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| Dockets Entered
On September 1, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications
for New Dietary Ingredients
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| 1998N-0359
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| Program priorities/Center for
Food Safety & Applied Nutrition
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|
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| 1999P-5106
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| Identify Sources of
Natural Flavorings
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| 2001E-0032
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| Patent Extension for
VISUDYNE, No. 5,095,030
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| 2002E-0065
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| Patent Term Application
for Kineret No. 5,075,222
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| 2003E-0033
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| Patent Extension Application
for DERMAGRAFT No. 4,963,489
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| 2003E-0037
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| Patent Term Extension
Application for LUMIGAN No. 5,688,819
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| 2003E-0081
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| Patent Term Extension
for ORTHO-EVRA No. 5,876,746
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| 2003P-0091
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| ANDA to declare that
drug prod Hydrocodone Polistirex & Chlo
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| 2003P-0574
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| Regulatory limit for Listeria
monocytogenes in ready-to-eat foods that do not support its growth
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| 2004D-0343
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| Hospital Bed System
Dimensional Guidance to Reduce Entrapment
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| 2004E-0389
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| Patent Extension for
SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| 2004E-0391
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| Patent Extension for
Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,211,244
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| 2004P-0183
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| Nutrient Content Claim:
Expand Lean Definition
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| 2004P-0390
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| ANDA Suitability for
Doxycycline Hyclate Tablets, 75mg and 100mg
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| 2004Q-0151
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| Qualified Health Claim
(QHC): soy protein and cancer
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| 1995S-0316
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| 75-Day Premarket
Notifications for New Dietary Ingredients
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| RPT
221
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| Omega- Bio-Pharma
(USA) LLC
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| Vol #:
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| 161
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| RPT
222
References
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| Cantox
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| Vol #:
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| 161
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| RPT
223
References
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| Cantox
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| Vol #:
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| 161
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| RPT
224
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| American Institute
for Biosocial and Medical Research (AIBMR), Inc.
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| Vol #:
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| 162
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| 1998N-0359
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| Program priorities/Center
for Food Safety & Applied Nutrition
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| EC 221
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| Mr. David Roth
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| Vol #:
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| 9
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| EC 222
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| Ms. Barbara Mullen
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| Vol #:
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| 9
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| EC 223
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| Dr. Paul D Naylor
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| Vol #:
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| 9
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| EC 224
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| Ms. Ellen koivisto
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| Vol #:
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| 9
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| EC 225
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| Mr. Terrence McGovern,
Jr.
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| Vol #:
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| 9
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| EC 226
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| Mr. Ralph Yarnall-Rodland
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| Vol #:
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| 9
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| EC 227
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| Mrs. Grace Gray
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| Vol #:
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| 9
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| EC 228
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| Ms. Rheta Johnson
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| Vol #:
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| 9
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| EC 229
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| Mr. Robert Fricke
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| Vol #:
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| 9
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| EC 230
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| Mr. Walter Wadas
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| Vol #:
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| 9
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| EC 231
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| Mr. Dave Karasic
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| Vol #:
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| 9
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| EC
232
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| Harvard University
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| Vol #:
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| 9
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| EC 233
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| Mr. Stuart Mork
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| Vol #:
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| 9
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| EC 234
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| Mr. Richard M Johnson
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| Vol #:
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| 9
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| EC 235
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| Mr. Doc Schaefer
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| Vol #:
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| 9
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| EC 236
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| Mr. Paul Kesler
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| Vol #:
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| 9
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| EC 237
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| Mr. David Angle
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| Vol #:
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| 9
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| EC 238
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| Mr. B. Wilson
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| Vol #:
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| 9
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| EC 239
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| Ms. Tara Perry
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| Vol #:
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| 9
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| EC 240
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| Ms. Natalie Blahut
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| Vol #:
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| 9
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| EC 241
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| Mrs. Theresa Andes
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| Vol #:
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| 9
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| EC 242
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| Mr. Sean Perry
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| Vol #:
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| 9
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| EC 243
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| (private citizen)
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| Vol #:
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| 9
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| EC 244
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| Mr. Mike Lynch
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| Vol #:
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| 9
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| EC 245
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| Mr. MICHAEL SABO
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| Vol #:
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| 9
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| EC 246
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| Miss. Heather Sage
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| Vol #:
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| 9
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| EC 247
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| Ms. Rebecca Hillman
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| Vol #:
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| 9
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| EC 248
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| Mr. Franklin Eventoff
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| Vol #:
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| 9
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| EC 249
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| Mr. John Micklewright
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| Vol #:
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| 9
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| EC 250
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| Ms. Judith Wilcox
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| Vol #:
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| 9
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| EC 251
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| Mr. Leonard Nadler
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| Vol #:
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| 9
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| EC 252
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| Ms. Karen Bowden
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| Vol #:
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| 9
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| EC 253
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| Ms. Anne Knafl
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| Vol #:
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| 9
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| EC 254
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| Ms. Judith Poxon
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| Vol #:
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| 9
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| EC 255
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| Mr. Thomas Turner
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| Vol #:
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| 9
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| EC 256
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| Dr. Stewart Farley
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| Vol #:
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| 9
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| EC 257
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| Mr. Evan Kendall
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| Vol #:
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| 9
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| EC 258
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| Ms. Leslie O'Neill
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| Vol #:
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| 9
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| EC 259
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| Ms. Lynda Buitrago
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| Vol #:
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| 9
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| EC 260
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| Ms. Janet Hanks
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| Vol #:
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| 9
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| EC 261
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| Mr. Art Whitfield
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| Vol #:
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| 9
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| EC 262
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| Mr. Burke Townsend
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| Vol #:
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| 9
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| EC 263
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| Mrs. Neely Stewart
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| Vol #:
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| 9
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| EC 264
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| Aloha Smiles
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| Vol #:
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| 9
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| EC 265
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| Mrs. Virginia DiVito
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| Vol #:
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| 9
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| EC 266
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| Individual
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| Vol #:
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| 9
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| EC 267
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| Ms. Robbie Staufer
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| Vol #:
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| 9
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| EC 268
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| Mr. Douglas Estes
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| Vol #:
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| 9
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| EC 269
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| Mr. Gary Hall
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| Vol #:
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| 9
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| EC 270
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| Ms. J Mandl
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| Vol #:
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| 9
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| EC 271
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| Ms. Linda Muralidharan
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| Vol #:
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| 9
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| EC 272
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| Mr. Cary Birdsall
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| Vol #:
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| 9
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| EC 273
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| MoveOn
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| Vol #:
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| 9
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| EC 274
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| Dr. Beverly Carver
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| Vol #:
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| 9
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| EC 275
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| Ms. Raksha Raksha
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| Vol #:
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| 9
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| EC 276
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| Ms. Paulette M. Switzer-Tatum
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| Vol #:
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| 9
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| EC 277
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| Ms. Lenore Dunlop
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| Vol #:
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| 9
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| EC 278
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| Mr. SAMUEL Massafra
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| Vol #:
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| 9
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| EC 279
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| Mrs. Margaret Sawyer
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| Vol #:
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| 9
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| EC 280
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| Product Awareness Consulting, LLC
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| Vol #:
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| 9
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| EC 281
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| Ms. Susanne Hesse
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| Vol #:
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| 9
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| EC 282
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| Mr. Michael Merenda
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| Vol #:
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| 9
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| EC 283
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| Ms. Robyne Hamme
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| Vol #:
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| 9
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| EC 284
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| Mrs. Nicole Killion
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| Vol #:
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| 9
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| EC 285
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| Ms. Susanne Beeber
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| Vol #:
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| 9
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| EC 286
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| Ms. Kathleen Borger
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| Vol #:
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| 9
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| EC 287
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| Mr. Jerry Hammond
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| Vol #:
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| 9
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| EC 288
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| Public Citizen
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| Vol #:
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| 9
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| EC 289
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| Mr. Eric Tardif
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| Vol #:
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| 9
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| EC 290
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| Mr. NED SKIPPER
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| Vol #:
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| 9
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| EC 291
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| Ms. Karen Cleveland
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| Vol #:
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| 9
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| EC 292
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| Ms. Susan Hathaway
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| Vol #:
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| 9
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| EC 293
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| Clare County Commissioner
