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| Dockets Entered
On July 27, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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|
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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|
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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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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| 2002E-0099
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| Patent Term Extension Application for XIGRIS No. 4,775,624
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| 2002E-0184
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| Patent Extension Application for XIGRIS, No. 5,681,932
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| 2002E-0342
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| Lea's Shield, U.S. Patent No. 4,703,752
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003E-0255
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| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004N-0114
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004N-0258
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| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0296
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14102
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| Northwest Natural Products, Inc.
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| Vol #:
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| 122
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| LET
14103
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| Northwest Natural Products, Inc.
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| Vol #:
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| 122
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| LET
14104
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| Arkopharma LLC
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| Vol #:
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| 122
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| LET
14105
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| Arkopharma LLC
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| Vol #:
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| 122
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| LET
14106
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| Arkopharma LLC
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| Vol #:
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| 122
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| LET
14107
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| Planetary Formulas
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| Vol #:
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| 122
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| LET
14108
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| Basic Organics, Inc.
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| Vol #:
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| 122
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| LET
14109
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| Bodyhealth.com Corporation
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| Vol #:
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| 122
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| LET
14110
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| The Hain Celestial Group
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| Vol #:
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| 122
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| C
102
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| Public Citizen
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| Vol #:
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| 8
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| | | | | | | | |
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| C 36
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| G. Mayer
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| Vol #:
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| 2
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| C 37
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| Eligible
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| Vol #:
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| 2
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| C 38
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| L. Lessa
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| Vol #:
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| 2
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| C 39
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| D. Finger
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| Vol #:
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| 2
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| C 40
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| Eligible
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| Vol #:
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| 2
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|
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| EC 2
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| Mr. will foster
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| Vol #:
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| 2
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|
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| C
265
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| Gold Kist, Inc.
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| Vol #:
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| 99
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| EXB 338
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 339
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 340
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 341
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 342
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 343
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 344
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 345
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 346
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 347
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 348
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 349
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 350
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 351
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 352
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 353
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 354
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 355
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 356
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 357
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 358
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 359
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 360
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
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| EXB 361
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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| EXB 362
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| Center for Veterinary Medicine
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| Vol #:
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| 423
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|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
| | | | | | | |
|
|
| EC 811
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| N/A
|
| Vol #:
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| 163
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|
|
| EMC 8654
|
| H. Drossos
|
| Vol #:
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| 283
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|
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| EMC 8655
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| P. Prager
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| Vol #:
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| 283
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|
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| EMC 8656
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| S. Drager
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| Vol #:
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| 283
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|
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| EMC 8657
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| M. Countey
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| Vol #:
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| 283
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|
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| EMC 8658
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| A. Wilson
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| Vol #:
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| 283
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|
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| EMC 8659
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| K. Salmon
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| Vol #:
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| 283
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|
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| EMC 8660
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| M. Schell
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| Vol #:
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| 283
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|
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| EMC 8661
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| E. Pannell
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| Vol #:
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| 283
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|
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| EMC 8662
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| R. Barba
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| Vol #:
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| 283
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|
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| EMC 8663
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| K.T. Prager
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| Vol #:
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| 283
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|
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| EMC 8664
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| T. McClean
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| Vol #:
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| 283
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|
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| EMC 8665
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| D. Baik
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| Vol #:
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| 283
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|
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| EMC 8666
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| J. Pannell
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| Vol #:
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| 283
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|
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| EMC 8667
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| B. McBride
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| Vol #:
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| 283
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|
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| EMC 8668
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| L. Curran
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| Vol #:
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| 283
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|
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| EMC 8669
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| E. Meany
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| Vol #:
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| 283
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|
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| EMC 8670
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| M. Joyner
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| Vol #:
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| 283
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|
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| EMC 8671
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| J. Franken
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| Vol #:
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| 283
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|
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| EMC 8672
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| C. Gabbay
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| Vol #:
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| 283
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|
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| EMC 8673
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| S. Eygendaal
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| Vol #:
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| 283
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|
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| EMC 8674
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| J. Winship
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| Vol #:
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| 283
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|
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| EMC 8675
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| C. Tunkel
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| Vol #:
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| 283
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|
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| EMC 8676
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| K. Spielberger
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| Vol #:
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| 283
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|
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| EMC 8677
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| B. Sorensen
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| Vol #:
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| 283
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|
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| EMC 8678
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| M. Simpson
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| Vol #:
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| 283
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|
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| EMC 8679
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| K.M. Warner
|
| Vol #:
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| 283
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|
|
| EMC 8680
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| W. E. Wallace
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| Vol #:
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| 283
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|
|
| EMC 8681
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| C. Scrafford
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| Vol #:
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| 283
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|
|
| EMC 8682
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| K. Noonan
|
| Vol #:
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| 283
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|
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| EMC 8683
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| M. Marucci
|
| Vol #:
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| 283
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|
|
| EMC 8684
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| K. Stachnik
|
| Vol #:
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| 283
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|
|
| EMC 8685
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| S. Trotman
|
| Vol #:
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| 283
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|
|
| EMC 8686
|
| T. Jodon
|
| Vol #:
|
| 283
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|
|
| EMC 8687
|
| E. Jodon
|
| Vol #:
|
| 283
|
|
|
| EMC 8688
|
| S. Parker
|
| Vol #:
|
| 283
|
|
|
| EMC 8689
|
| C. P.R.
