DOCKETS ENTERED on 06/30/00

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]

DOCKETS ENTERED on June 30, 2000

Table of Contents

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97N-484S Human Cellular and Tissue-Based Products *
00P-1279 Extend the Compliance Dates for Electrode Lead Wires and Pat *
00P-1349 Variance for Electrode Lead Wires and Patient Cables *
00P-1370 ANDA for generic verions of Zaroxolyn Tablets(metolazone *
00P-1371 Performance Standard for Electrode Lead Wires and Patient *
00P-1378 Cosmetic Products Containing Alpha Hydroxy Acids *
00V-1381 Laser Light Show*

97N-484S Human Cellular and Tissue-Based Products

C 480 Nova in Vitro Vol#: 26

C 481 Am. Assn of Neurological & Congress of N Vol#: 26

99H-1931 Civil Money Penalty;Walgreen Co,dba Walgreens #2896

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1932 Civil Money Penalty;Walgreen Co,dba Walgreens Drug Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1933 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #365

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1934 Civil Money Penalty;Waring Oil Co,dba Interstate Station

CR 1 GCF-1 Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1940 Civil Money Penalty;Amoco Oil co,dba Amoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1942 Civil Money Penalty;Crosson OIl Co Inc,dba Crosson Oil Co

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1943 Civil Money Penalty;Del's Liquors Inc,dba Del's Liquors

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1944 Civil Money Penalty;Fast Lane Inc,dba Fast Lane Stores

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1945 Civil Money Penalty;Michael Gaughan & Jerry Herbst,dba Gold

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1960 Civil Money Penalty;Na Tran,dba Dan's Convenient Mart

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1962 Civil Money Penalty;Fast Lane Inc,dba Fast Lane

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1964 Civil Money Penalty;FS Energy Fuel 24,LLC,dba FS Fast Stop

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1965 Civil Money Penalty;Food Lion Inc,dba Food Lion #406

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1968 Civil Money Penalty;J & B Handy Mart Inc,dba Handy Mart #3

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1969 Civil Money Penalty;Patty Bess,dba Highland Grocery

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1970 Civil Money Penalty;Kmart Corp,dba Kmart #3726

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2465 Civil Money Penalty;Cooperative Oil Company,dba Le Roy Ampri

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2714 Civil Money Penalty;Rite Aid Corp dba Rite Aid #4925

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2734 Civil Money Penalty;Randy Audette & Marsha Audette,dba Big

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2735 Civil Money Penalty;Greg Pillow & Charlene Bristene,dba York

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2737 Civil Money Penalty;Toot 'N Totum Food Stores Inc,dba Toot

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2738 Civil Money Penalty;Toot 'N Totum Food Stores Inc, dba Toot

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2739 Civil Money Penalty;Toot 'N Totum Food Stores Inc,dba Toot

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2740 Civil Money Penalty;Trenton Foods Inc,dba Piggly Wiggly #47

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2741 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #107

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2743 Civil Money Penalty;Service Energy LLC,dba Milford Mobile

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2744 Civil Money Penalty;Phuong Rowlett & Hoa Tran,dba Super Gas

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2745 Civil Money Penalty;J L Menees Foods Inc,dba 3 J's Food &

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2746 Civil Money Penalty;Mike Stafford,dba Gleason Deli & Market

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2749 Civil Money Penalty;Andlar Ent Inc,dba Fast Break Food Mart

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2752 Civil Money Penalty;Robert L Buehler,dba Bob's Texaco

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2753 Civil Money Penalty;Chon Inc,dba Cheyenne Mountain Liquors

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2769 Civil Money Penalty;Victor Thomas,dba Mattapan Square Mobil

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2770 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Diamo

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2771 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Total

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2773 Civil Money Penalty;Angela Williams & Linda Deymonaz,dba Esm

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2780 Civil Money Penalty;Coastal Energy Co of Mississippi Inc

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2781 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #1984

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2782 Civil Money Penalty;Ewn Inc,dba Iron Bridge Amoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2783 Civil Money Penalty;Food Lion Inc,dba Food Lion Store #477

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2784 Civil Money Penalty;Food Lion Inc,dba Food Lion Store #1157

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2788 Civil Money Penalty;Miller Oil Co Inc,dba Breez-In Convenien

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2790 Civil Money Penalty;Nabil Ndel Rahman,dba Lexus Food & Liquo

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2791 Civil Money Penalty;Preston Taylor Foods Inc,dba Iga Foodlin

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2792 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2793 Civil Money Penalty;Two Brothers Inc,dba Airport Getty

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2794 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2795 Civil Money Penalty;West Star Corp,dba Northwest Deli Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2796 Civil Money Penalty;Stanley Vaysman & Ilona Vaysman,dba J &

