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 July 18, 2001

TABLE OF CONTENTS

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97N-0314 Prescription Drug Products; Levothyroxine Sodium *
98N-0495 Prescription Drug User Fee Act,Pdufa II Five-Year Plan *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1548 Neoral Soft Gelatin Capsules *
01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to *
01N-0205 Applications for FDA Approval to Market a New Drug *
01N-0222 Medical Devices: Third-Party review under FDAMA;Agency Infor *
01N-0231 Verterinary adverse drug reaction, lack of effect, product *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *

97N-0314 Prescription Drug Products; Levothyroxine Sodium

EC 1 Mr. Mark MacInnes Vol#: 1

EC 2 Mrs. EDYTHE SANDS Vol#: 1

EC 3 Mr. Jay Ter Louw Vol#: 1

EC 4 Dr. Arthur Goldwyn Vol#: 1

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

N 3 Vol#: 6

98N-0495 Prescription Drug User Fee Act,Pdufa II Five-Year Plan

EC 1 Ms. Joanna Mahoney Vol#: 1

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

C 5072 Andree L. Maddox Vol#: 158

C 5073 Linda M. Sisco Vol#: 158

C 5074 R. Hicks Vol#: 158

C 5075 Emil Heintzelmann Vol#: 158

C 5076 Summer Yule & Rich Bolliger Vol#: 158

C 5077 Robin Jacobson Vol#: 158

C 5078 Fatima Goldman Vol#: 158

C 5079 Mrs. Mary Snodgrass Vol#: 158

C 5080 Danielle E. Jesensky Vol#: 158

EMC 2166 Timothy Somers Vol#: 158

EMC 2167 Beth Laurer Vol#: 158

EMC 2168 Dora Brooks Vol#: 158

EMC 2169 Jean Cockburn Vol#: 158

EMC 2170 Sharon Scheulen Vol#: 158

EMC 2171 Michael Porteus Vol#: 158

EMC 2172 Mrs. Mary A. Leon Vol#: 158

EMC 2173 Taryn Vol#: 158

EMC 2174 Sara Lewis Vol#: 158

EMC 2175 Claire Morey Vol#: 158

EMC 2176 Vanessa Marcol Vol#: 158

EMC 2177 Heather Crans-Vargas Vol#: 158

EMC 2178 Ted Petrikis Vol#: 158

EMC 2179 Robyn Hicks Vol#: 158

EMC 2180 Barbara Boltz Vol#: 158

EMC 2181 Danielle Jesensky Vol#: 158

EMC 2182 Phyllis Femmer Vol#: 158

EMC 2183 Julie Moya Vol#: 158

EMC 2184 Chrisley V. Pickens Vol#: 158

00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1555 Refusal of Inspection or Access to HACCP recods pertaining

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 8893 Paula MacKay Vol#: 367

