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| Dockets Entered
On February 8, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1993F-0357
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| Safe use of Source of Fast (high energy) Neutrons
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0466
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Safety of Resid
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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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-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0361
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| Guidance for Industry; Prior Notice of Imported Food Contingency Plan for System Outages
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0422
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| Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004D-0462
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| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| 2004G-0381
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| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2004N-0093
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| Agency Information Collection Activities: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution , 21 CFR Part 207.
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| 2004N-0416
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| Beverages: Bottled Water
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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-0498
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005A-0014
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| Regarding hip joint metal constrained
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005N-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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| 2005N-0031
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
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| 2005N-0032
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0045
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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| EMC 124
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| L. Marshall
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| Vol #:
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| 2
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| EMC 125
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| M. Reed
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| Vol #:
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| 2
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| EMC 126
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| R. Pullen
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| Vol #:
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| 2
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| EMC 127
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| W. McClatchey
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| Vol #:
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| 2
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| EMC 128
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| W. Stroud
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| Vol #:
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| 2
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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 523
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| K. Makimaa
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| Vol #:
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| 9
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| EMC 524
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| J. Lavin
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| Vol #:
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| 9
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| EMC 525
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| A. Christensen
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| Vol #:
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| 9
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| EMC 526
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| K. Hansell
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| Vol #:
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| 9
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| EMC 527
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| M. Yamada
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| Vol #:
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| 9
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| EMC 528
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| U. Foggetti
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| Vol #:
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| 9
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| BKG
3
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| Background
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| Vol #:
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| 4
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| NM
2
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| FDA
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| Vol #:
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| 4
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| 2004D-0361
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| Guidance for Industry; Prior Notice of Imported Food Contingency Plan for System Outages
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| EC
4
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| OLBIS Ltd., Moscow
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 462
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| Miss. Carmen Olmedo
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| Vol #:
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| 17
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| EC 463
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| Miss. Laurie Leibel
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| Vol #:
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| 17
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| EC 464
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| Mr. Tom Rigby
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| Vol #:
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| 17
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| EC 465
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| Ms. Anna Reggiani
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| Vol #:
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| 17
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| EC
466
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| planet Earth
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| Vol #:
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| 17
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| EC 467
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| Mr. Bret walburg
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| Vol #:
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| 17
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| EC
468
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| The George Washington University Economics Dep't
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| Vol #:
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| 17
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| EC 469
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| Ms. Katherine Kemp
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| Vol #:
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| 17
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| EC 470
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| Ms. Sara Pic
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| Vol #:
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| 17
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| EC 471
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| Ms. eve mitchell
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| Vol #:
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| 17
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| EC 472
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| Dr. Monica Bolton
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| Vol #:
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| 17
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| EC
473
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| United Fresh Fruit and Vegetable Association
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| Vol #:
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| 17
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| EC 474
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| Mr. David Ingalsbe
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| Vol #:
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| 17
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| EC
475
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| Pioneer Hi-Bred International, Inc.
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| Vol #:
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| 17
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| EC
476
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| Law Offices of Steven D. Wiener
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| Vol #:
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| 17
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| EC 477
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| Mr. Thomas OConnor
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| Vol #:
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| 17
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| | | | | | | | |
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| EC 478
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| Dr. Frances Lamberts
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| Vol #:
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| 17
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| EC 479
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| Mr. Keith Abeles
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| Vol #:
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| 17
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| EC
480
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| National Campaign for Sustainable Agriculture
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| Vol #:
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| 17
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| EC 481
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| None
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| Vol #:
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| 17
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| EC 482
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| None
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| Vol #:
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| 17
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| EC 483
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| Mrs. Tere Daane
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| Vol #:
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| 17
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| EC 484
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| Ms. Vicki Gay
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| Vol #:
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| 17
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| EC 485
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| Dr. Michael Phillips
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| Vol #:
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| 17
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| EC 486
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| Miss. Anna Galle
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| Vol #:
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| 17
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| EC 487
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| Mr. Greg Blomstrom
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| Vol #:
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| 17
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| EC
488
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| HEB Grocery Co LP
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| Vol #:
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| 17
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| EC
489
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| ILSI Health and Environmental Sciences Institute
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| Vol #:
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| 17
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| EC
490
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| Consumers Union
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| Vol #:
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| 17
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| EC 491
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| Ms. Justine Holgan
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| Vol #:
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| 17
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| EC 492
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| Ms. Patricia O'Leary
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| Vol #:
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| 17
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| EC 493
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| independent citizen
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| Vol #:
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| 17
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| EC
494
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| Grupo de Estudios Ambientales
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| Vol #:
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| 17
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| EC
495
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| University of California Santa Cruz
|
| Vol #:
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| 17
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| EC 496
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| Ms. Debby Bolen RN
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| Vol #:
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| 17
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| EC 497
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| Mrs. Isobel Reinhardt
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| Vol #:
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| 17
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| EC
498
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| The Center for Food Safety
|
| Vol #:
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| 17
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| EC 499
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| Ms. Lisa Reinhardt
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| Vol #:
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| 17
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| EC 500
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| Mr. Ray Reinhardt
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| Vol #:
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| 17
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|
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| EC 501
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| Ms. Raquel Carrillo
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| Vol #:
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| 17
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|
|
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| EC 502
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| Ms. Babette Bolton
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| Vol #:
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| 17
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|
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| EC 503
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| Miss. Lisa Marselle
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| Vol #:
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| 17
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| EC 504
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| Mr. Trey Carland
|
| Vol #:
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| 17
|
|
|
|
|
| 2004D-0422
|
| Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
|
|
|
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 1
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
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| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0460
|
| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
|
|
|
|
|
|
|
|
|
| EC 3
|
| Mr. Peter Ritz
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0462
|
| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
|
|
| | | | | | | | |
|
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| EC
1
|
| Sangart, Inc.
