| | | | | | | | | | |
|
|
| Dockets Entered
April 12, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| 2005V-0141
|
| Laser Light Show
|
|
|
| 2005V-0142
|
| Laser Light show
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
| LET
15872
|
| Pharmavite LLC
|
| Vol #:
|
| 140
|
|
|
| LET
15873
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15874
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15875
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15876
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15877
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15878
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15879
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15880
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15881
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15882
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15883
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15884
|
| Enzymatic Therapy
|
| Vol #:
|
| 140
|
|
|
| LET
15885
|
| NOW Foods
|
| Vol #:
|
| 140
|
|
|
| LET
15886
|
| Pharmavite LLC
|
| Vol #:
|
| 140
|
|
|
| LET
15887
|
| NOW Foods
|
| Vol #:
|
| 140
|
|
|
| LET
15888
|
| NOW Foods
|
| Vol #:
|
| 140
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| EXB 1155
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1156
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1157
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1158
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1159
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1160
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1161
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1162
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1163
|
| Animal Health Institute
|
| Vol #:
|
| 475
|
|
|
| EXB 1164
|
| Animal Health Institute
|
| Vol #:
|
| 476
|
|
| | | | | | | | |
|
|
| EXB 1165
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1166
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1167
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1168
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1169
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1170
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1171
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1172
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1173
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1174
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1175
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1176
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| EXB 1177
|
| Animal Health Institute
|
| Vol #:
|
| 477
|
|
|
| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
|
|
|
| GDL
2
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| C 1
|
| A Zamora
|
| Vol #:
|
| 1
|
|
|
| C 2
|
| S Gralnik
|
| Vol #:
|
| 1
|
|
|
| C 3
|
| J. Amodio
|
| Vol #:
|
| 1
|
|
|
| C
4
|
| American Institute of Engineers
|
| Vol #:
|
| 1
|
|
|
| EMC 1
|
| Number not used
|
| Vol #:
|
| 3
|
|
|
| EMC
2
|
| The Univeristy of Georgia Extension Service
|
| Vol #:
|
| 3
|
|
|
| EMC 3
|
| M. Painter
|
| Vol #:
|
| 3
|
|
|
| EMC 4
|
| A. Atchison
|
| Vol #:
|
| 3
|
|
|
| EMC 5
|
| no signature
|
| Vol #:
|
| 3
|
|
|
| EMC 6
|
| S. Roberts
|
| Vol #:
|
| 3
|
|
|
| EMC 7
|
| C. Kurtz
|
