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| Dockets Entered
On March 16, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0169
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| Dental Amalgam; Request for Information
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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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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004N-0559
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| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| 2004P-0544
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| ANDA for ondansetron hydrochloride injection, 8mg/4mL prefilled syringes
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0030
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| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
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| 2005N-0036
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| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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|
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| |
|
|
| EMC 77
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| E Wood
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| Vol #:
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| 141
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| |
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| EMC 78
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| R Trefts
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| Vol #:
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| 141
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| |
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| EMC 79
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| T Trefts
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| Vol #:
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| 141
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| |
|
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| EMC 80
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| Military Vaccine Education Center, Inc
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| Vol #:
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| 9
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| |
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| EMC 81
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| D Holmes
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| Vol #:
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| 141
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| |
|
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| EMC 82
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| E Estes
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| Vol #:
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| 141
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| |
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| EMC 83
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| P Kelly
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| Vol #:
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| 141
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| |
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| EMC 84
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| K Cradit
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| Vol #:
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| 141
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| |
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| EMC 85
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| J Watt
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| Vol #:
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| 141
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| |
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| EMC 86
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| T Trefts
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| Vol #:
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| 141
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| EMC 87
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| J Kirk
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| Vol #:
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| 141
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| |
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| EMC 88
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| $ Trefts
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| Vol #:
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| 141
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| |
|
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| EMC 89
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| L Whatley
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| Vol #:
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| 141
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| |
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| EMC
90
|
| Parkman Associates
|
| Vol #:
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| 141
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| |
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| EMC 91
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| J Brown
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| Vol #:
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| 141
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| |
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| EMC 92
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| T Trefts
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| Vol #:
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| 141
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| |
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| EMC 93
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| T Trefts
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| Vol #:
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| 141
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| |
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| EMC 94
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| J Stroh
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| Vol #:
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| 141
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| |
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| EMC 95
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| V Shemeley
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| Vol #:
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| 141
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| |
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| EMC 96
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| J Sotomayor
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| Vol #:
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| 141
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| |
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| EMC 97
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| C Kutz
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| Vol #:
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| 141
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| |
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| EMC 98
|
| R Browne MD
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| Vol #:
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| 141
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| |
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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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| LET
15693
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| Ortho Molecular Products
|
| Vol #:
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| 138
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| |
|
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| LET
15694
|
| Enzymatic Therapy
|
| Vol #:
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| 138
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| |
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| LET
15695
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| P.L. Thomas & Company, Inc.
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| Vol #:
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| 138
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| LET
15696
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| Enzymatic Therapy
|
| Vol #:
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| 138
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| |
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| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
