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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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|
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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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|
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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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|
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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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|
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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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|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EMC 14001
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| J. Poulson
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| Vol #:
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| 324
|
|
|
| EMC 14002
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| D. Kerr
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| Vol #:
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| 324
|
|
|
| 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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|
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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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|
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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
|
| Vol #:
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| 324
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|
|
| EMC 14011
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| P Horvath, MD
|
| 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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|
|
| EMC 14013
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| J. Klobutcher, MD
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| Vol #:
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| 324
|
|
|
| EMC 14014
|
| B. Welch, MD, FACOG
|
| Vol #:
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| 324
|
|
|
| EMC 14015
|
| K. Holloway, MD, FACOG
|
| Vol #:
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| 324
|
|
|
| EMC 14016
|
| S. Haack, MD, FACOG
|
| Vol #:
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| 324
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|
|
| EMC 14017
|
| R. Bremner, MD, FACOG
|
| Vol #:
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| 324
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|
|
| EMC 14018
|
| S. Roth, MD, FACOG
|
| Vol #:
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| 324
|
|
|
| EMC 14019
|
| R. Bremner, MD, FACOG
|
| Vol #:
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| 324
|
|
|
| EMC 14020
|
| J. Ray
|
| Vol #:
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| 324
|
|
|
| EMC 14021
|
| S. Mazenko
|
| Vol #:
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| 324
|
|
|
| EMC 14022
|
| S. Morgan
|
| Vol #:
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| 324
|
|
|
| EMC 14023
|
| J. Quinn
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| Vol #:
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| 324
|
|
|
| EMC 14024
|
| M. Voorhies
|
| Vol #:
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| 324
|
|
|
| EMC 14025
|
| S. Hager
|
| Vol #:
|
| 324
|
|
|
| EMC 14026
|
| B. Moore
|
| Vol #:
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| 324
|
|
|
| EMC 14027
|
| G. Walker
|
| Vol #:
|
| 324
|
|
|
| EMC 14028
|
| B. Christensen
|
| Vol #:
|
| 324
|
|
|
| EMC 14029
|
| M. Adams
|
| Vol #:
|
| 324
|
|
|
| EMC 14030
|
| M. Adams
|
| Vol #:
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| 324
|
|
|
| EMC 14031
|
| M. Semchenko
|
| Vol #:
|
| 324
|
|
|
| EMC 14032
|
| K. Revie
|
| Vol #:
|
| 324
|
|
|
| EMC 14033
|
| K. Frindik
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| Vol #:
|
| 324
|
|
|
| EMC 14034
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| K. Lavigne
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| Vol #:
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| 324
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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
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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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|
|
| 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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|
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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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|
| | | | | | | | |
|
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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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|
|
| 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
|
| Vol #:
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| 324
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|
|
| EMC 14057
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| T. Covert
|
| Vol #:
|
| 324
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|
|
| EMC 14058
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| E. Chapin
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| Vol #:
|
| 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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|
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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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|
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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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|
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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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|
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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
|
| R. Cantey
|
| Vol #:
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| 324
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|
|
| EMC 14067
|
| B. Chancellor
|
| Vol #:
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| 324
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|
|
| EMC 14068
|
| M. Nelson
|
| Vol #:
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| 324
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|
|
| EMC 14069
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| A. Froese
|
| Vol #:
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| 324
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|
|
| EMC 14070
|
| T. McCarthy
|
| Vol #:
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| 324
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|
|
| EMC
14071
|
| American Medical Association
|
| Vol #:
|
| 324
|
|
|
| EMC 14072
|
| K. Troyan
|
| Vol #:
|
| 324
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|
|
| EMC 14073
|
| A. Burnham
|
| Vol #:
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| 324
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|
|
| EMC 14074
|
| E. Cornwell
|
| Vol #:
|
| 324
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|
|
| EMC 14075
|
| E. Cornwell
|
| Vol #:
|
| 324
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|
|
| EMC 14076
|
| M. Olson
|
| Vol #:
|
| 324
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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 #:
|
| 7
|
|
|
| EMC
420
|
| Mission Possible International
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
|
| EMC
421
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
|
|
| EMC
422
|
| Mission Possible International
|
| Vol #:
|
| 7
|
|
|
| EMC
423
|
| Mission Possible International
|
| Vol #:
|
| 7
|
|
|
| EMC
424
|
| Mission Possible International
|
| Vol #:
|
| 7
|
|
|
| EMC
425
|
| IFHP Advanced Wellness Services, Inc.
