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| Dockets Entered
On April 16, 2004
Table of Contents
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| Docket
#
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| Title
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| 1995V-0043
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| Variance for the Scanning Beam Digital X-ray System
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| |
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0506
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| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004N-0158
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| Referral of Zonegran (Zonisamide), Wellbutrin and Zyban (Bupropion), and Renagel (Sevelamer) for the Conduct of Pediatric Studies
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| 2004P-0043
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| Require Purdue Pharma to revise labeling of OxyContin Tablets
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| 2004V-0112
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| Laser Light Show
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| 2004V-0120
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| Laser Light Show
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| 1995V-0043
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| Variance for the Scanning Beam Digital X-ray System
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| ACK
1
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| NexRay
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| Vol #:
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| 1
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| ACK
2
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| HFA-305 to NexRay
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| Vol #:
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| 1
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| VAR
2
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| NexRay
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13640
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13641
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13642
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13643
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13644
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 114
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| LET
13645
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13646
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| LET
13647
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 114
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EMC 558
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| Paul Martin MD
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| Vol #:
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| 271
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| EMC 559
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| Mr. Bobbie Dee Flowers
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| Vol #:
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| 271
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| EMC 560
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| Mary Cherry
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| Vol #:
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| 271
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| EMC 561
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| Mary Wilson
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| Vol #:
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| 271
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| EMC 562
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| Peter Crownfield
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| Vol #:
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| 271
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| EMC 563
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| Meredith Neria
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| Vol #:
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| 271
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| EMC 564
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| David Michaelson
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| Vol #:
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| 271
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| EMC 565
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| Steven Fenster
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| Vol #:
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| 271
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| EMC 566
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| Judith H. Hayes
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| Vol #:
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| 271
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| EMC 567
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| Dr. Andrew C. Millard
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| Vol #:
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| 271
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| EMC 568
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| Dei Scott
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| Vol #:
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| 271
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| EMC 569
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| Paula Stone
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| Vol #:
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| 271
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| EMC 570
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| Michelle Norton
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| Vol #:
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| 271
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| |
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| EMC 571
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| Bill & Marilyn Voorhies
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| Vol #:
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| 271
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| EMC 572
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| Joseph Shirk
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| Vol #:
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| 271
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| EMC 573
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| Stephen Fisher, PhD
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| Vol #:
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| 271
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| EMC 574
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| K. Watson
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| Vol #:
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| 271
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| EMC 575
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| Jonathan Foise
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| Vol #:
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| 271
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| EMC 576
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| Martin Marinoff
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| Vol #:
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| 271
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| EMC 577
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| Cheryl Gross
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| Vol #:
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| 271
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| EMC 578
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| Joe Castello
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| Vol #:
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| 271
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| EMC 579
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| Carrie Elsass
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| Vol #:
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| 271
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| EMC 580
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| Neil Young
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| Vol #:
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| 271
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| EMC 581
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| Sean Spada
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| Vol #:
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| 271
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| EMC 582
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| Joan Mendelson
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| Vol #:
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| 271
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| EMC 583
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| Sue Shaw
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| Vol #:
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| 271
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| EMC 584
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| Mary Rossi & Family
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| Vol #:
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| 271
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| EMC 585
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| Chris Casper
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| Vol #:
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| 271
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| EMC 586
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| Jonathan Coker
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| Vol #:
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| 271
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| EMC 587
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| Wyatt Eddy
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| Vol #:
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| 271
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| EMC 588
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| Harold Rapp
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| Vol #:
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| 271
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| EMC 589
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| Mary Branch
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| Vol #:
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| 271
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| EMC 590
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| Jane Winn
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| Vol #:
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| 271
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| EMC 591
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| Angela Nations
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| Vol #:
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| 271
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| EMC 592
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| Carole Jackson
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| Vol #:
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| 271
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| EMC
593
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| The Annie Appleseed Project
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| Vol #:
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| 271
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| EMC 594
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| Judy Schriebman
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| Vol #:
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| 271
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| EMC 595
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| Lizbeth Williamson
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| Vol #:
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| 271
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| EMC 596
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| Roseann Wright
