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 17, 2001

TABLE OF CONTENTS

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97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
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-0481 In Vivo Bioequivalance Study for Generic Skelaxin Tablets *

77N-0085 Saccharin and Its Salts

LETA7 Amy Lu & Myron J. Thompson Vol#: 348

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 8116 Essential Phytosterolins Inc Vol#: 60

LET 8117 NOW Foods Vol#: 60

LET 8118 NOW Foods Vol#: 60

LET 8119 NOW Foods Vol#: 60

LET 8120 Metabolic Nutrition Inc Vol#: 60

LET 8121 Kroeger Herb Products Co Inc Vol#: 60

LET 8122 McLind Corporation Vol#: 60

LET 8123 Twin Laboratories Inc Vol#: 60

LET 8124 Twin Laboratories Inc Vol#: 60

LET 8125 Twin Laboratories Inc Vol#: 60

LET 8126 Twin Laboratories Inc Vol#: 60

LET 8127 Twin Laboratories Inc Vol#: 60

LET 8128 Twin Laboratories Inc Vol#: 60

LET 8129 Twin Laboratories Inc Vol#: 60

LET 8130 Twin Laboratories Inc Vol#: 60

LET 8131 Twin Laboratories Inc Vol#: 60

LET 8132 Twin Laboratories Inc Vol#: 60

LET 8133 Metagenics Vol#: 60

LET 8134 Med2000 Inc Vol#: 60

LET 8135 Med2000 Inc Vol#: 60

LET 8136 Winning Combination Vol#: 60

LET 8137 Nutrition21 Vol#: 60

LET 8138 Solgar Vitamin and Herb Vol#: 60

LET 8139 Solgar Vitamin and Herb Vol#: 60

LET 8140 Cognis Corporation Vol#: 60

LET 8141 American Health Packaging Vol#: 60

LET 8142 American Health Packaging Vol#: 60

LET 8143 American Health Packaging Vol#: 60

LET 8144 American Health Packaging Vol#: 60

LET 8145 American Health Packaging Vol#: 60

LET 8146 American Health Packaging Vol#: 60

LET 8147 American Health Packaging Vol#: 60

LET 8148 American Health Packaging Vol#: 60

LET 8149 American Health Packaging Vol#: 60

LET 8150 American Health Packaging Vol#: 60

LET 8151 American Health Packaging Vol#: 60

LET 8152 American Health Packaging Vol#: 60

LET 8153 American Health Packaging Vol#: 60

LET 8154 Traditional Medicinals Vol#: 60

LET 8155 Efficient Laboratories Inc Vol#: 60

LET 8156 CCA Industries Inc Vol#: 60

LET 8157 Eniva Corporation Vol#: 60

LET 8158 Eniva Corporation Vol#: 60

LET 8159 Eniva Corporation Vol#: 60

LET 8160 Eniva Corporation Vol#: 60

LET 8161 Eniva Corporation Vol#: 60

LET 8162 Eniva Corporation Vol#: 60

LET 8163 Eniva Corporation Vol#: 60

LET 8164 Eniva Corporation Vol#: 60

LET 8165 Eniva Corporation Vol#: 60

LET 8166 Ganeden Biotech Inc Vol#: 60

LET 8167 Solgar Vitamin and Herb Vol#: 60

LET 8168 Perrigo Company of South Carolina Vol#: 60

LET 8169 Perrigo Company of South Carolina Vol#: 60

LET 8170 Solgar Vitamin and Herb Vol#: 60

LET 8171 Nature's Sunshine Products Inc Vol#: 60

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9529 Form Letter Count 11 Vol#: 541

