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| Dockets Entered
On February 22, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003F-0535
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| Chlorine Dioxide (FAP 4A4751)
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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-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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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-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0512
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| Health Claim Petition for Soluble Fiber from Barley
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005N-0031
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0079
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| Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
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| 2005P-0080
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| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| EMC 44
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| C. Hungerford, Jr.
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| Vol #:
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| 141
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| EMC 45
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| C. sedotto
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| Vol #:
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| 141
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| EMC 46
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| C. Trefts
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| Vol #:
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| 141
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| EMC 47
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| L. Brown, CRNP
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| Vol #:
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| 141
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| EMC 48
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| C. Trefts
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| Vol #:
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| 141
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| EMC 49
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| E. Wood
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| Vol #:
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| 141
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| EMC 50
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| E. Wood
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| Vol #:
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| 141
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| EMC 51
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| E. Wood
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| Vol #:
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| 141
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| EMC 52
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| L. Williams
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| Vol #:
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| 141
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4299
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| N. Shah
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| Vol #:
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| 320
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| 2000N-0504
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| Egg Safety Action Plan
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| EMC 1902
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| N. Shinn
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| Vol #:
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| 31
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 14099
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| K. Deissroth
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| Vol #:
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| 324
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| EMC 14100
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| K. Swanekamp
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| Vol #:
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| 324
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| EMC 14101
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| B. Wagenseller
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| Vol #:
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| 324
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| EMC 14102
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| A. Heimonen
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| Vol #:
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| 324
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| EMC 14103
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| J. Johnson
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| Vol #:
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| 324
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| EMC 14104
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| A. Russell
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| Vol #:
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| 324
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| EMC 14105
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| T. Odlevak
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| Vol #:
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| 324
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| EMC 14106
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| O. Newbury
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| Vol #:
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| 324
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| EMC 14107
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| A. Contreras
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| Vol #:
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| 324
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| EMC 14108
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| B. Dershem
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| Vol #:
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| 324
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| EMC 14109
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| V. Crossley
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| Vol #:
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| 324
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| EMC 14110
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| E. Gage
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| Vol #:
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| 324
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| EMC 14111
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| A. Knotor, MD, FAAP
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| Vol #:
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| 324
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| EMC 14112
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| A. Thompson
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| Vol #:
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| 324
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| EMC 14113
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| N. Calzone
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| Vol #:
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| 324
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| EMC 14114
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| C. Marino
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| Vol #:
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| 324
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| EMC 14115
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| W. Beasley
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| Vol #:
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| 324
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| EMC 14116
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| K. Yaged
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| Vol #:
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| 324
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| EMC 14117
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| M. Olson
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| Vol #:
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| 324
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| EMC 14118
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| S. Nichols
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| Vol #:
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| 324
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| EMC 14119
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| A. Mathews
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| Vol #:
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| 324
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| EMC 14120
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| J. Young
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| Vol #:
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| 324
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| EMC 14121
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| K. Sky
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| Vol #:
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| 324
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| EMC 14122
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| E. Schultz
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| Vol #:
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| 324
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| EMC 14123
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| D. Bansal
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| Vol #:
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| 324
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| EMC 14124
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| L. Gaynon
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| Vol #:
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| 324
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| EMC 14125
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| L. Parada
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| Vol #:
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| 324
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| EMC 14126
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| T. Manell
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| Vol #:
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| 324
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| EMC 14127
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| A. Mosby
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| Vol #:
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| 324
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| EMC 14128
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| J. Sands
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| Vol #:
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| 324
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| EMC 14129
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| J. Sands
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| Vol #:
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| 324
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| EMC 14130
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| L. Wigen
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| Vol #:
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| 324
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| EMC 14131
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| J. Russell
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| Vol #:
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| 324
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| EMC 14132
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| D. Heydt
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| Vol #:
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| 324
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| EMC 14133
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| J. Sedlacek
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| Vol #:
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| 324
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| EMC 14134
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| J. Bradford
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| Vol #:
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| 324
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| EMC 14135
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| N. Haley
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| Vol #:
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| 324
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| EMC 14136
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| D. Lieberman
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| Vol #:
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| 324
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| EMC 14137
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| J. Hedge
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| Vol #:
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| 324
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| EMC 14138
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| C. Santos
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| Vol #:
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| 324
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| EMC 14139
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| J. Johnson
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| Vol #:
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| 324
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| EMC 14140
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| K. Draayer
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| Vol #:
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| 324
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| EMC 14141
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| D. Moss
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| Vol #:
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| 324
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| EMC 14142
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| S. Teslow
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| Vol #:
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| 324
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| EMC 14143
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| K. Waller
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| Vol #:
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| 324
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| EMC 14144
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| E. Leeper
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| Vol #:
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| 324
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| EMC 14145
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| R. Renken
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| Vol #:
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| 324
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| EMC 14146
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| J. Augstums
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| Vol #:
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| 324
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| EMC 14147
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| P. Tolle
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| Vol #:
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| 324
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| EMC 14148
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| E. Clinchard
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| Vol #:
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| 324
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| EMC 14149
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| E. Summer
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| Vol #:
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| 324
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| EMC 14150
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| A. Doyle
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| Vol #:
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| 324
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| EMC 14151
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| K. Knutson
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| Vol #:
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| 324
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| EMC 14152
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| K. Hall
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| Vol #:
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| 324
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| EMC 14153
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| D. Bell
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| Vol #:
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| 324
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| EMC 14154
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| C. Johnson
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| Vol #:
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| 324
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| EMC 14155
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| G. Adams
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| Vol #:
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| 324
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| EMC 14156
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| J. Kuheana
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| Vol #:
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| 324
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| EMC 14157
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| A. Meints
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| Vol #:
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| 324
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| EMC 14158
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| N. Kaplan
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| Vol #:
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| 324
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| EMC 14159
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| C. Greenberg
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| Vol #:
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| 324
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| |
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| EMC 14160
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| A. Hoskovec
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| Vol #:
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| 324
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| EMC 14161
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| P. Baker
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| Vol #:
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| 324
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| |
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| EMC 14162
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| K and J Leech
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| Vol #:
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| 324
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| |
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| EMC 14163
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| P. Forcier
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| Vol #:
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| 324
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| |
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| EMC 14164
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| J. Brt
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| Vol #:
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| 324
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| |
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| EMC 14165
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| L. Case
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| Vol #:
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| 324
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| EMC 14166
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| L. Granger
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| Vol #:
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| 324
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| |
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| EMC 14167
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| J. Sitrick, Jr.
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| Vol #:
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| 324
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| EMC 14168
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| G. Herndon
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| Vol #:
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| 324
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| |
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| EMC 14169
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| N. Nair
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| Vol #:
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| 324
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| |
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| EMC 14170
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| W. West
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| Vol #:
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| 324
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| |
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| EMC 14171
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| L. Jacobs
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| Vol #:
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| 324
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| EMC 14172
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| L. Bottsford
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| Vol #:
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| 324
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| EMC 14173
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| P. Gomez
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| Vol #:
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| 324
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| EMC 14174
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| T. Johnson
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| Vol #:
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| 324
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| |
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| EMC 14175
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| J. Crane
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| Vol #:
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| 324
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| |
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| EMC 14176
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| N. Olds
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| Vol #:
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| 324
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| EMC 14177
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| M. Beecham
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| Vol #:
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| 324
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| EMC 14178
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| S. Thompson
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| Vol #:
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| 324
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| EMC 14179
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| M. Zych
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| Vol #:
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| 324
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| EMC 14180
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| A and L Hansen
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| Vol #:
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| 324
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| EMC 14181
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| L. Schulze
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| Vol #:
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| 324
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| EMC 14182
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| S. Dawes
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| Vol #:
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| 324
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| EMC 14183
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| E. Keller
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| Vol #:
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| 324
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| |
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| EMC 14184
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| S. Easton
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| Vol #:
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| 324
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| EMC 14185
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| K. Wamsley
