Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on October 18, 2002

TABLE OF CONTENTS

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97P-0154 Require a boxed warning on the labeling of OPV *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec *
01P-0120 Ban Unsafe IV Catheters and other Devices *
02P-0177 Health Claim: D-tagatose and Noncariogenicity *
02P-0349 Amend product insert and/or label for Hemophilus Vaccines *
02P-0457 Selenium and Anticarcinogenic effects in certain caners *

97P-0154 Require a boxed warning on the labeling of OPV

WDL 1 Informed Parents Against VAPP Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

EC 15 Number Not Used Vol#: 2

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

EC 18 University of Virginia Medical Center Vol#: 5

EC 19 Mr. Thomas Bowen Vol#: 5

EC 20 Alice Hyde Medical Center Vol#: 5

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EC 3 QAD, Inc. Vol#: 6

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9403 Jeannette Lee Vol#: 408

01D-0202 Provisions of the FDA Modernization Act of 1997

EC 1 Mrs. patty buzzelli Vol#: 1

01N-0589 Extralabel Drug Use in Animals;Information Collection

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

C 31 Antares Pharma, Inc. Vol#: 3

02D-0073 Validation of Procedures for Processing of Human Tissues

EC 3 Mr. James Joseph Lynch, Jr. Vol#: 1

02D-0303 Guidance for Industry on Formal Dispte Resolution

N 2 Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

EC 1 Number Not Used Vol#: 1

02D-0326 Safety of Residues of Veterinary Drugs in Human Food

EC 1 Number Not Used Vol#: 1

02D-0385 Approval of Labeling for Foods Treated by Irradiation

EC 1 Mr. Joseph Lombardi Vol#: 1

EC 2 Mr. Gary Don Popken Vol#: 1

02F-0327 ADM Alliance Nutrition, Inc.;Animal Use Feed-Grade Biuret

EC 2 Mrs. Cori Darley Vol#: 1

02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling

EC 1 Number Not Used Vol#: 1

02N-0131 Generic FDA Rapid Response Surveys;Information Collection Ac

N 2 Vol#: 1

02N-0209 Governing First Amendment Case Law

EC 439 Mr. Rich Peppers Vol#: 6

EC 440 Mr. Tim Rosenstein Vol#: 6

EC 441 Ms. odette peteersen Vol#: 6

02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling

EC 17 Ms. holly tomatis Vol#: 1

02N-0284 Record Retention Requirements/Soy Protein/Risk of Coronary

N 2 Vol#: 1

02N-0309 Reclassification Petitions for Medical Devices;Agency Inform

N 2 Vol#: 1

02N-0355 Medical Device Recall Authority;Agency Information Collectio

EC 1 Number Not Used Vol#: 1

02N-0359 Ingrown Toenail Relief drug products OTC human use

EC 1 Woodbury Student Vol#: 1

02P-0009 Amend 21 CFR 120.24 concentrated and shelf-stable juice

EC 1 Number Not Used Vol#: 1

02P-0177 Health Claim: D-tagatose and Noncariogenicity

C 1 Kellogg Vol#: 1

02P-0349 Amend product insert and/or label for Hemophilus Vaccines

C 1 Aventis Pasteur Vol#: 1

02P-0457 Selenium and Anticarcinogenic effects in certain caners

ACK 1 HFS-275 Vol#: 1

CP 1 Wellness Lifestyles, Inc. Vol#: 1

LET 1 HFS-800 Vol#: 3