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 October 9, 2001

TABLE OF CONTENTS

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00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru *
01D-0269 Clinical Studies Section for Prescription Drugs & Biologics *
01N-0319 Agency Information Collection Health and Diet Survy *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 9 Acurian, Inc. Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

C 9507 Form Letter Count 99 signatures Vol#: 522

C 9508 Form Letter Count 177 Signatures Vol#: 523

C 9509 Form Letter Count 118 Signatures Vol#: 524

00P-1322 Food Labeling and Allergen Contamination Control

C 413 Private Label Manufacturers Assn Vol#: 25

C 414 Dawn M. Blanchet Vol#: 25

01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru

C 1 Animal Health Institute Vol#: 1

01D-0269 Clinical Studies Section for Prescription Drugs & Biologics

C 1 AstraZeneca Vol#: 1

01M-0453 P990042; DiaSorin ETI-AB-AUK PLUS ASSAY

AAV 1 DiaSorin S.r.1 Vol#: 1

01M-0454 P990043; DiaSorin ETI-EBK PLUS ASSAY

AAV 1 DiaSorin S.r.1 Vol#: 1

01M-0455 P990044; DiaSorin ETI-CORE-IGMK PLUS ASSAY

AAV 1 DiaSorin S.r.1 Vol#: 1

01M-0456 P990045; DiaSorin ETI-AB-COREK PLUS ASSAY

AAV 1 DiaSorin S.r.1 Vol#: 1

01N-0319 Agency Information Collection Health and Diet Survy

C 2 National Nutritional Foods Assn Vol#: 1

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

EMC 109 Laura Newman Vol#: 2

EMC 110 Maddie Krause Vol#: 2

EMC 111 Rhonda Miga Vol#: 2

EMC 112 Margaret Krehbiel Vol#: 2

EMC 113 Angela van Son Vol#: 2

EMC 114 BethAnn Wright Vol#: 2

EMC 115 Julie Hagood Vol#: 2

EMC 116 Ben Sharp Vol#: 2

EMC 117 L. Palumbo Vol#: 2

EMC 118 Patricia Kelly Vol#: 2

EMC 119 Rachael Bickhardt Vol#: 2

EMC 120 Jeffrey Sexson Vol#: 2

EMC 121 John C. Taylor Vol#: 2

EMC 122 K. Mallory Vol#: 2

EMC 123 Daria Leos Vol#: 2

EMC 124 Glenn Sundbakken Vol#: 2

EMC 125 Dee Miller Vol#: 2

EMC 126 Kathryn Nordstrom Vol#: 2

EMC 127 April Nozicka Vol#: 2

EMC 128 Anne Petzoldt Vol#: 2

EMC 129 Lora Hollins Vol#: 2

EMC 130 Karen Coffman Vol#: 2

EMC 131 No signature Vol#: 2

EMC 132 Renee Kowalczyk Vol#: 2

EMC 133 Joyce Ehlerding Vol#: 2

EMC 134 Aimee Waguespack Vol#: 2

EMC 135 Cher Swanson Vol#: 2

EMC 136 Marysue Griffin Vol#: 2

EMC 137 Barbara Westmoreland Vol#: 2

EMC 138 Cherie Rivers Vol#: 2

EMC 139 Sherri L. Leu Vol#: 2

EMC 140 Beth Allen Vol#: 2

EMC 141 Joan Gantz Vol#: 2

EMC 142 Paula Palmore Vol#: 2

EMC 143 Michelle Esposito Vol#: 2

EMC 144 Ralph & Judy Hyde Vol#: 2

EMC 145 Sheryl Weise Vol#: 2

EMC 146 Lori Van Driesen Vol#: 2

EMC 147 Deborah Keaton Vol#: 2

EMC 148 Susan Steffens Vol#: 2

EMC 149 Sophia Knapinsky Vol#: 2

EMC 150 Lori Adler Kapit Vol#: 2

EMC 151 Julie Oliver Vol#: 2

EMC 152 Kathleen Fontaine Vol#: 2

