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| Dockets Entered
On April 17, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2006D-0526
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| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0422
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| Refrain from approval of any ANDA for metoprolol succinate extended release 100 mg and 200 mg tablets subsequent to ANDA 76-640 from KV Pharmaceutical
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| 2006P-0423
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| Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
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| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 1978N-0038
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| Sunscreen Drug Products
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| RPT 11
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| DMS Nutritional Products, Inc.
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| Vol #:
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| 153
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 645
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| J. Walford
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| Vol #:
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| 56
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| C 646
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| R. Drummond
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| Vol #:
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| 56
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| C 647
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| D. Nina
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| Vol #:
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| 56
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| C 648
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| M. Jackson
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| Vol #:
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| 56
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| C 649
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| M. B.
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| Vol #:
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| 56
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| C 650
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| V. Mendoza
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| Vol #:
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| 56
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| C 651
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| O. McEwen
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| Vol #:
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| 56
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| C 652
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| G. Jimenez
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| Vol #:
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| 56
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| C 653
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| N. Johnson
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| Vol #:
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| 56
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| C 654
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| B. Yaria
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| Vol #:
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| 56
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| C 655
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| C. Swanson
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| Vol #:
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| 56
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| C 656
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| R. Pardini
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| Vol #:
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| 56
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| C 657
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| C. Hellinger
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| Vol #:
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| 56
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| C 658
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| R. Mabery
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| Vol #:
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| 56
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| C 659
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| R. Franco
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| Vol #:
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| 56
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| C 660
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| D. Martinez
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| Vol #:
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| 56
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| C 661
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| G. Contreras
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| Vol #:
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| 56
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| C 662
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| L. perez
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| Vol #:
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| 56
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| C 663
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| M. Anguiano
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| Vol #:
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| 56
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| C 664
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| T. Diaz
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| Vol #:
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| 56
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| C 665
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| A.Kamitses
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| Vol #:
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| 56
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| C 666
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| Association of Veterinarians for Animal Rights (AVAR)
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| Vol #:
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| 56
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| C 667
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| A. Blackwelder
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| Vol #:
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| 56
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| C 668
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| V. Myers
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| Vol #:
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| 56
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| C 669
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| K. Chapple
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| Vol #:
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| 56
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| C 670
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| M. Starner
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| Vol #:
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| 56
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| C 671
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| E. Bianco
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| Vol #:
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| 56
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| C 672
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| A. Sololow
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| Vol #:
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| 56
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| C 673
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| G. Hung
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| Vol #:
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| 56
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| C 674
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| R. Mann
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| Vol #:
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| 56
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| C 675
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| F. Glicksmon
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| Vol #:
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| 56
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| C 676
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| A. Bianco
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| Vol #:
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| 56
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| C 677
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| J. Yasord
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| Vol #:
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| 56
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| C 678
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| P. Relynard
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| Vol #:
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| 56
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| C 679
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| K. Rose
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| Vol #:
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| 56
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| C 680
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| L. Rapp
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| Vol #:
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| 56
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| C 681
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| B. Keenan
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| Vol #:
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| 56
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| C 682
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| J. Schiffman
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| Vol #:
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| 56
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| C 683
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| M. Perrotti
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| Vol #:
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| 56
