Dockets Entered on February 7, 2005

Dockets Management



Dockets Entered On February 7, 2005 Table of Contents



Docket #	Title

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

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

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

2003H-0432	Civil Money Penalty, Korangy Radiology Associates, PA

2004D-0465	Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)


2004D-0468	Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals

2004N-0559	Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents

2004P-0003	Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint

2004P-0334	Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories

2005P-0046	removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed

1980N-0208	Biological Products; Bacterial Vaccines and Toxiods

EC 21	Dr. Mary Cummings	Vol #:	140

EC 22	Ms. Sarah Berdugo	Vol #:	140

EC 23	U.S. Air Force	Vol #:	140

EREG 4	Grijalva, Galo	Vol #:	140

EREG 5	Jones, Teresa	Vol #:	140

EREG 6	Meyer, Roger	Vol #:	140

EREG 7	Glenn, John	Vol #:	140

EREG 8	Potts, Gregory	Vol #:	140

EREG 9	Rogers, Linda	Vol #:	140

EREG 10	Pastora, Reinaldo	Vol #:	140

EREG 11	Austin, Deanna	Vol #:	140

EREG 12	Coryat, Kimberly	Vol #:	140

EREG 13	Vick, Debbie	Vol #:	140

EREG 14	Shaffer, Donald	Vol #:	140

EREG 15	Krueger, Robert	Vol #:	140

EREG 16	Krafft, Edward	Vol #:	140

EREG 17	Blanco, Amanda	Vol #:	140

EREG 18	Boylan, Mary	Vol #:	140

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

LET 15403	Amerifit Nutrition	Vol #:	136

LET 15404	Amerifit Nutrition	Vol #:	136

LET 15405	Amerifit Nutrition	Vol #:	136

LET 15406	Amerifit Nutrition	Vol #:	136



LET 15407	Amerifit Nutrition	Vol #:	136

LET 15408	Amerifit Nutrition	Vol #:	136

LET 15409	Amerifit Nutrition	Vol #:	136

LET 15410	Amerifit Nutrition	Vol #:	136

LET 15411	Amerifit Nutrition	Vol #:	136

LET 15412	Amerifit Nutriltion	Vol #:	136

LET 15413	Amerifit Nutrition	Vol #:	136

LET 15414	Amerifit Nutrition	Vol #:	136

LET 15415	Amerifit Nutrition	Vol #:	136

LET 15416	Amerifit Nutrition	Vol #:	136

LET 15417	McLind Corporation	Vol #:	136

LET 15418	McLind Corporation	Vol #:	136

LET 15419	McLind Corporation	Vol #:	136

LET 15420	McLind Corporation	Vol #:	136

LET 15421	McLind Corporation	Vol #:	136

LET 15422	McLind Corporation	Vol #:	136

LET 15423	McLind Corporation	Vol #:	136

LET 15424	McLind Corporation	Vol #:	136

LET 15425	McLind Corporation	Vol #:	136

LET 15426	McLind Corporation	Vol #:	136

LET 15427	McLind Corporation	Vol #:	136

LET 15428	McLind Corporation	Vol #:	136

LET 15429	McLind Corporation	Vol #:	136

LET 15430	McLind Corporation	Vol #:	136

LET 15431	McLind Corporation	Vol #:	136

LET 15432	McLind Corporation	Vol #:	136

LET 15433	McLind Corporation	Vol #:	136

LET 15434	McLind Corporation	Vol #:	136

LET 15435	McLind Corporation	Vol #:	136

LET 15436	McLind Corporation	Vol #:	136

LET 15437	McLind Corporation	Vol #:	136

LET 15438	McLind Corporation	Vol #:	136

LET 15439	Ideasphere TM Inc.	Vol #:	136

LET 15440	Ideasphere TM Inc.	Vol #:	136

LET 15441	Ideasphere TM Inc.	Vol #:	136

LET 15442	Ideasphere TM Inc.	Vol #:	136

LET 15443	Ideasphere TM Inc.	Vol #:	136



LET 15444	Ideasphere TM Inc.	Vol #:	136

LET 15445	Ideasphere TM Inc.	Vol #:	136

LET 15446	Ideasphere TM Inc.	Vol #:	136

LET 15447	Ideasphere TM Inc.	Vol #:	136

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

EXB 1081	Bayer Corporation	Vol #:	480

EXB 1082	Bayer Corporation	Vol #:	480

EXB 1083	Bayer Corporation	Vol #:	480

EXB 1084	Bayer Corporation	Vol #:	480

EXB 1085	Bayer Corporation	Vol #:	480

EXB 1086	Bayer Corporation	Vol #:	480

EXB 1087	Bayer Corporation	Vol #:	480

2003H-0432	Civil Money Penalty, Korangy Radiology Associates, PA

RMO 4	GCF 1 to Departmental Appeals Board	Vol #:	8

SUP 2	number not used	Vol #:	2

2004D-0465	Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)


