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| Dockets Entered
On September 17, 2004
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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|
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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|
|
| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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|
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2003M-0172
|
| PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| 2003N-0455
|
| Training Program for Regulatory Project Managers; Information Available to Industry
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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|
|
| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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|
|
| 2004E-0426
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
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|
|
| 2004E-0427
|
| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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|
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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|
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0214
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| Public Information Regulations
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|
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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|
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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|
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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|
|
| 2004V-0424
|
| Laser Light Show
|
|
|
| 1976N-0052N
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| OTC Nasal Decongestants
|
|
|
| M
1
|
| Public Health Advisory; Safety of Phenylpropanolamine
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| Vol #:
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| 77
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|
|
| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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|
|
| M
7
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| Public Health Advisory; Safety of Phenylpropanolamine
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| Vol #:
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| 95
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|
|
| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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|
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| SUP
8
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| Dyclo9, Inc.
|
| Vol #:
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| 72
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|
| | | | | | | | |
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| EMC
8
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| International Dairy Foods Assn (IDFA)
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| Vol #:
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| 7
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|
|
| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| EMC
8
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
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| 9
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
| EMC 795
|
| A. Marvin
|
| Vol #:
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| 33
|
|
|
| EMC 796
|
| S. Swanson
|
| Vol #:
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| 33
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
| EMC 206
|
| M. Bonazzoli
|
| Vol #:
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| 3
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EMC 10310
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| E. Edenfield
|
| Vol #:
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| 287
|
|
|
| EMC 10311
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| T. Thompson
|
| Vol #:
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| 287
|
|
|
| EMC 10312
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| C. Prevosto
|
| Vol #:
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| 287
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|
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| EMC 10313
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| Erin
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| Vol #:
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| 287
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|
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| EMC 10314
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| G. Cheeseman
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| Vol #:
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| 287
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|
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| EMC 10315
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| D. Hanlon
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| Vol #:
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| 287
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|
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| EMC 10316
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| J. Castro
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| Vol #:
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| 287
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|
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| EMC 10317
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| K. Biesenbach
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| Vol #:
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| 287
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|
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| EMC 10318
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| M. Casino
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| Vol #:
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| 287
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| EMC 10319
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| J. Thompson
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| Vol #:
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| 287
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|
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| EMC 10320
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| K. Mackey
|
| Vol #:
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| 287
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|
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| EMC 10321
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| J. Gilles
|
| Vol #:
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| 287
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| EMC 10322
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| D. Erickson
|
| Vol #:
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| 287
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|
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| EMC 10323
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| S. Roberson
|
| Vol #:
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| 287
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| EMC 10324
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| S. Roberson
|
| Vol #:
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| 287
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| EMC 10325
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| R. Redtail
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| Vol #:
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| 287
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| EMC 10326
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| L. Stuparitz
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| Vol #:
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| 287
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| EMC 10327
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| S. Pederson
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| Vol #:
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| 287
