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| Dockets
Entered On February 11, 2004
Table of Contents
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|
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| |
|
|
| Docket #
|
| Title
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|
|
|
|
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2001P-0471
|
| Issue the NFR Placement of Anthrax Vaccine as Category II
|
| |
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
| |
|
|
| 2002P-0267
|
| Amend Mammography Quality Standards Act & FOIA
|
| |
|
|
| 2002P-0472
|
| Petition to Post Statement in Response to Warning Letter
|
| |
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| 2003N-0529
|
| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
|
| |
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| C
15
|
| City of Austin/Travis County Emergency Services Clinical Partnership
|
| Vol #:
|
| 23
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12650
|
| PEZ International AG
|
| Vol #:
|
| 103
|
| |
|
|
| LET
12651
|
| PEZ International AG
|
| Vol #:
|
| 103
|
|
| |
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7378
|
| H. Lyons
|
| Vol #:
|
| 307
|
| |
|
|
| C 7379
|
| E. Manheim
|
| Vol #:
|
| 307
|
| |
|
|
| C 7380
|
| Eligible
|
| Vol #:
|
| 307
|
| |
|
|
| C 7381
|
| J. Mckenzie
|
| Vol #:
|
| 307
|
| |
|
|
| C 7382
|
| M. Fritz
|
| Vol #:
|
| 307
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 356
|
| K. Park
|
| Vol #:
|
| 162
|
| |
|
|
| EC 355
|
| Hughes, Melinda
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 356
|
| Granberg, Lori
|
| Vol #:
|
| 163
|
| |
|
|
| EC 357
|
| Anderson, Kerry
|
| Vol #:
|
| 163
|
| |
|
|
| EC 358
|
| Lenyo, Elaine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 359
|
| Aubrey, Robert F.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 360
|
| Guthrie, Carol
|
| Vol #:
|
| 163
|
| |
|
|
| EC 361
|
| Tyler, Frank
|
| Vol #:
|
| 163
|
| |
|
|
| EC 362
|
| White, Pat
|
| Vol #:
|
| 163
|
| |
|
|
| EC 363
|
| Stewart, Melissa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 364
|
| Leger, Dalton
|
| Vol #:
|
| 163
|
| |
|
|
| EC 365
|
| Goldenberg, Rabbi Rachel
|
| Vol #:
|
| 163
|
| |
|
|
| EC 366
|
| Robinson, Paul
|
| Vol #:
|
| 163
|
| |
|
|
| EC 367
|
| Foldberg, Carrie
|
| Vol #:
|
| 163
|
| |
|
|
| EC 368
|
| Carlton, Robert
|
| Vol #:
|
| 163
|
| |
|
|
| EC 369
|
| McMenamin, Kathy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 370
|
| Haines, Susan
|
| Vol #:
|
| 163
|
| |
|
|
| EC 371
|
| magnopope, martha
|
| Vol #:
|
| 163
|
| |
|
|
| EC 372
|
| Stuck, K
|
| Vol #:
|
| 163
|
| |
|
|
| EC 373
|
| Maloy, Kimberly
|
| Vol #:
|
| 163
|
| |
|
|
| EC 374
|
| Basnett, Cindy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 375
|
| Thurman, Judith
|
| Vol #:
|
| 163
|
| |
|
|
| EC 376
|
| Realini, Janet
|
| Vol #:
|
| 163
|
| |
|
|
| EC 377
|
| mueller, gina
|
| Vol #:
|
| 163
|
| |
|
|
| EC 378
|
| Calhoun, Byron
|
| Vol #:
|
| 163
|
| |
|
|
| EC 379
|
| McMaster, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 380
|
| Donahue, Mary
|
| Vol #:
|
| 163
|
| |
|
|
| EC 381
|
| Gres, Aaron
