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| Dockets Entered On
December 1, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006E-0488
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| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
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| 2006E-0489
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| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
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| 2006N-0277
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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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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| 2006P-0491
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| make a determination that the withdrawal of the Reference Listed Drug (RLD), Psorcon E (diflorasone diacetate oin tment) Emollient , Ointment, 0.05%, was not for safety or effectiveness reasons.
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC
102
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| Mrs. C. Denise Wright
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| Vol #:
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| 14
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| EC
103
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| American Society for Dermatologic Surgery
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| Vol #:
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| 14
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 362
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| JML Marketing Inc
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| Vol #:
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| 270
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| RPT 363
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| TJ Panorama Inc
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| Vol #:
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| 270
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| RPT 364
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| SK Chemical Co., Ltd
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| Vol #:
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| 283
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| RPT 365
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| JML Marketing Inc
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| Vol #:
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| 270
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| EC
7
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| QA
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| Vol #:
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| 3
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| EC
8
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| Ben Venue Laboratories, Inc.
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| Vol #:
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| 3
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC
2395
Attachment
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| Self
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| Vol #:
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| 10
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| EC
2396
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| Mr. Dan Waters
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| Vol #:
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| 10
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| EC
2397
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| Mr. Steveb O'Hara
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| Vol #:
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| 10
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| EC
2398
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| Ms. Frances DaGrossa
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| Vol #:
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| 10
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| EC
2399
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| Mr. Kevin Mark
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| Vol #:
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| 10
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| EC
2400
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| Mr. Jason R. Johnson
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| Vol #:
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| 10
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| EC
2401
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| Mrs. Bonnie Hillary
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| Vol #:
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| 10
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| EC
2402
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| Mrs. Celia Rico
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| Vol #:
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| 10
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| EC
2403
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| Mrs. Dianna DeBarberie
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| Vol #:
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| 10
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| | | | | | | |
| |
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| EC
2404
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| Mr. George Lightner
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| Vol #:
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| 10
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| EC
2405
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| Mrs. Pamela Sherstad
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| Vol #:
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| 10
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| EC
2406
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| Mr. Miguel corbaton
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| Vol #:
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| 10
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| EC
2407
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| Mr. Mike Orradre
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| Vol #:
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| 10
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| EC
2408
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| Ms. Rita Deniger
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| Vol #:
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| 10
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| EC
2409
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| Mr. Ron and Sandra Grefke
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| Vol #:
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| 10
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| EC
2410
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| Hospital of St Raphael
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| Vol #:
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| 10
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| EC
2411
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| Mrs. Valerie Porter
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| Vol #:
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| 10
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| EC
2412
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| Mrs. Peggy Schlitz
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| Vol #:
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| 10
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| EC
2413
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| Ms. Diane Conover
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| Vol #:
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| 10
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| EC
2414
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| Mrs. Shirley Livingston
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| Vol #:
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| 10
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| EC
2415
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| Mrs. Deborah Stennett
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| Vol #:
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| 10
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| EC
2416
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| Miss. Karen Gardner
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| Vol #:
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| 10
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| EC
2417
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| Mrs. Maria O'Rourke
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| Vol #:
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| 10
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| EC
2418
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| Ms. Marsha Kettering
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| Vol #:
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| 10
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| EC
2419
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| Mrs. Tammy Earl
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| Vol #:
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| 10
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| EC
2420
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| Mrs. Jeri Dubbert
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| Vol #:
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| 10
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| EC
2421
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| Mrs. Joyce Bickel
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| Vol #:
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| 10
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| EC
2422
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| Mrs. Miki Jarvie
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| Vol #:
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| 10
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| EC
2423
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| Mr. Mike Shevy
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| Vol #:
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| 10
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| EC
2424
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| Mrs. Joanne Savage
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| Vol #:
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| 10
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| EC
2425
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| Mr. Kenneth Nowak
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| Vol #:
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| 10
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| EC
2426
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| Benedictine College
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| Vol #:
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| 10
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| EC
2427
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| Mrs. Helen Wilcox
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| Vol #:
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| 10
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| EC
2428
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| Mrs. Leticia Rosas
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| Vol #:
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| 10
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| EC
2429
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| Mr. Bruce Ludwick, Jr.
