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 August 7, 2001

TABLE OF CONTENTS

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80N-0348 Ingrown Toenail Drug Products for OTC Human Use *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1621 ANDA suitability for cladribine-lipomed 10 mg/5ml *
01D-0177 Immunotoxicology Evaluation of Investigational New Drugs *
01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic *
01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA *
01P-0085 ANDA Suitable for topical cream containing 2% Hyrocortisone *
01P-0109 Declare doxycycline monohydrate capules suitable for ANDA *
01P-0125 ANDA Suitability Petition for Amiodarone Hydrochloride Table *
01P-0340 Regulate Reprocessed Single Use Medical Devices as Reusable *
77N-0085 Saccharin and Its Salts

C 21754 Nancy L. Parr Vol#: 170

LETA1 William V. Whitehorn, M. D. Vol#: 171

MA 1 Clarance L. Waltrous Vol#: 171

80N-0348 Ingrown Toenail Drug Products for OTC Human Use

PDN 1 HFD-560 & Schering-Plough Corp. Vol#: 1

85V-0287 Laser light show & projector

VRA 9 HFZ-340 to Centrak Lasers Corp. Vol#: 1

86V-0476 Laser light show

VRA 9 HFZ-340 to Stone Mountain Lasers Inc Vol#: 1

87V-0156 STARLIGHT SERIES (FC) LASER PROJECTION SYSTEM

VRA 7 HFZ-340 to Six Flags Worlds of Adventure Vol#: 1

96V-0088 Variance for Laser Light Show

VRA 3 HFZ-340 to East Coast Control Systems, I Vol#: 1

97V-0455 Laser Light Show

VRA 2 HFZ-340 to CourtYards of Mackinaw Vol#: 1

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

NFR 3 Vol#: 1

98P-0493 Stay Approval of ANDA for Tamoxifen othan Than from Barr Lab

REF 1 Court Opinion Mylan Pharma. v. Henney Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 6579 Mary Ann Denton Vol#: 416

