DOCKETS ENTERED on 01/28/00

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 January 28, 2000

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

[FDA DOCKETS PAGE][FDA HOME PAGE] [ ITEM CODES ]

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
97N-484S Human Cellular and Tissue-Based Products *
98N-1265 Distribution of Compounded Drug Products *
99P-2630 Establish a Daily Value for "added sugars" *
00V-0310 Laser Light Show *

79N-0113 Parenteral Multivitamin Products

N 3 Notice Vol#: 5

90N-0056 Parenteral Drug Prod. Containing Aluminum as an Ingredient

BKG 1 Background material/reference 1 & 2 Vol#: 4

NFR 1 Vol#: 4

91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

NEC 2 Notice of extension for comments Vol#: 20

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

NEC 3 Notice of extension for comments Vol#: 101

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

NEC 2 Notice of extension for comments Vol#: 29

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

NEC 2 Notice of extension for comments Vol#: 11

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 1098 FARM Vol#: 36

C 1099 Gaynell Stone PhD Vol#: 36

C 1100 Jack F Bashor Vol#: 36

C 1101 Lois F Smalley Vol#: 36

C 1102 Fay S Flack Vol#: 36

C 1103 Lois C Burgermaster Vol#: 36

C 1104 William R Glovan Vol#: 36

C 1105 Gilbert F O'Grady Vol#: 36

C 1106 Edward F Beaupeurt Vol#: 36

C 1107 Sherry Horton Vol#: 36

C 1108 Peter J Botzek Vol#: 36

C 1109 William R Skinner Vol#: 36

C 1110 David Steele Bresnahan DDS Ltd Vol#: 36

C 1111 Mary Huder Vol#: 36

C 1112 Joyce Smith Vol#: 36

C 1113 Jackey Connor Vol#: 36

C 1114 Kenneth J Gunn Vol#: 36

C 1115 KV Enterprises Vol#: 36

C 1116 Peter Cameron Vol#: 36

C 1117 Mary Ann Wilson Vol#: 36

C 1118 Yvonne A Hilden Vol#: 36

C 1119 Florence Marsh Vol#: 36

C 1120 Ronald Carl Bruns PE LS Vol#: 36

C 1121 Amy K Gregory Vol#: 36

C 1122 Kathleen M Kennelly Vol#: 36

C 1123 Mary L Stuart Vol#: 36

C 1124 Don Falk Vol#: 36

C 1125 Michele Chollet RN BSN MPH Vol#: 36

C 1126 Barbara Wells Vol#: 36

C 1127 Rosemary James Nye Vol#: 36

C 1128 Wilbanks & Joanne K Smith Vol#: 36

C 1129 Anne S White Vol#: 36

C 1130 Brigham & Women's Hospital Vol#: 36

C 1131 Brigham & Women's Hospital Vol#: 36

C 1132 M Belusar-Purdy Vol#: 36

C 1133 The Children's Foundation Vol#: 36

C 1134 Isabel A Leonard Vol#: 36

C 1135 Doris L Carey Vol#: 36

C 1136 Susan Jones Vol#: 36

C 1137 Julian and Patricia Kindred Vol#: 36

C 1138 Jan Davenport Vol#: 36

C 1139 Mary L Wright Vol#: 36

C 1140 Earl E La Pointe Vol#: 36

C 1141 King County Councilman, VA Vol#: 36

C 1142 Lenore Berner Vol#: 36

C 1143 John Milem Vol#: 36

C 1144 Alice Slaman Vol#: 36

C 1145 Giant Eagle Pharmacy #4009 Vol#: 36

EMC 13 Form Letter count 2 Vol#: 35

EXT 7 NFPA Vol#: 36

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

C 441 Samuel J. Chantilis, M.D., P.A. Vol#: 23

C 442 Elizabeth Cohen Vol#: 23

C 443 Donor Network of Arizona Vol#: 23

C 444 OSMA, Orthopedic Surgical Mfrs Assn. Vol#: 23

C 445 Laservision Correction Vol#: 24

C 446 Yale University Vol#: 24

C 447 Leland Traiman, RN/FNP Vol#: 24

C 448 Byron J. Russell Vol#: 24

C 449 Lions Eye Bank of Texas Vol#: 24

EMC 28 Byron J. Russell Vol#: 23

98E-0782 Patent Extension RELUDAN No. 5,180,668

N 1 Vol#: 1

98E-0837 Patent Extension AZOPT (brinsolamide) 5,378,703

N 1 Vol#: 1

98E-0852 Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)

N 1 Vol#: 1

98E-0853 Patent Extension # 4,826,763, GlucaGen (glucagon (rDNA Origi

N 1 Vol#: 1

98E-0860 Patent Extension 4,847,265 PLAVIX

N 1 Vol#: 1

98E-1222 Vitravene Injection; Patent Term Extension Application

N 1 Vol#: 1

98N-0170 Manufacturer Reporting, Importer Reporting, User Facility

NFR 2 Vol#: 1

98N-0595 Reporting&Recordkeeping of Medical Devices under FDAMA

N 1 Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 6147 Joan Baren Vol#: 171

