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 3, 2000

TABLE OF CONTENTS

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91P-0510 Establish coffee labeled as 'Kona Coffee' be 100% Kona Coffe *
98P-0236 Establishing a Food Standard for Cappuccino. *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat *
00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug*
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1554 Exempt pharmacy compounding systems/Class II devices from PM *
00V-1552 Laser light show*
00V-1553 *
91P-0510 Establish coffee labeled as 'Kona Coffee' be 100% Kona Coffe

PDN 1 HFC-1 to Kona Coffee Council Vol#: 1

93N-0372 Medical Devices; Hearing Aid Requirements

C 4537 Form letter count 13 Vol#: 80

C 4538 Form letter count 40 Vol#: 80

C 4539 Form letter count 177 Vol#: 82

C 4540 Form letter count 9 Vol#: 83

94N-0371 Rami Eisharaiha; Proposal to Debar

N 1 Vol#: 1

94N-0424 Proposal to Debar Mohammad Uddin; NPH

N 1 Vol#: 1

98F-0290 Safe Use of Olefin Basic Copolymers

NWL 1 Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

NFR 2 Vol#: 882

98P-0236 Establishing a Food Standard for Cappuccino.

PDN 1 HFC-1 to Richard Bouril Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 788 Caroline Medlinger Vol#: 28

EMC 35 Sheila Hall Vol#: 28

EMC 36 Amy Marie Campbell Vol#: 28

EMC 37 Melissa Wayne Vol#: 28

EMC 38 Carol Smith Vol#: 28

EMC 39 Dr Dorothy K Cinquemani Vol#: 28

EMC 40 David Shelton Vol#: 28

99C-1455 Safe Use of D&C Violet No. 2 as a Color Additive

NFR 2 Vol#: 1

99N-2674 Proposal to Debar Jay Marcus

N 1 Vol#: 1

00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat

C 7 AstraZeneca Pharmaceuticals LP Vol#: 1

C 8 Merck & Co., Inc. Vol#: 1

00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug

C 4 Allergy Medical Grp of San Diego, Inc. Vol#: 1

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 10 Wyeth-Ayerst Laboratories Vol#: 2

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 37 Gray Panthers of Sacramento Vol#: 15