EMC 8894 Dr. Patrick M. Sobota Vol#: 367

EMC 8895 Dr. Patrick M. Sobota Vol#: 367

EMC 8896 Rachel Shively Vol#: 367

EMC 8897 Rachel Shively Vol#: 367

EMC 8898 Lisa Threadgill Vol#: 367

EMC 8899 Lisa Threadgill Vol#: 367

EMC 8900 unsigned Vol#: 367

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 6401 unreadable Vol#: 246

C 6402 Michael Hill Vol#: 246

C 6403 Madonna Brock Vol#: 246

C 6404 Ann Maria Bell Vol#: 246

C 6405 George Lawson Vol#: 246

C 6406 Wayne Forbes Vol#: 246

C 6407 Jackie Willey Vol#: 246

C 6408 Mark E. Basken Vol#: 246

C 6409 Jennifer Kane Vol#: 246

C 6410 Margaret Levy Vol#: 246

C 6411 John Oritz Vol#: 246

C 6412 Shawna McPherson Vol#: 246

C 6413 Tim Crowley Vol#: 246

C 6414 Jana Corris Vol#: 246

C 6415 Dot Dipalo Vol#: 246

C 6416 Nancy Audredge Vol#: 246

C 6417 Linda Stark Vol#: 246

C 6418 Judy Campbell Vol#: 246

C 6419 Nancy Buck Vol#: 246

C 6420 Deena Metzqu Vol#: 246

C 6421 Michael O. Fostar Vol#: 246

C 6422 Edwina Brock Vol#: 246

C 6423 unreadable Vol#: 246

C 6424 Robin Espana Vol#: 246

C 6425 unreadable Vol#: 246

C 6426 P. Sinnis Vol#: 246

C 6427 C. & R. Hagen Vol#: 246

C 6428 Sue Spaven Vol#: 246

C 6429 Engene E. Graf Vol#: 246

C 6430 Donna G. Noonan Vol#: 246

C 6431 Ms. Russa Delarosa Vol#: 246

C 6432 Jane E. Zimmer Vol#: 246

C 6433 Mrs. Nancy Peterson Vol#: 246

C 6434 Christina McElroy Vol#: 246

C 6435 Terri Bullert Vol#: 246

C 6436 Dr. Ron Vogel, Ph.D. Vol#: 246

C 6437 Cheryl Henley Vol#: 246

C 6438 Brooke M. Griffin Vol#: 246

C 6439 D. J. Francis Vol#: 246

C 6440 Justin Mouske Vol#: 246

C 6441 Megan McCollam Vol#: 246

C 6442 S. Thompson Vol#: 246

C 6443 Eileen Archer Vol#: 246

C 6444 Connie Peabody Vol#: 246

C 6445 Dana Doler Vol#: 246

C 6446 Amy Berardi Vol#: 246

C 6447 A. J. Berardi Vol#: 246

C 6448 Steve Spaniol Vol#: 246

C 6449 Ba Fitzgerald Vol#: 246

C 6450 Susan Richter Vol#: 246

C 6451 Alex Eiserloh Vol#: 246

C 6452 Valarie Holtister Vol#: 246

C 6453 Bruce Hartley Vol#: 246

C 6454 Frances Rinaldo Vol#: 246

C 6455 M. Frank Vol#: 246

C 6456 S. McGuire Vol#: 246

C 6457 Blasto Simo Uma Bay Vol#: 246

C 6458 unreadable Vol#: 246

C 6459 Tim Morton Vol#: 246

C 6460 Robin Morton Vol#: 246

C 6461 Jordan Voelker Vol#: 246

C 6462 Mr. Roderick Ward Vol#: 246

C 6463 no signature Vol#: 246

C 6464 Noella Poinsette Vol#: 246

C 6465 Nancy Gallagher Vol#: 246

C 6466 Ms. Shahoma McAlister Vol#: 246

C 6467 Steve DePalma Vol#: 246

C 6468 Dan & Terri Lynn Keller Vol#: 246

C 6469 Mia MacDonald & Martin Rowe Vol#: 246

C 6470 Colleen Castagna Vol#: 246

C 6471 Joe Borkowski Vol#: 246

C 6472 Francine Ortega Vol#: 246

