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Dockets Management
Dockets Entered On March 9, 2005
Table of Contents
Docket # Title
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
2004D-0438 Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
2004D-0524 Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0527 Medical Devices; Medical Device Reporting
2005D-0021 International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
2005D-0043 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy; Draft Revised Compliance Policy Guide
2005D-0047 Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
2005H-0099 Civil Money Penalty Complaint in the Matter of Gerald Dorros, M.D.
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EAPE 10 Shore, Scott Vol #: 4
EAPE 11 Beech, Camilla Vol #: 4
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
C 77 P Bostard Vol #: 15
C 78 R Plevin Vol #: 15
C 79 J GUnder Vol #: 15
C 80 D Sorenson, R H Sorenson Vol #: 15
C 81 W Bault Vol #: 15
C 82 H Misserli Vol #: 15
C 83 D Shively Vol #: 15
C 84 Mercy Investment Program Vol #: 15
C 85 M MacKinnon Vol #: 15
C 86 S Wolf Vol #: 15
C 87 J Michael Vol #: 15
C 88 P McCauley Vol #: 15
C 89 C Sabin Vol #: 15
C 90 S Gunder Vol #: 15
C 91 M Neeks Vol #: 15
C 92 E Echlin Vol #: 15
C 93 R Dupray Vol #: 15
C 94 W Loftus + 8 signatures Vol #: 15
C 95 Winkfield Woomens' Institute Vol #: 15
EMC 1432 S Pedersen Vol #: 22
EMC 1433 J Crowley Vol #: 22
EMC 1434 C Riggs Vol #: 22
EMC 1435 A Baker Vol #: 22
EMC 1436 A Brown Vol #: 22
EMC 1437 C Iverson Vol #: 22
EMC 1438 J Roullier Vol #: 22
EMC 1439 J Pittman Vol #: 22
EMC 1440 T Ballanco Vol #: 22
EMC 1441 K Patterson Vol #: 22
EMC 1442 S Daniels Vol #: 22
EMC 1443 R Lacey Vol #: 22
EMC 1444 P Sbardella Vol #: 22
EMC 1445 M Weir Vol #: 22
EMC 1446 L Bode Vol #: 22
EMC 1447 A Schueler Vol #: 22
EMC 1448 B McGiffert Vol #: 22
EMC 1449 M Hoffman Vol #: 22
EMC 1450 Form Letter count 154 Vol #: 23
EMC 1451 Z Daniek Vol #: 22
EMC 1452 D Herman Vol #: 22
EMC 1453 K Alarie Vol #: 22
EMC 1454 T Seccombe Vol #: 22
EMC 1455 R Rea Vol #: 22
EMC 1456 A Diaz Vol #: 22
EMC 1457 C Haven Vol #: 22
EMC 1458 E Slaughter Vol #: 22
EMC 1459 D Moreno Vol #: 22
EMC 1460 F Garfinkle Vol #: 22
EMC 1461 S Stewart Vol #: 22
EMC 1462 S Glover Vol #: 22
EMC 1463 P Roden Vol #: 22
EMC 1464 C Allwein Vol #: 22
EMC 1465 J Ellsworth Vol #: 22
EMC 1466 C Hey Vol #: 22
EMC 1467 J Carey Vol #: 22
EMC 1468 L Norton Vol #: 22
EMC 1469 C Hall Vol #: 22
EMC 1470 S Shamblin Vol #: 22
EMC 1471 D Christie Vol #: 22
EMC 1472 A Navarro Vol #: 22
EMC 1473 S Archer Vol #: 22
EMC 1474 W Smirnow Vol #: 22
EMC 1475 T Hightower Vol #: 22
EMC 1476 T O'Connell Vol #: 22
EMC 1477 B Wolf Vol #: 22
EMC 1478 A Statton Vol #: 22
EMC 1479 M Nelson Vol #: 22
EMC 1480 P Haengel Vol #: 22
