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 7, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products*
83V-0151 LASER LIGHT SHOW*
88V-0116 VARIANCE RE LASER LIGHT SHOW *
92V-0286 Variance Request for Mobilazer ML-10A Light Show *
92V-0435 Variance for 909 Laser Head & Laser Prod. Beam Machine *
95V-0105 Laser Light Show*
96V-0432 Laser light show application *
97N-0289 Pregnancy Labeling; Content & Format Requirements *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0342 The symbol 'R'or Rx''' or alternatively *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99V-3021 Laser Light Show*
00N-0504 Egg Safety Action Plan *
00N-1266 Report to Congress on Pediatric Exclusivity *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1295 Performance Standard for Electrode Lead Wires & Patient Cabl *
00V-1312 Variance to Performance Standard for Electrical Lead Wires *
00V-1356 Laser light show*
00V-1362 *
00V-1420 Laser Light Show*
76N-052T OTC ANTITUSSIVES

NFR 2 Vol#: 8

78N-0038 Sunscreen Drug Products

C 563 The Cosmetic, Toiletry & Fragrance Assn Vol#: 133

MM 21 HFD-560 with CTFA (07-22-99) Vol#: 133

MM 22 HFD-560 with CTFA (10-26-99) Vol#: 133

SUP 31 The Cosmetic, Toiletry, & Fragrance Assn Vol#: 133

83V-0151 LASER LIGHT SHOW

VRA 9 HFZ-330 to Precision Projection Systems Vol#: 1

88V-0116 VARIANCE RE LASER LIGHT SHOW

VRA 7 HFZ-330 to LaserMation, LLC Vol#: 1

92V-0286 Variance Request for Mobilazer ML-10A Light Show

VRA 4 HFZ-330 to Mobolazer, Inc. Vol#: 1

92V-0435 Variance for 909 Laser Head & Laser Prod. Beam Machine

VRA 7 HFZ-330 to A Candie's Production, Inc Vol#: 1

95V-0105 Laser Light Show

VRA 3 HFZ-330 to Stellar Designs, Inc. Vol#: 1

96V-0432 Laser light show application

VRA 2 HFZ-330 to N Effect Productions Vol#: 1

97N-0289 Pregnancy Labeling; Content & Format Requirements

C 5 R Zisa, C.P.A. Vol#: 6

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

C 109 H & I Casas Vol#: 2

C 110 T Schaltz Vol#: 2

C 111 E Mcelligott Vol#: 2

C 112 L Gougherty Vol#: 2

C 113 L Sunday Vol#: 2

C 114 K. Beard-Tittone Vol#: 2

C 115 R Rousselle Vol#: 2

C 116 S Pease Vol#: 2

C 117 A. Fritz Vol#: 2

C 118 N Tushinsky Vol#: 2

C 119 L Wolfe Vol#: 2

C 120 Jan Kramer Vol#: 2

C 121 P Joralemon Vol#: 2

C 122 K. Fletcher Vol#: 2

C 123 S Owen Vol#: 2

C 124 C Wampler Vol#: 2

C 125 J Bonazzoli & Family Vol#: 2

C 126 C Caret Vol#: 2

C 127 B & L Summers Vol#: 2

C 128 R & J Wilson Vol#: 2

C 129 N. Curd Vol#: 2

C 130 J Doob Vol#: 2

C 131 L Williams Vol#: 2

C 132 S Foster Vol#: 2

C 133 A Shatas Vol#: 2

C 134 A Canaday Vol#: 2

C 135 S Winters Vol#: 2

C 136 B Manley Vol#: 2

98F-0165 safe use of ionizing radition for reduction of salmonella

C 2 Farm Animal Reform Movement Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 41 Independent Cosmetic Manuf & Distributor Vol#: 1

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

C 5181 C. Allen Vol#: 150

C 5182 P Shah Vol#: 150

C 5183 T Lafur Vol#: 150

EMC 212 S Marchesani Vol#: 150

98N-1265 Distribution of Compounded Drug Products

C 6154 R Hix Vol#: 171

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

C 2315 S Dicker Vol#: 67

C 2316 J. Pryor Vol#: 67

99N-2151 New Animal Drug Applications; Sheep as a Minor Species

NFR 1 Vol#: 1

99P-0342 The symbol 'R'or Rx''' or alternatively

CR 1 HFZ-300 to Kleinfeld, Kaplan & Becker Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 663 A. Barrow Vol#: 16

EMC 157 H. & E. Keeler Vol#: 16

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

EC 12 C Laurino Vol#: 1

EC 13 G Bond Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

C 1331 C. Wilkinson Vol#: 43

C 1332 E. Garofalo Vol#: 43

99V-3021 Laser Light Show

VRA 1 HFZ-330 to George's Ringside Inc DBA Sne Vol#: 1

00D-1385 Investigational Device Exemption (IDE's) & (PMA)

