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| Dockets Entered
On August 15, 2005
Table of Contents
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 2000D-0835
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| Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic
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| 2000P-1443
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| Stay against approval of Alendronate Sodium Tablets
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| 2000P-1445
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| Paragraph IV ANDAs/180-Day Exclusivity Purporses
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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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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0217
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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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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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
757
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| Statistical Report - Month of July 2005
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| Vol #:
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| 54
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| C
98
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| Chocolate Manufacturers Association (CMA)
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| Vol #:
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| 3
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| C
99
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| Association for Dressings and Sauces (ADS)
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| Vol #:
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| 3
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| EC
1
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| Calorie Control Council
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| Vol #:
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| 3
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| EC
2
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| International Food Additives Council
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| Vol #:
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| 3
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7502
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| L. Scinto
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| Vol #:
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| 319
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| NFR
1
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| FDA
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| Vol #:
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| 5
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| 2000D-0835
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| Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2000P-1443
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| Stay against approval of Alendronate Sodium Tablets
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| GDL
1
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| Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
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| Vol #:
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| 1
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| 2000P-1445
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| Paragraph IV ANDAs/180-Day Exclusivity Purporses
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| GDL
1
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| Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
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| Vol #:
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| 1
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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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| C
7
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| C 68
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| J. C. Wimmer
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| Vol #:
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| 5
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| LET
9
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| Marine Bio Co Ltd
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| Vol #:
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| 15
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| LET
11
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| Marine Bio Co Ltd
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| Vol #:
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| 9
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| LET
9
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| Marine Bio Co Ltd
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| Vol #:
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| 4
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| LET
9
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| Marine Bio Co Ltd
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| Vol #:
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| 6
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| C
11
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| Quintiles Transnational Corp
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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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| CS 1
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| HFA-305
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| Vol #:
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| 1
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| OR 1
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| HF-3 to TMJ Implants, Inc.
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| Vol #:
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| 1
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| 2005N-0217
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
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| C
1
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| L'Oreal USA Products, Inc.
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| Vol #:
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| 1
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| EC 1
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| L'O'real USA
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| Vol #:
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| 1
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| EC 2
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| L'Oreal USA
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| Vol #:
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| 1
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| EC 3
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| CTFA
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| Vol #:
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| 1
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| NM
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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