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| Dockets Entered
On April 5, 2007
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2007E-0131
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| Patent Term Extension for OMNARIS (ciclesonide), U.S. Patent No. 5,482,934
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0110
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| To enforce pediatric exclusivity rights for amlodipine
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| 2007P-0111
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| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| 2007P-0130
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| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19852
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| Natural Factors Nutritional Products, Inc.
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| Vol #:
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| 175
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| LET 19853
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| Natural Organics, Inc.
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| Vol #:
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| 175
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| LET 19854
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19855
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19856
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19857
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19858
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19859
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19860
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19861
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19862
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19863
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19864
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| Natural Organics, Inc.
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| Vol #:
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| 175
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| LET 19865
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| Natural Organics, Inc.
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| Vol #:
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| 175
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| LET 19866
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| Natural Organics, Inc.
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| Vol #:
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| 175
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| LET 19867
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| Natural Organics, Inc.
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| Vol #:
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| 175
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| LET 19868
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| Primordial Performance LLC
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| Vol #:
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| 175
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| LET 19869
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| Doctors' Research, Inc.
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| Vol #:
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| 175
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4442
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| C. Varner
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| Vol #:
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| 320
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 676
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| A. Snyder
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| Vol #:
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| 24
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 789
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 790
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 791
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 792
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 793
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| Mission Possible International
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| Vol #:
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| 10
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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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| EMC 1467
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| L. & E. Crowley
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| Vol #:
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| 12
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| EMC 1468
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| K. Neistat
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| Vol #:
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| 12
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| EMC 1469
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| L. Moore
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| Vol #:
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| 12
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 4310
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| Mrs. Ruth Joseph
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| Vol #:
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| 50
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| EC 4311
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| Ms. JoAnn Withrow
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| Vol #:
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| 50
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| EC 4312
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| Mrs. Marla Krause-Molina
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| Vol #:
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| 50
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| EC 4313
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| Mr. Mark Draughn
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| Vol #:
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| 50
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| EC 4314
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| Mr. daniel webb
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| Vol #:
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| 50
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| EC 4315
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| Ms. Theresa Halter
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| Vol #:
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| 50
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| EC 4316
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| Mr. Geoff Fein
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| Vol #:
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| 50
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| EC 4317
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| Mrs. Michelle Clark
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| Vol #:
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| 50
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| EC 4318
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| Ms. Pat DuVall
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| Vol #:
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| 50
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| EC 4319
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| Dr. David Mercantini
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| Vol #:
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| 50
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| EC 4320
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| Mrs. Tonya Crego
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| Vol #:
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| 50
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| EC 4321
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| Ms. Claire Kozower
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| Vol #:
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| 50
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| EC 4322
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| Mr. Glenn Schmitz
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| Vol #:
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| 50
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| EC 4323
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| Ms. Stacey Olson
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| Vol #:
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| 50
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| EC 4324
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| Dr. barb spector
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| Vol #:
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| 50
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| EC 4325
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| Ms. Jennie Curtis
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| Vol #:
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| 50
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| EC 4326
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| Mr. Troy Reynolds
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| Vol #:
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| 50
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| EC 4327
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| Mrs. Mary Boppe
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| Vol #:
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| 50
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| EC 4328
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| Ms. gwen harris
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| Vol #:
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| 50
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| EC 4329
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| Ms. Beth Zellner
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| Vol #:
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| 50
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| EC 4330
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| public school
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| Vol #:
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| 50
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| EC 4331
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| Ms. Deborah Lain
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| Vol #:
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| 50
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| EC 4332
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| Mr. ED ALEXANDER
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| Vol #:
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| 50
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| EC 4333
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| Mr. Robert Nolan
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| Vol #:
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| 50
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| EC 4334
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| Mr. Monte Hines
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| Vol #:
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| 50
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| EC 4335
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| Mrs. Gina Varitek
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| Vol #:
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| 50
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| EC 4336
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| Ms. Christy Randall
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| Vol #:
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| 50
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| EC 4337
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| Ms. Tracey Nafekh
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| Vol #:
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| 50
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| EC 4338
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| Vortex Racing
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| Vol #:
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| 50
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| EC 4339
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| Ms. Ardell Price
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| Vol #:
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| 50
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| EC 4340
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| Mrs. carol shimkowiak
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| Vol #:
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| 50
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| EC 4341
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| Mr. Daniel Hess
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| Vol #:
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| 50
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| EC 4342
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| Mr. JONATHAN STILLWELL
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| Vol #:
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| 50
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| EC 4343
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| Mrs. Lisa Guthrie
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| Vol #:
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| 50
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| EC 4344
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| Mrs. Jessica Arndt
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| Vol #:
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| 50
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| EC 4345
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| Ms. Debra Conroy
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| Vol #:
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| 50
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| EC 4346
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| Mrs. Sandra Thornburgh
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| Vol #:
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| 50
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| EC 4347
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| Ms. Mary Xakellis Chapman
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| Vol #:
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| 50
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| EC 4348
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| Ms. Joan Yenawine
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| Vol #:
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| 50
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| EC 4349
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| Mr. HOWARD K. BURKE JR.
