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| Dockets Entered
On October 4, 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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| 2002D-0320
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| Hold following clinical investigator
misconduct
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| 2002P-0025
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| Immediate suspension
all vaccine containing Thimerosal
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| 2002P-0520
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| Reclassification of Beta-Tricalcium
Phosphate,
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| 2003D-0117
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| Implementation of
Inspection by Accredited Persons Program
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| 2004N-0242
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| Institutional Review
Boards; Registration Requirements
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| 2004N-0408
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| Regulatory Site Visit
Training Program
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone
acetonide 0.01% topical oil)
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| 2004V-0449
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
14599
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| Loders Croklaan, Lipid
Nutrition
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| Vol #:
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| 127
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| LET
14600
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| Loders Croklaan, Lipid
Nutrition
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| Vol #:
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| 127
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| LET
14601
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| Atkins Nutritionals,
Inc.
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| Vol #:
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| 127
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| LET
14602
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| Atkins Nutritionals,
Inc.
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| Vol #:
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| 127
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| LET
14603
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| Dragon Herbs
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| Vol #:
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| 127
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| LET
14604
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14605
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14606
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14607
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14608
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14609
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| Perrigo Company of
South Carolina
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| Vol #:
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| 127
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| LET
14610
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| Perrigo Company of
South Carolina
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| Vol #:
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| 128
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| LET
14611
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| Perrigo Company of
South Carolina
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| Vol #:
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| 128
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| LET
14612
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| Perrigo Company of
South Carolina
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| Vol #:
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| 128
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| LET
14613
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| Indiana Botanic Gardens,
Inc.
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| Vol #:
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| 128
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| LET
14614
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| Indiana Botanic Gardens,
Inc.
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| Vol #:
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| 128
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| LET
14615
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| Indiana Botanic Gardens,
Inc.
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| Vol #:
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| 128
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| LET
14616
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| Indiana Botanic Gardens,
Inc.
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| Vol #:
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| 128
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| LET
14617
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| Indiana Botanic Gardens,
Inc.
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| Vol #:
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| 128
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| LET
14618
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| Shaklee Corporation
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| Vol #:
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| 128
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| 2001P-0075
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| Switch Status of
Emergency Contraceptives from Rx to OTC
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| EC 819
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| Mrs. Lisa Rentz
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| Vol #:
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| 163
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| 2002D-0320
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| Hold following
clinical investigator misconduct
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| EC
2
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| Citizens for Honest
Govenment
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| Vol #:
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| 1
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| 2002P-0025
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| Immediate suspension
all vaccine containing Thimerosal
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| | | | | | | | |
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| |
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| EMC
1
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| Facility Automation Management Engineering (FAME) Systems
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| Vol #:
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| 1
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| 2002P-0520
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| Reclassification of Beta-Tricalcium Phosphate,
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| EC 1
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| American Dental Association
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| Vol #:
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| 1
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| |
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| 2003D-0117
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| Implementation of Inspection by Accredited Persons Program
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| GDL
2
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| Guidance
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| Vol #:
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| 3
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| NAD
2
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| FDA
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| Vol #:
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| 3
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| 2004N-0242
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| Institutional Review Boards; Registration Requirements
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| C
2
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| Association of American Medical Colleges
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| Vol #:
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| 1
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| C
3
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| AAHRPP, Association for the Accreditation of Human Research Protection Programs Inc
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| Vol #:
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| 2
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| C
4
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
5
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| Applied Research Ethics National Association (ARENA)
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| Vol #:
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| 1
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| EMC
2
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| Biotechnology Industry Organization
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| Vol #:
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| 1
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| EMC
3
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| Merck & Co., Inc
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| Vol #:
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| 1
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| EMC
4
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| Council on Governmental Relations (COGR)
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| Vol #:
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| 1
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| EMC
5
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| Consortium of Independent Review Boards
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| Vol #:
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| 1
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| EMC
6
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| National Health Council
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| Vol #:
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| 1
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| EMC
7
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| C
1
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| Aseptic Technologies SA
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| Vol #:
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| 1
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| EC 1
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| Midwest Eye-Banks
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| Vol #:
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| 1
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| EC 2
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| Mayo Clinic Rochester Transfusion Medicine
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| Vol #:
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| 1
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| EC 3
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| Merck
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| Vol #:
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| 1
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| EMC
1
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| Midwest Eye-Banks
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| Vol #:
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| 1
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| 2004P-0448
|
| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
|
|
|
|
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| ACK
1
|
| HFA-305 to Dermaceuticals, Inc.
|
| Vol #:
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| 1
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|
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| 2004V-0449
|
| Laser Light Show
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|
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| ACK
1
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| HFA-305 to Pacific Science Center
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| Vol #:
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| 1
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| VAR
1
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| Pacific Science Center
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| Vol #:
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| 1
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