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| Vol #:
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| 271
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| EMC 597
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| Beth Smith
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| Vol #:
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| 271
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| EMC 598
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| Dr. James Wagner
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| Vol #:
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| 271
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| EMC 599
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| Anatole Besman, MD
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| Vol #:
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| 271
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| |
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| EMC 600
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| Joseph & Phyllis O'Donnell
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| Vol #:
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| 271
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| |
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| EMC 601
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| Paul Brandon
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| Vol #:
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| 271
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| |
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| EMC 602
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| Nathan Schofer
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| Vol #:
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| 271
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| EMC 603
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| John Kesich
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| Vol #:
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| 271
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| |
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| EMC 604
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| Harold & Navaz Hurd
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| Vol #:
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| 271
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| |
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| EMC 605
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| Pamela Davis
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| Vol #:
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| 271
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| |
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| EMC 606
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| Susan Trivisonno
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| Vol #:
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| 271
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| |
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| EMC 607
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| Walter Kowalski
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| Vol #:
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| 271
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| |
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| EMC 608
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| Karen Williams
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| Vol #:
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| 271
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| EMC 609
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| Jan Jarrett
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| Vol #:
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| 271
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| EMC 610
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| Ravi Grover
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| Vol #:
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| 271
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| |
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| EMC 611
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| Nina Keefer
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| Vol #:
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| 271
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| EMC 612
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| Jordan Moore
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| Vol #:
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| 271
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| |
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| EMC 613
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| Carol Gray
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| Vol #:
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| 271
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| EMC 614
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| Charles Rinehart
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| Vol #:
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| 271
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| |
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| EMC 615
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| Pedro Alves
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| Vol #:
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| 271
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| |
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| EMC 616
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| William Freeto
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| Vol #:
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| 271
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| |
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| EMC 617
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| Carl Andrews
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| Vol #:
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| 271
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| |
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| EMC 618
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| M. Leslie Correa
|
| Vol #:
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| 271
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| |
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| EMC 619
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| Veronica Cox
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| Vol #:
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| 271
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| |
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| EMC 620
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| Jennifer Heavilin
|
| Vol #:
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| 271
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| |
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| EMC 621
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| Teri Greene
|
| Vol #:
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| 271
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| |
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| EMC 622
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| Nancy Couch, MD
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| Vol #:
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| 271
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| |
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| EMC 623
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| James McCarthy
|
| Vol #:
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| 271
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| |
|
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| EMC 624
|
| Karna Barquist
|
| Vol #:
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| 271
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| |
|
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| EMC 625
|
| Irv & Lila Berman
|
| Vol #:
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| 271
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| |
|
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| EMC 626
|
| Jeff Engel
|
| Vol #:
|
| 271
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| |
|
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| EMC 627
|
| Donna Foley
|
| Vol #:
|
| 271
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| |
|
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| EMC 628
|
| Susan Bourg
|
| Vol #:
|
| 271
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| |
|
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| EMC 629
|
| A. S. Duggan
|
| Vol #:
|
| 271
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| |
|
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| EMC 630
|
| Norman Hallal
|
| Vol #:
|
| 271
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| |
|
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| EMC 631
|
| Paul Case
|
| Vol #:
|
| 271
|
| |
|
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| EMC 632
|
| Thom Sulanke
|
| Vol #:
|
| 271
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| |
|
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| EMC 633
|
| Noah Silverglade
|
| Vol #:
|
| 271
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| |
|
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| EMC 634
|
| Cheryl Casey
|
| Vol #:
|
| 271
|
| |
|
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| EMC 635
|
| Jim Payette
|
| Vol #:
|
| 271
|
| |
|
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| EMC 636
|
| Larry D. Little
|
| Vol #:
|
| 271
|
| |
|
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| EMC 637
|
| John Birnel
|
| Vol #:
|
| 271
|
| |
|
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| EMC 638
|
| Daniel Vice
|
| Vol #:
|
| 271
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| |
|
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| EMC 639
|
| Rita Walton
|
| Vol #:
|
| 271
|
|
| | | | | | | | |
| |
|
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| EMC 640
|
| Dr. Daniel Wainstock
|
| Vol #:
|
| 271
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| |
|
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| EMC 641
|
| Ocie Hudson
|
| Vol #:
|
| 271
|
| |
|
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| EMC 642
|
| Theodore K. Raab
|
| Vol #:
|
| 271
|
| |
|
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| EMC 643
|
| Pierre Catala
|
| Vol #:
|
| 271
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| |
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| EMC 644
|
| Judy F. Brouillette
|
| Vol #:
|
| 271
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| |
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| EMC 645
|
| Aleksandar Totic
|
| Vol #:
|
| 271
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| |
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| EMC 646
|
| Mark Johnson
|
| Vol #:
|
| 271
|
| |
|
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| EMC 647
|
| Ken Charman
|
| Vol #:
|
| 271
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| |
|
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| EMC 648
|
| Amy Robinson
|
| Vol #:
|
| 271
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| |
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| EMC 649
|
| Richard Kulmacz
|
| Vol #:
|
| 271
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| |
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| EMC 650
|
| Carol Siewert
|
| Vol #:
|
| 271
|
| |
|
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| EMC 651
|
| Allen Kelson
|
| Vol #:
|
| 271
|
| |
|
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| EMC 652
|
| Michelle Abernathy
|
| Vol #:
|
| 271
|
| |
|
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| EMC 653
|
| Melissa Moore
|
| Vol #:
|
| 271
|
| |
|
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| EMC 654
|
| Maya Be
|
| Vol #:
|
| 271
|
| |
|
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| EMC 655
|
| Kate Gale
|
| Vol #:
|
| 271
|
| |
|
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| EMC 656
|
| Terry Edlin
|
| Vol #:
|
| 271
|
| |
|
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| EMC 657
|
| Preston C. Manning, M.D.