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| Vol #:
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| 50
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| EC 4350
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| Mrs. Kelly Mauer
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| Vol #:
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| 50
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| EC 4351
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| Ms. Rita Street
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| Vol #:
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| 50
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| EC 4352
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| Mrs. Michele Ryska
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| Vol #:
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| 50
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| EC 4353
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| Ms. Cynthia Grippaldi
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| Vol #:
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| 50
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| EC 4354
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| Mr. James lordi
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| Vol #:
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| 50
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| EC 4355
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| Mrs. Bonnie Jordan
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| Vol #:
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| 50
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| EC 4356
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| Mrs. Maureen Deppe
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| Vol #:
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| 50
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| EC 4357
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| Ms. Shirley Johnson
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| Vol #:
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| 50
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| EC 4358
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| Mrs. Lina Herrera
|
| Vol #:
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| 50
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| EC 4359
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| Mr. Joseph Ritter
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| Vol #:
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| 50
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| EC 4360
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| Dymond S Ranch
|
| Vol #:
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| 50
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| EC 4361
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| Mr. Mitchell Mercurio
|
| Vol #:
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| 50
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| EC 4362
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| Mrs. Frances Gray
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| Vol #:
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| 50
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| | | | | | | |
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| EC 4363
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| Ms. Linda Allen
|
| Vol #:
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| 50
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| EC 4364
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| Miss. Melissa King
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| Vol #:
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| 50
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| EC 4365
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| Ms. LIZ Stack
|
| Vol #:
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| 50
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| |
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| EC 4366
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| Dr. Jennifer Sokolove
|
| Vol #:
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| 50
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| EC 4367
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| Miss. Jessica Collins
|
| Vol #:
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| 50
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| EC 4368
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| Dr. Daniel Hanf
|
| Vol #:
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| 50
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| EC 4369
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| Mrs. Joellen Hoffman
|
| Vol #:
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| 50
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| EC 4370
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| Ms. Christy Spurlock
|
| Vol #:
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| 50
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| EC 4371
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| Wheatsville food co-op
|
| Vol #:
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| 50
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| |
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| EC 4372
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| Mr. Richard Paul
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| Vol #:
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| 50
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| EC 4373
|
| Mr. Mitchell Grossman RCP RRT
|
| Vol #:
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| 50
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| EC 4374
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| Ms. Claire Kia
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| Vol #:
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| 50
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| EC 4375
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| Mrs. L Archibald
|
| Vol #:
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| 50
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| |
|
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| EC 4376
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| Mrs. Sonia Muriel
|
| Vol #:
|
| 50
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| |
|
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| EC 4377
|
| Miss. Jennifer Simerly
|
| Vol #:
|
| 50
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| |
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| EC 4378
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| Ms. Micki Haverland
|
| Vol #:
|
| 50
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| |
|
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| EC 4379
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| Mrs. Shannon Valderas
|
| Vol #:
|
| 50
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| |
|
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| EC 4380
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| Mrs. Shirley Troup
|
| Vol #:
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| 50
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| |
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| EC 4381
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| Ms. Paula Clark
|
| Vol #:
|
| 50
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| |
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| EC 4382
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| Miss. Amity Dehoff
|
| Vol #:
|
| 50
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| |
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| EC 4383
