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 June 11, 2002

TABLE OF CONTENTS

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78N-036L OTC Laxative *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00P-1687 Amend definition & standard of identity for parmesan cheese *
02N-0169 Combination Products Containing Live Cellular Components *
02N-0209 Governing First Amendment Case Law *

78N-036L OTC Laxative

ACK 4 HFA-305 Vol#: 120

CP 25 American Herbal Products Assn. Vol#: 120

84N-0102 Orphan Product Designations

NAD 16 Vol#: 4

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 2899 June F. Chapman Vol#: 5016

CA 2900 Edward McLaughlin Vol#: 5016

CA 2901 William Nustyel Vol#: 5016

CA 2902 Margaret Quigley Vol#: 5016

CA 2903 Robert L. Quigley Vol#: 5016

CA 2904 Beverly McLaughlin Vol#: 5016

CA 2905 A. V. Sommerville Vol#: 5016

CA 2906 Russell Sciandra Vol#: 5016

CA 2907 Kay Hosack Vol#: 5016

CA 2908 Jennifer K. Russell Vol#: 5016

CA 2909 Frank H. Galloway Vol#: 5016

CA 2910 Kathryne M. LaGrange, R. N. Vol#: 5016

CA 2911 M. Georice Hollingdale, R. N. Vol#: 5016

CA 2912 Charlotte Eddy Vol#: 5016

CA 2913 Neil Dugen Vol#: 5016

CA 2914 Catherine Ferree Vol#: 5016

CA 2915 Nancy Long Vol#: 5016

CA 2916 L. W. Long Vol#: 5016

CA 2917 Philip A. Chapman Vol#: 5016

CA 2918 Paul D. May Vol#: 5016

CA 2919 Joan Sorkin Vol#: 5016

CA 2920 William Moran Vol#: 5016

CA 2921 Regina M. Reiser Vol#: 5016

CA 2922 Dixie N. Samson Vol#: 5016

CA 2923 Eva S. Hardwick Vol#: 5016

CA 2924 Sally S. Kellum Vol#: 5016

CA 2925 Jane Fail Vol#: 5016

CA 2926 Barbara R. James Vol#: 5016

CA 2927 Vijay R. Patrick, M. D. Vol#: 5016

CA 2928 Anna Singer Vol#: 5016

CA 2929 Mary Ann Clark Vol#: 5016

CA 2930 M. Cheshire, M. D. Vol#: 5016

CA 2931 Marina Lewis Vol#: 5016

CA 2932 Brennan Cheshire, Ph. D. Vol#: 5016

CA 2933 Denise Sabol, R. D. Vol#: 5016

CA 2934 Edgar Lichstein Vol#: 5016

CA 2935 Thomas A. Littlefield Vol#: 5016

CA 2936 Virginia E. Anderson Vol#: 5016

CA 2937 Barbara Numan Vol#: 5016

CA 2938 Ann Rose Simon Vol#: 5016

CA 2939 Mary Schmid Vol#: 5016

CA 2940 Beatrice Zaruba Vol#: 5016

CA 2941 Kaye Emrick Vol#: 5016

CA 2942 Connie Cosgrove Vol#: 5016

CA 2943 Mara Marich Vol#: 5016

CA 2944 Jack Kotin Vol#: 5016

CA 2945 Coleen Evans Vol#: 5016

CA 2946 Sheila P. Englebardt, R. N., Ph. D. Vol#: 5016

CA 2947 Linda Hill Vol#: 5016

CA 2948 Joann T. Gaediardo Vol#: 5016

CA 2949 James K. Aud, Sr. Vol#: 5016

CA 2950 R. J. Stephens Vol#: 5016

CA 2951 Don Condon Vol#: 5016

CA 2952 Richard S. Kochmann Vol#: 5016

CA 2953 Cindy Ernst Vol#: 5016

CA 2954 Bernard C. Pettit Vol#: 5016

CA 2955 George Poucher Vol#: 5016

CA 2956 James R. Osteens Vol#: 5016

CA 2957 Arthur J. Englebardt Vol#: 5016

CA 2958 Katherine A. Woods, R. D. H., M. P. H. Vol#: 5016

CA 2959 Julia Avramides Vol#: 5016

CA 2960 Lois Knight Larue Vol#: 5016

CA 2961 Terry Scholm Vol#: 5016

CA 2962 Dr. Jeanne L. Smith Vol#: 5016

CA 2963 Carole J. Hausen Vol#: 5016

CA 2964 Thomas D. Harle, M. D. Vol#: 5016

CA 2965 William W. Lander Vol#: 5016

CA 2966 Rhonda Marshall Vol#: 5016

CA 2967 Timothy L. Mason Vol#: 5016

CA 2968 Pat Drea Vol#: 5016

CA 2969 Carolyn Marsdea Vol#: 5016

