| | | | | | | | | | |
|
|
| Dockets Entered
On December 5, 2006
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| 2003V-0306
|
| Laser Light Show
|
|
|
| 2005D-0356
|
| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
|
|
|
| 2005D-0490
|
| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
|
|
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
|
|
| 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
|
|
|
| 2005P-0495
|
| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
|
|
|
| 2006D-0303
|
| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
|
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
|
|
| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
| 2006P-0369
|
| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
|
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
| 2006P-0484
|
| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
|
|
|
| 2006V-0499
|
| Laser Light Show
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| EMC 661
|
| S. Jannarone
|
| Vol #:
|
| 24
|
|
|
| 1999P-4613
|
| Revoke the Regulation That Approved Posilac
|
|
|
| EMC 2432
|
| University of Phoenix-Atlanta, Georgia
|
| Vol #:
|
| 46
|
|
|
| EMC 2433
|
| T. White
|
| Vol #:
|
| 46
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 1389
|
| R. Coleman
|
| Vol #:
|
| 12
|
|
|
| EMC 1390
|
| M. Zimmer
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
|
| EMC 1391
|
| J. & R. Sperbeck
|
| Vol #:
|
| 12
|
|
|
| EMC 1392
|
| J. & R. Sperbeck
|
| Vol #:
|
| 12
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
| EC
30
|
| Mrs. Tamara Wilhite
|
| Vol #:
|
| 8
|
|
|
| 2003V-0306
|
| Laser Light Show
|
|
|
| VRA 2
|
| FDA/CDRH to Visiotopic Systems LLC`
|
| Vol #:
|
| 1
|
|
|
| 2005D-0356
|
| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
|
|
|
| EC
5
|
| Mrs. Tamara Wilhite
|
| Vol #:
|
| 1
|
|
|
| 2005D-0490
|
| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
|
|
|
| EC
21
|
| Mrs. Tamara Wilhite
|
| Vol #:
|
| 1
|
|
|
| 2005P-0383
|
| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
|
|
|
| ACK 2
|
| FDA/DDM to Savient Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|
|
| PRC 1
|
| Savient Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| EMC 4157
|
| V. George
|
| Vol #:
|
| 195
|
|
|
| EMC 4158
|
| S. Martin
|
| Vol #:
|
| 195
|
|
|
| EMC 4159
|
| C. McCann
|
| Vol #:
|
| 195
|
|
|
| EMC 4160
|
| D. Farren
|
| Vol #:
|
| 195
|
|
|
| EMC 4161
|
| D. Haggard
|
| Vol #:
|
| 195
|
|
|
| EMC 4162
|
| L. Dilley
|
| Vol #:
|
| 195
|
|
|
| EMC 4163
|
| D. Roper
|
| Vol #:
|
| 195
|
|
|
| EMC 4164
|
| C. DePiano
|
| Vol #:
|
| 195
|
|
|
| EMC 4165
|
| S. O'Connor
|
| Vol #:
|
| 195
|
|
|
| EMC 4166
|
| M. Holden
|
| Vol #:
|
| 195
|
|
|
| EMC 4167
|
| Y. Patch
|
| Vol #:
|
| 195
|
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
| EMC 8
|
| A. Hill
|
| Vol #:
|
| 7
|
|
|
| 2005P-0495
|
| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
|
|
|
| SUP 1
|
| R DeWitty
|
| Vol #:
|
| 2
|
|
|
| 2006D-0303
|
| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
|
|
|
| EC
3
|
| Mrs. Tamara Wilhite
