Dockets Entered on September 13, 2007

Dockets Management



Dockets Entered On September 13, 2007



Docket #	Title

1992S-0251	Electronic Submissions; Establishment of Public Docket

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

2000N-1484	Safety Reporting Requirements Human Drug/Biological Products

2004P-0448	DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007M-0151	P05048 - MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit

2007M-0152	P060007 - ARCHITECT HBsAg Reagent Kit, ARCHITECT HBsAg Calibrators, ARCHITECT HBsAg Controls, ARCHITECT HBsAg Confirmatory Reagent Kit,

2007M-0153	P060012 - AxSYM CORE 2.0 and AxSYM CORE 2.0 Controls

2007M-0154	P050046 - Guidant CRM ACUITY Steerable Lead Models 4554, 4555, 4556

2007M-0156	H060003, Onyx Liquid Embolic System (Onyx HD-500, Model 105-8101-500)

2007M-0160	Premarket Approval for AxSYM CORE-M 2.0 and AxSYM CORE-M 2.0 Controls by Abbott Laboratories, P060009.

2007M-0161	Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003

2007M-0174	P050049 - Abbott AxSYM HBsA Assay

2007M-0180	P040024/S006 - Perlane Injectable Gel

2007M-0188	P990037/S024 - Vascular Solutions D-Stat Flowable Hemostat

2007M-0189	P060011 - C-flex Model 570C Intraocular Lens (IOL)

2007M-0190	H060001 - Enterprise Vascular Reconstruction Device and Delivery System

2007M-0253	P050004 - EMS Swiss Dolorclast

2007M-0254	P060034 - Bio-Rad MONOLISA Anti-HBc IgM EIA

2007M-0255	P050012/S001 - STS-7 Continuous Glucose Monitoring System

2007M-0259	P040048 - Trilogy AB Acetabular System

2007N-0330	Presidential Interagency Working Group on Import Safety; Public Meeting

2007P-0341	To permit an ANDA New Drug Application for Formulation of Zometa (Zoledronic acidfor injection) containing Zoledronic acid 4 mg.

