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Dockets Management
Dockets Entered On December 22, 2003
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003P-0270 Prohibit False and Misleading Labeling
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 11986 Now Foods Vol #: 95
LET 11987 Natural Organics Inc. Vol #: 96
LET 11988 Twin Laboratories, Inc. Vol #: 96
LET 11989 Nature's Health Corporation Vol #: 96
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7332 Karen Faxon Vol #: 305
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
REF 2
Tab A, B
OMB Review December 11, 2003 Vol #: 1
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12720 Virginia Williams Vol #: 788
C 12721 Patricia Kenschaft Vol #: 788
C 12722 Stephenie Stephens Vol #: 788
EMC 5699 James Stout Vol #: 788
EMC 5700 Mike Perez Vol #: 788
EMC 5701 Jill Albanese Vol #: 788
EMC 5702 Lorissa Byely Vol #: 788
EMC 5703 Harold Tuchel Vol #: 788
EMC 5704 Richard Phillips Vol #: 788
EMC 5705 Richard Phillips Vol #: 788
EMC 5706 Mark Wilcher Vol #: 788
EMC 5707 Mark Wilcher Vol #: 788
EMC 5708 Mark Wilcher Vol #: 788
EMC 5709 Vincent Mori Vol #: 788
EMC 5710 Karin Ruoff Vol #: 788
EMC 5711 Julia Thompson Vol #: 788
EMC 5712 Julia Thompson Vol #: 788
EMC 5713 Jaime Shapiro Vol #: 788
EMC 5714 Jay Kloss Vol #: 788
EMC 5715 Robin Kolnicki Vol #: 788
EMC 5716 Robin Kolnicki Vol #: 788
EMC 5717 Robin Kolnicki Vol #: 788
EMC 5718 Robin Kolnicki Vol #: 788
EMC 5719 Wayne Yardley Vol #: 788
EMC 5720 Wayne Yardley Vol #: 788
EMC 5721 Wayne Yardley Vol #: 788
EMC 5722 Daniel Shively Vol #: 788
EMC 5723 Mary Marshall White Vol #: 788
EMC 5724 Mary Marshall White Vol #: 788
EMC 5725 Mary Marshall White Vol #: 788
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 307 Honorable Pitts Vol #: 125
C 308 Raffaella Dietz Vol #: 125
C 309 American Academy of Family Physicians (AAFP) Vol #: 125
C 310 Disciples Justice Action Network Vol #: 125
C 311 29 signatures Vol #: 125
C 312 Kathy Hixson Vol #: 125
C 313 Donald and Carol Thomas Vol #: 125
C 314 Thomas and Sally Wallace Vol #: 125
C 315 C. Thomas Vol #: 125
C 316 S. Lefton Vol #: 125
C 317 E. Bickford Vol #: 125
C 318 S. Fink Vol #: 125
C 319 The Assembly State of New York Albany Vol #: 125
C 320 D. Weiss-Brock Vol #: 125
C 321 R.N. Dansereau, R.Ph.,PhD Vol #: 125
EC 61 Meyer, Alexis Vol #: 124
EC 62 Davis, Cyndi Vol #: 124
EC 63 HARDY, SHENATA Vol #: 124
EC 64 Lindenfelser, Marlene Vol #: 124
EC 65 Reznik, Makhmood Vol #: 124
EC 67 Smith, Timothy Vol #: 124
EC 68 Brown, carolyn V Vol #: 124
EC 69 Higgins, Rachael Vol #: 124
EC 70 Cain, Bonnie Vol #: 124
EC 71 Jones, Lauren Rae (LaRae) Vol #: 124
EC 72 Shochet, Tara Vol #: 124
EC 74 Pittman, Theda Vol #: 124
EC 75 Ingallinera, Kathy Vol #: 124
EC 76 Sotheran, Jo Vol #: 124
EC 77 Ireland, Heather Vol #: 124
EC 78 Webber, Alicia Vol #: 124
EC 79 WALSH, KRISTIN Vol #: 124