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
| EMC 1150
|
| L. Sledge
|
| Vol #:
|
| 24
|
|
|
| EMC 1151
|
| P. Bullington
|
| Vol #:
|
| 24
|
|
|
| EMC 1152
|
| M. Hanson
|
| Vol #:
|
| 24
|
|
|
| EMC 1153
|
| M. Hanson
|
| Vol #:
|
| 24
|
|
|
| EMC 1154
|
| F. Berglund
|
| Vol #:
|
| 24
|
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
|
|
| C
4
|
| Alliance for Human Research Protection (AHRP)
|
| Vol #:
|
| 1
|
|
|
| C 5
|
| P Breggin MD
|
| Vol #:
|
| 1
|
|
|
| C 6
|
| G Todovich
|
| Vol #:
|
| 1
|
|
|
| C 7
|
| F Lahman
|
| Vol #:
|
| 1
|
|
|
| C 8
|
| E Hanson
|
| Vol #:
|
| 1
|
|
|
| C 9
|
| H Patenaude
|
| Vol #:
|
| 1
|
|
|
| EMC 2
Published
Material
|
| The International Center for The Study of Psychiatry & Phychology
|
| Vol #:
|
| 2
|
|
|
| EMC 3
|
| V. Sharav
|
| Vol #:
|
| 2
|
|
|
| EMC 4
|
| V. Sharav
|
| Vol #:
|
| 2
|
|
|
| EMC 5
|
| L. Milanese
|
| Vol #:
|
| 2
|
|
|
| EMC
6
|
| Pfizer Inc
|
| Vol #:
|
| 2
|
|
|
| EMC 7
|
| D. Tucker
|
| Vol #:
|
| 2
|
|
|
| EMC 8
|
| C. Harter
|
| Vol #:
|
| 2
|
|
|
| EMC 9
|
| N. Brownlow
|
| Vol #:
|
| 2
|
|
|
| EMC 10
|
| A. Warwick
|
| Vol #:
|
| 2
|
|
|
| EMC 11
|
| A. Warwick
|
| Vol #:
|
| 2
|
|
|
| EMC 12
|
| F. Merritt
|
| Vol #:
|
| 2
|
|
|
| EMC
13
|
| The International Center for The Study of Phychiatry & Phychology
|
| Vol #:
|
| 2
|
|
|
| 2006N-0464
|
| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
|
|
|
| EC 2
|
| AGA Medical
|
| Vol #:
|
| 1
|
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
|
|
| EMC 90
|
| L. Foster
|
| Vol #:
|
| 1
|
|
|
| EMC 91
|
| K. Abbas
|
| Vol #:
|
| 1
|
|
|
| EMC 92
|
| K. McCluskey
|
| Vol #:
|
| 1
|
|
|
| EMC 93
|
| C. Crusha
|
| Vol #:
|
| 1
|
|
|
| EMC 94
|
| M. Thrantell
|
| Vol #:
|
| 1
|
|
|
| EMC 95
|
| P. Tomlin
|
| Vol #:
|
| 1
|
|
|
| EMC 96
|
| K. Meyers
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| EMC 97
|
| S. Weyand
|
| Vol #:
|
| 1
|
|
|
| EMC 98
|
| G. Gohr
|
| Vol #:
|
| 1
|
|
|
| EMC 99
|
| K. Knudsen
|
| Vol #:
|
| 1
|
|
|
| 2006P-0369
|
| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
|
|
|
| AMD 1
|
| Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 1
|
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
|
|
|
|
| EC
11
|
| Ms. Nancy Thompson
|
| Vol #:
|
| 1
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| EC
433
|
| Miss. Rosemary Wike
|
| Vol #:
|
| 7
|
|
|
| EC
434
|
| Mrs. Joyce Janicki
|
| Vol #:
|
| 7
|
|
|
| EC
435
|
| Ms. Deborah Romero
|
| Vol #:
|
| 7
|
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
|
|
| AMD 1
|
| B Braun Medical
|
| Vol #:
|
| 1
|
|
|
| 2006P-0484
|
| Change the indication for Stimulant Medications for the Treatment of Mental Diseases
|
|
|
| EC 1
|
| Mrs. Tamara Wilhite
|
| Vol #:
|
| 1
|
|
|
| 2006P-0498
|
| Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
|
|
|
| ACK 1
|
| FDA/DDM to Center for Science in the Public Interest
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
| 2006V-0499
|
| Laser Light Show
|
|
|
| ACK 1
|
| FDA/DDM to Des Monies Astronomical Society, Inc.
|
| Vol #:
|
| 1
|
|
|
| VAR 1
|
| Des Monies Astronomical Society, Inc.
|
| Vol #:
|
| 1
|
|