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 November 14, 2002

TABLE OF CONTENTS

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00N-1367 Postmarket Surveillance *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02P-0484 ANDA for Amiodarone Hydrochloride Injection 50 mg/mL *

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

C 6106 Mrs. Helen Neely Vol#: 266

C 6107 Ms. Nancy Sailor Vol#: 266

C 6108 Mullankey Vol#: 266

C 6109 Donna E. Young Vol#: 266

C 6110 Anne Prescott Vol#: 266

C 6111 M. D. Hanson Vol#: 266

C 6112 Brigitte Rahm Vol#: 266

C 6113 Ms. Pam Konyk Vol#: 266

C 6114 Mrs. Eric Weinmann Vol#: 266

C 6115 Virginia Lamarche Vol#: 266

C 6116 Jane C. Barbato Vol#: 266

C 6117 John Riddell Vol#: 266

C 6118 Fae Russell Vol#: 266

C 6119 Bridget Blitz, LICSW Vol#: 266

C 6120 Allison G. Burgess Vol#: 266

C 6121 Ms. Roberta Bentz Letts RN Vol#: 266

C 6122 Jan Kemmerer Vol#: 266

C 6123 Carol Gardner Vol#: 266

C 6124 Mrs. Joanne W. Stamm Vol#: 266

C 6125 Erin O'Keefe Vol#: 266

C 6126 Diane Riel Vol#: 266

C 6127 Susan Welker et al Vol#: 266

C 6128 Michele Moss Vol#: 266

C 6129 Cheryl C. McNeal Vol#: 266

C 6130 Lillian McKinstry Vol#: 266

C 6131 Barbara A. Manaro Vol#: 266

C 6132 Regina Hirtle Vol#: 266

C 6133 Elizabeth Sterenberg Shulman, Ph.D. Vol#: 266

C 6134 R. Fogan Vol#: 266

C 6135 Wilhelm Winter Vol#: 266

C 6136 Frank & Faye Evans Vol#: 266

EMC 2990 Bonnie Shaffer Vol#: 265

EMC 2991 Douglas C. Shohan Vol#: 265

EMC 2992 Emily Fabiano Vol#: 265

EMC 2993 Lila Kelly Vol#: 265

EMC 2994 Judith E. Embry Vol#: 265

EMC 2995 Andrea Brinley Vol#: 265

EMC 2996 Lisa Norman Vol#: 265

EMC 2997 number not used Vol#: 265

EMC 2998 Gary Yokie Vol#: 265

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9841 Dianna Johnson Vol#: 572

00N-1367 Postmarket Surveillance

ANS 1 HFZ-510 to Stehen Dolle Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9404 Dianna Johnson Vol#: 408

00N-1529 Proposal to Debar Elaine Yee-Ling Lai:Notice of Opportunity

N 1 Vol#: 1

01E-0091 Argatroban, Patent Extension Application No.5,214,052

N 1 Vol#: 1

01E-0094 Calozal, Patent Extension Application No. 4,412,992

N 1 Vol#: 1

01E-0420 Patent Term Extension Application for Lotronex No. 5,360,800

N 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2529 Daniel Gale Vol#: 220

EMC 2530 Adam Solomon Vol#: 220

EMC 2531 Laura Kelly Vol#: 220

EMC 2532 Jose Manuel Prados Ojeda (Spain) Vol#: 220

EMC 2533 Sarah Louise Batt (United Kingdom) Vol#: 220

EMC 2534 Robbie Kelly (United Kingdom) Vol#: 220

EMC 2535 Heidi Sandstrom (Australia) Vol#: 220

EMC 2536 Victoria Konig Vol#: 220

EMC 2537 Luke Watts (United Kingdom) Vol#: 220

EMC 2538 Anna Freeman (Philippines) Vol#: 220

EMC 2539 Carly Cooper (Australia) Vol#: 220

EMC 2540 Adrijana Radosevic Vol#: 220

EMC 2541 Brian Donnelly Vol#: 220

EMC 2542 Sam Krymalowski (Canada) Vol#: 220

EMC 2543 Mathilde Sangare (France) Vol#: 220

EMC 2544 Alison Oakes (United Kingdom) Vol#: 220

EMC 2545 Shea Karssing (South Africa) Vol#: 220

EMC 2546 Nancy Miller Vol#: 220

EMC 2547 Margaret Jackson Vol#: 220

EMC 2548 Sophie Querouil (Portugal) Vol#: 220

EMC 2549 Clare Burgess (United Kingdom) Vol#: 220

EMC 2550 Kim Healy (Australia) Vol#: 220

EMC 2551 Howard Wapner Vol#: 220

EMC 2552 Gianmarco Cilli Vol#: 220

EMC 2553 Jim Wagner Vol#: 220

EMC 2554 Chou Yang Vol#: 220

EMC 2555 Larry F. Coonrod, Jr. Vol#: 220

EMC 2556 Eleanor Garrell Berger Vol#: 220

EMC 2557 A. Passamante Vol#: 220

EMC 2558 F. Genniro Vol#: 220

EMC 2559 S. Haus Vol#: 220

EMC 2560 Sherry Lynn McLaughlin Vol#: 220

EMC 2561 David Cohen Vol#: 220

EMC 2562 C. Marcial Vol#: 220

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

C 3 Gilead Sciences, Inc. Vol#: 1

02E-0022 Patent Term Application for Solage No. 5,194,247

N 1 Vol#: 1

02M-0471 PMA Lea's Shield Barrier Contraceptive, P010043

AAV 1 Yama, Inc. Vol#: 1

02N-0355 Medical Device Recall Authority;Agency Information Collectio

N 2 Vol#: 1

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

APE 28 EPIX Medical Inc. Vol#: 3

APE 29 Novo Nordisk Pharmaceuticals Inc. Vol#: 3

02N-0452 Effectiveness of New Drugs When Human Efficacy Studies

N 1 Vol#: 1

02P-0484 ANDA for Amiodarone Hydrochloride Injection 50 mg/mL

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

02V-0485 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Twilight Lighting Systems Vol#: 1