| | | | | | | | | | |
|
|
| Dockets Entered
On January 10, 2006
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| 2000P-0586
|
| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
|
|
|
| 2000P-1411
|
| Set a regulatory limit for methylmercury in seafood
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
| 2001D-0489
|
| Establishment & Operation of Clinical Trial Monitoring Comm
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
| 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
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
| 2004D-0156
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
|
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
| 2005D-0356
|
| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
|
|
|
| 2005N-0178
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
|
|
|
| 2005N-0216
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
|
|
|
| 2005N-0217
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
| 2005P-0265
|
| Over-the Counter Sale of Modafinil
|
|
|
| 2005P-0305
|
| Remove Dietary Supplements that Contain the Drug Pyridoxamine
|
|
|
| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2006FL-0017
|
| Food Allergen Labeling Notification for Purity Foods Vita Spelt
|
|
|
| 1990S-0308
|
| Generic Drug Speeches & Policy and Procedure Guides
|
|
|
| RPT
762
|
| Statistical Report - Month of December 2005
|
| Vol #:
|
| 54
|
|
|
| 2000P-0586
|
| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
|
|
|
| EMC 15
|
| T. Waltz
|
| Vol #:
|
| 2
|
|
|
| 2000P-1411
|
| Set a regulatory limit for methylmercury in seafood
|
|
|
| C 10
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
|
|
|
| EC
16
|
| Arthur Schuman Inc.
|
| Vol #:
|
| 1
|
|
|
| EC
17
|
| Kraft Foods Global, Inc.
|
| Vol #:
|
| 1
|
|
|
| EC
18
|
| National Milk Producers Federation
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| EC
19
|
| Scott's Dairy Farm, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2001D-0489
|
| Establishment & Operation of Clinical Trial Monitoring Comm
|
|
|
| GDL
2
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
| EMC 236
|
| Y. Erke, PhD
|
| Vol #:
|
| 4
|
|
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
|
|
| C 520
|
| J. Zeltman
|
| Vol #:
|
| 40
|
|
|
| C 521
|
| J. Beck
|
| Vol #:
|
| 40
|
|
|
| C
522
|
| Griffin Industries
|
| Vol #:
|
| 40
|
|
|
| EMC 132
|
| R. Winter
|
| Vol #:
|
| 14
|
|
|
| EMC 133
|
| K. Lyke
|
| Vol #:
|
| 14
|
|
|
| EMC
134
|
| McDonald's Corporation
|
| Vol #:
|
| 14
|
|
|
| LET
4
|
| Honorable Paul Sarbanes
|
| Vol #:
|
| 40
|
|
|
| LET
5
|
| Honorable Jim Bunning
|
| Vol #:
|
| 40
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
| EMC 587
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
| EMC 588
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
| EMC
589
|
| Calorie Control Council
|
| Vol #:
|
| 9
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 1193
|
| K. Rudisill
|
| Vol #:
|
| 12
|
|
|
| EMC 1194
|
| S. DeWolfe
|
| Vol #:
|
| 12
|
|
|
| EMC 1195
|
| A. Taylor
|
| Vol #:
|
| 12
|
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
|
| C 42
|
| B. Brand
|
| Vol #:
|
| 2
|
|
|
| C
43
|
| Upstate Farms Cooperative, Inc.
|
| Vol #:
|
| 2
|
|
|
| 2004D-0156
|
| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on b
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
| 2004D-0369
|
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
|
|
|
| C 98
|
| P. Patrick
|
| Vol #:
|
| 15
|
|
|
| 2005D-0356
|
| Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
|
|
| | | | | | | | |
|
|
| EC 3
|
| Miss. Marie Ruano
|
| Vol #:
|
| 1
|
|
|
| 2005N-0178
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2005N-0216
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2005N-0217
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
| EC
3
|
| Mrs. BARBARA TOCCO
|
| Vol #:
|
| 1
|
|
|
| EC
4
|
| American Academy and College of Allergy, Asthma, a
|
| Vol #:
|
| 1
|
|
|
| EC
5
|
| National Latina Health Network
|
| Vol #:
|
| 1
|
|
|
| EC
6
|
| National Association of Chain Drug Stores
|
| Vol #:
|
| 1
|
|
|
| EC
7
|
| National Puerto Rican Coalition
|
| Vol #:
|
| 1
|
|
|
| EC
8
|
| National Consumers League
|
| Vol #:
|
| 1
|
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
|
|
| EMC 8
|
| J. Yankowsky
|
| Vol #:
|
| 3
|
|
|
| EMC 9
|
| N. Ratto, PharmD
|
| Vol #:
|
| 3
|
|
|
| EMC
10
|
| National Consumers League
|
| Vol #:
|
| 3
|
|
|
| EMC
11
|
| American Association of Oral and Maxillofacial Surgeons (AAOMS)
|
| Vol #:
|
| 3
|
|
|
| TR
1
|
| December 7, 2005 Transcript
|
| Vol #:
|
| 4
|
|
|
| TR
2
|
| December 8, 2005 Transcript
|
| Vol #:
|
| 5
|
|
|
| 2005P-0265
|
| Over-the Counter Sale of Modafinil
|
|
|
| LET 2
|
| J. Salsman
|
| Vol #:
|
| 1
|
|
|
| 2005P-0305
|
| Remove Dietary Supplements that Contain the Drug Pyridoxamine
|
|
|
| RC
3
|
| BioStratum Inc
|
| Vol #:
|
| 1
|
|
|
| 2005P-0377
|
| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
|
|
|
| SUP 3
|
| Department of the Planet Earth
|
| Vol #:
|
| 3
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 216
|
| P. Branchaud
|
| Vol #:
|
| 3
|
|
|
| C 217
|
| K. Earley
|
| Vol #:
|
| 3
|
|
|
| C 218
|
| S. Wilkins
|
| Vol #:
|
| 3
|
|