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| Miss. Amanda Moore
|
| Vol #:
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| 50
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| |
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| EC 4384
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| Ms. Barbara Heinsohn
|
| Vol #:
|
| 50
|
| |
|
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| EC 4385
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| Mr. jeff mcgowan
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4386
|
| Mrs. Deb Hughes
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4387
|
| Mr. Ross Martinek LPG
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4388
|
| Mr. Peter Kowalke
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4389
|
| Mrs. April Goldberg
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4390
|
| food
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4391
|
| Mrs. Stephanie Beckett
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4392
|
| Mr. Arran Thomson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4393
|
| Miss. Kathleen Leary
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4394
|
| Mr. David Stansbury
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4395
|
| Mrs. Nancy Fleming
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4396
|
| Ms. Gail Matusovich
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4397
|
| Mrs. Jessica Pyle
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4398
|
| Mrs. Christy Bridges
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4399
|
| Ms. Jill Mclaughlin
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4400
|
| Teays Valley Board of Education
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4401
|
| Ordinary Mom
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4402
|
| Mr. Dan McDonald
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4403
|
| Mrs. Patricia Daily
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4404
|
| Ms. Shari Greenfield
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4405
|
| Mr. Mickey Lynn
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4406
|
| Mrs. Tina Burns
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4407
|
| Ms. andrea korovesis
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4408
|
| Mr. Wallace Gieringer
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4409
|
| Mrs. Tamara Swenson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4410
|
| Conservative Party of Madison County, NY
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4411
|
| Ms. Candis Haley
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4412
|
| Mrs. Kathleen Fennelly
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4413
|
| Mr. Steven Korovesis
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4414
|
| Mr. Joel McKee
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4415
|
| none
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4416
|
| Miss. Lisa Palmer
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4417
|
| Mrs. Alicia Gill
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4418
|
| Ms. mary jo marshall
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4419
|
| Mrs. Jeannie Quave
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4420
|
| Mr. Joseph Sapere
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4421
|
| Ms. Whitney Nickol
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4422
|
| Mrs. Brenda Burge
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4423
|
| Mr. Todd Hudson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4424
|
| Ms. Anne Ellsworth
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4425
|
| Ms. E. Stone
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4426
|
| inhnews
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4427
|
| CCNH
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4428
|
| Miss. Brighid Hierholzer
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4429
|
| Ms. Regina Gardiner
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4430
|
| Mr. Richard Mackin
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4431
|
| Ms. Nichole Reno
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4432
|
| Mr. Daniel Roper
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4433
|
| Mrs. Monica Erskine
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4434
|
| Mrs. Kerry Oliver
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4435
|
| Mr. A. Gaguine
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4436
|
| Mr. Russ Barnes
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4437
|
| Mrs. Michelle Presley
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4438
|
| Mrs. blaire kribs
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4439
|
| Ms. Loretta Dunne
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4440
|
| Phamacy
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4441
|
| NYU MPH student
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4442
|
| Mrs. Lori Gieseking
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4443
|
| Mr. Joshua Lemonds
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4444
|
| Mrs. Christine Pozniewski
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4445
|
| Mr. Glenn Francis
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4446
|
| Mrs. Shauna Abbenhaus
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4447
|
| Miss. Rosemary O'Neill
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4448
|
| Mrs. Vickei Myers
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4449
|
| New Seasons Market
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4450
|
| Mr. Michael Musumeci
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4451
|
| Mr. KC LOWERY
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4452
|
| AAVS (American Anti-Vivisection Society
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4453
|
| Mr. Eric Stensrud
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4454
|
| Ms. Michelle Coakley
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4455
|
| Mrs. Cheri Rivers
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4456
|
| Mrs. Gennel Baehr
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4457
|
| Ms. K Rabon
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4458
|
| Mr. kerry reynolds
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4459
|
| Mr. kerry mcdowell
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4460
|
| Mr. Brad Johnson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4461
|
| Ms. sheryl bryant
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4462
|
| Miss. JULIA BLUM
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4463
|
| Mrs. jonelle eike
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4464
|
| Mrs. Karen Moore
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4465
|
| Service Center for Latinos
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4466
|
| Ms. Nicole Dery
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4467
|
| Mr. Tandy Royal
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4468
|
| Ms. Jennifer Borchardt
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4469
|
| Ms. Valerie Smith
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4470
|
| Mrs. Brenda Lamb
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4471
|
| Miss. Esther Arnelas
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4472
|
| Mrs. Amber Booy
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4473
|
| Mr. John Murphy
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4474
|
| School District of Upper Dublin
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4475
|
| Mrs. Nancy Fox
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4476
|
| Green Earth Enterprises Llc.
