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 February 9, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
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-1669 Electronic filing of drug registration and listing informati *
00P-1369 Prohibit Making an Unapproved Health Claim *
01P-0066 ANADA which differs in dosage form from innovator product *

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

C 3771 L. C. Werner Vol#: 118

C 3772 Nancy Winters Vol#: 118

C 3773 Holly Knight et al Vol#: 118

C 3774 Barbara & Jonathan Allen-Daniel Vol#: 118

C 3775 Kelsey Kleer Vol#: 118

C 3776 Mr. & Mrs. Edgar H. Brown Vol#: 118

C 3777 Johanna Coxeter Vol#: 118

C 3778 Ronnie D. Rosenberg Vol#: 118

C 3779 Sandy Whittington Vol#: 118

C 3780 Lisa Beatrice Kolman Vol#: 118

C 3781 Doreen McKeon Vol#: 118

C 3782 Wayne MacNerland Vol#: 118

C 3783 Carol A. Loomis Vol#: 118

C 3784 Mario Vol#: 118

C 3785 Christine Nassikas Vol#: 118

C 3786 Natalie Mades Vol#: 118

C 3787 Sheryl J. Street Vol#: 118

C 3788 Christa Tinari Vol#: 118

C 3789 Michel E. Kabay, Ph.D, CISSP Vol#: 118

C 3790 Karen Hawn Vol#: 118

C 3791 John G. Campbell Vol#: 118

C 3792 Mrs. Harold Cole Vol#: 118

C 3793 Polly Harker-Smith Vol#: 118

C 3794 Weona Cleveland Vol#: 118

C 3795 Valerie Yeffersern Vol#: 118

C 3796 Tami Kutz-Robertson Vol#: 118

C 3797 Alma F. Blackwelder Vol#: 118

C 3798 Karen M. Hughes Vol#: 118

C 3799 Diane Danielson Vol#: 118

C 3800 Rachel Fishelman Vol#: 118

C 3801 Joan M. Ronaldo Vol#: 118

C 3802 Amy J. Kearns Vol#: 118

C 3803 Mrs. Eileen Adamec Vol#: 118

C 3804 A. Kathleen Anderson Vol#: 118

C 3805 Meryl J. Lewin & K. B. Welse Vol#: 118

C 3806 Philip C. Graham Vol#: 118

C 3807 David Hansen Vol#: 118

C 3808 Carol Penun Vol#: 118

C 3809 R. Dykes Vol#: 118

C 3810 Tami Kutz-Robertson Vol#: 118

C 3811 ENVOY Entertainment Management Productio Vol#: 118

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2766 Mavrik Zavarin PhD Vol#: 199

