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| Dockets Entered
On July 12, 2005
Table of Contents
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| Docket #
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| Title
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| 1975N-0256
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| Food Labeling & Label Declaration of Ingredient Requireme
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0549
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| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
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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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| 2003V-0131
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| Laser Light Show
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005V-0053
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| Projector for a Laser Light Show
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| 2005V-0126
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| Projector for a Laser Light Show
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| 2005V-0141
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| Laser Light Show
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| 2005V-0163
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| Projector for a Laser light Show
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| 2005V-0171
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| Laser Light Show
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| 2005V-0194
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| Laser Light Show
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| 1975N-0256
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| Food Labeling & Label Declaration of Ingredient Requireme
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| ANS 14
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| Office of Legislative Services
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| Vol #:
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| 2
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
756
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| Statistical Report - Month of June 2005
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| Vol #:
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| 54
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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| EMC 3
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| S. Levy, RN
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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 606
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| J. Butler
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| Vol #:
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| 24
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| EMC 11589
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| No signature
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| Vol #:
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| 349
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| EMC 11590
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| R. Holbert
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| Vol #:
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| 349
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| EMC 11591
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| A. Olejnik
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| Vol #:
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| 349
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 14477
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| C. Stubbs
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| Vol #:
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| 342
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| EMC 14478
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| R. Raymond
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| Vol #:
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| 342
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| EMC 14479
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| S. Tariot
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| Vol #:
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| 342
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| EMC 14480
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| L. Gaviria
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| Vol #:
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| 342
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| EMC 14481
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| B. Merlie
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| Vol #:
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| 342
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| EMC 14482
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| J. Porras
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| Vol #:
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| 342
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| EMC 14483
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| S. Dunn
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| Vol #:
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| 342
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3173
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| G. Lehman
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| Vol #:
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| 261
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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 1271
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| A. Erhard
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| Vol #:
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| 6
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| EMC 1272
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| W. Chiu
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| Vol #:
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| 6
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| EMC 1273
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| S. Dadswell
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| Vol #:
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| 6
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| EMC 1274
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| B. Longstreet
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| Vol #:
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| 6
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 226
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| E. Woodstock
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
480
Attachment
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| Calorie Control Council
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| Vol #:
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| 8
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| EMC 481
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 482
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 483
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| Mission Possible International
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| Vol #:
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| 8
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| EMC
484
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| Calorie Control Council
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| Vol #:
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| 8
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| EMC 485
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 486
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 487
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| Mission Possible International
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| Vol #:
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| 8
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| 2003D-0549
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| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
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| EMC 1
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| B. Sachau
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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 821
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| S. Arena
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| Vol #:
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| 11
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| EMC 822
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| D. Pang
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| Vol #:
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| 11
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| EMC 823
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| T. Miller
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| Vol #:
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| 11
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| EMC 824
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| J. Clark
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| Vol #:
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| 11
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| EMC 825
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| S. Phillips
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| Vol #:
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| 11
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| 2003V-0131
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| Laser Light Show
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| VRA
3
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| HFZ-200 to Laser Design Productions Inc
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| Vol #:
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| 1
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| EMC
13
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| RDRC 0038 - Lawrence Berkeley National Laboratory
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| Vol #:
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| 2
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| 2004N-0539
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| Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
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| EMC
2
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| 2005D-0106
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| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
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| EMC
2
Attachment
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| Aspreva Pharmaceuticals Corp.
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| Vol #:
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| 1
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| EMC 3
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| G. Ewing
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| EMC
2
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| RDRC #0038
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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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| EMC
1
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| Tatia Oden French Memorial Foundation
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| Vol #:
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| 1
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| EMC 2
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| B. Sachau
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| Vol #:
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| 1
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| EMC 3
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| B. Sachau
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| Vol #:
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| 1
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| EMC 1
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| S. Rampton
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| Vol #:
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| 1
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| EMC 1
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| M. Machacek
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| Vol #:
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| 1
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| EMC 2
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| J. Ley
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| Vol #:
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| 1
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| 2005P-0139
|
| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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