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 April 21, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
94F-0405 Safe use of aspartame as general purpose sweetener *
97N-0436 Methods informing consumers of contents of bottle water *
99N-1852 Status reports/postmarketing studies-human drugs&biological *
99P-4613 Revoke the Regulation That Approved Posilac *
00P-1265 Performance standard for electrode lead wires & patient cabl *
79N-0113 Parenteral Multivitamin Products

NCR 1 Vol#: 5

94F-0405 Safe use of aspartame as general purpose sweetener

EMC 1 Rich Murray Vol#: 2

EMC 2 Edward Bryant Holman Vol#: 2

EMC 3 Myathenia Gravis Vol#: 2

EMC 4 Sandy Vol#: 2

EMC 5 Bert Fregosi Vol#: 2

EMC 6 Sandy Vol#: 2

EMC 7 Lauri Vol#: 2

EMC 8 Bob Wylie Vol#: 2

EMC 9 Anthony M. Strassell Vol#: 2

EMC 10 Lana Stubbs Vol#: 2

EMC 11 Beverly Price Vol#: 2

EMC 12 Jen Rogers Vol#: 2

EMC 13 Dusty Vol#: 2

EMC 14 Betty Martini Vol#: 2

EMC 15 Janice L. Reddy Vol#: 2

EMC 16 Trina Vol#: 2

EMC 17 Beth Winchenbach Vol#: 2

EMC 18 Dave Rietz Vol#: 2

EMC 19 Anna Dulaney Vol#: 2

EMC 20 Betty Vol#: 2

EMC 21 Jacinto Esteban Vol#: 2

EMC 22 Mark Twain Vol#: 2

EMC 23 Jacinto Esteban Vol#: 2

EMC 24 Mark Vol#: 2

EMC 25 Doris Vol#: 2

EMC 26 Karen D. Vol#: 2

EMC 27 Connie Vol#: 2

EMC 28 Jenelle Vol#: 2

EMC 29 Betty Martini Vol#: 2

EMC 30 Patty Vol#: 2

EMC 31 Sherry Molteni Vol#: 2

EMC 32 Betty Martini Vol#: 2

EMC 33 Sherry Molteni Vol#: 2

EMC 34 Robert Sutherland Vol#: 2

EMC 35 Phyllis Vol#: 2

EMC 36 Jenelle Vol#: 2

EMC 37 Jacinto Vol#: 2

EMC 38 Pam Vol#: 2

EMC 39 Judy Leslie Vol#: 2

EMC 40 Jacinto Vol#: 2

94P-0347 Reclassification of Nonabsorbable ePTFE Surgical Suture

NFR 1 Vol#: 5

97N-0135 OTC Test Sample Collection Systems

NFR 1 Vol#: 1

97N-0436 Methods informing consumers of contents of bottle water

C 53 Sparkling Spring Water Co. Vol#: 1

C 54 Jean E. Mitchell Vol#: 1

EMC 1 No not used Vol#: 1

EMC 2 Adrian Chang Vol#: 1

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

NEC 1 Vol#: 1

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

NEC 1 Vol#: 25

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

N 2 Vol#: 3

99F-0925 Paper and Paperboard in Contact with Aqueous & Fatty Foods

NFR 1 The Dow Chemical CO. Vol#: 1

99H-4977 Civil Money Penalty;E-Z Serve Convenience Stores, Inc;dba E-

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4979 Civil Money Penalty;Wilborn Garner;dba Country Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4981 Civil Money Penalty;HA, Inc;dba Easy Stop

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4983 Civil Money Penalty;Billy Helmes;dba Helmes Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4998 Civil Money Penalty;TI & K, Inc;dba Macphail Exxon

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4999 Civil Money Penalty;W.B. Stone, Inc;dba Valley Junction Amoc

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5006 Civil Money Penalty;Safeway Inc,dba Safeway Store #4928

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5007 Civil Money Penalty;Eulalio Maldonado,dba Eulalio Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5009 Civil Money Penalty;Dennis Rieken,dba Rieken's Sports Bar &

