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 Us]

DOCKETS ENTERED on September 7, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
78N-0038 Sunscreen Drug Products

C 574 Suncare Research Laboratories, LLC Vol#: 141

C 575 The North American Alliance of TSO Vol#: 141

C 576 American Academy of Dermatology Vol#: 141

C 577 AVON Vol#: 141

C 578 UNMC Dermatology Vol#: 141

C 579 The Estee Lauder Companies Inc. Vol#: 141

C 580 Procter & Gamble Vol#: 142

EMC 1 Robert M. Sayre Vol#: 139

EMC 2 Joe Stanfield Vol#: 139

EMC 3 Robert M. Sayre Vol#: 139
 
 

99D-4575 New Use of a Food Contact Substance Notification System

N 2 HFA-250 Vol#: 1

SS 1 Supporting Statemenr Vol#: 1
 
 

99D-4576 New Use of a Food Contact Substance Notification Systems

N 2 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#:

00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

C 12 Cook Group Incorporated Vol#: 2

C 13 Baxter Healthcare Corporation Vol#: 2

C 14 ConvaTec Vol#: 2
 
 

00D-1455 Premarket Notification for Totally Implanted Spinal Cord

GDL 1 Guideline Vol#: 1

NAL 1 HFA-220 Vol#: 1
 
 

00M-1215 P970055; Biotrin Parvovirus B19 IgM Enzyme Immunoassay

NAD 2 HFZ-402 Vol#: 1
 
 

00M-1216 P970054; Biotrin Parvovirus B19 IgG Enzyme Immunoassay

NAD 2 HFZ-402 Vol#: 1
 
 

00M-1228 H990008; Telescopic Plate Space (TPS) Spinal System

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1229 PMA FloSeal matrix, FloSeal Matrix Hemostatic Sealant & Proc

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1230 P990013; Collamer Ultraviolet Absorbing Posterior Chamber

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1231 P980008 LaserScan LSX Excimer Laser System

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1298 Cutting Balloon, P950020

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1299 PMA, Coherent Opal Photoactivator Laser, P990049

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1300 PMA Visulas 690's Laser & Visulink PDT Adapter, P990048

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1354 H990012; TAS Ecarin Clotting Time Test

NAD 1 HFZ-402 Vol#: 1
 
 

00M-1447 PMA Visx Inc Excimer Laser System Model C (STAR S2)

AAV 1 CRS Clinical Research Inc Vol#: 1
 
 

00M-1448 PMA OxiFirst Fetal Oxygen Saturation Monitoring System

AAV 1 Nellcore Puritan Bennett Vol#: 1
 
 

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

CH 624 Gayle Nelson-Blomquist Vol#: 24

CH 625 John A. MacDonald Vol#: 24

CH 626 Sarah Perkins Vol#: 24

CH 627 Jennifer leMat Vol#: 24

CH 628 Erica Gutmann Strohl Vol#: 24

CH 629 SD Gutmann Vol#: 24

CH 630 Nicole Messinger Vol#: 24

CH 631 Anonymous Vol#: 24

CH 632 Irene Willis Vol#: 24

CH 633 Anne Koch Vol#: 24

CH 634 Greta Ai-Yu Niu, PhD Vol#: 24

CH 635 Deb Russcol Vol#: 24

CH 636 Jennifer Doyle Vol#: 24

CH 637 Janet B. Cook, DJM Vol#: 24

CH 638 Alan Hoffman Vol#: 24

CH 639 Diane Haugesag Vol#: 24

EC 533 Mrs. Jennifer Waldman Vol#: 14
 
 

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

C 1 Les Sheaffer Vol#: 1

EAPE60 Schering-Plough Animal Health Vol#: 1

EAPE61 Alpharma Inc. Vol#: 1

EAPE62 imss Vol#: 1

EAPE63 Pfizer Global R&D Vol#: 1

EAPE64 FDA Vol#: 1

EAPE65 Clinical Trials Advisor Vol#: 1

EAPE66 Washington Business Information, Inc. Vol#: 1

EAPE67 Washington Business Information Vol#: 1

EAPE68 Department of Health and Human Services Vol#: 1

EAPE69 FDA/CBER/OM Vol#: 1

EAPE70 Schering-plough Research Institute Vol#: 1

EAPE71 Mr. Michael McCaughan Vol#: 1

EAPE72 PhRMA Vol#: 1

EAPE73 American Pharmaceutical Association Vol#: 1

EAPE74 Video On Location Vol#: 1

EC 19 Number Not Used Vol#: 1
 
 

00N-1485 Report of FDA Retail food Program Database of Foodborne Illn

NM 1 HFS-065 Vol#: 1
 
 

00P-0788 Totally Implanted Spinal Cord Stimulator

N 1 Vol#: 5

REF 2 HFZ-410 Vol#: 5
 
 

00P-1210 Restrict Sale of Coal Tar-Containing Products

LET 1 CRP2 to Carol Brophy Vol#: 1