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| Dockets Entered On November 20, 2006
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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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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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0528
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| ANDA suitability for preoperative prep containing a chlorhexidine gluconate (CHG)/isopropol alcohol (IPA) solution with tint
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0444
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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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-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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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-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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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-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0361
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| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
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| 2006P-0392
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| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
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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-0469
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| Declare that a new drug application for Ibuprofen Potassium 200 mg Phenylephine Hydrochloride 10 mg Capsules is suitable for submission as an Abbreviated New Drug Application, pursuant to 21 CFR 314.9
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| 2006P-0471
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| Issue standards and regulations to help ensure the safe productions of fresh fruits and vegetable
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| 2006V-0470
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| Laser Light Show Projector
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| 1976N-0052N
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| OTC Nasal Decongestants
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| EMC 140
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| WYETH CONSUMER HEALTHCARE
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| Vol #:
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| 106
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 73
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| Dr. Amit Pandya
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| Vol #:
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| 14
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| EC 74
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| Dr. Gina Ang
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| Vol #:
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| 14
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| EC 75
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| Key Laser Institute for Aesthetic Medicine
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| Vol #:
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| 14
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| EC 76
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| Leonard J. Swinyer, M.D., P.C.
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| Vol #:
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| 14
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| EC 77
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| Dr. Bernard Burton
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| Vol #:
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| 14
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| EC 78
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| Dr. Diane Bernardi
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| Vol #:
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| 14
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| EC 79
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| Belle Meade Dermatology
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| Vol #:
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| 14
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| EC 80
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| American Society for Dermatological Surgery
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| Vol #:
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| 14
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| EC 81
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| American Osteopathic College of Dermatology
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| Vol #:
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| 14
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| EC 82
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| Accent Dermatology and Laser Institute
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| Vol #:
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| 14
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| EC 83
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| Dr. cindy hoffman
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| Vol #:
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| 14
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| EMC 3
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| F. D'Alessandro
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| Vol #:
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| 4
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| |
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| C 1396
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| G. Caughlan
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| Vol #:
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| 259
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 739
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| V. Inness-Brown
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| Vol #:
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| 10
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| EMC 740
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| D. Fleming
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| Vol #:
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| 10
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| |
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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 1382
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| D. Garcia
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| Vol #:
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| 12
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| EMC 1383
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| L. Edan
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| Vol #:
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| 12
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| EMC 1384
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| P. Langevin
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| Vol #:
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| 12
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 27
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| Dr. Nondas Bellos
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| Vol #:
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| 8
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| EC 28
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| Marcelo Ricci Uvinha
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| Vol #:
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| 8
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| 2004P-0349
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| Action on Products containing added Mercury
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| EC 26
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| Ms. Betty Wireman
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| Vol #:
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| 4
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| 2004P-0528
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| ANDA suitability for preoperative prep containing a chlorhexidine gluconate (CHG)/isopropol alcohol (IPA) solution with tint
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| WDL 1
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| Cardinal Health
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| Vol #:
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| 1
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| |
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| EMC 11
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| C. Paugh
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| Vol #:
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| 2
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| 2005N-0444
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
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| SUP 1
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| Procter & Gamble
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| Vol #:
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| 4
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| |
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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| PDN 1
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| FDA/CDRH to Zuckerman Spaeder LLP
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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 18211
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| L. Arnold
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| Vol #:
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| 198
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| C 18212
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| T. Luedeman
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| Vol #:
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| 198
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| EMC 4113
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| D. Burton
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| Vol #:
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| 195
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| EMC 4114
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| N. Snow
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| Vol #:
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| 195
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| EMC 4115
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| K. Peterson
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| Vol #:
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| 195
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| EMC 4116
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| R. Bolduc
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| Vol #:
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| 195
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| EMC 4117
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| K. Gray
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| Vol #:
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| 195
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| EMC 4118
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| D. Ferguson
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| Vol #:
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| 195
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| EMC 4119
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| W. Card
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| Vol #:
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| 195
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| EMC 4120
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| J. Sloan
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| Vol #:
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| 195
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| EMC 4121
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| A. Woods
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| Vol #:
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| 195
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| EMC 4122
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| C. Roberts
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| Vol #:
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| 195
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| EMC 4123
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| P. Horton
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| Vol #:
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| 195
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| EMC 4124
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| C. Shade
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| Vol #:
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| 195
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| EMC 4125
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| M. Conklin
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| Vol #:
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| 195
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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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| C 2
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals
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| Vol #:
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| 1
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| C 3
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| Genzyme Corporation
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| Vol #:
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| 1
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| C 4
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| Genentech, Inc.
