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| Dockets Entered
On November 24, 2004
Table of Contents
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| Docket #
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| Title
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| 1997N-0484P
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| Current Good Tissue Practice for Mfrs. of Human Cellular
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| 2004D-0481
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
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| 2004N-0461
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| Amendment to 25.34; Categorical Exclusions Environmental Assessment
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| 2004N-0482
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
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| 2004N-0503
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| 1997N-0484P
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| Current Good Tissue Practice for Mfrs. of Human Cellular
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| BKG 2
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| Background Information refs 1 -42
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| Vol #:
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| 7
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| NFR
1
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| FDA
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| Vol #:
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| 7
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14844
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14845
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14846
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14847
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14848
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| Enzymatic Therapy
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| Vol #:
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| 130
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| N
4
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| FDA
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| GDL
1
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| Guideline
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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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| 2004D-0460
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| Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0481
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| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
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|
|
|
|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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| | | | | | | | |
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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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| 2004N-0461
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| Amendment to 25.34; Categorical Exclusions Environmental Assessment
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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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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| RA
1
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| Risk Assessment
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| Vol #:
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| 1
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| 2004N-0482
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| |
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| 2004N-0503
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| Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| ACK
1
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| HFA-305 to GlaxoSmith Kline
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| Vol #:
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| 1
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| CP
1
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| GlaxoSmith Kline
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| Vol #:
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| 1
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