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 11/26/02

TABLE OF CONTENTS

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97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01N-0496 Patient Profile Viewer *
02D-0333 Juice HACCP Hazards and Controls *
02N-0209 Governing First Amendment Case Law *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0498 ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets) *

92V-0278 Laser Light Show

EXP 1 Jeff Cone Studios Vol#: 1

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 647 HFS-810 to Vital Living Vol#: 19

LET 648 HFS-810 to Market America, Inc. Vol#: 19

LET 649 HFS-810 to Soft Gel Technologies, Inc. Vol#: 19

LET 650 HFS-810 to 21st Century Nutritional Prod Vol#: 19

LET 651 HFS-810 to Living Essentials Vol#: 19

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

EMC 375 Ruth Stambaugh Vol#: 15

EMC 376 CE Gac Vol#: 15

EMC 377 Patricia Barnett Vol#: 15

EMC 378 Linda Swartz Vol#: 15

EMC 379 Steve Davies-Sigmund Vol#: 15

EMC 380 Tami McDonald Vol#: 15

EMC 381 Ethan Wearn Vol#: 15

EMC 382 Dr. Gary Greenberg Vol#: 15

EMC 383 Karen Kolphin Vol#: 15

EMC 384 Peggy Schram Vol#: 15

EMC 385 Venetia Pimley Vol#: 15

EMC 386 Vivian Layton Vol#: 15

EMC 387 Lisa Khalil Vol#: 15

EMC 388 Gordan McCurry Vol#: 15

EMC 389 Debra Erenberg Vol#: 15

EMC 390 Christina Schultz Vol#: 15

EMC 391 Steve & Patti Devine Vol#: 15

EMC 392 Debbie Boudreau Vol#: 15

EMC 393 Emily Hartmeyer Vol#: 15

EMC 394 Sheila Swigert Vol#: 15

EMC 395 Elizabeth Kitson Vol#: 15

EMC 396 George Schneiderman Vol#: 15

EMC 397 Rose Kervabon Vol#: 15

EMC 398 William Stavisky Vol#: 15

EMC 399 Don Gordon, PhD Vol#: 15

EMC 400 Sam E. Asseff, Jr Vol#: 15

EMC 401 Jean Basinger Vol#: 15

EMC 402 Lin Romano Vol#: 15

EMC 403 Eric Hohlfeld Vol#: 15

EMC 404 Roger Gray Vol#: 15

EMC 405 Kristine Hurst-Wajszczuk Vol#: 15

EMC 406 Terry Stella Vol#: 15

EMC 407 Robert Silvestri Vol#: 15

EMC 408 Janice Boyd Vol#: 15

EMC 409 Robert M. Hamm, PhD Vol#: 15

EMC 410 Lela Mikell Vol#: 15

EMC 411 Dorna Lange Vol#: 15

EMC 412 Claire Toohey Vol#: 15

EMC 413 Norman Schwartz Vol#: 15

EMC 414 Patti Thompson Vol#: 15

EMC 415 Alice McLerran Vol#: 15

EMC 416 William Wilgus Vol#: 15

EMC 417 Karl Stahl Vol#: 15

EMC 418 Bruce Bushong Vol#: 15

EMC 419 Kim Pezza Vol#: 15

EMC 420 Kevin Braun Vol#: 15

EMC 421 Richard D. Sampson Vol#: 15

EMC 422 Laurel Black Vol#: 15

EMC 423 Scott Devine Vol#: 15

EMC 424 Mary Gibson Vol#: 15

EMC 425 Eric Pihl Vol#: 15

EMC 426 Frank Campbell Vol#: 15

EMC 427 Edward Roggenkamp Vol#: 15

