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| Dockets Entered
On May 17, 2004
Table of Contents
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| Docket #
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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|
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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|
|
|
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| 2002N-0278
|
| Bioterrorism; Prior Notice of
Imported Food Shipments
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|
|
| 2003Q-0401
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| Qualified Health Claim
(QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 2003V-0131
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| Laser Light Show
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| 2004P-0231
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| Deny approval of NDA
21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection,
lyophilized powder and diluent with preservative
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| 2004Q-0072
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| QHC Eggs w/Enhanced
omega-3 fatty acid content and reduced risk of heart disease and sudden
fatal heart attack
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| 2004Q-0151
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| Qualified Health Claim
(QHC): soy protein and cancer
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| 2004Q-0201
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| Qualified Health Claim
(QHC): Lycopene, Tomatoes and Various Cancers
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| 2004V-0229
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| Projector for a Laser
Light Show
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| 2004V-0232
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| Laser Light Show
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|
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| 2000N-1571
|
| Enrofloxacin for
Poultry: Opportunity for Hearing
|
|
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| EXC 1
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| Center for Veterinary
Medicine
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| Vol #:
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| 444
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|
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| 2001P-0075
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| Switch Status of
Emergency Contraceptives from Rx to OTC
|
|
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|
| EC 764
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| Dr. Irene Sills
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| Vol #:
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| 163
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|
|
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| EC 765
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| Mr. Hal Kass
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| Vol #:
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| 163
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| EC 766
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| Mr. Benjamin Wood
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| Vol #:
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| 163
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| EC
767
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| National Latina Institute
for Reproductive Health
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| Vol #:
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| 163
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| EC
768
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| Republican choice majority
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| Vol #:
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| 163
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| EC 769
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| Miss. Myrra Windau
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| Vol #:
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| 163
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| EMC 6727
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| Dr. N. Palmer
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| Vol #:
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| 235
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|
| EMC 6728
|
| Christopher Dougherty
|
| Vol #:
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| 235
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|
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|
|
| EMC 6729
|
| J. Kohr
|
| Vol #:
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| 235
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|
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|
|
| EMC 6730
|
| L. Cohen
|
| Vol #:
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| 235
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|
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|
|
| EMC 6731
|
| N. Fish
|
| Vol #:
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| 235
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|
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|
|
| EMC 6732
|
| M. Metrens
|
| Vol #:
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| 235
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|
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|
|
| EMC 6733
|
| E. Quezada
|
| Vol #:
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| 235
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|
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|
|
| EMC 6734
|
| M. Chilcote
|
| Vol #:
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| 235
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|
|
| EMC 6735
|
| E. J. Hammond
|
| Vol #:
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| 235
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|
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|
|
| EMC 6736
|
| M. Welk
|
| Vol #:
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| 235
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|
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|
|
| EMC 6737
|
| I. Hurt
|
| Vol #:
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| 235
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|
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|
|
| EMC 6738
|
| J. Braga
|
| Vol #:
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| 235
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|
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|
|
| EMC 6739
|
| G. Doukas
|
| Vol #:
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| 235
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|
|
|
|
| EMC 6740
|
| A. Roy
|
| Vol #:
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| 235
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|
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|
|
| EMC 6741
|
| N. Fleming
|
| Vol #:
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| 235
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|
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|
|
| EMC 6742
|
| S. Shapiro
|
| Vol #:
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| 235
|
|
| | | | | | | |
| |
|
|
| EMC 6743
|
| J. Lee
|
| Vol #:
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| 235
|
| |
|
|
| EMC 6744
|
| S. Eberhardt
|
| Vol #:
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| 235
|
| |
|
|
| EMC 6745
|
| A. Campbell
|
| Vol #:
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| 235
|
| |
|
|
| EMC 6746
|
| K. Lems
|
| Vol #:
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| 235
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| |
|
|
| EMC 6747
|
| G. Anglum
|
| Vol #:
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| 235
|
| |
|
|
| EMC 6748
|
| V. Heard
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6749
|
| Gwen Berger
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6750
|
| G. VanCamp
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6751
|
| 11/25/2003
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6752
|
| M. Roden
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6753
|
| K. Swanson
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6754
|
| S. Van Gunten
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6755
|
| G. Clayton
|
| Vol #:
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| 235
|
| |
|
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| EMC 6756
|
| B. Sterling
|
| Vol #:
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| 235
|
| |
|
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| EMC 6757
|
| S. Arcarese
|
| Vol #:
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| 235
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| |
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| EMC 6758
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| A. E. Munz
|
| Vol #:
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| 235
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| |
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| EMC 6759
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| Kari Sullivan
|
| Vol #:
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| 234
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| |
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| EMC 6760
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| D. Kinsley
|
| Vol #:
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| 235
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| |
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| EMC 6761
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| E. Fry
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| Vol #:
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| 235
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| |
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| EMC 6762
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| R. Rodwell
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| Vol #:
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| 235
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| |
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| EMC 6763
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| T. Maher
|
| Vol #:
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| 235
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| |
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| EMC 6764
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| J. Bryant
|
| Vol #:
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| 235
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| |
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| EMC 6765
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| E. Lee
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| Vol #:
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| 235
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| |
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| EMC 6766
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| M. Lee
|
| Vol #:
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| 235
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| |
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| EMC 6767
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| G. Janzen
|
| Vol #:
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| 235
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| |
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| EMC 6768
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| S. Moody
|
| Vol #:
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| 235
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| |
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| EMC 6769
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| K. Hartwing
|
| Vol #:
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| 235
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| |
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| EMC 6770
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| S. Rogers
|
| Vol #:
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| 235
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| |
|
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| EMC 6771
|
| Pat Allgood
|
| Vol #:
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| 235
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| |
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| EMC 6772
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| J. E. Roszell
|
| Vol #:
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| 235
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| |
|
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| EMC 6773
|
| M. Luris
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6774
|
| E. Zwibel
|
| Vol #:
|
| 235
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| |
|
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| EMC 6775
|
| H. T. Ross
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6776
|
| S. J. Geraldi
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6777
|
| K. T. Mal
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6778
|
| Donis J.
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6779
|
| L. Healy
|
| Vol #:
|
| 235
|
|
| | | | | | | | |
| |
|
|
| EMC 6780
|
| N. Berman
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6781
|
| C. Huerta
|
| Vol #:
|
| 235
|
|
| |
|
| EMC 6782
|
| L. Ourlicht
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6783
|
| B. Berman
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6784
|
| L. Ourlicht
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6785
|
| A. N. Kozanli
|
| Vol #:
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| 235
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| |
|
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| EMC 6786
|
| B. Shipman
|
| Vol #:
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| 235
|
| |
|
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| EMC 6787
|
| Simiya S.
|
| Vol #:
|
| 235
|
| |
|
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| EMC 6788
|
| A. Kasakitis
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6789
|
| N. Evans
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6790
|
| K. E. Rusinack
|
| Vol #:
|
| 235
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| EC 405
|
| Mr. David Giroux
|
| Vol #:
|
| 23
|
| |
|
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| EC 406
|
| Mr. David Giroux
|
| Vol #:
|
| 23
|
| |
|
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| EC 407
|
| Ms. Jackie Masse
|
| Vol #:
|
| 23
|
| |
|
|
| EC
408
|
| SDV (USA) Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
409
|
| bi-pro Marketing Limited
|
| Vol #:
|
| 23
|
| |
|
|
| EC
410
|
| Detroit
|
| Vol #:
|
| 23
|
| |
|
|
| EC
411
|
| new world freight systems
|
| Vol #:
|
| 23
|
| |
|
|
| EC
412
|
| CF Fresh
|
| Vol #:
|
| 23
|
| |
|
|
| EC
413
|
| TLR-Total Logistics Resource Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
414
|
| Port Brokers
|
| Vol #:
|
| 23
|
| |
|
|
| EC 415
|
| Evelina Hwang CHB
|
| Vol #:
|
| 23
|
| |
|
|
| EC
416
|
| HOYT, SHEPSTON INC.
