Dockets Entered on December 8, 2006

Dockets Management



Dockets Entered On December 8, 2006 Table of Contents



Docket #	Title

1976N-0052N	OTC Nasal Decongestants

1978N-0065	Skin Bleaching Drug Products

1981N-0022	OTC Weight Control Drug Products for Human Use

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

2003P-0276	Establish Interim Acceptable Levels for Acrylamide In Major Food Sources

2004D-0198	Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components

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

2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

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-0335	Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of

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

2006N-0452	Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization

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

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

2006P-0505	ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg

1976N-0052N	OTC Nasal Decongestants

MT 13	FDA/Office of Nonprescription Products and Walter N Kernan MD, Yale University	Vol #:	86

1978N-0065	Skin Bleaching Drug Products

EC 130	Dr. Jamison Strahan	Vol #:	14

EC 131	Dr. Heather Woolery-Lloyd	Vol #:	14

EC 132	Dorn VA Medical Center	Vol #:	14

EC 133	Northwestern Dept of Dermatology	Vol #:	14

EC 134	Dr. RACHEL REYNOLDS	Vol #:	14

1981N-0022	OTC Weight Control Drug Products for Human Use

MT 11	FDA/Office of Nonprescription Products and Walter N Kernan MD, Yale University	Vol #:	98

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

EC 31	Ms. Isobel Sebastain	Vol #:	8

2003P-0276	Establish Interim Acceptable Levels for Acrylamide In Major Food Sources

LET 2	Center for Science in the Public Interest	Vol #:	1

2004D-0198	Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components

EC 6	Mrs. Tracie Kroenert	Vol #:	1

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



EXB 79	R-74 Adverse Event Reports MW1026650	Vol #:	85

EXB 80	R-75 Adverse Event Reports MW1026765	Vol #:	86

EXB 81	R-75 Adverse Event Reports MW1027889	Vol #:	87

EXB 82	R-76 Adverse Event Reports MW1027889	Vol #:	88

EXB 83	R-78 Adverse Event Reports MW1027891	Vol #:	89

EXB 84	R-79 Adverse Event Reports MW1028047	Vol #:	90

EXB 85	R-80 Thrid Party Approvals, U.S. Approval P000023, Total Joint System	Vol #:	91

EXB 86	R-81 Thrid Party Approvals, U.S. Approval P000035 , Partial Joint System	Vol #:	92

EXB 87	R-82 Canada Medical Device Regulation SOR/98-282	Vol #:	93

2006D-0226	Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability

EC 10	Mrs. Mara Fritts	Vol #:	1

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 2762	Ms. Leah Mickens	Vol #:	16

