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 23, 2001

TABLE OF CONTENTS

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00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0492 ANDA Suitability Petition for Ondansetron HCL Tablets, 16 mg *
00D-1598 Voluntary Labeling for Bioengineered Foods

C 9542 Form Letter Count 5,332 Signatures Vol#: 369

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9053 Form Letter Count 5,332 Signatures Vol#: 369

00N-1637 Promotional Labeling for Drugs and Biologics for Human Use

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

00N-1682 Radioactive Drug Research Committee

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

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

C 12516 Elizabeth Morton Vol#: 772

C 12517 Victoria McDonald Vol#: 722

C 12518 Robert Fernandez Vol#: 722

C 12519 Kim Worobec Vol#: 722

C 12520 Corrie Carlisle Vol#: 722

C 12521 Amanda Yaggy Vol#: 722

C 12522 Judy Ambrose Vol#: 722

C 12523 Sara Fishersmith Vol#: 722

C 12524 Angela Schatz Vol#: 722

C 12525 Chad Skowronski Vol#: 722

C 12526 Michael Laskavy Vol#: 722

C 12527 Sandra M Williams Vol#: 722

01D-0276 Channels of trade policy for Commodities with Vinclozolin

N 1 Vol#: 1

01M-0478 P990050 Optical Biopsy System

AAV 1 SpectraScience Inc. Vol#: 1

01M-0479 Focus Night & Day (Lotrafilcon A) Soft Contact Lenses

AAV 1 Ciba Vision Corporation Vol#: 1

01M-0480 Focus Night & Day (Lotrafilcon A) Soft Contact Lenses P00030

AAV 1 Ciba Vision Corporation Vol#: 1

01M-0482 OP-1 Implant, H010002

AAV 1 Stryker Biotech Vol#: 1

01M-0485 PROSTALAC Hip TEmporary Prosthesis System, H000004

AAV 1 DePuy orthopaedics Inc Vol#: 1

01N-0175 Survey of Single-Use Medical Device Reuse & Reprocessing

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

01N-0178 Premarket Notification 510(k) Submissions

NAL 1 Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

CV 1 National Institute of Forensic Toxicolog Vol#: 1

CV 2 Duke University Vol#: 1

CV 3 International Pharmaceutical Federation Vol#: 1

CV 4 United States Navy Vol#: 1

CV 5 OccuMedix Inc Vol#: 1

CV 6 Royal Canadian Mounted Police Vol#: 1

CV 7 Consumer HealthCare Products Association Vol#: 1

CV 8 Pharmaceutical Research and Manufacturer Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 12 Canadian Food Inspection Agency Vol#: 2

APE 13 Kaluzny Bothers, Inc. Vol#: 2

APE 14 Griffin Industries, Inc. Vol#: 2

APE 15 Valley Proteins, Inc. Vol#: 2

APE 16 Pet Food Institute Vol#: 2

APE 17 Ag Innovations LLC Vol#: 2

APE 18 American Meat Institute Vol#: 2

01N-0458 Fast Track Drug Development Programs Designation,Development

N 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 1035 Elisabeth Roorbach Vol#: 32

EMC 1036 Laurin Vinson Vol#: 32

EMC 1037 Sharon Butler Vol#: 32

EMC 1038 Marlice Jobe Vol#: 32

EMC 1039 Dawne Wilson Vol#: 32

EMC 1040 John McKenna Vol#: 32

EMC 1041 Michael Federico Vol#: 32

EMC 1042 Ann Dudler Vol#: 32

EMC 1043 Greg Gillis Vol#: 32

EMC 1044 Lynn Marsh Vol#: 32

EMC 1045 Edward Cubero Vol#: 32

EMC 1046 Carolyn Westmoreland/Waller Vol#: 32

EMC 1047 Catherine Gould Vol#: 32

EMC 1048 Thomas V. Connor Vol#: 32

EMC 1049 Allan Weinberger Vol#: 32

EMC 1050 Jonathan and Sylvia Michaels Vol#: 32

EMC 1051 Ariadne de Carvalho Vol#: 32

EMC 1052 number not used Vol#: 32

EMC 1053 Jeri Leitch Vol#: 32

EMC 1054 Oliver Deex Vol#: 32

EMC 1055 Phil Kaplan Vol#: 32

EMC 1056 Charlotte Silverman Vol#: 32

EMC 1057 Aliceanne Obryant Vol#: 32

EMC 1058 Helene Grynberg Vol#: 32

EMC 1059 Bonita Smith Vol#: 32

EMC 1060 Gretchen Parker Vol#: 32

EMC 1061 Jim Clements Vol#: 32

EMC 1062 Cindy McDaniel Vol#: 32

EMC 1063 Christine Pruett Vol#: 32

EMC 1064 Rebecca Christie Vol#: 32

EMC 1065 Mary Greear Vol#: 32

EMC 1066 Erin Steurer Vol#: 32

EMC 1067 Homer Simpson Vol#: 32

EMC 1068 Steven Linder Vol#: 32

EMC 1069 Lorrie Forster Vol#: 32

EMC 1070 Mindy Pennybacker Vol#: 32

EMC 1071 Bernice Gordon Vol#: 32

EMC 1072 Susan Lieber Vol#: 32

EMC 1073 Theresa Dale Vol#: 32

EMC 1074 Curt Stewart Vol#: 32

EMC 1075 Bonnie Piccolo Vol#: 32

EMC 1076 MaryBeth Houser Vol#: 32

EMC 1077 Zorina Wolf Vol#: 32

EMC 1078 Ronald W. Gillen Vol#: 32

EMC 1079 Peter Scharnell Vol#: 32

EMC 1080 Leonard Baron Vol#: 32

EMC 1081 Dr. Andrew C. Millard Vol#: 32

EMC 1082 Keith Winston Vol#: 32

EMC 1083 Ruben Artero Vol#: 32

EMC 1084 Theresa Williamson Vol#: 32

EMC 1085 Hal Floyd Vol#: 32

EMC 1086 number not used Vol#: 32

EMC 1087 Susan Rosenblatt Vol#: 32

EMC 1088 Robin Allison Roth Vol#: 32

01P-0492 ANDA Suitability Petition for Ondansetron HCL Tablets, 16 mg

ACK 1 HFA-305 Vol#: 1

CP 1 McDermott, Will & Emery Vol#: 1

01V-0477 Laser Light Show re: Mobolazer: ML8-50RG

ACK 1 HFA-305 Vol#: 1

01V-0491 SKI Dazzle Laser Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Daystar Laser Systems Vol#: 1