EMC 428 Mary Markus Vol#: 15

EMC 429 Karen Asbelle Vol#: 15

EMC 430 Cynthia Cotton Vol#: 15

EMC 431 Lois A. Levin Vol#: 15

EMC 432 Will Coughlin Vol#: 15

EMC 433 James McGrath, MD & Charlotte McGrath Vol#: 15

EMC 434 Thomas Garrison Vol#: 15

EMC 435 Lance Bannerman Vol#: 15

EMC 436 Stewart Peckham Vol#: 15

EMC 437 J.P. Gagnon Vol#: 15

EMC 438 Jeff Hawkins Vol#: 15

EMC 439 Frank & Lavinia Reno Vol#: 15

EMC 440 Maurice Blaug Vol#: 15

EMC 441 Elizabeth Westphal Vol#: 15

EMC 442 Gerrit Crouse, PhD Vol#: 15

EMC 443 Kristen Day Vol#: 15

EMC 444 Beth Bastiaans Vol#: 15

EMC 445 Cheryl Vallone Vol#: 15

EMC 446 Linn Jacobs Vol#: 15

EMC 447 Marin Kress Vol#: 15

EMC 448 John Marshall Vol#: 15

EMC 449 Harlan Solomon Vol#: 15

EMC 450 Pamela & Peter Slowkowski Vol#: 15

EMC 451 Carol Thomas Vol#: 15

EMC 452 Chrys Ballerano Vol#: 15

EMC 453 Don Belding, III Vol#: 15

EMC 454 Jim Heisinger Vol#: 15

EMC 455 P. Graef Vol#: 15

EMC 456 Marcia Butchart Vol#: 15

EMC 457 Treasa VanEaton Vol#: 15

EMC 458 Amy Rogan Vol#: 15

EMC 459 Edith de la Fuente RN, MSN, CS, NP Vol#: 15

EMC 460 Joan Culhane Vol#: 15

EMC 461 Robert Fries Vol#: 15

EMC 462 Marta Stern Vol#: 15

EMC 463 Michael Larson Vol#: 15

EMC 464 Sylvia Haven Vol#: 15

EMC 465 Erika Sandberg Vol#: 15

EMC 466 Robert MacVittie Vol#: 15

EMC 467 Kzena Ross Vol#: 15

EMC 468 Dwight Rousu Vol#: 15

EMC 469 Janet Collins Vol#: 15

EMC 470 Linda DeWitt Vol#: 15

EMC 471 John Fischer Vol#: 15

EMC 472 Robert Burr Vol#: 15

EMC 473 Glenn Burney Vol#: 15

EMC 474 John Baltic Vol#: 15

EMC 475 Jeff Byers Vol#: 15

EMC 476 Janette Jakobs Vol#: 15

EMC 477 Karen Saum Vol#: 15

EMC 478 Jill Craig Vol#: 15

EMC 479 Angela Christman Vol#: 15

EMC 480 Linda Sander Vol#: 15

EMC 481 George Shanahan Vol#: 15

EMC 482 John Robert Conway Vol#: 15

EMC 483 Margaret Wood Vol#: 15

EMC 484 Danny Hawkins Vol#: 15

EMC 485 Lance Polya, PhD Vol#: 15

EMC 486 Ann Ogle Vol#: 15

EMC 487 Keena York Vol#: 15

EMC 488 Bonnie Schuldt Vol#: 15

EMC 489 Nadine Goldin Vol#: 15

EMC 490 Martin Baskin Vol#: 15

EMC 491 Marcia Liotard Vol#: 15

EMC 492 Mae Strenciwilk Vol#: 15

EMC 493 David Oliver, MD Vol#: 15

EMC 494 Jeff Manning Vol#: 15

EMC 495 Sheridan Neimark Vol#: 15

EMC 496 Angela Charles Vol#: 15

EMC 497 Christina Weinhaus Vol#: 15

EMC 498 K. Maple Vol#: 15

EMC 499 Katherine Davis Vol#: 15

EMC 500 Taina Litwak Vol#: 15

EMC 501 John Fay Vol#: 15

EMC 502 Ron Johnson Vol#: 15

EMC 503 Dorothy Hickson Vol#: 15

EMC 504 Heather Hetzeck Vol#: 15

EMC 505 Kevin Myers Vol#: 15

