Dockets Entered on April 15, 2004

Dockets Management



Dockets Entered On April 15, 2004 Table of Contents



Docket #	Title

1986V-0327	LASER-GRAPH SERIES I, SERIES II

1988P-0072	NIFEDIPINE HARD GELATIN CAPSULES 20MG ANDA SUITABILITY

1995P-0326	ANDA for Nifedipine Extended-release Capsules

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

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

1999N-4282	Biotechnology in the Year 2000 and Beyond; Public Meetings

1999P-1340	Declared Eternity eau de Parfum Misbranded

1999P-2630	Establish a Daily Value for "added sugars"

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

2001P-0145	Change the classification of colonic irrigation systems

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2002P-0377	Petition Requesting Stay of Approval of Mifeprex

2003D-0493	Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen

2003D-0522	Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability

2003D-0558	Guidance Levels for Radionuclides in Domestic and Imported Foods

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

2003P-0270	Prohibit False and Misleading Labeling

2003P-0362	Over-the-counter Hearing Aids

2003P-0363	Professional and Patient Labeling for Hearing Aid Devices

2003P-0555	Maintain the Electroconvulsive Therapy Device in Class III for All Indications

2004D-0002	Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

2004D-0035	Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis

2004N-0115	Prescription Drug Importation Study

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer

1986V-0327	LASER-GRAPH SERIES I, SERIES II

VRA 8	HFZ-300 to Rarefied Media Productions	Vol #:	1

1988P-0072	NIFEDIPINE HARD GELATIN CAPSULES 20MG ANDA SUITABILITY

ACK 1	HFA-305 to Marteo Pharmaceutical, Inc.	Vol #:	1

1995P-0326	ANDA for Nifedipine Extended-release Capsules

ACK 1	HFA-305 to KV Pharmaceutical Co.	Vol #:	1

ACK 2	HFA-305 to Bayer Corporation	Vol #:	1

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



LET 13599	Perrigo Company of South Carolina	Vol #:	113

LET 13600	Perrigo Company of South Carolina	Vol #:	113

LET 13601	Dynamic Nutrional Products	Vol #:	113

LET 13602	Twin Laboratories	Vol #:	113

LET 13603	Amrita Veda	Vol #:	113

LET 13604	Herb Pharm	Vol #:	113

LET 13605	Herb Pharm	Vol #:	113

LET 13606	Awareness Corporation	Vol #:	114

LET 13607	Awareness Corporation	Vol #:	114

LET 13608	AdvoCare International, L.P.	Vol #:	114

LET 13609	Perrigo Company of South Carolina	Vol #:	114

LET 13610	InteMedica, LLC	Vol #:	114

LET 13611	Metagenics, Inc.	Vol #:	114

LET 13612	Gaia Herbs	Vol #:	114

LET 13613	Herb Pharm	Vol #:	114

LET 13614	Herb Pharm	Vol #:	114

LET 13615	Herb Pharm	Vol #:	114

LET 13616	Herb Pharm	Vol #:	114

LET 13617	Herb Pharm	Vol #:	114

LET 13618	Perrigo Company of South Carolina	Vol #:	114

LET 13619	Perrigo Company of South Carolina	Vol #:	114

LET 13620	Perrigo Company of South Carolina	Vol #:	114

LET 13621	Perrigo Company of South Carolina	Vol #:	114

LET 13622	Perrigo Company of South Carolina	Vol #:	114

LET 13623	Perrigo Company of South Carolina	Vol #:	114

LET 13624	Perrigo Company of South Carolina	Vol #:	114

LET 13625	Vitacorp International, Inc.	Vol #:	114

LET 13626	Shaklee's Corporation	Vol #:	114

LET 13627	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13628	Wise Women Herbals	Vol #:	114

LET 13629	PhytoPharmica Natural Medicines	Vol #:	114

LET 13630	PhytoPharmica Natural Medicines	Vol #:	114

LET 13631	PhytoPharmica Natural Medicines	Vol #:	114

LET 13632	PhytoPharmica Natural Medicines	Vol #:	114

LET 13633	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13634	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13635	Enzymatic Therapy Natural Medicines	Vol #:	114



LET 13636	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13637	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13638	Enzymatic Therapy Natural Medicines	Vol #:	114

