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 March 14, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0989 Human Gene Therapy *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio *
00P-1411 Set a regulatory limit for methylmercury in seafood *
01P-0061 Request to file an ANDA for Ifosfamide for Injection *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *

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

C 4122 Kristin A. Montag Vol#: 130

C 4123 Patricia L. Parks Vol#: 130

C 4124 Linda S. Richards Vol#: 130

C 4125 Ms Linda Adams Vol#: 130

C 4126 Mrs. Margaret L. S. Barier Vol#: 130

C 4127 Iris S. Carr Vol#: 130

C 4128 Jackie Burdi Vol#: 130

C 4129 Sally A. Cannavo Vol#: 130

C 4130 Donna Drebron Vol#: 130

C 4131 John & Mary Ann Jazylo Vol#: 130

C 4132 Lawrence G. Carradine Vol#: 130

C 4133 Susan Erickson Vol#: 130

C 4134 Environmental Assn for Great Lakes Educa Vol#: 130

C 4135 Beatrice Mannering Vol#: 130

C 4136 Monica E. Middleton Vol#: 130

C 4137 Andrew J. Zovak Vol#: 130

C 4138 Ann Palmer Vol#: 130

EMC 1373 Nanci Fowler Vol#: 130

EMC 1374 Sandy Watson Vol#: 130

EMC 1375 Gene Goldschmidt Vol#: 130

EMC 1376 Chris Schreiner Vol#: 130

EMC 1377 Saxyn Piffath Vol#: 130

EMC 1378 Diana Astarita Vol#: 130

EMC 1379 Michael Astarita Vol#: 130

EMC 1380 Melchio Astarita Vol#: 130

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 16 McMaster UN Vol#: 2

99P-1340 Declared Eternity eau de Parfum Misbranded

C 677 Ms Beatrice Roth Vol#: 17

C 678 Linda Pomerantz Vol#: 17

C 679 Beatrice Roth Vol#: 17

C 680 Brian Clarke Vol#: 17

C 681 Cecile Sastre Vol#: 17

C 682 Audrey Cruickshank Vol#: 17

C 683 Meredith & Cary Terrall Vol#: 17

EMC 222 Lillian Sinnamon Vol#: 17

EMC 223 Conne Modzelewski Vol#: 17

EMC 224 Charla Keck Vol#: 17

EMC 225 Valerie Piedmont Vol#: 17

EMC 226 B. Vol#: 17

EMC 227 Diana Ake Vol#: 17

EMC 228 Katherine K. Vol#: 17

EMC 229 Linda J. McElver Vol#: 17

EMC 230 Virginia Hicks Vol#: 17

EMC 231 Sandy McKinnon Vol#: 17

EMC 232 Mary M. Boone Vol#: 17

EMC 233 xxxxxxxxxxxxxxxx Vol#: 17

EMC 234 Debbie Munson Vol#: 17

EMC 235 Anthony Cresci & Family Vol#: 17

EMC 236 Alice Shields Vol#: 17

EMC 237 Bruce Illig Vol#: 17

EMC 238 Nadine L. Porter Vol#: 17

EMC 239 Nadine L. Porter Vol#: 17

EMC 240 Cynthia Barracca Vol#: 17

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2378 University of Memphis Vol#: 44


