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| Dockets Entered On November
10, 2005
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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| 1999N-4282
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| Biotechnology in the Year 2000
and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum
Misbranded
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| 2000P-1211
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| Establish Mandatory Pre-Market
Safety Testing for GE Foods
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| 2001D-0281
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| Proposed Globally Harmonized
Alternative for PMA Procedures
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| 2003N-0502
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| Agency Information
Collection Activities; Proposed Collection; Comment Request; Study
to Measure the Compliance of Prescribers with the Contraindication
of the Use of b Triptansb in Migraine Headac
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| 2004N-0081
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| BSE Risk Materials in Foods
and Cosmetics
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| 2005D-0334
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| Guidance for Industry on the
Pediatric Research Equity Act
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| 2005D-0401
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| Guidance for Industry
and FDA Staff: Compliance with Section 301 of the Medical Device User
Fee and Modernization Act of 2002, as amended Prominent and Conspicuous
Mark of Manufacturers on Single-Us
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| 2005N-0354
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| Consumer-Directed Promotion
of Regulated Medical Products; Part 15 Public Hearing
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| 2005P-0267
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| Remove from label for propofol
(Diprivan) the warning that propofol should be administered only by
trained persons
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| 2005P-0366
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| Classification of the Low Energy
Ultrasound Wound Cleaner
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| 2005P-0452
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| FDA's decisions concerning approvals
of generic versions of atorvastatin
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| 2005P-0453
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| FDA to establish tighter regulations
governing the process by which medical devices are reviewed and recalled
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| 1997S-0162
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| 30-Day Structure Function
Claim Notification Letters Dietary
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| LET
16827
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| Tabak's Health Products
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| Vol #:
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| 152
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| LET
16828
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16829
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET 16830
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| IdeaSphere Inc.
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| Vol #:
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| 151
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| LET
16831
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16832
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16833
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16834
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16835
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16836
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| IseaSphere Inc.
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| Vol #:
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| 152
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| LET
16837
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16838
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16839
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| IdeaSpkhere Inc.
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| Vol #:
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| 152
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| LET
16840
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16841
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16842
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16843
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16844
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| LET
16845
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| IdeaSphere Inc.
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| Vol #:
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| 152
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| | | | | | | | |
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| |
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| LET
16846
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| Univera, Inc.,d.b.a. Oassis LifeSciences
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| Vol #:
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| 152
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| LET
16847
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| Hillestad Pharmaceuticals
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| Vol #:
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| 152
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| |
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
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|
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| EMC 4233
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| J. Maples
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| Vol #:
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| 515
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| EMC 4234
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| R. Glade
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 616
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| J. McCloskey
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| Vol #:
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| 21
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 5850
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| J. Maples
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| Vol #:
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| 789
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| EMC 5851
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| R. Glade
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| Vol #:
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| 789
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| 2001D-0281
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| Proposed Globally Harmonized Alternative for PMA Procedures
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| GDL
4
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| Guideline
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| Vol #:
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| 1
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| NAD
4
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| FDA
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| Vol #:
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| 1
|
|
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| 2003N-0502
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Study to Measure the Compliance of Prescribers with the Contraindication of the Use of b Triptansb in Migraine Headac
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|
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| BKG 2
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| References 1 - 13
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| Vol #:
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| 1
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| REF
2
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| OMB Review for November 9, 2005
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| Vol #:
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| 17
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| |
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| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
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|
|
|
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| EMC
1
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
|
|
|
|
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| 2005D-0401
|
| Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended Prominent and Conspicuous Mark of Manufacturers on Single-Us
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|
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|
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| EMC
1
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| Medical Device Manufacturers Association (MDMA)
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| Vol #:
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| 1
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| |
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| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
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| EMC 55
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| N. Lovejoy
|
| Vol #:
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| 2
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| EMC 56
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| A. Woytowich
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| Vol #:
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| 2
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| EMC 57
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| S. Brown
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| Vol #:
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| 2
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| EMC 58
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| M. Lark
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| Vol #:
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| 2
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| EMC 59
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| J. Madore
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| Vol #:
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| 2
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| EMC 60
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| K. Jarpow
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| Vol #:
|
| 2
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| EMC 61
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| J. Rhines
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| Vol #:
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| 2
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|