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

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

MO 4 GCF-1 and Buc & Beardsley Vol#: 1

00H-1436 Civil Money Penalty;Pure Water Inc.,& Ted M Walters & Cynthi

LET 1 HFZ-215 Vol#: 1

NPH 1 HHS/FDA/CDHR Vol#: 1

00N-0504 Egg Safety Action Plan

EMC 14 A Heaton Vol#: 1

EMC 15 J Breslauer Vol#: 1

EMC 16 A Skeats Vol#: 1

EMC 17 J West Vol#: 1

EMC 18 F Hawkins Vol#: 1

EMC 19 P Fulda Vol#: 1

EMC 20 E. Boyhan Vol#: 1

EMC 21 J Gibson Vol#: 1

EMC 22 J Corcoran Vol#: 1

EMC 23 J Armer Vol#: 1

EMC 24 A Rehkemper Vol#: 1

00N-0725 Interstate Shellfish Dealers Certificate

NAL 1 Vol#: 1

S 1 Supporting Statement Vol#: 1

00N-1060 Adoption of FDA Food Code

N 2 Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 15 M. Robinson Vol#: 60

EC 4 L Dixon Vol#: 1

LET 3 American Phytotherapy Research Laborator Vol#: 60

00N-1256 Over-the-Counter Drug Products;Public Hearing

EC 398 none Vol#: 14

EC 399 American Life League Vol#: 14

EC 400 A Mills Vol#: 14

EC 401 ACOG, ME Section, Vice-Chair Vol#: 14

EC 402 B Richter Vol#: 14

EC 403 R Pluta Vol#: 14

EC 404 Student Vol#: 14

EC 405 Pacific Institute for Women's Health Vol#: 14

EC 406 C Wilson Vol#: 14

EC 407 M Marsteller Vol#: 14

EC 408 N Love Vol#: 14

EC 409 D Johnson Vol#: 14

EC 410 J Barker Vol#: 14

EC 411 M Halstead Vol#: 14

EC 412 none Vol#: 14

EC 413 M Berger Vol#: 14

EC 414 r Qualkinbush Vol#: 14

EC 415 P King Vol#: 14

EC 416 A Hunter Vol#: 14

EC 417 Law Office of Colbe Mazzarella Vol#: 14

EC 418 G Johnson Vol#: 14

EC 419 J Berrettini Vol#: 14

00N-1266 Report to Congress on Pediatric Exclusivity

C 13 The Honorable Deborah Pryce (CI) Vol#: 1

00N-1268 Food Additives and Food Additives Petitions;Agency Informati

N 2 Vol#: 1

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

NM 1 Vol#: 1

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 1 Gen-Probe Vol#: 1

00N-1426 Emergency Health Surveys

N 1 Vol#: 1

00P-1117 Reclassify QuickAir Choke Reliever, Model 59-001A

NCR 1 Vol#: 1

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

C 3706 T. Seatrom Vol#: 145

C 3707 D Crayne Vol#: 145

C 3708 C Kavanash Vol#: 145

C 3709 F. Beveridge Vol#: 145

C 3710 L Baldwin Vol#: 145

C 3711 V Noechel Vol#: 145

C 3712 R Nayyar Vol#: 145

C 3713 L Donkle Vol#: 145

C 3714 R Seeber Vol#: 145

C 3715 M Fultz Vol#: 145

C 3716 D Hackman Vol#: 145

C 3717 M. Fertschneider Vol#: 145

C 3718 M. Choun Vol#: 145

C 3719 C. Humphrey Vol#: 145

C 3720 A Phelps Vol#: 145

C 3721 C Barger Vol#: 145

C 3722 A Clarke Vol#: 145

C 3723 S. Kent Vol#: 145

C 3724 E Ogaz Vol#: 145

C 3725 L. Redding Vol#: 145

C 3726 J Brown Vol#: 145

C 3727 L Knight Vol#: 145

C 3728 L Hinkle Vol#: 145

C 3729 M Riviera Vol#: 145

C 3730 E Duckeworth Vol#: 145

C 3731 R Ohveira Vol#: 145

C 3732 J. Yeager Vol#: 145

C 3733 P Turner Vol#: 145

C 3734 M Gates Vol#: 145

C 3735 S. Porter Vol#: 145

C 3736 L. Pantoja Vol#: 145