C 6580 Karen Sonnabend Vol#: 416

C 6581 C.A. Dann Vol#: 416

C 6582 C. Paulding Vol#: 416

C 6583 Diana Clarisse, PhD Vol#: 416

C 6584 Paul W. Jackson Vol#: 416

C 6585 Monte Walker Vol#: 416

C 6586 Lynnda Bartlett Vol#: 416

C 6587 Margaret Gorden Vol#: 416

C 6588 Elizabeth Scott-Janda Vol#: 416

C 6589 Brad Barnes Vol#: 416

C 6590 Jenny McFeely Vol#: 416

C 6591 Patricia Devitt Vol#: 416

C 6592 Chris Stipp Vol#: 416

C 6593 J. Franzen Vol#: 416

C 6594 Deborah Brak-Gibson Vol#: 416

C 6595 Sharon Schwandt Vol#: 416

C 6596 Joan LaMoure Vol#: 416

C 6597 Alexa Henry Vol#: 416

C 6598 No Signature Vol#: 416

C 6599 Renee McGuire Vol#: 416

C 6600 David Drexler Vol#: 416

C 6601 Shauna Bretzman Vol#: 418

C 6602 Terry Bobb Vol#: 418

C 6603 Joni Bosh Vol#: 418

C 6604 M. Newman Vol#: 418

C 6605 Anthony Calascibetto Vol#: 418

C 6606 J. Van di beer Vol#: 418

C 6607 Karen Irby Vol#: 418

C 6608 Fran Poniatowski Vol#: 418

C 6609 Caroline Rasco Vol#: 418

C 6610 Beverly Peterson Vol#: 418

C 6611 Paula Dieker Vol#: 418

C 6612 Penny Friend Vol#: 418

C 6613 A. Kelly Vol#: 418

C 6614 Susan Breitbach Vol#: 418

C 6615 Wayne Logsdon Vol#: 418

C 6616 Marlyn L. Taylor Vol#: 418

C 6617 Lynn Dodd Vol#: 418

C 6618 Shay Clayton Vol#: 418

C 6619 Doreen Dessereau Vol#: 418

C 6620 Peggi Woodmansee Vol#: 418

C 6621 Morgen McGraw Vol#: 418

C 6622 Ellen Cordey Vol#: 418

C 6623 Andrea Alcorn Vol#: 418

C 6624 Korina Schwarz Vol#: 418

C 6625 Lisa Hewitt Vol#: 418

C 6626 Alexander G. Schwarz Vol#: 418

C 6627 D. Lowell Vol#: 418

C 6628 Beth Donnell Vol#: 418

C 6629 M.S. Lebo Vol#: 418

C 6630 Gina Beinecke Vol#: 418

C 6631 Jill Goldman Vol#: 418

C 6632 Cynthia Goretto Vol#: 418

C 6633 Diane DiMaggio Vol#: 418

C 6634 Donna Hyatt Vol#: 418

C 6635 Michael Hochlerin Vol#: 418

C 6636 Rhonda Wozman Vol#: 418

C 6637 Leonard J. Piro Vol#: 418

C 6638 Gail Stirling Vol#: 418

C 6639 Marianna Roehe Vol#: 418

C 6640 Terri Perkins Vol#: 418

C 6641 Rachel Goldman Vol#: 418

C 6642 Peter Daniels Vol#: 418

C 6643 Phil Ellin Vol#: 418

C 6644 Sue Ellin Vol#: 418

C 6645 Geraldine Daloia Vol#: 418

C 6646 M. Seebeck Vol#: 418

C 6647 DeAnne Dingwall Vol#: 418

C 6648 JoDean Cooper Vol#: 418

C 6649 A. Wiedmann Vol#: 418

C 6650 Bonnie Bird Vol#: 418

C 6651 Sara Ross Vol#: 418

C 6652 J.B. Burbsholclir Vol#: 418

C 6653 Mr & Mrs C.R. White Vol#: 418

C 6654 Jean Schwennesen Vol#: 418

C 6655 M.T. Madden Vol#: 418

C 6656 S. Dashiell Vol#: 418

C 6657 Jill M. Plevell Vol#: 418

C 6658 Cari Spring Vol#: 418

C 6659 Keith Krush Vol#: 418

C 6660 Eligible Vol#: 418

C 6661 Cheryl Casati Vol#: 418

