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 15, 2001

TABLE OF CONTENTS

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

LET 5 OmegaTech Inc. Vol#: 77

LET 6 HFSA-811 to Malabar Productos Naturales Vol#: 77

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3255 Earl Shiffman Vol#: 210

C 3256 Kathryn A. Watkins Vol#: 210

C 3257 Rosalia Cancian Vol#: 210

C 3258 Darlene Oliver Vol#: 210

C 3259 Frances Friedman Vol#: 210

C 3260 Rose Feldon Vol#: 210

C 3261 Eva Van Houten Vol#: 210

C 3262 Stephen D. Emerson Vol#: 210

C 3263 Carol A. Krawczyk Vol#: 210

C 3264 Judith E. Embry Vol#: 210

C 3265 Jean Allison Thaler Vol#: 210

C 3266 Sandra Kopell Vol#: 210

C 3267 Myrna Brown Vol#: 210

C 3268 Wilhelm Winter Vol#: 210

C 3269 John Spezia Vol#: 210

C 3270 Jane Breazzano Vol#: 210

C 3271 Linda Jackson Vol#: 210

C 3272 Carol McGrechen Vol#: 210

C 3273 Jill Fetel, MD Vol#: 210

C 3274 Helen H. Wallace Vol#: 210

C 3275 Roald Cann Vol#: 210

C 3276 Harold Panciera Vol#: 210

C 3277 Dr. William N. Leonard Vol#: 210

C 3278 Andre T. Horvath Vol#: 210

C 3279 Helen Jo Williams Vol#: 210

C 3280 Anton K. Richter Vol#: 210

C 3281 Virginia T. Stott Vol#: 210

C 3282 Louis S. Campbell Vol#: 210

C 3283 Henry Bragdon Vol#: 210

C 3284 Misty Callies Vol#: 210

C 3285 Ann Mazzer Vol#: 210

C 3286 Paula Wilson Vol#: 210

C 3287 Louis DiNucci Vol#: 210

C 3288 Roger Van Dyke Vol#: 210

C 3289 Patricia Ensign Vol#: 210

C 3290 Dorothea Goetz Vol#: 210

C 3291 Kathy Kauffman Vol#: 210

C 3292 Susan Kroner Vol#: 210

C 3293 Bernice Van Steenhergen Vol#: 210

C 3294 Edward L. Koenig Vol#: 210

C 3295 Jill Baron Vol#: 210

C 3296 William E. Dilday Vol#: 210

C 3297 J. Geller, DDS Vol#: 210

C 3298 Dr. Corrie Norrborn Vol#: 210

C 3299 Jennifer McConathery Vol#: 210

C 3300 Miriam L. Sivak Vol#: 210

C 3301 Rosanne Asero Vol#: 210

C 3302 Marie Sullivan Vol#: 210

C 3303 Carol Hayman Vol#: 211

C 3304 Catherine Reich Vol#: 211

C 3305 Beverly Southern Vol#: 211

C 3306 Regina Preis Vol#: 211

C 3307 Carol Floomis Vol#: 211

C 3308 Edgar Lehman Vol#: 211

C 3309 Loretta Wrobel Vol#: 211

C 3310 Letitia O. Principato Vol#: 211

C 3311 Peter Betts Vol#: 211

C 3312 Judith Hoffman Vol#: 211

C 3313 J. LaFreniere Vol#: 211

C 3314 Faith LaFortune Vol#: 211

C 3315 Mollie Portner Vol#: 211

C 3316 Gene Blossom Vol#: 211

C 3317 Sheryl Ann Lopez Vol#: 211

C 3318 Steve Hopkins Vol#: 211

C 3319 Miriam Dailey Vol#: 211

C 3320 Lydia Garvey Vol#: 211

C 3321 Lois E. Graham Vol#: 211

C 3322 Frances Kennedy Vol#: 211

C 3323 Merrily Davies Vol#: 211

C 3324 E. Borgerhoff Vol#: 211

C 3325 Maurine A. Witte Vol#: 211

C 3326 Linden Martineau Vol#: 211

C 3327 Paul R. Thorson Vol#: 211

C 3328 Helen Yarletz Vol#: 211

C 3329 Lillian Perlman Vol#: 211

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

C 8 Public Citizen Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 601 Lissa Adams Vol#: 30