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| EMC 10328
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| A. Smith
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| Vol #:
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| 287
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| EMC 10329
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| J. Salomon
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| Vol #:
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| 287
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| EMC 10330
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| R. Dennis
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| Vol #:
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| 287
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| EMC 10331
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| T. Reynolds
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| Vol #:
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| 287
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| EMC 10332
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| T. Reynolds
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| Vol #:
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| 287
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| EMC 10333
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| S. Lintott
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| Vol #:
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| 287
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| | | | | | | |
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| EMC 10334
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| K. Dague
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| Vol #:
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| 287
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|
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| EMC 10335
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| C. Howard
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| Vol #:
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| 287
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|
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| EMC 10336
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| J. Collings, MD
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| Vol #:
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| 287
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|
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| EMC 10337
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| L. Hibberts
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| Vol #:
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| 287
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|
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| EMC 10338
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| K. Anderson
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| Vol #:
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| 287
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|
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| EMC 10339
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| N. Wallin
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| Vol #:
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| 287
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|
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| EMC 10340
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| J. Kennedy
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| Vol #:
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| 287
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|
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| EMC 10341
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| C. Hembd
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| Vol #:
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| 287
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|
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| EMC 10342
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| V. Jackson
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| Vol #:
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| 287
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|
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| EMC 10343
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| M. Nolan
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| Vol #:
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| 287
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|
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| EMC 10344
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| J. Londrigan
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| Vol #:
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| 287
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|
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| EMC 10345
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| K. Kennedy
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| Vol #:
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| 287
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|
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| EMC 10346
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| M. Stacy
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| Vol #:
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| 287
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|
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| EMC 10347
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| B. Milby
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| Vol #:
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| 287
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|
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| EMC 10348
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| B. Milby
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| Vol #:
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| 287
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|
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| EMC 10349
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| G. Floren
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| Vol #:
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| 287
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|
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| EMC 10350
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| T. Widger
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| Vol #:
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| 287
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|
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| EMC 10351
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| M. Klein
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| Vol #:
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| 287
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|
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| EMC 10352
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| A. Langley
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| Vol #:
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| 287
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| EMC 10353
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| Y. Zimmerman
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| Vol #:
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| 287
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| EMC 10354
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| D. Eades
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| Vol #:
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| 287
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| EMC 10355
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| H. Baburek
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| Vol #:
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| 287
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|
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| EMC 10356
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| L. Brognano
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| Vol #:
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| 287
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| EMC 10357
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| M. Gunatilleke
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| Vol #:
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| 287
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|
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| EMC 10358
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| C. Nussbaum
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| Vol #:
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| 287
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|
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| EMC 10359
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| K. Smith
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| Vol #:
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| 287
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|
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| EMC 10360
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| Inna K.
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| Vol #:
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| 287
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|
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| EMC 10361
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| L. Pietroniro
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| Vol #:
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| 287
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|
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| EMC 10362
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| L. Jackson
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| Vol #:
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| 287
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|
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| EMC 10363
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| A. Hurley
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| Vol #:
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| 287
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|
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| EMC 10364
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| A. Hurley
|
| Vol #:
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| 287
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|
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| EMC 10365
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| L. Hughes
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| Vol #:
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| 287
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|
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| EMC 10366
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| E. Cotterman
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| Vol #:
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| 287
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|
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| EMC 10367
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| S. Shepard
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| Vol #:
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| 297
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|
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| EMC 10368
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| J. Thomas
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| Vol #:
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| 287
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|
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| EMC 10369
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| L. Lewis
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| Vol #:
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| 287
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|
|
| EMC 10370
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| K. McAbee
|
| Vol #:
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| 287
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|
| | | | | | | |
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| EMC 10371
|
| L. Lewis
|
| Vol #:
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| 287
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|
|
| EMC 10372
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| N. Anderson
|
| Vol #:
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| 287
|
|
|
| EMC 10373
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| K. Okuda
|
| Vol #:
|
| 287
|
|
|
| EMC 10374
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| J. Laidlaw
|
| Vol #:
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| 287
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|
|
| EMC 10375
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| R. Lehman
|
| Vol #:
|
| 287
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|
|
| EMC 10376
|
| R. Lehman
|
| Vol #:
|
| 287
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|
|
| EMC 10377
|
| K. Foster
|
| Vol #:
|
| 287
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|
|
| EMC 10378
|
| K. Foster
|
| Vol #:
|
| 374
|
|
|
| EMC 10379
|
| K. McVerry
|
| Vol #:
|
| 287
|
|
|
| EMC 10380
|
| L. Mendizabal
|
| Vol #:
|
| 287
|
|
|
| EMC 10381
|
| J. Hohn
|
| Vol #:
|
| 287
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|
|
| EMC 10382
|
| K. Strickland
|
| Vol #:
|
| 287
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|
|
| EMC 10383
|
| L. Murray
|
| Vol #:
|
| 287
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|
|
| EMC 10384
|
| A. Ferguson
|
| Vol #:
|
| 287
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|
|
| EMC 10385
|
| A. Thomson
|
| Vol #:
|
| 287
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|
|
| EMC 10386
|
| J. Burghoffer
|
| Vol #:
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| 287
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|
|
| EMC 10387
|
| T. Thomas
|
| Vol #:
|
| 287
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|
|
| EMC 10388
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| T. Gable
|
| Vol #:
|
| 287
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|
|
| EMC 10389
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| J. Gailey
|
| Vol #:
|
| 287
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|
|
| EMC 10390
|
| B. Hubbell
|
| Vol #:
|
| 287
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|
|
| EMC 10391
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| L. Profeit
|
| Vol #:
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| 287
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|
|
| EMC 10392
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| P. Blake
|
| Vol #:
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| 287
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|
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| EMC 10393
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| E. Salsbiru
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| Vol #:
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| 287
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|
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| EMC 10394
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| S. Hund
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| Vol #:
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| 287
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|
|
| EMC 10395
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| E. Christenson
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| Vol #:
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| 287
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|
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| EMC 10396
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| K. Pratt
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| Vol #:
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| 287
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|
|
| EMC 10397
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| M. Welka
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| Vol #:
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| 287
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|
|
| EMC 10398
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| T. Mark
|
| Vol #:
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| 287
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|
|
| EMC 10399
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| D. Pennington
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| Vol #:
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| 287
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|
|
| EMC 10400
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| K and T Burgess
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| Vol #:
|
| 287
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|
|
| EMC 10401
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| J. Hawkins
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| Vol #:
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| 287
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|
|
| EMC 10402
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| A. Riley
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| Vol #:
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| 287
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|
|
| EMC 10403
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| K. Pollock
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| Vol #:
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| 287
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|
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| EMC 10404
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| J. DeForge
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| Vol #:
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| 287
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|
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| EMC 10405
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| K. Jennings
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| Vol #:
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| 287
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|
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| EMC 10406
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| A. Guthery
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| Vol #:
|
| 287
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|
|
| EMC 10407
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| S. Ginsberg
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| Vol #:
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| 287
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| | | | | | | | |
|
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| EMC 10408
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| T. Check
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| Vol #:
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| 287
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|
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| EMC 10409
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| K. Halom
|
| Vol #:
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| 287
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|
|
| EMC 10410
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| S. Stewart
|
| Vol #:
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| 287
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|
|
| EMC 10411
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| A. Frie
|
| Vol #:
|
| 287
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|
|
| EMC 10412
|
| C. Goodwin
|
| Vol #:
|
| 287
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|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
| EMC 1246
|
| B. Fennell
|
| Vol #:
|
| 5
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| EMC 185
|
| P. Shepard
|
| Vol #:
|
| 3
|
|
|
| EMC 186
|
| P. Shepard
|
| Vol #:
|
| 3
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC
364
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| EMC
365
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| EMC
366
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| EMC
367
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| EMC
368
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
| 2003M-0172
|
| PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
|
|
|
| SUP
1
|
| Corid Corporation
|
| Vol #:
|
| 1
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 370
|
| N. Landas
|
| Vol #:
|
| 9
|
|
|
| EMC 371
|
| J. Simmons
|
| Vol #:
|
| 9
|
|
|
| EMC 372
|
| A. Golan
|
| Vol #:
|
| 9
|
|
|
| EMC 373
|
| S. Fugua
|
| Vol #:
|
| 9
|
|
|
| EMC 374
|
| WM Wassell, MD
|
| Vol #:
|
| 9
|
|
|
| EMC 375
|
| C. Reid
|
| Vol #:
|
| 9
|
|
|
| EMC 376
|
| R. Hmelo
|
| Vol #:
|
| 9
|
|
|
| EMC 377
|
| A. Pagtalonia
|
| Vol #:
|
| 9
|
|
|
| EMC 378
|
| D. Gibson
|
| Vol #:
|
| 9
|
|
|
| EMC 379
|
| M. Goodman
|
| Vol #:
|
| 9
|
|
|
| EMC 380
|
| M. Goodman
|
| Vol #:
|
| 9
|
|
|
| EMC 381
|
| S. Hwang
|
| Vol #:
|
| 9
|
|
|
| EMC 382
|
| J. King
|
| Vol #:
|
| 9
|
|
|
| EMC 383
|
| J. Taylor
|
| Vol #:
|
| 9
|
|
|
| EMC 384
|
| L. Jowers
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
|
|
| EMC 385
|
| R> Williams
|
| Vol #:
|
| 9
|
|
|
| EMC 386
|
| S. Goodman
|
| Vol #:
|
| 9
|
|
|
| EMC 387
|
| No signature
|
| Vol #:
|
| 9
|
|
|
| EMC 388
|
| J. Gleason
|
| Vol #:
|
| 9
|
|
|
| EMC 389
|
| J. Jesus
|
| Vol #:
|
| 9
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
| EMC
248
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| EMC
4
|
| National Grain and Feed Assn (NGFA)
|
| Vol #:
|
| 4
|
|
|
| 2003N-0455
|
| Training Program for Regulatory Project Managers; Information Available to Industry
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
|
|
| EMC 289
|
| M. Carpenter
|
| Vol #:
|
| 5
|
|
|
| EMC 290
|
| P. Kurella
|
| Vol #:
|
| 5
|
|
|
| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
|
|
|
| APP
1
|
| Praecis Pharmaceuticals, Incorporated
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0426
|
| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
|
|
|
| APP
1
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| LET
2
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0427
|
| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
|
|
|
| APP
1
Continued
|
| Aventis S.A.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
| MO
1
|
| Ecumed Health Group and Amador Reyes
|
| Vol #:
|
| 1
|
|
|
| 2004N-0018
|
| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
|
|
|
| EMC 5
|
| S. Vermund, MD, PhD
|
| Vol #:
|
| 1
|
|
|
| EMC 6
|
| R. Candelaria
|
| Vol #:
|
| 1
|
|
|
| EMC 7
|
| R. Newman,MD,MPH
|
| Vol #:
|
| 1
|
|
|
| EMC 8
|
| J. Leiss, PhD
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| EMC
9
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
| EMC 10
|
| D. Salerno, PhD
|
| Vol #:
|
| 1
|
|
|
| EMC 11
|
| J. Beloqui, PhD
|
| Vol #:
|
| 1
|
|
|
| EMC 12
|
| D. Greco
|
| Vol #:
|
| 1
|
|
|
| EMC 13
|
| J. Tealdi, MD
|
| Vol #:
|
| 1
|
|
|
| EMC
14
|
| Latin American Forum for Ethics Committees for Health Research (FLACEIS)
|
| Vol #:
|
| 1
|
|
|
| EMC
15
|
| Latin American Forum for Ethics Committees for Health Research (FLACEIS)
|
| Vol #:
|
| 1
|
|
|
| EMC
16
|
| Prescrire International
|
| Vol #:
|
| 1
|
|
|
| EMC
17
|
| International Department of the Austrian Medical Chamber
|
| Vol #:
|
| 1
|
|
|
| EMC
18
|
| AIDS Vaccine Advocacy Coalition (AVAC)
|
| Vol #:
|
| 1
|
|
|
| EMC 19
|
| Dr. F Luna
|
| Vol #:
|
| 1
|
|
|
| EMC 20
|
| D. Egilman,MD,MPH
|
| Vol #:
|
| 1
|
|
|
| EMC
21
|
| European Forum for Good CLinical Practice (EFGCP)
|
| Vol #:
|
| 1
|
|
|
| EMC
22
|
| Bayer Pharmaceuticals Corporation
|
| Vol #:
|
| 1
|
|
|
| EMC
23
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
| EMC 24
|
| K. Fagan,MD,MPH
|
| Vol #:
|
| 1
|
|
|
| EMC 25
|
| R. Malone,RN,PhD
|
| Vol #:
|
| 1
|
|
|
| EMC 26
|
| J. Oleske,MD,MPH
|
| Vol #:
|
| 1
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
| EMC 8
|
| R. Chamberlain
|
| Vol #:
|
| 8
|
|
|
| EMC
9
|
| The Hymed Group
|
| Vol #:
|
| 8
|
|
|
| 2004N-0214
|
| Public Information Regulations
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
| EMC
6
|
| Assn of Food and Drug Officials (AFDO)
|
| Vol #:
|
| 2
|
|
|
| EMC
7
|
| Kraft Foods Global, Inc.