|
| Vol #:
|
| 7
|
|
|
| 2003F-0088
|
| Increase the Maximum Permitted Energy Level of X-rays
|
|
|
| EMC 2
|
| Number Not Used
|
| Vol #:
|
| 2
|
|
|
| EMC 3
|
| R. Schneider
|
| Vol #:
|
| 2
|
|
|
| EMC 4
|
| H. Gilmore
|
| Vol #:
|
| 2
|
|
|
| EMC 5
|
| D. McNeill
|
| Vol #:
|
| 2
|
|
|
| EMC 6
|
| T. Ritz
|
| Vol #:
|
| 2
|
|
|
| EMC 7
|
| D. Puckett
|
| Vol #:
|
| 2
|
|
|
| EMC 8
|
| K. Perkins
|
| Vol #:
|
| 2
|
|
|
| EMC 9
|
| V. Cousins
|
| Vol #:
|
| 2
|
|
|
| EMC 10
|
| R. Berghofer
|
| Vol #:
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| 2
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|
|
| EMC 11
|
| C. Alvarez
|
| Vol #:
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| 2
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|
|
| EMC 12
|
| P M and I Vergun
|
| Vol #:
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| 2
|
|
|
| EMC 13
|
| No signature
|
| Vol #:
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| 2
|
|
|
| EMC 14
|
| W. McClatchey, Jr.
|
| Vol #:
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| 2
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|
|
| EMC 15
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| P and C Marciniak
|
| Vol #:
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| 2
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|
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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
|
| 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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|
|
| EMC 20
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| R. Lang
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| Vol #:
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| 2
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|
|
| EMC 21
|
| T. Turner
|
| Vol #:
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| 2
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|
|
| EMC 22
|
| 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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|
|
| EMC 24
|
| 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
|
| 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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|
|
| EMC 27
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| S. Saberon
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| Vol #:
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| 2
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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
|
| 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
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| W. Howald
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| Vol #:
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| 2
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|
|
| EMC 33
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| M. Feldman
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| Vol #:
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| 2
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|
|
| EMC 34
|
| R and E Fitch
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| Vol #:
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| 2
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|
|
| EMC 35
|
| D. Turnoy
|
| Vol #:
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| 2
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|
|
| EMC 36
|
| R. West
|
| Vol #:
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| 2
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|
|
| EMC 37
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| J. Berdis
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| Vol #:
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| 2
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|
|
| EMC 38
|
| S. Wilcox
|
| Vol #:
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| 2
|
|
|
| EMC 39
|
| B. Freeman
|
| Vol #:
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| 2
|
|
|
| EMC 40
|
| M. Horowitz
|
| Vol #:
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| 2
|
|
|
| EMC 41
|
| J. Logie
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| Vol #:
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| 2
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|
|
| EMC 42
|
| K. Penley
|
| Vol #:
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| 2
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|
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| EMC 43
|
| J. Edwards
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| Vol #:
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| 2
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|
|
| EMC 44
|
| B. Lutenegger
|
| Vol #:
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| 2
|
|
|
| EMC 45
|
| D. Wichar
|
| Vol #:
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| 2
|
|
|
| EMC 46
|
| M. Horowitz
|
| Vol #:
|
| 2
|
|
|
| EMC 47
|
| M. Rivera
|
| Vol #:
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| 2
|
|
|
| EMC 48
|
| B. Sutter
|
| Vol #:
|
| 2
|
|
|
| EMC 49
|
| R. Long
|
| Vol #:
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| 2
|
|
|
| EMC 50
|
| G. Rupert
|
| Vol #:
|
| 2
|
|
|
| EMC 51
|
| S. Argani, MD
|
| Vol #:
|
| 2
|
|
|
| EMC 52
|
| R. Camp
|
| Vol #:
|
| 2
|
|
|
| EMC 53
|
| D. Ortaman
|
| Vol #:
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| 2
|
|
|
| EMC 54
|
| P and R Ratte
|
| Vol #:
|
| 2
|
|
|
| EMC 55
|
| C. Kalinowski
|
| Vol #:
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| 2
|
|
|
| EMC 56
|
| K. Jackson
|
| Vol #:
|
| 2
|
|
|
| EMC 57
|
| M. Thompson
|
| Vol #:
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| 2
|
|
|
| EMC 58
|
| J. Schneider
|
| Vol #:
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| 2
|
|
|
| EMC 59
|
| M. Broussard
|
| Vol #:
|
| 2
|
|
|
| EMC 60
|
| C. Hoefnagels
|
| Vol #:
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| 2
|
|
|
| EMC 61
|
| C. Schuett
|
| Vol #:
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| 2
|
|
|
| EMC 62
|
| B. Toynes
|
| Vol #:
|
| 2
|
|
|
| EMC 63
|
| Dr. J. Roizin
|
| Vol #:
|
| 2
|
|
|
| EMC 64
|
| M. Hoodwin
|
| Vol #:
|
| 2
|
|
|
| EMC 65
|
| L. Morales
|
| Vol #:
|
| 2
|
|
|
| EMC 66
|
| W. Stroud
|
| Vol #:
|
| 2
|
|
|
| EMC 67
|
| D. Watson
|
| Vol #:
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| 2
|
|
|
| EMC 68
|
| R. Kaleopa
|
| Vol #:
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| 2
|
|
| | | | | | | |
|
|
| EMC 69
|
| R. Heymann
|
| Vol #:
|
| 2
|
|
|
| EMC 70
|
| B. Demar
|
| Vol #:
|
| 2
|
|
|
| EMC 71
|
| Michael J.
|
| Vol #:
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| 2
|
|
|
| EMC 72
|
| J. Byrne
|
| Vol #:
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| 2
|
|
|
| EMC 73
|
| T. Ritz
|
| Vol #:
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| 2
|
|
|
| EMC 74
|
| D. Hope
|
| Vol #:
|
| 2
|
|
|
| EMC 75
|
| A. Edwardson
|
| Vol #:
|
| 2
|
|
|
| EMC 76
|
| C. Kinnaird
|
| Vol #:
|
| 2
|
|
|
| EMC 77
|
| S. Tjessem
|
| Vol #:
|
| 2
|
|
|
| EMC 78
|
| K. Self
|
| Vol #:
|
| 2
|
|
|
| EMC 79
|
| F. Long
|
| Vol #:
|
| 2
|
|
|
| EMC 80
|
| C. LaFollette
|
| Vol #:
|
| 2
|
|
|
| EMC 81
|
| P. Willie
|
| Vol #:
|
| 2
|
|
|
| EMC 82
|
| J. Holt
|
| Vol #:
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| 2
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| EMC 83
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| F. Horton
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| 2
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| EMC 84
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| J. Berids
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| 2
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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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| 2
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| EMC 87
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| M. Lebert
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| 2
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| EMC 88
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| J. Weishaar
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| 2
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| EMC 89
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| J. Elzinga
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| 2
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| EMC 90
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| S. Biesek
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| 2
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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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|
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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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| 2
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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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| 2
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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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| 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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| 2
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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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|
|
| 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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| EMC 509
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| A. Kime
|
| Vol #:
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| 9
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|
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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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| 324
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| EMC 513
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| J. Hudson
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| 324
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| EMC 514
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| M. Ross
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| 324
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| EMC 515
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| P. Fleischman
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| 9
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| EMC 516
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| T. Adevai
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| 9
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| EMC 517
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| K. Koehler
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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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| 9
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| EMC 520
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| S. Friedland
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| 9
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| EMC 521
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| T. Wilson
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| 9
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| EMC 522
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| M. Grondiness
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| 9
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|
|
| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
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| EMC
42
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| IVAX Research, Inc.
