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DOCKETS ENTERED on 3/11/03

Docket Number - Title

78N-036L OTC Laxative *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability*
98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA*
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
02D-0468 Manufacture and Labeling of Raw Meat Foods *
02D-0515 Health Claims labeling conventional foods/dietary supplement*
02N-0534 Medical Device User Fee and Modernization Act of 2002*
02P-0478 Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA *
02P-0505 Labeling nuts & eligible nut containing products reduce risk *
03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey*
03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach*
76N-0482 Estab of Monograph for OTC Topical Antibiotic Products

C 22 Jose Iscovich, MD, MSc Vol#: 5

78N-036L OTC Laxative

LET 198 HFD-1 to Arnall Golden Gregory LLP Vol#: 121

LET 199 HFD-1 to American Herbal Products Assn Vol#: 121

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

EC 123 MPRES Vol#: 14

EC 124 Mrs. Lee Hendrickson Vol#: 14

EC 125 Ms. donna beaumont Vol#: 14

EC 126 Mrs. tina symons Vol#: 14

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

BKG 3 Background Information Vol#: 300

C 3704 Form Letters 18 Vol#: 301

C 3705 Lissa Spies Vol#: 299

C 3706 Dr. Harris Original Formulas Vol#: 299

C 3707 GH Associates, Inc. Vol#: 299

C 3708 Sanjiu-Vitahut Vol#: 299

C 3709 Sanjiu USA, Inc. Vol#: 299

C 3710 Daphna Abel Vol#: 299

C 3711 Peter M. Varga Vol#: 299

C 3712 Michael Richcreek Vol#: 299

C 3713 Joe D. Wimberly Vol#: 299

C 3714 Scott Crocker Vol#: 299

C 3715 Chris Carson Vol#: 299

C 3716 Diane L. Samble Vol#: 299

C 3717 Kim Huff Vol#: 299

C 3718 Marilyn Rodgers Vol#: 299

C 3719 Eric Riegler Vol#: 299

C 3720 Dave Vogel Vol#: 299

C 3721 Charles Rollo Vol#: 299

C 3722 Christina Coleman Vol#: 299

C 3723 Tawni A. Schwochow Vol#: 299

C 3724 Jean Bultemeier Vol#: 299

C 3725 Judy DeCrescente Vol#: 299

C 3726 Judy Zwiebach Vol#: 299

C 3727 Tom Brignall Vol#: 299

C 3728 Perry Kent Vol#: 299

C 3729 Ken Reddick Vol#: 299

C 3730 Scott Hartman Vol#: 299

C 3731 Brenda Collins Vol#: 299

C 3732 Christine A. Schmitz Vol#: 299

C 3733 Chuck Morris Vol#: 299

C 3734 Tad Marshall Vol#: 299

C 3735 Arthur Graham Vol#: 299

C 3736 Alice A. Lott Vol#: 299

C 3737 Thomas N. Tiedt, MD Vol#: 299

EC 35 Mr. Peter Camillo Vol#: 298

EC 36 Increase Fitness Initiative Vol#: 298

EC 37 Mrs. Emily K. Golden Vol#: 298

EC 38 Mr. Brad Cleveland Vol#: 298

EC 39 Ms. Paula Diley Vol#: 298

EC 40 Mrs. celeste rossi Vol#: 298

EC 41 South Pacific Trading Company, Inc. Vol#: 298

EC 42 Annasa, Inc. Vol#: 298

EC 43 First Aternative Co-op Vol#: 298

EC 44 Food For Thought Vol#: 298

EC 45 RainTree Vol#: 298

EC 46 Nature's Life Vol#: 298

EC 47 Country Vitamins Vol#: 298

EC 48 Number Not Used Vol#: 298

EC 49 Mrs. Cynthia Davidson Vol#: 298

EC 50 Natural-Immunogenics Corp. Vol#: 298

EC 51 Mr. Matt Quanrud Vol#: 298

EC 52 Mr. Robert Wheeler Vol#: 298

EC 53 retail insights Vol#: 298

EC 54 Good Earth Natural Foods Vol#: 298