|
| Vol #:
|
| 283
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|
| | | | | | | |
|
|
| EMC 8690
|
| M. Batz
|
| Vol #:
|
| 283
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|
|
| EMC 8691
|
| M. Roepe
|
| Vol #:
|
| 283
|
|
|
| EMC 8692
|
| A. Rissmiller
|
| Vol #:
|
| 283
|
|
|
| EMC 8693
|
| D. Camera
|
| Vol #:
|
| 283
|
|
|
| EMC 8694
|
| R. Scrafford
|
| Vol #:
|
| 283
|
|
|
| EMC 8695
|
| A. Rissmiller
|
| Vol #:
|
| 283
|
|
|
| EMC 8696
|
| L. Thompson
|
| Vol #:
|
| 283
|
|
|
| EMC 8697
|
| D. A. Stewart
|
| Vol #:
|
| 283
|
|
|
| EMC 8698
|
| D. Bennett
|
| Vol #:
|
| 283
|
|
|
| EMC 8699
|
| K. Keeling
|
| Vol #:
|
| 283
|
|
|
| EMC 8700
|
| G. Gomez
|
| Vol #:
|
| 283
|
|
|
| EMC 8701
|
| J. Swanson
|
| Vol #:
|
| 283
|
|
|
| EMC 8702
|
| E. Buckwalter
|
| Vol #:
|
| 283
|
|
|
| EMC 8703
|
| M. Leavell
|
| Vol #:
|
| 283
|
|
|
| EMC 8704
|
| W. Crispell
|
| Vol #:
|
| 283
|
|
|
| EMC 8705
|
| B. Rogers
|
| Vol #:
|
| 283
|
|
|
| EMC 8706
|
| S. Boone
|
| Vol #:
|
| 283
|
|
|
| EMC 8707
|
| P. Williams Rodoski
|
| Vol #:
|
| 283
|
|
|
| EMC 8708
|
| C. Absher
|
| Vol #:
|
| 283
|
|
|
| EMC 8709
|
| J. Peguero II
|
| Vol #:
|
| 283
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|
|
| EMC 8710
|
| J. Solis
|
| Vol #:
|
| 283
|
|
|
| EMC 8711
|
| P. Wollum
|
| Vol #:
|
| 283
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|
|
| EMC 8712
|
| A. Hall
|
| Vol #:
|
| 283
|
|
|
| EMC 8713
|
| P. Capocchi
|
| Vol #:
|
| 283
|
|
|
| EMC 8714
|
| S. Haugh
|
| Vol #:
|
| 283
|
|
|
| EMC 8715
|
| R. Angevine
|
| Vol #:
|
| 283
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|
|
| EMC 8716
|
| S. Jodon
|
| Vol #:
|
| 283
|
|
|
| EMC 8717
|
| D. Kosup-Kennedy
|
| Vol #:
|
| 283
|
|
|
| EMC 8718
|
| E. Lyles
|
| Vol #:
|
| 283
|
|
|
| EMC 8719
|
| M. Kelson-Podolsky
|
| Vol #:
|
| 283
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|
|
| EMC 8720
|
| P. Podolsky
|
| Vol #:
|
| 283
|
|
|
| EMC 8721
|
| J. Gialelis
|
| Vol #:
|
| 283
|
|
|
| EMC 8722
|
| T. Duffy Jr.
|
| Vol #:
|
| 283
|
|
|
| EMC 8723
|
| S. McKinley
|
| Vol #:
|
| 284
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|
|
| EMC 8724
|
| M. J. Best
|
| Vol #:
|
| 284
|
|
|
| EMC 8725
|
| S. McClain
|
| Vol #:
|
| 284
|
|
|
| EMC 8726
|
| B. K. Kravec
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8727
|
| R. J. Butler
|
| Vol #:
|
| 284
|
|
|
| EMC 8728
|
| L. Koen
|
| Vol #:
|
| 284
|
|
|
| EMC 8729
|
| P. Driscoll
|
| Vol #:
|
| 284
|
|
|
| EMC 8730
|
| S. G. Jones
|
| Vol #:
|
| 284
|
|
|
| EMC 8731
|
| K. O'Regan
|
| Vol #:
|
| 284
|
|
|
| EMC 8732
|
| N. James
|
| Vol #:
|
| 284
|
|
|
| EMC 8733
|
| J. Parker
|
| Vol #:
|
| 284
|
|
|
| EMC 8734
|
| J. W. Mack
|
| Vol #:
|
| 284
|
|
|
| EMC 8735
|
| D. Bare
|
| Vol #:
|
| 284
|
|
|
| EMC 8736
|
| C. Richardson
|
| Vol #:
|
| 284
|
|
|
| EMC 8737
|
| J. O'Connor
|
| Vol #:
|
| 284
|
|
|
| EMC 8738
|
| P. Mazzantiq
|
| Vol #:
|
| 284
|
|
|
| EMC 8739
|
| None
|
| Vol #:
|
| 284
|
|
|
| EMC 8740
|
| M. Czinski
|
| Vol #:
|
| 284
|
|
|
| EMC 8741
|
| K. M. Biener
|
| Vol #:
|
| 284
|
|
|
| EMC 8742
|
| M. V. Pereira
|
| Vol #:
|
| 284
|
|
|
| EMC 8743
|
| G. Floyd
|
| Vol #:
|
| 284
|
|
|
| EMC 8744
|
| S. Gordon
|
| Vol #:
|
| 284
|
|
|
| EMC 8745
|
| N. Palmatier
|
| Vol #:
|
| 284
|
|
|
| EMC 8746
|
| C. Dazey
|
| Vol #:
|
| 284
|
|
|
| EMC 8747
|
| K. Fix
|
| Vol #:
|
| 284
|
|
|
| EMC 8748
|
| E. Cardinal Hand
|
| Vol #:
|
| 284
|
|
|
| EMC 8749
|
| A. Sherwood
|
| Vol #:
|
| 284
|
|
|
| EMC 8750
|
| L. Fineson
|
| Vol #:
|
| 284
|
|
|
| EMC 8751
|
| L. Garren
|
| Vol #:
|
| 284
|
|
|
| EMC 8752
|
| P. Childs
|
| Vol #:
|
| 284
|
|
|
| EMC 8753
|
| E. S. Brody
|
| Vol #:
|
| 284
|
|
|
| EMC 8754
|
| E. Connor
|
| Vol #:
|
| 284
|
|
|
| EMC 8755
|
| M. Brechwald
|
| Vol #:
|
| 284
|
|
|
| EMC 8756
|
| A. Denholtz
|
| Vol #:
|
| 284
|
|
|
| EMC 8757
|
| B. Wicklund
|
| Vol #:
|
| 284
|
|
|
| EMC 8758
|
| M. Hayne
|
| Vol #:
|
| 284
|
|
|
| EMC 8759
|
| J. Purdue
|
| Vol #:
|
| 284
|
|
|
| EMC 8760
|
| S. Gourley
|
| Vol #:
|
| 284
|
|
|
| EMC 8761
|
| D. G. Mitchell
|
| Vol #:
|
| 284
|
|
|
| EMC 8762
|
| B. Muehlhausen
|
| Vol #:
|
| 284
|
|
|
| EMC 8763
|
| S. D. Noack
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8764
|
| J. Inwood
|
| Vol #:
|
| 284
|
|
|
| EMC 8765
|
| M. Munday
|
| Vol #:
|
| 284
|
|
|
| EMC 8766
|
| M. Mauro
|
| Vol #:
|
| 284
|
|
|
| EMC 8767
|
| R. S. Allison
|
| Vol #:
|
| 284
|
|
|
| EMC 8768
|
| J. F. Adams
|
| Vol #:
|
| 284
|
|
|
| EMC 8769
|
| L. Friedkin
|
| Vol #:
|
| 284
|
|
|
| EMC 8770
|
| J. E. Marks
|
| Vol #:
|
| 284
|
|
|
| EMC 8771
|
| E. Falk
|
| Vol #:
|
| 284
|
|
|
| EMC 8772
|
| D. L. Masters
|
| Vol #:
|
| 284
|
|
|
| EMC 8773
|
| M. E. Buszek
|
| Vol #:
|
| 284
|
|
|
| EMC 8774
|
| F. Jones
|
| Vol #:
|
| 284
|
|
|
| EMC 8775
|
| S. Lewis
|
| Vol #:
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| 284
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| EMC 8776
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| E. A. Hammad
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| Vol #:
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| 284
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|
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| EMC 8777
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| J. Aten
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| Vol #:
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| 284
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| EMC 8778
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| A. s. Abernethy
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| Vol #:
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| 284
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| EMC 8779
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| A. Benefico
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| Vol #:
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| 284
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|
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| EMC 8780
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| J. T. Gordon
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| Vol #:
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| 284
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| EMC 8781
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| B. Van Davis
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| Vol #:
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| 284
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| EMC 8782
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| J. Van Davis
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| Vol #:
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| 284
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| EMC 8783
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| R. Stull
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| Vol #:
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| 284
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| EMC 8784
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| E. Wickstrom
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| Vol #:
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| 284
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| EMC 8785
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| K. L. McKenna
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| Vol #:
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| 284
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|
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| EMC 8786
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| K. Cafasso
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| Vol #:
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| 284
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|
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| EMC 8787
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| N. Anderson
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| Vol #:
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| 284
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|
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| EMC 8788
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| M. M. Drake
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| Vol #:
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| 284
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|
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| EMC 8789
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| N. Friauf
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| Vol #:
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| 284
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|
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| EMC 8790
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| B. Rauch
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| Vol #:
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| 284
