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 March 22, 2002

TABLE OF CONTENTS

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00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01P-0426 Determine Status of Oxycontin Extended-Release Tabs. 160 mg *
01P-0447 Withdrawn for Safety or Effectivess of Ardeparin Sodium *
01P-0481 In Vivo Bioequivalance Study for Generic Skelaxin Tablets *
02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20 *
02P-0120 Request the immediate ban of Meridia (sibutramine) *
02P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com. *

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 94 Debbie McKillop Vol#: 4988

CA 95 Tom Humm Vol#: 4988

CA 96 Lori L. Rothermel Vol#: 4988

CA 97 Richard Bean, II Vol#: 4988

CA 98 Dave Costanzo Vol#: 4988

CA 99 William V. Collison Vol#: 4988

CA 100 Kevin P. Slater Vol#: 4988

CA 101 Robert G. Sell, Jr. Vol#: 4988

CA 102 William R. Neff, Jr. Vol#: 4988

CA 103 Carl Vandenbraak Vol#: 4988

CA 104 Edward T. Huff Vol#: 4988

CA 105 Holly Ann DeAmelia Vol#: 4988

CA 106 Frederick E. Deamelm Vol#: 4988

CA 107 Mitzie S. Myers Vol#: 4988

CA 108 Timothy T. Hartzog Vol#: 4988

CA 109 Robert Hill Vol#: 4988

CA 110 Jack Schlessman Vol#: 4988

CA 111 Ray Pott Vol#: 4988

CA 112 Gloria T. Wilhelm Vol#: 4988

CA 113 Judy Jance Vol#: 4988

CA 114 Samuel W. Troup Vol#: 4988

CA 115 Mike Seebold Vol#: 4988

CA 116 Richard Sanders Vol#: 4988

CA 117 Charles Evans Vol#: 4988

CA 118 John A. Cross Vol#: 4988

CA 119 Paul Richard Vol#: 4988

CA 120 Anthony Parlack Vol#: 4988

CA 121 Jay A. Hollenback, Sr. Vol#: 4988

CA 122 Virginia A. Huff Vol#: 4988

CA 123 Joee Busila Vol#: 4988

CA 124 Steven Sochinski Vol#: 4988

CA 125 Micheal Kuzma Vol#: 4988

CA 126 Tim Muller Vol#: 4988

CA 127 John Mazack Vol#: 4988

CA 128 Diann Mazack Vol#: 4988

CA 129 Bryan K. Smith Vol#: 4988

CA 130 Micheal Mazack Vol#: 4988

CA 131 Mike Spanik Vol#: 4988

CA 132 Joseph C. Fuller Vol#: 4988

CA 133 Rebecca Turk Vol#: 4988

CA 134 Jim McAuliffe Vol#: 4988

CA 135 Paul E. Willison Vol#: 4988

CA 136 R. L. Martinson Vol#: 4988

CA 137 James Carney Vol#: 4988

CA 138 Doug Damecki Vol#: 4988

CA 139 Edward V. Blick Vol#: 4988

CA 140 Brian K. Skidmore Vol#: 4988

CA 141 Larry G. Freeman Vol#: 4988

CA 142 James Giandalia Vol#: 4988

CA 143 Wendell W. Nale, III Vol#: 4988

CA 144 Tommy Davis Vol#: 4988

CA 145 Vince Burroughs Vol#: 4988

CA 146 Bill Hall Vol#: 4988

CA 147 Richard J. Papile Vol#: 4988

CA 148 Thomas J. Carroll Vol#: 4988

CA 149 Nathan E. Parrish Vol#: 4988

CA 150 C. W. Reed Vol#: 4988

CA 151 Chris Reavis Vol#: 4988

CA 152 Charles E. Wilson Vol#: 4988

CA 153 William S. Banznof Vol#: 4988

CA 154 Penny Davidson Vol#: 4988

CA 155 Sam A. Agajanian, Jr. Vol#: 4988

CA 156 Clayton J. McGeehon Vol#: 4988

CA 157 Helene C. Steves Vol#: 4988

CA 158 J. E. Sims Vol#: 4988

CA 159 Barbara Lynn Madonia Vol#: 4988

