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| Dockets Entered
On November 20, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1999D-2013
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| Cooperative Manufacturing Arrangements for Licensed
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006F-0058
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| Poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) Hydrochloride (FAP 6B4764)
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2006N-0221
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| Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0449
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| Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
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| 2007M-0446
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| P040040 - The Amplatzer Muscular VSD Occluder
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| 2007M-0447
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| P060035 - ARCHITECT CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, and ARCHITECT CORE-M Controls
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| 2007N-0219
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Animal Drug User Fees and Fee Waivers and Reductions
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| 2007N-0220
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546
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| 2007N-0227
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| 2007N-0278
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
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| 2007N-0305
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| Current Good Manufacturing Practice Regulations for Medicated Feeds; Agency Information Collection Activities
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| 2007N-0325
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| Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Section 502 of the Federal Food, Drug and Cosmetic Act / Section 351 of the Public Health Service Act; A
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0444
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0097
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| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
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| 2007P-0205
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| Withdraw approval of and recall all available stock of Ziana or require the immediate initiation of long-term safety studies evaluating the incidence and prevalence of antibiotic resistance associated
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|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
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|
| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 2007P-0456
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| Amend exiting regulations 21 CFR, Part 202.1 (e)(1)
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| |
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| 1978N-0038
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| Sunscreen Drug Products
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| C 639
|
| R. Wagner
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| Vol #:
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| 163
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|
| | | | | | | | |
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| |
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| C 640
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| Commwealth of Virginia, House of Representatives
|
| Vol #:
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| 163
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| C 641
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| Dunes Golf Club
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| Vol #:
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| 163
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| C 642
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| YMCA
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| Vol #:
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| 163
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| C 643
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| Independence Township Parks and Recreation
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| Vol #:
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| 163
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| C 644
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| T. Lowe
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| Vol #:
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| 163
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| C 645
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| Your Aging Well Advisor
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| Vol #:
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| 163
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| C 646
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| E. Wall
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| Vol #:
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| 163
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| C 647
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| Albion College
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| Vol #:
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| 163
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| C 648
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| R. Kerwin
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| Vol #:
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| 163
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| C 649
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| Lwen Gift Shop
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| Vol #:
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| 163
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| C 650
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| Bentsen - Combies Insurance
|
| Vol #:
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| 163
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| C 651
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| Commonwealth of Virginia, Senate
|
| Vol #:
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| 163
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| C 652
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| USF Health
|
| Vol #:
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| 163
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| C 653
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| Bach, LLC
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| Vol #:
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| 163
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| C 654
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| R. Goldfaden
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| Vol #:
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| 163
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|
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| C 655
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| Commonwealth of Virginia, House of Delegates
|
| Vol #:
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| 163
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| C 656
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| State Representative, Michigan House of Representatives
|
| Vol #:
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| 163
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| C 658
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| Commonwealth of Virginia, Senate
|
| Vol #:
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| 163
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| C 659
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| Borough of Stone Harbor
|
| Vol #:
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| 163
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|
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|
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| EC 2660
|
| American Society for Dermatologic Surgery
|
| Vol #:
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| 163
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|
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|
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| EC 2661
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| Ms. Peggy Chan
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| Vol #:
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| 163
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|
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|
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| EC 2662
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| Mrs. Elizabeth Earnst
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| Vol #:
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| 163
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| EC 2663
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| Info-Graph Creative
|
| Vol #:
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| 163
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|
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|
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| EC 2664
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| Independent
