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| Dockets Entered
On February 3, 2004
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 2000N-1531
|
| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| 2004P-0048
|
| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
12422
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12423
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12424
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12425
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12426
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12427
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12428
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12429
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12430
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12431
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12432
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12433
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12434
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12435
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12436
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12437
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
| |
|
|
| LET
12438
|
| NBTY Inc.
|
| Vol #:
|
| 101
|
|
| | | | | | | | |
| |
|
|
| LET
12476
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 101
|
| |
|
|
| 2000N-1531
|
| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
|
| |
|
|
| MT
1
|
| HFD-7 and Robert Glickman
|
| Vol #:
|
| 1
|
| |
|
|
| 2001F-0047
|
| Foodborne pathogens in raw-frozen-cooked-partially cooked
|
| |
|
|
| EMC 462
|
| M. Harmer
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 463
|
| B. Centofante
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 464
|
| B. Centofante
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 465
|
| B. Centofante
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 466
|
| B. Centofante
|
| Vol #:
|
| 8
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 2831
|
| Number Not Used
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2832
|
| D. Sippel
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2833
|
| T. Perriello
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2834
|
| J. Libove
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2835
|
| M. Brown
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2836
|
| M. Hardin
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2837
|
| J. Corwin
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2838
|
| S. Stafford
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2839
|
| T. Thorne
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2840
|
| J. Wheeler
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2841
|
| S. Judge
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2842
|
| R. Mandelcorn
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2843
|
| M. Phillips
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2844
|
| A. VerSteeg
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2845
|
| K. Hodne
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2846
|
| K. White
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2847
|
| V. Lawrence
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2848
|
| N. Tomkins
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2849
|
| C. Henderson
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2850
|
| A. Daines
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2851
|
| S. McKuhen
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2852
|
| B. Davis
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2853
|
| R. Stull
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2854
|
| J. Davis
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2855
|
| D. McKenzie
|
| Vol #:
|
| 130
|
|
| | | | | | | |
| |
|
|
| EMC 2856
|
| P. Seidel
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2857
|
| D. Ferne
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2858
|
| K. Shirey
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2859
|
| S. Campbell
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2860
|
| R. Williams
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2861
|
| J. Kennedy
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2862
|
| E. Glenn
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2863
|
| M. Shapiro
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2864
|
| D. Bashkow
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2865
|
| G. Richardson
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2866
|
| L. Prine
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2867
|
| S. Rice
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2868
|
| E. Bingham
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2869
|
| B. Dunn
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2870
|
| K. Neuendorf
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2871
|
| L. Rentz
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2872
|
| M. Riquier
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2873
|
| J. Wayne
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2874
|
| D. Young
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2875
|
| A. Fortson
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2876
|
| K. Schrader
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2877
|
| C. Pyle
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2878
|
| T. Logan
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2879
|
| M. Drake
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2880
|
| V. Adamson
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2881
|
| J. Abbott
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2882
|
| L. Magnus
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2883
|
| F. Cone
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2884
|
| C. Wallis
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2885
|
| S. Williford
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2886
|
| D. Reuler
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2887
|
| J. Lizak
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2888
|
| C. McKee
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2889
|
| A. Prior
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2890
|
| T. G'uyant
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2891
|
| P. Yates
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2892
|
| S. Cagno
|
| Vol #:
|
| 130
|
|
| | | | | | | |
| |
|
|
| EMC 2893
|
| J. Mann
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2894
|
| L. Knauf
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2895
|
| H. Smith
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2896
|
| M. Klems
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2897
|
| J. Wooden
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2898
|
| E. Kissling
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2899
