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| Dockets Entered
On February 1, 2005
Table of Contents
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| Docket #
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| Title
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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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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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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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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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0441
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
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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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| 2004P-0015
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| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2005N-0029
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005P-0044
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| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| GDL
3
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| Guidance
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| Vol #:
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| 1
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| NAD
3
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| FDA
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| Vol #:
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| 1
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
|
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| EMC 14001
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| J. Poulson
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| Vol #:
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| 324
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| EMC 14002
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| D. Kerr
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| Vol #:
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| 324
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| EMC 14003
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| S. Kazmierczak
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| Vol #:
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| 324
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| EMC 14004
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| J. Palmore
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| Vol #:
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| 324
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| EMC 14005
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| V. Childs
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| Vol #:
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| 324
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| EMC 14006
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| A. Patterson
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| Vol #:
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| 324
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| EMC 14007
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| A. Plitman
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| Vol #:
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| 324
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| |
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| EMC 14008
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| J. Miller
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| Vol #:
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| 324
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| EMC 14009
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| M. Nearman
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| Vol #:
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| 324
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| |
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| EMC 14010
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| L. Holt
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| Vol #:
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| 324
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| |
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| EMC 14011
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| P Horvath, MD
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| Vol #:
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| 324
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|
| | | | | | | |
| |
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| EMC 14012
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| A. Murnane, MD, FACOG
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| Vol #:
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| 324
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| |
|
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| EMC 14013
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| J. Klobutcher, MD
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| Vol #:
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| 324
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| EMC 14014
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| B. Welch, MD, FACOG
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| Vol #:
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| 324
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| EMC 14015
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| K. Holloway, MD, FACOG
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| Vol #:
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| 324
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| |
|
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| EMC 14016
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| S. Haack, MD, FACOG
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| Vol #:
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| 324
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| EMC 14017
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| R. Bremner, MD, FACOG
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| Vol #:
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| 324
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| |
|
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| EMC 14018
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| S. Roth, MD, FACOG
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| Vol #:
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| 324
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| |
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| EMC 14019
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| R. Bremner, MD, FACOG
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| Vol #:
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| 324
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| |
|
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| EMC 14020
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| J. Ray
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| Vol #:
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| 324
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| |
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| EMC 14021
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| S. Mazenko
|
| Vol #:
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| 324
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| |
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| EMC 14022
|
| S. Morgan
|
| Vol #:
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| 324
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| |
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| EMC 14023
|
| J. Quinn
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| Vol #:
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| 324
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| |
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| EMC 14024
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| M. Voorhies
|
| Vol #:
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| 324
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| EMC 14025
|
| S. Hager
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| Vol #:
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| 324
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| |
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| EMC 14026
|
| B. Moore
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| Vol #:
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| 324
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| |
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| EMC 14027
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| G. Walker
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| Vol #:
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| 324
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| EMC 14028
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| B. Christensen
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| Vol #:
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| 324
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| EMC 14029
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| M. Adams
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| Vol #:
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| 324
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| EMC 14030
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| M. Adams
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| Vol #:
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| 324
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| EMC 14031
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| M. Semchenko
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| Vol #:
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| 324
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| EMC 14032
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| K. Revie
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| Vol #:
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| 324
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| EMC 14033
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| K. Frindik
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| Vol #:
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| 324
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| EMC 14034
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| K. Lavigne
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| Vol #:
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| 324
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| EMC 14035
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| A. Whitley
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| Vol #:
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| 324
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| EMC 14036
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| K. Akin
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| Vol #:
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| 324
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| EMC 14037
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| A. Cohen
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| Vol #:
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| 324
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| EMC 14038
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| I. Kyle
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| Vol #:
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| 324
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| EMC 14039
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| R. Zerner
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| Vol #:
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| 324
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| EMC 14040
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| T. Meronk
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| Vol #:
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| 324
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| EMC 14041
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| J. Nielsen
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| Vol #:
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| 324
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| EMC 14042
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| C. Baxter
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| Vol #:
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| 324
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| EMC 14043
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| E. Thompson
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| Vol #:
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| 324
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| |
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| EMC 14044
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| B. Baksh
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| Vol #:
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| 324
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| |
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| EMC 14045
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| A. Mayrofer
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| Vol #:
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| 324
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| |
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| EMC 14046
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| M. Allekotte
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| Vol #:
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| 324
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| EMC 14047
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| P. York
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| Vol #:
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| 324
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| EMC 14048
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| C. Schmitz
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| Vol #:
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| 324
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| EMC 14049
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| D. Demers
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| Vol #:
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| 324
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| EMC 14050
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| S. Telander