CA 2970 Joanne Engle Vol#: 5016

CA 2971 Mark Lundberg Vol#: 5016

CA 2972 Marion LeBaron Vol#: 5016

CA 2973 S. Vargas, M. D. Vol#: 5016

CA 2974 Kristine Ball Vol#: 5016

CA 2975 Robert Stouffer Vol#: 5016

CA 2976 Virginia R. Partain Vol#: 5016

CA 2977 Christine M. Gaylord Vol#: 5016

CA 2978 J. Jewett Vol#: 5016

CA 2979 Marant MeSow Vol#: 5016

CA 2980 M. Litterst Vol#: 5016

CA 2981 Jennifer Toney Vol#: 5016

CA 2982 Miriam Rooney Vol#: 5016

CA 2983 Carol K. Herman Vol#: 5016

CA 2984 Amila Poore Vol#: 5016

CA 2985 S. Holman Braddock Vol#: 5016

CA 2986 Kevin S. Olson Vol#: 5016

CA 2987 Larry D. Olson Vol#: 5016

CA 2988 Mrs. Carol Radulovich Vol#: 5016

CA 2989 Frances Murray Vol#: 5016

CA 2990 Pat O'Connor Vol#: 5016

CA 2991 Bruce Baldwin Vol#: 5016

CA 2992 Julian Diaz Vol#: 5016

CA 2993 Ellen Num Pepper Vol#: 5016

CA 2994 Kalyanee Vaidya Vol#: 5016

CA 2995 Mary Alice Blake Vol#: 5016

CA 2996 Carolyn Weinhold Vol#: 5016

CA 2997 Louis R. Pisaniello Vol#: 5016

CA 2998 Jean Olson Vol#: 5016

CA 2999 Tanya Vreebe Vol#: 5017

CA 3000 Tracy Mixdorf Vol#: 5017

CA 3001 Brad Johnson Vol#: 5017

CA 3002 Sara E. Liter Vol#: 5017

CA 3003 Julie F. Cirau Vol#: 5017

CA 3004 Marnie Loftus Vol#: 5017

CA 3005 Carmen Doty Vol#: 5017

CA 3006 Dana Rhode Vol#: 5017

CA 3007 Janet S. Libbing Vol#: 5017

CA 3008 Sharon M. Kimbell Vol#: 5017

CA 3009 Patricia G. Sandercock Vol#: 5017

CA 3010 Kathy Schrenbaum Vol#: 5017

CA 3011 Carole Thornman Vol#: 5017

CA 3012 Ann Terranova Vol#: 5017

CA 3013 Alida E. Marks Vol#: 5017

CA 3014 Mary Jo Stults Vol#: 5017

CA 3015 Karla Lolan Vol#: 5017

CA 3016 Carol Grobner Vol#: 5017

CA 3017 Crystal Schmotz Vol#: 5017

CA 3018 Marlene Birkholtz Vol#: 5017

CA 3019 Del Meier Vol#: 5017

CA 3020 Del Meier Vol#: 5017

CA 3021 Del Meier Vol#: 5017

CA 3022 Del Meier Vol#: 5017

CA 3023 Del Meier Vol#: 5017

CA 3024 Del Meier Vol#: 5017

CA 3025 Del Meier Vol#: 5017

CA 3026 Del Meier Vol#: 5017

CA 3027 Jolene Funk Vol#: 5017

CA 3028 Richard Sun Vol#: 5017

CA 3029 Jose L. Aurleo Vol#: 5017

CA 3030 M. Santello Vol#: 5017

CA 3031 Marilyn AllDitcher Vol#: 5017

CA 3032 Angela Bracye Vol#: 5017

CA 3033 Janice Gagel Vol#: 5017

CA 3034 J. Keith Rice Vol#: 5017

CA 3035 Heather Childers Vol#: 5017

CA 3036 Joy Dewenskus Vol#: 5017

CA 3037 Nathalie S. Herve' Vol#: 5017

CA 3038 Marlona Harting Vol#: 5017

CA 3039 Jennifer Scheidt Vol#: 5017

CA 3040 James H. Ray Vol#: 5017

CA 3041 Sally Shankland Vol#: 5017

CA 3042 Illegible Vol#: 5017

CA 3043 Carol Saveda Vol#: 5017

CA 3044 Michele Brodsky Vol#: 5017

CA 3045 Diane Carr Vol#: 5017

CA 3046 Roberta Thanklib Vol#: 5017

CA 3047 Louis Kimball Vol#: 5017

CA 3048 Walter Woo Vol#: 5017

CA 3049 Monica S. Combs Vol#: 5017

CA 3050 Caren Bowling Vol#: 5017

CA 3051 Masha C. Archer Vol#: 5017

CA 3052 Merle J. Dord Vol#: 5017

CA 3053 Jennifer Masing Vol#: 5017

CA 3054 Barbara J. Hanson Vol#: 5017

CA 3055 Judith K. Suese Vol#: 5017

CA 3056 Bernadette Everman Vol#: 5017

CA 3057 Lynda Rallo Vol#: 5017

CA 3058 Sharon Barbour, R. N. Vol#: 5017

CA 3059 Ronald J. Nyco Vol#: 5017

CA 3060 Melissa L. Currie Vol#: 5017

CA 3061 Derek A. Damin Vol#: 5017

