Dockets Management

Dockets Entered On July 31, 2003

Table of Contents

Docket #

Title

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

1979D-0465. 1        LIMULUS AMEBOCYTE LYSATE. 1

1988N-0038. 1        Records & Reports concerning experience w/ new animal drugs. 1

2000N-1484. 2        Safety Reporting Requirements Human Drug/Biological Products. 2

2001Q-0313. 2        Health Claim Petition for Soluble Fiber from Oatrim.. 2

2002D-0526. 2        Guidance for drug Chemistry, Manufacturing, Control Info. 2

2002E-0339. 2        Benicar, U.S. Patent No. 5,616,599. 2

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

2002N-0276. 2        Bioterrorism Preparedness; Registration of Food Facilities. 2

2002N-0277. 2        Bioterrorism; Establishment & Maintenance of Records. 2

2002N-0278. 2        Bioterrorism; Prior Notice of Imported Food Shipments. 2

2003D-0112. 2        Independent Consultants for Biotechnology Clinical Trials. 2

2003D-0120. 2        Multiplex Tests for Heritable DNA Markers, Mutations & Expre. 2

2003D-0299. 2        Class II Special Controls Guidance Document: Breast Lesion Documentation System   2

2003D-0317. 2        Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products  2

2003N-0034. 2        FDA Safety Alert/ Public Health Advisory Readership Survey. 2

2003N-0106. 2        Using FDA forms 3503/3504 submissions Petitions, Food/color 2

2003N-0211. 2        Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma  2

2003N-0294. 2        Risk Management Plans for Opiate Analgesic Drug. 2

2003N-0318. 2        Agency Information Collection Activities: Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products. 2

2003P-0301. 2        Classification of the Breast Lesion Documentation System.. 2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

ANS 4

Attachment

HFD-560 to SDA & CTFA

Vol #:

149

1979D-0465

LIMULUS AMEBOCYTE LYSATE

GDL 2

Guidance

Vol #:

2

1988N-0038

Records & Reports concerning experience w/ new animal drugs

NAL 1

FDA

Vol #:

3

SS 1

Supporting Statement

Vol #:

3

1998D-1146

Microbial effects of antimicrobial new animal drugs/human sa

EMC 690

Eileen Schram

Vol #:

19

EMC 691

Lynne Turner

Vol #:

19

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 6771

Julie

Vol #:

291

C 6772

Karen Zielen

Vol #:

291

C 6773

Jeannie Kahany

Vol #:

291

C 6774

Evy Borggren

Vol #:

291

C 6775

Melanie Szekeres

Vol #:

291

C 6776

Tanya Gelfand

Vol #:

291

C 6777

Arleen Rich

Vol #:

291

C 6778

Shirley O'Connor

Vol #:

291

C 6779

Victoria Antman

Vol #:

291

C 6780

B. R.

Vol #:

291

C 6781

Stephanie Horn

Vol #:

291

C 6782

Martine Sankari

Vol #:

291

C 6783

Ms. Jill Cresko

Vol #:

291

C 6784

Ella E. Peterson & Edna F. Dugger

Vol #:

291

C 6785

John T. Guntrum

Vol #:

291

C 6786

Dr. Mitchell Peritz

Vol #:

291

C 6787

Ms. Marilyn Sue Betman

Vol #:

291

C 6788

Ms. June Tilson

Vol #:

291

C 6789

Angie Choren

Vol #:

291

C 6790

Thomas Swann

Vol #:

291

C 6791

Nora Kramer

Vol #:

291

C 6792

Edith J. Leibe

Vol #:

291

C 6793

Mrs. Jennifer Gillen

Vol #:

291

EMC 3463

Ellen Gleskow

Vol #:

281

EMC 3464

Sharon Hodges

Vol #:

281

EMC 3465

Justin

Vol #:

281

EMC 3466

Tom Nixon

Vol #:

281

EMC 3467

David Schneider

Vol #:

281

EMC 3468

Renee S. Cariglia

Vol #:

281

EMC 3469

Diandra Sanphy

Vol #:

281

EMC 3470

John Vrabel

Vol #:

281

EMC 3471

Cindy Keegan

Vol #:

281

EMC 3472

Connie Bozeman

Vol #:

281

2000N-1484

Safety Reporting Requirements Human Drug/Biological Products

EMC 7

American Pharmaceutical Partners, Inc.