00D-1598 Voluntary Labeling for Bioengineered Foods

EC 193 Mr. Zac Cogle Vol#: 64

EC 194 Ms. Vanessa Alexander Vol#: 64

EC 195 Dr. Jocelyn Hollander Vol#: 64

EC 196 Mrs. Jennifer ONG Vol#: 64

EC 197 Chez Panisse Vol#: 64

EC 198 Mr. Karl Dickensheets Vol#: 64

EC 199 Ms. Leslie Black Vol#: 64

EC 200 Ms. Wendy Krueger Vol#: 64

EC 201 Ms. Gabriela Goldfarb Vol#: 64

EC 202 Self Vol#: 64

EC 203 Mrs. SauFung Yeung-Blaufox Vol#: 64

EC 204 Ms. Emily Springfield Vol#: 64

EC 205 Mr. D Stanger Vol#: 64

EC 206 none Vol#: 64

EC 207 Mr. Torsten Mueller Vol#: 64

EC 208 Mr. Mark Jolly Vol#: 64

EC 209 Mr. Donald Scott Vol#: 64

EC 210 Ms. Josselyn Staff Vol#: 64

EC 211 Ms. Deb Merchant Vol#: 64

EC 212 Ms. Gabriella Good Vol#: 64

EC 213 gostenhofer designs Vol#: 64

EC 214 Mr. Andrew Reynolds Vol#: 64

EC 215 Ms. Rita Altamore Vol#: 64

EC 216 Ms. Terra Williams Vol#: 64

EC 217 Mr. andy peri Vol#: 64

EC 218 Ms. devi peri Vol#: 64

EC 219 Mr. James Wheaton Vol#: 64

EC 220 Mr. Michael Costello Vol#: 64

EC 221 Vanderbilt Consulting Vol#: 64

EC 222 Mr. Ralph Sharrett Vol#: 64

EC 223 Mr. John Cook Vol#: 64

EC 224 Honest Weight Food Co-op Vol#: 64

EC 225 Camp Dresser & McKee Vol#: 64

EC 226 University of California at Irvine Vol#: 64

EC 227 Mr. Patrick Espinosa Vol#: 64

EC 228 Mr. Patrick Espinosa Vol#: 64

EC 229 Mr. David Menefee Vol#: 64

EC 230 Ms. Karin Anderson Vol#: 64

EC 231 Mrs. Rebecca Zimman Vol#: 64

EC 232 The Center for Food Safety Vol#: 64

EC 233 Periscopics Vol#: 64

EC 234 none Vol#: 64

EC 235 for humanity sake Vol#: 64

EC 236 Ms. Teresa Cook Vol#: 64

00N-0989 Human Gene Therapy

C 9 PETA Vol#: 2

C 10 Merck Vol#: 2

C 11 M Engebretson Vol#: 2

C 12 Emory Healthcare Vol#: 2

C 13 Jane Hoffman Vol#: 2

EMC 43 Marc Krimen Vol#: 2

EMC 44 J Heins Vol#: 2

EMC 45 K LaShelle Vol#: 2

EMC 46 Patrizia Lodi Vol#: 2

EMC 47 Dana T H Fillion Vol#: 2

EMC 48 Elide Vento Vol#: 2

EMC 49 Am Prem Niseema Vol#: 2

EMC 50 Andrea Casiraghi Vol#: 2

EMC 51 David & Ann Peck Vol#: 2

EMC 52 Cristina Pinzauti Vol#: 2

EMC 53 J Harpaz Vol#: 2

EMC 54 Maria Rantano Vol#: 2

EMC 55 Linda Gentille & Jan Knepper Vol#: 2

EMC 56 Letizia Cuscela Vol#: 2

EMC 57 Ann Leitgeb Vol#: 2

EMC 58 Christina Pino Vol#: 2

EMC 59 D Elstein Vol#: 2

EMC 60 B Gale Vol#: 2

EMC 61 Mr & Mrs J L Denison Vol#: 2

EMC 62 K Miller Vol#: 2

EMC 63 W Lochner Vol#: 2

EMC 64 Vasu Murti Vol#: 2

EMC 65 William & Myriam Parham Vol#: 2

EMC 66 Justin Sivey Vol#: 2

EMC 67 W Valender Vol#: 2

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 113 K D Johnson Vol#: 24

C 114 Donald Danforth Plant Science Center Vol#: 24

C 115 Sister Alice Dugar, SND Vol#: 24

C 116 C Houtakken Vol#: 24

C 117 M Seely Vol#: 24

C 118 N Hildt Vol#: 24

C 119 Form Letter Count Vol#: 25

C 120 H M Baker Vol#: 24

C 121 Unreadable Vol#: 24

C 122 T S Woodruff Vol#: 24

C 123 G Mehring Vol#: 24

C 124 A G Lucas-W Vol#: 24

C 125 H McClelland Vol#: 24

C 126 R & T Swain Vol#: 24

C 127 E Douglas Vol#: 24

C 128 D W Marshall Vol#: 24

C 129 J Avery Vol#: 24

C 130 L G Clark Vol#: 24

C 131 G D Lauradurn Vol#: 24

C 132 C S Hart Vol#: 24

C 133 T N Berlin, M.D. Vol#: 24

C 134 L Horochowski Vol#: 24

C 135 P Robinson Vol#: 24

C 136 M Weitz Vol#: 24

C 137 F Senadom Vol#: 24

C 138 S Condon Vol#: 24

C 139 T Happy Vol#: 24

C 140 Y Shimano Vol#: 24

C 141 J Reichert Vol#: 24

C 142 J Bittinger Vol#: 24

C 143 J J Dancer Vol#: 24

C 144 S Matsoeto Vol#: 24

C 145 P Schnellinger Vol#: 24

C 146 S Wolterstorff Vol#: 24

C 147 L Vottero Vol#: 24

C 148 C Short Vol#: 24

C 149 P Weiler Vol#: 24

C 150 A Anderson Vol#: 24

C 151 N Lamn Vol#: 24

C 152 A C Montoya Vol#: 24