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| Vol #:
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| 9
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| EC 294
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| Miss. sondra dunne
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| Vol #:
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| 9
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| EC 295
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| Ms. Lynn Cremona
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| Vol #:
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| 9
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| EC 296
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| Ms. Rebecca Hoffman
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| Vol #:
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| 9
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| EC 297
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| Mr. Joshua Anderson
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| Vol #:
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| 9
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| EC 298
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| Ms. Sylvia Nibley
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| Vol #:
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| 9
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| EC 299
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| Dr. j bates
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| Vol #:
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| 9
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| EC 300
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| Mr. Paul Jacobs
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| Vol #:
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| 9
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| EC 301
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| Mrs. Carol Ann Goldstein
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| Vol #:
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| 9
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| EC 302
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| Ms. Jane Affonso
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| Vol #:
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| 9
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| EC 303
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| Ms. anne behroozi
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| Vol #:
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| 9
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| EC 304
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| Ms. Kathy Maschal-Walsh
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| Vol #:
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| 9
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| EC 305
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| Mr. Carl Sewall
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| Vol #:
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| 9
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| EC 306
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| Ms. eileen troberman
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| Vol #:
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| 9
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| EC 307
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| Ms. Rebecca Beard
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| Vol #:
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| 9
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| EC 308
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| Ms. Debra Le
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| Vol #:
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| 9
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| EC 309
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| Ms. Lynn Frost
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| Vol #:
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| 9
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| EC 310
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| Public Citizen
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| Vol #:
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| 9
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| EC 311
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| Mr. Carleton Spotts
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| Vol #:
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| 9
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| EC 312
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| Mr. R. Ross
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| Vol #:
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| 9
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| EC 313
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| Mr. Ed Benner
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| Vol #:
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| 9
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| EC 314
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| Mr. Kenneth Keeley
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| Vol #:
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| 9
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| EC 315
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| Dr. Jeffrey Dickemann
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| Vol #:
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| 9
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| EC 316
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| Ms. Lura Irish
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| Vol #:
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| 9
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| EC 317
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| Mr. Norm Conrad
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| Vol #:
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| 9
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| EC 318
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| Dr. Robert E. Pittenger, M.D.
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| Vol #:
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| 9
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| EC 319
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| Mrs. Lisa Olauson
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| Vol #:
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| 9
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| EC 320
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| Ms. Yvonne Soto
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| Vol #:
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| 9
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| EC 321
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| Mr. J. W. Oman
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| Vol #:
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| 9
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| EC 322
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| Mr. David Patenaude
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| Vol #:
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| 9
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| EC 323
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| Mrs. Corinne Livesay
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| Vol #:
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| 9
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| EC 324
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| Mrs. Mary Frances Fernung
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| Vol #:
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| 9
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| EC 325
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| Myself
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| Vol #:
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| 9
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| EC 326
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| Mr. John Plair
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| Vol #:
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| 9
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| EC 327
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| Mr. Michael Plumley
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| Vol #:
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| 9
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| EC 328
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| Ms. Colleen Lindsey
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| Vol #:
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| 9
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| EC 329
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| Ms. Anne Edwardson
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| Vol #:
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| 9
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| EC 330
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| Mrs. Michele Donnelly
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| Vol #:
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| 9
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| EC 331
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| Mr. James Bonaventure
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| Vol #:
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| 9
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| EC 332
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| Mr. howard woo
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| Vol #:
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| 9
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| EC 333
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| Ms. Anne Marchin
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| Vol #:
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| 9
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| EC 334
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| Mr. Ralph Leach
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| Vol #:
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| 9
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| EC 335
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| Mrs. Gloria Kuhn
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| Vol #:
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| 9
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| EC 336
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| Ms. Bunny(June S.) Daubner
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| Vol #:
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| 9
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| EC 337
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| Ms. Helen Kopp
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| Vol #:
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| 9
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| EC 338
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| Ms. S. Welsh
