DOCKETS ENTERED on February 21, 2001

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products

C 593 L'Oreal USA Inc Vol#: 146

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

C 77 L'Oreal USA Inc Vol#: 8

95N-0259 Over the Counter Drug Labeling; Public Hearing

C 23 L'Oreal USA Inc Vol#: 13

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

C 1029 L'Oreal USA Inc Vol#: 25

98D-0994 Draft Guidance for Industry on BACPAC I

GDL 2 GUIDANCE Vol#: 2

NAD 2 Vol#: 2

98N-0337 Over the counter human drugs labeling requirements

C 9 L'Oreal USA Inc Vol#: 6

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

C 3899 Mrs. Anna Maranzani Vol#: 121

C 3900 Nancy Priest Vol#: 121

C 3901 Leslie Vol#: 121

C 3902 Matthew Perchemlides Vol#: 121

C 3903 Jeanne M. Wright Vol#: 121

C 3904 Karen Curcio Vol#: 121

C 3905 Mrs. Jan Peterson Vol#: 121

C 3906 Robert J. Buczek Vol#: 121

C 3907 Melody Struna Vol#: 121

C 3908 Sue Clark Vol#: 121

C 3909 Theron C. Ris Vol#: 123

C 3910 Peggy Monning Porteau (Mexico) Vol#: 123

C 3911 Amy K. Metzner Vol#: 123

C 3912 Eleanor Obrychi Vol#: 123

C 3913 Caroline Falzarano Vol#: 123

C 3914 Terri, Enid & James Morhaleck Vol#: 123

C 3915 Philomena Glowka Vol#: 123

C 3916 Lori J. Rumpf Vol#: 123

C 3917 T.M. Locklear Vol#: 123

C 3918 Tami Kutz Robertson Vol#: 123

C 3919 K. A. Costello Vol#: 123

C 3920 Tina Locklear Vol#: 123

C 3921 JoAnn Amato Vol#: 123

C 3922 Mr. & Mrs. Frank Evans Vol#: 123

C 3923 J. Burmahl Vol#: 123

C 3924 Ronnie Carole Poplock Vol#: 123

C 3925 Lucille B. Messinger Vol#: 123

C 3926 Lisa A. Reager Vol#: 123

C 3927 Dorothy M. Egeland Vol#: 123

C 3928 Patricia G. Boyer Vol#: 123

C 3929 Rachel M. Lang Vol#: 123

EMC 1119 Amanda Jimenez Vol#: 121

EMC 1120 Junia d'Affonseca Vol#: 121

EMC 1121 Business Development Vol#: 123

EMC 1122 Rachel M. Lang Vol#: 123

EMC 1123 Margo Johnson Vol#: 123

EMC 1124 Cynthia Krueger Vol#: 123

EMC 1125 Georgiana & Richard Bishop Vol#: 123

EMC 1126 Ruth Abbott Vol#: 123

EMC 1127 Mindy R. MacKay Vol#: 123

EMC 1128 Karen Lane Vol#: 123

EMC 1129 Shannon Jacobs Vol#: 123

EMC 1130 Environmental Assn for Great Lakes Educa Vol#: 123

EMC 1131 Carol Marthaller Vol#: 123

EMC 1132 Kristine Dempze Vol#: 123

EMC 1133 Roger Kimble Vol#: 123

EMC 1134 Erin Anshanslin Vol#: 123

EMC 1135 Doug Lenier Vol#: 123

EMC 1136 Carri King Vol#: 123

EMC 1137 Tavia Lin Gilbert Vol#: 123

EMC 1138 Christine Johnes Vol#: 123

EMC 1139 Dean Anderson Vol#: 123

EMC 1140 Diana Artemis Vol#: 123

EMC 1141 Sharon M. Krawczyk Vol#: 123

EMC 1142 Melanie Streitfeld Vol#: 123

EMC 1143 Stacie DeFontes Vol#: 123

EMC 1144 Ruth Abbott Vol#: 123

EMC 1145 Kerry-Ann Stanley (London) Vol#: 123

EMC 1146 Lou Rhodes Vol#: 123

EMC 1147 Bobbie D. Flowers Vol#: 123

EMC 1148 Michael L. Rickson Vol#: 123

EMC 1149 Wendy Lochner Vol#: 123

EMC 1150 J.M. Rudder Vol#: 123

EMC 1151 C. Ptolemy Vol#: 123

EMC 1152 Calder Martin Vol#: 123

EMC 1153 Stefany Vol#: 123

EMC 1154 Lydia Ciacci Vol#: 123

EMC 1155 Cburres Vol#: 123

EMC 1156 Cecilie Finkelstein & John Waters Vol#: 123

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 104 Paul Scilipote Vol#: 40