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4477
|
| Mr. Nima Khosrowshahian
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4478
|
| Mrs. Mary Podziomek
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4479
|
| Ms. LORETTA WISE
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4480
|
| Mr. Carl Donsbach
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4481
|
| Ms. Heather Muir
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4482
|
| Orange County Goverment
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4483
|
| Holistic Homestead
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4484
|
| Liberty Ark Coalition
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4485
|
| Mrs. Courtney Clasen
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4486
|
| Ben
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4487
|
| Miss. Lori Nelson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4488
|
| Ms. taryn vogt
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4489
|
| Ms. Yvonne Flynn
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4490
|
| Ms. Janis Boyd
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4491
|
| Ms. Sherri Hansen
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4492
|
| Mrs. Rachael Sanders
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4493
|
| Ms. Deborah Emory
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4494
|
| Sierra Club
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4495
|
| Ms. Karen Allemand
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4496
|
| Ms. Monica Schwenke
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4497
|
| Ms. Monique Constant
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4498
|
| Ms. Kate Jackson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4499
|
| Ms. Jenna Rose
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4500
|
| N/A
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4501
|
| Mrs. Sara O'Connor
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4502
|
| Mr. Donald Hayward
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4503
|
| Ms. Samantha Bennett
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4504
|
| Ms. Betsy Garbe
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4505
|
| Ms. Kathy Moore
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4506
|
| Ms. carl kakasuleff
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4507
|
| Ms. Torrie McDonald
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4508
|
| Meson GlassWorks
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4509
|
| Miss. Shelby Varian
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4510
|
| Miss. Evelyn Miller
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4511
|
| Mrs. Dawn Nugent
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4512
|
| Ms. Sally Lawrence
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4513
|
| Mrs. Sara Kaufman
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4514
|
| Mrs. Diane Rogers
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4515
|
| Mrs. kimberly kothman
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4516
|
| Miss. Corinne Crawford
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4517
|
| none
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4518
|
| Ms. Kathy Perles
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4519
|
| n/a
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4520
|
| Ms. Naomi Haruko
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4521
|
| Ms. Harriet Behar
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4522
|
| Mrs. brenda bestle
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4523
|
| Mr. Terence Pfaff
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4524
|
| Mrs. Monica Mills
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4525
|
| Ms. Abigail Crawshaw
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4526
|
| Mrs. marian Alfoldy
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4527
|
| Ms. Peggy Goodale
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4528
|
| Ms. Sharon Martin
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4529
|
| American Anti - Vivisection
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4530
|
| Mrs. Candace Arnold
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4531
|
| Ms. Danielle Dillon
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4532
|
| Mrs. Linda Van Hoorebeke
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4533
|
| Mrs. rebecca mckenna
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4534
|
| Ms. Chris Rife
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4535
|
| Ms. Suzanne Friesen
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4536
|
| Ms. Meghan Reiff
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4537
|
| Dr. Alicia Noonan
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4538
|
| Mr. Brian Noonan
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4539
|
| Mrs. Jessica Doss
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4540
|
| Mr. Robert W. Sagerer
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4541
|
| Miss. Gillian Booth
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4542
|
| Ms. Janine Bryant
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4543
|
| Mrs. Patsy Neely
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4544
|
| Ms. Louise Skog
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4545
|
| Ms. Karin Leary
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4546
|
| Mrs. Kara Sprague
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4547
|
| University of Wisconsin School of Veterinary Medic
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4548
|
| Miss. Amanda K
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4549
|
| Ms. Melissa Bailey
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4550
|
| Mrs. Anna Arneson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4551
|
| Ms. Bunnell M. Moseley
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4552
|
| Mrs. Brenda Martinez
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4553
|
| Ms. Julie Ford
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4554
|
| Ms. Lillian Askue
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4555
|
| Mr. Neil Glaser
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4556
|
| Mrs. Alicia Higginbotham
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4557
|
| Mr. Jeffrey Stewart
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4558
|
| Miss. sara lefsyk
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4559
|
| Ms. Kelsey Tollefson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4560
|
| Ms. Jennifer Lynch
