Dockets Management

Dockets Entered On July 30, 2003

Docket #

Title

1976N-0482

Estab of Monograph for OTC Topical Antibiotic Products

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

1998P-0446

Stop Distribution of Dangerously Misleading Rx Drug Info

2000D-1384

Physical Examination of Surgeons' &/or Patient Exam Gloves

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

2002D-0232

S7B Pharmacology Studies re:Potential Delayed Ventricular Re

2003D-0228

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA

2003D-0229

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA

2003N-0143

Continued Over-the-Counter Status of Ipecac Syrup

2003N-0233

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

2003P-0029

Remove metered-dose inhalers (MDI) containing moiety albuter

2003P-0321

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

1976N-0482

Estab of Monograph for OTC Topical Antibiotic Products

PDN 1

HFC-1 to Dr. Leslie Steven Aufseeser

Vol #:

5

Attachment

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 821

M. Saltzman

Vol #:

375

EMC 822

Janet Powell

Vol #:

375

EMC 823

Bill Eckroade

Vol #:

375

EMC 824

No signature

Vol #:

375

EMC 825

Donna M. VanDamme

Vol #:

375

EMC 826

Norma J. Ashmore

Vol #:

375

EMC 827

Maryann Kaul, RN

Vol #:

375

EMC 828

Rebecca Jones

Vol #:

375

EMC 829

Sue Prieto

Vol #:

375

EMC 830

Joseph Conti

Vol #:

375

EMC 831

Michelle Dennis

Vol #:

375

EMC 832

Ron Waters

Vol #:

375

EMC 833

Garner Davidson

Vol #:

375

EMC 834

James R. Ewen

Vol #:

375

EMC 835

Maryann Williard

Vol #:

375

EMC 836

George Waring

Vol #:

375

EMC 837

Bill Livingston

Vol #:

375

EMC 838

Barb Reese

Vol #:

375

EMC 839

Terri Laughlin

Vol #:

375

EMC 840

No signature

Vol #:

375

EMC 841

Andrew Kelly

Vol #:

375

EMC 842

Sarah Watts

Vol #:

375

EMC 843

Matt Swezey

Vol #:

375

EMC 844

No signature

Vol #:

375

EMC 845

Ty R. Nordic, CSCS

Vol #:

375

EMC 846

Angela Westmorland

Vol #:

375

EMC 847

Rhonda Kriesel

Vol #:

375

EMC 848

Rhonda Kriesel

Vol #:

375

EMC 849

Anthony

Vol #:

375

EMC 850

Deborah Sheypuk

Vol #:

375

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 132

Abbott Laboratories

Vol #:

21

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

EMC 3455

Chris Mayer

Vol #:

281

EMC 3456

Laura Schauble

Vol #:

281

EMC 3457

Jan Brown

Vol #:

281

EMC 3458

Amy Miller Bunk

Vol #:

281

EMC 3459

Karla McBride

Vol #:

281

EMC 3460

Shana Maechetti

Vol #:

281

EMC 3461

Catherine Osterbye

Vol #:

281

EMC 3462

Mrs. Michele M. Makrucki

Vol #:

281

1998P-0446

Stop Distribution of Dangerously Misleading Rx Drug Info

PDN 1

DHHS/PHS/FDA

Vol #:

1

1999P-1340

Declared Eternity eau de Parfum Misbranded

EMC 455

No signature

Vol #:

21

EMC 456

No signature

Vol #:

21

1999P-5198

Request amendment of the definition of milk

EMC 8

National Farmers Union (NFU)

Vol #:

1

2000D-1384

Physical Examination of Surgeons' &/or Patient Exam Gloves

C 9

Malaysian Rubber Glove Manufacturers Assn (MARGMA)

Vol #:

1

EMC 2

Malaysian Rubber Glove Manufacturers Assn (MARGMA)

Vol #:

1

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

TR 15

Corrected May 6, 2003 Transcript

Vol #:

387

Attachment

TR 16

Corrected May 7, 2003 Transcript

Vol #:

388

Attachment 1, 2

2000P-0586

Amend Pt 133.3 re: Milk and Nonfat Milk for use in Standardiz

EMC 14

National Farmers Union (NFU)

Vol #:

2

2001P-0230

Domestic Marketing & Importation of Transgenic Fish

EMC 2990

Uriah Mills

Vol #:

252

EMC 2991

Nichole Siegal

Vol #:

252

EMC 2992

Kathryn Colbrese

Vol #:

252

EMC 2993

Marcella Varnado

Vol #:

252

EMC 2994

Robyn Davis

Vol #:

252

EMC 2995

Dan Rynberg

Vol #:

252

EMC 2996

Lauren O'Reilly

Vol #:

252

EMC 2997

Brad Nahill

Vol #:

252

EMC 2998

Casssandra Redding

Vol #:

252

EMC 2999

Jeanne Dauzvardis

Vol #:

252

2001P-0345

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

EMC 1187

Ganesh

Vol #:

5

2002D-0232

S7B Pharmacology Studies re:Potential Delayed Ventricular Re

C 6

Multi Channel Systems MSC GmbH (Germany)

Vol #:

1

2003D-0228

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA

C 3

Biotechnology Industry Organization (BIO)

Vol #:

1

2003D-0229

Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA

C 3

Biotechnology Industry Organization (BIO)

Vol #:

1

2003N-0069

FDA Task Force on Consumer Health Info for Better Nutrition

BKG 1

BACKGROUND

Vol #:

3

EMC 12

Lisa Rufo

Vol #:

1

EMC 13

Kay Low

Vol #:

1

EMC 14

Sun Microsystems

Vol #:

1

EMC 15

Sun Microsystems

Vol #:

1

EMC 16

Gregg Hesling

Vol #:

1

2003N-0076

Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1

Judith L. Osmon

Vol #:

1

2003N-0143

Continued Over-the-Counter Status of Ipecac Syrup

C 6

New Jersey Poison Information & Education System

Vol #:

1

2003N-0203

Innovative Systems for Delivery of Drugs and Biologics

TS 1

Emerging Techniques and Technologies for Treatment of Solid Tumors

Vol #:

1

TS 2

Preclinical Development considerations for the pulmonary delivery of drugs approved by oth

Vol #:

1

TS 3

Vol #:

1

TS 4

Developing a Local Delivery Combination Product for Postoperative Atrial Fibrillation

Vol #:

1

TS 5

An Perspective on Quality by Design: A Preclinical Opportunity

Vol #:

1

TS 6

Surgeon's Perspective

Vol #:

1

TS 7

Regulatory and Legal Challenges for Developers of Drug Delivery Devices

Vol #:

1

TS 8

Indusry Perspective on Challenges for Product Developers - Drugs

Vol #:

1

TS 9

Office of Combination Products: Current Initiatives

Vol #:

1

TS 10

Innovative Systems for Delivery of Drugs and Biologics; Drug-Eluting Stents Current Appr

Vol #:

1

TS 11

Review Pathway for Photodynamic Therapy Systems

Vol #:

1

TS 12

Perspective from CDER's Division of Reproductive and Urologic Drug Products (DRUDP)

Vol #:

1

TS 13

Innovative Systems for Delivery of Drugs and Biologics: Regulatory Challenges

Vol #:

1

2003N-0233

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

BKG 1

BACKGROUND

Vol #:

1

N 1

FDA

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

EMC 1

Michael M. Daly, D.O.

Vol #:

1

2003P-0029

Remove metered-dose inhalers (MDI) containing moiety albuter

LET 1

HFD-005 to American Lung Association

Vol #:

1

2003P-0321

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

C 2

Hepatitis C Action & Advocacy Coalition (HAAC)

Vol #:

1

SUP 1

ICN Pharmaceuticals, Inc. and Ribapharm Inc.

Vol #:

1