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Dockets Management
Dockets Entered On February 22, 2005
Table of Contents
Docket # Title
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2000N-0504 Egg Safety Action Plan
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003F-0088 Increase the Maximum Permitted Energy Level of X-rays
2003F-0535 Chlorine Dioxide (FAP 4A4751)
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
2003P-0362 Over-the-counter Hearing Aids
2004D-0443 Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
2004D-0465 Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
2004P-0512 Health Claim Petition for Soluble Fiber from Barley
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005N-0031 Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
2005N-0036 Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2005P-0079 Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
2005P-0080 ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
EMC 44 C. Hungerford, Jr. Vol #: 141
EMC 45 C. sedotto Vol #: 141
EMC 46 C. Trefts Vol #: 141
EMC 47 L. Brown, CRNP Vol #: 141
EMC 48 C. Trefts Vol #: 141
EMC 49 E. Wood Vol #: 141
EMC 50 E. Wood Vol #: 141
EMC 51 E. Wood Vol #: 141
EMC 52 L. Williams Vol #: 141
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4299 N. Shah Vol #: 320
2000N-0504 Egg Safety Action Plan
EMC 1902 N. Shinn Vol #: 31
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 14099 K. Deissroth Vol #: 324
EMC 14100 K. Swanekamp Vol #: 324
EMC 14101 B. Wagenseller Vol #: 324
EMC 14102 A. Heimonen Vol #: 324
EMC 14103 J. Johnson Vol #: 324
EMC 14104 A. Russell Vol #: 324
EMC 14105 T. Odlevak Vol #: 324
EMC 14106 O. Newbury Vol #: 324
EMC 14107 A. Contreras Vol #: 324
EMC 14108 B. Dershem Vol #: 324
EMC 14109 V. Crossley Vol #: 324
EMC 14110 E. Gage Vol #: 324
EMC 14111 A. Knotor, MD, FAAP Vol #: 324
EMC 14112 A. Thompson Vol #: 324
EMC 14113 N. Calzone Vol #: 324
EMC 14114 C. Marino Vol #: 324
EMC 14115 W. Beasley Vol #: 324
EMC 14116 K. Yaged Vol #: 324
EMC 14117 M. Olson Vol #: 324
EMC 14118 S. Nichols Vol #: 324
EMC 14119 A. Mathews Vol #: 324
EMC 14120 J. Young Vol #: 324
EMC 14121 K. Sky Vol #: 324
EMC 14122 E. Schultz Vol #: 324
EMC 14123 D. Bansal Vol #: 324
EMC 14124 L. Gaynon Vol #: 324
EMC 14125 L. Parada Vol #: 324
EMC 14126 T. Manell Vol #: 324
EMC 14127 A. Mosby Vol #: 324
EMC 14128 J. Sands Vol #: 324
EMC 14129 J. Sands Vol #: 324
EMC 14130 L. Wigen Vol #: 324
EMC 14131 J. Russell Vol #: 324
EMC 14132 D. Heydt Vol #: 324
EMC 14133 J. Sedlacek Vol #: 324
EMC 14134 J. Bradford Vol #: 324
EMC 14135 N. Haley Vol #: 324
