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| Dockets Entered
On October 24, 2003
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0033A
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| Oral Health Care Drug Product; Oral Antiseptic Drug Products
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0610
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| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0163
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| Expedite Over-the-Counter Approval for Desloratidine
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| 2002P-0168
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| Request better product labeling of sports & energy beverages
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| 2003N-0338
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| Obesity
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0313
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| Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing
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| 2003P-0408
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| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
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| 2003V-0430
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| Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| EMC 131
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| K. Todd
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| Vol #:
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| 77
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| 1981N-0033A
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| Oral Health Care Drug Product; Oral Antiseptic Drug Products
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| LET
3
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| HFD-001 to Olsson, Frank and Weeda, PC
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| 1
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| EMC 929
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| J. Stumme
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| Vol #:
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| 375
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| EMC 930
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| No signature
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| Vol #:
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| 375
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| EMC 931
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| J.G. Murphy
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| Vol #:
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| 375
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| EMC 3830
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| Mary Ashley White
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| Vol #:
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| 281
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| EMC 3831
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| Amie Benedetto
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| Vol #:
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| 281
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| EMC 3832
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| Kathy Andrew
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| Vol #:
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| 281
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| EMC 3833
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| Michele A. Valli
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| Vol #:
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| 281
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| EMC 3834
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| Sally Ackerman
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| Vol #:
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| 281
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| EMC 3835
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| Meredith Erickson
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| Vol #:
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| 281
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| EMC 3836
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| Rebecca
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| Vol #:
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| 281
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| EMC 3837
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| Joviann Mech
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| Vol #:
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| 281
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| EMC 3838
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| Alice Solilman
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| Vol #:
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| 281
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| EMC 3839
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| Alice Soliman
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| Vol #:
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| 281
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| EMC 3840
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| Aslan Brooke
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| Vol #:
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| 281
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| EMC 3841
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| Vicki Castrejon
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| Vol #:
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| 281
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| EMC 3842
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| Charlotta Beavers
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| Vol #:
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| 281
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| EMC 3843
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| Kandi Jones
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| Vol #:
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| 281
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| 1998P-0610
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| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
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| EMC
94
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| Citizen Outreach
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| Vol #:
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| 5
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| EMC
95
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| Citizen Outreach
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| Vol #:
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| 5
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| EMC
96
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| National Consumers League
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| Vol #:
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| 5
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 476
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| Chris
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| Vol #:
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| 21
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| EMC 477
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| Kelly Villalobos
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| Vol #:
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| 21
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 566
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| Ronit Feinglass
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| Vol #:
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| 32
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| EMC
57
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| Applied Research Ethics National Assn (ARENA)
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| Vol #:
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| 5
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| EMC 58
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| Lu Hubert,MS,MT(ASCP)BB
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| Vol #:
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| 5
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| EMC 59
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| Kitty Guild, M.T.
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| Vol #:
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| 5
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| EMC
60
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| Fujisawa Healthcare, Inc.
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| Vol #:
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| 5
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| EMC
61
Attachment 1,
2
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| MSSO Products & Services
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| Vol #:
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| 5
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| EMC
62
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| AIDS Treatment Activist Coalition (ATAC)
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| Vol #:
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| 5
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| EMC 63
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| Alain J. Marengo-Rowe, MD
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| Vol #:
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| 5
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| EMC
64
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| Allina Medical Laboratories
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| Vol #:
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| 5
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| EMC
65
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| Berlex Laboratories, Inc.
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| Vol #:
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| 5
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| EMC 66
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| Janice M. Sigmon
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| Vol #:
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| 5
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| EMC
67
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| Amgen, Inc.
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| Vol #:
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| 5
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3144
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| Alison Payne
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| Vol #:
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| 252
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| EMC 97
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| No signature
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| Vol #:
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| 15
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| EMC
98
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| Honorable Russell D. Feingold
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| Vol #:
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| 15
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| EMC
99
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| Honorable Russell D. Feingold
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| Vol #:
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| 15
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| EMC
120
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| Honorable Russell D. Feingold
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| Vol #:
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| 17
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| EMC
121
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| Honorable Russell D. Feingold
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| Vol #:
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| 17
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| 2002P-0163
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| Expedite Over-the-Counter Approval for Desloratidine
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| EMC
5
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| National Consumers League
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| Vol #:
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| 1
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| 2002P-0168
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| Request better product labeling of sports & energy beverages
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| EMC
3
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| Citizen Outreach
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| Vol #:
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| 1
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| EMC
4
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| Citizen Outreach
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 283
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| Betty Martini
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| Vol #:
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| 5
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| EMC 284
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| Betty Martini
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| Vol #:
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| 5
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| EMC 285
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| Betty Martini
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| Vol #:
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| 5
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| EMC
1
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| Grocery Manufacturers of America (GMA)
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| Vol #:
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| 4
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| C
1
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| The Williamsburg Group
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| Vol #:
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| 1
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| 2003N-0211
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| Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma
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| C
5
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| Henry County Health Center
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| Vol #:
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| 1
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| 2003N-0324
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| Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing
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| SF
1
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| GCF-1
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| Vol #:
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| 1
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| 2003N-0338
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| Obesity
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| C
5
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| American Obesity Assn (AOA)
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| Vol #:
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| 1
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| C 3
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| Ruth Schiedermayer
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| Vol #:
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| 3
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| C
4
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| Closure Manufacturers Assn (CMA)
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| Vol #:
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| 3
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 32
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| Lisa Barton
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| Vol #:
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| 5
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| C 33
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| Rita A. Campbell
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| Vol #:
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| 5
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| C 34
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| Jane Kramer
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| Vol #:
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| 5
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| 2003P-0313
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| Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing
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| LET
3
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| HFS-811 to Bumble Bee Seafoods, Inc
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| Vol #:
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| 1
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| 2003P-0408
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| Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets
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| PDN
1
|
| HFD-1 toTorPharm, Inc.
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| Vol #:
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| 1
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| 2003V-0430
|
| Laser Light Show
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| VRA
1
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| HFZ-300 to Laser Magic Productions
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| Vol #:
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| 1
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