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| Dockets Entered
On February 15, 2005
Table of Contents
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| Docket #
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| Title
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-0504
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| Egg Safety Action Plan
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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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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| 2005D-0033
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| Guidance for Industry on Internal Radioactive Contamination -- Development of Decorporation Agents
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| 2005D-0042
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| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0070
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| ANDA Suitability for Oral Salmon Calcitonin
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| 2005P-0072
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| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 580
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| D. Buckland
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| Vol #:
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| 24
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| 2000N-0504
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| Egg Safety Action Plan
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| EMC 1900
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| R. Steele
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| Vol #:
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| 31
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| EMC 1901
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| No signature
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| Vol #:
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| 31
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| EMC 129
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| D. Erickson
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| Vol #:
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| 2
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| EMC 130
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| Number Not Used
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| Vol #:
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| 2
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| EMC 131
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| Number Not Used
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| Vol #:
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| 2
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| EMC 132
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| Number Not Used
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| Vol #:
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| 2
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| EMC 133
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| V. Levasseur
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| Vol #:
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| 2
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| EMC 134
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| D. Shelton
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| Vol #:
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| 2
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| EMC 135
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| M. Bess
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| Vol #:
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| 2
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| EMC 136
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| Y. Saavedra
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| Vol #:
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| 2
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| EMC 137
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| A. Hojnowski
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| Vol #:
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| 2
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| EMC 138
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| L. Peck, PhD
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| Vol #:
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| 2
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| EMC 139
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| L. Drew
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| Vol #:
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| 2
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| EMC 140
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| H. Robertson
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| Vol #:
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| 2
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| EMC 141
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| L. Seff
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| Vol #:
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| 2
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| EMC 142
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| M. Zwaenepoel
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| Vol #:
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| 2
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| EMC 143
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| D. May
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| Vol #:
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| 2
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| | | | | | | |
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| EMC 144
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| N. Edmonson
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| Vol #:
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| 2
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| EMC 145
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| P. Swindells
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| Vol #:
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| 2
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| EMC 146
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| P. Starkey
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| Vol #:
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| 2
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| EMC 147
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| J. Cross
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| Vol #:
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| 2
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| EMC 148
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| H. Pieper
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| Vol #:
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| 2
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| EMC 149
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| E. Walker
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| Vol #:
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| 2
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| EMC 150
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| D. Palumbo
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| Vol #:
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| 2
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| EMC 151
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| S. Tiwald
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| Vol #:
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| 2
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| EMC 152
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| S. Shelton
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| Vol #:
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| 2
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| EMC 153
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| G. Kenton
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| Vol #:
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| 2
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| EMC 154
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| D. Coffin
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| Vol #:
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| 2
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| EMC 155
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| W. Woets
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| Vol #:
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| 2
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| EMC 156
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| J. Sarstedt
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| Vol #:
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| 2
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| EMC 157
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| B. Everson
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| Vol #:
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| 2
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| EMC 158
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| M. Lake
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| Vol #:
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| 2
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| EMC 159
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| No signature
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| Vol #:
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| 2
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| EMC 160
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| W. Hicks
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| Vol #:
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| 2
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| EMC 161
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| G. Irizarry
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| Vol #:
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| 2
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| EMC 162
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| No signature
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| Vol #:
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| 2
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| |
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| EMC 163
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| J. Knudsen
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| Vol #:
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| 2
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| EMC 164
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| C. and C Garner
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| Vol #:
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| 2
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| EMC 165
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| T. Walsh
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| Vol #:
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| 2
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| EMC 166
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| M. Glasgow
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| Vol #:
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| 2
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| EMC 167
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| T. Bleeke
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| Vol #:
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| 2
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| EMC 168
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| S. Proffitt
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| Vol #:
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| 2
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| EMC 169
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| J. Lizak
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| Vol #:
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| 2
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| EMC 170
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| M. Gaylor
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| Vol #:
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| 2
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| EMC 171
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| P. Brenenstahl
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| Vol #:
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| 2
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| EMC 172
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| M. Adams
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| Vol #:
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| 2
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| EMC 173
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| J. Barr
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| Vol #:
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| 2
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| EMC 174
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| V. Gilbert
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| Vol #:
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| 2
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| EMC 175
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| D. Cool
