Dockets Entered on January 6, 2005

Dockets Management



Dockets Entered On January 6, 2005 Table of Contents



Docket #	Title

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

1982N-0166	OTC Drug Products for Overindulgence of Alcohol

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

1998N-0046	Comprehensive List of Current Guidance Documents at FDA

2003D-0568	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices

2003F-0128	Permitted Use Concentration and to Expand pH Range for acidi

2003N-0232	Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

2003N-0567	Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices

2004D-0377	International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

2004D-0378	International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

2004D-0509	Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association

2004N-0437	Agency Information Collection Activities: Proposed Collection; Medical Devices; Third Party Review under FDAMA Third-Party Premarket Submission Review, and Quality System Inspections Under U.S./E.U. M


2004N-0479	Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability

2004N-0545	Nonclinical and Clinical Datasets; Notice of Pilot Project

2004P-0059	Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis

2004P-0060	Health Claim Petition: Glucosamine Sulfate and Osteoarthritis

2004P-0223	Whole Grain Descriptive Claims

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

NPR 2	FDA	Vol #:	3

NWL 1	FDA	Vol #:	3

1982N-0166	OTC Drug Products for Overindulgence of Alcohol

NPR 3	FDA	Vol #:	26

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 15204	NBTY Inc.	Vol #:	134

LET 15205	NBTY Inc.	Vol #:	134

LET 15206	NBTY Inc.	Vol #:	134

LET 15207	NBTY Inc.	Vol #:	134

LET 15208	NBTY Inc.	Vol #:	134

LET 15209	NBTY Inc.	Vol #:	134

LET 15210	NBTY Inc.	Vol #:	134

LET 15211	NBTY Inc.	Vol #:	134

LET 15212	NBTY Inc.	Vol #:	134

LET 15213	NBTY Inc.	Vol #:	134



LET 15214	NBTY Inc.	Vol #:	134

LET 15215	NBTY Inc.	Vol #:	134

LET 15216	NBTY Inc.	Vol #:	134

LET 15217	NBTY Inc.	Vol #:	134

LET 15218	NBTY Inc.	Vol #:	134

LET 15219	NBTY Inc.	Vol #:	134

LET 15220	NBTY Inc.	Vol #:	134

LET 15221	Traditional Medicinals, Inc.	Vol #:	134

LET 15222	Lifexpand, Inc.	Vol #:	134

LET 15223	International Nature Nutraceuticals, Inc.	Vol #:	134

LET 15224	Interceuticals, Inc.	Vol #:	134

LET 15225	Interceuticals, Inc.	Vol #:	134

LET 15226	Interceuticals, Inc.	Vol #:	134

LET 15227	Bluebonnet Nutrition Corporation	Vol #:	134

LET 15228	Bluebonnet Nutrition Corporation	Vol #:	134

LET 15229	Nature's Way Products, Inc.	Vol #:	134

LET 15230	Nature's Way Products, Inc.	Vol #:	134

LET 15231	Nature's Way Products, Inc.	Vol #:	134

LET 15232	Source Naturals	Vol #:	134

LET 15233	Source Naturals	Vol #:	134

LET 15234	Sedona Labs	Vol #:	134

LET 15235	Sedona labs	Vol #:	134

LET 15236	Perrigo Company of South Carolina	Vol #:	134

LET 15237	Perrigo Company of South Carolina	Vol #:	134

LET 15238	Perrigo Company of South Carolina	Vol #:	134

LET 15239	Perrigo Company of South Carolina	Vol #:	134

LET 15240	Perrigo Company of South Carolina	Vol #:	134

LET 15241	Perrigo Company of South Carolina	Vol #:	134

LET 15242	Perrigo Company of South Carolina	Vol #:	134

LET 15243	Perrigo Company of South Carolina	Vol #:	134

LET 15244	Perrigo Company of South Carolna	Vol #:	134

LET 15245	Natural Source International, Ltd.	Vol #:	134

LET 15246	Enzymatic Therapy	Vol #:	134

LET 15247	Enzymatic Therapy	Vol #:	134

LET 15248	Enzymatic Therapy	Vol #:	134

LET 15249	NOW Foods	Vol #:	134

LET 15250	NOW Foods	Vol #:	134



LET 15251	Perrigo Company of South Carolina	Vol #:	134

LET 15252	Arbonne International	Vol #:	134

LET 15253	Arise and Shine Herbal Products, Inc.	Vol #:	134

LET 15254	NBTY Inc.	Vol #:	134

LET 15255	Logan Pharmaceuticals	Vol #:	134

LET 15256	NBTY Inc.	Vol #:	134

LET 15257	NBTY Inc.	Vol #:	134

LET 15258	NBTY Inc.	Vol #:	134

LET 15259	NBTY Inc.	Vol #:	134

LET 15260	NBTY Inc.	Vol #:	134

1998N-0046	Comprehensive List of Current Guidance Documents at FDA

N 10	FDA	Vol #:	2

2003D-0568	Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2003F-0128	Permitted Use Concentration and to Expand pH Range for acidi

NFR 1	FDA	Vol #:	2

2003N-0232	Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

N 2	FDA	Vol #:	1

2003N-0567	Cardiovascular and Neurological Devices; Reclassification of Two Embolization Devices

NFR 1	FDA	Vol #:	1

2004D-0377	International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs


NEC 1	FDA	Vol #:	1

2004D-0378	International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals


NEC 1	FDA	Vol #:	1

2004D-0509	Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association

NEC 1	FDA	Vol #:	1

2004N-0437	Agency Information Collection Activities: Proposed Collection; Medical Devices; Third Party Review under FDAMA Third-Party Premarket Submission Review, and Quality System Inspections Under U.S./E.U. M


N 2	FDA	Vol #:	2



2004N-0479	Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability

NEC 1	FDA	Vol #:	1

2004N-0545	Nonclinical and Clinical Datasets; Notice of Pilot Project

N 1	FDA	Vol #:	1

2004P-0059	Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis

REF 1	References to LET11	Vol #:	20

2004P-0060	Health Claim Petition: Glucosamine Sulfate and Osteoarthritis

LET 11	Rotta Pharmaceuticals Inc	Vol #:	3

2004P-0223	Whole Grain Descriptive Claims

ANS 1	DHHS Secretary to Hon. Henry Bonilla	Vol #:	5

ANS 2	HHS Secretary to Hon. Je Bradley (CI)	Vol #:	5

ANS 3	DHHS Secretary to Hon. Tom Latham	Vol #:	5

ANS 4	DHHS Secretary to Hon. Judd Gregg	Vol #:	5

C 1	Whole Grain Council	Vol #:	5

C 2	University of Minnesota	Vol #:	6

C 3	University of Kentucky	Vol #:	5

C 4	University of Massachusetts-Amherst	Vol #:	5

C 5	The Wistar Institute	Vol #:	5

C 6	American Soceity for Clinical Nutrtion, Inc	Vol #:	5

C 7	The Cooper Institute	Vol #:	5

C 8	Congress of the United States (CI)	Vol #:	5

C 9	United States House of Representatives (CI)	Vol #:	5

C 10	Congress of the United States (CI)	Vol #:	5

C 11	United States Senate (CI)	Vol #:	5

C 12	Cooper Clinic	Vol #:	5

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FDA/Dockets Management