EC 55 A Better Herb Shop Vol#: 298

EC 56 Irwin Naturals Vol#: 298

EC 57 Ms. M C Vol#: 298

EC 58 Healthy Instinct Vol#: 298

EC 59 Jagulana Herbal Products Vol#: 298

EC 60 Mrs. Patricia OConnor Vol#: 298

EC 61 Ms. Ruth Boll Vol#: 298

EC 62 healthy solutions a tatra mnt. herb co. Vol#: 298

EC 63 Mrs. Concetta Ragan Vol#: 298

EC 64 Arlington Laboratories Vol#: 298

EC 65 NUTRITION WORLD Vol#: 298

EC 66 WIN, LTD Vol#: 298

EC 67 None Vol#: 298

EC 68 Mr. Paul Bierly Vol#: 298

EC 69 Mrs. Vivian Ware Vol#: 298

EC 70 Aro Counseling Centers Inc Vol#: 298

EC 71 Ms. lauralee ledbetter Vol#: 298

EC 72 self Vol#: 298

EC 73 Microchip Technology Vol#: 298

EC 74 Mrs. LISA BURKHARD Vol#: 298

EC 75 Wellness International Network, Ltd. Vol#: 298

EC 76 Ms. Jeanette Camp Vol#: 298

EC 77 Mr. Paul Pearson Vol#: 298

EC 78 Wellness Naturecoast Group Vol#: 298

EC 79 Ms. Mary Jo Hoffman Vol#: 298

EC 80 BIONEXUS LTD Vol#: 298

EC 81 Secure Your Future Vol#: 298

EC 82 Wilhelm Company Vol#: 298

EC 83 Wellness Global Business Vol#: 298

EC 84 The Granary Vol#: 298

EC 85 Mr. Jack Marsh Vol#: 298

EC 86 Wellness International Network Vol#: 298

EC 87 Mrs. Marjorie Kemp Vol#: 298

EC 88 Wellness International Network Vol#: 298

EC 89 Wellness International Network Vol#: 298

EC 90 1st Street Wellness Vol#: 298

EC 91 Applitech Inc Vol#: 298

EC 92 Wellness International Network Vol#: 298

EC 93 Mrs. Myra Fleischer Vol#: 298

EC 94 Mr. Jan Pieter Benne Vol#: 298

EC 95 The Ventures Group Vol#: 298

EC 96 Mrs. Sheryl Russum Vol#: 298

EC 97 Georgia Wellness Network, Inc. Vol#: 298

EC 98 Wellness International Network, Ltd. Vol#: 298

EC 99 Mrs. dunnaree helm Vol#: 298

EC 100 Health Mobius, Inc. Vol#: 298

EC 101 Wellness International Vol#: 298

EC 102 Mr. Frank Steegmans Vol#: 298

EC 103 Mr. Paul Kaufman Vol#: 298

EC 104 Verdugo Plaza Pharmacy Vol#: 298

EC 105 West Coast Wellness Vol#: 298

EC 106 West Coast Wellness Vol#: 298

EC 107 Michael Stevens Painting & Decorating Vol#: 298

EC 108 West Coast Wellness Vol#: 298

EC 109 Mrs. Rosemary Auclair Vol#: 298

EC 110 Wellness Business Partners Vol#: 298

EC 111 Wellness International Network Vol#: 298

EC 112 The Wellness Group Vol#: 298

EC 113 National Capital Wellness Vol#: 298

EC 114 Dr. Harbhajan Ajrawat Vol#: 298

EC 115 Biotron Laboratories, Inc. Vol#: 298

EC 116 Mr. Sean Braun Vol#: 298

EC 117 Ms. Heather Jewell Vol#: 298

EC 118 McNamara's Band, Ltd. Vol#: 298

EC 119 Mr. Joseph Stewart Vol#: 298

EC 120 Healthy Living Choices Vol#: 298

EC 121 Mr. Matthew Petersen Vol#: 298

EC 122 Wellness Opportunities Gruop Vol#: 298

EC 123 Mr. Neil Johnson Vol#: 298

EC 124 none Vol#: 298

EC 125 AA Vol#: 298

EC 126 Dr. Andrew Konan Vol#: 298

EC 127 L.J. Sibum Beheer BV Vol#: 298

EC 128 Berry Family Care, LLC Vol#: 298

EC 129 Mr. Paul Wamble Vol#: 298

EC 130 Wellness Opportunities Group Vol#: 298

EC 131 Berry Family Care, LLC Vol#: 298

EC 132 extreme-athlete.com Vol#: 298

EC 133 winltd.com Vol#: 298

EC 134 ManKind Project of Kentucky Vol#: 298

EC 135 Wellness Network Marketing Vol#: 298

