Dockets Entered on September 30, 2004

Dockets Management



	Dockets Entered On September 30, 2004 Table of Contents



	Docket #			Title

	1977P-0185			Ban on Cigarettes Containing Nicotine

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

	2001N-0234			Food Contact Substance Notification System

	2002V-0143			Laser Light Show

	2003E-0033			Patent Extension Application for DERMAGRAFT No. 4,963,489

	2003E-0260			Patent Extension for Amevive (alefacept), 5,547,853

	2003N-0161			Medical Devices;Reprocessed Single-Use Devices;Termination

	2003N-0565			Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys

	2003P-0126			Refrain from approving (ANDA)for Levothyroxine Sodium Tablet

	2003P-0270			Prohibit False and Misleading Labeling

	2003P-0357			Update the Drug/Laboratory Test Interactions section of the prescribing information of all strenghts of Premarin tablets (.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased levels of testo

	2003P-0387			Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products

	2003P-0564			513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies

	2004D-0385			Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus

	2004M-0145			P020006 - Enteryx Procedure Kit, Approved 4/22/03

	2004M-0147			P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test

	2004M-0165			H020008; OP-1 Putty

	2004M-0199			P030032 - Hylaform (hylan B gel)

	2004M-0200			P010014 - Oxford Meniscal Unicompartmental Knee System

	2004M-0207			P970027 - Abbott AxSYM Anti-HCV

	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


	2004M-0253			P980007 - AxSYM Free PSA

	2004M-0256			Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.

	2004M-0259			P030045 -IntraStent DoubleStrut Stent

	2004M-0260			P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

	2004N-0017			Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices

	2004N-0081			BSE Risk Materials in Foods and Cosmetics

	2004N-0242			Institutional Review Boards; Registration Requirements

	2004N-0264			Federal Measures to Mitigate BSE Risks: Considerations for Further Action

	2004N-0355			Scientific Considerations Related to Developing Follow-on Protein Products

	2004P-0139			approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product

	2004P-0162			Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg

	2004P-0202			Notify State & Federal regulators of GRAS requirements of milk protein Concentrate

