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DOCKETS ENTERED on March 16, 2001

DOCKETS ENTERED on March 17, 2001

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
DOCKETS ENTERED on March 16, 2001

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1665 Consumer Roundtable; Notice of Meeting *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
01N-0063 Medical Devices; CGMP Quality System Regulation *
01P-0130 Hydrocodone Bitartrate and Acetaminophen Products *
01P-0133 Dermatop Ointment voluntariy withdrawn *

DOCKETS ENTERED on March 17, 2001

00D-1598 Voluntary Labeling for Bioengineered Foods

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 488 Amanda Klein Vol#: 203

EMC 489 Maria S Belli Vol#: 203

EMC 490 C Livingston Vol#: 203

EMC 491 Karen Clyde Vol#: 203

EMC 492 J Bishton Vol#: 203

EMC 493 David Benson Vol#: 203

EMC 494 Kitty McCague Vol#: 203

EMC 495 Eleanor B Wireman Vol#: 203

EMC 496 Cheryl Mero Vol#: 203

EMC 497 Sunnie Noellert Vol#: 203

EMC 498 Thomas Pliske Vol#: 203

EMC 499 Nadine Scott Vol#: 203

EMC 500 Krisitn Basta Vol#: 203

EMC 501 Frederica B Neal Vol#: 203

EMC 502 Deborah Wool Vol#: 203

EMC 503 Melinda Routh Vol#: 203

EMC 504 Mary Rapaport Vol#: 203

EMC 505 Katherine Jackson Vol#: 203

EMC 506 Melanie Lapointe Vol#: 203

EMC 507 John Dziak Vol#: 203

EMC 508 Rita Margarita Vol#: 203

EMC 509 Chas L Stoltz Vol#: 203

EMC 510 Raymond Chavira Vol#: 203

EMC 511 Dr Michael D Rohr Vol#: 203

EMC 512 Don & Norma Boswell Vol#: 203

EMC 513 LaDonna Smith Vol#: 203

EMC 514 Janet Steelman Vol#: 203

EMC 515 Hart Matthews Vol#: 203

EMC 516 Susan Harris Vol#: 203

EMC 517 Amy Karafin Vol#: 203

EMC 518 Joy Downey Vol#: 203

EMC 519 Debbie Rutledge Vol#: 203

EMC 520 NUMBER NOT USED Vol#: 203

EMC 521 Heather Fong Vol#: 203

EMC 522 Carlos Bohorquez Vol#: 204

EMC 523 Kirsten Maue Vol#: 204

EMC 524 Jennifer Kemnitz Vol#: 204

EMC 525 Ingrid Lundahl Vol#: 204

EMC 526 Mary Stone Vol#: 204

EMC 527 Gaybra Raymond Vol#: 204

EMC 528 Ian Boardman Vol#: 204

EMC 529 Sue Donora Vol#: 204

EMC 530 Bernadette Rosenstiel Vol#: 204

EMC 531 Linda Spiegler Vol#: 204

EMC 532 M P Vol#: 204

EMC 533 Diane Lake Vol#: 204

EMC 534 Malcolm Kenton Vol#: 204

EMC 535 Eleanor W Helper Vol#: 204

EMC 536 Kristin Doubet Vol#: 204

EMC 537 Heather Plattenberger Vol#: 204

EMC 538 Cara Emery Vol#: 204

EMC 539 Laura Stucin Vol#: 204

EMC 540 Wendie Lash Vol#: 204

EMC 541 Philip Berlier Vol#: 204

EMC 542 Ann Ulmer Vol#: 204

EMC 543 Elizabeth Westphal Vol#: 204

EMC 544 Carla Pickett Vol#: 204

EMC 545 Pete Kallinger Vol#: 204