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| |
|
|
| EMC 581
|
| J. Lundquist
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| Vol #:
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| 24
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| EMC 582
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| A. Kelley
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| Vol #:
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| 24
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| |
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| EMC 583
|
| J. Laffin
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| Vol #:
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| 24
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| |
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| EMC 584
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| No signature
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| Vol #:
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| 24
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| |
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| EMC 585
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| P. Tousa
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| Vol #:
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| 24
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| |
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| EMC 586
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| D. Chambers
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| Vol #:
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| 24
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| |
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| EMC 587
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| T. Woods
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| Vol #:
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| 24
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| |
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| |
|
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| EMC 12020
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| S. Sullivan
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| Vol #:
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| 574
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| |
|
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| 2000N-0504
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| Egg Safety Action Plan
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| |
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| EMC 1903
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| No signature
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| Vol #:
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| 31
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| |
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| EMC 1904
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| N. Campbell
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| Vol #:
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| 31
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| |
|
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| EMC 1905
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| No signature
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| Vol #:
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| 31
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| |
|
|
| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
|
| |
|
|
| EMC 11574
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| S. Sullivan
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| Vol #:
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| 349
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|
| | | | | | | | |
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| |
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
|
|
| C
299
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| Congress of the United States
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| Vol #:
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| 403
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|
| |
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| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
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| EMC 14208
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| J. Kerr
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| Vol #:
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| 324
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| |
|
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| EMC 14209
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| A. Grottveit
|
| Vol #:
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| 324
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| |
|
|
| EMC 14210
|
| S. Kent
|
| Vol #:
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| 324
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| |
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| EMC 14211
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| A. Fussell
|
| Vol #:
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| 324
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| |
|
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| EMC 14212
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| J. Meredith
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| Vol #:
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| 324
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| |
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| EMC 14213
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| L. Baird
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| Vol #:
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| 324
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| |
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| EMC 14214
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| N and C Keith
|
| Vol #:
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| 324
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| |
|
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| EMC 14215
|
| L. Rittel
|
| Vol #:
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| 324
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| |
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| EMC 14216
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| K. Tracy
|
| Vol #:
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| 324
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| |
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| EMC 14217
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| J. Johnson
|
| Vol #:
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| 324
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| |
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| EMC 14218
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| J. Ives
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| Vol #:
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| 324
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| |
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| EMC 14219
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| S. Orth
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| Vol #:
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| 324
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| |
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| EMC 14220
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| M. Gurewitz
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| Vol #:
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| 324
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| |
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| EMC 14221
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| C. Winkler
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| Vol #:
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| 324
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| |
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| EMC 14222
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| S. Blaschko
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| Vol #:
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| 324
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| |
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| EMC 14223
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| L. Kraft
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| Vol #:
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| 324
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| EMC 14224
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| T. Sofie
|
| Vol #:
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| 324
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| EMC 14225
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| E. Teuber
|
| Vol #:
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| 324
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| |
|
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| EMC 14226
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| M. Reeves
|
| Vol #:
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| 324
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| |
|
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| EMC 14227
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| S. Conlon
|
| Vol #:
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| 324
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| |
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| EMC 14228
|
| T. Kremer
|
| Vol #:
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| 324
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| |
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| EMC 14229
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| K. Dolcini
|
| Vol #:
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| 324
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| |
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| EMC 14230
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| T. Douville
|
| Vol #:
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| 324
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| |
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| EMC 14231
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| J. Kromberg
|
| Vol #:
|
| 324
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| |
|
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| EMC 14232
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| A. Zipp
|
| Vol #:
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| 324
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| |
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| EMC 14233
|
| K. Heuss
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14234
|
| W. Hay, MD
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14235
|
| B. Pratt
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14236
|
| A. Moshman
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14237
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| G. Price
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14238
|
| R. Paskowitz
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14239
|
| D. Krinsky
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14240
|
| R. Kierstead
|
| Vol #:
|
| 324
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|
| | | | | | | |
| |
|
|
| EMC 14241
|
| C. Asrir
|
| Vol #:
|
| 324
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| |
|
|
| EMC 14242
|
| D. Marburg
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14243
|
| T. Hegel
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14244
|
| A. Kelly
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14245
|
| J. Brestel
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14246
|
| E. Beck
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14247
|
| E. Sullivan
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14248
|
| T. Beermann
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14249
|
| P. Ellis
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14250
|
| K. Davis
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14251
|
| S. Saunders
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14252
|
| K. Walker
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14253
|
| P. Smith
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14254
|
| R. Smith
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14255
|
| T. Edgerton
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14256
|
| K. Hanlon
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14257
|
| A. Fabel
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14258
|
| M. Whitis
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14259
|
| M. Duncan
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14260
|
| D. Rosen
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14261
|
| K. Wolfram
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14262
|
| C. Swatzell
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14263
|
| C. Zahid
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14264
|
| C. Zahid
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14265
|
| E. Barnawell
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14266
|
| A. Dick
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14267
|
| C. Haglund
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14268
|
| N. Edwards
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14269
|
| A. Brister
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14270
|
| R. Band
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14271
|
| L. Koch
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14272
|
| K. Anderson
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14273
|
| S. Beran
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14274
|
| A. Norris
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14275
|
| B.J. and B. Wheeler
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14276
|
| C. Turnbull
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14277
|
| L. Schafer, MD
|
| Vol #:
|
| 324
|
|
| | | | | | | | |
| |
|
|
| EMC 14278
|
| L. Schafer, MD
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14279
|
| L. Holliday
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14280
|
| M. Olson
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14281
|
| E. Kenney
|
| Vol #:
|
| 324
|
| |
|
|
| EMC
14282
|
| Representative Beth Kerttula
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14283
|
| J. Dinkel
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14284
|
| K. Juntunen
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14285
|
| C. Prichard, RN, BSN
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14286
|
| M. Jackson
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14287
|
| A. Kurtzman
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14288
|
| G. Lopez
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14289
|
| N. Khwaja
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14290
|
| J. Marcus
|
| Vol #:
|
| 324
|
| |
|
|
| EMC 14291
|
| M. Elledge
|
| Vol #:
|
| 324
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3161
|
| L. Slitt
|
| Vol #:
|
| 261
|
| |
|
|
| EMC 3162
|
| S. Segal
|
| Vol #:
|
| 261
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 208
|
| R. Jose
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 209
|
| C. Lee
|
| Vol #:
|
| 4
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 433
|
| Mission Possible International
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 434
|
| R. Brinckman
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
435
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 436
|
| Mission Possible International
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
437
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 438
|
| Mission Possible International
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 439
|
| J. Bowen, MD
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 440
|
| Mission Possible International
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
441
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
| |
|
|
| 2003F-0088
|
| Increase the Maximum Permitted Energy Level of X-rays
|
| |
|
|
| EMC 384
|
| B. Laincz, RN
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 385
|
| C. Miller, MD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 386
|
| N. Hagen
|
| Vol #:
|
| 2
|
|
| | | | | | | |
| |
|
|
| EMC 387
|
| R. Radzai
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 388
|
| D. Pasekoff
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 389
|
| D. Butler
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 390
|
| J. Cardano
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 391
|
| Rev G. Swearengen
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 392
|
| E. Maciejunes
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 393
|
| J. Kapczynski
|
| Vol #:
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| 2
|
| |
|
|
| EMC 394
|
| A. Vallery
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 395
|
| C. Caldwell
|
| Vol #:
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| 2
|
| |
|
|
| EMC 396
|
| J. Maniatis
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 397
|
| P. Verin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 398
|
| D. Jackson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 399
|
| E. Bak
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 400
