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 August 27, 2001

TABLE OF CONTENTS

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96P-0460 Add Clotrimazole 1.0% for Treatment of Athlete's Foot etc. *
98N-1038 Irradiation in the production, processing, &handling of food *
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 *
01D-0193 Premarket Notifications for Biological Indicators Intended *
01D-0202 Provisions of the FDA Modernization Act of 1997 *
01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin *
01P-0130 Hydrocodone Bitartrate and Acetaminophen Products *
01P-0144 ANDA for hydrocodone bitartrate & acetaminophen elixir produ *
01P-0156 ANDA Suitability for Ketamine Hydrochloride Injection *
01P-0186 Determination that ANDA for Propoxyphene Napsylate and Napsy *
01P-0214 Declare ANDA may be submitted for Hydrocodone bitartrate & A *
01P-0343 Metal/Metal Semi-Constrained Hip Joint Prosthesis *
01P-0372 Require Box Warning *

77N-0085 Saccharin and Its Salts

LETA6 Morris Farr Vol#: 260

94V-0328 Laser Light Show

EXP 2 Laser Fascinations Vol#: 1

VRA 4 HFZ-300 to Laser Fascinations Vol#: 1

96P-0460 Add Clotrimazole 1.0% for Treatment of Athlete's Foot etc.

C 2 Schering-Plough Care Products Vol#: 1

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

C 5401 Almut E. Dettmers Vol#: 169

C 5402 Joseph & Rose Lutri Vol#: 169

C 5403 Brent L. Wendling, Ph.D. Vol#: 169

C 5404 Nancy O. Allen Vol#: 169

C 5405 Alyssa Solomon Vol#: 169

C 5406 Jerry Morphis Vol#: 169

C 5407 John & Loretta Van Coppenolle Vol#: 169

C 5408 Ms. Laurel Leslie Vol#: 169

C 5409 Greg S. Corvi Vol#: 169

C 5410 Daniel Wovcha Vol#: 169

C 5411 Patricia Pope Vol#: 169

C 5412 Elaine Herzog Vol#: 169

C 5413 Dawn Mallow Vol#: 169

C 5414 Paul R. Jackson Vol#: 169

C 5415 Kathy Dorn Vol#: 169

C 5416 Kjersti A. Cochran & Stella Lundeberg Vol#: 169

C 5417 Salomea T. Montroy Vol#: 169

C 5418 Barbara A. & Stephen Emerson Vol#: 169

C 5419 Christine Johnson Vol#: 169

C 5420 Dr. Mha Atma S. Khalsa & Martha Oaklande Vol#: 169

C 5421 Organic Consumers Assn. Vol#: 169

C 5422 Nicole Fox Vol#: 169

C 5423 Dr. & Mrs. N. Gura Vol#: 169

C 5424 Ms. Inge Szacs Vol#: 169

C 5425 Judi Peman Vol#: 169

C 5426 Sarah Wovcha, J.D., M.P.H. Vol#: 169

C 5427 Majorie Sportsman Vol#: 169

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

C 5154 Teresa M. Gross Vol#: 168

C 5155 Teresa Corio Vol#: 168

C 5156 Kelly Hachtel Vol#: 168

C 5157 Laura Groman Vol#: 168

C 5158 Hane Kerst Kranjer Vol#: 168

C 5159 Robin N. Wojtach Vol#: 168

EMC 2297 Michelle McAlister Vol#: 168

EMC 2298 Stefanie Jacobs Vol#: 168

EMC 2299 Nancy Draper Vol#: 168

EMC 2300 Natasha Ann Bennett Vol#: 168

EMC 2301 Sandra Vol#: 168

EMC 2302 Linda R. Bolella Vol#: 168

EMC 2303 Tina Novakovich Vol#: 168

EMC 2304 Shari Lakin Vol#: 168

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

C 11 Health Canada Vol#: 1

00C-1444 filing of Color Additive Petition in fingernail polish

NWL 1 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 8354 Rita Weintraub Vol#: 436

