Food and Drug Administration

DOCKETS ENTERED on July 6, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
80N-0042 Anticaries Drug Products for OTC Human Use *
97D-0228 Computerized Systems Used in Clinical Trials *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
99N-1174 Development of Strategy for Dietary Supplements *
99N-1979 Apple Cider Food Safety Control *
99P-2172 Reclassify ocular prosthetic (artificial eye) lubricant *
80N-0042 Anticaries Drug Products for OTC Human Use

SUP 12 Tom's of Maine Vol#: 31

SUP 13 Tom's of Maine Vol#: 31

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 45 List as of June 29, 1999 Vol#: 3

97D-0228 Computerized Systems Used in Clinical Trials

C 25 Merck & Co., Inc. Vol#: 2

98H-0685 Civil Money Penalties;Crown Central Petroleum,d/b/a Crown

BRF 1 Crown Central Petroleum Corp Vol#: 1

LET 5 HFA-305 Vol#: 1

98H-0688 Civil Money Penalties;Fast Fare Inc,d/b/a Fast Fare Store

BRF 1 Crown Central Petroleum Corp Vol#: 1

LET 5 HFA-305 Vol#: 1

98H-0736 Civil Money Penalties;Crown Central Petroleum Corp

BRF 1 Crown Central Petroleum Corp Vol#: 1

LET 7 HFA-305 Vol#: 1

98M-0722 SoundScan, Models 2000 & Compact

N 1 Vol#: 1

98M-0835 Possis Perma-Seal Dialysis Access Graft, Model 2C20

N 1 Vol#: 1

98M-0855 UV-Absorbing PMMA Posterior Chamber IOLs

N 1 Vol#: 1

98M-0856 Logicon Caries Detector

N 1 Vol#: 1

98M-0857 P980018; DAKO HercepTest

N 1 Vol#: 1

98M-0897 P960014; Magellan-C PTCA Catheter

N 1 Vol#: 1

98M-0907 Model 7271 GEM Dr Dual Chamber Implantable Cardioverter Defi

N 1 Vol#: 1

98M-0972 P980023; Phylax Implantable ICD System

N 1 Vol#: 1

98M-0999 AMS 700 Series Inflatable Penile Prosthesis Product Line

N 1 Vol#: 1

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

C 3100 Charles Von Himmel Vol#: 85

C 3101 William Kreuter Vol#: 85

C 3102 Larry Andrews Vol#: 85

C 3103 Gary Burt Vol#: 85

C 3104 Daniel Hirsch Vol#: 85

C 3105 Marty Walter Vol#: 85

C 3106 Nuclear Control Institute Vol#: 85

C 3107 John Madsen Vol#: 85

C 3108 Michael W. Hurst Vol#: 85

C 3109 Cynthia Marshall Vol#: 85

C 3110 Steven J. Samario Vol#: 85

C 3111 Scott & Laura Luxor Vol#: 85

C 3112 Sheleigh Highsmith Vol#: 85

C 3113 Ms Laura Lichtenstein Vol#: 85

C 3114 Jim Roy Vol#: 85

C 3115 The Stadicks Vol#: 85

C 3116 Bruce Robinson Vol#: 85

C 3117 Jean M. Okazaki Vol#: 85

C 3118 C. Harris Vol#: 85

C 3119 Nancy Bourne Vol#: 85

C 3120 David & Arlene Mac Candlish Vol#: 85

C 3121 Sylvia Goldsmith Vol#: 85

C 3122 Keisti Young Vol#: 85

C 3123 F. W. Block Vol#: 85

C 3124 Mary Rolger Vol#: 85

C 3125 Michael Durell Vol#: 85

C 3126 Women's Intl League for Peace & Freedom Vol#: 85

C 3127 Joyce Strahn Vol#: 93

98N-1265 Distribution of Compounded Drug Products

C 3338 Louis S Zappulla Vol#: 122

C 3339 Mary Eloise Schafer Vol#: 122

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 264 Paddimiton Zurgard Vol#: 18

99F-1879 2-bromo-2-nitro-1,3-propanediol as an antimicrobial for use

NFL 1 Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-1446 Civil Money Penalties;Edward Lorenz,d/b/a Super Stop

LET 2 Office of Tobacco Programs Vol#: 1

99M-0034 P980024; PathVysion HER-2 DNA Probe Kit

N 1 Vol#: 1

99M-0237 Premarket App of PureVision Visibility Tinted Concat Lens

N 1 Vol#: 1

99M-0793 Access AFP Immunoassay Analyzer - P980041

N 1 Vol#: 1

99M-0894 PMA Lumbar I/F Cage with VSP Spine System, P960025

N 1 Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

LET 1 Paul G King Consulting Vol#: 3

99N-1174 Development of Strategy for Dietary Supplements

C 25 American Preventive Medical Assn et al Vol#: 1

C 26 K D Consultants Vol#: 2

99N-1737 Cinical trials for Investigational devices Intended to treat

N 1 Vol#: 1

99N-1979 Apple Cider Food Safety Control

C 1 Michael Beck Vol#: 1

99P-2172 Reclassify ocular prosthetic (artificial eye) lubricant

ACK 1 HFA-305 Vol#: 1

CCP 1 E F Associates Vol#: 1