|
| Vol #:
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| 6
|
|
|
| 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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| EMC 947
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| I Johnson
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| 14
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| EMC 948
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| E Coombs
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| 14
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| EMC 949
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| J Nolan
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| 14
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| EMC 950
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| M Stoffregen
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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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| 14
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| EMC 952
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| P Hadam
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| 14
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| EMC 953
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| K Power
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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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| 14
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|
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| EMC 957
|
| P Brichford
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| Vol #:
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| 14
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|
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| EMC 958
|
| K Beaulieu
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| Vol #:
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| 14
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|
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| EMC 959
|
| S Fletcher
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| Vol #:
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| 14
|
|
|
| EMC 960
|
| k kUUSINEN
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| Vol #:
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| 14
|
|
|
| EMC 961
|
| A Nisbet
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| Vol #:
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| 14
|
|
|
| EMC 962
|
| M Rajkowski
|
| Vol #:
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| 14
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|
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| EMC 963
|
| D Peterson
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| Vol #:
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| 14
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|
|
| EMC 964
|
| T Hotis
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| Vol #:
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| 14
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|
|
| EMC 965
|
| B Smidt
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| Vol #:
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| 14
|
|
|
| EMC 966
|
| G O'Shea
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| Vol #:
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| 14
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|
|
| EMC 967
|
| D Crake
|
| Vol #:
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| 14
|
|
|
| EMC 968
|
| L Steiner
|
| Vol #:
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| 14
|
|
|
| EMC 969
|
| G Balduf
|
| Vol #:
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| 14
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|
|
| EMC 970
|
| P Brown
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| Vol #:
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| 14
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|
|
| EMC 971
|
| R Savage
|
| Vol #:
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| 14
|
|
|
| EMC 972
|
| C Villandry
|
| Vol #:
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| 14
|
|
|
| EMC 973
|
| C Pettey
|
| Vol #:
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| 14
|
|
|
| EMC 974
|
| H Siegel
|
| Vol #:
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| 14
|
|
|
| EMC 975
|
| L Cooper
|
| Vol #:
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| 14
|
|
|
| EMC 976
|
| M Renner
|
| Vol #:
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| 14
|
|
|
| EMC 977
|
| H Alexander
|
| Vol #:
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| 14
|
|
|
| EMC 978
|
| J Burke
|
| Vol #:
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| 14
|
|
|
| EMC 979
|
| C Konzen
|
| Vol #:
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| 14
|
|
|
| EMC 980
|
| D Ingalsbe
|
| Vol #:
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| 14
|
|
|
| 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
|
|
|
| EMC
9
|
| Facility Automation Information Management (FAME) Systems
|
| Vol #:
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| 2
|
|
|
| EMC
10
|
| Facility Automation Information Management (FAME) Systems
|
| Vol #:
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| 2
|
|
| | | | | | | | |
|
|
| 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
|
|
|
| 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
|
|
|
| EMC 10
|
| R. Thurlow
|
| Vol #:
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| 2
|
|
|
| EMC 11
|
| C. Traylor
|
| Vol #:
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| 2
|
|
|
| 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
|
|
|
| EMC 259
|
| C. Edwards
|
| Vol #:
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| 4
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|
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| EMC 260
|
| C. Bowen
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| Vol #:
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| 4
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|
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| EMC 261
|
| M. Pall
|
| Vol #:
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| 4
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|
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| EMC 262
|
| C. Kitchen
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| 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
|
| T. Wojtowicz
|
| Vol #:
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| 4
|
|
|
| EMC 265
|
| M. Kaye
|
| Vol #:
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| 4
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|
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| EMC 266
|
| A. Hoffer
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| Vol #:
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| 4
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| EMC 267
|
| G. Cranston
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| Vol #:
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| 4
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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
|
| C. Lescs
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| Vol #:
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| 4
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|
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| EMC 274
|
| 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
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| Vol #:
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| 4
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| EMC 276
|
| M. Meeks
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| Vol #:
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| 4
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| EMC 277
|
| D. Snyder
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| Vol #:
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| 4
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| EMC 278
|
| W. Osborn
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| Vol #:
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| 4
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|