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| C 684
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| S. Hamann
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| Vol #:
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| 56
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| C 685
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| C. Dendinger
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| Vol #:
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| 56
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| C 686
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| W. Lehner
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| Vol #:
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| 56
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| C 687
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| S. Werthimer
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| Vol #:
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| 56
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| C 688
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| J. Beckham
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| Vol #:
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| 56
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| C 689
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| B. Liberty
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| Vol #:
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| 56
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| C 690
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| M. Harms
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| Vol #:
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| 56
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| C 691
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| R. Bohr
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| Vol #:
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| 56
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| C 692
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| D. DeLuca
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| Vol #:
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| 56
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| C 693
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| E. Spring
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| Vol #:
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| 56
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| C 694
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| F. Halimi
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| Vol #:
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| 56
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| C 695
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| l. Helminski
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| Vol #:
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| 56
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| C 696
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| C. Vhalen
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| Vol #:
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| 56
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| C 697
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| T. Gaian
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| Vol #:
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| 56
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| C 698
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| D. Montgomery
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| Vol #:
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| 56
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| C 699
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| B. Weiland
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| Vol #:
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| 56
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| C 700
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| S. Hernandez
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| Vol #:
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| 56
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| C 701
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| P. Sullivan
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| Vol #:
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| 56
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| C 702
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| M. May
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| Vol #:
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| 56
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| C 703
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| B. Thompson
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| Vol #:
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| 56
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| C 704
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| M. DeSantis
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| Vol #:
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| 56
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| C 705
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| A. Jorjorian
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| Vol #:
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| 56
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| C 706
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| P. Frisbie
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| Vol #:
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| 56
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| C 707
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| G. Miolombatto
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| Vol #:
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| 56
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| C 708
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| W. Phignthisen
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| Vol #:
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| 56
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| C 709
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| C. Walker
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| Vol #:
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| 56
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| C 710
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| Sisters of St. Joseph of Carondelet
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| Vol #:
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| 56
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| C 711
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| Y. Bernstein
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| Vol #:
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| 56
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| C 712
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| E. Hodgman
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| Vol #:
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| 56
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| C 713
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| L. Lyall
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| Vol #:
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| 56
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| C 714
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| L. Frye
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| Vol #:
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| 56
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| C 715
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| T. Bush
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| Vol #:
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| 56
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| C 716
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| Animal Welfare Institute
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| Vol #:
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| 56
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| C 717
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| D. Schut
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| Vol #:
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| 56
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| C 718
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| C. Bianco
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| Vol #:
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| 56
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| C 719
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| T. Bianco
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| Vol #:
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| 56
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| C 720
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| J. Bulik
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| Vol #:
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| 56
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| C 721
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| W. Atchison
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| Vol #:
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| 56
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| C 722
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| J. Diehl
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| Vol #:
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| 56
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| C 723
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| J. Knapp
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| Vol #:
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| 56
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| C 724
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| L. SprayBerry
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| Vol #:
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| 56
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| C 725
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| A. Ammons
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| Vol #:
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| 56
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| EC 4941
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| Ms. Patricia Vargas
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| Vol #:
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| 54
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| EC 4942
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| Ms. Harriet Rankin
