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| Dockets Entered
On March 4, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004N-0033
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| Factor VIII Inhibitors
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004Q-0144
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| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0093
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| revoke part of 5 CFR 5501.104(b)(3) prohibits owership of financial interest in a publicly traded or publicly available inestment funds
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| 2005P-0094
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| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
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| 2005P-0095
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| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| CR
1
Attachment
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| HFM-17
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| Vol #:
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| 128
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| C 2653
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| J. Heath
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| Vol #:
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| 90
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| C 2654
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| J. Robbins
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| Vol #:
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| 90
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| C 2655
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| P. Lindex
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| Vol #:
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| 90
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| C 2656
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| J. frontz
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| Vol #:
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| 90
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| C 2657
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| J. Wiss
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| Vol #:
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| 90
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| C 2658
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| F. Diamond
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| Vol #:
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| 90
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| C 2659
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| T. Lubey
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| Vol #:
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| 90
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| C 2660
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| R. Freedman
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| Vol #:
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| 90
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| C 2661
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| R. Freedman
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| Vol #:
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| 90
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| C 2662
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| J. Rein'l
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| Vol #:
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| 90
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| C 2663
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| V. Gentry
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| Vol #:
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| 90
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| C 2664
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| C. Kokis
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| Vol #:
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| 90
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| C 2665
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| F. Graning
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| Vol #:
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| 90
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| C 2666
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| C. Grenier
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| Vol #:
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| 90
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| C 2667
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| Dr and Mrs D. Taylor
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| Vol #:
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| 90
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| C 2668
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| L. Freeman, RN
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| Vol #:
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| 90
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| C 2669
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| E. Miller
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| Vol #:
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| 90
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| C 2670
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| V. Chaney
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| Vol #:
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| 90
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| C 2671
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| C. Kosek
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| Vol #:
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| 90
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| C 2672
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| P. Burkus
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| Vol #:
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| 90
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| C 2673
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| M. Conway
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| Vol #:
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| 90
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| C 2674
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| M. Kostya
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| Vol #:
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| 90
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| C 2675
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| C. Green
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| Vol #:
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| 90
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| C 2676
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| N. Hiestand
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| Vol #:
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| 90
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| C 2677
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| Illegible
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| Vol #:
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| 90
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| C 2678
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| L. Pappas
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| Vol #:
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| 90
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| C 2679
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| J. Bonagura and L. Heilweil
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| Vol #:
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| 90
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| C 2680
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| Mr and Mrs G. Pechacek
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| Vol #:
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| 90
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| C 2681
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| T. Desimone
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| Vol #:
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| 90
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| C 2682
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| P. Abramson and L. Waronen
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| Vol #:
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| 90
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| C 2683
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| H. Hendricks
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| Vol #:
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| 90
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| C 2684
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| R. Albergo
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| Vol #:
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| 90
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| C 2685
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| B. Harris
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| Vol #:
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| 90
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| C 2686
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| J. McKibben
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| Vol #:
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| 90
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| C 2687
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| M. Ciavola
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| Vol #:
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| 90
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| C 2688
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| V. Mock
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| Vol #:
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| 90
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| C 2689
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| J. Grant
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| Vol #:
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| 90
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| C 2690
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| G. Martino
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| Vol #:
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| 90
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| C 2691
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| J, Barron
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| Vol #:
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| 90
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| C 2692
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| M. Heffner
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| Vol #:
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| 90
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| C 2693
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| J. Solenberger
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| Vol #:
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| 90
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| C 2694
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| C. Carlson
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| Vol #:
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| 90
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| C 2695
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| Cary and Ann Rader
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| Vol #:
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| 90
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| C 2696
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| M. Bystrowski
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| Vol #:
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| 90
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| C 2697
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| M. Beardsley
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| Vol #:
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| 90
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| C 2698
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| N. Weber
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| Vol #:
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| 90
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| C 2699