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| Vol #:
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| 1
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| EC
2
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| Sangart, Inc.
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| Vol #:
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| 1
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| EC
3
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| Alliance Pharmaceutical Corp.
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| Vol #:
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| 1
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| EC
4
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| AABB
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| Vol #:
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| 1
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|
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| EC
5
Attachment
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| Health Research Associates
|
| Vol #:
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| 1
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|
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|
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| EC
6
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| America's Blood Centers
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0493
|
| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
|
|
|
|
|
| EC
1
|
| GlaxoSmithKline
|
| Vol #:
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| 1
|
|
|
|
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| EC
2
|
| Pfizer
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004G-0381
|
| Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
|
|
| EC
5
|
| Food Marketing Institute
|
| Vol #:
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| 1
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|
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|
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| EC
6
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| International Fresh-cut Produce Association
|
| Vol #:
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| 1
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|
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| EC
7
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| Federal Express Corporation
|
| Vol #:
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| 1
|
|
|
|
|
| EC
8
|
| Grocery Manufacturers of America
|
| Vol #:
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| 1
|
|
|
|
|
| 2004N-0093
|
| Agency Information Collection Activities: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution , 21 CFR Part 207.
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
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| SS
1
|
| Supporting Statement
|
| Vol #:
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| 1
|
|
|
|
|
| 2004N-0416
|
| Beverages: Bottled Water
|
|
|
|
|
| EMC
2
|
| International Bottled Water Assn (IBWA)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
|
|
|
|
| EMC 526
|
| G. West
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 527
|
| D. McMahon, ND
|
| Vol #:
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| 8
|
|
|
|
|
| EMC 528
|
| S. Seay
|
| Vol #:
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| 8
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|
|
|
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| EMC 529
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| D. Stittgen
|
| Vol #:
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| 8
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|
|
|
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| EMC 530
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| M. Brenard
|
| Vol #:
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| 8
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|
|
|
|
| EMC 531
|
| D. Beamer
|
| Vol #:
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| 8
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|
|
|
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| EMC 532
|
| C. Squier
|
| Vol #:
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| 8
|
|
|
|
|
| EMC 533
|
| J. Zayachek
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 534
|
| M. McDaniel
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 535
|
| K. Eisenhart
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 536
|
| S. Knutson
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 537
|
| E. Leach
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 538
|
| R. Fucetola, JD
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 539
|
| V. Fisher
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
|
|
|
| EC 32
|
| Ms. donna powell
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 33
|
| Mrs. Tina Moore
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 34
|
| Dr. Richard Seedman, DVM
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 35
|
| Dr. gigi gaulin
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 36
|
| Dr. Paula Broadfoot
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 37
|
| Ms. Susan Michetti
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0498
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
|
|
|
|
|
| EC
1
|
| EID Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| EMC
17
|
| Westeon A. Price Foundation
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005A-0014
|
| Regarding hip joint metal constrained
|
|
|
|
|
| ACK 2
|
| HFA-305 to Bill G. Pierson # 907177
|
| Vol #:
|
| 1
|
|
|
|
|
| AP 2
|
| Bill G. Pierson # 907177
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0022
|
| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0016
|
| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0031
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
|
|
| |
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0032
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
|
|
|
|
| NH
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0045
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