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| Vol #:
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| 10
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| EC
2430
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| Mrs. Stacy Middaugh
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| Vol #:
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| 10
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| EC
2431
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| Mr. Casey Truelove
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| Vol #:
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| 10
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| EC
2432
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| Mr. Jason Jones
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| Vol #:
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| 10
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| EC
2433
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| Jesus Through Mary Foundation
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| Vol #:
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| 10
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| EC
2434
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| Mr. Myron Kralis
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| Vol #:
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| 10
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| EC
2435
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| Mrs. Sharon Harrigan
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| Vol #:
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| 10
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| EC
2436
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| Mr. Jeffrey Jones
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| Vol #:
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| 10
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| EC
2437
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| Mr. Clifford Meier
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| Vol #:
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| 10
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| EC
2438
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| Mrs. Mary Keller
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| Vol #:
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| 10
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| EC
2439
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| none
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| Vol #:
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| 10
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| EC
2440
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| Mr. John Kilikevicius
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| Vol #:
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| 10
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| | | | | | | | |
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| EC
2441
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| Mr. Kevin Costello
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| Vol #:
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| 10
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| EC
2442
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| Mrs. Carol Baron
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| Vol #:
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| 10
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| EC
2443
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| Mrs. Jennifer Sammons
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| Vol #:
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| 10
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| EC
2444
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| Mrs. Kimberly Neumaier
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| Vol #:
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| 10
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| EC
2445
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| Mrs. Karen Schooley
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| Vol #:
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| 10
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| 2006E-0488
|
| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 4,965,204
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| APP 1
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| The Johns Hopkins University
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| Vol #:
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| 1
|
| |
|
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| 2006E-0489
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| Patent Extension Application for Isolex 300 (Human Stem Cells and Monoclonal Antibodies), U.S. Patent No. 5,130,144
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| APP 1
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| The Johns Hopkins University
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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 to FDA/CDER
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| Vol #:
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| 1
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| |
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| 2006N-0277
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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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-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| |
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| C 711
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| D. Madronero
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| Vol #:
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| 28
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| C 712
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| J. Bryan
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| Vol #:
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| 28
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| |
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| C 713
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| Dr. B. Zander
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| Vol #:
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| 28
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| |
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| C 714
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| Woman's Voices for the Earth
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| Vol #:
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| 28
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| |
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| C 715
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| R. Kopitzke
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| Vol #:
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| 28
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| |
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| C 716
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| Consumers for Dental Choice
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| Vol #:
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| 28
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| |
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| C 717
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| R. Dudley, PhD
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| Vol #:
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| 28
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| |
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| C 718
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| F. MArtinez
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| Vol #:
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| 28
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| |
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| C 719
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| S. Farrell
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| Vol #:
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| 28
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| |
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| C 720
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| N. Shapka B.Sc., D.D.S.
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| Vol #:
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| 28
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| |
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| C 721
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| IAOMT
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| Vol #:
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| 28
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| |
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| C 722
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| L. Lewis
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| Vol #:
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| 28
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| |
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| C 723
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| R. Taylor
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| Vol #:
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| 28
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| |
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| C 724
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| M and J Impellizzeri
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| Vol #:
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| 28
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| |
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| C 725
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| M. LAmbert
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| Vol #:
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| 28
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| |
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| C 726
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| R. Whittinghill
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| Vol #:
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| 28
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| |
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| C 727
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| L. Hopkins
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| Vol #:
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| 28
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| |
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| C 728
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| M. Sunanda
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| Vol #:
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| 28
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| |
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| C 729
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| S. Taylor
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| Vol #:
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| 28
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| |
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| C 730
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| D. Kennedy, DDS
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| Vol #:
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| 28
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| |
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| C 731
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| C. Mannhardt, RN, BSN
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| Vol #:
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| 28
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| | | | | | | |
| |
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| C 732
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| Dr. BAttey
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| Vol #:
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| 28
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| |
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| C 733
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| J. Elliott
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| Vol #:
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| 28
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| |
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| C 734
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| B. Wilkie
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| Vol #:
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| 28
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| |
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| C 735
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| J. Elliott
|
| Vol #:
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| 28
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| |
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| C 736
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| R. Firebaugn
|
| Vol #:
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| 28
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| |
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| C 737
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| S. Lumsden
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| Vol #:
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| 28
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| |
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| C 738
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| B and D Buckel
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| Vol #:
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| 28
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| |
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| C 739
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| Consumers for Dental Choice
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| Vol #:
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| 28
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| |
|
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| C 740
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| K. Martin
|
| Vol #:
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| 28
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| |
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| C 741
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| K. Kennedy
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| Vol #:
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| 28
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| |
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| C 742
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| F. Koss
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| Vol #:
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| 28
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| |
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| C 743
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| L. Salzer
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| Vol #:
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| 28
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| |
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| C 744
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| S. Frye
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| Vol #:
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| 28
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| |
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| C 745
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| B. Hartmann, L.Ac.