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| Vol #:
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| 1
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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 56
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| The Cato Institute
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| Vol #:
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| 3
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| EC 57
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| Quintiles Transnational Corp.
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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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| |
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| C 2
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| Nanogen, Inc.
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| Vol #:
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| 1
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| |
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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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| C 81
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| M. Tillman, J.D.
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| Vol #:
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| 7
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| C 82
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| B. Mormando
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| Vol #:
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| 7
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| |
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| C 83
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| E. Heaney
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| Vol #:
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| 7
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| |
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| C 84
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| M. Palmieri
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| Vol #:
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| 7
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| C 85
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| R. Soucy
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| Vol #:
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| 7
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| |
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| C 86
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| C. Brown
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| Vol #:
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| 7
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| |
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| C 87
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| Y. Tenorio
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| Vol #:
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| 7
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| | | | | | | |
| |
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| C 88
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| P. Cummings
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| Vol #:
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| 7
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| |
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| C 89
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| S. Galligan
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| Vol #:
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| 7
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| |
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| C 90
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| E. Brunkhorst, RN
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| Vol #:
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| 7
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| |
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| C 91
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| S. Milam
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| Vol #:
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| 7
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| |
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| C 92
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| J. Lynch
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| Vol #:
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| 7
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| |
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| C 93
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| H. Leonard
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| Vol #:
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| 7
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| |
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| C 94
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| M. Miller
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| Vol #:
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| 7
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| |
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| C 95
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| M. Jude C.P.
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| Vol #:
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| 7
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| |
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| C 96
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| D. Neal
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| Vol #:
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| 7
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| |
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| C 97
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| P. Miller
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| Vol #:
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| 7
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| |
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| C 98
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| A. Scheett
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| Vol #:
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| 7
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| |
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| C 99
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| S and D McEnery
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| Vol #:
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| 7
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| |
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| C 100
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| S. and D. McEnry
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| Vol #:
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| 7
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| |
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| C 101
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| K. Fucci
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| Vol #:
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| 7
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| |
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| C 102
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| M. O'Donnell
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| Vol #:
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| 7
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| |
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| C 103
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| L. Kozlowski, M.D.
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| Vol #:
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| 7
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| |
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| C 104
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| S. Shambro
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| Vol #:
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| 7
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| |
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| C 105
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| M. Palmieri
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| Vol #:
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| 7
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| |
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| C 106
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| B. Shambro
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| Vol #:
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| 7
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| |
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| EC 1891
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| Mrs. Michelle Carner
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| Vol #:
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| 8
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| |
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| EC 1892
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| Mr. Kevin O'Brien
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| Vol #:
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| 8
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| |
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| EC 1893
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| Ms. Meaghan Dalferro
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| Vol #:
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| 8
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| |
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| EC 1894
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| Dr. Paul Bauer
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| Vol #:
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| 8
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| |
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| EC 1895
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| Dr. Peter Jahnke
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| Vol #:
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| 8
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| |
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| EC 1896
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| Mrs. Jane Cops
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| Vol #:
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| 8
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| |
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| EC 1897
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| Mr. Gerry Hatcher
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| Vol #:
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| 8
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| |
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| EC 1898
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| SEM Publishing
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| Vol #:
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| 8
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| |
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| EC 1899
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| Mrs. Geraldine Comeau
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| Vol #:
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| 8
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| |
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| EC 1900
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| Mr. David Reeves
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| Vol #:
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| 8
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| |
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| EC 1901
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| Miss. Leah Ghazal