EMC 14136 D. Lieberman Vol #: 324
EMC 14137 J. Hedge Vol #: 324
EMC 14138 C. Santos Vol #: 324
EMC 14139 J. Johnson Vol #: 324
EMC 14140 K. Draayer Vol #: 324
EMC 14141 D. Moss Vol #: 324
EMC 14142 S. Teslow Vol #: 324
EMC 14143 K. Waller Vol #: 324
EMC 14144 E. Leeper Vol #: 324
EMC 14145 R. Renken Vol #: 324
EMC 14146 J. Augstums Vol #: 324
EMC 14147 P. Tolle Vol #: 324
EMC 14148 E. Clinchard Vol #: 324
EMC 14149 E. Summer Vol #: 324
EMC 14150 A. Doyle Vol #: 324
EMC 14151 K. Knutson Vol #: 324
EMC 14152 K. Hall Vol #: 324
EMC 14153 D. Bell Vol #: 324
EMC 14154 C. Johnson Vol #: 324
EMC 14155 G. Adams Vol #: 324
EMC 14156 J. Kuheana Vol #: 324
EMC 14157 A. Meints Vol #: 324
EMC 14158 N. Kaplan Vol #: 324
EMC 14159 C. Greenberg Vol #: 324
EMC 14160 A. Hoskovec Vol #: 324
EMC 14161 P. Baker Vol #: 324
EMC 14162 K and J Leech Vol #: 324
EMC 14163 P. Forcier Vol #: 324
EMC 14164 J. Brt Vol #: 324
EMC 14165 L. Case Vol #: 324
EMC 14166 L. Granger Vol #: 324
EMC 14167 J. Sitrick, Jr. Vol #: 324
EMC 14168 G. Herndon Vol #: 324
EMC 14169 N. Nair Vol #: 324
EMC 14170 W. West Vol #: 324
EMC 14171 L. Jacobs Vol #: 324
EMC 14172 L. Bottsford Vol #: 324
EMC 14173 P. Gomez Vol #: 324
EMC 14174 T. Johnson Vol #: 324
EMC 14175 J. Crane Vol #: 324
EMC 14176 N. Olds Vol #: 324
EMC 14177 M. Beecham Vol #: 324
EMC 14178 S. Thompson Vol #: 324
EMC 14179 M. Zych Vol #: 324
EMC 14180 A and L Hansen Vol #: 324
EMC 14181 L. Schulze Vol #: 324
EMC 14182 S. Dawes Vol #: 324
EMC 14183 E. Keller Vol #: 324
EMC 14184 S. Easton Vol #: 324
EMC 14185 K. Wamsley Vol #: 324
EMC 14186 P. Gallimore Vol #: 324
EMC 14187 V. Pozek Vol #: 324
EMC 14188 M. Bittner Vol #: 324
EMC 14189 C. Spann Vol #: 324
EMC 14190 R. Swanek Vol #: 324
EMC 14191 A. Rogers Vol #: 324
EMC 14192 T. Shepard Vol #: 324
EMC 14193 K. Wheeler Vol #: 324
EMC 14194 J. Nelson Vol #: 324
EMC 14195 N. Brt Vol #: 324
EMC 14196 N. Hansen Vol #: 324
EMC 14197 J. Kissel Vol #: 324
EMC 14198 K. Denker Vol #: 324
EMC 14199 H. Hunter Vol #: 324
EMC 14200 C. Curry Vol #: 324
EMC 14201 J. Coles Vol #: 324
EMC 14202 R. Fuelberth Vol #: 324
EMC 14203 G. Kenkel Vol #: 324
EMC 14204 M. Haftings Vol #: 324
EMC 14205 A. Cotton Vol #: 324
EMC 14206 J. Cornell Vol #: 324
EMC 14207 D. Teche Vol #: 324
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 207 L. Husted Vol #: 4
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 429
Attachment
Calorie Control Council Vol #: 7
EMC 430 Mission Possible International Vol #: 7
EMC 431 Mission Possible International Vol #: 7
EMC 432 Mission Possible International Vol #: 7