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| Vol #:
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| 324
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| |
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| EMC 14051
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| R. Gutmaker
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| Vol #:
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| 324
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| EMC 14052
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| S. Weiner
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| Vol #:
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| 324
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| EMC 14053
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| J. Kurnik
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| Vol #:
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| 324
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| EMC 14054
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| J. Varner
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| Vol #:
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| 324
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| EMC 14055
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| J. Weiner
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| Vol #:
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| 324
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| EMC 14056
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| N. Corning
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| Vol #:
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| 324
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| EMC 14057
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| T. Covert
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| Vol #:
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| 324
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| EMC 14058
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| E. Chapin
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| Vol #:
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| 324
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| EMC 14059
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| S. Roeding
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| Vol #:
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| 324
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| EMC 14060
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| C. Sottile
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| Vol #:
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| 324
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| EMC 14061
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| F. Greenberg
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| Vol #:
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| 324
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| EMC 14062
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| J. Bowen
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| Vol #:
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| 324
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| EMC 14063
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| K. Arnett
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| Vol #:
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| 324
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| EMC 14064
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| M. Haine
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| Vol #:
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| 324
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| EMC 14065
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| J. Smith
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| Vol #:
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| 324
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| EMC 14066
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| R. Cantey
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| Vol #:
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| 324
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| |
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| EMC 14067
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| B. Chancellor
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| Vol #:
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| 324
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| |
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| EMC 14068
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| M. Nelson
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| Vol #:
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| 324
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| EMC 14069
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| A. Froese
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| Vol #:
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| 324
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| |
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| EMC 14070
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| T. McCarthy
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| Vol #:
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| 324
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| |
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| EMC
14071
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| American Medical Association
|
| Vol #:
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| 324
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| |
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| EMC 14072
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| K. Troyan
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| Vol #:
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| 324
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| |
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| EMC 14073
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| A. Burnham
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| Vol #:
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| 324
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| |
|
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| EMC 14074
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| E. Cornwell
|
| Vol #:
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| 324
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| |
|
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| EMC 14075
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| E. Cornwell
|
| Vol #:
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| 324
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| |
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| EMC 14076
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| M. Olson
|
| Vol #:
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| 324
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| |
|
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| EMC 14077
|
| E. Ellcessor
|
| Vol #:
|
| 324
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3160
|
| I. Brown
|
| Vol #:
|
| 261
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC
418
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
419
|
| Mission Possible International
|
| Vol #:
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| 7
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| |
|
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| EMC
420
|
| Mission Possible International
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| Vol #:
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| 7
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|
| | | | | | | | |
| |
|
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| EMC
421
|
| Calorie Control Council
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| Vol #:
|
| 7
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|
| |
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| EMC
422
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| Mission Possible International
|
| Vol #:
|
| 7
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| |
|
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| EMC
423
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| Mission Possible International
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| Vol #:
|
| 7
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| |
|
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| EMC
424
|
| Mission Possible International
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| Vol #:
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| 7
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| |
|
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| EMC
425
|
| IFHP Advanced Wellness Services, Inc.
|
| Vol #:
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| 7
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| |
|
|
| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| |
|
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| EMC 2
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| Number Not Used
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| Vol #:
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| 2
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| |
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| EMC 3
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| R. Schneider
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| Vol #:
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| 2
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| |
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| EMC 4
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| H. Gilmore
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| Vol #:
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| 2
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| EMC 5
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| D. McNeill
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| Vol #:
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| 2
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| |
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| EMC 6
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| T. Ritz
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| Vol #:
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| 2
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| |
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| EMC 7
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| D. Puckett
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| Vol #:
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| 2
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| |
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| EMC 8
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| K. Perkins
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| Vol #:
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| 2
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| |
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| EMC 9
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| V. Cousins
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| Vol #:
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| 2
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| EMC 10
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| R. Berghofer
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| Vol #:
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| 2
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| |
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| EMC 11
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| C. Alvarez
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| Vol #:
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| 2
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| EMC 12
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| P M and I Vergun
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| Vol #:
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| 2
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| |
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| EMC 13
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| No signature
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| Vol #:
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| 2
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| |
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| EMC 14
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| W. McClatchey, Jr.
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| Vol #:
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| 2
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| |
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| EMC 15
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| P and C Marciniak
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| Vol #:
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| 2
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| EMC 16
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| B. Ruzak
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| Vol #:
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| 2
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| EMC 17
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| K. Kiebler
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| Vol #:
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| 2
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| EMC 18
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| A. Plato
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| Vol #:
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| 2
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| EMC 19
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| P. Moss
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| Vol #:
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| 2
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| |
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| EMC 20
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| R. Lang
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| Vol #:
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| 2
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| |
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| EMC 21
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| T. Turner
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| Vol #:
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| 2
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| |
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| EMC 22
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| Celina A.