EMC 153 Jane Ford Vol#: 2

EMC 154 Rob Bethlenfalvay Vol#: 2

EMC 155 Robin Rosen Chang Vol#: 2

EMC 156 Pam Utterback Vol#: 2

EMC 157 Caryn Mittleman Vol#: 2

EMC 158 Anna Baumgaertel Vol#: 2

EMC 159 Kim Jewett Vol#: 2

EMC 160 Pamela S. Pund Vol#: 2

EMC 161 Teresa Gentile Vol#: 2

EMC 162 Karen Sandburg Vol#: 2

EMC 163 Ann Harding Vol#: 2

EMC 164 Melinda Ronca-Battista Vol#: 2

EMC 165 Thomas K. Lyman Vol#: 2

EMC 166 Susan Sawyer Vol#: 2

EMC 167 Sandy Fiumano Vol#: 2

EMC 168 Laura A. Stinsman Vol#: 2

EMC 169 Marianne Schultz Vol#: 2

EMC 170 Aureliano Soto Vol#: 2

EMC 171 Trudy McEwen Vol#: 2

EMC 172 L. Quinn Vol#: 2

EMC 173 Laurie Tissington Vol#: 2

EMC 174 Rev. Dorthea K. Dumas Vol#: 2

EMC 175 Berniece Claus Vol#: 2

EMC 176 No signature Vol#: 2

EMC 177 Dee Sopher Vol#: 2

EMC 178 Mary Dailey Vol#: 2

EMC 179 Jennifer Shaw Vol#: 2

EMC 180 Sahron Fekrat, MD Vol#: 2

EMC 181 Sally Marinelli Vol#: 2

EMC 182 Sherri Beusoleil Vol#: 2

EMC 183 Daniel T. Moore, PhD Vol#: 2

EMC 184 Janey Funston Vol#: 2

EMC 185 Cyndi Raabe Vol#: 2

EMC 186 Barb Norden Vol#: 2

EMC 187 Heidi Kameron Vol#: 2

EMC 188 No signature Vol#: 2

EMC 189 Jenny Saal Vol#: 2

EMC 190 Arlene Tollison Vol#: 2

EMC 191 Esther C. Getker Vol#: 2

EMC 192 Fern Morin Vol#: 2

EMC 193 Michael & Melinda Gardner Vol#: 2

EMC 194 Laura Conness Vol#: 2

EMC 195 Gail Brewster Vol#: 2

EMC 196 Karen P. Lawson Vol#: 2

EMC 197 Roxanne Traver Vol#: 2

EMC 198 No signature Vol#: 2

EMC 199 Ashley Webster Vol#: 2

EMC 200 Tina Gardner Vol#: 2

EMC 201 Number not Used Vol#: 2

EMC 202 Ann Croskrey Vol#: 2

EMC 203 Ann & Jeff Confer Vol#: 2

EMC 204 Kristen Kowalski Vol#: 2

EMC 205 Lauren Auichincloss Vol#: 2

EMC 206 Starr Cookson Vol#: 2

EMC 207 Joyce Anderson Vol#: 2

EMC 208 Paula Palmore Vol#: 2

EMC 209 Helen Willey Vol#: 2

EMC 210 Jerry Freeman Vol#: 2

EMC 211 Cindy O'Donnell Vol#: 2

EMC 212 Luanne Coccaro Vol#: 2

EMC 213 Beth Hurst Vol#: 2

EMC 214 Johanne Knowlton Vol#: 2

EMC 215 Julie Rule Vol#: 2

EMC 216 Christine Trevino Vol#: 2

EMC 217 Kathleen Teator Vol#: 2

EMC 218 Kristin Moore Vol#: 2

EMC 219 Rae S. McCarthy Vol#: 2

EMC 220 Kelly Ivett Vol#: 2

EMC 221 Patricia A. Chazin Vol#: 2

EMC 222 Jean Frank Vol#: 2

EMC 223 Maria Acosta Vol#: 2

EMC 224 Claudia R. Bessette Vol#: 2

EMC 225 Duane C. Basch Vol#: 2

EMC 226 Richard & Joyce Kennedy Vol#: 2

EMC 227 Pamela Samaniego Vol#: 2

EMC 228 Kelly M. Zavala Vol#: 2

EMC 229 Melissa Thompson Vol#: 2

EMC 230 Tina M. Ibach Vol#: 2

EMC 231 Tina Sheldon Vol#: 2

EMC 232 Lucinda Selzler Vol#: 2

EMC 233 Dottie Heckman Vol#: 2

EMC 234 Margaret H. Carden Vol#: 2

EMC 235 Peter Goldberg Vol#: 2

EMC 236 Mary Milleville Vol#: 2

EMC 237 Shonda Palmer Vol#: 2

EMC 238 Andrea Henkart Vol#: 2

EMC 239 Carolyn R. Knandel Vol#: 2

