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| Dockets Entered
On March 2, 2005
Table of Contents
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| Docket #
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| Title
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| 1999P-0485
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| Rescind Approval of Subtherapeutic Antibiotic Use Livestock
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| |
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| |
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| |
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| 2004P-0349
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| Action on Products containing added Mercury
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| |
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 1999P-0485
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| Rescind Approval of Subtherapeutic Antibiotic Use Livestock
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| C 3644
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| M. Ewing,DVM,MS,MAM,ACPV and P. Stayer,DVM,MS,ACPV
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| Vol #:
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| 217
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1119
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| Bayer Corporation
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| Vol #:
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| 480
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1051
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| B Banever
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| Vol #:
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| 14
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| EMC 1052
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| J LeViness
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| Vol #:
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| 14
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| EMC
1053
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| Foundation for Nutritional Therapy and Applications
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| Vol #:
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| 14
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| EMC 1054
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| C Banever
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| Vol #:
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| 14
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| EMC 1055
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| F Chen
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| Vol #:
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| 14
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| EMC 1056
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| M Bray
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| Vol #:
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| 14
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| EMC 1057
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| R Kowalski
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| Vol #:
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| 14
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| EMC 1058
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| L Laure
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| Vol #:
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| 14
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| EMC 1059
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| M Pieri
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| Vol #:
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| 14
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| EMC 1060
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| S Rajan
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| Vol #:
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| 14
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| EMC 1061
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| K Beaulieu
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| Vol #:
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| 14
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| EMC 1062
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| R Miller
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| Vol #:
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| 14
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| EMC 1063
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| M Cooper
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| Vol #:
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| 14
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| EMC
1064
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| Somerset Invertebrates Group & Christchuch Harbour Ornithological Society
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| Vol #:
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| 14
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| EMC 1065
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| T Batley
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| Vol #:
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| 14
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| EMC 1066
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| J White
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| Vol #:
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| 14
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| EMC 1067
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| P White
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| Vol #:
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| 14
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| EMC 1068
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| E Utschig
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| Vol #:
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| 14
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| |
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| EMC 1069
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| N Reinstein
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| Vol #:
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| 14
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| |
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| EMC 1070
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| N Smukler
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| Vol #:
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| 14
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| C
7
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 53
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| D. Brown
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| Vol #:
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| 30
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| C 54
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| C. McAlllister
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| Vol #:
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| 30
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| C 55
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| L. Mills et al.
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| Vol #:
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| 30
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| C 56
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| H. Morie
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| Vol #:
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| 30
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| C 57
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| R. Fahringer, Jr.
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| Vol #:
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| 30
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| C 58
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| K. Aisup
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| Vol #:
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| 30
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| C 59
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| K. Goodrich
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| Vol #:
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| 30
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| C 60
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| K. Goodwrich
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| Vol #:
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| 30
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| C 61
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| D. Johnson
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| Vol #:
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| 30
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| C 62
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| L. Blugrind
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| Vol #:
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| 30
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| C 63
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| R. Ucci, MD
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| Vol #:
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| 30
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| C 64
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| M. Lynn et al
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| Vol #:
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| 30
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| C 65
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| J. Godat, MD
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| Vol #:
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| 30
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| C 66
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| M. Boggia
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| Vol #:
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| 30
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| C 67
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| C. Loehlein
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| Vol #:
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| 30
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| C 68
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| J. Cholewa
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| Vol #:
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| 30
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| C 69
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| J and P Horn
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| Vol #:
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| 30
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| C 70
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| T. Willis
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| Vol #:
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| 30
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| C 71
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| P. Maffeo, PhD
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| Vol #:
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| 30
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| |
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| C 72
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| L. Smith
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| Vol #:
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| 30
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| C 73
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| C. Albert
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| Vol #:
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| 30
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| C 74
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| R. Redinger
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| Vol #:
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| 30
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| C 75
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| L. Jaeggli
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| Vol #:
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| 30
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| C 76
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| S. Giuliano
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| Vol #:
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| 30
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| C 77
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| E and D Backholm
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| Vol #:
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| 30
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| C 78
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| D. Weber
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| Vol #:
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| 30
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| C 79
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| P. Suffredini
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| Vol #:
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| 30
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| C 80
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| F and G Hulce
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| Vol #:
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| 30
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| C
81
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| Moore, Winter, Skebba & McLennan, LLP
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| Vol #:
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| 30
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| C 82
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| P. Bueltel
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| Vol #:
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| 30
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| C 83
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| R. Good
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| Vol #:
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| 30
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| C 84
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| J. Kane
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| Vol #:
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| 30
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| C 85
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| M. Sarazin
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| Vol #:
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| 30
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| |
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| C 86
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| K. Moretti
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| Vol #:
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| 30
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| |
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| C 87
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| S. Froehlich, MAcOM, LAc
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| Vol #:
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| 30
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| |
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| C 88
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| N. Narcowich
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| Vol #:
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| 30
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| |
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| C 89
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| E. Terry
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| Vol #:
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| 30
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| C 90
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| M. Cottle
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| Vol #:
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| 30
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| C 91
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| B. Kotwica
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| Vol #:
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| 30
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| C 92
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| F. Guros
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| Vol #:
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| 30
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| C 93
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| J. Guenthner
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| Vol #:
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| 30
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| C 94
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| C and D Hamm
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| Vol #:
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| 30
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| |
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| C 95
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| R. Krolo
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| Vol #:
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| 30
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| |
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| C 96
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| O. Markowitz, L.Ac.
