Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on 12/06/02

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
99P-2630 Establish a Daily Value for "added sugars" *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0333 Juice HACCP Hazards and Controls *
02D-0389 Nonclinical Studies for Development of Pharmaceutical Excipi *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0166 Print clear, legible & intelligible product expiration date *
02P-0170 ANDAs relaying Permax as reference listed drug not be appove *
02P-0247 ANDA Suitability for Clozapine 50 mg Tablets *
02P-0358 ANDA for amoxicillin tabs for oral suspension 300 & 600mg *
02P-0394 Make determination of ANDA suitability for Amiodarone Hydroc *
02P-0506 Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons *

78N-0038 Sunscreen Drug Products

C 600 Beiersdorf, Inc. Vol#: 147

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 727 HFD-600 Vol#: 51

M 728 HFD-600 Vol#: 51

M 729 HFD-600 Vol#: 51

93V-0443 Laser Light Show

VRA 4 HFZ-300 to MGM Grand Hotel Inc. Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EXT 10 American Baskers Asn et al. Vol#: 65

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 77 Animal Welfare Institute (AWI) Vol#: 2

C 78 Environmental Defense Vol#: 2

C 79 Mississippi Pork Producers Assn Vol#: 2

C 80 Honorable Edward M. Kennedy Vol#: 2

C 81 Eric Gonder, DVM, MS, PhD, PAS, ACPV Vol#: 2

C 82 Eric Gonder, DVM, MS, PhD, PAS, ACPV Vol#: 2

99P-2630 Establish a Daily Value for "added sugars"

LET 5 HFS-800 to Arthur G. Epstein, PhD Vol#: 32

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 14 AdvaMed Vol#: 7

C 15 Johnson & Johnson Vol#: 7

C 16 GlaxoSmithKline Vol#: 7

C 17 Merck KGaA Vol#: 7

C 18 Genzyme Corporation Vol#: 7

C 19 Barr Laboratories, Inc. Vol#: 7

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

C 1 Industry Coalition Vol#: 6

00V-1469 Laser Light Show

VRA 2 HFZ-300 to Level Entertainment, LLC Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 51 Phyllis Solomon Vol#: 1