EMC 240 Michelle Caruthers Vol#: 2

EMC 241 Lisa Zerby Vol#: 2

EMC 242 Kris Bloss Vol#: 2

EMC 243 Patricia A. Hacker Vol#: 2

EMC 244 Cheryl Bitner Vol#: 2

EMC 245 Joyce L. Patterson Vol#: 2

EMC 246 Martha A. Wells Vol#: 2

EMC 247 Marsha Magazzu Vol#: 2

EMC 248 Sheila Richardson Vol#: 2

EMC 249 Susan Ashmore Vol#: 2

EMC 250 Cheryl Weckle Vol#: 2

EMC 251 Marjorie Rosenfeld Vol#: 2

EMC 252 Number not Used Vol#: 2

EMC 253 Robin Raney Vol#: 2

EMC 254 Demi Laino Vol#: 2

EMC 255 Erin Ross Vol#: 2

EMC 256 Betty M. Sherman Vol#: 2

EMC 257 Vicki Huff Vol#: 2

EMC 258 Victoria A. Shellhase Vol#: 2

EMC 259 Suzie Lostaunau Vol#: 2

EMC 260 Jeanne Cutrona Vol#: 2

EMC 261 Cheryl Casey Vol#: 2

EMC 262 Karla Boulanger-Solis Vol#: 2

EMC 263 Sharon Sholette Vol#: 2

EMC 264 Pegi Redix Vol#: 2

EMC 265 Elena Murphy Vol#: 2

EMC 266 Elena Murphy Vol#: 2

EMC 267 Sally Paist Vol#: 2

EMC 268 Jacquie Fraser, PhD Vol#: 2

EMC 269 Amy Stone Vol#: 2

EMC 270 Stephani Bryson Vol#: 2

EMC 271 Jenifer Cotcher Vol#: 2

EMC 272 Janice Merck Vol#: 2

EMC 273 Gina M. Bacon Vol#: 2

EMC 274 Cherie M. Leck Vol#: 2

EMC 275 Ginger Garbarini Vol#: 2

EMC 276 Celeste Clevenger Vol#: 2

EMC 277 Pamela Sliwoski Vol#: 2

EMC 278 Kathy Longaker Vol#: 2

EMC 279 Tami Tarasi Vol#: 2

EMC 280 Diana Boules Vol#: 2

EMC 281 Kim Miller Vol#: 2

EMC 282 Wayne Lessard Vol#: 2

EMC 283 Melanie Harper Vol#: 2

EMC 284 Melissa Zentgraf Vol#: 2

EMC 285 Jan Hobbs Vol#: 2

EMC 286 Kelly Bordner Vol#: 2

EMC 287 Sherry Tompkins Vol#: 2

EMC 288 Laurie Carollo Vol#: 2

EMC 289 Elizabeth R. Chiono Vol#: 2

EMC 290 Wendy Askew Vol#: 2

EMC 291 Carl Benefiel Vol#: 2

EMC 292 No signature Vol#: 2

EMC 293 Margaret E. Harp Vol#: 2

EMC 294 Marybeth De Filippis Vol#: 2

EMC 295 Donna Ferrara Vol#: 2

EMC 296 Beverly Yach Vol#: 2

EMC 297 Misty Buchanan Vol#: 2

EMC 298 Heather Ficton Vol#: 2

EMC 299 Lynda Mantalas Vol#: 2

EMC 300 Rosalind Romero Vol#: 2

EMC 301 Thelma Rose Weathers Vol#: 2

EMC 302 Jim Martin Vol#: 2

EMC 303 Kimberly A. Finney-Gilmore Vol#: 2

EMC 304 Diana Boysen Vol#: 2

EMC 305 Jody Petersen Vol#: 2

EMC 306 Wendy Emmert Vol#: 2

EMC 307 Richard Moriarty Vol#: 2

EMC 308 M. Massie Vol#: 2

EMC 309 Edward Baietto, MD, FCCM Vol#: 2

EMC 310 John Redmond Vol#: 2

EMC 311 Jan Trimble Vol#: 2

EMC 312 Amy Mogil Vol#: 2

EMC 313 Rick Wahl Vol#: 2

EMC 314 Lisa Martin Vol#: 2

EMC 315 Jody Halton Vol#: 2

EMC 316 Zochar Edelkind Vol#: 2

EMC 317 Sheila Vuckovich Vol#: 2

EMC 318 Teresa Hendrinks Vol#: 2

EMC 319 Regina Vera Vol#: 2

EMC 320 Chris Boyce Vol#: 2

EMC 321 Dr. Laura Foster Vol#: 2

EMC 322 Kurt McClinchie Vol#: 2

EMC 323 Robyn Keele Vol#: 2

EMC 324 Lorena Streb Vol#: 2

EMC 325 Usha Krishnamurthy Vol#: 2

EMC 326 Meredith Murray Vol#: 2

EMC 327 LaVonne Ellis Vol#: 2