|
| H. Ivy
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2900
|
| L. Bishop
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2901
|
| B. Perkins
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2902
|
| M. Simon
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2903
|
| D. Hinman
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2904
|
| M. Flam
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2905
|
| N. Jackson, MD
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2906
|
| M. Hickner
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2907
|
| L. Lombardi
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2908
|
| A. McConnachie
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2909
|
| P. Schwortz
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2910
|
| D. Lafond
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2911
|
| M. Ralph
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2912
|
| M. Edwards
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2913
|
| S. Granger
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2914
|
| J. Augustaitus
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2915
|
| L. Tarnowski
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2916
|
| S. Wolfe
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2917
|
| S. Murphy
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2918
|
| A. Brunt
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2919
|
| P. Wehrle
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2920
|
| R. Miller
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2921
|
| L. Young
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2922
|
| E. Wahl
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2923
|
| M. O'Brien
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2924
|
| F. Patch
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2925
|
| S. Hawkins
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2926
|
| K. O'Neal
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2927
|
| K. Griffin
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2928
|
| M. Milton
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2929
|
| E. McKenzie
|
| Vol #:
|
| 130
|
|
| | | | | | | | |
| |
|
|
| EMC 2930
|
| No signature
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2931
|
| E. Turner
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2932
|
| R. Calderon
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2933
|
| J. Tucker
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2934
|
| N. Martinez
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2935
|
| C. Willis
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2936
|
| J. Flinchum
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2937
|
| R. DerHohannesian
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2938
|
| J. Ertl
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2939
|
| J. Sprinkle
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2940
|
| Jennifer Haynes
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2941
|
| J. Gmeinder
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2942
|
| H. Hill
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2943
|
| L. Erwin
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2944
|
| L. Matthews
|
| Vol #:
|
| 130
|
| |
|
|
| EMC 2945
|
| No signature
|
| Vol #:
|
| 130
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3151
|
| M. Harmer
|
| Vol #:
|
| 252
|
| |
|
|
| EMC 3152
|
| K. Copenhagen
|
| Vol #:
|
| 252
|
| |
|
|
| EMC 3153
|
| B. Centofante
|
| Vol #:
|
| 252
|
| |
|
|
| EMC 3154
|
| G. Shawver
|
| Vol #:
|
| 252
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1215
|
| No signature
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 1216
|
| C. Townley
|
| Vol #:
|
| 5
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 144
|
| M. Johnson
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 145
|
| S. Tegen
|
| Vol #:
|
| 3
|
| |
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
| |
|
|
| EMC 160
|
| R. Howe
|
| Vol #:
|
| 16
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EMC
164
|
| USDA
|
| Vol #:
|
| 22
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 303
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
| |
|
|
| EMC 304
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 305
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 306
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 307
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 308
|
| Dr. B. Martini
|
| Vol #:
|
| 6
|
| |
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
| |
|
|
| EMC
1
|
| Society of Quality Assurance
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 127
|
| S. Kanars
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 128
|
| T. Lobel
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| EMC 48
|
| L. Happold
|
| Vol #:
|
| 10
|
| |
|
|
| EMC
49
|
| Virginia Tech University,
Maureen L. Storey, PhD
|
| Vol #:
|
| 10
|
| |
|
|
| EMC 50
|
| C. Franke, RN,FNP
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
| |
|
|
| EMC
1
|
| Generic Pharmaceutical Assn (GPhA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| EMC 25
|
| G. Rast,MA,CCC-A,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 26
|
| J. Ziegler, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 27
|
| K. Dennis, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 28
|
| A. Nadler, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 29
|
| M. Herzfeld, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 30
|
| D. Colucci, AuD,MA,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 31
|
| M. Bean, MS,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 32
|
| M. Meier, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 33
|
| D. Abel, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 34
|
| R. Norwood, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 35
|
| S. Bish
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 36
|
| L. Schmeisser
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 37
|
| L. Wildmo,MSc,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0363
|
| Professional and Patient Labeling for Hearing Aid Devices
|
| |
|
|
| EMC 10
|
| M. Bean,MS,FAAA
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 11
|
| D. Abel, AuD
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 12
|
| R. Norwood, AuD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 13
|
| S. Bish
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 14
|
| L.A. Schmeisser
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0048
|
| Abbreviated new drug application (ANDA) Suitability for Ondanaetron Hydrochloride Injection (8 mg/4 mL prefilled syringe)
|
| |
|
|
| ACK
1
|
| HFA-305 to Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Exhibit
1-4, 5
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
