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| Dockets Management
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| Dockets Entered On
June 26, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| 2006M-0264
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| P040052 -MonoPrep Pap Test (MPPT)
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| 2006P-0267
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| to permit an ANDASuitability for Dextroamphetamine Sulfate Tablets
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17954
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| Sunrider International
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| Vol #:
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| 165
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| LET 17955
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| Sunrider International
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| Vol #:
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| 165
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| |
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| LET 17956
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| Sunrider Interanational
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| Vol #:
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| 165
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| LET 17957
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| Sunrider International
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| Vol #:
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| 1265
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| LET 17958
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| Sunrider International
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| Vol #:
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| 165
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| SUP 1
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| Hoffmann-La Roche Inc.
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 13493
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| S. Edwards
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| Vol #:
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| 156
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| C 13494
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| P. Krause
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| Vol #:
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| 156
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| C 13495
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| P. Perona
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| Vol #:
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| 156
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| C 13496
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| D. J. Rookhizen
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| Vol #:
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| 156
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| C 13497
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| N. Hollis
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| Vol #:
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| 156
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| C 13498
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| S. Manghera
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| Vol #:
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| 156
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| C 13499
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| C. Stanford
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| Vol #:
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| 156
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| C 13500
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| Ms. S. R. Powell
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| Vol #:
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| 156
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| C 13501
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| B. Ryan
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| Vol #:
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| 156
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| C 13502
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| J. Elliott
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| Vol #:
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| 156
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| C 13503
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| Ms. J. Keaney
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| Vol #:
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| 156
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| C 13504
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| M. Spivack
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| Vol #:
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| 156
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| C 13505
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| J. Pappalardo
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| Vol #:
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| 156
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| C 13506
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| S. L. Thompson
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| Vol #:
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| 156
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| C 13507
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| L. Crawford
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| Vol #:
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| 156
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| C 13508
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| P. A. Allen
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| Vol #:
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| 156
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| C 13509
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| L. Burns
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| Vol #:
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| 156
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| C 13510
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| P. J. Czys
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| Vol #:
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| 156
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| C 13511
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| M. G. Benton
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| Vol #:
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| 156
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| C 13512
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| L. Apple
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| Vol #:
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| 156
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| C 13513
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| Mrs. A. Langdon
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| Vol #:
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| 156
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| C 13514
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| N. Alexander
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| Vol #:
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| 156
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| C 13515
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| B. Ventro
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| Vol #:
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| 156
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| C 13516
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| G. Hikade
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| Vol #:
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| 156
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| C 13517
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| M. G. Fotoplos
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| Vol #:
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| 156
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| C 13518
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| J. H. Sutton
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| Vol #:
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| 156
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| C 13519
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| P. Thomas
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| Vol #:
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| 156
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| C 13520
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| J. Gerth
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| Vol #:
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| 156
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| C 13521
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| C. Meeks
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| Vol #:
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| 156
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| C 13522
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| L. H. Jung
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| Vol #:
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| 156
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| C 13523
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| M. Davenport
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| Vol #:
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| 156
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| C 13524
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| D. Black
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| Vol #:
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| 156
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| C 13525
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| A. Lehr
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| Vol #:
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| 156
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| C 13526
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| A. L. Freedman
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| Vol #:
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| 156
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| C 13527
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| P. Glenn
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| Vol #:
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| 156
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| C 13528
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| M. Janes
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| Vol #:
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| 156
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| C 13529
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| R. Griffith
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| Vol #:
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| 156
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| C 13530
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| C. Davidson
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| Vol #:
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| 156
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| C 13531
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| Ms. S. Thjompson
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| Vol #:
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| 156
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| C 13532
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| Miss J. Potter
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| Vol #:
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| 156
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| C 13533
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| B. Knowles
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| Vol #:
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| 156
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| C 13534
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| Mrs. D. Luongo
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| Vol #:
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| 156
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| C 13535
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| M. T. Maldonado
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| Vol #:
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| 156
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| C 13536
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| E. D. Green
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| Vol #:
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| 156
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| C 13537
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| C. L. Mathie
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| Vol #:
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| 156
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| C 13538
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| S. Derence
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| Vol #:
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| 156
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| C 13539
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| T. J. Krajnak
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| Vol #:
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| 156
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| C 13540
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| D. Walter
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| Vol #:
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| 156
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| C 13541
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| D. Blumberg
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| Vol #:
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| 156
