| | | | | | | | | | |
| |
|
|
| Dockets Entered On
March 9, 2004
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1980N-0418
|
| Deletion of GRAS Status of Caffeine
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| 1995S-0117
|
| Human Drugs Patent Term Extension & New Patents
|
| |
|
|
| 1997D-0530
|
| Use of IEC 60601 Standards; Medical Electrical;
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| 2003D-0379
|
| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
|
| |
|
|
| 2003D-0493
|
| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
| |
|
|
| 2003D-0553
|
| Guidance on Developing Drugs to Mitigate the Complications Associated With Vaccinia Virus Used for Smallpox Vaccination
|
| |
|
|
| 2003N-0222
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications
|
| |
|
|
| 2003N-0302
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling
|
| |
|
|
| 2003N-0508
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
|
| |
|
|
| 2003N-0542
|
| Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
|
| |
|
|
| 2004N-0079
|
| Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of Geriatric Use Subsection in the Labeling
|
| |
|
|
| 2004N-0089
|
| Antimicrobial Drug Development; Public Workshop
|
| |
|
|
| 2004P-0048
|
| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
|
| |
|
|
| 2004P-0122
|
| Petition to Remove Category X Categorization for Estradiol in Use-in-Pregnancy Labeling
|
| |
|
|
| 2004V-0119
|
| Laser Light Show
|
| |
|
|
| 2004V-0120
|
| Laser Light Show
|
| |
|
|
| 2004V-0121
|
| Laser Light Show
|
| |
|
|
| 1980N-0418
|
| Deletion of GRAS Status of Caffeine
|
|
|
| BKG 1
|
| Background Material
|
| Vol #:
|
| 22
|
| |
|
|
| 1993D-0398
|
| Microbiological Testing Antimicrobial Drug Residues in Foods
|
| |
|
|
| EC 1
|
| Safdar, Shabbir
|
| Vol #:
|
| 1
|
| |
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 23
|
| |
|
|
| 1995S-0117
|
| Human Drugs Patent Term Extension & New Patents
|
| |
|
|
| RPT 90
|
| List as of March 2, 2004
|
| Vol #:
|
| 7
|
| |
|
|
| 1997D-0530
|
| Use of IEC 60601 Standards; Medical Electrical;
|
| |
|
|
| NAD
9
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
| | | | | | | | |
| |
|
|
| LET
13105
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13106
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13107
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13108
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13109
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13110
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13111
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13112
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13113
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13114
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13115
|
| NBTY Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13116
|
| Melaleuca, Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13117
|
| Pure Encapsulations, Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13118
|
| Mannatech Incorporated
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13119
|
| Sato Pharmaceutical Co., Ltd.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13120
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13121
|
| Applied Medical System, Inc.
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13122
|
| PMAI
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13123
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13124
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13125
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 106
|
| |
|
|
| LET
13126
|
| Pharmanex, LLC
|
| Vol #:
|
| 106
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EC 516
|
| Jackson, Nedra
|
| Vol #:
|
| 163
|
| |
|
|
| EC 517
|
| Biswell, Chris
|
| Vol #:
|
| 163
|
| |
|
|
| EC 518
|