EMC 105 Cate Nelson Vol#: 40

EMC 106 Judy Turk Vol#: 40

EMC 107 Neysa Linzer Vol#: 40

EMC 108 Harry & Anne Ellis Vol#: 40

EMC 109 Jerrie Song Vol#: 40

EMC 110 Stephenie Halpert Vol#: 40

EMC 111 Nicole Anderson Vol#: 40

EMC 112 Miro Reverby Vol#: 40

EMC 113 Terry Huey Vol#: 40

EMC 114 Connie Grant Vol#: 40

EMC 115 Avalyn Pitts Vol#: 40

EMC 116 Anne E Boccini Vol#: 40

EMC 117 Eve Cruse Vol#: 40

EMC 118 Kathryn J Monro Vol#: 40

EMC 119 NUMBER NOT USED Vol#:

EMC 120 Patricia Friedman Vol#: 40

EMC 121 Candice Cooper-Greinke Vol#: 40

EMC 122 Heather Contreras Vol#: 40

EMC 123 Alexander Contreras Vol#: 40

EMC 124 Marvin Perez Vol#: 40

EMC 125 Shari Wildschutte Vol#: 40

EMC 126 NUMBER NOT USED Vol#: 40

EMC 127 Jon Fiebelkorn Vol#: 40

EMC 128 Deborah K Britt Vol#: 40

EMC 129 Robin Grae Vol#: 40

EMC 130 Valerie Byxbe Vol#: 40

EMC 131 Mark Lipsman Vol#: 40

EMC 132 Vol#: 40

00D-1313 Disposition of Animals

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1316 Request for a Meeting to the office of new Animal Drug Eval

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 351 Jo Jo Dancer Vol#: 27

C 352 Sarah Matsoeto Vol#: 27

C 353 Paula Schnelling Vol#: 27

C 354 Susan Wolterstorff Vol#: 27

C 355 Lou Vottero Vol#: 27

C 356 Claudia Short Vol#: 27

C 357 Pat Weiler Vol#: 27

C 358 Agnes Anderson Vol#: 27

C 359 Nancy Lamn Vol#: 27

C 360 Andrea C. Montoya Vol#: 27

C 361 B. Winans Vol#: 27

C 362 Fredricka Stoller Vol#: 27

C 363 Kelly Bradsher Vol#: 27

C 364 Edith Richman Vol#: 27

C 365 Peg Maxwell Vol#: 27

C 366 Evelyn Knazek Vol#: 27

C 367 Michael D. Michon Vol#: 27

C 368 John L. Scripp III Vol#: 27

C 369 C & Betty P. Funk Vol#: 27

C 370 David Shelly Vol#: 27

C 371 Elizabeth Gerstley Vol#: 27

C 372 Betty Funk Vol#: 27

C 373 Lorna G. Clark Vol#: 27

C 374 Gayle Lauradurn Vol#: 27

00F-0789 Safe Use for X-radiation and Electron Beam Energy Sources

NFR 1 Vol#: 1

00N-1269 Labeling for human prescription drug/Biologic Products

EC 1 Ms. Julana Powell Vol#: 2

EMC 1 Angelo Martignoni Vol#: 2

EMC 2 Sylvia Shallon Vol#: 2

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EC 1 Mr. Patrick Kliner Vol#: 17

