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Dockets Management
Dockets Entered On May 6, 2004
Table of Contents
Docket #   Title
 
2000D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2004D-0042 Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
2004M-0199 P030032 - Hylaform (hylan B gel)
2004M-0200 P010014 - Oxford Meniscal Unicompartmental Knee System
2004M-0207 P970027 - Abbott AxSYM Anti-HCV
2004N-0087 Request for Comment on Generic Drug Issues
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
2004N-0166 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
2004P-0213 Determine that Pravastatin Soduim Tablets 60mg is suitable for consideration in an abbreviated new drug application (ANDA)
2004P-0216 ANDA Suitability for Pravastatin Sodium Tablets 30 mg
2004S-0170 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
2000D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers
EC 4 US Agency for International Development Vol #: 6
EC 5 U of Texas at Austin Vol #: 6
EC 6
Attachment
Family Health International Vol #: 6
EC 7 National Women's Health Network Vol #: 6
EC 8 Planned Parenthood Federation of America, Inc. Vol #: 6
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EMC 745 Kira Patefield-Smith Vol #: 271
EMC 746 Barbara Klestzick Vol #: 271
EXB 29 CVM Vol #: 403
EXB 30 CVM Vol #: 403
EXB 31 CVM Vol #: 404
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EC 741 Veterans Affairs Medical Center Vol #: 163
EMC 6312 K. Stepp Vol #: 234
EMC 6313 M. Larson-Edwards Vol #: 234
EMC 6314 J. Rigney Vol #: 234
EMC 6315 J. Holdren Vol #: 234
EMC 6316 R. Mangio Vol #: 234
EMC 6317 G. H. Ransom Vol #: 234
EMC 6318 P. Leffmann Vol #: 234
EMC 6319 V. Lilly Vol #: 234
EMC 6320 M. Murphy Vol #: 234
EMC 6321 S. Zawadski-Meredith Vol #: 234
EMC 6322 S. Pager Vol #: 234
EMC 6323 V. Jacobi Vol #: 234
EMC 6324 S. Kramer Vol #: 234
EMC 6325 J. Gauthier Vol #: 234
EMC 6326 K. Wonnell Vol #: 234
EMC 6327 M. McClean Vol #: 234
EMC 6328 S. B. Skinner Vol #: 234
EMC 6329 A. Korzyniowski Vol #: 234
EMC 6330 L. Martin Vol #: 234
EMC 6331 M. Gillis Vol #: 234
EMC 6332 D. Porter Vol #: 234
EMC 6333 J. Stoud Vol #: 234
EMC 6334 S. Yen Vol #: 234
EMC 6335 K. Leisure Vol #: 234
EMC 6336 D. C. Whalen Vol #: 234
EMC 6337 K. Crocker Vol #: 234
EMC 6338 J. Clark Vol #: 234
EMC 6339 D. Herzog Vol #: 234
EMC 6340 C. Owen Vol #: 234
EMC 6341 T. Hayden Vol #: 234
EMC 6342 Ruth E. H. Martin Vol #: 234
EMC 6343 T. Hayden Vol #: 234
EMC 6344 M. Dixon Vol #: 234
EMC 6345 D. Whiting Vol #: 234
EMC 6346 L. Jafolla Vol #: 234
EMC 6347 L. Polya Ph. D. Vol #: 234
EMC 6348 L. Jafolla Vol #: 234
EMC 6349 C. Dunham Vol #: 234
EMC 6350 M. Malgesini Vol #: 234
EMC 6351 T. Daly Vol #: 234
EMC 6352 L. Lento Vol #: 234
EMC 6353 K. Marks Vol #: 234
EMC 6354 L. Zaitlin Vol #: 234
EMC 6355 B. Copeland Vol #: 234
EMC 6356 B. Roberts Vol #: 234
EMC 6357 R. Williams Vol #: 234
EMC 6358 A. Rapport Vol #: 234
EMC 6359 A. Megger Vol #: 234