C 2767 Marvin E Howe Vol#: 199

C 2768 Ken & Julie Ford-Maloney Vol#: 199

C 2769 Barbara Curtis Vol#: 199

C 2770 Thomas V Connor Vol#: 199

C 2771 Wolfgang Benz Vol#: 199

C 2772 Lise Brody Vol#: 199

C 2773 Elizabeth G Jackson Vol#: 199

C 2774 Leah R Karpen Vol#: 199

C 2775 Larry Lynch Vol#: 199

C 2776 Annette Weaver Vol#: 199

C 2777 Nancy Bulman Vol#: 199

C 2778 Katrin A Aback Vol#: 199

C 2779 Judith Campbell Vol#: 199

C 2780 Gwen Quinn Vol#: 199

C 2781 Claire Dross Vol#: 199

C 2782 Elliott M Krackhardt Vol#: 199

C 2783 Erin Rychel Vol#: 199

C2784 Larui Zarin Vol#: 199

C 2785 Laura Anderson Vol#: 199

C 2786 Alice Slater Vol#: 199

C 2787 Kenny Lerner Vol#: 199

C 2788 Mary H Luebbers Vol#: 199

C 2789 Mr & Mrs Edgar Lehman Vol#: 199

C 2790 Grace Ertel Vol#: 199

C 2791 Maxine Hull Vol#: 199

C 2792 Janet M Courtney Vol#: 199

C 2793 Bruce J Bishoff Vol#: 199

C 2794 Duane de Long Vol#: 199

C 2795 Ruth M Jonas Vol#: 199

C 2796 Nancy E Ryther Vol#: 199

C 2797 Phyllis J Crolius Vol#: 199

C 2798 Anna Lee Broadfield Vol#: 199

C 2799 Lyndia Garvey Vol#: 199

C 2800 Mrs Frank A Record Vol#: 199

C 2801 Isabel Kimble Vol#: 199

C 2802 Elizabeth Riley Vol#: 199

C 2803 Denise Ulrich Vol#: 199

C 2804 Frances J Lentz Vol#: 199

C 2805 R W Handley Vol#: 199

C 2806 Ruth Clair Vol#: 199

C 2807 K Bandell Vol#: 199

C 2808 Joan G Gambill Vol#: 199

C 2809 Debbie Blue Vol#: 199

C 2810 Shirley Fassencourt Vol#: 199

C 2811 Jennifer Crispin Vol#: 199

C 2812 Margaret Thurston Vol#: 199

C 2813 Fred T Darvill Jr MD Vol#: 199

C 2814 John Kavalunas Vol#: 199

C 2815 Klaus & H Franke Muller Vol#: 199

C 2816 Ray Hearne Vol#: 199

C 2817 Nancy S Reynolds Vol#: 199

C 2818 Owen K Hughes Vol#: 199

C 2819 J Patterson Vol#: 199

C 2820 B Muzzey Vol#: 199

C 2821 Ann Sniedze Vol#: 199

C 2822 Dr T Christopher Englert Vol#: 199

C 2823 M Ruth Niswander Vol#: 199

C 2824 J William Kohl MD Vol#: 199

C 2825 Rodney Busskohl Vol#: 199

C 2826 Hilda W Sokol Vol#: 199

C 2827 Beth Schuller Vol#: 199

C 2828 Joe Cotter Vol#: 199

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 488 Lisa Saunders Vol#: 13

EMC 489 Lauren Henderson Vol#: 13

EMC 490 Tracy Clark Vol#: 13

EMC 491 Greg Moorcroft Vol#: 13

EMC 492 Jennifer Kuyava Vol#: 13

EMC 493 Carole Connet Vol#: 13

EMC 494 Janet Foster Vol#: 13

EMC 495 Melanie Lenart Vol#: 13

EMC 496 Linda Boutros-Wilson Vol#: 13

EMC 497 Chastity Simmons Vol#: 13

EMC 498 Lynn Mishoe Vol#: 13

EMC 499 Wes Baker Vol#: 13

EMC 500 Hayyim Felbman Vol#: 13

EMC 501 Dan Fleming Vol#: 13

EMC 502 Stephanie Baldwin Vol#: 13

EMC 503 Randy Reeder Vol#: 13

EMC 504 Nicole Castle Vol#: 13

EMC 505 Mezzo Tint Vol#: 13

EMC 506 Tonya Hammond Vol#: 13

EMC 507 Viviane Paolini Vol#: 13

EMC 508 Kim Lehner Vol#: 13

EMC 509 Laura B. Vol#: 13

EMC 510 Dale Underwood Vol#: 13

EMC 511 Number Not Used Vol#: 13

EMC 512 Gloria Lorenzo Vol#: 13

EMC 513 Katherine Beer Vol#: 13

EMC 514 Mary Rittenhouse Vol#: 13

EMC 515 Jeremy Apgar Vol#: 13

EMC 516 Kathy Smith Vol#: 13

EMC 517 Charles & Elizabeth Dahan Vol#: 13

EMC 518 Number Not Used Vol#: 13

EMC 519 Grace Rooney Vol#: 13

EMC 520 Marilynn MacKey Vol#: 13

EMC 521 Dan Hamilton Vol#: 13

EMC 522 Gabriel Weiss Vol#: 13

EMC 523 Andrew Zuckerman Vol#: 13

EMC 524 Rachele Shaw Vol#: 13

EMC 525 Number Not Used Vol#: 13

00D-1662 Use of Xenotransplantation Products in Humans

BKG 1 Background material Vol#: 2

00N-1198 Proposal to withdraw approval of 158 (ANDA)