|
| Vol #:
|
| 163
|
| |
|
|
| EC 382
|
| Just, John
|
| Vol #:
|
| 163
|
| |
|
|
| EC 383
|
| Watson, Mary
|
| Vol #:
|
| 163
|
| |
|
|
| EC 384
|
| Taylor, Anna
|
| Vol #:
|
| 163
|
| |
|
|
| EC 385
|
| Landau, Lorraine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 386
|
| White, Nicolle
|
| Vol #:
|
| 163
|
| |
|
|
| EC 387
|
| Crawford, John
|
| Vol #:
|
| 163
|
| |
|
|
| EC 388
|
| Fountaine, Dessa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 389
|
| Tomutsa, Catherine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 390
|
| Tyler, Kas
|
| Vol #:
|
| 163
|
| |
|
|
| EC 391
|
| Siex, Dwayne
|
| Vol #:
|
| 163
|
| |
|
|
| EC 392
|
| Johnson, Shawn and Tanya
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 393
|
| Echols, Tim
|
| Vol #:
|
| 163
|
| |
|
|
| EC 394
|
| Caldwell, Annette
|
| Vol #:
|
| 163
|
| |
|
|
| EC 395
|
| York, Jessica
|
| Vol #:
|
| 163
|
| |
|
|
| EC 396
|
| Beninati, Daniel
|
| Vol #:
|
| 163
|
| |
|
|
| EC 397
|
| Rivera, Elizabeth
|
| Vol #:
|
| 163
|
| |
|
|
| EC 398
|
| Hess, Claire
|
| Vol #:
|
| 163
|
| |
|
|
| EC 399
|
| Pratt, Kim
|
| Vol #:
|
| 163
|
| |
|
|
| EC 400
|
| Cloud, Barbara R.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 401
|
| Secchio, Debora
|
| Vol #:
|
| 163
|
| |
|
|
| EC 402
|
| McGraw, Dennis
|
| Vol #:
|
| 163
|
| |
|
|
| EC 403
|
| Smith, Andre
|
| Vol #:
|
| 163
|
| |
|
|
| EC 404
|
| Williams, Joanna
|
| Vol #:
|
| 163
|
| |
|
|
| EC 405
|
| arellano, m
|
| Vol #:
|
| 163
|
| |
|
|
| EC 406
|
| Taylor, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 407
|
| Rich, Justin
|
| Vol #:
|
| 163
|
| |
|
|
| EC 408
|
| White, James
|
| Vol #:
|
| 163
|
| |
|
|
| EC 409
|
| Piepho, Rae
|
| Vol #:
|
| 163
|
| |
|
|
| EC 410
|
| Grass, Donna
|
| Vol #:
|
| 163
|
| |
|
|
| EC 411
|
| Thomas, Teresa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 412
|
| Steidl, Roxanne
|
| Vol #:
|
| 163
|
| |
|
|
| EC 413
|
| Ross, Bette
|
| Vol #:
|
| 163
|
| |
|
|
| EC 414
|
| Azar, Jeanene
|
| Vol #:
|
| 163
|
| |
|
|
| EC 415
|
| DeLong, Sara
|
| Vol #:
|
| 163
|
| |
|
|
| EC 416
|
| Huband, Stephanie
|
| Vol #:
|
| 163
|
| |
|
|
| EC 417
|
| Piazza, Melissa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 418
|
| Monroe, Tona
|
| Vol #:
|
| 163
|
| |
|
|
| EC 419
|
| Lacek, Margaret
|
| Vol #:
|
| 163
|
| |
|
|
| EC 420
|
| EVANSGARDNER, J. E.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 421
|
| Russo, David
|
| Vol #:
|
| 163
|
| |
|
|
| EC 422
|
| Hand, Erika
|
| Vol #:
|
| 163
|
| |
|
|
| EC 423
|
| Dickeson, Angela
|
| Vol #:
|
| 163
|
| |
|
|
| EC 424
|
| Lawrence, Harriet
|
| Vol #:
|
| 163
|
| |
|
|
| EC 425
|
| Kimball/Graham, Shelly
|
| Vol #:
|
| 163
|
| |
|
|
| EC 426
|
| butkiewicz, caroline
|
| Vol #:
|
| 163
|
| |
|
|
| EC 427
|
| Baldwin, R.David
|
| Vol #:
|
| 163
|
| |
|
|
| EC 428
|
| Nussbaum, Irene
|
| Vol #:
|
| 163
|
| |
|
|
| EC 429
|
| Sundberg, Susie
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 430
|
| Stout, Audrey
|
| Vol #:
|
| 163
|
| |
|
|
| EC 431
|
| Singhasri, Lalita
|
| Vol #:
|
| 163
|
| |
|
|
| EC 432
|
| Tobin, Lorette
|
| Vol #:
|
| 163
|
| |
|
|
| EC 433
|