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5016 Civil Money Penalty;Battleship Cove Gas Station,Inc;Battlesh

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5026 Civil Money Penalty;Kerr Drug, Inc.;dba Smart Dollar Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5038 Civil Money Penalty;Kenneth Brasell,dba Brasell Service Stat

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5039 Civil Money Penalty;H & F Services Inc,dba Texaco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5041 Civil Money Penalty;Helen Mills,dba Mill's Tobacco Shack

LET 2 office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5050 Civil Money Penalty;John Lee,dba Perry County Mall

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5051 Civil Money Penalty;Bertha Mae Singleton;dba El Morocco Club

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5053 Civil Money Penalty;Charles Wilkerson;dba Wilkeron's County

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5056 Civil Money Penalty;Loethen Oil Company, Inc;dba Loethen Oil

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5059 Civil Money Penalty;Dwight Ray Cherry and Kathi Cherry,dba Q

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5060 Civil Money Penalty;Cloverland Farms Dairy Inc,dba Royal Far

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5081 Civil Money Penalty;Rogers Oil Company of Columbia Inc,dba 6

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5082 Civil Money Penalty;Carolyn Ann Scully,dba Newfane Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5083 Civil Money Penalty;Silver City Service Inc,dba Silver City

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5087 Civil Money Penalty;Arkco Petroleum Inc,dba Arkco #121

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5102 Civil Money Penalty;Store 24 Inc,dba Store 24 #35

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5104 Civil Money Penalty;Christopher Paicos;dba Christopher's Mar

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5107 Civil Money Penalty;Phar-Mor Inc LLC,dba Phar-Mor #182

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5119 Civil Money Penalty;Danielson Oil Company of Oklahoma, Inc.

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5120 Civil Money Penalty;Daniels Texaco, Inc;Daniels Texaco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5121 Civil Money Penalty;Hinson Food Service, Inc;dba Hinson Food

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5124 Civil Money Penalty;Issa Shaikh;dba Variety Pic Up Market #1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5126 Civil Money Penalty;Amoco Oil Company;dba Split Second Food

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5127 Civil Money Penalty;BP America Inc;dba BP

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5129 Civil Money Penalty;High's of Baltimore, Incorporated;dba Hi

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5130 Civil Money Penalty;Ingles Markets, Incorporated;dba Ingles

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5136 Civil Money Penalty;Grand Casinos of Mississippi,LLC-Gulfpor

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5142 Civil Money Penalty;Fred's Stores of Tennessee,Inc;dba Fred

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5143 Civil Money Penalty;Jerald Vlamnick;dba County Line Bar

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5145 Civil Money Penalty;Larry Seamans;dba Larry's Shop Rite

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5147 Civil Money Penalty;Med-X Corporation;dba Med-X Drug #12

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5154 Civil Money Penalty;S.S. Services,Inc;dba Perring Exxon

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5158 Civil Money Penalty;ABFB Corp;dba The White Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5161 Civil Money Penalty;Cecilton Market, Inc;dba Cecilton Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5168 Civil Money Penalty;Phillip Gealy;dba Arlington 98 Cent Stor

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5169 Civil Money Penalty;H & 5th, Inc;dba Corner Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5177 Civil Money Penalty;J & J Marts, Inc;dba Mountaineer Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5180 Civil Money Penalty;McClure Company, Inc;dba C & E Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5192 Civil Money Penalty;Wal-Mart Stores, Inc;dba Wal-Mart #1188

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5205 Civil Money Penalty;Sang Yong, Inc;dba Astro Liquors

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5209 Civil Money Penalty;St.Joseph Gas & Bait, Inc;dba St.Joseph

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99N-1852 Status reports/postmarketing studies-human drugs&biological