C 6473 Ashley Stilleson Vol#: 246

C 6474 Ryan McGraw Vol#: 246

C 6475 Albert Sotelo Vol#: 246

C 6476 Stacey Kimball Vol#: 246

C 6477 Sara Alexis Smith Vol#: 246

C 6478 Lena Park Vol#: 246

C 6479 JoAnna Sablan Vol#: 247

C 6480 Rachel Elizabeth Potter Vol#: 246

C 6481 Jennifer Smith Vol#: 246

C 6482 Cassandra Murray Vol#: 246

C 6483 Anthony Branconi Vol#: 246

C 6484 Joshua Lease Vol#: 246

C 6485 unreadable Vol#: 246

C 6486 no signature Vol#: 246

C 6487 Jason Blodgett Vol#: 246

C 6488 unreadable Vol#: 246

C 6489 Mike & Wendy Boals Vol#: 246

C 6490 Jon Lauren Vol#: 246

C 6491 Stanley A. Goldman Vol#: 246

EMC 8801 Bobbi Wolner Vol#: 247

EMC 8802 Dawn Van Fleteren Vol#: 247

EMC 8803 Kristin Allsbrook Vol#: 247

EMC 8804 Kristin Allsbrook Vol#: 247

EMC 8805 Karen Teplik Vol#: 247

EMC 8806 Deborah Dooley Vol#: 247

EMC 8807 Sean C. Massey Vol#: 247

EMC 8808 Ute Engelke, Ph.D. Vol#: 247

EMC 8809 Dwight Duke Vol#: 247

EMC 8810 Diane Stewart Vol#: 247

EMC 8811 L. Darlene Pratt + 3 signatures Vol#: 247

EMC 8812 Lorrie Forster Vol#: 247

EMC 8813 Lorrie Forster Vol#: 247

EMC 8814 Ralph Jackson Vol#: 247

EMC 8815 Becky Sheets Vol#: 247

EMC 8816 Carol Casalino Vol#: 247

EMC 8817 Elaine Hilliard Vol#: 247

EMC 8818 Elaine Hilliard Vol#: 247

EMC 8819 Mary Loney Bichell Vol#: 247

EMC 8820 Menshahat Ebron Vol#: 247

EMC 8821 Alan Martin Vol#: 247

EMC 8822 Deborah & Mark Webb Vol#: 247

EMC 8823 MaryAnn O'Connor Vol#: 247

EMC 8824 MaryAnn O'Connor Vol#: 247

EMC 8825 Ellen Zehr Vol#: 247

EMC 8826 Ellen Zehr Vol#: 247

EMC 8827 Michele Ortega Vol#: 247

EMC 8828 John Riege Vol#: 247

EMC 8829 Number not used Vol#: 247

EMC 8830 Jerry Anderson Vol#: 247

EMC 8831 Donna LeRoy Vol#: 247

EMC 8832 S. Wells Vol#: 247

EMC 8833 Mandi Campbell Vol#: 247

EMC 8834 Reagan Wilson Vol#: 247

EMC 8835 Sarah Parks Vol#: 247

EMC 8836 Richard Herman Vol#: 247

EMC 8837 Eva Catania-Allen Vol#: 247

EMC 8838 Number not used Vol#: 247

EMC 8839 Karen Masterson Vol#: 247

00N-1503 Agency Information Collection:Orphan Drugs

NAL 1 Vol#: 1

SS 1 Supporting statement Vol#: 1

00N-1674 Geriatric Use subsection in the labeling for human RX Drugs

NAL 1 Vol#: 1

SS 1 Supporting statement Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

C 181 Suzanne Flemino Vol#: 13

C 182 Food Allergy & Anaphylaxix Vol#: 13

C 183 Food Allergy & Anaphylaxix Vol#: 13

C 184 CSPI Vol#: 13

C 185 CSPI Vol#: 13

EMC 212 Christopher & Jami Moss Vol#: 12

EMC 213 Russell Black Vol#: 12

EMC 214 Tami Black Vol#: 12

EMC 215 Mary Adams Vol#: 12

EMC 216 Jan B Pantaleo Vol#: 12

EMC 217 Joleen Arnold Vol#: 12