CA 160 Mark M. Savage Vol#: 4988

CA 161 Tarene Christenson Vol#: 4988

CA 162 Steve Masoner Vol#: 4988

CA 163 Jay L. Angel, Sr. Vol#: 4988

CA 164 Frances J. Sahaida Vol#: 4988

CA 165 Matthew S. Spurlock Vol#: 4988

CA 166 Bill Dambacher Vol#: 4988

CA 167 Bill Wasson Vol#: 4988

CA 168 Patricia D. Coyle Vol#: 4988

CA 169 T. A. Steele, Sr. Vol#: 4988

CA 170 Ed H. Davidson Vol#: 4988

CA 171 Harold C. Barry, Jr. Vol#: 4988

CA 172 John J. Maftin Vol#: 4988

CA 173 Dale Estes Vol#: 4988

CA 174 Gail Beekman Vol#: 4988

CA 175 Thomas H. Correll Vol#: 4988

CA 176 Ann R. Leckenby Vol#: 4988

CA 177 Steve Worth Vol#: 4988

CA 178 Jose' A. Burgos Vol#: 4988

CA 179 Jose R. Ibanez Vol#: 4988

CA 180 Susan A. DeWatt Vol#: 4988

CA 181 Cathy K. Miller Vol#: 4988

CA 182 Sean Ligtenberg & 2 other signatures Vol#: 4988

CA 183 Jerome L. Echelberger Vol#: 4988

CA 184 Keith McKenzie Vol#: 4988

CA 185 Rocky W. Coller Vol#: 4988

CA 186 Darlene Berk Vol#: 4988

CA 187 Barry R. Hafer Vol#: 4988

CA 188 Lyle Smith Vol#: 4988

CA 189 Stuart Gaplan Vol#: 4988

CA 190 Robin McGuire Vol#: 4988

CA 191 Shirley Berger Vol#: 4988

CA 192 Kerry Anne Young Vol#: 4988

CA 193 Wayne Truesdell Vol#: 4988

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

EMC 1 Annick Losier Vol#: 6

97P-0130 Require Percentage Ingredient Labeling

EMC 316 Sally Rotunno Vol#: 4

EMC 317 Maureen Schatzman Vol#: 4

98N-1038 Irradiation in the production, processing, &handling of food

C 5671 Carolyn G. Hall Vol#: 193

EMC 1016 Frances Archuleta Vol#: 197

EMC 1017 Matthew Hamilton Vol#: 197

EMC 1018 Max Madd Vol#: 197

EMC 1019 Jeanne Peppard Vol#: 197

EMC 1020 Emily Morich Vol#: 197

EMC 1021 J'Quita Anderson Vol#: 197

EMC 1022 Rick D. Byler Vol#: 197

EMC 1023 William J. Gillis Vol#: 197

EMC 1024 Dorothy Martirano Vol#: 197

EMC 1025 Joann Gann Vol#: 197

EMC 1026 Jimmy Gann Vol#: 197

EMC 1027 David Cayford Vol#: 197

EMC 1028 Paul Croser Vol#: 197

EMC 1029 Mark Herman Vol#: 197

EMC 1030 Susan Emge Milliner Vol#: 197

EMC 1031 David Gregal Vol#: 197

EMC 1032 Melissa Ballenberg Vol#: 197

EMC 1033 Kevin Smith Vol#: 197

EMC 1034 Bill Goedecke Vol#: 197

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

C 5686 Ms. Rose Ann Skirha Vol#: 233

C 5687 Merry T. O'Donnell Vol#: 233

EMC 2672 Starla Sholl Vol#: 188

EMC 2673 Frances Ward (England) Vol#: 188

EMC 2674 Mark Herman Vol#: 188

EMC 2675 Lori Sklar Vol#: 188

EMC 2676 Gloria Freeman Vol#: 188

EMC 2677 Lauran Bohdan Vol#: 188

EMC 2678 Christian Trumbull Vol#: 188

EMC 2679 Sherry Adams & Lorrie Scime Vol#: 188

EMC 2680 Anje C. van der Naald Vol#: 188

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 145 Brian Sussman Vol#: 28

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

EMC 3602 Martha Mickey Vol#: 511

EMC 3603 Garrett Kelly Vol#: 511

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 361 Virginia Osborne Vol#: 21