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| Vol #:
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| 324
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| EMC 14186
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| P. Gallimore
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| Vol #:
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| 324
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| EMC 14187
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| V. Pozek
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| Vol #:
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| 324
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| |
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| EMC 14188
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| M. Bittner
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| Vol #:
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| 324
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| EMC 14189
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| C. Spann
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| Vol #:
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| 324
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| EMC 14190
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| R. Swanek
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| Vol #:
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| 324
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| EMC 14191
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| A. Rogers
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| Vol #:
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| 324
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| EMC 14192
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| T. Shepard
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| Vol #:
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| 324
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| |
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| EMC 14193
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| K. Wheeler
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| Vol #:
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| 324
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| |
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| EMC 14194
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| J. Nelson
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| Vol #:
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| 324
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| |
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| EMC 14195
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| N. Brt
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| Vol #:
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| 324
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| EMC 14196
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| N. Hansen
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| Vol #:
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| 324
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| |
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| EMC 14197
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| J. Kissel
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| Vol #:
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| 324
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| EMC 14198
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| K. Denker
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| Vol #:
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| 324
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| |
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| EMC 14199
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| H. Hunter
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| Vol #:
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| 324
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| EMC 14200
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| C. Curry
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| Vol #:
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| 324
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| |
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| EMC 14201
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| J. Coles
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| Vol #:
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| 324
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| |
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| EMC 14202
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| R. Fuelberth
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| Vol #:
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| 324
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| | | | | | | | |
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| |
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| EMC 14203
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| G. Kenkel
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| Vol #:
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| 324
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| |
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| EMC 14204
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| M. Haftings
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| Vol #:
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| 324
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| |
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| EMC 14205
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| A. Cotton
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| Vol #:
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| 324
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| |
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| EMC 14206
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| J. Cornell
|
| Vol #:
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| 324
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| |
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| EMC 14207
|
| D. Teche
|
| Vol #:
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| 324
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| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 207
|
| L. Husted
|
| Vol #:
|
| 4
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC
429
Attachment
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| Calorie Control Council
|
| Vol #:
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| 7
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| |
|
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| EMC
430
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| Mission Possible International
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| Vol #:
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| 7
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| |
|
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| EMC
431
|
| Mission Possible International
|
| Vol #:
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| 7
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| |
|
|
| EMC
432
|
| Mission Possible International
|
| Vol #:
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| 7
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|
| |
|
| 2003F-0088
|
| Increase the Maximum Permitted Energy Level of X-rays
|
| |
|
|
| EMC 292
|
| M. Greenberg
|
| Vol #:
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| 2
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| |
|
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| EMC 293
|
| J. Hamre
|
| Vol #:
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| 2
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| |
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| EMC 294
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| T. Reynolds
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| Vol #:
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| 2
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| |
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| EMC 295
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| J. Walters
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| Vol #:
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| 2
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| |
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| EMC 296
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| P. Levinson
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| Vol #:
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| 2
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| |
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| EMC 297
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| S. Chen
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| Vol #:
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| 2
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| |
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| EMC 298
|
| S. Michelson
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| Vol #:
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| 2
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| |
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| EMC 299
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| L. Hekker
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| Vol #:
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| 2
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| |
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| EMC 300
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| P. Mann
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| Vol #:
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| 2
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| |
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| EMC 301
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| K. Conroy
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| Vol #:
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| 2
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| |
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| EMC 302
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| K. Mellett
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| Vol #:
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| 2
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| |
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| EMC 303
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| P. Cox
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| Vol #:
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| 2
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| |
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| EMC 304
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| K. Niehoff
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| Vol #:
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| 2
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| |
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| EMC 305
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| J. Slocum
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| Vol #:
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| 2
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| |
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| EMC 306
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| A. Bijur
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| Vol #:
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| 2
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| |
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| EMC 307
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| I. Hyman
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| Vol #:
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| 2
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| |
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| EMC 308
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| N. Jensen
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| Vol #:
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| 2
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| |
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| EMC 309
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| S. Mitchell
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| Vol #:
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| 2
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| |
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| EMC 310
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| I. Barger
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| Vol #:
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| 2
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| |
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| EMC 311
|
| L. Braschayko
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| Vol #:
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| 2
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| |
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| EMC 312
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| J. Langdon
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| Vol #:
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| 2
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|
|
| EMC 313
|
| J. Paixao
|
| Vol #:
|
| 2
|
|
| | | | | | | |
|
| |
|
| EMC 314
|
| R. Bron
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 315
|
| C. Judson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 316
|
| C. Girardot
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 317
|
| M. Caffrey
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 318
|
| M. Aubry
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 319
|
| A. Malek
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 320
|
| V. Swanson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 321
|
| E. Elliot
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 322
|
| B. Downey
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 323
|
| T. Franklin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 324
|
| J. Maxfield
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 325
|
| J. Levine
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 326
|
| S. Hodges
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 327
|
| F. Reed
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 328
|
| W. Waldeck
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 329
|
| Mr and Mrs D. Santerre
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 330
|
| E. Silverman
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 331
|
| S and J Cutler
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 332
|
| P. Smith
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 333
|
| M. Merrill
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 334
|
| S. Penny
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 335
|
| M. Schwahn
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
336
Attachment
|
| Public Citizen
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 337
|
| G. Mesa
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 338
|
| J. Hague, RN
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 339
|
| P. Alberts
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 340
|
| C. Sawyer
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 341
|
| S. Goncalves
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 342
|
| S. Haynes
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 343
|
| A. Williams
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 344
|
| I. Szucs
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 345
|
| S. Dunning
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 346
|
| N. Noble
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 347
|
| B. Voorhees
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 348
|
| M. Horowitz
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 349
|
| C. Richard
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 350
|
| M. Makrucki
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EMC 351
|
| M. Halligan
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 352
|
| D. O'Donnell
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 353
|
| J. Storino
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 354
|
| R. Stockstill
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 355
|
| K. Lee
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 356
|
| E. Ting
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 357
|
| M. Scott
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 358
|
| E. Hughes
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 359
|
| N. Warwick
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 360
|
| C. Laxton
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 361
|
| P. Johns
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 362
|
| D. Edmonson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 363
|
| M. DeGirolomo
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 364
|
| J. Kurkinen
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 365
|
| P. Perretty
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 366
|
| A. Absil
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 367
|
| E. Hartgering
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 368
|
| C. Foulk
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 369
|
| J. Frontz
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 370
|
| R and B Champany
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 371
|
| E. Hepburn
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 372
|
| B. Bryant
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 373
|
| S. Manno
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 374
|
| E. Mass
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 375
|
| J. Szela
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 376
|
| K. Conners
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 377
|
| D. Brandt
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 378
|
| E. Penny
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 379
|
| L. Smith
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 380
|
| C. Wineburgh
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 381
|
| J. Wineburgh
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 382
|
| M. Freed
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 383
|
| M. Bouche
|
| Vol #:
|
| 2
|
| |
|
|
| 2003F-0535
|
| Chlorine Dioxide (FAP 4A4751)
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| |
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
| | | | | | | |
|
| |
|
| EMC 534
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 535
|
| C. Briggs
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 536
|
| C. Perez
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 537
|
| C. DuBois
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 538
|
| J. Hubbard
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 539
|
| C. Rhoades
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 540
|
| J. Grocki
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 541
|
| S. Ferguson
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 542
|
| S. Hrin
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 543
|
| J. Smith
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 544
|
| T. Vliet
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 545
|
| H. Peck
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 546
|
| R. Connolly
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 547
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 548
|
| D. Murray
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 549
|
| D. Murray
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 550
|
| P. Campisi
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 551
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 552
|
| D. Cannistraci
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 553
|
| D. Herrin
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 554
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 555
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 556
|
| P. Curry
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 557
|
| J. Cowperthwaite
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 558
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 559
|
| C. Ewin
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 560
|
| C. Ewin
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 561
|
| P. DeSilva
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 562
|
| C. D'Urso
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 563
|
| D. Braun
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 564
|
| K. Boccuzzi
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 565
|
| K. Boccuzzi
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 566
|
| D. Braun
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 567
|
| J. Sessa
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 568
|
| A. Cerqua
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 569
|
| Matt
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 570
|
| L. Blodgett
|
| Vol #:
|
| 9
|
|
| | | | | | | |
|
| |
|
| EMC 571
|
| M. Goldstein
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 572
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 573
|
| M. Blizzard
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 574
|
| D. Yates
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 575
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 576
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 577
|
| C. Jackson
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 578
|
| Z. Wolfram
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 579
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 580
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 581
|
| G. Benedetto
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 582
|
| Bob
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 583
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 584
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 585
|
| J. Christie
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 586
|
| J. Ulmer
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 587
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 588
|
| K. Mixon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 589
|
| A. Cotta
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 590
|
| E. Bunch
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 591
|
| B. MacLean
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 592
|
| SL Collins
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 593
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 594
|
| J. DeCoopman, MS, CNM
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 595
|
| S. Bryan
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 596
|
| M. Dowdell
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 597
|
| W. Goode
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 598
|
| C. Frederick
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 599
|
| C. Frederick
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 600
|
| R. Larkowski
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 601
|
| R. Larkowski
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 602
|
| K. Siewierski
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 603
|
| P. Farris
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 604
|
| J. Heck, PhD
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 605
|
| A. Bernhard
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 606
|
| K. Ulibarri
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 607
|
| M. Shalhoob
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
|
| |
|
| EMC 608
|
| J. Prial
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 609
|
| J. Prial
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 610
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 611
|
| M. Amoia
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 612
|
| D. Snell
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 613
|
| K. Claus
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 614
|
| A. Laney, PhD
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 615
|
| N. Musgrove
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 616
|
| K. Bateman
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 617
|
| C. Copperstein
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 618
|
| P. Pentoney
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 619
|
| D. Allen
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 620
|
| D and T Rhuland
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 621
|
| H. Reiser
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 622
|
| B. Horton
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 623
|
| J and V Seidenberger
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 624
|
| N. Cartier
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 625
|
| D. Karius
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 626
|
| D. Gardner
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 627
|
| R. Razum
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 628
|
| H. Fielding
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 629
|
| S. Robbins
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 630
|
| E Cleary and P Hasty
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 631
|
| M. Skorodin, MD
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 632
|
| M. Jones
|
| Vol #:
|
| 9
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| EMC
5
|
| Pet Food Institute (PFI) and National Grain and Feed Assn (NGFA)
|
| Vol #:
|
| 1
|
|
| |
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| EMC
74
|
| MyerEmco, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 75
|
| P. Feder
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
| |
|
|
| EMC
11
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| Lloyd's Register Serentec, Inc.