CA 3062 Jennifer Catlett Vol#: 5017

CA 3063 Stacey Fagenbaker Vol#: 5017

CA 3064 Susan M. Taylor Vol#: 5017

CA 3065 S. M. Oglundhand Vol#: 5017

CA 3066 Lori Devlin Vol#: 5017

CA 3067 Elizabeth M. Martin Vol#: 5017

CA 3068 Tara Knipper Vol#: 5017

CA 3069 Harold S. Hammond Vol#: 5017

CA 3070 Barbara J. Anderson, R. C. Vol#: 5017

CA 3071 Vickie Jolly Vol#: 5017

CA 3072 Sid Slufield Vol#: 5017

CA 3073 Rose Rhoden Vol#: 5017

CA 3074 Sonja Cookson Vol#: 5017

CA 3075 Merilyn Presten Vol#: 5017

CA 3076 Brenda Goldstein Vol#: 5017

CA 3077 Linda Colesville Vol#: 5017

CA 3078 Crystal M. Marks Vol#: 5017

CA 3079 Carol Landon Vol#: 5017

CA 3080 Laura Hynes Vol#: 5017

CA 3081 Amy Waltrop Vol#: 5017

CA 3082 Klara Gal Vol#: 5017

CA 3083 Harry L. Werner Vol#: 5017

CA 3084 Vincent Geets Vol#: 5017

CA 3085 Susan Bowman Vol#: 5017

CA 3086 Bernadette Olin Vol#: 5017

CA 3087 Donald Bowman Vol#: 5017

CA 3088 Charles P. McCall, M. D. Vol#: 5017

CA 3089 Larry McKenzie Vol#: 5017

CA 3090 Joanne W. Moffitt Vol#: 5017

CA 3091 Teri Parker, R. N. Vol#: 5017

CA 3092 Barry Miller Vol#: 5017

CA 3093 Andrea S. Regge Vol#: 5017

CA 3094 Alida E. Marks Vol#: 5017

CA 3095 Tohinh Jensen Vol#: 5017

CA 3096 Michelle DeWolf Vol#: 5017

CA 3097 Karen M. Lommel Vol#: 5017

CA 3098 Jack Power Vol#: 5017

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

EMC 98 Martin Blazevich Vol#: 1

EMC 99 Bruce Goldfaden Vol#: 1

EMC 100 Darlyne Jarrett Vol#: 1

EMC 101 Rachel Marita Gabaldon Vol#: 1

EMC 102 Chelsea Delz Vol#: 1

EMC 103 Kameron Knight Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

MO 6 CVM & Bayer Corporation Vol#: 259

00P-1687 Amend definition & standard of identity for parmesan cheese

MT 1 HFS-822 & Sartori Food Corp. Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 240 Homer R. Reese, Jr. Vol#: 4

EMC 241 Ed Johnson Vol#: 4

EMC 242 Benjamin Clark Vol#: 4

EMC 243 Andrea Mateo Vol#: 4

EMC 244 number not used Vol#: 4

EMC 245 number not used Vol#: 4

01N-0587 Changes to an approved application labeling forms 356h&2567

N 2 Vol#: 1

02D-0242 Pharmacy Compounding Compliance Policy Guide

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect

N 2 Vol#: 1

02N-0125 New Food Chemicals Codex Monographs, General Test Procedures

N 1 Vol#: 1

02N-0169 Combination Products Containing Live Cellular Components

APE 8 BioWhittaker, a Cambrex Company Vol#: 2

02N-0209 Governing First Amendment Case Law

EMC 1 Jim Whitney Vol#: 3

EMC 2 Hazel M. Dorman Vol#: 3

EMC 3 Jim Gullett Vol#: 3

EMC 4 Dennis O'Shea Vol#: 3

EMC 5 Marilyn Sunia Vol#: 3

EMC 6 Salianne A. Hetland Vol#: 3

EMC 7 Darl & Karen Heatherly Vol#: 3

EMC 8 June Russell Vol#: 3

EMC 9 Terri Brooks Vol#: 3

EMC 10 Robert Friedlander Vol#: 3

EMC 11 Eliza Moore Vol#: 3

11

02V-0040 Laser Light Show

VRA 1 HFZ-300 to Defiant Film Effects, Inc. Vol#: 1

02V-0072

VRA 1 HFZ-300 to Hotel Develment-Texas dba Ill Vol#: 1

02V-0110

VRA 1 HFZ-300 to Music Gladiators Mobile Entet Vol#: 1

02V-0119 Laser light show

VRA 1 HFZ-300 to George W Long, Inc/SeaBreeze Vol#: 1

02V-0146 Laser Light Show

VRA 1 HFZ-300 to Electro Magic Vol#: 1

02V-0158

VRA 1 HFZ-300 to Sorcar Engineering, Inc. Vol#: 1