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| Vol #:
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| 8
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| |
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| EC 1902
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| University of Wisconsin Medical School
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| Vol #:
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| 8
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| |
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| EC 1903
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| Mrs. J McCarthy
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| Vol #:
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| 8
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| |
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| EC 1904
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| Mrs. Fidelis Lindner
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| Vol #:
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| 8
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| |
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| EC 1905
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| US Oncology
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| Vol #:
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| 8
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| |
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| EC 1906
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| Individual Consumer
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| Vol #:
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| 8
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| |
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| EC 1907
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| Dr. Tim Lichter
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| Vol #:
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| 8
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| |
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| EC 1908
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| Mr. J Neil Schunke
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| Vol #:
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| 8
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| | | | | | | |
| |
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| EC 1909
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| Mrs. Marcia Towle
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| Vol #:
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| 8
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| |
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| EC 1910
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| Mrs. Elizabeth Larson
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| Vol #:
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| 8
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| |
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| EC 1911
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| Mrs. Lauretta Taylor
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| Vol #:
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| 8
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| |
|
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| EC 1912
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| Mr. Michael Puljic
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| Vol #:
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| 8
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| |
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| EC 1913
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| Ms. Candice Botner
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| Vol #:
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| 8
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| |
|
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| EC 1914
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| Mrs. Joy Schoenberger
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| Vol #:
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| 8
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| |
|
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| EC 1915
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| Mrs. Rebecca Kirchberg
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| Vol #:
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| 8
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| |
|
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| EC 1916
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| Mr. Steve Beren
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| Vol #:
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| 8
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| |
|
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| EC 1917
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| Mr. Joel Willmarth
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| Vol #:
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| 8
|
| |
|
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| EC 1918
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| Mrs. Abbie Risteen
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| Vol #:
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| 8
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| |
|
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| EC 1919
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| Miss. Lynne Shea
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| Vol #:
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| 8
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| |
|
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| EC 1920
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| Mr. Craig Gilbert
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| Vol #:
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| 8
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| |
|
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| EC 1921
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| Ms. Sarah Wilkinson
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| Vol #:
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| 8
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| |
|
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| EC 1922
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| Mr. Lloyd and Faie Duplantis
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| Vol #:
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| 8
|
| |
|
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| EC 1923
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| Ms. Mary Zaeske-Weltzer
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| Vol #:
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| 8
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| |
|
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| EC 1924
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| Mrs. Nancy McCafferty
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| Vol #:
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| 8
|
| |
|
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| EC 1925
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| Mrs. Luci Hannegan
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| Vol #:
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| 8
|
| |
|
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| EC 1926
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| Mrs. Linda Stone
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| Vol #:
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| 8
|
| |
|
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| EC 1927
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| Mrs. Bobi Beth Kallenbach
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| Vol #:
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| 8
|
| |
|
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| EC 1928
|
| Mr. Jeff Gura
|
| Vol #:
|
| 8
|
| |
|
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| EC 1929
|
| Human Life Council
|
| Vol #:
|
| 8
|
| |
|
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| EC 1930
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| Mr. Ronald Storts
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| Vol #:
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| 8
|
| |
|
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| EC 1931
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| Mrs. Norma Peters
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| Vol #:
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| 8
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| |
|
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| EC 1932
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| Ms. Joan Angevine
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| Vol #:
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| 8
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| |
|
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| EC 1933
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| Mr. Samuel Dean
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| Vol #:
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| 8
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| |
|
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| EC 1934
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| Mrs. Erin Rapp
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| Vol #:
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| 8
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| |
|
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| EC 1935
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| self
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| Vol #:
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| 8
|
| |
|
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| EC 1936
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| Mrs. Pamela Brindley
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| Vol #:
|
| 8
|
| |
|
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| EC 1937
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| Ms. K. Gilson
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| Vol #:
|
| 8
|
| |
|
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| EC 1938
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| Mr. Eric Soiu
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| Vol #:
|
| 8
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| |
|
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| EC 1939
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| Ms. Ashley Albers
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| Vol #:
|
| 8
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| |
|
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| EC 1940
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| Mrs. Christine Potter
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| Vol #:
|
| 8
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| |
|
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| EC 1941
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| Mrs. Christie Sherwood
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| Vol #:
|
| 8
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| |
|
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| EC 1942
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| Mrs. Louise Juliano
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| Vol #:
|
| 8
|
| |
|
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| EC 1943
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| Mrs. Christine D'Angelo
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| Vol #:
|
| 8
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| |
|
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| EC 1944
|
| Mrs. Maura Butler
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| Vol #:
|
| 8
|
| |
|
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| EC 1945
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| Ms. Elizabeth Marie Peters
|
| Vol #:
|
| 8
|
|
| | | | | | | |
| |
|
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| EC 1946
|
| Ms. Diane Bond
|
| Vol #:
|
| 8
|
| |
|
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| EC 1947
|
| Dr. Michele Yi
|
| Vol #:
|
| 8
|
| |
|
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| EC 1948
|
| Mrs. cynthia duvall
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| Vol #:
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| 8
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| EC 1949
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| Mrs. Jeanne Krien
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| Vol #:
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| 8
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| EC 1950
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| St. Mary's Community Hospital
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| Vol #:
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| 8
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| EC 1951
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| Ms. mary hesse
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| Vol #:
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| 8
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| EC 1952
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| Ms. Lillian Thompson
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| 8
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| EC 1953
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| Mr. Donald Patrich
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| 8
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| EC 1954
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| Mr. David Barker
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| Vol #:
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| 8
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| EC 1955
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| Miss. Hanna Miecznikowski
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| 8
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| EC 1956
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| Mr. William Werner
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| 8
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| EC 1957
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| Mrs. Anita Usher
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| Vol #:
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| 8
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| EC 1958
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| Ms. susan loftis
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| Vol #:
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| 8
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| EC 1959
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| Mrs. Regina Michael
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| Vol #:
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| 8
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| EC 1960
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| Mrs. Margaret Stender
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| Vol #:
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| 8
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| EC 1961
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| Mrs. Juliana Gonzalez
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| Vol #:
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| 8
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| EC 1962
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| Mr. Jarl Renn
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| Vol #:
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| 8
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| EC 1963
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| Mr. Joseph Bruce
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| Vol #:
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| 8
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| EC 1964
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| Mr. Patrick O'Hearn
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| Vol #:
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| 8
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| EC 1965
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| Mr. Simon Penhalagan
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| Vol #:
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| 8
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| EC 1966
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| Mrs. Sharon Widman
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| Vol #:
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| 8
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| EC 1967
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| Mr. David Dufresne
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| Vol #:
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| 8
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| EC 1968
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| Ms. Suzanne Rider
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| Vol #:
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| 8
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| EC 1969
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| Mr. nat parisi
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| Vol #:
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| 8
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| EC 1970
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| Ms. Daun Dunlap
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| Vol #:
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| 8
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| EC 1971
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| Mrs. Jean Gaes
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| Vol #:
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| 8
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| EC 1972
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| Mr. Bob Pikul
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| Vol #:
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| 8
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| EC 1973
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| NIH
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| Vol #:
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| 8
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| EC 1974
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| Mrs. Jean Troop
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| Vol #:
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| 8
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| EC 1975
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| Mrs. denise lynch
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| Vol #:
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| 8
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| EC 1976
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| Mr. Brian Gomolski
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| Vol #:
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| 8
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| EC 1977
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| Mr. Theodore Johnson
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| Vol #:
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| 8
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| EC 1978
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| Mrs. Lori Sims
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| Vol #:
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| 8
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| EC 1979
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| Mr. John Martino
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| Vol #:
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| 8
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| EC 1980
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| Mr. Bob Williams
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| Vol #:
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| 8
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| EC 1981
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| Mrs. Gretchen Malovoz
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| Vol #:
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| 8
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| EC 1982
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| Mrs. Kathleen Rahe
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| Vol #:
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| 8
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| EC 1983
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| Mrs. Jackie Lagemaat
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| Vol #:
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| 8
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| EC 1984
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| Mrs. Arielle Kurtze
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| Vol #:
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| 8
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|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
| |
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|
| C 16
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| K. Miller
|
| Vol #:
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| 15
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| |
|
|
| C 17
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| American Association of Orthopaedic Surgeons (AAOS)
|
| Vol #:
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| 15
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| |
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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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| |
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|
| C 160
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| F. Nelson
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| Vol #:
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| 25
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| |
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| C 161
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| S. Kreider, MSIT, RN, CPC
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| Vol #:
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| 25
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| |
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| C 162
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| P. Caruso
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| Vol #:
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| 25
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| C 163
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| D. Pohlman
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| Vol #:
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| 25
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| C 164
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| Mercury Policy Project/Tides Center
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| Vol #:
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| 25
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| |
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| C 165
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| K. Fitzpatrick
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| Vol #:
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| 25
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| C 166
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| B. Barewald, R.N.