| Vol #:
|
| 3
|
|
|
| EMC 8
|
| G. Yazak
|
| Vol #:
|
| 3
|
|
|
| EMC 9
|
| B. Kupersmith
|
| Vol #:
|
| 3
|
|
|
| EMC 10
|
| L. Chenowith
|
| Vol #:
|
| 3
|
|
|
| EMC 11
|
| C. Henrich
|
| Vol #:
|
| 3
|
|
|
| EMC 12
|
| J. Glanton
|
| Vol #:
|
| 3
|
|
|
| EMC 13
|
| A. Chisari
|
| Vol #:
|
| 3
|
|
|
| EMC 14
|
| Kathy
|
| Vol #:
|
| 3
|
|
| | | | | | | |
|
|
| EMC 15
|
| Jenna
|
| Vol #:
|
| 3
|
|
|
| EMC 16
|
| R. Schneider
|
| Vol #:
|
| 3
|
|
|
| EMC 17
|
| B. Morse
|
| Vol #:
|
| 3
|
|
|
| EMC 18
|
| C. Smith
|
| Vol #:
|
| 3
|
|
|
| EMC 19
|
| L. Graziano
|
| Vol #:
|
| 3
|
|
|
| EMC 20
|
| D. West
|
| Vol #:
|
| 3
|
|
|
| EMC 21
|
| J. Buberel
|
| Vol #:
|
| 3
|
|
|
| EMC 22
|
| no signature
|
| Vol #:
|
| 3
|
|
|
| EMC 23
|
| G. Topolinicki
|
| Vol #:
|
| 3
|
|
|
| EMC 24
|
| A. Moore
|
| Vol #:
|
| 3
|
|
|
| EMC
25
|
| Country Mason Jar Gourmet Gifts
|
| Vol #:
|
| 3
|
|
|
| EMC 26
|
| A. Nowak
|
| Vol #:
|
| 3
|
|
|
| EMC 27
|
| E. Peterson
|
| Vol #:
|
| 3
|
|
|
| EMC 28
|
| E. Allen
|
| Vol #:
|
| 3
|
|
|
| EMC 29
|
| N. Papermaster
|
| Vol #:
|
| 3
|
|
|
| EMC 30
|
| G. Linz
|
| Vol #:
|
| 3
|
|
|
| EMC 31
|
| C. Perez
|
| Vol #:
|
| 3
|
|
|
| EMC 32
|
| K. Goudreau
|
| Vol #:
|
| 3
|
|
|
| EMC 33
|
| L. Mallon
|
| Vol #:
|
| 3
|
|
|
| EMC 34
|
| L. Kelly
|
| Vol #:
|
| 3
|
|
|
| EMC 35
|
| T. Carey
|
| Vol #:
|
| 3
|
|
|
| EMC 36
|
| J. Davis
|
| Vol #:
|
| 3
|
|
|
| EMC 37
|
| P. Gati
|
| Vol #:
|
| 3
|
|
|
| EMC 38
|
| K. Putnam
|
| Vol #:
|
| 3
|
|
|
| EMC 39
|
| D. Brandon
|
| Vol #:
|
| 3
|
|
|
| EMC 40
|
| N. Comstock
|
| Vol #:
|
| 3
|
|
|
| EMC 41
|
| M. Stachel
|
| Vol #:
|
| 3
|
|
|
| EMC 42
|
| no signature
|
| Vol #:
|
| 3
|
|
|
| EMC 43
|
| R. Felix
|
| Vol #:
|
| 3
|
|
|
| EMC 44
|
| J. Blanchard
|
| Vol #:
|
| 3
|
|
|
| EMC 45
|
| A. O'Connor
|
| Vol #:
|
| 3
|
|
|
| EMC 46
|
| J. Shafer
|
| Vol #:
|
| 3
|
|
|
| EMC 47
|
| A. Papale
|
| Vol #:
|
| 3
|
|
|
| EMC 48
|
| J. Barlow
|
| Vol #:
|
| 3
|
|
|
| EMC 49
|
| J. Hanks
|
| Vol #:
|
| 3
|
|
|
| EMC 50
|
| D. Lauer
|
| Vol #:
|
| 3
|
|
|
| EMC 51
|
| C. McQuown
|
| Vol #:
|
| 3
|
|
| | | | | | | |
|
|
| EMC 52
|
| K. Macy
|
| Vol #:
|
| 3
|
|
|
| EMC 53
|
| no signature
|
| Vol #:
|
| 3
|
|
|
| EMC 54
|
| M. Washburn
|
| Vol #:
|
| 3
|
|
|
| EMC 55
|
| B. Fowler
|
| Vol #:
|
| 3
|
|
|
| EMC 56
|
| B. and T. Miller
|
| Vol #:
|
| 3
|
|
|
| EMC 57
|
| J. Ecker
|
| Vol #:
|
| 3
|
|
|
| EMC 58
|
| Roger
|
| Vol #:
|
| 3
|
|
|
| EMC 59
|
| D. Dobbie
|
| Vol #:
|
| 3
|
|
|
| EMC 60
|
| D. Dobbie
|
| Vol #:
|
| 3
|
|
|
| EMC 61
|
| C. Jarrett
|
| Vol #:
|
| 3
|
|
|
| EMC 62
|
| L. Smith
|
| Vol #:
|
| 3
|
|
|
| EMC 63
|
| L. King
|
| Vol #:
|
| 3
|
|
|
| EMC
64
|
| Barbecue Presbyterian Church
|
| Vol #:
|
| 3
|
|
|
| EMC 65
|
| J. Donnelly
|
| Vol #:
|
| 3
|
|
|
| EMC 66
|
| G.Wynn
|
| Vol #:
|
| 3
|
|
|
| EMC 67
|
| R. Bob
|
| Vol #:
|
| 3
|
|
|
| EMC 68
|
| M. Shepard
|
| Vol #:
|
| 3
|
|
|
| EMC 69
|
| R. Jorge
|
| Vol #:
|
| 3
|
|
|
| EMC 70
|
| no signature
|
| Vol #:
|
| 3
|
|
|
| EMC 71
|
| V. Denz
|
| Vol #:
|
| 3
|
|
|
| EMC 72
|
| L. Bailis
|
| Vol #:
|
| 3
|
|
|
| EMC 73
|
| T. Dietz
|
| Vol #:
|
| 3
|
|
|
| EMC 74
|
| P. and J. Gullo
|
| Vol #:
|
| 3
|
|
|
| EMC 75
|
| M. Velchek
|
| Vol #:
|
| 3
|
|
|
| EMC 76
|
| Mrs. R. Hooper
|
| Vol #:
|
| 3
|
