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 September 26, 2001

TABLE OF CONTENTS

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97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00P-1322 Food Labeling and Allergen Contamination Control *
01P-0152 Determine that Neurontin capsules was not withdrawn for safe *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0245 Determination that Disulfiram was withdrawn for reasons othe *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0428 Generic Cefuroxime Axetil Products *

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

C 18 Ronald G. Strauss, MD Vol#: 1

EXT 4 Bayer Corporation Vol#: 1

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

C 5220 Mrs. Virgel Clark Vol#: 169

C 5221 Colleen Biffen Vol#: 169

00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac

GDL 2 GUIDANCE Vol#: 2

NAD 2 Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9485 Form Letter Count 172 Vol#: 491

00P-1322 Food Labeling and Allergen Contamination Control

C 392 Kelly Donadio Vol#: 25

C 393 Dana Eddy Vol#: 25

C 394 Dale Martenson Vol#: 25

C 395 Sally Usdin Yasuda, MS, PharmD Vol#: 25

C 396 William and Nadine Gamello Vol#: 25

C 397 Sheryl Keevak-Signore Vol#: 25

C 398 Vonita Shank Vol#: 25

C 399 Ann Brown Vol#: 25

C 400 Michelle K. Robinson Vol#: 25

C 401 Pam Edwards, RDCP Vol#: 25

C 402 Lewis Shank Vol#: 25

C 403 A. Rotondo Vol#: 25

C 404 Peggy Massoumi Vol#: 25

C 405 Donna Kalahar Vol#: 25

C 406 Engena M. Eckert Vol#: 25

C 407 Diane Holmes Vol#: 25

C 408 Michelle Brochu Vol#: 25

C 409 Holly Trull Vol#: 25

C 410 Gail E. McGee Vol#: 25

C 411 Sandra Cartwright Vol#: 25

EMC 390 Cassie & John Porterfield Vol#: 20

EMC 391 Jan Lamb Vol#: 20

EMC 392 Sobha Pisharody, PhD Vol#: 20

EMC 393 Teri Carabello Vol#: 20

EMC 394 Linda Haviland Vol#: 20

EMC 395 Linda Haviland Vol#: 20

EMC 396 Kathryn Butterfield Vol#: 20

EMC 397 Christi Smith Vol#: 20

EMC 398 John Chickering Vol#: 20

EMC 399 Evelyn Peelle Vol#: 20

EMC 400 Jamie Breazeale Vol#: 20

EMC 401 E. Leyburn Vol#: 20

EMC 402 Debi Panyko Vol#: 20

EMC 403 Alyson Hall Vol#: 20

EMC 404 Barbara Baker Vol#: 20

EMC 405 Ferre Hockensmith Vol#: 20

EMC 406 Alyson Hall & Donald Wilkerson Vol#: 20

EMC 407 Alyson Hall & Donald Wilkerson Vol#: 20

EMC 408 No signature Vol#: 20

01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

N 2 Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EMC 104 Linda H. Nelson Vol#: 2