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2797 Civil Money Penalty;Keith Cole & Cynthia Cole,dba Short Stop

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2801 Civil Money Penalty;American Drug Stores Inc,dba Sav-On Drug

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2858 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug Store

SET 1 GCF-1 Vol#: 1

99H-2976 Civil Money Penalty;BP Amoco plc,dba Amoco #2826

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2977 Civil Money Penalty;CBM Ventures LLC,dba Towson Park Exxon,d

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2978 Civil Money Penalty;Cedar Heights Service Center Inc,dba Fir

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2980 Civil Money Penalty;Cox Oil Company Inc,dba Little General #

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2983 Civil Money Penalty;John Ioranidis,dba Trinity Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2984 Civil Money Penalty;katherine Lewellan,dba Lewellan's Food M

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2985 Civil Money Penalty;Kelly Bell,dba kelly's Texaco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2986 Civil Money Penalty;Mazen Mutan,dba G&S Market

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2988 Civil Money Penalty;Patricia Gunn,dba North Highland Express

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-3065 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #2172

SET 1 GCF-1 Vol#: 1

99H-3066 Civil Money Penalty;Donald K. McDowell,dba McDowell's Exxon

SET 1 GCF-1 Vol#: 1

99H-3067 Civil Money Penalty;Fred Darling & Jan Darling,dba 7-Eleven

SET 1 GCF-1 Vol#: 1

99H-3068 Civil Money Penalty;George Collins,dba Mc Henry Beverage Sho

SET 1 GCF-1 Vol#: 1

99H-3069 Civil Money Penalty;Gerald Welty,dba 7-Eleven Food Store #29

SET 1 GCF-1 Vol#: 1

99H-3071 Civil Money Penalty;Malik H. Latif,dba 7-Eleven Food Store #

SET 1 GCF-1 Vol#: 1

99H-3072 Civil Money Penalty;Mike Benward & Jack Hughes,dba Short Sho

SET 1 GCF-1 Vol#: 1

99H-3073 Civil Money Penalty;NAN Corporation,dba Kwik Way Store

SET 1 GCF-1 Vol#: 1

99H-3074 Civil Money Penalty;Nick Pace of maryland Inc,dba Frostburg

SET 1 GCF-1 Vol#: 1

99H-3075 Civil Money Penalty;Steve Mercer,dba Mercer 66

SET 1 GCF-1 Vol#: 1

99H-3076 Civil Money Penalty;Susan Brenneman,dba Brenneman's Store

SET 1 GCF-1 Vol#: 1

99H-4305 Civil Money Penalty;Lee O Ruwe Inc,dba Gas N Dash

SET 1 GCF-1 Vol#: 1

99H-4319 Civil Money Penalty;TPI Petroleum Inc,dba Total #2743

SET 1 GCF-1 Vol#: 1

99H-4339 Civil Money Penalty;Food Lion Inc,dba Food Lion #901

SET 1 GCF-1 Vol#: 1

99H-4341 Civil Money Penalty;Ingles Markets Incorporated,dba Ingles M

SET 1 GCF-1 Vol#: 1

99H-4494 Civil Money Penalty;Brabham Petroleum Co,dba Lancer Mart

SET 1 GCF-1 Vol#: 1

99H-4495 Civil Money Penalty;Broome's Grocery & Market Inc,dba Broome

SET 1 GCF-1 Vol#: 1

99H-4498 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #851

SET 1 GCF-1 Vol#: 1

99H-4499 Civil Money Penalty;Davis Company Incorporated,dba Fillers 1

SET 1 GCF-1 Vol#: 1

99H-4501 Civil Money Penalty;Suzan Greer,dba Cockrum Country Grocery

SET 1 GCF-1 Vol#: 1

99H-4502 Civil Money Penalty;Griffis Oil Company Inc,dba Pacesetter

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4503 Civil Money Penalty;Hy-Vee Inc,dba Regal Liquors

SET 1 GCF-1 Vol#: 1

99H-4507 Civil Money Penalty;Krause Gentle Corporation,dba Kum & Go

SET 1 GCF-1 Vol#: 1

99H-4508 Civil Money Penalty;Krause Gentle Corporation,dba Kum & Go #

SET 1 GCF-1 Vol#: 1

99H-4509 Civil Money Penalty;Liberty Petroleum Inc,dba Liberty A Plus

SET 1 GCF-1 Vol#: 1

99H-4638 Civil Money Penalty;Motiva Ent LLC,dba Texaco #1096

SET 1 GCF-1 Vol#: 1

99H-4682 Civil Money Penalty;Dalip Singh Bedi,dba N K Food Mart

SET 1 GCF-1 Vol#: 1

99H-4772 Civil Money Penalty;Shaw's Supermarkets Inc,dba Shaw's River

SET 1 GCF-1 Vol#: 1

99H-4777 Civil Money Penalty;Tony Ahmad,dba Minnesota Exxon

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4795 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven

SET 1 GCF-1 Vol#: 1

99H-5139 Civil Money Penalty;Encinitas Investment Partners,Ltd;dba Ga

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-5140 Civil Money Penalty;Fastop Stores of Oklahoma,Inc;dba Fastop

SET 1 GCF-1 Vol#: 1

99H-5144 Civil Money Penalty;Joe Groves;dba Groves Foodland

SET 1 GCF-1 Vol#: 1

99H-5149 Civil Money Penalty;Mobil Oil Corporation;dba Mobil Service

SET 1 GCF-1 Vol#: 1

99H-5150 Civil Money Penalty;Myrtle Cummins;dba Mac's Easy Shop

SET 1 GCF-1 Vol#: 1

99H-5151 Civil Money Penalty;Paul Davenport;dba Paul's Market & Deli

SET 1 GCF-1 Vol#: 1

99H-5153 Civil Money Penalty;Rite Aid of Maryland,Inc;dba Rite Aid #3

SET 1 GCF-1 Vol#: 1

99H-5185 Civil Money Penalty;Sonny's Cup & Saucer, Inc;dba C & S Beve

SET 1 GCF-1 Vol#: 1

99H-5189 Civil Money Penalty;Jimmy L. Tipton, Jr;dba Tipton's Grocery

SET 1 GCF-1 Vol#: 1

99H-5194 Civil Money Penalty;Winn-Dixie Montgomery, Inc;dba Winn-Dixi

SET 1 GCF-1 Vol#: 1

99H-5206 Civil Money Penalty;Shirkand Parikh & Devika Parikh;dba Pyra

SET 1 GCF-1 Vol#: 1

99H-5208 Civil Money Penalty;SPJP, Inc;dba Park's Food

SET 1 GCF-1 Vol#: 1

99H-5213 Civil Money Penalty;Junction Grocery, Inc;dba Junction Groce

SET 1 GCF-1 Vol#: 1

99H-5218 Civil Money Penalty;Avon Liquor Locker, Inc;dba Liquor Locke

SET 1 GCF-1 Vol#: 1

99H-5242 Civil Money Penalty;Walco Oil Company, Inc;dba Walco Mart #1

SET 1 GCF-1 Vol#: 1

99H-5290 Civil Money Penalty;Seung S. Shin;dba Honey Carry Out

SET 1 GCF-1 Vol#: 1

99H-5299 Civil Money Penalty;1-2-3-4-5,Inc,dba Bourbon St Hotel Gift

SET 1 GCF-1 Vol#: 1

99H-5301 Civil Money Penalty;E-Z Mart Stores,Inc;dba E-Z Mart #686

SET 1 GCF-1 Vol#: 1

99H-5381 Civil Money Penalty;Elliot Sanchez;dba Elliot's Place

CR 1 GCF-1 Vol#: 1

CR 2 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-5400 Civil Money Penalty;B & K Foods, Inc;dba B & K Foods

SET 1 GCF-1 Vol#: 1

99H-5423 Civil Money Penalty;Town & Country Grocers of Fredericktown

SET 1 GCF-1 Vol#: 1

99P-4932 ANDA Suitability Petitions for Parenteral Drugs

WDL 1 Hyman, Phelps & McNamara, P.C. Vol#: 1

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

C 1752 Form Letter Count (308 Vol#: 104

00P-1279 Extend the Compliance Dates for Electrode Lead Wires and Pat

PAV 1 HFZ-215 to Chattanooga Group Inc Vol#: 1

00P-1349 Variance for Electrode Lead Wires and Patient Cables

PAV 1 HFZ-1 to St. Jude Medical Vol#: 1

00P-1370 ANDA for generic verions of Zaroxolyn Tablets(metolazone

ACK 1 HFA-305 Vol#: 1

PSA 1 Medeva Pharmaceuticals, Inc Vol#: 1

00P-1371 Performance Standard for Electrode Lead Wires and Patient

ACK 1 HFA-305 Vol#: 1

CP 2 IOMED,Inc Vol#: 1

00P-1378 Cosmetic Products Containing Alpha Hydroxy Acids

ACK 1 HFA-305 Vol#: 1

CP 1 CTFA Vol#: 1

00V-1381 Laser Light Show

VAR 1 Daddy Rocks Inc Vol#: 1