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Dockets Management
Dockets Entered On February 9, 2006
Table of Contents
Docket # Title
1995S-0158 Community Disclosure of Institutional Review Boards
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2004P-0183 Nutrient Content Claim: Expand Lean Definition
2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006P-0068 Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
2006P-0070 Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
1995S-0158 Community Disclosure of Institutional Review Boards
SUP 49
Documentation 		Northfield Laboratories BB IND #10719 Vol #: 52
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 532 J. Kaufman Vol #: 45
2004P-0183 Nutrient Content Claim: Expand Lean Definition
C 2 National Cattlemen's Beef Association (NCBA) Vol #: 4
C 3 Washington Legal Foundation (WLF) Vol #: 4
C 4 ConAgra Foods, Inc. (CAF) Vol #: 4
2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
C 8 S. Tumbarello Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EC 1082 Mrs. patty adamik Vol #: 7
EC 1083 none Vol #: 7
EC 1084 Mrs. Pat Otterson Vol #: 7
EC 1085 none Vol #: 7
EC 1086 Mrs. Doris Phelps Vol #: 7
EC 1087 Mrs. Brenda Stevens Vol #: 7
EC 1088 Mrs. lilt vergara Vol #: 7
EC 1089 Mrs. JoAnna Scott Vol #: 7
EC 1090 Mrs. Betty Sieber Vol #: 7
EC 1091 Ms. Angela Myers Vol #: 7
EC 1092 Ms. Nina Horowitz Vol #: 7
EC 1093 Dr. Louis Frost Vol #: 7
EC 1094 Mrs. vickie gasiorowski Vol #: 7
EC 1095 Mrs. Cristine Pulatie Vol #: 7
EC 1096 Mrs. Jillian Enyart Vol #: 7
EC 1097 Mrs. Linnea Robinson Vol #: 7
EC 1098 Mrs. Regina Krenzin Vol #: 7
EC 1099 Ms. Phyllis Smith Vol #: 7
EC 1100 Mrs. Charlene Robinson Vol #: 7
EC 1101 Ms. Lori Hennington Vol #: 7
EC 1102 Ms. Marianne Carey Vol #: 7
EC 1103 Miss. Suzanne McReynolds Vol #: 7
EC 1104 Ms. Kerry Willis Vol #: 7
EC 1105 Mrs. Karen Davey Vol #: 7
EC 1106 Mrs. Kathryn Chafin Vol #: 7
EC 1107 Mrs. Janice Medina Vol #: 7
EC 1108 Mrs. Kay Stringer Vol #: 7
EC 1109 Mrs. Sandra Seifert Vol #: 7
EC 1110 Dr. Charlene Bradshaw Vol #: 7
EC 1111 Ms. Diana Hartley Hartley Vol #: 7
EC 1112 Ms. Susan Daubman Vol #: 7
EC 1113 Mrs. Anita Simpson Vol #: 7
EC 1114 Ms. angie potucek Vol #: 7
EC 1115 Mrs. Michele Albini Vol #: 7
EC 1116 Mrs. Martha Butler Vol #: 7
EC 1117 Ms. Lynn Van Den Hende Vol #: 7
EC 1118 Mrs. Elizabeth Swearsky Vol #: 7
