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| Dockets Entered
On June 30, 2006
Table of Contents
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| Docket #
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| Title
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| 1998D-0106
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| Procedures to determine application of postmarket survellane
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2005D-0356
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| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
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| 2005N-0290
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Importers Entry Notice
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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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-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0021
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006N-0247
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 1998D-0106
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| Procedures to determine application of postmarket survellane
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| C 2
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| Cook Group Incorporated (Cook)
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| 1
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| N 8
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| FDA
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| Vol #:
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| 9
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| EC 5
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| AdvaMed
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 513
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| Cocamar Cooperativa Agroindustrial
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| Vol #:
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| 17
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| N 6
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| FDA
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| 1
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| LET 8
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| BioLife Plasma Services, L.P.
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| Vol #:
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| 1
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| 2005D-0356
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| C 14015
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| L. McEvoy
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| Vol #:
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| 159
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| C 14016
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| D. Ingle
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| Vol #:
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| 159
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| C 14017
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| T. Marins
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| Vol #:
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| 159
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| C 14018
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| A. Buss
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| Vol #:
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| 159
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| C 14019
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| D. B. Norton
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| Vol #:
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| 159
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| C 14020
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| B. Upton
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| Vol #:
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| 159
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| C 14021
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| R. Folkes
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| Vol #:
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| 159
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| C 14022
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| A. Tribun
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| Vol #:
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| 159
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| LET 2
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| Keller and Heckman LLP
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| Vol #:
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| 1
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0021
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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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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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| C 3
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| M. Patterson
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| Vol #:
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| 4
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| MM 2
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| Revised May 11, 2006 Meeting Summary
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| Vol #:
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| 2
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| EC 6
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| Dr. Allan Grossman
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| C 4
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| Furnas Consulting
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| Vol #:
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| 1
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| 2006N-0247
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 71
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| National Organization for Women
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| Vol #:
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| 2
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| EC 72
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| Mrs. Genevra Erickson
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| Vol #:
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| 2
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| EC 73
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| Dr. Tara McCafferty
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| Vol #:
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| 2
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| EC 74
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| Mr. Francis Kintz
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| Vol #:
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| 2
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| EC 75
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| Mrs. Yvette Correa
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| Vol #:
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| 2
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| EC 76
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| Mrs. Anna Runyan
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| Vol #:
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| 2
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| EC 77
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| Ms. Joan Smelkinson
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| Vol #:
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| 2
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