|
| M. Lewis
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 401
|
| C. Tietjen
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 402
|
| J. White
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 403
|
| B. Phillips
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 404
|
| J. Reed
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 405
|
| S. Aripotch
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 406
|
| L. DeBow
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 407
|
| N. Mulder
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 408
|
| A. Thompson
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 409
|
| P. Auerbach
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 410
|
| B. Dively
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 411
|
| M. Peterson
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 412
|
| D. Reardon
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 413
|
| R. Pell
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 414
|
| L. Baxter
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 415
|
| R. and C Dean
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 416
|
| M. Turner
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 417
|
| W. Vanschel
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 418
|
| E. LaBeau
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 419
|
| N. Macasek
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 420
|
| D. Ortman
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 421
|
| C. Mayer
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 422
|
| G. Schmitz, SSND
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
| |
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 633
|
| D Altmeyer
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 634
|
| P Tyndale, D Foddrell
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 635
|
| D
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 636
|
| D Nedde
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 637
|
| V Forbes
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 638
|
| J Ducklow
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 639
|
| Dawson
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 640
|
| J Parrino
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 641
|
| N Neubauer
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 642
|
| J DeMille
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 643
|
| D Fogel
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 644
|
| D Fogel
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 645
|
| P Fiorentino
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 646
|
| R Phillips
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 647
|
| Number not used
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 648
|
| Kathy
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 649
|
| J Sue
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 650
|
| R Seder
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 651
|
| G Erwin
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 652
|
| D McLennon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 653
|
| C Hamilton
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 654
|
| A Sonnier MS RD
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 655
|
| J Walz
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 656
|
| G Christen
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 657
|
| R Wood
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 658
|
| D McLennon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 659
|
| D McLennon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 660
|
| Simpson
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 661
|
| S Loganadan
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 662
|
| S Loganadan
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 663
|
| C Keane
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 664
|
| D McLennon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 665
|
| D McLennon
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 666
|
| J Price
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 667
|
| E Jarard
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
| |
|
|
| EMC 668
|
| R Beverly
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 669
|
| J Gibson
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 670
|
| C Dalton
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 671
|
| K. Miller
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 672
|
| K. Angell
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 673
|
| B. Bradfield
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 674
|
| P. Herring
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 675
|
| J. Sticher
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 676
|
| C. Ashworth
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 677
|
| C. Ashworth
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 678
|
| V. Marcks
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 679
|
| V. Marcks
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 680
|
| P. Amoroso, MD, MPH
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 681
|
| No signature
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 682
|
| K. Barnett
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 683
|
| W. Salerno
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 684
|
| M. arcoleo
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 685
|
| S. Arcoleo
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 686
|
| Dr. J. Weiss
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 687
|
| A. Needle
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 688
|
| J. Alfe
|
| Vol #:
|
| 9
|
| |
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
| |
|
|
| EMC
286
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
287
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
288
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
289
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
290
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
291
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| EMC
292
|
| Consumers for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EMC 56
|
| B. Mosher
|
| Vol #:
|
| 15
|
| |
|
|
| 2004D-0524
|
| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| C
1
|
| Eon Labs Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
1
|
| Teva Pharmaceutical Industries, Ltd. (TEVA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0559
|
|
| | | | | | | | |
| |
|
|
| Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
|
| |
|
|
| C 14
|
| M Martinen MD
|
| Vol #:
|
| 2
|
| |
|
|
| C 15
|
| J Indiveri
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0068
|
| Establish specific bioequivalence requirements for oral products contanining desmopressin
|
| |
|
|
| C
1
|
| Barr Laboratories Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0522
|
| Off label drug use for CYTOTEC
|
| |
|
|
| EMC 1
|
| T. Griffin
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0544
|
| ANDA for ondansetron hydrochloride injection, 8mg/4mL prefilled syringes
|
| |
|
|
| C
1
|
| Hyman Phelps & McNamara
|
| Vol #:
|
| 1
|
| |
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
| |
|
|
| RC
2
|
| The Solae Company
|
| Vol #:
|
| 5
|
| |
|
|
| 2005D-0030
|
| Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling
|
| |
|
|
| C
1
|
| UCSD Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0036
|
| Use of Color on Pharmaceutical Product Labels, Labeling and Packaging; Public Hearing
|
| |
|
|
| EMC 5
|
| L Koehn RPH MS
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 6
|
| M Moore PharmD RPh
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0038
|
| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
|
| |
|
|
| ANS
1
|
| HFD-1 to Aspreva Pharmaceuticals Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| APE 9
|
| Georgetown University Medical Center
|
| Vol #:
|
| 2
|
| |
|
|
| APE 10
|
| Association of Clinical Research Professionals (ACRP)
|
| Vol #:
|
| 2
|
| |
|
|
| APE 11
|
| OC Office of Pediatric Therapeutics
|
| Vol #:
|
| 2
|
| |
|
|
| APE 12
|
| Zimmer Spine Inc
|
| Vol #:
|
| 2
|
| |
|
|
| APE 13
|
| Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 2
|
| |
|
|
| APE 14
|
| Consortium of Independent Review Boards
|
| Vol #:
|
| 2
|
| |
|
|
| APE 15
|
| NHLBI, NIH
|
| Vol #:
|
| 2
|
| |
|
|
| APE 16
|
| Aspreva Pharmaceuticals Corporation
|
| Vol #:
|
| 2
|
| |
|
|
| APE 17
|
| US Public Interest Research Group (US PIRG)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
2
|
| Minneapolis VAMC
|
| Vol #:
|
| 2
|
| |
|
|
| LST
1
|
| List of Speakers for 03/21/2005 Hearing
|
| Vol #:
|
| 2
|
| |
|
|
| TS
1
Attachment
1, 2
|
| Wendy Stephenson & Associates LLC
|
| Vol #:
|
| 2
|
|
|
