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 03/31/00

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 ]

 
84V-0380 Variance 21CFR 1020.32 RE: source skin distance mininums *
95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97N-484S Human Cellular and Tissue-Based Products*
97P-0093 Modify Package Labeling for Ultane (Sevoflurane) Anesthetic *
98P-0434 Standards for Generic Transdermal Estradiol Patches *
99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma *
99P-1340 Declared Eternity eau de Parfum Misbranded*
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-2148 Label or Labeling of food ingredients and regulation *
99P-2548 Performance Standard for Electrode Lead Wires*
99P-5298 Request for an Exemption Performance Standard 21 CFR Part898 *
99P-5519 Exempt Daig from compliance to Regulation 21 CFR, Part 898 *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00P-0117 ANADA Suitability for Lincomycin-Spectinomycin Water Soluble
00P-0788 Totally Implanted Spinal Cord Stimulator*
00P-1225 ANADA Suitability for Ivermectin Liquid for Horses *

84V-0380 Variance 21CFR 1020.32 RE: source skin distance mininums

EXP 2 Fluoroscan Imaging Systems, Inc Vol#: 1

95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr

C 17 KORSCH America Inc Vol#: 2

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

BKG 1 BACKGROUND MATERIAL Vol#: 294

RPT 6 GAO REPORT Vol#: 293

95P-0078 Permit the removal of fat from standardized foods

WDL 1 Calorie Control Council Vol#: 1

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 98 The Honorable Barbara Boxer (CI) Vol#: 3

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 222 Kinder R. Van Pelt Vol#: 6

97F-0157 2-Propenoic Acid, Polymer with 2-Ethyl-2- as fluid Absorbent

EA 1 Environmental Assessment Vol#: 1

FONS1 Findings of No Significant Impact Vol#: 1

NFR 1 Vol#: 1

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

C 468 Emory Healthcare Vol#: 24

C 469 Saint Louis Orthopedic Institute, Inc Vol#: 24

C 470 Emory Healthcare Vol#: 24

97P-0093 Modify Package Labeling for Ultane (Sevoflurane) Anesthetic

PAV 1 HFD-001 to Professor Dept of Anesthesia Vol#: 1

98H-1271 Civil Money Penalties; Cumberland Farms Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98N-0786 Liquid chemical sterilants/general purpose disinfectants

REF 1 HFZ-215 Vol#: 1

98P-0434 Standards for Generic Transdermal Estradiol Patches

LET 3 The Weinberg Group Inc. Vol#: 4

PDN 1 HFC-1 to Berlex Labs Inc & 3M Pharm Vol#: 1

99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma

C 4 Alpha Therapeutic Corporation Vol#: 1

99H-0098 Civil Money Penalties; Cronin's Market Inc.

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0099 Civil Money Penalties; Geissler's Supermarket Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0415 Civil Money Penalties;Hattie Davis,d/b/a Buds Pick Up

CR 1 Office of Tobacco Programs Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1081 Civil Money Penalties;Local Inc,d/b/a Local Food Stop

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1084 Civil Money Penalties;Walgreen Eastern Co Inc,d/b/a Walgreen

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1095 Civil Money Penalties;Iantha Staffenhagen,d/b/a Mom's Longbr

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1312 Civil Money Penalties;Charles Green & Annie Bell,d/b/a TCB

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1314 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #409

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1315 Civil Money Penalties;Trade Oil Co,d/b/a Trade Mart #57

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1316 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1317 Civil Money Penalties;Four Star Ent Inc,d/b/a 13th St Mini

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1318 Civil Money Penalties;Walgreen Co,d/b/a Walgreens #3196

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1319 Civil Money Penalties;Nash-Finch Co,d/b/a Econofoods #439

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1321 Civil Money Penalties;Nash-Finch Co,d/b/a Food Folks #971

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1323 Civil Money Penalties;Eblen Short Stop Stores Inc,d/b/a Eble

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1324 Civil Money Penalties;Stameys Ent Inc,d/b/a Stamey's Grocery

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1325 Civil Money Penalties;GFJ Ent Inc,d/b/a Jake's Kwik Stop #3

