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| Dockets Entered
On November 14, 2006
Table of Contents
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000V-1127
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| Laser Light Show
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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-0522
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| Off label drug use for CYTOTEC
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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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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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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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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| 2006D-0419
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| Voluntary National Retail Food Regulatory Program Standards
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| 2006D-0441
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| Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0329
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application 21 CFR Part 515 - Extension
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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-0432
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine
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| 2006N-0433
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-mail to Submit A Notice of Final Disposition Of Animals Not Intended For Immediate
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| 2006N-0435
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
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| 2006N-0436
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit A Study Protocol
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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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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| 2006Q-0458
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| Health Claim Notification (HCN): Saturated and Trans Fat, Cholesterol and Heart Disease
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT 771
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| Statistical Report - Month of October 2006
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| Vol #:
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| 55
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 659
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| J. Jennings
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| Vol #:
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| 24
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| 2000V-1127
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| Laser Light Show
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| VRA 2
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| FDA/CDRH to South Florida Science Museum
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| Vol #:
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| 1
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 256
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| M. Kofahl
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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 736
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 737
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| D. Timmons
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| Vol #:
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| 10
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| EMC 738
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| T. Jardine
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| Vol #:
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| 10
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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 1380
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| Apex Morgage Services
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| Vol #:
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| 12
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| EMC 1381
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| J. Mainhart
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| Vol #:
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| 12
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| SUP 3
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| The Tatia Oden French Memorial Foundation
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| Vol #:
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| 2
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| 2005P-0352
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| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
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| PAV 1
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| FDA/CDER to Ortho-McNeil Pharmaceutical, Inc.
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| Vol #:
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| 2
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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 18206
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| T. Drum
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| Vol #:
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| 198
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| C 18207
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| L. Criner
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| Vol #:
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| 198
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| C 18208
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| C. Blakly
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| Vol #:
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| 198
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| C 18209
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| K. Gallagher
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| Vol #:
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| 198
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| EMC 4085
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| S. Debusman
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| Vol #:
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| 195
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| EMC 4086
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| P. Berrett
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| Vol #:
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| 195
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| EMC 4087
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| R. Horwich
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| Vol #:
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| 195
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| EMC 4088
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| D. Martin
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| Vol #:
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| 195
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| EMC 4089
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| C. Walton
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| Vol #:
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| 195
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| EMC 4090
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| L. Osadchuk
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| Vol #:
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| 195
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| EMC 4091
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| A. Weyant
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| Vol #:
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| 195
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| EMC 4092
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| D. Ahlers
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| Vol #:
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| 195
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| EMC 4093
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| L. Matheson
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| Vol #:
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| 195
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| EMC 4094
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| S. Larsen
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| Vol #:
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| 195
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| EMC 4095
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| M. Maisel
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| Vol #:
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| 195
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| EMC 4096
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| B. Palmer
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| Vol #:
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| 195
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| EMC 4097
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| D. Barrans
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| Vol #:
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| 195
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| EMC 4098
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| P. Selby
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| Vol #:
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| 195
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| EMC 4099
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| P. Nathan
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| Vol #:
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| 195
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| EMC 4100
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| C. Vostry
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| Vol #:
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| 195
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| | | | | | | | |
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| |
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| EC 1700
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| Mrs. Annette Backmann
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| Vol #:
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| 6
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| EC 1701
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| Dr. Ronald Konopaski
