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 October 25, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
97N-484S Human Cellular and Tissue-Based Products *
98N-1038 Irradiation in the production, processing, &handling of food *
99M-4276 PMA Cook MBC PTCA Balloon Dilatation Catheter, P990008 *
99M-4277 PMA INTER FIX Threaded Fusion Device, P970015 *
99M-4278 PMA Durasphere Injectable Bulking Agent, P980053 *
99M-4279 PMA Medtronic Hancock II Bioprosthetic Heart Valve, models t *
99M-4280 PMA ANCURE Tube & Bifurcated Systems, ANCURE Iliac
99M-4281 PMA Diva Platform Implantable Pulse Generators, P990001 *
99M-4330 PMA FemSoft Insert, P990002*
99M-4331 PMA AneuRx Stent Graft System, P990020 *
99M-4361 PMA Norian SRS Skeletal Repair System Cement, P970010 *
97N-484S Human Cellular and Tissue-Based Products

EC 1 J D Benson Vol#: 6

EC 2 Lin Larson Vol#: 6

EC 3 H Kosovitz Vol#: 6

EC 4 Celine-Marie Pascale Vol#: 6

EC 5 Doug Larsen Vol#: 6

EC 6 Bob Topor Vol#: 6

EC 7 Clifford D Carte Vol#: 6

EC 8 Joe McFerran Vol#: 6

EC 9 Phoenix Rudner Vol#: 6

EC 10 Erik Botsford Vol#: 6

EC 11 Fred Harvey Vol#: 6

EC 12 Tim Sally Vol#: 6

EC 13 Kristen Loomis Vol#: 6

EC 14 Michael Barker Vol#: 6

EC 15 Mio Alter Vol#: 6

EC 16 Kelley Shewmaker Vol#: 6

EC 17 Steven Baratz Vol#: 6

EC 18 Jason Serinus Vol#: 6

EC 19 Cliff Anchor Vol#: 6

EC 20 Tom Cardellino Vol#: 6

EC 21 Paul Hurst Vol#: 6

EC 22 James W Dewsnap PhD Vol#: 6

EC 23 Ellen Press Vol#: 6

98N-0222 Dissemination of Information on Unapproved/New Uses

N 4 Vol#: 4

98N-0617 Treatment of Narcotic Dependence

C 13 CAP of Downers Grove Vol#: 1

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

C 4733 Form letter count 13 Vol#: 136

C 4734 Form letter count 56 Vol#: 137

C 4735 Marvin E Molberg Vol#: 135

EC 3 Denise Hart Vol#: 135

EC 4 Linda Rogers Vol#: 135

EC 5 Noah & Natasha Brenner Vol#: 135

EC 6 Steven Ignots Vol#: 135

EC 7 Renee Ross Vol#: 135

EC 8 Leigh Hauter Vol#: 135

EC 9 Karina Garbesi Vol#: 135

99H-0105 Civil Money Penalties;Boris Sapozhnikov, d/b/a ABS Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-0446 Civil Money Penalties;Honey Farms Inc,d/b/a Honey Farms

LET 2 Office of Tobacco Programs Vol#: 1

99H-0499 Civil Money Penalties;Ports Petroleum Co Inc,d/b/a Fuel Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1199 Civil Money Penalties;Hollis Sturdy,d/b/a Circle S Gas & Foo

LET 2 Office of Tobacco Programs Vol#: 1

99H-1394 Civil Money Penalty; Bland Corner Market Inc d/b/a The Corne

LET 2 Office of Tobacco Programs Vol#: 1

99H-1727 Civil Money Penalty;Hagerla's Markets Inc,dba Magerla's Mark

LET 2 Office of Tobacco Programs Vol#: 1

99H-2182 Civil Money Penalty;Mikey's One Stop Inc,dba Mike's One Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-2251 Civil Money Penalty;Francisco Espindola,dba La Flor