|
| Vol #:
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| 2
|
| |
|
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
|
|
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| | | | | | | | |
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| |
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| EMC
1
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| Merck & Co., Inc. (Merck)
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| Vol #:
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| 1
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| |
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| |
|
|
| CS
4
|
| HFA-305
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| Vol #:
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| 1
|
| |
|
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| LET
4
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| Ecumed Health Group, Amador Reyes, Juan C Carrai, Richard W. Stone, M.D, & Erlinda E. Enriquez
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| Vol #:
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| 1
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| |
|
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| LET
5
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| Ecumed Health Group, Amador Reyes, Juan C Carrai, Richard W. Stone, M.D, & Erlinda E. Enriquez
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| Vol #:
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| 1
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| |
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| OR
4
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| HF-3
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| Vol #:
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| 1
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| |
|
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| |
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| EMC 1141
|
| N Shinn et al.
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| Vol #:
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| 15
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| |
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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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| |
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| EC 231
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| Mrs. Janet Ziegler
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| Vol #:
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| 31
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| |
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| EC 232
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| Mrs. Judith Peloquin
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| Vol #:
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| 31
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| EC 233
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| Mrs. Shirley Chappell
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| Vol #:
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| 31
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| EC 234
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| Mrs. Mercedes Garces
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| Vol #:
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| 31
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| EC 235
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| Ms. Cathy Slaght
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| Vol #:
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| 31
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| |
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| EC 236
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| Mrs. Charlyne Lane
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| Vol #:
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| 31
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| |
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| EC 237
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| Mrs. Betty George
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| Vol #:
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| 31
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| |
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| EC 238
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| Mrs. Mercedes Garces
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| Vol #:
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| 31
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| |
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| EC 239
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| none
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| Vol #:
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| 31
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| |
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| EC 240
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| Ms. ingrid walther
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| Vol #:
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| 31
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| |
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| EC 241
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| Mrs. Tanna Storie
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| Vol #:
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| 31
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| |
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| EC 242
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| Miss. Robin Carney
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| Vol #:
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| 31
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| |
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| EC 243
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| Mrs. Jo Ann Shepard
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| Vol #:
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| 31
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| |
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| EC
244
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| Helthe Connections
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| Vol #:
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| 31