EC 80 Hertel, Elaine Vol #: 124
EC 81 Mural, Alice Vol #: 124
EC 83 Beisel, Monica Vol #: 124
EC 84 Nimmo, Susan Vol #: 124
EC 85 Stands, James Vol #: 124
EC 86 Van Meter, Sherry Vol #: 124
EC 87 Smith, Judy Rae Vol #: 124
EC 88 Laws, Timothy Vol #: 124
EC 89 Smith, Judith Vol #: 124
EC 90 Williams, Greg Vol #: 124
EC 91 Krewson, Pat Vol #: 124
EC 92 Buchanan, Sean Vol #: 124
EC 93 King, Craig Vol #: 124
EC 94 Brake, Linda Vol #: 124
EC 95 Enyart, Bob Vol #: 124
EC 96 Kramer, Paul Vol #: 124
EC 97 Kramer, Debby Vol #: 124
EC 98 Fulenwider, Chris Vol #: 124
EC 99 Kramer, Natalie Vol #: 124
EC 100 Kramer, Matthew Vol #: 124
EC 101 Kittrell, Melva Vol #: 124
EC 102 Sherk, Patricia Vol #: 124
EC 103 Fallon, James Vol #: 124
EC 104 Foley, Deanna Vol #: 124
EC 105 Wallace, Holly Vol #: 124
EC 106 Parsons, Brittany Vol #: 124
EC 107 Guynn, Preston Vol #: 124
EC 108 Anderson, Priscilla Vol #: 124
EC 109 Kaufman, Dan Vol #: 124
EC 110 Scherer, John Vol #: 124
EC 111 Poissant, Robert Vol #: 124
EC 112 Transom, George Vol #: 124
EC 113 Glover, Suzanne Vol #: 124
EC 114 soltes, shirley Vol #: 124
EC 115 Kingdon, Shirley Vol #: 124
EC 116 Moersdorf, Steven Vol #: 124
EC 117 DiPiazza, Sharon Vol #: 124
EC 118 Marschall, Susan Vol #: 124
EC 119 Giglio, Camille Vol #: 124
EC 120 Cosenza, Christine Vol #: 124
EC 121 Edgil, Theresa Vol #: 124
EC 122 Simpson, Nicole Vol #: 124
EC 123 Monin, Carl Vol #: 124
EC 124 Santiago, Lillian Vol #: 124
EC 125 Dessommes, Marie Vol #: 124
EC 126 Conley, Regina Vol #: 124
EC 127 Zormeir, Joan Vol #: 124
EC 128 travis, shawna Vol #: 124
EC 129 Weir, Roger Vol #: 124
EC 130 Lefever, Mary E (Dolly) Vol #: 124
EC 131 Mauro, Melissa Vol #: 124
EC 132 Plash, Heidi Vol #: 124
EC 133 Horsefield, Earl Vol #: 124
EC 134 Morvant, Dana Vol #: 124
EC 135 Taylor, Marsha Vol #: 124
EC 136 Greer, Wayne Vol #: 124
EC 137 Listing, Barbara Vol #: 124
EC 138 Buchholz, Brittany Vol #: 124
EC 139 Banaga, Frankee Vol #: 124
EC 140 Brown, Timothy Vol #: 124
EC 141 Guerra, Lilia Vol #: 124
EC 142 Goc, Mary Vol #: 124
EC 143 Konitzer, Allen Vol #: 124
EC 144 Menhart, Robert Vol #: 124
EC 145 Haynes, Dianne Vol #: 124
EC 146 DeBellas, Nicholas Vol #: 124
EC 147 Dick, David Vol #: 124
EC 148 Bishop, Justin Vol #: 124
EC 149 Howard, Elizabeth Vol #: 124
EC 150 Lavergne, Debbie Vol #: 124
EC 151 richter, louis Vol #: 124
EC 152 Richter-Allen, Cindy Vol #: 124
EC 153 McLaughlin, Kevin Vol #: 124
EC 154 Naughton, John Vol #: 124
EC 155 Ramos, Mary Vol #: 124
EC 156 Pappas, Michael Vol #: 124
EC 157 Buchholz, Donna Vol #: 124
EC 158 Pfaff, Bonnie A Vol #: 124
EC 159 Kreger, Mary Lee Vol #: 124
EC 160 Walsh, Joseph Vol #: 124
EC 161 Harrison Condon, Rev. Barbara Vol #: 124
EC 162 Davis, Joetta Vol #: 124
EC 163 Ford, Daniel Vol #: 124
EC 164 Streck, Nancy Vol #: 124
EC 165 Delaporte, Margaret Vol #: 124
EC 166 Ronovech, Heather Vol #: 124
EC 167 Trigo, Lisa Vol #: 124
EC 168 Merritt, Charlene Vol #: 124
EC 169 Hunter, Diana Vol #: 124
EC 170 Peters, Jane Vol #: 124
EC 171 Suarez, Connie Vol #: 124
EC 172 Hicks, Darlene Vol #: 124
EC 173 Rautenberg, Ellen Vol #: 124
EC 174 Larsen, Laurel Vol #: 124
EC 175 Lloyd, Stan Vol #: 124
EC 176 Moffett, Tony Vol #: 124
EC 177 wasson, patrick Vol #: 124
EC 178 Feist, Vickie Vol #: 124
EC 179 osborn, emily Vol #: 124
EC 180 Klubertanz, Yvonne Vol #: 124
EC 181 Torrence, Marie Vol #: 124
EC 182 Leitzel, Dwain Vol #: 124
EC 183 Wacker, Betsy Vol #: 124
EC 184 Zook, Scott Vol #: 124
EC 185 Greene, Charles Vol #: 124
EC 186 Girard, Catherine Vol #: 124
EC 187 Leporte, Lori Vol #: 124
EC 188 Rettig, Keith Vol #: 124
EC 189 Hopkins, Pamela Vol #: 124
EC 190 FORD, LAURA Vol #: 124
EC 191 Gutmann, Karen Vol #: 124
EC 192 Gutmann, Thomas Vol #: 124
EC 193 Liegle, Jens Vol #: 124
EC 194 Huyser Smith, Brittany Vol #: 124
EC 195 Duffy, Marilyn Vol #: 124
EC 196 Walker, John Vol #: 124
EC 197 Kuhn, Sam Vol #: 124
EC 198 Mertzenich, Claude Vol #: 124
EC 199 Graybill, Micah Vol #: 124
EC 200 Leveille, Shauna Vol #: 124
EC 201 Brauer, Karen Vol #: 124
EC 202 Huband, Jana Vol #: 124
EC 203 Villanueva, Connie Vol #: 124
EC 204 Federmeier, Geoff Vol #: 124
EC 205 Hall, Erika Vol #: 124
EC 206 HORRIGAN, STACY Vol #: 124
EC 207 Trinidad, Jennifer Vol #: 124
EC 208 Isgrigg, Danny Vol #: 124
EC 209 ciampaglia, marcia Vol #: 124
EC 210 McClenny, William Vol #: 124
EC 211 Federmeier, Kristen Vol #: 124
EC 212 Howell, John Vol #: 124
EC 213 Haradon, Howard Vol #: 124
EC 214 Cooley, Martha Vol #: 124
EC 215 Nuckols, Beverly Vol #: 124
EC 216 Billings, Becky Vol #: 124
EC 217 Whelchel, Andrew Vol #: 124
EC 218 Chancey, Matthew Vol #: 124
EC 219 Klimek, Mary Vol #: 124
EC 220 Hadsell, Cynthia Vol #: 124
EC 221 Young, Robert Vol #: 124
EC 222 Belver, Carole Vol #: 124
EC 223 McManamon, Luke Vol #: 124
EC 224 Moore, Alice Vol #: 124
EC 225 Spears, Cynthia Vol #: 124
EC 226 champion, wanda Vol #: 124
EC 227 schaefer, gail Vol #: 124
EC 228 Russell, Bonnie Vol #: 124
EC 229 Sunderland, Margaret Vol #: 124
EC 230 Armstrong, Anne Vol #: 124
EC 231 Leininger, Greg Vol #: 124
EC 232 Tynan, Edmund Vol #: 124
EC 233 Courter, Barbara Vol #: 124
EC 234 Barrett, Charles Vol #: 124
EC 235 Keenan, Miranda Vol #: 124
EC 236 Maxson, LTC, (ret.), Ronald Vol #: 124
EC 237 Yelkovan, Carla Vol #: 124
EC 238 Davidson, J Michael Vol #: 124
EC 239 Lynk, Mary Jane Vol #: 124
EC 240 Dickens, Eva Vol #: 124
EC 241 Mader, Barry Vol #: 124
EC 242 missey, jerry Vol #: 124
EC 243 Maralit, Angelica Vol #: 124
EC 244 Wennerlind, Emily Vol #: 124
EC 245 Magnus, Ron Vol #: 124
EC 246 Morse, Bevinne Vol #: 124
EC 247 Labat, Trudy Vol #: 124
EC 248 Harrington, Robert Vol #: 124
EC 249 giese, tony Vol #: 124
EC 250 Klier, Catherine Vol #: 124
EC 251 Miller, Connie Vol #: 124
EC 252 Endicott, Terri Vol #: 124
EC 253 Coffin, Laurie Vol #: 124