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| Vol #:
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| 9
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| EC 339
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| none - just a concerned citizen
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| Vol #:
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| 9
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| EC 340
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| Mrs. Linda Browne
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| Vol #:
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| 9
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| EC 341
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| Mr. Tim Leimberer
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| Vol #:
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| 9
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| EC 342
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| Mr. christopher thibodeau
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| Vol #:
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| 9
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| EC 343
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| Mrs. Carol Rose
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| Vol #:
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| 9
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| EC 344
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| Mr. Ben Winthrop
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| Vol #:
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| 9
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| EC 345
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| Mrs. Christie Beck
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| Vol #:
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| 9
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| EC 346
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| Mrs. Lauren Miller
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| Vol #:
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| 9
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| EC 347
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| Ms. Ann Pierce-Gardner
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| Vol #:
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| 9
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| EC 348
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| Mrs. Joanna Pope
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| Vol #:
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| EC 349
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| Mr. Erik Lutzker
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| Vol #:
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| 9
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| EC 350
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| Mr. Tom Valenzuela
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| Vol #:
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| 9
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| EC 351
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| Ms. Barbara Zaroff
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| Vol #:
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| EC 352
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| Mrs. D. Iris Thor
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| Vol #:
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| 9
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| EC 353
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| carol royce-wilder
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| Vol #:
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| 9
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| EC 354
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| Ms. Fay Walton
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| Vol #:
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| 9
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| EC 355
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| Mr. Kurt Kiebler
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| Vol #:
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| 9
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| EC 356
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| Mrs. Caroline Hesse
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| Vol #:
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| 9
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| EC 357
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| Mr. Robert Rutkowski
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| Vol #:
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| 9
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| EC 358
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| Ginseng Board of Wisconsin
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| Vol #:
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| 9
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| EC 359
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| Ms. Moira Mack
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| Vol #:
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| 9
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| EC 360
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| Ms. Mary Perner
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| Vol #:
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| 9
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| EC 361
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| Ms. Jacqueline Ward
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| Vol #:
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| 9
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| EC 362
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| Ms. A. Keith
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| Vol #:
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| 9
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| EC 363
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| Mrs. Donna Bykowski
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| Vol #:
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| 9
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| EC 364
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| Mr. Adam Biegeleisen
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| Vol #:
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| 9
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| EC 365
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| Dr. Frances Day
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| Vol #:
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| 9
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| EC 366
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| Ms. Ann Tiedeman
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| Vol #:
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| 9
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| EC 367
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| Mr. Andrew Clarke
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| Vol #:
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| 9
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| EC 368
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| Denver Public Library
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| Vol #:
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| 9
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| EC 369
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| Mr. Lawrence Carroll
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| Vol #:
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| 9
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| EC 370
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| Ms. Gwendolyn Debrow
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| Vol #:
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| 9
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| EC 371
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| Ms. Margaret Welke
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| Vol #:
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| 9
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| EC 372
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| Miss. Mariola Capiak
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| Vol #:
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| 9
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| EC 373
|
| Ms. Jeannine Coleman
|
| Vol #:
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| 9
|
| |
|
|
| EC 374
|
| Miss. Linda Eberhard
|
| Vol #:
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| 9
|
| |
|
|
| EC 375
|
| Ms. Seana Blake
|
| Vol #:
|
| 9
|
| |
|
|
| EC 376
|
| westom a price
|
| Vol #:
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| 9
|
| |
|
|
| EC 377
|
| Mr. Blayne Brokens
|
| Vol #:
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| 9
|
| |
|
|
| EC 378
|
| Mr. Bruce Relkin
|
| Vol #:
|
| 9
|
| |
|
|
| EC
379
|
| National Milk Producers Federation
|
| Vol #:
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| 9
|
| |
|
|
| EC
380
|
| U.S. Public Interest Research Group
|
| Vol #:
|
| 9
|
| |
|
|
| EC
381
|
| The Food Allergy
|
| Vol #:
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| 9
|
|
| |
|
| 1999P-5106
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| Identify Sources of Natural Flavorings
|
|
| | | | | | | | |
|
| |
|
| C 66
|
| J. Hartmann
|
| Vol #:
|
| 3
|
| |
|
|
| 2001E-0032
|
| Patent Extension for VISUDYNE, No. 5,095,030
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002E-0065
|
| Patent Term Application for Kineret No. 5,075,222
|
| |
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0033
|
| Patent Extension Application for DERMAGRAFT No. 4,963,489
|
| |
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0091
|
| ANDA to declare that drug prod Hydrocodone Polistirex & Chlo
|
| |
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
| |
|
|
| EC
5
|
| National Frozen Pizza Institute
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0389
|
| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
|
| |
|
|
| APP
1
|
| Mezei Associates, Ltd.
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0391
|
| Patent Extension for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,211,244
|
| |
|
|
| APP
1
|
| NPS Pharmaceuticals Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0337
|
| Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study.
|
| |
|
|
| EC 2
|
| Dr. Ellen Bernal
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0183
|
| Nutrient Content Claim: Expand Lean Definition
|
| |
|
|
| LET
1
|
| Nestle Prepared Foods Company
|
| Vol #:
|
| 4
|
|
| |
|
| 2004P-0390
|
| ANDA Suitability for Doxycycline Hyclate Tablets, 75mg and 100mg
|
|
| | | | | | | | |
|
| |
|
| ACK 1
|
| HFA-305 to Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| EMC 11
|
| Gerald Hernesmaa
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 12
|
| Gerald Hernesmaa
|
| Vol #:
|
| 5
|
| |
|
|
| RC
1
|
| The Solae Company
|
| Vol #:
|
| 5
|
|
|