2003F-0088 Increase the Maximum Permitted Energy Level of X-rays
EMC 292 M. Greenberg Vol #: 2
EMC 293 J. Hamre Vol #: 2
EMC 294 T. Reynolds Vol #: 2
EMC 295 J. Walters Vol #: 2
EMC 296 P. Levinson Vol #: 2
EMC 297 S. Chen Vol #: 2
EMC 298 S. Michelson Vol #: 2
EMC 299 L. Hekker Vol #: 2
EMC 300 P. Mann Vol #: 2
EMC 301 K. Conroy Vol #: 2
EMC 302 K. Mellett Vol #: 2
EMC 303 P. Cox Vol #: 2
EMC 304 K. Niehoff Vol #: 2
EMC 305 J. Slocum Vol #: 2
EMC 306 A. Bijur Vol #: 2
EMC 307 I. Hyman Vol #: 2
EMC 308 N. Jensen Vol #: 2
EMC 309 S. Mitchell Vol #: 2
EMC 310 I. Barger Vol #: 2
EMC 311 L. Braschayko Vol #: 2
EMC 312 J. Langdon Vol #: 2
EMC 313 J. Paixao Vol #: 2
EMC 314 R. Bron Vol #: 2
EMC 315 C. Judson Vol #: 2
EMC 316 C. Girardot Vol #: 2
EMC 317 M. Caffrey Vol #: 2
EMC 318 M. Aubry Vol #: 2
EMC 319 A. Malek Vol #: 2
EMC 320 V. Swanson Vol #: 2
EMC 321 E. Elliot Vol #: 2
EMC 322 B. Downey Vol #: 2
EMC 323 T. Franklin Vol #: 2
EMC 324 J. Maxfield Vol #: 2
EMC 325 J. Levine Vol #: 2
EMC 326 S. Hodges Vol #: 2
EMC 327 F. Reed Vol #: 2
EMC 328 W. Waldeck Vol #: 2
EMC 329 Mr and Mrs D. Santerre Vol #: 2
EMC 330 E. Silverman Vol #: 2
EMC 331 S and J Cutler Vol #: 2
EMC 332 P. Smith Vol #: 2
EMC 333 M. Merrill Vol #: 2
EMC 334 S. Penny Vol #: 2
EMC 335 M. Schwahn Vol #: 2
EMC 336
Attachment
Public Citizen Vol #: 2
EMC 337 G. Mesa Vol #: 2
EMC 338 J. Hague, RN Vol #: 2
EMC 339 P. Alberts Vol #: 2
EMC 340 C. Sawyer Vol #: 2
EMC 341 S. Goncalves Vol #: 2
EMC 342 S. Haynes Vol #: 2
EMC 343 A. Williams Vol #: 2
EMC 344 I. Szucs Vol #: 2
EMC 345 S. Dunning Vol #: 2
EMC 346 N. Noble Vol #: 2
EMC 347 B. Voorhees Vol #: 2
EMC 348 M. Horowitz Vol #: 2
EMC 349 C. Richard Vol #: 2
EMC 350 M. Makrucki Vol #: 2
EMC 351 M. Halligan Vol #: 2
EMC 352 D. O'Donnell Vol #: 2
EMC 353 J. Storino Vol #: 2
EMC 354 R. Stockstill Vol #: 2
EMC 355 K. Lee Vol #: 2
EMC 356 E. Ting Vol #: 2
EMC 357 M. Scott Vol #: 2
EMC 358 E. Hughes Vol #: 2
EMC 359 N. Warwick Vol #: 2
EMC 360 C. Laxton Vol #: 2
EMC 361 P. Johns Vol #: 2
EMC 362 D. Edmonson Vol #: 2
EMC 363 M. DeGirolomo Vol #: 2
EMC 364 J. Kurkinen Vol #: 2
EMC 365 P. Perretty Vol #: 2
EMC 366 A. Absil Vol #: 2
EMC 367 E. Hartgering Vol #: 2
EMC 368 C. Foulk Vol #: 2
EMC 369 J. Frontz Vol #: 2
EMC 370 R and B Champany Vol #: 2
EMC 371 E. Hepburn Vol #: 2
EMC 372 B. Bryant Vol #: 2
EMC 373 S. Manno Vol #: 2
EMC 374 E. Mass Vol #: 2
EMC 375 J. Szela Vol #: 2
EMC 376 K. Conners Vol #: 2
EMC 377 D. Brandt Vol #: 2
EMC 378 E. Penny Vol #: 2
EMC 379 L. Smith Vol #: 2
EMC 380 C. Wineburgh Vol #: 2
EMC 381 J. Wineburgh Vol #: 2
EMC 382 M. Freed Vol #: 2