C 3737 C Gutierrg Vol#: 145

C 3738 A Urda Vol#: 145

C 3739 N Madan Vol#: 145

C 3740 J Miller Vol#: 145

C 3741 S. Winters Vol#: 145

C 3742 D Kamanda Vol#: 145

C 3743 L Torres Vol#: 145

C 3744 Rev. J Conn Vol#: 145

C 3745 B Eggleston Vol#: 145

C 3746 F Cottle Vol#: 145

C 3747 M West Vol#: 145

C 3748 D. West Vol#: 145

C 3749 R Reichel Vol#: 145

C 3750 M Cohen Vol#: 145

C 3751 L Fekete Vol#: 145

C 3752 J Weissberg Vol#: 145

C 3753 S Howell Vol#: 145

C 3754 S Caine Vol#: 145

C 3755 M Smith Vol#: 145

C 3756 E Strousburg Vol#: 145

C 3757 M Guscette Vol#: 145

C 3758 B Bye Vol#: 145

C 3759 M Goebring Vol#: 145

C 3760 L Harrison Vol#: 145

>C 3761 J. Green Vol#: 145

C 3762 P Schmidt Vol#: 145

C 3763 G. Mead Vol#: 145

C 3764 N Meier Vol#: 145

C 3765 K Ward Vol#: 145

C 3766 K Dunning Vol#: 145

C 3767 A Kirk Vol#: 145

C 3768 L. Schleaht Vol#: 145

C 3769 D. Bohannon Vol#: 145

C 3770 N Johnson Vol#: 145

C 3771 B. Kuester Vol#: 145

C 3772 B Ferrell Vol#: 145

C 3773 B Scott Vol#: 145

C 3774 G Ward Vol#: 145

C 3775 J Lahien Vol#: 145

C 3776 S. Coon Vol#: 145

C 3777 S Ferrill Vol#: 145

C 3778 J. Hanson Vol#: 145

C 3779 S Mcans Vol#: 145

C 3780 M Willis Vol#: 145

C 3781 B David Vol#: 145

C 3782 M. Kelly Vol#: 145

C 3783 M. Reiner Vol#: 145

C 3784 C Ellis Vol#: 145

C 3785 P Spells Vol#: 145

C 3786 M Arena Vol#: 145

C 3787 E Nassam Vol#: 145

C 3788 M Spirgdowicz Vol#: 145

C 3789 A Paige Vol#: 145

C 3790 A Blumer Vol#: 145

C 3791 S Clarkson Vol#: 145

C 3792 N. Robinson Vol#: 145

C 3793 G Nelson Vol#: 145

C 3794 W Marsh Vol#: 145

C 3795 K & D Morehouse Vol#: 145

C 3796 R Sutherland Vol#: 145

C 3797 L Bind Vol#: 145

C 3798 A Leal Vol#: 145

C 3799 K Kavanagh Vol#: 145

C 3800 E Lanier Vol#: 145

C 3801 C Prize Vol#: 145

C 3802 M Bialuski Vol#: 145

C 3803 A Angel Vol#: 145

C 3804 B Weber Vol#: 145

C 3805 J. Staub Vol#: 145

C 3806 C. Booswan Vol#: 147

C 3807 H Davidson Vol#: 147

C 3808 A Young Vol#: 147

C 3809 M Marsh Vol#: 147

C 3810 P. Sebring Vol#: 147

EMC 539 K Marohn Vol#: 145

EMC 540 M. Porter Vol#: 145

EMC 541 R. Maehr, Jr. Vol#: 145

EMC 542 J Lefkkowitz Vol#: 145

EMC 543 D. Weinstein Vol#: 145

EMC 544 Y Rousseau Vol#: 145

EMC 545 D. Golembeski Vol#: 145

EMC 546 F. Valsangiacomo Vol#: 145

EMC 547 K MacLean Vol#: 145

EMC 548 C Pietras Vol#: 145

EMC 549 C Rossell Vol#: 145

EMC 550 C Rossell Vol#: 145

EMC 551 D Palucci Vol#: 145

EMC 552 J Brevoort Vol#: 145

EMC 1752 Form Letter Count 568 Vol#:

00P-1295 Performance Standard for Electrode Lead Wires & Patient Cabl

PAV 1 HFZ-1 to Accelerated Care Plus Vol#: 1

00V-1312 Variance to Performance Standard for Electrical Lead Wires

VRA 1 HFZ-1 to Cox Chiropractic Associates In Vol#: 1

00V-1356 Laser light show

VRA 1 HFZ-330 to Rock Capital Systems, Corp. Vol#: 1

00V-1362

VRA 1 HFZ-330 to Powerhouse Pro Vol#: 1

00V-1420 Laser Light Show

VRA 1 HFZ-330 to Deceptikon Visuals Vol#: 1