2007V-0339	Laser Light Show

2007V-0340	Laser Light Show

1992S-0251	Electronic Submissions; Establishment of Public Docket

M 34	Tim Mahoney	Vol #:	1

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

LET 20662	Jarrow Formulas	Vol #:	180

LET 20663	Agel Enterprises	Vol #:	180

LET 20664	Agel Enterprises	Vol #:	180

LET 20665	Agel Enterprises	Vol #:	180

LET 20666	Agel Enterprises	Vol #:	180

LET 20667	Agel Enterprises	Vol #:	180



LET 20668	Agel Enterprises	Vol #:	180

LET 20669	Agel Enterprises	Vol #:	180

LET 20670	Agel Enterprises	Vol #:	180

LET 20671	Phyto-Technolgies, Inc.	Vol #:	180

LET 20672	Probio-Welness	Vol #:	180

LET 20673	Market America, Inc.	Vol #:	180

LET 20674	Market America, Inc.	Vol #:	180

LET 20675	Sources Naturals	Vol #:	180

LET 20676	Sources Naturals	Vol #:	180

LET 20677	Sources Naturals	Vol #:	180

LET 20678	Cyanotech	Vol #:	180

LET 20679	Chattem, Inc.	Vol #:	180

LET 20680	PuraPharma	Vol #:	180

LET 20681	PuraPharma	Vol #:	180

LET 20682	PuraPharma	Vol #:	180

LET 20683	PuraPharma	Vol #:	180

LET 20684	PuraPharma	Vol #:	180

LET 20685	PuraPharma	Vol #:	180

LET 20686	PuraPharma	Vol #:	180

LET 20687	PuraPharma	Vol #:	180

LET 20688	Natrol	Vol #:	180

LET 20689	DHC Corporation	Vol #:	180

LET 20690	Aboca USA, Inc.	Vol #:	180

LET 20691	Cardiacwellness Supplements	Vol #:	180

LET 20692	Cardiacwellness Supplements	Vol #:	180

LET 20693	Cardiacwellness Supplements	Vol #:	180

LET 20694	Cardiacwellness Supplements	Vol #:	180

LET 20695	Enzmatic	Vol #:	180

LET 20696	Enzmatic	Vol #:	180

LET 20697	Enzmatic	Vol #:	180

LET 20698	Enzmatic	Vol #:	180

LET 20699	Enzmatic	Vol #:	180

LET 20700	Enzmatic	Vol #:	180

LET 20701	Enzmatic	Vol #:	180

LET 20702	Enzmatic	Vol #:	180

LET 20703	Enzmatic	Vol #:	180

LET 20704	Enzmatic	Vol #:	180



LET 20705	Enzmatic	Vol #:	180

LET 20706	Enzmatic	Vol #:	180

LET 20707	Enzmatic	Vol #:	180

LET 20708	Enzmatic	Vol #:	180

LET 20709	Enzmatic	Vol #:	180

LET 20710	Enzmatic	Vol #:	180

LET 20711	Enzmatic	Vol #:	180

LET 20712	Enzmatic	Vol #:	180

LET 20713	Enzmatic	Vol #:	180

LET 20714	Enzmatic	Vol #:	180

LET 20715	Enzmatic	Vol #:	180

LET 20716	Enzmatic	Vol #:	180

LET 20717	Enzmatic	Vol #:	180

LET 20718	Enzmatic	Vol #:	180

LET 20719	Enzmatic	Vol #:	180

LET 20720	Enzmatic	Vol #:	180

LET 20721	Enzmatic	Vol #:	180

LET 20722	Enzmatic	Vol #:	180

LET 20723	Enzmatic	Vol #:	180

LET 20724	Enzmatic	Vol #:	180

LET 20725	Enzmatic	Vol #:	180

LET 20726	Enzmatic	Vol #:	180

LET 20727	Nature's Way Products, Inc.	Vol #:	180

LET 20728	Market Americca, Inc.	Vol #:	180

LET 20729	Vita-Herbs, Inc.	Vol #:	180

LET 20730	Pharmavite	Vol #:	180

LET 20731	Meditrend, Inc.	Vol #:	180

LET 20732	Babener & Associates	Vol #:	180

LET 20733	Healthcare Brand International	Vol #:	180

LET 20734	Iovate	Vol #:	180

LET 20735	Iovate	Vol #:	180

LET 20736	Zycal Bioceutical, Inc.	Vol #:	180

LET 20737	Babener & Associates	Vol #:	180

LET 20738	Bayer Healthcare	Vol #:	180

LET 20739	Bayer Healthcare	Vol #:	180

2000N-1484	Safety Reporting Requirements Human Drug/Biological Products



C 52	Unknown	Vol #:	6

2004P-0448	DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)

LET 7	Hill Dermaceuticals, Inc.	Vol #:	1

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

C 18	BD Diagnostics	Vol #:	9

C 19	Pharmaceutical quality and Compliance Services	Vol #:	9

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

C 18	Center for Science in the Public Interest	Vol #:	18

2007M-0151	P05048 - MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit

NAL 1	FDA	Vol #:	1

2007M-0152	P060007 - ARCHITECT HBsAg Reagent Kit, ARCHITECT HBsAg Calibrators, ARCHITECT HBsAg Controls, ARCHITECT HBsAg Confirmatory Reagent Kit,

NAL 1	FDA	Vol #:	1

2007M-0153	P060012 - AxSYM CORE 2.0 and AxSYM CORE 2.0 Controls

NAL 1	FDA	Vol #:	1

2007M-0154	P050046 - Guidant CRM ACUITY Steerable Lead Models 4554, 4555, 4556

NAL 1	FDA	Vol #:	1

2007M-0156	H060003, Onyx Liquid Embolic System (Onyx HD-500, Model 105-8101-500)

NAL 1	FDA	Vol #:	1

2007M-0160	Premarket Approval for AxSYM CORE-M 2.0 and AxSYM CORE-M 2.0 Controls by Abbott Laboratories, P060009.

NAL 1	FDA	Vol #:	1

2007M-0161	Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003

NAL 1	FDA	Vol #:	1

2007M-0174	P050049 - Abbott AxSYM HBsA Assay

NAL 1	FDA	Vol #:	1

2007M-0180	P040024/S006 - Perlane Injectable Gel

NAL 1	FDA	Vol #:	1

2007M-0188	P990037/S024 - Vascular Solutions D-Stat Flowable Hemostat

NAL 1	FDA	Vol #:	1

2007M-0189	P060011 - C-flex Model 570C Intraocular Lens (IOL)



NAL 1	FDA	Vol #:	1

2007M-0190	H060001 - Enterprise Vascular Reconstruction Device and Delivery System

NAL 1	FDA	Vol #:	1

2007M-0253	P050004 - EMS Swiss Dolorclast

NAL 1	FDA	Vol #:	1

2007M-0254	P060034 - Bio-Rad MONOLISA Anti-HBc IgM EIA

NAL 1	FDA	Vol #:	1

2007M-0255	P050012/S001 - STS-7 Continuous Glucose Monitoring System

NAL 1	FDA	Vol #:	1

2007M-0259	P040048 - Trilogy AB Acetabular System

NAL 1	FDA	Vol #:	1

2007N-0330	Presidential Interagency Working Group on Import Safety; Public Meeting