EMC 218 Sondra Long Vol#: 12

EMC 219 Kathleen Huber Vol#: 12

EMC 220 Ann B McKellips Vol#: 12

EMC 221 Robert Medicus Vol#: 12

EMC 222 Christina M Casey Vol#: 12

EMC 223 John Rolfe Vol#: 12

EMC 224 Linda Vilcone Vol#: 12

EMC 225 Carol Petras Vol#: 12

EMC 226 Brian Shelton Vol#: 12

EMC 227 Doug Keefer Vol#: 12

EMC 228 Saima Hug Vol#: 12

EMC 229 Catherine Lautenbacher Vol#: 12

EMC 230 Mary Kay Ballasiotes Vol#: 12

EMC 231 Guillermo N Bachiller Vol#: 12

EMC 232 Jeff & Lisa James Vol#: 12

EMC 233 Holly Rotondi Vol#: 12

EMC 234 Stephen E Rotondi Vol#: 12

EMC 235 June Hackett Vol#: 12

EMC 236 Karen Medicus Vol#: 12

EMC 237 Jessica Vol#: 12

EMC 238 Det Picher Vol#: 12

EMC 239 Diane Crouch Vol#: 12

EMC 240 Dana Kaempen Vol#: 12

EMC 241 Merna Strassner Vol#: 12

EMC 242 Jeanne Gates Vol#: 12

EMC 243 Mary Hartman Vol#: 12

EMC 244 Helen Ortmann Vol#: 12

EMC 245 Tanya Cardwell Vol#: 12

EMC 246 NUMBER NOT USED Vol#: 12

EMC 247 David & Lillian Fung Vol#: 12

EMC 248 Peggy Sobodos Vol#: 12

EMC 249 Suzan Lamberson Vol#: 12

EMC 250 Rebecca Andrusiak Vol#: 12

EMC 251 J Kropf Vol#: 12

EMC 252 John & Michelle Laflamme Vol#: 12

EMC 253 TYH Vol#: 12

EMC 254 Mary Ann LaFlamme Vol#: 12

EMC 255 Mark Medicus Vol#: 12

EMC 256 Amy Harrison Vol#: 12

EMC 257 Lise Gloede Vol#: 12

EMC 258 Juliet Viola Vol#: 12

EMC 259 Carrie MacGillis Vol#: 12

EMC 260 Terry Sopher Sr Vol#: 12

EMC 261 Brenda McClellan-Tilson Vol#: 12

EMC 262 Karen Achor Vol#: 12

EMC 263 Naomi Roach Vol#: 12

EMC 264 Virginia Waters Vol#: 12

EMC 265 Alisa Kirkham Vol#: 12

EMC 266 NUMBER NOT USED Vol#: 12

EMC 267 Jeffrey & Peggy Morse Vol#: 12

EMC 268 Miriam Powell Vol#: 12

EMC 269 Jackie Hunt Vol#: 12

EMC 270 Sang Nahm Vol#: 12

EMC 271 Cathleen Trezza Vol#: 12

EMC 272 Rosalind Skinner Vol#: 12

EMC 273 Michelle Jarnjevic Vol#: 12

EMC 274 Leila Rouse Vol#: 12

EMC 275 Christine Elliott Vol#: 12

EMC 276 Kim Dilorenzo Vol#: 12

EMC 277 Andrea Mosmann Vol#: 12

EMC 278 Matthew Husmann Vol#: 12

EMC 279 Colleen Ameel Vol#: 12

EMC 280 K Klapatch Vol#: 12

EMC 281 Sheila Clonan PhD Vol#: 12

EMC 282 Julia Coleman Vol#: 12

EMC 283 Margaret R Weeks Vol#: 12

EMC 284 AnneMarie Hanlon Vol#: 12

EMC 285 Amy Johnson Vol#: 12

EMC 286 Scott Clarke Vol#: 12

EMC 287 Karen Rheault Vol#: 12

EMC 288 Jacqueline Ahlquist Vol#: 12

EMC 289 Jennifer Betz Vol#: 12

EMC 290 Judith A Vickers Vol#: 12

EMC 291 Julia A Ohman Vol#: 12

EMC 292 Donnell Larson Vol#: 12

EMC 293 Cat Carpenter Vol#: 12

EMC 294 Rebecca Theberge Vol#: 12

EMC 295 Elfriede Smith Vol#: 12

EMC 296 Marnie Bailey Vol#: 12

EMC 297 Frank Larson Vol#: 12

