| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On April 27, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999P-0033
|
| Combat the spread of transmissible spongiform encephalopathy
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
|
| 2006D-0441
|
| Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
|
|
|
|
|
| 2006N-0416
|
| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| 2006P-0450
|
| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
|
|
|
|
|
| 2006P-0523
|
| Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
|
|
|
|
|
| 2007D-0122
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
|
|
|
|
|
| 2007N-0018
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El
|
|
|
|
|
|
|
|
|
| 2007N-0068
|
| Medical Device User Fee and Modernization Act: Public Meeting
|
|
|
|
|
| 2007N-0120
|
| Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System
|
|
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
|
|
| 2007P-0044
|
| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
|
|
| 2007P-0149
|
| Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
|
|
|
| 2007P-0150
|
| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
| |
|
| 1999P-0033
|
| Combat the spread of transmissible spongiform encephalopathy
|
|
|
|
|
| EMC 15
|
| Form Letters (1)
|
| Vol #:
|
| 11
|
|
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
|
|
| C 1414
|
| L Lipman
|
| Vol #:
|
| 262
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1480
|
| J. Sequeira
|
| Vol #:
|
| 12
|
|
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
|
|
| EMC 352
|
| J. Burley
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 353
|
| J. Stockman
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 354
|
| J. Stockman
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
| |
|
| EMC 355
|
| B. Lugaresi
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 356
|
| K. Lintner
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 357
|
| B. Dively
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 358
|
| I. Price
|
| Vol #:
|
| 5
|
|
|
|
|
| EMC 359
|
| J. Mueller
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| MO 25
|
| TMJ Implants, Inc, and Robert W. Christensen, and Maureen K Mooney
|
| Vol #:
|
| 240
|
|
|
|
|
| MO 26
|
| TMJ Implants, Inc, and Robert W. Christensen, and Maureen K Mooney
|
| Vol #:
|
| 240
|
|
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
|
|
|
|
| EREG 591
|
| D. Witmer
|
| Vol #:
|
| 4
|
|
|
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
|
|
|
|
| EMC 593
|
| M. Wolfe
|
| Vol #:
|
| 12
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| EMC 4375
|
| D. Davis
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4376
|
| S. McClellan
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4377
|
| C. Kirts
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4378
|
| C. Wyatt
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4379
|
| L. Wavrin
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4380
|
| D. Baker
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4381
|
| P. Russen
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4382
|
| K. Prewitt
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4383
|
| D. DePoyster
|
| Vol #:
|
| 199
|
|
|
|
|
| EMC 4384
|
| J. Edmonds
|
| Vol #:
|
| 199
|
|
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
|
| SUP 2
|
| American Meat Institute (AMI)
|
| Vol #:
|
| 7
|
|
|
|
|
| 2006D-0441
|
| Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 2
|
|
|
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0416
|
| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
|
|
|
|
|
| NFR 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 89
|
| K Elgin
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
| |
|
| 2006P-0450
|
| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
|
|
|
|
|
| RC 1
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0523
|
| Require ANDA applicant for generic of Eloxatin solution as reference drug to perform clinical testing
|
|
|
|
|
| SUP 1
|
| Sanofi-aventis U.S LLC
|
| Vol #:
|
| 2
|
|
| |
|
| 2007D-0122
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0018
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; El
|
|
|
|
|
|
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0068
|
| Medical Device User Fee and Modernization Act: Public Meeting
|
|
|
|
|
| NCR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0120
|
| Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System
|
|
|
|
|
| CP 1
|
| Barnev Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
|
|
| EAPE 110
|
| McEvoy, Gerald
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 111
|
| Mentari, Evelyn
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 112
|
| madani, soraya
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 113
|
| madani, soraya
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 114
|
| Korab, Darlene
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 115
|
| Korab, Darlene
|
| Vol #:
|
| 1
|
|
|
|
|
| EAPE 116
|
| Grijalva, Juan Carlos
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 3
|
| J. Ellis
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 4
|
| S. Harley
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007P-0044
|
| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
|
|
|
|
|
| EMC 184
|
| Form Letters (1)
|
| Vol #:
|
| 6
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
|
|
| EMC 65
|
| C. Sims
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 66
|
| P. Hoage
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 67
|
| D. Gabe
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 68
|
| A. & C. Hile
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 69
|
| M. Butler
|
| Vol #:
|
| 4
|
|
