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| Dockets Entered
On November 13, 2006
Table of Contents
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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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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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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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| 2006M-0459
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| P050025 - Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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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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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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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-0461
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| To Permit the Filing of an ANDA Suitability for Cefepime for Injection
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| 2006P-0462
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| Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 12
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| Mrs. Alicia Bell
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| Vol #:
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| 4
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| EC 13
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| Ms. Lauraetta Tucker
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| Vol #:
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| 4
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| EC 14
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| Federal Government Retiree
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| Vol #:
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| 4
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| EC 15
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| Ms. LOLITA DAVIS
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| Vol #:
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| 4
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| EC 16
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| Aroma Listic Spa
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| Vol #:
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| 4
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| NFR 6
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| FDA
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| Vol #:
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| 10
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 358
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| Natural ASA
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| Vol #:
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| 280
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18216
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| LET 18217
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| Enzymatic Therapy Inc
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| Vol #:
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| 167
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| LET 905
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| FDA/CFSAN to KSERO Corporation Inc
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| Vol #:
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| 27
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| LET 906
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| FDA/CFSAN to PuraPharm International HK Ltd c/o Amerisearch Inc
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| 27
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| LET 907
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| FDA/CFSAN to Global Healing Center Inc
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| Vol #:
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| 27
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| LET 908
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| FDA/CFSAN to Iovate Health Sciences USA Inc
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| Vol #:
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| 27
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| EC 4
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| Mr. Joseph Duggins
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 24
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| Mrs. Georgia Bailey
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| Vol #:
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| 2
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| EC 6
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| BD Biosciences
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| Vol #:
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| 1
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| EC 7
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| Pfizer
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| Vol #:
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| 1
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| EC 8
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| Procter and Gamble Pharmaceuticals
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| Vol #:
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| 1
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| EC 9
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| XenoTech, LLC
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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 1200
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| Mr. Miles and Patsy LaHue
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| Vol #:
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| 5
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| EC 1201
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| TN 4 Safer Vaccines
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| Vol #:
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| 5
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| EC 1202
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| WiseScribe
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| Vol #:
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| 5
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| EC 1203
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| Mr. Stefan Neikes
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| Vol #:
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| 5
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| EC 1204
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| Ms. Mary Huebscher
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| Vol #:
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| 5
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| EC 1205
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| Ms. Douglas Thorn
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| Vol #:
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| 5
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| EC 1206
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| Mrs. Peggy Wolock, Esq.
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| Vol #:
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| 5
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| EC 1207
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| Ms. Margaret Stump
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| Vol #:
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| 5
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| EC 1208
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| Ms. MARY GIBSON
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| Vol #:
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| 5
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| EC 1209
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| Mr. GREG hyatt
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| Vol #:
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| 5
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| EC 1210
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| Mrs. Valerie Mitchell
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| Vol #:
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| 5
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| EC 1211
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| Mrs. winifred hubner
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| Vol #:
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| 5
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| EC 1212
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| Mrs. Sheila Casey
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| Vol #:
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| 5
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| EC 1213
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| Anne R. Dugan, L.Ac.
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| Vol #:
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| 5
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| EC 1214
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| Greek Orthodox Church
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| Vol #:
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| 5
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| EC 1215
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| Miss. Mary Blazier
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| Vol #:
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| 5
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| EC 1216
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| Ms. Amanda Graf
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| Vol #:
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| 5
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| EC 1217
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| Ms. Rebecca Yates
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| Vol #:
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| 5
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| EC 1218
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| Mr. Paul Pompeii
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| Vol #:
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| 5
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