C 6662 Marea P. Isebampil Vol#: 418

C 6663 Julie Lee Vol#: 418

C 6664 James R. Saunders Vol#: 418

C 6665 Eligible Vol#: 418

C 6666 Lindsay Perry Vol#: 418

C 6667 Donna Scribner Vol#: 418

C 6668 Pat Beckers Vol#: 418

C 6669 Greg Cooke Vol#: 418

C 6670 Joanne Decoulds-Hight Vol#: 418

C 6671 William Huntress, III Vol#: 418

C 6672 Ramona Hancock Vol#: 418

C 6673 W. Lavender Vol#: 418

C 6674 Anna Moore Vol#: 418

C 6675 Sterling E. Raynor Jr. Vol#: 418

C 6676 Mildred L. Corvin Vol#: 418

C 6677 Jeri McGovern Vol#: 418

C 6678 Fred Johnson, III Vol#: 418

C 6679 Kevin Williams Vol#: 418

C 6680 Anita Sarkeesian Vol#: 418

C 6681 Jim Barbec Vol#: 418

C 6682 Eligible Vol#: 418

C 6683 R. Hamre Vol#: 418

C 6684 Hedy Byzan Vol#: 418

C 6685 Daria Leland Vol#: 418

C 6686 Kathy Bohkis Vol#: 418

C 6687 Ricky Maxwell Vol#: 418

C 6688 Brooke Engelback Vol#: 418

C 6689 Liz Farwell Vol#: 418

C 6690 Loretta Almada Vol#: 418

C 6691 Louise Molieri Vol#: 418

C 6692 Stacie Preston Vol#: 418

C 6693 Regan Schaefhorn Vol#: 418

C 6694 Joan Conlan Vol#: 418

C 6695 Denver Saunders Vol#: 418

C 6696 Lee & Susan Tyler Vol#: 418

C 6697 Annie Baker Vol#: 418

C 6698 Jordan Donohue-White Vol#: 418

C 6699 Chelsie Falk Vol#: 418

C 6700 Erin Lodahl Vol#: 418

C 6701 Alan Tolletr Vol#: 418

C 6702 Charla Ranch Vol#: 418

C 6703 June Clark Vol#: 418

C 6704 Chris Kozura Vol#: 418

C 6705 R. Doernik Vol#: 418

C 6706 Rita Albert Vol#: 418

C 6707 Eligible Vol#: 418

C 6708 Barbara Morlon Vol#: 418

C 6709 Rebecca Johnson Vol#: 418

C 6710 J. Reed Vol#: 418

C 6711 Michele Jordan Vol#: 418

C 6712 Ingrid McGehee Vol#: 418

C 6713 Joyce Woodley Vol#: 418

C 6714 Kimberlee Jameson Vol#: 418

C 6715 Michelle Bowling Vol#: 418

C 6716 Markus Maromey Vol#: 418

C 6717 Stephanie Lerche Vol#: 418

C 6718 Michelle & David Neils Vol#: 418

C 6719 Steve Thomas Vol#: 418

C 6720 Pam Jones Vol#: 418

C 6721 Joyce Rose Vol#: 418

C 6722 Kate Gormlz Vol#: 418

C 6723 Johnna Baroso Vol#: 418

C 6724 Lyle S. Mills Vol#: 418

EMC 10835 Claire Cabeza de Baca, M Sc Vol#: 417

EMC 10836 Claire Cabeza de Baca, M Sc Vol#: 417

EMC 10837 Esther and Elliott Robbins, M.D.'s Vol#: 417

EMC 10838 Jack Moss Vol#: 417

EMC 10839 Donna Brock Vol#: 417

EMC 10840 Sheila Fox Vol#: 417

EMC 10841 Marcie E. Delia Vol#: 417

EMC 10842 Badger Brock Vol#: 417

EMC 10843 Maureen Horowitz Vol#: 417

EMC 10844 Maureen Horowitz Vol#: 417

EMC 10845 Cheryl Frankfurth Vol#: 417

EMC 10846 Anne Moss Vol#: 417

EMC 10847 Michele Hughes Vol#: 417

EMC 10848 Sue Becker Vol#: 417

EMC 10849 Amy Zappia Vol#: 417

EMC 10850 John Smith Vol#: 417

EMC 10851 Nicole Matthews Vol#: 417

