson & Johnson	Vol #:	1

LET 1	U.S. Patent and Trademark Office	Vol #:	1

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

C 831	W. Whitley, DDS	Vol #:	29

C 832	V. Barber	Vol #:	29

C 833	M. Young, DDS	Vol #:	29

C 834	M. Bender	Vol #:	29

C 835	M. Bender	Vol #:	29

C 836	Dr. P. Gilbert	Vol #:	29

C 837	L. Yauch	Vol #:	29

C 838	B. Sharp	Vol #:	29

C 839	A. DeFelice DDS	Vol #:	29

C 840	D. Kling	Vol #:	29

C 841	R. Boyd	Vol #:	29

C 842	J and R Ritter	Vol #:	29

C 843	D. Oelkers	Vol #:	29

C 844	J. Bryan	Vol #:	29

C 845	T. Irvin	Vol #:	29

C 846	E. Thrasher	Vol #:	29

C 847	A. Storey	Vol #:	29

C 848	B. Levy, DDS	Vol #:	29

C 849	B. Amit	Vol #:	29

C 850	N. Gardner, LCSW	Vol #:	29



C 851	B. Sage	Vol #:	29

C 852	R. Ausili	Vol #:	29

C 853	A. Meyer, DDS	Vol #:	29

C 854	R. Cronin	Vol #:	29

C 855	L. Brocato	Vol #:	29

C 856	J. Jenson, OBDS	Vol #:	29

C 857	R. Wilson, N.D.	Vol #:	29

C 858	DAMS, Intl	Vol #:	29

C 859	J. Ray, D.C., N.D.	Vol #:	29

C 860	J. Viglielmo, DDS, AIAOMT	Vol #:	29

C 861	E. Cantin	Vol #:	29

C 862	The Elka Best Foundation	Vol #:	29

C 863	W. Morse	Vol #:	29

C 864	No signature	Vol #:	29

C 865	K. Hoffman D.Ac., L.Ac, CCH	Vol #:	29

C 866	J. Gruber	Vol #:	29

C 867	A. Bonte	Vol #:	29

C 868	No signature	Vol #:	29

C 869	E. Gowell ARNP PhD	Vol #:	29

C 870	M. Wilson	Vol #:	29

C 871	L. Kichula	Vol #:	29

C 872	E. Barlow	Vol #:	29

C 873	J. Munick	Vol #:	29

C 874	D. Silver	Vol #:	29

C 875	M. Jenkinson	Vol #:	29

C 876	S. Wardrip	Vol #:	29

C 877	R. Shannon	Vol #:	29

C 878	C. Metz	Vol #:	29

C 879	S. Justice	Vol #:	29

C 880	K. James	Vol #:	29

C 881	E. Wash	Vol #:	29

C 882	K. Lindsey	Vol #:	29

C 883	W. Bridges	Vol #:	29

C 884	K. Prior	Vol #:	29

C 885	K. Harwood	Vol #:	29

C 886	K. Goldman	Vol #:	29

C 887	M. Stallings	Vol #:	29



C 888	D/ Chong	Vol #:	29

C 889	M. Chase, MPA	Vol #:	29

C 890	C. Else	Vol #:	29

C 891	M. Kirkley	Vol #:	29

C 892	H. Huggins, DDS, MS	Vol #:	29

C 893	R. Sica, MD	Vol #:	29

C 894	N. Meyer	Vol #:	29

C 895	R. Osornio	Vol #:	29

C 896	John	Vol #:	29

C 897	J. Vojtko	Vol #:	29

C 898	H. Koplev	Vol #:	29

2006N-0414	Suicidality Data from Adult Antidepressant Trials

EMC 14	J. McFall	Vol #:	2

EMC 15	Number not used	Vol #:	2

2006N-0464	Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

EC 3	Newtech Global Solutions LLC	Vol #:	1

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FDA/Dockets Management