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| Dockets Entered
On May 26, 2005
Table of Contents
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| Docket #
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| Title
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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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-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005D-0056
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| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0068
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
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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-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| EC
11
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| Sunbury Train
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| Vol #:
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| 1
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| EC
12
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| Sunbury Train
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| Vol #:
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| 1
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| EC
1
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| Gravity Consulting
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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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| C 51
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| Mrs. Jord'an
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| Vol #:
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| 5
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| EC 11
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| Honest Tea
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| Vol #:
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| 6
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| EMC 748
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| Elaine
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| Vol #:
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| 4
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| EMC 749
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| L. Rusen
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| Vol #:
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| 4
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| EC 14
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| Ms. Wanda LaCroix
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| Vol #:
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| 1
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| EC 15
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| Ms. Lila Shelton
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| Vol #:
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| 1
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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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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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| EC
4
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| Alegent Health
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| Vol #:
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| 1
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| EC
5
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| Respironics, Inc.
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| Vol #:
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| 1
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C
4
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
1
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| PowderMed Ltd.
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| Vol #:
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| 1
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| EC
2
Attachment
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| Vical Incorporated
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| Vol #:
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| 1
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| 2005D-0056
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| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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| EC 1
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| dove's world
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| Vol #:
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| 1
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| EC 2
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| Ms. Janie Cohen
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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
1
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| Pharma Marketing News
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| Vol #:
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| 1
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| 2005D-0068
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
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| EC 2
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| Ms. Dixie Cook
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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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| C
5
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| AstraZeneca
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| Vol #:
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| 1
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| C
2
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| University of Iowa Hospitals & Clinics
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| Vol #:
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| 1
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| C
3
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| Puget Sound Blood Center
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| Vol #:
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| 1
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| C
4
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| EC
1
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| AABB
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| Vol #:
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| 1
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| EMC
1
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| Plasma Protein Therapeutics Association (PPTA)
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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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| GDL
1
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| Draft Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| EC
3
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| American Frozen Food Institute
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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
1
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| National Starch Food Innovation
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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