|
| Vol #:
|
| 2
|
|
|
| EMC
8
|
| National Nutritional Foods Assn (NNFA)
|
| Vol #:
|
| 2
|
|
|
| EMC
9
|
| Grocery Manufacturers of America (GMA)
|
| Vol #:
|
| 2
|
|
|
| EMC
10
|
| Food Allergy & Anaphylaxis Network (FAAN)
|
| Vol #:
|
| 2
|
|
|
| EMC
11
|
| Northwest Food Processors Assn (NWFPA)
|
| Vol #:
|
| 2
|
|
|
| EMC
12
|
| General Mills
|
| Vol #:
|
| 2
|
|
|
| EMC
13
|
| Shell Lubricants Global Brand
|
| Vol #:
|
| 2
|
|
|
| EMC
14
|
| International Dairy Foods Assn (IDFA)
|
| Vol #:
|
| 2
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
| | | | | | | | |
|
|
| EMC 1413
|
| L. Prchlik
|
| Vol #:
|
| 19
|
|
|
| EMC 1414
|
| No signature
|
| Vol #:
|
| 19
|
|
|
| EMC 1415
|
| No signature
|
| Vol #:
|
| 19
|
|
|
| EMC 1416
|
| K. Boatman
|
| Vol #:
|
| 19
|
|
|
| EMC 1417
|
| M. Preston
|
| Vol #:
|
| 19
|
|
|
| EMC 1418
|
| J. Shumaker
|
| Vol #:
|
| 19
|
|
|
| EMC
1419
|
| Penn State University
|
| Vol #:
|
| 19
|
|
|
| EMC 1420
|
| Caryn T. Addonizio
|
| Vol #:
|
| 19
|
|
|
| EMC 1421
|
| P. Schoenberg
|
| Vol #:
|
| 19
|
|
|
| EMC
1422
|
| Penn State University
|
| Vol #:
|
| 19
|
|
|
| EMC 1423
|
| M and S Lichtenfeld
|
| Vol #:
|
| 19
|
|
|
| EMC
1424
|
| South American Gelatin Manufacturers Assn (SAGMA)
|
| Vol #:
|
| 19
|
|
|
| EMC 1425
|
| G. Kuyava
|
| Vol #:
|
| 19
|
|
|
| EMC 1426
|
| IBM Business Consulting Services
|
| Vol #:
|
| 19
|
|
|
| EMC
1427
|
| Ranchers Cattleman Action Legal Fund - United Stockgrowers of America (R-CALF USA)
|
| Vol #:
|
| 19
|
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
|
|
| EMC
1
|
| National Mental Health Assn (NMHA)
|
| Vol #:
|
| 1
|
|
|
| EMC
2
|
| National Mental Health Assn (NMHA)
|
| Vol #:
|
| 1
|
|
|
| EMC 3
|
| M. Carbetta
|
| Vol #:
|
| 1
|
|
|
| EMC 4
|
| K. Eagle
|
| Vol #:
|
| 1
|
|
|
| 2004V-0424
|
| Laser Light Show
|
|
|
| ACK
1
|
| HFA-305 To Poet Productions,
LLC
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Poet Productions, LLC
|
| Vol #:
|
| 1
|
|
|