C 9530 Form Letters 21 Vol#: 542

C 9531 Form Letter Count 197 Signatures Vol#: 543

C 9532 Form Letter Count 268 Signatures Vol#: 544

C 9533 38 signatures Vol#: 476

C 9534 64 Signatures Vol#: 476

C 9535 Form Letter Count 14 Vol#: 545

C 9536 25 Signatures Vol#: 476

C 9537 Form Letter Count 24 Vol#: 546

C 9538 Form Letter Count 14 Vol#: 547

C 9539 Form Letter Count 12 Vol#: 548

C 9540 Form Letter Count 48 Vol#: 549

C 9541 Form Letter Count 39 Vol#: 550

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

APE 8 Land O'Lakes Farmland Feed Vol#: 2

APE 9 Consumer Policy Institute Vol#: 2

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 946 Delores Dean Vol#: 32

EMC 947 Linda Thomas Vol#: 32

EMC 948 Kelly McKay Vol#: 32

EMC 949 Christine Aquilino Vol#: 32

EMC 950 Elizabeth Vance Vol#: 32

EMC 951 Mary Beth Lovett Vol#: 32

EMC 952 Virginia Gulino Vol#: 32

EMC 953 Melodie Chrislock Vol#: 32

EMC 954 Patricia C. Gorton Vol#: 32

EMC 955 Kevin Swallow Vol#: 32

EMC 956 Jean House Vol#: 32

EMC 957 Monique Attinger Vol#: 32

EMC 958 Jeanie Lerner Vol#: 32

EMC 959 Joan Altman Vol#: 32

EMC 960 R. Ruediger Vol#: 32

EMC 961 Arlene Montgomery Vol#: 32

EMC 962 Jill Landshof Vol#: 32

EMC 963 Howard Traite Vol#: 32

EMC 964 Sandy Fuchs Vol#: 32

EMC 965 Jane McCloskey Vol#: 32

EMC 966 Susie Jennings Vol#: 32

EMC 967 James M. Nordlund Vol#: 32

EMC 968 Kari Pond Vol#: 32

EMC 969 Benjamin Ericson Vol#: 32

EMC 970 David McBride Vol#: 32

EMC 971 Bryony Smith Vol#: 32

EMC 972 Carol Buonopane Vol#: 32

EMC 973 Darren Prine Vol#: 32

EMC 974 Val and Ken Hansen Vol#: 32

EMC 975 David R. Sofair, MD, MBA Vol#: 32

EMC 976 Audrey F. Sofair, MD Vol#: 32

EMC 977 Bertha Sofair Vol#: 32

EMC 978 Alice Asher Vol#: 32

EMC 979 Nancy Macy Vol#: 32

EMC 980 Linda Hock Vol#: 32

EMC 981 Mona Morstein Vol#: 32

EMC 982 Stephen Geddie Vol#: 32

EMC 983 Marcia Henning Vol#: 32

EMC 984 Bianca Lozada Vol#: 32

EMC 985 Daniella Cortreau Vol#: 32

EMC 986 Maya Fischhoff Vol#: 32

EMC 987 Casey Renegar Vol#: 32

EMC 988 J. Comery Vol#: 32

EMC 989 Rik Deskin Vol#: 32

EMC 990 Natasha Maggi Vol#: 32

EMC 991 Martin Walter Vol#: 32

EMC 992 Elise Anderson Vol#: 32

EMC 993 Katy Moffat Vol#: 32

EMC 994 Dan Robl Vol#: 32

EMC 995 Ajax Eastman Vol#: 32

EMC 996 number not used Vol#: 32

EMC 997 Steve Schroeder Vol#: 32

EMC 998 Amit Majumder Vol#: 32

EMC 999 Jennifer Hunter Vol#: 32

EMC 1000 Guillermo Kuhl Vol#: 32

EMC 1001 Shira Nahari Vol#: 32

EMC 1002 Elizabeth Kuczynski Vol#: 32

EMC 1003 Alexis Sivulich Vol#: 32

EMC 1004 Tony Kaperick Vol#: 32

EMC 1005 number not used Vol#: 32

EMC 1006 Margaret Pedroza Vol#: 32

EMC 1007 Calm Doggy Vol#: 32

EMC 1008 Sandilee Lloyd Vol#: 32

EMC 1009 Devin Joshi Vol#: 32

