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 April 30, 2002

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
97P-0324 Withdraw approval Intramucular for Injectable Iron Dextran *
01D-0584 Reduce the Risk of Transmission of HIV-1 & HCV *
01P-0495 Determine Ultram's safety or effectiveness reasons *
02N-0115 Risk Management of Prescription Drugs; Public Hearing *
02P-0187 Exemption of any connector in lead having a conductive conne *
02P-0189 Physical form of drug product in to a oral liquid generic *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *

78N-0038 Sunscreen Drug Products

WDL 1 BASF AG Vol#: 146

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 999 Danny Holladay Vol#: 4997

CA 1000 John Capponi Vol#: 4997

CA 1001 Thomas J. Boyer Vol#: 4997

CA 1002 James R. Kirchner Vol#: 4997

CA 1003 Patricia A. Kochel Vol#: 4997

CA 1004 Dwayne Lindenmuth Vol#: 4997

CA 1005 Keith Forguson Vol#: 4997

CA 1006 William G. Davidson Vol#: 4997

CA 1007 Meagan Dau Vol#: 4997

CA 1008 Paul Sampion Vol#: 4997

CA 1009 Sherry Hogan Vol#: 4997

CA 1010 Mike Palank Vol#: 4997

CA 1011 Philip Peura Vol#: 4997

CA 1012 John J. Joyce Vol#: 4997

CA 1013 Bruce Dunlop Vol#: 4997

CA 1014 Virginia I. Long Vol#: 4997

CA 1015 Michele Yerger Vol#: 4997

CA 1016 Barry Miller Vol#: 4997

CA 1017 Paul Fisher Vol#: 4997

CA 1018 Mark S. Galkowski Vol#: 4997

CA 1019 Evan Argerines Vol#: 4997

CA 1020 Brenda Ream Vol#: 4997

CA 1021 Alan K. Shomsky Vol#: 4997

CA 1022 Melanie Kotkowsla Vol#: 4997

CA 1023 R. Darrin White Vol#: 4997

CA 1024 Patrick S. Bullard Vol#: 4997

CA 1025 James E. Adams Vol#: 4997

CA 1026 Dennis Bushrud Vol#: 4997

CA 1027 George Gorsuch Vol#: 4997

CA 1028 Matthew Collins Vol#: 4997

CA 1029 Paul Woryauez Vol#: 4997

CA 1030 Steve Myers Vol#: 4997

CA 1031 Gayle Daranijit Vol#: 4997

CA 1032 Richard Cornelia Vol#: 4997

CA 1033 Kristi S. Zakrie Vol#: 4997

CA 1034 Ava M. Cuevas Vol#: 4997

CA 1035 Thomas R. April Vol#: 4997

CA 1036 David S. Gram Vol#: 4997

CA 1037 Nancy Tighe Vol#: 4997

CA 1038 Aaron D. Kreider Vol#: 4997

CA 1039 Scott R. Morell Vol#: 4997

CA 1040 Wayne Kohart Vol#: 4997

CA 1041 LuAnn Pierce Vol#: 4997

CA 1042 Diana Satterwhite Vol#: 4997

CA 1043 Dorothy Chesley Vol#: 4997

CA 1044 A. J. Lundgren Vol#: 4997

CA 1045 Deb Grever Vol#: 4997

CA 1046 Carol Z. Barnett Vol#: 4997

CA 1047 Jorge Cuevas Vol#: 4997

CA 1048 True D. Ho Vol#: 4997

CA 1049 Wendy R. Taylor Vol#: 4997

CA 1050 Betty Moore Vol#: 4997

CA 1051 Dr. Earl Moore Vol#: 4997

CA 1052 Robert Mahan Vol#: 4997

CA 1053 Philip Huang Vol#: 4997

CA 1054 Lori A. Huang Vol#: 4997

CA 1055 Sharon Kohout Vol#: 4997

CA 1056 David Reynolds Vol#: 4997

CA 1057 Lana Stewart Vol#: 4997

CA 1058 Cassandra Harris Vol#: 4997

CA 1059 Mike Crossor Vol#: 4997

CA 1060 Mary Maiteson Vol#: 4997

CA 1061 Jill Ratermann Vol#: 4997

CA 1062 Roberta Reitz Vol#: 4997

CA 1063 Mike Harris Vol#: 4997

CA 1064 Salina Brown Vol#: 4997

CA 1065 Karen Morehead Vol#: 4997