C 38 Ruth Niswander Vol#: 15

C 39 Sean Gale Vol#: 15

C 40 Michele M Makrucki Vol#: 15

C 41 Ann Gautier Vol#: 15

C 42 Joe Alexander Vol#: 15

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

TS 19 Tufts Center for the Study of Drug Dev Vol#: 1

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

C 6340 Patta M. Waring Vol#: 276

C 6341 Bob Basdan Vol#: 276

C 6342 Alice Armen Vol#: 276

C 6343 Peggy Donahue Vol#: 276

C 6344 Constance Small Vol#: 276

C 6345 Collette A. Matling Vol#: 276

C 6346 Olga Kuprevirz Vol#: 276

C 6347 Kathy Gambino Vol#: 276

C 6348 Helen Cranmer Vol#: 276

C 6349 Patricia J. Plesh Vol#: 276

C 6350 Jonathan S. Burnworth Vol#: 276

C 6351 Anna S. Husband Vol#: 276

C 6352 Karen J. Long Vol#: 276

C 6353 Carroll Beaky Vol#: 276

C 6354 Teresa Badillo Vol#: 276

C 6355 Anih Rameshwar Vol#: 276

C 6356 Bradley Kennedy Vol#: 276

C 6357 Connie R. Henry Vol#: 276

C 6358 Sharon Andrews Vol#: 276

C 6359 Yvonne Ngbag Vol#: 276

C 6360 Carolyn A. Hejkal Vol#: 276

C 6361 Don Fox Vol#: 276

C 6362 Moro Sandro Vol#: 276

C 6363 Mr & Mrs Donald C. Brummitt, Jr. Vol#: 276

C 6364 Deedee Green Vol#: 276

C 6365 Jane Keating-Jones Vol#: 276

C 6366 Susan Hixson Vol#: 276

C 6367 Donna Sciarrone Vol#: 276

EMC 2876 Marcus Williamson Vol#: 275

EMC 2877 Jerry McGeorge Vol#: 275

EMC 2878 Lisa DeVaney Vol#: 275

EMC 2879 Traci Kuechenmeister Vol#: 275

EMC 2880 L. Bishop Vol#: 275

EMC 2881 Meredith Mohr Vol#: 275

EMC 2882 Robert Fisher Vol#: 275

EMC 2883 Kenneth MacArthur Vol#: 275

EMC 2884 Liane Casten Vol#: 275

EMC 2885 Mary Gibson Vol#: 275

EMC 2886 Serena Tupper Vol#: 275

EMC 2887 Sandra Castro-Nguyen Vol#: 275

EMC 2888 Trina Paulus Vol#: 275

EMC 2889 Summer Jarvis Vol#: 275

EMC 2890 Michael Johnston Vol#: 275

EMC 2891 Pat Lawrence Vol#: 275

EMC 2892 Diane Winters Vol#: 275

EMC 2893 Phyllis Bedford Vol#: 275

EMC 2894 Gayle Birk Vol#: 275

EMC 2895 Mark Watkins Vol#: 275

EMC 2896 Isa-Anice Sutphen Vol#: 275

EMC 2897 Amanda Rhea Vol#: 275

EMC 2898 Janis Marion Vol#: 275

EMC 2899 Clare Martin Vol#: 275

EMC 2900 Michael Sarafian Vol#: 275

EMC 2901 Colin Rudd Vol#: 275

EMC 2902 Robyn Squier Vol#: 275

EMC 2903 Diane Weddell Vol#: 275

EMC 2904 Timothy Mahar Vol#: 275

EMC 2905 Martin Bakker Vol#: 275

EMC 2906 Ellen Heckman Vol#: 275

EMC 2907 Jill Howe Vol#: 275

EMC 2908 Mark Almond Vol#: 275

EMC 2909 David A. Kirk Vol#: 275

EMC 2910 Lindsey Mann Vol#: 275

EMC 2911 Gay Hart Vol#: 275

EMC 2912 Lois Banks Vol#: 275

EMC 2913 Sean McNamara Vol#: 275

EMC 2914 Kathryn Everling Vol#: 275

EMC 2915 John Pustaver Vol#: 275

EMC 2916 David Schaffer Vol#: 275

EMC 2917 Guyna Russell Vol#: 275

EMC 2918 Sharon Collins Vol#: 275

EMC 2919 Janetta York Vol#: 275

EMC 2920 Erin Garber-Pearson Vol#: 275

EMC 2921 Kara Sullivan Vol#: 275

EMC 2922 Sarah Ottosen Vol#: 275

EMC 2923 Stephanie Stoneleigh Vol#: 275

EMC 2924 Roger Pyle Vol#: 275

EMC 2925 Kristi Manning Vol#: 275

EMC 2926 George Naylor Vol#: 275

EMC 2927 Pattie Schey Vol#: 275

EMC 2928 Steve Miller Vol#: 275

EMC 2929 Karen Tidwell Vol#: 275

EMC 2930 Gian Andea Morresi Vol#: 275

EMC 2931 Ruth Berman Vol#: 275

EMC 2932 Cory Mermer Vol#: 275

EMC 2933 Anesa Miller Vol#: 275

EMC 2934 Betty Fussell Vol#: 275

EMC 2935 Nathan Sharman Vol#: 275

EMC 2936 Rick DeSanto Vol#: 275

EMC 2937 Ingrid Planert Vol#: 275

EMC 2938 Joseph Cacace Vol#: 275

EMC 2939 Ron Pitt Vol#: 275

EMC 2940 James Wilson Vol#: 275

EMC 2941 Elsie Beck Vol#: 275

EMC 2942 Barry Ryan Vol#: 275

EMC 2943 William McCall Vol#: 275

EMC 2944 Charles Law Vol#: 275

EMC 2945 Cindy Odman Vol#: 275

EMC 2946 Lee Halper & Family Vol#: 275

EMC 2947 Patrick Walsh Vol#: 275

EMC 2948 Linda C. Holmes Vol#: 275

EMC 2949 Mary Jane Schoeneman Vol#: 275

EMC 2950 Cheryl Pritchard Vol#: 275

EMC 2951 Julie Noel Vol#: 275

EMC 2952 Hugh Carson Vol#: 275

EMC 2953 Suzy Argumeto Vol#: 275