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| C 13542
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| J. Stafford
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| Vol #:
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| 156
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| C 13543
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| Ms. L. Glover
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| Vol #:
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| 156
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| C 13544
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| J. Feldman
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| Vol #:
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| 156
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| C 13545
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| M. Pfannenstein
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| Vol #:
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| 156
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| C 13546
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| S. Payne
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| Vol #:
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| 156
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| C 13547
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| C. Dalton
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| Vol #:
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| 156
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| C 13548
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| J. Woodard
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| Vol #:
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| 156
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| C 13549
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| J. Rendle
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| Vol #:
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| 156
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| C 13550
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| M. Johnson and C. Southworth
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| Vol #:
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| 156
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| C 13551
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| S. Poznanovich
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| Vol #:
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| 156
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| C 13552
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| Wm Berger and Ms. P. J. Shaffer-Cloutier
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| Vol #:
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| 156
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| C 13553
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| S. Schmidt
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| Vol #:
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| 156
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| C 13554
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| D. Holden
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| Vol #:
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| 156
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| C 13555
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| W. Roach
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| Vol #:
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| 156
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| C 13556
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| C. Cervantes
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| Vol #:
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| 156
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| C 13557
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| C. Bland
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| Vol #:
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| 156
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| C 13558
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| C. Davis
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| Vol #:
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| 156
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| C 13559
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| C. M. Heckathorn
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| Vol #:
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| 156
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| C 13560
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| P. Forester
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| Vol #:
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| 156
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| C 13561
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| V. Brickholtz
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| Vol #:
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| 156
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| C 13562
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| J. Pagett
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| Vol #:
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| 156
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| C 13563
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| K. Franklin
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| Vol #:
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| 156
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| C 13564
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| J. Chauncey
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| Vol #:
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| 156
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| C 13565
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| L. Whitman
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| Vol #:
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| 156
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| C 13566
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| K. Latiano
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| Vol #:
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| 156
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| C 13567
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| B. Carlebach
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| Vol #:
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| 156
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| C 13568
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| A. Karpas, M.D.
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| Vol #:
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| 156
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| C 13569
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| J. Jones
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| Vol #:
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| 156
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| C 13570
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| T. L. Rathburn
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| Vol #:
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| 156
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| C 13571
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| A. Honda and M. Honda
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| Vol #:
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| 156
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| C 13572
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| L. Lovejoy
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| Vol #:
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| 156
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| C 13573
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| V. Siggers
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| Vol #:
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| 156
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| C 13574
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| C. Battee
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| Vol #:
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| 156
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| C 13575
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| H. McNabs
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| Vol #:
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| 156
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| C 13576
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| D. Lee
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| Vol #:
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| 156
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| C 13577
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| V. McCutchan
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| Vol #:
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| 156
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| C 13578
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| L. Londeen
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| Vol #:
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| 156
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| C 13579
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| S. Sutch
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| Vol #:
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| 156
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| C 13580
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| C. Jeffreys
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| Vol #:
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| 156
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| C 13581
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| L. C. Driehaus
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| Vol #:
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| 156
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| C 13582
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| C. Snyder
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| Vol #:
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| 156
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| C 13583
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| M. J. Velez, D.O.
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| Vol #:
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| 156
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| | | | | | | |
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| C 13584
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| L. Willard
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| Vol #:
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| 156
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| C 13585
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| J. Casmer
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| Vol #:
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| 156
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| C 13586
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| P. R. Hanger
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| Vol #:
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| 156
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| C 13587
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| B. Learmont
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| Vol #:
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| 156
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| C 13588
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| S. Mulvain
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| Vol #:
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| 156
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| C 13589
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| J. McCathen-Howard
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| Vol #:
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| 156
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| C 13590
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| L. Maccarone
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| Vol #:
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| 156
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| C 13591
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| J. Homan
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| Vol #:
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| 156
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| C 13592
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| D. Gerston
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| Vol #:
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| 156
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| C 13593
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| D. Hedges
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| Vol #:
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| 156
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| C 13594
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| D. A. Sofil
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| Vol #:
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| 156
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| C 13595
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| J. B. Poole
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| Vol #:
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| 156
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| C 13596
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| L. L. Himan
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| Vol #:
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| 156
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| C 13597
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| S. Willson
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| Vol #:
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| 156
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| C 13598
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| M. Snowman, Ph.D.