C 8355 Margaret A. Silverman Vol#: 436

C 8356 Eligible Vol#: 436

C 8357 Harriet A. King Vol#: 436

C 8358 William Cwik Vol#: 436

C 8359 Anna Landauer Vol#: 436

C 8360 Hazzel Scheller Vol#: 436

C 8361 Melissa G. Lee Vol#: 436

C 8362 Aida S. Tallman Vol#: 436

C 8363 Marguerite Dunn Vol#: 436

C 8364 Kathleen Skoller Vol#: 436

C 8365 Greg Vogtritter Vol#: 436

C 8366 James Hedeen Vol#: 436

C 8367 Barbara A. Zink Vol#: 436

C 8368 Judith M. Currie Vol#: 436

C 8369 Andrea Ross Vol#: 436

C 8370 Sarah Rosenfield Vol#: 436

C 8371 Jean M. Moser Vol#: 436

C 8372 Marie V. Porter Vol#: 436

C 8373 Marie B. BauerJones Vol#: 436

C 8374 Mary Beth Hooper Vol#: 436

C 8375 S. Smith Vol#: 436

C 8376 Lisa Coplantz Vol#: 436

C 8377 Linda Hickok Vol#: 436

C 8378 Linda Stimson Vol#: 436

C 8379 Auria Gerhardt Vol#: 436

C 8380 Pat Piper Vol#: 436

C 8381 Willard G. Van Hoorn Vol#: 436

C 8382 David Mitchell Vol#: 436

C 8383 Eligible Vol#: 436

C 8384 Jennifer R. Kern Vol#: 436

C 8385 Laura Lee Manley Vol#: 436

C 8386 Aaron Petz Vol#: 436

C 8387 Kelli Reitzer Vol#: 436

C 8388 Sue Miller Vol#: 436

C 8389 Mr & Mrs Robert F and Janet Johnson Vol#: 436

C 8390 Lillian Thompson Vol#: 436

C 8391 Gina Cooke & Jon Fiebelkorn Vol#: 436

C 8392 Barbara Kelly Vol#: 436

C 8393 Evelyn Brew Vol#: 436

C 8394 Robin Daniels Vol#: 436

C 8395 Leon Black Vol#: 436

C 8396 David Wilkins Vol#: 437

C 8397 Jennifer Daryl Slack, PhD Vol#: 437

C 8398 Kelly McMenimen Vol#: 437

C 8399 Patricia Samuel Vol#: 437

C 8400 Deborah Lyle Vol#: 437

C 8401 Walter Bill Vol#: 437

C 8402 Sarah Webber Vol#: 437

C 8403 Deane Rousseau Vol#: 437

C 8404 Michael Durrell Vol#: 437

C 8405 Clifford I. Leckliter Vol#: 437

C 8406 Jonathan Wieder Vol#: 437

C 8407 Alison Swan Vol#: 437

C 8408 Debbie Mancuso Vol#: 437

C 8409 Claire O'Leary Vol#: 437

C 8410 Kendra Eneroth Vol#: 437

C 8411 Henry Peck Vol#: 437

C 8412 Beckner & Beckner Vol#: 437

C 8413 Susan Junda Vol#: 437

C 8414 Claire Haddad Vol#: 437

C 8415 Mark Davis Vol#: 437

C 8416 Barbara Green Vol#: 437

C 8417 Kathy Adams Vol#: 437

C 8418 Krista Sickler Vol#: 437

C 8419 Hope Anwyll Vol#: 437

C 8420 Hyla Fetler Vol#: 437

C 8421 Patrick Brown Vol#: 437

C 8422 Jenny Cortina Vol#: 437

C 8423 Sara Polgar Vol#: 437

C 8424 Lorraine Jackson Vol#: 437

C 8425 The Nesbitt Family Vol#: 437

C 8426 Anne Adams Vol#: 437

C 8427 Susan Bradfield Vol#: 437

C 8428 Kari Lemieux Vol#: 437

C 8429 Orpha Hinkley Vol#: 437

C 8430 H.R. Kruger Vol#: 437

C 8431 Elizabeth Patsis Vol#: 437

C 8432 John Patsis Vol#: 437

C 8433 Zach Castleman Vol#: 437

C 8434 Marilyn E. Logan Vol#: 437

C 8435 Joyce Poudrier Vol#: 437

C 8436 Joanne Holbrook Vol#: 437

C 8437 Dolores Tippett Vol#: 437

C 8438 Frances Peshkin Vol#: 437

C 8439 Martin M. Kellerman Vol#: 437

C 8440 Paul D. Konopelski Vol#: 437

C 8441 Tracey Brown Vol#: 437

C 8442 William Baggins Vol#: 437

C 8443 Mona Christenson Vol#: 437

C 8444 David Lieberman Vol#: 437

C 8445 Heidi Feistone Vol#: 437

C 8446 Becki Kuhn Vol#: 437

