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| Dockets Entered
On December 15, 2006
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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| 1978N-0038
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| Sunscreen Drug Products
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999E-5117
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| Patent Extension: Uvadex, #4,999,375
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2001V-0102
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| Laser light show projector
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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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| 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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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006D-0463
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| Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
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| 2006E-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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| 2006M-0015
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| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| 2006M-0512
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| P040023 - Duraloc Option Ceramic Hip System
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006N-0476
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| Drug Products Containing Quinine; Enforcement Action Dates
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| 2006N-0493
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome
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| 2006P-0249
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| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0484
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| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| 2006V-0485
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| Projector for a Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| SUP 11
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| Number not Used
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| Vol #:
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| 107
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| 1978N-0038
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| Sunscreen Drug Products
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| LET 180
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| FDA/CDER to Schering-Plough Consumer Healthcare
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| Vol #:
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| 150
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 52
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| F. Quarles, M.D.
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| Vol #:
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| 15
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| C 53
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| H. Brody, M.D.
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| Vol #:
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| 15
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| C 54
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| Dr. K. Maggio
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| Vol #:
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| 15
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| C 55
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| L. Thomas, M.D.
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| Vol #:
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| 15
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4436
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| Y. Bernstein
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| Vol #:
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| 320
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| 1999E-5117
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| Patent Extension: Uvadex, #4,999,375
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 662
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| S. Colquitt
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| Vol #:
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| 24
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| EMC 663
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| A. Braida
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| Vol #:
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| 24
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1398
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| M. Ryan
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| Vol #:
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| 259
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| 2001V-0102
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| Laser light show projector
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| VRA 2
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| FDA/CDRH to Nth Degree Creative
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| Vol #:
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| 1
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| C 368
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| Philip H. Dolinsky
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| Vol #:
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| 30
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 744
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| J. Bowen, MD
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| Vol #:
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| 10
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| EMC 745
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| F. Sturtevant, PhD
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| Vol #:
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| 10
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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 1393
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| C. Leong
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| Vol #:
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| 12
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| EMC 1394
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| N. Donovan
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| Vol #:
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| 12
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| EMC 1395
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| T. Weems
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| Vol #:
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| 12
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| EMC 1396
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| J. Thompson
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| Vol #:
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| 10
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| EMC 1397
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| I. Dana
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| Vol #:
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| 12
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| EMC 1398
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| T. Pickett
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| Vol #:
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| 12
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| APP 1
, Part 2
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER
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| Vol #:
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| 1
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| LET 2
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| U.S. Patent and Trademark Office to Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| 2006M-0015
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| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| CR 1
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| Biomet Manufacturing Corporation
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| Vol #:
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| 1
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| 2006M-0512
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| P040023 - Duraloc Option Ceramic Hip System
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| AAV 1
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| DePuy Orthopedics, Inc.
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| Vol #:
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| 1
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| 2006N-0037
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Trans Fat Claims on Foods
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2006N-0197
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EMC 1155
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| L. Brocato
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| Vol #:
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| 30
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| EMC 1156
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| M.E. Godfrey
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| Vol #:
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| 30
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| EMC 1157
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| T. Gaunt
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| Vol #:
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| 30
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| EXT 1
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| Ferrosan A/S, Sydmarken 5, DK-2860 Soeborg
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| Vol #:
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| 1
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| EMC 16
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| P. Gosler
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| Vol #:
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| 2
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| EMC 17
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| R. Cleghorn
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| Vol #:
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| 2
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| EC 24
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| Octagon Research Solutions
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| Vol #:
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| 2
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| 2006N-0476
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| Drug Products Containing Quinine; Enforcement Action Dates
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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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| 2006N-0493
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome
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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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| 2006P-0249
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| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
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| LET 1
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| FDA/CVM to Sidley Austin LLP
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| Vol #:
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| 1
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| C 1
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| Orthopedic Surgical Manufacturers Association (OSMA)
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| EC
446
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| Ms. Suzanne Jacobs
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| Vol #:
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| 7
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| C 2
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| C. Burroughs
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| Vol #:
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| 2
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| EMC 10
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| B. Luddington
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| Vol #:
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| 2
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| 2006P-0484
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| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
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| EC 2
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| Ms. Davis Mary C
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| Vol #:
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| 1
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| LET 1
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| Cargill, Inc.
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| Vol #:
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| 1
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| LET 2
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| FDA/CFSAN to Hyman Phelps & McNamara PC
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| Vol #:
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| 1
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| 2006V-0485
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| Projector for a Laser Light Show
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| VRA 1
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| FDA/CDRH to N9NE Group dba Moon Bar
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| Vol #:
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| 1
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