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|
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| EMC 8791
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| D. Federici
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| Vol #:
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| 284
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|
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| EMC 8792
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| K. Gedge
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| Vol #:
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| 284
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| EMC 8793
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| B. Plummer
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| Vol #:
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| 284
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|
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| EMC 8794
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| E. Rothstein
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| Vol #:
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| 284
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|
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| EMC 8795
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| T. Masters
|
| Vol #:
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| 284
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| EMC 8796
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| E. Fulton
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| Vol #:
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| 284
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|
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| EMC 8797
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| R. Lavash
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| Vol #:
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| 284
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|
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| EMC 8798
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| S. DeSimone
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| Vol #:
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| 284
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|
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| EMC 8799
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| T. L. Felice
|
| Vol #:
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| 284
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|
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| EMC 8800
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| A. Roberts
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| Vol #:
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| 284
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| | | | | | | |
|
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| EMC 8801
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| K. Petronko
|
| Vol #:
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| 284
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|
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| EMC 8802
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| I. Griffiths
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| Vol #:
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| 284
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|
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| EMC 8803
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| D. Wilson
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| Vol #:
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| 284
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|
|
| EMC 8804
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| J. Hamilton
|
| Vol #:
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| 284
|
|
|
| EMC 8805
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| S. Dolen
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| Vol #:
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| 284
|
|
|
| EMC 8806
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| D. Binder
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| Vol #:
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| 284
|
|
|
| EMC 8807
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| M. C. Ludwig-Crangle
|
| Vol #:
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| 284
|
|
|
| EMC 8808
