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| Dockets Entered
On December 16, 2005
Table of Contents
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| Docket #
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| Title
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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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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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005P-0237
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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0295
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| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| C 10011
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| K. Blevins
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| Vol #:
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| 580
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| LET 4
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| K. Blevins
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| Vol #:
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| 580
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C
50
Attachment
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| Biosite Incorporated
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| Vol #:
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| 5
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1298
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| S. Hosking
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| Vol #:
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| 6
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| EMC 1299
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| S. Milles
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| Vol #:
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| 6
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
413
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| Farmers Union Industries, LLC
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| Vol #:
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| 36
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| C
414
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| Northwest Meat Processors Association
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| Vol #:
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| 36
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| C
415
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| American Association of Meat
Processors (AAMP)
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| Vol #:
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| 36
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| C
416
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| Valley Proteins, Inc.
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| Vol #:
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| 36
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| C 417
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| R. Vogler
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| Vol #:
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| 36
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| C 418
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| H. Barlow, III
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| Vol #:
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| 36
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| C 419
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| D. Luckey
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| Vol #:
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| 36
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| C 420
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| D. Cowherd
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| Vol #:
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| 36
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| C
421
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| Baker Commodities, Inc.
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| Vol #:
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| 36
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| C
422
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| Land O'Lakes Purina Feed, LLC (LOLPF)
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| Vol #:
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| 36
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| C 423
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| M. Horn
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| Vol #:
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| 36
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| C 424
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| D. Taylor
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| Vol #:
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| 36
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| C 425
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| D. Godin
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| Vol #:
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| 36
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| C
426
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| Fayetteville animal Clinic, P.C.
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| Vol #:
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| 36
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| C 427
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| Form Letters
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| Vol #:
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| 38
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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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| EMC 1175
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| No signature
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| Vol #:
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| 12
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| EMC 1176
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| No signature
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| Vol #:
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| 12
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 10
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| Family Dairies, USA
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| Vol #:
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| 1
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| C 11
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| E and D Roth
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| Vol #:
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| 1
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| C 12
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| D. Siegmann
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| Vol #:
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| 1
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| C
2
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| Public----Seattle & King County
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| Vol #:
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| 1
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| LET
3
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| ConAgra Foods
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| Vol #:
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| 1
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| LET
4
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| Unilever United States, Inc.
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| Vol #:
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| 2
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| LET
4
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| Frito-Lay, Inc.
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| Vol #:
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| 1
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| C
2
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| EXT 3
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| AMerican Pet Products Manufacturers Association (APPMA)
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| EMC 4
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| B. Raez
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| Vol #:
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| 1
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| EMC 5
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| C. Hodson
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| Vol #:
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| 1
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| EMC
6
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| Association for Molecular Pathology (AMP)
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| Vol #:
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| 1
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| LST
1
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| Agenda for December 7-8, 2005 Hearing
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| Vol #:
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| 2
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| TS
1
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| Director, Center for Drugs Evaluation and Research, FDA
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| Vol #:
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| 2
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| TS
2
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| WVU College of Law
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| Vol #:
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| 2
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| TS
3
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| Feinburg School of Medicine, Northwestern University
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| Vol #:
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| 2
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| TS
4
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| RTI Health Solutions
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| Vol #:
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| 2
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| TS
5
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| National Research Center for Women and Families
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| Vol #:
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| 2
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| TS
6
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| Plain Language Action and Information Network
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| Vol #:
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| 2
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| TS
7
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| E Liversidge
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| Vol #:
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| 2
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| TS
8
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| Time Inc
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| Vol #:
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| 2
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| TS
9
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| Cerner Corporation
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| Vol #:
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| 2
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| TS
10
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| APhaRC
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| Vol #:
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| 2
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| TS
11
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| Pharmaceutical Research & Manufacturers of America (PhRMA)
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| Vol #:
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| 2
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| TS
12
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| Stephen A Goldman Consulting Services LLC
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| Vol #:
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| 2
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| TS
13
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| ISMP
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| Vol #:
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| 2
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| TS
14
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| American Medical Association
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| Vol #:
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| 2
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| TS
15
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| American Pharmacists Association
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| Vol #:
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| 2
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| TS
16
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| Walgreen Co
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| Vol #:
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| 2
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| TS
17
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| Time Inc
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| Vol #:
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| 2
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| TS
18
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| Healthcare Communication
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| Vol #:
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| 2
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| TS
19
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| Healthcare CommunicatiCenter for Plain Language
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| Vol #:
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| 2
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| TS
20
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| Coalition for Healthcare Communication
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| Vol #:
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| 2
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| TS
21
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| List of Attendees for 12/7-8/2005 Public Meeting
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| Vol #:
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| 2
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| C
4
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| Fleminger, Inc.
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| Vol #:
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| 2
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| 2005P-0237
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| Re-Listing Petition to determine that two strenghths, 50 mg and 250 mg lamotrigene oral tablets, were not withdrawn due to safety nor efficacy concerns
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| LET
1
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| HFD-005 to Pharmaceutical Patent Attorneys, LLC
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| Vol #:
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| 1
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| C
80
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| Anesthesiologists for the Safe Administration of Propofol
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| Vol #:
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| 20
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| C 81
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| H. Galoob, MD
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| Vol #:
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| 20
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| 2005P-0295
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| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
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| LET
1
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| HFS-800 to Alaska Birch Syrupmakers Association
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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