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| Dockets Entered
November 9, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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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-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0183
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0420
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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| 2006N-0433
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-mail to Submit A Notice of Final Disposition Of Animals Not Intended For Immediate
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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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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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 11
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| Miss. Sabrina Payne
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| Vol #:
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| 4
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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 18203
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| Puronyx Inc
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| Vol #:
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| 167
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| LET 18204
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| Mannatech Incorporated
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| Vol #:
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| 167
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| LET 18205
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| Mannatech Incorporated
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| Vol #:
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| 167
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| LET 18206
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18207
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18208
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18209
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18210
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18211
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| NewMark: A Division of New Chapter Inc
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| Vol #:
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| 167
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| LET 18212
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| LET 18213
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| | | | | | | | |
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| |
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| LET 18214
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| LET 18215
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| |
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 36
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| Strides Inc.
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| Vol #:
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| 5
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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 1378
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| K. Jackson
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| Vol #:
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| 12
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| EMC 1379
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| No Submitter
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| Vol #:
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| 12
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| EC 20
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| Ms. Theresa Dowling
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18200
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| L. Westover
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| Vol #:
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| 198
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| C 18201
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| L. Westover
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| Vol #:
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| 198
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| C 18202
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| A. Kalokermos
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| Vol #:
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| 198
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| C 18203
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| M. Morgan
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| Vol #:
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| 198
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| C 18204
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| S. Hegstad
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| Vol #:
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| 198
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| C 18205
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| S. Paulson
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| Vol #:
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| 198
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| EMC 4084
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| E. Munoz
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| Vol #:
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| 195
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 54
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| R Adams Cowley Shock Trauma Center
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| Vol #:
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| 3
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| EC 6
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| NYU School of Medicine
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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 833
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| Mr. Rodrigo Gormaz T.
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| Vol #:
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| 4
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| EC 834
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| Mr. Chris Fasnacht
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| Vol #:
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| 4
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| EC 835
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| Mrs. Becky Fasnacht
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| Vol #:
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| 4
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| EC 836
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| University of Massachusetts
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| Vol #:
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| 4
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| EC 837
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| Mrs. Lisa Buss
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| Vol #:
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| 4
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| EC 838
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| Commonwealth Insurance of Seminole, Inc.
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| Vol #:
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| 4
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| EC 839
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| Carenet-Educational
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| Vol #:
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| 4
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| EC 840
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| Mrs. Peggy Oshinski
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| Vol #:
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| 4
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| EC 841
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| Mr. Geoffrey Measel
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| Vol #:
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| 4
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| EC 842
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| Mrs. Mary Rhyne
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| Vol #:
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| 4
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| | | | | | | | |
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| |
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| EC 1178
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| Mrs. Marie Conroy-Salbi
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| Vol #:
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| 5
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| EC 1179
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| Mrs. Jodie Peyton
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| Vol #:
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| 5
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| EC 1180
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| Tyler Diocesan Council of Catholic Women
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| Vol #:
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| 5
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| EC 1181
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| Mr. Steve DeDecker
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| Vol #:
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| 5
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| EC 1182
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| Mrs. Lucy Maes
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| Vol #:
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| 5
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| EC 1183
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| Mrs. Katie Drolshagen
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| Vol #:
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| 5
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| EC 1184
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| Ms. Brenda Polk
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| Vol #:
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| 5
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| EC 1185
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| Mrs. Carol Recker
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| Vol #:
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| 5
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| EC 1186
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| RN
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| Vol #:
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| 5
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| EC 1187
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| Mrs. Connie Vreeland
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| Vol #:
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| 5
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| EC 1188
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| Mrs. Catherine Mungo
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| Vol #:
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| 5
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| EC 1189
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| Mrs. Anne Netzel
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| Vol #:
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| 5
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| EC 1190
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| Mrs. Virginia Mikell
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| Vol #:
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| 5
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|
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| EC 1191
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| Mrs. Patricia Hart
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| Vol #:
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| 5
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| EC 1192
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| Mrs. Stacy Byce
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| Vol #:
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| 5
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| EC 1193
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| Mrs. Susan Elsen
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| Vol #:
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| 5
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| EC 1194
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| NA
|
| Vol #:
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| 5
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| EC 1195
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| Mrs. Ruth Longwell
|
| Vol #:
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| 5
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| EC 1196
|
| Mrs. eileen huber
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| Vol #:
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| 5
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| EC 1197
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| Mr. Mark Bradford
|
| Vol #:
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| 5
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|
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| EC 1198
|
| Mr. Zachariah Clark
|
| Vol #:
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| 5
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|
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|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
|
|
| EC 24
|
| Ms. Jane Hollenberg
|
| Vol #:
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| 12
|
|
|
|
|
| 2006N-0183
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
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| 1
|
|
|
|
|
| 2006N-0292
|
| Unique Device Identification
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|
|
|
|
| EC 32
|
| ASPECT MEDICAL SYSTEMS, INC.
