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| Dockets Entered
On September 15, 2003
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| 1979P-0236
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| Laser light show
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2003D-0118
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| Decorative Contact Lens (Import alert #86-10)
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| 2003D-0317
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| Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| 2003N-0201
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| Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| 2003P-0291
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| Enforce the law and prevent unlaw sale of contact lens
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003V-0430
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| Laser Light Show
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| 2003V-0431
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| Laser Light Show
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| Contents |
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| C
242
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| Reddy-Cheminor and Dr. Reddy's Laboratories
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| Vol #:
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| 235
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| 1977N-0094I
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| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
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| C
5
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| Albemarle Corporation
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| Vol #:
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| 8
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| 1979P-0236
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| Laser light show
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| EXP
7
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| Laser Magic
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| Vol #:
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| 1
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C
245
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| Utah Natural Products Alliance (UNPA)
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| Vol #:
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| 41
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| C
246
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| American Herbal Products Assn (AHPA)
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| Vol #:
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| 41
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| C
247
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| American Herbal Pharmacopoeia (AHP)
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| Vol #:
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| 41
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| EMC
254
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| Council for Responsible Nutrition
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| Vol #:
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| 41
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| EMC
255
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| Council for Responsible Nutrition
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| Vol #:
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| 41
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
10911
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 82
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| LET
10912
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 82
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| LET
10913
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 82
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| LET
10914
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| Leiner Health Products
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| Vol #:
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| 83
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| LET
10915
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| Global Chinese Herbs Depot Inc.
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| Vol #:
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| 83
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| LET
10916
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| Global Chinese Herbs Depot Inc.
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| Vol #:
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| 83
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| LET
10917
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| Doctor's Best, Inc.
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| Vol #:
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| 83
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| LET
10918
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| Dolisos Laboratories
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| Vol #:
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| 83
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| LET
10919
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| Ancient Herbs, Inc.
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| Vol #:
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| 83
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| LET
10920
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| Cognis Nutrition and Health
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| Vol #:
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| 83
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| LET
10921
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| Leiner Health Products
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| Vol #:
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| 83
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| LET
10922
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 83
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| LET
10923
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| Natural Organics Inc.
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| Vol #:
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| 83
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| LET
10924
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| Natural Organics Inc.
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| Vol #:
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| 83
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| LET
10925
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| Natural Organics Inc.
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| Vol #:
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| 83
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| LET
10926
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| Natural Organics Inc.
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| Vol #:
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| 83
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| LET
10927
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 83
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| LET
10928
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| Doctor's Best, Inc.
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| Vol #:
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| 83
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| LET
10929
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 83
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| LET
10930
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| E. Excel International, Inc.
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| Vol #:
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| 83
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| C 538
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| Edna Cain
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| Vol #:
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| 30
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| 2003D-0118
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| Decorative Contact Lens (Import alert #86-10)
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| C 50
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| Frank B. Villa II, O.D.
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| Vol #:
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| 1
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| C
24
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| American Safety & Health Institute (ASHI)
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| Vol #:
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| 1
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| 2003D-0317
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| Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products
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| C
3
Attachment
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 1
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| 2003D-0367
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| Draft Guidance for Industry on Providing Regulatory Submissions in Electronic FormatbHuman Pharmaceutical Applications and Related Submissions
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0016
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| MedWatch: The FDA Medical Products Reporting Program
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| C
5
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| 2003N-0201
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| Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting
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| C
1
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| Bristol-Myers Squibb
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| Vol #:
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| 1
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| 2003N-0268
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing
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| EMC
1
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| America's Blood Centers
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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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| APE 7
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| Applied DNA Sciences, Inc
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| Vol #:
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| 1
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| APE 8
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| AC Compacting LLC
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| Vol #:
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| 1
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| APE 9
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| PhotoSecure, Inc
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| Vol #:
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| 1
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| APE 10
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| ScanAvert Inc
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| Vol #:
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| 1
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| C
1
Attachment 1,
2, 3
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| Uniform Code Council Inc
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| Vol #:
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| 1
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| NCR
1
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| FDA
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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 35
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| Rebecca M. Kiraly, O.D.
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| Vol #:
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| 1
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| C 36
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| Cindy M. McGarry, O.D.
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| Vol #:
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| 1
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| C 37
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| Eugene O'Leary, O.D.
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| Vol #:
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| 1
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| C 38
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| Ben T. Balkema, O.D.
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| Vol #:
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| 1
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| C 1
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| Patricia A. Niquette, M.A., CCC-A,FAAA
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| Vol #:
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| 1
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| 2003V-0430
|
| Laser Light Show
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| ACK
1
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| HFA-305 to Laser Magic Productions
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| Vol #:
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| 1
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| VAR
1
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| Laser Magic Productions
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| Vol #:
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| 1
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| 2003V-0431
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| Laser Light Show
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| ACK
1
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| HFA-305 to Laserworks
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| Vol #:
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| 1
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| ACK 2
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| Number not used
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| Vol #:
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| 1
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| VAR
1
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| Laserworks
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| Vol #:
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| 1
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