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| Dockets Entered
On June 1, 2005
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2004P-0280
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| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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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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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16113
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| Arkopharma, LLC
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| Vol #:
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| 143
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| LET
16114
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| InterMedica, LLC
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| Vol #:
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| 143
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| LET
16115
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| Tronex Pharmaceuitcal Industries
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| Vol #:
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| 143
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| LET
16116
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| Neways International, Inc.
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| Vol #:
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| 143
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| LET
16117
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| Neways International, Inc.
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| Vol #:
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| 143
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| C
83
Attachments
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| Public Citizen and Center for Food Safety
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| Vol #:
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| 8
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| C
81
Attachments
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| Public Citizen and Center for Food Safety
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| Vol #:
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| 8
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| C
80
Attachments
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| Public Citizen and Center for Food Safety
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| Vol #:
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| 6
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| 2000N-0504
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| Egg Safety Action Plan
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| EXT 1
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| United Egg Producers/United Egg Association
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| Vol #:
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| 32
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| C
79
Attachments
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| Center for Food Safety and Public Citizen
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| Vol #:
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| 8
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| C
2
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| Abbott
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| Vol #:
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| 1
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| SUP
4
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| Compassion Over Killing, Inc
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| Vol #:
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| 9
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| 2004P-0280
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| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
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| PDN
1
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| HFD-600 to Nico Worldwide, LLC
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| Vol #:
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| 1
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| 2005D-0101
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| Guidance: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Asociated Delivery System
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| C
3
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| Quintiles, Inc.
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| Vol #:
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| 1
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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
6
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| ASCO
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| Vol #:
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| 1
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| C
7
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| Quorum Review, Inc.
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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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| EXT 1
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| B. Sachau
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| Vol #:
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| 1
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| CR
1
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| IVAX Pharmaceuticals, Inc.
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| Vol #:
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| 1
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