EC 136 Ms. Jennifer Fulton Vol#: 298

EC 137 The Healthy Grocer Inc. Vol#: 298

EC 138 West Coast Wellness Vol#: 298

EC 139 Wagner & Company Vol#: 298

EC 140 Boston Wellness Vol#: 298

EC 141 Mr. Theo Karnebeek Vol#: 298

EC 142 Retired Radiologist Vol#: 298

EC 143 Braakman Financiele Diensten Vol#: 298

EC 144 Miss rachel riter Vol#: 298

EC 145 Mrs. Cody Wigle Vol#: 298

EC 146 Schloss Consultancy Vol#: 298

EC 147 Mrs. Paula Maroney Vol#: 298

EC 148 Grodner & Associates Vol#: 298

EC 149 E B Blackmon, Jr, MD Inc Vol#: 298

EC 150 John Vravick DDS MS Ltd. Vol#: 298

EC 151 Mr. D.H. Price Vol#: 298

EC 152 Motown Wellness Vol#: 298

EC 153 Mr. rob Schouteten Vol#: 298

EC 154 Mrs. Annette Johnston Vol#: 298

EC 155 Mr. J. Hoven van Vol#: 298

EC 156 Wellness Global Marketing Vol#: 298

EC 157 Mr. Aschwin van Diermen Vol#: 298

EC 158 Mrs. GJH Groot Vol#: 298

EC 159 JUB Marketing Vol#: 298

EC 160 Mrs. GJH Groot Vol#: 298

EC 161 Mr. Faun Ramey Vol#: 298

EC 162 MERON WELLNESS B.V. Vol#: 298

EC 163 Miss Laura Lugtenaar Vol#: 298

EC 164 Abbott Laboratories Vol#: 298

EC 165 Mr. Duane Gluck Vol#: 298

EC 166 Wellness International Lemmer Vol#: 298

EC 167 wellness world wide Vol#: 298

EC 168 Wellness world wide Vol#: 298

EC 169 Living Well Solutions Vol#: 298

EC 170 Wellness International Network, Ltd. Vol#: 298

EC 171 West Coast Wellness Vol#: 298

EC 172 Ms. rebecca laurain Vol#: 298

EC 173 WELLNESS INTERNATIONAL Vol#: 298

EC 174 Mr. Wouter Lens Vol#: 298

EC 175 Mrs. Pennie Blair Vol#: 298

EC 176 Ms. Patricia Hofer Vol#: 298

EC 177 Wellness International Vol#: 298

EC 178 Mrs. myung choi Vol#: 298

EC 179 Wellness International Network Vol#: 298

EC 180 Wellness Vol#: 298

EC 181 Win Distributor Vol#: 298

EC 182 Wellness Management Group Vol#: 298

EC 183 Mr. Raimond Geluk Vol#: 298

EC 184 Ms. Lissa Christenberry Vol#: 298

EC 185 n/a Vol#: 298

EC 186 Win LTD Vol#: 298

EC 187 STAP Vol#: 298

EC 188 Ms. Sandy Camper Vol#: 298

EC 189 Trimedica Inc. Vol#: 298

EC 190 Concerned Consumer Vol#: 298

EC 191 Mr. Mike Medley Vol#: 298

EC 192 Dr. Donald Christy Vol#: 298

EC 193 University of Minnesota Vol#: 298

EC 194 Ms. Barbara Bainbridge Vol#: 298

EC 195 Shenandoah University Vol#: 298

EC 196 Quantum Research, Inc. Vol#: 298

EC 197 Wellness Marketing Vol#: 298

EC 198 Ms. Maureen Teal Vol#: 298

EC 199 Mr. Ira Barnes Vol#: 298

EC 200 Mr. Tony Davis Vol#: 298

EC 201 self-employed Vol#: 298

EC 202 FireLight Creations Vol#: 298

EC 203 Bastyr University Vol#: 298

EMC 73 Jean Bultemeier Vol#: 299

NPR 3 Vol#: 300

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 85 Katman Vol#: 5

97N-0165 Pediatric Patients certain new drugs/biological Products

EMC 2 Chris Williams Vol#: 6

EMC 3 Annick Losier (Quebec) Vol#: 6

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

TR 6 Transcript of May 21, 2002 public meetin Vol#: 14

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

C 101 Keep Antibiotics Working Vol#: 19

98P-0151 Introduction Of Downed Cattle Into The Food Supply

EMC 3120 Kathy B. Newman Vol#: 265

EMC 3121 Mark J. & Jennifer Christiano Michaud, M Vol#: 265

