Food and Drug AdministrationDockets 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 August 4, 2000

Table of Contents

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
98N-1038 Irradiation in the production, processing, &handling of food *
98V-0454 Laser light show*
98V-0703 Laser Light Show*
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-5215 Provisions of Title 21 of the Code of Federal Regulations *
99V-0125 Laser Light Show Laserium CSMX250 *
00N-1262 Improving Premarket Review/Approval of Food/Color Additives *
00N-1283 Reporting & Recordkeeping Requirements/Electronic Products *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1406 Stay Presenting, publishing promulgating "Fresh Air" Speeche *
00V-1438 Laser Light Show*

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 57 CTFA & SDA Vol#: 60

93F-0360 Safe use pentaerythritol mixed esters of C16-18 fatty acids

EA 1 Environmental Assessment Vol#: 1

EA 2 Environmental Assessment Vol#: 1

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8560 Alyssa L Kruizenga Vol#: 116

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 9 C Schumacher Vol#: 4

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

LET 2 HFS-22 to Nancy Chapman Vol#: 2

98N-1038 Irradiation in the production, processing, &handling of food

C 5178 Aimee Schaffer Vol#: 150

C 5179 Lucia Tabac Vol#: 150

C 5180 Ursula E. Vol#: 150

98V-0454 Laser light show

EXP 1 Universal Studios Florida Vol#: 1


98V-0703 Laser Light Show

EXP 1 Universal Studios Florida Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 662 Carol Kuczora Vol#: 16

EMC 156 Faith Wurtzel Vol#: 16

99P-2630 Establish a Daily Value for "added sugars"

C 127 Cynthia Floyd Vol#: 7

99P-4613 Revoke the Regulation That Approved Posilac

C 1328 no signature Vol#: 43

C 1329 illegible Vol#: 43

C 1330 Emily S. Carter Vol#: 43

EMC 2320 Gina Petruziello Vol#: 43

99P-5215 Provisions of Title 21 of the Code of Federal Regulations

LET 2 HFD-1 to Wiley, Rein & Felding Vol#: 3

99V-0125 Laser Light Show Laserium CSMX250

EXP 1 Universal Studios Florida Vol#: 1

00N-1262 Improving Premarket Review/Approval of Food/Color Additives

C 8 International Assoc of Color Mfr (IACM) Vol#: 1

C 9 Calorie Control Council Vol#: 1

00N-1283 Reporting & Recordkeeping Requirements/Electronic Products

C 1 Sony Electronics Inc Vol#: 1

C 2 Consumer Electronics Assoc Vol#: 1

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

EMC 1 Public Citizen's Health Research Group Vol#: 1

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 13 North American Spine Society Vol#: 1