EMC 506 James Conroy Vol#: 15

EMC 507 Forrest Halford Vol#: 15

EMC 508 Gitana Chunyo Vol#: 15

EMC 509 Jacqueline Geoffroy Vol#: 15

EMC 510 Elizabeth Tuohy Vol#: 15

EMC 511 Melissa Thompson Vol#: 15

EMC 512 Carolyn E. Carr Vol#: 15

EMC 513 Deborah Miller Vol#: 15

EMC 514 Laura G. Homeyer Vol#: 15

EMC 515 Deborah Tappan Vol#: 15

EMC 516 Pat Guman Vol#: 15

EMC 517 Gary Kenton Vol#: 15

EMC 518 Alexandria Anderson Vol#: 15

EMC 519 Diana Oleskevich Vol#: 15

EMC 520 Karen M. Hiones Vol#: 15

EMC 521 Kim Deignan Vol#: 15

EMC 522 Chris Arn Vol#: 15

EMC 523 Jennifer Wabin Vol#: 15

EMC 524 A.J. Scott Vol#: 15

EMC 525 Lee Wilson Vol#: 15

EMC 526 Heather Nordstrom Vol#: 15

EMC 527 Jeffrey Ainis Vol#: 15

EMC 528 Ron Masa, PhD Vol#: 15

EMC 529 Cheryl Tate Vol#: 15

EMC 530 Donna Menard Vol#: 15

EMC 531 Bill Testerman Vol#: 15

EMC 532 Beth Perry Vol#: 15

EMC 533 Adeline Lodder Vol#: 15

EMC 534 Hermana Greta Hart Vol#: 15

EMC 535 Devin Joshi Vol#: 15

EMC 536 Naomi Tsu Vol#: 15

EMC 537 Adam Savett Vol#: 15

EMC 538 Coleman Tanner Vol#: 15

EMC 539 Tony Cheng Yang Vol#: 15

EMC 540 Allison Cook Vol#: 15

EMC 541 Julia Cheng Vol#: 15

EMC 542 Walter Maloney Vol#: 15

EMC 543 Larry Lawton Vol#: 15

EMC 544 Chris Coen Vol#: 15

EMC 545 Jennifer Oliver Vol#: 15

EMC 546 Joshua Rabinowitz Vol#: 15

EMC 547 Atiya Rasheed Vol#: 15

EMC 548 JoAnn Durfee Vol#: 15

EMC 549 JA Rodine Vol#: 15

EMC 550 Mary Krane Derr Vol#: 15

EMC 551 Holly Eaton Vol#: 15

EMC 552 Marie Sullivan Vol#: 15

EMC 553 Jacki Lavoie-staples Vol#: 15

EMC 554 Jim & Virginia Wagner Vol#: 15

EMC 555 Monica Allen Vol#: 15

EMC 556 Joanna Nelson Vol#: 15

EMC 557 Eric Foster Vol#: 15

EMC 558 Jennifer Broman Vol#: 15

EMC 559 Sara Lovell Vol#: 15

EMC 560 Matthew P. Davies Vol#: 15

EMC 561 Andrew Butz Vol#: 15

EMC 562 Christine Larson Vol#: 15

EMC 563 Matthew Lebrato Vol#: 15

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

C 6140 Ryan O'Byrne Vol#: 266

C 6141 Carolyn Parker & H. M. Jones Vol#: 266

C 6142 Yoko Fumoto Vol#: 266

C 6143 Dorothy & Walter Pratt Vol#: 266

C 6144 Christine Wright Vol#: 266

C 6145 Ms. Tamra J. Phelps Vol#: 266

C 6146 Valerie Lynn Bartlett Vol#: 266

C 6147 John Riddell Vol#: 266

C 6148 Donna SantaMaria Vol#: 266

C 6149 Ms. Roberta Ann Claypool Vol#: 266

C 6150 Nancy Kutta Vol#: 266

C 6151 Cynthia Embree-Lavoie Vol#: 266

C 6152 Jean Drabble, Sr. Vol#: 266

C 6153 Delia N. Daniels Vol#: 266

C 6154 Mr. & Mrs. Eric Nelson & Family Vol#: 266

C 6155 Mrs. Melody Boime Vol#: 266

99N-5556 Food Contact Substance Notification System