EMC 298 Cynthia Craft Vol#: 12

EMC 299 Betty L Larson Vol#: 12

EMC 300 R I Stapenhorst Vol#: 12

EMC 301 Catherine Trahiotis Vol#: 12

EMC 302 Ty & Sherry Benway Vol#: 12

EMC 303 Jeffry S Powell PhD Vol#: 12

EMC 304 JO-Ann Minogue Vol#: 12

EMC 305 Judy Kravitz Vol#: 12

EMC 306 Phil Mixter Vol#: 12

EMC 307 Carol Ramirez Vol#: 12

EMC 308 Jude & Greg Houda Vol#: 12

EMC 309 Lara Wieczezynski Vol#: 12

EMC 310 Michele Nihipali Vol#: 12

EMC 311 Nina Blumenfeld Vol#: 12

EMC 312 Ron Lesher Vol#: 12

EMC 313 Mike Morton Vol#: 12

EMC 314 Sally McFarlane Vol#: 12

EMC 315 Al & Jean Cella Vol#: 12

EMC 316 Anne Hucek Vol#: 12

EMC 317 Christina Hucek Vol#: 12

EMC 318 Cathy T Owen Vol#: 12

EMC 319 Beth Bianco Vol#: 12

EMC 320 Pat Scribner Vol#: 12

EMC 321 Mia E Vol#: 12

EMC 322 David Kenny Vol#: 12

EMC 323 Frank Fish Vol#: 12

EMC 324 Marcia Hoodwin Vol#: 12

EMC 325 Kristen Mebruer Vol#: 12

EMC 326 Charles F Lamphear Vol#: 12

EMC 327 Gary Zimmerman Vol#: 12

EMC 328 David O'Grady Vol#: 12

EMC 329 Emily O'Grady Vol#: 12

EMC 330 Tina M Hamiel Vol#: 12

EMC 331 Marian Wemple Vol#: 12

EMC 332 Eileen Peters Vol#: 12

EMC 333 Lorraine O Gloede Vol#: 12

EMC 334 L Henry Vol#: 12

EMC 335 Amy Prudhomme Vol#: 12

EMC 336 Erin London Vol#: 12

EMC 337 Laura J Litchert Vol#: 12

EMC 338 Karen Chauvin Vol#: 12

EMC 339 Susan Kennedy Vol#: 12

EMC 340 Susan Orwoll Vol#: 12

EMC 341 Joanne R Johnson Vol#: 12

EMC 342 Barbara T Cavanaugh Vol#: 12

EMC 343 Barbara Girga Vol#: 12

EMC 344 Corey Swain Vol#: 12

EMC 345 Dar Bickford Vol#: 12

EMC 346 Elizabeth Starr Vol#: 12

EMC 347 Bettina Bergh Vol#: 12

EMC 348 Jo & Linda Caswell Vol#: 12

EMC 349 Karen Brancy Vol#: 12

EMC 350 Mitchel Laman Vol#: 12

EMC 351 Judith Holland Vol#: 12

EMC 352 Karen Ansel Vol#: 12

00P-1548 Neoral Soft Gelatin Capsules

LET 2 HFD-7 to Lachman Consultant Services, In Vol#: 1

N 1 Vol#: 1

01D-0297 Avail. of Info Given to Advisory Committee Members CDRH

GDL 2 Guideline Vol#: 1

NAD 1 Vol#: 1

01F-0293 Novus International, Inc., Animal Use Ethoxyquin Phosphate

N 1 Vol#: 1
 
 

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

EMC 8 Scott Cohn Vol#: 2

EMC 9 hoppc Vol#: 2

01N-0178 Premarket Notification 510(k) Submissions

N 2 Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

EC 5 None Vol#: 1

EC 6 Physician Vol#: 1

EC 7 Suffering Patient Vol#: 1

01N-0222 Medical Devices: Third-Party review under FDAMA;Agency Infor

EC 1 Number Not Used Vol#: 1

01N-0231 Verterinary adverse drug reaction, lack of effect, product

EC 1 Ms. Joanie Kindblade Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 9 Dr. Daniel Handel Vol#: 3