| Gifford, Martha E.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 434
|
| Blanca, Susan
|
| Vol #:
|
| 163
|
| |
|
|
| EC 435
|
| McGill, Bridget
|
| Vol #:
|
| 163
|
| |
|
|
| EC 436
|
| Weil, Louise
|
| Vol #:
|
| 163
|
| |
|
|
| EC 437
|
| Weil, Louise
|
| Vol #:
|
| 163
|
| |
|
|
| EC 438
|
| Douglas, Alexandrea
|
| Vol #:
|
| 163
|
| |
|
|
| EC 439
|
| Kotyuk, Gerald
|
| Vol #:
|
| 163
|
| |
|
|
| EC 440
|
| Lynch, Catherine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 441
|
| Kipp, William
|
| Vol #:
|
| 163
|
| |
|
|
| EC 442
|
| Canadeo, Daniel
|
| Vol #:
|
| 163
|
| |
|
|
| EC 443
|
| Fleming, Philip
|
| Vol #:
|
| 163
|
| |
|
|
| EC 444
|
| McMillan, M.N.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 445
|
| Kramer, Lisa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 446
|
| Kramer, Brenda
|
| Vol #:
|
| 163
|
| |
|
|
| EC 447
|
| Potempa, Jennifer
|
| Vol #:
|
| 163
|
| |
|
|
| EC 448
|
| CLARK, DIANA
|
| Vol #:
|
| 163
|
| |
|
|
| EC 449
|
| Pascuzzi, Elizabeth
|
| Vol #:
|
| 163
|
| |
|
|
| EC 450
|
| Greenberg, Gary
|
| Vol #:
|
| 163
|
| |
|
|
| EC 451
|
| Fiorella, Michelle
|
| Vol #:
|
| 163
|
| |
|
|
| EC 452
|
| Mixon, JB
|
| Vol #:
|
| 163
|
| |
|
|
| EC 453
|
| Nickels, Angela
|
| Vol #:
|
| 163
|
| |
|
|
| EC 454
|
| Gedaminski, Lauren
|
| Vol #:
|
| 163
|
| |
|
|
| EC 455
|
| Miller, Merrilee
|
| Vol #:
|
| 163
|
| |
|
|
| EC 456
|
| Ralston, Susan
|
| Vol #:
|
| 163
|
| |
|
|
| EC 457
|
| Laties, Martha
|
| Vol #:
|
| 163
|
| |
|
|
| EC 458
|
| Forburger, Dianne
|
| Vol #:
|
| 163
|
| |
|
|
| EC 459
|
| Hedberg, Viking
|
| Vol #:
|
| 163
|
| |
|
|
| EC 460
|
| Andreski, Michael
|
| Vol #:
|
| 163
|
| |
|
|
| EC 461
|
| Roach, Deborah
|
| Vol #:
|
| 163
|
| |
|
|
| EC 462
|
| Sutton, Kay
|
| Vol #:
|
| 163
|
| |
|
|
| EC 463
|
| Holdridge, Douglas
|
| Vol #:
|
| 163
|
| |
|
|
| EC 464
|
| Nelson, Vicki
|
| Vol #:
|
| 163
|
| |
|
|
| EC 465
|
| Balm-Demmel, Darline
|
| Vol #:
|
| 163
|
| |
|
|
| EC 466
|
| Martin, Anita
|
| Vol #:
|
| 163
|
|
| | | | | | | | |
| |
|
|
| EC 467
|
| Darweesh, Judith
|
| Vol #:
|
| 163
|
| |
|
|
| EC 468
|
| Stennett, Edwin
|
| Vol #:
|
| 163
|
| |
|
|
| EC 469
|
| Rosenberg, Hiram
|
| Vol #:
|
| 163
|
| |
|
|
| EC 470
|
| Centeno, Rosa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 471
|
| Rusk, Margaret
|
| Vol #:
|
| 163
|
| |
|
|
| EC 472
|
| Roberts, Carol
|
| Vol #:
|
| 163
|
| |
|
|
| EC 473
|
| Waldron, Abigail
|
| Vol #:
|
| 163
|
| |
|
|
| EC 474
|
| Benedetto, Susan
|
| Vol #:
|
| 163
|
| |
|
|
| EC 475
|
| Nelson, Nicola
|
| Vol #:
|
| 163
|
| |
|
|
| EC 476
|
| Houk, Randall
|
| Vol #:
|
| 163
|
| |
|
|
| EC 479
|
| Metzger, Hannah
|
| Vol #:
|
| 163
|
| |
|
|
| EC 480
|
| Hilse, Regina S.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 481
|
| Bowes, Maxine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 482
|
| Smarr, Janet
|
| Vol #:
|
| 163
|
| |
|
|
| EC 483
|
| Nelson, Elaine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 484
|
| Webster, Margaret L.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 485
|
| Danielson, Jessica
|
| Vol #:
|
| 163
|
| |
|
|
| EC 486
|
| Rodriguez, Diana
