Dockets Entered On October 15, 2003

Dockets Management



Dockets Entered On October 15, 2003 Table of Contents



Docket #	Title

1978N-0021A	Skin Protectant Drug Prod to OTC, Astringent Drug Products

1978N-0038	Sunscreen Drug Products

1995N-0071	Proposal to Debar Amirul Islam; Notice of Opportunity for He

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

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

1999P-0033	Combat the spread of transmissible spongiform encephalopathy

2000D-1598	Voluntary Labeling for Bioengineered Foods

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

2002H-0443	Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

2002N-0475	Financial Relationships & Interest in Research Involving Hum

2002P-0226	ANDA for methotrexate sodium oral solution, 5mg/ml

2003D-0165	Current Good Manufacturing Practices for Medical Gases

2003D-0319	Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices

2003D-0434	Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability

2003N-0066	Inspection by Accredited Persons Under MDUFMA

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2003N-0294	Risk Management Plans for Opiate Analgesic Drug

2003N-0295	Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile

2003N-0338	Obesity

2003N-0361	Anti-Counterfeit Drug Initiative

2003P-0270	Prohibit False and Misleading Labeling

2003P-0274	In re Tier 1 initial Approval Program

2003P-0283	ANDA Suitable for Glimepiride Tablets, 8 mg

2003P-0307	ANDA suitability for a new strength of Warfarin Sodium Tablets, USP 1.5mg

2003P-0479	Allow importation of Canadian versions of drugs that are approved to the United States

2003V-0480	Laser Light Show

1978N-0021A	Skin Protectant Drug Prod to OTC, Astringent Drug Products

NCD 1	FDA	Vol #:	3

1978N-0038	Sunscreen Drug Products

C 603	BDF Beiersdorf, Inc.	Vol #:	150

1995N-0071	Proposal to Debar Amirul Islam; Notice of Opportunity for He

NFR 2	FDA	Vol #:	1

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



LET 11259	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11260	PhytoPharmica Natural Medicines	Vol #:	86

LET 11261	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11262	A Way of Life, Inc.	Vol #:	86

LET 11263	Market America, Inc.	Vol #:	86

LET 11264	Pure Encapsulations, Inc.	Vol #:	86

LET 11265	Mera Pharmaceuticals	Vol #:	86

LET 11266	Taiko Pharmaceutical Co., Ltd.	Vol #:	86

LET 11267	Unicity Network, Inc.	Vol #:	86

LET 11268	Uncity Network, Inc.	Vol #:	86

LET 11269	Uncity Network, Inc.	Vol #:	86

LET 11270	Uncity Network, Inc.	Vol #:	86

LET 11271	Uncity Network, Inc.	Vol #:	86

LET 11272	Nature's Sunshine Products, Inc.	Vol #:	86

LET 11273	CCA Industries, Inc.	Vol #:	86

LET 11274	Innovative Botanical solutions, Inc.	Vol #:	86

LET 11275	Unicity Network, Inc.	Vol #:	86

LET 11276	Unicity Network, Inc.	Vol #:	86

LET 11277	Unicity Network, Inc.	Vol #:	86

LET 11278	Unicity Nertwork, Inc.	Vol #:	86

LET 11279	Unicity Network, Inc.	Vol #:	86

LET 11280	EuroPharma	Vol #:	86

LET 11281	Eu Yan Sang (hong Hong) Limited	Vol #:	86

LET 11282	CCA Industries, Inc.	Vol #:	86

LET 11283	Advanced Vision Research	Vol #:	86

LET 11284	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11285	Twin Laboratories, Inc.	Vol #:	86

LET 11286	Twin Laboratories, Inc.	Vol #:	86

LET 11287	Twin Laboratories, Inc.	Vol #:	86

LET 11288	Twin Laboratories, Inc.	Vol #:	86

LET 11289	PhytoPharmica Natural Medicines	Vol #:	86

LET 11290	Enzymatic Therapy Natural Medicines	Vol #:	86

LET 11291	Zand Herbal Formulas	Vol #:	86

LET 11292	Zand herbal Formulas	Vol #:	86

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

C 7073	Tina Orwig	Vol #:	301



C 7074	Elisa Frey	Vol #:	301

C 7075	Cherie Moncrief	Vol #:	301

C 7076	Elena McCracken	Vol #:	301

C 7077	Jenny Martin	Vol #:	301

C 7078	Mary Groff	Vol #:	301

C 7079	Mireya Landin et al.	Vol #:	301

C 7080	Lorraine Nicotera	Vol #:	301

C 7081	Marta M. Guzman	Vol #:	301

C 7082	Margaret Falino	Vol #:	301

C 7083	Kelly K. Brinkman	Vol #:	301

C 7084	George Allison	Vol #:	301

C 7085	Victoria Crompton	Vol #:	301

1999P-0033	Combat the spread of transmissible spongiform encephalopathy

C 389	George and Donna Allison	Vol #:	9

2000D-1598	Voluntary Labeling for Bioengineered Foods

EMC 12014	Char Alford	Vol #:	574

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

C 33	Robert J. Reinhard	Vol #:	4

C 34	Aventis Pharmaceuticals, Inc.	Vol #:	4

C 35	Consumer healthcare Products Assn (CHPA)	Vol #:	4

C 36	GlaxoSmithKline	Vol #:	4

C 37	Luitpold Pharmaceuticals, Inc. (Luitpold)	Vol #:	4

C 38	Amgen, Inc. (Amgen)	Vol #:	4

C 39	Millennium Pharmaceuticals, Inc.	Vol #:	4

C 40	Pfizer	Vol #:	4

C 41	EMEA	Vol #:	4

2002H-0443	Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

CS 17	HFA-305	Vol #:	1

OR 15	HF-3	Vol #:	1

2002N-0475	Financial Relationships & Interest in Research Involving Hum
C 36	Bristol-Myers Squibb Pharmaceutical Research Institute	Vol #:	2

2002P-0226	ANDA for methotrexate sodium oral solution, 5mg/ml

PAV 1	HFD-600 toKirkpatrick & Lockhart LLP	Vol #:	1



2003D-0165	Current Good Manufacturing Practices for Medical Gases

C 25	Essex P.B.&R Corp. (Essex)	Vol #:	1

2003D-0319	Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices

C 1	Respironics, Inc.	Vol #:	1

2003D-0434	Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance Assessment; Availability

GDL 1	Guideline	Vol #:	1

NAD 1	FDA	Vol #:	1

2003N-0066	Inspection by Accredited Persons Under MDUFMA

N 2	FDA	Vol #:	1

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

C 8	Center for Science in the Public Interest (CSPI)	Vol #:	1

C 9	Center for Science in the Public Interest (CSPI)	Vol #:	1

2003N-0294	Risk Management Plans for Opiate Analgesic Drug

C 4 Attachment	Purdue Pharma, L.P.	Vol #:	1

2003N-0295	Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile

N 2	FDA	Vol #:	1

2003N-0338	Obesity

NM 1	FDA	Vol #:	1

2003N-0361	Anti-Counterfeit Drug Initiative

EMC 2	Angstrom Technologies, Inc.	Vol #:	2

2003P-0270	Prohibit False and Misleading Labeling

C 31	Chris Goodwin	Vol #:	1

2003P-0274	In re Tier 1 initial Approval Program

RC 1	Abigail Alliance and the Washington Legal Foundation	Vol #:	1

2003P-0283	ANDA Suitable for Glimepiride Tablets, 8 mg

PAV 1	HFD-600 to Lachman Consultant Services, Inc.	Vol #:	1

2003P-0307	ANDA suitability for a new strength of Warfarin Sodium Tablets, USP 1.5mg

PAV 1	HFD-600 toTaro Pharmaceuticals	Vol #:	1

2003P-0479	Allow importation of Canadian versions of drugs that are approved to the United States



ACK 1	HFA-305 to The City of Springfield, Massachusetts	Vol #:	1

CP 1	The City of Springfield, Massachusetts	Vol #:	1

2003V-0480	Laser Light Show

ACK 1	HFA-305 to Laser Design Productions Inc.	Vol #:	1

VAR 1	Laser Design Productions Inc.	Vol #:	1

Page Posted October 16, 2003 dp
Page updated October 24, 2003 jb

FDA/Dockets Management