Dockets Entered on December 12, 2006

Dockets Management



Dockets Entered On December 11, 2006 Table of Contents



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

1980N-0042	Anticaries Drug Products for OTC Human Use

1998P-0043	Permit the label statement of "Supplement Facts"

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

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

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

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2006P-0506	Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods.

2006P-0507	to permit an ANDA Suitability for Methotrexate Injection

1978N-0065	Skin Bleaching Drug Products

EC 135	American Academy of Dermatology	Vol #:	14

EC 136	Loyola University Medical Center	Vol #:	14

EC 137	Dr. Melissa Rubenstein	Vol #:	14

1980N-0042	Anticaries Drug Products for OTC Human Use

PDN 8	FDA/ORA	Vol #:	34

1998P-0043	Permit the label statement of "Supplement Facts"

SS 2	Supporting Statement	Vol #:	1

2003N-0312	Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds

EC 32	Mr. kent johnson	Vol #:	8

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

EXB 88	R-83 Canada: Notice of Compliance from Health Canada	Vol #:	94

EXB 89	R-84 European Union: Notified Body Certificates	Vol #:	95

EXB 90	R-85 European Union: Medical Device Reporting Guidance Document	Vol #:	96

EXB 91	R-86 European Union: Notified Body Audit Reports	Vol #:	97

EXB 92	R-87 Quality Certificates	Vol #:	98

EXB 93	R-88 Essential Requirements Checklist	Vol #:	99

EXB 94	R-89 Not Used	Vol #:	100

EXB 95	R-90 TMJ's Quality Manual (TMJ-001)	Vol #:	101

EXB 96	R-91 Post Market Surveillance Program (SOP 217-001)	Vol #:	102

EXB 97	R-92 Management Involvement (SOP 215-001)	Vol #:	103

EXB 98	R-93 Year 2006 Management Meeing	Vol #:	104



EXB 99	R-94 Year 2005 Management Meeing	Vol #:	105

EXB 100	R-95 Year 2004 Management Meeting	Vol #:	106

EXB 101	R-96 Rist Analysis	Vol #:	107

EXB 102	R-97 FDA Correspondence 1/7/92 Form 483	Vol #:	108

EXB 103	R-98 FDA Correspondence 1/27/92 Warning Letter	Vol #:	109

EXB 104	R-99 Not Used	Vol #:	110

EXB 105	R-100 TMJ's Response to 1/7/92 FDA Form 483	Vol #:	111

EXB 106	R-101 Letter of 12/2/92, Marketing & Distribution and Preamendment	Vol #:	112

EXB 107	R-102 FDA Correspondence, Form 483	Vol #:	113

EXB 108	R-103 FDA Correspondence, Letter of 10/25/93	Vol #:	114

EXB 109	R-104 FDA Correspondence, Form 483	Vol #:	115

EXB 110	R-105 TMJI Response to 483s	Vol #:	116

EXB 111	R-106 FDA Letter of 7/15/96	Vol #:	117

EXB 112	R-107 7/31/96: FDA Website Information on Medical Device Reporting	Vol #:	118

EXB 113	R-108 5/14/97 : FDA 483	Vol #:	119

EXB 114	R-109 6/12/97: EIR Report	Vol #:	120

EXB 115	R-110 2/25/99 EIR Report for 11/98 Inspection	Vol #:	121

EXB 116	R-111 6/7/99: FDA -483	Vol #:	122

EXB 117	R-112 6/5/2000: FDA -483	Vol #:	123

EXB 118	R-113 10/10/2000: FDA -483	Vol #:	124

EXB 119	R-114 1/4/2001: FDA 483	Vol #:	125

EXB 120	R-115 1/5/2001: P000023 Approval Letter for the TMJ Fossa Eminence/Condoylar Prosthesis Syste	Vol #:	126

EXB 121	R-116 2/27/2001: P000035 Approval Letter for the TMJ Fossa Eminence Prosthesis	Vol #:	127

EXB 122	R-117 2/22/2002: FDA-483	Vol #:	128

EXB 123	R-118 3/27/2002: FDA Warning Letter	Vol #:	129

EXB 124	R-119 4/18/2002: TMJI Response to FDA 483	Vol #:	130

EXB 125	R-120 5/2//2002: TMJI Notes regarding FDA Meeting	Vol #:	131

EXB 126	R-121 5/2/2002 TMJI's Response to FDA-483	Vol #:	132

EXB 127	R-122 10/1/2002 TMJI's Letter to Regina Barrell	Vol #:	133

EXB 128	R-123 10/23/2002 FDA Untitled Letter	Vol #:	134

EXB 129	R-124 11/1/2002 TMJI Response to FDA FDR Letter	Vol #:	135

EXB 130	R-125 11/21/2002 FDA Telephone call notes	Vol #:	136

EXB 131	R-126 11/25/2002 Submission of Complaint Handking Procedures	Vol #:	137

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 2818	Mrs. Melissa Ashley	Vol #:	16