|
| Vol #:
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| 28
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| |
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| C 746
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| M. Wilson
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| Vol #:
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| 28
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| |
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| C 747
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| V. Cain, Jr.
|
| Vol #:
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| 28
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| |
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| C 748
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| P. Smith
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| Vol #:
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| 28
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| |
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| C 749
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| F. Koss
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| Vol #:
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| 28
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| |
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| C 750
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| Dr. P. Gilbert
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| Vol #:
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| 28
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| |
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| C 751
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| S. Murray
|
| Vol #:
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| 28
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| |
|
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| C 752
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| F. Koss
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| Vol #:
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| 28
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| |
|
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| C 753
|
| L. Washburn
|
| Vol #:
|
| 28
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| |
|
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| C 754
|
| C. Cave
|
| Vol #:
|
| 28
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| |
|
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| C 755
|
| Dr. P. Daney
|
| Vol #:
|
| 28
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| |
|
|
| C 756
|
| D. Showalter
|
| Vol #:
|
| 28
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| |
|
|
| C 757
|
| M. Hageman
|
| Vol #:
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| 28
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| |
|
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| C 758
|
| Dr. M. Milburn
|
| Vol #:
|
| 28
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| |
|
|
| C 759
|
| M. Koerner
|
| Vol #:
|
| 28
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| |
|
|
| C 760
|
| K. Crawford
|
| Vol #:
|
| 28
|
| |
|
|
| C 761
|
| J. Pennell
|
| Vol #:
|
| 28
|
| |
|
|
| C 762
|
| J. Pennell
|
| Vol #:
|
| 28
|
| |
|
|
| C 763
|
| N. Hokkanen
|
| Vol #:
|
| 28
|
| |
|
|
| C 764
|
| H. Nguyen
|
| Vol #:
|
| 28
|
| |
|
|
| C 765
|
| V. Varela, A.R.N.P.
|
| Vol #:
|
| 28
|
| |
|
|
| C 766
|
| M. Porter
|
| Vol #:
|
| 28
|
| |
|
|
| C 767
|
| A. Warn
|
| Vol #:
|
| 28
|
| |
|
|
| C 768
|
| D. Wimberly
|
| Vol #:
|
| 28
|
|
| | | | | | | |
| |
|
|
| C 769
|
| Dr. J. Bromboz
|
| Vol #:
|
| 28
|
| |
|
|
| C 770
|
| P. Nupponen, DMD, MAGD
|
| Vol #:
|
| 28
|
| |
|
|
| C 771
|
| S. Easton
|
| Vol #:
|
| 28
|
| |
|
|
| C 772
|
| No signature
|
| Vol #:
|
| 28
|
| |
|
|
| C 773
|
| K. Ringo
|
| Vol #:
|
| 28
|
| |
|
|
| C 774
|
| J. Hershman
|
| Vol #:
|
| 28
|
| |
|
|
| C 775
|
| N. Oakes
|
| Vol #:
|
| 28
|
| |
|
|
| C 776
|
| D. Moore, PhD
|
| Vol #:
|
| 28
|
| |
|
|
| C 777
|
| M. Kane
|
| Vol #:
|
| 28
|
| |
|
|
| C 778
|
| S. Hines
|
| Vol #:
|
| 28
|
| |
|
|
| C 779
|
| N. Oakes
|
| Vol #:
|
| 28
|
| |
|
|
| C 780
|
| L. Shein
|
| Vol #:
|
| 28
|
| |
|
|
| C 781
|
| R and P. Golus
|
| Vol #:
|
| 28
|
| |
|
|
| C 782
|
| Mission Possible International
|
| Vol #:
|
| 28
|
| |
|
|
| C 783
|
| C. Rebman
|
| Vol #:
|
| 28
|
| |
|
|
| C 784
|
| G. Alonzo
|
| Vol #:
|
| 28
|
| |
|
|
| C 785
|
| K. Leavitt
|
| Vol #:
|
| 28
|
| |
|
|
| C 786
|
| J. Duncan
|
| Vol #:
|
| 28
|
| |
|
|
| C 787
|
| B. Shoaf
|
| Vol #:
|
| 28
|
| |
|
|
| C 788
|
| S. Gikas
|
| Vol #:
|
| 28
|
| |
|
|
| C 789
|
| M. Pytela
|
| Vol #:
|
| 28
|
| |
|
|
| C 790
|
| T. Crocker
|
| Vol #:
|
| 28
|
| |
|
|
| C 791
|
| E. Grow
|
| Vol #:
|
| 28
|
| |
|
|
| C 792
|
| D. Rhoades
|
| Vol #:
|
| 28
|
| |
|
|
| C 793
|
| Becky
|
| Vol #:
|
| 28
|
| |
|
|
| C 794
|
| M. Lauvray
|
| Vol #:
|
| 28
|
| |
|
|
| C 795
|
| E. Margalith
|
| Vol #:
|
| 28
|
| |
|
|
| C 796
|
| L. Duda
|
| Vol #:
|
| 28
|
| |
|
|
| C 797
|
| B. White
|
| Vol #:
|
| 28
|
| |
|
|
| C 798
|
| S. Hines
|
| Vol #:
|
| 28
|
| |
|
|
| C 799
|
| M and P Steele
|
| Vol #:
|
| 28
|
| |
|
|
| C 800
|
| M. Burke
|
| Vol #:
|
| 28
|
| |
|
|
| C 801
|
| No signature
|
| Vol #:
|
| 29
|
| |
|
|
| C 802
|
| W. McMillan, DMD
|
| Vol #:
|
| 29
|
| |
|
|
| C 803
|
| R. Holgers
|
| Vol #:
|
| 29
|
| |
|
|
| C 804
|
| J. Milota
|
| Vol #:
|
| 29
|
| |
|
|
| C 805
|
| W. Domb, DMD
|
| Vol #:
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| 29
|
|
| | | | | | | | |
| |
|
|
| C 806
|
| M. Thompson
|
| Vol #:
|
| 29
|
| |
|
|
| C 807
|
| G. Marshall
|
| Vol #:
|
| 29
|
| |
|
|
| C 808
|
| B. Rider
|
| Vol #:
|
| 29
|
| |
|
|
| C 809
|
| DAMS, Intl
|
| Vol #:
|
| 29
|
| |
|
|
| C 810
|
| N. Crosby
|
| Vol #:
|
| 29
|
| |
|
|
| C 811
|
| G and J Marshall
|
| Vol #:
|
| 29
|
| |
|
|
| C 812
|
| R. Petro
|