EC 2 Veritas Vol#: 17

EC 3 Mrs. Cheri Smith Vol#: 17

EC 4 Mrs. Danielle Schoonover Vol#: 17

EC 5 Mr. Frank Welsch Vol#: 17

EC 6 Mrs. Linda Kocsis Vol#: 17

EC 7 Writing Solutions Vol#: 17

EC 8 Mr. Peter C. Browning Vol#: 17

EC 9 Ms. Julie Alpers Vol#: 17

EC 10 Mr. Patrick Dominguez Vol#: 17

EC 11 Ms. Jo Ann Morgan Vol#: 17

EC 12 Mr. Daniel Daley Vol#: 17

EC 13 Mrs. Monica Johnson Vol#: 17

EC 14 Mr. Jon Thompson Vol#: 17

EC 15 Ms. Jenine Gironda Vol#: 17

EC 16 Mr. Joshua Forgotson Vol#: 17

EC 17 Mr. Fred Powledge Vol#: 17

EC 18 Dr. Hamer Paschal Vol#: 17

EC 19 Baylor College of Medicine Vol#: 17

EC 20 Ceres, Inc Vol#: 17

EC 21 American Council on Science and Health Vol#: 17

EC 22 University of Utah Vol#: 17

EC 23 www.gmfoodnews.com Vol#: 17

EC 24 Dr. Roger Morton Vol#: 17

EC 25 none Vol#: 17

EC 26 Ms. Diana Law Vol#: 17

EC 27 Brigham Young University Vol#: 17

EC 28 Dr. David Alban Vol#: 17

EC 29 Ms. TINA FALASCA Vol#: 17

EC 30 us citizen Vol#: 17

EC 31 none Vol#: 17

EC 32 Mr. Donald Hepler Vol#: 17

EC 33 Mrs. Lora DAlton Vol#: 17

EC 34 Ms. Martha Caster Lloyd Vol#: 17

EC 35 Dr. Geoff Canty Vol#: 17

EC 36 N/A Vol#: 17

EC 37 Mr. Milton Willford Vol#: 17

EC 38 Ms. Teresa Anderson Vol#: 17

EC 39 Ms. Martha Nelson Vol#: 17

EC 40 n/a Vol#: 17

EC 41 individual Vol#: 17

EC 42 Ms. Loretta Jewell Vol#: 17

EC 43 Mr. Dan Perkins Vol#: 17

EC 44 Mr. George Sirianni Vol#: 17

EC 45 Mrs. Karen Fitch Vol#: 17

EC 46 Ms. Amy Fowler-Howell Vol#: 17

EC 47 Ms. Kathyrn Dawson Vol#: 17

EC 48 Ms. Kathy Robles Vol#: 17

EC 49 Mr. John Fitch Vol#: 17

EC 50 Ms. Hannah Redd Vol#: 17

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 143 Eric Gonder, DVM,MS,PhD,PAS,ACPV Vol#: 19

C 144 Food Chain Quality and Zoonoses Vol#: 19

C 145 Environmental Defense Vol#: 19

C 146 North Carolina State University Vol#: 19

C 147 California Poultry Federation Vol#: 19

C 148 The Humane Society Vol#: 19

C 149 National Chicken Council Vol#: 19

C 150 Veterinary Laboratories Agency Vol#: 19

C 151 Louisiana State University Vol#: 19

C 152 Mary Alice Smith, Ph.D Vol#: 19

C 153 Dr. Trudy M. Wassenaar, BSc PhD Vol#: 19

C 154 Massachusetts General Hospital Vol#: 19

C 155 National Turkey Federation (NTF) Vol#: 19

C 156 School of Environmental Science,Engineer Vol#: 19

C 157 Veterinary Laboratories Agency Vol#: 19

C 158 University of Freiburg Vol#: 23

C 159 University of Cologne Vol#: 23

C 160 Cox Associates Vol#: 23

C 161 Eva Berndtson, DVM PhD Vol#: 23

C 162 Agrimetrics Associates Inc. Vol#: 23

HER 2 Animal Health Institute Vol#: 23

SUP 1 Bayer Corporation Vol#: 21

00N-1637 Promotional Labeling for Drugs and Biologics for Human Use

EC 7 Mrs. Stephanie Morales Vol#: 1

00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt

EMC 4 Donald J Walski Vol#: 1

EMC 5 Wayne P Lill Jr Vol#: 1

EMC 6 Martha Carey Vol#: 1

EMC 7 Leslie Zucker Vol#: 1

EMC 8 L Robinson Vol#: 1

EMC 9 Mark Gallin Vol#: 1

EMC 10 Mark Gallin Vol#: 1

EMC 11 Rebecka Tyre Vol#: 1

EMC 12 Kim Hanks Vol#: 1

EMC 13 John Melnychuk Vol#: 1

EMC 14 Bernard W Miltenberger Vol#: 1

EMC 15 John Hall Vol#: 1

EMC 16 Tom Owen Vol#: 1

EMC 17 Anita Shattuck Vol#: 1

01N-0057 Safety or Effectiveness not reason for withdrawal of ANDA

N 1 Vol#: 1

01V-0076 Laser Light Show

ACK 1 HFA-305 Vol#: 1

01V-0077 Laser light show

ACK 1 HFA-305 Vol#: 1

01V-0080 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Audio Climax Sound & Light Co. Vol#: 1