Dockets Entered On September 11, 2003

Table of Contents

Docket #

Title

1977N-0094. 1           OTC Internal Analgesic, Antipyretic & Antirheumatic Products. 1

1994P-0036. 1           Req labeling of trans fatty acid & prohibit deceptive claims. 1

1997S-0162. 1           30-Day Structure Function Claim Notification Letters Dietary. 1

1998F-0196. 2           Safe use of Selenium Yeast in Animal Feeds. 2

2002N-0178. 2           Canned Tomatoes Deviating from Identity Standard. 2

2003D-0317. 2           Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products  2

2003N-0053. 2           Interstate Shellfish Dealers Certificate; Information Collect 2

2003N-0075. 2           Administrative Detention and Banned Med. Devices; Agency Infor 2

2003N-0198. 2           Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License  2

2003N-0369. 2           Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications; Determination That LUVOX (Fluvoxamine Maleate) 25-Milligram (mg), 50-mg, 100-mg, and 150-mg Tablets Was Not Withdrawn. 2

2003N-0376. 2           Medical Devices: Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees  2

2003V-0426. 2           Laser Light Show. 2

1977N-0094

OTC Internal Analgesic, Antipyretic & Antirheumatic Products

EMC 1

Reddy-Cheminor and Dr. Reddy's Laboratories

Vol #:

235

1978N-0038

Sunscreen Drug Products

EMC 7

Doreen Tuell

Vol #:

150

1994P-0036

Req labeling of trans fatty acid & prohibit deceptive claims

NAL 1

FDA

Vol #:

84

SS 1

Supporting Statement

Vol #:

84

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 894

Natalie Thackston

Vol #:

375

EMC 895

Mary Dumdey

Vol #:

375

EMC 896

Leandra Reyes

Vol #:

375

EMC 897

No signature

Vol #:

375

EMC 898

Vanessa Pagan

Vol #:

375

EMC 899

James Randall

Vol #:

375

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

EMC 253

Louis Shoe

Vol #:

41

1997P-0329

Require Quantitative Labeling of Caffeine Content

EMC 82

Traci Bynum

Vol #:

7

EMC 83

Cappiill3

Vol #:

7

EMC 84

Nancy S. Keithley, M.Ed., B.A.T.

Vol #:

7

EMC 85

Jo - Ann Villani

Vol #:

7

EMC 86

Linda Davis

Vol #:

7

EMC 87

Lisa Diebel

Vol #:

7

EMC 88

H. Jellison

Vol #:

7

EMC 89

Carla Berra

Vol #:

7

EMC 90

Bill Peterson

Vol #:

7

EMC 91

NODNOLKRAM

Vol #:

7

EMC 92

Noel Brinkerhoff

Vol #:

7

EMC 93

Anne Lynch

Vol #:

7

EMC 94

Mrs. Ann Bach

Vol #:

7

EMC 95

Shauna Rivas

Vol #:

7

EMC 96

Craig Nelson

Vol #:

7

EMC 97

Steven P. Alpert

Vol #:

7

EMC 98

Tami

Vol #:

7

EMC 99

Leona A. Rivera

Vol #:

7

EMC 100

Leslie Howard

Vol #:

7

EMC 101

Alma Ramos

Vol #:

7

EMC 102

David Sauerwein

Vol #:

7

EMC 103

Sydney M. Coffin

Vol #:

7

EMC 104

Susan Amerson

Vol #:

7

EMC 105

Timothy A. Harrison

Vol #:

7

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10854

PhytoPharmica Natural Medicines

Vol #:

82

LET 10855

Perrigo Company of South Carolina

Vol #:

82

LET 10856

PhytoPharmica Natural Medicines

Vol #:

82

LET 10857

Twin Laboratories, Inc.

Vol #:

82

LET 10858

Twin Laboratories, Inc.

Vol #:

82

LET 10859

Twin Laboratories, Inc.

Vol #:

82

LET 10860

Twin Laboratories, Inc.