EMC 1481 P Nagy Vol #: 22
EMC 1482 P Nagy Vol #: 22
EMC 1483 M Mieloch Vol #: 22
EMC 1484 M Mieloch Vol #: 22
EMC 1485 C Franklin Vol #: 22
EMC 1486 C Franklin Vol #: 22
EMC 1487 C Schmidt Vol #: 22
EMC 1488 M Hilgeman Vol #: 22
EMC 1489 J Hnnessy Vol #: 22
EMC 1490 R van Veenendaal Vol #: 22
EMC 1491 K Chittenden Vol #: 22
EMC 1492 D Palkowski Vol #: 22
2004D-0438 Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
EC 4 Alpacalocks farm Vol #: 1
2004D-0524 Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
EC 2 Teva Pharmaceutical Industries Ltd. Vol #: 1
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
C 194 A. Indeck Vol #: 6
C 195 P. Fernandez Vol #: 6
C 196 R and J Reese Vol #: 6
C 197 A. Kreiner Vol #: 6
C 198 S and C Harpole Vol #: 6
C 199 S Scott and T Jones Vol #: 6
C 200 D. Roberts Vol #: 6
C 201 R and J Rettenmund Vol #: 7
C 202 C and M Bowman Vol #: 7
C 203 D. Horton Vol #: 7
C 204 S. Russell Vol #: 7
C 205 D. Jordan Vol #: 7
C 206 A. Gabb Vol #: 7
C 207 D and P Nathanson Vol #: 7
C 208 S. Dennis Vol #: 7
C 209 S. Mackie Vol #: 7
C 210 B. Lichtman Vol #: 7
C 211 W. Vennema Vol #: 7
C 212 P. Zimmer Vol #: 7
C 213 W. Nielsen Vol #: 7
C 214 S and J Kimlinger Vol #: 7
C 215 B and C Garey Vol #: 7
C 216 C. Kim Vol #: 7
C 217 T. Hill Vol #: 7
C 218 L. Roberts Vol #: 7
C 219 J. Pivotto Vol #: 7
C 220 M. Daitzman Vol #: 7
C 221 D. Waldusky Vol #: 7
C 222 Dr. E. Apel Vol #: 7
C 223 L. Calliott Vol #: 7
C 224 K. Rozanski Vol #: 7
C 225 L. Rothstein Vol #: 7
C 226 J. Wolfe Vol #: 7
C 227 D. Radke Vol #: 7
C 228 K. Horn Vol #: 7
C 229 K. Kennedy Vol #: 7
C 230 L. Jones Vol #: 7
C 231 S. VanTssel Vol #: 7
C 232 C. Reed Vol #: 7
C 233 D and P LaVault Vol #: 7
C 234 E. Jones Vol #: 7
C 235 L. Pasno Vol #: 7
C 236 L. White Vol #: 7
C 237 K. Helms Vol #: 7
C 238 B. Gaffield, MS, RD Vol #: 7
C 239 L. Mitchell Vol #: 7
C 240 R. Gorton Vol #: 7
C 241 S. Herzig Vol #: 7
C 242 T and L Khoury Vol #: 7
C 243 C. Carrier Vol #: 7
C 244 J. Teague Vol #: 7
C 245 J. Barth Vol #: 7
C 246 Illegible Vol #: 7
C 247 Illegible Vol #: 7
C 248 K. Seisser Vol #: 7
C 249 R. Tucker Vol #: 7
C 250 K. Pellegrini Vol #: 7
C 251 L. Wichstrom Vol #: 7
C 252 J. Cool Vol #: 7
C 253 B. Cool Vol #: 7
C 254 K. Heino Vol #: 7
C 255 M. Hada Vol #: 7
C 256 D. Scherer Vol #: 7
C 257 S. Korec Vol #: 7
C 258 K and P Mehta Vol #: 7
C 259 M. Reid Vol #: 7
C 260 I. Tannenbaum Vol #: 7
C 261 N. Winton Vol #: 7
C 262 A. Warder Vol #: 7
C 263 D. Roberson, MD Vol #: 7
C 264 M. Lorenzen Vol #: 7
C 265 N and L Anastasopoulos Vol #: 7
C 266 K. Konieczny Vol #: 7
C 267 C. Turay Vol #: 7
C 268 T. Flaherty Vol #: 7
C 269 D. Elbaum Vol #: 7
C 270 S. Young Vol #: 7
C 271 J and M Finkelstein Vol #: 7
C 272 S and S Mistretta Vol #: 7
C 273 D and G Brown Vol #: 7
C 274 D. Corba Vol #: 7
C 275 P. MacLeod Vol #: 7