| Mobley, Barbara
|
| Vol #:
|
| 163
|
| |
|
|
| EC 519
|
| Socher, Michael
|
| Vol #:
|
| 163
|
| |
|
|
| EC 520
|
| Hinton, Jamie
|
| Vol #:
|
| 163
|
| |
|
|
| EC 521
|
| Elmore, David
|
| Vol #:
|
| 163
|
| |
|
|
| EC 522
|
| Byrne, William
|
| Vol #:
|
| 163
|
| |
|
|
| EC 523
|
| Morse, Bevinne
|
| Vol #:
|
| 163
|
| |
|
|
| EC 524
|
| Rosenberg, Naomi
|
| Vol #:
|
| 163
|
| |
|
|
| EC 525
|
| Troy, Patrick
|
| Vol #:
|
| 163
|
| |
|
|
| EC 526
|
| Clayton, Cyle
|
| Vol #:
|
| 163
|
| |
|
|
| EC 527
|
| Walls, Mark
|
| Vol #:
|
| 163
|
| |
|
|
| EC 528
|
| Mangieri-Omps, Elizabeth
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 529
|
| Mc Cue, John
|
| Vol #:
|
| 163
|
| |
|
|
| EC 530
|
| lowery, janet
|
| Vol #:
|
| 163
|
| |
|
|
| EC 531
|
| pierce, victoria
|
| Vol #:
|
| 163
|
| |
|
|
| EC 532
|
| Manring, Edward
|
| Vol #:
|
| 163
|
| |
|
|
| EC 533
|
| Lynch, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 534
|
| Thome, Marian
|
| Vol #:
|
| 163
|
| |
|
|
| EC 535
|
| Gilson, Sherry
|
| Vol #:
|
| 163
|
| |
|
|
| EC 536
|
| Hilburn, Jacqueline
|
| Vol #:
|
| 163
|
| |
|
|
| EC 537
|
| Dees, Melissa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 538
|
| Tan, Amy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 539
|
| Garigan, Thomas
|
| Vol #:
|
| 163
|
| |
|
|
| EC 540
|
| O'Loughlin, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 541
|
| Naliboff, Jay
|
| Vol #:
|
| 163
|
| |
|
|
| EC 542
|
| Burton, William
|
| Vol #:
|
| 163
|
| |
|
|
| EC 543
|
| Talkington, Margaret
|
| Vol #:
|
| 163
|
| |
|
|
| EC 544
|
| Hammond, Janie
|
| Vol #:
|
| 163
|
| |
|
|
| EC 545
|
| Reilly, Melissa
|
| Vol #:
|
| 163
|
| |
|
|
| EC 546
|
| Crittenden, Linda
|
| Vol #:
|
| 163
|
| |
|
|
| EC 547
|
| King, Janis
|
| Vol #:
|
| 163
|
| |
|
|
| EC 548
|
| Lehmann, Eileen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 549
|
| May, Jennifer
|
| Vol #:
|
| 163
|
| |
|
|
| EC 550
|
| Olson, Mary Lu
|
| Vol #:
|
| 163
|
| |
|
|
| EC 551
|
| Harrison, Patricia
|
| Vol #:
|
| 163
|
| |
|
|
| EC 552
|
| charles, maureen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 553
|
| Winder, Elizabeth
|
| Vol #:
|
| 163
|
| |
|
|
| EC 554
|
| Freeman, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 555
|
| Winder, Clarence
|
| Vol #:
|
| 163
|
| |
|
|
| EC 556
|
| Gilzean, Susan
|
| Vol #:
|
| 163
|
| |
|
|
| EC 557
|
| Williams, Joanna
|
| Vol #:
|
| 163
|
| |
|
|
| EC 558
|
| Walton, Brian
|
| Vol #:
|
| 163
|
| |
|
|
| EC 559
|
| Dennison, Timothy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 560
|
| Fisher, Leah
|
| Vol #:
|
| 163
|
| |
|
|
| EC 561
|
| delory, mercedes
|
| Vol #:
|
| 163
|
| |
|
|
| EC 562
|
| Donatelli, Audrey
|
| Vol #:
|
| 163
|
| |
|
|
| EC 563
|
| Foster, Michael
|
| Vol #:
|
| 163
|
| |
|
|
| EC 564
|
| Cohen, Irma
|
| Vol #:
|
| 163
|
| |
|
|
| EC 565
|
| Freemyer, Lori
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 566
|
| Campbell, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 567
|
| Lewis, Paul
|
| Vol #:
|
| 163
|
| |
|
|
| EC 568
|
| wolfe, melinda
|
| Vol #:
|
| 163
|
| |
|
|
| EC 569
|
| Sheetz, Marlene Hartman
|
| Vol #:
|
| 163
|
| |
|
|
| EC 570
|
| Bell, Patricia
|
| Vol #:
|
| 163
|
| |
|
|
| EC 571
|
| Carsten, Diana
|
| Vol #:
|
| 163
|
| |
|
|
| EC 572
|
| Walker, James
|
| Vol #:
|
| 163
|
| |
|
|
| EC 573
|
| Smith, Sandra
|
| Vol #:
|
| 163
|
| |
|
|
| EC 574
|
| Blum, Marilyn
|
| Vol #:
|
| 163
|
| |
|
|
| EC 575
|
| Meehan-Crossley, Melanie
|
| Vol #:
|
| 163
|
| |
|
|
| EC 576
|
| wolf, anita
|
| Vol #:
|
| 163
|
| |
|
|
| EC 577
|
| kirnig, ann
|
| Vol #:
|
| 163
|
| |
|
|
| EC 578
|
| Thomas, Carroll
|
| Vol #:
|
| 163
|
| |
|
|
| EC 579
|
| Morse, JOHN
|
| Vol #:
|
| 163
|
| |
|
|
| EC 580
|
| hertwig, sara
|
| Vol #:
|
| 163
|
| |
|
|
| EC 581
|
| Smith, Angela D.
