| | | | | | | | | | |
|
| |
|
| Dockets Entered
On June 6, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1981P-0001
|
| Laser Lumia Projection System
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998N-0046
|
| Comprehensive List of Current Guidance Documents at FDA
|
|
|
|
|
| 2000V-1076
|
| Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| 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
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
|
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| 2005D-0004
|
| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
|
|
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
|
|
|
| 2005N-0347
|
| Biological Products for Treatment of Rare Plasma Protein Disorders
|
|
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
|
|
|
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
|
|
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
|
|
|
|
| 2006D-0128
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
|
|
|
|
|
| 2006D-0191
|
| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
|
|
|
|
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
|
|
|
|
| 2006N-0133
|
| 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
|
|
|
|
|
|
|
|
|
| 2006N-0184
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| 2006P-0126
|
| Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
|
|
|
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
|
|
|
|
| 2006P-0230
|
| Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride
|
|
|
|
|
| 1981P-0001
|
| Laser Lumia Projection System
|
|
|
|
|
| VRA 13
|
| FDA/CDRH to Lighting Systems Design, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 17804
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17805
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17806
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
| | | | | | | | |
|
| |
|
| LET 17807
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17808
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17809
|
| NOW Foods
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17810
|
| Flora, Inc.
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17811
|
| Bausch and Lomb Incorporated
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17812
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17813
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 164
|
|
|
|
|
| LET 17814
|
| A.L.A. Corporation
|
| Vol #:
|
| 164
|
|
|
|
|
| 1998N-0046
|
| Comprehensive List of Current Guidance Documents at FDA
|
|
|
|
|
| EC 6
|
| Mr. John Hansen
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 7
|
| Mr. Nicholas Burke
|
| Vol #:
|
| 2
|
|
|
|
|
| 2000V-1076
|
| Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100
|
|
|
|
|
| VRA 2
|
| FDA/CDRH to GDM Event Services
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1324
|
| No signature
|
| Vol #:
|
| 6
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 652
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 653
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 654
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 655
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 656
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 657
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
| |
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1297
|
| Ed
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1298
|
| D. Farr
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1299
|
| C. Dwyer
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1300
|
| E. Sack
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1301
|
| No signature
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1302
|
| A. Fosnaugh
|
| Vol #:
|
| 12
|
|
|
|
|
| 2004D-0283
|
| Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
|
|
|
|
|
| EC 4
|
| Mr. Peter Sassi
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Ms. Susan Dudley
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
|
|
| | | | | | | | |
|
| |
|
| EC 63
|
| Mrs. Tillie Harrison
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
|
|
|
|
| EC 26
|
| Bonfils Blood Center and Laboratory at Bonfils
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 27
|
| DeGowin Blood Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
|
|
|
|
| EMC 9
|
| Mission Possible International
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0004
|
| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
|
|
|
|
|
| EC 6
|
| Ms. Susan Dudleu
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
|
|
|
|
| EC 9
|
| Dolle Communications
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0347
|
| Biological Products for Treatment of Rare Plasma Protein Disorders
|
|
|
|
|
| EMC 1
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 2
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0437
|
| Medical Gas Containers and Closures; Current Good Manufacturing
|
|
|
|
|
| EC 4
|
| Compressed Gas Assoication
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| C 11767
|
| M. L. Wagoner,M.D.
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11768
|
| B. Downham
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11769
|
| C. Harlan
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11770
|
| H. Williamson
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11771
|
| D. Conwell
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11772
|
| S. Sanchez, M.D.
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11773
|
| S. Demaris Matthews
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11774
|
| S. Diceston
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11775
|
| D. J. Wagoner
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11776
|
| M. Nefliu, M.D.
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11777
|
| G. Hartman
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11778
|
| L. Richards
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11779
|
| P. Blake
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11780
|
| L. Johnston
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11781
|
| A. Leanna
|
| Vol #:
|
| 149
|
|
|
|
|
| C 11782
|
| K. Nemeth
|
| Vol #:
|
| 149
|
|
| | | | | | | | |
|
| |
|
| EC 33076
|
| Ms. Drusilla Lawton
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33077
|
| Mrs. Darla Dernovsek
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33078
|
| Ms. Quealma Panczenko
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33079
|
| Ms. Connie Colaianni
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33080
|
| Ms. Barbara Grandolfo
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33081
|
| Mrs. Opal Thompson
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33082
|
| N/A
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33083
|
| Mrs. Melanie Pruitt
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33084
|
| Mrs. Belinda Hovey
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33085
|
| Ms. Hollis Schmaling
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33086
|
| Mrs. Sigrid Pittman
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33087
|
| Ms. Jodi McDonald
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33088
|
| Mrs. BARB REIS
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33089
|
| Mrs. Christine Ludington
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33090
|
| Mrs. Leah Prine
|
| Vol #:
|
| 142
|
|
|
|
|
| EC 33091
|
| Ms. Pamela Springsteen
|
| Vol #:
|
| 142
|
|
|
|
|
| 2006D-0079
|
| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
|
|
|
|
|
| EC 1
|
| The Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Ecolab Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006D-0083
|
| Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines
|
|
|
|
|
| EC 2
|
| PowderMed
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0088
|
| Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
|
|
|
|
|
| EC 3
|
| PowderMed Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0128
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions
|
|
|
|
|
| EC 1
|
| Pharm Res
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0191
|
| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
|
|
|
|
|
| EC 2
|
| Vanderbilt University School of Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006E-0234
|
| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
|
|
|
|
|
| APP 1
|
| BioMimetic Therapeutics, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0133
|
| 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
|
|
|
|
|
|
|
|
|
| EMC 3
|
| B. Poynter
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006N-0184
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| EC 13
|
| Mr. Fred Mayer
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Mr. Thomas Myers
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0126
|
| Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
|
|
|
|
|
| EC 20
|
| Mrs. Kim Rhodes
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
|
|
|
|
| EC 1
|
| Mrs. vera ippolito
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0230
|
| Abbrevation New Drug Application Suitability for Lidocaine Hydrochloride
|
|
|
|
|
| ACK 1
|
| FDA/ DDM to Kamins Dermatologics, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Kamins Dermatologics, Inc.
|
| Vol #:
|
| 1
|
|
