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Dockets Management

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dockets Entered On June 23, 2003

TABLE OF CONTENTS (Linked)

 

 

 

Docket #

 

Title

 

 

1980N-0348

 

Ingrown Toenail Drug Products for OTC Human Use

 

 

1995N-0304

 

Ephedrine Alkaloids: Reports of Adverse Events; Availability

 

 

1996N-0417

 

CGMP in Mfg. Packing or Holding Dietary Supplements

 

 

1998D-0785

 

Medical imaging drugs and biologics

 

 

1998N-0359

 

Program priorities/Center for Food Safety & Applied Nutritin

 

 

2002D-0526

 

Guidance for drug Chemistry, Manufacturing, Control Info.

 

 

2002N-0204

 

Bar Code Label Requirements for human drug products

 

 

2002N-0417

 

Applications for FDA Approval to Market a New Drug

 

 

2002N-0475

 

Financial Relationships & Interest in Research Involving Hum

 

 

2003D-0061

 

Comparability Protocols Chemistry Manufacturing and controls

 

CONTENTS

 

1978N-0021A

 

Skin Protectant Drug Prod to OTC, Astringent Drug Products

 

 

NFR 3

 

FDA

 

Vol #:

 

1

 

 

 

NPR 2

 

FDA

 

Vol #:

 

1

 

 

1980N-0348

 

Ingrown Toenail Drug Products for OTC Human Use

 

 

LET 4

 

HFD-560 to Schering-Plough HealthCare Products

 

Vol #:

 

1

 

 

1990S-0308

 

Generic Drug Speeches & Policy and Procedure Guides

 

 

M 730

 

Monthly Quantitative Report and Statistical Charts 12/31/2002

 

Vol #:

 

52

 

 

 

M 731

 

Quantitative Report Statistical Charts 9/30/2002

 

Vol #:

 

52

 

 

 

M 732

 

Statistical Report for March 2003

 

Vol #:

 

52

 

 

 

M 733

 

Statistical Report for Month of May 2003

 

Vol #:

 

52

 

 

 

1994P-0036

 

Req labeling of trans fatty acid & prohibit deceptive claims

 

 

EMC 549

 

Dan Early

 

Vol #:

 

72

 

 

 

EMC 550

 

Matt Hays and Students of Platt College

 

Vol #:

 

72

 

 

 

1994V-0365

 

Laser Light Show

 

 

VRA 2

 

HFZ-300 to The United Center

 

Vol #:

 

1

 

 

 

1995N-0304

 

Ephedrine Alkaloids: Reports of Adverse Events; Availability

 

 

EMC 789

 

Ephedra Education Council (EEC)

 

Vol #:

 

375

 

 

 

EMC 790

 

Helen J. Westfall

 

Vol #:

 

375

 

 

 

EMC 791

 

Pete King

 

Vol #:

 

375

 

 

 

EMC 792

 

Nancy M. Winter

 

Vol #:

 

375

 

 

 

EMC 793

 

Representative Dan Burton

 

Vol #:

 

375

 

 

 

EMC 794

 

Keith Hoffman

 

Vol #:

 

375

 

 

 

EMC 795

 

no signature

 

Vol #:

 

375

 

 

 

EMC 796

 

Judith J. Doebereiner

 

Vol #:

 

375

 

 

 

EMC 797

 

no signature

 

Vol #:

 

375

 

 

 

EMC 798

 

Amy Huffman

 

Vol #:

 

375

 

 

 

EMC 799

 

John Curley

 

Vol #:

 

375

 

 

 

EMC 800

 

Fugua & Keim, L.L.P.

