Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on August 12, 2002

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t *
98N-0337 Over the counter human drugs labeling requirements *
98N-0583 Exports: Notification and Recordkeeping requirements *
99P-1041 Temporary Marketing Permit Salad Dressing *
00N-1652 Human Prescripton Drugs/Biologics in Electronic Format *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0435 International Conference on Harmonisation *
01N-0234 Food Contact Substance Notification System *
01P-0524 Hydrocodone Bitartrate & Acetaminophen Oral Solution 10 mg *
02D-0113 Root-Form Endosseous Dental Implants and Abutments *
02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV *
02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re *
02D-0237 QIE Evaluation of Stability Data *
02D-0242 Pharmacy Compounding Compliance Policy Guide *
02D-0258 Sudies for Orally Administered Drug Products *
02N-0058 Pediculicide Drug Products for OTC Human Use *
02P-0105 ANDA Suitability for Oxycodone and Acetaminophen Tablets *
02P-0139 Arava (leflunomide;Aventis) remove from the market *
02P-0161 ANDA Suitability for Isotretinoin Capsules 30 mg *
02P-0360 Chemical Cleaning Products for Industrial Food *

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

LET 144 HFD-560 to McNeil Consumer Healthcare Vol#: 235

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

LET 21 University of Illinois at Urbana-Champai Vol#: 65

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

C 341 Suzanne M. Shepke Vol#: 12

C 342 K. Stanley Vol#: 12

C 343 Sandy Usher Vol#: 12

C 344 Marton, Inc. Vol#: 12

C 345 Education & Therapy Associates, Inc. Vol#: 13

C 346 Carla K. Gilbert Vol#: 13

98N-0337 Over the counter human drugs labeling requirements

ANS 18 HFD-560 to Becton Dickinson & Company Vol#: 9

98N-0583 Exports: Notification and Recordkeeping requirements

LET 7 Covington & Burling Vol#: 2

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 314 Daniel Barnett Vol#: 5

EMC 315 Malissa Grimm Vol#: 5

EMC 316 Lee Hutchings Vol#: 5

EMC 317 Debra Dekelaita Vol#: 5

EMC 318 Gertrude Stein Vol#: 5

EMC 319 Mary McGuire Vol#: 5

EMC 320 Christine Farlow Vol#: 5

EMC 321 Catherine Dowling Vol#: 5

EMC 322 Catherine Dowling Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 217 Daniel Barnett Vol#: 5

EMC 218 Malissa Grimm Vol#: 5

EMC 219 Lee Hutchings Vol#: 5

EMC 220 Debra Dekelaita Vol#: 5

EMC 221 Gertrude Stein Vol#: 5

EMC 222 Mary McGuire Vol#: 5

EMC 223 Christine Farlow Vol#: 5

EMC 224 Catherine Dowling Vol#: 5

EMC 225 Catherine Dowling Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 216 Daniel Barnett Vol#: 4

EMC 217 Malissa Grimm Vol#: 4

EMC 218 Lee Hutchings Vol#: 4

EMC 219 Debra Dekelaita Vol#: 4

EMC 220 Gertrude Stein Vol#: 4

EMC 221 Mary McGuire Vol#: 4

EMC 222 Christine Farlow Vol#: 4

EMC 223 Catherine Dowling Vol#: 4

EMC 224 Catherine Dowling Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 219 Daniel Barnett Vol#: 4

EMC 220 Malissa Grimm Vol#: 4

EMC 221 Lee Hutchings Vol#: 4

EMC 222 Debra Dekelaita Vol#: 4

EMC 223 Gertrude Stein Vol#: 4

EMC 224 Mary McGuire Vol#: 4

EMC 225 Christine Farlow Vol#: 4

EMC 226 Catherine Dowling Vol#: 4

EMC 227 Catherine Dowling Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3683 Oren Gordin Vol#: 512

EMC 3684 Oren Gordin Vol#: 512

EMC 3685 Daniel Barrett Vol#: 512

EMC 3686 Stephen Wilcox Vol#: 512

EMC 3687 Lee Hutchings Vol#: 512

EMC 3688 Kori Kubusek Vol#: 512

EMC 3689 Mary McGuire Vol#: 512

EMC 3690 Catherine Dowling Vol#: 512

99P-1041 Temporary Marketing Permit Salad Dressing

C 1 HFS-003 to United Egg Producers Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

EMC 141 Sharon Hughes Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9820 Margaret K. Manning Vol#: 570