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| Vol #:
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| 6
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| EC 1702
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| Dr. karen macdonald
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| Vol #:
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| 6
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| EC 1703
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| Mrs. Melissa Mark
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| Vol #:
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| 6
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| EC 1704
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| Mrs. LIN CRIDER
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| Vol #:
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| 6
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| EC 1705
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| Mr. Kurt Gregory
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| Vol #:
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| 6
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| EC 1706
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| Mr. Charles Eddleman ll
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| Vol #:
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| 6
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| EC 1707
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| United For Life
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| Vol #:
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| 6
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| EC 1708
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| Mrs. Jill Sanchez
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| Vol #:
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| 6
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| EC 1709
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| Dr. Pamela Hamman
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| Vol #:
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| 6
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| EC 1710
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| Mr. David Drozd
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| Vol #:
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| 6
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| EC 1711
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| Mrs. A Volino
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| Vol #:
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| 6
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| EC 1712
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| Mrs. Kristin Weisel
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| Vol #:
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| 6
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| EC 1713
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| Mr. David Snyder
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| Vol #:
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| 6
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| EC 1714
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| Mrs. Jan Farthing
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| Vol #:
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| 6
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| EC 1715
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| Mrs. Linda Smith
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| Vol #:
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| 6
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| EC 1716
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| Mr. Robert Valdez
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| Vol #:
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| 6
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| EC 1717
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| Mrs. Margaret White
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| Vol #:
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| 6
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| EC 1718
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| Mr. Rudy C Poglitsh
|
| Vol #:
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| 6
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| EC 1719
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| California Nurses for Ethical Standards
|
| Vol #:
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| 6
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| EC 1720
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| Dr. Jerry Mack
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| Vol #:
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| 6
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|
|
|
|
| 2006D-0419
|
| Voluntary National Retail Food Regulatory Program Standards
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006D-0441
|
| Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
|
|
|
|
| C 14
|
| Cosmetic, Toiletry and Fragrance Association (CTFA)
|
| Vol #:
|
| 16
|
|
|
|
|
| EMC 3
|
| S. Dozier
|
| Vol #:
|
| 12
|
|
|
|
|
| TS 1
|
| NanoViricides, Inc.
|
| Vol #:
|
| 15
|
|
|
|
|
| TS 2
|
| Cosmetic, Toiletry, and Fragrance Association (CTFA)
|
| Vol #:
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| 15
|
|
|
|
|
| TS 3
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| University of Queensland
|
| Vol #:
|
| 15
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|
|
|
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| TS 4
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| Rice University
|
| Vol #:
|
| 15
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|
|
|
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| TS 5
|
| Woodrow Wilson International Center for Scholars
|
| Vol #:
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| 15
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|
| | | | | | | | |
|
| |
|
| TS 6
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| Avidimer Therapeutics
|
| Vol #:
|
| 15
|
|
|
|
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| TS 7
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| Health Canada
|
| Vol #:
|
| 15
|
|
|
|
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| TS 8
|
| International Center for Technology Assessment (CTA)
|
| Vol #:
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| 15
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|
|
|
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| TS 9
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| Intertox, Inc.
|
| Vol #:
|
| 15
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|
|
|
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| TS 10
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| Environmental Defense
|
| Vol #:
|
| 15
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|
|
|
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| TS 11
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| ETC Group
|
| Vol #:
|
| 15
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|
|
|
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| TS 12
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| BASF Aktiengesellschaft
|
| Vol #:
|
| 15
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|
|
|
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| TS 13
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| Center for Risk Science and Communication
|
| Vol #:
|
| 15
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|
|
|
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| TS 14
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| University of Queensland
|
| Vol #:
|
| 15
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|
|
|
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| TS 15
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| Abraxis BioScience, Inc.
|
| Vol #:
|
| 15
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|
|
|
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| TS 16
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| Kobo Products, Inc.
|
| Vol #:
|
| 15
|
|
|
|
|
| TS 17
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| Kereos, Inc.
|
| Vol #:
|
| 15
|
|
|
|
|
| TS 18
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| National Cancer Institute
|
| Vol #:
|
| 15
|
|
|
|
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| TS 19
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| SAIC-Frederick, Inc.
|
| Vol #:
|
| 15
|
|
|
|
|
| TS 20
|
| University of Oregon
|
| Vol #:
|
| 15
|
|
|
|
|
| 2006N-0292
|
| Unique Device Identification
|
|
|
|
|
| C 5
|
| Bon Secours Health System, Inc.
|
| Vol #:
|
| 8
|
|
|
|
|
| C 6
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| Novation
|
| Vol #:
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| 8
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|
|
|
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| C 7
|
| American Association for Homecare (AAHomecare)
|
| Vol #:
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| 8
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|
|
|
|
| C 8
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| Avera Holy Family HEalth
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| Vol #:
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| 8
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|
|
|
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| C 9
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| Cook Group Inc,
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| Vol #:
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| 8
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|
|
|
|
| C 10
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| Tyco Healthcare Group LP (Tyco Healthcare)
|
| Vol #:
|
| 8
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|
|
|
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| C 11
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| Haemonetics Corporation
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| Vol #:
|
| 8
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|
|
|
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| C 12
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| Abbott Laboratories
|
| Vol #:
|
| 8
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|
|
|
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| C 13
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| Central Baptist Hospital
|
| Vol #:
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| 8
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|
|
|
|
| C 14
|
| Sanofi-Synthelabo, Inc.
