Dockets Management

Dockets Entered On June 16, 2003

TABLE OF CONTENTS (Linked)

Docket #

Title

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

1976N-0377

Certain Drugs Containing Fluoxymesterone & Ethinyl Estrad

1991N-0278

New Drug, Antibiotic, & Biological Drug Product Regulations

1998D-0727

Interpretation on-farm feed mfg and mixing operations

2001D-0221

Biological Product Deviation Reporting for Licensed Manufact

CONTENTS

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

LET 41

Buchanan Ingersoll

Vol #:

149

1976N-0377

Certain Drugs Containing Fluoxymesterone & Ethinyl Estrad

RPT 1

Syntho Pharmaceutical, Inc. (Syntho)

Vol #:

5

Additional Materials

1991N-0278

New Drug, Antibiotic, & Biological Drug Product Regulations

NFR 2

FDA

Vol #:

1

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 4032

Richard S. Griffith

Vol #:

374

C 4033

Valerie Carter

Vol #:

374

C 4034

Nola Elson

Vol #:

374

C 4035

Steven Wood

Vol #:

374

C 4036

Matthew Polly

Vol #:

374

C 4037

Tariq Khan

Vol #:

374

C 4038

Diana Berrier

Vol #:

374

C 4039

Octaviano Aja

Vol #:

374

1998D-0727

Interpretation on-farm feed mfg and mixing operations

NWL 1

FDA

Vol #:

1

1998P-0610

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C 50

Massachusetts Institute of Technology

Vol #:

5

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

CS 44

HFA-305

Vol #:

378

EXB 17

Bayer Corporation

Vol #:

378

EXB 18

Bayer Corporation

Vol #:

378

EXB 19

Center for Veterinary Medicine

Vol #:

378

OR 46

HF-3

Vol #:

378

2001D-0221

Biological Product Deviation Reporting for Licensed Manufact

LET 1

Certified Software Solutions, Inc.

Vol #:

1

2001D-0368

Submitting Marketing Applications according to ICH/CTD Forma

C 8

Johnson & Johnson Pharmaceutical Research & Development, LLC

Vol #:

1

2001D-0435

ICH Technical Requirements: Registration of Pharmaceuticals

EC 2

Perisin, Toni

Vol #:

1

2002D-0526

Guidance for drug Chemistry, Manufacturing, Control Info.

EXT 1

Pharmaceutical Research and Manufacturers of America (PhRMA)

Vol #:

1

2002H-0443

Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

MO 7

GCF-1

Vol #:

1

2002N-0077

Emergency Med. Device Shortage Program Survey;Agency Informa

SS 2

Emergency Medical Device Shortage Program Survey

Vol #:

1

2002N-0204

Bar Code Label Requirements for human drug products

C 87

American Pharmacists Assn

Vol #:

14

C 88

Advanced Medical Technology Assn (AdvaMed)

Vol #:

14

C 89

American Red Cross

Vol #:

14

C 90

Cosmetic, Toiletry, and Frangrance Assn (CTFA)

Vol #:

14

C 91

Aventis Pasteur, Inc.

Vol #:

14

C 92

American Assn of Orthopaedic Surgeons

Vol #:

14

C 93

Health Industry Business Communications Council (HIBCC)

Vol #:

14

C 94

Alcon research, Ltd

Vol #:

14

C 95

Novartis Pharmaceuticals, Corporation

Vol #:

14

C 96

AdvancePCS

Vol #:

14

C 97

Wyeth Pharmaceuticals (Wyeth)

Vol #:

14

C 98

National Quality Forum

Vol #:

14

C 99

Assn for Automatic Identification and Data Capture Technologies

Vol #:

14

C 100

International Assn for Pharmaceutical Science and Technology (PDA)

Vol #:

14

C 101

Roshani Vinod Patel

Vol #:

15

C 102

Joseph Buccine

Vol #:

15

C 103

Consumer Healthcare Products Assn (CHPA)

Vol #:

15

C 104

Gases and welding Distributors Assn (GAWDA)

Vol #:

15

C 105

Healthcare Compliance Packaging Council (HCPC)

Vol #:

15

C 106

Healthcare Assn of New York State (HANYS)

Vol #:

15

C 107

Lincare Inc.

Vol #:

15

C 108

Gas Regs, Inc.

Vol #:

15

C 109

RDG & BarCodeAmerica.com

Vol #:

15

C 110

National Assn of Chain Drug Stores

Vol #:

15

C 111

Apria Healthcare

Vol #:

15

EXT 1

American Academy of Pediatrics

Vol #:

14

M 1

HF-23 to Dockets Management Branch

Vol #:

14

2002N-0383

Veterinary Adverse Drug Reaction; Product Defect Report

NAL 1

FDA

Vol #:

1

SS 1

Veterinary Adverse Drug reaction, Lack of Effectivenes Product Defect Report and Transmi

Vol #:

1

2002P-0391

Determine Whether Alphagan has been Voluntarily Withdrawn

N 1

FDA

Vol #:

1

2002P-0404

Determination re: Withdraw of ALPHAGAN

N 1

FDA

Vol #:

1

2002P-0464

DES 1.0 mg & 5.0 mg

LET 1

HFD-1 to PCH Integrated Regulatory Services, Inc.

Vol #:

1

2003D-0051

Draft Guidance for Industry on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance

GDL 1

Guideline

Vol #:

1

NAD 1

FDA

Vol #:

1

2003D-0137

Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability

C 1

Cardinal Health

Vol #:

1

C 2

University of Minnesota

Vol #:

1

C 3

3M Health Care

Vol #:

1

C 4

Kimberly-Clark Health Care

Vol #:

1

2003N-0169

Dental Amalgam; Request for Information

EC 18

by amalgams, poisoned

Vol #:

4

2003N-0213

Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products

N 1

FDA

Vol #:

1

2003P-0091

ANDA to declare that drug prod Hydrocodone Polistirex & Chlo

C 1

Celltech Pharmaceuticals, Inc.

Vol #:

1