EMC 383 M. Bouche Vol #: 2
2003F-0535 Chlorine Dioxide (FAP 4A4751)
EMC 1 B. Sachau Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 534 No signature Vol #: 9
EMC 535 C. Briggs Vol #: 9
EMC 536 C. Perez Vol #: 9
EMC 537 C. DuBois Vol #: 9
EMC 538 J. Hubbard Vol #: 9
EMC 539 C. Rhoades Vol #: 9
EMC 540 J. Grocki Vol #: 9
EMC 541 S. Ferguson Vol #: 9
EMC 542 S. Hrin Vol #: 9
EMC 543 J. Smith Vol #: 9
EMC 544 T. Vliet Vol #: 9
EMC 545 H. Peck Vol #: 9
EMC 546 R. Connolly Vol #: 9
EMC 547 No signature Vol #: 9
EMC 548 D. Murray Vol #: 9
EMC 549 D. Murray Vol #: 9
EMC 550 P. Campisi Vol #: 9
EMC 551 No signature Vol #: 9
EMC 552 D. Cannistraci Vol #: 9
EMC 553 D. Herrin Vol #: 9
EMC 554 No signature Vol #: 9
EMC 555 No signature Vol #: 9
EMC 556 P. Curry Vol #: 9
EMC 557 J. Cowperthwaite Vol #: 9
EMC 558 No signature Vol #: 9
EMC 559 C. Ewin Vol #: 9
EMC 560 C. Ewin Vol #: 9
EMC 561 P. DeSilva Vol #: 9
EMC 562 C. D'Urso Vol #: 9
EMC 563 D. Braun Vol #: 9
EMC 564 K. Boccuzzi Vol #: 9
EMC 565 K. Boccuzzi Vol #: 9
EMC 566 D. Braun Vol #: 9
EMC 567 J. Sessa Vol #: 9
EMC 568 A. Cerqua Vol #: 9
EMC 569 Matt Vol #: 9
EMC 570 L. Blodgett Vol #: 9
EMC 571 M. Goldstein Vol #: 9
EMC 572 No signature Vol #: 9
EMC 573 M. Blizzard Vol #: 9
EMC 574 D. Yates Vol #: 9
EMC 575 No signature Vol #: 9
EMC 576 No signature Vol #: 9
EMC 577 C. Jackson Vol #: 9
EMC 578 Z. Wolfram Vol #: 9
EMC 579 No signature Vol #: 9
EMC 580 No signature Vol #: 9
EMC 581 G. Benedetto Vol #: 9
EMC 582 Bob Vol #: 9
EMC 583 No signature Vol #: 9
EMC 584 No signature Vol #: 9
EMC 585 J. Christie Vol #: 9
EMC 586 J. Ulmer Vol #: 9
EMC 587 No signature Vol #: 9
EMC 588 K. Mixon Vol #: 9
EMC 589 A. Cotta Vol #: 9
EMC 590 E. Bunch Vol #: 9
EMC 591 B. MacLean Vol #: 9
EMC 592 SL Collins Vol #: 9
EMC 593 No signature Vol #: 9
EMC 594 J. DeCoopman, MS, CNM Vol #: 9
EMC 595 S. Bryan Vol #: 9
EMC 596 M. Dowdell Vol #: 9
EMC 597 W. Goode Vol #: 9
EMC 598 C. Frederick Vol #: 9
EMC 599 C. Frederick Vol #: 9
EMC 600 R. Larkowski Vol #: 9
EMC 601 R. Larkowski Vol #: 9
EMC 602 K. Siewierski Vol #: 9
EMC 603 P. Farris Vol #: 9
EMC 604 J. Heck, PhD Vol #: 9
EMC 605 A. Bernhard Vol #: 9
EMC 606 K. Ulibarri Vol #: 9
EMC 607 M. Shalhoob Vol #: 9
EMC 608 J. Prial Vol #: 9
EMC 609 J. Prial Vol #: 9
EMC 610 No signature Vol #: 9
EMC 611 M. Amoia Vol #: 9
EMC 612 D. Snell Vol #: 9
EMC 613 K. Claus Vol #: 9
EMC 614 A. Laney, PhD Vol #: 9
EMC 615 N. Musgrove Vol #: 9
EMC 616 K. Bateman Vol #: 9
EMC 617 C. Copperstein Vol #: 9
EMC 618 P. Pentoney Vol #: 9
EMC 619 D. Allen Vol #: 9
EMC 620 D and T Rhuland Vol #: 9
EMC 621 H. Reiser Vol #: 9