C 276 S. Morgan Vol #: 7
C 277 P and M Conger Vol #: 7
C 278 S. Halloran Vol #: 7
C 279 M. Dukes Vol #: 7
C 280 Leadership Network Corporation Vol #: 7
C 281 K. Pacht Vol #: 7
C 282 L. Guley Vol #: 7
C 283 B and R Gaskin Vol #: 7
C 284 P. Suba Vol #: 7
C 285 C. Stidham Vol #: 7
C 286 K. Hackett Vol #: 7
C 287 Hickory Allergy & Asthma Clinic, P.A. Vol #: 7
C 288 E. Witten Vol #: 7
C 289 S. Brust Vol #: 7
C 290 J. Silberman Vol #: 7
C 291 J and G Kiehne Vol #: 7
C 292 D and M Cave Vol #: 7
C 293 J. Anastasio Vol #: 7
C 294 M. Anastasio Vol #: 7
C 295 M and K Parker Vol #: 7
C 296 E. Melnick Vol #: 7
C 297 A. Grace Vol #: 7
C 298 D. Grace Vol #: 7
C 299 B. Smith Vol #: 7
C 300 S. Smith Vol #: 7
C 301 D and S Siebert Vol #: 8
C 302 S. Kaufman Vol #: 8
C 303 T. Yammamoto Vol #: 8
C 304 J. Marcus Vol #: 8
C 305 H. Reinhardt Vol #: 8
C 306 Providence Community Health Centers, Inc. Vol #: 8
C 307 S. Ruppel Vol #: 8
C 308 K. Melnick Vol #: 8
C 309 H. Faske Vol #: 8
C 310 R. Peet Vol #: 8
C 311 E. Latture Vol #: 8
C 312 M. Monahan Vol #: 8
C 313 L. Rohleder Vol #: 8
C 314 E. Weitzman Vol #: 8
C 315 S. Brown Vol #: 8
C 316 C. Groote, MD Vol #: 8
C 317 C. Schoenauer Vol #: 8
C 318 S. Meyers Vol #: 8
C 319 E. Malcolm, MD Vol #: 8
C 320 D. Rodman Vol #: 8
C 321 W and B Chmura Vol #: 8
C 322 E. Enteman Vol #: 8
C 323 I and J Morris Vol #: 8
C 324 J and K Climpson Vol #: 8
C 325 A. Cohen Vol #: 8
C 326 L. Casey Vol #: 8
C 327 C. Esbig Vol #: 8
C 328 K. Borg Vol #: 8
C 329 D. Carswell Vol #: 8
C 330 J. Sturn Vol #: 8
C 331 K. Stillman Vol #: 8
C 332 C. Waldren Vol #: 8
C 333 P. Schonauer Vol #: 8
C 334 C. Leppert Vol #: 8
C 335 D. Gilson Vol #: 8
C 336 L. Rued Vol #: 8
C 337 J. James, MD Vol #: 8
C 338 L and J Dugal Vol #: 8
C 339 J. Stus Vol #: 8
C 340 L. Herrmann Vol #: 8
2004N-0527 Medical Devices; Medical Device Reporting
EC 1 Cortek, Inc Vol #: 1
EC 2 Dr. Patricia Kihn Vol #: 1
EREG 1 Lannen, Theresa Vol #: 1
2005D-0021 International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
EC 1 GlaxoSmithKline Vol #: 1
2005D-0043 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy; Draft Revised Compliance Policy Guide
EC 1 AAMI Vol #: 1
2005D-0047 Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
BKG 1 Background Information Vol #: 2
2005H-0099 Civil Money Penalty Complaint in the Matter of Gerald Dorros, M.D.
LET 1 CDRH-215, GCF-1 Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
EAPE 190 Pinizzotto, Marie Vol #: 1
EAPE 191 Lucius, Kathryn Vol #: 1
EAPE 192 Jenkins-Showalter, Janet Vol #: 1
EAPE 193 Cohen, Perry D Vol #: 1
EAPE 194 reed, kristin Vol #: 1
EAPE 195 Mehigan, Maureen Vol #: 1
EAPE 196 Johnson, Ronald Vol #: 1
EAPE 197 PAIGE, JOSEPH Vol #: 1
EAPE 198 Juhl, Renee Vol #: 1
EAPE 199 Fehrs, Peter Vol #: 1

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