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 6, 2002

TABLE OF CONTENTS

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00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01N-0322 Institutional Review Boards *
01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits *
01P-0356 Amend approved drug products with "Orange Book" 21st list *
01P-0546 ANDA for Covera-HS *
02D-0039 Medical Sterilization Packaging Systems *
02D-0095 Exposure-Response Relaionship;Study Design,Data Analysis *
02D-0103 Draft Revised Compliance Policy Guide; Male Condom Defects *
02P-0120 Request the immediate ban of Meridia (sibutramine) *
02P-0135 Orally-Administered Levothyroxine Sodium all NDAs & ANDAs *
02P-0141 ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate) *
02P-011 Request for immediate final approval of tramadol Hydrochlori *

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

EMC 5 Maria Bernhardt Vol#: 2

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

C 8 PETNet Pharmaceuticals, Inc. Vol#: 11

C 9 Syncor Interenational Corporation Vol#: 11

C 10 CORAR Vol#: 11

C 11 Kettering Medical Center Vol#: 11

C 12 Tyco Healthcare/Mallinckrodt Vol#: 1

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 5811 Larry Weiss & Kirk Brandt Vol#: 241

C 5812 Terri Sider Vol#: 241

C 5813 Ms. Cord Qualls Vol#: 241

C 5814 Lusa Snyder Vol#: 241

EMC 2748 Johnson-Matthey, Catalytic Systems Div. Vol#: 243

EMC 2749 Malcolm Kenton Vol#: 243

EMC 2750 Ms. D. Masturzo Vol#: 243

EMC 2751 Kevin M. Crupi Vol#: 243

EMC 2752 Mr. Corey Paul Mondello Vol#: 243

EMC 2753 Mr. Corey Paul Mondello Vol#: 243

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 222 Michele Chollet Vol#: 29

EMC 223 Claudio Musajo Vol#: 29

EMC 224 Tracy Miller Vol#: 29

EMC 225 Beth Anne Baker Vol#: 29

EMC 226 Bruce F. Jones Vol#: 29

EMC 227 Joseph Tripi Vol#: 29

EMC 228 MaryAnn Jurgus Vol#: 29

EMC 229 Windy Graham Vol#: 29

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 239 Ed Johnson Vol#: 3

EMC 240 Benjamin Clark Vol#: 3

EMC 241 Andrea Mateo Vol#: 3

EMC 242 Andrea Mateo Vol#: 3

EMC 243 Andrea Mateo Vol#: 3

EMC 244 Homer R. Reese, Jr. Vol#: 3

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 142 Ed Johnson Vol#: 3

EMC 143 Benjamin Clark Vol#: 3

EMC 144 Andrea Mateo Vol#: 3

EMC 145 Andrea Mateo Vol#: 3

EMC 146 Andrea Mateo Vol#: 3

EMC 147 Homer R. Reese, Jr. Vol#: 3

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 142 Ed Johnson Vol#: 2

EMC 143 Benjamin Clark Vol#: 2

EMC 144 Andrea Mateo Vol#: 2

EMC 145 Andrea Mateo Vol#: 2

EMC 146 Andrea Mateo Vol#: 2

EMC 147 Homer R. Reese, Jr. Vol#: 2

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 144 Ed Johnson Vol#: 2

EMC 145 Benjamin Clark Vol#: 2

EMC 146 Andrea Mateo Vol#: 2

EMC 147 Andrea Mateo Vol#: 2

EMC 148 Andrea Mateo Vol#: 2

EMC 149 Homer R. Reese, Jr. Vol#: 2

99N-4063 Positron emmission tomography drug products

C 5 Tyco Healthcare/Mallinckrodt Vol#: 1

C 6 CORAR Vol#: 1

C 7 PETNet Pharmaceuticals, Inc. Vol#: 1

C 8 Syncor Interenational Corporation Vol#: 1

C 9 Kettering Medical Center Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3662 E. Bounker Vol#: 511

EMC 3663 Tyler Holmberg Vol#: 511

99P-1340 Declared Eternity eau de Parfum Misbranded

C 741 Hazel Shockley Vol#: 21

C 742 Sue Doran Vol#: 21

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 10 AstraZeneca Pharmaceuticals Vol#: 1

00D-1542 Electronic Signatures: Time Stamps

C 2 Baxter Healthcare Corporation Vol#: 6

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11870 Kathleen Powers Vol#: 426

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9367 Catherine C. Burt Vol#: 408

C 9368 Rosa E. Venegas Vol#: 408

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CR 1 Center for Veterinary Medicine Vol#: 259

00P-1322 Food Labeling and Allergen Contamination Control

EMC 484 No signature Vol#: 20

01N-0067 Reclassification of Dental Mercury

C 14 Jean E. Mitchell Vol#: 3

C 15 Jan Gleiter Vol#: 3

C 16 Sandra Redemske Vol#: 3

M 1 Devin Koontz (DHHS/FDA/DDO) Vol#: 3

01N-0322 Institutional Review Boards

EMC 18 Children's Hospital of Philadelphia Vol#: 1

EMC 19 Walter Wolf, PhD Vol#: 1

01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits

C 4 Food Marketing Institute Vol#: 1

C 5 American Dietetic Assn Vol#: 1

EMC 1 Cynthia Svensson Vol#: 1

EMC 2 Produce Marketing Assn Vol#: 1

EMC 3 Food Marketing Institute Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

EMC 295 Colleen J. Spallino Vol#: 10

EMC 296 Jeanne B. Billy Vol#: 10

EMC 297 Claudia J. Naples Vol#: 10

01P-0356 Amend approved drug products with "Orange Book" 21st list

PAV 1 HFD-1 to Lachman Consultant Services Inc Vol#: 1

01P-0546 ANDA for Covera-HS

LET 1 HFD-1 to Morgan, Lewis & Bockius LLP Vol#: 1

01P-0573 Petition for Regulation of S & F Nicotine Water

EMC 1 Daniel DeMarco Vol#: 1

02D-0039 Medical Sterilization Packaging Systems

C 8 DuPont Nonwvens Vol#: 1

C 9 Exactech Vol#: 1

C 10 ADDM, Assn. of Disposable Device Mfrs. Vol#: 1

C 11 Allegiance Healthcare Corp. Vol#: 1

02D-0095 Exposure-Response Relaionship;Study Design,Data Analysis

C 9 Otsuka Maryland research Institute (OMRI Vol#: 1

C 10 Georgetown Univ Center for Drug Developm Vol#: 1

C 11 PhRMA Vol#: 1

EMC 1 Georgetown Univ Center for Drug Developm Vol#: 1

02D-0103 Draft Revised Compliance Policy Guide; Male Condom Defects

C 2 Ansell Healthcare Inc. Vol#: 1

02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling

EMC 10 Trudy Wylie Vol#: 1

02N-0215 Export Certificates

N 1 Vol#: 1

02P-0120 Request the immediate ban of Meridia (sibutramine)

C 2 Abbott Labs. Vol#: 1

02P-0135 Orally-Administered Levothyroxine Sodium all NDAs & ANDAs

M 2 HFD-600 Vol#: 1

02P-0141 ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate)

AMD 1 Women First Healthcare Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

RC 3 Teva Pharmaceuticals USA, Inc. Vol#: 1

02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water

EMC 1 Daniel DeMarco Vol#: 1