|
|
| EMC 77
|
| I. McBride
|
| Vol #:
|
| 3
|
|
|
| EMC 78
|
| T. Suttles
|
| Vol #:
|
| 3
|
|
|
| EMC 79
|
| J. Timmerman
|
| Vol #:
|
| 3
|
|
|
| EMC 80
|
| G. Doore
|
| Vol #:
|
| 3
|
|
|
| EMC 81
|
| N. Christian
|
| Vol #:
|
| 3
|
|
|
| EMC 82
|
| C. Phillips
|
| Vol #:
|
| 3
|
|
|
| EMC 83
|
| S. Hanson
|
| Vol #:
|
| 3
|
|
|
| EMC 84
|
| R. Edington
|
| Vol #:
|
| 3
|
|
|
| EMC 85
|
| N. Davis
|
| Vol #:
|
| 3
|
|
|
| EMC 86
|
| J. Hickman
|
| Vol #:
|
| 3
|
|
|
| EMC 87
|
| D. Ruiter
|
| Vol #:
|
| 3
|
|
|
| EMC 88
|
| A. Heppner
|
| Vol #:
|
| 3
|
|
| | | | | | | |
|
|
| EMC 89
|
| D. and S. Splain
|
| Vol #:
|
| 3
|
|
|
| EMC 90
|
| K. Welch
|
| Vol #:
|
| 3
|
|
|
| EMC 91
|
| E. and B. Harding
|
| Vol #:
|
| 3
|
|
|
| EMC 92
|
| B. E. Hankins
|
| Vol #:
|
| 3
|
|
|
| EMC 93
|
| J. Rasmussen
|
| Vol #:
|
| 3
|
|
|
| EMC 94
|
| S. Jones
|
| Vol #:
|
| 3
|
|
|
| EMC 95
|
| J. Wilson
|
| Vol #:
|
| 3
|
|
|
| EMC 96
|
| J. Fournier
|
| Vol #:
|
| 3
|
|
|
| EMC 97
|
| A. Dakan
|
| Vol #:
|
| 3
|
|
|
| EMC 98
|
| E. Ptak
|
| Vol #:
|
| 3
|
|
|
| EMC 99
|
| M. Wells
|
| Vol #:
|
| 3
|
|
|
| EMC 100
|
| K. Selvig
|
| Vol #:
|
| 3
|
|
|
| EMC 101
|
| J. Terpay
|
| Vol #:
|
| 3
|
|
|
| EMC 102
|
| L. J. Kohman
|
| Vol #:
|
| 3
|
|
|
| EMC 103
|
| L. Haynes
|
| Vol #:
|
| 3
|
|
|
| EMC 104
|
| R. Stimpson
|
| Vol #:
|
| 3
|
|
|
| EMC 105
|
| D. Hantschel
|
| Vol #:
|
| 3
|
|
|
| EMC 106
|
| Mrs. R. J. Telfer
|
| Vol #:
|
| 3
|
|
|
| EMC 107
|
| J. Chance
|
| Vol #:
|
| 3
|
|
|
| EMC 108
|
| C. Rhine
|
| Vol #:
|
| 3
|
|
|
| EMC 109
|
| B. and W. Quist
|
| Vol #:
|
| 3
|
|
|
| EMC 110
|
| J. Welch
|
| Vol #:
|
| 3
|
|
|
| EMC 111
|
| C. L. Caldwell
|
| Vol #:
|
| 3
|
|
|
| EMC 112
|
| J. Welch
|
| Vol #:
|
| 3
|
|
|
| EMC 113
|
| S. Phillipson
|
| Vol #:
|
| 3
|
|
|
| EMC 114
|
| D. Piper
|
| Vol #:
|
| 3
|
|
|
| EMC 115
|
| T. Deneaux
|
| Vol #:
|
| 3
|
|
|
| EMC 116
|
| T. Deneaux
|
| Vol #:
|
| 3
|
|
|
| EMC 117
|
| J. and K. Kennedy
|
| Vol #:
|
| 3
|
|
|
| EMC 118
|
| J. Baca
|
| Vol #:
|
| 3
|
|
|
| EMC 119
|
| L. J. Pepion
|
| Vol #:
|
| 3
|
|
|
| EMC 120
|
| Mrs. S. D. Kish
|
| Vol #:
|
| 3
|
|
|
| EMC 121
|
| B. Davis
|
| Vol #:
|
| 3
|
|
|
| EMC
122
|
| Madison County High School
|
| Vol #:
|
| 3
|
|
|
| EMC 123
|
| M. and D. Lerma
|
| Vol #:
|
| 3
|
|
|
| EMC 124
|
| L. and N. Ellis
|
| Vol #:
|
| 3
|
|
|
| EMC 125
|
| D. Mitchell
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
|
| EMC 126
|
| J. Evans
|
| Vol #:
|
| 3
|
|
|
| EMC 127
|
| T. Dubler
|
| Vol #:
|
| 3
|
|
|
| EMC 128
|
| J. and P. Babb
|
| Vol #:
|
| 3
|
|
|
| EMC
129
|
| Rex Healthcare, Inc.
|
| Vol #:
|
| 3
|
|
|
| EMC 130
|
| N. Payne
|
| Vol #:
|
| 3
|
|
|
| EMC 131
|
| A. Callaway
|
| Vol #:
|
| 3
|
|
|
| EMC 132
|
| A. Dyer
|
| Vol #:
|
| 3
|
|
|
| EMC 133
|
| M. Richardson
|
| Vol #:
|
| 3
|
|
|
| EMC 134
|
| K. Jefferis
|
| Vol #:
|
| 3
|
|
|
| 2005V-0141
|
| Laser Light Show
|
|
|
| ACK
1
|
| HFA_305 to Scott Laser Technologies
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Scott Laser Technologies
|
| Vol #:
|
| 1
|
|
|
| 2005V-0142
|
| Laser Light show
|
|
|
| ACK
1
|
| HFA 305 to Off The Record Mobile Dance Club & Video
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Off The Record Mobile Dance Club & Video
|
| Vol #:
|
| 1
|
|
|