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 November 18, 2002

TABLE OF CONTENTS

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89P-0044 ANDA SUITABILITY - PSEUDOEPHEDRINE HCL 12HR CAPSULES *
91P-0203 Revision of Fluoxetine (Prozac) Labeling *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
02D-0320 Hold following clinical investigator misconduct *
02D-0333 Juice HACCP Hazards and Controls *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0462 Use of Implied Nutrient Content Claim - "Carbolite" *
02P-0489 Request Revision of CVM's Bioequivalence Guidelines *

89P-0044 ANDA SUITABILITY - PSEUDOEPHEDRINE HCL 12-HR CAPSULES

ACK 1 HFA-305 Vol#: 1

91P-0203 Revision of Fluoxetine (Prozac) Labeling

ACK 1 HFA-305 Vol#: 1

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

C 63 Honorable Gordon H. Smith (CI) Vol#: 2

C 64 Honorable Gordon H. Smith (CI) Vol#: 2

C 65 The Canberra Hospital Vol#: 2

EMC 4 E.J. Chichilnisky Vol#: 7

EMC 5 Jeffrey Brown, PhD Vol#: 7

EMC 6 Sarah Pope Vol#: 7

EMC 7 Pamala Murphy Vol#: 7

EMC 8 Karen Bennett Vol#: 7

EMC 9 Rolland Miller Vol#: 7

EMC 10 Tucker Ruberti Vol#: 7

EMC 11 Richard Lahn Vol#: 7

EMC 12 Paul Steffen Vol#: 7

EMC 13 Sophia Conroy Vol#: 7

EMC 14 Krista Leraas Vol#: 7

EMC 15 Scott Sanders Vol#: 7

EMC 16 Martine Chirayath Vol#: 7

EMC 17 Gail Cole Vol#: 7

EMC 18 Jennifer Galloway Vol#: 7

EMC 19 Mindy Barker Vol#: 7

EMC 20 Anthony Gazzillo Vol#: 7

EMC 21 Janis Sawyer Vol#: 7

EMC 22 Tom Pendleton Vol#: 7

EMC 23 Gene Hanson Vol#: 7

EMC 24 Hannah Mason Vol#: 7

EMC 25 Shannon Erwin Vol#: 7

EMC 26 Michael Cummings Vol#: 7

EMC 27 Linda Schneider Vol#: 7

EMC 28 Clay Campbell Vol#: 7

EMC 29 Jonathan Mueller Vol#: 7

EMC 30 Pamela Fregeau Vol#: 7

EMC 31 Becky Russell Vol#: 7

EMC 32 Charles R. Cooper Vol#: 7

EMC 33 Cathie Silano Vol#: 7

EMC 34 Rev John C. Fowler Vol#: 7

EMC 35 Keith Gillette Vol#: 7

EMC 36 Eston & Peggy Evans Vol#: 7

EMC 37 Judith A. Kaluzny Vol#: 7

EMC 38 Wendy Abrams Vol#: 7

EMC 39 K. Higgins Vol#: 7

EMC 40 James Spaulding Vol#: 7

EMC 41 Joseph Newton Vol#: 7

EMC 42 Wendy Chou Vol#: 7

EMC 43 Robin Williams Vol#: 7

EMC 44 Gene Zaglin, MD Vol#: 7

EMC 45 Nancy Brown Vol#: 7

EMC 46 Jon McCann Vol#: 7

EMC 47 Renee Cossutta Vol#: 7

EMC 48 Amy Granato, VMD Vol#: 7

EMC 49 Gary Zimmerman Vol#: 7

EMC 50 Susan Piulsipher Vol#: 7

EMC 51 Sharon Brown Vol#: 7

EMC 52 Virginia Sullivan Vol#: 7

