| | | | | | | | | | |
|
Dockets Management
|
|
| Dockets Entered
On August 8, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1992S-0251
|
| Electronic Submissions; Establishment of Public Docket
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 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
|
|
|
|
|
| 2003N-0355
|
| Medical Devices; Exception from General Requirements for Informed Consent
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2006D-0296
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
|
|
|
|
|
|
| 2006D-0297
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
|
|
|
|
|
| 2006P-0101
|
| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
| 2006P-0313
|
| Removal of labeling for MediSense Precision Advanced Diabetes Management System
|
|
|
|
|
| 1992S-0251
|
| Electronic Submissions; Establishment of Public Docket
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 18015
|
| Waiora International Inc
|
| Vol #:
|
| 166
|
|
|
|
|
| LET 18016
|
| Waiora International Inc
|
| Vol #:
|
| 166
|
|
|
|
|
| LET 18017
|
| WN Pharmaceuticals Ltd
|
| Vol #:
|
| 166
|
|
|
|
|
| LET 18018
|
| WN Pharmaceuticals Ltd
|
| Vol #:
|
| 166
|
|
|
|
|
| LET 18019
|
| WN Pharmaceuticals Ltd
|
| Vol #:
|
| 166
|
|
|
|
|
| LET 18020
|
| WN Pharmaceuticals Ltd
|
| Vol #:
|
| 166
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7535
|
| E. Anderson
|
| Vol #:
|
| 319
|
|
|
|
|
| EMC 4418
|
| M. Rourke
|
| Vol #:
|
| 320
|
|
|
|
|
| EMC 4419
|
| R. Claypool
|
| Vol #:
|
| 320
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 254
|
| J. Hagar
|
| Vol #:
|
| 4
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1330
|
| A. Rand
|
| Vol #:
|
| 12
|
|
|
|
|
| EMC 1331
|
| P. Hafey
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
|
|
|
| EMC 3583
|
| R. Jones
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3584
|
| L. Reynolds
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3585
|
| J. Wright
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3586
|
| V. Adams
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3587
|
| Dr. J. Caldwell
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3588
|
| D. Wulfe
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3589
|
| J. Weideman
|
| Vol #:
|
| 176
|
|
|
|
|
| EMC 3590
|
| M. Henson
|
| Vol #:
|
| 176
|
|
|
|
|
| 2006D-0296
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
|
|
|
|
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0297
|
| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0101
|
| Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
|
|
|
|
|
| EC 2
|
| National Assn. of State Departments of Agriculture
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
|
|
|
|
| EC 686
|
| Ms. Allison Sherwat
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
|
|
| C 2
|
| T. Redding
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006P-0313
|
| Removal of labeling for MediSense Precision Advanced Diabetes Management System
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Bayer Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Bayer Corporation
|
| Vol #:
|
| 1
|
|
