Dockets Entered on March 30, 2004

Dockets Management



Dockets Entered On March 30, 2004 Table of Contents



Docket #	Title

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

2000D-1350	Combined Oral Contraceptives/Labeling/Healthcare Providers
2001P-0145	Change the classification of colonic irrigation systems

2002D-0371	Human Dura Mater; Class II Special Controls Guidance
2002N-0278	Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0570	Draft on the Clinical Evaluation of Weight-Control Drugs
2003N-0575	Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients
2004D-0014	Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
2004D-0117	International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning

2004D-0118	International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

2004D-0124	Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
2004P-0152	ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths

2004P-0153	ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg.

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary
LET 13413	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13414	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13415	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13416	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13417	Phyto Pharmica Natural Medicines	Vol #:	111

LET 13418	Millennium Biotechnologies, Inc.	Vol #:	111

LET 13419	Millennium Biotechnologies, Inc.	Vol #:	111

LET 13420	Millennium Biotechnologies, Inc.	Vol #:	111

LET 13421	Synergy	Vol #:	111

LET 13422	Herbal Source	Vol #:	111

LET 13423	Herbal Source	Vol #:	111

LET 13424	Herbal Source	Vol #:	111

LET 13425	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13426	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13427	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13428	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13429	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13430	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13431	Phyto Pharmica Natural Medicines	Vol #:	111

LET 13432	PhytoPharmica Natural Medicines	Vol #:	111

LET 13433	PhytoPharmica Natural Medicines	Vol #:	111

LET 13434	Suarez Corporation Industries	Vol #:	111

LET 13435	Naturade, Inc.	Vol #:	111

LET 13436	Tom's of Maine	Vol #:	111

LET 13437	Highland Laboratories	Vol #:	111

LET 13438	Juvenon, Inc.	Vol #:	111

LET 13439	Enzymatic Therapy Natural Medicines	Vol #:	111

LET 13440	Enzymatic Therapy Natural Medicines	Vol #:	111



LET 13441	Square Enterprises Corp.	Vol #:	111

LET 13442	Nature's Way Products, Inc.	Vol #:	111

LET 13443	Synergy Worldwide	Vol #:	111

LET 13444	Optigenex Inc.	Vol #:	111

LET 13445	Optigenex Inc.	Vol #:	111

LET 13446	Optigenex Inc.	Vol #:	111

LET 13447	Atkins Nutritionals, Inc.	Vol #:	111

LET 13448	Boots Retail USA Inc.	Vol #:	111

LET 13449	AdvoCare International, LP	Vol #:	111

LET 13450	Boots Retail USA Inc.	Vol #:	111

LET 13451	Boots Retail USA Inc.	Vol #:	111

LET 13452	Boots Retail USA Inc.	Vol #:	111

LET 13453	Boots Retail USa Inc.	Vol #:	111

LET 13454	Boots Retail USA Inc.	Vol #:	111

LET 13455	Boots Retail USA Inc.	Vol #:	111

LET 13456	Boots Retail USA Inc.	Vol #:	111

2000D-1350	Combined Oral Contraceptives/Labeling/Healthcare Providers

EC 1	Family Health International	Vol #:	1

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

EC 645	Mrs. Karen White	Vol #:	163

EC 646	Mr. Brett Brunkenhoefer	Vol #:	163

EC 647	Mr. Ademar R. Rakowsky	Vol #:	163

EC 648	Mrs. Therese More	Vol #:	163

EC 649	Miss. H Bollman	Vol #:	163

EC 650	Ms. Rebecca Cosby	Vol #:	163

2001P-0145	Change the classification of colonic irrigation systems

PDN 1 Attachment	CDRH to A. R. Hoenninger	Vol #:	3

2002D-0371	Human Dura Mater; Class II Special Controls Guidance

EC 5	University of Utah Neuropsychiatric Institute	Vol #:	1

2002N-0278	Bioterrorism; Prior Notice of Imported Food Shipments

EC 388	W.J. Byrnes & Co.	Vol #:	22

EC 389	W.J. Byrnes & Co.	Vol #:	22

EC 390	FedEx Express	Vol #:	22

EC 391	Federal Express Corporation	Vol #:	2



2003D-0570	Draft on the Clinical Evaluation of Weight-Control Drugs

EC 2	Peptimmune, Inc.	Vol #:	1

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

EC 11	Mr. Scott Kulas	Vol #:	3

EC 12	Mrs. Rhonda Horner-Bohaty	Vol #:	3

EC 13	none	Vol #:	3

2003N-0575	Agency Information Collection Activities; Proposed Collection; Comment Request; 2004 National Tracking Survey of Prescription Drug Information Provided to Patients

EC 1	Nat'l Council on Patient Information	Vol #:	1

2004D-0014	Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions

EC 1	University of Arkansas for Medical Sciences	Vol #:	1

2004D-0041	Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling

EC 2	Mr. Don Sieg	Vol #:	1

EC 3	Mrs. Sandra Thweatt	Vol #:	1

2004D-0117	International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
GDL 1	Guidance	Vol #:	1

NAL 1	FDA	Vol #:	1

2004D-0118	International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

GDL 1	Guidance	Vol #:	1

NAL 1	FDA	Vol #:	1

2004D-0124	Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

EC 1	University of Arkansas for Medical Sciences	Vol #:	1

2004P-0152	ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths

ACK 1	HFA-305 to The Weinberg Group Inc.	Vol #:	1

CP 1 Attachment 1, 2, 3	The Weinberg Group Inc.	Vol #:	1

2004P-0153	ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg.

ACK 1	HFA-305 to The Weinberg Group Inc.	Vol #:	1

CP 1 Attachment 1, 2, 3, 4	The Weinberg Group Inc.	Vol #:	1

Page created on March 31, 2004 dp
Page updated on April 5, 2004 rc

FDA/Dockets Management