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 September 4, 2002

TABLE OF CONTENTS

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78N-036L OTC Laxative *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
01P-0120 Ban Unsafe IV Catheters and other Devices *
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-0349 Amend product insert and/or label for Hemophilus Vaccines *
02P-0391 Determine Whether Alphagan has been Voluntarily Withdrawn *
02P-0392 Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily *
02P-0394 Make determination of ANDA suitability for Amiodarone Hydroc 
02P-0395 Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have *

78N-036L OTC Laxative
ACK 6 HFA-305 Vol#: 122

CP 27 Arnall Golden Gregroy LLP Vol#: 122

95N-253J Jurisdiction nicotine cigarette/smokeless tobacco products

C 1628 Form Letters Vol#: 764

98D-0729 Content & format of 510(k) Washers and Washer-Disinfectors

EC 2 Number Not Used Vol#: 1

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

EMC 7 number not used Vol#: 7

EMC 8 number not used Vol#: 7

EMC 9 number not used Vol#: 7

EMC 10 American Heart Assn. Vol#: 7

EMC 11 CHPA, Consumer Healthcare Prods. Assn. Vol#: 7

98N-1215 Foreign Establishment Registration and Listing

EC 14 Number Not Used Vol#: 2

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9393 No Signature Vol#: 408

C 9394 Brandon Juhl Vol#: 408

C 9395 V. Byrd Vol#: 408

01P-0120 Ban Unsafe IV Catheters and other Devices

EC 12 Ms. Sandra Natolly Vol#: 1

EC 13 Creighton Area Health Services Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1088 Mary Jo Lindeberg Vol#: 218

C 1089 Clark H. Coan Vol#: 218

C 1090 Betty Hutchinson Vol#: 218

C 1091 A. Loescher Vol#: 218

C 1092 Rosemary K. Coffey Vol#: 218

C 1093 Joanna Willimetz Vol#: 218

C 1094 E. Kaye Vol#: 218

C 1095 Dr. A. Lea Silas Lovis Vol#: 218

C 1096 Virginia S. Lyman Vol#: 218

C 1097 Elizabeth S. Hoefer Vol#: 218

C 1098 Mrs. Maxine Sampson Vol#: 218

C 1099 Ms. Ione Dusinberre Vol#: 218

C 1100 Mr. & Mrs. Micheal Kevany Vol#: 218

C 1101 Juliana K. Dulmage Vol#: 218

C 1102 Frank Goulart Vol#: 218

C 1103 Carol L. Else Vol#: 218

C 1104 Ilene Van Bruggen Vol#: 218

C 1105 Vidal S. Clay Vol#: 218

C 1106 Mr. Robert A. Newgard Vol#: 218

C 1107 Ellen Kieval Vol#: 218

C 1108 Margaret V. H. Hubbard Vol#: 218

C 1109 Karl J. Volk Vol#: 218

C 1110 Mary E. Gamson Vol#: 218

C 1111 Lornie White Vol#: 218

C 1112 Glenys Spitze Vol#: 218

C 1113 Joanna Jacobson & Stuart Richter Vol#: 218

C 1114 Steven Kossow Vol#: 218

C 1115 Jack W. Fleming Vol#: 218

EC 13 Dr. Aaron Mitchell Vol#: 218

EC 14 Ms. Gloria Larkin Vol#: 141

02N-0275 Bioterrorism Preparedness; Administrative Detention

EC 1 Fisheries Council of Canada Vol#: 2

EC 2 Dutch Produce Association (DPA) Vol#: 2

EC 3 Association of Food Industries Vol#: 2

EC 4 National Food Processors Association Vol#: 2

EC 5 United Fresh Fruit and Vegetable Associa Vol#: 2

EC 6 European Union Vol#: 2

EC 7 Grocery Manufacturers of America, Inc. Vol#: 2

EC 8 Pet Food Institute Vol#: 2

EC 9 Embassy of Argentina Vol#: 2

EC 10 Piper Rudnick Vol#: 2

EC 11 Produce Marketing Association Vol#: 2

EC 12 Japanese Embassy Vol#: 2

EC 13 Embassy of Mexico Vol#: 2

EC 14 Embassy of Mexico Vol#: 2

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 8 Fisheries council of Canada Vol#: 2