EMC 53 Douglas Underwood Vol#: 7

EMC 54 Leroy G. Fox Vol#: 7

EMC 55 Anna Sommer Vol#: 7

EMC 56 John Van Arnold Vol#: 7

EMC 57 Debra Johnson Vol#: 7

EMC 58 Susan D. Lannin Vol#: 7

EMC 59 C.E. Linderman Vol#: 7

EMC 60 Evangelos Kappos Vol#: 7

EMC 61 Rev Stewart Wilber Vol#: 7

EMC 62 Chris Jacobs Vol#: 7

EMC 63 Edgar D. Short Vol#: 7

EMC 64 Terese Bridges Vol#: 7

EMC 65 Greg Baskin Vol#: 7

EMC 66 Fred Leonard Vol#: 7

EMC 67 Kellilee Williams Vol#: 7

EMC 68 Maximilian Eisenburger Vol#: 7

EMC 69 Eric Wallander Vol#: 7

EMC 70 Rick & Joan Meierotto Vol#: 7

EMC 71 Lynn Bowen Vol#: 7

EMC 72 Brian Guice Vol#: 7

EMC 73 Susan Emge Milliner Vol#: 7

EMC 74 Ed Haffmans Vol#: 7

EMC 75 Stanley Bishop Vol#: 7

EMC 76 Edward Kadane Vol#: 7

EMC 77 Lisa Slepetski Vol#: 7

EMC 78 James Conroy Vol#: 7

EMC 79 Dahv Kliner Vol#: 7

EMC 80 Tom and Barbara Hamilton Vol#: 7

EMC 81 Robert Jacobson Vol#: 7

EMC 82 Mike Stoakes Vol#: 7

EMC 83 Dan Gordan Vol#: 7

EMC 84 Andrew Sieff Vol#: 7

EMC 85 Sean Bailey Vol#: 7

EMC 86 Erin Maloney Vol#: 7

EMC 87 Peter Roberts Vol#: 7

EMC 88 C. Jessye McPherson, DVM Vol#: 7

EMC 89 Emerson Kindy Vol#: 7

EMC 90 Sheri R. Murphy Vol#: 7

EMC 91 Michael McCarthy Vol#: 7

EMC 92 June Kidd Vol#: 7

EMC 93 Patricia Morgan Vol#: 7

EMC 94 Margaret Marvell Vol#: 7

EMC 95 Noreen Smith Vol#: 7

EMC 96 JF & PE Savage Vol#: 7

EMC 97 Susan Scalia Vol#: 7

EMC 98 Rosemary L'Erario Vol#: 7

EMC 99 Chloe Metz Vol#: 7

EMC 100 Susanna Smith Vol#: 7

EMC 101 Dave Snedeker Vol#: 7

EMC 102 Donna Funk-Smith Vol#: 7

EMC 103 Marvin Rothfusz Vol#: 7

EMC 104 Amy Belile Vol#: 7

EMC 105 G. Yazersky Vol#: 7

EMC 106 Mike Korah Vol#: 7

EMC 107 Margo Somma Vol#: 7

EMC 108 Mary Abercrombie Vol#: 7

EMC 109 Malcolm J. Bowman Vol#: 7

EMC 110 Margaret Lydecker Vol#: 7

EMC 111 John Disher Vol#: 7

EMC 112 Elisabeth L. Shaw Vol#: 7

EMC 113 Laura Hughes Vol#: 7

EMC 114 Gaby Gollub Vol#: 7

EMC 115 Janie Ackerman Vol#: 7

EMC 116 Sarah Marter Vol#: 7

EMC 117 Robert Bisson Vol#: 7

EMC 118 Nancy Davlantes Vol#: 7

EMC 119 Ann Hollyfield Vol#: 7

EMC 120 Maxine Youngelman Vol#: 7

EMC 121 Jeffifer Eck Vol#: 7

EMC 122 Mia Morosoff Vol#: 7

EMC 123 Susan Vancil Vol#: 7

EMC 124 Samantha Fite Vol#: 7

EMC 125 Linda Block Vol#: 7

EMC 126 Paul R.W. Anthony Vol#: 7

EMC 127 Rhea Hoch Vol#: 7

EMC 128 Dr. Dan Chiras Vol#: 7

EMC 129 Elizabeth Huibregtse Vol#: 7

EMC 130 Jennifer Moix Vol#: 7

EMC 131 Randolph Schoedler Vol#: 7