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1326 Civil Money Penalties;GFJ Ent Inc,d/b/a Jake's Kwik Stop #2

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1327 Civil Money Penalties;Krause Gentle Corp,d/b/a Kum & Go #701

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1328 Civil Money Penalties;Danlee Corp,d/b/a Jiffy

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1331 Civil Money Penalties;E and J Package Liquors Inc,dba E and

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1332 Civil Money Penalties;Glenn Lee Henry,d/b/a Oak Street Texac

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1333 Civil Money Penalties;Edward Eugene Armbruster,d/b/a Circle

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1334 Civil Money Penalties;Farouk Hamdan,d/b/a Regal Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1335 Civil Money Penalties;John Spurgeon,d/b/a Spurgeon's Phillip

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1336 Civil Money Penalties;Lowell Krewson,d/b/a Krewson's Conoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1337 Civil Money Penalties;Hamid Paracha,d/b/a 7-Eleven Food Stor

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1338 Civil Money Penalties;Jeff Lipe,d/b/a 7-Eleven Food Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1343 Civil Money Penalty;Albertson's Inc d/b/a Seessel's Supermar

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1344 Civil Money Penalty; Mohamed Y Bahra d/b/a Bahra's Market

CR 1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1345 Civil Money Penalty; Luther Lee Barnes d/b/a Community Groce

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1346 Civil Money Penalty;Casey's Marketing Co d/b/a Casey's #1658

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1347 Civil Money Penalty; Randall F Cullen Sr d/b/a Cullen's

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1348 Civil Money Penalty; Jerry E Hamika d/b/a Topaz Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1350 Civil Money Penalty; Iowa Oil Company d/b/a Ioco Speede Shop

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1351 Civil Money Penalty;Krause Gentle Corporation d/b/a Kum & Go

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1434 Civil Money Penalties;Branson Heights Service Center Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1445 Civil Money Penalties;Kelly Camp,d/b/a Eagles Nest Grocery

CR 1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1605 Civil Money Penalty; Gerry Lynn Neely dba Humphammer Market

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1684 Civil Money Penalty;Q&T Food Stores Inc dba Q&T Food Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1685 Civil Money Penalty;Food Lion Inc dba Food Lion #359

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1687 Civil Money Penalty; Swifty Oil Co Inc dba Swift Oil Co

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1688 Civil Money Penalty; Van Lee dba X O Liquor

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1689 Civil Money Penalty; Frank Dusalacchi dba Hampton House of L

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1690 Civil Money Penalty;Busy Corner Inc dba Busy Corner Market &

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1691 Civil Money Penalty;Jack Reed dba Professional Car Service

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1694 Civil Money Penalty;Food Lion Inc dba Food Lion #993

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1697 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug #8927

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1698 Civil Money Penalties;Kenyon-Nerstrand Cooperative Oil Assn

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1699 Civil Money Penalties;Winn-Dixie Stores Inc,d/b/a Winn-Dixie

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1701 Civil Money Penalties;Madson's Food Store Inc,d/b/a Madson's

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1703 Civil Money Penalty;Glynn's Motormart Inc,d/b/a Glynn's Moto

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2030 Civil Money Penaltyl;B & F Liquors Inc,dba Hewitt's Package

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2031 Civil Money Penalty;John Wayne Barrow & Nancy Barrow,dba A

CR 1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-2184 Civil Money Penalty;Surendra Patel,dba E Z Way Grocery

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4020 Civil Money Penalty; TPI Petroleum Inc,dba Total Petroleum

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4021 Civil Money Penalty;Turnpike Market Inc,dba Turnpike Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4022 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Diamo

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4024 Civil Money Penalty;VMM & Associates Inc,dba Stevenson Crown

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4025 Civil Money Penalty;Walgreen Drug Store #356

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4026 Civil Money Penalty;Walgreen Co,dba Walgreens Drug Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4029 Civil Money Penalty;Balafas Enterprises Inc,dba Campus Liquo

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4032 Civil Money Penalty;Grace Energy Corporation,dba Fastrip #18

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4033 Civil Money Penalty;Hy-Vee Inc,dba Hy-Vee West #1450

