| | | | | | | | | | |
|
|
| Dockets Entered
On June 9, 2006
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
| 2005D-0310
|
| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
|
|
|
| 2005N-0364
|
| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
|
|
|
| 2005N-0393
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
|
|
|
| 2005N-0426
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2006D-0191
|
| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
|
|
|
| 2006E-0240
|
| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
|
|
|
| 2006M-0233
|
| H040002, INTACS Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm)
|
|
|
| 2006N-0081
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203
|
|
|
| 2006N-0187
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
|
|
|
|
| 2006N-0215
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon
|
|
|
|
|
|
| 2006P-0089
|
| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
|
|
|
| 2006P-0241
|
| Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy
|
|
|
| 2006P-0242
|
| Approval of any Budesonide Inhalation Suspension Product usin PULMICORT RESPULES
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| RPT 337
|
| Global Cancer Strategies
|
| Vol #:
|
| 264
|
|
|
| RPT 338
|
| The Pryde Company
|
| Vol #:
|
| 263
|
|
|
| RPT 339
|
| The Pryde Company
|
| Vol #:
|
| 263
|
|
|
| RPT 340
|
| TJ Panorama Inc
|
| Vol #:
|
| 263
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET 17826
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17827
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17828
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17829
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17830
|
| Ortho Molecular Products, Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17831
|
| Iovate Health Sciences U.S.A., Inc.
|
| Vol #:
|
| 164
|
|
|
| LET 17832
|
| ZeaVision LLC
|
| Vol #:
|
| 164
|
|
| | | | | | | | |
|
|
| LET 17833
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17834
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17835
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17836
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17837
|
| Enzyamtc Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17838
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17839
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17840
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17841
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17842
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17843
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17844
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17845
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17846
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17847
|
| Enzymatic Therapy
|
| Vol #:
|
| 164
|
|
|
| LET 17848
|
| Infinity 2, Inc.
|
| Vol #:
|
| 164
|
|
|
| 1998P-0724
|
| Prohibition of Cochineal Extract and Carmine Color Additives
|
|
|
| EMC 25
|
| M. Murphy
|
| Vol #:
|
| 3
|
|
|
| EMC 26
|
| L. Gracia
|
| Vol #:
|
| 3
|
|
|
| EMC 27
|
| Form Letters
|
| Vol #:
|
| 4
|
|
|
| EMC 28
|
| R. Martin
|
| Vol #:
|
| 3
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| PDN 1
|
| FDA to Center for Reproductive Rights
|
| Vol #:
|
| 348
|
|
|
| REF 1
|
| Petition Response References
|
| Vol #:
|
| 348
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 658
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
| EMC 659
|
| Calorie Control Council
|
| Vol #:
|
| 9
|
|
|
| EMC 660
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
| EMC 661
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 1303
|
| V. Jaynes
|
| Vol #:
|
| 12
|
