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DOCKETS ENTERED on June 19, 2002

TABLE OF CONTENTS

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00D-1598 Voluntary Labeling for Bioengineered Foods *
02N-0169 Combination Products Containing Live Cellular Components *
02P-0205 SRNT petition to regulate Ariva tobacco lozenges *

92S-0251 Electronic Submissions; Establishment of Public Docket

M 21 CBER Investigational NDA Vol#: 1

M 22 CBER Postmarketing Expedited & Periodic Vol#: 1

M 23 CDER Postmarketing Expedited & Periodic Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2268 Jillian Helm Vol#: 65

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 3268 Lauren O'Shea Vol#: 5019

CA 3599 Jeff Vosmak Vol#: 5023

CA 3600 Sam Robertson Vol#: 5023

CA 3601 Mary Alba Vol#: 5023

CA 3602 Jerry Kuistad Vol#: 5023

CA 3603 Amy Jo Meadows Vol#: 5023

CA 3604 Jeanne M. Old Vol#: 5023

CA 3605 John Smith Vol#: 5023

CA 3606 Holly Kelley Vol#: 5023

CA 3607 Peggy A. Willis Vol#: 5023

CA 3608 Rob Johanns Vol#: 5023

CA 3609 Gail Anzalme Vol#: 5023

CA 3610 Steve Wentland Vol#: 5023

CA 3611 Vince Hippe Vol#: 5023

CA 3612 Joseph M. Estay Vol#: 5023

CA 3613 R. I. Trone Vol#: 5023

CA 3614 Charles Bitler Vol#: 5023

CA 3615 Jeffrey Schifano Vol#: 5023

CA 3616 Ronald W. Armstead Vol#: 5023

CA 3617 L. Reinchard Vol#: 5023

CA 3618 Sharyn E. Mobley Vol#: 5023

CA 3619 Steve Sanchez Vol#: 5023

CA 3620 James C. Green Vol#: 5023

CA 3621 Walter E. Dotson, III Vol#: 5023

CA 3622 Mrs. Nancy Holland Vol#: 5023

CA 3623 Lorraine Wray Vol#: 5023

CA 3624 Robert W. Wray, Jr. Vol#: 5023

CA 3625 Diane Christopher Vol#: 5023

CA 3626 James C. Thatcher Vol#: 5023

CA 3627 Dawn Brown Vol#: 5023

CA 3628 Joseph Shelak Vol#: 5023

CA 3629 Roger Hyde Vol#: 5023

CA 3630 Donald J. Postema Vol#: 5023

CA 3631 Debi Dannenberger Vol#: 5023

CA 3632 James J. Orf Vol#: 5023

CA 3633 Paul R. Bacon Vol#: 5023

CA 3634 Ric Williams Vol#: 5023

CA 3635 Fred Martin Vol#: 5023

CA 3636 Peter D. Parkinson Vol#: 5023

CA 3637 B. Jeanne Gilbert Vol#: 5023

CA 3638 Tim Armstead Vol#: 5023

CA 3639 Gail Ward Vol#: 5023

CA 3640 Billy Lee Timmermann Vol#: 5023

CA 3641 Marvin L. Ferrell, Jr. Vol#: 5023

CA 3642 Deborah Lynn Fulp Vol#: 5023

CA 3643 Craig Sheppard Vol#: 5023

CA 3644 Bill Hunter Vol#: 5023

CA 3645 Robert S. Lake Vol#: 5023

CA 3646 Chris Adkins Vol#: 5023

CA 3647 David E. Jones Vol#: 5023

CA 3648 Raymond J. Barnette Vol#: 5023

CA 3649 John L. Quirk, Jr. Vol#: 5023

CA 3650 William M. Katinowsky Vol#: 5023

CA 3651 Kathy M. Buer Vol#: 5023

CA 3652 Larry Long Vol#: 5023

CA 3653 Barry Wellborn Vol#: 5023

CA 3654 Sonja A. Chappell Vol#: 5023

CA 3655 Joel G. Binford Vol#: 5023

CA 3656 Joan E. Browne Vol#: 5023

CA 3657 Mark A. Savin Vol#: 5023

CA 3658 Richard S. Hinkle Vol#: 5023

CA 3659 Nancy M. Dick Vol#: 5023

CA 3660 Dan Bouryet Vol#: 5023

CA 3661 Vernon Reifeis Vol#: 5023

CA 3662 Randall M. Voss Vol#: 5023

CA 3663 Warren Vandish Vol#: 5023

CA 3664 John O. Bdaner Vol#: 5023

CA 3665 Pamela Conant Vol#: 5023

CA 3666 Micheal Dean Caudle Vol#: 5023

CA 3667 Pat Adams Vol#: 5023

CA 3668 Scott Buckway Vol#: 5023

CA 3669 Bob Curtis Vol#: 5023

CA 3670 Micheal L. Harrell Vol#: 5023