EMC 105 Coral J. Childs Vol#: 2

EMC 106 No signature Vol#: 2

EMC 107 Bruce Walters Vol#: 2

EMC 108 John J. Pizzo Vol#: 2

EMC 109 Gerry Ann Vol#: 2

EMC 110 James N. Oss Vol#: 2

EMC 111 No signature Vol#: 2

EMC 112 Randy Atwell Vol#: 2

EMC 113 Jane McGuire Vol#: 2

EMC 114 Catherine Rice Vol#: 2

EMC 115 Todd Mullins Vol#: 2

EMC 116 No signature Vol#: 2

EMC 117 Philip J. Molloy, MD Vol#: 2

EMC 118 Coralee H. McCleary Vol#: 2

EMC 119 Dr. Benjamin Moore Vol#: 2

EMC 120 Harriet Lowell Vol#: 2

EMC 121 Deborah Knowlton Vol#: 2

EMC 122 Karen Anne Duffy Vol#: 2

EMC 123 Brad Morgan Vol#: 2

EMC 124 Cam Wilbur Vol#: 2

EMC 125 James Haines Vol#: 2

EMC 126 T. Floyd Vol#: 2

EMC 127 No signature Vol#: 2

EMC 128 Greg Oneill Vol#: 2

EMC 129 Jeffrey Slezak Vol#: 2

EMC 130 Vicki Bowes Vol#: 2

EMC 131 Louise Davidson Vol#: 2

EMC 132 Kayla Rosetta Vol#: 2

EMC 133 David H. Thurman Vol#: 2

EMC 134 Monya Compton Vol#: 2

EMC 135 Phillip L. Bendall Vol#: 2

EMC 136 Joseph C. Landolfi, D.O. Vol#: 2

EMC 137 Brenda Fountain, BSN, RN Vol#: 2

EMC 138 Sandy Young Vol#: 2

EMC 139 Susan Vol#: 2

EMC 140 Lisa Rhodes Vol#: 2

EMC 141 Barb Reisinger Vol#: 2

EMC 142 Sandra Hodge Vol#: 2

EMC 143 Susan J. Williams Vol#: 2

EMC 144 Nancy Sokoloski Vol#: 2

EMC 145 Jeff Crittenden Vol#: 2

EMC 146 J. Keith Miller, MD Vol#: 2

EMC 147 Robert F. Manges, MD Vol#: 2

EMC 148 Charles W. Humphrey Vol#: 2

EMC 149 Kathy Replogle Vol#: 2

EMC 150 M. Josephine Speed Vol#: 2

EMC 151 Debra B. Gordon Vol#: 2

EMC 152 Melissa Ann Keck, RN Vol#: 2

EMC 153 Kathryn G. Watkins Vol#: 2

EMC 154 Joseph A. Walter Vol#: 2

EMC 155 Robert Gerwin, M.D. Vol#: 2

EMC 156 Patrick R. Danaher Vol#: 2

EMC 157 Michael A. Boyajian Vol#: 2

EMC 158 Patrick Morris Vol#: 2

EMC 159 Jeanni Rogers Vol#: 2

EMC 160 Karen Kos Vol#: 2

EMC 161 Amy L. Killmeyer Vol#: 2

EMC 162 Nicole Skinner Vol#: 2

EMC 163 American Alliance of Cancer Initiatives Vol#: 2

EMC 164 American Alliance of Cancer Initiatives Vol#: 2

EMC 165 Justin Wasserman, MD Vol#: 2

EMC 166 Rick Coburn, PA Vol#: 2

EMC 167 Larry A. Pearce, MD Vol#: 2

EMC 168 Rev James W. Davis Vol#: 2

EMC 169 Nance Cunningham, MA Vol#: 2

EMC 170 Beth Cita, RN Vol#: 2

EMC 171 Nicole Skinner Vol#: 2

EMC 172 Deborah Page Vol#: 2

EMC 173 Gerald R. Kloth Vol#: 2

EMC 174 Scott M. Peterson Vol#: 2

EMC 175 Virginia K. Caraway Vol#: 2

EMC 176 Barbara J. Sosin Vol#: 2

EMC 177 Melvyn L. Sterling, MD, FACP Vol#: 2

EMC 178 Mary K. Colabrese Vol#: 2

EMC 179 Todd B. Taylor, MD, FACEP Vol#: 2

EMC 180 Howard J. Hoffberg, MD Vol#: 2

EMC 181 Jason Shaffer Vol#: 2

EMC 182 Charles R. Judy, MD Vol#: 2

EMC 183 Margaret Snow Vol#: 2

EMC 184 Jacalyn Cutler Vol#: 2

EMC 185 Lynnea Jasper Vol#: 2

EMC 186 No signature Vol#: 2

EMC 187 James F. Cotter Vol#: 2

EMC 188 K. Carter Vol#: 2

EMC 189 James O. Oliver Vol#: 2

EMC 190 C. Damon Vol#: 2

01N-0393 Prescription Drug Product Labeling; Medication Guide Require

N 1 Vol#:

01N-0418 Withdrawal of Approval of Two New Drug Applications

NWL 1 Vol#: 1

01P-0152 Determine that Neurontin capsules was not withdrawn for safe

LET 1 HFD-1 to Apotex Corp. Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 206 Roy Sletson Vol#: 23

01P-0245 Determination that Disulfiram was withdrawn for reasons othe

LET 1 HFD-7 to Sidmak Laboratories, Inc. Vol#: 1

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

EMC 2 Barbara Lougheed Vol#: 2

EMC 3 Russ T. Lentol Vol#: 2

EMC 4 Linda G. Trosper Vol#: 2

EMC 5 George F. Meyer Jr. Vol#: 2

EMC 6 William Bottomley Vol#: 2

EMC 7 Lara Quevillon Vol#: 2

EMC 8 Alex Quevillon Vol#: 2

EMC 9 Suzie Chabot Vol#: 2

EMC 10 Linda & John Walter Vol#: 2

EMC 11 Iulia Ioanitoaia-Chaudhry, MD Vol#: 2

EMC 12 Wenonah Miller Vol#: 2

EMC 13 Walter Lougheed Vol#: 2

EMC 14 Julie Walker Vol#: 2

EMC 15 Kirk Lougheed Vol#: 2

EMC 16 J. Barillet Vol#: 2

EMC 17 C. Langdon Vol#: 2

EMC 18 Elizabeth Gibson Vol#: 2

EMC 19 Mary Bateman Vol#: 2

EMC 20 Margaret Collins Vol#: 2

EMC 21 Bev Laumann Vol#: 2

EMC 22 No signature Vol#: 2

01P-0428 Generic Cefuroxime Axetil Products

ACK 2 HFA-305 Vol#: 1

PSA 1 Professional Detailing, Inc. Vol#: 1

01V-0438 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 The Temple Club Vol#: 1