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| Vol #:
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| 2
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| EMC 176
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| S. Cardella
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| Vol #:
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| 2
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| EMC 177
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| H. Jackson
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| Vol #:
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| 2
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| EMC 178
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| W. Croce
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| Vol #:
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| 2
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| EMC 179
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| I. Miracle
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| Vol #:
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| 2
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| EMC 180
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| Dr. Nehrlich
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| Vol #:
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| 2
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| EMC 181
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| G. Y=Taylor
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| Vol #:
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| 2
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| EMC 182
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| R. Hines
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| Vol #:
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| 2
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| EMC 183
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| B. Gibson
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| Vol #:
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| 2
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| EMC 184
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| M. Sica
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| Vol #:
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| 2
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| EMC 185
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| T. Norton
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| Vol #:
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| 2
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| EMC 186
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| R and H McNeill
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| Vol #:
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| 2
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| EMC 187
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| J. Meissner
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| Vol #:
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| 2
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| EMC 188
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| B. McDermott
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| Vol #:
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| 2
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| EMC 189
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| C. Hastings
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| Vol #:
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| 2
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| EMC 190
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| C. Dempsey
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| Vol #:
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| 2
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| EMC 191
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| R. Levine
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| Vol #:
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| 2
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| EMC 192
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| No signature
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| Vol #:
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| 2
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| EMC 193
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| Z. DeBrecht
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| Vol #:
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| 2
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| EMC 194
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| S. Edmonson
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| Vol #:
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| 2
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| EMC 195
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| L. LoCicero
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| Vol #:
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| 2
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| EMC 196
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| F. Castellani
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| Vol #:
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| 2
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| EMC 197
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| C. Payne
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| Vol #:
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| 2
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| EMC 198
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| S. Miller
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| Vol #:
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| 2
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| EMC 199
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| S. Best
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| Vol #:
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| 2
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| EMC 200
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| K. Bannerman
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| Vol #:
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| 2
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| EMC 201
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| B. Boyts
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| Vol #:
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| 2
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| EMC 202
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| A. Hill
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| Vol #:
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| 2
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| EMC 203
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| M. Dillon
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| Vol #:
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| 2
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| EMC 204
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| M. Carroll
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| Vol #:
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| 2
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| EMC 205
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| J. Budrevich
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| Vol #:
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| 2
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| EMC 206
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| E. Rosenberg
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| Vol #:
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| 2
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| EMC 207
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| J. Kleindienst
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| Vol #:
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| 2
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| EMC 208
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| K. Barnwell
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| Vol #:
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| 2
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| |
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| EMC 209
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| R. Lackey
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| Vol #:
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| 2
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| EMC 210
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| R. Serenbetz
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| Vol #:
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| 2
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| EMC 211
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| D. Quintana
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| Vol #:
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| 2
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| EMC 212
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| J. Martin
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| Vol #:
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| 2
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| |
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| EMC 213
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| H. Koelle
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| Vol #:
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| 2
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| EMC 214
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| L. Lassiter
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| Vol #:
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| 2
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| EMC 215
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| K. Gilmour
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| Vol #:
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| 2
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| |
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| EMC 216
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| D. Simmons
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| Vol #:
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| 2
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| |
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| EMC 217
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| A. Wieland
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| Vol #:
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| 2
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| | | | | | | |
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| |
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| EMC 218
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| W. Russell
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| Vol #:
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| 2
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| |
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| EMC 219
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| B. Pence
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| Vol #:
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| 2
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| |
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| EMC 220
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| B. Thompson
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| Vol #:
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| 2
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| |
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| EMC 221
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| M. Jones
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| Vol #:
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| 2
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| |
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| EMC 222
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| B. Thompson
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| Vol #:
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| 2
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| |
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| EMC 223
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| A. Cardenas
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| Vol #:
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| 2
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| EMC 224
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| M. Young
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| Vol #:
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| 2
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| EMC 225
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| T. Tuffy
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| Vol #:
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| 2
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| |
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| EMC 226
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| R. Stuve
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| Vol #:
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| 2
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| |
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| EMC 227
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| J. Wenglin
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| Vol #:
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| 2