EC 2763	Mr. John Krebs	Vol #:	16

EC 2764	Lockheed Martin Corporation	Vol #:	16

EC 2765	Mr. Matthew Farinholt	Vol #:	16

EC 2766	Mr. Bill Wehnert	Vol #:	16

EC 2767	Empowered Birth	Vol #:	16

EC 2768	Mrs. Faith` Evans	Vol #:	16

EC 2769	Family Virtue Ministry	Vol #:	16

EC 2770	Dr. Erik Spence	Vol #:	16

EC 2771	Pro-Life	Vol #:	16

EC 2772	Mrs. Judith Corbett	Vol #:	16

EC 2773	Mr. Steven Noll	Vol #:	16

EC 2774	Mrs. Mara Fritts	Vol #:	16

EC 2775	Ms. Nancy Joseph	Vol #:	16

EC 2776	Mrs. Marilyn Farinholt	Vol #:	16

EC 2777	Mrs. Edvin Farinholt III	Vol #:	16

EC 2778	Me, Myself and I	Vol #:	16

EC 2779	Mrs. sara fair	Vol #:	16

EC 2780	Mrs. Debra Walker	Vol #:	16

EC 2781	Mrs. Doris Chasse	Vol #:	16

EC 2782	Mrs. Mary Clark	Vol #:	16

EC 2783	Mrs. Cammy Cothren	Vol #:	16

EC 2784	Mrs. Robin Johnston	Vol #:	16



EC 2785	Mrs. JULIE DAW	Vol #:	16

EC 2786	Miss. Mary Hudak	Vol #:	16

EC 2787	Mrs. Patricia Sands	Vol #:	16

EC 2788	Concerned Citizens for Life	Vol #:	16

EC 2789	Mrs. Alison Landis	Vol #:	16

EC 2790	Mrs. Carol O'Connor Murphy	Vol #:	16

EC 2791	Mrs. Loralee Mills	Vol #:	16

EC 2792	none	Vol #:	16

EC 2793	Mrs. Donna Ploof	Vol #:	16

EC 2794	Ms. Mary Gibson	Vol #:	16

EC 2795	Mrs. Rebecca Hanning	Vol #:	16

EC 2796	Mrs. Cleta Jasper	Vol #:	16

EC 2797	Miss. Kelly Schexnayder	Vol #:	16

EC 2798	Miss. Judith Krzebiot	Vol #:	16

EC 2799	Mrs. Colleen Wolbert	Vol #:	16

EC 2800	Mr. Charles Rice	Vol #:	16

EC 2801	Mrs. Sarah Outlaw	Vol #:	16

EC 2802	Mrs. nora woods	Vol #:	16

EC 2803	Miss. Georgiana Miller	Vol #:	16

EC 2804	Mrs. Donna Franco	Vol #:	16

EC 2805	Mr. David Smedberg	Vol #:	16

EC 2806	Mrs. Jennifer Atkins	Vol #:	16

EC 2807	Mrs. IDA BOWEN	Vol #:	16

EC 2808	Mrs. Nancy Fohlbrook	Vol #:	16

EC 2809	Miss. Kimberly Rogers	Vol #:	16

EC 2810	Mrs. Joy Marshall	Vol #:	16

EC 2811	Mrs. Deborah Kistner	Vol #:	16

EC 2812	Mrs. Jennifer Bolt	Vol #:	16

EC 2813	Ms. Hannah Reynolds	Vol #:	16

EC 2814	Mrs. Susan Evon	Vol #:	16

EC 2815	Mrs. Regina Blodgett	Vol #:	16

EC 2816	Dr. Terence Coyne	Vol #:	16

EC 2817	Mr. Patrick McLain	Vol #:	16

2006N-0335	Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of

EC 2	Alcon Research, Ltd.	Vol #:	1

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



C 920	P. McIntyre	Vol #:	29

C 921	S.Thomas	Vol #:	29

C 922	K. Humiston, MD	Vol #:	29

C 923	M. Petranek	Vol #:	29

C 924	D. Brolin	Vol #:	29

C 925	R. Dawes	Vol #:	29

C 926	M. Sieren	Vol #:	29

C 927	A. Wall	Vol #:	29

C 928	L. Weishan	Vol #:	29

C 929	S. Whitmer	Vol #:	29

C 930	No signature	Vol #:	29

C 931	I. Moore, MD	Vol #:	29

C 932	E. Lowe	Vol #:	29

C 933	G. DeLong	Vol #:	29

C 934	J. Anderson, MD	Vol #:	29

C 935	The Brain Trust	Vol #:	29

C 936	C. Kamin	Vol #:	29

C 937	Tom Cramer Companies, Inc.	Vol #:	29

C 938	C. Gustafson	Vol #:	29

C 939	M. Meredith	Vol #:	29

C 940	L. LAwhorn	Vol #:	29

C 941	No signature	Vol #:	29

C 942	A. Foos	Vol #:	29

C 943	M. Stauffer	Vol #:	29

C 944	D. Emch	Vol #:	29

C 945	J. Foreman	Vol #:	29

C 946	J. DeFlorio	Vol #:	29

C 947	V. Rohrback	Vol #:	29

C 948	C. Irwin	Vol #:	29

C 949	T. Paolucci	Vol #:	29

C 950	M. Epstein	Vol #:	29

C 951	G. Daunhauer	Vol #:	29

C 952	S. Lyons	Vol #:	29

C 953	K. Paradis	Vol #:	29

C 954	No signature	Vol #:	29

