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| Dockets Entered
On December 22, 2006
Table of Contents
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| Docket #
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| Title
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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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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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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0172
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| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
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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-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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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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| 2006N-0494
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| Medical Device Regulations; Disqualification of a Clinical Investigator; Technical Amendment
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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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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| EMC 1
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| Number Not Used
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| Vol #:
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| 10
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| 1977N-0094L
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| Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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| EC
3
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| Mr. Arthur Slutzah
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| Vol #:
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| 1
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| EMC
1
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| J.
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| Vol #:
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| 1
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC
459
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| Mrs. Candy Vandewater
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| Vol #:
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| 14
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| EC
460
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| Mrs. Teresa McDonagh
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| Vol #:
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| 14
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| EC
461
Attachment
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| Tidewater Dermatological Society
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| Vol #:
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| 14
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| EC
462
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| Dr. John Jennings
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| Vol #:
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| 14
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| EC
463
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| Mrs. Sandra Adkins
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| Vol #:
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| 14
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| EC
464
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| self
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| Vol #:
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| 14
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| EC
465
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| Mrs. elizabeth sheehan
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| Vol #:
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| 14
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| EC
466
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| Ms. Lori Ogurek
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| Vol #:
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| 14
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| EC
467
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| cleveland clinic
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| Vol #:
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| 14
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| LET 915
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| FDA/CFSAN to Tronex Company
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| Vol #:
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| 27
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| LET 916
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| FDA/CFSAN to Enzymatic Therapy Inc
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| Vol #:
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| 27
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| LET 917
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| FDA/CFSAN to Calgenex Corporation
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| Vol #:
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| 27
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| LET 918
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| FDA/CFSAN to World Nutrition Inc
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| Vol #:
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| 27
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 748
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| Mission Possible International
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| Vol #:
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| 10
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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 1406
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| J. Holmes
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| Vol #:
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| 12
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| EMC 1407
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| K. Fields
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| Vol #:
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| 12
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| EMC 1408
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| K. W.
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| Vol #:
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| 12
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| EMC 1409
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| D. Mani
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| Vol #:
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| 12
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| 2005D-0390
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| International Conference on Harmonisation; Guidance on E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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| EMC 1
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| Number Not Used
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| Vol #:
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| 1
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| |
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| EMC 1
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| J. Korning
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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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| EMC 4187
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| A. Jacobi
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| Vol #:
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| 199
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| EMC 4188
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| J. Herr
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| Vol #:
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| 199
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| EMC 4189
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| S. Smalley
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| Vol #:
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| 199
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| 2006D-0172
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| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
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| GDL
2
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| Guidance
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| Vol #:
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| 1
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| NAD
2
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| FDA
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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
4131
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| Mr. Dale Kimball
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| Vol #:
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| 23
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| EC
4132
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| Mr. Thomas Helbling
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| Vol #:
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| 23
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| EC
4133
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| Mr. Randolph Weedman
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| Vol #:
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| 23
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| EC
4134
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| Mrs. Marina Sheen
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| Vol #:
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| 23
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| EC
4135
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| Mrs. Sheri Menard
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| Vol #:
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| 23
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| EC
4136
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| Mr. David Wehrle
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| Vol #:
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| 23
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| EC
4137
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| Mr. Carl Aumen
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| Vol #:
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| 23
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| EC
4138
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| Mrs. Judy Bowes
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| Vol #:
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| 23
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