LET 2 Office of Tobacco Programs Vol#: 1

99H-2514 Civil Money Penalty;Steven Johnson,dba Papa Joe's

LET 2 Office of Tobacco Programs Vol#: 1

99H-2516 Civil Money Penalty;Taneycomo Market & Campground Inc,dba

LET 2 Office of Tobacco Programs Vol#: 1

99H-2557 Civil Money Penalty;Mike Brawner,dba A J's Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-2625 Civil Money Penalty;Tim Humbert Carol Humbert Billy Buck & B

LET 2 Office of Tobacco Programs Vol#: 1

99H-2697 Civil Money Penalty;Oeu Ghov,dba Al's Donuts

LET 2 Office of Tobacco Programs Vol#: 1

99H-2704 Civil Money Penalty;Carefree Convenience Store LLC dba Caref

LET 2 Office of Tobacco Programs Vol#: 1

99H-2732 Civil Money Penalty;Talat M. Khan,dba Lil Short Stop #4

LET 2 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-2851 Civil Money Penalty;Linda Doggett Hunt.dba Fleming Grocery

LET 2 Office of Tobacco Programs Vol#: 1

99H-2859 Civil Money Penalty;Henderson Oil Company Inc,dba Energy Mar

MO 2 Energy Mart Store Inc Vol#: 1

99H-2871 Civil Money Penalty;Michael S. Singley,dba Church Street Gro

LET 2 Office of Tobacco Programs Vol#: 1

99H-2939 Civil Money Penalty;Michael Seroy & Nancy E Seroy,dba Arco

LET 2 Office of Tobacco Programs Vol#: 1

99H-2954 Civil Money Penalty;Day Square Getty Inc,dba Day Square Gett

LET 2 Office of Tobacco Programs Vol#: 1

99H-2981 Civil Money Penalty;Ekelund Enterprises Inc,dba Trout Liquor

LET 2 Office of Tobacco Programs Vol#: 1

99H-4131 Civil Money Penalty;Tobacco Superstores Inc,dba Tobacco Shop

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4135 Civil Money Penalty;AM/PM Gas Inc,dba Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4136 Civil Money Penalty;Andlar Enterprises Inc,dba 460 Express M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4137 Civil Money Penalty;Dent Anglin,dba Atkins Ridgewood Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4138 Civil Money Penalty;Archer's Mobil Inc,dba Archer's Mobil Ce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4139 Civil Money Penalty;Kenneth Bauer,dba Bauer's Market

LET 1 Office Of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#:

99H-4140 Civil Money Penalty;Calibur Systems Inc,dba Calibur Car Wash

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4141 Civil Money Penalty;Cantrell Road Package Store Inc,dba Cant

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4142 Civil Money Penalty;Daniel Chang & Karen Chang,dba Columbia

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4143 Civil Money Penalty;Conoco Inc,dba Conoco #42029

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4144 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #2310

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4145 Civil Money Penalty;Delchamps Inc,dba Delchamps #296

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4146 Civil Money Penalty;Dell Oil Ltd,dba Dell Oil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4147 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4148 Civil Money Penalty;E-Z Mart Stores Inc,dba E-Z Mart Store #

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4149 Civil Money Penalty;Family Foods of Gatesville Inc,dba Famil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4150 Civil Money Penalty;Gold Strike Fuel Company;dba Gold Strike

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4151 Civil Money Penalty;Randy Hinton,dba Fountain City Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4152 Civil Money Penalty;Homeland Stores Inc,dba Homeland Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4153 Civil Money Penalty;Ingles Markets Incorporated,dba Ingles M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4154 Civil Money Penalty;Jean Fuel Company West,dba Nevada Landin

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4155 Civil Money Penalty;Jernigan Oil Co Inc,dba Duck Thru Food S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4156 Civil Money Penalty;Jhonny Inc,dba Nik-Nak Foods Pizza & Ice

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4157 Civil Money Penalty;Will Kitchens,dba Kitchen's Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4158 Civil Money Penalty;Robert A. Koch,dba Chicopee Self Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4159 Civil Money Penalty;Peterborough Oil Co Inc,dba Mr. Mike's

LET 1 Office of Tobacco Programs Vol#:

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4160 Civil Money Penalty;Catherine Sharp,dba Bob Sharp's Union

LET 1 Office of tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4161 Civil Money Penalty;Dong Seo Shin,dba East 4th Avenue Food M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4162 Civil Money Penalty;Southgate Liquors inc,dba Southgate Liqu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4163 Civil Money Penalty;Three Plus Inc,dba Spur

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4164 Civil Money Penalty;Pearl Kenneth Updike and Della Updike,db

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4165 Civil Money Penalty;Smith & Woods Management Coporation,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4171 Civil Money Penalty;Krause Gentle Corporation,dba Kum & Go #

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4182 Civil Money Penalty;B S R Entl Inc,dba Budget Mart #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#:

99H-4183 Civil Money Penalty;Colorado Retail Ventures Services, LLC,

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4184 Civil Money Penalty;Colorado Retail Ventures Services LLC,

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4185 Civil Money Penalty;Dale Albert & Natoma Albert,dba Rockin'H

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4186 Civil Money Penalty;Doc's Stop Inc,dba Doc's Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4187 Civil Money Penalty;Equilon Ent LLC,dba Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4188 Civil Money Penalty;Harold Hawkins,dba Hawkins Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4189 Civil Money Penalty;Jeff's One Stop Inc,dba National Pike Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4190 Civil Money Penalty;K-C Distributors Inc,dba K-C Distributor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4191 Civil Money Penalty;Mary Felts,dba Felts Superette

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4192 Civil Money Penalty;Muzammil Columbia Heights Corp,dba Colum

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4193 Civil Money Penalty;Nick Kolas,dba Apollo III

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4194 Civil Money Penalty;O'Connell Oil Associates Inc,dba Conveni

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4195 Civil Money Penalty;Rite aid of Maryland Inc,dba Rite Aid

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4196 Civil Money Penalty;Sav-O-Mat Inc,dba Sav-O-Mat

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4197 Civil Money Penalty;Sheetz Inc, dba Sheetz

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4198 Civil Money Penalty;State St Food Mart Inc,dba Shell Food Ma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4199 Civil Money Penalty;Tobacco Town Inc,dba Tobacco Town

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4200 Civil Money Penalty;Welch Ent Inc,dba Welch Oil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-4234 Civil Money Penalty;M&B Inc,dba Augusta Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4257 Civil Money Penalty;Food Maxx Inc,dba Food Maax

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-4276 PMA Cook MBC PTCA Balloon Dilatation Catheter, P990008

AAV 1 Cook Inc Vol#: 1

99M-4277 PMA INTER FIX Threaded Fusion Device, P970015

AAV 1 Sofamor Danek USA Vol#: 1

99M-4278 PMA Durasphere Injectable Bulking Agent, P980053

AAV 1 Advanced UroScience Inc Vol#: 1

99M-4279 PMA Medtronic Hancock II Bioprosthetic Heart Valve, models t

AAV 1 Medtronic Inc Vol#: 1

99M-4280 PMA ANCURE Tube & Bifurcated Systems, ANCURE Iliac Balloon

AAV 1 Guidant Corp Vol#: 1

99M-4281 PMA Diva Platform Implantable Pulse Generators, P990001

AAV 1 Vitatron Inc Vol#: 1

99M-4330 PMA FemSoft Insert, P990002

AAV 1 Rochester Medical Corp Vol#: 1

99M-4331 PMA AneuRx Stent Graft System, P990020

AAV 1 Medtronic Inc Vol#: 1

99M-4361 PMA Norian SRS Skeletal Repair System Cement, P970010

AAV 1 Norian Corp Vol#: 1

99N-2097 Humanitarian Use Devices;Agency Information Collection

N 2 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

NM 1 Vol#: 1

99N-4329 Filing Objections & Requests for Hearing on Reg or Order

N 1 Vol#: 1