EMC 602 Julie Bete Vol#: 30

EMC 603 Lenore H. Miller Vol#: 30

EMC 604 Patricia Rodgers Vol#: 30

EMC 605 Michael Cerkowski Vol#: 30

EMC 606 Robert Whitney Vol#: 30

EMC 607 Beverly Thatcher Vol#: 30

EMC 608 Lynn Marsh Vol#: 30

EMC 609 Angela Kearin Vol#: 30

EMC 610 Edward Cubero Vol#: 30

EMC 611 Ray Giff Vol#: 30

EMC 612 Larry Zalewski Vol#: 30

EMC 613 Joanne Young Vol#: 30

EMC 614 Natasha & Noah Brenner Vol#: 30

EMC 615 Jovi Young Vol#: 30

EMC 616 Margrethe Winslow Vol#: 30

EMC 617 B. Long Vol#: 30

EMC 618 Helen Lembeck Vol#: 30

EMC 619 Andrew Bisset Vol#: 30

EMC 620 Richard Pyle Vol#: 30

EMC 621 number not used Vol#: 30

EMC 622 Alaine Ginocchio Vol#: 30

EMC 623 Roy Tuckman Vol#: 30

EMC 624 Karen Carson Vol#: 30

EMC 625 John Miller Vol#: 30

EMC 626 John L. Lomitola Vol#: 30

EMC 627 Julia Wallace Vol#: 30

EMC 628 Mary Hinrichs Vol#: 30

EMC 629 Rebecca Hopkins Vol#: 30

EMC 630 Kara S. Jankowski Vol#: 30

EMC 631 Deborah and Mar Webb Vol#: 30

EMC 632 Jane Stevens Vol#: 30

EMC 633 Frances Nelson Vol#: 30

EMC 634 Donald Kotelko Vol#: 30

EMC 635 Carol Lonsdale Vol#: 30

EMC 636 Marian Carter Vol#: 30

EMC 637 Cole McRory Vol#: 30

EMC 638 Aliceanne Obryant Vol#: 30

EMC 639 Alice Dugar Vol#: 30

EMC 640 Jennifer E. Jenkins Vol#: 30

EMC 641 Dan Brook Vol#: 30

EMC 642 Sidney Goodman Vol#: 30

EMC 643 Jane Alexander Vol#: 30

EMC 644 Katrin Spiess Vol#: 30

EMC 645 Loren Clift Vol#: 30

EMC 646 Erin Steurer Vol#: 30

EMC 647 Karen Strickland Vol#: 30

EMC 648 Cynthia Carlson Vol#: 30

EMC 649 Candy Davis Vol#: 30

EMC 650 Marilyn Depew-Hillman Vol#: 30

EMC 651 Debi Scanlon Vol#: 30

EMC 652 Roswitha Hurst Vol#: 30

EMC 653 Nancy Rowe Vol#: 30

EMC 654 Bonnie J. Chiara Vol#: 30

EMC 655 Jeff Schiller Vol#: 30

EMC 656 Tibor Jankovich Vol#: 30

EMC 657 Stacy Schutten Vol#: 30

EMC 658 Eric Higbee Vol#: 30

EMC 659 Friends of Merrymeeting Bay Vol#: 30

EMC 660 Marie Pendzich Vol#: 30

EMC 661 Barbara Bardwell Vol#: 30

EMC 662 Catherine Muller Vol#: 30

EMC 663 Margaret Garrigues-Cortelyou Vol#: 30

EMC 664 Donna Nesselbush Vol#: 30

EMC 665 Melanie Diana Vol#: 30

EMC 666 Carol Mitchell Vol#: 30

EMC 667 Bill Swiatek Vol#: 30

EMC 668 Karen Gialdella Vol#: 30

EMC 669 Roger Wiley Vol#: 30

EMC 670 John Angello Vol#: 30

EMC 671 Katye Long Vol#: 30

EMC 672 Kathleen Noonan Vol#: 30

EMC 673 Mary Studer Vol#: 30

EMC 674 Michael Faulkner Vol#: 30

EMC 675 Deborah Wood Vol#: 30

EMC 676 Lois Lopez Vol#: 30

EMC 677 Betty Kidwiler Vol#: 30

EMC 678 Marilin Engelman Vol#: 30

EMC 679 Andrew Schuler Vol#: 30

EMC 680 Andrea Dion Vol#: 30

EMC 681 Margaret Nagel Vol#: 30

EMC 682 Link Schumaker Vol#: 30

