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 11, 2002

TABLE OF CONTENTS

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77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro *
00D-1538 Electronic Records; Electronic Signatures, Validation *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0209 Governing First Amendment Case Law *
02N-0275 Bioterrorism Preparedness; Administrative Detention *
02P-0246 Pharmacies of hospitals/other health care entities *
02P-0444 cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg *

77N-094I Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

EXT 1 Wyeth Consumer Healthcare Vol#: 1

86P-0297 Standards of Identity to Amend Certain Chocolate Products

NFR 2 Vol#: 3

93P-0091 Amend Standard Identity Cacao Products re: White Chocolate

NFR 1 Vol#: 1

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 5925 Mr. Booth K. Bender Vol#: 251

00D-1538 Electronic Records; Electronic Signatures, Validation

MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 7

MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 7

MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 7

MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 7

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

MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6

MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6

MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6

MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6

MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6

MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6

MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6

00D-1541 Electronic Signatures: Audit Trails

MM 29 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6

MM 30 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6

MM 31 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6

MM 32 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6

00D-1542 Electronic Signatures: Time Stamps

MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 6

MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 6

MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 6

MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

MM 28 HFC-240 & IntraLinks, Inc. & SEC Associa Vol#: 7

MM 29 HFC-240 & Daon, Co. (Met 08/07/02) Vol#: 7

MM 30 HFC-240 & IMAGe-X, Inc. (Met 07/25/02) Vol#: 7

MM 31 HFC-240 & Agile Software Inc Met 8/28/02 Vol#: 7

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

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

01D-0493 Exemptions from the Warning Label Requirement for Juice;Reco

GDL 2 Guidance for Industry Vol#: 1

NAD 2 Guidance for Industry Vol#: 1

01P-0396 Request that FDA ban the production and sale of all ephedra

EMC 8 Kathleen Ann Zimmerman Vol#: 1

EMC 9 Mike Carroll Vol#: 1

02D-0384 Standardized Training Curriculum for Application of HACCP

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Guidance for Industry Vol#: 1

02N-0062 New Dietary Ingredient Premarket Notification,Info. Collect

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

02N-0112 Regulations Under the Federal Import Milk Act

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

APE 114 American Medical Assn Vol#: 7

APE 115 Dave Collins Vol#: 7

APE 116 HDMA Vol#: 7

02N-0209 Governing First Amendment Case Law

EMC 202 Monica Combs Vol#: 21

02N-0275 Bioterrorism Preparedness; Administrative Detention

EMC 10 NASFT, Nat. Assn for the Specialty Food Vol#: 3

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EMC 12 NASFT, Nat. Assn for the Specialty Food Vol#: 3

02N-0277 Bioterrorism; Establishment & Maintenance of Records

EMC 10 NASFT, Nat. Assn for the Specialty Food Vol#: 3

02N-0278 Bioterrorism;Prior Notice of Imported Food Shipments

EMC 11 NASFT, Nat. Assn for the Specialty Food Vol#: 3

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

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Guidance for Industry Vol#: 1

02P-0246 Pharmacies of hospitals/other health care entities

LET 2 University of Colorado Hospital Vol#: 1

02P-0444 cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg

ACK 1 HFA-305 Vol#: 1

CP 1 The Weinberg Group Inc. Vol#: 1