Dockets Entered On July 23, 2003

Table of Contents

Docket #

Title

1991N-0384H

Nutrient Content Claims, Definition of Term: Healthy

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

2003D-0120

Multiplex Tests for Heritable DNA Markers, Mutations & Expre

2003D-0263

Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti

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-0069

FDA Task Force on Consumer Health Info for Better Nutrition

2003N-0084

Electronic Records; Electronic Signatures; Agency Information

2003N-0142

Submitting & Reviewing Complete Responses for Clinical Holds

2003N-0203

Innovative Systems for Delivery of Drugs and Biologics

2003N-0281

SARS Diagnostics: Scientific and Regulatory Challenges Public Workshop

2003N-0314

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements

2003P-0331

ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg)

Details

1991N-0384H

Nutrient Content Claims, Definition of Term: Healthy

C 127

ConAgra Foods Inc

Vol #:

16

Exhibits

C 128

Salt Institute, Inc

Vol #:

13

C 129

American Dietetic Association

Vol #:

13

C 130

Center for Science in the Public Interest (CSPI)

Vol #:

13

C 131

Quaker Foods & Beverages

Vol #:

13

C 132

Nestle USA

Vol #:

13

EMC 2

U S Chamber of Commerce

Vol #:

13

Attachment

SUP 2

ConAgra Foods, Inc

Vol #:

13

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

C 6731

R. Siegel

Vol #:

291

C 6732

Pat Currow

Vol #:

291

C 6733

R. Siegel

Vol #:

291

C 6734

no signature

Vol #:

291

C 6735

Frank & Faye Evans

Vol #:

291

C 6736

Valerie Barnard

Vol #:

291

C 6737

Bernard Caley

Vol #:

291

C 6738

Janet Bloor

Vol #:

291

C 6739

J. Capozzelli

Vol #:

291

C 6740

Darlene Wheeler

Vol #:

291

C 6741

Marilyn Florez Mosel

Vol #:

291

C 6742

Arlana Blue

Vol #:

291

C 6743

Genie S. Avant

Vol #:

291

C 6744

Tess Loewen

Vol #:

291

C 6745

Sarah G. Florez

Vol #:

291

C 6746

Paul & Dolores Koleda

Vol #:

291

C 6747

Doris E. B.

Vol #:

291

C 6748

Gail A. Wilson

Vol #:

291

C 6749

Stephen & Christine Heller

Vol #:

291

C 6750

Jane A. Pickering

Vol #:

291

C 6751

Ruth Bloom

Vol #:

251

C 6752

J. A. Hyra

Vol #:

291

C 6753

Marilynn Harmon

Vol #:

291

C 6754

Miss Poornima Dasgupta

Vol #:

291

C 6755

Charles T. Kivette

Vol #:

291

C 6756

Naomi Caplan

Vol #:

291

C 6757

Jennifer Ann Collins-Jones

Vol #:

291

C 6758

Mireya Landin et al

Vol #:

291

C 6759

E. Ann Chavez

Vol #:

291

C 6760

Blanche M. Pinkerton

Vol #:

291

C 6761

J. V. Romano

Vol #:

291

C 6762

Wilhelm Winter

Vol #:

291

C 6763

Winifred & John Reuter

Vol #:

291

C 6764

Bob & Nan Gacey

Vol #:

291

C 6765

Jane Katz

Vol #:

291

C 6766

Lyn Rosen

Vol #:

291

C 6767

Alice & Melissa McTague

Vol #:

291

C 6768

Eileen Tobin Perlman

Vol #:

291

C 6769

Eva & Wayne MacNerland

Vol #:

291

C 6770

M. S. Piccione

Vol #:

291

EMC 3447

Donna M. Shoesmith

Vol #:

281

EMC 3448

Rita Weiss

Vol #:

281

EMC 3449

Heather Rende

Vol #:

281

EMC 3450

Meredith Erickson

Vol #:

281

EMC 3451

Janet Knox

Vol #:

281

EMC 3452

Erik R. Odegard

Vol #:

281

EMC 3453

Jon Hatanpa

Vol #:

281

EMC 3454

Diane Gifford

Vol #:

281

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

CR 3

Bayer Corporation

Vol #:

380

MO 52

Bayer Corporation

Vol #:

380

2003D-0120

Multiplex Tests for Heritable DNA Markers, Mutations & Expre

C 11

Roche Molecular Systems, Inc.

Vol #:

1

C 12

GlaxoSmithKline

Vol #:

1

2003D-0263

Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protecti

GDL 1

Background Material

Vol #:

1

NAD 1

FDA

Vol #:

1

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

NCR 1

FDA

Vol #:

1

2003N-0069

FDA Task Force on Consumer Health Info for Better Nutrition

GDL 1

GUIDANCE

Vol #:

1

GDL 2

GUIDANCE

Vol #:

1

NAD 1

FDA

Vol #:

1

NCR 1

FDA

Vol #:

1

2003N-0084

Electronic Records; Electronic Signatures; Agency Information

N 2

FDA

Vol #:

1

2003N-0142

Submitting & Reviewing Complete Responses for Clinical Holds

N 2

FDA

Vol #:

1

2003N-0203

Innovative Systems for Delivery of Drugs and Biologics

TR 1

Transcript of July 8, 2003 Workshop

Vol #:

2

2003N-0281

SARS Diagnostics: Scientific and Regulatory Challenges Public Workshop

LST 1

Program for the July 14, 2003 Meeting

Vol #:

1

TS 1

CDRH - Elements of FDA Review for a New Diagnostic Assay

Vol #:

1

TS 2

Update on SARS Diagnostic Assays in China

Vol #:

1

TS 3

Real Time under an IDE-CDC's PCR & ELISA Investigational Protocols

Vol #:

1

TS 4

Evaluating a New Diagnostic Assay: Industry Perspective

Vol #:

1

TS 5

NIAID Funding Opportunities

Vol #:

1

TS 6

Clinical Approach to Diagnosis of SARS

Vol #:

1

TS 7

Public Health Perspective on SARS Diagnostic

Vol #:

1

TS 8

SARS Diagnostics and Laboratory Needs: the WHO Perspective

Vol #:

1

TS 9

SPECIMEN HANDLING: from patient bedside to the laboratories (clinical, commercial and

Vol #:

1

TS 10

Using Non-human Sourced and Banked Human Specimen Material for Nucleic Acid Based A

Vol #:

1

TS 11

SARS Research Resources
at NIAID

Vol #:

1

TS 12

Rapid Development of Diagnostic Devices for Infectious Threats

Vol #:

1

TS 13

SARS Coronavirus Detection

Vol #:

1

2003N-0314

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements

N 1

FDA

Vol #:

1

2003P-0331

ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg)

ACK 1

HFA-305 to Lachman Consultant Services, Inc.

Vol #:

1

CP 1

Lachman Consultant Services, Inc.

Vol #:

1