	2004P-0386			Reject New Drug Application 21-695



2004S-0233	Stimulating Innovation in Medical Technologies

1977P-0185	Ban on Cigarettes Containing Nicotine

ACK 2	HFA-305 to Director and General Counsel	Vol #:	1

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

LET 14552	NBTY, Inc.	Vol #:	127

LET 14553	NBTY, Inc.	Vol #:	127

LET 14554	Enzymatic Therapy	Vol #:	127

LET 14555	Enzymatic Therapy	Vol #:	127

LET 14556	Enzymatic Therapy	Vol #:	127

LET 14557	Enzymatic Therapy	Vol #:	127

LET 14558	Enzymatic Therapy	Vol #:	127

LET 14559	Enzymatic Therapy	Vol #:	127

LET 14560	Natural Factors Nutritional Products Inc.	Vol #:	127

LET 14561	Perrigo Company of South Carolina	Vol #:	127

LET 14562	Perrigo Company of South Carolina	Vol #:	127

LET 14563	Perrigo Company of South Carolina	Vol #:	127

LET 14564	Perrigo Company of South Carolina	Vol #:	127

LET 14565	Perrigo Company of South Carolina	Vol #:	127

LET 14566	Perrigo Company of South Carolina	Vol #:	127

LET 14567	Perrigo Company of South Carolina	Vol #:	127

LET 14568	Perrigo Company of South Carolina	Vol #:	127

LET 14569	Nature's Sunshine Products, Inc.	Vol #:	127

LET 14570	Ortho Molecular Products	Vol #:	127

LET 14571	Ortho Molecular Products, Inc.	Vol #:	127

LET 14572	Ortho Molecular Products, Inc.	Vol #:	127

LET 14573	Ortho Molecular Products, Inc.	Vol #:	127

LET 14574	Ortho Molecular Products, Inc.	Vol #:	127

LET 14575	Ortho Molecular Products, Inc.	Vol #:	127

LET 14576	Ortho Molecular Products, Inc.	Vol #:	127

LET 14577	Pharmessen Scientific	Vol #:	127

LET 14578	Pharmessen Scientific	Vol #:	127

LET 14579	Pharmessen Scientific	Vol #:	127

LET 14580	Pharmessen Scientific	Vol #:	127

LET 14581	Pharmessen Scientific	Vol #:	127



2001N-0234	Food Contact Substance Notification System

NWL 1	FDA	Vol #:	1

2002V-0143	Laser Light Show

EXP 1	Pacific Laser Productions	Vol #:	1

2003E-0033	Patent Extension Application for DERMAGRAFT No. 4,963,489

N 1	FDA	Vol #:	1

2003E-0260	Patent Extension for Amevive (alefacept), 5,547,853

N 1	FDA	Vol #:	1

2003N-0161	Medical Devices;Reprocessed Single-Use Devices;Termination

C 4 Attachment 1, 2	Guidant Corporation (Guidant or the Company)	Vol #:	1

2003N-0565	Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys

BKG 1	Number Not Used	Vol #:	1

NAL 1	FDA	Vol #:	1

SS 1	Supporting Statement	Vol #:	1

2003P-0126	Refrain from approving (ANDA)for Levothyroxine Sodium Tablet

C 4	Jones Pharma, Inc. (Jones)	Vol #:	4

SUP 7 Letter, Enclosure	Abbott Laboratories	Vol #:	4

2003P-0270	Prohibit False and Misleading Labeling

C 79	S. Brown	Vol #:	9

2003P-0357	Update the Drug/Laboratory Test Interactions section of the prescribing information of all strenghts of Premarin tablets (.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased levels of testo


PAV 1	HFD-001 to Beth Rosenshein	Vol #:	1

2003P-0387	Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products

C 4	Jones Pharma, Inc. (Jones)	Vol #:	5

SUP 8 Letter, Enclosure	Abbott Laboratories	Vol #:	5

2003P-0564	513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies

BKG 1	References 1 - 10	Vol #:	1

NPR 1	FDA	Vol #:	1

2004D-0385	Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus

GDL 1	Guideline	Vol #:	1



NAD 1	FDA	Vol #:	1

2004M-0145	P020006 - Enteryx Procedure Kit, Approved 4/22/03

N 2	FDA	Vol #:	1

2004M-0147	P890064/S009 - Digene Hybrid Capture 2 (HC2) High-Risk HPV DNA Test

N 2	FDA	Vol #:	1

2004M-0165	H020008; OP-1 Putty

N 1	FDA	Vol #:	1

2004M-0199	P030032 - Hylaform (hylan B gel)

N 1	FDA	Vol #:	1

2004M-0200	P010014 - Oxford Meniscal Unicompartmental Knee System

N 1	FDA	Vol #:	1

2004M-0207	P970027 - Abbott AxSYM Anti-HCV

N 1	FDA	Vol #:	1

2004M-0248	P030023 - Oculaid Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)

N 1	FDA	Vol #:	1

2004M-0249	P000054 - INFUSE Bone Graft

N 1	FDA	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



N 1	FDA	Vol #:	1

2004M-0253	P980007 - AxSYM Free PSA

N 1	FDA	Vol #:	1

2004M-0256	Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.