EMC 2954 N. Pratt Vol#: 275

EMC 2955 Steve Morris Vol#: 275

EMC 2956 Jody Ruff Vol#: 275

EMC 2957 Thomas Morris Vol#: 275

EMC 2958 Wayne Horvath Vol#: 275

EMC 2959 Jeffrey Geurin Vol#: 275

EMC 2960 Michael Parker Vol#: 275

EMC 2961 Ryan McMullan Vol#: 275

EMC 2962 Holly Walz Vol#: 275

EMC 2963 Jonathan Neiss Vol#: 275

EMC 2964 Helen Kaidan Vol#: 275

EMC 2965 David Porter Vol#: 275

EMC 2966 Louise Gall Vol#: 275

EMC 2967 Diane Falk Vol#: 275

EMC 2968 Jordan Vexler Vol#: 275

EMC 2969 Paul Young Vol#: 275

EMC 2970 Gary Hardy Vol#: 275

EMC 2971 Frankie Summers Vol#: 275

EMC 2972 J. Williams Vol#: 275

EMC 2973 Judith Foster Vol#: 275

EMC 2974 Debbie Lee Vol#: 275

EMC 2975 Scott Morris Vol#: 275

EMC 2976 Kathy Helen Warner Vol#: 275

EMC 2977 Lawrence McManus Vol#: 275

EMC 2978 Jim Davis Vol#: 275

EMC 2979 Michael Morris Vol#: 275

EMC 2980 Delia Pratt Vol#: 275

EMC 2981 Kari Pond Vol#: 275

EMC 2982 Virginia Husbands Vol#: 275

EMC 2983 Nancy Wilson Vol#: 275

EMC 2984 Kathryn Strick Vol#: 275

EMC 2985 Susan Jordan Vol#: 275

EMC 2986 Diana Mann Vol#: 275

EMC 2987 Deo Shanker Vol#: 275

EMC 2988 Amy Landon Vol#: 275

EMC 2989 Ed Cooper Vol#: 275

EMC 2990 Larry Sapp Vol#: 275

EMC 2991 William Meachman Vol#: 275

EMC 2992 Kate Brock Vol#: 275

EMC 2993 Karin Spieker Vol#: 275

EMC 2994 Mark Kissinger Vol#: 275

EMC 2995 Rachel Taylor Vol#: 275

EMC 2996 Jo Jordon Vol#: 275

EMC 2997 Sara Krizan Vol#: 275

EMC 2998 Erin Trask Vol#: 275

EMC 2999 Ken Robart Vol#: 275

EMC 3000 Ruth Ann Ranstrom Vol#: 275

EMC 3001 Michael Privette Vol#: 275

EMC 3002 Allison Baker Vol#: 275

EMC 3003 Diana M. Johnson Vol#: 275

EMC 3004 Kathleen Badeaux Vol#: 276

EMC 3005 Rachel Goldberg Vol#: 276

EMC 3006 Carol Brown Vol#: 276

EMC 3007 Daniel Feldman Vol#: 276

EMC 3008 Heidi MacKay Vol#: 276

EMC 3009 Andres Mejides Vol#: 276

EMC 3010 Bea Stenger Vol#: 276

EMC 3011 Erin Hill Vol#: 276

EMC 3012 Al Foote Vol#: 276

EMC 3013 Liberte Reinke Vol#: 276

EMC 3014 James Leupold Vol#: 276

EMC 3015 Rita Glover Vol#: 276

EMC 3016 Tina Duley Vol#: 276

EMC 3017 Lisa Carr Vol#: 276

EMC 3018 Diana Austin Vol#: 276

EMC 3019 Jan Jarvis Vol#: 276

EMC 3020 Tracey Rembert Vol#: 276

EMC 3021 Dr. Dorothy K. Cinquemani Vol#: 276

EMC 3022 Karyn Fenton Vol#: 276

EMC 3023 Karen Frankel Vol#: 276

EMC 3024 Joan Summers Vol#: 276

EMC 3025 Arch McCulloch Vol#: 276

EMC 3026 Joshua Wittmer Vol#: 276

EMC 3027 Chris Graham Vol#: 276

EMC 3028 Erich Pearson Vol#: 276

EMC 3029 Melanie Lenart Vol#: 276

EMC 3030 Theresa Bonetti Vol#: 276

EMC 3031 Elizabeth Alvanas Vol#: 276

EMC 3032 Denise Nizza Vol#: 276

EMC 3033 Mike Gervais Vol#: 276

EMC 3034 Mirka Morales Vol#: 276

EMC 3035 Audrey Maxwell Vol#: 276

EMC 3036 Judith McGeary Vol#: 276

EMC 3037 Nancy Chapman Vol#: 276

EMC 3038 Terrence McGovern, Jr. Vol#: 276

EMC 3039 Patricia Urkuti Vol#: 276

EMC 3040 Lorrie Smith Vol#: 276

EMC 3041 Maggie Lettvin Vol#: 276

EMC 3042 Nancy Rutigliano Vol#: 276

EMC 3043 Joanne Collins Vol#: 276

EMC 3044 Barbara L. Wood Vol#: 276

EMC 3045 Bonnie Brown-Bonse Vol#: 276

EMC 3046 M. Gorman Vol#: 276

EMC 3047 Solenne Vanne Vol#: 276

EMC 3048 Concerned Youth Vol#: 276

EMC 3049 Peggy Waller Waller Vol#: 276

EMC 3050 Joel Dee Vol#: 276

EMC 3051 Christine Blackard Vol#: 276

EMC 3052 Angi Hansen Vol#: 276

EMC 3053 Jack Nolle Vol#: 276

EMC 3054 Page Gardner Vol#: 276

EMC 3055 Kathleen Pfoutz Vol#: 276

EMC 3056 Steve Sugarman Vol#: 276

EMC 3057 Bronie Massey Vol#: 276

EMC 3058 Christopher Kinnick Vol#: 276

EMC 3059 Jill Lucht Vol#: 276

EMC 3060 Sarah Kahn Vol#: 276

00P-1554 Exempt pharmacy compounding systems/Class II devices from PM

ACK 1 HFA-305 Vol#: 1

CP 1 Baxter Healthcare Corp Vol#: 1

00V-1552 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Pittsburgh Penguins Hockey Club Vol#: 1

00V-1553

ACK 1 HFA-305 Vol#: 1

VAR 1 Metropolis Theater Vol#: 1