C 9821 Rachel Ballaretine Vol#: 570

00N-1652 Human Prescripton Drugs/Biologics in Electronic Format

EMC 1 Eli Lilly & Co. Vol#: 1

EMC 2 GlaxoSmithKline Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

EMC 491 The Food Allergy & Anaphylaxis Network Vol#: 20

01D-0435 International Conference on Harmonisation

EMC 1 GlaxoSmithKline Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 317 Daniel Barnett Vol#: 6

EMC 318 Malissa Grimm Vol#: 6

EMC 319 Lee Hutchings Vol#: 6

EMC 320 Debra Dekelaita Vol#: 6

EMC 321 Gertrude Stein Vol#: 6

EMC 322 Mary McGuire Vol#: 6

EMC 323 Christine Farlow Vol#: 6

EMC 324 Catherine Dowling Vol#: 6

01N-0067 Reclassification of Dental Mercury

C 29 Dr. James Medlock, DDS, PA Vol#: 5

01N-0234 Food Contact Substance Notification System

EMC 1 American Plastics Council Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2064 Dario Ravera Vol#: 212

EMC 2065 Alex Casalboni Vol#: 212

EMC 2066 Emma Papworth Vol#: 212

EMC 2067 Simeon Steenbergen Vol#: 212

EMC 2068 Barbara Darwish Vol#: 212

EMC 2069 Barbara Darwish Vol#: 212

EMC 2070 A.M. Brown Vol#: 212

EMC 2071 Jennifer Cavallaro Vol#: 212

EMC 2072 Stacy Cousin Vol#: 212

EMC 2073 Samantha Goldman Vol#: 212

EMC 2074 Olivia Vol#: 212

EMC 2075 Emmett White Vol#: 212

EMC 2076 Joel Lapointe Vol#: 212

EMC 2077 Will Simmons Vol#: 212

EMC 2078 Doug Burton Vol#: 212

EMC 2079 No signature Vol#: 212

EMC 2080 Nicholas Irvine Vol#: 212

EMC 2081 Stacy Goodman Vol#: 212

EMC 2082 Max Goodrich Vol#: 212

EMC 2083 Lori Vol#: 212

EMC 2084 Howard Traite Vol#: 212

EMC 2085 Gisela Ferrer Vol#: 212

EMC 2086 Susana Rodriguez Blanco Vol#: 212

EMC 2087 Elena Petrova Vol#: 212

EMC 2088 Andy Spittle Vol#: 212

EMC 2089 Stephanie Smith Vol#: 212

EMC 2090 Luko Vol#: 212

EMC 2091 Janet Barber Vol#: 212

EMC 2092 Florence Dacey Vol#: 212

EMC 2093 Nancy Lott-Schlicher Vol#: 212

EMC 2094 Raina Kelly Vol#: 212

EMC 2095 Jonathan Scolnik Vol#: 212

EMC 2096 Martina Beverly Vol#: 212

EMC 2097 Michelle Vol#: 212

EMC 2098 Paula Leponiemi Vol#: 212

EMC 2099 Stephanie West Vol#: 212

EMC 2100 Darren Jackson Vol#: 212

EMC 2101 Michael Gillert Vol#: 212

EMC 2102 Emma Nickelson Vol#: 212

EMC 2103 Jennifer Rodriguez Vol#: 212

EMC 2104 Steven Schafer Vol#: 212

EMC 2105 Theodore Turner Vol#: 212

EMC 2106 Jeanette Smith Vol#: 212

EMC 2107 Carla Eggert Vol#: 212

EMC 2108 Ian Forbes Vol#: 212

EMC 2109 Katherine Baluta Vol#: 212

EMC 2110 James R. Scott Vol#: 212

EMC 2111 Peter L. Gebhardt Vol#: 212

EMC 2112 Mary Ann Schwenk Vol#: 212

EMC 2113 Jeanne Bergman Vol#: 212

EMC 2114 Michelle Morgan Vol#: 212

EMC 2115 Anne Fraser Vol#: 212

EMC 2116 Carrie Kinghorn Vol#: 212

EMC 2117 Thomas Ruedas Vol#: 212

EMC 2118 J. Andy Cline Vol#: 212

EMC 2119 Charles Flower Vol#: 212

EMC 2120 Misha Fredericks Vol#: 212

EMC 2121 Jackie Pomies Vol#: 212

EMC 2122 Holly James Vol#: 212

EMC 2123 Anna Saxon-Taylor Vol#: 212

EMC 2124 Felicity Vol#: 212

EMC 2125 France Perlman Vol#: 212

