Dockets Entered On September 23, 2003

Dockets Management



Dockets Entered On September 23, 2003 Table of Contents



Docket #	Title

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use

1991V-0200	Variance requesting projector model #1001,1002,1003 & 1004

1993P-0174	Amend Regs for Liquid Medicated Animal Feed

1995N-0304	Ephedrine Alkaloids: Reports of Adverse Events; Availability

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

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

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

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

2000P-0685	Revise of Yogurt Standards

2000V-1281	Laser Light Show, LM 8 Projection System

2002N-0534	Medical Device User Fee and Modernization Act of 2002

2003D-0044	Reporting Results for Studies Evaluating Diagnostic Tests

2003D-0317	Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products

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

2003N-0169	Dental Amalgam; Request for Information

2003N-0338	Secretary's Roundtable on Obesity/Nutrition

2003N-0344	Consumer-Directed Promotion; Public Meeting

2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter

2003P-0270	Prohibit False and Misleading Labeling

2003P-0274	In re Tier 1 initial Approval Program

2003P-0291	Enforce the law and prevent unlaw sale of contact lens

2003V-0435	Laser Light Show

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use
C 88	David W. Potts,MD,FACP	Vol #:	200

1991V-0200	Variance requesting projector model #1001,1002,1003 & 1004

VRA 4	HFZ-300 to Specialty Laser and Lighting	Vol #:	1

1993P-0174	Amend Regs for Liquid Medicated Animal Feed

C 4	American Feed Industry Assn (AFIA)	Vol #:	1

1995N-0304	Ephedrine Alkaloids: Reports of Adverse Events; Availability

SUP 3	LifeSpan Nutrition	Vol #:	374

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

C 248	Durk Pearson & Sandy Shaw	Vol #:	41

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



LET 10991	Source Naturals	Vol #:	83

LET 10992	Source Naturals	Vol #:	83

LET 10993	PhytoPharmica Natural Medicines	Vol #:	83

LET 10994	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10995	Alcon, Inc.	Vol #:	83

LET 10996	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10997	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10998	Enzymatic Theray Natural Medicines	Vol #:	83

LET 10999	NOW Foods	Vol #:	83

LET 11000	NOW Foods	Vol #:	83

LET 11001	NOW Foods	Vol #:	83

LET 11002	NOW Foods	Vol #:	83

LET 11003	NOW Foods	Vol #:	83

LET 11004	NOW Foods	Vol #:	83

LET 11005	NOW FOODS	Vol #:	83

LET 11006	Indium for Life, Inc.	Vol #:	83

LET 11007	Source Naturals	Vol #:	83

LET 11008	Planetary Formulas	Vol #:	83

LET 11009	Source Naturals	Vol #:	83

LET 11010	New Vision International Holdings, Inc.	Vol #:	83

LET 11011	FoodScience of Vermont	Vol #:	83

LET 11012	FoodScience of Vermont	Vol #:	83

LET 11013	PhytoPharmica Natural Medicines	Vol #:	83

LET 11014	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 11015	Twin Laboratories, Inc.	Vol #:	83