EMC 6360 J. Thornborrow Vol #: 234
EMC 6361 J. Rawlings Vol #: 234
EMC 6362 I. Alba Vol #: 234
EMC 6363 K. Yost Vol #: 234
EMC 6364 C. D. Valle Vol #: 234
EMC 6365 G. Farmer Vol #: 234
EMC 6366 M. Geyer Vol #: 234
EMC 6367 N. Vezendi Vol #: 234
EMC 6368 S. McGee Vol #: 234
EMC 6369 J. Canale Vol #: 234
EMC 6370 A. Greene Vol #: 234
EMC 6371 G. Kelly Vol #: 234
EMC 6372 E. F. Byrne Vol #: 234
EMC 6373 K. Womack Vol #: 234
EMC 6374 A. Flournoy Vol #: 234
EMC 6375 R. Del Castillo Vol #: 234
EMC 6376 S. Stoesz Vol #: 234
EMC 6377 M. Russell Vol #: 234
EMC 6378 S. Ayres-Thomas Vol #: 234
EMC 6379 D. B. Ring Vol #: 234
EMC 6380 L. Leo Vol #: 234
EMC 6381 J. Wygand III Vol #: 234
EMC 6382 N. Scala Vol #: 234
EMC 6383 H. Newman Vol #: 234
EMC 6384 G. Chynoweth Vol #: 234
EMC 6385 N. K. Burns Vol #: 234
EMC 6386 A. Weaver Vol #: 234
EMC 6387 L. Millard Vol #: 234
EMC 6388 L. Levin Vol #: 234
EMC 6389 L. Rittinger Vol #: 234
EMC 6390 J. Richards Vol #: 234
EMC 6391 V. Castaneda Vol #: 234
EMC 6392 Y. Assefa Vol #: 234
EMC 6393 G. Powsner Vol #: 234
EMC 6394 E. Johnson Vol #: 2234
EMC 6395 P. Gilmer Vol #: 234
EMC 6396 C. Baker Vol #: 234
EMC 6397 M. Wison Vol #: 234
EMC 6398 M. Ramos Vol #: 234
EMC 6399 E. Rae Vol #: 234
EMC 6400 S. Jackson Vol #: 234
EMC 6401 B. Woehrle Vol #: 234
EMC 6402 E. Donegan Vol #: 234
EMC 6403 N. Taylor Vol #: 234
EMC 6404 K. Heinekamp Vol #: 234
EMC 6405 K. Wilson Vol #: 234
EMC 6406 R. A. Brown Vol #: 234
EMC 6407 D. Blau Vol #: 234
EMC 6408 P. Aughney Vol #: 234
EMC 6409 A. Dunn Vol #: 234
EMC 6410 B. D. Flowers Vol #: 234
EMC 6411 C. Peters Vol #: 234
EMC 6412 R. S. Chernin Vol #: 234
EMC 6413 C. Hayes Vol #: 234
EMC 6414 B. Jackson Vol #: 234
EMC 6415 A. Jacques Vol #: 234
EMC 6416 J. Groshong Vol #: 234
EMC 6417 W. Belew Vol #: 234
EMC 6418 R. Gutierrez Vol #: 234
EMC 6419 Susan k. Vol #: 234
EMC 6420 E. Foster Vol #: 234
EMC 6421 J. Herd Vol #: 234
EMC 6422 J. Heald Vol #: 234
EMC 6423 V. Brown Vol #: 234
EMC 6424 R. Duplease Vol #: 234
EMC 6425 J. Tai Vol #: 234
EMC 6426 K. Shelley Vol #: 234
EMC 6427 J. Miller Vol #: 234
EMC 6428 M. Ramaciotti Vol #: 234
EMC 6429 L. Cameron Vol #: 234
EMC 6430 L. Akers Vol #: 234
EMC 6431 R. S. Wilson Vol #: 234
EMC 6432 A. Profumo Vol #: 234
EMC 6433 G. Starrett Vol #: 234
EMC 6434 C. Rivera Vol #: 234
EMC 6435 M. Valko Vol #: 234
EMC 6436 Johnathan Conley Vol #: 234
EMC 6437 C. Giessing Vol #: 234
EMC 6438 G. Straeffer Vol #: 234
EMC 6439 O. Sargeant Vol #: 234
EMC 6440 S. Keeney Vol #: 234
EMC 6441 V. Mullins Vol #: 234
EMC 6442 C. Cammann Vol #: 234
EMC 6443 R. Hardy Vol #: 234
EMC 6444 L. Florio Vol #: 234
EMC 6445 F. Romero Vol #: 234
EMC 6446 E. Bingham Vol #: 234
EMC 6447 C. Parker Vol #: 234
EMC 6448 M. Jones Vol #: 234
EMC 6449 B. Pittsley Vol #: 234
EMC 6450 J. Omori Vol #: 234
EMC 6451 M. Jones Vol #: 234
EMC 6452 A. Harper Vol #: 234
EMC 6453 S. Stivers Vol #: 234
EMC 6454 M. Bronson Vol #: 234
EMC 6455 E. McFarlane Vol #: 234
