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| Dockets Entered
On November 22, 2004
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| 2000N-0504
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| Egg Safety Action Plan
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0352
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| Global Harmonization Task Force, Study Groups 1 and 2; New Proposed Documents
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0175
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| ANADA for ageneric intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED TM CIDR
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 2004V-0521
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| Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| BKG 1
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| Background Information
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| Vol #:
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| 77
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| C
832
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| Primera Foods
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| Vol #:
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| 33
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| C
833
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| Wilcox Family Farms
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| Vol #:
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| 33
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| C
856
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| Primera Foods
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| Vol #:
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| 32
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| C
857
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| Wilcox Family Farms
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| Vol #:
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| 32
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7462
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| E. Teixeira
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| Vol #:
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| 319
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| C 7463
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| K. Cassidy
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| Vol #:
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| 319
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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| C
1966
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| Primera Foods
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| Vol #:
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| 47
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| C
1967
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| Wilcox Family Farms
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| Vol #:
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| 47
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| 2000N-0504
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| Egg Safety Action Plan
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| C
129
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| Primera Foods
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| Vol #:
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| 10
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| C
130
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| Wilcox Family Farms
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| Vol #:
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| 10
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| C
1
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| National Association of Beverage Importers, Inc.
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| Vol #:
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| 1
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| C
11
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| Star Food Products, Inc.
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| Vol #:
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| 2
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| ANS
1
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| HF-22 to Emord & Associates PC (Wellness Lifestyles Inc & Life Extension Foundation Buyers Clu
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| Vol #:
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| 13
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| ANS
2
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| HF-22 to Hogan & Hartson LLP (Martek Biosciences Corp)
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| Vol #:
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| 13
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| REF 1
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| References & Footnotes to ANS1
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| 14
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| REF 2
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| References & Footnotes to ANS2
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| Vol #:
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| 25
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C
3
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| James Wells Associates (JWA)
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| Vol #:
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| 1
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| 2004D-0352
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| Global Harmonization Task Force, Study Groups 1 and 2; New Proposed Documents
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| C
2
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| Abbott Laboratories
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| Vol #:
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| 1
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| C
3
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| C
1
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS
3
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| HFA-305
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| Vol #:
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| 1
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| OR
3
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| HF-3
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| Vol #:
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| 1
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| 2004P-0175
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| ANADA for ageneric intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED TM CIDR
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| PAV
1
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| HFV-100 to Intervet Inc.
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| Vol #:
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| 1
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| C
2
Tab 1, Tab
2
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| IVAX Pharmaceuticals, Inc. (IVAX)
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| Vol #:
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| 1
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| 2004P-0411
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| Compel Enforcement and Regulation of Amyl Nitrate
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| SUP 2
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| H. Wilson
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| Vol #:
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| 3
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| ACK
1
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| HFA-305 to IVAX Pharmaceuticals, Inc.
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| Vol #:
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| 1
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