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 August 29, 2002

TABLE OF CONTENTS

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01N-0067 Reclassification of Dental Mercury *
01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities *
02P-0226 ANDA for methotrexate sodium oral solution, 5mg/ml *

75N-0205 Plant Protein Products

BKG 1 William Horowitz Vol#: 6

BKG 2 Waldo E. Nelson, M. D. & 2 other signs. Vol#: 7

BKG 3 No Submitter Vol#: 8

BKG 4 Various Submitters Vol#: 9

BKG 5 Various Submitters Vol#: 10

BKG 6 No Submitter Vol#: 11

BKG 7 No Submitter Vol#: 12

BKG 8 No Submitter Vol#: 13

BKG 9 No Submitter Vol#: 14

BKG 10 No Submitter Vol#: 15

78N-0064 OTC Antiperspirant

C 6 Number Not Used Vol#: 2

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

C 5887 Evie Kramer Vol#: 251

C 5888 Mary Ann Lorentzos Vol#: 251

C 5889 Barbara A. Harmening Vol#: 251

C 5890 David K. Thompson Vol#: 251

C 5891 J. B. Adams Vol#: 251

C 5892 Chris C. Vol#: 251

C 5893 Moriah J. Williams Vol#: 251

C 5894 Marilyn A. Greb Vol#: 251

C 5895 Tillie Scruton Vol#: 251

C 5896 Eleanor Ramson Vol#: 251

C 5897 Assante Vol#: 251

C 5898 Dale Johnston Vol#: 251

C 5899 Michael Venzor Vol#: 251

C 5900 Audrie Clark Vol#: 251

C 5901 Annamarie Crelli Vol#: 251

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

EMC 325 Christopher Russell Vol#: 5

EMC 326 Laurie Heriz-Smith Vol#: 5

EMC 327 Camie McCorkle Vol#: 5

EMC 328 Theresa DeMello Vol#: 5

EMC 329 John Demet Vol#: 5

EMC 330 Cesar Goncalves Vol#: 5

EMC 331 Roland Press Vol#: 5

EMC 332 Jeff Kershaw Vol#: 5

EMC 333 Roland Press Vol#: 5

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

EMC 228 Christopher Russell Vol#: 5

EMC 229 Laurie Heriz-Smith Vol#: 5

EMC 230 Camie McCorkle Vol#: 5

EMC 231 Theresa DeMello Vol#: 5

EMC 232 John Demet Vol#: 5

EMC 233 Cesar Goncalves Vol#: 5

EMC 234 Roland Press Vol#: 5

EMC 235 Jeff Kershaw Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 227 Christopher Russell Vol#: 4

EMC 228 Laurie Heriz-Smith Vol#: 4

EMC 229 Camie McCorkle Vol#: 4

EMC 230 Theresa DeMello Vol#: 4

EMC 231 John Demet Vol#: 4

EMC 232 Cesar Goncalves Vol#: 4

EMC 233 Roland Press Vol#: 4

EMC 234 Jeff Kershaw Vol#: 4

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

EMC 230 Christopher Russell Vol#: 4

EMC 231 Laurie Heriz-Smith Vol#: 4

EMC 232 Camie McCorkle Vol#: 4

EMC 233 Theresa DeMello Vol#: 4

EMC 234 John Demet Vol#: 4

EMC 235 Cesar Goncalves Vol#: 4

EMC 236 Roland Press Vol#: 4

EMC 237 Jeff Kershaw Vol#: 4

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

EMC 3692 Tegwyn Bath Vol#: 512

EMC 3693 Laurie Heriz-Smith Vol#: 512

EMC 3694 Hugo Heriz-Smith Vol#: 512

EMC 3695 Laura Schmidt Vol#: 512

EMC 3696 Theresa DeMello Vol#: 512

EMC 3697 Marcello Lanfranchi Vol#: 512

EMC 3698 John Demet Vol#: 512

EMC 3699 Cesar Goncalves Vol#: 512

EMC 3700 Roland Press Vol#: 512

EMC 3701 Peter Clark Vol#: 512

EMC 3702 Terri Madden Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 878 Kathleen M. Streetman, R.N., C.P.A., M.A Vol#: 212

EMC 879 Gail C. Herath-Veiby Vol#: 212

EMC 880 Claire Ledet Vol#: 212

EMC 881 Claire Ledet Vol#: 212

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

EMC 108 Krista Reno Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9825 No signature Vol#: 570

00N-1663 Investigational New Drugs: Export Requirements

EMC 1 Juan-Carlos Mestre Vol#: 1

01D-0583 Food Security Guidance

EMC 7 Robert J. Heilman Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 327 Christopher Russell Vol#: 6