EC 1	Mr. Thomas Foster	Vol #:	1

EC 2	Cookware Manufacturers Association	Vol #:	1

EC 3	www.MadeDeadlyInChina.com	Vol #:	1

EC 4	Mr. D Seaton	Vol #:	1

EC 5	Ms. A Gifford	Vol #:	1

EC 6	aarp	Vol #:	1

EC 7	Ms. Marie Frank	Vol #:	1

EC 8	Mr. guy mallarino	Vol #:	1

EC 9	Ms. Cheryl Collins	Vol #:	1

EC 10	Ms. Linda Robinson	Vol #:	1

EC 11	Mr. Herman Eaton	Vol #:	1

EC 12	Mrs. angelia fletcher	Vol #:	1

EC 13	Mr. wm finley	Vol #:	1

EC 14	Mrs. Jerilyn Palmer	Vol #:	1

EC 15	grandmother	Vol #:	1

EC 16	Private citizen	Vol #:	1

EC 17	Mrs. Shirley Hurley	Vol #:	1

EC 18	Ms. Ruth Taylor	Vol #:	1

EC 19	Mr. George Caruso	Vol #:	1

EC 20	was citizen of U.S.A.?	Vol #:	1

EC 21	Mr. R Dean	Vol #:	1



EC 22	Mr. Larry Heines	Vol #:	1

EC 23	Ms. Lynda Stewart	Vol #:	1

EC 24	Mr. Stanley McNeil	Vol #:	1

EC 25	Ms. M. Hearn	Vol #:	1

EC 26	Ms. Marie Welbourne	Vol #:	1

EC 27	Mrs. Barbara Weigle	Vol #:	1

EC 28	Mr. Douglas Raymond	Vol #:	1

EC 29	Mr. Roland Madore	Vol #:	1

EC 30	Mr. Raymond Foret	Vol #:	1

EC 31	Mrs. Michaelyn Mohr	Vol #:	1

EC 32	Mr. john bodiford	Vol #:	1

EC 33	Ms. Trez Hokstat	Vol #:	1

EC 34	Mrs. Loanne Rebuck	Vol #:	1

EC 35	Mrs. lyn weinrich	Vol #:	1

EC 36	Mrs. Roseann Stefanopoulos	Vol #:	1

EC 37	Ms. dianne Britt	Vol #:	1

EC 38	Mr. paul dennehy jr	Vol #:	1

EC 39	Mrs. Julie Sonstegard	Vol #:	1

EC 40	Mrs. Beverly Reynolds	Vol #:	1

EC 41	Mrs. Renee Rhodes	Vol #:	1

EC 42	Ms. Lisa Eberhard	Vol #:	1

EC 43	Mr. Ken Sparrow	Vol #:	1

EC 44	private citizen	Vol #:	1

EC 45	Retired	Vol #:	1

EC 46	Mr. Arthur Robinson	Vol #:	1

EC 47	Ms. Lorena Yeates	Vol #:	1

EC 48	Ms. Karen sMITH	Vol #:	1

EC 49	Ms. katherine loy	Vol #:	1

EC 50	Mr. Jeremy La Belle	Vol #:	1

EC 51	Mr. Demar Boren	Vol #:	1

EC 52	Mr. Don Bell	Vol #:	1

EC 53	Ms. Barbara Sinclair	Vol #:	1

EC 54	Ms. Jean Parkhurst	Vol #:	1

EC 55	Mr. Al Lovasz	Vol #:	1

EC 56	Mr. Robert Shorter	Vol #:	1

EC 57	Ms. Dhristine Statler	Vol #:	1

EC 58	Mr. dan doshan	Vol #:	1



EC 59	Mr. Chris Merkel	Vol #:	1

EC 60	Mr. Fred Tholen	Vol #:	1

EC 61	Mrs. Virginia Everman	Vol #:	1

EC 62	Ms. Linda Bradley	Vol #:	1

EC 63	Mrs. Margaret VanDyk	Vol #:	1

EC 64	Mrs. Joan Ropiza	Vol #:	1

EC 65	Ms. j herder	Vol #:	1

EC 66	Mr. HAROLD STARR	Vol #:	1

EC 67	Mrs. Pamela Stevens	Vol #:	1

EC 68	Mr. carl winters	Vol #:	1

EC 69	Mrs. Judy Sulser	Vol #:	1

EC 70	Mrs. Patricia Henry	Vol #:	1

EC 71	Mrs. Sue Diamond	Vol #:	1

EC 72	Mr. George Butterworth	Vol #:	1

EC 73	Ms. Lora Mac Alistaire	Vol #:	1

EC 74	Ms. Carolyn Maulding	Vol #:	1

EC 75	Mr. Ranel Cox	Vol #:	1

EC 76	Ms. Carmen Reynolds	Vol #:	1

EC 77	Mr. Michael McBride	Vol #:	1

EC 78	none	Vol #:	1

EC 79	Mrs. Barbara Worley	Vol #:	1

EC 80	Inspectorate America Corp.	Vol #:	1

EC 81	Mr. James Veerkamp	Vol #:	1

EC 82	Ms. Cathryn Kulat	Vol #:	1

EC 83	Ms. Joe Frangiosa	Vol #:	1

EC 84	Ms. donella scott	Vol #:	1

EC 85	Ms. joe frangiosa	Vol #:	1

EC 86	private citizen	Vol #:	1

EC 87	Mr. ken hall	Vol #:	1

EC 88	Mr. Richard Thomason	Vol #:	1

EC 89	Ms. Millicent J. Aynes	Vol #:	1

EC 90	Mr. Si Contino	Vol #:	1

EC 91	National Association of Dental Laboratories	Vol #:	1

EC 92	Mr. craig williams	Vol #:	1

EC 93	Mr. Brad Lirot	Vol #:	1

EC 94	Mrs. Jacquelyn Burns	Vol #:	1

EC 95	Ms. Janice Chandler	Vol #:	1



EC 96	Mrs. Dorothy Berzins	Vol #:	1

EC 97	Miss. Kellyn Maillard	Vol #:	1

EC 98	Mrs. Marilyn Gover	Vol #:	1

EC 99	Mr. Kenneth Golaszewski	Vol #:	1

EC 100	Banana Pack	Vol #:	1

EC 101	Creative Concepts Link	Vol #:	1

EC 102	Citizen of the United States	Vol #:	1

EC 103	Mrs. Caroline Getz	Vol #:	1

EC 104	Mrs. Suzanne Johnson	Vol #:	1

2007P-0341	To permit an ANDA New Drug Application for Formulation of Zometa (Zoledronic acidfor injection) containing Zoledronic acid 4 mg.

ACK 1	FDA/ DDM/ to Kendle Regulatory Affairs	Vol #:	1

CP 1	Kendle Regulatory Affairs	Vol #:	1

2007V-0339	Laser Light Show

ACK 1	FDA/ DDM/ to Top Shelf Club	Vol #:	1

VAR 1	Top Shelf Club	Vol #:	1

2007V-0340	Laser Light Show

ACK 1	FDA/ DDM/ to Eastside Entertainment LLC	Vol #:	1

VAR 1	Eastside Entertainment LLC	Vol #:	1

Page created on September 14, 2007 ue

FDA/Dockets Management