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| Vol #:
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| 2
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| |
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| EMC 23
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| H. Smith
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| Vol #:
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| 2
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| |
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| EMC 24
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| S. Jabs
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| Vol #:
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| 2
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| |
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| EMC 25
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| E. Chieco, PhD
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| Vol #:
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| 2
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| |
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| EMC 26
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| Holmes Family
|
| Vol #:
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| 2
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| |
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| EMC 27
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| S. Saberon
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| Vol #:
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| 2
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| |
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| EMC 28
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| A. Burke
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| Vol #:
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| 2
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| |
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| EMC 29
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| M. Courter
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| Vol #:
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| 2
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| |
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| EMC 30
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| L. Menken
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| Vol #:
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| 2
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| |
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| EMC 31
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| L. Menken
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| Vol #:
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| 2
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| | | | | | | |
| |
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| EMC 32
|
| W. Howald
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| Vol #:
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| 2
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| |
|
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| EMC 33
|
| M. Feldman
|
| Vol #:
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| 2
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| |
|
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| EMC 34
|
| R and E Fitch
|
| Vol #:
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| 2
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| |
|
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| EMC 35
|
| D. Turnoy
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| Vol #:
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| 2
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| |
|
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| EMC 36
|
| R. West
|
| Vol #:
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| 2
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| |
|
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| EMC 37
|
| J. Berdis
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| Vol #:
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| 2
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| |
|
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| EMC 38
|
| S. Wilcox
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| Vol #:
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| 2
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| |
|
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| EMC 39
|
| B. Freeman
|
| Vol #:
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| 2
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| |
|
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| EMC 40
|
| M. Horowitz
|
| Vol #:
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| 2
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| |
|
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| EMC 41
|
| J. Logie
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| Vol #:
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| 2
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| |
|
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| EMC 42
|
| K. Penley
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| Vol #:
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| 2
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| |
|
|
| EMC 43
|
| J. Edwards
|
| Vol #:
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| 2
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| |
|
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| EMC 44
|
| B. Lutenegger
|
| Vol #:
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| 2
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| |
|
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| EMC 45
|
| D. Wichar
|
| Vol #:
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| 2
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| |
|
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| EMC 46
|
| M. Horowitz
|
| Vol #:
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| 2
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| |
|
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| EMC 47
|
| M. Rivera
|
| Vol #:
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| 2
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| |
|
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| EMC 48
|
| B. Sutter
|
| Vol #:
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| 2
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| |
|
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| EMC 49
|
| R. Long
|
| Vol #:
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| 2
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| |
|
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| EMC 50
|
| G. Rupert
|
| Vol #:
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| 2
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| |
|
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| EMC 51
|
| S. Argani, MD
|
| Vol #:
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| 2
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| |
|
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| EMC 52
|
| R. Camp
|
| Vol #:
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| 2
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| |
|
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| EMC 53
|
| D. Ortaman
|
| Vol #:
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| 2
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| |
|
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| EMC 54
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| P and R Ratte
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| Vol #:
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| 2
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| |
|
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| EMC 55
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| C. Kalinowski
|
| Vol #:
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| 2
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| |
|
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| EMC 56
|
| K. Jackson
|
| Vol #:
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| 2
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| |
|
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| EMC 57
|
| M. Thompson
|
| Vol #:
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| 2
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| |
|
|
| EMC 58
|
| J. Schneider
|
| Vol #:
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| 2
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| |
|
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| EMC 59
|
| M. Broussard
|
| Vol #:
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| 2
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| |
|
|
| EMC 60
|
| C. Hoefnagels
|
| Vol #:
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| 2
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| |
|
|
| EMC 61
|
| C. Schuett
|
| Vol #:
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| 2
|
| |
|
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| EMC 62
|
| B. Toynes
|
| Vol #:
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| 2
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| |
|
|
| EMC 63
|
| Dr. J. Roizin
|
| Vol #:
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| 2
|
| |
|
|
| EMC 64
|
| M. Hoodwin
|
| Vol #:
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| 2
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| |
|
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| EMC 65
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| L. Morales
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| EMC 66
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| W. Stroud
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| EMC 67
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| D. Watson
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| R. Kaleopa
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| EMC 69
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| R. Heymann
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| EMC 70
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| B. Demar
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| EMC 71
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| Michael J.