EMC 132 Dr. Robert Ewing Vol#: 7

EMC 133 Kathleen Walek Vol#: 7

EMC 134 Katherine Hopkins Vol#: 7

EMC 135 Guy Harrison Vol#: 7

EMC 136 Eric Chercover Vol#: 7

EMC 137 Matthew Foley Vol#: 7

EMC 138 Sharon Anderson Vol#: 7

EMC 139 Adrienne Auerbach Vol#: 7

EMC 140 Robert Johnson Vol#: 7

EMC 141 Fred Jakobcic Vol#: 7

EMC 142 Frank Heilmann Vol#: 7

EMC 143 Kathy Urffer Vol#: 7

EMC 144 S. Fierling Vol#: 7

EMC 145 Ann Runyard Vol#: 7

EMC 146 Scott Aycock Vol#: 7

EMC 147 Diane Krell-Bates Vol#: 7

EMC 148 Sara Kube Vol#: 7

EMC 149 Andru Eron Vol#: 7

EMC 150 Amy Sloan Vol#: 7

EMC 151 Brenna Cardy Vol#: 7

EMC 152 Mary Dichtl Vol#: 7

EMC 153 Christopher Diamond Vol#: 7

EMC 154 Jane Rubey Vol#: 7

EMC 155 Nanette Yannuzzi Macias Vol#: 7

EMC 156 Raena Guillotte Vol#: 7

EMC 157 Marsha Feimster Vol#: 7

EMC 158 Marjorie Hughes Vol#: 7

EMC 159 Jill Muse Vol#: 7

EMC 160 Debbie Kruenegel-Farr Vol#: 7

EMC 161 Colleen Morris Vol#: 7

EMC 162 Cory Champagne Vol#: 7

EMC 163 Addi Jyurovat Vol#: 7

EMC 164 Elaine Caton Vol#: 7

EMC 165 Wendy Bartel Vol#: 7

EMC 166 Damianna Purple-Crow Vol#: 7

EMC 167 Cynthia Markiewicz Vol#: 7

EMC 168 Jim Johnson Vol#: 7

EMC 169 Nicole Jardis Vol#: 7

EMC 170 Mark Brakeman Vol#: 7

EMC 171 Diane Anderson Vol#: 7

EMC 172 Jessica Duroe Vol#: 7

EMC 173 Tom W. Hamilton Vol#: 7

EMC 174 Saran & Norton Kirschbaum Vol#: 7

EMC 175 Liz Clements Vol#: 7

EMC 176 Brianna Borders Vol#: 7

EMC 177 Leslie Marshall Vol#: 7

EMC 178 Jennifer Hofmeister Vol#: 7

EMC 179 Ryuichi Fujino Vol#: 7

EMC 180 David Braun Vol#: 7

EMC 181 Mary Reynolds Vol#: 7

EMC 182 Katy Fogg Vol#: 7

EMC 183 Robert Ross Vol#: 7

EMC 184 Kris Rohrsen Vol#: 7

EMC 185 Joyce Meyenberg Vol#: 7

EMC 186 Lyle F & June W. Guion Vol#: 7

EMC 187 Beth Braun Vol#: 7

EMC 188 Mary Myers Vol#: 7

EMC 189 Katherine Kilroy Vol#: 7

EMC 190 Steve Spacek Vol#: 7

EMC 191 Essra Mohawk Vol#: 7

EMC 192 Stewart Wilber Vol#: 7

EMC 193 Donna Walters Vol#: 7

EMC 194 Tom Soppe Vol#: 7

EMC 195 Kristin Schimik Vol#: 7

EMC 196 Hilary Leithauser Vol#: 7

EMC 197 Eric White Vol#: 7

EMC 198 Mike Heaney Vol#: 7

EMC 199 Jay Albrecht, PhD Vol#: 7

EMC 200 Charles Alvarez Vol#: 7

EMC 201 Crystal Wooldridge Vol#: 7

EMC 202 Khoi Nguyen Vol#: 7

EMC 203 John Bonn Vol#: 7

EMC 204 Scott Ripple Vol#: 7

EMC 205 Roland Pierson Vol#: 7

EMC 206 Wayne Ude Vol#: 7

EMC 207 Paul Brown Vol#: 7

EMC 208 Micah Franks Vol#: 7