CA 1066 Amy Danalory, R. N. Vol#: 4997

CA 1067 Sherry Read Vol#: 4997

CA 1068 Bonnie Kirkpatrick Vol#: 4997

CA 1069 Pamela M. Phillips Vol#: 4997

CA 1070 Michelle Luig Vol#: 4997

CA 1071 Hallijeanne Chalker Vol#: 4997

CA 1072 Lynn Gordon Vol#: 4997

CA 1073 Frank McHelis Vol#: 4997

CA 1074 Karen A. Grosse Vol#: 4997

CA 1075 A. De Wilde Vol#: 4997

CA 1076 Frank A. Tarawtim, Jr. Vol#: 4997

CA 1077 W. Jenics Vol#: 4997

CA 1078 N. Starace Vol#: 4997

CA 1079 Sarah B. Hamze Vol#: 4997

CA 1080 Luela Lee Vol#: 4997

CA 1081 Sara Rider Vol#: 4997

CA 1082 Carol N. Pabago Vol#: 4997

CA 1083 Morris Gottesman Vol#: 4997

CA 1084 Eileen Kslatz Vol#: 4997

CA 1085 Carl G. Robertson Vol#: 4997

CA 1086 Mary Lou Adams Vol#: 4997

CA 1087 Margaret Jameson Vol#: 4997

CA 1088 Donna S. Draskovich Vol#: 4997

CA 1089 Mary A. Viney Vol#: 4997

CA 1090 Valerie J. Krueger Vol#: 4997

CA 1091 Sharon McGraw Vol#: 4997

CA 1092 Robin Griffin Vol#: 4997

CA 1093 Karen Vaughn Vol#: 4997

CA 1094 Mary Harris Vol#: 4997

CA 1095 Judy Chesser Vol#: 4997

CA 1096 Merritt Scott Vol#: 4997

CA 1097 Marcia L. Leonard Vol#: 4997

CA 1098 Bill Leonard Vol#: 4997

CA 1099 Lizette Alexander Vol#: 4998

CA 1100 Stacy Kushner Vol#: 4998

CA 1101 Sy Ubanez Vol#: 4998

CA 1102 Melissa Kitman Vol#: 4998

CA 1103 Jessica A. Jiosne Vol#: 4998

CA 1104 Gretchen Burks Vol#: 4998

CA 1105 Matthew M. Sheridan Vol#: 4998

CA 1106 Cheryl Pynes Vol#: 4998

CA 1107 Mrs. Betty White Vol#: 4998

CA 1108 Michelle Moore Vol#: 4998

CA 1109 Preacco Lara Vol#: 4998

CA 1110 Caroline Farley Vol#: 4998

CA 1111 Shannon Berger Vol#: 4998

CA 1112 Amanda P. Adams Vol#: 4998

CA 1113 Sandra K. Fullinger Vol#: 4998

CA 1114 Barbara Johnson Vol#: 4998

CA 1115 Laura Curtis Vol#: 4998

CA 1116 Barbara Ward Vol#: 4998

CA 1117 Frederick Fromm Vol#: 4998

CA 1118 Nancy A. Wilson Vol#: 4998

CA 1119 Illegible Vol#: 4998

CA 1120 Robert R. Yar Vol#: 4998

CA 1121 Vinnie Gaid Vol#: 4998

CA 1122 Grizelle Reed Vol#: 4998

CA 1123 Illegible Vol#: 4998

CA 1124 Dianne Bailey Vol#: 4998

CA 1125 Elyse Greene Vol#: 4998

CA 1126 Andrea Foley Vol#: 4998

CA 1127 James H. Culver Vol#: 4998

CA 1128 Imunita Johnson Vol#: 4998

CA 1129 Gabriel L. Kaelin Vol#: 4998

CA 1130 Sylvia A. Ramsey Vol#: 4998

CA 1131 Rosalina Reyes Vol#: 4998

CA 1132 Heilinda Urguiola Vol#: 4998

CA 1133 Kenneth P. Burks Vol#: 4998

CA 1134 Mellisa Burks Vol#: 4998

CA 1135 Carole Stockman Vol#: 4998

CA 1136 Peggy Young Vol#: 4998

CA 1137 Bari Grossman Vol#: 4998

CA 1138 A. Fegan Vol#: 4998

CA 1139 Dillorah R. Campbell Vol#: 4998

CA 1140 Jacques Nerisset Vol#: 4998

CA 1141 Hong Stera Vol#: 4998

CA 1142 Leslie Moore Vol#: 4998

CA 1143 Sally Welder Vol#: 4998

CA 1144 Illegible Vol#: 4998

CA 1145 Suzanne Macowber Vol#: 4998

CA 1146 Phyllis K. Yorah Vol#: 4998

CA 1147 Darla Nunley Vol#: 4998

CA 1148 Lawrence E. Hurley Vol#: 4998

CA 1149 Anne Marie Fissne Vol#: 4998

CA 1150 Amy C. Lee Vol#: 4998

CA 1151 Cheryl Rodriquez Vol#: 4998

