Dockets Entered on December 7, 2006

Dockets Management



Dockets Entered On December 7, 2006 Table of Contents



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

1998E-0490	Synvisc Hylan G-F 20; U. S. Patent Extension # 5,099,013

1998E-0861	Patent Extension 4,713,448 SYNVISC Hylan G-F 20

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.

2005N-0077	Color Additive Certification; Increase in Fees for Certification Services

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

2006D-0336	Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

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

2006M-0490	P020056 - Inamed Silicone-Filled Breast Implants (Styles 10, 15, 20, 40, 45, 110, 115, and 120)

2006M-0492	P030053 - Mentor MemoryGel Silicone Gel-Filled Breast Implants (Moderate Profile Style 7000, High Profile Style 4000, and Moderate Plus Profile Style 8000)

2006N-0274	Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile


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

2006N-0416	Use of Ozone-Depleting Substances; Removal of Essential Use Designations

2006N-0426	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)

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-0503	to permit an ANDA Suitability for Propoxyphene Napsylate and Acetaminophen

1978N-0065	Skin Bleaching Drug Products

EC 106	New England Medical Center	Vol #:	14

EC 107	Henry Ford HOspital	Vol #:	14

EC 108	Dr. Julie Voss	Vol #:	14

EC 109	Bella Skin Institute	Vol #:	14

EC 110	Dr. Stephen Glinick	Vol #:	14

EC 111	314 MDG LITTLE ROCK AFB, AR	Vol #:	14

EC 112	Dr. Melissa Camouse	Vol #:	14

EC 113	ST. JUDE HERITAGE MEDICAL GROUP	Vol #:	14

EC 114	Ocala Dermatology and Skin Cancer Center	Vol #:	14

EC 115	Dr. John Pelachyk	Vol #:	14

EC 116	Professor of Dermatology UCLA	Vol #:	14

EC 117	associates in dermatology	Vol #:	14

EC 118	UAB Dermatology	Vol #:	14

EC 119	Bronx Lebanon Hospital Center	Vol #:	14

EC 120	Pioneer Valley Dermatology, p.c.	Vol #:	14

EC 121	ASDS	Vol #:	14



EC 122	UCLA Dermatology	Vol #:	14

EC 123	Dr. Benjamin Dubin	Vol #:	14

EC 124	Dr. Dreama Pilcher	Vol #:	14

EC 125	Northwestern University, Chicago	Vol #:	14

EC 126	Dr. Jonathan Winter	Vol #:	14

EC 127	Dr. Sharon Kessler	Vol #:	14

EC 128	Dr. Wieke Liem	Vol #:	14

EC 129	Dr. Bernie Recht	Vol #:	14

1998E-0490	Synvisc Hylan G-F 20; U. S. Patent Extension # 5,099,013

WDL 1	U.S. Patent & Trademark Office	Vol #:	1

1998E-0861	Patent Extension 4,713,448 SYNVISC Hylan G-F 20

WDL 1	U.S. Patent & Trademark Office	Vol #:	1

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.

APE 1	E Richards	Vol #:	2

TS 15	American Dietetic Association	Vol #:	2

TS 16	B Petersen	Vol #:	2

TS 17	Public Hearing on Foods Being Marketed as "Functional Foods"	Vol #:	2

TS 18	Public Hearing on Foods Being Marketed as "Functional Foods" - Issues and Questions from FR Not	Vol #:	2

TS 19	FDA - Statutory and Regulatory Framework for the Labeling of Food	Vol #:	2

TS 20	FDA - Statutory and Regulatory Framework for the Safety of Food Ingredients	Vol #:	2

2005N-0077	Color Additive Certification; Increase in Fees for Certification Services

NIR 1	FDA	Vol #:	1

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs



EC 9	Anabolic Laboratories, Inc.	Vol #:	3

2006D-0336	Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions

EC 9	Eli Lilly and Company	Vol #:	1

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

EC 12	Eli Lilly and Company	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 2699	Mr. Mark Kozlowski	Vol #:	10