EMC 683 Leslie Frodema Vol#: 30

EMC 684 Ariella Cook Vol#: 30

EMC 685 Nanci Gavin Vol#: 30

EMC 686 Thom Speidel Vol#: 30

EMC 687 Frank Binder Vol#: 30

EMC 688 Tom Moore Vol#: 30

EMC 689 Michael Jones Vol#: 30

EMC 690 Jonathan Janssen Vol#: 30

EMC 691 AMR Remos Vol#: 30

EMC 692 Julie Price Vol#: 30

EMC 693 Stacey L. Coleman Vol#: 30

EMC 694 Meredith Sterk Vol#: 30

EMC 695 Larraine Feldman Vol#: 30

EMC 696 Charles and Donna Steadman Vol#: 30

EMC 697 Brian Smith Vol#: 30

EMC 698 Igor Kiselev Vol#: 30

EMC 699 Mary McMahon Vol#: 30

EMC 700 Laurel R. Shouvlin Vol#: 30

EMC 701 Erika Walker Vol#: 31

EMC 702 Angela & Douglas Parker Simkin Vol#: 31

EMC 703 Cassie Scott Vol#: 31

EMC 704 Pinky Jain Pan Vol#: 31

EMC 705 William DeFoore Vol#: 31

EMC 706 Michael Edwards Vol#: 31

EMC 707 Jill Olswanger Vol#: 31

EMC 708 Clifford DeVries Vol#: 31

EMC 709 Pete Muller Vol#: 31

EMC 710 Jeff Toste Vol#: 31

EMC 711 Charlene Hoag Vol#: 31

EMC 712 David Heberer Vol#: 31

EMC 713 Carol Reuther Vol#: 31

EMC 714 Lana Miller Vol#: 31

EMC 715 Mary O'Herron Vol#: 31

EMC 716 Russ Wyatt Vol#: 31

EMC 717 number not used Vol#: 31

EMC 718 Donald Smith Vol#: 31

EMC 719 Glennis Merrill Vol#: 31

EMC 720 Marian Sonnenfeld Vol#: 31

EMC 721 Jon Griffin Vol#: 31

EMC 722 Bob Lander Vol#: 31

EMC 723 Demelza Costa Vol#: 31

EMC 724 Leonard Korenek Vol#: 31

EMC 725 Robert Rose Vol#: 31

EMC 726 Julia Smith Vol#: 31

EMC 727 Karla McBride Vol#: 31

EMC 728 Nancy Lopin Vol#: 31

EMC 729 Rodney Webb Vol#: 31

EMC 730 Heather Webb Vol#: 31

EMC 731 Mary Turner Vol#: 31

EMC 732 Ann Rehme Vol#: 31

EMC 733 Benita Cohen Vol#: 31

EMC 734 N. Jordan Dimick Vol#: 31

EMC 735 Kimberly Francano Vol#: 31

EMC 736 James B. Gilmore Vol#: 31

EMC 737 Tiffany Brandon Vol#: 31

EMC 738 Lori Russell Bologna Vol#: 31

EMC 739 Benjamin Ericson Vol#: 31

EMC 740 Florence Reed Vol#: 31

EMC 741 Tony Costa Vol#: 31

EMC 742 Mrs. Carol Dovel Vol#: 31

EMC 743 Jean Davis Vol#: 31

EMC 744 B. Pila Vol#: 31

EMC 745 Jed Jones Vol#: 31

EMC 746 Barbara Krentzman Vol#: 31

EMC 747 Carla N. S. Ingersoll Vol#: 31

EMC 748 Michele M. Makrucki Vol#: 31

EMC 749 Tobi Davis Vol#: 31

EMC 750 James Kowalski Vol#: 31

EMC 751 James Long Vol#: 31

EMC 752 Nan Fornal Vol#: 31

EMC 753 Sunna Gunnlaugsdottir Vol#: 31

EMC 754 Ronnie Wilson Vol#: 31

EMC 755 Melinda Farrar Vol#: 31

EMC 756 Evelyn Buntz Vol#: 31

EMC 757 Lucas Finnegan Vol#: 31

EMC 758 Roger Brenneise Vol#: 31

EMC 759 number not used Vol#: 31

EMC 760 Nellie Bailey Vol#: 31

EMC 761 Stefanie Collins Vol#: 31

EMC 762 David Benjamin Vol#: 31

EMC 763 Diane Bardwell Vol#: 31

EMC 764 Andy Mahler & Linda Lee Vol#: 31