C 8447 Mary A. Layne Vol#: 437

C 8448 Dawn Magro Vol#: 437

C 8449 Ward D. Hull Vol#: 437

C 8450 Deborah Benner Vol#: 437

C 8451 William Crenshaw Vol#: 437

C 8452 Laura King Vol#: 437

C 8453 Donald P. Robinson Vol#: 437

C 8454 Richard Setd Vol#: 437

C 8455 Dorothy Campbell Vol#: 437

C 8456 Joyce Wilbourn Vol#: 437

C 8457 Patricia L. Trumball Vol#: 437

C 8458 Ann K. Kirkland Vol#: 437

C 8459 Lisa Salvatore Vol#: 437

C 8460 Alan D. Conner Vol#: 437

C 8461 Brenda Maurer Vol#: 437

C 8462 Armilda Marie Adams Vol#: 437

C 8463 David L. Wolery Vol#: 437

C 8464 T. DeMott Vol#: 437

C 8465 Walter Wright Vol#: 437

C 8466 Mrs Fred Sampson Vol#: 437

C 8467 Allen E. Stanley Vol#: 437

C 8468 Monica K. Decheniny Vol#: 437

C 8469 Carl P. Johnson Vol#: 437

C 8470 Barbara S. Smith Vol#: 437

C 8471 Ray & Virginia McCall Vol#: 437

C 8472 Connie D. Webben Vol#: 437

C 8473 Foy & Mary Jo Magee Vol#: 437

C 8474 Jacqueline L. Anthony Vol#: 437

C 8475 Bill Graves Vol#: 437

C 8476 Cheryl Fragans Vol#: 437

C 8477 Randolph E. Hays Vol#: 437

C 8478 Eyleen Smith Vol#: 437

C 8479 Linda Curto Vol#: 437

C 8480 Linda B. Aldrich Vol#: 437

C 8481 JoAnn Pearce Vol#: 437

C 8482 Shirley L. Durfey Vol#: 437

C 8483 Pat Danczek Vol#: 437

C 8484 Edward Snyder Vol#: 437

C 8485 Julene Brown Vol#: 437

C 8486 Eloise Cottrell Vol#: 437

C 8487 Mary Belais Vol#: 437

C 8488 Paul Boerum Vol#: 437

C 8489 Jeanne Frazee Vol#: 437

C 8490 Julie Amundson Vol#: 437

C 8491 Gladys Diamond Vol#: 437

C 8492 Fred Clement Vol#: 437

C 8493 Elaine Schenk Vol#: 437

C 8494 Rosemary Saba Vol#: 437

C 8495 Harriet Brooks Vol#: 437

C 8496 D.R. Crichton Vol#: 437

C 8497 Lois Kathleen Snyder Vol#: 437

C 8498 MG Hudson Vol#: 437

C 8499 Cynthia Morelli Vol#: 437

C 8500 Lisbeth Ann Williams Vol#: 437

C 8501 Hans Christian Davis Vol#: 438

C 8502 Ellen Voegtle Vol#: 438

C 8503 No Signature Vol#: 438

C 8504 Joan McCullough Vol#: 438

C 8505 Nancy Margaret Lyons Vol#: 438

C 8506 Laura Buchite Vol#: 438

C 8507 Joyce M. Poudrier Vol#: 438

C 8508 Martha F. Martin Vol#: 438

C 8509 Tiffany Gossett Vol#: 438

C 8510 Florence Jacobson Vol#: 438

C 8511 Julia M. Hayes Vol#: 438

C 8512 Laura Merrill Vol#: 438

C 8513 Tim J. Smith Sr. Vol#: 438

C 8514 Carolyn Amick Vol#: 438

C 8515 J.D. Walker Vol#: 438

C 8516 Linda M. Williams Vol#: 438

C 8517 George B. Bishop Vol#: 438

C 8518 Julie T. Payton Vol#: 438

C 8519 Suzanne Danbam Vol#: 438

C 8520 Jeanne Steeber Vol#: 438

C 8521 Paul Levy Vol#: 438

C 8522 Kathleen N. Jackson Vol#: 438

C 8523 Jean Robb Vol#: 438

C 8524 Sandra E. Mitchell Vol#: 438

C 8525 Mary E. Lukjza Vol#: 438

C 8526 Julie Sabia Vol#: 438

C 8527 Todd Scott Vol#: 438

C 8528 Todd & Susan Menges Vol#: 438

C 8529 Lauri Crossman Vol#: 438

C 8530 Mrs. Phil Williams Vol#: 438

C 8531 Nancy A. Sica Vol#: 438

C 8532 Karen Scheel Vol#: 438

C 8533 No signature Vol#: 438

C 8534 Mary D. McHenry Vol#: 438

C 8535 Cheryl R. Cromer Vol#: 438

C 8536 Bernard Petley Vol#: 438

C 8537 Gerald Leigh Vol#: 438

C 8538 Mary Lou Begnaud Vol#: 438