EMC 3122 Steve Paylor Vol#: 265

EMC 3123 Lauren Lewis Vol#: 265

EMC 3124 Lori Korell Vol#: 265

EMC 3125 Kristine Szabo Vol#: 265

EMC 3126 Yvette Post Goldman Vol#: 265

EMC 3127 Alice & James Crocker Vol#: 265

EMC 3128 Lori Williamson Vol#: 265

EMC 3129 Emily Fabiano Vol#: 265

EMC 3130 Karen Norback Vol#: 265

EMC 3131 April Morris Vol#: 265

EMC 3132 Marilyn Mosel Vol#: 265

EMC 3133 Bill Gaffney Vol#: 265

EMC 3134 Suzanne Heyd Vol#: 265

EMC 3135 L. Coffman Vol#: 265

EMC 3136 Peter & Pamela Sabatini Vol#: 265

EMC 3137 Dana Weiss Vol#: 265

EMC 3138 S. Eakin Vol#: 265

EMC 3139 C. Cate Vol#: 265

EMC 3140 Elaine Lupinetti Vol#: 265

EMC 3141 Art Zernis Vol#: 265

EMC 3142 Nicole Lents Vol#: 265

EMC 3143 Metanon Vol#: 265

EMC 3144 Miriam G. Inhelder RPA-C Vol#: 265

EMC 3145 Sandra King Vol#: 265

EMC 3146 Maria L. Therese Vol#: 265

EMC 3147 Julie Stafford Vol#: 265

EMC 3148 Debra Lanoue Vol#: 265

98P-0683 Soy Protein Containing Products

EMC 3 Lynda Thompson Vol#: 25

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 240 Mary Janke Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1319 Michelle Bienick Vol#: 233

02D-0385 Approval of Labeling for Foods Treated by Irradiation

EC 13 Mr. Lief Fitzpatrick Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

EC 19 National By-Products, LLC Vol#: 1

02D-0515 Health Claims labeling conventional foods/dietary supplement

EMC 1 Knowledge of Health, Inc. Vol#: 1

02F-0160 Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices

EC 2 Mr. Blaine Collins Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 60 TROY PRODUCTS Vol#: 7

EC 61 National Restaurant Association Vol#: 7

EC 62 Wisconsin Bakers Association Vol#: 7

EC 63 Mr. Dietmar Schott Vol#: 7

EC 64 Brecon Foods inc Vol#: 7

NCR 1 Vol#: 7

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

EC 66 PS Inc Vol#: 7

EMC 12 Jessica M. Novak Vol#: 7

EMC 13 Linson Antony Vol#: 7

EMC 14 Jackie Rowe Vol#: 7

02N-0534 Medical Device User Fee and Modernization Act of 2002

C 15 AdvaMed, Advanced Medical Technology Ass Vol#: 1

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

EMC 1 Gerald Robinson Vol#: 1

02P-0478 Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA

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

02P-0505 Labeling nuts & eligible nut containing products reduce risk

LET 3 INC Nutrition Res. & Education Foundatio Vol#: 4

03D-0060 Part11, Electronic records, electronic signatures scope

EC 3 Mr. Dennis Tajiri Vol#: 1

03F-0048 Safe use of Conjugated linoleic acid in animal feed

EA 1 Environmental Assessment Vol#: 1

NFL 1 Vol#: 1

03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey

EC 3 sherwyns health inc. Vol#: 1

03N-0053 Interstate Shellfish Dealers Certificate;Information Collect

N 1 Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 9 Mr. Dennis Tajiri Vol#: 1

EC 10 na Vol#: 1

EC 11 Number Not Used Vol#: 1

EC 12 Feel Better Group, LLC Vol#: 1

EC 13 Number Not Used Vol#: 1

03N-0068 Beverages: Bottled Water

EC 2 Number Not Used Vol#: 1

EC 3 Number Not Used Vol#: 1