EMC 546 W Jean Rohrer Vol#: 204

EMC 547 Gerard Cookson Vol#: 204

EMC 548 Ski Taylor Vol#: 204

EMC 549 Linda Martinek Vol#: 204

00D-1598 Voluntary Labeling for Bioengineered Foods

EC 237 Ms. Mary Shesgreen Vol#: 64

EC 238 Ms. Marilyn Kahn Vol#: 64

EC 239 Ms. Susanne Harrison Vol#: 64

EC 240 Ms. Jean Allen Vol#: 64

EC 241 Ms. Eriks Blaschka Vol#: 64

EC 242 Ms. Barbara Likens Vol#: 64

EC 243 n/a Vol#: 64

EC 244 Mr. Daniel Schab Vol#: 64

EC 245 Ms. Connie Luna Vol#: 64

EC 246 Dr. Michael Callahan Vol#: 64

EC 247 Mr. dennis kneff Vol#: 64

EC 248 Mr. Otto Schaaf Vol#: 64

EC 249 Mr. ray kirsch Vol#: 64

EC 250 Ms. Sandra Pittman Vol#: 64

EC 251 Miss helen mcgreary Vol#: 64


00N-1396 Bioengineered Foods Consumed By Humans or Animals

EC 133 Miss Katie Kunze Vol#: 23

EC 134 University of California San Francisco Vol#: 23

EC 135 Mahakaqli Saranam Temple Vol#: 23

EC 136 Ms. Marilyn Kahn Vol#: 23

EC 137 Ms. Lisa Valdmets Vol#: 23

EC 138 Miss Irene Mills Vol#: 23

EC 139 Mr. Daniel Schab Vol#: 23

EC 140 Dr. Michael Callahan Callahan Vol#: 23

EC 141 private citizen Vol#: 23

EC 142 NOBLE BEEKEEPERS ASSOC. Vol#: 23

EC 143 Ms. Sandra Pittman Vol#: 23

EC 144 Ms. Jessica Kem Vol#: 23

EC 145 Ms. Laura Buttenbaum Vol#: 23

EMC 670 W Ekstrom Vol#: 21

EMC 671 E Schwarzwald Vol#: 21

EMC 672 S EtShalom Vol#: 21

EMC 673 A J Henning Vol#: 21

EMC 674 Number not used Vol#: 21

EMC 675 Number not used Vol#: 21

EMC 676 A Schackow Vol#: 21

EMC 677 A Disler Vol#: 21

EMC 678 P E Adams Vol#: 21

EMC 679 Number not used Vol#: 21

EMC 680 W J Harper Vol#: 21

EMC 681 C Chen Vol#: 21

EMC 682 A L Feifer Vol#: 21

EMC 683 L Garvin Vol#: 21

EMC 684 A Jelinke Vol#: 21

EMC 685 K Varnes Vol#: 21

EMC 686 USDA-ARS Vol#: 21

EMC 687 M Lester Vol#: 21

EMC 688 A Condon Vol#: 21

EMC 689 R Scibek Vol#: 21

EMC 690 J Bradley Vol#: 21

EMC 691 C Johnson Vol#: 21

EMC 692 B J Van Wicklen Vol#: 21

EMC 693 B J Van Wicklen Vol#: 21

EMC 694 J Shupe Vol#: 21

EMC 695 D Hoaglin Vol#: 21

EMC 696 A Kobrin Vol#: 21

EMC 697 M B Vol#: 21

EMC 698 Number not used Vol#: 21

EMC 699 B DeBolt Vol#: 21

EMC 700 M Mochizuki Vol#: 21

EMC 701 S Halpert Vol#: 21

EMC 702 G Magaro Vol#: 21

EMC 703 B Graham Vol#: 21

EMC 704 B Anton Vol#: 21

EMC 705 B Pletschke Vol#: 21

EMC 706 E Gilmore Vol#: 21

EMC 707 R Siebold Vol#: 21

EMC 708 Drs. E & W Trought Vol#: 21

EMC 709 N Fan Vol#: 21

EMC 710 P Porter Vol#: 21

EMC 711 A Hankins Vol#: 21

EMC 712 S A L Vol#: 21

EMC 713 C Ruble Vol#: 21

EMC 714 P Lawton Vol#: 21

EMC 715 E Klein Vol#: 21

EMC 716 M Van Handel Vol#:

EMC 717 R E Frank Vol#: 21

EMC 718 R DeWeese Vol#: 21

EMC 719 S Liang Vol#: 21

EMC 720 R Vance Vol#: 21

EMC 721 K Solberg Vol#: 21

EMC 722 M Coles Vol#: 21

EMC 723 B Wisthoff Vol#: 21

EMC 724 Dr. H Kiesecker Vol#: 21

EMC 725 M Zanni Vol#: 21

EMC 726 P Schechter Vol#: 21

EMC 727 M Borden Vol#: 21

EMC 728 C Christensen Vol#: 21

EMC 729 M Rakestraw Vol#: 21

EMC 730 C Clarke Vol#: 21

EMC 731 M Rinkenberger Vol#: 21

EMC 732 S E Davis Vol#: 21

EMC 733 C Svehla Vol#: 21

EMC 734 D Fredle Vol#: 21

EMC 735 E Sedgwick Vol#: 21

EMC 736 M Wegs Vol#: 21

EMC 737 just@letting.com Vol#: 21

EMC 738 M Chelini Vol#:

EMC 739 Dr. G Rassner Vol#: 21

EMC 740 G Kemppainen Vol#: 21

EMC 741 K Madden Vol#: 21

EMC 742 N Anderson Vol#: 21

EMC 743 B Mihopulos Vol#: 21

EMC 744 M Saraceni Vol#: 21

EMC 745 D Corson-Knowles Vol#: 21

EMC 746 E M Moore Vol#: 21

EMC 747 R-E Holland Vol#: 21

EMC 748 J & C Lennon Vol#: 21

EMC 749 M Werner Vol#: 21

EMC 750 A Farnsworth Vol#: 21

EMC 751 A Silva Vol#: 21

EMC 752 J Koran Vol#: 21

EMC 753 B & D Vol#: 21

EMC 754 E Savage Vol#: 21

EMC 755 M Marks Vol#: 21

EMC 756 S Gertsch Vol#: 21

EMC 757 K Greagen Vol#: 21

EMC 758 J S Maw Vol#: 21

EMC 759 K Wencl Vol#: 21

EMC 760 P Lee Vol#: 21

EMC 761 M Mitchell Vol#: 21

EMC 762 D Moss Vol#: 21

EMC 763 C Folkerth Vol#: 21

EMC 764 D Kramer-Urner Vol#: 21

EMC 765 C Donk Vol#: 21

EMC 766 L Phillips Vol#: 21

EMC 767 ? Vol#: 21

EMC 768 R Flint Vol#: 21

EMC 769 C Burgerworth Vol#: 21

EMC 770 G Gainsforth Vol#: 21

EMC 771 M James Vol#: 21

EMC 772 R Alex Vol#: 21

EMC 773 Number not used Vol#: 21

EMC 774 M Mulligan Vol#: 21

EMC 775 D Dahlinghaus Vol#: 21

EMC 776 B Freeman Vol#: 21

EMC 777 Reserve Technology Institute Vol#: 21

EMC 778 J Cerio Vol#: 21

EMC 779 J B Lewis Vol#: 21

EMC 780 K Hoffman-Rankin Vol#: 21

EMC 781 P Schmitt Vol#: 21

EMC 782 T Huey Vol#: 21

EMC 783 V Fitch Vol#: 21

EMC 784 R Tafari Vol#: 21

EMC 785 D Wirth Vol#: 21


00N-1665 Consumer Roundtable; Notice of Meeting

EC 15 Department of Marine Resources Vol#: 1


00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

EXT 2 Unilever Vol#: 13

00P-1276 Health Claim: Plant stanol esters and heart disease

EXT 1 Unilever Vol#: 12

00P-1499 Remove alosetron (Lotronex) from the market

EMC 264 NUMBER NOT USED Vol#: 3

EMC 265 Brenda Bren Vol#: 3

EMC 266 Victor Williams Vol#: 3