EMC 2126 Frederick Manslau Vol#: 212

EMC 2127 Anthony Green Vol#: 212

EMC 2128 Eric Althoff Vol#: 212

EMC 2129 Lynne Matthews Vol#: 212

EMC 2130 Julia Macdonell Vol#: 212

EMC 2131 Jason Sherman Vol#: 212

EMC 2132 Chris Simon Vol#: 212

EMC 2133 Bob Segal Vol#: 212

EMC 2134 Cinnamon Williams Vol#: 212

EMC 2135 Leif Olsen Vol#: 212

EMC 2136 Cleo Borac Vol#: 212

EMC 2137 Susan Tauger Vol#: 212

EMC 2138 J. Cohen Vol#: 212

EMC 2139 Scott Edmondson Vol#: 212

EMC 2140 Zsolt Jaray Vol#: 212

EMC 2141 Thom Lanigan Vol#: 212

EMC 2142 Dr. Nick Drake Vol#: 212

EMC 2143 Jessica Zern Vol#: 212

EMC 2144 Peter Boyle Vol#: 212

EMC 2145 Zoe Redgrove Vol#: 212

EMC 2146 E. Coldwell-Hall Vol#: 212

EMC 2147 Deborah Loe Vol#: 212

EMC 2148 Brian DeLay Vol#: 212

EMC 2149 Andy Lynn Vol#: 212

EMC 2150 Kelly MacInnis Vol#: 212

EMC 2151 Nancy Berggren Vol#: 212

EMC 2152 Hazel Landa Vol#: 212

EMC 2153 Keiley Shearer Vol#: 212

EMC 2154 Nathan Paternostro Vol#: 212

EMC 2155 Amanda Young Vol#: 212

EMC 2156 Anna Cimini Vol#: 212

EMC 2157 Patty Hall Vol#: 212

EMC 2158 Kalin Nenov Vol#: 212

EMC 2159 Hannah Irwin Vol#: 212

EMC 2160 Gisela Kelso Vol#: 212

EMC 2161 Alison Cox Vol#: 212

EMC 2162 Oscar Amaral Palafox Leal Vol#: 212

EMC 2163 Elizabeth Simpson Vol#: 212

EMC 2164 Michael Vol#: 212

EMC 2165 Audra Conard Vol#: 212

EMC 2166 Rachel Sorock Vol#: 212

EMC 2167 Cristina Riefkohl Vol#: 212

EMC 2168 Jesus Quintanilla Osorio Vol#: 212

EMC 2169 Matthew Green Vol#: 212

EMC 2170 Steve Golding Vol#: 212

EMC 2171 Norbert Owtscharenko Vol#: 212

EMC 2172 Susie Green Vol#: 212

EMC 2173 Annapoorne Colangelo Vol#: 212

EMC 2174 Daniel Brower Vol#: 212

EMC 2175 Crystal Rose Henson Vol#: 212

EMC 2176 Dan Hoal Vol#: 212

EMC 2177 Lillian Morrison Vol#: 212

EMC 2178 Cassi Arrowsmith Vol#: 212

EMC 2179 Lydia Lopez Arteaga Vol#: 212

EMC 2180 Patrick Heffer Vol#: 212

EMC 2181 John Economou Vol#: 212

EMC 2182 Juliann Murphy Vol#: 212

EMC 2183 Charlie Radcliffe Vol#: 212

EMC 2184 Lei Zhang Vol#: 212

EMC 2185 William Estep Vol#: 212

EMC 2186 Sander Hollestelle Vol#: 212

EMC 2187 Valerie Tomlinson Vol#: 212

EMC 2188 Roberta Gogos Vol#: 212

EMC 2189 Carole Mortimer Vol#: 212

EMC 2190 Tracey Barkman Vol#: 212

EMC 2191 Donncha McDermott Vol#: 212

EMC 2192 Asa Gronlund Vol#: 212

EMC 2193 Shana Gross Vol#: 212

EMC 2194 Nicola Hesketh Vol#: 212

EMC 2195 Kathy Cox Vol#: 212

EMC 2196 Morand Muriel Vol#: 212

EMC 2197 Brenda Curran Vol#: 212

EMC 2198 William Ruisbroek Vol#: 212

EMC 2199 Kyle Jeffries Vol#: 212

EMC 2200 No signature Vol#: 212

EMC 2201 Brenna Lee Vol#: 212

EMC 2202 Jill Sweeney Vol#: 212

EMC 2203 Claudia Vaz Vol#: 212

EMC 2204 Gabi Eichl Vol#: 212

EMC 2205 Terah Walkup Vol#: 212

EMC 2206 no signature Vol#: 212

EMC 2207 Codey Brown Vol#: 212

EMC 2208 Matthias Hillmann Vol#: 212

EMC 2209 Claire Insley Vol#: 212

EMC 2210 Kara Fosbender Vol#: 212

EMC 2211 Maria Palacio Vol#: 212

EMC 2212 Leah McInnes Vol#: 212