EMC 1 Larry Sasich Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

C 46 Lori Dority Vol#: 22

C 47 Freya L. Moskowite Vol#: 22

C 48 Bernard Caley Vol#: 22

C 49 Pauline D'Esposito Vol#: 22

C 50 Michelle Lukasiewicz Vol#: 22

C 51 Angela M. Fumando Vol#: 22

C 52 Mrs. Joan Dienst Vol#: 22

C 53 Diane Reese Vol#: 22

C 54 Rita Flygar Vol#: 22

C 55 Lois Montalbano Vol#: 22

C 56 Marlene Cranmer Vol#: 22

C 57 Heather M. Sloat Vol#: 22

C 58 Mrs Frances Julseth & Geo. & Kathy Thode Vol#: 22

C 59 Mrs. Marilyn Evenson Vol#: 22

C 60 June McCarthy Vol#: 22

C 61 Kim Boretsky Vol#: 22

C 62 Dr. Leah Olsen Vol#: 22

C 63 Dairy Education Board Vol#: 22

EMC 1943 Eric O. Troldahl Vol#: 22

EMC 1944 Heather Paslay Vol#: 22

EMC 1945 Lisa M. DeLand Vol#: 22

EMC 1946 Sheila Hamann Vol#: 22

EMC 1947 Constance Young Vol#: 22

EMC 1948 Erin Griffin Vol#: 22

EMC 1949 Peary Vol#: 22

PDN 1 HFC-1 to Robert Cohen Vol#: 22

00H-0516 Civil Money Penalty;Jose M. Herrera,dba Jalisco Mexican Prod

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0518 Civil Money Penalty;Emad Abdullah,dba Paradise Valley Liquor

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0519 Civil Money Penalty;Charles Mason,dba Raymond Como Amoco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0525 Civil Money Penalty;BC Oil Ventures LLC,dba Arco Haleiwa

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0526 Civil Money Penalty;Francis Becher,dba Frank's Bargains

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0527 Civil Money Penalty;June Benne,dba Benne's Gas & Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0528 Civil Money Penalty;Lucille Burnett,dba Kayce's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0529 Civil Money Penalty;Calhoun Enterprises Inc,dba Calhoun Food

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0534 Civil Money Penalty;Graves Oil & Butane Co Inc,dba Graves Oi

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0536 Civil Money Penalty;Cleta Hulsey,dba Wakita Foodland

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0538 Civil Money Penalty;Jones Oil Company Oil,dba Mr Roy's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0540 Civil Money Penalty;Michael "Mick" LaFevers,dba Tote-A-Poke

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0541 Civil Money Penalty;Lindsey's Auto Repair Inc,dba Lindsey's

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0543 Civil Money Penalty;Dan Miller,dba Digby's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0544 Civil Money Penalty;O'Rourke's Inc,dba O'Rourkes Restaurant

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0545 Civil Money Penalty;Paul's Quick Shop Inc,dba Paul's Quick S

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0547 Civil Money Penalty;Sheehan's Mini Market Inc,dba Sheehan's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0549 Civil Money Penalty;Tri-Valley Distributing Inc,dba Montpeli

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0550 Civil Money Penalty;United Oil Marketes inc,dba United Oil #

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0551 Civil Money Penalty;Billy Whittet,dba Whittet's Grocery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0552 Civil Money Penalty;Dan Wilkinson,dba Alberta Chain Saw Sale

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0557 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #534

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0559 Civil Money Penalty;Cleta Hulsey,dba Pond Creek Food Land

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0560 Civil Money Penalty;Edward Bourg Sr,dba Chevy Chase Citgo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0561 Civil Money Penalty;D&S Food Centers Inc,dba D&S Food Center

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0562 Civil Money Penalty;Christine Gorra & Darren Gorra,dba DG's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0563 Civil Money Penalty;Grunst Brothers Inc,dba Grunst Brothers

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0567 Civil Money Penalty;Ohio Valley Supermarkets Inc,dba Twin Ri

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00P-1120 UroSurge Percutaneous SANS Device

N 1 Vol#: 1

00P-1209 Laser Flurescence Caries Detection Device

N 1 Vol#: 1

00P-1265 Performance standard for electrode lead wires & patient cabl

ACK 1 HFA-305 Vol#:

CP 1 Biosense Webster Inc Vol#: 1