EMC 765 James Leong Vol#: 31

EMC 766 Barry Benjamin Vol#: 31

EMC 767 Lois Robin Vol#: 31

EMC 768 Kellie Robertson Vol#: 31

EMC 769 Patrick Worden Vol#: 31

EMC 770 Gina Denn Vol#: 31

EMC 771 Mark C. Bigley Vol#: 31

EMC 772 Scott Rankin Vol#: 31

EMC 773 Amber Nolder Vol#: 31

EMC 774 Cheryl McPherron Vol#: 31

EMC 775 Roge Stocksdale Vol#: 31

EMC 776 Gail Chaipel Vol#: 31

EMC 777 Jean King Vol#: 31

EMC 778 Sherry Seese Vol#: 31

EMC 779 Laureen Guthrie Vol#: 31

EMC 780 Kathleen Ochs Vol#: 31

EMC 781 Mark Armantrout Vol#: 31

EMC 782 Alicia Hanta Vol#: 31

EMC 783 Donald Matsas Vol#: 31

EMC 784 Rene Umberger Vol#: 31

EMC 785 Dr. Lynn Allen Vol#: 31

EMC 786 Mark Reback Vol#: 31

EMC 787 Rhonda Foster Vol#: 31

EMC 788 Jerry Steffen Vol#: 31

EMC 789 E. Martinho Vol#: 31

EMC 790 Gayla L. Gipson Vol#: 31

EMC 791 Nancy Hartnett Vol#: 31

EMC 792 Kristin Costley Vol#: 31

EMC 793 Renske van Staveren Vol#: 31

EMC 794 Alex Antoniou Vol#: 31

EMC 795 Peter von Conta Vol#: 31

EMC 796 Janet Garry Sguera Vol#: 31

EMC 797 Kathleen Perkins Vol#: 31

EMC 798 Danielle A. Schoonover and family Vol#: 31

EMC 799 Louise Gikow Vol#: 31

EMC 800 Keith Winston Vol#: 31

EMC 801 Elizabeth Patsis Vol#: 31

EMC 802 Titus A. Meissner Vol#: 31

EMC 803 Gary Mager Vol#: 31

EMC 804 Pat Lee Vol#: 31

EMC 805 Floyd Ricketts Vol#: 31

EMC 806 Mark Newell Vol#: 31

EMC 807 Wendy R. Brown Vol#: 31

EMC 808 Birgit Widegren Vol#: 31

EMC 809 Martin Thompson Vol#: 31

EMC 810 Karen Bucklin Vol#: 31

EMC 811 Michael Keenan Vol#: 31

EMC 812 Brant Ingalsbe Vol#: 31

EMC 813 James Steinberg Vol#: 31

EMC 814 Euridice Miranda Lopez Vol#: 31

EMC 815 number not used Vol#: 31

EMC 816 Gregory Militello Vol#: 31

EMC 817 Gilbert Morrison Vol#: 31

EMC 818 Timur Shtatland, PhD Molecular, Cellular Vol#: 31

EMC 819 Vivien Arguelles Vol#: 31

EMC 820 Vivien C. Arguelles Vol#: 31

EMC 821 Don Baron Vol#: 31

EMC 822 Regina Bacanskas, Edward Bacanskas Vol#: 31

EMC 823 Ruth Berman Vol#: 31

EMC 824 Sheila Colonese Vol#: 31

EMC 825 Arlene Erven Vol#: 31

EMC 826 Cecile Even Vol#: 31

EMC 827 Kimberly Conrad Vol#: 31

EMC 828 Diane Hatz Vol#: 31

EMC 829 Christopher Malley Vol#: 31

EMC 830 Kim Bonanno Vol#: 31

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

C 1 Juliann Seebauer Vol#: 3

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

ACK 1 HFA-305 Vol#: 1

CP 1 Russell E. Dingle & Thomas L. Rempfer Vol#: 1

01V-0472 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Barrio Latino, Inc Vol#: 1

01V-0473

ACK 1 HFA-305 Vol#: 1

VAR 1 Liquid 3D Communications Vol#: 1

01V-0474

ACK 1 HFA-305 Vol#: 1

VAR 1 Mobolazer Vol#: 1