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| Dockets Entered
On May 15, 2006
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0005
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| Packaging & Labeling Requirements for Carbonyl Iron
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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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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| 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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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2005N-0157
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| Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
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| 2005N-0425
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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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-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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| 2005P-0463
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| requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
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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-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006E-0204
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| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
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| 2006N-0038
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006P-0201
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| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 326
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| Brock Scientific Consulting LLC
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| Vol #:
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| 259
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| RPT 327
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| FDA Experts
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| Vol #:
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| 255
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| RPT 328
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| Oral Delivery Technology
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| Vol #:
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| 255
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| RPT 329
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| Oral Delivery Technology
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| Vol #:
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| 255
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| RPT 330
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| Oral Delivery Technology
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| Vol #:
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| 255
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| RPT 331
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| CVT Technologies Inc
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| Vol #:
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| 260
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| RPT 332
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| Louis Montgomery Enterprises
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| Vol #:
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| 261
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| RPT 333
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| pH Sciences
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| Vol #:
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| 255
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17596
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| Novex Biotech TM, LLC
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| Vol #:
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| 162
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| LET 17597
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| CCA Industries, Inc.
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| Vol #:
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| 162
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| LET 17598
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17599
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17600
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17601
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| Ezymatic Therapy
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| Vol #:
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| 162
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| LET 17602
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17603
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17604
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17605
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17606
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| ProCaps Laboratories
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| Vol #:
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| 162
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| LET 17607
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| ProCaps Laboratories
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| Vol #:
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| 162
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| LET 17608
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| Herb Pharm
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| Vol #:
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| 162
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| LET 17609
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| Hillestad Pharmaceuticals
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| Vol #:
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| 162
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| LET 17610
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| Hillestad Pharmaceuticals
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| Vol #:
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| 162
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| LET 17611
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| JOL Management
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| Vol #:
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| 162
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| LET 17612
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| Source Naturals
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| Vol #:
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| 162
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| LET 17613
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17614
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17615
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17616
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17617
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17618
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| Enzymatic Therapy
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| Vol #:
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| 162
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| LET 17619
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| USANA Health Sciences, Inc.
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| Vol #:
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| 162
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| LET 17620
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| Hillestad Pharmaceuticals
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| Vol #:
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| 162
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| 1998P-0005
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| Packaging & Labeling Requirements for Carbonyl Iron
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| PDN 1
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| FDA to International Specialty Products
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| Vol #:
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| 8
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18268
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| W. Hill
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| Vol #:
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| 516
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| 2000D-1632
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| Management of Adverse Event Reports (AER's) (VICH GL24)
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| EMC 1
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| L. Grassie
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| Vol #:
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| 1
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| C 12862
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| W. Hill
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| Vol #:
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| 806
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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 1322
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| J. Estrange
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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 248
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| P. Swenson
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| Vol #:
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| 4
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| EMC 249
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| P. Swenson
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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 644
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| Mission Possible Intl
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| Vol #:
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| 9
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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 1288
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| No signature
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| Vol #:
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| 12
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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| WDL 1
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| Endo Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2005N-0157
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| Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005N-0425
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| Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005P-0360
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| salmon calcitonin products unless certain conditions are met FDA should not approved
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| C 3
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| Nastech Pharmaceutical Company, Inc. (Nastech)
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| Vol #:
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| 1
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
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| C 2
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| American Psychiatric association (APA)
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| Vol #:
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| 5
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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 9125
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| B Hawskins-McElfunn
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| Vol #:
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| 133
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| C 9126
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| B. Radclith, MD
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| Vol #:
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| 133
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| C 9127
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| C. Jaye
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| Vol #:
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| 133
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| C 9128
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| G. Bell
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| Vol #:
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| 133
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| C 9129
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| H. James
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| Vol #:
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| 133
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| C 9130
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| S. Diebolt
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| Vol #:
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| 133
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| C 9131
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| S. Werner
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| Vol #:
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| 133
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| C 9132
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| A. M. Fredrick
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| Vol #:
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| 133
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| C 9133
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| Unreaable
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| Vol #:
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| 133
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| | | | | | | | |
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| |
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| EMC 1938
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| S. Caudle
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| Vol #:
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| 123
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| EMC 1939
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| P. Creighton
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| Vol #:
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| 123
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| EMC 1940
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| H. Woodward
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| Vol #:
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| 123
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| EMC 1941
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| R. Stitt
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| Vol #:
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| 123
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| EMC 1942
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| C. Smith
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| Vol #:
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| 123
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| EMC 1943
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| K. Thornberry
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| Vol #:
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| 123
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| EMC 1944
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| B. B.
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| Vol #:
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| 123
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| EMC 1945
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| S. Allen
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| Vol #:
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| 123
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| EMC 1946
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| L. Peterson
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| Vol #:
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| 123
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| EMC 1947
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| D. Williams
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| Vol #:
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| 123
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| |
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| 2005P-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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| PDN 1
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| FDA/CDRH to Wright Medical Technology, Inc.
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| Vol #:
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| 2
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| 2005P-0463
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| requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
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| LET 1
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| FDA/CDER to Rosei Rocha-Judd
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| Vol #:
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| 1
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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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| C 5
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| Advanced Medical Technology Association (AdvaMed)
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| Vol #:
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| 1
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| EMC 1
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| Hoffmann-La Roche, Inc.
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| Vol #:
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| 1
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| EMC 2
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| Genetics and Public Policy Center
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| Vol #:
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| 1
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| EMC 3
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| Genzyme Corporation (Genzyme)
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| Vol #:
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| 1
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| EMC 4
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 23
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 4
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| EMC 1
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| The Brand Marketing Group, Inc.
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| Vol #:
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| 4
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| EMC 2
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| G. Pasquale
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| Vol #:
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| 4
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| 2006E-0204
|
| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
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| APP 1
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| Scios Inc.
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0038
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| TS 1
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| Veterans Affairs Medical Center
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| Vol #:
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| 1
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| TS 2
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| Miech
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| Vol #:
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| 1
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