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
| REF 2
|
| References - Administrative File
|
| Vol #:
|
| 24
|
|
| | | | | | | | |
|
|
| 2005D-0310
|
| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
|
|
|
| EMC 5
|
| O. Hagenauer
|
| Vol #:
|
| 1
|
|
|
| 2005N-0364
|
| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
|
|
|
| TR 2
|
| Transcript of the May 22, 2006 Meeting
|
| Vol #:
|
| 3
|
|
|
| TS 12
|
| Barnett Intro for MDUFMA
|
| Vol #:
|
| 3
|
|
|
| TS 13
|
| Linda Kahan Remarks for 05/22/2006 meeting
|
| Vol #:
|
| 3
|
|
|
| 2005N-0393
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS 1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2005N-0426
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| SS 1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 12143
|
| C.Brown
|
| Vol #:
|
| 150
|
|
|
| C 12144
|
| S. Mason
|
| Vol #:
|
| 150
|
|
|
| C 12145
|
| S. M Helfers
|
| Vol #:
|
| 150
|
|
|
| C 12146
|
| R. Brack
|
| Vol #:
|
| 150
|
|
|
| C 12147
|
| D. Robin
|
| Vol #:
|
| 150
|
|
|
| C 12148
|
| L. M. Sills
|
| Vol #:
|
| 150
|
|
|
| C 12149
|
| J. Heath
|
| Vol #:
|
| 150
|
|
|
| C 12150
|
| D. Heath
|
| Vol #:
|
| 150
|
|
|
| C 12151
|
| D. Weils
|
| Vol #:
|
| 150
|
|
|
| C 12152
|
| D. G. Schwartz, MD
|
| Vol #:
|
| 150
|
|
|
| C 12153
|
| L. Brown
|
| Vol #:
|
| 150
|
|
|
| C 12154
|
| M. Bradley
|
| Vol #:
|
| 150
|
|
|
| C 12155
|
| V. Grimmes
|
| Vol #:
|
| 150
|
|
|
| C 12156
|
| S. E. Raisen
|
| Vol #:
|
| 150
|
|
|
| C 12157
|
| M. L. Macomb
|
| Vol #:
|
| 150
|
|
|
| C 12158
|
| M. Holland
|
| Vol #:
|
| 150
|
|
|
| C 12159
|
| L. Amsbaugh
|
| Vol #:
|
| 150
|
|
|
| C 12160
|
| J. Hoots
|
| Vol #:
|
| 150
|
|
|
| C 12161
|
| L. L. MacElree
|
| Vol #:
|
| 150
|
|
|
| C 12162
|
| T. Murphy
|
| Vol #:
|
| 150
|
|
|
| C 12163
|
| L. McFletcher
|
| Vol #:
|
| 150
|
|
| | | | | | | | |
|
|
| EMC 2704
|
| J. Phillips
|
| Vol #:
|
| 124
|
|
|
| EMC 2705
|
| R. Dees
|
| Vol #:
|
| 124
|
|
|
| EMC 2706
|
| Dr. M. Sonnenfeld
|
| Vol #:
|
| 124
|
|
|
| EMC 2707
|
| M. Flynn
|
| Vol #:
|
| 124
|
|
|
| EMC 2708
|
| C. Brown
|
| Vol #:
|
| 124
|
|
|
| EMC 2709
|
| E. Houghton
|
| Vol #:
|
| 124
|
|
|
| EMC 2710
|
| A. Ehlert
|
| Vol #:
|
| 124
|
|
|
| EMC 2711
|
| L. Romanoff
|
| Vol #:
|
| 124
|
|
|
| EMC 2712
|
| D. Parad
|
| Vol #:
|
| 124
|
|
|
| EMC 2713
|
| S. Shearman
|
| Vol #:
|
| 124
|
|
|
| EMC 2714
|
| B. Taylor
|
| Vol #:
|
| 124
|
|
|
| EMC 2715
|
| Dr. M. Lewis, PhD
|
| Vol #:
|
| 124
|
|
|
| EMC 2716
|
| N. Niece
|
| Vol #:
|
| 124
|
|
|
| 2006D-0191
|
| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
|
|
|
| C 1
|
| London School of Hygiene and Tropical Medicine
|
| Vol #:
|
| 1
|
|
|
| 2006E-0240
|
| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
|
|
|
| APP 1
|
| Celgene Corporation
|
| Vol #:
|
| 1
|
|
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2006M-0233
|
| H040002, INTACS Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm)
|
|
|
| AAV 1
|
| Addition Technology
|
| Vol #:
|
| 1
|
|
|
| 2006N-0081
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2006N-0187
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
|
|
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2006N-0215
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon
|
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2006P-0089
|
| Stay approval of all supplements to biologics licenses issued to Genentech ( BLA# 103705 ) and Biogen ( BLA# 103737) for Rituxan ( Rituximab)
|
|
|
| C 2
|
| Genentech, Inc. (Genentech) and Idec, Inc. (Biogen)
|
| Vol #:
|
| 1
|
|
|
| 2006P-0241
|
| Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy
|
|
|
| CP 1
|
| Zydus Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|