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| Dockets Entered
On August 17, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2005N-0500
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
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| 2006D-0301
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| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
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| 2006N-0312
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| Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
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| 2006P-0077
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| Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.
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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-0334
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| Reclassification Petition fo Bone Heterografts
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| 1978N-0036L
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| OTC Laxative
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| C 216
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| C.B. Fleet Co., Inc.
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| Vol #:
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| 138
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| RPT 19
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| William Beaumont Hospital
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| Vol #:
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| 54
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| ANS 1
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| FDA/CFSAN to Z Karpukhina
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| Vol #:
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| 580
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| C 10015
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| Z Karpukhina
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| Vol #:
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| 580
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| NCR 2
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| FDA
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| Vol #:
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| 5
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| 2005N-0500
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities - Survey
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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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| 2006D-0301
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| Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| LET 2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0166
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| Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners
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| | | | | | | | |
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| organizations
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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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| 2006N-0312
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| Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
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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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| 2006P-0077
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| Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.
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| LET 1
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| FDA/CDER to Covington & Burling
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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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| C 3
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| Women's Bioethics Project
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| Vol #:
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| 1
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| ACK 1
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| FDA/DDM to Regeneration Technologies, Inc.
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| Vol #:
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| 1
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| CCP 1
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| Regeneration Technologies, Inc.
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| Vol #:
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| 1
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