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| Dockets Entered
On June 21, 2005
Table of Contents
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| Docket #
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| Title
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| 1998V-0868
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| Variance of the Lasette Finger Perforator.
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001N-0275
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| Performance standard for Diagnostic X-Ray Systems & Major Co
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003D-0549
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| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
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| 2003F-0128
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| Permitted Use Concentration and to Expand pH Range for acidi
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0401
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0526
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| Agency Information Collection Activities; Proposed Collection; Comment Request;
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| 2004P-0239
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| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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|
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| 2005D-0068
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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|
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|
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| 2005D-0223
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| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
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| 2005E-0245
|
| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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|
|
|
|
| 2005M-0241
|
| P040026 - Orthospec Extracorporeal Shock Wave Therapy Device, Approved 4/1/05
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|
|
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| 2005N-0184
|
| Precursor Preference in Surfactant Synthesis of Newborns
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|
|
|
|
| 2005N-0186
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
|
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|
|
| 2005N-0210
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Veterinary Feed Directive
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
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|
|
| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
|
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| |
|
| 1998V-0868
|
| Variance of the Lasette Finger Perforator.
|
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|
| VRA
1
|
| HFZ-300 to Cell Robotics Inc.
|
| Vol #:
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| 1
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|
| | | | | | | | |
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| |
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| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
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|
| C 18234
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| S. Wiener
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| Vol #:
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| 516
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| C 18235
|
| J. Correll
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| Vol #:
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| 516
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| |
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
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| C 759
|
| F. Caruso
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| Vol #:
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| 21
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| 2000N-0504
|
| Egg Safety Action Plan
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| C
380
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| State of California
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| Vol #:
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| 32
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| C
381
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| United States Animal Health Assn (USAHA)
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| Vol #:
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| 32
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| EMC
1909
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| Ohio Department of Agriculture
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| Vol #:
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| 31
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| EMC 1910
|
| D. Kuney
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| Vol #:
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| 31
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|
| EMC
1911
|
| United States Animal Health Assn (USAHA)
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| Vol #:
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| 31
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|
|
| EMC 1912
|
| R. Couturier
|
| Vol #:
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| 31
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| EMC 1913
|
| B. Sachau
|
| Vol #:
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| 31
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|
| |
|
| 2001N-0275
|
| Performance standard for Diagnostic X-Ray Systems & Major Co
|
|
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|
|
| NFR
1
|
| FDA
|
| Vol #:
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| 4
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
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|
| EMC 14454
|
| A. Plitman
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| Vol #:
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| 342
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| EMC 14455
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| D. MArtin
|
| Vol #:
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| 342
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| EMC 14456
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| S. Hargrave
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| Vol #:
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| 342
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| EMC 14457
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| E. Arpawong
|
| Vol #:
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| 342
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| EMC
14458
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| Children's Hospital of Pittsburgh
|
| Vol #:
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| 342
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|
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| EMC 14459
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| M. Scanlon
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| Vol #:
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| 342
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| EMC 14460
|
| H. Cindrich
|
| Vol #:
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| 342
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|
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|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
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|
|
| EMC 1266
|
| R. Greene
|
| Vol #:
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| 5
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|
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| EMC 1267
|
| J. Overton
|
| Vol #:
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| 5
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|
|
|
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| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 217
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| R. McNeff
