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| Dockets Entered
On January 31, 2007
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| Docket #
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| Title
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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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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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0136
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealers Certificate
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| 2006P-0392
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| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0510
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| ANDA Suitability for Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg Tablets
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| 2006P-0513
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| Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0029
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| Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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| LET 9
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| DairiConcepts, L.P.
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| Vol #:
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| 2
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| LET 10
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| FDA/CFSAN to DairiConcepts, L.P.
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| Vol #:
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| 2
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1406
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| S. Shockley
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| Vol #:
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| 262
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| EC 14
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| Environmental Defense
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| 2
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 132
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| E. Dorf
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| Vol #:
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| 18
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| C 133
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| D. Schumacher
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| Vol #:
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| 18
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| EC 3219
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| Mrs. Kimberly Wisehart
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| Vol #:
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| 17
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| EC 3220
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| Miss. Brittany Harris
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| Vol #:
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| 17
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| EC 3221
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| Ms. Kathy King
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| Vol #:
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| 17
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| EC 3222
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| Ms. Charmaine crowell
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| Vol #:
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| 17
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| EC 3223
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| Ms. Briana Maughan
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| Vol #:
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| 17
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| EC 3224
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| Mrs. Rena Hicks
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| Vol #:
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| 17
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| EC 3225
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| Miss. Rachel Deering
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| Vol #:
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| 17
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| EC 3226
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| Mr. William Rice
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| Vol #:
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| 17
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| EC 3227
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| Mrs. angela birks
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| Vol #:
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| 17
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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 73
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| S. Shockley
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| Vol #:
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| 5
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| C 673
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| Form Letters
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| Vol #:
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| 26
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| EC 1576
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| Mrs. laura egger
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| Vol #:
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| 24
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| EC 1577
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| Ms. Cameron DeBarry
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| Vol #:
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| 24
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| EC 1578
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| Mrs. Judith Herman
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| Vol #:
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| 24
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| EC 1579
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| Mr. Carlyle Owens
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| Vol #:
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| 24
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 80
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| Butler Gas Products Company
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| Vol #:
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| 8
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| C 81
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| Boots Retail USA, Inc.
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| Vol #:
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| 8
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| C 82
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| Interstate Welding & Steel Supply
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| Vol #:
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| 8
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| C 83
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| General Welding Supply Corporation
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| Vol #:
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| 8
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| C 84
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| Southern Welding Supply, Inc.
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| Vol #:
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| 8
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| EC 17
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| Mr. stephen g powers
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| Vol #:
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| 1
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| C 4
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| Coalition for 21st Century Medicine
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| Vol #:
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| 1
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| EC 14
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| McDermott, Will
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| C 1590
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| R. Marcellino
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| Vol #:
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| 46
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| C 1591
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| D. Enz
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| Vol #:
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| 46
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| 2006N-0061
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| Charging for Investigational Drugs
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| C 3
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| Vital Therapies
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| Vol #:
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| 1
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| C 5
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| Vital Therapies
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| 1
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| 2006N-0136
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealers Certificate
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2006P-0306
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| Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
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| C 6
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| State of Washington
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| Vol #:
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| 1
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| C 7
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| State of Nevada
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| Vol #:
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| 1
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| 2006P-0392
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| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 50
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| A. Blackwelder
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| Vol #:
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| 6
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| C 51
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| Wegmans Consumer Affairs
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| Vol #:
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| 6
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| C 52
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| J. Harker
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| Vol #:
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| 6
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| C 53
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| Kofkoff Egg Farms, LLC
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| Vol #:
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| 6
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| EC 998
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| Mrs. audrey stuia
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| Vol #:
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| 8
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| EC 999
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| Mrs. Elise Ammeux
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| Vol #:
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| 8
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| EC 1000
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| Ms. Jo Tyler
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| Vol #:
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| 8
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| EC 1001
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| Mrs. Lydia Claes
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| Vol #:
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| 8
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| EC 1002
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| HSUS
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| Vol #:
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| 8
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| EC 1003
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| Mr. Olivier Topart
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| Vol #:
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| 8
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| EC 1004
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| Miss. Jessica Filippone
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| Vol #:
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| 8
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| EC 1005
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| Ms. Deborah Trendel
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| Vol #:
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| 8
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| C 3
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| MedImmune Oncology, Inc. (MedImmune)
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| Vol #:
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| 1
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| C 46
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| A. Max
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| Vol #:
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| 6
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| C 47
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| G. Devine
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| Vol #:
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| 6
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| C 48
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| G. Kromer
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| Vol #:
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| 6
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| C 49
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| A. Makrides
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| Vol #:
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| 6
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| C 50
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| S. Ocepa
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| Vol #:
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| 6
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| EC 914
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| Mrs. Christina Barnes
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| Vol #:
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| 7
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| EC 915
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| The Institute for Science and Society
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| Vol #:
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| 7
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| EC 916
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| Ms. Taline Nikolopoulos
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| Vol #:
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| 7
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| EC 917
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| Mr. Barry Abshere
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| Vol #:
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| 7
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| EC 918
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| Mr. EUGENE OSULLIVAN
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| Vol #:
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| 7
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| 2006P-0510
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| ANDA Suitability for Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg Tablets
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| CR 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0513
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| Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
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| EC 1
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| Mr. Keith Pratt
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| Vol #:
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| 1
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| EAPE 92
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| Corsico, Christopher
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| Vol #:
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| 1
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| EAPE 93
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| Phan, Anh
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| Vol #:
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| 1
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| EAPE 94
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| Beakes-Read, Virginia
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| Vol #:
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| 1
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| 2007N-0029
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| Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application
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| LET 1
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| FDA/DDM to Indevus Pharmaceuticals, Inc
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| Vol #:
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| 1
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