EMC 362 Judy Reeves Vol#: 21

EMC 363 Ann Fonda Vol#: 21

EMC 364 M. Jaynes Vol#: 21

EMC 365 Teresa Lane Vol#: 21

EMC 366 Natalie Knight Vol#: 21

EMC 367 Natalie Knight Vol#: 21

00D-1542 Electronic Signatures: Time Stamps

GDL 2 Guideline Vol#: 6

NAD 1 Vol#: 6

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9710 Anna M. Konopka, M.D., D.P., F.A.A.P Vol#: 460

C 9711 N. Anderson, RN Vol#: 460

C 9712 Sidney S. Letter Vol#: 460

C 9713 Jean Gerber Vol#: 460

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9262 Anna M. Konopka, M.D. Vol#: 404

C 9263 Nancy A. Newbury-Andresen Vol#: 404

C 9264 Sidney S. Letter Vol#: 404

C 9265 Jean Gerber Vol#: 404

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

APE 3 Bayer Corporation Vol#: 96

APE 4 Animal Health Institute Vol#: 96

EMC 17 Shawn Best Vol#: 107

EMC 18 Geoffrey Doman Vol#: 107

EMC 19 Rosemary Massie Vol#: 107

EMC 20 LaDonna Evans Vol#: 107

EMC 21 Diana Oleskevich Vol#: 107

EMC 22 Bonnie Haufe Vol#: 107

EMC 23 Steve Cullen Vol#: 107

EMC 24 Barbara Hart Vol#: 107

EMC 25 Ed DeLeon Vol#: 107

EMC 26 Angela Alston Vol#: 107

EMC 27 Arrie Hammel Vol#: 107

EMC 28 Judy Zabriskie Vol#: 107

EMC 29 Cynthia Clark Vol#: 107

EMC 30 Andi Luke Vol#: 107

EMC 31 Kevin Covey Vol#: 107

EMC 32 Jessica Johnson Vol#: 107

EMC 33 Lynne Gabbe-Harkcom Vol#: 107

EMC 34 Andrew Zuckerberg Vol#: 107

EMC 35 Patsy Wilson Vol#: 107

EMC 36 Genie Kerr Vol#: 107

EMC 37 Scot Waring Vol#: 107

EMC 38 Donna Spencer Vol#: 107

EMC 39 Carmen Johnston Vol#: 107

EMC 40 Suzan Stewart Vol#: 107

EMC 41 Tammy LaRue Vol#: 107

EMC 42 Claire Todd Vol#: 107

EMC 43 Jocelyn Chalmers Vol#: 107

EMC 44 Elizabeth Dominguez Vol#: 107

EMC 45 Clare & Zoltan Szilagyi Vol#: 107

EMC 46 Edward Eschweiler Vol#: 107

EMC 47 David Kiley Vol#: 107

EMC 48 Dawn Kudish Vol#: 107

EMC 49 Kate Davis Vol#: 107

EMC 50 Cecilia Stancell Vol#: 107

EMC 51 David Weinstein Vol#: 107

EMC 52 Rachel Van Sickle Vol#: 107

EMC 53 Jessica King Vol#: 107

EMC 54 Lauryn Slotnick Vol#: 107

EMC 55 Shari Wildschutte Vol#: 107

EMC 56 Joy Newbold Vol#: 107

EMC 57 Sandra Stocke Vol#: 107

EMC 58 Katherine Heiser Vol#: 107

EMC 59 Sara Herlock Vol#: 107

EMC 60 Gregg Severson Vol#: 107

EMC 61 Ben Dyckman Vol#: 107

EMC 62 Richard Ballerand Vol#: 107

EMC 63 Bruce Selyem Vol#: 107

EMC 64 Chris Lade Vol#: 107

EMC 65 SK Wies Vol#: 107

EMC 66 Judy Smith Vol#: 107

