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| Dockets Entered On May 10, 2006
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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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-0420
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| Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen, Bone Sonometers
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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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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004P-0149
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| ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2005D-0057
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| Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability
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| 2005D-0392
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| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2005V-0326
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| Projector for a Laser Light Show
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| 2006D-0012
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| Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
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| 2006D-0020
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
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| 2006D-0172
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| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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| 2006P-0122
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| ANDA Suitability for Cetirizine Hydrochloride Orally Disintegrating Tablets, 5 mg and 10 mg
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| 2006P-0145
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| ANDA suitability for Gemcitabine
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| 2006P-0160
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| Request ANDA Suitability of Dichlorphenamide Tablets USP, 50 mg,
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| 2006P-0196
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| ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834)
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17573
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| Swanson Health Products
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| Vol #:
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| 162
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| LET 17574
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| Advocare International, L.P.
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| Vol #:
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| 162
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| | | | | | | | |
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| LET 17575
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| Garden of Life
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| Vol #:
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| 162
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| LET 17576
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| Garden of Life
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| Vol #:
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| 162
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| LET 17577
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| Garden of Life
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| Vol #:
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| 162
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| LET 17578
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| Garden of Life
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| Vol #:
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| 162
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| LET 17579
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| Garden of Life
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| Vol #:
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| 162
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| LET 17580
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| FoodScience Corporation
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| Vol #:
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| 162
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| LET 17581
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| FoodScience Corporation
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| Vol #:
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| 162
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18267
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| E. Videtta
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| Vol #:
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| 516
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12861
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| E. Videtta
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| Vol #:
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| 806
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1384
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| C. Leiszter
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| Vol #:
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| 259
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| C 1385
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| E. Videtta
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| Vol #:
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| 259
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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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| EMC 1321
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| S. Josey
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| Vol #:
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| 6
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 246
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| B. Ottawa
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| Vol #:
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| 4
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| EMC 247
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| E. Lamont
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 641
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 642
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 643
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| Calorie Control Council
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| Vol #:
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| 9
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| 2003D-0420
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| Class II Special Controls Guidance Document: Pressure Regulators for Use with Medical Oxygen, Bone Sonometers
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| EMC 1
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| University of Sheffield
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| Vol #:
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| 1
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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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| EMC 1287
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| C. Landers
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| Vol #:
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| 12
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C 49
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| O-AT-KA Milk Products Cooperative, Inc. (O-AT-KA)
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| Vol #:
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| 2
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|
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 59
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| E. Videtta
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| Vol #:
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| 5
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| | | | | | | | |
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| C 60
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| R. Herrmann
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| Vol #:
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| 5
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| 2004P-0149
|
| ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen
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|
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|
|
| C 1
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| D. Lowe
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| Vol #:
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| 2
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|
|
|
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| 2005D-0057
|
| Reviewer Guidance on Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review; Availability
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|
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|
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| EMC 1
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| Dr. C. Mahl, MD and Dr. R. Scharpf, PhD
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| Vol #:
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| 1
|
|
|
|
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| 2005D-0392
|
| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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|
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| C 1
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| Association for Molecular Pathology (AMP)
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| Vol #:
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| 1
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|
|
|
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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|
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|
