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| Dockets Entered
On September 20, 2005
Table of Contents
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| Docket #
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| Title
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0338
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| Medical Devices; Dental Devices; Classification of Oral Rinse to Reduce the Adhesion of Dental Plaque
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0384
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| Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| GDL
2
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| Background Material
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| Vol #:
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| 15
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| NAD
2
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| FDA
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| Vol #:
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| 15
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| GDL
2
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| Guidance
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| Vol #:
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| 2
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| NAD
2
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| FDA
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| Vol #:
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| 2
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| EC
4
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| DR Systems, Inc.
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| Vol #:
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| 1
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| 2005D-0337
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
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| BKG 1
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| HFZ-400
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| Vol #:
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| 1
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| GDL
1
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| 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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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| GDL
1
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| 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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| | | | | | | | |
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| EC 27
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| Ms. Patricia Marseglia
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| Vol #:
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| 1
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| EC 28
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| Mrs. Marion Hammond
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| Vol #:
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| 1
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| EC 29
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| Mrs. Marlyn Kenney
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| Vol #:
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| 1
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| EC 30
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| N/A
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| Vol #:
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| 1
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| EC 31
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| Mrs. Peggy Melton
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| Vol #:
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| 1
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| EC 32
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| Ms. Sherry Conaway
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| Vol #:
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| 1
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| EC 33
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| Mrs. Lori Skalitzky
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| Vol #:
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| 1
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| EC 34
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| Mr. James Jackson
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| Vol #:
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| 1
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| EC 35
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| Mrs. Lesley Clark
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| Vol #:
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| 1
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| EC 36
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| Mrs. Linda Donaldson
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| Vol #:
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| 1
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| EC 37
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| Ms. Amy Manning
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| Vol #:
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| 1
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| EC 38
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| Ms. Carlene Ruesenberg
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| Vol #:
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| 1
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| EC 39
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| Mrs. Dorothy Britt
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| Vol #:
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| 1
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| EC 40
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| Mrs. Carollene Cagle
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| Vol #:
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| 1
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| EC 41
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| Mrs. Judith Walker
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| Vol #:
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| 1
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| EC 42
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| Ms. Cathy Smith
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| Vol #:
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| 1
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| EC 43
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| Mrs. Sandra Bill
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| Vol #:
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| 1
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| EC 44
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| Ms. C Schneider
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| Vol #:
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| 1
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| EC 45
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| Mrs. Mary Ellen Gordon
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| Vol #:
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| 1
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| EC 46
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| Mr. Robert Schweitzer
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| Vol #:
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| 1
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| EC 47
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| Mrs. Darleen Souder
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| Vol #:
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| 1
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| EC
2
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| American College of Neuropsychopharmacology
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| Vol #:
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| 1
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| C
4
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| Grocery Manufacturers Association (GMA)
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| NEC
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EC
1005
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| Mrs. Jayne Zook
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| Vol #:
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| 18
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| EC
1006
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| Ms. Carolyn Dunaway
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| Vol #:
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| 18
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| EC
1007
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| Ms. Carol Mangano
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| Vol #:
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| 18
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| EC
1008
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| Ms. Amber Hicks
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| Vol #:
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| 18
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