EMC 10852 Narayanan Krishnamurthy Vol#: 417

EMC 10853 Jana Pedemonte Vol#: 417

EMC 10854 Gabi Zois Vol#: 417

EMC 10855 Morris Saltekoff Vol#: 417

EMC 10856 Marie Silva Vol#: 417

EMC 10857 Eric Jaquay Vol#: 417

EMC 10858 Jenny Smith Vol#: 417

EMC 10859 Jenny Smith Vol#: 417

EMC 10860 Mary Stafford Vol#: 417

EMC 10861 Charles Emory Vol#: 417

EMC 10862 Kim McBreen Vol#: 417

EMC 10863 Dorli T. Rainey Vol#: 417

EMC 10864 Janet Ashford Vol#: 417

EMC 10865 Shelley Bossert Vol#: 417

EMC 10866 Davina Hostetter Vol#: 417

EMC 10867 Lara Kaskabas Vol#: 417

EMC 10868 Sara Sparks Vol#: 417

EMC 10869 Warren Holmes Vol#: 417

EMC 10870 Yvonne Baker Vol#: 417

EMC 10871 Selena Mordue Vol#: 417

EMC 10872 Dianne Holmgren Vol#: 417

EMC 10873 Peggy-Lynn Boggs Vol#: 417

EMC 10874 Neeru Cerny Vol#: 417

EMC 10875 Karolina Maslanka Vol#: 417

EMC 10876 Shannon Hoffman Vol#: 417

EMC 10877 Sandra Trinidad Vol#: 417

EMC 10878 Lynn Fogg Vol#: 417

EMC 10879 Gail Erickson Vol#: 417

EMC 10880 Ann Songayllo Vol#: 417

EMC 10881 Vicki Lane Vol#: 417

EMC 10882 Vicki Lane Vol#: 417

EMC 10883 Ronda Lynch Vol#: 417

EMC 10884 Ronda Lynch Vol#: 417

EMC 10885 Cori Huenink Vol#: 417

EMC 10886 Mary Neland Vol#: 417

EMC 10887 Natalie Mannering Vol#: 417

EMC 10888 Bren Leves Vol#: 417

EMC 10889 Lauren Bell Vol#: 417

EMC 10890 Melissa Lorentz Vol#: 417

EMC 10891 Melissa Lorentz Vol#: 417

EMC 10892 Deana Jewett Vol#: 417

EMC 10893 Rachel Kaiser Vol#: 417

EMC 10894 Dolores DeMarco Vol#: 417

EMC 10895 Sisters of St Joseph of Carondelet-6sign Vol#: 417

EMC 10896 Joanne Sharpe Vol#: 417

EMC 10897 Charles and Mary Koenig Vol#: 417

EMC 10898 Angela Fishman Vol#: 417

EMC 10899 Joseph Swartz Vol#: 417

EMC 10900 Cai King-Young Vol#: 417

EMC 10901 Melinda Farrar Vol#: 417

EMC 10902 Cheryl Barr Vol#: 417

EMC 10903 Leonard Cole Vol#: 417

EMC 10904 John Sorflaten Vol#: 417

EMC 10905 unsigned Vol#: 417

EMC 10906 Angela Devargas Vol#: 417

EMC 10907 Reyna Ambrose Vol#: 417

EMC 10908 Grace Ma Vol#: 417

EMC 10909 Don Giffin Vol#: 417

EMC 10910 J Crotty Vol#: 417

EMC 10911 Laura Brackett Vol#: 417

EMC 10912 Frank Demeis Vol#: 417

EMC 10913 Anabella Perez-Midence Vol#: 417

EMC 10914 MJ Maroney Vol#: 417

EMC 10915 Lori Ankney Vol#: 417

EMC 10916 Jill Koenigsdorf Vol#: 417

EMC 10917 Frederick Pinard Vol#: 417

EMC 10918 Frederick Pinard Vol#: 417

EMC 10919 Ryan Warren Vol#: 417

EMC 10920 Ryan Warren Vol#: 417

EMC 10921 Dan Cherney Vol#: 417

EMC 10922 Dan Wilde Vol#: 417

EMC 10923 Debbie Burns Vol#: 417

EMC 10924 David Maple Vol#: 417

EMC 10925 number not used Vol#: 417