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| Vol #:
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| 156
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| C 13599
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| Ms. C. Malloy
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| Vol #:
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| 156
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| C 13600
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| A. Simmons
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| Vol #:
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| 156
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| C 13601
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| Ms. S. May
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| Vol #:
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| 158
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| C 13602
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| P. A. Epple
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| Vol #:
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| 158
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| C 13603
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| E. Brown
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| Vol #:
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| 158
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| C 13604
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| L. Scott
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| Vol #:
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| 158
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| C 13605
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| K. Nelson
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| Vol #:
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| 158
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| C 13606
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| S. E. DiMartino
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| Vol #:
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| 158
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| C 13607
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| S. Duff
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| Vol #:
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| 158
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| C 13608
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| P. A. Hawthorne
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| Vol #:
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| 158
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| C 13609
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| K. Behrens
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| Vol #:
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| 158
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| |
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| C 13610
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| M. F. Mason
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| Vol #:
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| 158
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| C 13611
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| P. Devine
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| Vol #:
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| 158
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| C 13612
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| K. Penrod
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| Vol #:
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| 158
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| C 13613
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| D. Huelsmann
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| Vol #:
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| 158
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| C 13614
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| D. Krumme
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| Vol #:
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| 158
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| C 13615
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| C. J. Pieschl
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| Vol #:
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| 158
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| |
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| C 13616
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| S. Brown
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| Vol #:
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| 158
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| |
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| C 13617
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| D. Arroyo
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| Vol #:
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| 158
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| |
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| C 13618
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| D. Bauer
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| Vol #:
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| 158
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| |
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| C 13619
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| D. Cirrincione
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| Vol #:
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| 158
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| |
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| C 13620
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| C. Tatge
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| Vol #:
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| 158
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| | | | | | | |
| |
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| C 13621
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| L. Kobzeff
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| Vol #:
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| 158
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| |
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| C 13622
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| G. D. Hollowood
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| Vol #:
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| 158
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| |
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| C 13623
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| S. Gilbert
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| Vol #:
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| 158
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| |
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| C 13624
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| B. Nangle
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| Vol #:
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| 158
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| |
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| C 13625
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| L. Licsko
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| Vol #:
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| 158
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| |
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| C 13626
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| J. Sheldrup
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| Vol #:
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| 158
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| |
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| C 13627
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| L. Swanson
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| Vol #:
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| 158
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| |
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| C 13628
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| G. E. Klipfel, M.D.
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| Vol #:
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| 158
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| |
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| C 13629
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| D. C. Cady
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| Vol #:
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| 158
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| |
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| C 13630
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| J. Smith
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| Vol #:
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| 158
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| |
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| C 13631
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| D. Lytz
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| Vol #:
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| 158
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| |
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| C 13632
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| P. Bachman
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| Vol #:
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| 158
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| |
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| C 13633
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| A. Rogers
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| Vol #:
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| 158
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| |
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| C 13634
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| L. Garland
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| Vol #:
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| 158
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| |
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| C 13635
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| B. J. Reed
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| Vol #:
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| 158
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| |
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| C 13636
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| K. Doty
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| Vol #:
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| 158
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| |
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| C 13637
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| K. L. Lester
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| Vol #:
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| 158
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| |
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| C 13638
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| L. Schreiber
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| Vol #:
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| 158
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| |
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| C 13639
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| M. Martin
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| Vol #:
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| 158
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| |
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| C 13640
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| S. Wooden
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| Vol #:
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| 158
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| |
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| C 13641
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| J. Dolton
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| Vol #:
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| 158
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| |
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| C 13642
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| J. A. Thelen
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| Vol #:
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| 158
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| |
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| C 13643
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| N. K. Smith
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| Vol #:
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| 158
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| |
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| C 13644
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| H. V. Goodman
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| Vol #:
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| 158
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| |
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| C 13645
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| K. Morrill
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| Vol #:
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| 158
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| |
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| C 13646
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| E. H. Schneider
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| Vol #:
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| 158
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| |
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| C 13647
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| J. S. Mitcham
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| Vol #:
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| 158
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| |
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| C 13648
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| Dr. J. Hofve
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| Vol #:
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| 158
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| |
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| C 13649
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| B. A. Homan
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| Vol #:
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| 158
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| |
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| C 13650
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| M. Vulgan
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| Vol #:
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| 158
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| |
|
|
| C 13651
|
| R. LeBlanc
|
| Vol #:
|
| 158
|
| |
|
|
| C 13652
|
| N. Curole
|
| Vol #:
|
| 158
|
| |
|
|
| C 13653
|
| L. Eymurd
|
| Vol #:
|
| 158
|
| |
|
|
| C 13654
|
| L. Fleck
|
| Vol #:
|
| 158
|
| |
|
|
| C 13655
|
| D. Clark
|
| Vol #:
|
| 158
|
| |
|
|
| C 13656
|
| G. Molner aka Julie Molner
|
| Vol #:
|
| 158
|
| |
|
|
| C 13657
|
| M. Katana
|
| Vol #:
|
| 158
|
|
| | | | | | | |
| |
|
|
| C 13658
|
| B. R. Crumpton
|
| Vol #:
|
| 158
|
| |
|
|
| C 13659
|
| J. McNiel, M.D.
