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| Dockets Entered
On November 30, 2006
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| Docket #
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| Title
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006E-0483
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| Patent Extension Application for Eraxis (anidulafugin), U.S. Patent No. 5,965,525
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| 2006E-0486
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| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006V-0485
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| Projector for a Laser Light Show
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| TS 1
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| G Burdock PhD
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| Vol #:
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| 1
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| TS 2
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| A Dickinson PhD
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| Vol #:
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| 1
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| TS 3
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| University of Maryland
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| Vol #:
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| 1
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| TS 4
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| Council for Responsible Nutrition
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| Vol #:
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| 1
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| TS 5
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
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| TS 6
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| G Burdock PhD
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| Vol #:
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| 1
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| TS 7
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| Hansen Natural Corporation
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| Vol #:
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| 1
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| TS 8
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| Grocery Manufacturers Association/Food Products Association
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| Vol #:
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| 1
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| TS 9
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| Health Freedom Foundation & American Association for Health Freedom
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| Vol #:
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| 1
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| TS 10
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| Hyman Phelps & McNamara PC
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| Vol #:
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| 1
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| TS 11
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| The Natural Products Association
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| Vol #:
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| 1
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| TS 12
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| North Dakota State University, Lallemand Inc
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| Vol #:
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| 1
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| TS 13
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| American Herbal Association
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| Vol #:
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| 1
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| TS 14
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| Texas A&M University
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| EXB 62
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| R-55 TMJ Concepts Approval Letter
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| Vol #:
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| 66
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| EXB 63
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| R-56 TMJ Concepts Summary of Safety and Effectiveness
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| Vol #:
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| 67
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| EXB 64
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| R-57 The Morgan
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| Vol #:
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| 68
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| EXB 65
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| R-58 02-063 (MV1026451
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| Vol #:
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| 69
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| EXB 66
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| R-59 02-064 (MV1026641, 1026649, 1026650)
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| Vol #:
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| 70
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| EXB 67
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| R-60 02-065 (MV1026765)
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| Vol #:
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| 71
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| EXB 68
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| R-61 03-010
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| Vol #:
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| 72
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| EXB 69
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| R-62 03-011
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| Vol #:
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| 73
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| EXB 70
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| R-63 03-017
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| Vol #:
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| 74
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| EXB 71
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| R-64 03-018
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| Vol #:
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| 75
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| EXB 72
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| R-65 Internal Memo 03-019
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| Vol #:
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| 76
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| EXB 73
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| R-66 Internal Memo 03-021
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| Vol #:
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| 77
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| EXB 74
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| R-67 Internal Memo 03-022(MW1027888,89,90, &91)
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| Vol #:
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| 78
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| EXB 75
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| R-68 Internal Memo 03-024(MW1028047)
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| Vol #:
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| 79
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| EXB 76
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| R-69 Internal Memo 03-025
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| Vol #:
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| 80
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| EXB 77
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| R-70 Internal Memo 03-030
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| Vol #:
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| 81
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| EXB 78
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| R-71 Adverse Event Report MW1026451
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| Vol #:
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| 82
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| LET 6
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| TMJ Implants Inc.
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| Vol #:
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| 9
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| EC 7
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| University of Michigan Medical School
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC 2330
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| Mr. Tom Altus
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| Vol #:
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| 10
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| EC 2331
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| Mrs. Stephanie Patag
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| Vol #:
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| 10
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| EC 2332
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| Mrs. Kathryn Hand
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| Vol #:
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| 10
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| EC 2333
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| Ms. Sebrina Di Francesca
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| Vol #:
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| 10
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| EC 2334
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| Mrs. Teresa Miller
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| Vol #:
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| 10
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| EC 2335
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| Mrs. Yvonne Hoffman
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| Vol #:
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| 10
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| EC 2336
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| Mrs. Lynne Spear
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| Vol #:
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| 10
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| EC 2337
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| Mr. Tom Albrethsen
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| Vol #:
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| 10
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| EC 2338
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| Mrs. Christine Butrim
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| Vol #:
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| 10
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| EC 2339
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| Mrs. Kerri Jones
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| Vol #:
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| 10
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| EC 2340
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| N/A
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| Vol #:
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| 10
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| EC 2341
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| Mrs. Denise Ehr
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| Vol #:
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| 10
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| EC 2342
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| Mr. Renato Baratto
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| Vol #:
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| 10
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| EC 2343
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| Mrs. Cindy Bilbrey
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| Vol #:
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| 10
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| EC 2344
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| Mr. Jacob Favaron
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| Vol #:
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| 10
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| EC 2345
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| Mrs. Lisa Lewis
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| Vol #:
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| 10
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| EC 2346
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| St. Remy Church
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| Vol #:
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| 10
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| EC 2347
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| Mr. Jeffrey Hoehne