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| |
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| EC 245
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| Miss. Toni Bucciero
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| Vol #:
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| 31
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| |
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| EC 246
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| Miss. Loren Dohl
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| Vol #:
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| 31
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| |
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| EC 247
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| Mrs. David Gardner
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| Vol #:
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| 31
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| |
|
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| EC 248
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| Mrs. Susan Gardner
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| Vol #:
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| 31
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| |
|
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| EC 249
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| Mrs. Patricia Livingston
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| Vol #:
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| 31
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| |
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| EC 250
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| Mr. Thomas Nola
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| Vol #:
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| 31
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| |
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| EC 251
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| Does Not Apply
|
| Vol #:
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| 31
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| |
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| EC 252
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| Mr. Sidney Bravmann
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| Vol #:
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| 31
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| |
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| EC 253
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| Mrs. Marcia Willhite
|
| Vol #:
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| 31
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| |
|
|
| EC 254
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| Ms. Laura Thelen
|
| Vol #:
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| 31
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| |
|
|
| EC 255
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| Mr. James Wert
|
| Vol #:
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| 31
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| |
|
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| EC 256
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| Mrs. Jeanne Grant
|
| Vol #:
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| 31
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|
| | | | | | | |
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| |
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| EC 257
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| Mrs. Dianne Frase
|
| Vol #:
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| 31
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| |
|
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| EC 258
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| Dr. Lois Evans
|
| Vol #:
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| 31
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| |
|
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| EC 259
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| Mrs. Barbara Schomberg
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| Vol #:
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| 31
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| |
|
|
| EC 260
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| Dr. Barbara Whaley
|
| Vol #:
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| 31
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| |
|
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| EC 261
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| Mr. Charles Erkfitz
|
| Vol #:
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| 31
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| |
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| EC 262
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| Dr. James Occhiogrosso
|
| Vol #:
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| 31
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| |
|
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| EC 263
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| Ms. Dana Ferrara
|
| Vol #:
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| 31
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| |
|
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| EC
264
|
| Healing Feats Holistic Health Services
|
| Vol #:
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| 31
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| |
|
|
| EC 265
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| Mrs. Rosemary Scott
|
| Vol #:
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| 31
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| |
|
|
| EC 266
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| Ms. Deborah Angell Smith
|
| Vol #:
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| 31
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| |
|
|
| EC 267
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| Mrs. Connie Newcome
|
| Vol #:
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| 31
|
| |
|
|
| EC 268
|
| Mrs. Debra Short
|
| Vol #:
|
| 31
|
| |
|
|
| EC 269
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| Mr. matt sexton
|
| Vol #:
|
| 31
|
| |
|
|
| EC 270
|
| Mrs. Kelly Ullmer
|
| Vol #:
|
| 31
|
| |
|
|
| EC 271
|
| Mrs. Elizabeth W dOZIER
|
| Vol #:
|
| 31
|
| |
|
|
| EC 272
|
| Mrs. Julie Disser
|
| Vol #:
|
| 31
|
| |
|
|
| EC 273
|
| Miss. karen locklear
|
| Vol #:
|
| 31
|
| |
|
|
| EC 274
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| Mrs. DIANA POWELL
|
| Vol #:
|
| 31
|
| |
|
|
| EC 275
|
| Mrs. Heather Messerli
|
| Vol #:
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| 31
|
| |
|
|
| EC 276
|
| Mrs. coni dutka
|
| Vol #:
|
| 31
|
| |
|
|
| EC 277
|
| Ms. Denise Herndon
|
| Vol #:
|
| 31
|
| |
|
|
| EC 278
|
| Mrs. Julie DeVisser
|
| Vol #:
|
| 31
|
| |
|
|
| EC 279
|
| Mr. Don Cogley
|
| Vol #:
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| 31
|
| |
|
|
| EC 280
|
| Mr. RICHARD STEPHEN
|
| Vol #:
|
| 31
|
| |
|
|
| EC 281
|
| Mrs. NORMA STEPHEN
|
| Vol #:
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| 31
|
| |
|
|
| EC 282
|
| Mrs. KJ EVANS
|
| Vol #:
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| 31
|
| |
|
|
| EC 283
|
| Mrs. Sharon Brock
|
| Vol #:
|
| 31
|
| |
|
|
| EC 284
|
| Mrs. Elizabeth Johnson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 285
|
| Mrs. Deborah Garces
|
| Vol #:
|
| 31
|
| |
|
|
| EC 286
|
| Mrs. Erika Glancy
|
| Vol #:
|
| 31
|
| |
|
|
| EC
287
|
| nature for your bod
|
| Vol #:
|
| 31
|
| |
|
|
| EC 288
|
| Ms. Christine Bast
|
| Vol #:
|
| 31
|
| |
|
|
| EC
289
|
| Mather Health Education Services
|
| Vol #:
|
| 31
|
| |
|
|
| EC
290
|
| Nature Sunshine
|
| Vol #:
|
| 31
|
| |
|
|
| EC 291
|
| Mrs. Sammye Lamb
|
| Vol #:
|
| 31
|
| |
|
|
| EC 292
|
| Mrs. Bobbie Baker
|
| Vol #:
|
| 31
|
| |
|
|
| EC 293
|
| Ms. Margaret Wernli
|
| Vol #:
|
| 31
|
|
| | | | | | | |
|
| |
|
| EC
294
|
| Nature's Sunshine Products
|
| Vol #:
|
| 31
|
| |
|
|
| EC 295
|
| Mrs. Heidi Neeley
|
| Vol #:
|
| 31
|
| |
|
|
| EC 296
|
| Mrs. Elizabeth Thomas
|
| Vol #:
|
| 31
|
| |
|
|
| EC 297
|
| Dr. A. B. Buchanan
|
| Vol #:
|
| 31
|
| |
|
|
| EC 298
|
| Mr. W. R, Huisman
|
| Vol #:
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| 31
|
| |
|
|
| EC
299
|
| Denali
|
| Vol #:
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| 31
|
| |
|
|
| EC
300
|
| TecBank Capital Holdings
|
| Vol #:
|
| 31
|
| |
|
|
| EC 301
|
| Mrs. Jerene Olsen
|
| Vol #:
|
| 31
|
| |
|
|
| EC 302
|
| N/A
|
| Vol #:
|
| 31
|
| |
|
|
| EC 303
|
| Dr. Judy Wright
|
| Vol #:
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| 31
|
| |
|
|
| EC 304
|
| Mrs. Nora Golay
|
| Vol #:
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| 31
|
| |
|
|
| EC 305
|
| Mrs. Cynthia Huddle
|
| Vol #:
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| 31
|
| |
|
|
| EC 306
|
| Mrs. Carolyn Gookins
|
| Vol #:
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| 31
|
| |
|
|
| EC 307
|
| Mrs. Margaret Schoeneck
|
| Vol #:
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| 31
|
| |
|
|
| EC 308
|
| Mr. David Gookins
|
| Vol #:
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| 31
|
| |
|
|
| EC 309
|
| individual
|
| Vol #:
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| 31
|
| |
|
|
| EC 310
|
| Mrs. Amy Longshore
|
| Vol #:
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| 31
|
| |
|
|
| EC 311
|
| Mrs. Candice Frantz
|
| Vol #:
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| 31
|
| |
|
|
| EC 312
|
| Mrs. Kari Branson
|
| Vol #:
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| 31
|
| |
|
|
| EC 313
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| Mr. Gregory Branson
|
| Vol #:
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| 31
|
| |
|
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| EC 314
|
| Mr. Stuart Branson
|
| Vol #:
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| 31
|
| |
|
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| EC 315
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| Mr. Charles Smith
|
| Vol #:
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| 31
|
| |
|
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| EC 316
|
| Mrs. Sharon Rosenbaum
|
| Vol #:
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| 31
|
| |
|
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| EC 317
|
| Ms. Donna Fox
|
| Vol #:
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| 31
|
| |
|
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| EC
318
|
| The Son Shine Shop
|
| Vol #:
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| 31
|
| |
|
|
| EC 319
|
| Ms. KRISTI MOSIER
|
| Vol #:
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| 31
|
| |
|
|
| EC 320
|
| Mrs. Rebecca Malter
|
| Vol #:
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| 31
|
| |
|
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| EC 321
|
| Ms. Donna Tritt
|
| Vol #:
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| 31
|
| |
|
|
| EC 322
|
| Dr. Samuel Thomas
|
| Vol #:
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| 31
|
| |
|
|
| EC 323
|
| Mrs. Myrna Schmidt
|
| Vol #:
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| 31
|
| |
|
|
| EC 324
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| owner
|
| Vol #:
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| 31
|
| |
|
|
| EC 325
|
| NIKKEN
|
| Vol #:
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| 31
|
| |
|
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| EC 326
|
| Ms. Sara Colburn
|
| Vol #:
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| 31
|
| |
|
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| EC 327
|
| Mr. Norman Schmidt
|
| Vol #:
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| 31
|
| |
|
|
| EC 328
|
| Ms. Muriel Shepard
|
| Vol #:
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| 31
|
| |
|
|
| EC 329
|
| Mrs. Kerri Smith
|
| Vol #:
|
| 31
|
| |
|
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| EC 330
|
| Mrs. Claire Slick
|
| Vol #:
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| 31
|
|
| | | | | | | |
|
| |
|
| EC 331
|
| none
|
| Vol #:
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| 31
|
| |
|
|
| EC 332
|
| Mrs. Lana Bush
|
| Vol #:
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| 31
|
| |
|
|
| EC 333
|
| Mrs. Helen Cox
|
| Vol #:
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| 31
|
| |
|
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| EC 334
|
| Mr. Ronald keddie
|
| Vol #:
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| 31
|
| |
|
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| EC 335
|
| Mr. Craig Triplett
|
| Vol #:
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| 31
|
| |
|
|
| EC 336
|
| Mrs. Michelle Shannon