EMC 209 Beth Partin Vol#: 7

EMC 210 Patricia Anne Swanson Vol#: 7

EMC 211 Brian Toro Vol#: 7

EMC 212 Gena Galenski Vol#: 7

EMC 213 Rich Fusco Vol#: 7

EMC 214 Dianne Light Vol#: 7

EMC 215 Marcia Serio Vol#: 7

EMC 216 Ron Gordon Vol#: 7

EMC 217 Dale Buskirk Vol#: 7

EMC 218 Kevin Krejci Vol#: 7

EMC 219 Mark Cosgriff Vol#: 7

EMC 220 Louise Raterman Vol#: 7

EMC 221 Christy Angell Vol#: 7

EMC 222 John McGruder Vol#: 7

EMC 223 Richard & De Anne Hart Vol#: 7

EMC 224 Melinda Olds Vol#: 7

EMC 225 Jacquelyn V. Strong Vol#: 7

EMC 226 Lily Roselyn Vol#: 7

EMC 227 Gene & Doris Peters Vol#: 7

EMC 228 Marty Lawrence Vol#: 7

EMC 229 Jeff Frontz Vol#: 7

EMC 230 Thomas Naff Vol#: 7

EMC 231 Sherry Seese Vol#: 7

EMC 232 Cassandra Ling Vol#: 7

EMC 233 Michael Harris, MD Vol#: 7

EMC 234 Karen Paulson Vol#: 7

EMC 235 Torrey Nielson Vol#: 7

EMC 236 Caroline Ciochetto Vol#: 7

EMC 237 Emily-Tara Allen Vol#: 7

EMC 238 Anna Tritschler Vol#: 7

EMC 239 Bruce Long Vol#: 7

EMC 240 Jean Reme Vol#: 7

EMC 241 Gary Webb Vol#: 7

EMC 242 Shon Stone Vol#: 7

EMC 243 Karen Richmond Vol#: 7

EMC 244 Steve Kohn Vol#: 7

EMC 245 Dan Carson Vol#: 7

EMC 246 Janice Mullen Vol#: 7

EMC 247 Hayley Moreland Vol#: 7

EMC 248 David Mikkelsen Vol#: 7

EMC 249 Raymond Samoska Vol#: 7

EMC 250 Paige Kenney Vol#: 7

EMC 251 Karen Reyna Vol#: 7

EMC 252 M. Katja Werlich Vol#: 7

EMC 253 Shannon Payne Vol#: 7

EMC 254 Tara Edick Vol#: 7

EMC 255 Caroll Fowler Vol#: 7

EMC 256 Marlene Shaw Vol#: 7

EMC 257 Juli McCormick Vol#: 7

EMC 258 Jon Rosenblatt Vol#: 7

EMC 259 Andrew Grigsby Vol#: 7

EMC 260 Joseph Graham Vol#: 7

EMC 261 Glen Sinks,RN,MSN,FNP Vol#: 7

EMC 262 Claire Wilmont Vol#: 7

EMC 263 Tom Keevey Vol#: 7

EMC 264 David Rech Vol#: 7

EMC 265 Marsha Wheaton Vol#: 7

EMC 266 Kristi Corbin Vol#: 7

EMC 267 David Leidig Vol#: 7

EMC 268 Peter Vachuska Vol#: 7

EMC 269 Kristeen Reilly Vol#: 7

EMC 270 Brad Freeman Vol#: 7

EMC 271 Valerie Hass-Martin Vol#: 7

EMC 272 Mackenzie Manning Vol#: 7

EMC 273 Ann Armstrong Patterson Vol#: 7

EMC 274 Judy Sexton Vol#: 7

EMC 275 Kimberly Armstrong Vol#: 7

EMC 276 R-Laurraine Tutihasi Vol#: 7

EMC 277 Sally van Schaick Vol#: 7

EMC 278 William Buehlman Vol#: 7

EMC 279 Charles Rinehart Vol#: 7

EMC 280 Sandra Rudy Vol#: 7

EMC 281 Doreen Rudnicki Vol#: 7

EMC 282 Donia Clark Vol#: 7

EMC 283 Mark Felice Vol#: 7

EMC 284 E.B. Zukoski Vol#: 7

EMC 285 Andrew Ferko Vol#: 7

EMC 286 Jannett Elaine Hudson Vol#: 7