EC 10 Number Not Used Vol#: 3

EC 11 Number Not Used Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 137 Kathy Labriola Vol#: 9

C 138 Rebecca Lintementer Vol#: 9

C 139 Judy Luetkemeyer Vol#: 9

C 140 Shanna Haines Vol#: 9

C 141 Mark Wieder Vol#: 9

C 142 Julia Cato Vol#: 9

C 143 illegible Vol#: 9

EMC 134 Margaret Fleming Vol#: 4

EMC 135 Deb Schwartz Vol#: 4

EMC 136 Michael Sholas Vol#: 4

EMC 137 Peter Winkler Vol#: 4

EMC 138 Paul Gaetani Vol#: 4

EMC 139 Donna Noonan Vol#: 4

EMC 140 David Sanor Vol#: 4

EMC 141 Michelle Gallant Vol#: 4

EMC 142 Carey Jung Vol#: 4

EMC 143 Hunter East Vol#: 4

EMC 144 Patricia Costello Vol#: 4

EMC 145 Julie Boerst Vol#: 4

EMC 146 Katherine Gauthier Vol#: 4

EMC 147 Jill Landshof Vol#: 4

EMC 148 Dale Kesler Vol#: 4

EMC 149 Doug Mattingly Vol#: 4

EMC 150 Darlene Humphries Vol#: 4

EMC 151 Kim Ripley Vol#: 4

EMC 152 Patricia Campbell Vol#: 4

EMC 153 Tony Kaperick Vol#: 4

EMC 154 Michael Parker Vol#: 4

EMC 155 Kathy Ramirez Vol#: 4

EMC 156 Valerie Quinlan Vol#: 4

EMC 157 Benjamin Irwin Vol#: 4

EMC 158 Caesar Albert Vol#: 4

EMC 159 Judith Nelson Vol#: 4

EMC 160 George Kassel Vol#: 4

EMC 161 Gary Baldowski Vol#: 4

EMC 162 Diana Ceccacci Vol#: 4

EMC 163 Nancy Cochran Vol#: 4

EMC 164 Jean-Paul LaCount Vol#: 4

EMC 165 Mark Bennett Vol#: 4

EMC 166 Daniela Elza Vol#: 4

EMC 167 Virginia M. Harper Vol#: 4

EMC 168 Reggie Qualls Vol#: 4

EMC 169 Jason P. Nazareno Vol#: 4

EMC 170 Kathryn Nance Vol#: 4

EMC 171 Priya Hudson-DiTraglia Vol#: 4

EMC 172 Catherine Gould Vol#: 4

EMC 173 Sandra Sarrouf Vol#: 4

EMC 174 Mr. Irucka Embry Vol#: 4

EMC 175 Laurie Powsner Vol#: 4

EMC 176 Lorrie Forster Vol#: 4

EMC 177 Carmen Guerra Vol#: 4

EMC 178 Mina Emamifar Vol#: 4

EMC 179 Gary Castro Vol#: 4

EMC 180 Kara Gelinas Vol#: 4

EMC 181 Mike Carroll Vol#: 4

EMC 182 Marcell Benoit Vol#: 4

EMC 183 Chris Striegel Vol#: 4

EMC 184 Ellen Woo Vol#: 4

EMC 185 Pinky Jain Pan Vol#: 4

EMC 186 Trish Comstock Vol#: 4

EMC 187 Marcia Bremmer Vol#: 4

EMC 188 Bari Schlosser Vol#: 4

EMC 189 James Little Vol#: 4

EMC 190 Jay Holmes Vol#: 4

EMC 191 Marcia Keller Vol#: 4