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| EMC 228
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| M. Frey
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| Vol #:
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| 2
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| |
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| EMC 229
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| R. Werlink
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| Vol #:
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| 2
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| |
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| EMC 230
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| E. Collins
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| Vol #:
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| 2
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| |
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| EMC 231
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| B. Lee
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| Vol #:
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| 2
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| |
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| EMC 232
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| D. Smith
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| Vol #:
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| 2
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| |
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| EMC 233
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| A. Hill
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| Vol #:
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| 2
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| |
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| EMC 234
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| L. Miller
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| Vol #:
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| 2
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| |
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| EMC 235
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| L. Miller
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| Vol #:
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| 2
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| |
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| EMC 236
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| E. Elliott
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| Vol #:
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| 2
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| |
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| EMC 237
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| J. Bart
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| Vol #:
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| 2
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| |
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| EMC 238
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| K. Lorenzen
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| Vol #:
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| 2
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| |
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| EMC 239
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| J. Galbraith Jr.
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| Vol #:
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| 2
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| EMC 240
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| C. Jentner
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| Vol #:
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| 2
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| EMC 241
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| S. Candiani
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| Vol #:
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| 2
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| |
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| EMC 242
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| K. Heffner
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| Vol #:
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| 2
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| |
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| EMC 243
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| C. Kane
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| Vol #:
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| 2
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| |
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| EMC 244
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| C. Simmons
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| Vol #:
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| 2
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| |
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| EMC 245
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| D. Hart
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| Vol #:
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| 2
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| |
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| EMC 246
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| Maja
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| Vol #:
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| 2
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| |
|
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| EMC 247
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| L. Turley
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| Vol #:
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| 2
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| |
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| EMC 248
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| C. Smeets
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| Vol #:
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| 2
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| |
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| EMC 249
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| J. Cronin
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| Vol #:
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| 2
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| |
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| EMC 250
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| P. Kindersley
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| Vol #:
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| 2
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| |
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| EMC 251
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| C. Kromann
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| Vol #:
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| 2
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| |
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| EMC 252
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| M. Golden
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| Vol #:
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| 2
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| |
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| EMC 253
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| N. Senft
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| Vol #:
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| 2
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| |
|
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| EMC 254
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| A. Bates
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| Vol #:
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| 2
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|
| | | | | | | |
|
| |
|
| EMC 255
|
| L. Lundemo
|
| Vol #:
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| 2
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| |
|
|
| EMC 256
|
| D. Helle
|
| Vol #:
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| 2
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| |
|
|
| EMC 257
|
| B. Wills
|
| Vol #:
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| 2
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| |
|
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| EMC 258
|
| A. Sutton
|
| Vol #:
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| 2
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| |
|
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| EMC 259
|
| T. Basile
|
| Vol #:
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| 2
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| |
|
|
| EMC 260
|
| A. Curtis
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| Vol #:
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| 2
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| |
|
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| EMC 261
|
| A. Curtis
|
| Vol #:
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| 2
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| |
|
|
| EMC 262
|
| B. Buchanan
|
| Vol #:
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| 2
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| |
|
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| EMC 263
|
| W. Mahmmod
|
| Vol #:
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| 2
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| |
|
|
| EMC 264
|
| M. Zarones
|
| Vol #:
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| 2
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| |
|
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| EMC 265
|
| S. Dexter
|
| Vol #:
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| 2
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| |
|
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| EMC 266
|
| F. Campbell
|
| Vol #:
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| 2
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| |
|
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| EMC 267
|
| L. Anderson
|
| Vol #:
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| 2
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| |
|
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| EMC 268
|
| N. Daoust
|
| Vol #:
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| 2
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| |
|
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| EMC 269
|
| J. Daoust
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| Vol #:
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| 2
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| |
|
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| EMC 270
|
| J. Negri
|
| Vol #:
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| 2
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| |
|
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| EMC 271
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| C. Mizerany
|
| Vol #:
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| 2
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| |
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| EMC 272
|
| S. Pinkerton
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| Vol #:
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| 2
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| |
|
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| EMC 273
|
| D. Rupiper
|
| Vol #:
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| 2
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| |
|
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| EMC 274
|
| A. Puris
|
| Vol #:
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| 2
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| |
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| EMC 275
|
| M. Herschler
|
| Vol #:
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| 2
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| |
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| EMC 276
|
| C. Norton
|
| Vol #:
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| 2
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| |
|
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| EMC 277
|
| M. Sher
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| Vol #:
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| 2
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| |
|
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| EMC 278
|
| T. Williams
|
| Vol #:
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| 2
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| |
|
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| EMC 279
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| L. Caverly
|
| Vol #:
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| 2
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| |
|
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| EMC 280
|
| T. Moore
|
| Vol #:
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| 2
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| |
|
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| EMC 281
|
| J. Riley
|
| Vol #:
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| 2
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| |
|
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| EMC 282
|
| K. Leuenroth Jr.
