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 September 13, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
85V-0324 VARIANCE RE PROJECTOR FOR LASER LIGHT  *
87V-0156 STARLIGHT SERIES (FC) LASER PROJECTION SYSTEM*
91V-0200 Variance requesting projector model #1001,1002,1003 & 1004 *
93V-0315 Laser Light Show *
94V-0411 *
95S-0117 Human Drugs Patent Term Extension & New Patents *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
95V-0388 Laser light show *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
96V-0319 Laser light show *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
97V-0246 Omniscan Laser Projection System, Model 2000*
97V-0491 Laser Light Show *
98V-0704 Laser Light Show, Mobolazer ML10-200, ML10-300,ML300W*
98V-1005 Variance for Mobolazer ML10-200, ML10-300, ML10-1000*
98V-1006 Variance for Mobolazer ML10-200, ML10-300, ML10-300W,  *
99P-4053 Sympathominetic Amine Phentermine*
99V-1342 Laser Light Show K.E.S. Laser*
99V-1617 Variance Mobolazer ML10-200, ML10-300, ML10-300W,  *
99V-2142 Laser light show *
99V-2531 MOBOLAZER ML10-200, ML10-300, ML10-300W, ML10-1000 *
99V-2536 Laser Light Show *
99V-2727 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, *
99V-4028 Laser Light Show Ar/kr LP1-1001, Ar - LP2 1002 *

85V-0324 VARIANCE RE PROJECTOR FOR LASER LIGHT SHOW/LUXME MOD 1001

VRA 7 HFZ-300 to Laser Spectacles, Inc. Vol#: 1

87V-0156 STARLIGHT SERIES (FC) LASER PROJECTION SYSTEM

VRA 6 HFZ-300 to SeaWorld Vol#: 1

91V-0200 Variance requesting projector model #1001,1002,1003 & 1004

VRA 3 HFZ-300 to Specialty Laser & Lighting Vol#: 1

93V-0315 Laser Light Show

VRA 3 HFZ-300 to Laser Display Associates Inc. Vol#: 1

94V-0411

VRA 3 HFZ-300 to MGM Grand Hotel Vol#: 1

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

LST 47 List as of September 3, 1999 Vol#: 3

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 51 New Age Health technologies Inc Vol#: 28

95V-0388 Laser light show

VRA 4 HFZ-300 to Laser Laser Productions Vol#: 1

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOS FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 198 PETA, People for the Ethical Treatment o Vol#: 8

C 199 Animal Place Vol#: 8

C 200 Holly R. Salamander Vol#: 8

C 201 The Fund For Animals, Inc. Vol#: 8

C 202 Rosemary Kent Vol#: 8

C 203 Dan Towns Vol#: 8

C 204 Bonnie Switka Vol#: 8

C 205 Jeanne S. Ellis Vol#: 8

C 206 Dezi Hemingway Vol#: 8

C 207 Genevieve Jenkins Vol#: 8

C 208 Joanne Petriello Vol#: 8

C 209 A. Mackler Vol#: 8

C 210 no signature Vol#: 8

C 211 Mr. & Mrs. Michael Alexander Vol#: 8

C 212 Christine Constantine Vol#: 8

C 213 Paula Van Curen Vol#: 8

C 214 Irving Applebaum Vol#: 8

C 215 Charlotte Marchese Vol#: 9

C 216 Janet & Herb Hanan Vol#: 9

C 217 Nancy Loewen, R.N. Vol#: 9

C 218 Linda L. Reichel Vol#: 9

C 219 Lorin Lindner, Ph.D. Vol#: 9

C 220 Sophia B. McAskill Vol#: 9

C 221 Douglas Lee Vol#: 9

C 222 Carolyn Kasper Vol#: 9

C 223 Janet Eisberner Vol#: 9

C 224 N. J. Billings Vol#: 9

C 225 Ann K. Johnson Vol#: 9

C 226 Kathleen A. Shopa Vol#: 9

C 227 Global Resource Action Ctr for the Envir Vol#: 9

C 228 United Poultry Concerns, Inc. Vol#: 9

96V-0319 Laser light show

VRA 2 HFZ-300 to Arnim D. Hummel Planetarium Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