EMC 622 B. Horton Vol #: 9
EMC 623 J and V Seidenberger Vol #: 9
EMC 624 N. Cartier Vol #: 9
EMC 625 D. Karius Vol #: 9
EMC 626 D. Gardner Vol #: 9
EMC 627 R. Razum Vol #: 9
EMC 628 H. Fielding Vol #: 9
EMC 629 S. Robbins Vol #: 9
EMC 630 E Cleary and P Hasty Vol #: 9
EMC 631 M. Skorodin, MD Vol #: 9
EMC 632 M. Jones Vol #: 9
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EMC 5 Pet Food Institute (PFI) and National Grain and Feed Assn (NGFA) Vol #: 1
2003P-0362 Over-the-counter Hearing Aids
EMC 74 MyerEmco, Inc. Vol #: 2
EMC 75 P. Feder Vol #: 2
2004D-0443 Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
EMC 11 Lloyd's Register Serentec, Inc. Vol #: 2
2004D-0465 Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
EMC 1 Merck & Co., Inc. (Merck) Vol #: 1
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
CS 4 HFA-305 Vol #: 1
LET 4 Ecumed Health Group, Amador Reyes, Juan C Carrai, Richard W. Stone, M.D, & Erlinda E. Enriquez Vol #: 1
LET 5 Ecumed Health Group, Amador Reyes, Juan C Carrai, Richard W. Stone, M.D, & Erlinda E. Enriquez Vol #: 1
OR 4 HF-3 Vol #: 1
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 1141 N Shinn et al. Vol #: 15
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EC 231 Mrs. Janet Ziegler Vol #: 31
EC 232 Mrs. Judith Peloquin Vol #: 31
EC 233 Mrs. Shirley Chappell Vol #: 31
EC 234 Mrs. Mercedes Garces Vol #: 31
EC 235 Ms. Cathy Slaght Vol #: 31
EC 236 Mrs. Charlyne Lane Vol #: 31
EC 237 Mrs. Betty George Vol #: 31
EC 238 Mrs. Mercedes Garces Vol #: 31
EC 239 none Vol #: 31
EC 240 Ms. ingrid walther Vol #: 31
EC 241 Mrs. Tanna Storie Vol #: 31
EC 242 Miss. Robin Carney Vol #: 31
EC 243 Mrs. Jo Ann Shepard Vol #: 31
EC 244 Helthe Connections Vol #: 31
EC 245 Miss. Toni Bucciero Vol #: 31
EC 246 Miss. Loren Dohl Vol #: 31
EC 247 Mrs. David Gardner Vol #: 31
EC 248 Mrs. Susan Gardner Vol #: 31
EC 249 Mrs. Patricia Livingston Vol #: 31
EC 250 Mr. Thomas Nola Vol #: 31
EC 251 Does Not Apply Vol #: 31
EC 252 Mr. Sidney Bravmann Vol #: 31
EC 253 Mrs. Marcia Willhite Vol #: 31
EC 254 Ms. Laura Thelen Vol #: 31
EC 255 Mr. James Wert Vol #: 31
EC 256 Mrs. Jeanne Grant Vol #: 31
EC 257 Mrs. Dianne Frase Vol #: 31
EC 258 Dr. Lois Evans Vol #: 31
EC 259 Mrs. Barbara Schomberg Vol #: 31
EC 260 Dr. Barbara Whaley Vol #: 31
EC 261 Mr. Charles Erkfitz Vol #: 31
EC 262 Dr. James Occhiogrosso Vol #: 31
EC 263 Ms. Dana Ferrara Vol #: 31
EC 264 Healing Feats Holistic Health Services Vol #: 31
EC 265 Mrs. Rosemary Scott Vol #: 31
EC 266 Ms. Deborah Angell Smith Vol #: 31
EC 267 Mrs. Connie Newcome Vol #: 31
EC 268 Mrs. Debra Short Vol #: 31
EC 269 Mr. matt sexton Vol #: 31
EC 270 Mrs. Kelly Ullmer Vol #: 31
EC 271 Mrs. Elizabeth W dOZIER Vol #: 31
EC 272 Mrs. Julie Disser Vol #: 31
EC 273 Miss. karen locklear Vol #: 31
EC 274 Mrs. DIANA POWELL Vol #: 31
EC 275 Mrs. Heather Messerli Vol #: 31
EC 276 Mrs. coni dutka Vol #: 31
EC 277 Ms. Denise Herndon Vol #: 31
EC 278 Mrs. Julie DeVisser Vol #: 31
EC 279 Mr. Don Cogley Vol #: 31
EC 280 Mr. RICHARD STEPHEN Vol #: 31
EC 281 Mrs. NORMA STEPHEN Vol #: 31
EC 282 Mrs. KJ EVANS Vol #: 31
EC 283 Mrs. Sharon Brock Vol #: 31
EC 284 Mrs. Elizabeth Johnson Vol #: 31
EC 285 Mrs. Deborah Garces Vol #: 31
EC 286 Mrs. Erika Glancy Vol #: 31
EC 287 nature for your bod Vol #: 31
EC 288 Ms. Christine Bast Vol #: 31
EC 289 Mather Health Education Services Vol #: 31
EC 290 Nature Sunshine Vol #: 31
EC 291 Mrs. Sammye Lamb Vol #: 31
EC 292 Mrs. Bobbie Baker Vol #: 31
EC 293 Ms. Margaret Wernli Vol #: 31
EC 294 Nature's Sunshine Products Vol #: 31
EC 295 Mrs. Heidi Neeley Vol #: 31
EC 296 Mrs. Elizabeth Thomas Vol #: 31
EC 297 Dr. A. B. Buchanan Vol #: 31
EC 298 Mr. W. R, Huisman Vol #: 31
EC 299 Denali Vol #: 31
EC 300 TecBank Capital Holdings Vol #: 31
EC 301 Mrs. Jerene Olsen Vol #: 31
EC 302 N/A Vol #: 31
EC 303 Dr. Judy Wright Vol #: 31
EC 304 Mrs. Nora Golay Vol #: 31
EC 305 Mrs. Cynthia Huddle Vol #: 31
EC 306 Mrs. Carolyn Gookins Vol #: 31
EC 307 Mrs. Margaret Schoeneck Vol #: 31
EC 308 Mr. David Gookins Vol #: 31
EC 309 individual Vol #: 31
EC 310 Mrs. Amy Longshore Vol #: 31
EC 311 Mrs. Candice Frantz Vol #: 31
EC 312 Mrs. Kari Branson Vol #: 31
EC 313 Mr. Gregory Branson Vol #: 31
EC 314 Mr. Stuart Branson Vol #: 31
EC 315 Mr. Charles Smith Vol #: 31
EC 316 Mrs. Sharon Rosenbaum Vol #: 31
EC 317 Ms. Donna Fox Vol #: 31
EC 318 The Son Shine Shop Vol #: 31
EC 319 Ms. KRISTI MOSIER Vol #: 31
EC 320 Mrs. Rebecca Malter Vol #: 31
EC 321 Ms. Donna Tritt Vol #: 31
EC 322 Dr. Samuel Thomas Vol #: 31
EC 323 Mrs. Myrna Schmidt Vol #: 31
EC 324 owner Vol #: 31
EC 325 NIKKEN Vol #: 31
EC 326 Ms. Sara Colburn Vol #: 31
EC 327 Mr. Norman Schmidt Vol #: 31
EC 328 Ms. Muriel Shepard Vol #: 31
EC 329 Mrs. Kerri Smith Vol #: 31
EC 330 Mrs. Claire Slick Vol #: 31
EC 331 none Vol #: 31
EC 332 Mrs. Lana Bush Vol #: 31
EC 333 Mrs. Helen Cox Vol #: 31
EC 334 Mr. Ronald keddie Vol #: 31
EC 335 Mr. Craig Triplett Vol #: 31
EC 336 Mrs. Michelle Shannon Vol #: 31
EC 337 Mr. Steve Farnes Vol #: 31
EC 338 Mrs. Ruth Mathews Vol #: 31
EC 339 Mr. DAVID MASON Vol #: 31
EC 340 Miss. Pat Smith Vol #: 31
EC 341 Nature Sunshine Products Member Vol #: 31
EC 342 Mr. Tim Egan Vol #: 31