|
| Vol #:
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| 163
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| EC 2665
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| Ms. Bethany Conte
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| Vol #:
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| 163
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|
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|
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| EC 2666
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| Mrs. Rachelle Hunter
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| Vol #:
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| 163
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|
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|
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| EC 2667
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| Mrs. alison collins
|
| Vol #:
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| 163
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|
|
|
|
| EC 2668
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| Dr. Henry Rikkers
|
| Vol #:
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| 163
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|
|
|
|
| EC 2669
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| Ms. S. Rosenblatt
|
| Vol #:
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| 163
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|
|
|
|
| EREG 11
|
| Thermo Fisher Scientific
|
| Vol #:
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| 163
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|
|
|
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| EREG 12
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| Accelerant Group
|
| Vol #:
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| 163
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|
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|
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| EXT 19
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| Mary Kay, Inc
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| Vol #:
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| 163
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|
|
|
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| EXT 20
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| Shiseido America Technocenter
|
| Vol #:
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| 163
|
|
|
|
|
| 1999D-2013
|
| Cooperative Manufacturing Arrangements for Licensed
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0557
|
| ANDA for a generic version of Efudex Cream(fluorouracil) cream
|
|
| | | | | | | | |
|
| |
|
| MM 1
|
| Ted Sherwood
|
| Vol #:
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| 3
|
|
|
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
|
|
| EC 39
|
| Ms. Gail Elbek
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| Vol #:
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| 2
|
|
| |
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
|
|
| EC 52
|
| DCP Midstream
|
| Vol #:
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| 1
|
|
|
|
|
| EC 53
|
| Mrs. shairy johnson
|
| Vol #:
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| 1
|
|
|
|
|
| 2005D-0490
|
| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
|
|
|
|
|
| ANS 13
|
| FDA/CFSAN to Su Alai
|
| Vol #:
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| 1
|
|
|
|
|
| ELET 13
|
| S. Alai
|
| Vol #:
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| 1
|
|
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
|
|
|
|
| EMC 13
|
| S. Tumbarello
|
| Vol #:
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| 1
|
|
|
|
|
| 2005P-0450
|
| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
|
|
|
|
|
| EC 7
|
| Ms. Helen Faught
|
| Vol #:
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| 1
|
|
|
|
|
| 2006F-0058
|
| Poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) Hydrochloride (FAP 6B4764)
|
|
|
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0168
|
| Food Labeling: Reference Daily Intakes & Daily Reference Values
|
|
|
|
|
| EC 92
|
| Ms. Maryann Foley-Sabol
|
| Vol #:
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| 1
|
|
|
|
|
| EC 93
|
| DSI Evanston Dialysis
|
| Vol #:
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| 1
|
|
|
|
|
| EC 94
|
| ADVOCATES FOR TRUTH
|
| Vol #:
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| 1
|
|
|
|
|
| EC 95
|
| Fresenius Medical Care
|
| Vol #:
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| 1
|
|
|
|
|
| EREG 2
|
| D. Wilkerson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0221
|
| Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
|
|
|
|
|
| EC 1
|
| Miss. Caitlin Fitzgerald
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| C 486
|
| Unknown
|
| Vol #:
|
| 14
|
|
|
|
|
| C 487
|
| M. Brosh
|
| Vol #:
|
| 14
|
|
|
|
|
| C 488
|
| K. Gronemeyer
|
| Vol #:
|
| 14
|
|
|
|
|
| C 489
|
| T. Bond
|
| Vol #:
|
| 14
|
|
|
|
|
| C 490
|
| A. Bond
|
| Vol #:
|
| 14
|
|
|
|
|
| 2007D-0449
|
| Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0446
|
| P040040 - The Amplatzer Muscular VSD Occluder
|
|
|
|
|
| AAV 1
|
| AGA Medical Corporation
|
| Vol #:
|
| 1
|
|
| |
|
| 2007M-0447
|
| P060035 - ARCHITECT CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, and ARCHITECT CORE-M Controls
|
|
|
|
|
| AAV 1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0219
|
| Agency Information Collection Activities: Proposed Collection; Comment Request: Animal Drug User Fees and Fee Waivers and Reductions
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0220
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0227
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0262
|
| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
|
|
|
|
|
| EC 8
|
| Ms. S T
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| asthma patients
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0277
|
| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
|
|
|
|
|
| M 2
|
| FDA/CFSAN/ONLDS
|
| Vol #:
|
| 5
|
|
|
|
|
| TR 1
|
| FDA/CFSAN/ONLDS
|
| Vol #:
|
| 5
|
|
|
|
|
| TR 2
|
| FDA/CFSAN/ONLDS
|
| Vol #:
|
| 6
|
|
|
|
|
| 2007N-0278
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0305
|
| Current Good Manufacturing Practice Regulations for Medicated Feeds; Agency Information Collection Activities
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0325
|
| Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Section 502 of the Federal Food, Drug and Cosmetic Act / Section 351 of the Public Health Service Act; A
|
|
|
|
|
|
| |
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0343
|
| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
|
|
|
|
|
| EC 1
|
| Genzyme Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007N-0356
|
| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
|
|
|
|
|
| EC 60
|
| Broadlawns Medical Center
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 61
|
| Tidewater Pharmacist Association President
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EC 62
|
| PRESTON'S PHARMACY
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 63
|
| Dr. kenneth Ukauwa
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 64
|
| Ms. Kristen Schultz
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 65
|
| meijer
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 66
|
| Dr. SUNNY WONG
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 67
|
| Dr. Robert Velarde
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 68
|
| Dr. Jeff Gonzalez
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 69
|
| Dr. James Wilde
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 70
|
| Mr. James Perkinson
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 71
|
| American College of Physicians
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 72
|
| ACCP
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 73
|
| Ms. Andrea Vincent
|
| Vol #:
|
| 2
|
|
|
|
|
| 2007N-0444
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
|
|
| C 353
|
| D. Zaccardi
|
| Vol #:
|
| 102
|
|
|
|
|
| C 354
|
| Unknown
|
| Vol #:
|
| 102
|
|
|
|
|
| 2007P-0097
|
| Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
|
|
|
|
|
|
| |
|
|
|
| C 16
|
| North Carolina Department of Commerce
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0205
|
| Withdraw approval of and recall all available stock of Ziana or require the immediate initiation of long-term safety studies evaluating the incidence and prevalence of antibiotic resistance associated
|
|
|
|
|
|
| |
|
|
|
| EC 1
|
| Mr. David Hanson
|
| Vol #:
|
| 1
|
|
|
|
|
| LET 1
|
| FDA/CDER to Center for Dermatology and Laser Surgery
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0297
|
| Request to reconsider the failure to approve Provenge
|
|
|
|
|
| EC 135
|
| Mrs. Suz Becker
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 136
|
| Mrs. Lisa crowder
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007P-0438
|
| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
|
|
|
|
|
|
| |
|
|
|
| EC 1
|
| Ms. Kathy Fitzpatrick
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Ms. Julie Genser
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Ms. Jennifer Pfennig
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| www.MCS-Global.Org
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Ms. Penny Gedeon
|
| Vol #:
|
| 1
|
|