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| C 4
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| D. Lowe
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| Vol #:
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| 1
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|
|
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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|
|
|
|
| C 8670
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| L. Yost
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| Vol #:
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| 128
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| C 8671
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| M. PeFriese
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| Vol #:
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| 128
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| C 8672
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| R. Kune
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| Vol #:
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| 128
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| C 8673
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| C. Buchsnsn
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| Vol #:
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| 128
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| C 8674
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| D. Davis
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| Vol #:
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| 128
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|
|
|
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| C 8675
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| C. Davis
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| Vol #:
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| 128
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|
|
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| C 8676
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| G. Whitl
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| Vol #:
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| 128
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|
|
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| C 8677
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| C. Skrent
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| Vol #:
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| 128
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|
|
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| C 8678
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| R. Cook
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| Vol #:
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| 128
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|
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| C 8679
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| P. Petersen
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| Vol #:
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| 128
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|
|
|
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| C 8680
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| S. Frarier
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| Vol #:
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| 128
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|
|
|
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| C 8681
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| M. Phillips
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| Vol #:
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| 128
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|
|
|
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| C 8682
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| R. Shrenk
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| Vol #:
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| 128
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|
|
|
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| C 8683
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| L. Grasso
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| Vol #:
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| 128
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|
|
|
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| C 8684
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| H. Grleni
|
| Vol #:
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| 128
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|
|
|
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| C 8685
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| K, Barty
|
| Vol #:
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| 128
|
|
|
|
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| C 8686
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| M. R. Miller
|
| Vol #:
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| 128
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|
|
|
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| C 8687
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| M. Shrerk
|
| Vol #:
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| 128
|
|
|
|
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| C 8688
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| D. Buchi
|
| Vol #:
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| 128
|
|
|
|
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| C 8689
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| M. Pelletch
|
| Vol #:
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| 128
|
|
|
|
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| C 8690
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| L. True
|
| Vol #:
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| 128
|
|
|
|
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| C 8691
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| J. M. Nichalels
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| Vol #:
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| 128
|
|
|
|
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| C 8692
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| Robert Micalak
|
| Vol #:
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| 128
|
|
|
|
|
| C 8693
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| A. Mana-Jansen
|
| Vol #:
|
| 128
|
|
| | | | | | | | |
|
|
|
|
| EMC 1645
|
| C. DeSophia
|
| Vol #:
|
| 121
|
|
|
|
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| EMC 1646
|
| A. Fain, R.N., PhD
|
| Vol #:
|
| 121
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|
|
|
|
| EMC 1647
|
| D. Pereira
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1648
|
| M. Ranieri
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1649
|
| M. Ranieri
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1650
|
| L. Bogle
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1651
|
| J. Rosario
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1652
|
| D. Sheikh
|
| Vol #:
|
| 121
|
|
|
|
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| EMC 1653
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| J. Carter
|
| Vol #:
|
| 121
|
|
|
|
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| EMC 1654
|
| C. McLarney
|
| Vol #:
|
| 121
|
|
|
|
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| EMC 1655
|
| P. Cummings
|
| Vol #:
|
| 121
|
|
|
|
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| EMC 1656
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| R. Jackson
|
| Vol #:
|
| 121
|
|
|
|
|
| EMC 1657
|
| D. Eaton
|
| Vol #:
|
| 121
|
|
|
|
|
| 2005P-0456
|
| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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|
|
|
|
| C 5
|
| Rakoczy Molino Mazzochi Siwik, LLP (RMMS)
|
| Vol #:
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| 2
|
|
|
|
|
| 2005V-0326
|
| Projector for a Laser Light Show
|
|
|
|
|
| M 1
|
| Reassign to 2002V-0453.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0012
|
| Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
|
|
|
|
|
| C 2
|
| AstraZeneca, LP
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| Hoffman-LaRoche, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0020
|
| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
|
|
|
|
|
| C 2
|
| Abbott Laboratories
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006D-0172
|
| Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations
|
|
|
|
|
|
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0019
|
| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
|
|
|
|
|
| C 7
|
| Abbott Laboratories
|
| Vol #:
|
| 2
|
|
|
|
|
| 2006N-0065
|
| Emerging Clostridial Disease; Public Workshop
|
|
|
|
|
| C 1
|
| Judical Watch
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0133
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
|
|
|
|
|
|
|
|
| | | | | | | | |
|
|
|
|
| EMC 1
|
| I. Lieberman
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
|
|
|
|
| LET 2
|
| The Quaker Oats Company
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0122
|
| ANDA Suitability for Cetirizine Hydrochloride Orally Disintegrating Tablets, 5 mg and 10 mg
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0145
|
| ANDA suitability for Gemcitabine
|
|
|
|
|
| C 2
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0160
|
| Request ANDA Suitability of Dichlorphenamide Tablets USP, 50 mg,
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
|
|
| C 1
|
| Rakoczy Molino Mazzochi Siwik, LLP (RMMS)
|
| Vol #:
|
| 1
|
|
|
|
|
| SUP 1
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0195
|
| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
|
|
|
|
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Rakoczy Molino Mazzochi Siwik LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Rakoczy Molino Mazzochi Siwik LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0196
|
| ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834)
|
|
|
|
|
| ACK 1
|
| FDA/DDMB to West-Ward Pharmaceutical, Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| West-Ward Pharmaceutical, Corp.
|
| Vol #:
|
| 1
|
|