EMC 6456 E. M. Macy Vol #: 234
EMC 6457 A. Carson Vol #: 234
EMC 6458 A. Keane-Evertz Vol #: 234
EMC 6459 J. Walsh Vol #: 234
EMC 6460 C. Dare Vol #: 234
EMC 6461 P. Drummond Vol #: 234
EMC 6462 C. Dare Vol #: 234
EMC 6463 B. Arvin Vol #: 234
EMC 6464 A. Johnson Vol #: 234
EMC 6465 M. Keller Vol #: 234
EMC 6466 A. Kreps-Long Vol #: 234
EMC 6467 A. Kessler Vol #: 234
EMC 6468 A. Cantrell Vol #: 234
EMC 6469 S. Groden Vol #: 234
EMC 6470 A. Wolfe Vol #: 234
EMC 6471 B. McComas Vol #: 234
EMC 6472 H. Adams Vol #: 234
EMC 6473 N. Stockert Vol #: 234
EMC 6474 G. May Vol #: 234
EMC 6475 S. Kuzmanoff Vol #: 234
EMC 6476 D. Grimesey Vol #: 234
EMC 6477 M. Brostrom Vol #: 234
EMC 6478 J. P. McCarthy Vol #: 234
EMC 6479 S. Stachowiak Vol #: 234
EMC 6480 Y. Valdez Vol #: 234
EMC 6481 S. Fox-Loken Vol #: 234
EMC 6482 E. B. Lyons Vol #: 234
EMC 6483 C. O'Connell Vol #: 234
EMC 6484 L. Bassett Vol #: 234
EMC 6485 G. Zuckier Vol #: 234
EMC 6486 E. P. Spalding Vol #: 234
EMC 6487 A. Kanuha Vol #: 234
EMC 6488 C. Douglas Vol #: 234
EMC 6489 B. S. Bissell Vol #: 234
EMC 6490 M. Higgins Vol #: 234
EMC 6491 S. Sprague Vol #: 234
EMC 6492 M. Birney Vol #: 234
EMC 6493 S. Potter Vol #: 234
EMC 6494 C. Messina Vol #: 234
EMC 6495 E. Snyder Vol #: 234
EMC 6496 M. Riggs Vol #: 234
EMC 6497 D. Erickson Vol #: 234
EMC 6498 L. Day Vol #: 234
EMC 6499 A. Ayotte Vol #: 234
EMC 6500 S. Attar Vol #: 234
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
EC 403 Umina Bros. Inc. Vol #: 22
EC 404 MISSION PRODUCE, INC Vol #: 22
2004D-0042 Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
EC 4 Advertising Standards Authority (New Zealand) Vol #: 1
2004M-0199 P030032 - Hylaform (hylan B gel)
AAV 1 Genzyme Corp. Vol #: 1
2004M-0200 P010014 - Oxford Meniscal Unicompartmental Knee System
AAV 1 Biomet, Inc. Vol #: 1
2004M-0207 P970027 - Abbott AxSYM Anti-HCV
AAV 1 Abbott Laboratories Vol #: 1
2004N-0087 Request for Comment on Generic Drug Issues
EC 2 Intellectual Property Owners Association (IPO) Vol #: 1
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
EC 3 QAD, Inc. Vol #: 1
2004N-0166 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Feeding Practices Study II
EC 1 public citizen Vol #: 1
2004P-0213 Determine that Pravastatin Soduim Tablets 60mg is suitable for consideration in an abbreviated new drug application (ANDA)
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1
Attachment 1, 2
Lachman Consultant Services, Inc. Vol #: 1
2004P-0216 ANDA Suitability for Pravastatin Sodium Tablets 30 mg
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1
Attachment 1, 2
Lachman Consultant Services, Inc. Vol #: 1
2004S-0170 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
EC 6 Dr. David Eddy Vol #: 1
EC 7 MissouriPRO Vol #: 1
EC 8 PacifiCare Vol #: 1
EC 9
Attachment
Rural Policy Research Institute Health Panel Vol #: 1
EC 10 The Cleveland Clinic Foundation Vol #: 1

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