Vol #:

3

EMC 8

National Assn. of Chain Drug Stores

Vol #:

3

2001Q-0313

Health Claim Petition for Soluble Fiber from Oatrim

NFR 1

FDA

Vol #:

4

2002D-0526

Guidance for drug Chemistry, Manufacturing, Control Info.

ANS 1

HFD-357 to PhRMA

Vol #:

1

2002E-0339

Benicar, U.S. Patent No. 5,616,599

N 1

FDA

Vol #:

1

2002N-0275

Bioterrorism Preparedness; Administrative Detention

C 48

Government of Japan

Vol #:

8

EMC 84

Attachment

Food and Drink Federation

Vol #:

8

MM 10

FDA and European Commissioner (July 17, 2003

Vol #:

8

2002N-0276

Bioterrorism Preparedness; Registration of Food Facilities

C 161

Uniform Code Council, Inc.

Vol #:

13

C 162

Canadian Plastics Industry Association

Vol #:

13

C 163

National Tank Truck Carriers

Vol #:

13

EMC 93

Iacobucci USA Inc

Vol #:

13

EMC 94

National Tank Truck Carriers

Vol #:

13

EMC 95

Mirasco Uruguay SA

Vol #:

13

EMC 96

Food and Drunk Federation

Vol #:

13

2002N-0277

Bioterrorism; Establishment & Maintenance of Records

C 96

Land O Lakes' Feed

Vol #:

16

C 97

Northwest Food Processors Association

Vol #:

16

C 98

Continental Airlines Inc/Chelsea Food Service

Vol #:

16

C 99

Schnucks Markets, Inc.

Vol #:

16

C 100

Mike Harrington

Vol #:

16

C 101

Department of the Treasury, Alcohol & Tobacco Tax and Trade Bureau

Vol #:

16

C 102

Harris Teeter, Inc.

Vol #:

16

C 103

Government of Japan

Vol #:

16

EMC 150

California Tomato Commission, Almond Hullers & Processor Association, et al

Vol #:

16

EMC 151

Freshfel Europe

Vol #:

16

EMC 152

Food and Drink Federation

Vol #:

16

Attachment 1, 2

EMC 153

Food Processors of Canada

Vol #:

16

EMC 154

Food and Drink Federation

Vol #:

16

Attachment 1, 2

MM 10

FDA and Special Advisor to European Commission

Vol #:

16

2002N-0278

Bioterrorism; Prior Notice of Imported Food Shipments

C 225

Canadian Plastics Industry Association

Vol #:

15

C 226

National Tank Truck Carriers

Vol #:

15

EMC 116

Iacobucci USA Inc

Vol #:

15

EMC 117

National Tank Truck Carriers

Vol #:

15

EMC 118

Attachment 1, 2

Food and Drink Federation

Vol #:

15

2003D-0112

Independent Consultants for Biotechnology Clinical Trials

EMC 1

Merck Research Laboratories/GRP

Vol #:

1

2003D-0120

Multiplex Tests for Heritable DNA Markers, Mutations & Expre

C 17

Gene Express, Inc.

Vol #:

1

2003D-0299

Class II Special Controls Guidance Document: Breast Lesion Documentation System

GDL 1

Guidance

Vol #:

1

NAD 1

FDA

Vol #:

1

2003D-0317

Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products

GDL 1

Guidance

Vol #:

1

NAD 1

FDA

Vol #:

1

2003N-0034

FDA Safety Alert/ Public Health Advisory Readership Survey

NAL 1

FDA

Vol #:

1

SS 1

Supporting Statement

Vol #:

1

2003N-0106

Using FDA forms 3503/3504 submissions Petitions, Food/color

N 2

FDA

Vol #:

1

2003N-0211

Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma

NPR 1

FDA

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

NM 1

FDA

Vol #:

1

2003N-0318

Agency Information Collection Activities: Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

N 1

FDA

Vol #:

1

2003P-0291

Enforce the law and prevent unlaw sale of contact lens

C 9

Jonathan L Warner, OD

Vol #:

1

2003P-0301

Classification of the Breast Lesion Documentation System

NFR 1

FDA

Vol #:

1

2003V-0345

Beam Bouncers Laser Show

ACK 1

HFA-305 to Beam Bounce Laser Show

Vol #:

1

VAR 1

Beam Bouncers Inc.

Vol #:

1