EC 2819	Mrs. Linda Adams	Vol #:	16

EC 2820	Mrs. Patricia Smith	Vol #:	16

EC 2821	Mrs. Kari Curtin	Vol #:	16

EC 2822	Mr. James Hassinger	Vol #:	16

EC 2823	Mrs. Mary Ann Bernard	Vol #:	16

EC 2824	Mrs. Amy Wise	Vol #:	16

EC 2825	Mrs. Emily Brew	Vol #:	16

EC 2826	Mr. Gene Hollowell	Vol #:	16

EC 2827	Mrs. theresa coughlin	Vol #:	16

EC 2828	Mrs. Patricia Kirchner	Vol #:	16

EC 2829	Mrs. marlene chambers	Vol #:	16

EC 2830	Ms. R Moyer	Vol #:	16

EC 2831	Mrs. Heather Braun	Vol #:	16

EC 2832	Mrs. Patricia Torpey	Vol #:	16

EC 2833	Ms. Diane Houle	Vol #:	16

EC 2834	Mrs. Debra Rohrbach	Vol #:	16

EC 2835	Ms. meghan williams	Vol #:	16

EC 2836	Mrs. Joan Rohr	Vol #:	16

EC 2837	Mr. Bry Shields	Vol #:	16

EC 2838	Mrs. Jennifer Flippen	Vol #:	16

EC 2839	Mrs. Rose Pieper	Vol #:	16

EC 2840	Mr. Bradley Pelzel	Vol #:	16

EC 2841	Mr. Antonio Geno	Vol #:	16

EC 2842	none	Vol #:	16

EC 2843	Mr. Tracquan Nguyen	Vol #:	16

EC 2844	Mrs. Amy Ogram	Vol #:	16

EC 2845	Mrs. Trudy Colflesh	Vol #:	16

EC 2846	Mrs. Grace Tomooka	Vol #:	16

EC 2847	Mrs. Leona Dickman	Vol #:	16

EC 2848	Mrs. Maria Woltornist	Vol #:	16

EC 2849	Mrs. Deborah Sweeney	Vol #:	16

EC 2850	Auburn Students for Life	Vol #:	16

EC 2851	Mr. Tom Margevicius	Vol #:	16

EC 2852	Mrs. Maria Claudet	Vol #:	16

EC 2853	Miss. Barbara Anderson	Vol #:	16

EC 2854	Miss. Mary Agnes Johnson	Vol #:	16

EC 2855	Mrs. Maria Acosta	Vol #:	16



EC 2856	Mr. Patrick O'Malley	Vol #:	16

EC 2857	Mrs. beth johnson	Vol #:	16

EC 2858	Mr. Luke Skinner	Vol #:	16

EC 2859	Ms. Meghan Cesar	Vol #:	16

EC 2860	Mr. Paul Moses	Vol #:	16

EC 2861	Miss. Susan Shields	Vol #:	16

EC 2862	United States Postal Service	Vol #:	16

EC 2863	Miss. Charlotte McGehee	Vol #:	16

EC 2864	Mrs. Kathy Ozmun	Vol #:	16

EC 2865	McGill-Toolen Pro-Life Club	Vol #:	16

EC 2866	True Life in God	Vol #:	16

EC 2867	Mrs. noreen dallaire	Vol #:	16

EC 2868	Mrs. Sara Annunziata	Vol #:	16

EC 2869	Mrs. Janine Rappuhn	Vol #:	16

EC 2870	Mr. Robert Woodruff	Vol #:	16

EC 2871	Mrs. Stephanie Buches	Vol #:	16

EC 2872	The Lewis Crusade	Vol #:	16

EC 2873	Mrs. Dawn Powers	Vol #:	16

EC 2874	Mr. devon vo	Vol #:	16

EC 2875	Mrs. Barbara Helm RN	Vol #:	16

EC 2876	Mrs. kay thomas	Vol #:	16

EC 2877	Mrs. kay thomas	Vol #:	16

EC 2878	Mrs. Angela Sissine	Vol #:	16

EC 2879	Dr. Belinda Walker Roccaforte	Vol #:	16

EC 2880	Ms. L F Cunning	Vol #:	16

EC 2881	Miss. Mary Sexton	Vol #:	16

EC 2882	Mr. Michael Hoffman	Vol #:	16

EC 2883	Mr. Juan Chavez	Vol #:	16

EC 2884	Respect Life, Raleigh, NC	Vol #:	16

EC 2885	private citizen	Vol #:	16

EC 2886	Mr. William Mihalski	Vol #:	16

EC 2887	Mrs. Bridgett Mihalski	Vol #:	16

EC 2888	Dr. Robert Chasuk	Vol #:	16

EC 2889	Mrs. marli serb	Vol #:	16

EC 2890	Miss. Courtney Gordon	Vol #:	16

EC 2891	Miss. Maria Silmaro	Vol #:	16

EC 2892	Mrs. TAMARA KOK	Vol #:	16



EC 2893	Mr. Brad Sjoquist	Vol #:	16

EC 2894	Dr. Ryan Tyler	Vol #:	16

EC 2895	Ms. Karen Fischer	Vol #:	16

EC 2896	Mrs. Sarah Hoops	Vol #:	16

EC 2897	Miss. Patricia Earley	Vol #:	16

EC 2898	Ms. Kristina Vise	Vol #:	16

EC 2899	Miss. Jennifer D'Souza	Vol #:	16

EC 2900	Miss. Teresa Fasanello	Vol #:	16

EC 2901	Miss. Suzanne Stack	Vol #:	16

EC 2902	Home	Vol #:	16

EC 2903	Mr. George Miller	Vol #:	16

EC 2904	Mr. John Fasanello	Vol #:	16

EC 2905	Mr. Rev. Robert Schultz	Vol #:	16

EC 2906	Mrs. Golda Peterson	Vol #:	16

EC 2907	Mr. Robert Peterson	Vol #:	16

EC 2908	Ms. Kathleen Muro	Vol #:	16

EC 2909	Mrs. Rebecca Bailey	Vol #:	16

EC 2910	Mrs. Stephanie Carlson	Vol #:	16

EC 2911	Mrs. Kate Vrazel	Vol #:	16

EC 2912	Mrs. Marianne Fahey	Vol #:	16

EC 2913	Mr. Patrick Fahey	Vol #:	16

EC 2914	Ms. Angela Rosson	Vol #:	16

EC 2915	Ms. Lisa Wong	Vol #:	16

EC 2916	Ms. Tammy Woempner	Vol #:	16

EC 2917	Mrs. Marie Hack	Vol #:	16

EC 2918	Mrs. Bonni Kanzenbach	Vol #:	16

EC 2919	Sancta Familia	Vol #:	16

EC 2920	Mrs. Christina Purnell	Vol #:	16

EC 2921	Mr. Joe Kolles	Vol #:	16

EC 2922	Mrs. Beverly Moran	Vol #:	16

EC 2923	Mrs. Mary Juanita Gutierrez	Vol #:	16

EC 2924	Mr. Chris Cohron	Vol #:	16

EC 2925	Mrs. GeriLynne Ryan	Vol #:	16

EC 2926	Mrs. Barbara Swiecki	Vol #:	16

EC 2927	Mrs. Rebecca Baab	Vol #:	16

EC 2928	Ms. Jaime Roth	Vol #:	16

EC 2929	Mr. Tim Stobaugh	Vol #:	16



EC 2930	Dr. Hilary Towers	Vol #:	16

EC 2931	Mrs. Gina Huff	Vol #:	16

EC 2932	Mrs. Rebecca Moak	Vol #:	16

EC 2933	Mrs. deqanna rombach	Vol #:	16

EC 2934	Mr. Hubert Mador	Vol #:	16

EC 2935	Mrs. Sonja Kluesener	Vol #:	16

EC 2936	Mrs. Catherine Osborn	Vol #:	16

EC 2937	Ms. Kathi Buskey	Vol #:	16

EC 2938	Ms. Kathy McGuire	Vol #:	16

EC 2939	Mrs. Jane Wilmer	Vol #:	16

EC 2940	Mrs. lorraine blescia	Vol #:	16

EC 2941	Mrs. Katie Amrhein	Vol #:	16

EC 2942	Ms. Roberta Sherry-Scelza	Vol #:	16

EC 2943	Mr. Rich Allen	Vol #:	16

EC 2944	Medical Associates Clnic-Pediatrics	Vol #:	16

EC 2945	Christianity	Vol #:	16

EC 2946	Mrs. Ruth Fransen	Vol #:	16

EC 2947	New York State Office Of Mental Health: Retired	Vol #:	16

EC 2948	Mr. Brett Fransen	Vol #:	16

EC 2949	Ms. Nancy Sandrock	Vol #:	16

EC 2950	Mrs. Charity Passalacqua	Vol #:	16

EC 2951	Mrs. Julia Terwilleger	Vol #:	16