C 199 PETA, People for the Ethical Treatment o Vol#: 7

C 200 Animal Place Vol#: 7

C 201 Holly R. Salamander Vol#: 7

C 202 The Fund For Animals, Inc. Vol#: 7

C 203 Rosemary Kent Vol#: 7

C 204 Dan Towns Vol#: 7

C 205 Bonnie Switka Vol#: 7

C 206 Jeanne S. Ellis Vol#: 7

C 207 Dezi Hemingway Vol#: 7

C 208 Genevieve Jenkins Vol#: 7

C 209 Joanne Petriello Vol#: 7

C 210 A. Mackler Vol#: 7

C 211 no signature Vol#: 7

C 212 Mr. & Mrs. Michael Alexander Vol#: 7

C 213 Christine Constantine Vol#: 7

C 214 Paula Van Curen Vol#: 7

C 215 Irving Applebaum Vol#: 7

C 216 Charlotte Marchese Vol#: 8

C 217 Janet & Herb Hanan Vol#: 8

C 218 Nancy Loewen, R.N. Vol#: 8

C 219 Linda L. Reichel Vol#: 8

C 220 Lorin Lindner, Ph.D. Vol#: 8

C 221 Sophia B. McAskill Vol#: 8

C 222 Douglas Lee Vol#: 8

C 223 Carolyn Kasper Vol#: 8

C 224 Janet Eisberner Vol#: 8

C 225 N. J. Billings Vol#: 8

C 226 Ann K. Johnson Vol#: 8

C 227 Kathleen A. Shopa Vol#: 8

C 228 Global Resource Action Ctr for the Envir Vol#: 8

C 229 United Poultry Concerns, Inc. Vol#: 9

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 295 HFS-456 to Mason Vitamins Inc Vol#: 6

LET 296 HFS-456 to Dannon Company Inc Vol#: 6

97V-0246 Omniscan Laser Projection System, Model 2000

VRA 1 HFZ-300 to Hansen Planetarium Vol#: 1

97V-0491 Laser Light Show

VRA 1 HFZ-300 to The Peter Schmitt Company Vol#: 1

98N-0617 Treatment of Narcotic Dependence

EC 3 Paul L (privacy) Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 198 PETA, People for the Ethical Treatment o Vol#: 11

