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| Dockets Entered
On June 5, 2007
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2006D-0083
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| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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| 2006E-0332
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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| 2006E-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006P-0351
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| Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
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| 2006P-0372
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| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2007D-0206
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| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
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| 2007D-0213
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| SUP 58
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| Brian Kaplan, M.D.
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| Vol #:
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| 257
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 1123
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| D. Clift
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| Vol #:
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| 68
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| C 1124
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| S. Needham
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| Vol #:
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| 68
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| C 1125
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| C. Gortner
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| Vol #:
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| 68
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| C 1126
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| D. Curtis
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| Vol #:
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| 68
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| C 1127
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| V. Jacobson
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| Vol #:
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| 68
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| C 1128
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| C. Hermance
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| Vol #:
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| 68
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| C 1129
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| I. Hodge
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| Vol #:
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| 68
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| C 1130
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| W. Lansdon
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| Vol #:
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| 68
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| C 1131
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| B. Thibault
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| Vol #:
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| 68
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| C 1132
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| S. White
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| Vol #:
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| 68
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| C 1133
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| M. Vojtko
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| Vol #:
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| 68
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| C 1134
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| T. Fortini
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| Vol #:
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| 68
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| C 1135
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| B. Zvolenski
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| Vol #:
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| 68
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| C 1136
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| P. Kauffman
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| Vol #:
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| 68
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| C 1137
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| M. Caponigro
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| Vol #:
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| 68
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| C 1138
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| P. Johnson
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| Vol #:
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| 68
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| C 1139
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| D. Peluso
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| Vol #:
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| 68
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| C 1140
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| H. Mezzadonna
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| Vol #:
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| 68
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| C 1141
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| K. Smith
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| Vol #:
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| 68
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| C 1142
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| J. Revere
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| Vol #:
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| 68
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| C 1143
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| P. Taboga
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| Vol #:
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| 68
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| C 1144
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| J. Bender
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| Vol #:
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| 68
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| C 1145
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| L. Scheffenacker
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| Vol #:
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| 68
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| C 1146
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| K. Koogler
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| Vol #:
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| 68
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| C 1147
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| D. Gailfus
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| Vol #:
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| 68
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| C 1148
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| T. Talentino
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| Vol #:
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| 68
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| C 1149
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| C. Allen
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| Vol #:
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| 68
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| C 1150
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| M. Lutz
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| Vol #:
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| 68
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| C 1151
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| A. Gutierrez
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| Vol #:
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| 68
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| C 1152
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| B. Glavin
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| Vol #:
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| 68
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| C 1153
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| T. Evans
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| Vol #:
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| 68
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| C 1154
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| C. Jones
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| Vol #:
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| 68
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| C 1155
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| E. Defrin
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| Vol #:
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| 68
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| C 1156
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| A. Lindell
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| Vol #:
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| 68
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| C 1157
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| R. Alpert
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| Vol #:
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| 68
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| C 1158
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| D. Linkowski
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| Vol #:
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| 68
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| C 1159
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| B. Mcallister
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| Vol #:
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| 68
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| C 1160
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| S. Bence
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| Vol #:
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| 68
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| C 1161
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| A. Anderson
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| Vol #:
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| 68
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| C 1162
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| A. Espiritiu
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| Vol #:
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| 68
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| C 1163
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| P. Knol
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| Vol #:
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| 68
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| C 1164
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| A. Rosen
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| Vol #:
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| 68
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| C 1165
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| S. Seese
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| Vol #:
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| 68
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| C 1166
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| M. Flietner
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| Vol #:
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| 68
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| C 1167
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| C. Fuenzalida
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| Vol #:
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| 68
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| C 1168
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| C. Micho
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| Vol #:
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| 68
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| C 1169
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| J. Parker
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| Vol #:
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| 68
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| C 1170
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| R. Sdano
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| Vol #:
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| 68
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| C 1171
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| C. Kuwasaki
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| Vol #:
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| 68
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| C 1172
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| T. Travis
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| Vol #:
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| 68
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| C 1173
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| C. Buitrago
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| Vol #:
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| 68
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| C 1174
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| T. DeCoamtis
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| Vol #:
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| 68
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| C 1175
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| P. Morgan
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| Vol #:
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| 68
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| C 1176
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| K. Olsen
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| Vol #:
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| 68
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| C 1177
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| J. Newfeld
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| Vol #:
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| 68
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| C 1178
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| K. Jacobson
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| Vol #:
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| 68
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| |
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| C 1179
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| E. Osgood
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| Vol #:
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| 68
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| C 1180
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| M. Lubeckyj
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| Vol #:
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| 68
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| C 1181
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| B. Vaughn
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| Vol #:
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| 68
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| C 1182
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| S. Adams
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| Vol #:
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| 68
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| C 1183
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| L. Bovasso
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| Vol #:
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| 68
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| C 1184
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| M. Sanders
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| Vol #:
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| 68
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| C 1185
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| G. Poertner
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| Vol #:
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| 68
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| C 1186
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| A. Messler
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| Vol #:
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| 68
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| C 1187
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| J. Hawthorne
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| Vol #:
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| 68
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| |
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| C 1188
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| W. Warren
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| Vol #:
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| 68
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| |
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| C 1189
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| E. Sprecher
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| Vol #:
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| 68
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| C 1190
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| J. Peratis
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| Vol #:
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| 68
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| C 1191
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| J. Mendoza
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| Vol #:
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| 68
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| C 1192
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| J. Nelson
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| Vol #:
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| 68
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| C 1193
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| B. Saxton
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| Vol #:
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| 68
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| |
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| C 1194
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| C. Hankinson
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| Vol #:
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| 68
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| C 1195
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| J. Pete
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| Vol #:
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| 68
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| |
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| C 1196
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| A. Paderna
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| Vol #:
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| 68
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| |
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| C 1197
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| F. Hill
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| Vol #:
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| 68
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| |
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| C 1198
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| K. Scheie
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| Vol #:
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| 68
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| |
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| C 1199
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| J. Valde
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| Vol #:
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| 68
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| C 1200
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| S. Weakly
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| Vol #:
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| 68
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| C 1201
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| R. Blaylock
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| Vol #:
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| 68
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| |
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| C 1202
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| P. Norris
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| Vol #:
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| 68
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| |
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| C 1203
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| P.Schulze
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| Vol #:
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| 68
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| |
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| C 1204
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| R. Craig
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| Vol #:
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| 68
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| |
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| C 1205
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| S. McVeigh
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| Vol #:
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| 68
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| |
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| C 1206
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| N. Brown
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| Vol #:
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| 68
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| |
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| C 1207
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| K. Sloan
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| Vol #:
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| 68
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| |
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| C 1208
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| S. Mohler
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| Vol #:
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| 68
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| |
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| C 1209
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| M. Smith
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| Vol #:
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| 68
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| |
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| C 1210
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| M. Leibich
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| Vol #:
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| 68
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| |
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| C 1211
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| C. Maibusch
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| Vol #:
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| 68
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| | | | | | | | |
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| |
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| C 1212
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| A. Raven
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| Vol #:
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| 68
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| |
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| C 1213
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| K. Carpenter
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| Vol #:
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| 68
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| |
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| C 1214
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| Coco
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| Vol #:
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| 68
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| |
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| C 1215
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| R. Hartmann
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| Vol #:
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| 68
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| |
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| C 1216
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| T. Gaston
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| Vol #:
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| 68
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| |
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| C 1217
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| E. Vichules
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| Vol #:
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| 68
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| |
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| C 1218
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| G. Goll
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| Vol #:
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| 68
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| |
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| C 1219
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| L. Beavon
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| Vol #:
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| 68
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| |
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| C 1220
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| K. Leach
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| Vol #:
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| 68
|
| |
|
|
| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 742
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| Ministry for Foreign Affairs of Finland
|
| Vol #:
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| 35
|
|
| |
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
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| 2006D-0088
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| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0332
|
| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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| |
|
|
| N 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006E-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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| |
|
|
| N 1
|
| FDA
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| Vol #:
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| 1
|
| |
|
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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|
|
|
|
| | |
|
|
| SS 1
|
| Supporting Statement
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| Vol #:
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| 1
|
| |
|
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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|
|
|
|
|
| | |
|
|
| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0362
|
| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
|
| |
|
|
| C 13
|
| Gropper Neurosurgical
|
| Vol #:
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| 1
|
| |
|
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| C 14
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| Capital City Neurosurgical
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| Vol #:
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| 1
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| |
|
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| C 15
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| Capital City Neurosurgical
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| Vol #:
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| 1
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| |
|
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| C 16
|
| University of Pennsylvania Health System
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| Vol #:
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| 1
|
| |
|
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| C 17
|
| University of Cincinnati Surgeons, Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0351
|
| Restriction or withdrawal of the use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy in the following conditions
|
|
| | | | | | | | |
|
| |
|
| SUP 1
|
| Diplomate of the American Board of Internal Medicine & Nephrology Fulbright Scholar in Medicine
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0372
|
| Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| LET 2
|
| FDA/CDER to Lachman Consultant Services
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0206
|
| Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0213
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0010
|
| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 242
|
| REDER, Robert
|
| Vol #:
|
| 7
|
| |
|
|
| EAPE 243
|
| mcvey, kevin
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| Vol #:
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| 7
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| |
|
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| EAPE 244
|
| Beilic, Daniela
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| Vol #:
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| 7
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| |
|
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| EAPE 245
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| Zong, Jihong
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| Vol #:
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| 7
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| |
|
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| EAPE 246
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| Bernstein, Ilisa
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| Vol #:
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| 7
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| |
|
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| EAPE 247
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| Talton, Wayne
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| Vol #:
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| 7
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| |
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| EAPE 248
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| Stoddard, Jeffrey
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| Vol #:
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| 7
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| |
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| EAPE 249
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| Gelsinger, Timothy
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| Vol #:
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| 7
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| |
|
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| EAPE 250
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| Kapsaskis, Tony
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| Vol #:
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| 7
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| |
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| EAPE 251
|
| Sasso, Ted
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| Vol #:
|
| 7
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| |
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| EAPE 252
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| Sasso, Darrell
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| Vol #:
|
| 7
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| |
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| EAPE 253
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| Liantonio, Carole
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| Vol #:
|
| 7
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| |
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| EAPE 254
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| Kim, Michael
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| Vol #:
|
| 7
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|
|