EC 254 MORRIS, MARJORIE Vol #: 124
EC 255 Korman, JIll Vol #: 124
EC 256 Gamble, Julia Vol #: 124
EC 257 Walker, Allison Vol #: 124
EC 258 Frieden, Thomas Vol #: 124
EC 259 Kelly, Sara Vol #: 124
EC 260 Veal, Eric Vol #: 124
EC 261 Billings, Robert Vol #: 124
EC 262 Ballard, Rachel Vol #: 124
EC 263 Gurak, Chantel Vol #: 124
EC 264 Spears, William Vol #: 124
EC 265 Wasson, Greg Vol #: 124
EC 266 Farah, Gretchen Vol #: 124
EC 267 Heath, Rebecca Vol #: 124
EC 268 Davis, Karen Vol #: 124
EC 269 Strom, Mary Vol #: 124
EC 270 Lucke, Kathy Vol #: 124
EC 271 McAneny, Bess Vol #: 124
EC 272 Turner, Sue Vol #: 124
EC 273 Miles, Vonda Vol #: 124
EC 274 Akers, Kyle Vol #: 124
EC 275 Vervena, Cynthia Vol #: 124
EC 276 Turcotte, Patricia Vol #: 124
EC 277 Mui, Chunka Vol #: 124
EC 278 Siefker, Monica Vol #: 124
EC 279 O'Rourke, Kathi Vol #: 124
EC 280 Goetz, Ruth Vol #: 124
EC 281 Arnold, Trudi Vol #: 124
EC 282 Priest, David Vol #: 124
EC 283 Ackerbauer, Denine Vol #: 124
EC 284 Smith, Kristina Vol #: 124
EC 285 welch, scott Vol #: 124
EC 286 Cornell, Kathryn Vol #: 124
EC 287 Morrow, Tevis Vol #: 124
EC 288 Depner, William Vol #: 124
EC 289 Alboniga, Elizabeth Vol #: 124
EC 290 Warren, Susan Vol #: 124
EC 291 Cashen, Diane Vol #: 124
EC 292 Benson, Sue Vol #: 124
EC 293 Lisenby, Amy Vol #: 124
EC 294 Knott, Dean Vol #: 124
EC 295 harris, sharon Vol #: 124
EC 296 Beal, Mark Vol #: 124
EC 297 Howard, Teresa Vol #: 124
EC 298 Little, William Vol #: 124
EC 299 Blackwell, Phyllis Vol #: 124
EC 300 Pistorino, Maria H. Vol #: 124
EC 301 Cannon, Barbara Vol #: 124
EC 302 Cabana, Christopher Vol #: 124
EC 303 Morse, John Vol #: 124
EC 304 Anderson, Sonja Vol #: 124
EC 305 Reynolds, Chris Vol #: 124
EC 306 Scheetz, Patrick Vol #: 124
EC 307 Roy, Lynne Vol #: 124
EC 308 Braker, Betsy Vol #: 124
EC 309 Pittman, David Vol #: 124
EC 310 Gose, Patricia Vol #: 124
EC 311 Name removed 4/18/2008 Vol #: 124
EC 312 Haradon, Gale Vol #: 124
EC 313 Younce, Sue Vol #: 124
EC 314 Matich, Robert Vol #: 124
EC 315 swartz, tonia Vol #: 124
EC 316 Hatfield, Roberta Vol #: 124
EC 317 Wade, Madeline Vol #: 124
EC 318 Imes, Peter Vol #: 124
EC 319 Keith, Guy Vol #: 124
EC 320 Keith, Caroline Vol #: 124
EC 321 Burenheide, Trudy Vol #: 124
EC 322 Cole, Dawn Vol #: 124
EC 323 Harris, A Vol #: 124
EC 324 Gartner, Mary Lou Vol #: 124
EC 325 Fenton, Kerri Vol #: 124
EC 326 Moore, Kevin Vol #: 124
EC 327 Signer, Marjorie Vol #: 124
EC 328 I., C. Vol #: 124
EC 329 Timmerman, Paul F. Vol #: 124
EC 330 Timmerman, Paul F. Vol #: 124
EC 331 Karlyn, Andrew Vol #: 124
EC 332 Brown, Robert Vol #: 124
EC 333 Glover, Tim Vol #: 124
EC 334 Banno, Annie Vol #: 124
EC 335 Middleton, Marsha Vol #: 124
EC 336 Bunzalik, Kristina Vol #: 124
EC 337 Beaver, Clair Vol #: 124
EC 338 Smith, Heather Vol #: 124
EC 339 Clark, John Vol #: 124
EC 340 Palmer, Kathi Vol #: 124
EC 341 Lewis, Jason Vol #: 124
EC 342 Farr, Sarah Vol #: 124