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| D. McClelland
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| Vol #:
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| 90
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| C 2700
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| J. Hagerich
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| Vol #:
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| 90
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| C 2701
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| B. Deptuls
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| Vol #:
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| 90
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| C 2702
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| J. Taylorfie
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| Vol #:
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| 90
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| C 2703
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| J. Kay
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| Vol #:
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| 90
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| C 2704
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| F. Graning
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| Vol #:
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| 90
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| C 2705
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| N. Shortridge, RD
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| Vol #:
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| 90
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| C 2706
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| D. Ebben
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| Vol #:
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| 90
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| C 2707
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| M. Swomley
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| Vol #:
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| 90
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| C 2708
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| R. Gilbert
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| Vol #:
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| 90
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| C 2709
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| E. Rychman
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| Vol #:
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| 90
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| C 2710
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| H. Lei
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| Vol #:
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| 90
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| C 2711
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| J. Walsh
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| Vol #:
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| 90
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| C 2712
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| M Matthews and J Marti
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| Vol #:
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| 90
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| C 2713
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| C. Lorenz
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| Vol #:
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| 90
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| C 2714
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| W Marefield and Dr and Mrs R. Shelden
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| Vol #:
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| 90
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| C 2715
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| L. Richardson
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| Vol #:
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| 90
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| C 2716
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| D abd G DeJoannis
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| Vol #:
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| 90
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| C 2717
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| J and J Veldey
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| Vol #:
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| 90
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| C 2718
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| L. Bloom
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| Vol #:
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| 90
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| C 2719
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| P. Parsick
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| Vol #:
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| 90
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| C 2720
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| C. Newman
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| Vol #:
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| 90
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| C 2721
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| M and J Gubala
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| Vol #:
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| 90
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| C 2722
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| V. Cage
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| Vol #:
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| 90
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| C 2723
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| C. Carson
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| Vol #:
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| 90
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| C 2724
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| L. Ostrenga
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| Vol #:
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| 90
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| C 2725
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| M. Maisch
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| Vol #:
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| 90
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| C 2726
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| J. Matthews
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| Vol #:
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| 90
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| C 2727
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| E. Burtner
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| Vol #:
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| 90
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| C 2728
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| J. Lang
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| Vol #:
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| 90
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| C 2729
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| M. Mountleon
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| Vol #:
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| 90
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| C 2730
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| A. Franowsky
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| Vol #:
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| 90
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| C 2731
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| E. Johnson
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| Vol #:
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| 90
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| C 2732
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| P and A Beasley
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| Vol #:
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| 90
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| C 2733
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| A. Iskian
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| Vol #:
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| 90
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| C 2734
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| J. Honcharik
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| Vol #:
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| 90
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| C 2735
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| V. Steele
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| Vol #:
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| 90
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| C 2736
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| A. Capua
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| Vol #:
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| 90
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| C 2737
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| B and D Schut
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| Vol #:
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| 90
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| C 2738
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| C. Renn
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| Vol #:
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| 90
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| C 2739
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| A. Morrison, MD
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| Vol #:
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| 90
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| C 2740
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| R. Harris
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| Vol #:
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| 90
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| C 2741
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| C. Budarz
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| Vol #:
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| 90
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| C 2742
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| A. Holten
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| Vol #:
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| 90
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| C 2743
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| G. Shimoko
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| Vol #:
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| 90
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| C 2744
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| J. King
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| Vol #:
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| 90
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| C 2745
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| M. Sorin
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| Vol #:
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| 90
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| C 2746
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| J. Garratt
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| Vol #:
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| 90
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| C 2747
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| J. Christensen
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| Vol #:
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| 90
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| C 2748
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| N. Forfia
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| Vol #:
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| 90
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| C 2749
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| G. Coker
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| Vol #:
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| 90
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| C 2750
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| L. Ferguson
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| Vol #:
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| 90
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| C 2751
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| J. Powell
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| Vol #:
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| 90
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| C 2752
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| W. Blackman
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| Vol #:
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| 90
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| C 2753
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| P. Ibello
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| Vol #:
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| 90
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| C 2754
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| D. Zeff
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| Vol #:
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| 90
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| C 2755
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| D. Long
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| Vol #:
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| 90
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| C 2756
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| No signature
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| Vol #:
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| 90
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| C 2757
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| M. Peterman
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| Vol #:
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| 90
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| C 2758
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| E. Rayburn
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| Vol #:
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| 90
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|
|
| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| |
|
|
| SUP
36
Attachment
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 40
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| SUP
37
Attachment
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 41
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| |
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| LET
803
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| HFS-800 to Eastern Wisdom Herb Company
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| Vol #:
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| 24
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| LET
804
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| HFS-800 to Trader Joe's Company
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| Vol #:
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| 24
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| LET
805
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| HFS-800 to Enzymatic Therapy Inc
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| Vol #:
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| 24
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| LET
806
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| HFS-800 to McLind Corporation
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| Vol #:
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| 24
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| LET
807
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| HFS-800 to KNature Corporation
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| Vol #:
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| 24
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| LET
808
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| HFS-800 to B2 Marketing Group LLC
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| Vol #:
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| 24
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| LET
809
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| HFS-800 to World Nutrition Inc
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| Vol #:
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| 24
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| |
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| LET
810
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| HFS-800 to Oregon's Wild Harvest
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| Vol #:
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| 24
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| LET
811
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| HFS-800 to Source Naturals
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| Vol #:
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| 24
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| |
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| LET
812
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| HFS-800 to VitaPharmica Inc
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| Vol #:
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| 24
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| |
|
|
| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| |
|
|
| C 12755
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| Stephen Piszar
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| Vol #:
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| 802
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| |
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| C 12756
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| Barbara Elder
|
| Vol #:
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| 802
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| |
|
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| C 12757
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| C A Person
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| Vol #:
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| 802
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| | | | | | | |
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| |
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| C 12758
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| C A Person
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| Vol #:
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| 802
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| |
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| C 12759
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| Cqarline Murillo
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| Vol #:
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| 802
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| |
|
|
| C 12760
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| Unknown
|
| Vol #:
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| 802
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| |
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| C 12761
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| Cheryl Zaslawky
|
| Vol #:
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| 802
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| |
|
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| C 12762
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| Lisa Millot
|
| Vol #:
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| 802
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| |
|
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| C 12763
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| Anne Bressler
|
| Vol #:
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| 802
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| |
|
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| C 12764
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| Linda Webster
|
| Vol #:
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| 802
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| |
|
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| C 12765
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| Joan Sage
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| Vol #:
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| 802
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| |
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| C 12766
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| Sara Conor
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| Vol #:
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| 802
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| |
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| C 12767
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| Becki Klauss
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| Vol #:
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| 802
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| |
|
|
| C 12768
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| Sonta Scholtis
|
| Vol #:
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| 802
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| |
|
|
| C 12769
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| Sharon Albertson
|
| Vol #:
|
| 802
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| |
|
|
| C 12770
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| Lesley Tate
|
| Vol #:
|
| 802
|
| |
|
|
| C 12771
|
| Erna Haaga
|
| Vol #:
|
| 802
|
| |
|
|
| C 12772
|
| William Edelsein
|
| Vol #:
|
| 802
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| |
|
|
| C 12773
|
| Tom Dahmlixk
|
| Vol #:
|
| 802
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| |
|
|
| C 12774
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| Peggy Shelton
|
| Vol #:
|
| 802
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| |
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| C 12775
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| Mr. & Mrs. M. Karsen
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| Vol #:
|
| 802
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| |
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| C 12776
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| Carol Stouffer
|
| Vol #:
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| 802
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| |
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| C 12777
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| Regina Betz
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| Vol #:
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| 802
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| |
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| C 12778
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| Martha Hohman
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| Vol #:
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| 802
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| |
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| C 12779
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| Theresa Damicone
|
| Vol #:
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| 802
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| |
|
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| C 12780
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| Sister Martha Fox, OP
|
| Vol #:
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| 802
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| |
|
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| C 12781
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| Robyn Shepheard
|
| Vol #:
|
| 802
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| |
|
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| C 12782
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| Danielle Salant
|
| Vol #:
|
| 802
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| |
|
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| C 12783
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| Tina Wimbush
|
| Vol #:
|
| 802
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| |
|
|
| C 12784
|
| Charles Billingtom
|
| Vol #:
|
| 802
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| |
|
|
| C 12785
|
| Stela Nedeva, et al.
