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| Dockets Entered
On June 7, 2004
Table of Contents
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| Docket
#
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| Title
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| 1984N-0102
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| Orphan Product Designations
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| 1993P-0174
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| Amend Regs for Liquid Medicated Animal Feed
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| 2003M-0462
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| Premarket Approval, BP 000023/0, MedMira Reveal Rapid HIV-1 Antibody Test
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2003P-0438
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| change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10
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| 2004D-0251
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| Requests for Inspection by an Accredited Person under the Inspections by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
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| 2004M-0248
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| P030023 - Oculaid Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)
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| 2004M-0249
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| P000054 - INFUSE Bone Graft
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| 2004M-0250
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| P030035 - St. Jude Frontier Biventricular Cardiac Pacing System including the Frontier Model 5508 and 5508L Pulse Generators, the Aescula LV Model 1055K Lead and the Model 3307 v4.4.2m programmer so
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| 2004N-0026
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Form FDA 3356
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004N-0246
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| Agency Emergency Processing Under OMB Review; Experimental Study of Qualified Health Claims for Glucosamine/Chondroitin
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 2004S-0170
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
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| 1984N-0102
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| Orphan Product Designations
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| NAD
18
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| FDA
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| 6
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| 1993P-0174
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| Amend Regs for Liquid Medicated Animal Feed
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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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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 6901
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| B. Lastiri
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| Vol #:
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| 237
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| EMC 6902
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| L. Nelson
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| Vol #:
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| 237
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| EMC 6903
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| S. Rothrock
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| Vol #:
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| 237
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| EMC 6904
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| M. A. O'Neill
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| Vol #:
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| 237
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| EMC 6905
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| K. Kelly
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| Vol #:
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| 237
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| EMC 6906
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| C. Sell
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| Vol #:
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| 237
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| EMC 6907
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| C. Sheck
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| Vol #:
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| 237
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| EMC 6908
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| J. Kloepping
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| Vol #:
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| 237
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| EMC 6909
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| C. Gourley
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| Vol #:
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| 237
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| EMC 6910
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| J. M. Meyers
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| Vol #:
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| 237
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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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| 2004M-0248
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| P030023 - Oculaid Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)
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| AAV
1
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| Ophtec USA, Inc
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| Vol #:
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| 1
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| 2004M-0249
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| P000054 - INFUSE Bone Graft
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| AAV
1
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| Wyeth Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004M-0250
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| P030035 - St. Jude Frontier Biventricular Cardiac Pacing System including the Frontier Model 5508 and 5508L Pulse Generators, the Aescula LV Model 1055K Lead and the Model 3307 v4.4.2m programmer so
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| AAV
1
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| St Jude Medical
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| Vol #:
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| 1
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| 2004N-0026
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Form FDA 3356
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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-0115
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| Prescription Drug Importation Study
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| C
30
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| Cardinal Health
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| Vol #:
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| 19
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| 2004N-0246
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| Agency Emergency Processing Under OMB Review; Experimental Study of Qualified Health Claims for Glucosamine/Chondroitin
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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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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| SUP
2
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| Fleminger, Inc
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| Vol #:
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| 8
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| ANS 1
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| HFS-800 to Wyeth Consumer Healthcare
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| Vol #:
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| 15
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| C
1
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| Wyeth Consumer Healthcare
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| Vol #:
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| 23
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| EXT
1
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| Wyeth Consumer Healthcare
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| Vol #:
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| 15
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| EMC
1
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| Univesity of Texas Southwestern Medical Center at Dallas
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| Vol #:
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| 6
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| 2004S-0170
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
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| EC
35
Attachment 1, 2
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| Last Acts Partnership
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| Vol #:
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| 1
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| EC 36
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| Medtronic MiniMed
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| Vol #:
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| 1
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| EC
37
Attachment
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| National Business Group on Health
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| Vol #:
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| 1
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| EC
38
Attachment
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| Consumer-Purchaser Disclosure Project
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| Vol #:
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| 1
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| EC 39
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| Dr. ANN ROSE
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| Vol #:
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| 1
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| EC 40
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| MTPPI
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| Vol #:
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| 1
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| EC 41
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| American Medical Association
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| Vol #:
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| 1
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