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| Vol #:
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| 54
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| EC 4943
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| Mr. mark berning
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| Vol #:
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| 54
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| EC 4944
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| R.E.A.D.
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| Vol #:
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| 54
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| EC 4945
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| Miss. Lily Wilson
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| Vol #:
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| 54
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| EC 4946
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| Mrs. Stephanie Dickmeyer
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| Vol #:
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| 54
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| EC 4947
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| Miss. Claudia Fonseca
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| Vol #:
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| 54
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| EC 4948
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| Mrs. Terry Mondo
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| Vol #:
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| 54
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| EC 4949
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| Miss. salina kinney
|
| Vol #:
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| 54
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| EC 4950
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| Mrs. Mary Plitt
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| Vol #:
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| 54
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| |
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| EC 4951
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| Ms. Judith Embry
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| Vol #:
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| 54
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| EC 4952
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| Mr. Max Cadji
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| Vol #:
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| 54
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| EC 4953
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| NH State Representative
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| Vol #:
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| 54
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| EC 4954
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| Ms. malachi melville
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| Vol #:
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| 54
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| EC 4955
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| Miss. Virginia Molina
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| Vol #:
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| 54
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| |
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| EC 4956
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| Ms. Vera Cousins
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| Vol #:
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| 54
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| |
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| EC 4957
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| Ms. Laura Hensley
|
| Vol #:
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| 54
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| EC 4958
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| Ms. L. Yaco
|
| Vol #:
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| 54
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| EC 4959
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| Mr. David Schuhknecht
|
| Vol #:
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| 54
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| EC 4960
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| Ms. Katharine VanSpeybroeck
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| Vol #:
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| 54
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| EC 4961
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| Mrs. Stacy Heath
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| Vol #:
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| 54
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| EC 4962
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| Ms. Sandra L Bogin
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| Vol #:
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| 54
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| EC 4963
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| Mrs. Debra Watson
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| Vol #:
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| 54
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| EC 4964
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| Ms. Amy Harlib
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| Vol #:
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| 54
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| EC 4965
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| Ms. Carina Vogt
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| Vol #:
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| 54
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| EC 4966
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| Ms. Doris Boggs
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| Vol #:
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| 54
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| EC 4967
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| Ms. Carole Fetterman
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| Vol #:
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| 54
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| EC 4968
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| Ms. Elizabeth Turner
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| Vol #:
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| 54
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| EC 4969
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| Mrs. Dana Mariasy
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| Vol #:
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| 54
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| EC 4970
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| Mrs. Tracey Goldie
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| Vol #:
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| 54
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| EC 4971
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| Ms. Regina Evans
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| Vol #:
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| 54
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| EC 4972
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| Miss. RAYA ENGLER
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| Vol #:
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| 54
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| EC 4973
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| Mrs. Cecelia Samp
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| Vol #:
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| 54
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| |
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| EC 4974
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| Mrs. L Gardner
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| Vol #:
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| 54
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| |
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| EC 4975
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| Mrs. Eve Gochis
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| Vol #:
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| 54
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| EC 4976
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| Ms. Wendy Clark
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| Vol #:
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| 54
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| EC 4977
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| Ms. Susan Uustal
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| Vol #:
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| 54
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| EC 4978
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| Miss. Nieves Pumarejo
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| Vol #:
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| 54
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| EC 4979
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| Mr. Keith Boehmer
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| Vol #:
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| 54
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| EC 4980
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| Ms. Claudia Bannister
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| Vol #:
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| 54
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| EC 4981
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| Mrs. Amy Weger
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| Vol #:
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| 54
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| |
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| EC 4982
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| Mrs. Kathleen Smith
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| Vol #:
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| 54
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| EC 4983
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| Mrs. Tammy Carrier
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| Vol #:
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| 54