|
| Vol #:
|
| 802
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| |
|
|
| C 12786
|
| Karimu Tunkara, et. al.
|
| Vol #:
|
| 802
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| |
|
|
| C 12787
|
| Joseph Donalies
|
| Vol #:
|
| 802
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| |
|
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| C 12788
|
| Kristina Waiss
|
| Vol #:
|
| 802
|
| |
|
|
| C 12789
|
| Serena Coates
|
| Vol #:
|
| 802
|
| |
|
|
| C 12790
|
| Dan Fiorito
|
| Vol #:
|
| 802
|
| |
|
|
| C 12791
|
| T Kanter
|
| Vol #:
|
| 802
|
| |
|
|
| C 12792
|
| John Rogers, Jr.
|
| Vol #:
|
| 802
|
| |
|
|
| C 12793
|
| Danielle Salant
|
| Vol #:
|
| 802
|
| |
|
|
| C 12794
|
| Marilyn Ambiance
|
| Vol #:
|
| 802
|
|
| | | | | | | | |
|
| |
|
| C 12795
|
| LEna Yoder
|
| Vol #:
|
| 802
|
| |
|
|
| C 12796
|
| Msawenkosi Jerome Ndlanzi
|
| Vol #:
|
| 802
|
| |
|
|
| C 12797
|
| Daniele Ralis
|
| Vol #:
|
| 802
|
| |
|
|
| C 12798
|
| Evelyn Eider
|
| Vol #:
|
| 802
|
| |
|
|
| C 12799
|
| Matthew Baran
|
| Vol #:
|
| 802
|
| |
|
|
| C 12800
|
| Lauren Fisher
|
| Vol #:
|
| 802
|
| |
|
|
| C 12801
|
| Millie Reynolds
|
| Vol #:
|
| 802
|
| |
|
|
| C 12802
|
| Jennifer Fawcett
|
| Vol #:
|
| 802
|
| |
|
|
| C 12803
|
| Reed Scocos
|
| Vol #:
|
| 802
|
| |
|
|
| C 12804
|
| Dmitriy Rapoport
|
| Vol #:
|
| 802
|
| |
|
|
| C 12805
|
| Dmitriy Rapoport
|
| Vol #:
|
| 803
|
| |
|
|
| C 12806
|
| Dmitriy Rapoport
|
| Vol #:
|
| 804
|
| |
|
|
| C 12807
|
| Barbara Sykes
|
| Vol #:
|
| 805
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 2081
|
| C. Greenberg
|
| Vol #:
|
| 300
|
| |
|
|
| C 2082
|
| L. Norlander, RPh
|
| Vol #:
|
| 300
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
367
|
| Canadian Ship Suppliers Assn (CSSA)
|
| Vol #:
|
| 30
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
| |
|
|
| C
41
|
| International Pharmaceutical Aerosol Consortium (IPAC)
|
| Vol #:
|
| 6
|
| |
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
| |
|
|
| C 29
|
| L Wood
|
| Vol #:
|
| 15
|
| |
|
|
| C
30
|
| Sierra Club
|
| Vol #:
|
| 15
|
| |
|
|
| C 31
|
| D Shelton, C Bodiford
|
| Vol #:
|
| 15
|
| |
|
|
| C 32
|
| D Ray
|
| Vol #:
|
| 15
|
| |
|
|
| C 33
|
| J Jacobson
|
| Vol #:
|
| 15
|
| |
|
|
| C 34
|
| C Rowan
|
| Vol #:
|
| 15
|
| |
|
|
| C 35
|
| C Johnson
|
| Vol #:
|
| 15
|
| |
|
|
| C 36
|
| S Kendall
|
| Vol #:
|
| 15
|
| |
|
|
| C 37
|
| Form Letter count 18
|
| Vol #:
|
| 19
|
| |
|
|
| C 38
|
| Form Letter count 35
|
| Vol #:
|
| 20
|
| |
|
|
| C 39
|
| M K
|
| Vol #:
|
| 15
|
| |
|
|
| C 40
|
| K Glazzard
|
| Vol #:
|
| 15
|
| |
|
|
| C
41
|
| GM Free CYMRU
|
| Vol #:
|
| 15
|
|
| | | | | | | |
|
| |
|
| C 42
|
| C Bianich + 17 signatures
|
| Vol #:
|
| 15
|
| |
|
|
| C 43
|
| P Kropp
|
| Vol #:
|
| 15
|
| |
|
|
| C 44
|
| M Williams
|
| Vol #:
|
| 15
|
| |
|
|
| C 45
|
| R Jones
|
| Vol #:
|
| 15
|
| |
|
|
| C 46
|
| C J Adnitt
|
| Vol #:
|
| 15
|
| |
|
|
| C 47
|
| J Lawman = 13 signatures
|
| Vol #:
|
| 15
|
| |
|
|
| C 48
|
| M Crug + 8 signatures
|
| Vol #:
|
| 15
|
| |
|
|
| EMC 1200
|
| Number not used
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1201
|
| Georgia Pacific Corporation
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1202
|
| S Fletcher
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1203
|
| I Bard
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1204
|
| H Franklin
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1205
|
| N Hannon
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1206
|
| D Webber
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1207
|
| D Wylie-Sears
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1208
|
| D Harvath
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1209
|
| E Stewart
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1210
|
| M Hoke
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1211
|
| J Shaw
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1212
|
| R Swails
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1213
|
| W Peltz
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1214
|
| M Kerpan
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1215
|
| J Spandow
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1216
|
| V Spandow
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1217
|
| L Arceneaux