EMC 10926 number not used Vol#: 417

EMC 10927 Constance Sweitzer Vol#: 417

EMC 10928 Katrina Baker Vol#: 417

EMC 10929 Lynne Russillo Vol#: 417

EMC 10930 Lynne Russillo Vol#: 417

EMC 10931 Vernon Jennings Vol#: 417

EMC 10932 Jonathan Kessler Vol#: 417

EMC 10933 Megan Milligan Vol#: 417

EMC 10934 Deborah Dlugos Vol#: 417

EMC 10935 Carolyn Johnson Vol#: 417

EMC 10936 Brian Skelton Vol#: 417

EMC 10937 Drew Lao Vol#: 417

EMC 10938 Drew Lao Vol#: 417

EMC 10939 Marilin Engelman Vol#: 417

EMC 10940 Suzanne Brown Vol#: 417

EMC 10941 Kelly Stechschulte Vol#: 417

EMC 10942 Julie Dean Vol#: 417

EMC 10943 Andrew Hartman Vol#: 417

EMC 10944 Joseph Pergolizzi Vol#: 417

EMC 10945 Mildred Weston Vol#: 417

EMC 10946 Irl Stalcup Vol#: 417

EMC 10947 Dr. Rodolfo Rodriguez Vol#: 417

EMC 10948 Edward Melendez Vol#: 417

EMC 10949 Penny Marquez Vol#: 417

EMC 10950 Sandra Baughman Vol#: 417

EMC 10951 Ted Quaday Vol#: 417

EMC 10952 Kathleen Donnelly Vol#: 417

EMC 10953 Jonathan Naimon Vol#: 417

EMC 10954 Santiago Edelmiro Vol#: 417

EMC 10955 M. Gregory Carbone Vol#: 417

EMC 10956 Traci Bryant Vol#: 417

EMC 10957 John Boucher Vol#: 417

EMC 10958 Linda Harmon Vol#: 417

EMC 10959 Rob Borchert Vol#: 417

EMC 10960 Christine Bruggemann Vol#: 417

EMC 10961 Robin Reed Vol#: 417

EMC 10962 Theresa Bark Vol#: 417

EMC 10963 Jina Wilson Vol#: 417

EMC 10964 Sharon Dipietro Vol#: 417

EMC 10965 Sharon Dipietro Vol#: 417

EMC 10966 Christian Roth Vol#: 417

EMC 10967 Carole Riley Vol#: 417

EMC 10968 O. Mikosza Vol#: 417

EMC 10969 Donald S. Jacobs Vol#: 417

EMC 10970 Kay Garrity-Roth Vol#: 417

EMC 10971 Vol#: 417

EMC 10972 Christina Hyde Vol#: 417

EMC 10973 Christina Hyde Vol#: 417

EMC 10974 Alex Brunette Vol#: 417

EMC 10975 Doreen Rebernak Vol#: 417

EMC 10976 unsigned Vol#: 417

EMC 10977 Vol#: 417

EMC 10978 Kathryn Hoover Vol#: 417

EMC 10979 Arlene Watters Vol#: 417

EMC 10980 Jessica Patton Vol#: 417

EMC 10981 number not used Vol#: 417

EMC 10982 James Melton Vol#: 417

EMC 10983 Paul Shaia Vol#: 417

EMC 10984 John Sorflaten Vol#: 417

EMC 10985 Marty Plemmons Vol#: 417

EMC 10986 Lucas Suer Vol#: 417

EMC 10987 Vol#: 417

EMC 10988 Dr. Keith F. Zeitlin Vol#: 417

EMC 10989 Victoria R. Winfield Vol#: 417

EMC 10990 Ann Grimm Vol#: 417

EMC 10991 Margaret Draper Vol#: 417

EMC 10992 Jo Diane Main Vol#: 417

EMC 10993 Tom Devine Vol#: 417

EMC 10994 Joel Kimmel and Tanya Pozzi Vol#: 417

EMC 10995 Joel Kimmel and Tanya Pozzi Vol#: 417

EMC 10996 Dave Wesendunk Vol#: 417

EMC 10997 Mark Pruhenski Vol#: 417

EMC 10998 P Marc Schwartz Vol#: 417

EMC 10999 Ahmed Jibril Vol#: 417

EMC 11000 Wendy Stowers Vol#: 417