EC 9 Dutch Produce Association (DPA) Vol#: 2

EC 10 Nova Scotia Fish Packers Association Vol#: 2

EC 11 All Pure Industries USA, Inc. Vol#: 2

EC 12 American Frozen Food Institute Vol#: 2

EC 13 Kemin Industries, Inc. Vol#: 2

EC 14 Association of Food Industries Vol#: 2

EC 15 National Food Processors Association Vol#: 2

EC 16 United Fresh Fruit and Vegetable Vol#: 2

EC 17 European Union Vol#: 2

EC 18 Grocery Manufacturers of America, Inc. Vol#: 2

EC 19 National Coffee Association of USA Vol#: 2

EC 20 Embassy of Argentina Vol#: 2

EC 21 Pet Food Institute Vol#: 2

EC 22 Procter & Gamble Vol#: 2

EC 23 Cooperative Federee de Quebec Vol#: 2

EC 24 Piper Rudnick Vol#: 2

EC 25 Produce Marketing Association Vol#: 2

EC 26 Interstate Shellfish Sanitation Conferen Vol#: 2

EC 27 Japanese Embassy Vol#: 2

EC 28 Embassy of Mexico Vol#: 2

EC 29 MIKAWAYA Vol#: 2

02N-0277 Bioterrorism; Establishment & Maintenance of Records

EC 6 Fisheries council of Canada Vol#: 2

EC 7 Grocery Manufacturers of America, Inc. Vol#: 2

EC 8 American Frozen Food Institute Vol#: 2

EC 9 International Bottled Water Association Vol#: 2

EC 10 International Bottled Water Association Vol#: 2

EC 11 International Bottled Water Association Vol#: 2

EC 12 National Food Processors Association Vol#: 2

EC 13 United Fresh Fruit and Vegetable Associa Vol#: 2

EC 14 National Coffee Association Vol#: 2

EC 15 European Union Vol#: 2

EC 16 Association of Food Industries Vol#: 2

EC 17 Embassy of Argentina Vol#: 2

EC 18 Procter & Gamble Vol#: 2

EC 19 Pet Food Institute Vol#: 2

EC 20 Piper Rudnick Vol#: 2

EC 21 Produce Marketing Association Vol#: 2

EC 22 Japanese Embassy Vol#: 2

EC 23 Interstate Shellfish Sanitation Conferen Vol#: 2

EC 24 Embassy of Mexico Vol#: 2

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

EC 6 Fisheries Council of Canada Vol#: 2

EC 7 Fisheries Council of Canada Vol#: 2

EC 8 Nova Scotia Fish Packers Association Vol#: 2

EC 9 Dutch Produce Association (DPA) Vol#: 2

EC 10 APL, Ltd. Vol#: 2

EC 11 Gay Lea Foods Co-operative Ltd. Vol#: 2

EC 12 American Frozen Food Institute Vol#: 2

EC 13 Kemin Industries, Inc. Vol#: 2

EC 14 Association of Food Industries Vol#: 2

EC 15 National Fisheries Institute Vol#: 2

EC 16 Number Not Used Vol#: 2

EC 17 National Food Processors Association Vol#: 2

EC 18 Chocolate Manufacturers/National Confect Vol#: 2

EC 19 Number Not Used Vol#: 2

EC 20 European Union Vol#: 2

EC 21 Number Not Used Vol#: 2

EC 22 National Coffee Association of USA Vol#: 2

EC 23 Grocery Manufacturers of America, Inc. Vol#: 2

EC 24 United Fresh Fruit and Vegetable Associa Vol#: 2

EC 25 Procter & Gamble Vol#: 2

EC 26 Embassy of Argentina Vol#: 2

EC 27 Pet Food Institute Vol#: 2

EC 28 Piper Rudnick Vol#: 2

EC 29 Produce Marketing Association Vol#: 2

EC 30 Japanese Embassy Vol#: 2

EC 31 Japanese Embassy Vol#: 2

EC 32 Embassy of Mexico Vol#: 2

EC 33 MIKAWAYA Vol#: 2

EC 34 Ministry of Agriculture and Forestry, Ko Vol#: 2

02P-0349 Amend product insert and/or label for Hemophilus Vaccines

SUP 1 Clasen Immunotherapies, Inc. Vol#: 1

02P-0391 Determine Whether Alphagan has been Voluntarily Withdrawn

ACK 1 HFA-305 Vol#: 1

CP 1 IVAX Pharmaceuticals Inc. Vol#: 1

02P-0392 Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily

ACK 1 HFA-305 Vol#: 1

CP 1 Barr Laboratories, Inc. Vol#: 1

02P-0394 Make determination of ANDA suitability for Amiodarone Hydroc</B>

ACK 1 HFA-305 Vol#: 1

CP 1 Taro Research Institute Ltd. Vol#: 1

02P-0395 Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have

ACK 1 HFA-305 Vol#: 1

CP 1 Barr Laboratories, Inc. Vol#: 1