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1218
|
| L Glenn
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1219
|
| E Severson
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1220
|
| E Mangal
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1221
|
| S Kleb
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1222
|
| Washington Biotechnology Action Council
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1223
|
| Oregon Physicians for Social Responsibility
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1224
|
| T Kauffman-Smith
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1225
|
| K Iverson
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1226
|
| R Asai
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1227
|
| Shore-tyers Mill Nature Park
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1228
|
| J Williams
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1229
|
| T Swerdlow
|
| Vol #:
|
| 18
|
|
| | | | | | | |
|
| |
|
| EMC 1230
|
| J Pompilio
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1231
|
| C McDowell
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1232
|
| L Larson
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1233
|
| W Sample
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1234
|
| S Ruark
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1235
|
| P Domena
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1236
|
| J Martincic
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1237
|
| J Martincic
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1238
|
| S Andrews
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1239
|
| E Weeks
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1240
|
| J Wintersgill
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1241
|
| C Binnings
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1242
|
| K Karlson
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1243
|
| C Gorman
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1244
|
| D Somma
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1245
|
| T Person
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1246
|
| P Kenschaft
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1247
|
| S Ladwig
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1248
|
| E Craig
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1249
|
| T Broskey
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1250
|
| M Engebretson
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1251
|
| J Foster
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1252
|
| M Vaughn
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1253
|
| T Ikelman
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1254
|
| D Steadman
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1255
|
| J Moore
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1256
|
| A Duncan
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1257
|
| G Dale
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1258
|
| T Weiss
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1259
|
| D Brichford
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1260
|
| North Carolina Citizens for Safe Food
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1261
|
| North Carolina Citizens for Safe Food
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1262
|
| North Carolina Citizens for Safe Food
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1263
|
| North Carolina Citizens for Safe Food
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1264
|
| K Karmick
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1265
|
| E Maxam
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1266
|
| D Van Ry
|
| Vol #:
|
| 18
|
|
| | | | | | | | |
|
| |
|
| EMC 1267
|
| A Tilton
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1268
|
| T Becica
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1269
|
| B Mayeri
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1270
|
| T Collyer
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1271
|
| C Pettey
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1272
|
| K McNeely-Nutting
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1273
|
| L Alley
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1274
|
| J Reb
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1275