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4035 Civil Money Penalty;Walgreen Co,dba Walgreen's Drug Store #1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4036 Civil Money Penalty;Albertson's Inc,dba Albertson's #778

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4038 Civil Money Penalty;CVS Revco DS Inc,dba CVS Pharmacy #6364

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4039 Civil Money Penalty;David's Food Center Inc,dba David's Food

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4040 Civil Money Penalty;Hy-Vee Inc,dba Hy-Hee Store #1065

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4041 Civil Money Penalty;Johnnie C. Williams,dba Williams Service

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4043 Civil Money Penalty;Kmart Corporation,dba Kmart Store #7154

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4044 Civil Money Penalty;Kmart Corporation, dba Kmart Store #4160

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4045 Civil Money Penalty;Larry Lilley,dba Lilley's Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4046 Civil Money Penalty;Merit Oil of Maryland Inc,dba Merit Reis

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4047 Civil Money Penalty;Saddika Mawla,dba 7-Eleven Food Store #2

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4048 Civil Money Penalty;Safeway Inc,dba Safeway Store #1559

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4050 Civil Money Penalty;Walgreen Co,dba Walgreens #1285

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4051 Civil Money Penalty;Walgreen Co,dba Walgreens #3330

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4056 Civil Money Penalty;Git-N-Go Convenience Stores Inc,dba Git-

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4057 Civil Money Penalty;Kenneth W Lazenby Trust,dba Bill & Tony

CR 1 Office of Tobacco Programs Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4059 Civil Money Penalty;Quiktrip Corporation,dba Quiktrip #535

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4061 Civil Money Penalty; U-City Quality Foods, Inc,dba U-City

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4062 Civil Money Penalty;Williams Express Inc,dba Williams Expres

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4095 Civil Money Penalty;Charles Schraeder & Sharon Schraeder

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4097 Civil Money Penalty;Daniel L Willie,dba Oasis Stop N Go #2

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4098 Civil Money Penalty;Allen Breaux & Darlene Breaux,dba Tobacc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4099 Civil Money Penalty;Cleveland Circle Gulf Inc,dba Cleveland

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4100 Civil Money Penalty;Crook's Inc,dba Crook's Sav-Mor Market

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4102 Civil Money Penalty;Manroy Corporation,dba Dandea's Superett

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4103 Civil Money Penalty;Mississippi Discount Drugs Inc,dba Missi

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4104 Civil Money Penalty;Fred Safi,dba Flash Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4105 Civil Money Penalty;Southern Iowa Petroleum Co LC,dba Lucas

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4106 Civil Money Penalty;Sunoco Inc,dba Great Road Sunoco

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4109 Civil Money Penalty;Steven D Allen,dba Prairie Street Pub

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4112 Civil Money Penalty;Stephen Wilmer Rasmus,dba Hurribak Club

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4113 Civil Money Penalty;Roberta Wilson,dba Russell Mall Grocery

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4115 Civil Money Penalty;Casey's Marketing Co,dba Casey's General

