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| Dockets Entered On
December 15, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 2004N-0442
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| 2005N-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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| 2005N-0389
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling
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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| 2005N-0491
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| Peer Review Agenda: December 2005
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| 2005P-0493
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| Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| BKG
6
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| Background Information
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| Vol #:
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| 225
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| BKG
7
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| Background Information
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| Vol #:
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| 226
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| 2004N-0442
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Recall Regulations
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| GDL
1
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| Guideline
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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-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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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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| 2005N-0389
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling
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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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| 2005N-0410
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| Prescription Drug User Fee Act (PDUFA): Public Meeting
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| TR
1
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| Transcript of the November 14, 2005 meeting
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| 2
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| 2005N-0491
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| Peer Review Agenda: December 2005
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| REF
1
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| Peer Review Plan: Cloning Risk Assessment Peer Review
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| Vol #:
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| 1
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| REF
2
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| Peer Review Plan: Prelim Estimation of Perchlorate Dietary Exposure
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| Vol #:
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| 1
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| 2005P-0493
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| Establish criteria, analogous to the criteria for marketing Category I drug products under OTC Drug Review regarding the substitutability of prescription hyoscyamine drug products
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| ACK
1
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| HFA-305 to Buchanan Ingersol PC
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| Vol #:
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| 1
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| CP
1
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| Breckenridge Pharmaceutical, Inc.
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| Vol #:
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| 1
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