C 955	K. Humiston, MD	Vol #:	29

C 956	D. BAttaglia	Vol #:	29



C 957	N. Fruchey	Vol #:	29

C 958	M. Buckley, DC	Vol #:	29

C 959	D. Zook	Vol #:	29

C 960	C. Yates	Vol #:	29

C 961	D. Kaiser	Vol #:	29

C 962	S. Wade	Vol #:	29

C 963	D. Brolin	Vol #:	29

C 964	P. McIntyre	Vol #:	29

C 965	M. Epstein	Vol #:	29

C 966	E. Brock	Vol #:	29

C 967	K. Smith	Vol #:	29

C 968	J. Shell	Vol #:	29

C 969	J. Karnehm	Vol #:	29

C 970	M. Stauffer	Vol #:	29

C 971	G. Daunhauer	Vol #:	29

C 972	A. Olsen	Vol #:	29

C 973	M. Petranek	Vol #:	29

C 974	P. HArding	Vol #:	29

C 975	S. Thomas	Vol #:	29

C 976	M. Duncan	Vol #:	29

C 977	B. Poulin	Vol #:	29

C 978	Carmel	Vol #:	29

C 979	T. Granuzzo	Vol #:	29

C 980	K. Paradis	Vol #:	29

C 981	M. Buckley, DC	Vol #:	29

C 982	C. Yates	Vol #:	29

C 983	D. Kaiser	Vol #:	29

C 984	M. Schooley	Vol #:	29

C 985	P. Martin	Vol #:	29

C 986	S. Flood	Vol #:	29

C 987	A. Helton	Vol #:	29

C 988	S. Baker, MD	Vol #:	29

C 989	P. Espstein	Vol #:	29

C 990	K Eckstrand and H White	Vol #:	29

C 991	K. Bruns	Vol #:	29

C 992	K. Newman	Vol #:	29

C 993	J. Bianchi	Vol #:	29



C 994	K. Russo	Vol #:	29

C 995	No signature	Vol #:	29

C 996	M. Maynard	Vol #:	29

C 997	L. Weishan	Vol #:	29

C 998	S. Schutz, MD	Vol #:	29

C 999	Cosumers for Dental Choice	Vol #:	29

C 1000	Dr. P. Layden	Vol #:	29

C 1001	No signature	Vol #:	30

C 1002	C. Lockner	Vol #:	30

C 1003	Sidney Baker, MD et al.	Vol #:	30

C 1004	Consumers for Dental Choice	Vol #:	30

C 1005	R. Sica, MD	Vol #:	30

C 1006	B. Haley, PhD	Vol #:	30

C 1007	M. Hilleman	Vol #:	30

C 1008	DAMS Inc.	Vol #:	30

C 1009	W. Webb	Vol #:	30

C 1010	F. Schubert	Vol #:	30

C 1011	M. Gilroy	Vol #:	30

C 1012	B. Lui	Vol #:	30

C 1013	K. Burns	Vol #:	30

C 1014	J. Gianoli	Vol #:	30

C 1015	J. Gruber	Vol #:	30

C 1016	J. Megalo	Vol #:	30

C 1017	P. Nupponen, DMD, MAGD, FISD, AIAOMT	Vol #:	30

C 1018	P. Nupponen, DMD, MAGD, FISD, AIAOMT	Vol #:	30

C 1019	P. Nupponen, DMD, MAGD, FISD, AIAOMT	Vol #:	30

SUP 11	M. Newell	Vol #:	30

SUP 12	IAOMT	Vol #:	30

SUP 13	IAOMT	Vol #:	30

SUP 14	R. Nash, MD	Vol #:	30

SUP 15	P. Muran, MD	Vol #:	30

SUP 16	R. Buttar, DO, FAAPM, FACAM, FAAIM	Vol #:	30

SUP 17	J. Kluger	Vol #:	30

SUP 18	M. Aboott	Vol #:	30

SUP 19	T. Burbacher et al	Vol #:	30

SUP 20	M. Dayton, DO	Vol #:	30

SUP 21	V. Suprynowicz	Vol #:	30



SUP 22	K.A. Ritchie et al	Vol #:	30

SUP 23	B. Shelton, MD, MD(h)	Vol #:	30

SUP 24	UnInformed Consent	Vol #:	31

SUP 25	Dr. J. Hardy	Vol #:	32

SUP 26	UnInformed Consent	Vol #:	33

TS 25	B. Haley, PhD	Vol #:	30

TS 26	A. Clifton	Vol #:	30

2006N-0452	Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization

EC 5	ASHCSP	Vol #:	1

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

APE 2	Alston & Bird LLP	Vol #:	1

EC 5	Virtify, Inc.	Vol #:	1

EC 6	TAP Pharmaceutical Products Inc	Vol #:	1

EC 7	Datafarm Inc.	Vol #:	1

EC 8	GlobalSubmit	Vol #:	1

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

ACK 1	FDA/CFSAN to Hyman, Phelps & McNamara PC for Cargill	Vol #:	1

CP 1	Cargill	Vol #:	1

2006P-0505	ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg

ACK 1	FDA/DDM to Lachman Consultant Services, Inc	Vol #:	1

CP 1	Lachman Consultant Services, Inc	Vol #:	1

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FDA/Dockets Management