|
| Vol #:
|
| 23
|
| |
|
|
| EC 417
|
| Evelina Hwang CHB
|
| Vol #:
|
| 23
|
| |
|
|
| EC
418
|
| Hoyt Shepston, Inc
|
| Vol #:
|
| 23
|
| |
|
|
| EC
419
|
| Hoyt Shepston, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
420
|
| Hoyt Shepston, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
421
|
| HOYT, SHEPSTON INC.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
422
|
| Hoyt Shepston, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
423
|
| Hoyt Shepston & Sciaroni, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
424
|
| Hoyt Shepston & Sciaroni, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
425
|
| HOYT SHEPSTON INC.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
426
|
| HOYT, SHEPSTON INC.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
427
|
| Hoyt Shepston and Sciaroni Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
428
|
| Hoyt-Shepston, Inc.
|
| Vol #:
|
| 23
|
|
| | | | | | | |
| |
|
|
| EC
429
|
| Hoyt Shepston, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
430
|
| Licensed Customs Broker
|
| Vol #:
|
| 23
|
| |
|
|
| EC
431
|
| Adventures in Wine
|
| Vol #:
|
| 23
|
| |
|
|
| EC
432
|
| Government of Argentina
|
| Vol #:
|
| 23
|
| |
|
|
| EC
433
|
| Corn Products International, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
434
|
| Adventures in Wine
|
| Vol #:
|
| 23
|
| |
|
|
| EC
435
|
| Bridge
|
| Vol #:
|
| 23
|
| |
|
|
| EC
436
|
| the wine library inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
437
|
| Italfoods, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
438
|
| Pacific Organic Produce
|
| Vol #:
|
| 23
|
| |
|
|
| EC
439
|
| Pacific Organic Produce
|
| Vol #:
|
| 23
|
| |
|
|
| EC
440
|
| BASF Corporation
|
| Vol #:
|
| 23
|
| |
|
|
| EC
441
|
| LSG Sky Chefs
|
| Vol #:
|
| 23
|
| |
|
|
| EC
442
|
| NATO (Supreme Allied Commander Transformation)
|
| Vol #:
|
| 23
|
| |
|
|
| EC
443
|
| Global Trading Resources, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
444
|
| W.J. Byrnes
|
| Vol #:
|
| 23
|
| |
|
|
| EC
445
|
| Government of Japan
|
| Vol #:
|
| 23
|
| |
|
|
| EC
446
|
| Federal Express
|
| Vol #:
|
| 23
|
| |
|
|
| EC
447
|
| Federal Express
|
| Vol #:
|
| 23
|
| |
|
|
| EC
448
|
| Acme Food Sales, Inc.
|
| Vol #:
|
| 23
|
| |
|
|
| EC 449
|
| Mr. james shoreman
|
| Vol #:
|
| 23
|
| |
|
|
| EC
450
|
| Alpha Flight Services
|
| Vol #:
|
| 23
|
| |
|
|
| EC 451
|
| W.J. Byrnes
|
| Vol #:
|
| 23
|
| |
|
|
| EC
452
|
| W.J. Byrnes
|
| Vol #:
|
| 23
|
| |
|
|
| EC
453
|
| AWBC
|
| Vol #:
|
| 23
|
| |
|
|
| EC
454
|
| Ministry of Economy, Trade and Industry(METI)
|
| Vol #:
|
| 23
|
| |
|
|
| EC
455
|
| British Airways plc
|
| Vol #:
|
| 23
|
| |
|
|
| EC
456
|
| COFEPRIS
|
| Vol #:
|
| 23
|
| |
|
|
| EC
457
|
| Pepsi QTG Canada Inc
|
| Vol #:
|
| 23
|
| |
|
|
| EC
458
|
| North American Millers Association
|
| Vol #:
|
| 23
|
| |
|
|
| EC
459
|
| North American Millers Association
|
| Vol #:
|
| 23
|
| |
|
|
| EC
460
|
| Pacific Coast Council
|
| Vol #:
|
| 23
|
| |
|
|
| EC
461
|
| Agricore United
|
| Vol #:
|
| 23
|
| |
|
|
| EC
462
|
| Agriculture Ocean Transportation Coalition
|
| Vol #:
|
| 23
|
| |
|
|
| EC
463
|
| American Bakers Association
|
| Vol #:
|
| 23
|
| |
|
|
| EC
464
|
| Pacific Coast Council
|
| Vol #:
|
| 23
|
| |
|
|
| EC
465
|
| U.S. Business Alliance for Customs Modernization