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-4116

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

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

NAD 1 Vol#: 1

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

NAD 1 Vol#: 1

99M-4278 PMA Durasphere Injectable Bulking Agent, P980053

NAD 1 Vol#: 1

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

NAD 1 Vol#: 1

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

NAD 1 Vol#: 1

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

NAD 1 Vol#: 1

99M-4330 PMA FemSoft Insert, P990002

NAD 1 Vol#: 1

99M-4331 PMA AneuRx Stent Graft System, P990020

NAD 1 Vol#: 1

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

NAD 1 Vol#: 1

99M-4692 PMA PepGen P-15, P990033

NAD 1 Vol#: 1

99M-4693 PMA Staarvisc Sodium Hyaluronate, P960033

NAD 1 Vol#: 1

99M-4776 PMA Surgifoam Absorbable Gelatin Spongel, P990004

NAD 1 Vol#: 1

99M-4810 H980007; Shelhigh Pulmonic Valve Conduit Model NR-4000

NAD 1 Vol#: 1

99M-5135 PMA Hydroview Composite Hydrogel Foldable UV-Absorbing Post

NAD 1 Vol#: 1

99M-5327 PMA BioGlue Surgical Adhesive, H990007

NAD 1 Vol#: 1

99M-5539 PMA TheraSphere, H980006

NAD 1 Vol#: 1

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

C 4480 Barbara DeMille Vol#: 290

C 4481 Linda Arreola Vol#: 291

C 4482 Barbara Berger Vol#: 291

C 4483 Maureen & Ken Dobert Vol#: 291

C 4484 Jean Schnick Vol#: 291

C 4485 Alan Ried Vol#: 291

C 4486 Adolyn DeLisle Vol#: 291

C 4487 L. Jensen Vol#: 291

C 4488 Lia Payne Vol#: 291

C 4489 Estelle H. Griffin Vol#: 291

C 4490 C.G. Stein Vol#: 291

C 4491 Jason Boehks Vol#: 291

C 4492 Sierra Price Vol#: 291

C 4493 Betty Salter Vol#: 291

C 4494 Daniel Shelly Vol#: 291

C 4495 Gloria Larkin Vol#: 291

C 4496 Ann & Dan Guenther Vol#: 291

C 4497 Michael J. Collins Vol#: 291

C 4498 Susan Goins Vol#: 291

C 4499 Dr. Christian Creteur Vol#: 291

C 4500 Franklin T. Brown Vol#: 291

C 4501 Ruth & George Schumacher Vol#: 291

C 4502 Roxanna & Johnathan Lahr Vol#: 291

C 4503 Robin Morton Vol#: 291

C 4504 Lidian Rose Vol#: 291

C 4505 Cheryl L. Vallone Vol#: 291

C 4506 Barbara Leeper Vol#: 291

C 4507 Becky Elder Vol#: 291

C 4508 Nancy K. Williams Vol#: 291

C 4509 Sharon Vanden Boom Vol#: 291

C 4510 Pat & Connie Lahr Vol#: 291

C 4511 Rolla I. Mires Vol#: 291

C 4512 Ruth Vickers Vol#: 291

C 4513 Anne R. Holmes Vol#: 291

C 4514 C. Hagner Vol#: 291

C 4515 Angela Medberg Vol#: 291

C 4516 Illegible Vol#: 291

C 4517 Barbara Visser Vol#: 291

C 4518 Howard E. Fox Vol#: 291

C 4519 William T. Main Vol#: 291

C 4520 JoAnn Eshelman Vol#: 291

C 4521 Virginia Edmiston Vol#: 291

C 4522 Walter G. Hayes Vol#: 291

C 4523 Barbara Hudson Vol#: 291

C 4524 Nancy C. Karterold Vol#: 291

C 4525 O'Shanghnessy Rice Vol#: 291

C 4526 Heidi G. Sloan Vol#: 291

C 4527 Jessica Lee Vol#: 291