|
| Vol #:
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| 4
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| EMC 218
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| J. Smiley
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| Vol #:
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| 4
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| EMC 219
|
| P. Webster
|
| Vol #:
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| 4
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|
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|
|
| EMC 220
|
| M. Stevevenson
|
| Vol #:
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| 4
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
| | | | | | | | |
|
| |
|
| EMC 468
|
| Mission Possible International
|
| Vol #:
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| 7
|
|
|
|
|
| EMC 469
|
| Mission Possible International
|
| Vol #:
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| 7
|
|
|
|
|
| EMC 470
|
| Mission Possible International
|
| Vol #:
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| 7
|
|
|
|
|
| EMC 471
|
| Mission Possible International
|
| Vol #:
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| 7
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|
|
|
|
| EMC
472
Attachment
|
| Calorie Control Council
|
| Vol #:
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| 7
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|
|
|
|
| EMC
473
Attachment
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 474
|
| Mission Possible International
|
| Vol #:
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| 7
|
|
|
|
|
| EMC 475
|
| Mission Possible International
|
| Vol #:
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| 7
|
|
|
|
|
| EMC 476
|
| Dr. J. Bowen
|
| Vol #:
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| 7
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|
|
|
|
| EMC 477
|
| No signature
|
| Vol #:
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| 7
|
|
|
|
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| EMC 478
|
| Dr. J. Bowen
|
| Vol #:
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| 7
|
|
| |
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 141
|
|
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0549
|
| Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003F-0128
|
| Permitted Use Concentration and to Expand pH Range for acidi
|
|
|
|
|
| EMC
2
|
| Philippine National SPS Enquiry Point
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 798
|
| O. Spruell
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 799
|
| J. Lamond
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 800
|
| F. Napolitano
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 801
|
| J. McKee
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 802
|
| E. Maddaleni
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 803
|
| J. Wiltshire
|
| Vol #:
|
| 11
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|
|
|
|
| EMC 804
|
| T. Thompson
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 805
|
| L. Rose
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 806
|
| R. Wittig
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 807
|
| Mike O
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 808
|
| C. Gonzalez
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 809
|
| V. Seth, MD
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 810
|
| K. Getz
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 811
|
| L. Lewis
|
| Vol #:
|
| 11
|
|
| | | | | | | | |
|
| |
|
| EMC 812
|
| L. Lewis
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 813
|
| K. Correll
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 814
|
| M. Rankins
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 815
|
| L. Chabau
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 816
|
| M. Allen
|
| Vol #:
|
| 11
|
|
|
|
|
| EMC 817
|
| D. Hazlett
|
| Vol #:
|
| 11
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| C
206
|
| Honorable Lisa Murkowski
|
| Vol #:
|
| 23
|
|
|
|
|
| 2004N-0401
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| SUPPORTING STATEMENT
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| EMC
12
|
| UCLA Radioactive Drug Research Committee (RDRC)
|
| Vol #:
|
| 2
|
|
| |
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
|
|
|
|
| EMC 1155
|
| J and P Hollister
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC 1156
|
| D. Shumway
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC 1157
|
| F. Brant
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC 1158
|
| N. Welsh
|
| Vol #:
|
| 29
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C
43
|
| Snack Food Association
|
| Vol #:
|
| 4
|
|
|
|
|
| C
44
|
| National Dairy Council
|
| Vol #:
|
| 4
|
|
|
|
|
| C
45
|
| The Grocery Manufacturers Association
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 287
|
| T. Goodwin
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 288
|
| M. Grim
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 289
|
| B. Hahn
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 290
|
| K. Salas
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 291
|
| L. Rose
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
292
|
| American Beverage Association
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 293
Attachment
|
| Vanderbilt University Medical Center
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
294
|
| Food Products Association(formerly National Food Processors Ass.)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 295
|
| A. M. Herling
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 296
|
| K. Couper
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
297
|
| McNeil Nutritionals
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 298
|
| S. O'Meara
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
|
| |
|
| EMC 299
|
| S. W. Uden
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 300
|
| P. Solis
|
| Vol #:
|
| 3
|
|
| |
|
| 2004N-0526
|
| Agency Information Collection Activities; Proposed Collection; Comment Request;
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0239
|
| Issue a Final and Complete Guidance Document to Determine Bioequivalence (BE) for Nasal Spray Products.
|
|
|
|
|
| SUP
2
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
|
|
|
|
|
| EMC 1
|
| L. Fairweather
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 2
|
| No signature
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
|
|
|
|
| C
1
|
| The Tatia Oden French Memorial Foundation
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0223
|
| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005E-0245
|
| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
|
|
|
|
|
| APP
1
|
| Chiron Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
|
|
|
|
|
| APP
1
|
| ELAN Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| LET
1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0241
|
| P040026 - Orthospec Extracorporeal Shock Wave Therapy Device, Approved 4/1/05
|
|
|
|
|
| AAV
1
|
| Medispec, Ltd.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0184
|
| Precursor Preference in Surfactant Synthesis of Newborns
|
|
|
|
|
| C 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 1
|
| b. sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0186
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0210
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Veterinary Feed Directive
|
|
| | | | | | | | |
|
| |
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
|
|
|
|
| BKG
1
References
|
| Background Material
|
| Vol #:
|
| 3
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| RPT
1
|
| CFSAN-24
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0139
|
| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
|
|
|
|
|
| C
2
|
| Animal Health Institute (AHI)
|
| Vol #:
|
| 1
|
|
|
|
| 2005P-0242
|
| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
|
|
|
|
|
| ACK
1
|
| HFA-305 to Samson Medical Technologies, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Samson Medical Technologies, LLC
|
| Vol #:
|
| 1
|
|