|
| Vol #:
|
| 271
|
| |
|
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| EMC 658
|
| Michelle Whitfield
|
| Vol #:
|
| 271
|
| |
|
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| EMC 659
|
| Lynda Bagot-Parker
|
| Vol #:
|
| 271
|
| |
|
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| EMC 660
|
| Deborah Longman-Marien
|
| Vol #:
|
| 271
|
| |
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| EMC 661
|
| Cathie Silano
|
| Vol #:
|
| 271
|
| |
|
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| EMC 662
|
| Ann Tate
|
| Vol #:
|
| 271
|
| |
|
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| EMC 663
|
| Jason Turner
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 664
|
| Peter Fulda
|
| Vol #:
|
| 271
|
| |
|
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| EMC 665
|
| Tom Nicholson
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 666
|
| Valerie Cusson
|
| Vol #:
|
| 271
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| NIR
2
|
| FDA
|
| Vol #:
|
| 20
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| BKG
2
|
| Joint FDA-CBP Plan
|
| Vol #:
|
| 22
|
| |
|
|
| NAD
3
|
| FDA
|
| Vol #:
|
| 22
|
| |
|
|
| NIR
2
|
| FDA
|
| Vol #:
|
| 22
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C 94
|
| Form letters
|
| Vol #:
|
| 15
|
|
| | | | | | | | |
| |
|
|
| C 95
|
| Form letters
|
| Vol #:
|
| 18
|
| |
|
|
| C 96
|
| Form letters
|
| Vol #:
|
| 31
|
| |
|
|
| C 97
|
| Form letters
|
| Vol #:
|
| 33
|
| |
|
|
| C 98
|
| Form letters
|
| Vol #:
|
| 36
|
| |
|
|
| 2003N-0506
|
| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
|
|
|
|
|
|
|
| |
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| APE 1
|
| Rick C Roberts
|
| Vol #:
|
| 1
|
| |
|
|
| APE 2
|
| Interamerican College of Physicians ans Surgeons
|
| Vol #:
|
| 1
|
| |
|
|
| APE 3
|
| Amyotrophic Lateral Sclerosis Association
|
| Vol #:
|
| 1
|
| |
|
|
| APE 4
|
| SPC Global Technolgies
|
| Vol #:
|
| 1
|
| |
|
|
| APE 5
|
| Healthcare Distribution Management Association (HDMA)
|
| Vol #:
|
| 1
|
| |
|
|
| APE 6
|
| Christensen, Miller, Fink, Jacobs,Glaser, Weil & Shapiro, LLP
|
| Vol #:
|
| 1
|
| |
|
|
| APE 7
|
| State of Wisconsin, Governor
|
| Vol #:
|
| 1
|
| |
|
|
| APE 8
|
| National Taxpayers Union
|
| Vol #:
|
| 1
|
| |
|
|
| APE 9
|
| King Pharmaceuticals, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| APE 10
|
| The Seniors Coalition
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| C. Bradley, Jr.
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Blue Cross Blue Shield of North Dakota
|
| Vol #:
|
| 1
|
| |
|
|
| LST
4
|
| Agenda for April 14, 2004 meeting
|
| Vol #:
|
| 1
|
| |
|
|
| TR
1
|
| Transcript of the April 5, 2004 Meeting
|
| Vol #:
|
| 2
|
| |
|
|
| TS
7
|
| SPC Global Technolgies
|
| Vol #:
|
| 1
|
| |
|
|
| TS
8
Slides
|
| drugstore.com, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| TS
9
|
| Biotechnology Industry Organization
|
| Vol #:
|
| 1
|
| |
|
|
| TS
10
|
| State of Wisconsin, Governor
|
| Vol #:
|
| 1
|
| |
|
|
| TS
11
|
| National Taxpayers Union
|
| Vol #:
|
| 1
|
| |
|
|
| TS
12
|
| Pharmaceutical Research and Manufacturing Association
|
| Vol #:
|
| 1
|
| |
|
|
| TS
13
|
| King Pharmaceuticals, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0158
|
| Referral of Zonegran (Zonisamide), Wellbutrin and Zyban (Bupropion), and Renagel (Sevelamer) for the Conduct of Pediatric Studies
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0043
|
| Require Purdue Pharma to revise labeling of OxyContin Tablets
|
|
|
| C
2
|
| Kleinfeld, Kaplan and Becker, LLP
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| 2004V-0112
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Intelligent Dance Factory
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0120
|
| Laser Light Show
|
| |
|
|
| VRA
1
|
| HFZ-300 to Laser Energy
|
| Vol #:
|
| 1
|
|
|