 

Vol #:

 

375

 

 

 

EMC 801

 

Shawn Jackson Shoulders

 

Vol #:

 

375

 

 

 

EMC 802

 

Victoria Kemp

 

Vol #:

 

375

 

 

 

EMC 803

 

Howard D. Swainston

 

Vol #:

 

375

 

 

 

EMC 804

 

Janet Lubrano

 

Vol #:

 

375

 

 

 

EMC 805

 

Jennifer Rasmussen

 

Vol #:

 

375

 

 

 

1996N-0417

 

CGMP in Mfg. Packing or Holding Dietary Supplements

 

 

EMC 21

 

T. Thorstensen

 

Vol #:

 

17

 

 

 

EMC 22

 

Team Indfrag

 

Vol #:

 

17

 

 

 

EMC 23

 

Sharon Knoll

 

Vol #:

 

17

 

 

 

EMC 24

 

Harry N. Dawson, RLA

 

Vol #:

 

17

 

 

 

EMC 25

 

George Mason University

 

Vol #:

 

17

 

 

 

1997P-0329

 

Require Quantitative Labeling of Caffeine Content

 

 

EMC 6

 

Claudio Freixas, Jr.

 

Vol #:

 

7

 

 

 

EMC 7

 

Allison Starsoneck

 

Vol #:

 

7

 

 

 

EMC 8

 

Jill Farnham

 

Vol #:

 

7

 

 

 

EMC 9

 

Lorie Mosteller

 

Vol #:

 

7

 

 

 

EMC 10

 

C.E. Ryan

 

Vol #:

 

7

 

 

 

EMC 11

 

Mike Heisler

 

Vol #:

 

7

 

 

 

EMC 12

 

Jeffrey Cohen

 

Vol #:

 

7

 

 

 

EMC 13

 

Lisa Chambers

 

Vol #:

 

7

 

 

 

EMC 14

 

Alydia

 

Vol #:

 

7

 

 

 

EMC 15

 

Theresa Ogden

 

Vol #:

 

7

 

 

 

EMC 16

 

Denise Veitch

 

Vol #:

 

7

 

 

 

EMC 17

 

Jack M. Beermann

 

Vol #:

 

7

 

 

 

EMC 18

 

Daniel Sandler

 

Vol #:

 

7

 

 

 

EMC 19

 

Ron Anderson

 

Vol #:

 

7

 

 

 

EMC 20

 

No signature

 

Vol #:

 

7

 

 

 

EMC 21

 

Barbara Whitfield

 

Vol #:

 

7

 

 

 

EMC 22

 

Kirk C. Peterson, MD

 

Vol #:

 

7

 

 

 

EMC 23

 

Kim Bryan

 

Vol #:

 

7

 

 

 

EMC 24

 

Melissa Wall

 

Vol #:

 

7

 

 

 

EMC 25

 

Patricia Scott

 

Vol #:

 

7

 

 

 

EMC 26

 

Laurie Dinwiddie

 

Vol #:

 

7

 

 

 

EMC 27

 

Jack Ceferin

 

Vol #:

 

7

 

 

 

EMC 28

 

Nancy Keenan

 

Vol #:

 

7

 

 

 

EMC 29

 

H. Johnson

 

Vol #:

 

7

 

 

 

EMC 30

 

Matt Wieler

 

Vol #:

 

7

 

 

 

EMC 31

 

Greg Smith

 

Vol #:

 

7

 

 

 

EMC 32

 

Bernie Rupe

 

Vol #:

 

7

 

 

 

EMC 33

 

Neal Lauron

 

Vol #:

 

7

 

 

 

EMC 34

 

Carol and Larry Blackhurst

 

Vol #:

 

7

 

 

 

EMC 35

 

Harold Seamen

 

Vol #:

 

7

 

 

1998D-0785

 

Medical imaging drugs and biologics

 

 

C 27

 

Amersham Health

 

Vol #:

 

5

 

 

 

C 28

 

Advanced Magnetics, Inc.

 

Vol #:

 

5

 

 

 

C 29

 

Academy of Molecular Imaging

 

Vol #:

 

5

 

 

 

C 30

 

American College of Cardiology (ACC)

 

Vol #:

 

5

 

 

 

EMC 4

 

Bristol-Myers Squibb Medical Imaging

 

Vol #:

 

5

 

 

 

EMC 5

 

Society of Nuclear Medicine (SNM) & American College of Nuclear Physicians (ACNP)

 

Vol #:

 

5

 

 

 

1998D-1146

 

Microbial effects of antimicrobial new animal drugs/human sa

 

 

EMC 681

 

Doug Akiyoshi

 

Vol #:

 

