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Dockets Management

Dockets Entered On August 17, 2006
Table of Contents
Docket # Title
1978N-0036L OTC Laxative
1995S-0158 Community Disclosure of Institutional Review Boards
2000D-1598 Voluntary Labeling for Bioengineered Foods
2001N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits
2005N-0500 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
2006D-0301 Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
2006N-0166 Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners organizations
2006N-0312 Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
2006P-0077 Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
2006P-0334 Reclassification Petition fo Bone Heterografts
1978N-0036L OTC Laxative
C 216 C.B. Fleet Co., Inc. Vol #: 138
1995S-0158 Community Disclosure of Institutional Review Boards
RPT 19 William Beaumont Hospital Vol #: 54
2000D-1598 Voluntary Labeling for Bioengineered Foods
ANS 1 FDA/CFSAN to Z Karpukhina Vol #: 580
C 10015 Z Karpukhina Vol #: 580
2001N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits
NCR 2 FDA Vol #: 5
2005N-0500 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
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006D-0301 Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waivers and Reductions
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006N-0166 Agency Emergency Processing Under OMB Review; MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners
organizations
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006N-0312 Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
NM 1 FDA Vol #: 1
2006P-0077 Refrain from lifting the administrative stay for amlodipine maleate tablets (NDA 21-435) until after September 25, 2007.
LET 1 FDA/CDER to Covington & Burling Vol #: 1
2006P-0151 Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
C 3 Women's Bioethics Project Vol #: 1
2006P-0334 Reclassification Petition fo Bone Heterografts
ACK 1 FDA/DDM to Regeneration Technologies, Inc. Vol #: 1
CCP 1 Regeneration Technologies, Inc. Vol #: 1

Page created on August 31, 2006 kk

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