|
| Vol #:
|
| 163
|
| |
|
|
| EC 582
|
| Jaynes, Amy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 583
|
| WEHNER, MICHAEL
|
| Vol #:
|
| 163
|
| |
|
|
| EC 584
|
| Bannon, Russ
|
| Vol #:
|
| 163
|
| |
|
|
| EC 585
|
| Revello, Gary
|
| Vol #:
|
| 163
|
| |
|
|
| EC 586
|
| Kuhn, Jill
|
| Vol #:
|
| 163
|
| |
|
|
| EC 587
|
| Perrin, Barbara
|
| Vol #:
|
| 163
|
| |
|
|
| EC 588
|
| Bormann, Kathy
|
| Vol #:
|
| 163
|
| |
|
|
| EC 589
|
| Norris, Virginia
|
| Vol #:
|
| 163
|
| |
|
|
| EC 590
|
| VanCuren, James
|
| Vol #:
|
| 163
|
| |
|
|
| EC 591
|
| jacobson, george
|
| Vol #:
|
| 163
|
| |
|
|
| EC 592
|
| Reback, Mark
|
| Vol #:
|
| 163
|
| |
|
|
| EC 593
|
| Susang-Talamo, MD, Barbara
|
| Vol #:
|
| 163
|
| |
|
|
| EC 594
|
| Draper, Michael
|
| Vol #:
|
| 163
|
| |
|
|
| EC 595
|
| Shores, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 596
|
| Pham, Jaime
|
| Vol #:
|
| 163
|
| |
|
|
| EC 597
|
| haddad, shirley
|
| Vol #:
|
| 163
|
| |
|
|
| EC 598
|
| Lang, David
|
| Vol #:
|
| 163
|
| |
|
|
| EC 599
|
| O'Connell, Kathleen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 600
|
| Hansen, Karen
|
| Vol #:
|
| 163
|
| |
|
|
| EC 601
|
| Bergen, Doris
|
| Vol #:
|
| 163
|
| |
|
|
| EC 602
|
| Davies, Janet
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 603
|
| Dalton, Jennifer
|
| Vol #:
|
| 163
|
| |
|
|
| EMC 3773
|
| M.Gross
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3774
|
| M. Marling
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3775
|
| J. Knoten
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3776
|
| R. Eckhart
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3777
|
| L. Milhaven
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3778
|
| M. Chapman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3779
|
| Rev. Louisa
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3780
|
| A. Lary
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3781
|
| J. Flores
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3782
|
| S. Camp-Goodman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3783
|
| N. Kuhn
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3784
|
| S. W. Baker
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3785
|
| R. Bush
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3786
|
| K. Reske
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3787
|
| I. Page-Echols
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3788
|
| G. Zahner
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3789
|
| Dr. B. Johnson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3790
|
| N. Curran
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3791
|
| A. Elbers
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3792
|
| C. J. Chrispher
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3793
|
| J. Morgan
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3794
|
| R. Danley-Kilgo
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3795
|
| M. Sisson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3796
|
| B. A. Hall
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3797
|
| L. Smith
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3798
|
| S. Stangby
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3799
|
| D. M. Petrie
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3800
|
| L. Lumiere
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3801
|
| M. King
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3802
|
| D. Wagner
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3803
|
| A. Gazdag
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3804
|
| J. Redmon
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3805
|
| R. Young
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3806
|
| M. Daugherty
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3807
|
| M. Meyer
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3808
|
| J. Cholette
|
| Vol #:
|
| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3809
|
| E. T
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3810
|
| M. Yoder
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3811
|
| M. Polk
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3812
|
| M. C. Adams
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3813
|
| R. Frederick
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3814
|
| T. A. Spong
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3815
|
| P. Bonney
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3816
|
| M. Wilson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3817
|
| S. Veillette
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3818
|
| R. Hunt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3819
|
| B. Galagan
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3820
|
| R. Hollenbach
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3821
|
| D. Willey
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3822
|
| D. Sinclair
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3823
|
| N. Childs
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3824
|
| B. Hubbard
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3825
|
| J. F. Elrod
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3826
|
| E. Davis
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3827
|
| T. Bautz
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3828
|
| M. Brizzolara
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3829
|
| J. Meyer
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3830
|
| J. Freewoman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3831
|
| L. Joffe
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3832
|
| K. Rudd
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3833
|
| R. E. Blenheim
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3834
|
| D. Crawford
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3835
|
| J. L. Spotts
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3836
|
| G. Peterson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3837
|
| M. Nardiello
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3838
|
| F. M. Puchi
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3839
|
| H. McNamara
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3840
|
| F.G. Holmes
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3841
|
| L. Lawler
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3842
|
| D. Greene
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3843
|
| G. Bridges
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3844
|
| J. D. Chazin
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3845
|
| A. Fonfa
|
| Vol #:
|
| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3846
|
| J. Atkin
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3847
|
| A. Bradley
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3848
|
| T. Moore
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3849
|
| L. Schmidt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3850
|
| M. Ullman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3851
|
| J. L. Ingress
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3852
|
| D. Russo