EMC 328 Erika Wood Vol#: 2

EMC 329 John P. Rivenburg Vol#: 2

EMC 330 Jennifer Beason Vol#: 2

EMC 331 Ann Pierre Vol#: 2

EMC 332 Martha Kreeger Vol#: 2

EMC 333 No signature Vol#: 2

EMC 334 Garnet Reardon Vol#: 2

EMC 335 Jean Keel Vol#: 2

EMC 336 Sharon Howarth Vol#: 2

EMC 337 Arthur Dellin Vol#: 2

EMC 338 Ailsa M. Thomas-Getts, RN, BSN Vol#: 2

EMC 339 Leslie Brown Vol#: 2

EMC 340 Linda McCabe Vol#: 2

EMC 341 Randy Chitwood Vol#: 2

EMC 342 Deborah Mulcahy Vol#: 2

EMC 343 Geri Bishop Vol#: 2

EMC 344 Teresa Miesch Vol#: 2

EMC 345 Barb Kehler Vol#: 2

EMC 346 Phyllis Shanks Vol#: 2

EMC 347 Lynne Sims Vol#: 2

EMC 348 Trish Badalamenti Vol#: 2

EMC 349 Jeff Bexson Vol#: 2

EMC 350 Beth Barclay Vol#: 2

EMC 351 Anne C. Saulkalns Vol#: 2

EMC 352 Karen Kabler Vol#: 2

EMC 353 Lara Davis Vol#: 2

EMC 354 Angie Stone Vol#: 2

EMC 355 Suzanne R. Gray Vol#: 2

EMC 356 Eric & Renee Kowalczyk Vol#: 2

EMC 357 Robert and Rhonda Salhaney Vol#: 2

EMC 358 Mary Jo Dorsey Vol#: 2

EMC 359 Twyla Puterbaugh Vol#: 2

EMC 360 Kathy Scarbrough Vol#: 2

EMC 361 Benjamin C. Kirkup Vol#: 2

EMC 362 Joanna L. Gold-Baker Vol#: 2

EMC 363 Patty Koonce Vol#: 2

EMC 364 Janet Gerla Vol#: 2

EMC 365 John Mitkowski Vol#: 2

EMC 366 Kathy Opeke Vol#: 2

EMC 367 Becky Morrison Vol#: 2

EMC 368 Nikki Gasper Vol#: 2

EMC 369 Nikki Gasper Vol#: 2

EMC 370 Randy Shay Vol#: 2

EMC 371 Kay English Vol#: 2

EMC 372 Bonnie L. Birmingham, RN Vol#: 2

EMC 373 Judy & John Gallagher Vol#: 2

EMC 374 Barbara Hannold Vol#: 2

EMC 375 Christine Parkes Vol#: 2

EMC 376 Emily Bentley Vol#: 2

EMC 377 Virginia Yuasa Vol#: 2

EMC 378 Mary K. Wagner Vol#: 2

EMC 379 Diana Krimerman Vol#: 2

EMC 380 Karen Sankman Vol#: 2

EMC 381 Lisa Charron Vol#: 2

EMC 382 Robert Danielian Vol#: 2

EMC 383 Floyd Minana Vol#: 2

EMC 384 Julie Rogers-Glabush Vol#: 2

EMC 385 Jennifer Durham Vol#: 2

EMC 386 Jeri Passera Vol#: 2

EMC 387 David Golinger Vol#: 2

EMC 388 Valerie Etienne Vol#: 2

EMC 389 Shawn Badik Vol#: 2

EMC 390 Linda Glatz Vol#: 2

EMC 391 Margaret King Vol#: 2

EMC 392 Rebecca Wagner Vol#: 2

EMC 393 Peter Blood, RN Vol#: 2

EMC 394 Dr. Jack Tips Vol#: 2

EMC 395 Paige L. Kokovich Vol#: 2

EMC 396 Dagmar Trunz Vol#: 2

EMC 397 Janice Lyman Vol#: 2

EMC 398 Sandra Walker Vol#: 2

EMC 399 Lisa Sorensen Vol#: 2

EMC 400 James & Karen Hevesy Vol#: 2

EMC 401 No signature Vol#: 2

EMC 402 Madeline Nugent Vol#: 2

EMC 403 Number not Used Vol#: 2

EMC 404 Ann Schimizzi Vol#: 2

EMC 405 Curtis Shenenberger Vol#: 2

EMC 406 Rhonda Ott Vol#: 2

EMC 407 Diana Franchak Vol#: 2

EMC 408 Number not Used Vol#: 2

EMC 409 Catheryne W. Cote Vol#: 2

EMC 410 Catherine M. Butryn Vol#: 2

EMC 411 Teresa Ellingen Vol#: 2

EMC 412 Katie Rizer Vol#: 2

EMC 413 Dan & June Ring Vol#: 2

EMC 414 Paul Nelson Vol#: 2