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| S. M. Borches
|
| Vol #:
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| 284
|
|
|
| EMC 8809
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| W. Rothkopf
|
| Vol #:
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| 284
|
|
|
| EMC 8810
|
| J. E. Allen
|
| Vol #:
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| 284
|
|
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| EMC 8811
|
| S. E. Morton
|
| Vol #:
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| 284
|
|
|
| EMC 8812
|
| K. O'Malley
|
| Vol #:
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| 284
|
|
|
| EMC 8813
|
| J. Bettinger
|
| Vol #:
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| 284
|
|
|
| EMC 8814
|
| M. Bettencourt
|
| Vol #:
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| 284
|
|
|
| EMC 8815
|
| A. Siracusa
|
| Vol #:
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| 284
|
|
|
| EMC 8816
|
| P. Galvin
|
| Vol #:
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| 284
|
|
|
| EMC 8817
|
| V. Burrows
|
| Vol #:
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| 284
|
|
|
| EMC 8818
|
| D. A. Fair
|
| Vol #:
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| 284
|
|
|
| EMC 8819
|
| B. Rosenthal
|
| Vol #:
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| 284
|
|
|
| EMC 8820
|
| K. Manta
|
| Vol #:
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| 284
|
|
|
| EMC 8821
|
| B. Bob
|
| Vol #:
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| 284
|
|
|
| EMC 8822
|
| A. Grover
|
| Vol #:
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| 284
|
|
|
| EMC 8823
|
| C. Fahey-Hunt
|
| Vol #:
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| 284
|
|
|
| EMC 8824
|
| L. G. Homeyer
|
| Vol #:
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| 284
|
|
|
| EMC 8825
|
| K. Beal
|
| Vol #:
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| 284
|
|
|
| EMC 8826
|
| C. Maness
|
| Vol #:
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| 284
|
|
|
| EMC 8827
|
| J. Ressinger
|
| Vol #:
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| 284
|
|
|
| EMC 8828
|
| B. Bassett
|
| Vol #:
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| 284
|
|
|
| EMC 8829
|
| S. Nicholas
|
| Vol #:
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| 284
|
|
|
| EMC 8830
|
| S. Hilt
|
| Vol #:
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| 284
|
|
|
| EMC 8831
|
| G. Maloney Lawrence
|
| Vol #:
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| 284
|
|
|
| EMC 8832
|
| R. Banov
|
| Vol #:
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| 284
|
|
|
| EMC 8833
|
| G. Longo
|
| Vol #:
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| 284
|
|
|
| EMC 8834
|
| P. W. Crandall
|
| Vol #:
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| 284
|
|
|
| EMC 8835
|
| B. W. Mosshart
|
| Vol #:
|
| 284
|
|
|
| EMC 8836
|
| D. K. Eckhardt
|
| Vol #:
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| 284
|
|
|
| EMC 8837
|
| D. Martin
|
| Vol #:
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| 284
|
|
| | | | | | | |
|
|
| EMC 8838
|
| C. Roach
|
| Vol #:
|
| 284
|
|
|
| EMC 8839
|
| A. Rooney
|
| Vol #:
|
| 284
|
|
|
| EMC 8840
|
| B. Natamoros
|
| Vol #:
|
| 284
|
|
|
| EMC 8841
|
| I. Garin
|
| Vol #:
|
| 284
|
|
|
| EMC 8842
|
| S. Oakley
|
| Vol #:
|
| 284
|
|
|
| EMC 8843
|
| J. Marshall
|
| Vol #:
|
| 284
|
|
|
| EMC 8844
|
| E. Barger
|
| Vol #:
|
| 284
|
|
|
| EMC 8845
|
| B. Clague
|
| Vol #:
|
| 284
|
|
|
| EMC 8846
|
| B. Schwenkmeyer
|
| Vol #:
|
| 284
|
|
|
| EMC 8847
|
| H. & E. Haight
|
| Vol #:
|
| 284
|
|
|
| EMC 8848
|
| J. R. Butcher
|
| Vol #:
|
| 284
|
|
|
| EMC 8849
|
| K. Luke
|
| Vol #:
|
| 284
|
|
|
| EMC 8850
|
| L. Imhoff
|
| Vol #:
|
| 284
|
|
|
| EMC 8851
|
| S. Bender
|
| Vol #:
|
| 284
|
|
|
| EMC 8852
|
| C. Tilton-Jones
|
| Vol #:
|
| 284
|
|
|
| EMC 8853
|
| J. Hinze
|
| Vol #:
|
| 284
|
|
|
| EMC 8854
|
| P. E. Pierson
|
| Vol #:
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| 284
|
|
|
| EMC 8855
|
| K. Bambrick
|
| Vol #:
|
| 284
|
|
|
| EMC 8856
|
| J. Barnard & M. Fain
|
| Vol #:
|
| 284
|
|
|
| EMC 8857
|
| P. J. Gogol
|
| Vol #:
|
| 284
|
|
|
| EMC 8858
|
| M. Thompson
|
| Vol #:
|
| 284
|
|
|
| EMC 8859
|
| B. Harley
|
| Vol #:
|
| 284
|
|
|
| EMC 8860
|
| R. Murphy
|
| Vol #:
|
| 284
|
|
|
| EMC 8861
|
| J. Altman
|
| Vol #:
|
| 284
|
|
|
| EMC 8862
|
| A. LaMonica
|
| Vol #:
|
| 284
|
|
|
| EMC 8863
|
| N. L. DeBlosi
