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| Dockets Entered
On August 16, 2005
Table of Contents
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| Docket #
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| Title
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| 2005M-0320
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| P040043 - GORE TAG Thoracic Endoprosthesis
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| 2005M-0321
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| P040021 - SJM Biocor Valve and SJM Biocor Supra Valve
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| 2005N-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 2005V-0326
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| Projector for a Laser Light Show
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| FF 2
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| Ecumed Health Group and Amador Reyes, Juan C. Carrai, Richard W. Stone, M.D. & Erlinda E. Enri
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| Vol #:
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| 2
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| FF 3
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| GCF-1 and CDRH
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| 2
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| FF 4
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| Ecumed Health Group and Amador Reyes, Juan c. Carrai, Richard W. Stone, M.D, & Erlinda Enrique
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| 2
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| 2004N-0535
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| Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005D-0019
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| Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
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| EMC
1
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| 2005D-0155
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| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
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| EMC
2
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| NIH
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| 1
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| 2005M-0320
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| P040043 - GORE TAG Thoracic Endoprosthesis
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| AAV
1
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| W.L. Gore and Associates
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| Vol #:
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| 1
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| 2005M-0321
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| P040021 - SJM Biocor Valve and SJM Biocor Supra Valve
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| AAV
1
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| St. Jude Medical, Inc.
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| Vol #:
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| 1
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| 2005N-0017
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| Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
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| EMC
1
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| Baxter Healthcare Corporation
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| Vol #:
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| 1
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| 2005N-0231
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| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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