Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on October 23, 2000

TABLE OF CONTENTS

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92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1577 Variance from source-skin distance requirement of perf. std. *
00P-1578 Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach *
78P-0148 LASER MEDIA ENTERTAINMENT SYSTEM

VRA 13 HFZ-330 to Laser Media Inc Vol#: 1
 

85V-0189 Laser Light Show

VRA 10 HFZ-330 to Laser Safety officer Vol#: 1
 

88V-0259 Laser Media LSM6 W Lexel 88 Laser Light Show

VRA 7 HFZ-330 to Twilight Theatrical Lighting Vol#: 1
 

90V-0282 Laser light show (Model LMS Projector/RZ Projectors).

VRA 4 HFZ-330 to Pegasus Productions Vol#: 1

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

LET 5 IACP Vol#: 6

92S-0181 Substances Exempt from Threshold of Regulation, Food Additiv

EA 1 CTS No. 59264 Environment Assessment Vol#: 1

FONS10 TR2000-3 BASF Corporation Vol#: 1

LST 12 List of exemptions Vol#: 1

95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr

C 18 Vector Corporation Vol#: 2

95V-0231 Laser Light Show

VRA 5 HFZ-330 to Production Design IntNatl Inc Vol#: 1

95V-0312

VRA 4 HFZ-330 to Laseronics Northwest Vol#: 1

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 383 Strictly Supplements, Inc. Vol#: 10

LET 384 Mariposa Botanicals Vol#: 10

LET 385 Intelligent Nutrients Vol#: 10

LET 386 Wind River Herbs Vol#: 10

LET 387 NOW Foods Vol#: 10

LET 388 Natural Balance, Inc. Vol#: 10

LET 389 Jarrow Formulas, Inc. Vol#: 10

LET 390 Strictly Supplements, Inc. Vol#: 10

LET 391 Rexall Sundown, Inc. Vol#: 10

LET 392 Shaklee Corporation Vol#: 10

LET 393 Tabak's Health Products Vol#: 10

LET 394 Maxcell bioscience, Inc. Vol#: 10

LET 395 Standard Process, Inc. Vol#: 10

97V-0095 Scanning band width changed from DC to 100 KHZ

VRA 2 HFZ-330 to George Carden Circus Internat Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

N 1 Vol#: 882

98V-0248 Laser Light Show/Mobolazer ML10-200ML10-300ML10-300W

VRA 2 HFZ-330 to NewAje Vol#: 1
 

98V-0454 Laser light show

VRA 2 HFZ-330 to Universal Studios Florida Vol#: 1
 

98V-0703 Laser Light Show

VRA 2 HFZ-330 to Universal Studios Florida Vol#: 1
 

98V-0876

EXP 1 Cramer Productions Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 669 Meaghan Simpson Vol#: 16

EMC 177 Melanie Johnson Vol#: 16

EMC 178 Sheila Booth Vol#: 16

EMC 179 E. Bryant Vol#: 16

EMC 180 Barbara Wilkie Vol#: 16

EMC 181 Logan Frederick Vol#: 16

EMC 182 Carolyn Leah Banks Vol#: 16

EMC 183 Julie Pardin Vol#: 16

EMC 184 Sarah J. Berger Vol#: 16

EMC 185 S. Daugherty Vol#: 16

EMC 186 S. Daugherty Vol#: 16

EMC 187 Brigadoon 33 Vol#: 16

EMC 188 Julie Evans Vol#: 16

EMC 189 David Granum Vol#: 16
 

99V-0125 Laser Light Show Laserium CSMX250

VRA 2 HFZ-330 to Universal Studios Florida Vol#: 1
 

99V-3021 Laser Light Show

VRA 2 HFZ-330 to Geroge's Ringside Inc Vol#: 1
 

99V-5196

VRA 2 HFZ-330 to Science City at Union Station Vol#: 1

00D-1532 Registration of Veterinary Medicinal Products

GDL 1 Guidance Vol#: 1

GDL 2 Guidance Vol#: 1

GDL 3 Guidance Vol#: 1

NAD 1 Vol#: 1

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

CS 4 HFA-305 Vol#: 1

OR 4 HF-3 Vol#: 1

00M-1569 PMA TRUFILL n-Butyl Cyanoacrylate Embolic System, P990040

AAV 1 Cordis Neurovascular Inc Vol#: 1

00M-1570 PMA ATS Open Pivot Bileaflet Heart Valve, P990046

AAV 1 ATS Medical Inc Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 35 Texas Department of Health Vol#: 68