EC 1119 Mrs. Kelley Vojtsek Vol #: 7
EC 1120 Individual Vol #: 7
EC 1121 Mrs. Ina Rucker Vol #: 7
EC 1122 Mrs. Carla Cooper Vol #: 7
EC 1123 Ms. Dory Colbert Vol #: 7
EC 1124 Mrs. Marianne Wronka Vol #: 7
EC 1125 Ms. Rosemary Barbour Vol #: 7
EC 1126 Mr. Frank Gonzales Jr. Vol #: 7
EC 1127 Focus Leadership Vol #: 7
EC 1128 Ms. lisa deroque Vol #: 7
EC 1129 Ms. Catherine Munoz Vol #: 7
EC 1130 Mrs. JoEllen Lang Vol #: 7
EC 1131 Mrs. Sandra Lowry Vol #: 7
EC 1132 Mrs. Jamie Davis Vol #: 7
EC 1133 Mrs. Carol Gaylor Vol #: 7
EC 1134 Mrs. Bonnie Katz Vol #: 7
EC 1135 Mrs. Marian Taylor Vol #: 7
EC 1136 Mrs. Pam Zercher Vol #: 7
EC 1137 Dr. Pamela Carr Vol #: 7
EC 1138 Ms. G Baxter Vol #: 7
EC 1139 Mrs. nancy cieszykowski Vol #: 7
EC 1140 Mrs. Regina May Vol #: 7
EC 1141 Ms. Jan Hoerrner Vol #: 7
EC 1142 Mrs. JoAnne Wells Vol #: 7
EC 1143 Mrs. doreen hughes Vol #: 7
EC 1144 Ms. Rachel Borst Vol #: 7
EC 1145 Ms. Mary Chicoine Vol #: 7
EC 1146 Mrs. Therea Studer-Simmons Vol #: 7
EC 1147 Mrs. Maryanne Bennett Vol #: 7
EC 1148 Ms. Martha Chapman Vol #: 7
EC 1149 Mrs. Rebecca Davus Vol #: 7
EC 1150 Mrs. Helen Coleman Vol #: 7
EC 1151 Mrs. Sue Kowal Vol #: 7
EC 1152 Mrs. Catherine Vail Vol #: 7
EC 1153 Mrs. Julie Probst Vol #: 7
EC 1154 Ms. Kathleen Curry Vol #: 7
EC 1155 Dr. Doug Valentine Vol #: 7
EC 1156 Mrs. Felisa Cepeda Vol #: 7
EC 1157 Ms. Jerilyn Fong Vol #: 7
EC 1158 Mrs. Colleen Robine Vol #: 7
EC 1159 Mrs. L. Rios-McNulty Vol #: 7
EC 1160 Arbonne International Vol #: 7
EC 1161 Mrs. Elia Mulshine Vol #: 7
EC 1162 Mrs. Laura Allen Vol #: 7
EC 1163 Arbonne International Vol #: 7
EC 1164 Mrs. Joan Deeley Vol #: 7
EC 1165 Mrs. Nancy Norton Vol #: 7
EC 1166 Dr. Melissa Hobday Vol #: 7
EC 1167 Mrs. Kay Stringer Vol #: 7
EC 1168 Ms. carol bennett Vol #: 7
EC 1169 Arbonne Vol #: 7
EC 1170 Mrs. marilyn zgorski Vol #: 7
EC 1171 Mrs. Pamela Ernst Vol #: 7
EC 1172 Ms. Jill Boullion Vol #: 7
EC 1173 Mrs. Pam Howe Vol #: 7
EC 1174 Ms. Leona Zaborowski Vol #: 7
EC 1175 Mrs. Lu-Ann Malizia Vol #: 7
EC 1176 Mr. Mark Allen Vol #: 7
EC 1177 Mrs. Jeannine Hague Vol #: 7
EC 1178 Mrs. Jeanette Edmonson Vol #: 7
EC 1179 Mrs. Cyndi Valdez Vol #: 7
EC 1180 Mrs. Debra Cavender Vol #: 7
EC 1181 Mrs. Judith Del Ninno Vol #: 7
EC 1182 Ms. madonna anderson Vol #: 7
EC 1183 Arbonne International Vol #: 7
EC 1184 Mrs. Marie Turnbull Vol #: 7
EC 1185 Ms. Mark Velasquez Vol #: 7
