Dockets Management

Dockets Entered On August 25, 2003

Table of Contents

Docket #

Title

1978N-0038. 1     Sunscreen Drug Products. 1

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

1998P-0151. 2     Introduction Of Downed Cattle Into The Food Supply. 2

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

2003D-0231. 2     Draft Guidance for Industry on Providing Regulatory Submissions in Electronic  Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability  2

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

2003P-0039. 2     Policy regarding users fee and Orphan Drug. 2

2003P-0178. 2     ANDA Suitability for Divalproex Sodium Extended-Release Tabs. 2

2003P-0184. 2     Permit filing of ANDA for nafcillin for injection, USP, phar 2

2003V-0378. 2     Laser Light Show. 2

1978N-0038

Sunscreen Drug Products

ACK 8

CTFA & CHPA

Vol #:

148

CP 14

CTFA & CHPA

Vol #:

148

Introduction, bibliography,

references

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10630

Global Chinese Herbs Depot Inc.

Vol #:

80

LET 10631

Solstice Medicine Company

Vol #:

80

LET 10632

Solstice Medicine Company

Vol #:

80

LET 10633

Tabak's Health Products

Vol #:

80

LET 10634

Leiner Health Products

Vol #:

80

LET 10635

Optio Health Products

Vol #:

80

LET 10636

Optio Health Products

Vol #:

80

LET 10637

Optio Health Products

Vol #:

80

LET 10638

Optio Health Products

Vol #:

80

LET 10639

Optio Health Products

Vol #:

80

LET 10640

Source Naturals

Vol #:

80

LET 10641

FoodScience corporation

Vol #:

81

LET 10642

FoodScience Corporation of Vermont

Vol #:

81

LET 10643

FoodScience Corporation of Vermont

Vol #:

81

LET 10644

FoodScience Corporation of Vermont

Vol #:

81

LET 10645

FoodScience corporation of Vermont

Vol #:

81

LET 10646

FoodScience Corporation of Vermont

Vol #:

81

LET 10647

PharmaVite

Vol #:

81

LET 10648

PharmaVite Corporation

Vol #:

81

LET 10649

Your Vitamins

Vol #:

81

LET 10650

RKS, Inc.

Vol #:

81

LET 10651

PhytoPharmica Natural Medicine

Vol #:

81

LET 10652

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10653

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10654

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10655

General Vitamin Corporation

Vol #:

81

LET 10656

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10657

Enzymatic Therapy Natural Medicines

Vol #:

81

LET 10658

PhytoPharmica Natural Medicines

Vol #:

81

LET 10659

Source Naturals

Vol #:

81

LET 10660

Twin Laboratories, Inc.

Vol #:

81

LET 10661

Twin Laboratories, Inc.

Vol #:

81

LET 10662

Twin laboratories, Inc.

Vol #:

81

LET 10663

Tech World Corporation

Vol #:

81

LET 10664

Leiner Health Products

Vol #:

81

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 6878

Lisa & Gregory Cross

Vol #:

293

C 6879

Sylvia J. Nichols

Vol #:

293

C 6880

Mr. & Mrs. William H. Vernon

Vol #:

293

C 6881

Mr. Donald Tinkham

Vol #:

293

C 6882

Betty Ann LaGrassa

Vol #:

293

C 6883

Frances Oelbaum

Vol #:

293

C 6884

Marian Penhorwood

Vol #:

293

C 6885

Heather Sigman

Vol #:

293

C 6886

Janice Emich

Vol #:

293

C 6887

Lois Hallas

Vol #:

293

C 6888

Linda Muggli

Vol #:

293

C 6889

Danita D. Sorenson, Ph.D.

Vol #:

293

C 6890

Karin M. Hart.

Vol #:

293

C 6891

Christine Morgan

Vol #:

293

C 6892

C. Murrow Quarter Horses

Vol #:

293

C 6893

Laura Andrulckaitis

Vol #:

293

C 6894

Lurin Jones

Vol #:

293

C 6895

Heather Harrison - Rouillard

Vol #:

294

C 6896

Vivienne De Maio

Vol #:

294

C 6897

Betty A. Gould

Vol #:

294

C 6898

Linda A. Brewster

Vol #:

294

C 6899

Mrs. Shirley Kusick

Vol #:

294

C 6900

Lesha Stull

Vol #:

294

C 6901

Crystal Wachter

Vol #:

294

EMC 3478

Maria Casson

Vol #:

281

EMC 3479

Cara Tomson

Vol #:

281

EMC 3480

Jennifer K. Himes

Vol #:

281

EMC 3481

pg Srubas

Vol #:

281

EMC 3482

Mrs. Phyllis Brown

Vol #:

281

EMC 3483

Rita Leone

Vol #:

281

EMC 3484

Mary Lou Little

Vol #:

281

EMC 3485

Dennis Sichner

Vol #:

281

EMC 3486

Lisa Carver

Vol #:

281

EMC 3487

Sophia Rubimstein

Vol #:

281

EMC 3488

Linda Benninghoff

Vol #:

281

EMC 3489

Toniann Minafo

Vol #:

281

EMC 3490

Liz Jamison

Vol #:

281

EMC 3491

Travis Sherer

Vol #:

281

EMC 3492

Nancy Malin

Vol #:

281

EMC 3493

Lisa R. Nelson

Vol #:

281

EMC 3494

Maxine Hillary, M.A.

Vol #:

281

EMC 3495

Katie Hogan

Vol #:

281

EMC 3496

Donna Chittum

Vol #:

281

EMC 3497

Gail Richardson

Vol #:

281

EMC 3498

Debra Kovacs

Vol #:

281

EMC 3499

Cheryl Schaile

Vol #:

281

EMC 3500

Cathy Foster

Vol #:

281

EMC 3501

Lisa Hilton

Vol #:

281

EMC 3502

Sandi Dahl

Vol #:

281

EMC 3503

Mary Belcastro

Vol #:

281

EMC 3504

Corinne Giles

Vol #:

281

EMC 3505

Maggie Zelonis

Vol #:

281

EMC 3506

Nancy Peterson

Vol #:

281

EMC 3507

The Notah Family

Vol #:

281

EMC 3508

Anne Peralta & Roman Gora

Vol #:

281

EMC 3509

Leslie Carver

Vol #:

281

EMC 3510

Alexa Stickel

Vol #:

281

EMC 3511

Lorna Phillipson

Vol #:

281

EMC 3512

Leslie C. Wilson

Vol #:

281

EMC 3513

Karen Kohlhoff

Vol #:

281

EMC 3514

number not used

Vol #:

281

EMC 3515

Patrick Cartwright, Jr.

Vol #:

281

EMC 3516

Nancy Mayo

Vol #:

281

EMC 3517

Meredith Erickson

Vol #:

281

EMC 3518

Leah McIvor

Vol #:

281

EMC 3519

Julia A. Keller

Vol #:

281

EMC 3520

Lillian L. Martin

Vol #:

281

EMC 3521

Susan Peters

Vol #:

281

EMC 3522

Karen Bruining

Vol #:

281

EMC 3523

Thomas R. Miller

Vol #:

281

EMC 3524

COG145

Vol #:

281

EMC 3525

Linda Muggli

Vol #:

281

2002N-0278

Bioterrorism; Prior Notice of Imported Food Shipments

ANS 3

HFW-1 to Hon. Sherrod Brown

Vol #:

15

ANS 4

HFW-1 to Hon Charles W 'Chip' Pickering

Vol #:

15

C 227

Congress of the US, House of Representatives

Vol #:

15

C 228

Congress of the US, House of Representatives

Vol #:

15

EMC 119

Suzanne

Vol #:

15

LET 10

HFW-1 to Hon. Thomas H Allen

Vol #:

15

2003D-0231

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic
Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability

C 3

Aventis Pharmaceuticals

Vol #:

1

C 4

Abbott Laboratories

Vol #:

1

EXT 1

Pharmaceutical Research and Manufacturers of America (PhRMA)

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

NM 2

FDA

Vol #:

1

2003P-0039

Policy regarding users fee and Orphan Drug

LET 1

HF-22 to Orphan Medical

Vol #:

1

2003P-0178

ANDA Suitability for Divalproex Sodium Extended-Release Tabs

PAV 1

HFD-600 to Lachman Consultant Services, Inc.

Vol #:

1

2003P-0184

Permit filing of ANDA for nafcillin for injection, USP, phar

PAV 1

HFD-600

Vol #:

1

2003V-0378

Laser Light Show

ACK 1

HFA-305 to Northwest Lanes

Vol #:

1

VAR 1

Northwest Lanes

Vol #:

1