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| EMC 72
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| J. Byrne
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| EMC 73
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| T. Ritz
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| EMC 74
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| D. Hope
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| EMC 75
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| A. Edwardson
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| EMC 76
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| C. Kinnaird
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| EMC 77
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| S. Tjessem
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| EMC 78
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| K. Self
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| EMC 79
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| F. Long
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| 2
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| EMC 80
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| C. LaFollette
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| EMC 81
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| P. Willie
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| EMC 82
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| J. Holt
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| EMC 83
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| F. Horton
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| EMC 84
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| J. Berids
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| EMC 85
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| J. Dangelo
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| 2
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| EMC 86
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| B. Brown
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| EMC 87
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| M. Lebert
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| EMC 88
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| J. Weishaar
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| EMC 89
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| J. Elzinga
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| EMC 90
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| S. Biesek
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| EMC 91
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| J. Payne
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| 2
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| EMC 92
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| K. Khalsa
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| 2
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| EMC
93
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| Public Citizen
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| 2
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| EMC 94
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| J. Berstein
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| 2
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| EMC 95
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| A. Bonvouloir
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| 2
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| EMC 96
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| No signature
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| 2
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| EMC 97
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| No signature
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| 2
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| EMC 98
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| J. Meuse
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| EMC 99
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| R. Anchordoguy
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| 2
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| EMC 100
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| G and E Smith
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| 2
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| EMC 101
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| A. Scialdone
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| EMC 102
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| C. Adams
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| 2
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| EMC 103
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| J. Pihl
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| 2
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| EMC 104
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| C. Thomas
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| 2
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| EMC 105
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| P. Payton
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| 2
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| EMC 106
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| C. Solomon
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| EMC 107
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| No signature
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| 2
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| EMC 108
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| No signature
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| 2
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| EMC 109
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| M. Donohoe, MD, FACP
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| 2
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| EMC 110
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| W. Norsworthy, Jr
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| 2
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| EMC 111
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| C. Hathaway
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| 2
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| EMC 112
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| E. Honey
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| 2
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| EMC 113
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| A. Plato
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| 2
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| EMC 114
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| C. Stivers
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| 2
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| EMC 115
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| No signature
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| 2
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| EMC 116
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| J. Peterson
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| 2
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| |
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| CS
14
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| HFA-305 to Henry E. Schwartz LLC
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| 6
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| |
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| OR
12
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| HF-3
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| 6
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| |
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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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| |
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| EMC 509
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| A. Kime
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| Vol #:
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| 9
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| EMC 510
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| N. Johnson
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| Vol #:
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| 324
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| EMC 511
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| L. Hatten
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| 9
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| EMC 512
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| C. Conrad
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| Vol #:
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| 324
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| EMC 513
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| J. Hudson
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| Vol #:
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| 324
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| EMC 514
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| M. Ross
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| Vol #:
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| 324
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| EMC 515
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| P. Fleischman
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| Vol #:
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| 9
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| EMC 516
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| T. Adevai
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| Vol #:
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| 9
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| EMC 517
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| K. Koehler
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| Vol #:
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| 9
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| EMC 518
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| P. Bartholomew
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| 9
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| EMC 519
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| D. Torinese
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| Vol #:
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| 9
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| EMC 520
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| S. Friedland
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| Vol #:
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| 9
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| EMC 521
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| T. Wilson
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| Vol #:
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| 9
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| EMC 522
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| M. Grondiness
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| Vol #:
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| 9
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| |
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| |
|
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| EMC
42
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| IVAX Research, Inc.
