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| Dockets Entered
On January 29, 2007
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| |
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| |
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| |
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| 1994V-0306
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| Laser Light Show
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| |
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| 2004D-0035
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| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| 2006D-0363
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| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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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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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| 2007N-0015
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
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| 2007P-0033
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| Amend the Nutrition Facts label on food products as it relates to trans fats.
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| 2007P-0037
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| Declare that Loratadine Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new drug application (ANDA)
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 80
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| M. Tutino, MD
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| Vol #:
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| 20
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| C 81
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| SkinMedica, Inc.
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| Vol #:
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| 20
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| C 82
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| Kirkpatrick & Lockhart Preston Gates Ellis, LLP (K&L Gates)
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| Vol #:
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| 21
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| C 83
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| Cosmetic, Toiletry, and Fragrance Association (CTFA)
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| Vol #:
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| 22
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| C 154
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| VET Brands International, Inc. (VBI)
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| Vol #:
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| 8
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 148
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| VET Brands International, Inc. (VBI)
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| Vol #:
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| 10
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| 1994V-0306
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| Laser Light Show
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| VRA 6
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| FDA/CDRH to West Coast Laser Services
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| Vol #:
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| 1
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1405
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| J. Keller
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| Vol #:
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| 262
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| | | | | | | | |
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| C 2
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| Lallemandm Inc.
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| Vol #:
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| 2
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| |
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| TR 1
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| Transcript of December 5, 2006
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| Vol #:
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| 3
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 112
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| M. Presley
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| Vol #:
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| 18
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| |
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| C 113
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| S. Wilson
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| Vol #:
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| 18
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| C 114
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| B. Belle
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| Vol #:
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| 18
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| |
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| C 115
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| L. Coleman
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| Vol #:
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| 18
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| |
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| C 116
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| J. Rich
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| Vol #:
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| 18
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| |
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| C 117
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| A. Bonner
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| Vol #:
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| 18
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| |
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| C 118
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| Cooperative Resources International
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| Vol #:
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| 18
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| |
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| C 119
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| N. Merjian
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| Vol #:
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| 18
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| |
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| C 120
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| C. Reyes
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| Vol #:
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| 18
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| |
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| C 121
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| K. Ave
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| Vol #:
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| 18
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| C 122
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| D. Kalisky
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| Vol #:
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| 18
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| |
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| C 123
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| P. Stanseski
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| Vol #:
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| 18
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| |
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| C 124
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| Genex Cooperative, Inc.
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| Vol #:
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| 18
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| |
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| C 125
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| Genex Cooperative, Inc.
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| Vol #:
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| 18
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| |
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| C 126
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| Genex Cooperative, Inc.
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| Vol #:
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| 18
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| |
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| C 127
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| Genex Cooperative, Inc.
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| Vol #:
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| 18
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| |
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| C 128
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| Genex Cooperative, Inc.
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| Vol #:
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| 18
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| |
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| C 129
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| T. Moody
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| Vol #:
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| 18
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| C 130
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| K. White
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| Vol #:
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| 18
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| |
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| C 131
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| J and R JAklich
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| Vol #:
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| 18
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| |
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| EC 3109
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| Mr. Perry Souchuk
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| Vol #:
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| 17
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| EC 3110
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| Ms. maria mcfadden
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| Vol #:
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| 17
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| EC 3111
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| Mrs. Adrienne Daigle
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| Vol #:
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| 17
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| |
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| EC 3112
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| Ms. lori henes
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| Vol #:
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| 17
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| |
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| EC 3113
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| Ms. Jaclyn Hudson
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| Vol #:
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| 17
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| |
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| EC 3114
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| Mrs. Catherine Bourdon
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| Vol #:
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| 17
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| |
