| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On March 30, 2006
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2000P-1577
|
| Variance from source-skin distance requirement of perf. std.
|
|
|
|
|
| 2000V-1377
|
| Laser Light Show(2) LM-10 Micro Yag Projection systems
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 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
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
|
|
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
|
|
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| 2005P-0144
|
| ANDA Suitability for Oxycodone Hydrochloride 20 mg/mL Oral Solution
|
|
|
|
|
| 2005P-0305
|
| Remove Dietary Supplements that Contain the Drug Pyridoxamine
|
|
|
|
|
| 2005P-0409
|
| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| 2005Q-0298
|
| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
|
|
|
|
|
| 2006N-0104
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
|
|
|
|
|
| 2006N-0105
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
|
|
|
|
| 2006Q-0091
|
| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
|
|
|
|
|
| 2006V-0141
|
| Laser Light Show
|
|
|
|
|
| 2006V-0142
|
| Laser Light Show
|
|
|
|
|
| 2006V-0143
|
| Laser Light Show
|
|
|
|
|
| 1981N-0022
|
| OTC Weight Control Drug Products for Human Use
|
|
|
|
|
| ACK 22
|
| HFA-305 to Wyeth
|
| Vol #:
|
| 98
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET 17410
|
| Jarrow Formulas
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17411
|
| RKS Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17412
|
| Natural Factors Nutritional Products, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17413
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17414
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17415
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17416
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
| | | | | | | | |
|
|
|
|
| LET 17417
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17418
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17419
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17420
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17421
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17422
|
| Adeeva Nutritionals Canada Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17423
|
| Swanson Health Products
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17424
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17425
|
| Enzymatic Therapy
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17426
|
| Swanson Health Products
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17427
|
| Somalabs, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17428
|
| Somalabs, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17429
|
| Somalabs, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17430
|
| Somalabs, inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17431
|
| R.A.M. Biotechnology Researchers Ltd.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17432
|
| Brownwood Acres Foods,Inc./Flavonoid Sciences
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17433
|
| Brownwood Acres Foods, Inc./Flavonoid Sciences
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17434
|
| Brownwood Acres Foods, Inc,\.Flavoid Sciences
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17435
|
| Brownwood Acres Foods, Inc./Flavonoid Sciences
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17436
|
| New Chapter, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17437
|
| New Chapter, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17438
|
| Ferrosan Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17439
|
| Weleda, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17440
|
| Weleda, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17441
|
| Weleda, Inc.
|
| Vol #:
|
| 160
|
|
|
|
|
| LET 17442
|
| Renassance Herbs
|
| Vol #:
|
| 160
|
|
|
|
|
| 2000P-1577
|
| Variance from source-skin distance requirement of perf. std.
|
|
|
|
|
| LET 1
|
| HFZ-200 to GE OEC Medical Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2000V-1377
|
| Laser Light Show(2) LM-10 Micro Yag Projection systems
|
|
|
|
|
| VRA 3
|
| HFZ-200 to Mighty Ducks Hockey Team
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1316
|
| R. Petrenko
|
| Vol #:
|
| 6
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 243
|
| L. Moore
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC 621
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 622
|
| Mission Possible International
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 623
|
| Calorie Control Council
|
| Vol #:
|
| 9
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 1259
|
| S. Patton
|
| Vol #:
|
| 12
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| BKG 2
|
| Refs 1 - 3
|
| Vol #:
|
| 2
|
|
|
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
|
|
|
|
| LET 1
|
| HHS
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005D-0286
|
| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
|
|
|
|
|
| C 12
|
| Schering-Plough
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
|
|
|
|
|
| C 5
|
| Parenteral Drug Association (PDA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0144
|
| ANDA Suitability for Oxycodone Hydrochloride 20 mg/mL Oral Solution
|
|
|
|
|
| PDN 1
|
| HFD-600 to The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0305
|
| Remove Dietary Supplements that Contain the Drug Pyridoxamine
|
|
|
|
|
| RC 4
|
| BioStratum, Inc. (BioStratum)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0409
|
| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
|
|
|
|
|
| LET 1
|
| HFD-005 to Sterne, Kessler, Goldstein & Fox, P.L.L.C.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
|
|
| EMC 631
|
| D. Treloar
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 632
|
| H. Piermatteo
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 633
|
| M. Lawrynenko
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 634
|
| K. Nelson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 635
|
| E. Aranda
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 636
|
| P. Sheldon
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 637
|
| L. Kenneday
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 638
|
| N. Stefanvo
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 639
|
| L. Haro
|
| Vol #:
|
| 76
|
|
| | | | | | | | |
|
|
|
|
| EMC 825
|
| K. Thompson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 826
|
| K. Zumbrunn
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 827
|
| J. Dana
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 828
|
| Dr. K. Kippels
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 829
|
| P. Altman
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 830
|
| L. Nelson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 831
|
| G. Weeks
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 832
|
| M. Lindbeck
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 833
|
| J. Stege
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 834
|
| J. Scotto
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 835
|
| L. Benest
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 836
|
| P. Reischman
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 837
|
| B. Long
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 838
|
| R. LaNore
|
| Vol #:
|
| 76
|
|
|
|
|
| 2005Q-0298
|
| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
|
|
|
|
|
| LET 2
|
| Nestle USA
|
| Vol #:
|
| 6
|
|
|
|
|
| 2006N-0104
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
|
|
|
|
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0105
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Environmental Impact Considerations Part 25 (21 CFR Part 25)
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
|
|
|
|
| ACK 2
|
| HFA-305 to ViroPharma Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| PSA 2
|
| ViroPharma Incorporated
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0144
|
| delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA
|
|
|
|
|
| CP 1
|
| Custopharm, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006Q-0091
|
| Qualified Health Claim (QHC): Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
|
|
|
|
|
| LET 1
|
| FDA/CFSAN to Johnson Nurition Solutions LLC
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006V-0141
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Mathew Raftery
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Mathew Raftery
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006V-0142
|
| Laser Light Show
|
|