C 4528 Janet Kirch Vol#: 291

C 4529 Eleanor Underhill Vol#: 291

C 4530 Gregory Gurchin Vol#: 291

C 4531 Anne-Marie Faiola Vol#: 291

C 4532 Benjamin C. Belden Vol#: 291

C 4533 James Grenslater Vol#: 291

C 4534 Amy Stack + 9 signatures Vol#: 291

C 4535 Herb O'Brien Vol#: 291

C 4536 Elizabeth Cammack Vol#: 291

C 4537 Eva Bluestein Vol#: 291

C 4538 Patricia Gladding Vol#: 291

C 4539 Judy Kern Vol#: 291

C 4540 Kathleen Brennan Vol#: 291

C 4541 Marge Gaebesek Vol#: 291

C 4542 Monica Spiller Vol#: 291

C 4543 P. Dines Vol#: 291

C 4544 Marjorie F. Ohm Vol#: 291

C 4545 Belinda Miller Vol#: 291

C 4546 Tom Wilson Vol#: 291

C 4547 Paul G. Montgomery Vol#: 291

C 4548 Paul J. Chilsen Vol#: 291

C 4549 Larry Mandt Vol#: 291

C 4550 Harold Radiloff Vol#: 291

C 4551 Salma Shamy Vol#: 291

C 4552 Sara Dorenkamp Vol#: 291

C 4553 Darrel Weiss Vol#: 291

C 4554 A. C. Velds-Bartstra Vol#: 291

C 4555 J. Boyce Vol#: 291

C 4556 Illegible Vol#: 291

C 4557 Harold Clement Vol#: 291

C 4558 Paul Seifert Vol#: 291

C 4559 L. Lombard Vol#: 291

C 4560 Lisa M. Maxwell Vol#: 291

C 4561 Lisa M. Maxwell Vol#: 291

C 4562 LeeAnn W. Smith Vol#: 291

C 4563 Edward D. Bangs Vol#: 291

C 4564 Laurie Bremmer Vol#: 291

C 4565 Mary Schneider Vol#: 291

C 4566 Mr & Mrs Heintz Vol#: 291

C 4567 Bill McCormack Vol#: 291

C 4568 Julie & Bruno Riechert Vol#: 291

C 4569 Ellen Twist Vol#: 291

C 4570 Sarah Gillespie Vol#: 291

C 4571 Jo M. Patt Vol#: 291

C 4572 Michelle Price Vol#: 291

C 4573 Rita McIntyre Vol#: 291

C 4574 Alison Forrest Vol#: 291

C 4575 John W. Hamilton Vol#: 291

C 4576 Jean Martine Vol#: 291

C 4577 Suzanne Gluck-Sosis Vol#: 291

C 4578 Lue Hartney Vol#: 291

C 4579 Robin Moline Vol#: 291

C 4580 Rose Shulman Vol#: 291

C 4581 Jason Bair Vol#: 291

C 4582 Mike Shortslef Vol#: 291

C 4583 Robert Wright Vol#: 291

C 4584 Rich Schlesinger Vol#: 291

C 4585 Tony Scarlata Vol#: 291

C 4586 Tim Morris Vol#: 291

C 4587 Donald E. Brown Vol#: 291

C 4588 Monique Sulliven Vol#: 291

C 4589 Jennifer Noll Vol#: 291

C 4590 Rosalie Kline Vol#: 291

C 4591 Daniel Schuler Vol#: 291

C 4592 Briony Walsh Vol#: 291

C 4593 Joseph Foppiano Vol#: 291

C 4594 Mr & Mrs Richard W. Bachtold Vol#: 291

C 4595 Thamar Wherrit Vol#: 291

C 4596 Lilian Rose Hartwig Vol#: 291

C 4597 Michael Childs Vol#: 291

C 4598 Pamela Bernard Vol#: 291

C 4599 Lynn M. Taplin Vol#: 291

C 4600 Claire L. Renn Vol#: 291

C 4601 Bronwyn B. Davis Vol#: 292

C 4602 Barbara Schur Vol#: 292

C 4603 Raymond W. Albright Vol#: 292

C 4604 Heidi R. Winters Vol#: 292

C 4605 Donald J. Jacobson Vol#: 292

C 4606 Roger A. Moulton Vol#: 292

C 4607 Tina M. Smaltz Vol#: 292

C 4608 Jane M. Wilkinson Vol#: 292

C 4609 Buford L. Locke Vol#: 292

C 4610 Allen Gardner Vol#: 292

C 4611 Heather Jackson Vol#: 292

C 4612 Louise V. Chenard Vol#: 292