EMC 67 Frances Perlman Vol#: 107

EMC 68 Bonnie Carollin Vol#: 107

EMC 69 Frank Ackerman Vol#: 107

EMC 70 Sarah Hanson Vol#: 107

EMC 71 Carolyn J. Bishop Vol#: 107

EMC 72 Anne Tice Vol#: 107

EMC 73 Ellen Bridle Vol#: 107

EMC 74 Ellen Westbrook Vol#: 107

EMC 75 Charlotte R. Hummon Vol#: 107

EMC 76 Paul Ardoin Vol#: 107

EMC 77 Kelly Krause Vol#: 107

EMC 78 Susan Robertson Vol#: 107

EMC 79 Dr. Stephanie Blackton Vol#: 107

EMC 80 Greg Apo Vol#: 107

EMC 81 Susan Tinkle Vol#: 107

EMC 82 Jay Antol Vol#: 107

EMC 83 Ron Gordon Vol#: 107

EMC 84 Laura Reese Vol#: 107

EMC 85 Jeannie Graham Vol#: 107

EMC 86 Martin Wolf Vol#: 107

EMC 87 W. James & Mary Beth Soetaert Vol#: 107

EMC 88 Jerry Roahrig Vol#: 107

EMC 89 Dr. Kenneth Koym Vol#: 107

EMC 90 Colin Doran Vol#: 107

EMC 91 Joanne Collins Vol#: 107

EMC 92 Lisanne Pearcy Vol#: 107

EMC 93 Dianne Burnham Vol#: 107

EMC 94 Sue Sherrill Vol#: 107

EMC 95 Heather Hweimel Vol#: 107

EMC 96 Brian Klein Vol#: 107

EMC 97 Joseph Armstrong Vol#: 107

EMC 98 Carl Preto Vol#: 107

EMC 99 Andrea Saunders Vol#: 107

EMC 100 William Hamilton Vol#: 107

EMC 101 Hanne J. Nielsen Vol#: 107

EMC 102 Judi Mangan Vol#: 107

EMC 103 Carla Beaudet Vol#: 107

EMC 104 Tim Irving Vol#: 107

EMC 105 Michelle Nettuno Vol#: 107

EMC 106 Linda Riebel Vol#: 107

EMC 107 Will Bond Vol#: 107

EMC 108 Kathy McElwain Vol#: 107

EMC 109 Jennifer Moix Vol#: 107

EMC 110 Nora Prentice Vol#: 107

EMC 111 Rene Maloney Vol#: 107

EMC 112 Lisa Hannon Vol#: 107

EMC 113 Judith McGeary Vol#: 107

EMC 114 Peter T. Tarpgaard Vol#: 107

EMC 115 Benjamin Randolph Vol#: 107

EMC 116 Angela Nations Vol#: 107

EMC 117 Barbara Bryden Vol#: 107

EMC 118 Shannon Russell Vol#: 107

EMC 119 Ali Ozgenc Vol#: 107

EMC 120 Carrie Paige Vol#: 107

EMC 121 Curtis Goss Vol#: 107

EMC 122 Julia Rajcan Vol#: 107

EMC 123 Burnell Vincent Vol#: 107

EMC 124 Sally LaJoie Vol#: 107

EMC 125 Sherry Glover Vol#: 107

EMC 126 Rik Farrow Vol#: 107

EMC 127 Paul Hubbard Vol#: 107

EMC 128 Frank Pilholski Vol#: 107

EMC 129 Mary G. Rust Vol#: 107

EMC 130 Milton Patrie Vol#: 107

EMC 131 Sarah Frenzel Vol#: 107

EMC 132 Kristen Nowicki Vol#: 107

EMC 133 Charlene Wagner Vol#: 107

EMC 134 Janet S. Johnson Vol#: 107

EMC 135 Robert Stone Vol#: 107

EMC 136 Ruth Zientek Vol#: 107

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12599 Chloe Kilman Vol#: 783