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| EMC 279
|
| R. Harris
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| Vol #:
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| 4
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| EMC 280
|
| 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
|
| Vol #:
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| 4
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|
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| EMC 283
|
| R. Ward
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| Vol #:
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| 4
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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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|
|
| EMC 287
|
| P. Christensen
|
| Vol #:
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| 4
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|
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| EMC 288
|
| L. Plumlee
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| 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
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| Vol #:
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| 4
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| EMC 291
|
| J. Lesperance
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| Vol #:
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| 4
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|
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| EMC 292
|
| K. Smoot
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| Vol #:
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| 4
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|
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| EMC 293
|
| M. Foster
|
| Vol #:
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| 4
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|
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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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|
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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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|
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| EMC 296
|
| G and K Baranek
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| Vol #:
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| 4
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|
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| EMC 297
|
| M. Marshall
|
| Vol #:
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| 4
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|
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| EMC 298
|
| M. Marshall
|
| Vol #:
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| 4
|
|
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| EMC 299
|
| P. Neary
|
| Vol #:
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| 4
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|
|
| EMC 300
|
| D. Chappell
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| 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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|
|
| EMC 302
|
| T. Kistler
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| Vol #:
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| 4
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|
|
| EMC 303
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| A. Deligant
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| Vol #:
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| 4
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|
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| EMC 304
|
| D. McBurnettt
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| 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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|
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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
|
| Vol #:
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| 4
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|
|
| EMC 308
|
| J. Tricomi
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| Vol #:
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| 4
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|
|
| EMC 309
|
| T. Conway
|
| Vol #:
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| 4
|
|
|
| EMC 310
|
| M. Ryan
|
| Vol #:
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| 4
|
|
|
| EMC 311
|
| K. Munson
|
| Vol #:
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| 4
|
|
|
| EMC 312
|
| T. Decker
|
| Vol #:
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| 4
|
|
|
| EMC 313
|
| M. Parcha
|
| Vol #:
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| 4
|
|
|
| EMC 314
|
| M. Sutherland
|
| Vol #:
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| 4
|
|
|
| EMC 315
|
| J. Brennan
|
| Vol #:
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| 4
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|
|
| EMC 316
|
| J. Kendrick
|
| Vol #:
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| 4
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|
|
| EMC 317
|
| J. Stege
|
| Vol #:
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| 4
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|
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| EMC 318
|
| L. Pierucki
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| Vol #:
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| 4
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|
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| EMC 319
|
| L. Rigby
|
| Vol #:
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| 4
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|
|
| EMC 320
|
| M. Chilton
|
| Vol #:
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| 4
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|
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| EMC 321
|
| L. Schar
|
| Vol #:
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| 4
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|
|
| EMC 322
|
| J. Brien
|
| Vol #:
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| 4
|
|
|
| EMC 323
|
| A. Engelbart
|
| Vol #:
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| 4
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|
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| EMC 324
|
| D. Ecoff
|
| Vol #:
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| 4
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|
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| EMC 325
|
| C. Hatok
|
| Vol #:
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| 4
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|
|
| EMC 326
|
| L. Grey
|
| Vol #:
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| 4
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|
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| EMC 327
|
| W and Y Mechem
|
| Vol #:
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| 4
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|
|
| EMC 328
|
| A. Maitha
|
| Vol #:
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| 4
|
|
|
| EMC 329
|
| M. Fleisher, MD
|
| Vol #:
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| 4
|
|
|
| EMC 330
|
| T. LeDoux
|
| Vol #:
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| 4
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|
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| EMC 331
|
| B. Clarke
|
| Vol #:
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| 4
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|
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| EMC 332
|
| J. Flynn
|
| Vol #:
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| 4
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|
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| EMC 333
|
| W. Wassell
|
| Vol #:
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| 4
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|
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| EMC 334
|
| O. Myhre
|
| Vol #:
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| 4