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| Vol #:
|
| 8
|
|
|
|
|
| C 15
|
| Welch Allyn, Inc.
|
| Vol #:
|
| 8
|
|
|
|
|
| C 16
|
| Coalition for Healthcare eStandards (CHeS)
|
| Vol #:
|
| 8
|
|
|
|
|
| C 17
|
| Aliance of Specialty Medicine (the Alliance)
|
| Vol #:
|
| 8
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|
|
|
|
| C 18
|
| Avery Dennsion Corporation (ADC)
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 1
|
| The Hewlett Packard Company
|
| Vol #:
|
| 6
|
|
|
|
|
| 2006N-0329
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application 21 CFR Part 515 - Extension
|
|
|
|
|
| N 2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
|
|
|
|
| EMC 984
|
| L. Williams
|
| Vol #:
|
| 20
|
|
| | | | | | | |
|
| |
|
| EMC 1022
|
| M. Lauvray
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1023
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1024
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1025
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1026
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1027
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1028
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1029
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1030
|
| The Phoenix Healing Centre (Galway, Ireland)
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1031
|
| F. Kadish
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1032
|
| M. Kiefer
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1033
|
| J. Cirillo
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1034
|
| R. Reeves
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1035
|
| W. Eisenman
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1036
|
| C. Fischer
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1037
|
| D. Stahley
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1038
|
| B.
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1039
|
| M.
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1040
|
| M. Newell
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1041
|
| University of Calgary
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1042
|
| V. Pritchett
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1043
|
| V. Karlsson
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1044
|
| L. Griffin
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1045
|
| M. Viglielmo
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1046
|
| E. Wilcox
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1047
|
| S. Micheletti
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1048
|
| H. Aktar
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1049
|
| R. Funk
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1050
|
| P. Nupponen
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1051
|
| K. Rettenwander
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1052
|
| P. Nupponen
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1053
|
| M. McGrath
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1054
|
| B. Lee
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1055
|
| J. Abdu
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1056
|
| M. Griffin
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1057
|
| C.
|
| Vol #:
|
| 20
|
|
|
|
|
| EMC 1058
|
| V. Foley
|
| Vol #:
|
| 20
|
|
| | | | | | | | |
|
| |
|
| EMC 1133
|
| A. Ferreira
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1134
|
| M. Kiefer
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1135
|
| R. Lavely
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1136
|
| V. Fisher
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1137
|
| S. Buck
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1138
|
| L. Trageser
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1139
|
| W. Whitworth
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1140
|
| F. Koss
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1141
|
| F. Koss
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 1142
|
| A. Ostroff
|
| Vol #:
|
| 24
|
|
| |
|
| 2006N-0432
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine
|
|
|
|
|
|
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0433
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-mail to Submit A Notice of Final Disposition Of Animals Not Intended For Immediate
|
|
|
|
|
|
|
|
|
| EC 1
|
| barb sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0435
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
|
|
|
|
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006N-0436
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit A Study Protocol
|
|
|
|
|
| EMC 1
|
| B. Achau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0085
|
| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
|
|
|
|
|
| EC 4
|
| Dr. Timothy Mapstone
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0123
|
| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
|
|
|
|
|
| SUP 4
|
| Mylan Laboratories Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
| EC 713
|
| Progressive Medical
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| EC 405
|
| Ms. Daidree Tofano
|
| Vol #:
|
| 7
|
|
|
|
|
| 2006Q-0458
|
| Health Claim Notification (HCN): Saturated and Trans Fat, Cholesterol and Heart Disease
|
|
|
|
|
| ACK 1
|
| FDA/CFSAN to Hogan & Hartson LLP
|
| Vol #:
|
| 1
|
|