C 12600 Dana Greci Vol#: 783

C 12601 Jill Tramontano Vol#: 783

C 12602 Shawn Carney Vol#: 783

C 12603 Pat & Bob Bertschy Vol#: 783

C 12604 Gaylord Yost Rushills Vol#: 783

C 12605 Sharon E Nelson Vol#: 783

C 12606 S Heddin Vol#: 783

C 12607 Sevelace Melik Vol#: 783

C 12608 P Sladek Vol#: 783

EMC 5190 Maryellen Keevers Vol#: 774

EMC 5191 Eli Sarnat Vol#: 774

EMC 5192 Rachel Trinidad Vol#: 774

EMC 5193 Pamela Smith Vol#: 774

EMC 5194 Angela Graziano Vol#: 774

EMC 5195 Phillip Morgan Vol#: 774

EMC 5196 Phillip Morgan Vol#: 774

EMC 5197 Anita Newman Vol#: 774

EMC 5198 Anita Newman Vol#: 774

EMC 5199 Terrie Monti Vol#: 774

EMC 5200 Terrie Monti Vol#: 774

EMC 5201 Heidi Rupley Vol#: 774

EMC 5202 katharine Treap Vol#: 774

EMC 5203 Donna Hoaglin Vol#: 774

EMC 5204 John Strouss Vol#: 774

EMC 5205 Curt Stewart Vol#: 774

EMC 5206 Jonathan Leiss Vol#: 774

EMC 5207 Annemarie Colbin Vol#: 774

EMC 5208 David Whitehouse Vol#: 774

EMC 5209 William B Winget Vol#: 774

EMC 5210 Gretchen Wernersbach Vol#: 774

EMC 5211 Tom Pendleton Vol#: 774

EMC 5212 Christopher Newhouse Vol#: 774

EMC 5213 Anne Powers-Beck Vol#: 774

EMC 5214 Tony Conrad Vol#: 774

EMC 5215 Sandra Grant Vol#: 774

EMC 5216 Sandra Grant Vol#: 774

EMC 5217 Lisa Christopherson Vol#: 774

EMC 5218 Phyllis Berentsen Vol#: 774

EMC 5219 Jessica Evans Vol#: 774

EMC 5220 Daniel Dubnicka Vol#: 774

EMC 5221 Natasha & Noah Brenner Vol#: 774

EMC 5222 John C Scott Vol#: 774

EMC 5223 Norma G Hunt Vol#: 774

EMC 5224 R Ruediger Vol#: 774

EMC 5225 Cynthia Carson Vol#: 774

EMC 5226 Meyer Scharlack Vol#: 774

EMC 5227 Martha Mickey Vol#: 774

EMC 5228 Garrett Kelly Vol#: 774

01N-0458 Fast Track Drug Development Programs Designation,Development

BKG 1 Background Material Refs 1-26 Vol#: 2

NPR 1 Vol#: 2

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 841 James French Vol#: 190

C 842 Derek Blackwell Vol#: 190

C 843 Randall Todd Vol#: 190

C 844 Nekoda Rowley Vol#: 190

C 845 Jennifer Jordan Vol#: 190

C 846 Anne Rodgers Hardy Vol#: 190

C 847 Andrew Moran Vol#: 190

C 848 Eda Cook Vol#: 190

C 849 Christina Loff Vol#: 190

C 850 Mr. K. Hurnam Vol#: 190

C 851 Dina Tagliabue Vol#: 190

C 852 Yamiery Vanessa Puchi Vol#: 190

C 853 Iris Smith Vol#: 190

C 854 Pella Coleman Vol#: 190

C 855 Kathy Albrecht Vol#: 190

C 856 Robert Pennington + 28 signatures Vol#: 190

01P-0426 Determine Status of Oxycontin Extended-Release Tabs. 160 mg

LET 1 HFD-1 to Lachman Consultant Services, In Vol#: 1

01P-0447 Withdrawn for Safety or Effectivess of Ardeparin Sodium

LET 1 HFD-1 to John W. Herr Vol#: 1

01P-0481 In Vivo Bioequivalance Study for Generic Skelaxin Tablets

PAV 1 HFD-1 to Elan Pharmaceuticals, Inc. Vol#: 1

02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20

AMD 1 Kleinfeld, Kaplan & Becker Vol#: 1

02P-0120 Request the immediate ban of Meridia (sibutramine)

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citzen Health Research Group Vol#: 1

02P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.

ACK 1 HFA-305 Vol#: 1

CP 1 CSPI Vol#: 1

02V-0119 Laser light show

ACK 1 HFA-505 Vol#: 1

VAR 1 George W. Long, Inc./SeaBreeze Amusement Vol#: 1