Dockets Entered On September 2, 2003

Table of Contents

Docket #

Title

1975N-0183H. 1        Health-Care Antiseptic Drug Products for OTC Human Use. 1

1994P-0215. 1          Amend monograph to include Valerian as OTC sleep-aid product 1

1997S-0163. 2          Dietary Supplements, Courtesy Letters (Letters of Objection) 2

1998P-0169. 2          Labeling Standards for Botanicals, Homeopathics, etc. 2

2001P-0572. 2          Petition for Regulation of Ariva Tobacco Lozenges. 2

2002N-0275. 2         Bioterrorism Preparedness; Administrative Detention. 2

2002P-0075. 2          Flavored Candy-like Products Containing Tobacco. 2

2003D-0092. 2         Food and Cosmetic Security Guidances. 2

2003D-0165. 2         Current Good Manufacturing Practices for Medical Gases. 2

2003D-0364. 2         Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs  2

2003E-0402. 2          Patent Term Extension Application for Acrysof, U.S. Patent No. 5,470,932. 2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

C 64

Attachment

Becton Dickinson & Company (BD)

Vol #:

149

C 65

Attachment

Southwestern

Vol #:

149

C 66

Attachment

CardinalHealth

Vol #:

149

C 67

Attachment

BD Infusion Therapy Systems, Inc,

Vol #:

149

C 68

Assn for Professionals in Infection Control and Epidemiology (APIC)

Vol #:

149

C 69

GOJO Industries, Inc.

Vol #:

149

C 70

Attachment 1, 2, 3, 4, 5

Hospital of Saint Raphael

Vol #:

149

C 71

Attachment

Aplicare, Inc.

Vol #:

149

C 72

Hyman, Phelps & McNamara, P.C. (HPM)

Vol #:

149

C 73

Attachment

Centers for Disease Control and Prevention (CDC)

Vol #:

149

C 74

GOJO Industries, Inc.

Vol #:

149

C 75

Attachments 1-13, 14

GOJO Industries, Inc.

Vol #:

154

C 76

Appendix A, B, C, D, E, F

Healthpoint, Ltd

Vol #:

155

C 77

Table of contents

Bayer Corporation (Bayer)

Vol #:

156

C 78

Table of contents

3M Health Care

Vol #:

159

EMC 2

Massachusetts Department of Public Health

Vol #:

149

EMC 3

Attachment 1, 2, 3

Hospital of Saint Raphael

Vol #:

149

EMC 4

Attachment

American Hospital Assn

Vol #:

149

EMC 5

Michele L. Pearson, MD

Vol #:

149

EMC 6

William E. Scheckler, MD

Vol #:

149

EMC 7

Loretta Litz Fauerbach

Vol #:

149

EMC 8

Viral Shield Pharmaceuticals, Inc.

Vol #:

149

EMC 9

Viral Shield Pharmaceuticals, Inc.

Vol #:

149

EMC 10

Beth H. Stover, RN, CIC

Vol #:

149

EMC 11

Raymond Chinn, MD, FACP

Vol #:

149

EMC 12

Attachment

GOJO Industries, Inc.

Vol #:

149

1994P-0215

Amend monograph to include Valerian as OTC sleep-aid product

ANS 1

HFC-1 to Bass & Ullman, PC

Vol #:

3

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 864

J Sheen

Vol #:

375

EMC 865

Robert P Roehm

Vol #:

375

EMC 866

Robert P Roehm

Vol #:

375

EMC 867

Jeannie Perry

Vol #:

375

EMC 868

Tomarnham

Vol #:

375

EMC 869

Jim FitzGerald

Vol #:

375

EMC 870

Plybybunn

Vol #:

375

EMC 871

Odis England

Vol #:

375

EMC 872

Odis England

Vol #:

375

EMC 873

Mrs. H

Vol #:

375

EMC 874

Brenda M Overcash

Vol #:

375

EMC 875

Delmar

Vol #:

375

EMC 876

J Cross

Vol #:

375

EMC 877

Nick Savko

Vol #:

375

EMC 878

John Snijders

Vol #:

375

EMC 879

bbdigger

Vol #:

375

EMC 880

Nancy Wetzel

Vol #:

375

EMC 881

Bill Todd

Vol #:

375

EMC 882

Coulter Gaddy

Vol #:

375

EMC 883

Dr Bob Willhite AMP

Vol #:

375

EMC 884

andrina Correia

Vol #:

375

EMC 885

Concerned Consumer

Vol #:

375

EMC 886

Steve Maser

Vol #:

375

EMC 887

Concerned Citizen

Vol #:

375

EMC 888

Joy Shorkey

Vol #:

375

EMC 889

Denise Brown

Vol #:

375

EMC 890

Brian Riely PhD

Vol #:

375

EMC 891

Ephedra taker for years and never been healthier

Vol #:

375

EMC 892

Lell

Vol #:

375

EMC 893

Mike Carroll

Vol #:

375

1997S-0163

Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 707

HFS-800 to Amasia Acupuncture & Herbs Ltd

Vol #:

21

LET 708

HFS-800 to Doctor's Brand, LP

Vol #:

21

LET 709

HFS-800 to New Chapter, Inc

Vol #:

21

LET 710

HFS-800 to Wellness International Network, Ltd

Vol #:

21

LET 711

HFS-800 to Jarrow Formulas

Vol #:

21

LET 712

HFS-800 to Prostate Rx, Inc

Vol #:

21

LET 713

HFS-800 to Tabak's Health Products

Vol #:

21

LET 714

HFS-800 to Source Naturals Inc

Vol #:

21

LET 715

HFS-800 to Rexall Inc

Vol #:

21

LET 716

HFS-800 to Weider Nutrition International Inc

Vol #:

21

LET 717

HFS-800 to Essere Corporation

Vol #:

21

LET 718

HFS-800 to Hyman, Phelps & McNamara for Purac Biochem bv

Vol #:

21

1998P-0169

Labeling Standards for Botanicals, Homeopathics, etc.

SUP 3

Pharmacists Planning Service, Inc

Vol #:

1

2001P-0572

Petition for Regulation of Ariva Tobacco Lozenges

PDN 1

HFC-1 to National Center for Tobacco-Free Kids Inc

Vol #:

3

2002N-0275

Bioterrorism Preparedness; Administrative Detention

C 50

Ontario Fruit and Vegetable Growers Association

Vol #:

8

EMC 85

Suzanne

Vol #:

8

EMC 86

Ministry of Fisheries of the Socialist Republic of Vietnam

Vol #:

8

2002P-0075

Flavored Candy-like Products Containing Tobacco

PDN 1

HFC-1 to Alan R Bennette for GlaxoSmithKline Consumer Healthcare

Vol #:

3

2003D-0092

Food and Cosmetic Security Guidances

C 4

National Council of Chain Restaurants

Vol #:

1

2003D-0165

Current Good Manufacturing Practices for Medical Gases

NEC 2

FDA

Vol #:

1

2003D-0364

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs

GDL 1

Guidance

Vol #:

1

NAD 1

FDA

Vol #:

1

2003E-0402

Patent Term Extension Application for Acrysof, U.S. Patent No. 5,470,932

APP 1

Alcon Research, Ltd.

Vol #:

1

LET 1

U.S. Patent & Trademark Office