C 6148 Renee Deutel Vol#: 171

C 6149 Annie Triplette Vol#: 171

C 6150 Patricia B. Bell Vol#: 171

C 6151 Mini Feldman Vol#: 171

C 6152 Marilyn Hassett Vol#: 171

99D-5333 Guidance on Submitting an Archival Copy of ANDA,Electronical

N 1 Vol#: 1

99E-0118 Patent Extension ARAVA, #4,284,786

N 1 Vol#: 1

99E-0119 Patent Extension Sentinel, #5,405,363

N 1 Vol#: 1

99E-1114 Ziagen, Patent No. 5,034,394

N 1 Vol#: 1

99H-1354 Civil Money Penalty; Newcomb Oil Co & John L Newcomb Jr d/b/

LET 2 Office of Tobacco Programs Vol#: 1

99H-1726 Civil Money Penalty;Jody Galler,dba Walker Springs BP

LET 2 Office of Tobacco Programs Vol#: 1

99H-4705 Civil Money Penalty;James R Dunlap,dba Handy Dandy Food

LET 2 Office of Tobacco Programs Vol#: 1

99H-5063 Civil Money Penalty;Deweese Enterprises Inc,dba Super Stop #

ANS 1 Deweese Ent Inc Vol#: 1

99H-5369 Civil Money Penalty;Steve Langston,J.R. Langston and Anna La

ANS 1 Steven R Langston,dba Jr's One Stop Vol#: 1

99H-5387 Civil Money Penalty;Farris Sukkar;dba Farmer's Market

ANS 1 Faris Sukkar,dba Farmer's Market Vol#: 1

99H-5406 Civil Money Penalty;James W. Suh;dba Sun Grocery

ANS 1 James W Suh, dba Sun Grocery Vol#: 1

99H-5436 Civil Money Penalty;Al Hamdi Corporation;dba One Stop Food

ANS 1 One Stop Food Store Vol#: 1

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

EMC 1143 Theresa Remley Vol#: 88

EMC 1144 Richard J Smith Vol#: 88

EMC 1145 Paula E Bishop Vol#: 88

EMC 1146 Donald L Deaton Vol#: 88

EMC 1147 Yuri Huta Vol#: 88

EMC 1148 Keith Moore Vol#: 88

EMC 1149 Jay Marx Vol#: 88

EMC 1150 Frank Clavelli Vol#: 88

EMC 1151 Russell Todd Vol#: 88

EMC 1152 Dan Johnson Vol#: 88

EMC 1153 Mary Wildfire Vol#: 88

EMC 1154 Nickie Dumke Vol#: 88

EMC 1155 Linda Tagliaferro Vol#: 88

EMC 1156 Linda E Nozicka Vol#: 88

EMC 1157 Steve Reinhardt Vol#: 88

EMC 1158 Gina Cawley Vol#: 88

EMC 1159 William Fil Vol#: 88

EMC 1160 Glenn Marshall Vol#: 88

EMC 1161 Ronald Bosch Vol#: 88

EMC 1162 Julie Elena Brown Vol#: 88

EMC 1163 Jon Stout Vol#: 88

EMC 1164 Kayla Cohen Vol#: 88

EMC 1165 Jacqueline Christensen Vol#: 88

EMC 1166 Jonn Salovaara Vol#: 88

EMC 1167 JR Nanczek Vol#: 88

EMC 1168 Peggy H Vol#: 88

EMC 1169 Sharla R Benedict Vol#: 88

EMC 1170 Diana McCarter Vol#: 88

EMC 1171 Susan Lindson Vol#: 88

EMC 1172 Abernstein Vol#: 88

EMC 1173 Robert Greenstreet Vol#: 88

EMC 1174 Pamela Peirce Vol#: 88

EMC 1175 Kyle Morrison Vol#: 88

EMC 1176 Mark K Huebner Vol#: 88

EMC 1177 Deanna L Steinke Vol#: 88

EMC 1178 Ewell Culbertson Vol#: 88

EMC 1179 Robin Ahle Vol#: 88

EMC 1180 Amy Lawrence Vol#: 88

EMC 1181 Brigitta Postma Vol#: 88

EMC 1182 Renate Mueller Vol#: 88

EMC 1183 Sage Hales Vol#: 88

EMC 1184 Sherri Diamandoglu Vol#: 88

EMC 1185 Lawrence Shaw Vol#: 88

EMC 1186 Bryan Kippen Vol#: 88

EMC 1187 Cheryl Schneekloth Vol#: 88

EMC 1188 Bill Freese Vol#: 88

EMC 1189 J F Stover Vol#: 88

EMC 1190 Randall Libero Vol#: 88

EMC 1191 Mark K Huebner Vol#: 88

EMC 1192 Dorah Rosen Vol#: 88

EMC 1193 Cosima Krueger PhD Vol#: 88

EMC 1194 Susan Snow Vol#: 88

EMC 1195 Theresa Gray Vol#: 88

EMC 1196 Andrew David Vol#: 88

EMC 1197 Gail Adrian Vol#: 88

EMC 1198 Carrie Clark Vol#: 88

EMC 1199 Dr Lorraine Parker Vol#: 88

EMC 1200 Benjamin M Stewart Vol#: 88

EMC 1201 Blaine Elliott Vol#: 88

EMC 1202 John Piekarski Vol#: 88

EMC 1203 A Spiegel Vol#: 88

EMC 1204 Jon Rowley Vol#: 88

EMC 1205 Anne Powers-Beck Vol#: 88

99P-2630 Establish a Daily Value for "added sugars"

C 106 Mildred Adams Vol#: 6

C 107 Florence Olivenbaum Vol#: 6

C 108 Anthony M. Cammarano Vol#: 6

C 109 ILSI Research Foundation Vol#: 6

C 110 Henry A. Waxman (CI) Vol#: 6

C 111 Yvonne Spaulding Vol#: 6

00H-0275 Civil Money Penalty;Atchafalaya Provisions Inc,dba Chevron

LET 1 Office of Tobacco Programs Vol#: 1