EMC 328 Laurie Heriz-Smith Vol#: 6

EMC 329 Camie McCorkle Vol#: 6

EMC 330 Theresa DeMello Vol#: 6

EMC 331 John Demet Vol#: 6

EMC 332 Cesar Goncalves Vol#: 6

EMC 333 Roland Press Vol#: 6

EMC 334 Jeff Kershaw Vol#: 6

01N-0067 Reclassification of Dental Mercury

ANS 3 HFZ-215 Vol#: 6

C 46 Ann B. Higgins et al. Vol#: 6

EMC 298 Larry Hanus Vol#: 6

EMC 299 Janice Meissner Vol#: 6

EMC 300 Robert W. Lavely, D.M.D. Vol#: 6

EMC 301 Glenn Marshall Vol#: 6

EMC 302 Phyllis Greenberg Vol#: 6

EMC 303 Phyllis Greenberg Vol#: 6

EMC 304 Sam Gittings, DDS Vol#: 6

EMC 305 Mary Ann Newell Vol#: 6

EMC 306 Mary Ann Newell Vol#: 6

01N-0234 Food Contact Substance Notification System

EMC 2 John J. Beggs Vol#: 1

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

CR 1 Food Research, Inc. Vol#: 1

EMC 5 Juan Carlos Rivera Vol#: 1

EMC 6 Citrus Research Board Vol#: 1

EMC 7 Food Research, Inc. Vol#: 1

EMC 8 National Fisheries Institute Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1081 Mr. Jay & Marilyn Good Vol#: 218

C 1082 Kathy & H. J. Saunders Vol#: 218

C 1083 Lorraine Hofmeister Vol#: 218

C 1084 Majorie Isaacs Vol#: 218

C 1085 Manchester Chiropractic Center Vol#: 218

C 1086 Elizabeth Rablen-Murray Vol#: 218

C 1087 Martha D. Austin Vol#: 218

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1101 David Locke Vol#: 5

EMC 1102 Christian Nitz Vol#: 5

EMC 1103 Patricia Lynch Vol#: 5

EMC 1104 Julia Henneke Vol#: 5

EMC 1105 Harry J. Van Noy Vol#: 5

EMC 1106 Justin Isaac Vol#: 5

EMC 1107 Mary Moser Vol#: 5

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

EMC 119 Uniform Code Council, Inc. Vol#: 5

EMC 120 Consumer Healthcare Products Assn (CHPA) Vol#: 5

EMC 121 Advanced Information Assurance Solutions Vol#: 5

EMC 122 RxScan, Ltd Vol#: 5

EMC 123 Patty Anderson Vol#: 5

EMC 124 Mueller Sports Medicine Vol#: 5

EMC 125 Richard Lewis Vol#: 5

EMC 126 Patricia A. Cochran Vol#: 5

EMC 127 Roy Guharoy, PharmD., MBA, FCP, FASHP Vol#: 5

EMC 128 RxScan, Ltd Vol#: 5

EMC 129 Richard Hinkle Vol#: 5

EMC 130 Rack Design Group, Inc. Vol#: 5

EMC 131 Rack Design Group, Inc. Vol#: 5

EMC 132 Roy Guharoy, PharmD., MBA, FCP, FASHP Vol#: 5

EMC 133 Robert A. Schubenel Vol#: 5

EMC 134 EAN International Vol#: 5

EMC 135 EAN Australia Vol#: 5

EMC 136 Edwin A. Steane, PhD Vol#: 5

EMC 137 Patty Davis Vol#: 5

EMC 138 Ed Hisscock Vol#: 5

EMC 139 Uniform Code Council, Inc. Vol#: 5

EMC 140 American Academy of Orth Surgeons (AAOS) Vol#: 5

EMC 141 Jim Rittenburg Vol#: 5

EMC 142 Cardinal Health Vol#: 5

EMC 143 Steve Coussins Vol#: 5

EMC 144 Alan Merry Vol#: 5

EMC 145 Dr. Rolf Spang Vol#: 5

EMC 146 Uniform Code Council, Inc. Vol#: 5

EMC 147 EAN Ireland Vol#: 5

EMC 148 AAOS American Academy of Orth Surgeons Vol#: 5

EMC 149 National Alliance of Health Info Tech Vol#: 5

EMC 150 Johns Hopkins Hospital Vol#: 5

EMC 151 Coalition for Healthcare Standards Vol#: 5

EMC 152 HIBCC Vol#: 5

EMC 153 HIBCC Vol#: 5

EMC 154 AdvaMed Vol#: 5

EMC 155 Bruce Ritchie Vol#: 5

EMC 156 Barcode Industrial Systems Vol#: 5

EMC 157 Karl B. Gills Vol#: 5

EMC 158 Centers for Disease Control & Prevention Vol#: 5

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EMC 4 Pacific Coast Producers Vol#: 1

02N-0277 Bioterrorism; Establishment & Maintenance of Records

EMC 2 Pacific Coast Producers Vol#: 1

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

EMC 4 Pacific Coast Producers Vol#: 1

02P-0226 ANDA for methotrexate sodium oral solution, 5mg/ml

SUP 1 Kirkpatrick & Lockhart LLP Vol#: 1