EC 2952	Mr. Stephen Vrazel	Vol #:	16

EC 2953	Mrs. Melinda Devillier	Vol #:	16

EC 2954	Mrs. Theresa Reist	Vol #:	16

EC 2955	Mrs. Sharon Murphy	Vol #:	16

EC 2956	Mr. frank bruns	Vol #:	16

EC 2957	Miss. Laurel J Roy	Vol #:	16

EC 2958	Mrs. Mary Kildea	Vol #:	16

EC 2959	Mrs. Teresa Fodor	Vol #:	16

EC 2960	Ms. Mary Buercke	Vol #:	16

EC 2961	Mr. Louis Sigwarth	Vol #:	16

EC 2962	Mrs. Blair Bailey	Vol #:	16

EC 2963	Mr. C Gloyeske	Vol #:	16

EC 2964	Consumer	Vol #:	16

EC 2965	Mrs. Jo An Bernard	Vol #:	16

EC 2966	Mr. Lothar Gilde	Vol #:	16



EC 2967	Mrs. Jo Ann Gerling, IBCLC	Vol #:	16

EC 2968	Mrs. Pam Hillary	Vol #:	16

EC 2969	Mrs. PAtricia HAck	Vol #:	16

EC 2970	Mr. Larry Burnside	Vol #:	16

EC 2971	Mrs. Patricia Burnside	Vol #:	16

EC 2972	Mrs. Veronica O'Hagan	Vol #:	16

EC 2973	Mr. Jaspar von Buelow	Vol #:	16

EC 2974	Mr. Carl von Buelow	Vol #:	16

EC 2975	Mr. Roland von Buelow	Vol #:	16

EC 2976	Mr. Arthur Meola	Vol #:	16

EC 2977	Mrs. Barbara Jones	Vol #:	16

EC 2978	Mr. Geoffrey Federmeier	Vol #:	16

EC 2979	Mrs. Judith Darweesh	Vol #:	16

EC 2980	Mrs. Roisin ONeill	Vol #:	16

EC 2981	Mrs. Julie Skeen	Vol #:	16

EC 2982	Mrs. Ellen Gross	Vol #:	16

EC 2983	Mr. Rudy Guerrero	Vol #:	16

EC 2984	Pharmaceutical Representative	Vol #:	16

EC 2985	Mrs. Linda Penn	Vol #:	16

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

EC 9	Biotechnology Industry Organization (BIO)	Vol #:	1

EC 10	CDISC	Vol #:	1

EC 11	CRIX International, Association	Vol #:	1

EC 12	Mr. Robert Rainer	Vol #:	1

EC 13	Octagon Research Solutions	Vol #:	1

EC 14	Genzyme Corporation	Vol #:	1

EC 15	SAS	Vol #:	1

EC 16	CommonPractice.org	Vol #:	1

EC 17	ThinSpring	Vol #:	1

EC 18	Genentech, Inc.	Vol #:	1

EC 19	MedWrite, Inc.	Vol #:	1

EC 20	Northrop Grumman Corporation	Vol #:	1

2006P-0394	Revise the labeling requirements for eggs sold in the United States

EC 438	Ms. Susan Grisham	Vol #:	7

EC 439	Ms. Janet Diehl	Vol #:	7



EC 440	God's Creatures Ministry	Vol #:	7

EC 441	Mrs. Heather Hembrey	Vol #:	7

EC 442	Mrs. Teresa Russo	Vol #:	7

EC 443	Ms. Marcia Sessions	Vol #:	7

EC 444	Mr. Eli Acosta	Vol #:	7

2006P-0506	Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods.


ACK 1	FDA/DDM to Center for Science in the Public Interest	Vol #:	1

CP 1	Center for Science in the Public Interest	Vol #:	1

2006P-0507	to permit an ANDA Suitability for Methotrexate Injection

ACK 1	FDA / DDM to Sicor Pharmaceuticals, Inc.	Vol #:	1

CP 1	Sicor Pharmaceuticals, Inc.	Vol #:	1

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FDA/Dockets Management