Vol #:

82

LET 10861

PhytoPharmica Natural Medicines

Vol #:

82

LET 10862

PhytoPharmica Natural Medicines

Vol #:

82

LET 10863

PhytoPharmica Natural Medicines

Vol #:

82

LET 10864

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10865

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10866

PhytoPharmica Natural Medicines

Vol #:

82

LET 10867

Bayer Corporation Consumer Care Division

Vol #:

82

LET 10868

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10869

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10870

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10871

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10872

PhytoPharmica Natural Medicines

Vol #:

82

LET 10873

PhytoPharmica Natural Medicines

Vol #:

82

LET 10874

PhytoPharmica Natural Medicines

Vol #:

82

LET 10875

Twin Laboratories, Inc.

Vol #:

82

LET 10876

Twin Laboratories, Inc.

Vol #:

82

LET 10877

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10878

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10879

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10880

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10881

Quality of Life Labs

Vol #:

82

LET 10882

Pure Encapsulations, Inc.

Vol #:

82

1998D-1146

Microbial effects of antimicrobial new animal drugs/human sa

EMC 693

Marie Beard

Vol #:

19

EMC 694

Joan Wiinblad

Vol #:

19

EMC 695

Joan Wiinblad

Vol #:

19

1998F-0196

Safe use of Selenium Yeast in Animal Feeds

NFR 3

FDA

Vol #:

1

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

EMC 3610

Jacquelyn Bruchis

Vol #:

295

EMC 3611

Kim Intino

Vol #:

295

EMC 3612

Jennifer Foley

Vol #:

295

EMC 3613

Odette J. Walkens

Vol #:

295

EMC 3614

Ruby Craven

Vol #:

295

EMC 3615

Donna Fontaine

Vol #:

295

EMC 3616

Marion E. Tobin

Vol #:

295

EMC 3617

Rebecca Rhodes

Vol #:

295

EMC 3618

Cathy Ely

Vol #:

295

EMC 3619

Y. Lebris

Vol #:

295

EMC 3620

Holly Bowe

Vol #:

295

EMC 3621

Jon Gordon

Vol #:

295

EMC 3622

Doraine Van Lew

Vol #:

295

EMC 3623

Susan Shields

Vol #:

295

EMC 3624

Eileen Stark

Vol #:

295

EMC 3625

William Jordan

Vol #:

295

EMC 3626

Mr. & Mrs. James L. Denison

Vol #:

295

EMC 3627

Kristina

Vol #:

295

EMC 3628

Jennifer Walter

Vol #:

295

EMC 3629

Ronda K. Everson

Vol #:

295

EMC 3630

Connie Garcia

Vol #:

295

EMC 3631

Maureen Mahon

Vol #:

295

EMC 3632

Alice Soliman

Vol #:

295

EMC 3633

Robin

Vol #:

295

EMC 3634

Barb Wilkie

Vol #:

295

EMC 3635

Jessica Lee

Vol #:

295

EMC 3636

Linda Benninghoff

Vol #:

295

EMC 3637

Stefanie Matula

Vol #:

295

1999D-1738

Bioavilability & Bioequivalence Studies for Nasal Aerosols

EMC 3

Claire Cordell

Vol #:

2

EMC 4

Claire Cordell

Vol #:

2

1999F-4372

National Fisheries Institute and the Louisiana Dep of Agricu

EMC 437

Scott Carpenter

Vol #:

8

EMC 438

Wendy W. Smith

Vol #:

8

EMC 439

Matt Smith

Vol #:

8

EMC 440

Lisa Lynn

Vol #:

8

1999F-5321

Food Safety & Inspection service safe use of ionizing radiai

EMC 340

Scott Carpenter

Vol #:

8

EMC 341

Wendy W. Smith

Vol #:

8

EMC 342

Matt Smith

Vol #:

8

EMC 343

Lisa Lynn

Vol #:

8

1999F-5322

Ionizing Radiation for the Treatment of Food

EMC 339

Scott Carpenter

Vol #:

6

EMC 340

Wendy W. Smith

Vol #:

6

EMC 341

Matt Smith

Vol #:

6

EMC 342

Lisa Lynn

Vol #:

6

1999F-5522

Ionizing radiation /control of Food-borne pathogens safe use

EMC 342

Scott Carpenter

Vol #:

6

EMC 343

Wendy W. Smith

Vol #:

6

EMC 344

Matt Smith

Vol #:

6

EMC 345

Lisa Lynn

Vol #:

6

1999N-4282

Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 4033

Tanya Baker

Vol #:

514

EMC 4034

Chris Morris

Vol #:

514

EMC 4035

Nicholas Malfitani

Vol #:

514

EMC 4036

Scott Carpenter

Vol #:

514

EMC 4037

Emmett J. Murphy

Vol #:

514

EMC 4038

Gregory Steel

Vol #:

514

2000D-1598

Voluntary Labeling for Bioengineered Foods

EMC 12013

Patricia Gavin

Vol #:

574

2000P-1211

Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12715

John Ball

Vol #:

785

EMC 5654

Tanya Baker

Vol #:

785

EMC 5655

Chris Morris

Vol #:

785

EMC 5656

Nicholas Malfitani

Vol #:

785

EMC 5657

Scott Carpenter

Vol #:

785

EMC 5658

Emmett J. Murphy

Vol #:

785

EMC 5659

Gregory Stell

Vol #:

785

EMC 5660

Lisa K. Altizer

Vol #:

785

EMC 5661

Dennis Robinson

Vol #:

785

2000P-1322

Food Labeling and Allergen Contamination Control

EMC 533

Mark and Lisa Lawrence

Vol #:

20

EMC 534

Charisma

Vol #:

20

2001F-0047

Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 444

Scott Carpenter

Vol #:

8

EMC 445

Wendy W. Smith

Vol #:

8

EMC 446

Matt Smith

Vol #:

8

EMC 447

Lisa Lynn

Vol #:

8

2001P-0345

Listing the color additive yellow #5 for use in food/Drug

EMC 1190

Robin Stillwell

Vol #:

5

EMC 1191

Anita Ribail

Vol #:

5

EMC 1192

Ellen Luke

Vol #:

5

EMC 1193

William Hopkins

Vol #:

5

EMC 1194

Virginia Jens

Vol #:

5

EMC 1195

Mary Ann Canter

Vol #:

5

EMC 1196

Penelope Bateman

Vol #:

5

2002D-0325

Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

EMC 125

Lainie Rossilli

Vol #:

3

EMC 126

Sherri VanDoren

Vol #:

3

EMC 127

Antoinette Cloutier

Vol #:

3

2002N-0178

Canned Tomatoes Deviating from Identity Standard

NEC 1

FDA

Vol #:

1

2002P-0317

Recall Aspartame as a Neurotoxic Drug

EMC 265

Maxine Murray, CNHP, ND, CNC

Vol #:

5

EMC 266

Charmelle

Vol #:

5

EMC 267

Don Harkins

Vol #:

5

EMC 268

Charmelle

Vol #:

5

EMC 269

Ingri Cassel

Vol #:

5

EMC 270

LeeAnn

Vol #:

5

2003D-0317

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

EMC 1

GlaxoSmithKline

Vol #:

1

2003N-0053

Interstate Shellfish Dealers Certificate; Information Collect

NAL 1

FDA

Vol #:

1

SS 1

Supporting Statement

Vol #:

1

2003N-0059

Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EMC 2

Dr. Thomas Kolesar, PhD

Vol #:

1

2003N-0075

Administrative Detention and Banned Med. Devices; Agency Infor

NAL 1

FDA

Vol #:

1

SS 1

Supporting Statement

Vol #:

1

2003N-0198

Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License

NCR 1

FDA

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

EC 20

Daniels, Rebecca

Vol #:

1

EC 21

Pillon, Priscilla

Vol #:

1

EC 22

Pessoney, Ann

Vol #:

1

2003N-0369

Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications; Determination That LUVOX (Fluvoxamine Maleate) 25-Milligram (mg), 50-mg, 100-mg, and 150-mg Tablets Was Not Withdrawn

NWL 1

FDA

Vol #:

1

2003N-0376

Medical Devices: Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees

N 1

FDA

Vol #:

1

2003P-0321

Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin

EMC 79

Merry

Vol #:

2

EMC 80

David Brown

Vol #:

2

2003V-0426

Laser Light Show

ACK 1

HFA-305 to Celebration City

Vol #:

1

VAR 1

Celebration City

Vol #:

1