EMC 1010 Sherry Brugioni Vol#: 32

EMC 1011 Susan Willsrud Vol#: 32

EMC 1012 number not used Vol#: 32

EMC 1013 Sean Massey Vol#: 32

EMC 1014 Jim Darrar Vol#: 32

EMC 1015 Hanson Tse Vol#: 32

EMC 1016 Anne Marie Havel Vol#: 32

EMC 1017 Maggie Armstrong Vol#: 32

EMC 1018 Linda Leatherwood Vol#: 32

EMC 1019 John Kroonen Vol#: 32

EMC 1020 Jens Eventyr Vol#: 32

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

EMC 460 Linda S. Locke Vol#: 4

EMC 461 Michael Davidson Vol#: 4

EMC 462 Francie Mills Vol#: 4

EMC 463 Iren Karacsony Vol#: 4

EMC 464 Melody Metzger Vol#: 4

EMC 465 Dr. Gregory Pouls Vol#: 4

EMC 466 Linda Grimes Vol#: 4

EMC 467 Lydia Anderson Vol#: 4

EMC 468 Kimberly Porter Vol#: 4

EMC 469 Karen Hyatt Vol#: 4

EMC 470 Lorna Crosby Vol#: 4

EMC 471 Harry J. Lister Vol#: 4

EMC 472 Mary Nasikan Vol#: 4

EMC 473 C.E. Skillings Vol#: 4

EMC 474 Karia Kolibab Vol#: 4

EMC 475 Rene's Seay Vol#: 4

EMC 476 Michelle Patrick Vol#: 4

EMC 477 Sharon DeWitt Vol#: 4

EMC 478 Collette Circelli Vol#: 4

EMC 479 Dana Sherrell Vol#: 4

EMC 480 Lisa Maniscalco Vol#: 4

EMC 481 Cathy Vivian Vol#: 4

EMC 482 Peter Gardiner Vol#: 4

EMC 483 Beth Mctaggart Vol#: 4

EMC 484 Al & Judy Jones Vol#: 4

EMC 485 Andrea Horst Vol#: 4

EMC 486 Julie Wells Vol#: 4

EMC 487 William Randall Vol#: 4

EMC 488 Joyce Leite Vol#: 4

EMC 489 Sonia Rijhsinghani Vol#: 4

EMC 490 Katherine Harrod Vol#: 4

EMC 491 Cheryl L. Swope Vol#: 4

EMC 492 Beatrice Jordan Vol#: 4

EMC 493 Carol Petty Vol#: 4

EMC 494 Elvira Beracochea Vol#: 4

EMC 495 Londa Vol#: 4

EMC 496 L. Marsh-McCullough Vol#: 4

EMC 497 Lori Bencsik Vol#: 4

EMC 498 Steve Kuciemba Vol#: 4

EMC 499 Laura Austin Santry Vol#: 4

EMC 500 Sally Haff Vol#: 4

EMC 501 J. Darnell Vol#: 4

EMC 502 Margaret Serandour Vol#: 4

EMC 503 Leanne Wickenden Vol#: 4

EMC 504 Jania Mooradian Vol#: 4

EMC 505 Peggy Lowell Vol#: 4

EMC 506 Ann Bowen Vol#: 4

EMC 507 Joan Moore Vol#: 4

EMC 508 D. Martino Vol#: 4

EMC 509 Rosina Gutierrez Vol#: 4

EMC 510 Jim Great Elk Waters Vol#: 4

EMC 511 Maggie & Darrell Schaver Vol#: 4

EMC 512 Alena Malat Vol#: 4

EMC 513 Sheila R. Bass Vol#: 4

EMC 514 Nina McCorkle Vol#: 4

EMC 515 Kathy McKinstry Vol#: 4

EMC 516 Michael L. Lam Vol#: 4

EMC 517 Phyllis Talbert Vol#: 4

EMC 518 Nancy Bluemel Vol#: 4

EMC 519 Dwight Bartlett Vol#: 4

EMC 520 Vivian Throckmorton Vol#: 4

EMC 521 No signature Vol#: 4

EMC 522 Craig Oberfield Vol#: 4

EMC 523 Mardi Demi Vol#: 4

EMC 524 Carol Sandusky Vol#: 4

EMC 525 Judith Iam Vol#: 4

EMC 526 Jackilyn Wallace Vol#: 4

EMC 527 Jackilyn Wallace Vol#: 4

EMC 528 Lucille Harris Vol#: 4

EMC 529 Karen Cavanagh Vol#: 4

EMC 530 Sue Dengate Vol#: 4

EMC 531 Laurie Tissington Vol#: 4

EMC 532 Linda Wood Vol#: 4

EMC 533 No signature Vol#: 4