LET 11016	Herbsforever	Vol #:	83

LET 11017	Michael's Naturopathic Programs	Vol #:	83

LET 11018	RKS Inc.	Vol #:	83

LET 11019	Sweet Aloha Farms	Vol #:	83

LET 11020	Sweet Aloha Farms	Vol #:	83

LET 11021	Nutrilogix, LLC	Vol #:	83

LET 11022	Gaia Herbs	Vol #:	83

LET 11023	Body Wise International	Vol #:	83

LET 11024	Boby Wise International	Vol #:	83

LET 11025	Nature's Way Products, Inc.	Vol #:	83

LET 11026	New Ylork Healthy Herbs Inc.	Vol #:	83



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

EMC 4039	Lisa Altizer	Vol #:	514

EMC 4040	Dennis Robinson	Vol #:	514

EMC 4041	Erin O'Connell	Vol #:	514

EMC 4042	No signature	Vol #:	514

EMC 4043	Kathy Keating	Vol #:	514

EMC 4044	Diane Galli	Vol #:	514

EMC 4045	Janice Breen	Vol #:	514

EMC 4046	Monika Pfiefle	Vol #:	514

EMC 4047	Bruce Moselle	Vol #:	514

EMC 4048	Kathleen Miller	Vol #:	514

EMC 4049	Richard Bronk	Vol #:	514

EMC 4050	Corinne Edwards	Vol #:	514

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

C 5	Teva Pharmaceutical Industries Ltd.	Vol #:	3

EMC 9	PharmaCompliance Consulting Services	Vol #:	3

2000P-0685	Revise of Yogurt Standards

C 7	Central America-U.S. Chammber of Commerce	Vol #:	1

EXT 1	National Yogurt Assn (NYA)	Vol #:	1

2000V-1281	Laser Light Show, LM 8 Projection System

VRA 2	HFS-300 to La Curacao Department Store	Vol #:	1

2001D-0202	Provisions of the FDA Modernization Act of 1997
EC 3	alves, judy	Vol #:	1

2001D-0583	Food Security Guidance

EC 15	alomar, antulio	Vol #:	1

2002N-0534	Medical Device User Fee and Modernization Act of 2002

C 36	Health Industry Distributors Assn (HIDA)	Vol #:	2

2003D-0025	Mammography Quality Standards Act Final Regs.Modifications

EC 5	Wessel, Eduardo Jorge	Vol #:	1

2003D-0044	Reporting Results for Studies Evaluating Diagnostic Tests

C 7	University of California San Francisco (UCSF)	Vol #:	1

2003D-0195	Draft Guidance for Industry on Necessity of the Use of Food Product Categories in Registration of Food Facilities



EC 11	DURAND, ROBERTO	Vol #:	1

2003D-0317	Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products

C 4	PhRMA, Pharamceutical Research and Manufacturers of America	Vol #:	1

C 5	Bristol-Myers Squibb Pharmaceutical Research Institute	Vol #:	1

C 6	Pfizer Inc	Vol #:	1

C 8	Wyeth Pharmaceuticals	Vol #:	1

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

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

EMC 2	No signature	Vol #:	1

EXT 2 Attachment	Snack Food Association	Vol #:	1

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

EC 3	Castle, Debbie	Vol #:	1

2003N-0169	Dental Amalgam; Request for Information

EMC 221	James Allen	Vol #:	6

2003N-0338	Secretary's Roundtable on Obesity/Nutrition

C 2	Mayo Clinic	Vol #:	1

2003N-0344	Consumer-Directed Promotion; Public Meeting

SUP 1 Attachment	Pfizer, Inc.	Vol #:	1

2003N-0346	Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals

EC 1	travnicek, lindsay	Vol #:	4

2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter

EMC 2	No signature	Vol #:	1

2003P-0270	Prohibit False and Misleading Labeling

C 27	Signe Razzi	Vol #:	1

C 28	Keith T. Previc	Vol #:	1

2003P-0274	In re Tier 1 initial Approval Program
EMC 1	Patients Against Lymphoma	Vol #:	1

EMC 2	Musa Mayer et al.	Vol #:	1

2003P-0291	Enforce the law and prevent unlaw sale of contact lens

C 39	A. Jackson Bailes, O.D.	Vol #:	1



C 40	Mark Ryan, O.D.	Vol #:	1

C 41	Gemini Eye Care Centers	Vol #:	1

C 42	Rhonda J. Manuel-Saldivar, O.D.	Vol #:	1

C 43	Julie A. Galbreath, O.D.	Vol #:	1

C 44	Michael J. Hill, O.D.	Vol #:	1

2003V-0435	Laser Light Show

ACK 1	HFA-305 to Warner Bros. Entertainment Inc.	Vol #:	1

Page Posted September 24, 2003 cp

Page updated October 3, 2003 jb

FDA/Dockets Management