Dockets Management

Dockets Entered On August 27, /2003

Table of Contents

Docket #

Title

1978N-0038. 1      Sunscreen Drug Products. 1

1981N-0033P. 1    Antiplaque & Antiplaque-Related Claims. 1

1992S-0251. 1      Electronic Submissions; Establishment of Public Docket 1

1994P-0268. 1      Essential Use Exemption for Implantable Infusion Pump. 1

1998P-0151. 1      Introduction Of Downed Cattle Into The Food Supply. 1

2003D-0061. 2      Comparability Protocols Chemistry Manufacturing and controls. 2

2003D-0231. 2      Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports; Availability  2

2003D-0317. 2      Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products  2

2003N-0200. 2      Agency Information Collection Activities: Proposed Collection; Comment Request; Export of Medical Devices ? Foreign Letters of Approval 2

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

2003N-0360. 2      Agency Info Collection: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank  2

2003P-0388. 2      ANDA Suitability for Metformin Hydrochloride Extended-Release (XR) Tablets, 1000 mg  2

2003V-0389. 2      Laser Light Show. 2

1978N-0038

Sunscreen Drug Products

C 602

Attachment 1, 2

Tanning Research Laboratories Inc (TRLI)

Vol #:

147

1981N-0033P

Antiplaque & Antiplaque-Related Claims

NEC 2

FDA

Vol #:

1

1992S-0251

Electronic Submissions; Establishment of Public Docket

M 27

INDA, NDA, ANDA, Master Files, Annual Reports, Promotional Materials, 21CFR312; 21CF

Vol #:

1

1994P-0268

Essential Use Exemption for Implantable Infusion Pump

LET 2

HFZ-1 to Medtronic MiniMed

Vol #:

1

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

AE 1

Number not used

Vol #:

294

C 6902

Mrs. Greta M. Bunting

Vol #:

294

C 6903

Farm Sanctuary

Vol #:

294

C 6904

Robert & Patricia Gault

Vol #:

294

C 6905

Nancy Bender

Vol #:

294

C 6906

Mr. & Mrs. V. Fusilier

Vol #:

294

C 6907

no signature

Vol #:

294

C 6908

Tina Santopoalo

Vol #:

294

C 6909

Paul D. Nordquist

Vol #:

294

C 6910

George Bauer

Vol #:

294

C 6911

Cindy L. Werking

Vol #:

294

C 6912

K. Holland

Vol #:

294

C 6913

Virginia Celmer

Vol #:

294

C 6914

Steven Weinstein

Vol #:

294

C 6915

Leslie Gougherty

Vol #:

294

C 6916

Elaine M. Osborne

Vol #:

294

C 6917

Patricia Briggs

Vol #:

294

C 6918

Mrs. Elinor Myrick

Vol #:

294

C 6919

Gloria Steindel

Vol #:

294

C 6920

Pamela A. Logan

Vol #:

294

C 6921

Barbara Lilly

Vol #:

294

C 6922

Nancy Clough

Vol #:

294

C 6923

Mrs. Pat Franzese

Vol #:

294

C 6924

Jerry L. Coalgate

Vol #:

294

C 6925

no signature

Vol #:

294

C 6926

Rene' Riddle

Vol #:

294

C 6927

R. Costello & Family

Vol #:

294

C 6928

Silvia St. John

Vol #:

294

C 6929

Patricia Polk

Vol #:

294

C 6930

Christina Hamberg

Vol #:

294

C 6931

Irene Redfield

Vol #:

294

C 6932

Dorothy J. Portukalian

Vol #:

294

C 6933

Janos & Jayna Dinnyes

Vol #:

294

C 6934

Ms. Joan Schuch

Vol #:

294

C 6935

Jennifer Schmidt

Vol #:

294

C 6936

John & Juliet Masucci

Vol #:

294

C 6937

Karen M. Prescott

Vol #:

294

C 6938

Yuriko Gessell

Vol #:

294

C 6939

Sally Ann Maggio

Vol #:

294

C 6940

Tenesa Tyler

Vol #:

296

C 6941

Laura Kaplan-Ortiz

Vol #:

296

C 6942

Ada E. Denkema

Vol #:

296

C 6943

Kim Marsala

Vol #:

296

C 6944

Lydia Schiro

Vol #:

296

C 6945

Gayle Celli

Vol #:

296

C 6946

Rita Barnes

Vol #:

296

C 6947

no signature

Vol #:

296

2003D-0061

Comparability Protocols Chemistry Manufacturing and controls

C 14

Active Pharmaceutical Ingredients Committee CEFIC/APIC

Vol #:

1

2003D-0231

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

C 5

Wyeth Pharmaceuticals

Vol #:

1

2003D-0317

Draft Guidance for Reviewers and Industry on Good Review Management Principles for PDUFA Products

C 1

Millennium Pharmaceuticals, Inc

Vol #:

1

2003N-0200

Agency Information Collection Activities: Proposed Collection; Comment Request; Export of Medical Devices ? Foreign Letters of Approval

N 2

FDA

Vol #:

1

2003N-0344

Consumer-Directed Promotion; Public Meeting

APE 1

Kaiser Permanente

Vol #:

1

APE 2

PhRMA Pharmaceutical Research and Manufacturers of America

Vol #:

1

APE 3

BC Centre for Health Services and Policy Research

Vol #:

1

APE 4

Mayo Clinic

Vol #:

1

2003N-0360

Agency Info Collection: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank

N 1

FDA

Vol #:

1

2003P-0388

ANDA Suitability for Metformin Hydrochloride Extended-Release (XR) Tablets, 1000 mg

ACK 1

HFA-305 to Lachman Consultant Services, Inc.

Vol #:

1

CP 1

Attachment 1

Attachment 2

Lachman Consultant Services, Inc.

Vol #:

1

2003V-0389

Laser Light Show

ACK 1

HFA-305 to I T Maintenance

Vol #:

1

VAR 1

I T Maintenance

Vol #:

1