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 November 2, 2000

TABLE OF CONTENTS

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91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
93N-0372 Medical Devices; Hearing Aid Requirements *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

LET 2 HFS-800 to Emord & Associates, P.C. Vol#: 46

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

LET 2 HFS 800 to Emord & Associates Vol#: 58

LET 3 HFS-800 to Emord & Associates Vol#: 58

REF 1 Reference 1-70 Vol#: 60

93N-0372 Medical Devices; Hearing Aid Requirements

C 4808 Miracle Ear Vol#: 92

C 4809 Beltone Vol#: 92

C 4810 Hearing Aid Care Vol#: 92

C 4811 Hearing Aid Consultants Vol#: 92

C 4812 Posey's Hearing Aid Center Vol#: 92

C 4813 Beltone Hearing Aid Center Vol#: 92

C 4814 Baldwin Optical & Hearing Aid Center Vol#: 92

C 4815 John W. Slembarski Vol#: 92

C 4816 Martha Fresquez Vol#: 92

C 4817 Sears Hearing Aid Center Vol#: 92

C 4818 Kwan H. Won Vol#: 92

C 4819 Hearing Aid Health Care Services Vol#: 92

C 4820 Tallahassee Hearing Aid Center Vol#: 92

C 4821 Hearing Aid Health Care Services Vol#: 92

C 4822 Hearing Aid Health Care Services Vol#: 92

C 4823 Carol Fazio Vol#: 92

C 4824 Thomas Mitchell Vol#: 92

C 4825 Mike Rider Vol#: 92

C 4826 Hearing Aid Health Care Services Vol#: 92

C 4827 Hearing Aid Health Care Services Vol#: 92

C 4828 Hearing Aid Health Care Services Vol#: 92

C 4829 Advanced Hearing Systems, Inc. Vol#: 92

C 4830 Advanced Hearing Systems, Inc. Vol#: 92

C 4831 Advanced Hearing Systems, Inc. Vol#: 92

C 4832 Hearing Aid Health Care Services Vol#: 92

C 4833 Miracle Ear Vol#: 92

C 4834 Miracle Ear Vol#: 92

C 4835 Miracle Ear Vol#: 92

C 4836 Miracle Ear Vol#: 92

C 4837 Miracle Ear Vol#: 92

C 4838 Miracle Ear Vol#: 92

C 4839 Miracle Ear Vol#: 92

C 4840 Miracle Ear Vol#: 92

C 4841 Miracle Ear Vol#: 92

C 4842 Miracle Ear Vol#: 92

C 4843 Miracle Ear Vol#: 92

C 4844 Miracle Ear Vol#: 92

C 4845 Miracle Ear Vol#: 92

C 4846 Miracle Ear Vol#: 92

C 4847 Darren Knott Vol#: 92

C 4848 Jeff Rupp Vol#: 92

C 4849 Anthony Suarez Vol#: 92

C 4850 Wanda Smith Vol#: 92

C 4851 Robert Smith Vol#: 92

C 4852 Ann Madden Vol#: 92

C 4853 Johnson Hearing Aid Service Vol#: 92

C 4854 Miracle Ear Center Vol#: 92

C 4855 Wake County Human Services Vol#: 92

C 4856 Johnson's Hearing Center Vol#: 92

C 4857 Southwestern Hearing Aid Co., Inc. Vol#: 92

C 4858 Edward F. Sickle Vol#: 92

C 4859 Miracle Ear Hearing Systems Vol#: 92

C 4860 Miracle Ear Hearing Systems Vol#: 92

C 4861 The Gillespie Clinic Vol#: 92

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

C 2408 Phyllis Ravalico Vol#: 72

C 2409 Cecilia Stancell Vol#: 72

C 2410 Antoinette Bushlack Vol#: 72

C 2411 Benjamin Landau, M.D., Inc. Vol#: 72

C 2412 Patricia Evelyn Culver Vol#: 72

C 2413 Dawn James Vol#: 72

C 2414 P. L. McDaniel, Jr. Vol#: 72

C 2415 Mrs. Bonnie Shopper Vol#: 72

C 2416 Chrisley V. Pickens & Greg Vol#: 72

C 2417 Mrs. Barbara Harder Vol#: 72

C 2418 Gail Pivar Vol#: 72

C 2419 Linda Gentille Vol#: 72

C 2420 Mrs. Sibyl Aloe Vol#: 72

C 2421 Karen Falk Vol#: 72

C 2422 Marian I. Lambros Vol#: 72

C 2423 Mr. & Mrs. Peter B. Fisher Vol#: 72

C 2424 Mr. Glenn A. Cronick Vol#: 72

C 2425 Ruth Lotz Ostrowski Vol#: 72

C 2426 Jean Bradley Vol#: 72

C 2427 Nita L. Ward Vol#: 72

C 2428 Brigitte M. Gatlin Vol#: 72

C 2429 Elizabeth Spencer Vol#: 72

C 2430 Lynn Ackerman Vol#: 72

C 2431 Ms. Theresa A. Keene Vol#: 72

C 2432 Janet Hanan Vol#: 72

C 2433 Mrs. Elisabeth Ward Vol#: 72

C 2434 Diane J. Sturts Vol#: 72

C 2435 Jennifer Houghtaling Vol#: 72

C 2436 Anthony Montapert Vol#: 72

C 2437 The Boyd Family Vol#: 72

C 2438 Suzanne Pease Vol#: 72

C 2439 no signature Vol#: 72

C 2440 Liza Maloney Vol#: 72

EMC 141 Form letter count 9 Vol#: 73

EMC 142 Joy Siddiqi Vol#: 74

EMC 143 M. Cohen Vol#: 74

EMC 144 Marcia Hoodwin Vol#: 74

EMC 145 Pam Vol#: 74

EMC 146 Tracy Jordan Vol#: 74

EMC 147 Jamie Wang Vol#: 74

EMC 148 Wendy Lochner Vol#: 74

EMC 149 Maryjo Brooks Vol#: 74

EMC 150 K. O. Olds Vol#: 74

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 789 Mrs. Janice S. Meyer Vol#: 36

C 790 Mona Christenson Vol#: 36

C 791 Gerald Sgro Vol#: 36

C 792 Kori Beck Vol#: 36

C 793 Dolores Tippett Vol#: 36

C 794 Illegible Vol#: 36

C 795 no signature Vol#: 36

C 796 Michelle Lieberman Vol#: 36

C 797 Renata Aylward Vol#: 36

C 798 Henry Peck Vol#: 36

C 799 P. L. McDaniels, Jr. Vol#: 36

C 800 W. Katherine Hoak Vol#: 36

EMC 41 Karah Stokes Vol#: 36

EMC 42 Nicole Krause Vol#: 36

EMC 43 Erin Taylor Vol#: 36

EMC 44 Erin Taylor Vol#: 36

EMC 45 Carolyn Turner Vol#: 36

EMC 46 Lisa DeVaney Vol#: 36

EMC 47 Mary Laura Calhoun Vol#: 36

EMC 48 Heather Cantino Vol#: 36

EMC 49 Stuart Zisman Vol#: 36

EMC 50 Gaby Gollub Vol#: 36

EMC 51 Tristen Tuckfield Vol#: 36

EMC 52 Lewis Kawecki Vol#: 36

EMC 53 Janet Harris Vol#: 36

EMC 54 Leigh Goldstein Vol#: 36

EMC 55 Jeanine Alcocer Vol#: 36

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 15686 Albin & Melisa Coyle Vol#: 463

C 15687 Patricia Chieffo Vol#: 463

C 15688 Anne-Well E.R. Andrews Vol#: 463

C 15689 Joan W. Rice Vol#: 463

C 15690 Marvin Stauffenberg Vol#: 463

C 15691 Katherine K. Elder Vol#: 463

C 15692 Margaret Sweetman Vol#: 463

C 15693 Alice Eppinger Vol#: 463

C 15694 Carol S. Jones Vol#: 463

C 15695 Alison Johnson Vol#: 463

C 15696 Mrs. Constance L. Mackey Vol#: 463

C 15697 Mr & Mrs Richardo Heater Vol#: 463

C 15698 Mary Spooner Vol#: 463

C 15699 Evelyn Goodlock Vol#: 463

C 15700 Mrs. Iamara Divine Vol#: 463

C 15701 Terry L. Stine Vol#: 463

C 15702 Nelson L. Rhoads Vol#: 463

C 15703 Kim Corle Vol#: 463

C 15704 Donald C. Falsome Vol#: 463

C 15705 Michael Ferguson Vol#: 463

C 15706 Mrs. Libby Katz Vol#: 463

C 15707 Alice Bailey Vol#: 463

C 15708 Hans & Hannflore Schiessl Vol#: 463

C 15709 Mrs. Eunice Skupski Vol#: 463

C 15710 Elizabeth S. Gruhler Vol#: 463

C 15711 Beth A. Queen Vol#: 463

C 15712 Clifford C. Davis Vol#: 463

C 15713 Cassy Edwards Vol#: 463

C 15714 Evonne Aockert Vol#: 463

C 15715 no signature Vol#: 463

C 15716 Faith Garfield Vol#: 463

C 15717 Valerie Curtiss Vol#: 463

C 15718 Charles R. Thompson Vol#: 463

C 15719 Melva Horton Vol#: 463

C 15720 Ms. Cindy A. Johns Vol#: 463

C 15721 Betty Waring Vol#: 463

C 15722 Kristen Mosbaek Vol#: 463

C 15723 Mr & Mrs William C. Waterman Vol#: 463

C 15724 Mr & Mrs George Schumacher Vol#: 463

C 15725 Kimberly M. Smith Vol#: 463

C 15726 Josephine Chebat Vol#: 463

C 15727 Ted Looyen Vol#: 463

C 15728 Dianne G. Risdon Vol#: 463

C 15729 David P. & Joan P. Sexton Vol#: 463

C 15730 Ed Pennecard Vol#: 463

C 15731 Rita K. Hussey Vol#: 463

C 15732 Vicki Hurlbrert Vol#: 463

C 15733 Frieda R. Steinjann Vol#: 463

C 15734 Marilyn Mayhone Vol#: 463

C 15735 Susan J. Dersch Vol#: 463

C 15736 Gigi Demarest Vol#: 463

C 15737 L. C. Hoover Vol#: 463

C 15738 Alfa I. Falke Vol#: 463

C 15739 Daun Scollay Vol#: 463

C 15740 Deborah Larkin Vol#: 463

C 15741 Sharon Roy Vol#: 463

C 15742 Deborah A. Moramarco Vol#: 463

C 15743 Ruby Jo Chilcoat Vol#: 463

C 15744 Sharon VanHaven Vol#: 463

C 15745 Shelley Frederick Vol#: 463

C 15746 R. A. Gill Vol#: 463

C 15747 Ms. Charlene Peterson Vol#: 463

C 15748 Joy Sunyato Vol#: 463

C 15749 Jacqueline M. Snow Vol#: 463

C 15750 Hope Gaines Vol#: 463

C 15751 Janeen Pond Vol#: 463

C 15752 Kathleen Wilson Vol#: 463

C 15753 Mrs. George Darnell Vol#: 463

C 15754 Mrs. Stanley Biblef Vol#: 463

C 15755 Dr. Dorothy A. Orenda Vol#: 463

C 15756 Jenny Danielson Vol#: 463

C 15757 James McCoy Vol#: 463

C 15758 Betty J. Bowling Vol#: 463

C 15759 Patricia Denx-Sasaki Vol#: 463

C 15760 Elisabeth McNevin Vol#: 463

C 15761 Ms. Joanne Schmid Vol#: 463

C 15762 Betty A. Dally Vol#: 463

C 15763 M. S. Weisman Vol#: 463

C 15764 Marla Ann Carpenter Vol#: 463

00D-1513 Bioavailabilitly/Bioequivalence Studies for Orally Drugs

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

00M-1591 PMA SVS Apex Plusn Excimer Laser Workstation & Emphasis 'M'

AAV 1 Summit Technology Inc Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

BKG 1 Background Material Vol#: 1

EMC 1 Wayne State University School of Medicin Vol#: 16

NPH 1 Vol#: 16

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 7194 Number not used Vol#: 319

C 7195 Number not used Vol#: 319

C 7196 Gene J Koprowski Vol#: 319

C 7197 Sharon Lampron Vol#: 319

C 7198 Taylor Moseng Vol#: 319

C 7199 Karen Allen Vol#:

C 7200 Stefanie Deddo-Evans Vol#: 319

C 7201 Barrie Colbath Vol#: 319

C 7202 Susan Kolenda Vol#: 319

C 7203 Jessica James Vol#: 319

C 7204 Mary C Russell Vol#: 319

C 7205 Xochill H Hance Vol#: 319

C 7206 Elizabeth Green Vol#: 319

C 7207 Joan Benoit Vol#: 319

C 7208 Debbie Jepsen Vol#: 319

C 7209 Joyce Crabbe Vol#: 319

C 7210 Marsha Fuller Vol#: 319

C 7211 Shirlee Kaighn Vol#: 319

C 7212 Joyce G Gibson Vol#: 319

C 7213 Thomas Bo Yegal Vol#: 319

C 7214 Sean McCall Vol#: 319

C 7215 Sharon Fischer Vol#: 319

C 7216 Jeane Payne Vol#: 319

C 7217 Lauric Hockinger Vol#: 319

C 7218 Kathy O'Neal Vol#: 319

C 7219 Feruze Rose Kehaygaulos Vol#: 319

C 7220 Josh Neubauer Vol#: 319

C 7221 Aria Seidl Vol#: 319

C 7222 Leslie Townsend Vol#: 319

C 7223 Sue Beageron Vol#: 319

C 7224 Judith E Schwartz Vol#: 319

C 7225 Katie Gunter Vol#: 319

C 7226 L J Guillory Vol#: 319

C 7227 Everett Patterson Vol#: 319

C 7228 Jennifer Guillory Vol#: 319

C 7229 Sonya Nesch Vol#: 319

C 7230 Rita M Palazzolo Vol#: 319

C 7231 Virginia Palmer Vol#: 319

C 7232 Barbara Owen Vol#: 319

C 7233 William Dickinson Vol#: 319

C 7234 Elizabeth Latz Vol#: 319

C 7235 S Shaw Vol#: 319

C 7236 Peter B Walker Vol#: 319

C 7237 Carela Spengler Vol#: 319

C 7238 A Kleine Vol#: 319

C 7239 Lynn P Mockus Vol#: 319

C 7240 Mary Livingston Vol#: 319

C 7241 Vera Lowdermilk Vol#: 319

C 7242 Susan Frederics Vol#: 319

C 7243 Chaillat Vol#: 319

C 7244 Kathy Duprey Vol#: 319

C 7245 Lucinda Birdsong Vol#: 319

C 7246 Wendy Barth Vol#: 319

C 7247 Mr & Mrs Gary Leva Vol#: 319

C 7248 Louren McConnell Vol#: 319

C 7249 Ronnie Lewis Vol#: 319

C 7250 McCuin Vol#: 319

C 7251 Melinda Trotti Vol#: 319

C 7252 Brandon Ross Vol#: 319

EMC 3568 Susan Blesek Vol#: 319

EMC 3569 Vicky Turner Vol#: 319

EMC 3570 Princess Smith Vol#: 319

EMC 3571 Christine Vander Ploeg Vol#: 319

EMC 3572 Carl Petteway Vol#: 319

EMC 3573 Kathryn Fairbanks Vol#: 319

EMC 3574 Jennifer Carison Vol#: 319

EMC 3575 Michael Morris Vol#: 319

EMC 3576 Mark Lanzrath Vol#: 319

EMC 3577 Lila Johnson Vol#: 319

EMC 3578 Edith Kantrowitz Vol#: 319

EMC 3579 Breta Collins Vol#: 319

EMC 3580 Danielle Schoonover Vol#: 319

EMC 3581 Judi Murphy Vol#: 319

EMC 3582 Michelle Roach Vol#: 319

EMC 3583 Helen Sanders Vol#: 319

EMC 3584 Carrie Lucas Vol#: 319

EMC 3585 Debra Blaszyk Vol#: 319

EMC 3586 Kel Pickens Vol#: 319

EMC 3587 Brian Schmitt Vol#: 319

EMC 3588 Deborah Woolston Vol#: 319

EMC 3589 Sharon Barnett Vol#: 319

EMC 3590 Lisa Cox Vol#: 319

EMC 3591 Cathy McCabe Vol#: 319

EMC 3592 Carol McLaughlin Vol#: 319

EMC 3593 Desiree Alvis Vol#: 319

EMC 3594 John Kaza Vol#: 319

EMC 3595 Carol Davis Vol#: 319

EMC 3596 Barbara Rose Vol#: 319

EMC 3597 Joy Downey Vol#: 319

EMC 3598 Candice Guth Vol#: 319

EMC 3599 Jonas Ehudin Vol#: 319

EMC 3600 Donna Worden Vol#: 319

EMC 3601 Stephanie Caruso Vol#: 319

EMC 3602 Howard Bender Vol#: 319

EMC 3603 Cheryl Bell Vol#: 319

EMC 3604 Eithne Nunez Vol#: 319

EMC 3605 W Olivieri Vol#: 319

EMC 3606 Jason Boehk Vol#: 319

EMC 3607 Claire O'Leary Vol#: 319

EMC 3608 Barbara R Duncan, PhD Vol#: 319

EMC 3609 Katya Walter Vol#: 319

EMC 3610 Joe Pleiman Vol#: 319

EMC 3611 Lorraine Girlington Vol#: 319

EMC 3612 Cory Houser Vol#: 319

EMC 3613 Steve Scholten Vol#: 319

EMC 3614 Mary Koutsgiannopoulos Vol#: 319

EMC 3615 Michael Winkler Vol#: 319

EMC 3616 John Kremer Vol#: 319

EMC 3617 Mark M Giese Vol#: 319

EMC 3618 Alan Druckman Vol#: 319

EMC 3619 Jim Phillips Vol#: 319

EMC 3620 Danielle Lo Giudice Vol#: 319

EMC 3621 Alan Kreglow Vol#: 319

EMC 3622 Daniel Read Vol#: 319

EMC 3623 Kalena Cook Vol#: 319

EMC 3624 David Akawie Vol#: 319

EMC 3625 Lori Anderson Vol#: 319

EMC 3626 Susan Church Vol#: 319

EMC 3627 Jack McKeehan Vol#: 319

EMC 3628 Taylor S Moseng Vol#: 319

EMC 3629 Lydia M Mortensen Vol#: 319

EMC 3630 Lynn Taylor Vol#: 319

EMC 3631 Sandra & Bob Hill Vol#: 319

EMC 3632 Darcia Bennie Vol#: 319

EMC 3633 Mishel Tarry Vol#: 319

EMC 3634 Robert Bailey Vol#: 319

EMC 3635 Jason Ei Vol#: 319

EMC 3636 Brett Goldstein Vol#: 319

EMC 3637 Terrence Hun Vol#: 319

EMC 3638 Jean Pendergraft Vol#: 319

EMC 3639 Eric Schroeder Vol#: 319

EMC 3640 Janelle Dote Vol#: 319

EMC 3641 Paul DeYoung-Martin Vol#: 319

EMC 3642 Tess Meyer Vol#: 219

EMC 3643 Ary Bruno Vol#: 319

EMC 3644 David Kopta Vol#: 319

EMC 3645 Elaine Powers Vol#: 319

EMC 3646 Carol Stechta Vol#: 319

EMC 3647 Lewis Kawecki Vol#: 319

EMC 3648 No mane Vol#: 319

EMC 3649 Olivia Zivney Vol#: 319

EMC 3650 Patricia Gates Vol#: 319

EMC 3651 Jan-Peter Flack Vol#: 319

EMC 3652 Terri Henry Vol#: 319

EMC 3653 Walt Stoll, MD Vol#: 319

EMC 3654 Karon Hilditch Vol#: 319

EMC 3655 Kathleen Diehl Vol#: 319

EMC 3656 Yvonne Amos Vol#: 319

EMC 3657 Reagan Cooter Vol#: 319

EMC 3658 Jeanette Wenzel Vol#: 319

EMC 3659 Estelle Lieberman Vol#: 319

EMC 3660 Diane Fountain Vol#: 319

EMC 3661 Wendy Draven Vol#: 319

EMC 3662 Jacqui Kopplin Vol#: 3199

EMC 3663 Rebecca Farris Vol#: 319

EMC 3664 Sheer Nisman Vol#: 319

EMC 3665 Katherine Allard Vol#: 319

EMC 3666 Char Magaro Vol#: 319

EMC 3667 Joseph Temple Vol#: 319

EMC 3668 Rianna R Lake Vol#: 319