|
| Vol #:
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| 6
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| |
|
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| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| |
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| EMC 947
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| I Johnson
|
| Vol #:
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| 14
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| EMC 948
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| E Coombs
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| Vol #:
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| 14
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| EMC 949
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| J Nolan
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| Vol #:
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| 14
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| EMC 950
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| M Stoffregen
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| Vol #:
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| 14
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| |
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| EMC 951
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| J Young
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| Vol #:
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| 14
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|
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| EMC 952
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| P Hadam
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| Vol #:
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| 14
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| |
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| EMC 953
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| K Power
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| Vol #:
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| 14
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|
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| EMC 954
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| M Sheehan
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| Vol #:
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| 14
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| |
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| EMC 955
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| M Moran
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| Vol #:
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| 14
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|
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| EMC 956
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| C Pezak
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| Vol #:
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| 14
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|
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| EMC 957
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| P Brichford
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| Vol #:
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| 14
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| |
|
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| EMC 958
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| K Beaulieu
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| Vol #:
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| 14
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| |
|
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| EMC 959
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| S Fletcher
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| Vol #:
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| 14
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| |
|
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| EMC 960
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| k kUUSINEN
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| Vol #:
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| 14
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| |
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| EMC 961
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| A Nisbet
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| Vol #:
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| 14
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| |
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| EMC 962
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| M Rajkowski
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| Vol #:
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| 14
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| |
|
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| EMC 963
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| D Peterson
|
| Vol #:
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| 14
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| |
|
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| EMC 964
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| T Hotis
|
| Vol #:
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| 14
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| |
|
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| EMC 965
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| B Smidt
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| Vol #:
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| 14
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| |
|
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| EMC 966
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| G O'Shea
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| Vol #:
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| 14
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| |
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| EMC 967
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| D Crake
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| Vol #:
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| 14
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| |
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| EMC 968
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| L Steiner
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| Vol #:
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| 14
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|
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| EMC 969
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| G Balduf
|
| Vol #:
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| 14
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| |
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| EMC 970
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| P Brown
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| Vol #:
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| 14
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| |
|
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| EMC 971
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| R Savage
|
| Vol #:
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| 14
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|
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| EMC 972
|
| C Villandry
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| Vol #:
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| 14
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|
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| EMC 973
|
| C Pettey
|
| Vol #:
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| 14
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| |
|
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| EMC 974
|
| H Siegel
|
| Vol #:
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| 14
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| |
|
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| EMC 975
|
| L Cooper
|
| Vol #:
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| 14
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| |
|
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| EMC 976
|
| M Renner
|
| Vol #:
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| 14
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| |
|
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| EMC 977
|
| H Alexander
|
| Vol #:
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| 14
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| |
|
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| EMC 978
|
| J Burke
|
| Vol #:
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| 14
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| |
|
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| EMC 979
|
| C Konzen
|
| Vol #:
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| 14
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| |
|
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| EMC 980
|
| D Ingalsbe
|
| Vol #:
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| 14
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| |
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
| |
|
|
| EMC
8
|
| Facility Automation Information Management (FAME) Systems
|
| Vol #:
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| 3
|
| |
|
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| EMC
9
|
| Facility Automation Information Management (FAME) Systems
|
| Vol #:
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| 2
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| |
|
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| EMC
10
|
| Facility Automation Information Management (FAME) Systems
|
| Vol #:
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| 2
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|
| | | | | | | | |
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| |
|
| 2004G-0381
|
| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
| |
|
|
| EMC
1
|
| International Foodservice Distributors Association (IFDA)
|
| Vol #:
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| 1
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| |
|
|
| EMC
2
|
| Kraft Foods Global, Inc. (Kraft)
|
| Vol #:
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| 1
|
| |
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
| |
|
|
| EMC 8
|
| D. Schlyer
|
| Vol #:
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| 2
|
| |
|
|
| EMC
9
|
| New Jersey Commission on Radiation
|
| Vol #:
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| 2
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| |
|
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| EMC 10
|
| R. Thurlow
|
| Vol #:
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| 2
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| |
|
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| EMC 11
|
| C. Traylor
|
| Vol #:
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| 2
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| |
|
|
| 2004N-0441
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Application For FDA Approval to Market a New Drug
|
| |
|
|
| N
2
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| EMC 258
|
| L. Bragg
|
| Vol #:
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| 4
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| |
|
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| EMC 259
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| C. Edwards
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| Vol #:
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| 4
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| |
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| EMC 260
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| C. Bowen
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| Vol #:
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| 4
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| |
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| EMC 261
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| M. Pall
|
| Vol #:
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| 4
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| |
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| EMC 262
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| C. Kitchen
|
| Vol #:
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| 4
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| |