|
| Vol #:
|
| 163
|
| |
|
|
| EC 487
|
| Bayles, Britt
|
| Vol #:
|
| 163
|
| |
|
|
| EC 488
|
| Johnson, Derek
|
| Vol #:
|
| 163
|
| |
|
|
| EC 489
|
| Bedell, Mary
|
| Vol #:
|
| 163
|
| |
|
|
| EC 490
|
| Carroll, Sean
|
| Vol #:
|
| 163
|
| |
|
|
| EC 491
|
| Durant, Katherine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 492
|
| Sunderland, Douglas
|
| Vol #:
|
| 163
|
| |
|
|
| 2001P-0471
|
| Issue the NFR Placement of Anthrax Vaccine as Category II
|
| |
|
|
| REF
1
Tab
D
|
| REFERENCE
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
| |
|
|
| C
53
|
| Doctors' Research, Inc.
|
| Vol #:
|
| 4
|
|
| |
|
| 2002P-0267
|
| Amend Mammography Quality Standards Act & FOIA
|
| |
|
|
| PAV
1
|
| HF-11 to Nocona General Hospital
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0472
|
| Petition to Post Statement in Response to Warning Letter
|
| |
|
|
| PAV
1
|
| HF-11 to Zuckerman Spaeder, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
| |
|
|
| EMC
3
|
| Japan Pharmaceutical Manufacturers Assn (JPMA)
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| EMC
4
Attachment
|
| GlaxoSmithKline
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
5
Attachments
|
| European Bioinformatics Institute (EBI)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
6
|
| Merck & Co., Inc. (Merck)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
7
|
| Abbott Laboratories
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
8
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
9
|
| NIH
|
| Vol #:
|
| 2
|
| |
|
|
| 2003D-0498
|
| Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
|
| |
|
|
| EC 7
|
| Forcier, jeff
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| EMC
1
|
| FAME Systems
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| C 17
|
| A. Elster, MD
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0529
|
| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
|
| |
|
|
| EMC
2
|
| Merck & Co., inc. (Merck)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
3
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
4
|
| National Medical Assn (NMA)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
5
Attachment
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
6
Attachment
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
| |
|
|
| SUP
2
|
| Abbott Laboratories
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| C
14
|
| International Hearing Society (IHS)
|
| Vol #:
|
| 2
|
| |
|
|
| C
15
|
| Hearing Centers Network
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| C
4
|
| International Hearing Society (IHS)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Hearing Centers Netwrok
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
| | | | | | | | |
| |
|
|
| SUP
3
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 4
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| EMC 2
|
| J. Friedberg, MD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 3
|
| J. Friedberg, MD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 4
|
| B. Karon, PhD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 5
|
| S. Rogers
|
| Vol #:
|
| 2
|
|
|
|