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4561
|
| Ms. Sarah Timmins DeGregory
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4562
|
| Ms. Carmela Beck
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4563
|
| Mrs. Barbara Birdsey
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4564
|
| Ms. Liza Vinci
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4565
|
| Ms. Diane Berliner
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4566
|
| Ms. Linda Bescript
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4567
|
| Ms. d hemingson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4568
|
| Miss. Brianne H
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4569
|
| Mrs. K Hodge
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4570
|
| Dr. Peter Glickman
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4571
|
| Mr. George Pollow
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4572
|
| Mr. Dennis Reiter
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4573
|
| Mr. james lutes
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4574
|
| Eden's Way Herbal Soap Factory
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4575
|
| Miss. Courtney Robinson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4576
|
| Mrs. Kasandra McBride
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4577
|
| Mr. Michael Sovacool
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4578
|
| Mr. Kevin Murphy
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4579
|
| Mrs. Terri Huitt
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4580
|
| Ms. Paula Wilson-Cazier
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4581
|
| Mr. Samuel Hicks
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4582
|
| Mrs. Natalie Reid
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4583
|
| Mr. Martin Perkins
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4584
|
| Ms. Jennifer Balas
|
| Vol #:
|
| 50
|
|
| | | | | | | |
|
| |
|
| EC 4585
|
| Ms. Nikila Okorowo
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4586
|
| Mrs. Roberta Krouth
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4587
|
| Mr. Jonathan Duke
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4588
|
| Ms. Brenda Thomas
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4589
|
| Ms. David Anderson
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4590
|
| Ms. Rebecca Sharp
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4591
|
| Ms. Leslie O'Neill
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4592
|
| Mrs. Pat Pickren
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4593
|
| Mr. John KLosterboer
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4594
|
| Dr. Shinya Watanabe
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4595
|
| Mr. Bobby Martin
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4596
|
| Ms. Jeanine McGuire
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4597
|
| Dr. Kim Sun
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4598
|
| Ms. Jane White
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4599
|
| Mr. James Chismark
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4600
|
| Mrs. Juliana Marques
|
| Vol #:
|
| 50
|
| |
|
|
| EC 4601
|
| Ms. Catelin Lindsay
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4602
|
| Mr. fred fall
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4603
|
| Mr. Matt Ross
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4604
|
| Ms. Yancey Stanforth-Migliore
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4605
|
| Ms. Lisa Malone
|
| Vol #:
|
| 54
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| |
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| EC 4606
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| Mrs. Pauline Colwell
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| Vol #:
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| 54
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| |
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| EC 4607
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| Mrs. Heather Chase
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| Vol #:
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| 54
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| |
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| EC 4608
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| Ms. Cheryl Gonzalez
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| Vol #:
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| 54
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| |
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| EC 4609
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| Mr. William Kinsey
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| Vol #:
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| 54
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| EC 4610
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| Ms. Jane Webster
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| Vol #:
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| 54
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| EC 4611
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| Ms. Maria Farina
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| Vol #:
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| 54
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| EC 4612
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| Ms. Heather Whitehead
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| Vol #:
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| 54
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| EC 4613
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| Ms. claudia patel
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| Vol #:
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| 54
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| EC 4614
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| Ms. Maureen Beck
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| Vol #:
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| 54
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| EC 4615
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| Miss. Ashley Messing
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| Vol #:
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| 54
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| |
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| EC 4616
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| Ms. Saara Behlim
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| Vol #:
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| 54
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| |