C 4613 Jane M. Frisch Vol#: 292

C 4614 Christopher Peck Vol#: 292

C 4615 Tom Belair Vol#: 292

C 4616 Patricia E. Long Vol#: 292

C 4617 Lena Murrell-White Vol#: 292

C 4618 Nancy Depew Vol#: 292

C 4619 Mr & Mrs Chris Meyer Vol#: 292

C 4620 Scott MacWilliams Vol#: 292

C 4621 William C. Whiffen Vol#: 292

C 4622 Linda J. Clifton Vol#: 292

C 4623 Thomas Umland Vol#: 292

C 4624 Alan Fausher Vol#: 292

C 4625 Roberta M. Long Vol#: 292

C 4626 Janelle M. Olney Vol#: 292

C 4627 Robert Lewis Vol#: 292

C 4628 Michelle Poolet, Michael Reilly Vol#: 292

C 4629 Carole Lomond Vol#: 292

C 4630 Mr & Mrs Ron Carlson Vol#: 292

C 4631 Joan Harp Vol#: 292

C 4632 William W. Mackey Vol#: 292

C 4633 Carol Price Vol#: 292

C 4634 George L. Lee Vol#: 292

C 4635 Barbara Davies Vol#: 292

C 4636 Fran Teplitz Vol#: 292

C 4637 Susan M. Glock Vol#: 292

C 4638 Dorothy M. Bowers Vol#: 292

C 4639 Donna M. Troisi Vol#: 292

C 4640 Maria Ariuefron Vol#: 292

C 4641 Elisabeth A. Clark Vol#: 292

C 4642 Kristi Ayala Vol#: 292

C 4643 Alex Harsmanka Vol#: 292

C 4644 Pat Connor Vol#: 292

C 4645 Stefano Barragastoe & M. Rolf Vol#: 292

C 4646 Irwin G. Jones Vol#: 292

C 4647 Darlyne Clark Vol#: 292

C 4648 Diana Wilbert Vol#: 292

C 4649 Mark Leventer Vol#: 292

C 4650 Jodie McCann Vol#: 292

C 4651 Gwen Hanson Vol#: 292

C 4652 Mr & Mrs Ray Giffen Vol#: 292

C 4653 Miriam Herandez Vol#: 292

C 4654 Val Zimprich Vol#: 292

C 4655 Michelle L. Johnson Vol#: 292

C 4656 Betty Malaney Vol#: 292

C 4657 Mary Kunard & Ed Rogers Vol#: 292

C 4658 Betty Boswell-Mitchell Vol#: 292

C 4659 Francine A.M. Griffiths Vol#: 292

C 4660 Evan Johnson Vol#: 292

C 4661 Shirley Kimjones-Sands Vol#: 292

C 4662 Mr & Mrs Jack Thomsen Vol#: 292

C 4663 Mary Storsved Vol#: 292

C 4664 Gregg & Debra Harrison Vol#: 292

C 4665 Lucille E. Holmes Vol#: 292

C 4666 Tammara VanRyn Vol#: 292

C 4667 Earl Martin Goebel Vol#: 292

C 4668 Irene M. McFarland Vol#: 292

C 4669 Roxana Robinson Vol#: 292

C 4670 Rachel E. Hoke Vol#: 292

C 4671 G.B. Arthur Vol#: 292

C 4672 Milton Cook Vol#: 292

C 4673 Roger W. Helmer Vol#: 292

C 4674 Lindsay Gilmour Vol#: 292

C 4675 Mark & Diana Elston Vol#: 292

C 4676 Douglas Higley Vol#: 292

C 4677 Carol A. Freeman Vol#: 292

C 4678 Raymond A. Mansfield Vol#: 292

C 4679 Rafel & Lisa Gil Diaz Vol#: 292

C 4680 Richard Wasek Vol#: 292

C 4681 John Williams Vol#: 292

C 4682 Owen Neal Hendrix Vol#: 292

C 4683 Cheryl Scheffey Vol#: 292

C 4684 Mila Cubillo Vol#: 292

C 4685 Joanne Metzler Vol#: 292

C 4686 Donna Ferguson-Mininni Vol#: 292

C 4687 Sally A. Fortney Vol#: 292

C 4688 Helga Fensterman Vol#: 293

C 4689 Sue Dauberman Vol#: 293

C 4690 Joyce Bentley Vol#: 293

C 4691 Emily Haddad Vol#: 293

C 4692 Lesha Brown Vol#: 293

C 4693 J. Stacey Vol#: 293

C 4694 Doug Puckett Vol#: 293

