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