Dockets Entered On September 16, 2003

Dockets Management



Dockets Entered On September 16, 2003 Table of Contents



Docket #	Title

1984F-0095	SAFE USE OF POLYAMINE-EPICHLOROHYDRIN RESIN IN CORN SYRUP

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

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

2002D-0094	IND Exemptions for Studies of Lawfully Marketed Cancer Drugs

2002N-0486	Prescription Drug Marketing Act of 1987

2003D-0186	Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

2003D-0399	Guidance: Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

2003M-0086	Carpentier-Edwards S.A.V. Bioprosthesis Model 1650 (Aortic)

2003M-0427	P020025 - EP Technologies EPT-1000 XPb

2003N-0361	Anti-Counterfeit Drug Initiative

2003N-0397	Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles

2003V-0433	Laser Light Show

1984F-0095	SAFE USE OF POLYAMINE-EPICHLOROHYDRIN RESIN IN CORN SYRUP

NWL 1	FDA	Vol #:	1

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

M 734	Statistical Report for June 2003	Vol #:	52

M 735	Statistical Report for July 2003	Vol #:	52

M 736	Statistical Report for August 2003	Vol #:	52

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

LET 10931	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10932	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10933	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10934	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10935	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10936	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10937	Tradeworks Group, Inc.	Vol #:	83

LET 10938	Iowa State University Research Park	Vol #:	83

LET 10939	O Premium Waters	Vol #:	83

LET 10940	PhytoPharmica Natural Medicines	Vol #:	83

LET 10941	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10942	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10943	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10944	PhytoPharmica Nautral Medicines	Vol #:	83



LET 10945	PhytoPharmica Natural Medicines	Vol #:	83

LET 10946	Gaia Herbs	Vol #:	83

LET 10947	Source Naturals	Vol #:	83

LET 10948	Source Naturals	Vol #:	83

LET 10949	Source Naturals	Vol #:	83

LET 10950	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10951	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10952	Perrigo Company of South Carolina	Vol #:	83

LET 10953	Enzymatic Therapy Natural Medicines	Vol #:	832

LET 10954	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10955	PhytoPharmica Natural Medicines	Vol #:	83

LET 10956	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10957	Solstice Medicine Company	Vol #:	83

LET 10958	Solstice Medicine Company	Vol #:	83

LET 10959	Solstice Medicine Company	Vol #:	83

LET 10960	Sostice Medicine Company	Vol #:	83

LET 10961	Global Chinese Herbs Depot Inc.	Vol #:	83

LET 10962	PhytoPharmica Natural Medicines	Vol #:	83

LET 10963	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10964	Wyeth Consumer Healthcare	Vol #:	83

LET 10965	Wyeth Consumer Healthcare	Vol #:	83

LET 10966	Wyeth Consumer Healthcare	Vol #:	83

LET 10967	Enzymatic Therapy Nautral Medicines	Vol #:	83

LET 10968	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10969	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10970	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10971	PhytoPharmica Natural Medicines	Vol #:	83

LET 10972	PhytoPharmica Natural Medicines	Vol #:	83

LET 10973	PhytoPharmica Natural Medicines	Vol #:	83

LET 10974	PhytoPharmica Natural Medicines	Vol #:	83

LET 10975	Herb Pharm	Vol #:	83

LET 10976	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10977	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10978	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10979	PhytoPharmica Natural Medicines	Vol #:	83

LET 10980	PhytoPharmica Natural Medicines	Vol #:	83

LET 10981	Dee Cee laboratories, Inc.	Vol #:	83



LET 10982	Dee Cee Laboratories, Inc.	Vol #:	83

LET 10983	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10984	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10985	Nutra Therapeutics	Vol #:	83

LET 10986	DMD Pharmaceuticals	Vol #:	83

LET 10987	Enzymatic Therapy Natural Medicines	Vol #:	83

LET 10988	Chattem, Inc.	Vol #:	83

LET 10989	Flora	Vol #:	83

LET 10990	Flora	Vol #:	83

2002D-0094	IND Exemptions for Studies of Lawfully Marketed Cancer Drugs

GDL 2	Guidance	Vol #:	1

2002N-0486	Prescription Drug Marketing Act of 1987

NAL 1	FDA	Vol #:	1

2003D-0186	Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2003D-0399	Guidance: Pentetate Calcium Trisodium and Pentetate Zinc Trisodium for Treatment of Internal Contamination with Plutonium, Americium, or Curium

BKG 1 Tab 1-72	Background Material	Vol #:	2

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

GDL 1	Guidance	Vol #:	1

2003M-0086	Carpentier-Edwards S.A.V. Bioprosthesis Model 1650 (Aortic)

CR 1	HFZ-402	Vol #:	1

2003M-0427	P020025 - EP Technologies EPT-1000 XPb

AAV 1	Boston Scientific Corporation	Vol #:	1

2003N-0361	Anti-Counterfeit Drug Initiative

APE 11	EPCglobal US	Vol #:	1

APE 12	SCA Ltd	Vol #:	1

APE 13	Isotag Technology, Inc	Vol #:	1

2003N-0397	Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles



N 1	FDA	Vol #:	1

2003V-0433	Laser Light Show

ACK 1	HFA-305 to Vandenberg Community Center	Vol #:	1

ACK 2	Number not used	Vol #:	1

VAR 1	Vandenberg Community Center	Vol #:	1

Page Posted September 17, 2003 dp

Page updated October 3, 2003 jb

FDA/Dockets Management