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| EC 3115
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| Mrs. Michelle Wilson
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| Vol #:
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| 17
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| |
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| EC 3116
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| Mr. Richard Kemp
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| Vol #:
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| 17
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| |
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| EC 3117
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| Mrs. Marietta Stokes
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| Vol #:
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| 17
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| |
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| EC 3118
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| Ms. Jamie Mershon
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| Vol #:
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| 17
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| |
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| EC 3119
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| Mr. Francisco Gadea
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| Vol #:
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| 17
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| |
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| EC 3120
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| Ms. Mirand Parker
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| Vol #:
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| 17
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|
| | | | | | | |
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| |
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| EC 3121
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| my money-my choice
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| Vol #:
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| 17
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| |
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| EC 3122
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| Ms. Cynthia Fravel
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| Vol #:
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| 17
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| |
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| EC 3123
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| none
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| Vol #:
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| 17
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| |
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| EC 3124
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| Ms. diana roses
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| Vol #:
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| 17
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| |
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| EC 3125
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| none
|
| Vol #:
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| 17
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| |
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| EC 3126
|
| Mr. james barrick
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| Vol #:
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| 17
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| |
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| EC 3127
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| Mr. Alex Castillo
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| Vol #:
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| 17
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| |
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| EC 3128
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| Ms. Elizabeth Curran
|
| Vol #:
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| 17
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| |
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| EC 3129
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| Mr. Michael Teele
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| Vol #:
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| 17
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| |
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| EC 3130
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| Ms. Ruta Murphy
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| Vol #:
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| 17
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| |
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| EC 3131
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| Mrs. Eileen Rider
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| Vol #:
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| 17
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| |
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| EC 3132
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| Miss. Steph Linn
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| Vol #:
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| 17
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| |
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| EC 3133
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| Mrs. Amber Amos
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| Vol #:
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| 17
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| |
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| EC 3134
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| None
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| Vol #:
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| 17
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| |
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| EC 3135
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| malnutrition
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| Vol #:
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| 17
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| |
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| EC 3136
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| Ms. CRYSTAL COAKLEY
|
| Vol #:
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| 17
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| |
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| EC 3137
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| Miss. E.R. Odom
|
| Vol #:
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| 17
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| |
|
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| EC 3138
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| Ms. Anna Schmalz
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| Vol #:
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| 17
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| |
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| EC 3139
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| Mr. Eric Deutsch
|
| Vol #:
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| 17
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| |
|
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| EC 3140
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| Mr. wade silk
|
| Vol #:
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| 17
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| |
|
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| EC 3141
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| Miss. Megan Hopkins
|
| Vol #:
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| 17
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| |
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| EC 3142
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| College of Saint Rose
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| Vol #:
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| 17
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| |
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| EC 3143
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| Mrs. Suzanne Skegrud
|
| Vol #:
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| 17
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| |
|
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| EC 3144
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| Mrs. Janice Goldstein
|
| Vol #:
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| 17
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| |
|
|
| EC 3145
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| Miss. Anni Mackin
|
| Vol #:
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| 17
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| |
|
|
| EC 3146
|
| Ms. Maureen Meex
|
| Vol #:
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| 17
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| |
|
|
| EC 3147
|
| Miss. Katrina Reittinger
|
| Vol #:
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| 17
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| |
|
|
| EC 3148
|
| Miss. Sabrina Leonguerrero
|
| Vol #:
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| 17
|
| |
|
|
| EC 3149
|
| Mr. John Alvarez
|
| Vol #:
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| 17
|
| |
|
|
| EC 3150
|
| Miss. Ann Hynek
|
| Vol #:
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| 17
|
| |
|
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| EC 3151
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| Mr. Timothy Pharr
|
| Vol #:
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| 17
|
| |
|
|
| EC 3152
|
| Mr. Paul Johnson
|
| Vol #:
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| 17
|
| |
|
|
| EC 3153
|
| Ms. M Kathleen Manafi
|
| Vol #:
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| 17
|
| |
|
|
| EC 3154
|
| Ms. Laura Durkee
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3155
|
| Ms. Sallie Wilson
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3156
|
| Mrs. Michelle McCann
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3157
|
| College Of Saint Rose
|
| Vol #:
|
| 17
|
|
| | | | | | | | |
|
| |
|
| EC 3158
|
| Mr. Edward Branstetter
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3159
|
| Ms. Kelly Neuberger
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3160
|
| Ms. Kelly Neuberger
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3161
|
| student
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3162
|
| Miss. Stephanie Gericke
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3163
|
| Mrs. anna calvaruso
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3164
|
| Mr. Sean Heerey
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3165
|
| Mrs. Linda Keating King
|
| Vol #:
|
| 17
|
| |
|
|
| EC 3166
|
| Mr. jack fischer
|
| Vol #:
|
| 17
|
| |
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
| |
|
|
| C 8
|
| Lilly Research Laboratories (Lilly)
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| C 669
|
| National Foundation for Celiac Awareness (NFCA)
|
| Vol #:
|
| 25
|
| |
|
|
| C 670
|
| K. Jarvis Sr.
|
| Vol #:
|
| 25
|
| |
|
|
| C 671
|
| J. McLean
|
| Vol #:
|
| 25
|
| |
|
|
| C 672
|
| P. Smith
|
| Vol #:
|
| 25
|
| |
|
|
| EC 1544
|
| Drossa Limited
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1545
|
| Ms. Tania Larson
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1546
|
| Ms. Karen McCoy
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1547
|
| Mr. Geoff Jennings
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1548
|
| Mrs. Beverly Buster
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1549
|
| Celiac Society
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1550
|
| Ener-G Foods, Inc.
