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 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
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 * |
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 1099 Gaynell Stone PhD Vol#: 36
C 1101 Lois F Smalley 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 1108 Peter J Botzek Vol#: 36
C 1109 William R Skinner Vol#: 36
C 1110 David Steele Bresnahan DDS Ltd Vol#: 36
C 1114 Kenneth J Gunn Vol#: 36
C 1115 KV Enterprises 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 1122 Kathleen M Kennelly Vol#: 36
C 1125 Michele Chollet RN BSN MPH Vol#: 36
C 1127 Rosemary James Nye Vol#: 36
C 1128 Wilbanks & Joanne K Smith 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 1137 Julian and Patricia Kindred Vol#: 36
C 1140 Earl E La Pointe Vol#: 36
C 1141 King County Councilman, VA Vol#: 36
C 1145 Giant Eagle Pharmacy #4009 Vol#: 36
EMC 13 Form Letter count 2 Vol#: 35
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 6149 Annie Triplette Vol#: 171
C 6150 Patricia B. Bell 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 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
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0276 Civil Money Penalty;Connecticut Meat Suppliers Inc,dba Centr
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0277 Civil Money Penalty;Gerich's Service Station Inc,dba Gerich'
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0278 Civil Money Penalty;Richard Hudlow Jr,dba Hudlow's Exxon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0279 Civil Money Penalty;J & A Ent Inc,dba Fast Trax #4
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0280 Civil Money Penalty;L M A Mobil Mart Inc,dba L & M Mobil Mar
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0281 Civil Money Penalty;Larry Meixner,dba Air Bears Restaurant
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0282 Civil Money Penalty;Paul Morgan,dba Morgan's Amoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0283 Civil Money Penalty;Nome Commercial Co & Wayne Brown & Carro
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0284 Civil Money Penalty;William Tong & Nancy Tong,dba Willmart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
00H-0285 Civil Money Penalty;Wilson Stores Inc,dba Wilson's Super Val
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1