EMC 534 Denise Bauer Vol#: 4

EMC 535 Karen Dill Vol#: 4

EMC 536 Kayla Wildman Vol#: 4

EMC 537 Della Allen Vol#: 4

EMC 538 Elke Meinel Vol#: 4

EMC 539 Scott Hastey Vol#: 4

EMC 540 Doris J. Wenger Vol#: 4

EMC 541 Laura Deck Vol#: 4

EMC 542 Cynthia McDonald Vol#: 4

EMC 543 Janine McGrath Vol#: 4

EMC 544 Rosemary Brazeau Vol#: 4

EMC 545 Dennis Osborne Vol#: 4

EMC 546 Britt A. Barnes Vol#: 4

EMC 547 Susan L. Varga Vol#: 4

EMC 548 Brenda Price Vol#: 4

EMC 549 Jackie Wilson, MD Vol#: 4

EMC 550 Jacqueline D. Stancil Vol#: 4

EMC 551 Jennifer Hoff Vol#: 4

EMC 552 Kathy N. Lamb Vol#: 4

EMC 553 Lori Cravener Vol#: 4

EMC 554 Irene Cole Vol#: 4

EMC 555 Joy Sanders, A.H.P. Vol#: 4

EMC 556 Jamie Imondo Vol#: 4

EMC 557 Ronda Blower Vol#: 4

EMC 558 Carolyn Shaner Vol#: 4

EMC 559 Brenda Hunting Vol#: 4

EMC 560 Gina Mork Vol#: 4

EMC 561 Kevin & Rhonda Wadds Vol#: 4

EMC 562 Valerie Atherton Vol#: 4

EMC 563 Mary A. Biddulph Vol#: 4

EMC 564 T. Martinson Vol#: 4

EMC 565 E. Walker Vol#: 4

EMC 566 Susan Moen Vol#: 4

EMC 567 Tony Troughton-Smith Vol#: 4

EMC 568 Michael Novakov Vol#: 4

EMC 569 Robert Hunting Vol#: 4

EMC 570 Laurie Campbell Vol#: 4

EMC 571 Lyn Hopkins Vol#: 4

EMC 572 Susan M. Bull Vol#: 4

EMC 573 Christine Finlay Vol#: 4

EMC 574 Paul Walker Vol#: 4

EMC 575 G. Huisman Vol#: 4

EMC 576 Debbi Grossfeld Vol#: 4

EMC 577 Monica Curran Vol#: 4

EMC 578 Anne-Louise Ferverda Vol#: 4

EMC 579 Staci Shelton Vol#: 4

EMC 580 Julie Jorgensen Vol#: 4

EMC 581 Susan Richardson Vol#: 4

EMC 582 Mary Mullin Vol#: 4

EMC 583 Chip Laughton Vol#: 4

EMC 584 Janet Gaston Vol#: 4

EMC 585 Lynne J. Richardson Vol#: 4

EMC 586 Beth Ann Bailey Vol#: 4

EMC 587 Susan McGlohn Vol#: 4

EMC 588 Richard Cravener Vol#: 4

EMC 589 Linda Sybert Vol#: 4

EMC 590 Charles Sybert Vol#: 4

EMC 591 Robyn Ann Owens Vol#: 4

EMC 592 Ellen Benavidez Vol#: 4

EMC 593 Debbie Menken Vol#: 4

EMC 594 J. Rahman Vol#: 4

EMC 595 Kristi Cornutt Vol#: 4

EMC 596 Stephanie Stevens Vol#: 4

EMC 597 Kim Idell Vol#: 4

EMC 598 Kassiane Vol#: 4

EMC 599 Nolleen Lim Vol#: 4

EMC 600 M. Lance Vol#: 4

EMC 601 Grant Sjoberg Vol#: 4

EMC 602 Angela Byrnes Vol#: 4

EMC 603 Betty Ann Director Vol#: 4

EMC 604 Joellyn Rustad Vol#: 4

EMC 605 Deborah Casswell Vol#: 4

EMC 606 Michele Denning Vol#: 4

EMC 607 Michelle McAnulty Vol#: 4

EMC 608 Gayle Brees Vol#: 4

EMC 609 Kathy Eller Vol#: 4

EMC 610 Elsa Raubenheimer Vol#: 4

EMC 611 Mark Schindler Vol#: 4

EMC 612 Peg O'Donnell Vol#: 4

EMC 613 Chris Britt Vol#: 4

EMC 614 Kristen Youl Vol#: 4

EMC 615 Catherine Keys Vol#: 4

EMC 616 Kristy C. Tallman Vol#: 4

EMC 617 Gerald & Arlene Tollison Vol#: 4

EMC 618 Susan Venable Grumman Vol#: 4

EMC 619 Evelyn Wilson Vol#: 4