EMC 287 John Simonian Vol#: 7

EMC 288 Karyl White Vol#: 7

EMC 289 Heather Blackburn Vol#: 7

EMC 290 Douglas Penn Vol#: 7

EMC 291 Susan Sophia Vol#: 7

EMC 292 Peter Wolanin Vol#: 7

EMC 293 Frank D' Aprile Vol#: 7

EMC 294 L.E. Huntoon Vol#: 7

EMC 295 Leah Wilkenloh Vol#: 7

EMC 296 Margaret Wood Vol#: 7

EMC 297 Carol Rovello Vol#: 7

EMC 298 Sydney Clemens Vol#: 7

EMC 299 Linda Hassa Vol#: 7

EMC 300 Donna McKee Vol#: 7

EMC 301 No signature Vol#: 7

EMC 302 Gian Andrea Morresi Vol#: 7

EMC 303 Judi van der Kaay Vol#: 7

EMC 304 Norbert Banholzer Vol#: 7

EMC 305 Neely Karl Slinkard Vol#: 7

EMC 306 Barbara Nye Vol#: 7

EMC 307 Preston C. Manning, MD Vol#: 7

EMC 308 Jill Alo Vol#: 7

EMC 309 Cheryl Kucsera Vol#: 7

EMC 310 Dolores C. Pino, Esq Vol#: 7

EMC 311 Janet Chafe Vol#: 7

EMC 312 Kim Mazik Vol#: 7

EMC 313 Sara Skinner Vol#: 7

EMC 314 Kathi Tammick Vol#: 7

EMC 315 Dorothy Buchi Vol#: 7

EMC 316 C.A. Shum Vol#: 7

EMC 317 Arash Sadati Vol#: 7

EMC 318 Susan Trivisonno Vol#: 7

EMC 319 Frances Cone Vol#: 7

EMC 320 Frank Worshek Vol#: 7

EMC 321 Rev Tom Brown Vol#: 7

EMC 322 Kelly Andrews Vol#: 7

EMC 323 Deanne Dale Vol#: 7

EMC 324 Bret Schacht Vol#: 7

EMC 325 Ann Babcock Vol#: 7

EMC 326 Lynne Taylor Vol#: 7

EMC 327 Richard Maxfield Vol#: 7

EMC 328 Ginger Lamp Vol#: 7

EMC 329 Thomas Brucia Vol#: 7

EMC 330 Erlene Jackson Vol#: 7

EMC 331 Karen Vaughan Vol#: 7

EMC 332 Margaret Fullam Vol#: 7

EMC 333 Jacqueline Geoffroy Vol#: 7

EMC 334 Masil Shrepherd Vol#: 7

EMC 335 Holy Holian Vol#: 7

EMC 336 No signature Vol#: 7

EMC 337 Judy Davis Vol#: 7

EMC 338 David Veenstra Vol#: 7

EMC 339 Holly Eaton Vol#: 7

EMC 340 Rommie Huntington Vol#: 7

EMC 341 Tom Nicholson Vol#: 7

EMC 342 Karen Salzgeber Vol#: 7

EMC 343 Rhonda D. Wright, MD Vol#: 7

EMC 344 Jon Crawford Vol#: 7

EMC 345 James McCarthy Vol#: 7

EMC 346 Dr. D.K. & F.L. Cinquemani Vol#: 7

EMC 347 Pamela Shaw Vol#: 7

EMC 348 T.W. & J.B. Stewart Vol#: 7

EMC 349 Chelsea Leplay Vol#: 7

EMC 350 Amy Beller Vol#: 7

EMC 351 Pat & Peter Wilson Vol#: 7

EMC 352 Lila & Irv Berman Vol#: 7

EMC 353 Dr. Mary Jo Ondrechen Vol#: 7

EMC 354 Brad Eardley Vol#: 7

EMC 355 Jeff Thayer Vol#: 7

EMC 356 Kimberly Wikman Vol#: 7

EMC 357 Mark Stimple Vol#: 7

EMC 358 Mary Silverman Vol#: 7

EMC 359 Annabelle Whettam Vol#: 7

EMC 360 B. Walsh Vol#: 7

EMC 361 Nancy Whitney Vol#: 7

EMC 362 Cheryl Gross Vol#: 7

EMC 363 Peter Adams Vol#: 7