C 199 Animal Place Vol#: 11

C 200 Holly R. Salamander Vol#: 11

C 201 The Fund For Animals, Inc. Vol#: 11

C 202 Rosemary Kent Vol#: 11

C 203 Dan Towns Vol#: 11

C 204 Bonnie Switka Vol#: 11

C 205 Jeanne S. Ellis Vol#: 11

C 206 Dezi Hemingway Vol#: 11

C 207 Genevieve Jenkins Vol#: 11

C 208 Joanne Petriello Vol#: 11

C 209 A. Mackler Vol#: 11

C 210 no signature Vol#: 11

C 211 Mr. & Mrs. Michael Alexander Vol#: 11

C 212 Christine Constantine Vol#: 11

C 213 Paula Van Curen Vol#: 11

C 214 Irving Applebaum Vol#: 11

C 215 Charlotte Marchese Vol#: 12

C 216 Janet & Herb Hanan Vol#: 11

C 217 Nancy Loewen, R.N. Vol#: 12

C 218 Linda L. Reichel Vol#: 12

C 219 Lorin Lindner, Ph.D. Vol#: 12

C 220 Sophia B. McAskill Vol#: 12

C 221 Douglas Lee Vol#: 12

C 222 Carolyn Kasper Vol#: 12

C 223 Janet Eisberner Vol#: 12

C 224 N. J. Billings Vol#: 12

C 225 Ann K. Johnson Vol#: 12

C 226 Kathleen A. Shopa Vol#: 12

C 227 Global Resource Action Ctr for the Envir Vol#: 12

C 228 United Poultry Concerns, Inc. Vol#: 12

98V-0704 Laser Light Show, Mobolazer ML10-200, ML10-300,ML300W

VRA 1 HFZ-300 to Brunswick U.S. Play Vol#: 1

98V-1005 Variance for Mobolazer ML10-200, ML10-300, ML10-1000, ML10-1

VRA 1 HFZ-300 to TMB Associates Vol#: 1

98V-1006 Variance for Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1

VRA 1 HFZ-300 to Curb Entertainment Vol#: 1

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

ANS 1 Humbert Store Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2853 Civil Money Penalty;Abernethy Texaco Inc,dba Abernethy Texac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2854 Civil Money Penalty;Thomas Buysse;dba Tom's Food Pride

LET 1 Office of Tobacco Program Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2855 Civil Money Penalty;Coloradopongas Inc,dba Coloradopongas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2856 Civil Money Penalty;Co-Op Service Inc of New York Mills,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2857 Civil Money Penalty;Corner Store Inc,dba Corner Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2858 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-2859 Civil Money Penalty;Henderson Oil Company Inc,dba Energy Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2860 Civil Money Penalty;R.G. Hill Oil Company;dba Happy Stop Foo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2861 Civil Money Penalty;Hyder's Kountry Kubbard Inc,dba Kountry

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2862 Civil Money Penalty;Market Basket Food Stores Inc,dba Little

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2863 Civil Money Penalty;Petro-Plus inc,dba petro Plus #103

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2864 Civil Money Penalty;James Willis,dba Willis Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2865 Civil Money Penalty;Wilwright Properties Inc,dba Forest Hill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2866 Civil Money Penalty;Winn-Dixie Stores Inc,dba Winn-Dixie Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2867 Civil Money Penalty;Stan Crapo,dba Huck Finn Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2868 Civil Money Penalty;Hubert & Ruby Johns,dba The Minit Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2869 Civil Money Penalty;Lonis P. Kelone,dba Kelone's Grocery & M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2870 Civil Money Penalty;Marohn's Cokato Marketplace Inc,dba Mark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2897 Civil Money Penalty;James Batts & James Krantz,dba H&J Marke

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2898 Civil Money Penalty;Consumers Gasoline Stations Inc,dba Scot

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2899 Civil Money Penalty;Farm Fresh Of Delaware Inc,dba Farm Fres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2900 Civil Money Penalty;Davis M. Hill & Yong Hill,dba Hill's Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2901 Civil Money Penalty;Kimmick Oil Co Inc,dba E-Z Food Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2902 Civil Money Penalty;Pearson Lane & Stephanie Lane,dba Silver

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-4053 Sympathominetic Amine Phentermine

ACK 1 HFA-305 Vol#: 1

CP 1 Massachusetts College of Pharmacy Vol#: 1

99V-1342 Laser Light Show K.E.S. Laser

VRA 1 HFZ-300 to K.E.S. LASERS Vol#: 1

99V-1617 Variance Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000

VRA 1 HFZ-300 to Amsterdam Vol#: 1

99V-2142 Laser light show

VRA 1 HFZ-300 to Laser Tek Vol#: 1

99V-2531 MOBOLAZER ML10-200, ML10-300, ML10-300W, ML10-1000 ML10-1.G,

VRA 1 HFZ-300 to Premium Systems Vol#: 1

99V-2536 Laser Light Show

VRA 1 HFZ-200 to Thunderbolt Sount & Light Inc Vol#: 1

99V-2727 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-1.0

VRA 1 HFZ-300 to Jillian's Entertainment Vol#: 1

99V-4028 Laser Light Show Ar/kr LP1-1001, Ar - LP2 1002

VAR 1 John's Laser Productions Vol#: 1