C 14 The Spine Specialist Vol#: 1

C 15 Orthoclinic Vol#: 1

C 16 Allo Source Vol#: 1

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

C 3566 Leslie Carroll Vol#: 144

C 3567 Iris M. Hutchinson Vol#: 144

C 3568 Helen N. Hill Vol#: 144

C 3569 Peter Prociuk Vol#: 144

C 3570 Eloise Drew Vol#: 144

C 3571 C. Jacobson Vol#: 144

C 3572 J. Dantonio Vol#: 144

C 3573 Gaylor Carson Family Vol#: 144

C 3574 Fran Ross Vol#: 144

C 3575 Stephen J. Healey Vol#: 144

C 3576 Brahma S. Dasi Vol#: 144

C 3577 Michele Beaulieu Vol#: 144

C 3578 Helene Toomey Vol#: 144

C 3579 Maria Macanon Vol#: 144

C 3580 Jill K. Raines Vol#: 144

C 3581 Sharon Searles Vol#: 144

C 3582 Larry & Jeanne Pullen Vol#: 144

C 3583 Suzy Miller Vol#: 144

C 3584 Joan Matzonkai Vol#: 144

C 3585 Gloria McAkin Vol#: 144

C 3586 Dorothy Carter Vol#: 144

C 3587 Linda Jenkins Vol#: 144

C 3588 Justin Langhille Vol#: 144

C 3589 Tammy Wallett Vol#: 144

C 3590 Bobbie Stepney Vol#: 144

C 3591 Catherine Davis Vol#: 144

C 3592 Mary F. Morris Vol#: 144

C 3593 Ti Harmony Vol#: 144

C 3594 Michael D. Vivian Vol#: 144

C 3595 Emily Barlow Vol#: 144

C 3596 Ms. P. Fiorini Vol#: 144

C 3597 Eve L. Posada Vol#: 144

C 3598 C. McBride Vol#: 144

C 3599 Margaret Hollander Vol#: 144

C 3600 Gloria Larkin Vol#: 144

C 3601 Phyllis Garlick Vol#: 144

C 3602 Rosemary Mical Vol#: 144

C 3603 L. Hilligas Vol#: 144

C 3604 Hazel Cox Vol#: 144

C 3605 George Odell Vol#: 144

C 3606 no signature Vol#: 144

C 3607 Scott Boggs Vol#: 144

C 3608 Kelly McMullen Vol#: 144

C 3609 Thelma Justiss Vol#: 144

C 3610 Roberta Connell Vol#: 144

C 3611 Barbara Morris Vol#: 144

C 3612 Suzanne D'Agnila Vol#: 144

C 3613 Gloria Estrada Vol#: 144

C 3614 Pat & Robert Shelton Vol#: 144

C 3615 Renee Daniels Vol#: 144

C 3616 Jean Wergin Vol#: 144

C 3617 Sherry Guffey Vol#: 144

C 3618 Paul W. & Patricia D. Eckert Vol#: 144

C 3619 Victoria Lynne Vol#: 144

C 3620 Shirley A. Dull Vol#: 144

C 3621 A W Vol#: 144

C 3622 D. Woodruff Vol#: 144

C 3623 Carol Kodner Vol#: 144

C 3624 Cheryl Ellis Vol#: 144

C 3625 Kristen Mowrey Vol#: 144

C 3626 Marjorie Pyner Vol#: 144

C 3627 Ann Garton Vol#: 144

C 3628 Paul Scnofrer Vol#: 144

C 3629 Cindra Halm Vol#: 144

C 3630 Beverly Dutra Vol#: 144

C 3631 Shan Tohan Vol#: 144

C 3632 Mike Checkatt Vol#: 144

C 3633 Gayle Cox Vol#: 144

C 3634 Daniel Vice Vol#: 144

C 3635 Deborah Voaf Vol#: 144

C 3636 Teresa Cisnis Vol#: 144

C 3637 L. D. Wood-Hull Vol#: 144

C 3638 Ken Ross Vol#: 144

C 3639 Eve Ross Vol#: 144

C 3640 David Southgate Vol#: 144

C 3641 Mary Ann Gianantoni Vol#: 144

C 3642 Claudia Clayton Vol#: 144

C 3643 Faith Morgan & Pat Murphy Vol#: 144

C 3644 Eleanor K. Mock Vol#: 144

C 3645 Raylene Pasquarella Vol#: 144

C 3646 Sanford M. Shapero Vol#: 144

C 3647 Richard Jenkins Vol#: 144

C 3648 Juliet Nicklon Vol#: 144

C 3649 Shawn E. Grey Vol#: 144

C 3650 Edna Beaty Vol#: 144

C 3651 Susan R. Clark Vol#: 144

C 3652 Gunther J. Perlwitz Vol#: 144

C 3653 Gillian Edgelow Vol#: 144

C 3654 Genevieve A. Perlwitz Vol#: 144

C 3655 Emma H. Moore Vol#: 144

C 3656 Deb Abberton Vol#: 144

C 3657 Linda Rudolph Vol#: 144

C 3658 Joe Livoti Vol#: 144

C 3659 Emily Dinsmore Vol#: 144

C 3660 Melva Yarnick Vol#: 144

C 3661 Karin Winegas Vol#: 144

C 3662 William Munser Vol#: 144

C 3663 Linda Green Vol#: 144

C 3664 Bess Redmond Vol#: 144

C 3665 Wendy Swann Vol#: 144

C 3666 Monique Grund Vol#: 144

C 3667 C. Trudeau Vol#: 144

C 3668 Les Goldstein Vol#: 144

C 3669 Peter Schwofron Vol#: 144

C 3670 Nancy M. Bell Vol#: 144

C 3671 Marlene Towne Vol#: 144

C 3672 Anne Benedict Vol#: 144

C 3673 Jeanette Lovvorn Vol#: 144

C 3674 Steve Consor Vol#: 144

C 3675 Cie Sharp Vol#: 144

C 3676 Rhea Russe Vol#: 144

C 3677 Jennifer Johnson Vol#: 144

C 3678 Dian Gawel Vol#: 144

C 3679 Adam & Rachel Strase Schofield Vol#: 144

C 3680 Pavel Savitsky Vol#: 144

C 3681 Margaret T. Elliott Vol#: 145

C 3682 Dian Barry Vol#: 145

C 3683 Michelle Lanne Vol#: 145

C 3684 Pamela Kemp Vol#: 145

C 3685 Robert L. Epps Vol#: 145

C 3686 Pat Dodson Vol#: 145

C 3687 Barbara Bellus Vol#: 145

C 3688 Betty Carpenter Vol#: 145

C 3689 Linda Solfen Vol#: 145

C 3690 Carol J. Johnson Vol#: 145

C 3691 Marion L. Bell Vol#: 145

C 3692 Ben Silva Bells Vol#: 145

C 3693 Jackie Montgomery Vol#: 145

C 3694 Nancy Waltling Vol#: 145

C 3695 Marjorie Southgate Vol#: 145

C 3696 Kristina Trotta Vol#: 145

C 3697 Sema Saifee Vol#: 145

C 3698 Kate Sanders-Fleming Vol#: 145

C 3699 Sunshine MacDonald Vol#: 145

C 3700 Myra Frank Vol#: 145

C 3701 Mary Winders Vol#: 145

C 3702 Rebecca Hubbard Vol#: 145

C 3703 Elaine Alden Vol#: 145

C 3704 Jared Alden Vol#: 145

C 3705 James F. McCormick Vol#: 145

00P-1406 Stay Presenting, publishing promulgating "Fresh Air" Speeche

C 1 Puritan-Bennett Medical Gases Vol#: 1

00V-1438 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Randy Johnson & Assoc Vol#: 1