| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On August 27, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1975N-0183F
|
| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| 1995V-0312
|
| Laser Light Show
|
|
|
|
|
| 1997V-0231
|
| Laser light show
|
|
|
|
|
| 1999D-1878
|
| Good Manufacturing Practice for Blood and Blood Components:
|
|
|
|
|
| 1999N-2337
|
| GMP for Blood & Blood Components;Increased Risk of Transmiti
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2006D-0246
|
| Manufactured Food Regulatory Program Standards
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| 2006N-0238
|
| Debarment of Maria Anne Kirkman Campbell
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| 2007A-0332
|
| Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products
|
|
|
|
|
| 2007D-0125
|
| Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
|
|
|
|
|
| 2007D-0173
|
| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
|
|
|
|
|
| 2007M-0244
|
| BP060002 /0 Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
|
|
|
|
|
| 2007M-0263
|
| BP050069/0 - Roche COBAS AmpliPrep/COBAS TaqManHIV-1 Test, 48 Tests, COBAS AmpliPrep/COBAS Taqman Wash Reagents, 5.1.L
|
|
|
|
|
| 2007M-0286
|
| P050016 - Cormet Hip Resurfacing System
|
|
|
|
|
| 2007N-0304
|
| Preparation for International Conference on Harmonization Meetings in Brussels, Belgium Public Meeting
|
|
|
|
|
| 2007N-0321
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
|
|
|
|
|
|
| 2007N-0323
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| 2007P-0074
|
| TTake action with respect to Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
|
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
|
|
|
| 2007V-0054
|
| Laser Light Show
|
|
|
|
|
| 2007V-0271
|
| Laser Light Show
|
|
|
|
|
| 2007V-0312
|
| Laser Display Device
|
|
| |
|
| 1975N-0183F
|
| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
|
|
|
|
|
| APE 1
|
| Alcavis International, Inc.
|
| Vol #:
|
| 13
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| APE 2
|
| Alcavis International, Inc.
|
| Vol #:
|
| 204
|
|
| |
|
| 1995V-0312
|
| Laser Light Show
|
|
|
|
|
| VRA 9
|
| Lynne L. Rice
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997V-0231
|
| Laser light show
|
|
| | | | | | | | |
|
| |
|
| VRA 6
|
| Lynne L. Rice
|
| Vol #:
|
| 1
|
|
|
|
|
| 1999D-1878
|
| Good Manufacturing Practice for Blood and Blood Components:
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1999N-2337
|
| GMP for Blood & Blood Components;Increased Risk of Transmiti
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| C 4065
|
| J. Molina
|
| Vol #:
|
| 238
|
|
|
|
|
| 2006D-0246
|
| Manufactured Food Regulatory Program Standards
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
|
|
| C 19
|
| American Association for Clinical Chemistry (AACC)
|
| Vol #:
|
| 3
|
|
|
|
|
| C 20
|
| American Clinical Laboratory Asociation (ACLA)
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 92
|
| Y-ME National Breast Cancer Organization
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 93
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 94
|
| XDx
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 95
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 96
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 97
|
| Expression Analysis, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 98
|
| Blue Cross and Blue Shield Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 99
|
| Scott
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 100
|
| Clinical Laboratory Management Association (CLMA)
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 101
|
| American Society for Microbiology
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 102
|
| American Clinical Laboratory Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 103
|
| American Society for Clinical Pathology
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 104
|
| National Breast Cancer Coalition Fund
|
| Vol #:
|
| 3
|
|
|
|
|
| EC 105
|
| Agendia BV
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006N-0238
|
| Debarment of Maria Anne Kirkman Campbell
|
|
|
|
|
| M 1
|
| FDA/CSO,CIN-DO
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0454
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
|
|
|
|
|
| C 1681
|
| E Ondich
|
| Vol #:
|
| 18
|
|
| | | | | | | | |
|
| |
|
| 2007D-0173
|
| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
|
|
|
|
|
| C 7
|
| Walter Gaman
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0244
|
| BP060002 /0 Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007M-0263
|
| BP050069/0 - Roche COBAS AmpliPrep/COBAS TaqManHIV-1 Test, 48 Tests, COBAS AmpliPrep/COBAS Taqman Wash Reagents, 5.1.L
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0286
|
| P050016 - Cormet Hip Resurfacing System
|
|
|
|
|
| CR 1
|
| Corin USA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0304
|
| Preparation for International Conference on Harmonization Meetings in Brussels, Belgium Public Meeting
|
|
|
|
|
| NCR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0321
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
|
|
|
|
|
|
| |
|
|
|
| EC 1
|
| amfAR
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Ms. barb sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0323
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0074
|
| TTake action with respect to Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
|
|
|
|
|
| ANS 1
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0333
|
| Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040(h); 21 CFR 820.170 requiring manufacturers to supply all information for installa
|
|
|
|
|
|
| |
|
|
|
| ACK 1
|
| FDA/DDM to Thomas J. Quinn
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Thomas J. Quinn
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007V-0054
|
| Laser Light Show
|
|
|
|
|
| VRA 1
|
| Lynne L. Rice
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007V-0271
|
| Laser Light Show
|
|
|
|
|
| VRA 1
|
| Lynne L. Rice
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007V-0312
|
| Laser Display Device
| |
|
|
|
| VRA 1
|
| Lynne L. Rice
|
| Vol #:
|
| 1
|
|