CA 3671 Thomas P. Edwards Vol#: 5023

CA 3672 Jerry Snider Vol#: 5023

CA 3673 Blake Cook Vol#: 5023

CA 3674 Jeffery M. Wilson Vol#: 5023

CA 3675 Kathy Hammitt Vol#: 5023

CA 3676 William N. Hurley Vol#: 5023

CA 3677 Mary Jane Rowe Vol#: 5023

CA 3678 Al Niehus Vol#: 5023

CA 3679 Jill Lumn Vol#: 5023

CA 3680 Robert H. Stamfield Vol#: 5023

CA 3681 Kevin S. Brown Vol#: 5023

CA 3682 Lisa J. Green Vol#: 5023

CA 3683 Norman V. DiCataldo Vol#: 5023

CA 3684 Jimmy Murphy Vol#: 5023

CA 3685 Pam O'Donnell Vol#: 5023

CA 3686 Franz Ramey Vol#: 5023

CA 3687 Dr. A. J. Wartg Vol#: 5023

CA 3688 Steve Bierwold Vol#: 5023

CA 3689 Cecil R. Rucker Vol#: 5023

CA 3690 Kelly Flynn Vol#: 5023

CA 3691 Lance Crook Vol#: 5023

CA 3692 Reece Lindstrom Vol#: 5023

CA 3693 Bill L. Rendes Vol#: 5023

CA 3694 Micheal Knouse Vol#: 5023

CA 3695 Nelvie G. Allen Vol#: 5023

CA 3696 Micheal L. White Vol#: 5023

CA 3697 Thomas M. Kuhlman Vol#: 5023

CA 3698 Jim Sudboda Vol#: 5023

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

REF 1 HFF-822 Vol#: 2

99N-0922 Obstetric & Gynecology Devices; Glans Sheath Devices

N 1 Vol#: 2

00D-1538 Electronic Records; Electronic Signatures, Validation

C 30 National Electrical Manufacturers Assn Vol#: 7

00D-1541 Electronic Signatures: Audit Trails

C 3 Industry Coalition on 21 CFR Part II Vol#: 6

00D-1542 Electronic Signatures: Time Stamps

C 7 Merck & Co., Inc. Vol#: 6

00D-1598 Voluntary Labeling for Bioengineered Foods

LET 2 HFS-822 Vol#: 570

00N-1663 Investigational New Drugs

NPR 1 Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12648 Mrs Jamini C Arcell Vol#: 784

C 12649 Quinn Whitten Vol#: 784

C 12650 Debra K Milestone Vol#: 784

C 12651 Jami Jeppson Vol#: 784

C 12652 Amy Van Voorhis Vol#: 784

C 12653 Penny Peckens Vol#: 784

C 12654 Alex Brewer Vol#: 784

C 12655 Elizabeth C Krogh Vol#: 784

C 12656 Donna L Konrad Vol#: 784

C 12657 Tracy Eggan Vol#: 784

C 12658 Kim Halls Vol#: 784

C 12659 Sarah McKee Vol#: 784

C 12660 Bill Camp Vol#: 784

01D-0435 International Conference on Harmonisation

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

01N-0590 Salmonella Discovery System Pilot Study;Information Collecti

N 2 Vol#: 1

02D-0231 Stability Data Pack for Registration Climatic Zones lll & IV

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re

GDL 1 GIUIDANCE Vol#: 1

NAD 1 Vol#: 1

02D-0237 QIE Evaluation of Stability Data

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02N-0054 Labeling Requirements for Color Additives

N 2 Vol#: 1

02N-0169 Combination Products Containing Live Cellular Components

APE 18 Americlan Academy of Orthopaedic Surgeon Vol#: 2

APE 19 Integra LifeSciences Corporation Vol#: 2

APE 20 Celadon Science Inc. Vol#: 2

APE 21 The United States Pharmacopeia Vol#: 2

APE 22 University of Toronto Vol#: 2

APE 23 PhRMA Vol#: 2

APE 24 University of Cincinnati Vol#: 2

APE 25 Advanced Cell & Gene Therapy Consulting Vol#: 2

APE 26 Intl Society for Cellular Therapy Vol#: 2

CR 1 Advanced Tissue Sciences Vol#: 2

CR 2 Celadon Science Inc. Vol#: 2

02P-0205 SRNT petition to regulate Ariva tobacco lozenges

C 1 McDermott, Will & Emery Vol#: 1

02V-0279 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Daamini Vol#: 1