EMC 11001 Sara Sandford Vol#: 419

EMC 11002 Tamara Quandt Vol#: 419

EMC 11003 Sven Lovegren Vol#: 419

EMC 11004 J. Snell Vol#: 419

EMC 11005 Camille Witten Vol#: 419

EMC 11006 Amy Sunderland Vol#: 419

EMC 11007 Andrea Wentland Vol#: 419

EMC 11008 Theresa Williamson Vol#: 419

EMC 11009 Elizabeth Aldrich Vol#: 419

EMC 11010 Dinorah Rodriguez Vol#: 419

EMC 11011 Augustus Colangelo Vol#: 419

EMC 11012 Jonathan Markowitz Vol#: 419

EMC 11013 Susan Markowitz Vol#: 419

EMC 11014 Andrew Markowitz Vol#: 419

EMC 11015 Kay Garrity-Roth Vol#: 419

EMC 11016 Danna Gonzales Vol#: 419

EMC 11017 Laura Spencer Vol#: 419

EMC 11018 Elwood Richard Vol#: 419

EMC 11019 Dicron Meneshian Vol#: 419

EMC 11020 William Taylor Vol#: 419

EMC 11021 Muriel Rothenberg Vol#: 419

EMC 11022 Stephanie Antoni Vol#: 419

EMC 11023 Susanne LaBarge Vol#: 419

EMC 11024 Mark Stout Vol#: 419

EMC 11025 Frampton Andrew Vol#: 419

EMC 11026 E Sam Arvizu Vol#: 419

EMC 11027 Lia Budd Vol#: 419

EMC 11028 Deirdre Quinn Vol#: 419

EMC 11029 Paul Williams Vol#: 419

EMC 11030 Jo Ingman Vol#: 419

EMC 11031 Jessica Bishop Vol#: 419

EMC 11032 Jessica Caron Vol#: 419

EMC 11033 Adeline Delia Vol#: 419

EMC 11034 Linda Paffel Vol#: 419

EMC 11035 David Haye Vol#: 419

EMC 11036 Angela Sansom Vol#: 419

EMC 11037 Lisa Dews Vol#: 419

EMC 11038 Martha Galan Vol#: 419

EMC 11039 Lynne Aldrich Vol#: 419

EMC 11040 Dharce Greenwald Vol#: 419

EMC 11041 Marilyn Morrison Vol#: 419

EMC 11042 Jeremiah Podleski Vol#: 419

EMC 11043 Kristin Wolinsky Vol#: 419

EMC 11044 Michelle Rich Vol#: 419

EMC 11045 Jill Lombardi Vol#: 419

EMC 11046 Kathleen Piet Vol#: 419

EMC 11047 Angelica Weiss Vol#: 419

EMC 11048 Emily Heaton Vol#: 419

EMC 11049 Cindy Cutter Vol#: 419

EMC 11050 Candace Signor Vol#: 419

EMC 11051 Kenn Nickell Vol#: 419

EMC 11052 Edward Jerome Vol#: 419

EMC 11053 John Whiton Vol#: 419

EMC 11054 Helen Wilson Vol#: 419

EMC 11055 Jason B Ball Vol#: 419

EMC 11056 Thomas Neal Vol#: 419

EMC 11057 John advertical Vol#: 419

EMC 11058 Susanne Kurtz Vol#: 419

EMC 11059 Renee Crowell Vol#: 419

EMC 11060 Cat Talbot Vol#: 419

EMC 11061 Nadia N.S. Maczaj Vol#: 419

EMC 11062 Charlotte Williams Vol#: 419

EMC 11063 Neil Levin Vol#: 419

EMC 11064 Lenora Hall Vol#: 419

EMC 11065 Laurie Powsner Vol#: 419

EMC 11066 Laurie Powsner Vol#: 419

EMC 11067 Carlyle Tom Vol#: 419

EMC 11068 David Hieatt Vol#: 419

EMC 11069 Gorus Bix Vol#: 419

EMC 11070 Michael Cullen Vol#: 419

EMC 11071 Michael Cullen Vol#: 419

EMC 11072 Cristobal Ramon Vol#: 419

EMC 11073 Cristobal Ramon Vol#: 419

EMC 11074 Jan Brooks Vol#: 419

EMC 11075 Beth Shore Vol#: 419

EMC 11076 Beth Shore Vol#: 419

EMC 11077 Claire Jackson Vol#: 419

EMC 11078 Bobbi Smith Vol#: 419

EMC 11079 Janet Hunt Vol#: 419

EMC 11080 Bernadette Chapin Vol#: 419

EMC 11081 Madeleine Mulanix Vol#: 419

EMC 11082 Seth Christian Vol#: 419

EMC 11083 Marisa Jacobs Vol#: 419

EMC 11084 Kristi Welch Vol#: 419

EMC 11085 Frank Chisholm Vol#: 419

EMC 11086 Frank Chisholm Vol#: 419

EMC 11087 David Falk Vol#: 419

EMC 11088 Bill and Jan Tache' Vol#: 419

EMC 11089 Bill and Jan Tache' Vol#: 419

EMC 11090 Miroslav Suta Vol#: 419

EMC 11091 Miroslav Suta Vol#: 419

EMC 11092 Rick Freeman Vol#: 419

EMC 11093 Rick Freeman Vol#: 419

EMC 11094 Michael Black Vol#: 419

EMC 11095 Michael Black Vol#: 419

00N-1665 Consumer Roundtable; Notice of Meeting

EC 19 Number Not Used Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

APE 74 American Peanut Council Vol#: 15

APE 75 Kraft Foods Vol#: 15

APE 76 Don Ellis Donna Spencer Tami Shuck Vol#: 15

APE 77 Food & Consumer Products Mfrs of Canada Vol#: 15

APE 78 Schwans Vol#: 15

APE 79 FDA Vol#: 15

APE 80 Kellogg Company Vol#: 15

APE 81 CFSAN/DFDA Vol#: 15

APE 82 National Food Processors Assocn Vol#: 15

APE 83 Food Allergy & Anaphylaxis Network Vol#: 15

APE 84 Embassy of the Agriculture Attache Vol#: 15

APE 85 DSM Food Specialties USA Inc Vol#: 15

APE 86 Mintz Levin Cohn Ferris Glovksy & Popes Vol#: 15

APE 87 Catherine Tretheway Vol#: 15

APE 88 German Embassy Vol#: 15

APE 89 Celiac Sprue Support Group Vol#: 15

APE 90 CFSAN/FDA Vol#: 15

APE 91 Buchanan Ingersol Vol#: 15

APE 92 R C Bigelow Inc Vol#: 15

APE 93 Claudette McIntyre & LeeAnn Romanelli Vol#: 15

APE 94 McKee Foods Corp Vol#: 15

APE 95 Lynx Street Inc Vol#: 15

APE 96 Celiac Foundation Vol#: 15

APE 97 Jorge Hernandez Baeza (Mexico) Vol#: 15

APE 98 Gustavo Frias Trevino (Mexico) Vol#: 15

APE 99 Javier Trujillo Aggriaga (Mexico) Vol#: 15

APE 100 Martin Aluja Shunemann (Mexico) Vol#: 15

APE 101 FEMA Vol#: 15

APE 102 ConAgra Foods Vol#: 15

APE 103 Dannon Company Inc Vol#: 15

APE 104 Access Business Group Vol#: 15

APE 105 Celiac Support Group Vol#: 15

APE 106 National Food Processors Assocn Vol#: 15

APE 107 Nutrition Labeling Watch Vol#: 15

APE 108 MREPC Vol#: 15

APE 109 Adams Worldwide Vol#: 15

APE 110 Food & Nutrition Board Inst of Medicine Vol#: 15

APE 111 Anita Klein Vol#: 15

APE 112 National Narrowcast Network Vol#: 15

C 222 Catherine Powell Vol#: 16

C 223 AnnaMarie Fusaro Vol#: 16

C 224 Merri I Bindas Vol#: 16

C 225 Helen Kochenderfer Vol#: 16

C 226 Lisa O Westcott Vol#: 16

C 227 Anita Jackson Vol#: 16

C 228 Heather G Tighe Vol#: 16

C 229 Tom & Martha Steger Vol#: 16

C 230 Nancy Hagemann Vol#: 16

C 231 Elizabeth Snow Vol#: 16

C 232 Peter R Clouser Vol#: 16

C 233 Valorie J Schofield Vol#: 16

C 234 Andrew Rodwin Vol#: 16

C 235 Christine M Hofstedt Vol#: 16

C 236 Robert & Mary Jo Oren Vol#: 16

C 237 Elizabeth Fotieo Vol#: 16

C 238 Michele Polen Vol#: 16

C 239 Penny D Rogers Vol#: 16

C 240 Victoria Geduld Vol#: 16

C 241 Jean Keel Vol#: 16

C 242 Patricia Pennington Vol#: 16

00P-1621 ANDA suitability for cladribine-lipomed 10 mg/5ml

PDN 1 HFD-600 to Lipomed, Inc. Vol#: 1

01D-0177 Immunotoxicology Evaluation of Investigational New Drugs

C 3 Triangle Pharmaceuticals Vol#: 1

C 4 Merck & Co. inc Vol#: 1

C 5 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 1

C 6 #M Pharmaceuticals Vol#: 1

C 7 ILSI Health & Environmental Sciences Ins Vol#: 1

01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic

C 5 American College of Veterinary Pathologi Vol#: 1

C 6 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 1

C 7 Abbott Laboratories Vol#: 1

C 8 Merck & Co. inc Vol#: 1

01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA

C 1 American Association of Orthopaedic Surg Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 15 Dr. Vincent Stravino Vol#: 3

EC 16 Dr. Vincent Stravino Vol#: 3

EC 17 N/A Vol#: 3

EC 18 Oregon Health & Sciences University Vol#: 3

EC 19 Gerontological Nurse Practitioner Vol#: 3

EC 20 Actiononpain Vol#: 3

EC 21 patient Vol#: 3

EC 22 Number Not Used Vol#: 3

EC 23 Dr. Benjamin Moore Vol#: 3

EC 24 Mrs. Mary Carol Elias Vol#: 3

EC 25 San Francisco General Hospital Vol#: 3

EC 26 Private Individual Vol#: 3

01N-0317 Withdrawal of Approval of 66 ANDAs

NWL 1 Vol#: 1

01P-0085 ANDA Suitable for topical cream containing 2% Hyrocortisone

PAV 1 HFD-600 to Ferndale Labs., Inc. Vol#: 1

01P-0109 Declare doxycycline monohydrate capules suitable for ANDA

PAV 1 HFD-600 to The Weinberg Grpou, Inc. Vol#: 1

01P-0125 ANDA Suitability Petition for Amiodarone Hydrochloride Table

PAV 1 HFD-600 to Olsson, Frank & Weeda, P.C. Vol#: 1

01P-0340 Regulate Reprocessed Single Use Medical Devices as Reusable

ACK 1 HFA-305 Vol#: 1

CP 1 Assn of Disposable Device Manufacturers Vol#: 1

01V-0212 Laser light show

VRA 1 HFZ-340 to Warehouse Sound & Light Vol#: 1

01V-0216 Projector for a laser light show

VRA 1 HFZ-340 to Foxwoods Resort Casino Vol#: 1

01V-0223 Laser Light Show

VRA 1 HFZ-340 to Rainbow Laser Display Vol#: 1

01V-0247

VRA 1 HFZ-340 to Carolina Bowling Center Vol#: 1

01V-0285

VRA 1 HFZ-340 to Visual Concepts 2000 Vol#: 1

01V-0341

ACK 1 HFA-305 Vol#: 1

VAR 1 Dr. Feelgoods Inc. Vol#: 1