EMC 364 Michelle & Kevin Parsneau Vol#: 7

EMC 365 May Chapman Vol#: 7

EMC 366 Kristina Kvarnlov-Leverty Vol#: 7

EMC 367 Chris Cooper Vol#: 7

EMC 368 Adam Savett Vol#: 7

EMC 369 Christine Caton-McGill Vol#: 7

EMC 370 Sonia Delgado Vol#: 7

EMC 371 Ann Steele Vol#: 7

EMC 372 Janeen Lee Vol#: 7

EMC 373 Archie Palmer Vol#: 7

LET 1 USDA Vol#: 2

LET 2 USDA Vol#: 2

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

EMC 409 Mark Olbrych Vol#: 5

EMC 410 Daniel Shively Vol#: 5

EMC 411 Daniel Shively Vol#: 5

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

EMC 312 Mark Olbrych Vol#: 5

EMC 313 Daniel Shively Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 311 Mark Olbrych Vol#: 4

EMC 312 Daniel Shively Vol#: 4

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

EMC 314 Mark Olbrych Vol#: 4

EMC 315 Daniel Shively Vol#: 4

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

EMC 3802 Janet Fernandez Vol#: 512

EMC 3803 Janet Fernandez Vol#: 512

EMC 3804 Martin Cibulka Vol#: 512

EMC 3805 Susan Grant Vol#: 512

EMC 3806 Jennifer Morris Vol#: 512

EMC 3807 Geoffrey Friesen Vol#: 512

EMC 3808 Ryan Janus Vol#: 512

EMC 3809 Steve Urban Vol#: 512

EMC 3810 Rae Ann Siewert Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 893 Elisa Beard Vol#: 212

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 419 Gail Skennion Vol#: 21

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

EMC 411 Mark Olbrych Vol#: 6

EMC 412 Daniel Shively Vol#: 4

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

EMC 1145 Amanda Fenyvesi Vol#: 5

EMC 1146 Allsion Therese Nash Vol#: 5

EMC 1147 Holly Nash Vol#: 5

EMC 1148 Allsion Nash Vol#: 5

EMC 1149 Clemencia Abalos Vol#: 5

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 382 Carl & Claire Hounshell Vol#: 4

01V-0110 Laser Light Show

EXP 1 HFA-305 Vol#: 1

VAR 2 OmniSistem Lights Effects Vol#: 1

02D-0320 Hold following clinical investigator misconduct

C 3 AstraZeneca Pharmaceuticals, LP Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

C 10 Safe Tables Our Priority (S.T.O.P.) Vol#: 1

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

C 5 Aventis Pharmaceuticals, Inc. Vol#: 1

02N-0273 Animal Proteins Prohibited in Ruminant Feed

EMC 1 Jodi Forrest Vol#: 1

02N-0275 Bioterrorism Preparedness; Administrative Detention

EC 16 Mr. Dwayne Hedges Vol#: 3

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 33 EL COCO MANUFACTURING Vol#: 3