EMC 2213 John O'Keefe Vol#: 212

EMC 2214 Marijke Wevers Vol#: 212

EMC 2215 Lauren Magnuson Vol#: 212

EMC 2216 Vered Gordan Vol#: 212

EMC 2217 Carmen Peozyn Vol#: 212

EMC 2218 Joanna McClatchie Vol#: 212

EMC 2219 Chris Svec Vol#: 212

EMC 2220 Amelia Nankivell Vol#: 212

EMC 2221 Anne Christiansen Vol#: 212

EMC 2222 Rachel Smith-Lyte Vol#: 212

EMC 2223 Pels Chris Vol#: 212

EMC 2224 Tracey Mills Vol#: 212

EMC 2225 Joao Zamite Vol#: 212

EMC 2226 Pamala Newland Vol#: 212

EMC 2227 Jaime Queen Vol#: 212

EMC 2228 Suzanne Oldham Vol#: 212

EMC 2229 Zoe Steeves Vol#: 212

EMC 2230 Alessandra Ferrari Vol#: 212

EMC 2231 Johnathan Keeney Vol#: 212

EMC 2232 Stephen Andrew Blydenburgh Vol#: 212

EMC 2233 Cheryl Thorne Vol#: 212

EMC 2234 Bradley Kennedy Vol#: 212

EMC 2235 Beth Layman Vol#: 212

EMC 2236 Myoung Lee Vol#: 212

EMC 2237 Clayton Perry Vol#: 212

EMC 2238 Jen von Sehlen Vol#: 212

EMC 2239 Elliot Reed Vol#: 212

EMC 2240 Jessie Ingram Vol#: 212

EMC 2241 Gary Moss Vol#: 212

EMC 2242 Katie Glodzik Vol#: 212

EMC 2243 Kathryn Sky Vol#: 212

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1097 Nancy Gibson Vol#: 5

EMC 1098 R. Wright Vol#: 5

01P-0524 Hydrocodone Bitartrate & Acetaminophen Oral Solution 10 mg

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

02D-0113 Root-Form Endosseous Dental Implants and Abutments

C 1 Implant Innovations, Inc. Vol#: 1

C 2 PaxMed International Vol#: 1

02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV

C 4 Merck & Co., Inc. Vol#: 1

02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re

C 5 Bioanalytical Systems Inc. Vol#: 1

02D-0237 QIE Evaluation of Stability Data

C 4 Bristol-Myers Squibb Vol#: 1

02D-0242 Pharmacy Compounding Compliance Policy Guide

C 2 International Academy of Compounding Pha Vol#: 1

02D-0258 Sudies for Orally Administered Drug Products

C 2 Pharmacia Corporation Vol#: 1

C 3 Merck & Co., Inc. Vol#: 1

C 4 Generic Pharmaceutical Assn (GPhA) Vol#: 1

C 5 Bristol-Myers Squibb Vol#: 1

02D-0307 Potassium Chloride Modified-Release Tablets and Capsules

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02N-0058 Pediculicide Drug Products for OTC Human Use

C 1 CHPA, Consumer Healthcare Products Assn. Vol#: 1

C 2 Qualis, Inc. Vol#: 1

02N-0104 Consumer Handling of Ready-To-Eat Foods;Collection Informati

N 2 Vol#: 1

02N-0208 State Enforcement Notifications

N 2 Vol#: 1

02N-0332 International Conference on Harmonization (Washington, DC)

NM 1 Meeting held 9 to 12, 2002 Vol#: 1

02P-0105 ANDA Suitability for Oxycodone and Acetaminophen Tablets

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

02P-0139 Arava (leflunomide;Aventis) remove from the market

C 1 Adventis Pharms, Inc. Vol#: 2

02P-0161 ANDA Suitability for Isotretinoin Capsules 30 mg

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

02P-0360 Chemical Cleaning Products for Industrial Food

ACK 1 HFA-305 Vol#: 1

PSA 1 J. B. Proveedores S.A. DE C. Vol#: 1