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| Dockets Entered On September
16, 2004
Table of Contents
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| Docket #
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| Title
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| 2003D-0476
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| Guidance for Industry on Product Recalls, Including Removals
and Corrections; Availability
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications;
Notice of Pilot Project
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer
Advertising for Medical Products
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| 2004D-0420
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| TDM Roundtable Recommendations: (Generic) Assay Validation
Guidance
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| 2004D-0421
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| TDM Roundtable Recommendations: Lamotrigine Assay Validation
Guidance
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| 2004F-0374
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| Amend food additive regulations in 172.380 Vitamin D3
to permit the use of vitamin D3 in cheese and cheese products at a
level above that permitted under 184.1950 Vitamin D
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not
Conducted Under an Investigational New Drug Application
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION
PRODUCT
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations;
Public Meetings
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| 2004N-0296
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| Agency Information Collection Activities: Proposed Collection;
Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical
Studies (21 CFR Part 58)
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| 2004N-0330
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| Suicidality in Clinical Trials for Antidepressant Drugs
in Pediatric Patients
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| 2004N-0401
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| Agency Information Collection Activities; Proposed Collection;
Comment Request; Customer/Partner Service Surveys
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| 2004N-0404
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| Novel Formulations of Dialysis Solutions; Public Meeting
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| 2004P-0351
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| Change the labeling and take further action to address
the association of Viagra (Sildenafil) use and increased STD transmission,
including HIV infection
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| 2003D-0476
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| Guidance for Industry on Product Recalls, Including
Removals and Corrections; Availability
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| EC 5
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| Cryonic Life Insurance Company
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| Vol #:
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| 1
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications;
Notice of Pilot Project
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| EC 3
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| Mrs. Janet Laury
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| Vol #:
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| 1
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer
Advertising for Medical Products
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| EC 11
Attachment 1, 2
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| Cryonic Life Insurance Company
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| Vol #:
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| 3
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| EC 12
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| National Association of Chain Drug Stores
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| Vol #:
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| 3
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| EC 13
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| Medtronic, Inc.
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| Vol #:
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| 3
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| EC 14
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| Eli Lilly and Company
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| Vol #:
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| 3
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| 2004D-0420
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| TDM Roundtable Recommendations: (Generic) Assay Validation
Guidance
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| GDL 1
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| GUIDANCE
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| Vol #:
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| 1
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| 2004D-0421
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| TDM Roundtable Recommendations: Lamotrigine Assay Validation
Guidance
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| GDL 1
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| GUIDANCE
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| Vol #:
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| 1
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| 2004F-0374
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| Amend food additive regulations in 172.380 Vitamin
D3 to permit the use of vitamin D3 in cheese and cheese products at
a level above that permitted under 184.1950 Vitamin D
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| NFL
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies
Not Conducted Under an Investigational New Drug Application
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| EC 1
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| Dr. Cynthia Kornegay
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| Vol #:
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| 1
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| EC 2
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| FLACEIS
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| Vol #:
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| 1
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION
PRODUCT
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| EC 1
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| Mr. Leighton Hansel
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| Vol #:
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| 1
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| EC 2
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| Cambrex Bio Science Walkersville
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| Vol #:
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| 1
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations;
Public Meetings
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| EC 4
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| American Frozen Food Institute
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| Vol #:
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| 1
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| EC 5
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| North American Millers' Association
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| Vol #:
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| 1
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| 2004N-0296
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| Agency Information Collection Activities: Proposed
Collection; Comment Request; Good Laboratory Practice (GLP) Regulations
for Nonclinical Studies (21 CFR Part 58)
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