CA 1152 Susan Sims Vol#: 4998

CA 1153 Mark L. Cohen Vol#: 4998

97E-0269 Riker Laboratories Inc Tradename ALDARA US Patent #5,238,944

ADN 1 United States Patent & Trademark Office Vol#: 1

97E-0465 Patent Extension; Bayer Corporation / Baycol

AAV 1 U. S. Patent & Trademark Office Vol#: 1

97P-0324 Withdraw approval Intramucular for Injectable Iron Dextran

LET 2 Luitpold Pharmaceuticals, Inc. Vol#: 1

98E-0838 Patent Extension DETROL (tolterodine tartrate) 5,382,600

AAV 1 U S Patent & Trademark Office Vol#: 1

98E-1222 Vitravene Injection; Patent Term Extension Application

AAV 1 U.S. Patent & Trademark Office Vol#: 1

99E-1071 Provigil, Patent No. 4,177,290

AAV 1 U.S. Patent & Trademark Office Vol#: 1

99E-1115 Lumbar I/F Cage, Patent No. 4,834,757

AAV 1 U.S. Patent & Trademark Office Vol#: 1

01D-0311 Class II Special Control Endolymphatic Shunt Tube With Valve

GDL 2 Guidance for Industry & FDA Vol#: 1

NAD 2 Guidance for Industry & FDA Vol#: 1

01D-0584 Reduce the Risk of Transmission of HIV-1 & HCV

C 4 Aventis Bio-Services, Inc. Vol#: 1

C 5 Nabi Vol#: 1

C 6 Plasma Protein Therapeutics Assn Vol#: 1

01E-0091 Argatroban, Patent Extension Application No.5,214,052

LET 3 U.S. Patent & Trademark Office Vol#: 1

01E-0094 Calozal, Patent Extension Application No. 4,412,992

LET 3 U.S. Patent & Trademark Office Vol#: 1

01E-0363 Patent Term Extension Application, MIFEPREX No. 4,386,085

LET 4 HFD-005 to Buc & Beardsley Vol#: 1

01E-0405 Patent Term Extension Application, Evoxac No. 4,855,290

LET 3 U.S. Patent & Trademark Office Vol#: 1

01E-0420 Patent Term Extension Application for Lotronex No. 5,360,800

LET 3 U.S. Patent & Trademark Office Vol#: 1

01P-0495 Determine Ultram's safety or effectiveness reasons

C 4 Teva Pharmaceuticals, USA, Inc. Vol#: 2

02E-0022 Patent Term Application for Solage No. 5,194,247

LET 3 U.S. Patent & Trademark Office Vol#: 1

02E-0024 Patent Term Application for Gleevac No. 5,521,184

LET 3 U.S. Patent & Trademark Office Vol#: 1

02N-0115 Risk Management of Prescription Drugs; Public Hearing

APE 9 American Society of Health-System Pharma Vol#: 1

APE 10 American Medical Association Vol#: 1

APE 11 Chris Bechtel RN, MSN Vol#: 1

02P-0187 Exemption of any connector in lead having a conductive conne

ACK 1 HFA-305 Vol#: 1

CP 1 Hako-Med Vol#: 1

02P-0189 Physical form of drug product in to a oral liquid generic

ACK 1 HFA-305 Vol#: 1

CP 1 Phoenix Scientific, Inc. Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

ACK 1 HFA-305 Vol#: 1

CP 1 Teva Pharmaceuticals USA, Inc. Vol#: 1

02V-0188 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Shore Lanes, Inc. Vol#: 1

02V-0190 laser light show re: SDS/400, SDS 400/P

ACK 1 HFA-305 Vol#: 1

VAR 1 Isorad Ltd. Vol#: 1

02V-0192 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Riverband Community Church Vol#: 1

02V-0193

ACK 1 HFA-305 Vol#: 1

VAR 1 Quark Lighting Technology Vol#: 1

02V-0194

ACK 1 HFA-305 Vol#: 1

VAR 1 Rauch Planetarium Vol#: 1