19

 

 

 

EMC 682

 

No signature

 

Vol #:

 

19

 

 

 

EMC 683

 

Bonnie Ritter

 

Vol #:

 

19

 

 

 

EMC 684

 

Donna Nunnally

 

Vol #:

 

19

 

 

 

EMC 685

 

Elaine Trogman

 

Vol #:

 

19

 

 

 

EMC 686

 

Paul Solomon

 

Vol #:

 

19

 

 

1998N-0359

 

Program priorities/Center for Food Safety & Applied Nutritin

 

 

EMC 13

 

International Food additives Council (IFAC)

 

Vol #:

 

7

 

 

 

1998P-0151

 

Introduction Of Downed Cattle Into The Food Supply

 

 

EMC 3278

 

Jill Graham

 

Vol #:

 

281

 

 

 

EMC 3279

 

Anna Bonanno

 

Vol #:

 

281

 

 

 

EMC 3280

 

Barbara Lee Brucker

 

Vol #:

 

281

 

 

 

EMC 3281

 

Ann Pieczek

 

Vol #:

 

281

 

 

 

EMC 3282

 

Peace Guy

 

Vol #:

 

281

 

 

 

EMC 3283

 

Robin Scharf

 

Vol #:

 

281

 

 

 

EMC 3284

 

Tina Deschambault

 

Vol #:

 

281

 

 

 

EMC 3285

 

Jennifer Peverill

 

Vol #:

 

281

 

 

 

EMC 3286

 

Lois Johnson, RN

 

Vol #:

 

281

 

 

 

EMC 3287

 

Lisa Levine

 

Vol #:

 

281

 

 

 

EMC 3288

 

Sheila Crane-Goldsborough

 

Vol #:

 

281

 

 

 

EMC 3289

 

Kelly Toole

 

Vol #:

 

281

 

 

 

EMC 3290

 

Alan Dakak

 

Vol #:

 

281

 

 

 

EMC 3291

 

Herb Joseph

 

Vol #:

 

281

 

 

 

EMC 3292

 

Stacey Nathan

 

Vol #:

 

281

 

 

 

EMC 3293

 

Kari Moore

 

Vol #:

 

281

 

 

 

EMC 3294

 

Carol Wells

 

Vol #:

 

281

 

 

 

EMC 3295

 

Robert S. Berthold

 

Vol #:

 

281

 

 

 

EMC 3296

 

Christine Houtz

 

Vol #:

 

281

 

 

 

EMC 3297

 

Casey Boblit

 

Vol #:

 

281

 

 

 

EMC 3298

 

Martin Heinrich

 

Vol #:

 

281

 

 

 

EMC 3299

 

Mary Myers

 

Vol #:

 

281

 

 

 

EMC 3300

 

Leslie Schomber

 

Vol #:

 

281

 

 

 

EMC 3301

 

Adrian Wright

 

Vol #:

 

281

 

 

 

EMC 3302

 

Dawn Hudson

 

Vol #:

 

281

 

 

 

EMC 3303

 

Murray S. Weiner

 

Vol #:

 

281

 

 

 

EMC 3304

 

Judy Bailey

 

Vol #:

 

281

 

 

 

EMC 3305

 

Christine Dale

 

Vol #:

 

281

 

 

 

EMC 3306

 

Keri Maiello

 

Vol #:

 

281

 

 

 

EMC 3307

 

cmcindoe

 

Vol #:

 

281

 

 

 

EMC 3308

 

Linda

 

Vol #:

 

281

 

 

 

EMC 3309

 

Jessica Schmid

 

Vol #:

 

281

 

 

 

EMC 3310

 

Mrs. Judy Plant

 

Vol #:

 

281

 

 

 

EMC 3311

 

Diana Zelnio

 

Vol #:

 

281

 

 

 

EMC 3312

 

Sonja Purtteman

 

Vol #:

 

281

 

 

 

EMC 3313

 

Catharine Drysdale

 

Vol #:

 

281

 

 

 

EMC 3314

 

Hope Laframboise

 

Vol #:

 

281

 

 

 

EMC 3315

 

Janet L. MacLean

 

Vol #:

 

281

 

 

 

EMC 3316

 

Sharon Piper

 

Vol #:

 

281

 

 

 

EMC 3317

 

Marie Squire

 

Vol #:

 

281

 

 

 

EMC 3318

 

Pam Hardimon

 

Vol #:

 

281

 

 

 

EMC 3319

 

Debra Murphy

 

Vol #:

 

281

 

 

 

EMC 3320

 

E. L.

 

Vol #:

 

281

 

 

 

EMC 3321

 

Sonja Purtteman

 

Vol #:

 

281

 

 

 

EMC 3322

 

Gail DeGirolamo

 

Vol #:

 

281

 

 

 

EMC 3323

 

Edwin Will

 

Vol #:

 

281

 

 

 

EMC 3324

 

Moonlitsky224

 

Vol #:

 

281

 

 

 

EMC 3325

 

Sally Proctor

 

Vol #:

 

281

 

 

 

EMC 3326

 

Alicia M. Henry

 

Vol #:

 

281

 

 

 

EMC 3327

 

Erik R. Odegard

 

Vol #:

 

281

 

 

 

1999N-4282

 

Biotechnology in the Year 2000 and Beyond; Public Meetings

 

 

EMC 4000

 

Molly Steele

 

Vol #:

 

514

 

 

 

EMC 4001

 

Sarah Reichert

 

Vol #:

 

514

 

 

 

EMC 4002

 

Sarah Reichert

 

Vol #:

 

514

 

 

 

EMC 4003

 

Nona Sturdevant

 

Vol #:

 

514

 

 

 

EMC 4004

 

Gina Zondorak

 

Vol #:

 

514

 

 

 

EMC 4005

 

Jill Hamilton

 

Vol #:

 

514

 

 

 

EMC 4006

 

Nicole Gershon

 

Vol #:

 

514

 

 

 

EMC 4007

 

Harriet Sharp

 

Vol #:

 

514

 

 

 

EMC 4008

 

Jason Mayfield

 

Vol #:

 

514

 

 

 

EMC 4009

 

Simon Ireland

 

Vol #:

 

514

 

 

 

 

EMC 4010

 

Jessica K. Fawver

 

Vol #:

 

514

 

 

 

EMC 4011

 

Brendon Drew

 

Vol #:

 

514

 

 

 

EMC 4012

 

Diane Thompson

 

Vol #:

 

514

 

 

 

EMC 4013

 

Jennifer Dedrick

 

Vol #:

 

514

 

 

 

EMC 4014

 

Phyllis Aniya Sladek

 

Vol #:

 

514

 

 

 

EMC 4015

 

Marc Levinthal

 

Vol #:

 

514

 

 

 

EMC 4016

 

Michael Pellecchia

 

Vol #:

 

514

 

 

 

EMC 4017

 

S.J. Todd

 

Vol #:

 

514

 

 

 

EMC 4018

 

Colin K. Ng

 

Vol #:

 

514

 

 

 

EMC 4019

 

Andrea Becker

 

Vol #:

 

514

 

 

 

EMC 4020

 

Constance Sheldon

 

Vol #:

 

314

 

 

 

1999P-1340

 

Declared Eternity eau de Parfum Misbranded

 

 

EMC 453

 

Michelle Patrick

 

Vol #:

 

21

 

 

 

2001P-0230

 

Domestic Marketing & Importation of Transgenic Fish

 

 

C 1335

 

Tarra Verkler

 

Vol #:

 

233

 

 

 

C 1336

 

Ellen Engelking

 

Vol #:

 

233

 

 

 

EMC 2795

 

Steven C. Serbins

 

Vol #:

 

228

 

 

 

EMC 2796

 

Eva Luchini

 

Vol #:

 

228

 

 

 

EMC 2797

 

Roger Brenneise

 

Vol #:

 

228

 

 

 

EMC 2798

 

Steve Knapp

 

Vol #:

 

228

 

 

 

EMC 2799

 

Karen Jones, R.N.