C 8539 Robert C. Hertiold Vol#: 438

C 8540 Nila J. Reineke Vol#: 438

C 8541 Michael Alexander Vol#: 438

C 8542 Nancy Pernell Vol#: 438

C 8543 P. Westbrook Vol#: 438

C 8544 Betsy Walker Vol#: 438

C 8545 Kathy Gerard Friedlander Vol#: 438

C 8546 Mary Heiker Vol#: 438

C 8547 Penny Blubaugh Vol#: 438

C 8548 Jonathan Jensen Vol#: 438

C 8549 Shirley Geiser Vol#: 438

C 8550 Anne Marie Whitney Vol#: 438

C 8551 Julie M. Emerson Vol#: 438

C 8552 Valerie Weiss Vol#: 438

C 8553 Ruth Gordon Vol#: 438

C 8554 Norma J. Bennett Vol#: 438

C 8555 Karen S. Clay Vol#: 438

C 8556 Susan Thompson Vol#: 438

C 8557 Jayne E. Tauscher Vol#: 438

C 8558 Stephen & Denise Dinsmore Vol#: 438

C 8559 Nanci Desautels Vol#: 438

C 8560 Mary L. Proffitt Vol#: 438

C 8561 Kirk Olsen Vol#: 438

C 8562 B.A. Hopp Vol#: 438

C 8563 Mardell Olsen Vol#: 438

C 8564 Beverly K. Hopp Vol#: 438

C 8565 Cami J. Klingonsmith Vol#: 438

C 8566 Yoko Iwaki Vol#: 438

C 8567 Linda Carpenter Vol#: 438

C 8568 Julie Ann Brady Vol#: 438

C 8569 Deb Bell Vol#: 438

C 8570 Matthew B. Hall Vol#: 438

C 8571 Edmond Baudino Vol#: 438

C 8572 Sue Amerson Vol#: 438

C 8573 Ella J. Sontheimer Vol#: 438

C 8574 Joyce S. Daggett Vol#: 438

C 8575 Margaret Hyman Vol#: 438

C 8576 Tyra Baker Vol#: 438

C 8577 Mary Grayson Vol#: 438

C 8578 Helen McGuigan-Kiperman Vol#: 438

00D-1618 Blood collection/persons with Hereditary Hemochromatosis

GDL 2 Guideline Vol#: 1

NAD 2 Guideline Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 8950 Nathaniel Whitmore Vol#: 332

C 8951 The Center for Food Safety Vol#: 332

C 8952 Mrs. Lou David Vol#: 332

C 8953 M. Hagens Vol#: 332

C 8954 Terry Poplawski Vol#: 332

C 8955 Tania Banak Vol#: 332

01D-0193 Premarket Notifications for Biological Indicators Intended

C 9 Steris CorporationD Vol#: 1

01D-0202 Provisions of the FDA Modernization Act of 1997

C 8 College of American Pathologists Vol#: 1

01D-0278 Type V Drug Master Files

GDL 1 Guideline Vol#: 1

NAD 1 Guideline Vol#: 1

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

N 2 Vol#: 1

01N-0336 Withdrawal of 51 NDAs and 25 ANDAs

NWL 1 Vol#: 1

01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin

LET 1 Ruth Armstrong Vol#: 1

01P-0130 Hydrocodone Bitartrate and Acetaminophen Products

PAV 1 HFD-600 to Pharmaceutical Associates Inc Vol#: 1

01P-0144 ANDA for hydrocodone bitartrate & acetaminophen elixir produ

PAV 1 HFD-600 to Pharmaceutical Associates Inc Vol#: 1

01P-0156 ANDA Suitability for Ketamine Hydrochloride Injection

PAV 1 HFD-600 to Bioniche Pharma (Canada) LTD Vol#: 1

SUP 1 Bioniche Pharma (Canada) Ltd. Vol#: 1

01P-0186 Determination that ANDA for Propoxyphene Napsylate and Napsy

PAV 1 HFD-600 to Arnall Golden Gregory LLP Vol#: 1

01P-0214 Declare ANDA may be submitted for Hydrocodone bitartrate & A

PAV 1 HFD-600 to Pharmaceutical Associates Inc Vol#: 1

01P-0343 Metal/Metal Semi-Constrained Hip Joint Prosthesis

SUP 1 OSMA Vol#: 5

01P-0372 Require Box Warning

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Vol#: 1