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| Dockets Entered
On December 21, 2004
Table of Contents
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| Docket #
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| Title
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| 1993F-0357
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| Safe use of Source of Fast (high energy) Neutrons
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001D-0582
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| Available Therapy
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|
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| 2001D-0584
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| Reduce the Risk of Transmission of HIV-1 & HCV
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|
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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|
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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|
|
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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|
|
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| 2004D-0478
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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|
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|
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| 2004D-0510
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| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
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|
|
|
|
| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| 2004N-0461
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| Amendment to 25.34; Categorical Exclusions Environmental Assessment
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|
|
|
|
| 2004N-0477
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| Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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|
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| 2004N-0486
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages
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|
|
|
| 2004P-0265
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| Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
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|
|
|
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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|
|
|
|
| 2004P-0551
|
| ANADA Suitablity petition for Omeprazole tablet for Horses
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| 2004V-0552
|
| Laser Light Show regarding Mobolazer RG-50 Beam
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|
|
|
|
| 2004V-0553
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| Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems
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|
|
|
| 1993F-0357
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| Safe use of Source of Fast (high energy) Neutrons
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|
|
| BKG 1
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| Background Material
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| Vol #:
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| 1
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|
|
|
|
| NFR
1
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| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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|
|
|
|
| LET
15034
|
| North American Pharmacal Inc,
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| Vol #:
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| 133
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|
|
|
|
| LET
15035
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15036
|
| Earthrise Nutritionals, Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15037
|
| Yu Sheng Tang Chinese Herbal Medicine, LLC
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15038
|
| Market America, Inc.
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15039
|
| Window Rock Enterprises, Inc.
|
| Vol #:
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| 133
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|
| | | | | | | | |
|
|
|
|
| LET
15040
|
| BioPerfect Research Institute
|
| Vol #:
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| 133
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|
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|
|
| LET
15041
|
| BioPerfect Research Institute
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15042
|
| Ajinomoto Corporate Services LLC
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15043
|
| Enzymatic Therapy
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15044
|
| Enzymatic Therapy
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15045
|
| Synergy Worldwide
|
| Vol #:
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| 133
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|
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|
|
| LET
15046
|
| Renaissance Herbs
|
| Vol #:
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| 133
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|
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|
|
| LET
15047
|
| Tabak's Health Products
|
| Vol #:
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| 133
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|
|
|
|
| LET
15048
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| Atkins N utritionals, Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15049
|
| Atkins Nutritionals, Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15050
|
| Atkins Nutritionals, Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15051
|
| Atkins Nutritionals, Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15052
|
| Shining Mountain Herbs
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15053
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15054
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15055
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| Source Naturals
|
| Vol #:
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| 133
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|
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|
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| LET
15056
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| Vital Nutrients
|
| Vol #:
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| 133
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|
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|
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| LET
15057
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| A.L.A. Corporation
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| Vol #:
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| 133
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|
|
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| LET
15058
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| A.L.A. Corporation
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| Vol #:
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| 133
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|
|
|
|
| LET
15059
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| FoodScience Corporation
|
| Vol #:
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| 133
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|
|
|
|
| LET
15060
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| North American Pharmacal Inc.
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| Vol #:
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| 133
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|
|
|
|
| LET
15061
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| North American Pharmacal Inc.
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| Vol #:
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| 133
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|
|
|
|
| LET
15062
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15063
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15064
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15065
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
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| LET
15066
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15067
|
| Enzymatic Therapy
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15068
|
| Atrium Biotechnologies Inc.
|
| Vol #:
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| 133
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|
|
|
|
| LET
15069
|
| Tradeworks Group, Inc.
|
| Vol #:
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| 133
|
|
|
|
|
| LET
15070
|
| North American Pharmacal Inc.
|
| Vol #:
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| 133
|
|
|
|
|
| 2000N-0504
|
| Egg Safety Action Plan
|
|
|
|
|
| C 192
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| L.S. Baumann
|
| Vol #:
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| 19
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|
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|
|
| C
193
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| Js West and Companies
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| Vol #:
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| 19
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|
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|
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| C 194
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| R. Chase
|
| Vol #:
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| 19
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|
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|
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| C 195
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| A. Blackwelder
|
| Vol #:
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| 19
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|
| | | | | | | | |
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| C 196
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| No signature
|
| Vol #:
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| 19
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| C 197
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| J. Holzman
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| Vol #:
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| 19
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| C 198
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| K. Hughes
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| Vol #:
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| 19
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| C 199
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| S. Pannell
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| Vol #:
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| 19
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| C 200
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| K. Dalenberg
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| Vol #:
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| 19
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| C 201
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| P. Breitman
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| Vol #:
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| 19
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|
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| C 202
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| Illegible
|
| Vol #:
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| 19
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|
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|
|
| C
203
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| Briarwood Farms
|
| Vol #:
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| 19
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|
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|
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| C 204
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| Form letter
|
| Vol #:
|
| 19
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|
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|
|
| C
205
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| Food Animal Concerns Trust (FACT)
|
| Vol #:
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| 19
|
|
|
|
|
| C
206
|
| US Poultry & Egg Assn
|
| Vol #:
|
| 19
|
|
|
|
|
| C
207
|
| Egg Fusion, Inc.
|
| Vol #:
|
| 19
|
|
|
|
|
| C
208
|
| Daybreak Foods
|
| Vol #:
|
| 19
|
|
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|
|
| C
209
|
| Michael Foods Egg Products Company
|
| Vol #:
|
| 19
|
|
|
|
|
| C
210
|
| Rembrandt Enterprises, Inc.
|
| Vol #:
|
| 19
|
|
|
|
|
| C
211
|
| Viva!USA
|
| Vol #:
|
| 19
|
|
|
|
|
| C 212
|
| C. Kucsera
|
| Vol #:
|
| 19
|
|
|
|
|
| C 213
|
| T. Kucsera
|
| Vol #:
|
| 19
|
|
|
|
|
| C 214
|
| J. Alexander
|
| Vol #:
|
| 19
|
|
|
|
|
| C 215
|
| G. Curry
|
| Vol #:
|
| 19
|
|
|
|
|
| C 216
|
| J.W.F. Holliday
|
| Vol #:
|
| 19
|
|
|
|
|
| C 217
|
| M and M Kelly
|
| Vol #:
|
| 19
|
|
|
|
|
| C 218
|
| J. Bulik
|
| Vol #:
|
| 19
|
|
|
|
|
| C 219
|
| A. Baekey
|
| Vol #:
|
| 19
|
|
|
|
|
| EC 19
|
| Ms. Linda Hawkins
|
| Vol #:
|
| 18
|
|
|
|
|
| EC
20
|
| Minnesota Department of Agriculture
|
| Vol #:
|
| 18
|
|
|
|
|
| 2001D-0582
|
| Available Therapy
|
|
|
|
|
| EC 2
|
| Dr. John R. Schneider MD, FACP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001D-0584
|
| Reduce the Risk of Transmission of HIV-1 & HCV
|
|
|
|
|
| EC 2
|
| Mr. john davis
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| EC
14
|
| Association of American Feed Control officials (AA
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
|
|
|
| C
13
|
| Wisconsin Healthcare engineering Assn
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
|
|
| EC 1
|
| Ms. Margaret Weber
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Swindon Friends of the Earth
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
|
| ActionAid Brasil
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Mr. Michael Sackin
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0377
|
| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
|
|
|
|
|
|
|
|
|
|
|
| C
7
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
8
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
9
|
| Novartis Pharmaceuticals Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0378
|
| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
|
|
|
|
|
|
|
|
|
| C
4
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
6
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
|
|
| C
7
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0440
|
| Guidance for Industry on Computerized Systems Used in Clinical Trials
|
|
|
|
|
| EC
2
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
|
| H. Lundbeck A/S
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0459
|
| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
|
|
|
|
|
| EC
1
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0478
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
|
|
|
|
|
|
|
|
|
| GDL
1
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0510
|
| Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
|
|
|
|
|
| EC
1
|
| National Fisheries Institute
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
1
|
| Mortillaro Lobster, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
2
|
| Boston Lobster Company
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
3
|
| ABX Logistics
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
4
|
| Main Lobster
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
5
|
| Congr4ess of the United States
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
6
|
| House of Representatives, Connecticut
|
| Vol #:
|
| 1
|
|
|
|
|
| EXT
7
|
| Garbo Lobster
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| C
1
|
| University of Southern California (USC)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0461
|
| Amendment to 25.34; Categorical Exclusions Environmental Assessment
|
|
|
|
|
| EC
1
|
| PPD INC.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0477
|
| Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0486
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Experimental Study of Health Claims on Food Packages
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0265
|
| Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
|
|
|
|
|
| LET
1
|
| HFD-005 to Winston Laboratories, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
|
|
| C
4
Attachment
1, 2
|
| Noven Pharmaceuticals, Inc. (Noven)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0551
|
| ANADA Suitablity petition for Omeprazole tablet for Horses
|
|
|
|
|
| ACK
1
|
| HFA-305 to Intervet Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| AKZO NOBEL
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| LST
1
|
| Agenda for November 8, 2004 meeting
|
| Vol #:
|
| 2
|
|
|
|
|
| LST
2
|
| Attendees to November 8, 2004 meeting
|
| Vol #:
|
| 2
|
|
|
|
|
| TR
1
|
| Transcript the November 8, 2004 meeting
|
| Vol #:
|
| 3
|
|
|
|
|
| TS
1
|
| Infectious Diseases Society of America (IDSA)
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
2
|
| Cook Group Incorporated
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
3
|
| Management Science Associates, Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
4
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
5
Attachment
|
| American Clinical Laboratory Association
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
6
|
| Pharmaceutical Research & Manufacturers of America (PhRMA)
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
7
|
| Cary Pharmaceuticals Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| TS
8
|
| CSM Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004V-0552
|
| Laser Light Show regarding Mobolazer RG-50 Beam
|
|
|
|
|
| ACK
1
|
| G and G Sound and Lighting
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| G and G Sound and Lighting
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0553
|
| Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems
|
|