 

Vol #:

 

228

 

 

 

EMC 2800

 

Jill Davies

 

Vol #:

 

228

 

 

 

EMC 2801

 

Mary Lockwwod

 

Vol #:

 

228

 

 

 

EMC 2802

 

Christine Georgiou

 

Vol #:

 

228

 

 

 

EMC 2803

 

Marlene Colgate

 

Vol #:

 

228

 

 

 

EMC 2804

 

Jessica Fawver

 

Vol #:

 

228

 

 

 

EMC 2805

 

Amy Brown

 

Vol #:

 

228

 

 

 

EMC 2806

 

Harriet Sharp

 

Vol #:

 

228

 

 

 

EMC 2807

 

Harriet Sharp

 

Vol #:

 

228

 

 

 

EMC 2808

 

Phyllis Aniya Sladek

 

Vol #:

 

228

 

 

 

2001V-0211

 

Laser light show

 

 

VRA 2

 

HFZ-300 to Mark R. Babcock

 

Vol #:

 

1

 

 

 

2002D-0384

 

Standardized Training Curriculum for Application of HACCP

 

 

GDL 2

 

GUIDANCE FOR INDUSTRY

 

Vol #:

 

1

 

 

 

NAD 2

 

FDA

 

Vol #:

 

1

 

 

 

 

2002D-0526

 

Guidance for drug Chemistry, Manufacturing, Control Info.

 

 

 

C 3

 

Aegis Pharmaceuticals, Inc.

 

Vol #:

 

1

 

 

 

 

2002N-0204

 

Bar Code Label Requirements for human drug products

 

 

 

C 114

 

Compressed Gas Assn

 

Vol #:

 

15

 

 

 

 

C 115

 

Novation Pharmacy

 

Vol #:

 

15

 

 

 

 

2002N-0277

 

Bioterrorism; Establishment & Maintenance of Records

 

 

 

C 31

 

International Warehouse Logistics Assn (IWLA)

 

Vol #:

 

4

 

 

2002N-0417

 

Applications for FDA Approval to Market a New Drug

 

 

 

LET 1

 

GCF-1 to Covington & Burling

 

Vol #:

 

4

 

 

2002N-0475

 

Financial Relationships & Interest in Research Involving Hum

 

 

 

C 34

 

Johns Hopkins University

 

Vol #:

 

2

 

 

 

 

C 35

 

Number Not Used

 

Vol #:

 

2

 

 

 

 

2003D-0061

 

Comparability Protocols Chemistry Manufacturing and controls

 

 

 

C 3

 

AstraZeneca Pharmaceuticals, LP

 

Vol #:

 

1

 

 

 

 

2003D-0118

 

Decorative Contact Lens (Import alert #86-10)

 

 

 

C 11

 

Tim Milburn, O.D.

 

Vol #:

 

1

 

 

 

 

C 12

 

Ryan Powell, O.D.

 

Vol #:

 

1

 

 

 

 

C 13

 

Margaret P. Johnson, O.D.

 

Vol #:

 

1

 

 

 

 

C 14

 

Michael A. Walby, O.D., F.A.A.O.

 

Vol #:

 

1

 

 

 

 

C 15

 

Dawn Hornberger,OD,MS

 

Vol #:

 

1

 

 

 

 

C 16

 

Parker T. May

 

Vol #:

 

1

 

 

 

 

C 17

 

Harvey M. Rosenwasser, O.D., F.A.A.O.

 

Vol #:

 

1

 

 

 

 

C 18

 

M.D. Young, O.D.

 

Vol #:

 

1

 

 

 

 

C 19

 

Todd Lang, O.D.

 

Vol #:

 

1

 

 

 

 

C 20

 

Robert L. Gordon, O.D., F.A.A.O.

 

Vol #:

 

1

 

 

 

 

C 21

 

Boyd Clark, O.D.

 

Vol #:

 

1

 

 

 

 

C 22

 

Paul Farkas, M.S., O.D., F.A.A.O.

 

Vol #:

 

1

 

 

 

 

C 23

 

Kevin J. Rehak, O.D.

 

Vol #:

 

1

 

 

 

 

2003N-0169

 

Dental Amalgam; Request for Information

 

 

 

SUP 6

 

Mark Thorson

 

Vol #:

 

1

 

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