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| Dockets Entered
On December 28, 2006
Table of Contents
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| Docket #
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| Title
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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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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| 2006N-0292
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| Unique Device Identification
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| 2006N-0465
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| Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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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-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2006P-0522
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| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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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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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 69
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| R. Yu, PhD, OMD
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| Vol #:
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| 15
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| C
70
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| Dermedica Innovative Dermatology
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| Vol #:
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| 15
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| C 71
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| L. Hobbs, MD
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| Vol #:
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| 15
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| C
72
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| State University of New York Downstate Medical Center
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| Vol #:
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| 15
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| C
73
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| Cosmetic & Laser Surgery Institute
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| Vol #:
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| 15
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| EC
542
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| Dr. Robin Septon
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| Vol #:
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| 19
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| EC
543
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| Hudson Dermatology
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| Vol #:
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| 19
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| EC
544
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| Dr. Vaughn Millner
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| Vol #:
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| 19
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| EC
545
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| American Academy of Dermatology Association
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| Vol #:
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| 19
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| EC
546
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| Mrs. Gail Churinetz
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| Vol #:
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| 19
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| EC
547
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| Mrs. Tracey Rowley
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| Vol #:
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| 19
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| EC
548
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| Mrs. rosalena garrett
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| Vol #:
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| 19
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| EC
549
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| Mrs. denise apicella
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| Vol #:
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| 19
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| EC
550
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| Dr. Pearl Grimes
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| Vol #:
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| 19
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| MM
4
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| FDA and Natural Products Association
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| Vol #:
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| 43
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| EC 4
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| Association of Food and Drug Officials (AFDO)
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| Vol #:
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| 2
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| EC 5
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| Natural Products Association
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| Vol #:
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| 2
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| BKG
1
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| Risk Management Plan
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| Vol #:
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| 1
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| GDL
1
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| Draft Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| RA
1
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| Risk Assessment
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| Vol #:
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| 2
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 71
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| I. Imbasciani
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| Vol #:
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| 5
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| 2004P-0349
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| Action on Products containing added Mercury
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| ANS 1
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| FDA/OC to CoMed, Coalition for Mercury-Free Drugs
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| Vol #:
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| 4
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| REF 1
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| Reference Material (1-75)
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| Vol #:
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| 6
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| EC 5
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| Mrs. Deb Hofstetter
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| Vol #:
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| 1
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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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| EC 4825
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| Miss. Janet Parkinson
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| Vol #:
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| 26
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| EC 4826
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| Miss. Diane Knowles
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| Vol #:
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| 26
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| EC 4827
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| Mrs. Laura Briggs
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| Vol #:
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| 26
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| EC 4828
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| Mrs. Merry Ford
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| Vol #:
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| 26
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| EC 4829
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| Mr. Gregor Dick
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| Vol #:
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| 26
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| EC 4830
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| Mrs. Tonia Helm
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| Vol #:
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| 26
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| EC 4831
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| Mrs. Charlotte Sponseller
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| Vol #:
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| 26
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| EC 4832
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| Mr. Joseph Pandolfi
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| Vol #:
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| 26
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| EC 4833
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| Mrs. Nora Beaulieu
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| Vol #:
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| 26
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| EC 4834
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| Mr. Pete Holter
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| Vol #:
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| 26
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| EC 4835
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| Mrs. Elisa Giallombardo
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| Vol #:
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| 26
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| EC 4836
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| Mrs. Janet Vandegrift
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| Vol #:
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| 26
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| EC 4837
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| Mr. Richard Meehan
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| Vol #:
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| 26
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| EC 4838
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| Mr. Donald Keefe
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| Vol #:
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| 26
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| EC 5098
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| Ms. Josia Martin
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| Vol #:
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| 26
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| EC 5099
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| Mr. Mike Meziere
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| Vol #:
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| 26
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| EC 5100
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| Dr. Timothy Lock
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| Vol #:
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| 26
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| EC 5101
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| Mr. David Nelson
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| Vol #:
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| 26
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| EC 5102
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| Mr. Rodolfo Mora
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| Vol #:
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| 26
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| EC 5103
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| Mrs. Erin Salter
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| Vol #:
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| 26
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| EC 5104
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| Mrs. Leanne Seguin
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| Vol #:
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| 26
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| EC 5105
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| Mr. George Loegering
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| Vol #:
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| 26
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| EC 5106
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| Mr. Aaron Salter
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| Vol #:
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| 26
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| 2006N-0292
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| Unique Device Identification
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| C 27
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| Orthopedic Surgical Manufacturers Association (OSMA)
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| Vol #:
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| 8
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| C 28
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| Healthcare Distribution Management Association (HDMA)
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| Vol #:
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| 8
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| 2006N-0465
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| Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
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| EC 1
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| ForHealth Technologies, Inc.
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| Vol #:
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| 1
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| EC 17
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| Mr. Jerry Staton
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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
455
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| Mrs. Heather Gonzales
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| Vol #:
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| 7
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| EC
456
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| Ms. Paula Sonney
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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 4
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| M. Gardan
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| Vol #:
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| 2
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| C 5
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| D. Finger
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| Vol #:
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| 2
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| C 6
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| P. Joralemon
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| Vol #:
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| 2
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| EC 6
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| Ms. Denise Brander
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| Vol #:
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| 2
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| EC 7
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| Ms. Mary Donovan
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| Vol #:
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| 2
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| EC 8
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| N/A
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| Vol #:
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| 2
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| EC 9
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| Mrs. Reyna Walsh
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| Vol #:
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| 2
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| EC 10
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| Mrs. Pam Bianco
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| Vol #:
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| 2
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| EC 11
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| Mr. Robert Reuer
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| Vol #:
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| 2
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| EC 12
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| Miss. Lisa Fennell
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| Vol #:
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| 2
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| EC 13
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| United States Citizen
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| Vol #:
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| 2
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| EC 14
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| Miss. halyn hughes
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| Vol #:
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| 2
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| EC 15
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| Mr. John Tarantino
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| Vol #:
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| 2
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