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| Dockets Entered
On September 26, 2003
Table of Contents
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| Docket #
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| Title
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| 1981N-0050
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| OTC for treatment of acute toxic ingestion human use
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| 2003D-0236
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| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| 2003E-0449
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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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-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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| 2003P-0278
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| Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs
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| 2003P-0280
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| Determine that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 1981N-0050
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| OTC for treatment of acute toxic ingestion human use
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| LET
18
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| HFD-560 to The American Assn of Poison Control Centers
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| Vol #:
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| 2
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11045
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| Twin laboratories, Inc.
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| Vol #:
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| 84
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| LET
11046
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| Twin laboratories, Inc.
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| Vol #:
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| 84
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| LET
11047
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| Twin Laboratories, Inc.
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| Vol #:
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| 84
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| LET
11048
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| Twinlab Laboratories, Inc.
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| Vol #:
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| 84
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| LET
11049
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| Twin Laboratories, Inc
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| Vol #:
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| 84
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| LET
11050
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| Twin Laboratories, Inc.
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| Vol #:
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| 84
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| LET
11051
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| Twin L aboratories, Inc.
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| Vol #:
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| 84
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| LET
11052
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| Twin Laboratories, Inc.
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| Vol #:
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| 84
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| LET
11053
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| Uncaria of Texas
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| Vol #:
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| 84
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| LET
11054
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11055
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| NBTY Inc.
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| Vol #:
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| 84
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| LET
11056
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| PhytoPharmica Nautral Medicines
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| Vol #:
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| 84
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| LET
11057
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 84
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| LET
11058
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 84
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| LET
11059
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 84
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| LET
11060
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| NutriMed, Inc.
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| Vol #:
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| 84
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| LET
11061
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 84
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| LET
11062
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 84
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| LET
11063
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 84
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| LET
11064
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 84
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| LET
11065
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 84
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| LET
11066
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| PhytoPharmica Nautral Medicines
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| Vol #:
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| 84
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| LET
11067
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| Weleda, Inc.
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| Vol #:
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| 84
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| LET
11068
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| Food Science of Vermont
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| Vol #:
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| 84
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| LET
11069
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| Twin Laboratories, Inc.
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| Vol #:
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| 84
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| LET
11070
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| Ashbury Biologicalls, Inc.
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| Vol #:
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| 84
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| LET
11071
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| Perrigo Company of South Carolina
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| Vol #:
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| 84
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| LET
11072
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| Perrigo Company of South Carolina
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| Vol #:
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| 84
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| LET
11073
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| Perrigo Company of South Carolina
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| Vol #:
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| 84
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| LET
11074
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| Pure Encapsulations, Inc.
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| Vol #:
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| 84
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| LET
11075
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| Natural 2 U
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| Vol #:
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| 84
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| C 9556
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| Jesse Brown et al
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| Vol #:
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| 415
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| 2000N-1484
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| Safety Reporting Requirements Human Drug/Biological Products
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| C
6
Attachment
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| Tularik, Inc.
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| Vol #:
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| 3
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| 2002P-0505
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| Labeling nuts & eligible nut containing products reduce risk
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| C
11
Attachment
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| Kraft Foods, Inc. (KRAFT)
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| Vol #:
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| 4
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| 2003D-0236
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| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
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| C
6
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| 2003D-0263
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| Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti
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| C
1
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| Minor Corp Farmer Alliance (MCFA)
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| Vol #:
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| 1
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| 2003E-0449
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| APP 1
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| LG Life Sciences, Ltd
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| Vol #:
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| 1
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| LET 1
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| U S Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| APP 1
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| Technology Transfer, Inc
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| Vol #:
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| 1
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| LET 1
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| U S Patent and Trademark Office
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| Vol #:
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| 1
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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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| EXT
4
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| Snack Food Assn (SFA)
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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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| EXT
1
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| Pennfield Oil Company/Pennfield Animal Health (Pennfield)
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| Vol #:
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| 1
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| 2003P-0278
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| Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs
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| C 1
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| Number Not Used
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| Vol #:
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| 1
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| RC
1
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| Associates of Cape Cod, Inc. (ACC)
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| Vol #:
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| 1
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| 2003P-0280
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| Determine that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices
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| RC
1
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| Associates of Cape Cod, Inc
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| Vol #:
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| 1
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| C 51
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| Susan M. Stan, O.D.
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| Vol #:
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| 1
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