|
| Vol #:
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| 3
|
|
|
|
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| EC 33
|
| HIBCC
|
| Vol #:
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| 3
|
|
|
|
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| EC 34
|
| Texas Health Resources
|
| Vol #:
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| 3
|
|
|
|
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| EC 35
|
| The Neuenschwander Company
|
| Vol #:
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| 3
|
|
|
|
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| EC 36
|
| Avera St. Luke's
|
| Vol #:
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| 3
|
|
|
|
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| EC 37
|
| American Association of People with Disabilities
|
| Vol #:
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| 3
|
|
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|
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| EC 38
|
| GS1 US
|
| Vol #:
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| 3
|
|
|
|
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| EC 39
|
| Medical Device Manufacturers Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 40
|
| 3M
|
| Vol #:
|
| 3
|
|
| | | | | | | |
|
| |
|
| EMC 940
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 941
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
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| EMC 942
|
| The Phoenix Healing Centre (Galway, Ireland)
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| Vol #:
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| 20
|
|
|
|
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| EMC 943
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 944
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 945
|
| M. Stanyk
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 946
|
| K. Burns
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 947
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 948
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 949
|
| S. Justice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 950
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 951
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 952
|
| The Phoenix Healing Centre (Galway, Ireland)
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| Vol #:
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| 20
|
|
|
|
|
| EMC 953
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 954
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 955
|
| C. Zimmerman
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 956
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 957
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 958
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 959
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 960
|
| K. Juarez
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 961
|
| D. O'Brien
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 962
|
| Consumers for Dental Choice
|
| Vol #:
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| 20
|
|
|
|
|
| EMC 963
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 964
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 965
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 966
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 967
|
| Consumers for Dental Choice
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 968
|
| J. Jallo
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 969
|
| E. Holmes
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 970
|
| A. Cutler
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 971
|
| S. Elsasser
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 972
|
| T. Treppiedi
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 973
|
| B. Juarez
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 974
|
| P. Field
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 975
|
| P. Nupponen
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 976
|
| R. Dunn
|
| Vol #:
|
| 20
|
|
| | | | | | | | |
|
| |
|
| EMC 977
|
| J. Cutler
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 978
|
| L. Bruce
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 979
|
| M. Epstein
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 980
|
| M. Armentano
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 981
|
| H. Bieley
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 982
|
| S. Jannarone
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 983
|
| P. Nupponen
|
| Vol #:
|
| 20
|
|
|
|
|
| 2006N-0420
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
|
|
|
|
|
| EC 1
|
| Eleos Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0433
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-mail to Submit A Notice of Final Disposition Of Animals Not Intended For Immediate
|
|
|
|
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0085
|
| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
|
|
|
|
|
| EC 2
|
| Monroe Prosthetics and Orthotics
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
|
|
|
|
|
|
| EC 2
|
| fluoroquinolone toxicity research foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Dr. Teri Walker
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Mr. Ron Rippy
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Mr. Mark Wenger
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Ms. Debra Morse
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0390
|
| 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"
|
|
|
|
|
| EC 12
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| EC 384
|
| Ms. Mary Wenzel
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 385
|
| Ms. Valerie Howell
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 386
|
| Ms. Lorien House
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 387
|
| Mr. Gary Loewenthal
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 388
|
| Miss. Leila Fusfeld
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 389
|
| Ms. cissy yung
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 390
|
| Ms. Angela Black
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 391
|
| Ms. Jennifer Mathews
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 392
|
| Mr. Peter Hauge
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 393
|
| Mrs. Kelli Morgan
|
| Vol #:
|
| 7
|
|