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| Vol #:
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| 25
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| C 167
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| H. Jankowski
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| Vol #:
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| 25
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| C 168
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| R. Murray
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| Vol #:
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| 25
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| C 169
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| A. Rust, DMD, MPA
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| Vol #:
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| 25
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| C 170
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| N. Ottawa
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| Vol #:
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| 25
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| C 171
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| M. Long, RN
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| Vol #:
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| 25
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| C 172
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| Fluoride Action Network
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| Vol #:
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| 25
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| C 173
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| Green Delaware
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| Vol #:
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| 25
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| C 174
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| L. Griffin
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| Vol #:
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| 25
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| C 175
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| T. Robson, D.C.
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| Vol #:
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| 25
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| C 176
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| K. Moore
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| Vol #:
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| 25
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| C 177
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| G. Taylor
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| Vol #:
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| 25
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| C 178
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| D and J Horner
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| Vol #:
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| 25
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| C 179
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| S. Friedman, D.C.
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| Vol #:
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| 25
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| C 180
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| D. Olah, DMD
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| Vol #:
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| 25
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| C 181
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| F. DDS
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| Vol #:
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| 25
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| C 182
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| R. Bianchi
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| Vol #:
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| 25
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| C 183
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| A. Gruber
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| Vol #:
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| 25
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| C 184
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| M. Norman
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| Vol #:
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| 25
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| |
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| C 185
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| B. Albrecht
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| Vol #:
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| 25
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| C 186
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| G. Herring
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| Vol #:
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| 25
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| C 187
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| C. Petersen
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| Vol #:
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| 25
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| |
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| C 188
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| G. Cole, DDS
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| Vol #:
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| 25
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| |
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| C 189
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| H. Hall
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| Vol #:
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| 25
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| |
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| C 190
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| C. Hallet
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| Vol #:
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| 25
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| |
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| C 191
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| E. Krinsky
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| Vol #:
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| 25
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| |
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| C 192
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| E. Birlem
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| Vol #:
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| 25
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| |
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| C 193
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| J. Stuart
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| Vol #:
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| 25
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| |
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| C 194
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| R. McCully
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| Vol #:
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| 25
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| |
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| C 195
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| S. Dicks, DC
|
| Vol #:
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| 25
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| |
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| C 196
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| N. Flack
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| Vol #:
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| 25
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| |
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| C 197
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| P. Momsen
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| Vol #:
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| 25
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| |
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| C 198
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| L. Thomas
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| Vol #:
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| 25
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| |
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| C 199
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| D. Martin
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| Vol #:
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| 25
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| |
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| C 200
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| T. Kruzen
|
| Vol #:
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| 25
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| |
|
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| C 201
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| Consumers for Dental Choice
|
| Vol #:
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| 25
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| |
|
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| C 202
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| T. Conroy
|
| Vol #:
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| 25
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| |
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| C 203
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| D. Kaiser
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| Vol #:
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| 25
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| |
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| C 204