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3853
|
| B. Morris
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3854
|
| D. Lander
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3855
|
| M. Mitchell
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3856
|
| B. Meyer
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3857
|
| T. J. Walsh
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3858
|
| A.A. Elder
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3859
|
| D. Beane
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3860
|
| I. Linssen
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3861
|
| D. Heslop
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3862
|
| C. Farsadi
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3863
|
| S. Lewis
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3864
|
| D. Cromer
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3865
|
| S. Shaiman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3866
|
| L. Lawton
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3867
|
| P. C. Lauenstein
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3868
|
| K. Nethercutt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3869
|
| D. Pell
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3870
|
| B. J. Grasso
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3871
|
| H. A. Bagnall
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3872
|
| D. Zeeb
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3873
|
| C. Partain
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3874
|
| J. Smith
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3875
|
| J. T. Alexander
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3876
|
| S. Ranney
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3877
|
| M. D. Fahey
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3878
|
| G. Thompson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3879
|
| J. S.
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3880
|
| M. Raushenbush
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3881
|
| G. Flackett
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3882
|
| D. C. Galante
|
| Vol #:
|
| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3883
|
| D. C. Galante
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3884
|
| K. Pond
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3885
|
| R. Sloan
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3886
|
| M. Hoffman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3887
|
| S. Howland
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3888
|
| Dr. W. B. Robinson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3889
|
| J. Freedriksen
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3890
|
| K. Campbell
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3891
|
| T. Holman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3892
|
| E. Kaczman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3893
|
| J. Herzig
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3894
|
| K. Buss
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3895
|
| P. Hugins
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3896
|
| A. Jefferson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3897
|
| C. A. Rocker
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3898
|
| K. Donnelly
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3899
|
| T. Carter
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3900
|
| A. Johnson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3901
|
| J. Mootry
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3902
|
| D. L. Zinn
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3903
|
| V. Hill
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3904
|
| L. Altenberg
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3905
|
| J. Cattrall
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3906
|
| D. Proctor
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3907
|
| A. M. Jackson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3908
|
| R. Sheaff
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3909
|
| J. Wrobel
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3910
|
| C. Brandt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3911
|
| J. Anderson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3912
|
| J. Peterson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3913
|
| G. S. Williams
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3914
|
| J. Lapkiewicz
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3915
|
| A. G. Loeb
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3916
|
| J. D. Wilson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3917
|
| S. B. Jewell
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3918
|
| L. Kahokualohi
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3919
|
| D. Romer
|
| Vol #:
|
| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3920
|
| A. L. Roland
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3921
|
| R. Simon
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3922
|
| R. Zankiw
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3923
|
| P. Santangelo
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3924
|
| T. G. Kirby
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3925
|
| E. E. Grimes
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3926
|
| Beverly Ammons
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3927
|
| M. A. Robinson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3928
|
| E. McDonald
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3929
|
| P. Brown
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3930
|
| T. Daniels
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3931
|
| K. Beard
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3932
|
| K. G. Thomas
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3933
|
| S. Manno
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3934
|
| R. Newman
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3935
|
| L. Parker
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3936
|
| A. Zorthian
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3937
|
| M. Washington
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3938
|
| A. Monat
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3939
|
| G. Martin
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3940
|
| K. King
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3941
|
| K. Nagel
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3942
|
| G. Owens
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3943
|
| R. Stephens
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3944
|
| S. MacDonald
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3945
|
| N. Abt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3946
|
| R. Mcteer-Ramirez
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3947
|
| H. Corneli
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3948
|
| J. Sachs
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3949
|
| A Frick
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3950