|
| Vol #:
|
| 23
|
|
| | | | | | | | |
| |
|
|
| EC
466
|
| Columbia River Brokers and Forwarders Association
|
| Vol #:
|
| 23
|
| |
|
|
| EC
467
|
| Agricore United
|
| Vol #:
|
| 23
|
| |
|
|
| EC
468
|
| U.S. Business Alliance for Customs Modernization
|
| Vol #:
|
| 23
|
| |
|
|
| EC 469
|
| ROBERT F. BARNES, CHB
|
| Vol #:
|
| 23
|
| |
|
|
| EC
470
|
| International Bottled Water Association
|
| Vol #:
|
| 23
|
| |
|
|
| EC
471
|
| Wild Bird Feeding Industry
|
| Vol #:
|
| 23
|
| |
|
|
| EC 472
|
| Mr. karl perman
|
| Vol #:
|
| 23
|
| |
|
|
| EC
473
|
| Wild Bird Feeding Industry
|
| Vol #:
|
| 23
|
| |
|
|
| EC
474
|
| Manitoba Agriculture, Food and Rural Initiatives
|
| Vol #:
|
| 23
|
| |
|
|
| EC
475
|
| Peruvian Commission for Export Promotion
|
| Vol #:
|
| 23
|
| |
|
|
| EC
476
|
| Canadian Pork Council
|
| Vol #:
|
| 23
|
| |
|
|
| EC
477
|
| Peruvian Commission for Export Promotion
|
| Vol #:
|
| 23
|
| |
|
|
| EC 478
|
| James J. Boyle
|
| Vol #:
|
| 23
|
| |
|
|
| EC
479
|
| FEPACH A.G.
|
| Vol #:
|
| 23
|
| |
|
|
| EC
480
|
| Houston Customs Brokers
|
| Vol #:
|
| 23
|
| |
|
|
| EC
481
|
| International Automated Brokers
|
| Vol #:
|
| 23
|
| |
|
|
| EC
482
|
| SAN DIEGO CUSTOMS BROKERS ASSOCIACION
|
| Vol #:
|
| 23
|
| |
|
|
| EC
483
|
| Peruvian Commission for Export Promotion
|
| Vol #:
|
| 23
|
| |
|
|
| 2003Q-0401
|
| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
|
| |
|
|
| C
7
|
| GFA Brands Inc (GFA)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
3
|
| Consumer Federation of America
|
| Vol #:
|
| 2
|
| |
|
|
| LET
5
|
| Market Biosciences Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| LET
6
|
| Emord & Associates PC
|
| Vol #:
|
| 2
|
| |
|
|
| SUP
3
Part
2,
3, 4
|
| Emord & Associates PC
|
| Vol #:
|
| 12
|
| |
|
|
| 2003V-0131
|
| Laser Light Show
|
| |
|
|
| ACK
2
|
| HFA-305 to Laser Design Productions Inc
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
2
|
| Laser Design Productions Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0114
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
| |
|
|
| EC 1
|
| Ms. Stephanie Fofonoff
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0231
|
| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
|
| |
|
|
| ACK
1
|
| HFA-305 to Pfizer Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Pfizer Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0072
|
| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
|
| |
|
|
| EMC
1
|
| Consumer Federation of America
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| ACK
2
|
| HFS-200 to Solae, LLC
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
1
|
| Soy Information Service
|
| Vol #:
|
| 4
|
| |
|
|
| EMC
2
|
| Soy Information Service
|
| Vol #:
|
| 4
|
| |
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
| |
|
|
| ACK
2
|
| HFS-200 to Emord & Associates PC
|
| Vol #:
|
| 16
|
| |
|
|
| 2004V-0229
|
| Projector for a Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to Thunder & Lightning Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Thunder & Lightning Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 2
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0232
|
| Laser Light Show
|
| |
|
|
| ACK
1
|
| HFA-305 to K/OS Promotions
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| K/os Promotions
|
| Vol #:
|
| 1
|
|
|
