Dockets Entered On August 14, 2003

Table of Contents

Docket #

Title

1975N-0183H. 1   Health-Care Antiseptic Drug Products for OTC Human Use. 1

1981N-0201. 1     Pediculicide Drug Products for OTC Human Use. 1

1995N-0309. 1     CGMPs for the Production of Infant Formula. 1

1995S-0117. 1     Human Drugs Patent Term Extension & New Patents. 1

2000F-0792. 1     OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT  1

2001D-0195. 1     The Leaveraging Handbook, An Agency Resource for Effective Collaborations. 1

2002N-0516. 1     Request for Samples and Protocols; Agency Information Collect 1

2003M-0352. 1     PMA P020049, ProColB. Vascular Bioprosthesis. 1

2003M-0356. 1     PMA P030027 - Ceramic TRANSCEND Hip Articulation System.. 1

2003N-0143. 2     Continued Over-the-Counter Status of Ipecac Syrup. 2

2003N-0194. 2     Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization  2

2003N-0201. 2     Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting  2

2003N-0202. 2     Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Public Perceptions and Knowledge of Clinical Trials and Informed Consent Human Subject Protection. 2

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

2003N-0324. 2     Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing. 2

2003N-0344. 2     Consumer-Directed Promotion; Public Meeting. 2

2003P-0176. 2     Follow-Up Approval of Therapeutic Protein Products. 2

2003P-0278. 2     Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing of drugs  2

2003P-0280. 2     Determine that a recombinant endotoxin tests intended for endotoxin testing of human drugs and medical devices  2

2003P-0321. 2     Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin. 2

2003P-0366. 2     Amend approval for a nonprescription form of Prilosec (omeprazole magnesium) 2

2003V-0368. 2     Laser Artistry Projector 2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

EMC 1

Microbiotest, Inc.

Vol #:

149

1981N-0201

Pediculicide Drug Products for OTC Human Use

ACK 1

HFA-305 to NDMA

Vol #:

1

ACK 2

HFA-305 to NDMA

Vol #:

1

1995N-0309

CGMPs for the Production of Infant Formula

EMC 2

European Union, Delegation of the European Commission

Vol #:

9

1995S-0117

Human Drugs Patent Term Extension & New Patents

LST 86

List as of August 12, 2003

Vol #:

7

2000F-0792

OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT

EMC 7

The SYGMA Network

Vol #:

10

EMC 8

Vicki Anderson

Vol #:

10

2001D-0195

The Leaveraging Handbook, An Agency Resource for Effective Collaborations

GDL 3

Corrected Final Guidance

Vol #:

1

2002N-0516

Request for Samples and Protocols; Agency Information Collect

NAL 1

FDA

Vol #:

1

2003M-0352

PMA P020049, ProColB. Vascular Bioprosthesis

AAV 1

Hancock Jaffe Laboratories, Inc.

Vol #:

1

Approval order, summary of safety,

labeling

2003M-0356

PMA P030027 - Ceramic TRANSCEND Hip Articulation System

AAV 1

Wright Cremascoli Ortho, SA

Vol #:

1

Approval order, summary of safety,

labeling

2003N-0143

Continued Over-the-Counter Status of Ipecac Syrup

EMC 1

New Jersey Poison Information & Education System

Vol #:

1

EMC 2

Nova Southeastern University

Vol #:

1

EMC 3

University of Colorado Health Sciences Center

Vol #:

1

EMC 4

University of Washington

Vol #:

1

EMC 5

American Pharmacists Association

Vol #:

1

2003N-0194

Agency Information Collection Activities: Proposed Collection: Comment Request; Agreement for Shipment of Devices for Sterilization

N 2

FDA

Vol #:

1

2003N-0201

Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting

EMC 3

Central Florida Society of Health Systems Pharmacists

Vol #:

1

2003N-0202

Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Public Perceptions and Knowledge of Clinical Trials and Informed Consent Human Subject Protection

EMC 1

Pharmaceutical Research and Manufacturers of American (PhRMA)

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

C 2

Margo McCaffery, RN, MS, FAAN

Vol #:

1

C 3

American Academy of Pain Management

Vol #:

1

2003N-0324

Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in Sections 510.515 and/or 558.15; Drugs Efficacy Study Implementation; Notice of Opportunity for Hearing

BKG 1

BACKGROUND

Vol #:

2

Tab 1, 2, 3, 4.1, 4.2, 4.3, 5, 6, 7, 8

NPH 1

FDA

Vol #:

1

NPR 1

FDA

Vol #:

1

2003N-0344

Consumer-Directed Promotion; Public Meeting

N 1

FDA

Vol #:

1

2003P-0176

Follow-Up Approval of Therapeutic Protein Products

EMC 1

Biotechnology Industry Organization

Vol #:

3

2003P-0278

Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing of drugs

EMC 1

Cambrex Bio Science

Vol #:

1

2003P-0280

Determine that a recombinant endotoxin tests intended for endotoxin testing of human drugs and medical devices

EMC 1

Cambrex Bio Science

Vol #:

1

2003P-0321

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

EMC 20

John M. Danneker

Vol #:

2

EMC 21

Angelia Impellicceiri

Vol #:

2

EMC 22

Debra Carlton

Vol #:

2

EMC 23

Jean Lynch

Vol #:

2

EMC 24

Number not used

Vol #:

2

EMC 25

Debra Carlton

Vol #:

2

EMC 26

Number not used

Vol #:

2

EMC 27

Gary Schneider

Vol #:

2

EMC 28

Renee

Vol #:

2

EMC 29

Jessica Link

Vol #:

2

EMC 30

Kevin Disease Medical Consultant

Vol #:

2

EMC 31

Adam Steinberg

Vol #:

2

EMC 32

Number not used

Vol #:

2

EMC 33

William Edward Ward IV

Vol #:

2

EMC 34

J Michael Merrill, DDS

Vol #:

2

EMC 35

Texas Liver Coalition

Vol #:

2

EMC 36

Joanie Liebman

Vol #:

2

EMC 37

New Horizons Independent Living Center

Vol #:

2

EMC 38

KernHEP

Vol #:

2

EMC 39

Alice Kluck

Vol #:

2

EMC 40

Lydia Chicoine

Vol #:

2

EMC 41

Nicki Leigh

Vol #:

2

EMC 42

Karl Stoll

Vol #:

3

EMC 43

Tom Green

Vol #:

3

EMC 44

Jennifer Cooksey

Vol #:

2

EMC 45

Alameda County Medical Center

Vol #:

2

EMC 46

R & L Sutter

Vol #:

3

EMC 47

Virginia Barker

Vol #:

2

EMC 48

Clarissa C Pyeatt

Vol #:

2

EMC 49

Vern Sutter

Vol #:

2

EMC 50

G Dye

Vol #:

2

EMC 51

Steven C Bluitt

Vol #:

1

EMC 52

Thomas McGuire

Vol #:

2

EMC 53

Jon J Houzet

Vol #:

2

EMC 54

Pat Luchs

Vol #:

2

EMC 55

Dragon Fighters of Washington County Support Group

Vol #:

2

EMC 56

Ivan Marinkovic

Vol #:

2

EMC 57

Anne Sutter

Vol #:

2

2003P-0366

Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)

ACK 1

HFA-305 to Mattingly, Stanger & Malur, P.C.

Vol #:

1

CP 1

Mattingly, Stanger & Malur, P.C.

Vol #:

1

2003V-0368

Laser Artistry Projector

VAR 1

Laser Vision Club Statik

Vol #:

1