NWL 2 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 1 E A & R D Van Horn Vol#: 9

C 2 Form Letter Count Vol#: 11

C 3 Form Letter Count Vol#: 12

C 4 M S Smitts Vol#: 9

C 5 L Pondar Vol#: 9

C 6 J Fitzgell Vol#: 9

C 7 M Schonbeck, Ph.D. Vol#: 9

C 8 M Vahey Vol#: 9

C 9 B J Hoag Vol#: 9

C 10 J B Lome Vol#: 9

C 11 R Cohen Vol#: 9

C 12 R Schwartz Vol#: 9

C 13 E Gralla Vol#: 9

C 14 S M Crane Vol#: 9

C 15 A McKay Vol#: 9

C 16 A Brockington Vol#: 9

C 17 M A Green Vol#: 9

C 18 D P Legendose Vol#: 9

C 19 S Goldberg Vol#: 9

C 20 Y Hodgkins Vol#: 9

C 21 A F Goodrum Vol#: 9

C 22 N Cohen Vol#: 9

C 23 Northeast Organic Farming Assn Vol#: 9

EMC 3 P Fischer Vol#: 9

EMC 4 Form Letter Count Vol#: 10

EMC 5 J Gironda Vol#: 9

EMC 6 D Read Vol#: 9

00N-1669 Electronic filing of drug registration and listing informati

LET 22 Genpharm Inc Vol#: 1

LET 23 Bayer Corp Vol#: 1

LET 24 Purepac Pharm Co Vol#: 1

LET 25 Whitehall-Robins Healthcare Vol#: 1

LET 26 Purdue Pharma LP Vol#: 1

LET 27 Glaxo Wellcome Inc Vol#: 1

LET 28 Aventis Pharmaceuticals Vol#: 1

LET 29 Wyeth-Ayerst Laboratories Vol#: 1

00P-1369 Prohibit Making an Unapproved Health Claim

REF 1 Vol#: 1

00V-1337 Laser Light Show

VRA 1 HFZ-340 to Miner Mike's, Inc. Vol#: 1

00V-1398 Laser light show

VRA 1 HFZ-340 to Micro Dot L.L.C. Vol#: 1

00V-1405 Telemetry transmitter cable

EXP 1 Bon Secours South County Heart Center Vol#: 1

00V-1547 John Coodey Laser Light Show

AMD 1 HFZ-340 to John Coodey Laser Light Show Vol#: 1

00V-1588 Laser Light Show

VRA 1 HFZ-340 to T & B Productions Vol#: 1

00V-1606

VRA 1 HFZ-340 to U. S. Space & Rocket Center Vol#: 1

00V-1614

VRA 1 HFZ-340 to Midwest Stereo Vol#: 1

00V-1619 Laser light show

VRA 1 HFZ-340 to Backwaters, Inc. Vol#: 1

00V-1624

VRA 1 HFZ-340 to The Club at II Panino Vol#: 1

00V-1626 Laser Light Show

VRA 1 HFZ-340 to SLV Vol#: 1

00V-1627 Laser light show

VRA 1 HFZ-340 to Gear Connections Vol#: 1

00V-1643 Laser Light Show

VRA 1 HFZ-340 to Wicked Angel Entertainment Vol#: 1

00V-1646

VRA 1 HFZ-340 to Eclipse Vol#: 1

00V-1647

VRA 1 HFZ-340 to Lumatech Lighting Vol#: 1

00V-1653 Laser light show

VRA 1 HFZ-340 to Marathon Marketing, LLC Vol#: 1

00V-1670 Laser Light Show

VRA 1 HFZ-340 to Pure Bar Room Vol#: 1

00V-1673 Request for Laser Light Show

VRA 1 HFZ-340 to The DJ Store Vol#: 1

01D-0027 Industry Statistical approaches establishing bioequivalence

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01P-0066 ANADA which differs in dosage form from innovator product

ACK 1 HFA-305 Vol#: 1