EC 2700	Mrs. Theresa Lawson	Vol #:	10

EC 2701	Mrs. Meredith Zalesak	Vol #:	10

EC 2702	Mrs. Georgia Ryan	Vol #:	10

EC 2703	Children of God	Vol #:	10

EC 2704	Mr. John Scanlon	Vol #:	10

EC 2705	Mrs. JaNeen Pouliot	Vol #:	10

EC 2706	Ms. Camille Amonino	Vol #:	10

EC 2707	Mr. Michael Smith	Vol #:	10

EC 2708	Ms. Karen Petit	Vol #:	10

EC 2709	Mrs. Mary Brazeau	Vol #:	10

EC 2710	Dr. Kevin Tutt	Vol #:	10

EC 2711	Ms. Katherine Orloff	Vol #:	10

EC 2712	Mrs. Maureen Griffin, RPN	Vol #:	10

EC 2713	Mr. Chinh Ngo	Vol #:	10

EC 2714	Mrs. Alice Perry	Vol #:	10

EC 2715	Mrs. Martha Mendoza- Guerra	Vol #:	10

EC 2716	Mrs. Annette Yates R.N.	Vol #:	10

EC 2717	Mrs. Kristen Lang	Vol #:	10

EC 2718	Mrs. Mary Walton	Vol #:	10

EC 2719	Ms. Molly Leping	Vol #:	10

EC 2720	Mrs. Lisa Smith	Vol #:	10

EC 2721	Ms. Elizabeth Hoolehan	Vol #:	10

EC 2722	Mrs. Cathy McLaughlin	Vol #:	10

EC 2723	Dr. Elizabeth Phalen	Vol #:	10

EC 2724	Mrs. Jo Markle	Vol #:	10

EC 2725	Mrs. Milghen McMahan	Vol #:	10

EC 2726	DIOCESE OF KANSAS CITY-ST. JOSEPH	Vol #:	10

EC 2727	none	Vol #:	10

EC 2728	Ms. Cynthia Delao	Vol #:	10

EC 2729	Mrs. LaVerne Havash	Vol #:	10

EC 2730	Mr. Mark Murphy	Vol #:	10

EC 2731	Mr. Jeremy Dugas	Vol #:	16

EC 2732	Mrs. Maribel Miranda	Vol #:	16

EC 2733	Self	Vol #:	16

EC 2734	Mrs. Malinda Rauschert	Vol #:	16

EC 2735	Miss. Amy Evon	Vol #:	16

EC 2736	Mr. Philip J. Meyers	Vol #:	16



EC 2737	Ms. Adelaide Sangiorgi	Vol #:	16

EC 2738	Miss. Meredith Wise	Vol #:	16

EC 2739	Mrs. Marie Raffin	Vol #:	16

EC 2740	Miss. Melissa Zingerli	Vol #:	16

EC 2741	Mrs. Kathie Wright	Vol #:	16

EC 2742	Mrs. Carmen Pacheco	Vol #:	16

EC 2743	Catholic layperson	Vol #:	16

EC 2744	Mr. mark simmons	Vol #:	16

EC 2745	Mrs. Rose Ann Feldpausch	Vol #:	16

EC 2746	Mrs. Dolores Brown	Vol #:	16

EC 2747	Mr. Thomas DeFelice	Vol #:	16

EC 2748	Mrs. Stephanie Sanders	Vol #:	16

EC 2749	Mrs. Ellen Curtin	Vol #:	16

EC 2750	Mr. Oscar Salas	Vol #:	16

EC 2751	Ms. Steven SINISE	Vol #:	16

EC 2752	Mrs. suzanne herbert	Vol #:	16

EC 2753	Mrs. Linda Gaboardi	Vol #:	16

EC 2754	Mr. Frank W. Russell	Vol #:	16

EC 2755	Mrs. Amy Anderson	Vol #:	16

EC 2756	Mrs. Maureen O'Donnell	Vol #:	16

EC 2757	none	Vol #:	16

EC 2758	Mrs. Mary Collins	Vol #:	16

EC 2759	Mr. Gary Flores	Vol #:	16

EC 2760	Mrs. Kathleen Tappel	Vol #:	16

EC 2761	Dr. John Tappel	Vol #:	16

2006M-0490	P020056 - Inamed Silicone-Filled Breast Implants (Styles 10, 15, 20, 40, 45, 110, 115, and 120)

AAV 1	Allergan	Vol #:	1

2006M-0492	P030053 - Mentor MemoryGel Silicone Gel-Filled Breast Implants (Moderate Profile Style 7000, High Profile Style 4000, and Moderate Plus Profile Style 8000)

AAV 1	Mentor Corporation	Vol #:	1

2006N-0274	Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile



N 2	FDA	Vol #:	1

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
C 899	J. Gianoli	Vol #:	29



C 900	No signature	Vol #:	29

C 901	R. Redden	Vol #:	29

C 902	V. Pritchett	Vol #:	29

C 903	R. Sica, MD	Vol #:	29

C 904	S. Scheckner, DMD	Vol #:	29

C 905	K. Lanford	Vol #:	29

C 906	M. Ganeles	Vol #:	29

C 907	T. Meloche, R.N., BSN	Vol #:	29

C 908	D. Robbins, DMD, FAGD	Vol #:	29

C 909	S. Harris	Vol #:	29

C 910	B. Kaplan	Vol #:	29

C 911	A. Foos	Vol #:	29

C 912	J. Baunach	Vol #:	29

C 913	L. Adams	Vol #:	29

C 914	M. McComb	Vol #:	29

C 915	B. Haley, PhD	Vol #:	29

C 916	S. June	Vol #:	29

C 917	F. Lorscheider, PhD	Vol #:	29

C 918 Attachment	Life Sciences Research Office, Inc.	Vol #:	29

C 919	K. Harner	Vol #:	29

2006N-0416	Use of Ozone-Depleting Substances; Removal of Essential Use Designations

NFR 1	FDA	Vol #:	1

NPR 1	FDA	Vol #:	1

2006N-0426	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)


NWL 1	FDA	Vol #:	1

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

EC 4	Pharm Res	Vol #:	1

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

EC 436	Miss. Indawaty Osman	Vol #:	7

EC 437	Syrian Council of Poultry Breeder	Vol #:	7

2006P-0503	to permit an ANDA Suitability for Propoxyphene Napsylate and Acetaminophen

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