C 52 Paul Mayhew Vol#: 1

C 53 Hilde Lehmann Vol#: 1

C 54 Miriam Dailey Vol#: 1

C 55 Constance Leete Vol#: 1

C 56 Sherry Anapol Vol#: 1

C 57 Don Strachan Vol#: 1

C 58 Sister Janet Corcoran Vol#: 1

C 59 Marian Cruz Vol#: 1

C 60 James Oren Andrew Vol#: 1

C 61 David Friedman Vol#: 1

C 62 Paul W. Rosenberger Vol#: 1

C 63 Michaelene Loughlin Vol#: 1

C 64 Yvonne Dunn Vol#: 1

C 65 Antoinette Ensley Vol#: 1

C 66 David O'Gorman Vol#: 1

C 67 Sylvia Wolf Vol#: 1

C 68 Frank D. Davis Vol#: 1

C 69 Lory Lazarus Vol#: 1

C 70 Janine Alderete Vol#: 1

C 71 Suzanne Licht Vol#: 1

C 72 Margaret Remington Vol#: 1

C 73 David Zeff Vol#: 1

C 74 Martha Oaklander Vol#: 1

C 75 Nicol Eisenberg Vol#: 1

C 76 Joan Heron Vol#: 1

C 77 Janet Tunick Vol#: 1

C 78 Kaamila Mohamed Vol#: 1

C 79 Craig S. Cramer Vol#: 1

C 80 Shanti Shanti Kaur Khalsa Vol#: 1

C 81 Richard K. Corbin Vol#: 2

C 82 David Bohn Vol#: 2

C 83 Lena Phoenix Vol#: 2

C 84 Heidi Brown Vol#: 2

C 85 Michael J. Grant Vol#: 2

C 86 Andrew Leighton Vol#: 2

C 87 Linda Kapfer Vol#: 2

C 88 John Adkins Vol#: 2

C 89 Jack Robert Burrow Vol#: 2

C 90 Ruby A. Cribbin Vol#: 2

C 91 Debbie Desmoulin Vol#: 2

C 92 Kathleen Hubbard Vol#: 2

C 93 Jean Sward Vol#: 2

C 94 Jennifer Doob Vol#: 2

C 95 Kevin Phillips Vol#: 2

C 96 Marie-France Boisselle Vol#: 2

C 97 Lynn A. Scheller Vol#: 2

C 98 Charles T. Kivette Vol#: 2

C 99 Pat Fowler Vol#: 2

C 100 Adam Chase Vol#: 2

C 101 Dr. Santokh Singh Khalsa Vol#: 2

C 102 Harold Altman Vol#: 2

C 103 Maxine Diane Wolf Vol#: 2

C 104 Diane Lohr Vol#: 2

C 105 Susan Bassein Vol#: 2

C 106 Margaret Short Vol#: 2

C 107 Jai Hari Sigh Khalsa Vol#: 2

C 108 George DeCarlo Vol#: 2

C 109 Alby Quinlan Vol#: 2

C 110 Martha B. Eaton Vol#: 2

C 111 Kristie Knoll Vol#: 2

C 112 Linda Goodman Vol#: 2

C 113 Bill Denneen Vol#: 2

C 114 Trina D'Amico Vol#: 2

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

C 22 HemoCleanse Vol#: 1

C 23 Misha Askren, MD Vol#: 1

C 24 Ferro, Corp. Vol#: 1

C 25 The Vinyl Institute Vol#: 1

C 26 Adrian Dominican Sisters Vol#: 1

C 27 Sisters of St. Joseph Vol#: 1

C 28 Sisters of St. Joseph Vol#: 1

C 29 Missionary Oblates of Mary Immaculate Vol#: 1

C 30 Dr. Mha Atma S. Khalsa Vol#: 1

C 31 JOLT Vol#: 1

C 32 Physicians for Social Responsibility Vol#: 1

C 33 American Chemistry Council Vol#: 2

EMC 1 Form Letter count Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

C 13 State of Washington Dept of Agriculture Vol#: 1

02D-0389 Nonclinical Studies for Development of Pharmaceutical Excipi

C 1 Novartis Pharma AG Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

C 23 ICCBBA, Inc. Vol#: 7

02N-0445 FDA Regulation of Combination Products; Public Hearing

C 1 FDLI Vol#: 4

C 2 VIVUS, Inc Vol#: 4

02N-0466 Safety, Clinical and Immune Response of Dryvax

C 28 213 signatures Vol#: 5

C 29 Bernard & Rita Brueggemann Vol#: 5

C 30 Winifred J. Diamond Vol#: 5

C 31 Nicole Maldera Vol#: 5

C 32 IPCCAA Vol#: 5

C 33 American Academy of Pediatrics Vol#: 5

C 34 Elaine Edwards, MA, BA, RN Vol#: 5

C 35 Taryn Kuchar Vol#: 5

C 36 Brent Kaloides Vol#: 5

C 37 No signature Vol#: 5

C 38 Dena Farber Vol#: 5

C 39 R.A. Bealer Vincent Vol#: 5

C 40 Stephanie Salazar Vol#: 5

C 41 Lauren Devine Vol#: 5

C 42 Kristin Williams Vol#: 5

C 43 Jennifer Sablitz Vol#: 5

C 44 Tiffany Jackson Vol#: 5

C 45 Yvonne Thornton Vol#: 5

C 46 Jane Mahon Vol#: 5

02P-0166 Print clear, legible & intelligible product expiration date

LET 3 HFW-1 to Honorable Barbara Lee (CI) Vol#: 1

02P-0170 ANDAs relaying Permax as reference listed drug not be appove

PDN 1 HFD-1 to Amarin Pharmaceuticals, Inc. Vol#: 2

02P-0247 ANDA Suitability for Clozapine 50 mg Tablets

PAV 1 HFD-600 to AAC Consulting Group Vol#: 1

02P-0358 ANDA for amoxicillin tabs for oral suspension 300 & 600mg

PAV 1 HFD-600 to The Weinberg Group Inc. Vol#: 1

02P-0394 Make determination of ANDA suitability for Amiodarone Hydroc

PAV 1 HFD-600 to Taro Research Institute Ltd. Vol#: 1

02P-0506 Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons

ACK 1 HFA-305 to Lachman Consultant Services Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

02V-0387 Laser Light Show

VRA 1 HFZ-300 to Sacramento Theatrical Lightin Vol#: 1

02V-0415 LAD-01 Medical Laser Product

VRA 1 HFZ-300 to Norwood Abbey Limited Vol#: 1

02V-0458 Laser Light Show

VRA 1 HFZ-300 to Columbia DJ Supply Vol#: 1

02V-0507

ACK 1 HFA-305 to Bear Productions Vol#: 1

VAR 1 Bear Productions Vol#: 1

02V-0508 Variance for Q-Beam Series, Projectors

ACK 1 HFA-305 to Kentwig Lanes Bowling Center Vol#: 1

VAR 1 Kentwig Lanes Bowling Center Vol#: 1