LET 1 HFD-1 to Public Citizen Vol#: 3

01N-0063 Medical Devices; CGMP Quality System Regulation

EC 1 Mr. Fred Dexter Vol#: 1


01P-0130 Hydrocodone Bitartrate and Acetaminophen Products

ACK 1 HFA-305 Vol#: 1

CP 1 Pharmaceutical Associates, Inc. Vol#: 1


01P-0133 Dermatop Ointment voluntariy withdrawn

ACK 1 HFA-305 Vol#: 1

CP 1 The Weinberg Group, Inc. Vol#: 1

DOCKETS ENTERED 03/17/01

Docket Title

Number

00D-1598 Voluntary Labeling for Bioengineered Foods*

00D-1598 Voluntary Labeling for Bioengineered Foods

C 421 Steven Jackson Vol#: 64

C 422 Bruce Clotworthy Vol#: 64

C 423 Ursula Wolf-Rottkay Vol#: 64

C 424 John Wurr Vol#: 64

C 425 Janyce Halligan Vol#: 64

C 426 Florence E. Oeke Vol#: 64

C 427 Claire Pestak Vol#: 64

C 428 Aja Myers-Taylor Vol#: 64

C 429 Heidi Grant Vol#: 64

C 430 Heather Griffin Vol#: 64

C 431 Loni Crowder Vol#: 64

C 432 Tom Stewart Vol#: 64

C 433 Karen Tal Calet Vol#: 64

C 434 Nelson Sapad Vol#: 64

C 435 Houston Gllins Vol#: 64

C 436 Sallie Wong Vol#: 64

C 437 Cynthia Bakke Vol#: 64

C 438 Katy Eagan Vol#: 64

C 439 Gary Sullivan Vol#: 64

C 440 Mattue E. Ratigan Vol#: 64

C 441 Leslie Corington Vol#: 64

C 442 Shawn Blaisdellim Vol#: 64

C 443 Karen Deuig Vol#: 64

C 444 Claryann Eddy Vol#: 64

C 445 Barbara B Vol#: 64

C 446 Maria Gillen Vol#: 64

C 447 Nora Fitzgerald Vol#: 64

C 448 John R. Vol#: 64

C 449 No Signature Vol#: 64

C 450 Anita C Vol#: 64

C 451 Mary E. Ricker Vol#: 64

C 452 Hamid Awr Vol#: 64

C 453 Dawn Sperby Vol#: 64

C 454 Nathen Joseph Vol#: 64

C 455 P Loomer Vol#: 64

C 456 O.B. Vol#: 64

C 457 Jane Garrett Vol#: 64

C 458 Paul Levy Vol#: 64

C 459 George Meyers Vol#: 64

C 460 Joyann Miler Vol#: 64

C 461 T Bladuf Vol#: 64

C 462 Carolyn K Vol#: 64

C 463 No Signature Vol#: 64

C 464 S. P Vol#: 64

C 465 Mary McConnell Vol#: 64

C 466 P R Vol#: 64

C 467 Marshall Kovitz Vol#: 64

C 468 Dusty Marie Vol#: 64

C 469 Linda Stanton Vol#: 64

C 470 Larry Kronen Vol#: 64

C 471 Scott Jackson Vol#: 64

C 472 Z Hertton Vol#: 64

C 473 Jane B Vol#: 64

C 474 I.R. Vol#: 64

C 475 Ramona Ried Vol#: 64

C 476 F. D. Vol#: 64

C 477 Lill Fitzbag Vol#: 64

C 478 Thora Giena Vol#: 64

C 479 Dena Thora Vol#: 64

C 480 Nancy Haynes Vol#: 64

C 481 Carolyn Mead Vol#: 64

C 482 Greg Hudsond Vol#: 64

C 483 Laurel Ladburg Vol#: 64

C 484 Harsitel Weiss Vol#: 64

C 485 Jean O'Neile Vol#: 64

C 486 Kim Gleason Vol#: 64

