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| Dockets Entered
On November 10, 2004
Table of Contents
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| Docket #
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| Title
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| 1986V-0090
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| SPECTRASCAN PROJECTOR WITH HS-100 SCANNING CONTROL SYSTEM
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| 1988N-0004
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| Pediatric dosing information for OTC; request for informatio
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| 1993V-0133
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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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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| 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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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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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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| 2003D-0562
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| Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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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-0481
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions
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| 2003V-0293
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| Laser Light Show
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| 2003V-0306
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| Laser Light Show
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| 2004N-0244
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2004N-0332
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Devices; Third Party Review under FDAMA
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| 2004N-0428
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| Preparation for the International Conference on Harmonization Meetings in Yokohama, Japan: Public Meeting
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004N-0470
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| 2004N-0502
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| Animal Models and Correlates of Protection for Plague Vaccines, Public Workshop
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| 2004P-0059
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| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0489
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| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
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| 2004P-0500
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| Meperidine Hydrochloirde Tablets in two strengths of 75 mg and 150 mg suitable for ANDA
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 1986V-0090
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| SPECTRASCAN PROJECTOR WITH HS-100 SCANNING CONTROL SYSTEM
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| VRA
7
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| HFZ-300 to Holo Spectra, Inc.
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| Vol #:
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| 1
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| 1988N-0004
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| Pediatric dosing information for OTC; request for informatio
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| BKG 1
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| Background Material
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| Vol #:
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| 1
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| 1993V-0133
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| Laser Light Show
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| VRA
6
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| HFZ-300 to Flandrau Science Center & Planetarium
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| Vol #:
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| 1
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14729
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14730
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14731
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| Perrigo Company of South Carolina
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| Vol #:
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| 129
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| LET
14732
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| Ashbury Biologicals Inc.
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| Vol #:
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| 129
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| LET
14733
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| Ashbury Biologicals Inc.
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| Vol #:
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| 129
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| LET
14734
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| Ajinomoto U.S.A., Inc.
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| Vol #:
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| 129
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| LET
14735
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| Advocare International, L.P.
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| Vol #:
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| 129
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| LET
14736
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 129
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| LET
14737
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 129
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| LET
14738
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| Fitness Labs Nutritiion Corporation
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| Vol #:
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| 129
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| LET
14739
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| Fitness Labs Nutrition Corporation
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| Vol #:
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| 129
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4288
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| P. Pannucci
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| Vol #:
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| 320
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| EMC 4289
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| P. Pannucci
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| Vol #:
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| 320
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| EMC 4290
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| A. Mithoff
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| Vol #:
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| 320
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 559
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| D. Steinberg
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| Vol #:
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| 24
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| |
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| C 617
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| S. Brown
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| Vol #:
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| 33
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| SUP 1
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| R. Claypool
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| Vol #:
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| 3
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 10987
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| N. Lai
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| Vol #:
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| 296
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| EMC 10988
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| B. Dore
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| Vol #:
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| 286
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| EMC 10989
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| E. Chang
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| Vol #:
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| 296
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| EMC 10990
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| S. Adams
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| Vol #:
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| 296
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| EMC 10991
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| F. Frenkel
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| Vol #:
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| 296
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| | | | | | | | |
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| EMC 11066
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| S. Draper
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| Vol #:
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| 296
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| EMC 11067
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| L. Brown
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| Vol #:
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| 296
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| EMC 11068
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| A. Alexy
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| Vol #:
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| 296
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| EMC 11069
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| B. Clapper
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| Vol #:
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| 296
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| EMC 11070
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| S. Trieu
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| Vol #:
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| 296
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| EMC 11071
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| B. Peterson
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| Vol #:
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| 296
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|
|
|
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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 1250
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| D. Jong
|
| Vol #:
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| 5
|
|
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 195
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| B. Hickey
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| Vol #:
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| 3
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| EMC 196
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| B. Hickey
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| Vol #:
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| 3
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|
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|
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| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| GDL
4
|
| Guidance
|
| Vol #:
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| 1
|
|
|
|
|
| NAD
4
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0562
|
| Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
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| 1
|
|
|
|
|
| NAD
2
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| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 450
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| No signature
|
| Vol #:
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| 9
|
|
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|
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| EMC 451
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| J. Stevens
|
| Vol #:
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| 9
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| EMC 452
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| C. Zvolanek
|
| Vol #:
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| 9
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|
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| EMC 453
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| J. Cline
|
| Vol #:
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| 9
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| EMC 454
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| B. Pinkham, Jr.
|
| Vol #:
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| 9
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| EMC 455
|
| M. Twyford
|
| Vol #:
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| 9
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|
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| EMC 456
|
| R. Bradsher
|
| Vol #:
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| 9
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
|
|
| EMC
276
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
277
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0481
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003V-0293
|
| Laser Light Show
|
|
| | | | | | | | |
|
| |
|
| VRA
2
|
| HFZ-300 to LumaLaser
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003V-0306
|
| Laser Light Show
|
|
|
|
|
| VRA
1
|
| HFZ-300 to Visiotopic System LLC
|
| Vol #:
|
| 1
|
|
| |
|
| 2004D-0465
|
| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
|
|
|
|
|
|
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0466
|
| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0468
|
| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
|
|
|
|
|
|
|
|
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0244
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0332
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Devices; Third Party Review under FDAMA
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0428
|
| Preparation for the International Conference on Harmonization Meetings in Yokohama, Japan: Public Meeting
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| TR
1
|
| Transcript of October 19, 2004 Public Meeting
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
|
|
|
|
| EMC 3
|
| T. Singeltary Sr.
|
| Vol #:
|
| 1
|
|
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|
| EMC 4
|
| T. Singeltary Sr.
|
| Vol #:
|
| 1
|
|
| |
|
| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
|
|
|
|
|
| BKG
1
|
| Implementation Strategy
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0470
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0480
|
| The Minor Use & Minor Species (MUMS) Animal Health Act
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| | | | | | | | |
|
|
|
| 2004N-0502
|
| Animal Models and Correlates of Protection for Plague Vaccines, Public Workshop
|
|
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| TR
1
Part 2, part
3
|
| Transcript of October 13, 2004 Workshop
|
| Vol #:
|
| 1
|
|
|
|
|
| TR
2
Part 2
|
| Transcript of October 14, 2004 Workshop
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| EMC
2
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 13
|
|
|
|
|
| 2004P-0489
|
| ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection
|
|
|
|
|
| WDL
1
|
| Bioniche Animal Health USA, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0500
|
| Meperidine Hydrochloirde Tablets in two strengths of 75 mg and 150 mg suitable for ANDA
|
|
|
|
|
| ACK
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
Attachment A,
B, C
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| EMC
2
|
| Emord & Associates, P.C.
|
| Vol #:
|
| 11
|
|