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| Vol #:
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| 10
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| EC 2348
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| Mr. David Blasland
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| Vol #:
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| 10
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| EC 2349
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| Mrs. Anne-Marie Miller
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| Vol #:
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| 10
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| EC 2350
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| Mrs. Jennifer Lothamer
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| Vol #:
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| 10
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| EC 2351
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| Mrs. Marlo Howell
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| Vol #:
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| 10
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| EC 2352
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| Mrs. Renee Laughery
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| Vol #:
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| 10
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| EC 2353
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| Mr. Jack Ennenbach
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| Vol #:
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| 10
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| EC 2354
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| Ms. Carol A. McMillan
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| Vol #:
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| 10
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| EC 2355
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| Field Bros Moving
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| Vol #:
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| 10
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| EC 2356
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| Mr. david wallace
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| Vol #:
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| 10
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| EC 2357
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| Mr. Paul Miller
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| Vol #:
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| 10
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| EC 2358
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| Mrs. shaune Pruitt
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| Vol #:
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| 10
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| EC 2359
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| Mrs. paula Maurer
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| Vol #:
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| 10
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| EC 2360
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| Ms. martha tenney
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| Vol #:
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| 10
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| EC 2361
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| Mr. Ted Ku
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| Vol #:
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| 10
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| EC 2362
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| Mr. Lauren Miller
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| Vol #:
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| 10
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| EC 2363
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| Mrs. Joanne Muniz
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| Vol #:
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| 10
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| EC 2364
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| Mrs. Claire Lyons
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| Vol #:
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| 10
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| EC 2365
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| Mrs. Sharon Orth
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| Vol #:
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| 10
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| EC 2366
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| Mrs. Elly Smyczynski
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| Vol #:
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| 10
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| EC 2367
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| Right to Life/Michigan
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| Vol #:
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| 10
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| EC 2368
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| Ms. Kate Walter
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| Vol #:
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| 10
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| EC 2369
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| Ms. Kate Walter
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| Vol #:
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| 10
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| EC 2370
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| Mrs. Kathleen Potts
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| Vol #:
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| 10
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| EC 2371
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| Mrs. Sheri Blome
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| Vol #:
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| 10
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| EC 2372
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| Mrs. Colette Healey
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| Vol #:
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| 10
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| EC 2373
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| Right to Life of Michigan
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| Vol #:
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| 10
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| EC 2374
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| Mrs. Christine MacDonald
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| Vol #:
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| 10
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| EC 2375
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| Mrs. Ann Marie Childs
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| Vol #:
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| 10
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| EC 2376
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| Mrs. Tracey Pearl
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| Vol #:
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| 10
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| EC 2377
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| Mrs. Pamela Mikrut
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| Vol #:
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| 10
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| EC 2378
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| Mr. Anthony Grundman
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| Vol #:
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| 10
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| EC 2379
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| Mrs. Pat Pajot
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| Vol #:
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| 10
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| EC 2380
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| Mrs. Heather Christie
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| Vol #:
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| 10
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| |
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| EC 2381
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| Mr. Donald Foster
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| Vol #:
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| 10
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| |
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| EC 2382
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| Mr. Peter Galligan
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| Vol #:
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| 10
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| EC 2383
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| Mrs. vicky shields
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| Vol #:
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| 10
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| |
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| EC 2384
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| Mr. D N
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| Vol #:
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| 10
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| |
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| EC 2385
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| Mr. George Durk
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| Vol #:
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| 10
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| |
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| EC 2386
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| Mrs. Joanne Bober
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| Vol #:
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| 10
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| |
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| EC 2387
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| Mr. Tom Stauble
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| Vol #:
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| 10
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| | | | | | | | |
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| |
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| EC 2388
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| Mrs. Nancy Omernik
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| Vol #:
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| 10
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| |
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| EC 2389
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| Mrs. Cynthia Prunty Prunty
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| Vol #:
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| 10
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| |
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| EC 2390
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| Mrs. Karen Dosch
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| Vol #:
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| 10
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| EC 2391
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| Mr. Robert Schuler
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| Vol #:
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| 10
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| |
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| EC 2392
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| Mr. John Wood
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| Vol #:
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| 10
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| EC 2393
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| Mr. Daniel Norick
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| Vol #:
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| 10
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| EC 2394
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| Miss. Jodie Riordan
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| Vol #:
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| 10
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| |
|
|
| 2006E-0483
|
| Patent Extension Application for Eraxis (anidulafugin), U.S. Patent No. 5,965,525
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| |
|
|
| APP 1
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| Eli Lilly and Company
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| Vol #:
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| 1
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| |
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| |
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| LET 2
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| U.S. Patent and Trademark Office to Pfizer Inc.