C 487 Aaron Bowen Vol#: 64

C 488 David R. Mangolin Vol#: 64

C 489 David Sherman Vol#: 64

C 490 Ben Bronatuto Vol#: 64

C 491 Perry R. Wilkes Vol#: 64

C 492 Aatlon Citrin Vol#: 64

C 493 J. Hmens Vol#: 64

C 494 Leigh O Vol#: 64

C 495 Peer King Vol#: 64

C 496 Karen Serrano Vol#: 64

C 497 Patrick Kraich Vol#: 64

C 498 Jacob S. Ware Vol#: 64

C 499 Emily Voslen Vol#: 64

C 500 Paul James Vol#: 64

C 501 Joyce Henderson Vol#: 74

C 502 Kim Savage Vol#: 74

C 503 Slice W. Douglas Vol#: 74

C 504 Sarah Clayton Kelly Vol#: 74

C 505 Margaret M. Sweeney Vol#: 74

C 506 Ann Paff Vol#: 74

C 507 Janet Smith Vol#: 74

C 508 Brenda Cheagrei Vol#: 74

C 509 Harry Pylor Vol#: 74

C 510 Carolyn P. Shaw Vol#: 74

C 511 Jinlen Silva Vol#: 74

C 512 Lori Lash Vol#: 74

C 513 Sara Hutchinson Vol#: 74

C 514 Gail Vol#: 74

C 515 Isdura Andaluz Vol#: 74

C 516 Clemond Vol#: 74

C 517 Kristen Barney Vol#: 74

C 518 Coon Vol#: 74

C 519 Karen Neisary Vol#: 74

C 520 Narce L. Crow Vol#: 74

C 521 Therece Vol#: 74

C 522 Mynatt Vol#: 74

C 523 M W Vol#: 74

C 524 Patricia Jackson Vol#: 74

C 525 John J. Fenske, Ph.d. Vol#: 74

C 526 Bengamine Cole Vol#: 74

C 527 Amy Wing Vol#: 74

C 528 Elizabeth F. Kurtik Vol#: 74

C 529 Judith B. Grace Vol#: 74

C 530 Ruth L. Hart Vol#: 74

C 531 Ileana R. Pisauro Vol#: 74

C 532 Peggy Graham Vol#: 74

C 533 Michael T. Siciliano Vol#: 74

C 534 Jacqueline Jones Vol#: 74

C 535 Drew Emery Battin Vol#: 74

C 536 Stephanie Olek Vol#: 74

C 537 Johnny Doherty Vol#: 74

C 538 Kathy Burke Vol#: 74

C 539 Elizabeth E. Legum Vol#: 74

C 540 Catherine Rees Vol#: 74

C 541 Terri Titcomb Vol#: 74

C 542 Karen Johnson Vol#: 74

C 543 Gene Vogel Vol#: 74

C 544 Virginia Stewart Vol#: 74

C 545 Mark Sciscenti & Kathleen Potter Vol#: 74

C 546 Mrs. Harry A. Goodridge Vol#: 74

C 547 Melinda C. McComb Vol#: 74

C 548 Virginia Stewart Vol#: 74

C 549 Abriano Marinelli Vol#: 74

C 550 Kathy Labriola Vol#: 74

C 551 Barbara F. Wellis Vol#: 74

C 552 Christopher M. Picone, Ph.D. Vol#: 74

C 553 Ms. Faith Clark Vol#: 74

C 554 Elisabeth Ehrlich Vol#: 74

C 555 M Vol#: 74

C 556 Cheryl Goldberg Vol#: 74

C 557 Peter S. Vol#: 74

C 558 Ms. Barbara Leeper Vol#: 74

C 559 Elizabeth LaForest Vol#: 74

C 560 Brian Haney Vol#: 74

C 561 Lesley Weinstock Vol#: 74

C 562 Janet Hathney Vol#: 74

C 563 D.H. Vol#: 74

C 564 Julia D.L. Vol#: 74

C 565 Bob Pelegin Vol#: 74