|
| Vol #:
|
| 284
|
|
|
| EMC 8864
|
| T. Welser
|
| Vol #:
|
| 284
|
|
|
| EMC 8865
|
| N. Kahan
|
| Vol #:
|
| 284
|
|
|
| EMC 8866
|
| C. A. Loscalzo
|
| Vol #:
|
| 284
|
|
|
| EMC 8867
|
| M. Sturza
|
| Vol #:
|
| 284
|
|
|
| EMC 8868
|
| E. Best
|
| Vol #:
|
| 284
|
|
|
| EMC 8869
|
| C. A. Hill-Gant
|
| Vol #:
|
| 284
|
|
|
| EMC 8870
|
| M. MacCrae
|
| Vol #:
|
| 284
|
|
|
| EMC 8871
|
| E. Renner
|
| Vol #:
|
| 284
|
|
|
| EMC 8872
|
| J. Edwardson
|
| Vol #:
|
| 284
|
|
|
| EMC 8873
|
| T. R. Nichols
|
| Vol #:
|
| 284
|
|
|
| EMC 8874
|
| M. Hoffnung
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8875
|
| J. Corbin Smith
|
| Vol #:
|
| 284
|
|
|
| EMC 8876
|
| P. N. Fonts
|
| Vol #:
|
| 284
|
|
|
| EMC 8877
|
| C. J. Adams
|
| Vol #:
|
| 284
|
|
|
| EMC 8878
|
| H. Wade Goolishian
|
| Vol #:
|
| 284
|
|
|
| EMC 8879
|
| C. Kuehl
|
| Vol #:
|
| 284
|
|
|
| EMC 8880
|
| J. Seibel
|
| Vol #:
|
| 284
|
|
|
| EMC 8881
|
| E. Pitt
|
| Vol #:
|
| 284
|
|
|
| EMC 8882
|
| K. Lee
|
| Vol #:
|
| 284
|
|
|
| EMC 8883
|
| S. M. Johnson
|
| Vol #:
|
| 284
|
|
|
| EMC 8884
|
| M. Ramjoue
|
| Vol #:
|
| 284
|
|
|
| EMC 8885
|
| K. Keifer-Boyd
|
| Vol #:
|
| 284
|
|
|
| EMC 8886
|
| K. M. Khan
|
| Vol #:
|
| 284
|
|
|
| EMC 8887
|
| M. G. Hoglund
|
| Vol #:
|
| 284
|
|
|
| EMC 8888
|
| C. Furey
|
| Vol #:
|
| 284
|
|
|
| EMC 8889
|
| S. Mozer
|
| Vol #:
|
| 284
|
|
|
| EMC 8890
|
| K. Harper Berkson
|
| Vol #:
|
| 284
|
|
|
| EMC 8891
|
| J. Holden
|
| Vol #:
|
| 284
|
|
|
| EMC 8892
|
| H. Silvert Newell
|
| Vol #:
|
| 284
|
|
|
| EMC 8893
|
| A. Young
|
| Vol #:
|
| 284
|
|
|
| EMC 8894
|
| B. Brownlee
|
| Vol #:
|
| 284
|
|
|
| EMC 8895
|
| J. Christensen
|
| Vol #:
|
| 284
|
|
|
| EMC 8896
|
| A. Jaffe
|
| Vol #:
|
| 284
|
|
|
| EMC 8897
|
| K. W. Ames
|
| Vol #:
|
| 284
|
|
|
| EMC 8898
|
| L. Wilburn
|
| Vol #:
|
| 284
|
|
|
| EMC 8899
|
| T. Gheen
|
| Vol #:
|
| 284
|
|
|
| EMC 8900
|
| A. Gollakner
|
| Vol #:
|
| 284
|
|
|
| EMC 8901
|
| H. Antoine
|
| Vol #:
|
| 284
|
|
|
| EMC 8902
|
| N. Parsons Craft
|
| Vol #:
|
| 284
|
|
|
| EMC 8903
|
| D. Devonis
|
| Vol #:
|
| 284
|
|
|
| EMC 8904
|
| B. Burns
|
| Vol #:
|
| 284
|
|
|
| EMC 8905
|
| R. O'Meara-Costello
|
| Vol #:
|
| 284
|
|
|
| EMC 8906
|
| C. M. Nichols
|
| Vol #:
|
| 284
|
|
|
| EMC 8907
|
| C. M. Nichols
|
| Vol #:
|
| 284
|
|
|
| EMC 8908
|
| L. Berger
|
| Vol #:
|
| 284
|
|
|
| EMC 8909
|
| K. Carnabucci
|
| Vol #:
|
| 284
|
|
|
| EMC 8910
|
| M. Pelletier
|
| Vol #:
|
| 284
|
|
|
| EMC 8911
|
| N. Chapman
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8912
|
| M. Shattuck
|
| Vol #:
|
| 284
|
|
|
| EMC 8913
|
| J. Ball
|
| Vol #:
|
| 284
|
|
|
| EMC 8914
|
| M. Roepe
|
| Vol #:
|
| 284
|
|
|
| EMC 8915
|
| E. Schneider
|
| Vol #:
|
| 284
|
|
|
| EMC 8916
|
| J. Watts Haresch
|
| Vol #:
|
| 284
|
|
|
| EMC 8917
|
| R. Rothman
|
| Vol #:
|
| 284
|
|
|
| EMC 8918
|
| L. H. Toole
|
| Vol #:
|
| 284
|
|
|
| EMC 8919
|
| A. Corrigan
|
| Vol #:
|
| 284
|
|
|
| EMC 8920
|
| K. A. Cowles
|
| Vol #:
|
| 284
|
|
|
| EMC 8921
|
| A. Terra
|
| Vol #:
|
| 284
|
|
|
| EMC 8922
|
| N. James
|
| Vol #:
|
| 284
|
|
|
| EMC 8923
|
| B. Kennedy
|
| Vol #:
|
| 284
|
|
|
| EMC 8924
|
| F. Burgess
|
| Vol #:
|
| 284
|
|
|
| EMC 8925
|
| C. Caporusso
|
| Vol #:
|
| 284
|
|
|
| EMC 8926
|
| A. Fulton-Cavett
|
| Vol #:
|
| 284
|
|
|
| EMC 8927
|
| M. Edwards
|
| Vol #:
|
| 284
|
|
|
| EMC 8928
|
| G. Floren
|
| Vol #:
|
| 284
|
|
|
| EMC 8929
|
| I. Innes
|
| Vol #:
|
| 284
|
|
|
| EMC 8930
|
| K. Gorosh
|
| Vol #:
|
| 284
|
|
|
| EMC 8931
|
| L. Lucchese
|
| Vol #:
|
| 284
|
|
|
| EMC 8932
|
| J. K. Obley
|
| Vol #:
|
| 284
|
|
|
| EMC 8933
|
| J. McGuire
|
| Vol #:
|
| 284
|
|
|
| EMC 8934
|
| W. Grigg
|
| Vol #:
|
| 284
|
|
|
| EMC 8935
|
| J. Bunning
|
| Vol #:
|
| 284
|
|
|
| EMC 8936
|
| H. S. Meyer
|
| Vol #:
|
| 284
|
|
|
| EMC 8937
|
| Dr. R. Klein
|
| Vol #:
|
| 284
|
|
|
| EMC 8938
|
| D. Couch
|
| Vol #:
|
| 284
|
|
|
| EMC 8939
|
| B.A. Greenwald
|
| Vol #:
|
| 284
|
|
|
| EMC 8940
|
| S. Parker
|
| Vol #:
|
| 284
|
|
|
| EMC 8941
|
| G. Holden
|
| Vol #:
|
| 284
|
|
|
| EMC 8942
|
| M. E. Roberts
|
| Vol #:
|
| 284
|
|
|
| EMC 8943
|
| A. Suarez
|
| Vol #:
|
| 284
|
|
|
| EMC 8944
|
| P. Self
|
| Vol #:
|
| 284
|
|
|
| EMC 8945
|
| D. Grabien
|
| Vol #:
|
| 284
|
|
|
| EMC 8946
|
| E. L. DeCoux
|
| Vol #:
|
| 284
|
|
|
| EMC 8947
|
| Dr. P. Hudson
|
| Vol #:
|
| 284
|
|
|
| EMC 8948
|
| E. Domagal
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8949
|
| C. Ward Darby
|
| Vol #:
|