C 36 Jane A. Whitnack Vol#: 68

EMC 17 Susan Calabrese Vol#: 6

00P-1210 Restrict Sale of Coal Tar-Containing Products

M 1 HFD-560 Vol#: 1

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

C 6727 Michael O'Brien Vol#: 298

C 6728 Lana Rozwadowski Vol#: 298

C 6729 Sandra L Clark Rn Vol#: 298

C 6730 Saralil Cleage Vol#: 298

C 6731 Rebecca J Pursell Vol#: 298

C 6732 Donald B Oeasau Vol#: 298

C 6733 Lynda Backer Vol#: 298

C 6734 Betty J Overby Vol#: 298

C 6735 Stuart Holper Vol#: 298

C 6736 Evelyn Kelso Vol#: 298

C 6737 April Boykin Vol#: 298

C 6738 Ruby M Creighton Vol#: 298

C 6739 Rosalie Zapotoczny Vol#: 298

C 6740 Julia Weaver Vol#: 298

C 6741 Rosi Bustamante Vol#: 298

C 6742 Toni Lubofsky Vol#: 298

C 6743 Vicki Murray-Kurzbas Vol#: 298

C 6744 Barbara McDaniel Vol#: 298

C 6745 Irma N LaRose Vol#: 298

C 6746 Vista McDonald Vol#: 298

C 6747 Robert D Haevens Vol#: 298

C 6748 Sherry Harpall Vol#: 298

C 6749 Barbara Olsen Vol#: 298

C 6750 B Beaulieu Vol#: 298

C 6751 Marjorie E Smith Vol#: 298

C 6752 Sam Ward Vol#: 298

C 6753 Rosita B Warchal Vol#: 298

C 6754 Monique Campbell Vol#: 298

C 6755 Itzpa Rojas Vol#: 298

C 6756 Wade Sarro Vol#: 298

C 6757 Jeff Williams Vol#: 298

C 6758 Jill Heinrich Vol#: 298

C 6759 Julie Hanna Vol#: 298

C 6760 Todd Bushbaker Vol#: 298

C 6761 Tony Novic Vol#: 298

C 6762 Delores Lockard Vol#: 298

C 6763 David M Lockard Vol#: 298

C 6764 Robert Copsey Vol#: 298

C 6765 Stephanie Pierce Vol#: 298

C 6766 Jeanne & Glen Enos Vol#: 298

C 6767 Deborah A Shook Vol#: 298

C 6768 Pele de Lappe Vol#: 298

C 6769 Donald G Slatter Vol#: 298

C 6770 Emmanuel Gillespie Vol#: 298

C 6771 George Castle Vol#: 298

C 6772 Cicely D Harris Vol#: 298

C 6773 Lois Johnson Vol#: 298

C 6774 Norma Flynn Vol#: 298

C 6775 John Luciano Vol#: 298

C 6776 Klaus Bock Vol#: 298

C 6777 Carol Aziz Vol#: 298

C 6778 Shirley Mellner Vol#: 298

C 6779 Deniz Domirer Vol#: 298

C 6780 Fred Gunning Vol#: 298

C 6781 Linda Laing Vol#: 298

C 6782 Phillis E Sunstein Vol#: 298

C 6783 Mary J Nacy Vol#: 298

C 6784 Liberty Goodwin Vol#: 298

C 6785 Elizabeth Malanaphy Vol#: 298

C 6786 Julius Small Vol#: 298

C 6787 Lois Loomis Vol#: 298

C 6788 Claudia L MacDonald Vol#: 298

C 6789 Heather Weinstein Vol#: 298

C 6790 Deborah L Bors Vol#: 298

C 6791 Rachel Dourec Vol#: 298

C 6792 G Isabel Rawson-Shipley Vol#: 298

C 6793 Matt Mariola Vol#: 298

C 6794 Pam Duemic Vol#: 298

C 6795 Natalie Jones Vol#: 298

C 6796 Raymond and Ethel Snooks Vol#: 298

C 6797 Earl Shook Vol#: 298

C 6798 Kathy Kidd Vol#: 298

C 6799 Jackie Loesche Vol#: 298

C 6800 Chris Gadbois Vol#: 298

C 6801 Darlene Layman Vol#: 298

C 6802 K Parvin Vol#: 298

C 6803 Sinead Cannon Vol#: 298

C 6804 Kathy S Palmer Vol#: 298

C 6805 Lynne Ammu Vol#: 298

C 6806 Linda Lamar-Ruff Vol#: 298

C 6807 Susan Jittler Vol#: 298

C 6808 Bill Pfeiffer Vol#: 298

C 6809 Kimberly Olds Craig Vol#: 298

C 6810 Tanya Osterson Vol#: 298

C 6811 Susan Halton Vol#: 298

C 6812 Keitheen Ione Vol#: 298

C 6813 Chary Deutsch Vol#: 298

C 6814 Margaret Clemens Vol#: 298

C 6815 Devan Miller Vol#: 298

C 6816 Sharon G Stauffacher Vol#: 298

C 6817 Patricia Sulger Vol#: 298

C 6818 Mark Hennessy Vol#: 298

C 6819 Aviva Maller Vol#: 298

C 6820 Marina Losina Vol#: 298

C 6821 Leea Gray Vol#: 298

C 6822 Bonnie Zehuntner Vol#: 298

C 6823 Walter Anderson Vol#: 298

C 6824 Debra Scott Vol#: 298

C 6825 Gladys Cheng Vol#: 298

C 6826 Marti Fallon Vol#: 298

C 6827 Jennifer Miller Vol#: 298

C 6828 Maggie Smith Vol#: 298

C 6829 Linda Martin Vol#: 298

C 6830 Andree R Storey Vol#: 298

C 6831 Kelley Bartlett Vol#: 298

C 6832 Carol Reece Vol#: 298

C 6833 Cindy Grochowski Vol#: 298

C 6834 N Nilsen Vol#: 298

C 6835 Thomas Slattery Vol#: 298

C 6836 G Bearden Vol#: 298

C 6837 Thomas D Walter Vol#: 298

C 6838 Quelene Slattery Vol#: 298

C 6839 Phil Scourby Vol#: 29

C 6840 Jane Terzis Vol#: 298

00P-1577 Variance from source-skin distance requirement of perf. std.

ACK 1 HFA-305 Vol#: 1

CP 1 GE OEC Medical Systems, Inc. Vol#: 1

00P-1578 Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach

ACK 1 HFA-305 Vol#: 1

CP 1 Michael R. Harbut, MD,MPH Vol#: 1
 

00V-0570 Laser Light Show

VRA 2 HFZ-330 to Pulse Laser Productions Vol#: 1

00V-1576 AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light

ACK 1 HFA-305 Vol#:

VAR 1 Insight Technology Incorporated Vol#: 1