|
| Vol #:
|
| 158
|
| |
|
|
| C 13660
|
| L. Beckett
|
| Vol #:
|
| 158
|
| |
|
|
| C 13661
|
| S. McLean
|
| Vol #:
|
| 158
|
| |
|
|
| C 13662
|
| M. J. Murphy
|
| Vol #:
|
| 158
|
| |
|
|
| C 13663
|
| L. Sintes
|
| Vol #:
|
| 158
|
| |
|
|
| C 13664
|
| no name
|
| Vol #:
|
| 158
|
| |
|
|
| C 13665
|
| no name
|
| Vol #:
|
| 158
|
| |
|
|
| EMC 2738
|
| J. Wyatt
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2739
|
| M. Mclendon
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2740
|
| D. McSwain
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2741
|
| C. Tessier
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2742
|
| M. Lavin
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2743
|
| C. Vukovich
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2744
|
| O. Jolly
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2745
|
| M. West
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2746
|
| D. Dean
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2747
|
| E. Harrison
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2748
|
| B. Smart
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2749
|
| C. Holt
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2750
|
| P. Olch
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2751
|
| C. Raymos
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2752
|
| N. Garon
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2753
|
| J. Ivey
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2754
|
| M. Sevastopoulos
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2755
|
| N. Politzer
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2756
|
| S. Williamson
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2757
|
| N. Vinson
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2758
|
| L. Meyers
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2759
|
| R. Wakefield
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2760
|
| K. Mack
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2761
|
| J. Odenwald
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2762
|
| P. Lemoine
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2763
|
| L. Doubleday
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2764
|
| P. McKenna
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2765
|
| M. Lavezzo
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2766
|
| J. Allyn
|
| Vol #:
|
| 157
|
|
| | | | | | | | |
| |
|
|
| EMC 2767
|
| L. Gagnon
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2768
|
| M. Millons
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2769
|
| Dr. M. Scalice
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2770
|
| T. Dunn
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2771
|
| S. Milliken
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2772
|
| K. Pence
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2773
|
| G. Prince
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2774
|
| M. Mitchell
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2775
|
| B. Ulmer
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2776
|
| R. McBryde
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2777
|
| M. Schlitt
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2778
|
| K. Weber
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2779
|
| P. Szabados
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2780
|
| M. Gutekanst
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2781
|
| K. Kamp
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2782
|
| J. McElroy
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2783
|
| A. Gaskill
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2784
|
| M. Maitland
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2785
|
| M. Winney
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2786
|
| C. Neifing
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2787
|
| L. Hillyer
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2788
|
| E. Collins
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2789
|
| J. Haftek
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2790
|
| S. Smith
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2791
|
| P. Mitchell
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2792
|
| E. Ollis
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2793
|
| E. Secrist
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2794
|
| C. Buiniskis
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2795
|
| N. Reed
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2796
|
| N. Dumke
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2797
|
| M. McIlhon
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2798
|
| C. Reichmuth
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2799
|
| J. O'Malley
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2800
|
| J. Simoneaux
|
| Vol #:
|
| 157
|
| |
|
|
| 2006D-0268
|
| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2006M-0264
|
| P040052 -MonoPrep Pap Test (MPPT)
|
| |
|
|
| AAV 1
|
| MonoGen, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
| |
|
|
| EMC 1
|
| E. Dubberke, MD
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0178
|
| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
|
| |
|
|
| SUP 1
|
| Public Citizen Health Research Group
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0267
|
| to permit an ANDASuitability for Dextroamphetamine Sulfate Tablets
|
| |
|
|
| ACK 1
|
| FDA/ DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