| 284
|
|
|
| EMC 8950
|
| N. O'Connell
|
| Vol #:
|
| 284
|
|
|
| EMC 8951
|
| D. Davis
|
| Vol #:
|
| 284
|
|
|
| EMC 8952
|
| M. Jack
|
| Vol #:
|
| 284
|
|
|
| EMC 8953
|
| C. Hardy
|
| Vol #:
|
| 284
|
|
|
| EMC 8954
|
| A. L. Katz
|
| Vol #:
|
| 284
|
|
|
| EMC 8955
|
| V. Jepson
|
| Vol #:
|
| 284
|
|
|
| EMC 8956
|
| C. Bercovitz
|
| Vol #:
|
| 284
|
|
|
| EMC 8957
|
| S. J. Lashley
|
| Vol #:
|
| 284
|
|
|
| EMC 8958
|
| L. Rinehart
|
| Vol #:
|
| 284
|
|
|
| EMC 8959
|
| A. Burgess
|
| Vol #:
|
| 284
|
|
|
| EMC 8960
|
| T. Miller
|
| Vol #:
|
| 284
|
|
|
| EMC 8961
|
| S. J. Weston
|
| Vol #:
|
| 284
|
|
|
| EMC 8962
|
| K. Doyle
|
| Vol #:
|
| 284
|
|
|
| EMC 8963
|
| N. M. Feltch I
|
| Vol #:
|
| 284
|
|
|
| EMC 8964
|
| R. Copeland
|
| Vol #:
|
| 284
|
|
|
| EMC 8965
|
| M. Richmond
|
| Vol #:
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| 284
|
|
|
| EMC 8966
|
| J. Stapleton
|
| Vol #:
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| 284
|
|
|
| EMC 8967
|
| T. Russo
|
| Vol #:
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| 284
|
|
|
| EMC 8968
|
| G. Salgado
|
| Vol #:
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| 284
|
|
|
| EMC 8969
|
| M. L. Kraft
|
| Vol #:
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| 284
|
|
|
| EMC 8970
|
| K. Redfern
|
| Vol #:
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| 284
|
|
|
| EMC 8971
|
| K. LaBonte
|
| Vol #:
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| 284
|
|
|
| EMC 8972
|
| A. Calhoun
|
| Vol #:
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| 284
|
|
|
| EMC 8973
|
| M. Garris
|
| Vol #:
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| 284
|
|
|
| EMC 8974
|
| D. Vandeventer
|
| Vol #:
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| 284
|
|
|
| EMC 8975
|
| R. Depart
|
| Vol #:
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| 284
|
|
|
| EMC 8976
|
| T. Lusciatti
|
| Vol #:
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| 284
|
|
|
| EMC 8977
|
| L. Breen
|
| Vol #:
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| 284
|
|
|
| EMC 8978
|
| A. Hansen-Higa
|
| Vol #:
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| 284
|
|
|
| EMC 8979
|
| A. Hasty
|
| Vol #:
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| 284
|
|
|
| EMC 8980
|
| C. Gleason
|
| Vol #:
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| 284
|
|
|
| EMC 8981
|
| K. Christensen
|
| Vol #:
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| 284
|
|
|
| EMC 8982
|
| J. A. Rosenfeld
|
| Vol #:
|
| 284
|
|
|
| EMC 8983
|
| J. Dukovich
|
| Vol #:
|
| 284
|
|
|
| EMC 8984
|
| C. Miller
|
| Vol #:
|
| 284
|
|
|
| EMC 8985
|
| E. Katz
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 8986
|
| C. Arbit
|
| Vol #:
|
| 284
|
|
|
| EMC 8987
|
| D. Hoke
|
| Vol #:
|
| 284
|
|
|
| EMC 8988
|
| T. Connors Daniel
|
| Vol #:
|
| 284
|
|
|
| EMC 8989
|
| S. S. Pastin
|
| Vol #:
|
| 284
|
|
|
| EMC 8990
|
| L. Coakley
|
| Vol #:
|
| 284
|
|
|
| EMC 8991
|
| N. D. Bosma
|
| Vol #:
|
| 284
|
|
|
| EMC 8992
|
| D. Maughan
|
| Vol #:
|
| 284
|
|
|
| EMC 8993
|
| K. Virago
|
| Vol #:
|
| 284
|
|
|
| EMC 8994
|
| R. Cole
|
| Vol #:
|
| 284
|
|
|
| EMC 8995
|
| P. Gibbs
|
| Vol #:
|
| 284
|
|
|
| EMC 8996
|
| C. Mandile
|
| Vol #:
|
| 284
|
|
|
| EMC 8997
|
| M. Scharphie
|
| Vol #:
|
| 284
|
|
|
| EMC 8998
|
| K. Jurrus
|
| Vol #:
|
| 284
|
|
|
| EMC 8999
|
| E. Denzau
|
| Vol #:
|
| 284
|
|
|
| EMC 9000
|
| A. Sharrow
|
| Vol #:
|
| 284
|
|
|
| EMC 9001
|
| J. Rathwell
|
| Vol #:
|
| 284
|
|
|
| EMC 9002
|
| A. J. Williams
|
| Vol #:
|
| 284
|
|
|
| EMC 9003
|
| K. Burchett
|
| Vol #:
|
| 284
|
|
|
| EMC 9004
|
| N. Ryder
|
| Vol #:
|
| 284
|
|
|
| EMC 9005
|
| S. J. Christiansen
|
| Vol #:
|
| 284
|
|
|
| EMC 9006
|
| Dr. T. Bobo
|
| Vol #:
|
| 284
|
|
|
| EMC 9007
|
| J. Brodziak
|
| Vol #:
|
| 284
|
|
|
| EMC 9008
|
| R. Levin
|
| Vol #:
|
| 284
|
|
|
| EMC 9009
|
| S. Blank
|
| Vol #:
|
| 284
|
|
|
| EMC 9010
|
| R. Bartlein
|
| Vol #:
|
| 284
|
|
|
| EMC 9011
|
| L. Newcomer
|
| Vol #:
|
| 284
|
|
|
| EMC 9012
|
| A. Varga
|
| Vol #:
|
| 284
|
|
|
| EMC 9013
|
| E. Coutts
|
| Vol #:
|
| 284
|
|
|
| EMC 9014
|
| A. Sudeikis
|
| Vol #:
|
| 284
|
|
|
| EMC 9015
|
| K. Kendall-Holliday
|
| Vol #:
|
| 284
|
|
|
| EMC 9016
|
| Dr. C. & G. Alden
|
| Vol #:
|
| 284
|
|
|
| EMC 9017
|
| A. R. Wood
|
| Vol #:
|
| 284
|
|
|
| EMC 9018
|
| J. Fergus
|
| Vol #:
|
| 284
|
|
|
| EMC 9019
|
| A. Moser
|
| Vol #:
|
| 284
|
|
|
| EMC 9020
|
| R. W. Moser Jr.