| Vol #:
|
| 29
|
| |
|
|
| C 813
|
| R. Petro
|
| Vol #:
|
| 29
|
| |
|
|
| C 814
|
| Jigsaw Health Foundation
|
| Vol #:
|
| 29
|
| |
|
|
| C 815
|
| R. Howard
|
| Vol #:
|
| 29
|
| |
|
|
| C 816
|
| L. Kowalis, RN
|
| Vol #:
|
| 29
|
| |
|
|
| C 817
|
| E. Picard
|
| Vol #:
|
| 29
|
| |
|
|
| C 818
|
| Consumers for Dental Choice
|
| Vol #:
|
| 29
|
| |
|
|
| C 819
|
| T. Crocker
|
| Vol #:
|
| 29
|
| |
|
|
| C 820
|
| D. Mariano
|
| Vol #:
|
| 29
|
| |
|
|
| C 821
|
| J. Simpson
|
| Vol #:
|
| 29
|
| |
|
|
| C 822
|
| H. Mylroie
|
| Vol #:
|
| 29
|
| |
|
|
| C 823
|
| R. Kulacz, DDS
|
| Vol #:
|
| 29
|
| |
|
|
| C 824
|
| N. Oakes
|
| Vol #:
|
| 29
|
| |
|
|
| C 825
|
| D. Scire
|
| Vol #:
|
| 29
|
| |
|
|
| C 826
|
| J. Malin
|
| Vol #:
|
| 29
|
| |
|
|
| C 827
|
| M. Davis
|
| Vol #:
|
| 29
|
| |
|
|
| C 828
|
| C. LArkin
|
| Vol #:
|
| 29
|
| |
|
|
| C 829
|
| J. Johnson
|
| Vol #:
|
| 29
|
| |
|
|
| C 830
|
| K. Orndorff
|
| Vol #:
|
| 29
|
| |
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
| |
|
|
| EC
24
|
| Mental Health America of Licking County
|
| Vol #:
|
| 1
|
| |
|
|
| EC
25
Attachment
|
| Families for Depression Awareness
|
| Vol #:
|
| 1
|
| |
|
|
| EC
26
|
| American Foundation for Suicide Prevention
|
| Vol #:
|
| 1
|
| |
|
|
| EC
27
|
| Maryland Psychiatric Society
|
| Vol #:
|
| 1
|
| |
|
|
| EC
28
|
| Mr. Eric Swan
|
| Vol #:
|
| 1
|
| |
|
|
| EC
29
|
| University of Maryland School of Medicine
|
| Vol #:
|
| 1
|
| |
|
|
| EC
30
|
| George Washington University MFA
|
| Vol #:
|
| 1
|
| |
|
|
| EC
31
|
| Dr. Bernard Fischer
|
| Vol #:
|
| 1
|
| |
|
|
| EC
32
|
| Pfizer
|
| Vol #:
|
| 1
|
| |
|
|
| EC
33
|
| Main Street Community Mental Health Center
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EC
34
|
| Ms. Mary Miles
|
| Vol #:
|
| 1
|
| |
|
|
| EC
35
|
| Mrs. Suzanne Gonzalez
|
| Vol #:
|
| 1
|
| |
|
|
| EC
36
|
| Mrs. Cynthia Schilf
|
| Vol #:
|
| 1
|
| |
|
|
| EC
37
|
| Mark S. Komrad M.D.
|
| Vol #:
|
| 1
|
| |
|
|
| EC
38
|
| American Foundation for Suicide Prevention
|
| Vol #:
|
| 1
|
| |
|
|
| EC
39
|
| Mrs. donna stevens
|
| Vol #:
|
| 1
|
| |
|
|
| EC
40
|
| Mrs. Annabel Dobbs
|
| Vol #:
|
| 1
|
| |
|
|
| EC
41
|
| Mrs. Cathy Harter
|
| Vol #:
|
| 1
|
| |
|
|
| EC
42
|
| Dr. Paulo Negro
|
| Vol #:
|
| 1
|
| |
|
|
| EC
43
|
| Sheppard Pratt Health System
|
| Vol #:
|
| 1
|
| |
|
|
| EC
44
|
| Mrs. Cassandra Dawn Casey
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC
432
|
| Dr. Loretta Pesteanu
|
| Vol #:
|
| 7
|
| |
|
|
| 2006P-0491
|
| make a determination that the withdrawal of the Reference Listed Drug (RLD), Psorcon E (diflorasone diacetate oin tment) Emollient , Ointment, 0.05%, was not for safety or effectiveness reasons.
|
|
|
|
|
|
|
| |
|
|
| ACK 1
|
| FDA / DDM to Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Kirkpatrick & Lockhart Nicholson Graham LLP
|
| Vol #:
|
| 1
|
|
|
|
|
|
|
|
|
|
|
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|