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| Vol #:
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| 1
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| |
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| LET 3
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| Eli Lilly and Company
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| Vol #:
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| 1
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| |
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| 2006E-0486
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| Patent Extension Application for Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent), U.S. Patent No. 5,626,851
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| |
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| APP 1
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| Wistar Institute of Anatomy and Biology and The Children's Hospital of Philadelphia
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| Vol #:
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| 1
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| |
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| |
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| |
|
|
| EMC 2
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| Consumers Union
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| Vol #:
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| 15
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| |
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| TS 21
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| Kobo Products Inc
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| Vol #:
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| 15
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| |
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| |
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|
| C 629
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| T. Moore
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| Vol #:
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| 28
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| |
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| C 630
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| B. Lackey
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| Vol #:
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| 28
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| |
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| C 631
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| E. Meininger
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| Vol #:
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| 28
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| |
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| C 632
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| J. Saepoff, DDS
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| Vol #:
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| 28
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| |
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| C 633
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| W. Whitworth
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| Vol #:
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| 28
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| |
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| C 634
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| E. Williams
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| Vol #:
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| 28
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| |
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| C 635
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| S. Rossi
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| Vol #:
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| 28
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| |
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| C 636
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| D. Cowan
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| Vol #:
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| 28
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| |
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| C 637
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| Dr. L. Mowbray
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| Vol #:
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| 28
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| |
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| C 638
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| V. Brandt
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| Vol #:
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| 28
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| |
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| C 639
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| Consumers for Dental Choice
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| Vol #:
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| 28
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| |
|
|
| C 640
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| N. Swift
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| Vol #:
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| 28
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| |
|
|
| C 641
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| A. Jabbour
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| Vol #:
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| 28
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| |
|
|
| C 642
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| E. Bubar
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| Vol #:
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| 28
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| |
|
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| C 643
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| N. Swift
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| Vol #:
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| 28
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|
| | | | | | | |
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| |
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| C 644
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| J. Hayes
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| Vol #:
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| 28
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| |
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| C 645
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| D. Castagno
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| Vol #:
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| 28
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| |
|
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| C 646
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| C. Brown
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| Vol #:
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| 28
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| |
|
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| C 647
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| R. Levine
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| Vol #:
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| 28
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| |
|
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| C 648
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| D. Trojan
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| Vol #:
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| 28
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| |
|
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| C 649
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| C. Lathan
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| Vol #:
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| 28
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| |
|
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| C 650
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| B. Roberts
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| Vol #:
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| 28
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| |
|
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| C 651
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| R. Cann, DMD
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| Vol #:
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| 28
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| |
|
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| C 652
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| M. Fu
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| Vol #:
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| 28
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| |
|
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| C 653
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| D. Coomer
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| Vol #:
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| 28
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| |
|
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| C 654
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| D. Gilbrech
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| Vol #:
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| 28
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| |
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| C 655
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| P. Allen
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| Vol #:
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| 28
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| |
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| C 656
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| A. Welber
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| Vol #:
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| 28
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| |
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| C 657
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| H. Spagna
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| Vol #:
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| 28
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| |
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| C 658
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| G. Bedding
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| Vol #:
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| 28
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| |
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| C 659
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| T and J Carlson
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| Vol #:
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| 28
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| |
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| C 660
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| S. Klotz
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| Vol #:
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| 28
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| |
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| C 661
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| F. Pane
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| Vol #:
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| 28
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| |
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| C 662
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| J. Scott
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| Vol #:
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| 28
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| |
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| C 663
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| L. Thomas
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| Vol #:
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| 28
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| |
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| C 664
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| A. Frankel
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| Vol #:
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| 28
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| |
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| C 665
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| A. Zakarian, DDS, MS
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| Vol #:
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| 28
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| |
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| C 666
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| R. Holgers, PhD
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| Vol #:
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| 28
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| |
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| C 667
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| S. Pearce
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| Vol #:
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| 28
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| |
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| C 668
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| J. Schultz
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| Vol #:
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| 28
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| |
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| C 669
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| E. McGrath
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| Vol #:
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| 28
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| |
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| C 670
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| E. Zamzow, DVM
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| Vol #:
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| 28
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| |
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| C 671
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| P. Liechty
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| Vol #:
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| 28
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| |
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| C 672
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| C. Fairbanks
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| Vol #:
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| 28
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| |
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| C 673
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| S. Home
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| Vol #:
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| 28
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| |
|
|
| C 674
|
| L. Skrine, D.C.
