Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on August 28, 2002

TABLE OF CONTENTS

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77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
02N-0209 Governing First Amendment Case Law *
02N-0275 Bioterrorism Preparedness; Administrative Detention *
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities *
02N-0277 Bioterrorism; Establishment & Maintenance of Records *
02N-0278 Bioterrorism;Prior Notice of Imported Food Shipments *
02P-0367 Doxycycline hyclate capsules 20mg,Periostat capsules,20mg

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

C 240 Pfizer, Inc. Vol#: 235

77N-0404 Protein Supplements

OB 24 Number Not Used Vol#: 35

PRC 2 Robert Ullman & Jacob Laufer Vol#: 45

PSA 6 Robert Ullman & Jacob Laufer Vol#: 45

77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

BKG 1 Background Material Refs 1-160 Vol#: 2

NPR 1 Vol#: 1

93D-0139 Stability Testing of Biotechnological/Biological Products

EC 7 Mr. Jason Neiber Vol#: 2

EC 8 EFFORTS Vol#: 2

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

EC 10 Food Animal Concerns Trust Vol#: 7

98N-0496 Import for Export; Reporting & Recordkeeping Requirement

NWL 1 Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

N 1 Vol#: 5

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

EC 2 Mr. James Fargo Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CS 12 HFA-305 Vol#: 270

MO 13 Bayer Corporation Vol#: 270

OR 13 HF-3 Vol#: 270

00N-1663 Investigational New Drugs: Export Requirements

NWL 1 Vol#: 1

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

C 12672 Susan Niswander Vol#: 785

C 12673 Paul Cumpian Vol#: 785

C 12674 Andrea Granby Vol#: 785

C 12675 Loma Moffat Vol#: 785

00P-1322 Food Labeling and Allergen Contamination Control

C 511 Thelma Cohen Vol#: 29

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1037 Judi Friedman Vol#: 218

C 1038 John J. Kirkwood Vol#: 218

C 1039 Robert & Helen Lane Vol#: 218

C 1040 Martha Osborn Vinick Vol#: 218

C 1041 Robert A. Fried, M.D. Vol#: 218

C 1042 Christine Word Vol#: 218

C 1043 Mary Rose Curtis Vol#: 218

C 1044 Randi Allfather Vol#: 218

C 1045 Peggy Heinrich Vol#: 218

C 1046 Zohra Lampert et al Vol#: 218

C 1047 Joe Wasserman Vol#: 218

C 1048 Therese P. Curtis Vol#: 218

C 1049 Susie Tanenbaum Vol#: 218

C 1050 John & Marilyn MacDougall Vol#: 218

C 1051 Robert W. Persons, PE Vol#: 218

C 1052 Joyce C. McKelvey Vol#: 218

C 1053 Philip Wiseley Vol#: 218

C 1054 Robert A. Bernhard Vol#: 218

C 1055 Sarah L. Barnett Vol#: 218

C 1056 Marjory M. Donn Vol#: 218

C 1057 Jenifer E. McKenna Vol#: 218

C 1058 Peter B. Cook Vol#: 218

C 1059 Clare McCaslin Vol#: 218

C 1060 Ms. Joyce Frohn Vol#: 218

C 1061 Ms. Carol Jean Newnan Vol#: 218

C 1062 Janet C. Tillotson Vol#: 218

C 1063 Judy A. Fitzgerald Vol#: 218

C 1064 Richard T. Ruth Vol#: 218

C 1065 Jan A. Cummings Vol#: 218

C 1066 David Capolarello Vol#: 218

C 1067 Sue Cowing Vol#: 218

C 1068 Julia Cummings Vol#: 218

C 1069 Stanley Bunce Vol#: 218

C 1070 Kristen Griffin Vol#: 218

C 1071 Tammy Jo O'Neal Vol#: 218

C 1072 Richard W. Tyler Vol#: 218

C 1073 Georgiann Olsgard Vol#: 218

C 1074 Charlotte Sagoff Vol#: 218

C 1075 Randall Chambers Vol#: 218

C 1076 Richard Himcker Vol#: 218

C 1077 Dorelen Bunting Vol#: 218

C 1078 Kenneth Brewster Vol#: 218

C 1079 Cullen Cramer Vol#: 218

C 1080 David C. Dunand Vol#: 218

EC 11 Ms. Pilar Johnson-Dae Vol#: 141

EC 12 Ms. Angela Mitchell Vol#: 141

02D-0320 Hold following clinical investigator misconduct

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02D-0350 Handling and Retention of Bioavailability and Bioequivalence

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02F-0327 ADM Alliance Nutrition, Inc.;Animal Use Feed-Grade Biuret

NFL 1 ADM Alliance Nutrition, Inc. Vol#: 1

02N-0007 CGMP Regulations for Finished Pharmaceuticals

GDL 1 GUIDANCE Vol#: 1

N 3 Vol#: 1

02N-0209 Governing First Amendment Case Law

EC 303 International Trademark Association Vol#: 4

02N-0241 Aluminum in Large & Small Volume Parenterals

NCR 1 Vol#: 1

02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling

EC 16 Mr. David Smi Vol#: 1

02N-0275 Bioterrorism Preparedness; Administrative Detention

CR 1 Stakeholder Meeting:Transportation Assn Vol#: 1


02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 4 National Nutritional Foods Association Vol#: 1

CR 1 Stakeholder Meeting:Transportation Assn Vol#: 1

EC 6 Mrs. Julia Naunheim-Hipps Vol#: 1

EC 7 Fanny Bay Oysters Ltd. Vol#: 1


02N-0277 Bioterrorism; Establishment & Maintenance of Records

CR 1 Stakeholder Meeting:Transportation Assn Vol#: 1

EC 4 Number Not Used Vol#: 1

EC 5 National Association of Convenience Stor Vol#: 1


02N-0278 Bioterrorism;Prior Notice of Imported Food Shipments

CR 1 Stakeholder Meeting:Transportation Assn Vol#: 1

EC 3 Number Not Used Vol#: 1

EC 4 Vitarich Laboratories Vol#: 1

EC 5 Fanny Bay Oysters Ltd. Vol#: 1


02P-0367 Doxycycline hyclate capsules 20mg,Periostat capsules,20mg

ACK 1 HFA-305 Vol#: 1

CP 1 West-Ward Pharmaceutical corp. Vol#: 1