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| Dockets Entered
On May 5, 2004
Table of Contents
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| Docket
#
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| Title
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim "Healthy" & Health Claims
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| 1997D-0411
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| (BSE) in Products for Human Use; Guidance for Industry.
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002V-0415
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| LAD-01 Medical Laser Product
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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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-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| 2004D-0182
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| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
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| 2004D-0210
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| Guidance: Clinical Trial Design for Hip Replacement Systems
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| 2004N-0076
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| Food and Color Additives and Generally Recognized As Safe Substances; Technical Amendments
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| 2004P-0140
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| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| 2004V-0211
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| Variance for Mobolazer ML 10 300
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| NPR
3
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| FDA
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| Vol #:
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| 5
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| 1995P-0241
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| Implied Nutrient Content Claim "Healthy" & Health Claims
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| NPR
3
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| FDA
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| Vol #:
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| 5
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| 1997D-0411
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| (BSE) in Products for Human Use; Guidance for Industry.
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| C
15
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| Gelatin Manufacturers of Europe (GME) and the Gelatin Manufacturers Institute of America (GMIA)
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| Vol #:
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| 2
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7433
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| J. Green
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| Vol #:
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| 307
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| EMC 4223
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| R. Dean
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| Vol #:
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| 304
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| EMC 4224
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| R. Dean
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| Vol #:
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| 304
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| EMC 4225
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| A. Spears
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| Vol #:
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| 304
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| EMC 471
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| M. Chambers
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| Vol #:
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| 8
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| EMC 472
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| M. Chambers
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| Vol #:
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| 8
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| 1999F-5321
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| Food Safety & Inspection service safe use of ionizing radiai
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| EMC 374
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| M. Chambers
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| Vol #:
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| 8
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| EMC 375
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| M. Chambers
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| Vol #:
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| 8
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| 1999F-5322
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| Ionizing Radiation for the Treatment of Food
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| EMC 373
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| M. Chambers
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| Vol #:
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| 6
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| EMC 374
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| M. Chambers
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| Vol #:
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| 6
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| 1999F-5522
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| Ionizing radiation /control of Food-borne pathogens safe use
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| EMC 376
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| M. Chambers
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| Vol #:
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| 6
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| EMC 377
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| M. Chambers
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| Vol #:
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| 6
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4212
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| M. Chambers
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| Vol #:
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| 515
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| EMC 4213
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| M. Chambers
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| Vol #:
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| 515
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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| EMC 782
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| B. Erlandsen
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| Vol #:
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| 33
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| |
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| C
18
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| Wyeth Pharmaceuticals
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| Vol #:
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| 6
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| C
19
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| Planned Parenthood Federation of America, Inc. (PPFA)
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| Vol #:
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| 6
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 28
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| CVM
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| Vol #:
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| 403
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 5824
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| Elaine Lynch
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| Vol #:
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| 789
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| EMC 5825
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| Linda M. Coleman
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| Vol #:
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| 789
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| EMC 5826
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| Linda M. Coleman
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| Vol #:
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| 789
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| EMC 5827
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| susan McHugh
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| Vol #:
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| 789
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| EMC 5828
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| Nathan Haslag
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| Vol #:
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| 789
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| EMC 5829
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| Kathy Johnson
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| Vol #:
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| 789
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| EMC 5830
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| Cherie Roberts
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| Vol #:
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| 789
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| EMC 5831
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| Cherie Roberts
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| Vol #:
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| 789
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| EMC 5832
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| Cherie Roberts
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| Vol #:
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| 789
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| EMC 5833
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| Cherie Roberts
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| Vol #:
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| 789
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| EMC 5834
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| Cherie Roberts
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| Vol #:
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| 789
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| 2001F-0047
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| Foodborne pathogens in raw-frozen-cooked-partially cooked
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| EMC 478
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| M. Chambers
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| Vol #:
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| 8
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| EMC 479
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| M. Chambers
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| Vol #:
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| 8
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 1349
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| M. Wiebe
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| Vol #:
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| 209
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 173
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| W. Cofield
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| Vol #:
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| 3
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
221
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| Fonterra (USA)
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| Vol #:
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| 20
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 333
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| Dr. B. Martini
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| Vol #:
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| 6
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| 2002V-0415
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| LAD-01 Medical Laser Product
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| VRA
2
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| HFZ-300 to Norwood Abbey Ltd.
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| Vol #:
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| 1
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| EMC
10
Attachment
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| Facility Automation Management Engineering Systems (FAME Systems)
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| Vol #:
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| 3
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|
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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 176
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| B. Sachau
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| Vol #:
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| 7
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| EMC 177
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| T and M Martino
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| Vol #:
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| 7
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| EMC
178
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| Cornell University
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| Vol #:
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| 7
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|
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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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|
| | | | | | | | |
|
|
|
|
| SUP 2
|
| J. Korsmo
|
| Vol #:
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| 15
|
|
|
|
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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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|
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|
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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|
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| SUP
7
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 2
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|
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| C 12
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| D. Weitz
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| Vol #:
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| 2
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|
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| 2004D-0182
|
| Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
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|
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| GDL
1
|
| Guidance
|
| Vol #:
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| 1
|
|
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|
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| NAD
1
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| FDA
|
| Vol #:
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| 1
|
|
|
|
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| 2004D-0210
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| Guidance: Clinical Trial Design for Hip Replacement Systems
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| GDL
1
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| Orthopedic Surgical Manufacturers Association
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| Vol #:
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| 1
|
|
|
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| 2004N-0076
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| Food and Color Additives and Generally Recognized As Safe Substances; Technical Amendments
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| NFR
1
|
| FDA
|
| Vol #:
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| 1
|
|
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| C
5
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| Mylan Pharmaceuticals, Inc. (Mylan)
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| Vol #:
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| 1
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| C
6
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| Generic Pharmaceutical Association (GPhA)
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| Vol #:
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| 1
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| EMC
2
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| Sandoz, Inc.
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| C
6
Continued
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| Covington & Burling
|
| Vol #:
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| 8
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|
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| EMC 10
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| M. Reidenberg, MD, FACP
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| Vol #:
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| 3
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|
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| APE 2
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| The Hollis Group, Inc.
|
| Vol #:
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| 1
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|
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| 2004P-0140
|
| Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling
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| C
1
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| Corepharma, LLC (Corepharma)
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| Vol #:
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| 3
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| EMC
2
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| Corepharma, LLC (Corepharma)
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| Vol #:
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| 2
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|
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| 2004V-0211
|
| Variance for Mobolazer ML 10 300
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| ACK 1
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| HFA-305 to Dreamspell
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| Vol #:
|
| 1
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| CR 1
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| HFA-305 to Dreamspell
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| Vol #:
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| 1
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