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| EMC 263
|
| J. Grisham
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| Vol #:
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| 4
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| |
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| EMC 264
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| T. Wojtowicz
|
| Vol #:
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| 4
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| |
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| EMC 265
|
| M. Kaye
|
| Vol #:
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| 4
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| |
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| EMC 266
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| A. Hoffer
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| Vol #:
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| 4
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| EMC 267
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| G. Cranston
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| Vol #:
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| 4
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| |
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| EMC 268
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| P. Bradshaw
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| Vol #:
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| 4
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| EMC 269
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| L. Meadows
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| Vol #:
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| 4
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| EMC 270
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| S. Hendricks
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| Vol #:
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| 4
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| EMC 271
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| V. Temple
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| Vol #:
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| 4
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| EMC 272
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| J. Vlasak
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| Vol #:
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| 4
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| EMC 273
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| C. Lescs
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| Vol #:
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| 4
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| EMC 274
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| V. Pare
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| Vol #:
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| 4
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| |
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| EMC 275
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| B. Bull
|
| Vol #:
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| 4
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| |
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| EMC 276
|
| M. Meeks
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| Vol #:
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| 4
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| EMC 277
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| D. Snyder
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| Vol #:
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| 4
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| EMC 278
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| W. Osborn
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| Vol #:
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| 4
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| |
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| EMC 279
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| R. Harris
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| Vol #:
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| 4
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| |
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| EMC 280
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| J. Mabel
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| Vol #:
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| 4
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| EMC 281
|
| A. Lewis
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| Vol #:
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| 4
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| EMC 282
|
| D. Smith
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| Vol #:
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| 4
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| EMC 283
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| R. Ward
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| Vol #:
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| 4
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| |
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| EMC 284
|
| H. Streit
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| Vol #:
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| 4
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| |
|
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| EMC 285
|
| L. McKibben
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| Vol #:
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| 4
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| |
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| EMC 286
|
| T and D LaRoux
|
| Vol #:
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| 4
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| |
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| EMC 287
|
| P. Christensen
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| Vol #:
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| 4
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| |
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| EMC 288
|
| L. Plumlee
|
| Vol #:
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| 4
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| |
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| EMC 289
|
| M. McKinley
|
| Vol #:
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| 4
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| |
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| EMC 290
|
| P. Madison
|
| Vol #:
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| 4
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| |
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| EMC 291
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| J. Lesperance
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| Vol #:
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| 4
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| EMC 292
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| K. Smoot
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| Vol #:
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| 4
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| |
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| EMC 293
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| M. Foster
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| Vol #:
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| 4
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| EMC 294
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| D. Walker
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| Vol #:
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| 4
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| EMC 295
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| K and C Adams
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| Vol #:
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| 4
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| EMC 296
|
| G and K Baranek
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| Vol #:
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| 4
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| EMC 297
|
| M. Marshall
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| Vol #:
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| 4
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| EMC 298
|
| M. Marshall
|
| Vol #:
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| 4
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| |
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| EMC 299
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| P. Neary
|
| Vol #:
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| 4
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| |
|
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| EMC 300
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| D. Chappell
|
| Vol #:
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| 4
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| |
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| EMC 301
|
| R. Self
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| Vol #:
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| 4
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| |
|
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| EMC 302
|
| T. Kistler
|
| Vol #:
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| 4
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| |
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| EMC 303
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| A. Deligant
|
| Vol #:
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| 4
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| |
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| EMC 304
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| D. McBurnettt
|
| Vol #:
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| 4
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| |
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| EMC 305
|
| K. Roberson
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| Vol #:
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| 4
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| EMC 306
|
| S. Goldman
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| Vol #:
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| 4
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| EMC 307
|
| R. Sica
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| Vol #:
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| 4
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| |
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| EMC 308
|
| J. Tricomi
|
| Vol #:
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| 4
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| |
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| EMC 309
|
| T. Conway
|
| Vol #:
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| 4
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| |
|
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| EMC 310
|
| M. Ryan
|
| Vol #:
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| 4
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| |
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| EMC 311
|
| K. Munson
|
| Vol #:
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| 4
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| |
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| EMC 312
|
| T. Decker
|
| Vol #:
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| 4
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| |
|
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| EMC 313
|
| M. Parcha
|
| Vol #:
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| 4
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| |
|
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| EMC 314
|
| M. Sutherland
|
| Vol #:
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| 4
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| EMC 315
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| J. Stege
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| L. Pierucki
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| L. Rigby
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| M. Chilton
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| L. Schar
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| J. Brien