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|
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| EMC 335
|
| S. Miners
|
| Vol #:
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| 4
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|
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| EMC 336
|
| J. Herrick
|
| Vol #:
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| 4
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|
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| EMC 337
|
| R. Jones
|
| Vol #:
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| 4
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|
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| EMC 338
|
| J. Yunker
|
| Vol #:
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| 4
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|
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| EMC 339
|
| P. Kositzka
|
| Vol #:
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| 4
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|
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| EMC 340
|
| B. Jones
|
| Vol #:
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| 4
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|
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| EMC 341
|
| D. McDonald
|
| Vol #:
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| 4
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|
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| EMC 342
|
| R. Johnston
|
| Vol #:
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| 4
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|
|
| EMC 343
|
| A. Breiner
|
| Vol #:
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| 4
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|
|
| EMC 344
|
| A. Monterice
|
| Vol #:
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| 4
|
|
|
| EMC 345
|
| P. Fields
|
| Vol #:
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| 4
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|
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| EMC 346
|
| T. Hollon
|
| Vol #:
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| 4
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|
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| EMC 347
|
| H. Ramby
|
| Vol #:
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| 4
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|
|
| EMC 348
|
| P. Higgins
|
| Vol #:
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| 4
|
|
|
| EMC 349
|
| L. Marchand
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| Vol #:
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| 4
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| EMC 350
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| I. Fisher
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| Vol #:
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| 4
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| EMC 351
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| M. Peterson
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| 4
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| EMC 352
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| R. Mack
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| 4
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| EMC 353
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| J. Bohannon
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| 4
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| EMC 354
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| B. Milosavljevic
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| 4
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| EMC 355
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| E. Mayer
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| 4
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| | | | | | | |
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| EMC 356
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| B. Bartlett
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| 4
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| EMC 357
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| H. Isely
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| 4
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| EMC 358
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| P. Barry
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| 4
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| EMC 359
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| R. white
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| 4
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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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| Vol #:
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| 4
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| EMC 362
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| W. Pruess
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| Vol #:
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| 4
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| EMC 363
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| M. Koepke
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| Vol #:
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| 4
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| EMC 364
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| J. Wood
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| Vol #:
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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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|
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| EMC 366
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| C. Odorizzi
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| Vol #:
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| 4
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|
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| EMC 367
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| N. Bariloni
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| Vol #:
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| 4
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|
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| EMC 368
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| B. Kline
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| Vol #:
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| 4
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|
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| EMC 369
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| J. Thornberry
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| Vol #:
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| 4
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|
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| EMC 370
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| M. Flack
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| Vol #:
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| 4
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| EMC 371
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| D. Hackett
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| Vol #:
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| 4
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| EMC 372
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| J. Cavalli
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| Vol #:
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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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|
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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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|
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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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|
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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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|
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| EMC 378
