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| Dockets Entered
On August 23, 2005
Table of Contents
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| Docket #
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| Title
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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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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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0469
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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| 2004N-0545
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| Nonclinical and Clinical Datasets; Notice of Pilot Project
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005N-0029
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
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| 2005N-0153
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| C
105
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| Chocolate Manufacturers Association (CMA)
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| Vol #:
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| 5
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| EMC
4
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| Hormel Foods Corporation (Hormel)
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| Vol #:
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| 5
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| EMC
5
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| Juice Products Association (JPA)
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| Vol #:
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| 5
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| EMC
6
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| United Egg Asociation (UEA)
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| Vol #:
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| 5
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| EMC
7
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| United Egg Asociation (UEA)
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| Vol #:
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| 5
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| EMC
8
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| MarlerClark, LLP
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| Vol #:
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| 5
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| EMC
9
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| California Farmers Union
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| Vol #:
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| 5
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| EMC
10
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| The Solae Company
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| Vol #:
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| 5
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| EMC
11
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| Nestle USA, Inc (Nestle)
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| Vol #:
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| 5
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16506
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16507
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16508
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16509
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16510
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16511
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| Laboratories Garden House S.A.
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| Vol #:
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| 148
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| LET
16512
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| Pharmavite LLC
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| Vol #:
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| 148
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| LET
16513
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| Pharmavite LLC
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| Vol #:
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| 148
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| LET
16514
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| Traditional Medicinals, Inc.
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| Vol #:
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| 148
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7503
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| E. Marcus
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| Vol #:
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| 319
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| C
7504
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| American Farm Bureau Federation (AFBF)
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| Vol #:
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| 319
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| C 7505
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| S. Prasad
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| Vol #:
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| 319
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| EMC 4364
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| C. Santos
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| Vol #:
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| 320
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| EMC 4365
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| H. McDonnell
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| Vol #:
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| 320
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| EMC 4366
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| K. Hall
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| Vol #:
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| 320
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| EMC 4367
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| K. Murphy
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| Vol #:
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| 320
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| EMC 4368
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| K. Robbins
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| Vol #:
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| 320
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| EMC 4369
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| J. Jasper
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| Vol #:
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| 320
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| EMC 4370
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| G. Schonholz
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| Vol #:
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| 320
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| EMC 4371
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| S. Prasad
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| Vol #:
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| 320
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| EMC 4372
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| D. Godin
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| Vol #:
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| 320
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| EMC 4373
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| R and E Jackson
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| Vol #:
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| 320
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| EMC 4374
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| M. Edwards
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| Vol #:
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| 320
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18236
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| Karen Kenning
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| Vol #:
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| 516
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| EMC 4219
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| I. Holte
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| Vol #:
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| 515
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| EMC 4220
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| M. Perkins
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| Vol #:
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| 515
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| EMC 4221
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| K. Woods
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| Vol #:
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| 515
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| EMC 4222
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| S. Ford
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| Vol #:
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| 515
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| EMC 4223
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| V. Zachary
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 608
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| J. Flowers
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| Vol #:
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| 24
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 212
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| A. Chamandy
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| Vol #:
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| 3
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2091
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| S. Adams, MD
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| Vol #:
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| 300
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| C
2092
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| Juridic Embassy - Micro ICU Project
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| Vol #:
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| 300
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| |
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1277
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| B. Wickes
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| Vol #:
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| 6
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| EMC 1278
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| K. Jeter
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| Vol #:
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| 6
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| EMC 1279
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| P. Klicin
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 502
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| Mission Possible International
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| Vol #:
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| 8
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| EMC
503
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| Calorie Control Council
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| Vol #:
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| 8
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| EMC
504
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| Calorie Control Council
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| Vol #:
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| 8
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| C
2
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| Advanced Medical Technology Association (AdvaMed)
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| EMC 1168
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| R. Marsh
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| Vol #:
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| 29
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| EMC 1169
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| C. Blake
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| Vol #:
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| 29
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| EMC 1170
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| R. Copeland
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| Vol #:
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| 29
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| EMC 1171
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| L. Alldrin
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| Vol #:
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| 29
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| EMC 1172
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| J. Poehlman
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| Vol #:
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| 29
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| 2004N-0469
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004N-0545
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| Nonclinical and Clinical Datasets; Notice of Pilot Project
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| EMC 3
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| E. Ohri
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| EMC
349
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| Weston A. Price Foundation
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| Vol #:
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| 9
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|
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| 2005D-0183
|
| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| C
3
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| Boehringer Ingelheim Pharmaceuticals
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| Vol #:
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| 1
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| 2005D-0203
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| Guidance for Industry on Safety Testing of Drug Metabolites
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| C 12
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| D. McGee, PhD., DABT
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| Vol #:
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| 1
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| |
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| BKG
1
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| Background Material
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| Vol #:
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| 2
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| |
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
|
|
| |
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| 2005N-0029
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
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| NAL
1
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| FDA
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| Vol #:
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| 1
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|
|
|
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| SS
1
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| Supporting Statement
|
| Vol #:
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| 1
|
|
|
|
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| 2005N-0153
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring
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| N
2
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| FDA
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| Vol #:
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| 1
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|
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| C
2
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| Foodservice & Packaging Institute
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| Vol #:
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| 1
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| EMC
2
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| American Forest & Paper Association (AF&PA)
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| Vol #:
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| 1
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| EMC
3
Attachment
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| Fibre Box Association (FBA)
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| C 84
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| M. Bemboom
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| Vol #:
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| 3
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| C 85
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| No signature
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| Vol #:
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| 3
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| C 86
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| T. Avelina
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| Vol #:
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| 3
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| C 87
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| J. Scott
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| Vol #:
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| 3
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| C 88
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| R. Sutter
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| Vol #:
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| 3
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| C 89
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| M. Stewart
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| Vol #:
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| 3
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| C 90
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| D. Mussman
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| Vol #:
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| 3
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| C 91
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| B. Whittington
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| Vol #:
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| 3
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| C 92
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| Eligible
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| Vol #:
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| 3
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| C 93
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| No signature
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| Vol #:
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| 3
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| C 94
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| D. Kellaway
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| Vol #:
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| 3
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| C 95
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| M. Morse
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| Vol #:
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| 3
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| C 96
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| J. Mullen
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| Vol #:
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| 3
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| C 97
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| A. Weedin
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| Vol #:
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| 3
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| C
98
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| National Foundation for Celiac Awareness
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| Vol #:
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| 6
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| C 99
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| M. Fossedal
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| Vol #:
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| 6
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| C 100
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| G. Hudreck
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| Vol #:
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| 6
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| C 101
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| M. Steier
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| Vol #:
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| 6
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| C 102
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| S and R Phillips
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| Vol #:
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| 6
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| C 103
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| M. Ratliff
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| Vol #:
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| 6
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