C 566 MK Coyie Vol#: 74

C 567 Sarah N. Lindenfeld Vol#: 74

C 568 Laura Laflamme Vol#: 74

C 569 Bonnie Myers Vol#: 74

C 570 David Monson Vol#: 74

C 571 Loretta Contie Vol#: 74

C 572 No Signature Vol#: 74

C 573 Thondop Sari Vol#: 74

C 574 Sarah McGonaly Vol#: 74

C 575 Maria S Vol#: 74

C 576 Kevin Cahill Vol#: 74

C 577 Dair Obenshain Vol#: 74

C 578 S Martin Vol#: 74

C 579 Betty Smay Vol#: 74

C 580 Louise LeGouir Vol#: 74

C 581 Paula Scott Vol#: 74

C 582 Jackie DeSar Vol#: 74

C 583 Ms. Anne Oehlschlaeger Vol#: 74

C 584 Dennis Roberts Vol#: 74

C 585 Zlat Goldberg Vol#: 74

C 586 Steven Wilbur Vol#: 74

EMC 1564 Seth Schneider Vol#: 74

EMC 1565 Christine Jennis Vol#: 74

EMC 1566 Elizabeth Read Vol#: 74

EMC 1567 Joseph Lemmond Vol#: 74

EMC 1568 Meredith Arnow Love Vol#: 74

EMC 1569 Cara L. Campbell Vol#: 74

EMC 1570 C. Ralston Allen Vol#: 74

EMC 1571 C. Ralston Allen Vol#: 74

EMC 1572 James Wall Vol#: 74

EMC 1573 Kristin Eggerling Vol#: 74

EMC 1574 Peter Alamilla Vol#: 74

EMC 1575 Sienna Olin Vol#: 74

EMC 1576 Sienna Olin Vol#: 74

EMC 1577 Christine Pfeffer Vol#: 74

EMC 1578 Barbara June Page Vol#: 74

EMC 1579 Steve Torma Vol#: 74

EMC 1580 Darlene Ballantine Vol#: 74

EMC 1581 Sherrie Ballantine Vol#: 74

EMC 1582 Joel Thorson Vol#: 74

EMC 1583 Number Not Used Vol#: 74

EMC 1584 Kirsten Maue Vol#: 74

EMC 1585 Michael Potter Vol#: 74

EMC 1586 George Schroeder Vol#: 74

EMC 1587 Jolene Michelle Reed Vol#: 74

EMC 1588 Sara Scoles Vol#: 74

EMC 1589 Julia Sathler Vol#: 74

EMC 1590 Mary Sipple Vol#: 74

EMC 1591 David Charbonneau Vol#: 74

EMC 1592 Julia Olmstead Vol#: 74

EMC 1593 Mark Levy Vol#: 74

EMC 1594 Billie L. Lee Vol#: 74

EMC 1595 Number Not Used Vol#: 74

EMC 1596 Hollis Watkins Vol#: 74

EMC 1597 Vanessa Boer Vol#: 74

EMC 1598 Thomas G. Kuzma, Jr. Vol#: 74

EMC 1599 Dana Davis Vol#: 74

EMC 1600 Cynthia Iberg Vol#: 74

EMC 1601 James Thomas Vol#: 74

EMC 1602 Andrea Thomas Vol#: 74

EMC 1603 Charles Srams Vol#: 74

EMC 1604 Chel Christopher Vol#: 74

EMC 1605 Paula Gansky Vol#: 74

EMC 1606 Carolyn Vadala Vol#: 74

EMC 1607 Diane Kirk Vol#: 74

EMC 1608 Beverly Rich Vol#: 74

EMC 1609 Daniel Yakoubian Vol#: 74

EMC 1610 Number Not Used Vol#: 74

EMC 1611 Paul Harrison Vol#: 74

EMC 1612 Gary Hecker Vol#: 74

EMC 1613 Brian Willey Vol#: 74

EMC 1614 Meryl Miller Vol#: 74

EMC 1615 Doug Hunt Vol#: 74

Page updated March 14, 2005