Dockets Entered On September 9, 2003

Table of Contents

Docket #

Title

1977N-0094. 1          OTC Internal Analgesic, Antipyretic & Antirheumatic Products. 1

1989V-0516. 1          Laser Light Show Re: Omnichrome Laser 1

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

2002P-0292. 2          Health Claims: Walnuts & Coronary Disease. 2

2002P-0505. 2          Labeling nuts & eligible nut containing products reduce risk. 2

2003D-0165. 2          Current Good Manufacturing Practices for Medical Gases. 2

2003D-0229. 2          Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA   2

2003D-0231. 2          Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability  2

2003N-0050. 2          Investigational Device Exemptions Reports and Records. 2

2003N-0168. 2          July 31, 2003 Public Meeting on Consumer Medication Information. 2

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

2003N-0273. 2          Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form  2

2003P-0029. 2          Remove metered-dose inhalers (MDI) containing moiety albuter 2

2003P-0310. 2          Nance Pretzel Dip. 2

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

2003V-0100. 2          Laser Light Show. 2

1977N-0094

OTC Internal Analgesic, Antipyretic & Antirheumatic Products

C 241

Reddy-Cheminor and Dr. Reddy's Laboratories

Vol #:

235

1989V-0516

Laser Light Show Re: Omnichrome Laser

VRA 7

HFZ-300 to Mr. Faith's Sound and Light, Inc.

Vol #:

1

1997P-0329

Require Quantitative Labeling of Caffeine Content

EMC 72

John L. Bauer

Vol #:

7

EMC 73

C6745

Vol #:

7

EMC 74

Goldie Lee

Vol #:

7

EMC 75

Vanna Condax

Vol #:

7

EMC 76

Nancy Howaniec

Vol #:

7

EMC 77

Suzanne Randall

Vol #:

7

EMC 78

Ryvonne38

Vol #:

7

EMC 79

Crutchn

Vol #:

7

EMC 80

Donald Allen

Vol #:

7

EMC 81

Eric H. Pahlke

Vol #:

7

1997S-0162

30-Day Structure Function Claim Notification Letters Dietary

LET 10830

NBTY, Inc.

Vol #:

82

LET 10831

NBTY, Inc.

Vol #:

82

LET 10832

NBTY, Inc.

Vol #:

82

LET 10833

NBTY, Inc.

Vol #:

82

LET 10834

NBTY, Inc.

Vol #:

82

LET 10835

NBTY, Inc.

Vol #:

82

LET 10836

NBTY, Inc.

Vol #:

82

LET 10837

NBTY, Inc.

Vol #:

82

LET 10838

NBTY, Inc.

Vol #:

82

LET 10839

NBTY, Inc.

Vol #:

82

LET 10840

NBTY, Inc.

Vol #:

82

LET 10841

NBTY, Inc.

Vol #:

82

LET 10842

NBTY, Inc.

Vol #:

82

LET 10843

NBTY, Inc.

Vol #:

82

LET 10844

NBTY, Inc.

Vol #:

82

LET 10845

NBTY, Inc.

Vol #:

82

LET 10846

NBTY, Inc.

Vol #:

82

LET 10847

Integrative Therapeutics Inc.

Vol #:

82

LET 10848

Integrative Therapeutics Inc.

Vol #:

82

LET 10849

Metagenics

Vol #:

82

LET 10850

MaxCell Bioscience, Inc.

Vol #:

82

LET 10851

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10852

Enzymatic Therapy Natural Medicines

Vol #:

82

LET 10853

PhytoPharmica Natural Medicines

Vol #:

82

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 7003

Mary Wicks

Vol #:

299

C 7004

Ms. Lisa F. Dews

Vol #:

299

C 7005

J. Selhower

Vol #:

299

C 7006

Kathy Kroll

Vol #:

299

C 7007

Barbara F. Davis

Vol #:

299

C 7008

Sam Starr

Vol #:

299

C 7009

Elisa Frey

Vol #:

299

C 7010

Eve Hoerler

Vol #:

299

C 7011

Thomas & Pamela Kulcher

Vol #:

299

C 7012

Stacey Murrow

Vol #:

299

C 7013

E. Jocelyn Tinney

Vol #:

299

1999P-1340

Declared Eternity eau de Parfum Misbranded

EMC 462

Deena Hubert

Vol #:

21

EMC 463

Chris Albertson

Vol #:

21

EMC 464

Connie Jo Gandy

Vol #:

21

EMC 465

Linda Adair

Vol #:

21

EMC 466

Diane Manzo

Vol #:

21

EMC 467

Barb Wilkie

Vol #:

21

EMC 468

Mrs. Janet Schodrof, R.N.

Vol #:

21

1999P-2630

Establish a Daily Value for "added sugars"

EMC 485

Leva Lessure

Vol #:

32

EMC 486

John Kesich

Vol #:

32

EMC 487

Peter Adams

Vol #:

32

EMC 488

Suki Ewers

Vol #:

32

EMC 489

Jerome Mc Collom

Vol #:

32

EMC 490

Melissa Hill-Anderson

Vol #:

32

EMC 491

Art Zernis

Vol #:

32

EMC 492

Madelyn Pesci

Vol #:

32

EMC 493

Kurt Wedel

Vol #:

32

EMC 494

Greg Schneider

Vol #:

32

EMC 495

John Miller

Vol #:

32

EMC 496

Matthew McGuire

Vol #:

32

EMC 497

Heather Gant

Vol #:

32

EMC 498

Michael Mihok

Vol #:

32

EMC 499

Curtis & Linda Harrington

Vol #:

32

EMC 500

Lily Caravello

Vol #:

32

EMC 501

John Buckley

Vol #:

32

EMC 502

Ron Tuason

Vol #:

32

EMC 503

Jeff Frontz

Vol #:

32

EMC 504

Norman Renfrow

Vol #:

32

EMC 505

Lauren Sharfman

Vol #:

32

EMC 506

Jana Happel

Vol #:

32

EMC 507

Bill Kinzie

Vol #:

32

EMC 508

Rich Faubion

Vol #:

32

2000N-1396

Bioengineered Foods Consumed By Humans or Animals

EMC 11570

Patricia Gavin

Vol #:

349

2002P-0292

Health Claims: Walnuts & Coronary Disease

LET 6

California Walnut Commission

Vol #:

6

LET 7

California Walnut Commission

Vol #:

6

LET 8

California Walnut Commission

Vol #:

6

LET 9

California Walnut Commission

Vol #:

6

MM 1

Memo of meeting held 3/24/2003

Vol #:

6

MM 2

Memo of meeting held 5/13/2003

Vol #:

6

MM 3

Memo of Meeting held 6/3/2003

Vol #:

6

MM 4

Memo of meeting held 6/26/2003

Vol #:

6

RPT 4

Covington & Burling

Vol #:

6

TS 1

Loma Linda University

Vol #:

6

2002P-0505

Labeling nuts & eligible nut containing products reduce risk

LET 5

HFS-800 to International Tree Nut Council

Vol #:

4

LET 6

HFS-800 to International Tree Nut Council

Vol #:

4

LET 7

INC Nutrition Research and Education Foundation

Vol #:

4

LET 8

HFS-800 to International Tree Nut Council

Vol #:

4

LET 9

INC Nutrition Research and Education Foundation

Vol #:

4

LET 10

INC Nutrition Research & Education Foundation

Vol #:

4

MM 1

Memo of meeting held on 3/27/2003

Vol #:

4

MM 2

Memo of meeting held on 5/5/2003

Vol #:

4

MM 3

Memo of meeting held on 06/09/2003

Vol #:

4

MM 4

Memo of meeting held on 07/07/2003

Vol #:

4

2003D-0165

Current Good Manufacturing Practices for Medical Gases

C 18          Enclosure

Medic First Aid International

Vol #:

1

C 19

SOS Technologies

Vol #:

1

C 20

Respond Systems

Vol #:

1

C 21

Respond First Aid Systems of Idaho

Vol #:

1

C 22

Respond First Aid Systems of Wyoming

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

N 1

FDA

Vol #:

1

2003D-0231

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

EMC 1

Merck Research Laboratories

Vol #:

1

2003N-0050

Investigational Device Exemptions Reports and Records

NAL 1

FDA

Vol #:

1

SS 1

Supporting Statement

Vol #:

1

2003N-0168

July 31, 2003 Public Meeting on Consumer Medication Information

C 7

American Pharmacists Assn (APhaA)

Vol #:

3

C 8

Pfizer, Inc. (Pfizer)

Vol #:

3

2003N-0201

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

EMC 4

Merck & Co., Inc.

Vol #:

1

2003N-0273

Agency Information Collection Activities; Proposed Collection; Comment Request; Research Study Complaint Form

EMC 1

Merck & Co., Inc

Vol #:

1

2003N-0294

Risk Management Plans for Opiate Analgesic Drug

EC 12

Weedman, Wendy

Vol #:

1

EC 13

Waldron, Joe

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

HER 1

Pennfield Oil Company/Pennfield Animal Health

Vol #:

1

HER 2

Pennfield Oil Company/Pennfield Animal Health

Vol #:

1

HER 3

Alpharma Inc

Vol #:

1

2003N-0361

Anti-Counterfeit Drug Initiative

APE 5

Bloomberg School of Public Health

Vol #:

1

APE 6

Kurz Transfer Products LP

Vol #:

1

2003P-0029

Remove metered-dose inhalers (MDI) containing moiety albuter

C 4

National Economic Research Associates Inc

Vol #:

1

EMC 1

International Pharmaceutical Aerosol Consortium (IPAC)

Vol #:

1

2003P-0270

Prohibit False and Misleading Labeling

C 26

Alicia Martin Melero

Vol #:

1

SUP 2

Margot Barg

Vol #:

1

2003P-0291

Enforce the law and prevent unlaw sale of contact lens

C 14

Cindy M. McGarry, O.D.

Vol #:

1

C 15

Rebecca M. Kiraly, O.D.

Vol #:

1

C 16

Daniel J. Anderson, O.D.

Vol #:

1

C 17

Dr. Michelle Pyle, O.D.

Vol #:

1

C 18

Michael I. Davis, O.D.

Vol #:

1

C 19

Henry F. Krauss, Jr. O.D.

Vol #:

1

C 20

Robert P. Kupse, O.D.

Vol #:

1

C 21

C.F. Castellano, O.D.

Vol #:

1

C 22

Michelle L. Spittler, O.D.

Vol #:

1

C 23

Dr. Heather Lantz

Vol #:

1

C 24

Michelle L. Spittler, O.D.

Vol #:

1

C 25

Robert K. Hurst, O.D.

Vol #:

1

C 26

Michael J. Molamphy, O.D.

Vol #:

1

2003P-0310

Nance Pretzel Dip

WDL 1

Baldwin Richardson Foods Co.

Vol #:

1

2003P-0321

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

C 6

Geneva Pharmaceuticals, Inc. (Geneva)

Vol #:

2

2003V-0100

Laser Light Show

VRA 1

HFZ-300 to Beam Bouncers Incorporated

Vol #:

1