N 1	FDA	Vol #:	1

2004M-0259	P030045 -IntraStent DoubleStrut Stent

N 1	FDA	Vol #:	1

2004M-0260	P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

N 1	FDA	Vol #:	1

2004N-0017	Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices



NAL 1	FDA	Vol #:	1

SS 1	Supporting Statement	Vol #:	1

2004N-0081	BSE Risk Materials in Foods and Cosmetics

C 15	K. Wells	Vol #:	8

C 16	B. Richards	Vol #:	8

C 17	A. Levy	Vol #:	8

C 18	A. Sigurdson	Vol #:	8

C 19	B. Patrick	Vol #:	8

C 20	J. Gorman	Vol #:	8

C 21	J. Cielukowski	Vol #:	8

C 22	R. Taksel	Vol #:	8

C 23	M. Forbes	Vol #:	8

C 24	P. Brant	Vol #:	8

C 25	Mr and Mrs M. Kevany	Vol #:	8

C 26	C. McAuliffe	Vol #:	8

C 27	M. Brockmeyer	Vol #:	8

C 28	J. Morrell	Vol #:	8

C 29	P. Callen	Vol #:	8

C 30	M. Rageth	Vol #:	8

C 31	L. Hahlen	Vol #:	8

C 32	E. Gordon	Vol #:	8

C 33	R. Gonzalez	Vol #:	8

C 34	M. Foster	Vol #:	8

C 35	J.W.F. Holliday	Vol #:	8

C 36	S. Brown	Vol #:	8

C 37	A. Vollmerhausen	Vol #:	8

C 38	A. Martin	Vol #:	8

C 39	D. Brown	Vol #:	8

2004N-0242	Institutional Review Boards; Registration Requirements

C 1	AstraZeneca Pharmaceuticals, LP	Vol #:	1

2004N-0264	Federal Measures to Mitigate BSE Risks: Considerations for Further Action

C 150	P. Scharko	Vol #:	23

C 151	C. Cripps, DVM	Vol #:	23

C 152	W. Hilton, DVM	Vol #:	23

C 153	A. Freedman	Vol #:	23



C 154	No signature	Vol #:	23

C 155	N. Turner	Vol #:	23

C 156	B. Sachau	Vol #:	23

C 157	B. Sachau	Vol #:	23

C 158	B. Sachau	Vol #:	23

C 159	Valley Proteins, Inc.	Vol #:	23

C 160	National By-Products, LLC	Vol #:	23

C 161	H. Post	Vol #:	23

C 162	C. Wattler	Vol #:	23

C 163	D. Carpenter	Vol #:	23

C 164	M. Kilgore	Vol #:	23

C 165	R. Gagliano	Vol #:	23

C 166	F. Engler	Vol #:	23

C 167	B and M Cooper	Vol #:	23

C 168	S. Lincke	Vol #:	23

C 169	L. Messner	Vol #:	23

C 170	C. Adair	Vol #:	23

C 171	P. Viers	Vol #:	23

C 172	M. Feldman	Vol #:	23

C 173	D. Ramelli	Vol #:	23

C 174	J. Sheppard	Vol #:	23

C 175	T. Schwei	Vol #:	23

C 176	N. Mannering	Vol #:	23

C 177	A. Taylor	Vol #:	23

C 178	D. Koloski	Vol #:	23

C 179	A. Sears	Vol #:	23

C 180	R. Sunbeam	Vol #:	23

C 181	L. Cherner	Vol #:	23

C 182	Simmons Foods, Inc.	Vol #:	23

C 183	T. Arvidson	Vol #:	23

C 184	A. Walker	Vol #:	23

C 185	N. Tennant	Vol #:	23

C 186	J. Head, Jr.	Vol #:	23

C 187	Humane Education Network	Vol #:	23

2004N-0355	Scientific Considerations Related to Developing Follow-on Protein Products

TS 1	Novartis Pharmaceuticals Corporation (Novartis)	Vol #:	1



2004P-0139	approval of generic versions of Concerta (methylphenidate HCI extended-release tablets are both bioequivalent and clinically equivalent to the innovator product

CR 1	McNeil Consumer & Specialty Pharmaceuticals	Vol #:	8

2004P-0162	Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg

LET 1	HFD-007 to Lachman Consultant Services, Inc.	Vol #:	1

2004P-0202	Notify State & Federal regulators of GRAS requirements of milk protein Concentrate

C 9	California Farmers Union	Vol #:	1

2004P-0386	Reject New Drug Application 21-695

C 1 Tab 1	Reliant Pharmaceuticals, Inc. (Reliant)	Vol #:	2

2004S-0233	Stimulating Innovation in Medical Technologies

C 18	Amgen	Vol #:	2

Page created on October 1, 2004 kk
Page updated on October 19, 2004 rc

FDA/Dockets Management