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| EMC 323
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| A. Engelbart
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| EMC 324
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| D. Ecoff
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| EMC 325
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| C. Hatok
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| EMC 326
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| L. Grey
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| EMC 327
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| W and Y Mechem
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| EMC 328
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| A. Maitha
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| EMC 329
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| M. Fleisher, MD
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| EMC 330
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| T. LeDoux
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| EMC 331
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| B. Clarke
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| EMC 332
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| J. Flynn
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| EMC 333
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| W. Wassell
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| EMC 334
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| O. Myhre
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| EMC 335
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| S. Miners
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| EMC 336
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| J. Herrick
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| EMC 337
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| R. Jones
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| EMC 338
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| J. Yunker
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| EMC 339
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| P. Kositzka
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| B. Jones
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| EMC 341
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| D. McDonald
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| EMC 342
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| R. Johnston
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| EMC 343
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| A. Breiner
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| EMC 344
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| A. Monterice
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| EMC 345
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| P. Fields
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| EMC 346
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| T. Hollon
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| EMC 347
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| H. Ramby
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| EMC 348
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| P. Higgins
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| EMC 349
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| L. Marchand
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| EMC 350
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| I. Fisher
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| EMC 351
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| M. Peterson
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| EMC 352
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| R. Mack
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| EMC 353
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| J. Bohannon
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| EMC 354
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| B. Milosavljevic
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| EMC 355
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| E. Mayer
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| EMC 356
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| B. Bartlett
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| EMC 357
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| H. Isely
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| EMC 358
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| P. Barry
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| EMC 359
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| R. white
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| EMC 360
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| B. Salsbury
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| 4
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| EMC 361
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| C. Fahrney
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| EMC 362
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| W. Pruess
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| EMC 363
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| M. Koepke
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| EMC 364
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| J. Wood
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| 4
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| EMC 365
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| B. Rahimzadeh
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| Vol #:
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| 4
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| EMC 366
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| C. Odorizzi
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| 4
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| EMC 367
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| N. Bariloni
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| 4
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| EMC 368
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| B. Kline
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| 4
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| EMC 369
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| J. Thornberry
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| 4
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| EMC 370
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| M. Flack
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| 4
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| EMC 371
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| D. Hackett
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| 4
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| EMC 372
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| J. Cavalli
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| 4
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| EMC 373
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| J. Olson
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| Vol #:
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| 4
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| EMC 374
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| J. Boyce
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| Vol #:
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| 4
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| EMC 375
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| H. Vedder
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| Vol #:
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| 4
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| EMC 376
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| D. Parker
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| Vol #:
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| 4
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| EMC 377
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| M.D. Jarrett
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| Vol #:
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| 4
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| EMC 378
|
| C. Graff
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| Vol #:
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| 4
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| EMC 379
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| A. Darman
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| Vol #:
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| 4
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| EMC 380
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| T. Atkins
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| Vol #:
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| 4
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| EMC 381
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| J. Luft
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| Vol #:
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| 4
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| EMC 382
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| D. Ammann
|
| Vol #:
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| 4
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| EMC 383
|
| B. Foley
|
| Vol #:
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| 4
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| EMC 384
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| J. Elder
|
| Vol #:
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| 4
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| EMC 385
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| K. Usher
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| Vol #:
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| 4
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| EMC 386
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| E. Barker
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| Vol #:
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| 4
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| EMC 387
|
| E. Angelo
|
| Vol #:
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| 4
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| EMC 388
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| M. Wysocki
|
| Vol #:
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| 4
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| |
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| EMC 389
|
| J. Floyd, Sr.
|
| Vol #:
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| 4
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| EMC 390
|
| C. Morris
|
| Vol #:
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| 4
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| EMC 391
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| V. Boyce
|
| Vol #:
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| 4
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| EMC 392
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| L. Sparks
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| Vol #:
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| 4
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| EMC 393
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| L. Sparks
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| Vol #:
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| 4
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| EMC 394
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| A. Frances
|
| Vol #:
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| 4
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| EMC 395
|
| W and K Cross
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| Vol #:
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| 4
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| EMC 396
|
| B. Gilpin
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| Vol #:
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| 4
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| EMC 397
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| K. Lee
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| Vol #:
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| 4
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| EMC 398
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| K. Weinschenk
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| Vol #:
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| 4
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| EMC 399