EC 34 Number Not Used Vol#: 3

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

APE 32 Reproductive Health Technologies Vol#: 3

APE 33 American Red Cross Vol#: 3

APE 34 Afemedica Corporation Vol#: 3

LST 1 Draft Agenda 11/25/02 Hearing Vol#: 4

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

C 1 Eileen Ford Vol#: 1

EC 237 Ms. Robyn Sealey Vol#: 3

EC 238 Duke University Medical Center Vol#: 3

EC 239 St. Louis County Public Health Departmen Vol#: 3

EC 240 Mr. Michael Dorsey Vol#: 3

EC 241 Mrs. Laurie Mulert Vol#: 3

EC 242 paradigm shift Vol#: 3

EC 243 Mr. Paul Durieux Vol#: 3

EC 244 Ms. Glory Leavins Vol#: 3

EC 245 People Advocating Vaccine Education Vol#: 3

EC 246 Ms. Debra Adler Vol#: 3

EC 247 Ms. carol caputo Vol#: 3

EC 248 Dr. Kenneth Unice Vol#: 3

EC 249 Law Offices of Valerie E. Looper Vol#: 3

EC 250 Mrs. Lee Osborne Vol#: 3

EC 251 Ms. Heidi Cohen Vol#: 3

EC 252 Mrs. Kristin Price Vol#: 3

EC 253 Mrs. Jeannie Julian Vol#: 3

EC 254 Mrs. TRACY CAST Vol#: 3

EC 255 Mrs. Kim Maldonado Vol#: 3

EC 256 Private citizen Vol#: 3

EC 257 Ms. SarahAnne Schapiro Vol#: 3

EC 258 -None- Vol#: 3

EC 259 Medshares Home Care of Stateline, KY Vol#: 3

EC 260 Dr. Dave Bergman Vol#: 3

EC 261 Reed Group, Ltd. Vol#: 3

EC 262 Dr. Gary McCready Vol#: 3

EC 263 Dr. Robert Cox Vol#: 3

EC 264 Miss caitlin m Vol#: 3

EC 265 Mrs. Mary Falzano Vol#: 3

EC 266 Mr. Robert G Levy Vol#: 3

EC 267 Mrs. Reva Levy Vol#: 3

EC 268 Ms. Jaime Miorin Vol#: 3

EC 269 Mrs. Joy Cristiao Vol#: 3

EC 270 Mrs. Peggy O'Connor Vol#: 3

EC 271 none Vol#: 3

EC 272 Mr. Neil Gray Vol#: 3

EC 273 Mr. Jeffrey Bennett Vol#: 3

EC 274 Ms. Laura Bourque Vol#: 3

EC 275 Dr. Daniel Waterman Vol#: 3

EC 276 Ms. Cheryl Angerer Vol#: 3

EC 277 Mrs. Wanda Peterson Vol#: 3

EC 278 Dr. Susan Allan Vol#: 3

EC 279 Ms. Alice Swanson Vol#: 3

EC 280 private citizen Vol#: 3

EC 281 Miss Angela Lessard Vol#: 3

EC 282 Ms. claudia morbiducci Vol#: 3

EC 283 Mr. J K Vol#: 3

EC 284 Ms. Sarah Knapp Vol#: 3

EC 285 Ms. Kristine Strauss Vol#: 3

EC 286 Dr. Jennifer Miano Vol#: 3

EC 287 Mrs. Melanie Reinke Vol#: 3

EC 288 Mrs. c jones Vol#: 3

EC 289 Mrs. Stacey Zierak Vol#: 3

EC 290 Mrs. Dana Boyle Vol#: 3

EC 291 Mrs. Jonene Cook Vol#: 3

EMC 56 Carol Boczarski Vol#: 1

EMC 57 Clifford Joseph Piel Jr. Vol#: 1

EMC 58 Moira Ratchford Vol#: 1

EMC 59 Johns Hopkins University School Of Medic Vol#: 1

EMC 60 No signature Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 60 Ian Downie Vol#: 1

EMC 61 Stacie Reid Vol#: 1

EMC 62 No signature Vol#: 1

EMC 63 M.P. Clarke Vol#: 1

02P-0462 Use of Implied Nutrient Content Claim - "Carbolite"

ACK 1 HFS-832 Vol#: 1

CP 1 Carbolite Foods, Inc. Vol#: 1

02P-0489 Request Revision of CVM's Bioequivalence Guidelines

ACK 1 HFA-305 Vol#: 1

CP 1 James H. Schafer, D.V.M. Vol#: 1