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

M 3 CVM & Bayer Vol#: 329

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

EMC 413 Jeanne Stancil Vol#: 6

01N-0496 Patient Profile Viewer

EMC 2 Sanofi-Synthelabo Research Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2584 Heather Combe (United Kingdom) Vol#: 228

EMC 2585 Ivy Lovell (Canada) Vol#: 228

EMC 2586 Kevin James Martin (Canada) Vol#: 228

EMC 2587 Alexandar (Yugoslavia) Vol#: 228

EMC 2588 Veronica Bautista (Spain) Vol#: 228

EMC 2589 Chris Buchholz Vol#: 228

EMC 2590 Carlie Melinda Bradley (Australia) Vol#: 228

EMC 2591 Samantha June Tyler (South Africa) Vol#: 228

EMC 2592 Kerry Leonard Vol#: 228

EMC 2593 Dawn Elliston (United Kingdom) Vol#: 228

EMC 2594 Darrel Hart Vol#: 228

EMC 2595 Craig Littleford (South Africa) Vol#: 228

EMC 2596 Jan Guill Vol#: 228

EMC 2597 Ada J. Kidd Vol#: 228

EMC 2598 Jeanne Stancil Vol#: 228

EMC 2599 Michael Thibodeau, M.D. Vol#: 228

EMC 2600 Ravi Grover Vol#: 228

EMC 2601 Sherry Bender Vol#: 228

EMC 2602 Daniel Kortsch Vol#: 228

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

EMC 383 Galo A. Grijalva, M.D. Vol#: 4

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 48 C. Livingston Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

EMC 2 S.T.O.P., Safe Tables Our Priority Vol#: 1

02N-0209 Governing First Amendment Case Law

EMC 225 Terry Moon Vol#: 25

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

EMC 61 Joan Taylor Vol#: 1

EMC 62 Phyllis Reilly, RN, PHN Vol#: 1

EMC 63 Kelly Farrell Vol#: 1

EMC 64 Teresa Theophano Vol#: 1

EMC 65 Julie Genovese Vol#: 1

EMC 66 Brandi Maynard Vol#: 1

EMC 67 Marielena Behm Vol#: 1

EMC 68 Robert G. Hamilton, PhD Vol#: 1

EMC 69 Barbara Gaines Vol#: 1

EMC 70 Candice Hughes Vol#: 1

EMC 71 Raquel Kebic Vol#: 1

EMC 72 Phyllis Miller Vol#: 1

EMC 73 No signature Vol#: 1

EMC 74 Fran & Ed Marcyjanik Vol#: 1

EMC 75 No signature Vol#: 1

EMC 76 No signature Vol#: 1

EMC 77 Patricia A. Bush Vol#: 1

EMC 78 Helen Kimball-Brooke Vol#: 1

EMC 79 Michele Logan Vol#: 1

EMC 80 Elisabeth Kristina Larson Vol#: 1

EMC 81 Morgan Larson Vol#: 1

EMC 82 Lori Gurule Vol#: 1

EMC 83 Janet Hickox Vol#: 1

EMC 84 No signature Vol#: 1

EMC 85 Carmela Webb Vol#: 1

EMC 86 Children's Hospital of Philadelphia Vol#: 1

02P-0498 ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets)

ACK 1 HFA-305 Vol#: 1

CP 1 Taro Pharmaceuticals Vol#: 1

02V-0497 Laser light show

ACK 1 HFA-305 Vol#: 1

LET 1 HFZ-342 to Penguin Promotions Vol#: 1

VAR 1 Penguin Promotions Vol#: 1