|
| Vol #:
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| 2
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| |
|
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| EMC 283
|
| E. Ferranti
|
| Vol #:
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| 2
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| |
|
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| EMC 284
|
| K. Brown
|
| Vol #:
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| 2
|
| |
|
|
| EMC 285
|
| T. Swartz
|
| Vol #:
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| 2
|
| |
|
|
| EMC 286
|
| C. Judge
|
| Vol #:
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| 2
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| |
|
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| EMC 287
|
| G. Dalton
|
| Vol #:
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| 2
|
| |
|
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| EMC 288
|
| J. Sneller
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 289
|
| B. Fabricius
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 290
|
| Darvin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 291
|
| T. Connor
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 529
|
| C. Daly
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 530
|
| L. Middleton
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 531
|
| C. Little
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 532
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 533
|
| B. Trimpey
|
| Vol #:
|
| 9
|
| |
|
|
| 2004D-0460
|
| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
|
|
|
|
|
|
|
|
|
| EMC
1
|
| Apotex, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004D-0510
|
| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
|
| |
|
|
| EMC
5
|
| New England Lobster Exporters Coalition
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0355
|
| Scientific Considerations Related to Developing Follow-on Protein Products
|
| |
|
|
| EMC
7
|
| Hoffman-La Roche, Inc. (Roche)
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| EMC 1100
|
| K. Holmes
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1101
|
| G. Smith
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1102
|
| D. Porter
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1103
|
| J. Harding
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1104
|
| W. Park
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1105
|
| O. Bessette
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1106
|
| J. Postell
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1107
|
| A. Ross
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1108
|
| L. Loon
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1109
|
| L. Loon
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1110
|
| B. Brown
|
| Vol #:
|
| 28
|
| |
|
|
| EMC 1111
|
| L. Hamlin
|
| Vol #:
|
| 28
|
|
| |
|
| 2005D-0033
|
| Guidance for Industry on Internal Radioactive Contamination -- Development of Decorporation Agents
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0042
|
| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
| | | | | | | | |
|
| |
|
| EAPE 48
|
| Idanpaan-Heikkila, Juhana
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 49
|
| Wong, Jennifer
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 50
|
| Kerwin, Rosemary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 51
|
| Queffelec, Denise
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 52
|
| Howland, Margaret
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 53
|
| Bankert, Elizabeth
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 54
|
| Goode, Donald
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 55
|
| Yonren, Samuel
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0070
|
| ANDA Suitability for Oral Salmon Calcitonin
|
| |
|
|
| ACK
1
|
| HFA-305
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Bone Medical Limited
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0072
|
| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
|
| |
|
|
| ACK
1
|
| HFA-305 to Professor of Surgery, Chief of Plastic Surgery
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Professor of Surgery, Chief of Plastic Surgery
|
| Vol #:
|
| 1
|
|
|
