DOCKETS MANAGEMENT

Dockets Entered On July 10, 2003

Table of Contents

Docket #

Title

1978N-0021

Skin Protectant Drugs for OTC Human Use

1978N-0021P

Skin Protectant Drug Products for OTC Human Use

1978N-0064

OTC Antiperspirant

2000D-1598

Voluntary Labeling for Bioengineered Foods

2002N-0277

Bioterrorism; Establishment & Maintenance of Records

2003D-0117

Implementation of Inspection by Accredited Persons Program

2003D-0282

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices; Guidance for Industry and FDA; Availa

2003N-0191

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices

2003N-0232

Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

2003N-0269

Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation

2003N-0285

Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

2003N-0295

Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile

2003P-0310

Nance Pretzel Dip

Details

1978N-0021

Skin Protectant Drugs for OTC Human Use

ACK 1

Number not used

Vol #:

0

ACK 2

HFA-305 to CTFA

Vol #:

43

PRC 1

CTFA

Vol #:

43

1978N-0021P

Skin Protectant Drug Products for OTC Human Use

ACK 1

HFA-305 to CTFA

Vol #:

1

PRC 1

CTFA

Vol #:

1

1978N-0064

OTC Antiperspirant

ACK 6

HFA-305 to Covington & Burling

Vol #:

51

PRC 2

Revlon, Inc.

Vol #:

51

2000D-1598

Voluntary Labeling for Bioengineered Foods

C 9927

Norman J. Birthmark

Vol #:

579

C 9928

Dominick G.

Vol #:

579

C 9929

Will Harlan

Vol #:

579

C 9930

James & Sharon Hoffman

Vol #:

579

C 9931

J. M. Lambert

Vol #:

579

C 9932

Ms. Judy Thomsen

Vol #:

579

C 9933

Bobbe Besold

Vol #:

579

C 9934

Tami Augustyn

Vol #:

579

C 9935

Erbin Crowell

Vol #:

579

C 9936

Hazel H. Landa

Vol #:

579

C 9937

Charles D. Stauffacher

Vol #:

579

C 9938

Angelina M. Hart

Vol #:

579

C 9939

Jean Groshek

Vol #:

579

C 9940

Alice M. Carron

Vol #:

579

C 9941

Barbara Joan Birnbaum

Vol #:

579

C 9942

Candace Young

Vol #:

579

C 9943

Mr. & Mrs. G. R. Denison

Vol #:

579

C 9944

Walt Blackford

Vol #:

579

C 9945

Mr. Karl J. Volk

Vol #:

579

C 9946

Kirk Wortman

Vol #:

579

C 9947

Christie D.

Vol #:

579

C 9948

Lovel Pratt

Vol #:

579

C 9949

Phyllis Swackhamer

Vol #:

579

C 9950

Kimberly Sims

Vol #:

579

C 9951

T. Maksimovich

Vol #:

579

C 9952

Liisa Wale

Vol #:

579

C 9953

Individual Consumer

Vol #:

579

C 9954

Stan Ayers

Vol #:

579

C 9955

Nancy Wong

Vol #:

579

C 9956

13 signatures

Vol #:

579

C 9957

Virginia Ahrens Nixon, M.S., L.C.S.W.

Vol #:

579

C 9958

Emily J. Delcarup

Vol #:

579

C 9959

Kenneth D. Johnsen

Vol #:

579

C 9960

Rebecca Oliver

Vol #:

579

C 9961

David M. Hiel

Vol #:

579

C 9962

no signature

Vol #:

579

C 9963

Elias W. Keim

Vol #:

579

C 9964

Kevyn Woven

Vol #:

579

C 9965

Joy Wolff

Vol #:

579

C 9966

Jen Punzel

Vol #:

579

C 9967

Alisha Rett

Vol #:

579

C 9968

Kimberly S. Kelton

Vol #:

579

C 9969

Carolyn Bobola

Vol #:

579

C 9970

Susan Coryell

Vol #:

579

C 9971

Desiree Ferrell

Vol #:

579

C 9972

Joseph D. Donalies

Vol #:

579

C 9973

Hans Kueck

Vol #:

579

C 9974

Mr. & Mrs. Mohandas T. R. Ah.

Vol #:

579

C 9975

Kyle Brewer

Vol #:

579

C 9976

Jeanette Thomas

Vol #:

579

C 9977

Zack Wood

Vol #:

579

C 9978

Isabel A. Leonard

Vol #:

579

C 9979

Alicia Dahlen

Vol #:

579

C 9980

Jeremy Schwartz

Vol #:

579

C 9981

Wild Oats Market, Inc

Vol #:

579

C 9982

Phyllis Johnsen

Vol #:

579

C 9983

Vivian Bryson

Vol #:

579

C 9984

Jacob Bricca

Vol #:

579

C 9985

Elenara Joubert

Vol #:

580

C 9986

Peter Miller

Vol #:

580

C 9987

Care Thailand

Vol #:

580

2002N-0277

Bioterrorism; Establishment & Maintenance of Records

C 55

National Restaurant Association

Vol #:

11

C 56

Processed Apple Institute

Vol #:

11

C 57

Horizon Lines, LLC

Vol #:

11

C 58

International Banana Association (IBA)

Vol #:

11

C 59

Fibre Box Association

Vol #:

11

C 60

American Forest & Paper Association

Vol #:

11

C 61

Shaklee Corporation

Vol #:

11

C 62

American Frozen Food Institute

Vol #:

11

C 63

National Soft Drink Association

Vol #:

11

C 64

Association of American Railroads

Vol #:

11

C 65

Government of the Republic of Indonesia

Vol #:

11

C 66

Menteri Pertainian Republik Indonesia

Vol #:

11

C 67

National Food Processors Association

Vol #:

11

C 68

Covington & Burling

Vol #:

11

C 69

American Herbal Products Association

Vol #:

11

C 70

Purity Wholesale Grocers, Inc

Vol #:

11

C 71

Cheese Importers Association of America, Inc

Vol #:

11

C 72

National Institute of Oilseed Products

Vol #:

12

C 73

Chocolate Manufacturers Association, National Confectioners Association

Vol #:

12

C 74

National Coalition of Food Importing Associations

Vol #:

12

C 75

International Foodservice Distributors Association (IFDA)

Vol #:

12

C 76

American Bakers Association

Vol #:

12

EMC 104

Washington State University

Vol #:

11

2003D-0117

Implementation of Inspection by Accredited Persons Program

N 1

FDA

Vol #:

2

2003D-0282

Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices; Guidance for Industry and FDA; Availa

BKG 1

BACKGROUND MATERIAL

Vol #:

1

Tab 1, 2, 3, 4, 5

GDL 1

Guideance

Vol #:

1

NAD 1

FDA

Vol #:

1

2003N-0191

Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices

N 1

FDA

Vol #:

1

2003N-0232

Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887

N 1

FDA

Vol #:

1

2003N-0269

Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation

N 1

FDA

Vol #:

1

2003N-0285

Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

NAD 1

FDA

Vol #:

1

2003N-0295

Agency Information Collection; Establish & Maintain List of US Dairy Product Manufacturers/Processors with interest in exporting to Chile

N 1

FDA

Vol #:

1

2003P-0310

Nance Pretzel Dip

ACK 1

HFA-305 to Baldwin Richardson Foods Co.

Vol #:

1

ACK 2

Number not used

Vol #:

1

CP 1

Baldwin Richardson Foods, Co.

Vol #:

1