C 4695 Robert H. Garmoe Vol#: 293

C 4696 Ann B. Whytemare Vol#: 293

C 4697 William C. Petersen Vol#: 293

C 4698 L.W. Kent Vol#: 293

C 4699 Geoffrey Gantt Vol#: 293

C 4700 Diane Graves Vol#: 293

C 4701 Stephen Kunin Vol#: 293

C 4702 Sandra Jensen Vol#: 293

C 4703 Halbey L. Hart Vol#: 293

C 4704 M.R. Defeo Vol#: 293

C 4705 Leslie Nicholas Vol#: 293

C 4706 W. Leigh Johnson Vol#: 293

C 4707 Barbara Meyer Vol#: 293

C 4708 Jennifer Joseph Vol#: 293

C 4709 Frances Greenlief Vol#: 293

C 4710 Mr & Mrs Michael Gehrig Vol#: 293

C 4711 Ralph DePhillips Vol#: 293

C 4712 Janet & Thomas Karwin Vol#: 293

C 4713 Mendi Messmer Vol#: 293

C 4714 Milton T. Blanton Vol#: 293

C 4715 Clifford & Mary Scholz Vol#: 293

C 4716 Richard Bruce Berman Vol#: 293

C 4717 Patricia B. Reibel Vol#: 293

C 4718 Muriel E. Smith Vol#: 293

C 4719 Cassandra Avonbeach Vol#: 293

C 4720 Patricia March Vol#: 293

C 4721 Marilyn DeFulvio Vol#: 293

C 4722 Teresa Johnson Vol#: 293

C 4723 Matt Fox Vol#: 293

C 4724 Sherri Anne Cantrell Vol#: 293

C 4725 Suzanne Ryerson Vol#: 293

C 4726 Yara Rogers-Silva Vol#: 293

C 4727 Roger Gamache Vol#: 293

C 4728 Fonda Witseh Vol#: 293

C 4729 Cheryl Lanjer-Julson Vol#: 293

C 4730 Shay M. Thompson Vol#: 293

C 4731 D. M. Johnson Vol#: 293

C 4732 Patricia Freeman Vol#: 293

C 4733 Paul L. Gersper Vol#: 293

C 4734 Laura A. Dowell Vol#: 293

C 4735 Lauralee Cude Vol#: 293

C 4736 Marie E. Van Vooren Vol#: 293

C 4737 Taimo Alt Vol#: 293

C 4738 Ernest Deringer Vol#: 293

C 4739 Lisa J. Aldrich Vol#: 293

C 4740 James W. Hamer Vol#: 293

C 4741 Thomas Boldenweck Vol#: 293

C 4742 Elaine McGrady Vol#: 293

C 4743 Badri Nathan Vol#: 293

C 4744 Kathryn Ackley Vol#: 293

C 4745 Debrah McGeehan Vol#: 293

C 4746 Janice Jones Vol#: 293

C 4747 Judy Stufflebeam Vol#: 293

C 4748 L.J. Shepherd Vol#: 293

C 4749 Noralee K. Rogers Vol#: 293

C 4750 Pat Hempey Vol#: 293

C 4751 Pam Resz Vol#: 293

C 4752 Betty Noga Vol#: 293

C 4753 Jeanne Bates Vol#: 293

C 4754 Charles Spencer Vol#: 293

C 4755 Pam Phillips Vol#: 293

C 4756 Harriett C. Maler Vol#: 293

C 4757 Carrie S. Tucker Vol#: 293

C 4758 Bill & Lila Flesher Vol#: 293

C 4759 John Toth Vol#: 293

C 4760 Katherine M. Andrews Vol#: 293

C 4761 Terry Bowen Vol#: 293

C 4762 Ann Kasparek Vol#: 293

C 4763 Michael OLandese Vol#: 293

C 4764 S. Romanelli Vol#: 293

C 4765 F. Stanley Wojcik Vol#: 293

C 4766 Jean Ushakoff Vol#: 293

C 4767 C. Eve Uthelyl Vol#: 293

C 4768 Julie A. Allender Vol#: 293

C 4769 Keegan Boulton Vol#: 293

C 4770 Lynn Hansen Vol#: 293

C 4771 Jean E. Snyder Vol#: 293

C 4772 Ray Griswold Vol#: 293

C 4773 A.J. O'Brien Vol#: 293

C 4774 Robert, Rita & Doug Eilenberg Vol#: 293

C 4775 Robert M. Leeds Vol#: 293

C 4776 Lisa Sayers Vol#: 293

C 4777 Karen Johnson Stoj Vol#: 293

C 4778 Susan Biederwolf Vol#: 293

C 4779 Nancy & Peter Sturm Vol#: 293

C 4780 Jean Wallace Vol#: 293

C 4781 Ann M. Still Vol#: 293

C 4782 Kenneth R. Calvert Vol#: 293

C 4783 Edith Webber Vol#: 293

C 4784 Ellen H. Phillips Vol#: 293

C 4785 Lynn Szanto Vol#: 293

C 4786 Harry Hill Vol#: 293

C 4787 Grady Bascom Nelson Vol#: 293

C 4788 Sara Morgan Vol#: 293

C 4789 Ellen A. Meadows Vol#: 293

C 4790 Eugene Weibl Vol#: 293

C 4791 Helen Lambrecht Vol#: 293

C 4792 L. Wayne Ostlund Vol#: 293

C 4793 Barbara Dellinger Vol#: 293

C 4794 Nona Farris Vol#: 293

C 4795 Virgie Thomuhe Vol#: 293

C 4796 Jane Simons Vol#: 293

EMC 1922 Debbie Longnecker Vol#:

EMC 1923 Matthew E. Maeder Vol#: 292

EMC 1924 Charlene Freeman Vol#: 292

EMC 1925 Simon Shapiro Vol#: 292

EMC 1926 Michele Voso Vol#: 292

EMC 1927 Marguerite Y. Wunderli Vol#: 292

EMC 1928 Heather & Jermiah Osmolinski Vol#: 292

EMC 1929 Igazio Capano Vol#: 292

EMC 1930 Timothy C. Coe Vol#: 292

EMC 1931 Sharon Aanstoos Vol#: 292

EMC 1932 Angela Dellaporta Vol#: 292

EMC 1933 Margaret Coddington Vol#: 292

EMC 1934 Andrea Mason Wilkes Vol#: 292

EMC 1935 Mary Anne Anseimino Vol#: 292

EMC 1936 Samson Blackwell Vol#: 292

EMC 1937 Mark Henry Vol#: 292

EMC 1938 H. Shadowens Vol#: 292

EMC 1939 K B Vol#: 292

EMC 1940 Jeanne Deimling Johns Vol#: 292

EMC 1941 Pam Bohmann Vol#: 292

EMC 1942 Annette M. Mello Vol#: 292

EMC 1943 LeAnn Skrzynski Vol#: 292

EMC 1944 Patty Adduci Vol#: 292

EMC 1945 Kimberly Brody Vol#: 292

EMC 1946 Judith Norton Vol#: 292

EMC 1947 Kathryn Stieren Vol#: 292

EMC 1948 Jeff Jordan Vol#: 292

EMC 1949 Forest Berg Vol#: 292

99P-1340 Declared Eternity eau de Parfum Misbranded

C 599 William Roth Vol#: 12

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

PAV 2 HF-11 to Roxane Laboratories, Inc Vol#: 1

99P-2148 Label or Labeling of food ingredients and regulation

C 10 Ray Gordon Vol#: 1

99P-2548 Performance Standard for Electrode Lead Wires

PAV 1 HFS-206 to PACEART Associates, L.P. Vol#: 1

99P-5298 Request for an Exemption Performance Standard 21 CFR Part898

PAV 1 HFS-206 to Product Regulation Associate Vol#: 1

99P-5519 Exempt Daig from compliance to Regulation 21 CFR, Part 898

PDN 1 HFS-206 to Daig Corporation Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 3 Society Gastroenterology Nurses & Assoc Vol#: 1

00D-1197 180-Day Exclusivity Under the Hatch-Waxman Amendments

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00M-0578 P940034/S8; Amplified Mycobacterium Tuberculosis (MTD) Test

NAD 1 Vol#: 1

00P-0117 ANADA Suitability for Lincomycin-Spectinomycin Water Soluble

PAV 1 HFV-100 to Phonex Scientific Inc Vol#: 1

00P-0788 Totally Implanted Spinal Cord Stimulator

C 2 Advanced Neuromodulation Systems, Inc Vol#: 1

00P-1225 ANADA Suitability for Ivermectin Liquid for Horses

ACK 1 HFA-305 Vol#: 1

CP 1 Equi Aid Products, Inc. Vol#: 1