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| C. Graff
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| Vol #:
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| 4
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|
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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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|
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| EMC 380
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| T. Atkins
|
| Vol #:
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| 4
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|
|
| EMC 381
|
| J. Luft
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| Vol #:
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| 4
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|
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| EMC 382
|
| D. Ammann
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| Vol #:
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| 4
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|
|
| EMC 383
|
| B. Foley
|
| Vol #:
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| 4
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|
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| EMC 384
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| J. Elder
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| Vol #:
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| 4
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|
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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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|
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| EMC 386
|
| E. Barker
|
| 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
|
| M. Wysocki
|
| Vol #:
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| 4
|
|
|
| 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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|
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| EMC 391
|
| V. Boyce
|
| Vol #:
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| 4
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|
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| EMC 392
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| L. Sparks
|
| Vol #:
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| 4
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|
| | | | | | | |
|
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| EMC 393
|
| L. Sparks
|
| Vol #:
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| 4
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|
|
| EMC 394
|
| A. Frances
|
| Vol #:
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| 4
|
|
|
| EMC 395
|
| W and K Cross
|
| Vol #:
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| 4
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|
|
| EMC 396
|
| B. Gilpin
|
| Vol #:
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| 4
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|
|
| EMC 397
|
| K. Lee
|
| Vol #:
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| 4
|
|
|
| EMC 398
|
| K. Weinschenk
|
| Vol #:
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| 4
|
|
|
| EMC 399
|
| W. D. Smith
|
| Vol #:
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| 4
|
|
|
| EMC 400
|
| D. Goodell
|
| Vol #:
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| 4
|
|
|
| EMC 401
|
| D. Zaleski
|
| Vol #:
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| 8
|
|
|
| EMC 402
|
| J. Olsen
|
| Vol #:
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| 8
|
|
|
| EMC 403
|
| M. Handler
|
| Vol #:
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| 8
|
|
|
| EMC 404
|
| B. Tarbell, OD, FAAO
|
| Vol #:
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| 8
|
|
|
| EMC 405
|
| M. Land
|
| Vol #:
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| 8
|
|
|
| EMC 406
|
| B. Halverson
|
| Vol #:
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| 6
|
|
|
| EMC 407
|
| A. Schwartz
|
| Vol #:
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| 8
|
|
|
| EMC 408
|
| S. Gerrard
|
| Vol #:
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| 8
|
|
|
| EMC 409
|
| L. Burns
|
| Vol #:
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| 8
|
|
|
| EMC 410
|
| G. Lugo
|
| Vol #:
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| 8
|
|
|
| EMC 411
|
| C. Duvall
|
| Vol #:
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| 8
|
|
|
| EMC 412
|
| P. Rousselot
|
| Vol #:
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| 8
|
|
|
| EMC 413
|
| K. Veen
|
| Vol #:
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| 8
|
|
|
| EMC 414
|
| C. Hinshaw
|
| Vol #:
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| 8
|
|
|
| EMC 415
|
| S. Gao
|
| Vol #:
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| 8
|
|
|
| EMC 416
|
| R. Kiner
|
| Vol #:
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| 8
|
|
|
| EMC 417
|
| J. Wang
|
| Vol #:
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| 8
|
|
|
| EMC 418
|
| K. Cummings
|
| Vol #:
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| 8
|
|
|
| EMC 419
|
| W. Clark
|
| Vol #:
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| 8
|
|
|
| EMC 420
|
| M. Trepke
|
| Vol #:
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| 8
|
|
|
| EMC 421
|
| D. Story
|
| Vol #:
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| 8
|
|
|
| EMC 422
|
| M. Russin
|
| Vol #:
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| 8
|
|
|
| EMC 423
|
| C. Mangum
|
| Vol #:
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| 8
|
|
|
| EMC 424
|
| K. Miles
|
| Vol #:
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| 8
|
|
|
| EMC 425
|
| J and M Vaine
|
| Vol #:
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| 8
|
|
|
| EMC 426
|
| D. Kennedy
|
| Vol #:
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| 8
|
|
|
| EMC 427
|
| M. Brownell
|
| Vol #:
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| 8
|
|
|
| EMC 428
|
| D. Sheldon
|
| Vol #:
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| 8
|
|
|
| EMC 429
|
| A. Horn
|
| Vol #:
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| 8
|
|
| | | | | | | | |
|
|
| EMC 430
|
| B. Patterson
|
| Vol #:
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| 8
|
|
|
| EMC 431
|
| M. Buckner
|
| Vol #:
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| 8
|
|
|
| EMC 432
|
| S. Powell
|
| Vol #:
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| 8
|
|
|
| EMC 433
|
| T. Selle
|
| Vol #:
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| 8
|
|
|
| EMC 434
|
| B. Newcomer
|
| Vol #:
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| 8
|
|
|
| EMC 435
|
| C. Wood
|
| Vol #:
|
| 8
|
|
|
| EMC 436
|
| P. Davey
|
| Vol #:
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| 8
|
|
|
| EMC 437
|
| E. Granai
|
| Vol #:
|
| 8
|
|
|
| EMC 438
|
| T. Green, L. Ac.
|
| Vol #:
|
| 8
|
|
|
| EMC 439
|
| N. Smith
|
| Vol #:
|
| 8
|
|
|
| EMC 440
|
| B and P Pelletier
|
| Vol #:
|
| 8
|
|
|
| EMC 441
|
| R. Pritchard
|
| Vol #:
|
| 8
|
|
|
| EMC 442
|
| L. Cascio
|
| Vol #:
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| 8
|
|
|
| EMC 443
|
| L. Faggion
|
| Vol #:
|
| 8
|
|
|
| EMC 444
|
| R. Embler
|
| Vol #:
|
| 8
|
|
|
| EMC 445
|
| R. Puryear
|
| Vol #:
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| 8
|
|
|
| EMC 446
|
| L. Musselman
|
| Vol #:
|
| 8
|
|
|
| EMC 447
|
| C. Stiles
|
| Vol #:
|
| 8
|
|
|
| EMC 448
|
| B. Hawes
|
| Vol #:
|
| 8
|
|
|
| EMC 449
|
| T. Tibbals
|
| Vol #:
|
| 8
|
|
|
| EMC 450
|
| B. Sundholm
|
| Vol #:
|
| 8
|
|
|
| EMC 451
|
| C. Durkin
|
| Vol #:
|
| 8
|
|
|
| EMC 452
|
| G. Shaffer
|
| Vol #:
|
| 8
|
|
|
| EMC 453
|
| L. Hanawalt
|
| Vol #:
|
| 8
|
|
|
| EMC 454
|
| F. Kimper
|
| Vol #:
|
| 8
|
|
|
| EMC 455
|
| A. Fonfa
|
| Vol #:
|
| 8
|
|
|
| EMC 456
|
| P. Murphy
|
| Vol #:
|
| 8
|
|
|
| EMC 457
|
| S. Snow
|
| Vol #:
|
| 8
|
|
|
| EMC 458
|
| S. Polo
|
| Vol #:
|
| 8
|
|
|
| EMC 459
|
| R. Choi
|
| Vol #:
|
| 8
|
|
|
| EMC 460
|
| E. Craig
|
| Vol #:
|
| 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 #:
|
| 1
|
|
|