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| Dockets Entered
On December 24, 2003
Table of Contents
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| Docket #
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| Title
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| |
|
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| 1995N-0304
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| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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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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| |
|
|
| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
|
|
| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2003D-0466
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on b
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| |
|
|
| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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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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| |
|
|
| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| |
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| 2003P-0289
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| outlaw and prohibit the use of hydrogenated and partially hydrogenated fats in all prepared,manufactured and processed food products intended for human consumption
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| |
|
|
| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| |
|
|
| PAV
1
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| HFC-1 to CSPI
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| Vol #:
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| 84
|
| |
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
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| |
|
|
| EMC 954
|
| Beth
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| Vol #:
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| 375
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| |
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| EMC 955
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| No signature
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| Vol #:
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| 375
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| |
|
|
| EMC 956
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| D. Scherer
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| Vol #:
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| 375
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| |
|
|
| EMC 957
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| H. Price
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| Vol #:
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| 375
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| |
|
|
| EMC 958
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| K. Keller
|
| Vol #:
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| 375
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| |
|
|
| EMC 959
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| D. Scholz
|
| Vol #:
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| 375
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| |
|
|
| EMC 960
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| Amy
|
| Vol #:
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| 375
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| |
|
|
| EMC 961
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| L. Southward
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| Vol #:
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| 375
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| |
|
|
| EMC 962
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| No signature
|
| Vol #:
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| 375
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| |
|
|
| EMC 963
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| S. Davis
|
| Vol #:
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| 375
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| |
|
|
| EMC 964
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| S. Henritzy
|
| Vol #:
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| 375
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| LET
12008
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 96
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| |
|
|
| LET
12009
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| PhytoPharmica Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12010
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12011
|
| Integrative Therapeutics Inc.
|
| Vol #:
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| 96
|
|
| | | | | | | |
| |
|
|
| LET
12012
|
| Integrative Therapeutics Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12013
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12014
|
| Rexall Sundown, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12015
|
| SomaLife Health Products, Ltd.
|
| Vol #:
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| 96
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| |
|
|
| LET
12016
|
| Source Naturals
|
| Vol #:
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| 96
|
| |
|
|
| LET
12017
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12018
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12019
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12020
|
| Enzymatic Therapy Natural medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12021
|
| PhytoPharmica Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12022
|
| PhytoPharmica Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12023
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12024
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12025
|
| New Chapter, Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12026
|
| New Chapter, Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12027
|
| New Chapter, Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12028
|
| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12029
|
| PhytoPharmica Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12030
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| Nutrivention Nutritional Programs
|
| Vol #:
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| 96
|
| |
|
|
| LET
12031
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| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12032
|
| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12033
|
| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12034
|
| New Chapter, Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12035
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| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12036
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| New Chapter, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12037
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| National Vitamin Company, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12038
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| National Vitamin Company, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12039
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| National Vitamin Company, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12040
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| PhytoPharmica Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12041
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| Contemporary Nutrition, Inc.
|
| Vol #:
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| 96
|
| |
|
|
| LET
12042
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12043
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 96
|
| |
|
|
| LET
12044
|
| Solstice Medicine Company
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12045
|
| Life Plus International
|
| Vol #:
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| 96
|
| |
|
|
| LET
12046
|
| Calpis Company, Ltd.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12047
|
| Market America, Inc.
|
| Vol #:
|
| 96
|
| |
|
|
| LET
12048
|
| Eco Nutrients Inc.
|
| Vol #:
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| 96
|
|
| | | | | | | | |
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C
7334
|
| Form Letter
|
| Vol #:
|
| 306
|
| |
|
|
| EMC 4032
|
| D. Watts
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4033
|
| E. Pickard
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4034
|
| M. Halligan
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4035
|
| M. Emmer
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4036
|
| M. Jacobs
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4037
|
| K. Whittington
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4038
|
| M.M. Blair
|
| Vol #:
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| 304
|
| |
|
|
| EMC 4039
|
| D. Browning
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4040
|
| M. Delbridge
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4041
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4042
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4043
|
| K. Kaiser
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4044
|
| L. Sapien
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4045
|
| J. Tew
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4046
|
| C. Duisin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4047
|
| M. Baker
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4048
|
| C. Fisher
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4049
|
| K. Zinner
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4050
|
| M. Mlodzik
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4051
|
| M. Lok
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4052
|
| K. Lol
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4053
|
| Bobby Chin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4054
|
| S. Martin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4055
|
| B. Dunbar
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4056
|
| B. Reed
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4057
|
| R. Wiebel
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4058
|
| S. Barney
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4059
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4060
|
| T. Willett
|
| Vol #:
|
| 304
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 496
|
| L. Pardy
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 497
|
| L. Roggman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 498
|
| G. Towse
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 499
|
| D. South
|
| Vol #:
|
| 23
|
|
| | | | | | | | |
| |
|
|
| EMC 500
|
| L. Brown
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 501
|
| P. Garcia
|
| Vol #:
|
| 23
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 737
|
| M. Abbott
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 738
|
| A. Soderman
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 739
|
| D. Abbate
|
| Vol #:
|
| 32
|
| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
|
|
| EMC 5696
|
| Brandon Burbach
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5697
|
| Nartha Herrero
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5698
|
| Audrey Minich
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5726
|
| Patricia Mayer
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5727
|
| Corrine Carlson
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5728
|
| Corrine Carlson
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5729
|
| Judy Findling
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5730
|
| JEssica Pardee
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5731
|
| Stacy Anderson
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5732
|
| Sallie Sandler
|
| Vol #:
|
| 788
|
| |
|
|
| EMC 5733
|
| Liz Pysar
|
| Vol #:
|
| 788
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C 322
|
| D. Mullins
|
| Vol #:
|
| 125
|
| |
|
|
| C 323
|
| R. Franzen
|
| Vol #:
|
| 125
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
251
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 20
|
| |
|
|
| C
252
|
| International Foodservice Distributors Association (IFDA)
|
| Vol #:
|
| 20
|
| |
|
|
| C
253
|
| Association of American Railroads
|
| Vol #:
|
| 20
|
| |
|
|
| C
254
|
| American Seed Trade Association, Inc.