|
| C O'Bryan
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1276
|
| M Navarro-McCullar
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1277
|
| P Field
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1278
|
| T Allen
|
| Vol #:
|
| 28
|
| |
|
|
| EMC
1279
|
| Izaak Walton League of America
|
| Vol #:
|
| 28
|
| |
|
|
| EMC
1280
|
| Weston A Price Foundation
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1281
|
| M Vansoest
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1282
|
| J Houston
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1283
|
| N Helmers
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1284
|
| T Spence
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1285
|
| V Butler
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1286
|
| P Szilard
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1287
|
| M Strykowski
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1288
|
| J Paxon
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1289
|
| A Stromeyer
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1290
|
| L Snyder
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1291
|
| S Adams
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1292
|
| N Tepedino
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1293
|
| M O'Donnell
|
| Vol #:
|
| 18
|
| |
|
|
| EMC
1294
|
| Shimer College
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1295
|
| M Sprowles
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1296
|
| K Fraser
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1297
|
| F Canzano
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1298
|
| M Feldman
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1299
|
| J DeNicola
|
| Vol #:
|
| 18
|
| |
|
|
| EMC 1300
|
| M Bailey
|
| Vol #:
|
| 18
|
|
| |
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
| |
|
|
| EC 7
|
| Mrs. Deborah Greenhalgh
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
|
|
| 2004P-0074
|
| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
|
| |
|
|
| SUP
3
|
| Savient Pharmaceuticalsl, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0144
|
| Qualified Health Claim (QHC): Chromium picolinate and Diabetes
|
| |
|
|
| LET
5
|
| Emord & Associates, P.C.
|
| Vol #:
|
| 11
|
|
| |
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| ANS
1
|
| HFS-830 to Soy Information Service
|
| Vol #:
|
| 5
|
| |
|
|
| C
2
|
| Soy Information Service
|
| Vol #:
|
| 5
|
| |
|
|
| LET
6
|
| Soy Information Service
|
| Vol #:
|
| 5
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| EAPE 163
|
| Schmidtlein, Janice
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 164
|
| Levin, Elizabeth
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 165
|
| Williams, III, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 166
|
| Williams, III, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 167
|
| Peddicord, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 168
|
| Fitzpatrick, Suzanne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 169
|
| Walsh, Maria
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 170
|
| Diamond, Richard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 171
|
| Ostrove, Nancy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 172
|
| Janik, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 173
|
| Rogan, Debra
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 174
|
| Otto, Amrie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 175
|
| Watkins, Vish
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 176
|
| Megargle, Lynnsay
|
| Vol #:
|
| 1
|
| |
|
|
| EC
5
|
| Purdue Pharma L.P.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0093
|
| revoke part of 5 CFR 5501.104(b)(3) prohibits owership of financial interest in a publicly traded or publicly available inestment funds
|
| |
|
|
| ACK
1
|
| HFA-305 to Arthur K. Yellin
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Arthur K. Yellin
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0094
|
| Remove the drug Iressa (gefitnib; AstraZeneca) from the market immediately
|
| |
|
|
| ACK
1
|
| HFA-305 to Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0095
|
| ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
|
| |
|
|
| CP
1
|
| Luitpold Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
