| | | | | | | | | | |
|
|
| Dockets Entered
On May 26, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
| 2004N-0382
|
| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
|
|
|
| 2004N-0456
|
| 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
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| 2004N-0516
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
|
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
| 2005D-0047
|
| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
|
|
|
| 2005D-0056
|
| 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
|
|
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
| 2005D-0133
|
| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
|
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
| 2005N-0120
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
|
|
| EC
11
|
| Sunbury Train
|
| Vol #:
|
| 1
|
|
|
| EC
12
|
| Sunbury Train
|
| Vol #:
|
| 1
|
|
|
| 2004N-0382
|
| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
|
|
|
| EC
1
|
| Gravity Consulting
|
| Vol #:
|
| 1
|
|
|
| 2004N-0456
|
| 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
|
|
|
|
|
|
|
| C 51
|
| Mrs. Jord'an
|
| Vol #:
|
| 5
|
|
|
| EC 11
|
| Honest Tea
|
| Vol #:
|
| 6
|
|
|
| EMC 748
|
| Elaine
|
| Vol #:
|
| 4
|
|
|
| EMC 749
|
| L. Rusen
|
| Vol #:
|
| 4
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| EC 14
|
| Ms. Wanda LaCroix
|
| Vol #:
|
| 1
|
|
|
| EC 15
|
| Ms. Lila Shelton
|
| Vol #:
|
| 1
|
|
|
| 2004N-0516
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
| EC
4
|
| Alegent Health
|
| Vol #:
|
| 1
|
|
|
| EC
5
|
| Respironics, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2005D-0047
|
| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
|
|
|
| C
4
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
| EC
1
|
| PowderMed Ltd.
|
| Vol #:
|
| 1
|
|
|
| EC
2
Attachment
|
| Vical Incorporated
|
| Vol #:
|
| 1
|
|
|
| 2005D-0056
|
| 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
|
|
|
|
|
|
| EC 1
|
| dove's world
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| Ms. Janie Cohen
|
| Vol #:
|
| 1
|
|
|
| 2005D-0062
|
| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
|
|
|
| EC
1
|
| Pharma Marketing News
|
| Vol #:
|
| 1
|
|
|
| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
|
|
|
| EC 2
|
| Ms. Dixie Cook
|
| Vol #:
|
| 1
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
| C
5
|
| AstraZeneca
|
| Vol #:
|
| 1
|
|
|
| 2005D-0133
|
| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
|
|
|
| C
2
|
| University of Iowa Hospitals & Clinics
|
| Vol #:
|
| 1
|
|
|
| C
3
|
| Puget Sound Blood Center
|
| Vol #:
|
| 1
|
|
|
| C
4
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
| EC
1
|
| AABB
|
| Vol #:
|
| 1
|
|
|
| EMC
1
|
| Plasma Protein Therapeutics Association (PPTA)
|
| Vol #:
|
| 1
|
|
|
| 2005D-0169
|
| Guidance on Useful Written Consumer Medication Information (CMI)
|
|
|
| GDL
1
|
| Draft Guidance
|
| Vol #:
|
| 1
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
| EC
3
|
| American Frozen Food Institute
|
| Vol #:
|
| 1
|
|
|
| 2005N-0120
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
| EC
1
|
| National Starch Food Innovation
|
| Vol #:
|
| 1
|
|
|
| 2005N-0137
|
| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
|
|