EXT 1	Merck Research Laboratories	Vol #:	1

2004D-0468	Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals



EC 1	Mr. John Green	Vol #:	1

2004N-0559	Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents

EC 24	Mr. Richard Eggleston	Vol #:	1

EC 25	Ms. gloria martinez	Vol #:	1

EC 26	Ms. Laura Giorgi	Vol #:	1

EC 27	Mr. JIM FREY	Vol #:	1

EC 28	Mr. Wayne Wickstrum	Vol #:	1

EC 29	Musella Foundation For Brain Tumor Research	Vol #:	1

EC 30	None	Vol #:	1

EC 31	Dr. Linda Silversmith	Vol #:	1

EC 32	Ms. Martha Toth	Vol #:	1

EC 33	Mr. Scott Cameron	Vol #:	1

EC 34	Albert Einstein College of Medicine/Montefiore Med	Vol #:	1

EC 35	Ms. Lydia Romer	Vol #:	1



EC 36	none	Vol #:	1

EC 37	Ms. Margaret Berliner	Vol #:	1

EC 38	(private individual)	Vol #:	1

EC 39	Ms. Martha Moore	Vol #:	1

EC 40	Mr. Franklin Gingrich	Vol #:	1

EC 41	Mr. Robert Reeves	Vol #:	1

EC 42	Northwestern University Medical Center	Vol #:	1

EC 43	Ms. Marsha Painter	Vol #:	1

EC 44	Mr. Eric Lee	Vol #:	1

EC 45	Miss. Margaret Hanson	Vol #:	1

EC 46	Mrs. DAWN SULLIVAN	Vol #:	1

EC 47 Attachments	Tufts University School of Medicine	Vol #:	1

EC 48	Piedmont Rheumatology	Vol #:	1

EC 49	Dr. Glenn Eisen	Vol #:	1

EC 50	Mrs. Joyce McMahon	Vol #:	1

EC 51	Mr. Erik Engberg	Vol #:	1

EC 52	Ms. Marsha Tiffany	Vol #:	1

EC 53	BTAN (http://www.btan.org/)	Vol #:	1

EC 54	FDA	Vol #:	1

EC 55	None	Vol #:	1

EC 56	Ms. Jenny Smith	Vol #:	1

EC 57	Lupus Foundation of America, Inc. , GA Chapter	Vol #:	1

EC 58	American Pain Foundation	Vol #:	1

EC 59	Ms. Jeanne Nehez	Vol #:	1

EC 60	Mrs. Nalini Pai	Vol #:	1

EC 61	American Society for Pain Management Nursing	Vol #:	1

EC 62	Psoriasis Cure Now!	Vol #:	1

EC 63	Dr. ROY ALTMAN	Vol #:	1

EC 65	Cure Arthritis Now	Vol #:	1

EC 66	Monte Vista Family Practice, PC	Vol #:	1

EC 67	American Chronic Pain Assocation	Vol #:	1

EC 68	National Organization for Rare Disorders (NORD)	Vol #:	1

EC 69	National Organization for Rare Disorders (NORD)	Vol #:	1

EC 70	None	Vol #:	1

EC 72	Mr. John Green	Vol #:	1

EC 73	Womack Army Medical Center	Vol #:	1

EC 74	Memorial Sloan-Kettering Cancer Center	Vol #:	1



EC 75	Johns Hopkins	Vol #:	1

EC 76	Mrs. Sandra Falkenhagen	Vol #:	1

EC 77	OSMC	Vol #:	1

EC 78	Harbor Hospital of Baltimore	Vol #:	1

EC 79	IBC Research Foundation	Vol #:	1

EC 80	Ms. Nancy McDuffee	Vol #:	1

EC 81	Mrs. Connie Muir	Vol #:	1

EC 82	Maryland Pain Initiative	Vol #:	1

EC 83	Mrs. Eileen Curran	Vol #:	1

EC 84	Ms. Ginger Sanchez	Vol #:	1

EC 85	Ms. Sue Rennie	Vol #:	1

EC 86	Mrs. Betsy Chaney	Vol #:	1

EC 87	Ms. Ginger Sanchez	Vol #:	1

EMC 2 Attachment	TMT Inc	Vol #:	1

2004P-0003	Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint

ACK 5	HFA-305 to Billy G. Pierson	Vol #:	1

PRC 2	Billy G. Pierson	Vol #:	1

2004P-0334	Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories

SUP 1	Hyman, Phelps & McNamara, P.C.	Vol #:	2

2005P-0046	removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed

ACK 1	HFA-305 to Buc & Beardsley	Vol #:	1

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FDA/Dockets Management