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| Dockets Entered
On June 17, 2005
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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| 2000N-0504
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| Egg Safety Action Plan
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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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-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005N-0097
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0184
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| Precursor Preference in Surfactant Synthesis of Newborns
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| 2005P-0243
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| Permit the filing for 2 % Lidocaine hydrochloride for topical ( spray ) anesthesia with a flavor as an ingredient
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
755
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| Statistical Report - Month of May, 2005
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| Vol #:
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| 55
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16230
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| Pure Encapsulations
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| Vol #:
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| 144
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| EC 9
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| Mr. RUSSELL KIRKSEY
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| Vol #:
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| 2
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| 2000N-0504
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| Egg Safety Action Plan
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| EC 24
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| Food Animal Concerns Trust
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| Vol #:
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| 32
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| EC
6
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| United States Potato Board
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| Vol #:
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| 5
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| EC
7
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| United Fresh Fruit and Vegetable Association
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| Vol #:
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| 5
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| EC
8
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| Produce Marketing Association
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| Vol #:
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| 5
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| EC
9
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| U.S. Apple Association
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| Vol #:
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| 5
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| EC
10
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| American Frozen Food Institute (AFFI)
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| Vol #:
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| 5
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| 2002D-0467
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| Blood products safety cases known/suspected West Nile Virus
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| EC
5
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| Wyeth
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| Vol #:
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| 1
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| EC 5
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| Miss. Christina Kendall
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| Vol #:
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| 2
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| LST
2
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| HFZ-215
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| Vol #:
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| 2
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| EC
2
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| Florida Department of Agriculture
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| Vol #:
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| 1
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| EC 12
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| Ms. Joan Doherty
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| Vol #:
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| 6
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| EC 13
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| UW Law School
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| Vol #:
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| 6
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| EC
14
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| Food and Nutrition Service, USDA
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| Vol #:
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| 6
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| EC
15
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| Produce Marketing Association
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| Vol #:
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| 6
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| EC 40
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| TAMMY KAYE SIMON PERSONAL TRAINER
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| EC
16
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| Calorie Control Council
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| Vol #:
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| 1
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| EC
17
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| Calorie Control Council
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| Vol #:
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| 1
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| EC
18
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| Food and Nutrition Service, USDA
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| Vol #:
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| 1
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| EC
19
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| Pennington Biomedical Research Center
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| Vol #:
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| 1
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| EC 1
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| tammy simon Certified personal trainer
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| Vol #:
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| 2
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| LET
10
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| Milford Hospital
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| Vol #:
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| 8
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| LET
11
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| Fleminger, Inc
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| Vol #:
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| 8
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| SUP
3
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| Fleminger, Inc
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| Vol #:
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| 8
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| 2005D-0021
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| International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development
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| EC
6
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| Teva Pharmaceutical Industries Ltd.
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| Vol #:
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| 1
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| EC
7
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| Teva Pharmaceutical Industries Ltd.
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| Vol #:
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| 1
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| EC
8
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| EC
9
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| Generic Pharmaceutical Association
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| Vol #:
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| 1
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| EC 2
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| National Organization for Rare Disorders (NORD)
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| Vol #:
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| 1
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| EC 3
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| National Organization for Rare Disorders (NORD)
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| Vol #:
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| 1
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| EC 4
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| National Organization for Rare Disorders (NORD)
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| Vol #:
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| 1
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| EC
1
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| Pharm Res
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| Vol #:
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| 1
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| EC 2
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| Dr. Gary Chadwick
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| Vol #:
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| 1
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| EC
3
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| Council on Governmental Relations
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| Vol #:
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| 1
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| EC
4
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| ASCO
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| Vol #:
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| 1
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| EC
5
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| EC
6
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| Consortium of Independent Review Boards
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| Vol #:
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| 1
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| EC
7
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| Novartis
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| Vol #:
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| 1
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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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| EC
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
2
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| Amgen
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| Vol #:
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC
1
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| The Tatia Oden French Memorial Foundation
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| Vol #:
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| 1
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| EC
1
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| Bayshore Community Hospital
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| Vol #:
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| 1
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| 2005N-0097
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| EC
2
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| American Heart Association
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| Vol #:
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| 1
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| EC
3
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| Pharmavite LLC
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| Vol #:
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| 1
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| EC
4
Continued
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| Emord & Associates, P.C.
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| Vol #:
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| 1
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| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| EC
1
Attachment
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| Regulatory Affairs Professionals Society
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| Vol #:
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| 1
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| EC
2
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| Calorie Control Council
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| Vol #:
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| 1
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| EC
3
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| Calorie Control Council
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| Vol #:
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| 1
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| EC
4
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| Grain Foods Foundation
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| Vol #:
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| 1
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| EC
5
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| Calorie Control Council
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| Vol #:
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| 1
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| EC
6
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| Grocery Manufacturers of America
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| Vol #:
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| 1
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| EC
7
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| The American Dietetic Association
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| Vol #:
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| 1
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| 2005N-0184
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| Precursor Preference in Surfactant Synthesis of Newborns
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| EC
1
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| NIH/NIEHS
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| Vol #:
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| 1
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| EC 2
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| Dr. Jon Ebbert
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| Vol #:
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| 1
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| EC
3
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| Case Western Reserve University
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| Vol #:
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| 1
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| EC
4
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| Columbus Childrens Hospital
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| Vol #:
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| 1
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| EC
5
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| St. Vincent's Medical Center
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| Vol #:
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| 1
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| EC
6
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| Van Andel Research Institute
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| Vol #:
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| 1
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| 2005P-0243
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| Permit the filing for 2 % Lidocaine hydrochloride for topical ( spray ) anesthesia with a flavor as an ingredient
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| ACK
1
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| HFA-305 to The International Institute for Clinical Research- New York
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| Vol #:
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| 1
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| CP
1
Appendix
A, B
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| The International Institute for Clinical Research- New York
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| Vol #:
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| 1
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