EC 343 NA Vol #: 31
EC 344 Mrs. Mary Knapp Vol #: 31
EC 345 Mr. Christopher Silcock Vol #: 31
EC 346 Mrs. Gretchen Swinney Vol #: 31
EC 347 Ms. Chris Diaz Vol #: 31
EC 348 Mr. David Fox Vol #: 31
EC 349 Mr. Alan Malter Vol #: 31
EC 350 Phoenix Journey Vol #: 31
EC 351 Ms. Sara Vogltranz Vol #: 31
EC 352 Ms. Liza Ely Vol #: 31
EC 353 Mr. Stephen Metcalfe Vol #: 31
EC 354 Miss. Jenna Thompson Vol #: 31
EC 355 Mrs. Debbie Metcalfe Vol #: 31
EC 356 Mr. Steve Metcalfe Vol #: 31
EC 357 Mrs. Beverly McIntosh Vol #: 31
EC 358 Mrs. Sue Munge Vol #: 31
EC 359 none Vol #: 31
EC 360 Dr. Anthony Archer Vol #: 31
EC 361 Ms. Carol Ann Thompson Vol #: 31
EC 362 Prime of Life Vol #: 31
EC 363 Ms. Sherrie Line-Coil Vol #: 31
EC 364 Mr. Keith Kozer Vol #: 31
EC 365 Mr. Timothy Hicks Vol #: 31
EC 366 public citizen retired Vol #: 31
EC 367 Ms. Robin Makar Vol #: 31
EC 368 Ms. Evelyn Muegge Vol #: 31
EC 369 Mrs. Elaine Gordon Vol #: 31
EC 370 Ms. Vanessa Justice Vol #: 31
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
EMC 3 HFV-6 Vol #: 2
EMC 4 J. Kurowski Vol #: 2
EMC 5 Consumers Union Vol #: 2
EMC 6 K. Swanson Vol #: 2
EMC 7 H. Maurice Vol #: 2
EMC 8 A. Pruitt Vol #: 2
EMC 9 B. Breskin Vol #: 2
EMC 10 A. Pruitt Vol #: 2
EMC 11 L. Watts Vol #: 2
EMC 12 E. Lancaster Vol #: 2
EMC 13 E. Lancaster Vol #: 2
EMC 14 K. Howell Vol #: 2
EMC 15 A. Talbott Vol #: 2
EMC 16 K. Ketchen Vol #: 2
EMC 17 A. Lucero Vol #: 2
EMC 18 R. Melamede Vol #: 2
EMC 19 L. Gosslin Vol #: 2
EMC 20 C. Benson, PhD Vol #: 2
EMC 21 J. Kurowski Vol #: 2
EMC 22 I. Waldron Vol #: 2
EMC 23 L. Kusani Vol #: 2
2004P-0512 Health Claim Petition for Soluble Fiber from Barley
LET 2 National Barley Foods Council Vol #: 10
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
LET 5 The Solae Company Vol #: 5
2005N-0031 Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
EMC 1 B. Sachau Vol #: 1
2005N-0036 Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
EMC 1 B. Sachau Vol #: 1
EMC 2 Dr. K. Waarde Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
EAPE 87 Hunt, Angelina Vol #: 1
EAPE 88 Vanderslice, April Vol #: 1
EAPE 89 Horner, Retta Vol #: 1
EAPE 90 Galbreath, Caroline Vol #: 1
EAPE 91 Swidersky, Paul Vol #: 1
EAPE 92 Engle, Cynthia Vol #: 1
EAPE 93 Drissel, Christina Vol #: 1
EAPE 94 Hassall, Thomas Vol #: 1
EAPE 95 McDaniel, Darren Vol #: 1
2005P-0079 Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
ACK 1 HFA-305 to Teva Pharmaceuticals USA Vol #: 1
CP 1 Teva Pharmaceuticals USA Vol #: 1
2005P-0080 ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1

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