|
| Vol #:
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| 28
|
| |
|
|
| C 675
|
| T. Danysh
|
| Vol #:
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| 28
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| |
|
|
| C 676
|
| M. Holcomb
|
| Vol #:
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| 28
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| |
|
|
| C 677
|
| C. Walker
|
| Vol #:
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| 28
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| |
|
|
| C 678
|
| T. Taylor
|
| Vol #:
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| 28
|
| |
|
|
| C 679
|
| C. Smith
|
| Vol #:
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| 28
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| |
|
|
| C 680
|
| M. Welles
|
| Vol #:
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| 28
|
|
| | | | | | | | |
|
| |
|
| C 681
|
| D. Gouge
|
| Vol #:
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| 28
|
| |
|
|
| C 682
|
| D. HArrell
|
| Vol #:
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| 28
|
| |
|
|
| C 683
|
| K. Williams
|
| Vol #:
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| 28
|
| |
|
|
| C 684
|
| R. Boe, DDS
|
| Vol #:
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| 28
|
| |
|
|
| C 685
|
| S. JAcobson, RN, MSN
|
| Vol #:
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| 28
|
| |
|
|
| C 686
|
| R. Terlecki
|
| Vol #:
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| 28
|
| |
|
|
| C 687
|
| Patients Against Mercury Amalgams
|
| Vol #:
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| 28
|
| |
|
|
| C 688
|
| A. Kenar
|
| Vol #:
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| 28
|
| |
|
|
| C 689
|
| I. Poole
|
| Vol #:
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| 28
|
| |
|
|
| C 690
|
| C. Irwin
|
| Vol #:
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| 28
|
| |
|
|
| C 691
|
| P. McIntyre
|
| Vol #:
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| 28
|
| |
|
|
| C 692
|
| S. Thomas
|
| Vol #:
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| 28
|
| |
|
|
| C 693
|
| K. Humiston, M.D.
|
| Vol #:
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| 28
|
| |
|
|
| C 694
|
| M. Petranek
|
| Vol #:
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| 28
|
| |
|
|
| C 695
|
| D. Brolin
|
| Vol #:
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| 28
|
| |
|
|
| C 696
|
| R. Dawes
|
| Vol #:
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| 28
|
| |
|
|
| C 697
|
| M. Sieren
|
| Vol #:
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| 28
|
| |
|
|
| C 698
|
| L. Darland
|
| Vol #:
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| 28
|
| |
|
|
| C 699
|
| L. Cone, DC
|
| Vol #:
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| 28
|
| |
|
|
| C 700
|
| M. Flowers
|
| Vol #:
|
| 28
|
| |
|
|
| C 701
|
| S. Fagan
|
| Vol #:
|
| 28
|
| |
|
|
| C 702
|
| M. McRedmond, Jr. DDS
|
| Vol #:
|
| 28
|
| |
|
|
| C 703
|
| P. Lalk
|
| Vol #:
|
| 28
|
| |
|
|
| C 704
|
| S. Machado
|
| Vol #:
|
| 28
|
| |
|
|
| C 705
|
| Women's Health & Environmental Network (WHEN)
|
| Vol #:
|
| 28
|
| |
|
|
| C 706
|
| A. Bates R.N., B.S.N.
|
| Vol #:
|
| 28
|
| |
|
|
| C 707
|
| Dr. K. Wilson
|
| Vol #:
|
| 28
|
| |
|
|
| C 708
|
| J. Wasko, MA, LMHC
|
| Vol #:
|
| 28
|
| |
|
|
| C 709
|
| Consumers for Dental Choice
|
| Vol #:
|
| 28
|
| |
|
|
| C 710
|
| J. Moskowitz
|
| Vol #:
|
| 28
|
| |
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
| |
|
|
| EC 15
|
| University of Rochester Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| Family of Sean Q. Richner
|
| Vol #:
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| 1
|
| |
|
|
| EC 17
|
| Mrs. Mary Hintz
|
| Vol #:
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| 1
|
| |
|
|
| EC 18
|
| Mrs. Diane Spencer
|
| Vol #:
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| 1
|
| |
|
|
| EC 19
|
| Self Employed
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
|
| EC 20
|
| Mrs. Terry Bearden
|
| Vol #:
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| 1
|
| |
|
|
| EC 21
|
| Ms. Alicia Warwick
|
| Vol #:
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| 1
|
| |
|
|
| EC 22
|
| Mr. David Cockrell
|
| Vol #:
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| 1
|
| |
|
|
| EC 23
|
| Mr. Concerned Citizen
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
|
|
|
|
| |
|
|
| EC 10
|
| Mrs. Jill Baird-Gent
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 431
|
| Ms. Krystal Mills
|
| Vol #:
|
| 7
|
| |
|
|
| 2006V-0485
|
| Projector for a Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA / DDM to N9NE Group dba Moon Bar
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| N9NE Group dba Moon Bar
|
| Vol #:
|
| 1
|
|
|