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| EC 4617
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| Mrs. Amber Kein
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| Vol #:
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| 54
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| |
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| EC 4618
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| Mrs. Nicki Harris
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| Vol #:
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| 54
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| |
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| EC 4619
|
| Ms. Sara Conley
|
| Vol #:
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| 54
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| |
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|
| EMC 155
|
| G. Eschinger
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| Vol #:
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| 5
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| |
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| EMC 156
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| H. Moser
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| Vol #:
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| 5
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|
| | | | | | | | |
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| |
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| EMC 157
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| P. Nelson
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| Vol #:
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| 5
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| |
|
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| EMC 158
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| A. Schreiner
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| Vol #:
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| 5
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| |
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| EMC 159
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| A. Cowen
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| Vol #:
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| 5
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| |
|
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| EMC 160
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| A. Cowen
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| Vol #:
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| 5
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| |
|
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| EMC 161
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| C. Rosenthal
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| Vol #:
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| 5
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| |
|
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| EMC 162
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| R. Robins
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| Vol #:
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| 5
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| |
|
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| EMC 163
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| J. Krause
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| Vol #:
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| 5
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| |
|
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| EMC 164
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| C. Beane-Martin
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| Vol #:
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| 5
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| |
|
|
| EMC 165
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| B. Langhus
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| Vol #:
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| 5
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| |
|
|
| EMC 166
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| J. Robinson
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| Vol #:
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| 5
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| |
|
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| EMC 167
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| J. Sullivan
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| Vol #:
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| 5
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| |
|
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| EMC 168
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| C. Burkholder
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| Vol #:
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| 5
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| |
|
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| EMC 169
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| N. Hampton
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| Vol #:
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| 5
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| |
|
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| EMC 170
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| V. Loo
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| Vol #:
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| 5
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| |
|
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| EMC 171
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| M. Gore
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| Vol #:
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| 5
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| |
|
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| EMC 172
|
| A. West
|
| Vol #:
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| 5
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| |
|
|
| EMC 173
|
| National Agriculture Biotechnology Council
|
| Vol #:
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| 5
|
| |
|
|
| EMC 174
|
| National Farmers Union
|
| Vol #:
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| 5
|
| |
|
|
| EMC 175
|
| A. Stefanchik
|
| Vol #:
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| 5
|
| |
|
|
| EMC 176
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| S. Surplus
|
| Vol #:
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| 5
|
| |
|
|
| EMC 177
|
| I. Johnson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 178