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1551
|
| Mr. Michael Kerkhoff
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1552
|
| Ms. D. Warrick
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1553
|
| Miss. Joellen Poot
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1554
|
| Dr. Lindy Friedlander
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1555
|
| Ms. Lori Otte
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1556
|
| Mr. Daniel Gastel
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1557
|
| Mr. Daniel Gastel
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1558
|
| Mr. James Barrett
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1559
|
| Mrs. vanessa reale
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1560
|
| Ms. Karen Solomon
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1561
|
| Mr. Colin Treen
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1562
|
| Ms. karen hall
|
| Vol #:
|
| 24
|
|
| | | | | | | | |
|
| |
|
| EC 1563
|
| Mr. Michael Gadow
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1564
|
| Mrs. Karen Jenkins
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1565
|
| Mrs. Barbara Moore
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1566
|
| Mrs. cheryl plencner
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1567
|
| Ms. Cynthia Rudin
|
| Vol #:
|
| 24
|
| |
|
|
| EC 1568
|
| Ms. Ciara Truglia
|
| Vol #:
|
| 24
|
| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
| |
|
|
| C 30
|
| DJB Gas Services, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 31
|
| National Committee on Vital and Health Statistics (NCVHS)
|
| Vol #:
|
| 3
|
| |
|
|
| C 32
|
| General Distributing Co.
|
| Vol #:
|
| 3
|
| |
|
|
| C 33
|
| Airgas, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 34
|
| National Association of Chain Drug Stores (NACDS)
|
| Vol #:
|
| 3
|
| |
|
|
| C 35
|
| Abbott Laboratories
|
| Vol #:
|
| 3
|
| |
|
|
| C 36
|
| Norco, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 37
|
| Bemidji Welders Supply
|
| Vol #:
|
| 3
|
| |
|
|
| C 38
|
| Quality Air Products, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 39
|
| OXARC, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 40
|
| Depke Gases & Welding Supplies
|
| Vol #:
|
| 3
|
| |
|
|
| C 41
|
| Specialy Gases of America, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 42
|
| Apotex Corp.
|
| Vol #:
|
| 3
|
| |
|
|
| C 43
|
| H.D. Smith
|
| Vol #:
|
| 3
|
| |
|
|
| C 44
|
| Purity Cylinder GAses, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 45
|
| Airgas, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 46
|
| Linde Gas, LLC (Linde)
|
| Vol #:
|
| 3
|
| |
|
|
| C 47
|
| Gas Innovations
|
| Vol #:
|
| 3
|
| |
|
|
| C 48
|
| American Association of Exporters and Importers (AAEI)
|
| Vol #:
|
| 3
|
| |
|
|
| C 49
|
| Hospira, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| C 50
|
| Puget Sound Blood Center
|
| Vol #:
|
| 3
|
| |
|
|
| C 51
|
| Genzyme Corporation (Genzyme)
|
| Vol #:
|
| 8
|
| |
|
|
| C 52
|
| West Penn LAco, Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 53
|
| Lab Gases Division
|
| Vol #:
|
| 8
|
| |
|
|
| C 54
|
| O.E. Meyer Company
|
| Vol #:
|
| 8
|
| |
|
|
| C 55
|
| Andy Oxy Co., Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 56
|
| Compressed Gas Association (CGA)
|
| Vol #:
|
| 8
|
| |
|
|
| C 57
|
| American Association for Homecare (AAHomecare)
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
| |
|
| C 58
|
| Allscripts, LLC
|
| Vol #:
|
| 8
|
| |
|
|
| C 59
|
| Valley Wholesale Drug Co., Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 60
|
| Roberts Oxygen Company, Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 61
|
| National Community Pharmacists Association (NCPA)
|
| Vol #:
|
| 8
|
| |
|
|
| C 62
|
| MAtheson Tri-Gas, Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 63
|
| Hoffmann-La Roche, Inc. (Roche)
|
| Vol #:
|
| 8
|
| |
|
|
| C 64
|
| Schering-Plough
|
| Vol #:
|
| 8
|
| |
|
|
| C 65
|
| Healthcare Distribution Management Association (HDMA)
|
| Vol #:
|
| 8
|
| |
|
|
| C 66
|
| Pfizer, Inc.