EMC 620 Connie Mashburn Vol#: 4

EMC 621 Evelyn L. Wilson Vol#: 4

EMC 622 Virginia Peters Vol#: 4

EMC 623 Joan Nagy Vol#: 4

EMC 624 Caroline Beutler Vol#: 4

EMC 625 Melodie Neil Vol#: 4

EMC 626 Taunya Stevenson Vol#: 4

EMC 627 Linda Gaebel Vol#: 4

EMC 628 Kelly Shea Vol#: 4

EMC 629 Marymar Goncalves-Butruille Vol#: 4

EMC 630 Paul Tammy Vol#: 4

EMC 631 Ann G. Martin Vol#: 4

EMC 632 Julie Sidhom Vol#: 4

EMC 633 Kevin Ahearn Vol#: 4

EMC 634 Elizabeth Ortega Vol#: 4

EMC 635 Sandra Kilborn Vol#: 4

EMC 636 Robert Grumman Vol#: 4

EMC 637 Cath Williams Vol#: 4

EMC 638 Jane Davis Vol#: 4

EMC 639 Donna Pittard Vol#: 4

EMC 640 John Court Vol#: 4

EMC 641 Jan Wockner Vol#: 4

EMC 642 Deborah Driver-Davis Vol#: 4

EMC 643 Diane Hersey Vol#: 4

EMC 644 Joan C. Shaw Vol#: 4

EMC 645 Colleen Burke Vol#: 4

EMC 646 Jane Stricklin Vol#: 4

EMC 647 Gisi Whittaker Vol#: 4

EMC 648 Jill Keith Vol#: 4

EMC 649 Angie Bischel Vol#: 4

EMC 650 Angie Bischel Vol#: 4

EMC 651 K.J. Forrest Vol#: 4

EMC 652 Trish Beson Vol#: 4

EMC 653 C. Miles Vol#: 4

EMC 654 Beth Amey Herman Vol#: 4

EMC 655 Yanet Ochoa Vol#: 4

EMC 656 Sally A. Martin Vol#: 4

EMC 657 Bruce & Susan Dabbs Vol#: 4

EMC 658 Stephanie White Vol#: 4

EMC 659 Denise Culin Vol#: 4

EMC 660 Jenny Shroff Vol#: 4

EMC 661 Salle & Mario Campa Vol#: 4

EMC 662 Fiona Watts Vol#: 4

EMC 663 Judy Johnson Vol#: 4

EMC 664 Heather Johnson Vol#: 4

EMC 665 Sheila Rogers Vol#: 4

EMC 666 Billie Jo McIntosh Vol#: 4

EMC 667 Jean M. Shick Vol#: 4

EMC 668 Zelma Urmston Vol#: 4

EMC 669 Janet Cope Vol#: 4

EMC 670 Pattie Kyger Vol#: 4

EMC 671 Susan Barrett Vol#: 4

EMC 672 Lisa K. Tingley Vol#: 4

EMC 673 Susan Leigh Vol#: 4

EMC 674 Chris Grayson Vol#: 4

EMC 675 Ellen D. Briggs Vol#: 4

EMC 676 Rob & Stephanie Pearce Vol#: 4

EMC 677 Janet Vickers Vol#: 4

EMC 678 Eman Ferrell Vol#: 4

EMC 679 Grace Kneeshaw Vol#: 4

EMC 680 Dawn Broderick Vol#: 4

EMC 681 Dan Holmes Vol#: 4

EMC 682 Deanne Decker Vol#: 4

EMC 683 Matthew Coghlan Vol#: 4

EMC 684 Susan Pulsifer Vol#: 4

EMC 685 JoAnn Genes Vol#: 4

EMC 686 Jim & Josie Ameden Vol#: 4

EMC 687 Nancy Masucci Vol#: 4

EMC 688 Thomas Polascik Vol#: 4

EMC 689 Gloria L. Flatt Vol#: 4

EMC 690 Pauline N. Harding Vol#: 4

EMC 691 Val Wilson Vol#: 4

EMC 692 S. Ehrenkranz Vol#: 4

EMC 693 Marlena Brown Vol#: 4

EMC 694 Cathy Wilson Vol#: 4

EMC 695 Lisa Griffiths Vol#: 4

EMC 696 Kent & Jean Moore Vol#: 4

EMC 697 Malcolm G. Dispain Vol#: 4

EMC 698 No signature Vol#: 4

EMC 699 Nerida Turrise Vol#: 4

EMC 700 Susan Knipe Vol#: 4

EMC 701 Esther Jennings Vol#: 4

EMC 702 Stacey Egerton Vol#: 4

01P-0481 In Vivo Bioequivalance Study for Generic Skelaxin Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Elan Pharmaceuticals, Inc. Vol#: 1