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| K. Huttleston
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| Vol #:
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| 25
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| |
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| C 205
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| A. Marcyoniak
|
| Vol #:
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| 25
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| |
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| C 206
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| M. Ehrech
|
| Vol #:
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| 25
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| |
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| C 207
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| T. McIlvaine
|
| Vol #:
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| 25
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| |
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| C 208
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| Y. Tal
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| Vol #:
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| 25
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| |
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| C 209
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| R. LaVlgne
|
| Vol #:
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| 25
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| |
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| C 210
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| S. Marad
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| Vol #:
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| 25
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| |
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| C 211
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| No signature
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| Vol #:
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| 25
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| |
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| C 212
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| T. Osmanski
|
| Vol #:
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| 25
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| |
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| C 213
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| A. Muhlberg
|
| Vol #:
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| 25
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| |
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| C 214
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| D. Dorsey
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| Vol #:
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| 25
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| |
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| C 215
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| D. Borzini
|
| Vol #:
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| 25
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| |
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| C 216
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| W. Overfelt
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| Vol #:
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| 25
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| |
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| C 217
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| L. Crosby
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| Vol #:
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| 25
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| |
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| C 218
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| P. Grimsley
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| Vol #:
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| 25
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| |
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| C 219
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| C. Andros
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| Vol #:
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| 25
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| |
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| C 220
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| L. Adams
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| Vol #:
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| 25
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| |
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| C 221
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| J. Riggs
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| Vol #:
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| 25
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| |
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| C 222
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| A. Cusick
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| Vol #:
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| 25
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| |
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| C 223
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| A. Castellano
|
| Vol #:
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| 25
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| |
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| C 224
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| No signature
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| Vol #:
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| 25
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| |
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| C 225
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| M. Brandt
|
| Vol #:
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| 25
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| | | | | | | |
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| C 226
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| K. Wolfram
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| Vol #:
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| 25
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| |
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| C 227
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| K. Buck
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| Vol #:
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| 25
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| |
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| C 228
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| T. Patton, LMBT
|
| Vol #:
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| 25
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| |
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| C 229
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| D. Boone
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| Vol #:
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| 25
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| |
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| C 230
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| L. Adams
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| Vol #:
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| 25
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| |
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| C 231
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| K. Kaiser
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| Vol #:
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| 25
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| |
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| C 232
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| R. Davis
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| Vol #:
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| 25
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| |
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| C 233
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| J. Wanner
|
| Vol #:
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| 25
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| |
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| C 234
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| M. Bernstein, M.D., M.S., J.D.
|
| Vol #:
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| 25
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| |
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| C 235
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| J. Marich
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| Vol #:
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| 25
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| |
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| C 236
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| N. Barnhart
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| Vol #:
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| 25
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| |
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| C 237
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| S. Gwinn
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| Vol #:
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| 25
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| |
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| C 238
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| J. Washick
|
| Vol #:
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| 25
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| |
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| C 239
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| N. Kwiatkowski
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| Vol #:
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| 25
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| |
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| C 240
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| D. Sluis
|
| Vol #:
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| 25
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| |
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| C 241
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| A. Jacobson, PhD
|
| Vol #:
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| 25
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| |
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| C 242
|
| J. Miller
|
| Vol #:
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| 25
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| |
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| C 243
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| O. Duke
|
| Vol #:
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| 25
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| |
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| C 244
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| J. Sachs
|
| Vol #:
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| 25
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| |
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| C 245
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| D. Peterson
|
| Vol #:
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| 25
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| |
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| C 246
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| R. Nelson
|
| Vol #:
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| 25
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| |
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| C 247
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| No signature
|
| Vol #:
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| 25
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| |
|
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| C 248
|
| K. Peterson, DCND
|
| Vol #:
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| 25
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| |
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| C 249
|
| J. Warren
|
| Vol #:
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| 25
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| |
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| C 250
|
| G. Odgers
|
| Vol #:
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| 25
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| |
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| C 251
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| Carbondale City Council
|
| Vol #:
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| 25
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| |
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| C 252
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| E. McDonagh BSc
|
| Vol #:
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| 25
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| |
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| C 253
|
| P. Owen
|
| Vol #:
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| 25
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| |
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| C 254
|
| V. Nolan
|
| Vol #:
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| 25
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| |
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| C 255
|
| V. Dong
|
| Vol #:
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| 25
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| |
|
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| C 256
|
| K. Morris
|
| Vol #:
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| 25
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| |
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| C 257
|
| T. Johnson
|
| Vol #:
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| 25
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| |
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| C 258
|
| K. Newman
|
| Vol #:
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| 25
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| |
|
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| C 259
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| R. Kerger
|
| Vol #:
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| 25
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| |
|
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| C 260
|
| R and R Foreman
|
| Vol #:
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| 25
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| |
|
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| C 261
|
| E. Krinsky
|
| Vol #:
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| 25
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| |
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| C 262
|
| N. Call
|
| Vol #:
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| 25
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| | | | | | | | |
| |
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| C 263
|
| L. Cifelli
|
| Vol #:
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| 25
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| |
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| C 264
|
| N. Coenen
|
| Vol #:
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| 25
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| |
|
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| C 265
|
| K. Burns
|
| Vol #:
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| 25
|
| |
|
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| C 266
|
| McBride Enterorises, Inc.
|
| Vol #:
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| 25
|
| |
|
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| C 267
|
| B. Mather
|
| Vol #:
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| 25
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| |
|
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| C 268
|
| N. Call
|
| Vol #:
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| 25
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| |
|
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| C 269
|
| Dr. M. Young
|
| Vol #:
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| 25
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| |
|
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| C 270
|
| I. Lawrence
|
| Vol #:
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| 25
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| |
|
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| C 271
|
| J. Abdu
|
| Vol #:
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| 25
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| |
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| C 272
|
| Linda S.
|
| Vol #:
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| 25
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| |
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| C 273
|
| D. Eheman
|
| Vol #:
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| 25
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| |
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| C 274
|
| D. Robbins, DMD, FAGD
|
| Vol #:
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| 25
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| |
|
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| C 275
|
| D. Mariano
|
| Vol #:
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| 25
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| |
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| C 276
|
| C. Leavitt
|
| Vol #:
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| 25
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| |
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| C 277
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| M. Graven
|
| Vol #:
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| 25
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| |
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
| |
|
|
| EMC 1
|
| H. Patenaude
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0085
|
| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
|
| |
|
|
| C 4
|
| Nobbe Orthopedics, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| AANS/CNS Joint Section for Pediatric Neurosurgery
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
| |
|
|
| C 4
|
| Valeant Pharmaceuticals International (Valeant)
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| FDA/CDER to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0361
|
| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
|
| |
|
|
| WDL 1
|
| Rakoczy Molino Mazzochi Siwik, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0392
|
| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
|
| |
|
|
| C 1
|
| Valeant Pharmaceuticals International (Valeant)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 415
|
| Mr. Jack Guthrie
|
| Vol #:
|
| 7
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| EC 2
|
| Ms. Betty Wireman
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0469
|
| Declare that a new drug application for Ibuprofen Potassium 200 mg Phenylephine Hydrochloride 10 mg Capsules is suitable for submission as an Abbreviated New Drug
|
|
| | | | | | | | |
| |
|
|
| Application, pursuant to 21 CFR 314.9
|
| |
|
|
| ACK 1
|
| FDA/DDM to Strides Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Strides Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0471
|
| Issue standards and regulations to help ensure the safe productions of fresh fruits and vegetable
|
| |
|
|
| ACK 1
|
| FDA/DDM to Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
| |
|
|
| 2006V-0470
|
| Laser Light Show Projector
|
| |
|
|
| ACK 1
|
| Club MO Lasers
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Club MO Lasers
|
| Vol #:
|
| 1
|
|
|
