FDA Logo links to FDA home page

U.S. Food and Drug Administration

HHS Logo links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | A-Z Index | Contact FDA

horizonal rule

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

Page created July 11, 2003 jb

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility