Dockets Entered On July 22, 2003

Table of Contents

Docket #

Title

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

1996P-0500

Amend "Healthy" Definition re: Sodium Levels

2000D-1538

Electronic Records; Electronic Signatures, Validation

2000D-1539

Electronic Records & Signatures, Retention of Electronic Rec

2000D-1540

Electronic Signatures, Electronic Copies of Electronic Recor

2000D-1541

Electronic Signatures: Audit Trails

2000D-1542

Electronic Signatures: Time Stamps

2000D-1543

Electronic Signatures: Glossary of Terms

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

2002D-0385

Approval of Labeling for Foods Treated by Irradiation

2003N-0017

Risk Management Programs on the Practice of Pharmacy

2003N-0076

Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2003N-0302

Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling

2003N-0311

Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)

2003P-0315

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

Details

1995N-0304

Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 4042

Ernest J. Istook, Jr. (CI)

Vol #:

374

C 4043

Ephedra Education Council

Vol #:

374

C 4044

Barry Sherr

Vol #:

374

EMC 810

Zoesfrogs

Vol #:

375

EMC 811

Anna P. Morones

Vol #:

375

EMC 812

Kelly Quellette

Vol #:

375

EMC 813

Harl & Melba Sims

Vol #:

375

EMC 814

John Diaz (Canada)

Vol #:

375

EMC 815

Nicolle J. White

Vol #:

375

EMC 816

number not used

Vol #:

375

EMC 817

number not used

Vol #:

375

EMC 818

Mike Sanchez

Vol #:

375

EMC 819

Joy K. Karschnik

Vol #:

375

EMC 820

Betty Martini

Vol #:

375

1996P-0500

Amend "Healthy" Definition re: Sodium Levels

C 37

ConAgra Foods

Vol #:

13

C 38

Salt Institute

Vol #:

10

C 39

American Dietetic Association

Vol #:

10

C 40

Center for Science in the Public Interest (CSPI)

Vol #:

10

C 41

Quaker Foods & Beverages

Vol #:

10

C 42

Nestle USA

Vol #:

10

SUP 1

ConAgra Foods

Vol #:

10

1998P-0151

Introduction Of Downed Cattle Into The Food Supply

EMC 3418

Diane M. Peluso

Vol #:

281

EMC 3419

Robin Reich

Vol #:

281

EMC 3420

Tana Gullotta

Vol #:

281

EMC 3421

Ed Cohen

Vol #:

281

EMC 3422

Marsha A. Matson

Vol #:

281

EMC 3423

Virginia Robertson

Vol #:

281

EMC 3424

Erik Odegard

Vol #:

281

EMC 3425

Keith Megow

Vol #:

281

EMC 3426

Newfs9

Vol #:

281

EMC 3427

Rachel Yenkinson

Vol #:

281

EMC 3428

Laura Klaw

Vol #:

281

EMC 3429

Barbara Altig

Vol #:

281

EMC 3430

Jayne Kaszas

Vol #:

281

EMC 3431

Sandi Hefner

Vol #:

281

EMC 3432

Susan Dillon

Vol #:

281

EMC 3433

Kate McGill

Vol #:

281

EMC 3434

Kelly

Vol #:

281

EMC 3435

The Krugs

Vol #:

281

EMC 3436

Eric Gastfriend

Vol #:

281

EMC 3437

Jolie Cannon

Vol #:

281

EMC 3438

Suzanne R. Viinikainen

Vol #:

281

EMC 3439

Rick Kump

Vol #:

281

EMC 3440

Sacha Krug

Vol #:

281

EMC 3441

Joanne Chang

Vol #:

281

EMC 3442

Grace Ertel

Vol #:

281

EMC 3443

Shelley McKee

Vol #:

281

EMC 3444

Eliane Melo De Avendano (Brazil)

Vol #:

281

EMC 3445

Fleur Wiorkowski

Vol #:

281

EMC 3446

Judith Fish

Vol #:

281

1999D-4130

Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems

C 5

Robert Ward

Vol #:

1

2000D-1538

Electronic Records; Electronic Signatures, Validation

LST 14

Gen. References for Guidance July 1, 2003

Vol #:

0

2000D-1539

Electronic Records & Signatures, Retention of Electronic Rec

LST 14

Gen. References for Guidance July 1, 2003

Vol #:

9

2000D-1540

Electronic Signatures, Electronic Copies of Electronic Recor

LST 14

Gen. References for Guidance July 1, 2003

Vol #:

6

2000D-1541

Electronic Signatures: Audit Trails

LST 14

Gen. References for Guidance July 1, 2003

Vol #:

6

2000D-1542

Electronic Signatures: Time Stamps

LST 14

Gen. References for Guidance as of July 1, 2003

Vol #:

7

2000D-1543

Electronic Signatures: Glossary of Terms

LST 14

Updated List of Part 11 Venders

Vol #:

7

2000D-1598

Voluntary Labeling for Bioengineered Foods

C 9998

Ms. Janet Cameron Duffy

Vol #:

580

C 9999

Ms. Shannon Holloway

Vol #:

580

LET 3

Ms. Demelza Costa

Vol #:

580

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

BRF 1

Center for Veterinary Medicine

Vol #:

379

BRF 2

Bayer Corporation

Vol #:

379

BRF 3

Bayer Corporation

Vol #:

379

2001P-0230

Domestic Marketing & Importation of Transgenic Fish

EMC 2982

Joseph Kalgren

Vol #:

252

EMC 2983

Christie Jones

Vol #:

252

EMC 2984

Mike Hargrave

Vol #:

252

EMC 2985

Priscilla McKillip

Vol #:

252

EMC 2986

Liz Fuerst

Vol #:

252

EMC 2987

Anna Jeavons

Vol #:

252

EMC 2988

Marilyn Magnus

Vol #:

252

EMC 2989

Joddie Powell

Vol #:

252

2002D-0385

Approval of Labeling for Foods Treated by Irradiation

C 16

Guardion

Vol #:

1

2003N-0017

Risk Management Programs on the Practice of Pharmacy

N 2

FDA

Vol #:

1

2003N-0076

Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

NAP 1

FDA

Vol #:

1

2003N-0302

Agency Information Collection Activities; Proposed Collection; Comment Request; Certain Biologics Labeling

N 1

FDA

Vol #:

1

2003N-0311

Agency Information Collection Activities: Proposed Collection; Comment Request; MDUFMA Small Business Qualification Certification (Form FDA 3602)

N 1

FDA

Vol #:

1

2003P-0315

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

ACK 2

HFA-305 to CollaGenex Pharmaceuticals

Vol #:

1

PSA 1

CollaGenex Pharmaceuticals

Vol #:

1