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| Dockets Entered
On July 20, 2005
Table of Contents
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| Docket #
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| Title
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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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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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005M-0024
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| P010058 - OSTEOSPACE
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| 2005M-0025
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| P030029 - ADVIA Centaur Anti-HBs ReadyPack Reagents and ADVIA Centaur Anti-HBs ReadyPack Calibrators
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| 2005M-0026
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| P030028 - ARTISAN (Model 206 and 204) Phakic Intraocular Lens (PIOL) Verisyse (VRSM5US and VRSM6US) Phakic Intraocular Lens (PIOL)
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| 2005M-0027
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| P030022 - Reflection Ceramic Acetabular System
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| 2005M-0028
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| P030034 - Cervical-Stim Model 505L Cervical Fusion System
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| 2005M-0055
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| P930016/S017, STAR S4 Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 12/14/04
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| 2005M-0087
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| Premarket Approval for Eastman Kodak Company ( P030007), Kodak Mammography CAD Engine
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| 2005M-0088
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| Premarket Approval for Irvine Biomedical (P040014), IBI Therapy Cardiac Ablation System
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| 2005M-0089
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| P030030 - URYX Urethral Bulking Agent, Approved 12/16/04
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| 2005M-0092
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| P040006 - CHARITE Artificial Disc, Approved 10/26/04
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| 2005M-0109
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| P040004 - ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials
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| 2005M-0110
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| P040017 - ADVIA Centaur HAV Total Assay and ADVIA Centaur HAV Total Quality Control Materials
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| 2005M-0132
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| HDE Number: H030005, CoAxia NeuroFlo Catheter
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| 2005N-0032
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
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| 2005N-0147
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| Sprout Safety Public Meeting
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| 2005N-0201
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| Change of Name and Address; Technical Amendment
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0023
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| Determine if Tequin Injection 10mg/ml (200mg)- 20 mL was withdrawn for safety or effectiveness reasons
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| 2005P-0072
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| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| EC
386
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| Consumer Healthcare Products Association
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| Vol #:
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| 9
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| EC
387
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| Consumer Healthcare Products Association
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| Vol #:
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| 9
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| EC
388
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| American Society for Microbiology
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| Vol #:
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| 9
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| EC
389
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| CTFA
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| Vol #:
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| 9
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| EC
390
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| National Milk Producers Federation
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| Vol #:
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| 9
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| EC
391
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| American Heart Association - Food Certification
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| Vol #:
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| 9
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| EC 392
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| International Dairy Foods Association
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| Vol #:
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| 9
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| EC
393
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| International Dairy Foods Association
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| Vol #:
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| 9
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| EC
394
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| The American Dietetic Association
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| Vol #:
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| 9
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7499
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| E. Frey and R. Jackson
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| Vol #:
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| 319
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
7
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| Amphastar Pharmaceuticals, Inc.
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| Vol #:
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| 3
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| C 1
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| S. Skowronski
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| Vol #:
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| 1
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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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| C 97
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| M. Halladin
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| Vol #:
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| 15
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| C
7
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| GlaxoSmithKline Consumer Healthcare (GSK)
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| Vol #:
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| 3
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| C
5
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| C
6
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
7
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| American Association for Clinical Chemistry (AACC)
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| Vol #:
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| 1
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| C
1
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| AARP
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| Vol #:
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| 3
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| EC
4
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| Center for Science in the Public Interest
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 50
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| Mrs. S. and Mr. W. Belkin
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| Vol #:
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| 4
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| C
51
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| Apple Processors Association
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| Vol #:
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| 4
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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| SUPPORTING STATEMENT
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| Vol #:
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| 1
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| SUP
4
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| Fleminger Inc
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| Vol #:
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| 8
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| SUP
5
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| Dr Lee's TeaForHealth
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| Vol #:
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| 8
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| C
7
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| University of Western Australia
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
14
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| Johnson & Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 1
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| C
1
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| DynPort Vaccine Company, LLC (DVC)
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC
2
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| National Consumers League
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| Vol #:
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| 1
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| C
1
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| Bristol-Myers Squibb (BMS)
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| Vol #:
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| 1
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| |
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0024
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| P010058 - OSTEOSPACE
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0025
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| P030029 - ADVIA Centaur Anti-HBs ReadyPack Reagents and ADVIA Centaur Anti-HBs ReadyPack Calibrators
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0026
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| P030028 - ARTISAN (Model 206 and 204) Phakic Intraocular Lens (PIOL) Verisyse (VRSM5US and VRSM6US) Phakic Intraocular Lens (PIOL)
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0027
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| P030022 - Reflection Ceramic Acetabular System
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0028
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| P030034 - Cervical-Stim Model 505L Cervical Fusion System
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| N
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2005M-0055
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| P930016/S017, STAR S4 Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 12/14/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0087
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| Premarket Approval for Eastman Kodak Company ( P030007), Kodak Mammography CAD Engine
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| N
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2005M-0088
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| Premarket Approval for Irvine Biomedical (P040014), IBI Therapy Cardiac Ablation System
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0089
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| P030030 - URYX Urethral Bulking Agent, Approved 12/16/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0092
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| P040006 - CHARITE Artificial Disc, Approved 10/26/04
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0109
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| P040004 - ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0110
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| P040017 - ADVIA Centaur HAV Total Assay and ADVIA Centaur HAV Total Quality Control Materials
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005M-0132
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| HDE Number: H030005, CoAxia NeuroFlo Catheter
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0032
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| SUPPORTING STATEMENT
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| Vol #:
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| 142
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| 2005N-0147
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| Sprout Safety Public Meeting
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| EC
5
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| University of Guelph
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| Vol #:
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| 1
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| EC
6
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| University of Florida
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| Vol #:
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| 1
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| EC 7
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| Dr. Kathleen T. Rajkowski
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| Vol #:
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| 1
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| EC 8
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| USDA, ARS
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| Vol #:
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| 1
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| EC 9
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| USDA, ARS
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| Vol #:
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| 1
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| EC
10
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| Center for Science in the Public Interest
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| Vol #:
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| 1
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| EC
11
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| Jonathans Sprouts, Inc.
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| Vol #:
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| 1
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| 2005N-0201
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| Change of Name and Address; Technical Amendment
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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