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| Dockets Entered
On October 13, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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| 2005P-0221
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| amend the regulations governing the labeling of milk products in Part 131 of the Title 21 of the Code of Federal Regulations
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0273
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| Add Calcium to the Mandatory List
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| 2005P-0376
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| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
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| 2005V-0266
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| Laser Light Show
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| 2005V-0415
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| performance standard for fluoroscopic equipment mfged by OrthoScan
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| 1976N-0052G
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| OTC general comments & combinations
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| EC
2
Attachment
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| American Council on Regulatory Compliance
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| Vol #:
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| 35
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| 1995N-0205
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| OTC Bronchodilator Drug Products
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| EC
2
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| Mr. Eric Harrington
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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
16632
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| Jarrow Formulas
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| Vol #:
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| 149
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| LET
16633
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| Jarrow Formulas
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| Vol #:
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| 149
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| 2001D-0044
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| Clinical Laboratory Improvement Amendments of 1988
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| C
38
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| State of Utah
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| Vol #:
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| 3
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| EC
5
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| GE Healthcare
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| Vol #:
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| 1
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| EC
6
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| NEMA
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| Vol #:
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| 1
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| 2005D-0310
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| Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
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| EC
856
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| Dr. Emily Godfrey
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| Vol #:
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| 6
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EC
2
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| Electronic Privacy Information Center (EPIC)
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| Vol #:
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| 2
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| 2005N-0364
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| Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting
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| APE
1
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| Association of Medical Device Reprocessors (AMDR)
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| Vol #:
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| 1
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| C
8
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| Foundren Orthopedic Group, LLC
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| Vol #:
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| 3
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| SUP
1
Attached CVs
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| DJ Ortho
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| Vol #:
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| 3
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| LET
1
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| HFD-005 to Salix Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005P-0204
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| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
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| C
1
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| Washington Legal Foundation
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| Vol #:
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| 1
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| 2005P-0221
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| amend the regulations governing the labeling of milk products in Part 131 of the Title 21 of the Code of Federal Regulations
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| C 1
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| K. Zapotoczny
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| Vol #:
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| 1
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| EC
100
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| Mr. Anthony Guglielmi
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| Vol #:
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| 2
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| EC
101
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| Mr. Peter Binder
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| Vol #:
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| 2
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| EC
102
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| None
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| Vol #:
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| 2
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| EC
103
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| Ms. Kristan Marter
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| Vol #:
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| 2
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| EC
104
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| Dr. R Sharma
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| Vol #:
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| 2
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| EC
105
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| Dr. PRADEEP KUMAR
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| Vol #:
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| 2
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| 2005P-0273
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| Add Calcium to the Mandatory List
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| C
1
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| University of Minnesota
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| Vol #:
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| 2
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| 2005P-0376
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| Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing
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| APP
1
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| ICEBERG Water Corporation
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| Vol #:
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| 1
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| LET
1
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| ICEBERG Water Corporation
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| Vol #:
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| 1
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| LET
2
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| HFS-800 to ICEBERG Water Corporation
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| Vol #:
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| 1
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| SUP
1
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| ICEBERG Water Corporation
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| Vol #:
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| 1
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| SUP
2
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| ICEBERG Water Corporation
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| Vol #:
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| 1
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| 2005V-0266
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| Laser Light Show
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