C 153 B Winams Vol#: 24

C 154 F Stoller Vol#: 24

C 155 K A Bradsher Vol#: 24

C 156 E Richman Vol#: 24

C 157 P Maxwell Vol#: 24

C 158 E V Knazek Vol#: 24

C 159 M D Michen Vol#: 24

C 160 J L Scripp III Vol#: 24

C 161 B & C Funk Vol#: 24

C 162 D Shelly Vol#: 24

C 163 E Gershey Vol#: 24

C 164 B & C Funk Vol#: 24

C 165 J Willebrand Vol#: 24

C 166 A S Lemos Vol#: 24

C 167 L & W Darr Vol#: 24

C 168 A J Zinaler Vol#: 24

C 169 J W Seidel Vol#: 24

C 170 R L Carrothers Vol#: 24

C 171 J F Sisk Vol#: 24

C 172 R C Love Vol#: 24

C 173 S Stockdale Vol#: 24

C 174 Unreadable Vol#: 24

C 175 Morika Vol#: 24

C 176 M Allen Vol#: 24

C 177 J Bowen Vol#: 24

C 178 L McMillan Vol#: 24

C 179 F Burghorn Vol#: 24

C 180 A Cooper Vol#: 24

C 181 J Dell'oro Vol#: 24

C 182 B Ruggeri Vol#: 24

C 183 J Wright, Ph.D. Vol#: 24

C 184 P Scott Vol#: 24

C 185 P Ballen Vol#: 24

C 186 J Brody Vol#: 24

C 187 C Muther Vol#: 24

C 188 P Nowak Vol#: 24

C 189 M D Toleson Vol#: 24

C 190 C J Tucci Vol#: 24

C 191 M C Harvey Vol#: 24

C 192 A & D Montoya Vol#: 24

C 193 G I Unger Vol#: 24

C 194 G I Unger Vol#: 24

C 195 K Anderson Vol#: 24

C 196 K Bernhard Vol#: 24

C 197 C Haynes Vol#: 24

C 198 M M Yeoman Vol#: 24

C 199 Dr. A J Lewis Vol#: 24

C 200 J M Patton Vol#: 24

C 201 K Kosse Vol#: 24

C 202 M J Iannone Vol#: 24

C 203 J Fajardo Vol#: 24

C 204 D J Lenzgrinden Vol#: 24

C 205 K Garrison Vol#: 24

C 206 A Moffitt Vol#: 24

C 207 M Abellera Vol#: 24

C 208 V Hunter Vol#: 24

C 209 C Ryplansky Vol#: 24

C 210 B Weith Vol#: 24

C 211 J Brown Vol#: 24

C 212 M Ryplansky Vol#: 24

C 213 E York Vol#: 24

C 214 W Courtemanche Vol#: 24

C 215 O Folda Vol#: 24

C 216 B Davis Vol#: 24

C 217 A I & M S Forbes Vol#: 24

C 218 S Beckman Vol#: 24

C 219 M Kola Vol#: 24

C 220 R Abraham Vol#: 24

C 221 M Forthe Vol#: 24

C 222 A Gottschalk Vol#: 24

C 223 J Turner Vol#: 24

C 224 B Schoufelberger Vol#: 24

C 225 S Streeter Vol#: 24

C 226 S Schulman, M.D. Vol#: 24

C 227 R S Keller Vol#: 24

C 228 R B Nesbit Vol#: 24

C 229 A M Walker Vol#: 24

C 230 S J Curran Vol#: 24

C 231 S B Chase Vol#: 24

C 232 T Kennedy Vol#: 24

C 233 H L Vol#: 24

C 234 M D Hager Vol#: 24

C 235 A W Files Vol#: 24

C 236 P Coladangelo Vol#: 24

C 237 C A Smith Vol#: 24

C 238 A Baier Vol#: 24

C 239 P Turner Vol#: 24

C 240 P Canosa Vol#: 24

C 241 D Creeksong Vol#: 24

C 242 R Cartwright Vol#: 24

C 243 H M Evans, L.Ac. Vol#: 24

C 244 C A Chase Vol#: 24

C 245 E Tocher Vol#: 24

C 246 R Jones Vol#: 24

C 247 G Bulisova Vol#: 24

C 248 D R Garlit Vol#: 24

C 249 J Tobin Vol#: 24

C 250 W C Jaspert Vol#: 24

C 251 Rev B Hogan Vol#: 24

C 252 M Kaminksy Vol#: 24

C 253 R Frees Vol#: 24

C 254 M A Taylor Vol#: 24

C 255 Form Letter Count Vol#: 26

C 256 A Margolis Vol#: 24

C 257 Mynatt Family Vol#: 24

00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio

C 1 American Medical Systems Vol#: 1

00P-1355 Labeling requirements for dietary supplements/St.John's wort

C 1 American Herbal Products Assn Vol#: 1

00P-1411 Set a regulatory limit for methylmercury in seafood

EMC 66 Emily Kenney Vol#: 1

EMC 67 Emily Kenney Vol#: 1

EMC 68 Emily Kenney Vol#: 1

01D-0127 Guidance on the Content of a Blue Bird Label

GDL 1 Animal Health Inst./American Feed Ind. Vol#: 1

LET 1 Animal Health Inst & AM Feed Ind Assn Vol#: 1

01P-0061 Request to file an ANDA for Ifosfamide for Injection

C 1 Bristol-Myers Squibb Co Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 12 Lucio Boccacci Vol#: 3

C 13 William Wekselman Vol#: 3

C 14 Beth A. Martin Vol#: 3

C 15 Mrs. Angela J. Marvin Vol#: 3

C 16 Leeta von Buelow Vol#: 3

EMC 173 Robert Macdonald Vol#: 3