|
| Vol #:
|
| 20
|
| |
|
|
| C
255
|
| Taylor & Grant Specialties Limited
|
| Vol #:
|
| 20
|
| |
|
|
| C
256
|
| Hoffmann-La Roche Inc
|
| Vol #:
|
| 20
|
| |
|
|
| C
257
|
| Pokon & Chrysal
|
| Vol #:
|
| 20
|
| |
|
|
| C
258
|
| International Food Coalition
|
| Vol #:
|
| 20
|
| |
|
|
| C
259
|
| American Free Trade Association (AFTA)
|
| Vol #:
|
| 20
|
| |
|
|
| C
260
|
| Department of Defense
|
| Vol #:
|
| 20
|
| |
|
|
| C
261
|
| National Soft Drink Association (NSDA)
|
| Vol #:
|
| 20
|
| |
|
|
| C
262
|
| Federal Express Corporation (FedEx)
|
| Vol #:
|
| 20
|
|
| | | | | | | | |
| |
|
|
| C
263
|
| American Frozen Food Institute
|
| Vol #:
|
| 20
|
| |
|
|
| C
264
|
| American Feed Industry Association (AFIA)
|
| Vol #:
|
| 20
|
| |
|
|
| C
265
|
| National Confectioners Association (NCA)
|
| Vol #:
|
| 20
|
| |
|
|
| C
266
|
| Border Trade Alliance
|
| Vol #:
|
| 21
|
| |
|
|
| C
267
|
| Fresh Produce Association of the Americas
|
| Vol #:
|
| 21
|
| |
|
|
| C
268
|
| Miami International Airport
|
| Vol #:
|
| 21
|
| |
|
|
| C
269
|
| National Association for the Specialty Food Trade, Inc.
|
| Vol #:
|
| 21
|
| |
|
|
| C
270
Attachment
|
| French Federatin of Exporters of WInes & Spirits
|
| Vol #:
|
| 21
|
| |
|
|
| C
271
|
| International Bottled Water Association
|
| Vol #:
|
| 21
|
| |
|
|
| C
272
|
| United States Senate
|
| Vol #:
|
| 21
|
| |
|
|
| C
273
|
| United States Senate
|
| Vol #:
|
| 21
|
| |
|
|
| C
274
|
| California Fine Wine Alliance
|
| Vol #:
|
| 21
|
| |
|
|
| C
275
|
| American Moving and Storage Association
|
| Vol #:
|
| 21
|
| |
|
|
| C
276
|
| Fedeartion des Producteurs Maraichers du Quebec
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
142
|
| Wine and Spirit Association
|
| Vol #:
|
| 20
|
| |
|
|
| EMC
143
|
| Agricultural and Food Transporters Conference
|
| Vol #:
|
| 20
|
| |
|
|
| EMC
144
|
| El Jarocho Distributors, Inc., Brito Produce, Co., Ruiz Wholesale Co. etc
|
| Vol #:
|
| 20
|
| |
|
|
| EMC
145
|
| Province of Manitoba
|
| Vol #:
|
| 20
|
| |
|
|
| EMC
146
|
| Alberta Agriculture, Food and Rural Development
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
147
|
| Secretaria de Agricultura, Ganaderia, Desarrollo Rural, Psca y Alimentacion (SAGARPA)
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
148
|
| Confectionery Manufacturers Association of Canada
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
149
|
| United Fresh Fruit & Vegetable Association
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
150
|
| Canadian Chamber of Commerce
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
151
|
| J & K Fresh LLC
|
| Vol #:
|
| 21
|
| |
|
|
| EMC
152
|
| Ministry of Agriculture of the Republic of Indonesia
|
| Vol #:
|
| 21
|
| |
|
|
| 2003D-0466
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on b
|
| |
|
|
| C
1
|
| Society of Toxicologic Pathology (STP)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| C
43
|
| Johnson & Johnson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 7
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C 39
|
| Honorable Jack Reed
|
| Vol #:
|
| 5
|
| |
|
|
| C 40
|
| Honorable Russell D. Feingold
|
| Vol #:
|
| 5
|
| |
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
| |
|
|
| SUP
1
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2003P-0289
|
| outlaw and prohibit the use of hydrogenated and partially hydrogenated fats in all prepared,manufactured and processed food products intended for human consumption
|
| |
|
|
| PDN
1
|
| HFC-1 to Ms. Diana E. Kelly
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
| |
|
|
| ACK 1
|
| HFA-305 to Hogan & Hartson L.L.P.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Reference
2-31, Cover Letter
|
| American Bakers Association et al
|
| Vol #:
|
| 1
|
|
|