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| W. D. Smith
|
| Vol #:
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| 4
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| EMC 400
|
| D. Goodell
|
| Vol #:
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| 4
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| EMC 401
|
| D. Zaleski
|
| Vol #:
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| 8
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| |
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| EMC 402
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| J. Olsen
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| Vol #:
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| 8
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| EMC 403
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| M. Handler
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| Vol #:
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| 8
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| |
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| EMC 404
|
| B. Tarbell, OD, FAAO
|
| Vol #:
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| 8
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| EMC 405
|
| M. Land
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| Vol #:
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| 8
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| |
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| EMC 406
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| B. Halverson
|
| Vol #:
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| 6
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| EMC 407
|
| A. Schwartz
|
| Vol #:
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| 8
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| EMC 408
|
| S. Gerrard
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| Vol #:
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| 8
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| EMC 409
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| L. Burns
|
| Vol #:
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| 8
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| EMC 410
|
| G. Lugo
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| Vol #:
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| 8
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| EMC 411
|
| C. Duvall
|
| Vol #:
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| 8
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| EMC 412
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| P. Rousselot
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| Vol #:
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| 8
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| EMC 413
|
| K. Veen
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| Vol #:
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| 8
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| EMC 414
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| C. Hinshaw
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| Vol #:
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| 8
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| EMC 415
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| S. Gao
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| Vol #:
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| 8
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| EMC 416
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| R. Kiner
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| Vol #:
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| 8
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| EMC 417
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| J. Wang
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| Vol #:
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| 8
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| EMC 418
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| K. Cummings
|
| Vol #:
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| 8
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| EMC 419
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| W. Clark
|
| Vol #:
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| 8
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| EMC 420
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| M. Trepke
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| Vol #:
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| 8
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| EMC 421
|
| D. Story
|
| Vol #:
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| 8
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| EMC 422
|
| M. Russin
|
| Vol #:
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| 8
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| EMC 423
|
| C. Mangum
|
| Vol #:
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| 8
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| EMC 424
|
| K. Miles
|
| Vol #:
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| 8
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| EMC 425
|
| J and M Vaine
|
| Vol #:
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| 8
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| EMC 426
|
| D. Kennedy
|
| Vol #:
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| 8
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| EMC 427
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| M. Brownell
|
| Vol #:
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| 8
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| EMC 428
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| D. Sheldon
|
| Vol #:
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| 8
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| EMC 429
|
| A. Horn
|
| Vol #:
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| 8
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| EMC 430
|
| B. Patterson
|
| Vol #:
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| 8
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|
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| EMC 431
|
| M. Buckner
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| Vol #:
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| 8
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| EMC 432
|
| S. Powell
|
| Vol #:
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| 8
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| EMC 433
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| T. Selle
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| Vol #:
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| 8
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| |
|
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| EMC 434
|
| B. Newcomer
|
| Vol #:
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| 8
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| |
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| EMC 435
|
| C. Wood
|
| Vol #:
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| 8
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|
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| EMC 436
|
| P. Davey
|
| Vol #:
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| 8
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| EMC 437
|
| E. Granai
|
| Vol #:
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| 8
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| EMC 438
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| T. Green, L. Ac.
|
| Vol #:
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| 8
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| |
|
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| EMC 439
|
| N. Smith
|
| Vol #:
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| 8
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| |
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| EMC 440
|
| B and P Pelletier
|
| Vol #:
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| 8
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| |
|
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| EMC 441
|
| R. Pritchard
|
| Vol #:
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| 8
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| |
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| EMC 442
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| L. Cascio
|
| Vol #:
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| 8
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| |
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| EMC 443
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| L. Faggion
|
| Vol #:
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| 8
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| |
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| EMC 444
|
| R. Embler
|
| Vol #:
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| 8
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| |
|
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| EMC 445
|
| R. Puryear
|
| Vol #:
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| 8
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| |
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| EMC 446
|
| L. Musselman
|
| Vol #:
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| 8
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| |
|
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| EMC 447
|
| C. Stiles
|
| Vol #:
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| 8
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| |
|
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| EMC 448
|
| B. Hawes
|
| Vol #:
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| 8
|
| |
|
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| EMC 449
|
| T. Tibbals
|
| Vol #:
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| 8
|
| |
|
|
| EMC 450
|
| B. Sundholm
|
| Vol #:
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| 8
|
| |
|
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| EMC 451
|
| C. Durkin
|
| Vol #:
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| 8
|
| |
|
|
| EMC 452
|
| G. Shaffer
|
| Vol #:
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| 8
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| |
|
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| EMC 453
|
| L. Hanawalt
|
| Vol #:
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| 8
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| |
|
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| EMC 454
|
| F. Kimper
|
| Vol #:
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| 8
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| |
|
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| EMC 455
|
| A. Fonfa
|
| Vol #:
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| 8
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| |
|
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| EMC 456
|
| P. Murphy
|
| Vol #:
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| 8
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| |
|
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| EMC 457
|
| S. Snow
|
| Vol #:
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| 8
|
| |
|
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| EMC 458
|
| S. Polo
|
| Vol #:
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| 8
|
| |
|
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| EMC 459
|
| R. Choi
|
| Vol #:
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| 8
|
| |
|
|
| EMC 460
|
| E. Craig
|
| Vol #:
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| 8
|
| |
|
|
| 2004P-0015
|
| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
|
| |
|
|
| EMC 1
|
| Investor in Unigene, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0411
|
| Compel Enforcement and Regulation of Amyl Nitrate
|
| |
|
|
| CR
1
|
| Committee to Monitor Poppers
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 7
|
| Number Not Used
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0029
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| NH
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0044
|
| ANDA Suitability for Chlorozoxazone Tablets USP, 375 mg
|
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| NUMBER NOT USED
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0046
|
| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
|
| |
|
|
| CP
1
|
| Ranbaxy Laboratories Limited
|
| Vol #:
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| 1
|
|
|