LET 13639	Enzymatic Therapy Natural Medicines	Vol #:	114

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

C 7416	P. Krudwig	Vol #:	307

C 7417	M. Winther	Vol #:	307

C 7418	M. Trzuskowski	Vol #:	307

C 7419	J. Quaine	Vol #:	307

C 7420	R. Church	Vol #:	307

C 7421	B. Towne	Vol #:	307

C 7422	T. Silva	Vol #:	307

C 7423	A. Spivey	Vol #:	307

C 7424	D. Reed	Vol #:	307

C 7425	L. Ayrapetov	Vol #:	307

C 7426	Z. Grondin	Vol #:	307

C 7427	S. Alexyon	Vol #:	307

C 7428	C. Boulais	Vol #:	307

C 7429	C. Anderson	Vol #:	307

C 7430	68 signatures	Vol #:	307

C 7431	Wisconsin Friends of Aimals, Inc.	Vol #:	307

EMC 4204	L. Mungavin	Vol #:	304

EMC 4205	L. Flook	Vol #:	304

EMC 4206	G. Willson	Vol #:	304

EMC 4207	G. Konecky	Vol #:	304

EMC 4208	E. Trombley	Vol #:	304

EMC 4209	M. Ellingsen	Vol #:	304

EMC 4210	L. Taliaferro	Vol #:	304

EMC 4211	C. Gomez	Vol #:	304

EMC 4212	K. Ociepka	Vol #:	304

EMC 4213	E. Dahl	Vol #:	304

EMC 4214	E. Dahl	Vol #:	304

EMC 4215	A. Sanchez	Vol #:	304

EMC 4216	J. Thomas	Vol #:	304

EMC 4217	J. Letard	Vol #:	304

EMC 4218	T. Maugeri	Vol #:	304



1999N-4282	Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 4195	G. Ocepeck	Vol #:	515

1999P-1340	Declared Eternity eau de Parfum Misbranded

EMC 531	A. Adams	Vol #:	24

1999P-2630	Establish a Daily Value for "added sugars"

EMC 779	J. Cecil	Vol #:	33

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing

EMC 557	Form Letter Count 2026	Vol #:	399

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

C 1340	Legal Center for Defense of Life, Inc.	Vol #:	209

2001P-0145	Change the classification of colonic irrigation systems

LET 1	HFZ-400 to Mr. A.R. Hoenninger	Vol #:	3

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 328	Dr. B. Martini	Vol #:	6

2002P-0377	Petition Requesting Stay of Approval of Mifeprex

EMC 1	American Assn of Pro-Life Obstetricians & Gynecologists	Vol #:	2

2003D-0493	Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen

C 12	International Assn for Pharmaceutical Science and Technology (PDA)	Vol #:	2

2003D-0522	Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability

C 14	Laboratory Corporation of America (LabCorp)	Vol #:	1

2003D-0558	Guidance Levels for Radionuclides in Domestic and Imported Foods

EMC 1	Chinese Government	Vol #:	1

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

C 18	American Palm Oil Council (APOC)	Vol #:	3

EMC 159	T. Slocombe	Vol #:	3

EMC 160	D. Young	Vol #:	3

EMC 161	K. Simpson	Vol #:	3

EMC 162	H. Walsh	Vol #:	3

2003P-0270	Prohibit False and Misleading Labeling



C 68	R. Berman	Vol #:	6

2003P-0362	Over-the-counter Hearing Aids

EMC 56	N. Norman	Vol #:	2

EMC 57	F. Nemkov	Vol #:	2

2003P-0363	Professional and Patient Labeling for Hearing Aid Devices

EMC 25	F. Nemkov	Vol #:	1

2003P-0555	Maintain the Electroconvulsive Therapy Device in Class III for All Indications

C 2	E. Abraham	Vol #:	2

C 3	W. Deehan	Vol #:	2

C 4	Illegible	Vol #:	2

2004D-0002	Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

C 13	Our Bodies Ourselves (OBOS)	Vol #:	1

C 14	National Women's Health Network	Vol #:	1

2004D-0035	Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
EMC 1	H. Bone, MD	Vol #:	1

EMC 2	Merck & Co., Inc.	Vol #:	1

EMC 3	P&G Pharmaceuticals, Inc.	Vol #:	1

2004N-0115	Prescription Drug Importation Study

EMC 6 Attachment	drugstore.com	Vol #:	1

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer

ACK 1	HFS-800 to Solae, LLC	Vol #:	4

LET 1	The Solae Company	Vol #:	4

QHC 1	Solae, LLC	Vol #:	1

Page updated on April 27, 2004 jb

FDA/Dockets Management