|
| D. Haugo
|
| Vol #:
|
| 162
|
| |
|
|
| EMC 3951
|
| A. Sadanand
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3952
|
| C. Lutness
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3953
|
| D. Himaya
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3954
|
| R. Doehn
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3955
|
| T. Walter
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3956
|
| P. Landres
|
| Vol #:
|
| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3957
|
| J. Anderson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3958
|
| B. Arzuaga
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3959
|
| P. Stucker
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3960
|
| H. W. Goolsby
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3961
|
| J. Gaintomasi
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3962
|
| M. Ehrhard
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3963
|
| B. Duchene
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3964
|
| E. Molina
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3965
|
| M. Jackson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3966
|
| T. Blaney
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3967
|
| L. Paschke
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3968
|
| G. Little
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3969
|
| M. Nazari
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3970
|
| S. Rudy
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3971
|
| S. Truss
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3972
|
| P. Legge
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3973
|
| K. Mikuliak
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3974
|
| M. Wolf
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3975
|
| A. J. Brown
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3976
|
| S. Khalili
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3977
|
| F. Purser
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3978
|
| P. Frank
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3979
|
| R. Geiger
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3980
|
| J. Wyant
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3981
|
| R. Grayshaw
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3982
|
| Sr. M. A. Hawxhurst
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3983
|
| D. Giraud
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3984
|
| R. Gaynor
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3985
|
| C. Matson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3986
|
| J. Powell
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3987
|
| L. B. monheit
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3988
|
| M. Marco
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3989
|
| J. Rand
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3990
|
| S. Zucker
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3991
|
| L. Tregoning
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3992
|
| J. Fasullo
|
| Vol #:
|
| 167
|
|
| | | | | | | | |
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| C 1355
|
| D. Shively
|
| Vol #:
|
| 233
|
| |
|
|
| C 1356
|
| L. Ruggles
|
| Vol #:
|
| 233
|
| |
|
|
| 2003D-0379
|
| Draft Guidance for Industry on Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; Availability
|
|
|
|
|
|
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0493
|
| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
| |
|
|
| C
3
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Product Quality Research Institute (PQRI)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Schering-Plough
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| Pfizer, Inc. (Pfizer)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
| |
|
|
| C 8
|
| B. Gross
|
| Vol #:
|
| 1
|
| |
|
|
| C
9
|
| One Source Toxicology Laborator, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0545
|
| Questions and Answers Regarding Registration of Food Facilities
|
| |
|
|
| EC 1
|
| anderson, carol
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Caballero, Juan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0553
|
| Guidance on Developing Drugs to Mitigate the Complications Associated With Vaccinia Virus Used for Smallpox Vaccination
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EC 7
|
| Houlberg, Magda
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0222
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0302
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
| |
|
|
| EC 12
|
| Stepaniak, Abby
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| dixon, ellen
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| Ternus, Maureen
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Schoeller, Dale
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EC 16
|
| Schoeller, Dale
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| How, James
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Burdock, George
|
| Vol #:
|
| 1
|
| |
|
|
| EC 19
|
| Burdock, George
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| How, James
|
| Vol #:
|
| 1
|
| |
|
|
| EC 21
|
| Burdock, George
|
| Vol #:
|
| 1
|
| |
|
|
| EC 22
|
| Burdock, George
|
| Vol #:
|
| 1
|
| |
|
|
| EC 23
|
| How, James
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| How, James
|
| Vol #:
|
| 1
|
| |
|
|
| EC 25
|
| Goh, Cindy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 26
|
| Brugler, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| EC 27
|
| Lynch, Nicole
|
| Vol #:
|
| 1
|
| |
|
|
| EC 28
|
| Brugler, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0508
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
|
| |
|
|
| N
3
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0542
|
| Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
|
| |
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0079
|
| Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of Geriatric Use Subsection in the Labeling
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0089
|
| Antimicrobial Drug Development; Public Workshop
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0048
|
| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
|
| |
|
|
| C
1
|
| Hyman, Phelps & McNamara, PC
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0122
|
| Petition to Remove Category X Categorization for Estradiol in Use-in-Pregnancy Labeling
|
| |
|
|
| ACK
1
|
| HFA-305 to UMDNJ-Robert Wood Johnson Medical School
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0119
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to John Coodey CLLS
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| John Coodey CLLS
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0120
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Laser Energy
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Laser Energy
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2004V-0121
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Ringtail Studios
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Ringtail Studios
|
| Vol #:
|
| 1
|
|
|