|
| Vol #:
|
| 8
|
| |
|
|
| C 67
|
| Pharmaceutical Technologies Services (PTS)
|
| Vol #:
|
| 8
|
| |
|
|
| C 68
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 8
|
| |
|
|
| C 69
|
| Advanced Medical Technology Association (AdvaMed) et al
|
| Vol #:
|
| 8
|
| |
|
|
| C 70
|
| Buchanan Ingersoll Rooney PC
|
| Vol #:
|
| 8
|
| |
|
|
| C 71
|
| Roche Diagnostics Corporation (Roche Diagnostics)
|
| Vol #:
|
| 8
|
| |
|
|
| C 72
|
| Cosmetic, Toiletry and Fragrance Association (CTFA)
|
| Vol #:
|
| 8
|
| |
|
|
| EC 21
|
| Generic Pharmaceutical Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC 22
|
| Healthcare Distribution Management Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC 23
|
| GlaxoSmithKline
|
| Vol #:
|
| 4
|
| |
|
|
| EC 24
|
| AmerisourceBergen Corporation
|
| Vol #:
|
| 4
|
| |
|
|
| EC 25
|
| Procter
|
| Vol #:
|
| 4
|
| |
|
|
| LET 1
|
| FDA
|
| Vol #:
|
| 3
|
| |
|
|
| 2006D-0363
|
| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
|
| |
|
|
| EC 1
|
| Kensey Nash Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Duke University
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0362
|
| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
|
| |
|
|
| EC 1
|
| Duke University
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0416
|
| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
|
| |
|
|
| EC 2
|
| Mr. Charles Sodersten
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 982
|
| Mrs. Lisa Fontanarosa
|
| Vol #:
|
| 8
|
| |
|
|
| EC 983
|
| Ms. stephanie rubin
|
| Vol #:
|
| 8
|
| |
|
|
| EC 984
|
| Ms. Dawn Chapdelaine
|
| Vol #:
|
| 8
|
| |
|
|
| EC 985
|
| Mrs. rosalyn malihan
|
| Vol #:
|
| 8
|
| |
|
|
| EC 986
|
| Ms. G. S
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
| |
|
| EC 987
|
| Ms. Jessica Camponovo
|
| Vol #:
|
| 8
|
| |
|
|
| EC 988
|
| Miss. Mahshid Chowdhury
|
| Vol #:
|
| 8
|
| |
|
|
| EC 989
|
| Ms. Marilyn Giardini
|
| Vol #:
|
| 8
|
| |
|
|
| EC 990
|
| Ms. Jocelyn Richards
|
| Vol #:
|
| 8
|
| |
|
|
| EC 991
|
| Ms. Marguerite Nicholson-Schenk
|
| Vol #:
|
| 8
|
| |
|
|
| EC 992
|
| Miss. Kelly Toole
|
| Vol #:
|
| 8
|
| |
|
|
| EC 993
|
| Miss. Astra Kalodukas
|
| Vol #:
|
| 8
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| EC 898
|
| Mrs. chasity hobbs
|
| Vol #:
|
| 4
|
| |
|
|
| EC 899
|
| Mr. Francisco Gadea
|
| Vol #:
|
| 4
|
| |
|
|
| EC 900
|
| Mr. timothy lee
|
| Vol #:
|
| 4
|
| |
|
|
| EC 901
|
| Mrs. Germaine Rodriguez
|
| Vol #:
|
| 4
|
| |
|
|
| EC 902
|
| Mrs. Erin Borofka
|
| Vol #:
|
| 4
|
| |
|
|
| EC 903
|
| Miss. Korie Green
|
| Vol #:
|
| 4
|
| |
|
|
| EC 904
|
| Ms. ANTOINETTE PANICO
|
| Vol #:
|
| 4
|
| |
|
|
| EC 905
|
| Ms. Christy Claybourne
|
| Vol #:
|
| 4
|
| |
|
|
| EC 906
|
| Ms. kathryn Nelligan
|
| Vol #:
|
| 4
|
| |
|
|
| EC 907
|
| Mrs. donna kinsey
|
| Vol #:
|
| 4
|
| |
|
|
| EC 908
|
| Mr. Mark Haymond
|
| Vol #:
|
| 4
|
| |
|
|
| EC 909
|
| Mrs. Tasha Burnett
|
| Vol #:
|
| 4
|
| |
|
|
| EC 910
|
| Mrs. Vicki Knight
|
| Vol #:
|
| 4
|
| |
|
|
| 2006P-0508
|
| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
|
| |
|
|
| EC 2
|
| Dr. Thomas Tomasco
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
| |
|
|
| EC 32
|
| none
|
| Vol #:
|
| 3
|
| |
|
|
| 2007N-0015
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
|
| |
|
|
| EC 1
|
| Miss. BARB SACHAU
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0033
|
| Amend the Nutrition Facts label on food products as it relates to trans fats.
|
| |
|
|
| EC 1
|
| Mr. Francisco Gadea
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0037
|
| Declare that Loratadine Orally-Dissolving Strips, 5mg and 10mg, for an abbreviated new drug application (ANDA)
|
| |
|
|
| ACK 1
|
| FDA/DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
