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| Dockets Entered
On July 17, 2007
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| Docket #
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| Title
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| 1991P-0298
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| Prescription devices such as nasal cannualas, oxygen mask
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| 1999V-0185
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| Variance Laser Light Show LT-1000
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005D-0490
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| Guidance for Industry:
Questions and Answers Regarding Food Allergens, including the Food
Allergen Labeling and Consumer Protection Act of 2004 ( Edition 2)
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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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-0480
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| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| 2007D-0027
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| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007D-0122
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
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| 2007D-0135
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| Guidance for Industry on Testing of Glycerin for Diethylene Glycol
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| 2007D-0223
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| Guidance for Industry on Use of the Computer Crossmatch
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| 2007N-0219
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Animal Drug User Fees and Fee Waivers and Reductions
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 1991P-0298
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| Prescription devices such as nasal cannualas, oxygen mask
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| ACK 1
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| Helen Harris
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| Vol #:
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| 1
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| ACK 2
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| Helen Harris
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| Vol #:
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| 1
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| 1999V-0185
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| Variance Laser Light Show LT-1000
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| VAR 2
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| Nu-salt laser
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| Vol #:
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| 1
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1426
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| K. Hopkins
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| Vol #:
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| 262
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| C 1427
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| B. Greeney
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| Vol #:
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| 262
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EMC 733
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| Theresa Herrick
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| Vol #:
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| 96
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| C 1723
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| M. Laplante
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| Vol #:
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| 19
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| C 1724
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| J. Downey
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| Vol #:
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| 19
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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 18326
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| D. Albus
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| Vol #:
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| 198
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| EMC 4440
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| Ms. Michelle Dexter
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| Vol #:
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| 199
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| EMC 4441
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| Mrs. Vesna Nikolich
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| Vol #:
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| 199
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| 2006D-0480
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| Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
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| EMC 286
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| Clarence Ellis
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| Vol #:
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| 9
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| EMC 287
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| Baba Nataraja
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| Vol #:
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| 9
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| EMC 288
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| Kay Cunningham
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| Vol #:
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| 9
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| LET 4
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| FDA
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| Vol #:
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| 1
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 3
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| The University of Alabama at Birmingham (UAB)
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| Vol #:
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| 1
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| 2006P-0534
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| ANDA for Sterile Vancomycin Hydrochloride USP, 750 mg
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| C 1
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| Comment number not used
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| Vol #:
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| 1
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| 2007D-0027
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| Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
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| EC 5
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| Dakotaland Feeds LLC
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| Vol #:
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| 1
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| EC 6
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| National Grain and Feed Association
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| Vol #:
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| 1
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| EMC 25
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| Susaan Aram
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| Vol #:
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| 3
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| EMC 26
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| Raymond Flory
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| Vol #:
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| 3
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| C 11
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2007D-0122
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
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| EC 2
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| shot energy drink gmbh
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| Vol #:
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| 1
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| EC 3
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| United States Pharmacopeia
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| Vol #:
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| 1
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| 2007D-0135
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| Guidance for Industry on Testing of Glycerin for Diethylene Glycol
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| EC 1
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| Human Race
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| Vol #:
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| 1
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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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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| EC 3
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| St. Jude Medical
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| Vol #:
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| 1
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| EC 4
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| AstraZeneca LP
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| Vol #:
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| 1
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| EC 5
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| 3 individuals and 2 HIV service organizations
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| Vol #:
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| 1
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| EC 6
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| Ms. Christiane Auston
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| Vol #:
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| 1
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| EC 7
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| Boehringer Ingelheim Pharmaceuticals Inc.
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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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| Association of Clinical Research Professionals
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| Vol #:
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| 1
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| EC 10
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| MedStar Research Institute
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| Vol #:
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| 1
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| EC 11
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| Federation American Hospitals
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| Vol #:
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| 1
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| EC 12
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| Medtronic, Inc.
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| Vol #:
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| 1
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| EC 13
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| Quintiles Transnational
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| Vol #:
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| 1
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| EC 14
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| Baylor College of Medicine
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| Vol #:
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| 1
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| 2007D-0223
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| Guidance for Industry on Use of the Computer Crossmatch
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| EC 1
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| Danbury Hospital
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| Vol #:
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| 2
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| EC 2
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| Truman Memorial Veteran's Hospital, Columbia, MO
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| Vol #:
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| 2
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| C 6
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| Sanofi Aventis
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| Vol #:
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| 7
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| EC 2
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| Mr. Doug Englebert
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| Vol #:
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| 1
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| EC 3
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| World Privacy Forum
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| Vol #:
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| 1
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| 2007N-0219
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Animal Drug User Fees and Fee Waivers and Reductions
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| EC 1
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| Ms. barb sachau
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| Vol #:
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| 1
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
|
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| LET 4
|
| FDA
|
| Vol #:
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| 1
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