|
| Form Letters (1)
|
| Vol #:
|
| 53
|
| |
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
| |
|
|
| EMC 1
|
| D.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| R. Donald
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| T. Katich
|
| Vol #:
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| 1
|
| |
|
|
| EMC 4
|
| M. Poole
|
| Vol #:
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| 1
|
| |
|
|
| EMC 5
|
| P. Carter
|
| Vol #:
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| 1
|
| |
|
|
| EMC 6
|
| Form Letters (1)
|
| Vol #:
|
| 2
|
| |
|
|
| EREG 1
|
| Citizens of the United States of America
|
| Vol #:
|
| 1
|
| |
|
|
| EREG 2
|
| R. Stoyer
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EC 1884
|
| Celiac Sprue Association
|
| Vol #:
|
| 31
|
| |
|
|
| EMC 312
|
| J. Williams
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 53
|
| A. Browning
|
| Vol #:
|
| 32
|
|
| | | | | | | | |
|
| |
|
| EREG 54
|
| M. Baker
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 55
|
| J. Evans
|
| Vol #:
|
| 32
|
|
| |
|
| 2005P-0325
|
| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
|
| |
|
|
| EMC 1
|
| J. Parks
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| EMC 86
|
| J. Hankins
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 87
|
| P. Christie
|
| Vol #:
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| 6
|
| |
|
|
| EMC 88
|
| A. Skorupski
|
| Vol #:
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| 6
|
| |
|
|
| EMC 89
|
| J. Hallawell
|
| Vol #:
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| 6
|
| |
|
|
| EMC 90
|
| E. Dale
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 91
|
| L. Filippo
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 92
|
| J. Hill
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 93
|
| L. Balukjian
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 94
|
| V. Bodig
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 95
|
| S. Butler
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 96
|
| D. Turner
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 97
|
| R. Castillo
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 98
|
| P. Deatherage
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 99
|
| M. Howard
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 100
|
| L. Blois
|
| Vol #:
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| 6
|
| |
|
|
| EMC 101
|
| P. Goltz
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 102
|
| M. Andrews
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 103
|
| L. Blais
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 104
|
| L. Long
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 105
|
| D. Nanos
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 106
|
| G. Gohr
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 107
|
| D. & C. Liolis
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 108
|
| L. Kasanoff
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 109
|
| S. Kieklak
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 110
|
| P. Arns
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 111
|
| J. Northey
|
| Vol #:
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| 6
|
| |
|
|
| EMC 112
|
| B. Cottingham
|
| Vol #:
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| 6
|
| |
|
|
| EMC 113
|
| R. Grammatico
|
| Vol #:
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| 6
|
| |
|
|
| EMC 114
|
| N. Faass
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 115
|
| B. Wheeler
|
| Vol #:
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| 6
|
|
| | | | | | | | |
|
| |
|
| EMC 116
|
| J. Buck
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 117
|
| G. Tilley
|
| Vol #:
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| 6
|
| |
|
|
| EMC 118
|
| J. Dalnoky
|
| Vol #:
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| 6
|
| |
|
|
| EMC 119
|
| K. Searle
|
| Vol #:
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| 6
|
| |
|
|
| EMC 120
|
| J. Kahler
|
| Vol #:
|
| 6
|
| |
|
|
| 2007E-0131
|
| Patent Term Extension for OMNARIS (ciclesonide), U.S. Patent No. 5,482,934
|
| |
|
|
| APP 1
|
| Altana Pharma AG
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| EAPE 17
|
| Krishnan, Kiran
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 18
|
| Coffey, Justine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 19
|
| Antoniuk, Susi
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 20
|
| Strickland, Dennis
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 21
|
| Goldhammer, Alan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 22
|
| Bayer, Mark
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0123
|
| Amlodipine Abbreviated New Drug Application Approvals
|
| |
|
|
| C 4
|
| Caraco Pharmaceutical Laboratories, LTD
|
| Vol #:
|
| 1
|
| |
|
|
| C 5
|
| Roxane Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| Aurobindo Pharma LTD
|
| Vol #:
|
| 1
|
| |
|
|
| C 7
|
| Watson Laboratories, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 6
|
| Mylan Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 7
|
| TEVA Pharmaceuticals USA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0070
|
| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
|
| |
|
|
| EC 1
|
| Ms. Jennifer Pan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Mr. Dee Master
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Ms. Susan Jamison
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Dr. catrina engle
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Mr. Richard Sorber
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Mrs. Susan Roenke
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Ms. Kimberly Fleury
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
| |
|
|
| EMC 1
|
| R. Peak
|
| Vol #:
|
| 2
|
| |
|
|
| 2007P-0110
|
| To enforce pediatric exclusivity rights for amlodipine
|
|
| | | | | | | | |
|
| |
|
| EMC 1
|
| Medco Health Solutions, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0111
|
| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
|
| |
|
|
| EMC 1
|
| Medco Health Solutions, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
|
|
| |
|
|
| C 1
|
| Mutual Pharmaceutical Co. Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| Heller Ehrman LLP
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| Medco Health Solutions, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0130
|
| Seeking Immediate Approval of ANDA No. 78-226 for Amlodipine Besylate
|
| |
|
|
| ACK 1
|
| FDA/DDM to Diamond Law Office LLC
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Zydus Pharmaceuticals USA, Inc.
|
| Vol #:
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| 1
|
|
|