EC 343 Morgenstern, Ava Vol #: 124
EC 344 Keegan, Irene Vol #: 124
EC 345 Reihman, Debra Vol #: 124
EC 346 robinson, mikell Vol #: 124
EC 347 Becker, Anna Vol #: 124
EC 348 Jansen, Seth Vol #: 124
EC 349 Steidl, Leon Vol #: 124
EC 350 Yakish, Frank Vol #: 124
EC 351 McKray, Joanne Vol #: 124
EC 352 Van Winkle, Ed Vol #: 124
EC 353 Arthaud, Karen Vol #: 124
EC 354 Cohen, Mark Vol #: 124
EMC 1241 L Robinson Vol #: 123
EMC 1242 C Rasmus Vol #: 123
EMC 1243 D Abraham Vol #: 123
EMC 1244 D Turman Vol #: 123
EMC 1245 M Pomietto Vol #: 123
EMC 1246 R Mason Vol #: 123
EMC 1247 V Combs Vol #: 123
EMC 1248 J Porter Vol #: 123
EMC 1249 K Priscak Vol #: 123
EMC 1250 T Christopherson Vol #: 123
EMC 1251 D Campbell Vol #: 123
EMC 1252 E Vogel Vol #: 123
EMC 1253 D Woerner Vol #: 123
EMC 1254 E Rosciam Vol #: 123
EMC 1255 B Grant Vol #: 123
EMC 1256 L Belay Vol #: 123
EMC 1257 R Taylor Vol #: 123
EMC 1258 M Gupta Vol #: 123
EMC 1259 C Morrison Vol #: 123
EMC 1260 J Puckett Vol #: 123
EMC 1261 P Koester Vol #: 123
EMC 1262 B Widener Vol #: 123
EMC 1263 E Morales Vol #: 123
EMC 1264 G Holden Vol #: 123
EMC 1265 C Young Vol #: 123
EMC 1266 S Stewart Vol #: 123
EMC 1267 C Hulsey Vol #: 123
EMC 1268 M Tomeho Vol #: 123
EMC 1269 K Watson Vol #: 123
EMC 1270 H Kriegh Vol #: 123
EMC 1271 A Johannesen Vol #: 123
EMC 1272 M Pappas MD Vol #: 123
EMC 1273 E Gadwa Vol #: 123
EMC 1274 W Escobar Vol #: 123
EMC 1275 N Sherer Vol #: 123
EMC 1276 L Biddle Vol #: 123
EMC 1277 C Nordgaard Vol #: 123
EMC 1278 J Arason Vol #: 123
EMC 1279 A Love Vol #: 123
EMC 1280 K Kaufer Vol #: 123
EMC 1281 M Edelstein Vol #: 123
EMC 1282 N Smith Vol #: 123
EMC 1283 C Cabernoch Vol #: 123
EMC 1284 K Myers Vol #: 123
EMC 1285 A Sistler Vol #: 123
EMC 1286 M Curtis Vol #: 123
EMC 1287 M Bailey Vol #: 123
EMC 1288 H Harding Vol #: 123
EMC 1289 C Huyser Vol #: 123
EMC 1290 K McKay Vol #: 123
EMC 1291 J Lee Vol #: 123
EMC 1292 M Beck Vol #: 123
EMC 1293 S Cohen Vol #: 123
EMC 1294 M Criser Vol #: 123
EMC 1295 A Hill Vol #: 123
EMC 1296 J Lefeaux Vol #: 123
EMC 1297 R Hilse Vol #: 123
EMC 1298 S Macdonald Vol #: 123
EMC 1299 O Khalid Vol #: 123
EMC 1300 E Gaudier Vol #: 123
SUP 3 No signature Vol #: 125
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
C 46 Arden Sleadd Vol #: 2
C 47 Harvey LeSueur Vol #: 2
C 48 Danna Shinaver Vol #: 2
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 33 Honorable Dan Burton Vol #: 5
C 34 Honorable Bill Nelson Vol #: 5
C 35 Honorable Patty Murray Vol #: 5
C 36 Form Letter Vol #: 6
C 37 Form Letter Vol #: 7
C 38 Lynda Edwards Vol #: 5
2003P-0270 Prohibit False and Misleading Labeling
C 43 Form Letters Vol #: 7
C 44 Alice C. Soliman Vol #: 6
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
SUP 1 Mylan Pharmaceuticals, Inc. Vol #: 2

Page created on December 22, 2003 kk
Page update on January 23, 2004 jb

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