Dockets Entered On July 2, 2003

Table of Contents

Docket #

Title

1995N-0309

CGMPs for the Production of Infant Formula

1999D-1738

Bioavilability & Bioequivalence Studies for Nasal Aerosols

2001D-0368

Submitting Marketing Applications according to ICH/CTD Forma

2002P-0413

Health Claim: Phosphatidylserine and cognitive dysfunction

2003N-0056

Patient Examination & Surgeons' Gloves; Test Procedures

Contents

1995N-0309

CGMPs for the Production of Infant Formula

C 19

Center for Science in the Public Interest (CSPI)

Vol #:

9

Attachment 1, 2

NEC 3

FDA

Vol #:

1

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 127

Michael T. Chang

Vol #:

17

1999D-1738

Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 20

Novex Pharma

Vol #:

2

EMC 1

GlaxoSmithKline

Vol #:

1

Attachment

2000D-1598

Voluntary Labeling for Bioengineered Foods

C 9853

Tamara Tuthill

Vol #:

572

C 9854

Gerald Theisen

Vol #:

572

C 9855

John Harmon

Vol #:

572

C 9856

Sylvia Forbes

Vol #:

572

C 9857

Joanne Steele

Vol #:

572

C 9858

Noel C. Nelson

Vol #:

572

C 9859

Lora Nell Davidson

Vol #:

572

C 9860

Melinda S. Morton

Vol #:

572

C 9861

Phillip Robert Miner

Vol #:

572

C 9862

Nancy Draper

Vol #:

572

C 9863

Vicke Leeds

Vol #:

572

C 9864

Jerry R. Williams

Vol #:

572

C 9865

Jessica Williams

Vol #:

572

C 9866

Nancy Morris

Vol #:

572

C 9867

Mamie Mary Hunt

Vol #:

572

C 9868

Delilah Smith

Vol #:

572

C 9869

Ronald Harris

Vol #:

572

C 9870

Marian Vimont

Vol #:

572

C 9871

Earl C. Brydon

Vol #:

572

C 9872

Margie M. Epp

Vol #:

572

C 9873

Frank Miller

Vol #:

572

C 9874

Melinda S. Morton

Vol #:

572

C 9875

Shirley Bowman

Vol #:

572

2001D-0368

Submitting Marketing Applications according to ICH/CTD Forma

C 9

Jerussi Consulting, Inc.

Vol #:

1

C 10

Baxter Healthcare Corporation (Baxter)

Vol #:

1

2002P-0413

Health Claim: Phosphatidylserine and cognitive dysfunction

ACK 1

HFS-800 to Emord & Associates, PC

Vol #:

6

ANS 1

HFS-800 to Emord and Associates for Dr. K Smith

Vol #:

7

LET 6

Dr. Kyle Smith

Vol #:

6

2003D-0118

Decorative Contact Lens (Import alert #86-10)

C 31

Erica A. Hacker, O.D.

Vol #:

1

C 32

Thomas Flickinger, O.D., PhD

Vol #:

1

C 33

William J. Lindahl, O.D.

Vol #:

1

C 34

Mark R. Flora, O.D.

Vol #:

1

C 35

Valley Eye Care, PC

Vol #:

1

2003N-0056

Patient Examination & Surgeons' Gloves; Test Procedures

C 2

American Dental Assn (ADA)

Vol #:

1

C 3

Thai Rubber Glove Manufacturers Association

Vol #:

1

C 4

JM Gloves Co., Ltd.

Vol #:

1

2003P-0270

Prohibit False and Misleading Labeling

C 10

Rita Flygar

Vol #:

1

C 11

Ryan R. Anderson

Vol #:

1

C 12

Ursula Pelka

Vol #:

1

C 13

Joan Armer, RN

Vol #:

1

C 14

Julie Eyrich

Vol #:

1

2003P-0291

Enforce the law and prevent unlaw sale of contact lens

C 1

Michael M. Judkins, O.D.

Vol #:

1

C 2

W. Edward Culbertson, O.D.

Vol #:

1

C 3

Thomas C. Mueller, O.D.

Vol #:

1