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| Dockets Entered
On April 6, 2004
Table of Contents
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| Docket #
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| Title
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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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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| 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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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002F-0181
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| Use of cetylpyridinium chloride as an antimicrobial
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004D-0027
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| Guidance for Industry on Time and Extent Applications
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| 2004N-0132
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
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| 2004N-0142
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| Removal of Delegations of Authority and Conforming Changes to Regulations
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
737
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| HFS-800 to Ullman, Shapiro & Ullman LLP
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| Vol #:
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| 22
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| LET
738
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| HFS-800 to Membrell LLC
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| Vol #:
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| 22
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| | | | | | | | |
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| LET
739
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| HFS-800 to Your Vitamins from Andrew Lessman
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| Vol #:
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| 22
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| LET
740
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| HFS-800 to Shaklee Corporation
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| Vol #:
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| 22
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| LET
741
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| HFS-800 to Health Direct
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| Vol #:
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| 22
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| LET
742
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| HFS-800 to Life Source Inc
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| Vol #:
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| 22
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| LET
743
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| HFS-800 to Aboca USA, Inc
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| Vol #:
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| 22
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| LET
744
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| HFS-800 to Bios Biochemicals
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| Vol #:
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| 22
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| LET
745
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| HFS-800 to Lyons Health Products
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| Vol #:
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| 22
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| LET
746
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| HFS-800 to Cell Tech International Incorporated
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| Vol #:
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| 22
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4176
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| D. Withers
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| Vol #:
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| 304
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| EMC 4177
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| D. Artemis
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| Vol #:
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| 304
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| EMC 4178
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| T. Ewing
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| Vol #:
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| 304
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| EMC 4179
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| P. Cavanagh
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| Vol #:
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| 304
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| EMC 4180
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| J. Bozzy
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| Vol #:
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| 304
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| EMC 4181
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| L. Loveman
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| Vol #:
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| 304
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| EMC 469
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| S. Donnelly
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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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| EMC 372
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| S. Donnelly
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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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| EMC 371
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| S. Donnelly
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| Vol #:
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| 6
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| EMC 374
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| S. Donnelly
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| Vol #:
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| 6
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4190
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| A. Scott
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| Vol #:
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| 515
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| EMC 4191
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| A. Scott
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| Vol #:
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| 515
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| EMC 4192
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| M. Hauck
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 530
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| K. Lukacovic
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| Vol #:
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| 24
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 771
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| R. Korenczuk
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| Vol #:
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| 33
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| EMC 772
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| L. Arnold
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| Vol #:
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| 33
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| EMC 5634
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| M. Ellingson
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| Vol #:
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| 200
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| EMC 5635
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| N. W. Alcock
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| Vol #:
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| 200
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| EMC 5636
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| A. Voet
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| Vol #:
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| 200
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| EMC 5637
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| P. McKinley
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| Vol #:
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| 200
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| EMC 5638
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| V. DeGrace
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| Vol #:
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| 200
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| EMC 5639
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| K. Towler
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| Vol #:
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| 200
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| EMC 5640
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| I. Hausner
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| Vol #:
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| 200
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| EMC 5641
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| R. Kevess MD
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| Vol #:
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| 200
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| EMC 5642
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| P. Meissner
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| Vol #:
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| 200
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| EMC 5643
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| M. Bernstein
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| Vol #:
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| 200
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| EMC 5644
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| G. Lengen
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| Vol #:
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| 200
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| EMC 5645
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| D. S. Clements
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| Vol #:
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| 200
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| 2001P-0345
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| Listing the color
additive yellow #5 for use in food/Drug
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| EMC 1227
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| A. Holmes
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| Vol #:
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| 5
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| EMC 1228
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| L. Thompson
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| Vol #:
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| 5
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| 2002F-0181
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| Use of cetylpyridinium
chloride as an antimicrobial
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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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| 2002N-0276
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| Bioterrorism Preparedness;
Registration of Food Facilities
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| C
219
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| Australian Government
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| Vol #:
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| 20
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| 2002N-0278
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| Bioterrorism; Prior
Notice of Imported Food Shipments
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| C
294
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| Australian Government
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| Vol #:
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| 22
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| EMC
165
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| Air Courier Conference of America
(ACCA)
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| Vol #:
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| 22
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| 2002P-0317
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| Recall Aspartame
as a Neurotoxic Drug
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| EMC 324
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| Dr. B. Martini
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| Vol #:
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| 6
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| EMC 325
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| Dr. B. Martini
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| Vol #:
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| 6
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| 2003D-0571
|
| Guidance for Industry
on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| C
1
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| DSM Anti-Infectives B.V.
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
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| EMC 153
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| P. Seibel
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| Vol #:
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| 3
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| EMC 154
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| S. Larsen
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| Vol #:
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| 3
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| EMC 155
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| F. Browning
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| Vol #:
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| 3
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| EMC 156
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| M. Gregory, RN,BSN
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| Vol #:
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| 3
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| EMC 157
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| R. Cline
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| Vol #:
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| 3
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| EMC 224
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| S. Rossi
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| Vol #:
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| 6
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| EMC 225
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| S. Rossi
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| Vol #:
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| 6
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| NAL
1
|
| FDA
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| Vol #:
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| 1
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|
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| SF
2
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| HF-1
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| Vol #:
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| 1
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| SF
3
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| HF-1
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| Vol #:
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| 1
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| EMC 50
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| G. Seaberg
|
| Vol #:
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| 9
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|
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 66
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| M. Brosh
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| Vol #:
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| 6
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| EMC 45
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| K. Amatneek
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| Vol #:
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| 2
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| EMC 19
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| K. Amatneek
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| Vol #:
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| 1
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| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| C
5
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| University of Florida
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| Vol #:
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| 1
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| 2004D-0027
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| Guidance for Industry on Time and Extent Applications
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| EMC
1
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 1
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| C
5
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| Wyeth Pharmaceuticals, Inc. (Wyeth)
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| Vol #:
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| 1
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| C
6
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| Bayer Pharmaceuticals Corporation (Bayer Pharma)
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| Vol #:
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| 1
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| C
7
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| Bayer HealthCare LLC, (Bayer BP)
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| Vol #:
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| 1
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| C
8
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| P&G Pharmaceuticals, Inc. (P&G)
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| Vol #:
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| 1
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| 2004N-0132
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
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| N
1
|
| FDA
|
| Vol #:
|
| 1
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| 2004N-0142
|
| Removal of Delegations of Authority and Conforming Changes to Regulations
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