|
| Vol #:
|
| 284
|
|
|
| EMC 9021
|
| S. L. Burley
|
| Vol #:
|
| 284
|
|
|
| EMC 9022
|
| E. Freed-Brown
|
| Vol #:
|
| 284
|
|
| | | | | | | |
|
|
| EMC 9023
|
| D. R. Carra
|
| Vol #:
|
| 284
|
|
|
| EMC 9024
|
| C. Kurtz
|
| Vol #:
|
| 284
|
|
|
| EMC 9025
|
| A. Vazquez
|
| Vol #:
|
| 284
|
|
|
| EMC 9026
|
| A. M. Walczak
|
| Vol #:
|
| 284
|
|
|
| EMC 9027
|
| J. Behrman
|
| Vol #:
|
| 284
|
|
|
| EMC 9028
|
| K. Keegan
|
| Vol #:
|
| 284
|
|
|
| EMC 9029
|
| P. Rackowski
|
| Vol #:
|
| 284
|
|
|
| EMC 9030
|
| S. Betzer
|
| Vol #:
|
| 284
|
|
|
| EMC 9031
|
| E. Reilly
|
| Vol #:
|
| 284
|
|
|
| EMC 9032
|
| C. Kalemba
|
| Vol #:
|
| 284
|
|
|
| EMC 9033
|
| H. Bilheimer
|
| Vol #:
|
| 284
|
|
|
| EMC 9034
|
| K. Lems
|
| Vol #:
|
| 284
|
|
|
| EMC 9035
|
| J. Sayre
|
| Vol #:
|
| 284
|
|
|
| EMC 9036
|
| S. Parker
|
| Vol #:
|
| 284
|
|
|
| EMC 9037
|
| M. J. Bridge
|
| Vol #:
|
| 284
|
|
|
| EMC 9038
|
| M. Fine
|
| Vol #:
|
| 284
|
|
|
| EMC 9039
|
| K. R. Galler
|
| Vol #:
|
| 284
|
|
|
| EMC 9040
|
| S. Agar
|
| Vol #:
|
| 284
|
|
|
| EMC 9041
|
| E. Vigneault
|
| Vol #:
|
| 284
|
|
|
| EMC 9042
|
| E. Bloomenthal
|
| Vol #:
|
| 284
|
|
|
| EMC 9043
|
| M. Camardella
|
| Vol #:
|
| 284
|
|
|
| EMC 9044
|
| S. K. Blaney
|
| Vol #:
|
| 284
|
|
|
| EMC 9045
|
| A. Campitelli
|
| Vol #:
|
| 284
|
|
|
| EMC 9046
|
| M. Hardison
|
| Vol #:
|
| 284
|
|
|
| EMC 9047
|
| R. Nussbaum
|
| Vol #:
|
| 284
|
|
|
| EMC 9048
|
| P. D. Berger
|
| Vol #:
|
| 284
|
|
|
| EMC 9049
|
| B. Greenbert
|
| Vol #:
|
| 284
|
|
|
| EMC 9050
|
| R. Sell
|
| Vol #:
|
| 284
|
|
|
| EMC 9051
|
| J. A. Holbrook
|
| Vol #:
|
| 284
|
|
|
| EMC 9052
|
| J. Marriott
|
| Vol #:
|
| 284
|
|
|
| EMC 9053
|
| M. J. Tacheron
|
| Vol #:
|
| 284
|
|
|
| EMC 9054
|
| B. Bradford
|
| Vol #:
|
| 284
|
|
|
| EMC 9055
|
| J. E. Wissler
|
| Vol #:
|
| 284
|
|
|
| EMC 9056
|
| D. Foster
|
| Vol #:
|
| 284
|
|
|
| EMC 9057
|
| K. Heebink
|
| Vol #:
|
| 284
|
|
|
| EMC 9058
|
| R. Shield
|
| Vol #:
|
| 284
|
|
|
| EMC 9059
|
| M. Bia
|
| Vol #:
|
| 284
|
|
| | | | | | | | |
|
|
| EMC 9060
|
| W. W. Conhaim
|
| Vol #:
|
| 284
|
|
|
| EMC 9061
|
| A. Haselberger
|
| Vol #:
|
| 284
|
|
|
| EMC 9062
|
| J. S. Jacobson
|
| Vol #:
|
| 284
|
|
|
| EMC 9063
|
| N. Belisle
|
| Vol #:
|
| 284
|
|
|
| EMC 9064
|
| B. Cobb
|
| Vol #:
|
| 284
|
|
|
| EMC 9065
|
| A. McMillan
|
| Vol #:
|
| 284
|
|
|
| 2002E-0099
|
| Patent Term Extension Application for XIGRIS No. 4,775,624
|
|
|
| LET
4
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0184
|
| Patent Extension Application for XIGRIS, No. 5,681,932
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2002E-0342
|
| Lea's Shield, U.S. Patent No. 4,703,752
|
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
| C
27
|
| Introractive Consulting Associates GmBH
|
| Vol #:
|
| 3
|
|
|
| C
28
|
| Introractive Consulting Associates GmBH
|
| Vol #:
|
| 3
|
|
|
| C
29
|
| Introractive Consulting Associates GmBH
|
| Vol #:
|
| 3
|
|
|
| 2003E-0255
|
| Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
|
|
|
| LET
3
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0407
|
| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
|
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| EC 11
|
| Ms. Carole Waina
|
| Vol #:
|
| 4
|
|
|
| 2003N-0342
|
| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
|
|
|
| C
8
|
| AARP
|
| Vol #:
|
| 2
|
|
|
| C
9
|
| National Council on Patient Information and Education (NCPIE)
|
| Vol #:
|
| 2
|
|
|
| EC
2
Attachment
|
| National Association of Chain Drug Stores
|
| Vol #:
|
| 2
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
| C
1
|
| Neese Country Sausage, Inc.
|
| Vol #:
|
| 2
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
| C
11
|
| Johnson and Johson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
| C
11
|
| Johnson and Johson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 1
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
| C
10
|
| Johnson and Johson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 1
|
|
|
| 2004N-0114
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
| EXT
1
|
| Grocery Manufacturers of America (GMA)
|
| Vol #:
|
| 1
|
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
| C
3
|
| Ohio Farm Bureau Federation
|
| Vol #:
|
| 1
|
|
|
| C
4
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
| C
5
|
| Government of Canada
|
| Vol #:
|
| 1
|
|
|
| C
6
|
| Canadian Produce Marketing Assn (CPMA)
|
| Vol #:
|
| 1
|
|
|
| C
7
|
| Produce Marketing Assn (PMA)
|
| Vol #:
|
| 1
|
|
|
| C
8
|
| United Fresh Fruit and Vegetable Assn (United)
|
| Vol #:
|
| 1
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
| EXT
12
|
| SmithField
|
| Vol #:
|
| 1
|
|
|
| EXT
13
|
| Packerland Packing
|
| Vol #:
|
| 1
|
|
|
| EXT
14
|
| Valley Proteins, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004N-0296
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|