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| |
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| EC 4984
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| Mrs. Deborah Nickerson
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| Vol #:
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| 54
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| |
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| EC 4985
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| n/a
|
| Vol #:
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| 54
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| |
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| EC 4986
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| Ms. Doris Taylor
|
| Vol #:
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| 54
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| |
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| EC 4987
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| Ms. Regina Benge
|
| Vol #:
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| 54
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| |
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| EC 4988
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| Mrs. Irene Von Leue
|
| Vol #:
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| 54
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| |
|
|
| EC 4989
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| Ms. Hilda Bolden
|
| Vol #:
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| 54
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| |
|
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| EC 4990
|
| Mr. Brian mcclure
|
| Vol #:
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| 54
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| |
|
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| EC 4991
|
| Mrs. Natalie Reid
|
| Vol #:
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| 54
|
|
| | | | | | | |
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| |
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| EC 4992
|
| Mr. Creighton Medlock
|
| Vol #:
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| 54
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| |
|
|
| EC 4993
|
| Ms. Lisa Douglass
|
| Vol #:
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| 54
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| |
|
|
| EC 4994
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| Mrs. Amy Hajec
|
| Vol #:
|
| 54
|
| |
|
|
| EC 4995
|
| Ms. Kimberly Hutchins
|
| Vol #:
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| 54
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| |
|
|
| EC 4996
|
| Ms. Sarah Amberge
|
| Vol #:
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| 54
|
| |
|
|
| EC 4997
|
| Dr. Cinzia Maddalena
|
| Vol #:
|
| 54
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| |
|
|
| EC 4998
|
| Mrs. Ann Marie Bohadel
|
| Vol #:
|
| 54
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| |
|
|
| EC 4999
|
| Mrs. Lisa Humphreys
|
| Vol #:
|
| 54
|
| |
|
|
| EC 5000
|
| Ms. Maura O'Connor
|
| Vol #:
|
| 54
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| |
|
|
| EC 5001
|
| Miss. Sandy Goettsch
|
| Vol #:
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| 54
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| |
|
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| EC 5002
|
| Ms. Elene Cafasso
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5003
|
| Private Citizen
|
| Vol #:
|
| 57
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| |
|
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| EC 5004
|
| Ms. Eve Reynolds
|
| Vol #:
|
| 57
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| |
|
|
| EC 5005
|
| Ms. Mary Gaston
|
| Vol #:
|
| 57
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| |
|
|
| EC 5006
|
| Ms. Julie Pope
|
| Vol #:
|
| 57
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| |
|
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| EC 5007
|
| Ms. Janis Kinslow
|
| Vol #:
|
| 57
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| |
|
|
| EC 5008
|
| Miss. Tessa van Dijk
|
| Vol #:
|
| 57
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| |
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| EC 5009
|
| SW Spine Center
|
| Vol #:
|
| 57
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| |
|
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| EC 5010
|
| Mr. Henry Rosenfeld
|
| Vol #:
|
| 57
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| |
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| EC 5011
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| Mr. Christopher Paige
|
| Vol #:
|
| 57
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| |
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| EC 5012
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| Ms. Lauren Stevens
|
| Vol #:
|
| 57
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| |
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| EC 5013
|
| Ms. Melanie Blackburn
|
| Vol #:
|
| 57
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| |
|
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| EC 5014
|
| Mr. Gary Reinbold
|
| Vol #:
|
| 57
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| |
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| EC 5015
|
| Mrs. Alejandra Nash
|
| Vol #:
|
| 57
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| |
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| EC 5016
|
| concerned consumer
|
| Vol #:
|
| 57
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| |
|
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| EC 5017
|
| Ms. Vira Confectioner
|
| Vol #:
|
| 57
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| |
|
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| EC 5018
|
| Mrs. Cheryl Martin
|
| Vol #:
|
| 57
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| |
|
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| EC 5019
|
| Mr. Richard Olson
|
| Vol #:
|
| 57
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| |
|
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| EC 5020
|
| Ms. Rene Succa-Ruston
|
| Vol #:
|
| 57
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| |
|
|
| EC 5021
|
| Mrs. Karen Burgoyne
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5022
|
| Miss. Donna M Meyer
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5023
|
| Ms. Kimberly Nicosia
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5024
|
| Mr. C Allen
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5025
|
| Mr. Jerald Kerlin
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5026
|
| Ms. Chris Leverich
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5027
|
| Ms. Megan Morytko
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5028
|
| Miss. Sophia Seeramlal
|
| Vol #:
|
| 57
|
|
| | | | | | | | |
|
| |
|
| EC 5029
|
| Ms. Kelly Henderson
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5030
|
| Mrs. Louise Hamm
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5031
|
| Ms. Judith Wolfe
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5032
|
| None
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5033
|
| Mrs. Jill Kotch
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5034
|
| Mr. david greenberg
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5035
|
| Ms. Rebecca Savage
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5036
|
| Ms. Michele Blaine
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5037
|
| Mrs. Maureen Jones
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5038
|
| Ms. Elaine Secondo
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5039
|
| Mrs. annette burns
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5040
|
| Mr. Benjamin Trussell
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5041
|
| Mrs. Grace Quinn
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5042
|
| Ms. Samantha Grieves
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5043
|
| Personal
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5044
|
| Mrs. Stacy Hortaridis
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5045
|
| Mr. Marc Arongino
|
| Vol #:
|
| 57
|
| |
|
|
| EC 5046
|
| Ms. Sheila ter Bruggen
|
| Vol #:
|
| 57
|
|
| |
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| CS 25
|
| FDA/DDM
|
| Vol #:
|
| 240
|
| |
|
|
| LET 8
|
| FDA/Administrative Law Judge
|
| Vol #:
|
| 240
|
| |
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
| |
|
|
| C 16
|
| Center for Orthopaedics
|
| Vol #:
|
| 7
|
| |
|
|
| C 17
|
| Healthonics-The Biophysics Health Company
|
| Vol #:
|
| 7
|
| |
|
|
| 2006D-0526
|
| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
|
| |
|
|
| C 1
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| C 59
|
| C. Clary
|
| Vol #:
|
| 6
|
| |
|
|
| LET 1
|
| FDA/CVM to The Center for Food Safety
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0422
|
| Refrain from approval of any ANDA for metoprolol succinate extended release 100 mg and 200 mg tablets subsequent to ANDA 76-640 from KV Pharmaceutical
|
| |
|
|
| LET 1
|
| FDA/CDER to KV Pharmaceutical Co
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0423
|
| Regulate Labeling and Packaging of Acetaminophen/APAP Containing Products
|
| |
|
|
| LET 1
|
| FDA/CDER to Pharmacists Planning Service, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007D-0040
|
| Guidance for Industry on Developing Products for Weight Management
|
| |
|
|
| C 4
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0106
|
| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
|
| |
|
|
| C 1
|
| Methodist Healthcare
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 65
|
| Diglisic, Gordana
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 66
|
| Diglisic, Gordana
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 67
|
| Edwards, Arthur
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 68
|
| Kamp, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 69
|
| Parker, James
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 70
|
| Strickland, Dennis
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 71
|
| Willer, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 72
|
| Willer, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 73
|
| Ernst, Elizabeth
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 74
|
| Craddock, Marissa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 75
|
| Lyons, Mary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 76
|
| Coffey, Justine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 77
|
| Liversidge, Ellen
|
| Vol #:
|
| 1
|
|
|
