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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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| 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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| 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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| 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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