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DOCKETS ENTERED on November 22, 2002

TABLE OF CONTENTS

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77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t *
95S-0158 Community Disclosure of Institutional Review Boards *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00P-1322 Food Labeling and Allergen Contamination Control *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20 *
02P-0243 Require Issuance of Medication Guide for All Statin Drugs *
02P-0494 CEREC Ceramic Dental Restoration Systems *

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

EC 1 BASF Corporation Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EC 13 PAREXEL International Vol#: 65

EC 14 Mr. David Chambers Vol#: 65

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

C 439 Honorable Gordon H. Smith (CI) Vol#: 13

C 440 Honorable Gordon H. Smith (CI) Vol#: 13

LET 1 USDA Vol#: 13

LET 2 USDA Vol#: 13

95S-0158 Community Disclosure of Institutional Review Boards

RPT 7 CPR, LLC IDE# 980125 Vol#: 5

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 66 Food Animal Concerns Trust (FACT) Vol#: 2

C 67 Alliance for the Product Use of Antibiot Vol#: 2

EC 2 Keep Antibiotics Working Vol#: 2

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

MO 18 Bayer Corporation Vol#: 329

00P-1322 Food Labeling and Allergen Contamination Control

ANS 9 HFW-1 to Honorable Jon S. Corzine Vol#: 29

01N-0067 Reclassification of Dental Mercury

HER 3 Heidi Heim Vol#: 15

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 35 Jean M. Geissler Vol#: 1

C 36 Steve Hopkins Vol#: 1

C 37 Carol Hayman Vol#: 1

C 38 Jennifer Crispin Vol#: 1

C 39 Nancy E. Ryther Vol#: 1

C 40 Judy O. LaSunille Vol#: 1

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

C 9 Pharmacia Vol#: 1

02M-0487 PMA LADARVision 4000 Excimer Laser System, P970043/s010

AAV 1 Alcon Laboratories, Inc. Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

C 22 Aventis Pasteur, Inc. Vol#: 7

02N-0445 FDA Regulation of Combination Products; Public Hearing

APE 36 The Biologics Consulting Group Vol#: 3

LST 2 Final Agenda 11/25/02 Hearing Vol#: 4

02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20

WDL 1 Kleinfeld, Kaplan & Becker Vol#: 1

02P-0243 Require Issuance of Medication Guide for All Statin Drugs

LET 1 HFD-1 to Julian M. Whitaker, M.D. Vol#: 4

02P-0244 Warning Statement for All HMG Co-A Reductase Inhibitors

LET 1 HFD-1 to Dr. Julian M. Whitaker, M.D. Vol#: 4

02P-0494 CEREC Ceramic Dental Restoration Systems

CCP 1 Medical Device Consultants, Inc. Vol#: 1

02V-0495 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Classic Computes Inc. Vol#: 1