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| Dockets Entered
On January 16, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| 2003D-0545
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| Questions and Answers Regarding Registration of Food Facilities
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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| 2003E-0406
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| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| 2003E-0458
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| Patent Extension, Velcade, bortezomib, #5,780,454
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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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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2003V-0546
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| Laser Light Show
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| LST
89
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| List as of January 14, 2004
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| Vol #:
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| 17
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C 61
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| L. Brackman
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| Vol #:
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| 5
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| C 62
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| J. O'Neill
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| Vol #:
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| 5
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| C 63
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| T. Harless
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| Vol #:
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| 5
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| 2003D-0497
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| Guidance for Industry on Pharmacogenomic Data Submissions
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| C
1
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| Lilly Research Laboratories
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| Vol #:
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| 1
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| 2003D-0545
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| Questions and Answers Regarding Registration of Food Facilities
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| GDL
2
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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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| 2003E-0405
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| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0406
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| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| LET
3
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| U.S. Patent & 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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| LET
4
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003E-0458
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| Patent Extension, Velcade, bortezomib, #5,780,454
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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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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| C
41
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| Zoological Imports
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| Vol #:
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| 5
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| C 42
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| G. Seaberg
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| Vol #:
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| 5
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| C 43
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| P. Prichard
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| Vol #:
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| 5
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| C 44
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| P. Prichard
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| Vol #:
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| 5
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| C
45
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| Form Letters
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| Vol #:
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| 8
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| EXT
2
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| Consumer Healthcare Products Assn (CHPA)
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| Vol #:
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| 1
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| C
1
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| 3M Pharmaceuticals
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| Vol #:
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| 1
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| LET
1
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 1
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| 2003P-0530
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| Silicone Gel-filled Breast Implants
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| C
4
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| SSF Switzerland
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| Vol #:
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| 1
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 1
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| D. M. Ingall
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| Vol #:
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| 2
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| 2003V-0546
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| Laser Light Show
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| VRA
1
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| HFZ-300 to The Ark/JGET
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| Vol #:
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| 1
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| GDL 1
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| Draft Level 2 Guidance
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| Vol #:
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| 1
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