|
| Vol #:
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| 31
|
| |
|
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| EC 337
|
| Mr. Steve Farnes
|
| Vol #:
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| 31
|
| |
|
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| EC 338
|
| Mrs. Ruth Mathews
|
| Vol #:
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| 31
|
| |
|
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| EC 339
|
| Mr. DAVID MASON
|
| Vol #:
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| 31
|
| |
|
|
| EC 340
|
| Miss. Pat Smith
|
| Vol #:
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| 31
|
| |
|
|
| EC
341
|
| Nature Sunshine Products Member
|
| Vol #:
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| 31
|
| |
|
|
| EC 342
|
| Mr. Tim Egan
|
| Vol #:
|
| 31
|
| |
|
|
| EC 343
|
| NA
|
| Vol #:
|
| 31
|
| |
|
|
| EC 344
|
| Mrs. Mary Knapp
|
| Vol #:
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| 31
|
| |
|
|
| EC 345
|
| Mr. Christopher Silcock
|
| Vol #:
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| 31
|
| |
|
|
| EC 346
|
| Mrs. Gretchen Swinney
|
| Vol #:
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| 31
|
| |
|
|
| EC 347
|
| Ms. Chris Diaz
|
| Vol #:
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| 31
|
| |
|
|
| EC 348
|
| Mr. David Fox
|
| Vol #:
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| 31
|
| |
|
|
| EC 349
|
| Mr. Alan Malter
|
| Vol #:
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| 31
|
| |
|
|
| EC
350
|
| Phoenix Journey
|
| Vol #:
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| 31
|
| |
|
|
| EC 351
|
| Ms. Sara Vogltranz
|
| Vol #:
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| 31
|
| |
|
|
| EC 352
|
| Ms. Liza Ely
|
| Vol #:
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| 31
|
| |
|
|
| EC 353
|
| Mr. Stephen Metcalfe
|
| Vol #:
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| 31
|
| |
|
|
| EC 354
|
| Miss. Jenna Thompson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 355
|
| Mrs. Debbie Metcalfe
|
| Vol #:
|
| 31
|
| |
|
|
| EC 356
|
| Mr. Steve Metcalfe
|
| Vol #:
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| 31
|
| |
|
|
| EC 357
|
| Mrs. Beverly McIntosh
|
| Vol #:
|
| 31
|
| |
|
|
| EC 358
|
| Mrs. Sue Munge
|
| Vol #:
|
| 31
|
| |
|
|
| EC 359
|
| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC 360
|
| Dr. Anthony Archer
|
| Vol #:
|
| 31
|
| |
|
|
| EC 361
|
| Ms. Carol Ann Thompson
|
| Vol #:
|
| 31
|
| |
|
|
| EC
362
|
| Prime of Life
|
| Vol #:
|
| 31
|
| |
|
|
| EC 363
|
| Ms. Sherrie Line-Coil
|
| Vol #:
|
| 31
|
| |
|
|
| EC 364
|
| Mr. Keith Kozer
|
| Vol #:
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| 31
|
| |
|
|
| EC 365
|
| Mr. Timothy Hicks
|
| Vol #:
|
| 31
|
| |
|
|
| EC
366
|
| public citizen retired
|
| Vol #:
|
| 31
|
| |
|
|
| EC 367
|
| Ms. Robin Makar
|
| Vol #:
|
| 31
|
|
| | | | | | | | |
|
| |
|
| EC 368
|
| Ms. Evelyn Muegge
|
| Vol #:
|
| 31
|
| |
|
|
| EC 369
|
| Mrs. Elaine Gordon
|
| Vol #:
|
| 31
|
| |
|
|
| EC 370
|
| Ms. Vanessa Justice
|
| Vol #:
|
| 31
|
|
| |
|
| 2004N-0559
|
| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
|
| |
|
|
| EMC
3
|
| HFV-6
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 4
|
| J. Kurowski
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
5
|
| Consumers Union
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 6
|
| K. Swanson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 7
|
| H. Maurice
|
| Vol #:
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| 2
|
| |
|
|
| EMC 8
|
| A. Pruitt
|
| Vol #:
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| 2
|
| |
|
|
| EMC 9
|
| B. Breskin
|
| Vol #:
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| 2
|
| |
|
|
| EMC 10
|
| A. Pruitt
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 11
|
| L. Watts
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 12
|
| E. Lancaster
|
| Vol #:
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| 2
|
| |
|
|
| EMC 13
|
| E. Lancaster
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 14
|
| K. Howell
|
| Vol #:
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| 2
|
| |
|
|
| EMC 15
|
| A. Talbott
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 16
|
| K. Ketchen
|
| Vol #:
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| 2
|
| |
|
|
| EMC 17
|
| A. Lucero
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 18
|
| R. Melamede
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 19
|
| L. Gosslin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 20
|
| C. Benson, PhD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 21
|
| J. Kurowski
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 22
|
| I. Waldron
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 23
|
| L. Kusani
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0512
|
| Health Claim Petition for Soluble Fiber from Barley
|
| |
|
|
| LET
2
|
| National Barley Foods Council
|
| Vol #:
|
| 10
|
| |
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| LET
5
|
| The Solae Company
|
| Vol #:
|
| 5
|
|
| |
|
| 2005N-0031
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Dr. K. Waarde
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| EAPE 87
|
| Hunt, Angelina
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 88
|
| Vanderslice, April
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 89
|
| Horner, Retta
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 90
|
| Galbreath, Caroline
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 91
|
| Swidersky, Paul
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 92
|
| Engle, Cynthia
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 93
|
| Drissel, Christina
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 94
|
| Hassall, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 95
|
| McDaniel, Darren
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0079
|
| Determine whether Vioxx Tablets, manufactured by Merck has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
|
| |
|
|
| ACK
1
|
| HFA-305 to Teva Pharmaceuticals USA
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Teva Pharmaceuticals USA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0080
|
| ANDA Suitability for Prednisolone Sodium Phosphate Solution 10 mg/5 mL, 20 mg/5 mL and 25 mg/5 mL (equivalent prednisolone base)
|
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