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| Vol #:
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| 30
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| |
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| C 97
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| S. Froehlich, LAc
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| Vol #:
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| 30
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| |
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| C 98
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| V. Quest
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| Vol #:
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| 30
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| |
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| C 99
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| M. Brancato
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| Vol #:
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| 30
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| |
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| C 100
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| M. Rodriguez, MD
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| Vol #:
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| 30
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| |
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| C 101
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| H. Owen
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| Vol #:
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| 30
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| |
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| C 102
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| W. Richardson, Jr.
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| Vol #:
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| 30
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| |
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| C 103
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| J. Eidenberg
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| Vol #:
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| 30
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| |
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| C 104
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| C and S Kinnen
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| Vol #:
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| 30
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| |
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| C 105
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| I Breeden
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| Vol #:
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| 30
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| |
|
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| C 106
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| B. Munguia
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| Vol #:
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| 30
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| |
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| C 107
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| P. Das
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| Vol #:
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| 30
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| |
|
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| C 108
|
| J. Benz
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| Vol #:
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| 30
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| |
|
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| C 109
|
| P. Schaffran
|
| Vol #:
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| 30
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| |
|
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| C 110
|
| V. Rodriguez, MD
|
| Vol #:
|
| 30
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| |
|
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| C 111
|
| M. Ellis
|
| Vol #:
|
| 30
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| |
|
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| C 112
|
| Eligible
|
| Vol #:
|
| 30
|
| |
|
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| C 113
|
| M. Bohr
|
| Vol #:
|
| 30
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| |
|
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| C 114
|
| C. Montelione
|
| Vol #:
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| 30
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| |
|
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| C 115
|
| P. Mazzoni
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| Vol #:
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| 30
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| |
|
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| C 116
|
| D. Morgan
|
| Vol #:
|
| 30
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| |
|
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| C 117
|
| J. Slama
|
| Vol #:
|
| 30
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| |
|
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| C 118
|
| M. James
|
| Vol #:
|
| 30
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| |
|
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| C 119
|
| C. Biasucci
|
| Vol #:
|
| 30
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| |
|
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| C 120
|
| P. Greb
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| Vol #:
|
| 30
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|
| | | | | | | |
| |
|
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| C 121
|
| D. Mulville
|
| Vol #:
|
| 30
|
| |
|
|
| C 122
|
| Illegible
|
| Vol #:
|
| 30
|
| |
|
|
| C 123
|
| D. Treptow
|
| Vol #:
|
| 30
|
| |
|
|
| C 124
|
| C. Crew
|
| Vol #:
|
| 31
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| |
|
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| C 125
|
| J. Reardon, PhD
|
| Vol #:
|
| 31
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| |
|
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| C 126
|
| D. Mulville
|
| Vol #:
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| 31
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| |
|
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| C 127
|
| Mr and Mrs A Prittman
|
| Vol #:
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| 31
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| |
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| C 128
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| Eligible
|
| Vol #:
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| 31
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| |
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| C 129
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| R. Buchacher
|
| Vol #:
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| 31
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| |
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| C 130
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| A. Flynn
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| Vol #:
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| 31
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| |
|
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| C 131
|
| A. Whitling
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| Vol #:
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| 31
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| |
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| C 132
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| M. Bandstra, RN
|
| Vol #:
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| 31
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| |
|
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| C 133
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| F. Jansen
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| Vol #:
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| 31
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| |
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| C 134
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| D. Price
|
| Vol #:
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| 31
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| |
|
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| C 135
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| Mr and Mrs I and L Griese
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| Vol #:
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| 31
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| |
|
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| C 136
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| D. Price
|
| Vol #:
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| 31
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| |
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| C 137
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| G. Uransky
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| Vol #:
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| 31
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| |
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| C 138
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| G. Hansen
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| Vol #:
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| 31
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| |
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| C 139
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| S. Egdal
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| Vol #:
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| 31
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| |
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| C 140
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| S. Showers
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| Vol #:
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| 31
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| |
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| C 141
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| R. Bohyer
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| Vol #:
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| 31
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| |
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| C 142
|
| A. Wenthing
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| Vol #:
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| 31
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| |
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| C 143
|
| B. Fischer
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| Vol #:
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| 31
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| |
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| C 144
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| W. Webber
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| Vol #:
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| 31
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| |
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| C 145
|
| M. Stricker
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| Vol #:
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| 31
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| |
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| C 146
|
| S. Kinnen
|
| Vol #:
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| 31
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| |
|
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| C 147
|
| G. Bryce, PhD
|
| Vol #:
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| 31
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| |
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| C 148
|
| C. Carricato
|
| Vol #:
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| 31
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| |
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| C 149
|
| M. Hoogers
|
| Vol #:
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| 31
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| |
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| C 150
|
| J. Vintilla, Esq
|
| Vol #:
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| 31
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| |
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| C 151
|
| W. Webber
|
| Vol #:
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| 31
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| |
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| C 152
|
| D. Gustafson
|
| Vol #:
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| 31
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| |
|
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| C 153
|
| P. Maffeo, PhD
|
| Vol #:
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| 31
|
| |
|
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| C 154
|
| J. Vintilla, Esq
|
| Vol #:
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| 31
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| |
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| C 155
|
| P. Sutton
|
| Vol #:
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| 31
|
| |
|
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| C 156
|
| J. Shelton, RN
|
| Vol #:
|
| 31
|
| |
|
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| C 157
|
| Form Letters
|
| Vol #:
|
| 32
|
|
| | | | | | | | |
| |
|
|
| C 158
|
| Form Letters
|
| Vol #:
|
| 33
|
| |
|
|
| C 159
|
| Form Letters
|
| Vol #:
|
| 34
|
| |
|
|
| C 160
|
| Form Letters
|
| Vol #:
|
| 35
|
| |
|
|
| C 161
|
| Form Letters
|
| Vol #:
|
| 36
|
| |
|
|
| C 162
|
| Form Letters
|
| Vol #:
|
| 37
|
| |
|
|
| C 163
|
| Form Letters
|
| Vol #:
|
| 38
|
| |
|
|
| 2004N-0479
|
| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
|
| |
|
|
| C
5
Attachment
|
| Phibro Animal Health (PAH)
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| American Veterinary Medical Assn (AVMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| Marshfield Clinic Research Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0559
|
| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
|
| |
|
|
| C
11
|
| American Academy of Orthopaedic Surgeons (AAOS)
|
| Vol #:
|
| 2
|
| |
|
|
| C 12
|
| D. Garrett
|
| Vol #:
|
| 2
|
| |
|
|
| C 13
|
| S.K. Eloff
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0329
|
| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
|
| |
|
|
| ELET 2
|
| Russel J Thomsen MD
|
| Vol #:
|
| 1
|
| |
|
|
| ELET 3
|
| HFZ-215 to Russel J Thomsen MD
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
| |
|
|
| LET
2
|
| Coalition for Mercury-free Drugs (CoMeD)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| C
1
|
| G. Ubogy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 140
|
| Fanaroff, Wendy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 141
|
| Pettit, Joan
|
| Vol #:
|
| 1
|
| |
|
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| EAPE 142
|
| Trunzo, Jeffrey
|
| Vol #:
|
| 1
|
| |
|
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| EAPE 143
|
| Mart, Alan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 144
|
| Schwetz, Bernard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 145
|
| Reese, Owen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 146
|
| Dickler, Howard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 147
|
| Greenberg, Karin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 148
|
| HALE, KAREN
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 149
|
| Mueller, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 150
|
| Wallman, Laurence
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 151
|
| Hostelley, Linda
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 152
|
| Bevan, Lynn
|
| Vol #:
|
| 1
|
|
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| |
|
|
| EAPE 153
|
| Claggett, Mary
|
| Vol #:
|
| 1
|
|
|