EC 1186 Ms. jane stroll Vol #: 7
EC 1187 Ms. pamela rich Vol #: 7
EC 1188 Dr. Ann Brandwein Vol #: 7
EC 1189 Ms. Katelyn Wagner Vol #: 7
EC 1190 Mrs. Pandora Pensiero Vol #: 7
EC 1191 Mrs. Tamara Stibal Vol #: 7
EC 1192 Mrs. Venus Mosher Vol #: 7
EC 1193 Ms. Maria Bielicki Vol #: 7
EC 1194 None Vol #: 7
EC 1195 Mrs. Valerie Vujs Vol #: 7
EC 1196 Mrs. Jeanne Dunbar Vol #: 7
EC 1197 Life Choice Pharmacy Vol #: 7
EC 1198 Mrs. Marijo Clemons Vol #: 7
EC 1199 Mrs. Edi Sowers Vol #: 7
EC 1200 Mrs. Leigh Lively Vol #: 7
EC 1201 Ms. ENEDINA RODRIGUEZ Vol #: 7
EC 1202 Ms. Patti Kelman Vol #: 7
EC 1203 Ms. Linda Dickinson Vol #: 7
EC 1204 Mrs. Christi Collins Vol #: 7
EC 1205 Ms. Collette Kellogg Vol #: 7
EC 1206 Mrs. Cathy Aller Vol #: 7
EC 1207 Ms. Frieda M. Barna Vol #: 7
EC 1208 Mrs. Caroline Collinske Vol #: 7
EC 1209 Mrs. Alice Koch Vol #: 7
EC 1210 Ms. E McCloskey Vol #: 7
EC 1211 Mrs. Terri Rausch Vol #: 7
EC 1212 ailey-wells communications Vol #: 7
EC 1213 Mrs. Brenda Boeckman Vol #: 7
EC 1214 Mrs. Bonnie Matheson Vol #: 7
EC 1215 Mrs. Nancy Peterson Vol #: 7
EC 1216 Dailey-Wells Communications Vol #: 7
EC 1217 Mrs. Yvonne Greenbaum Vol #: 7
EC 1218 Mrs. Maria Figueroa Vol #: 7
EC 1219 Dr. Richard Linchitz Vol #: 7
EC 1220 Ms. Jody Rueber Vol #: 7
EC 1221 Mrs. Loraine Grover Vol #: 7
EC 1222 Arbonne International Vol #: 7
EC 1223 Ms. Karen Vernon Vol #: 7
EC 1224 Mrs. Laura Bishop Vol #: 7
EC 1225 none Vol #: 7
EC 1226 Miss. Analia Szyszlican Vol #: 7
EC 1227 Mrs. Roberta Schmidt Vol #: 7
EC 1228 Mrs. Sandy Matussek Vol #: 7
EC 1229 Ms. Lisa Bohnert Vol #: 7
EC 1230 Ms. Donna Hird Vol #: 7
EC 1231 Ms. Carol Bloemer Vol #: 7
EC 1232 Miss. Megan Adams Vol #: 7
EC 1233 Ms. Spice Williams-Crosby, BSc Vol #: 7
EC 1234 Medline Industries Inc Vol #: 7
EC 1235 Mrs. Connie Iddings Vol #: 7
EC 1236 Mrs. Mila Jouravleva Vol #: 7
EC 1237 Mrs. Diane Levy Vol #: 7
EC 1238 Mrs. Kelly Shiraki Vol #: 7
EC 1239 Ms. Kathleen Engel Vol #: 7
EC 1240 Mrs. Jana Meisler Vol #: 7
EC 1241 Mrs. Connie Lee Cowan Vol #: 7
EC 1242 Arbonne Vol #: 7
EC 1243 Mrs. Dawn West Vol #: 7
EC 1244 Mrs. Brenda Wilson Vol #: 7
EC 1245 Ms. Deane Biscorner Vol #: 7
EC 1246 Mrs. Debbie Fontana Vol #: 7
EC 1247 Ms. Denise Barnes Vol #: 7
EC 1248 Arbonne International Vol #: 7
EC 1249 Ms. Karen Priemer Vol #: 7
EC 1250 Mr. Jerry Romig Vol #: 7
EC 1251 Mrs. Connie England Vol #: 7
EC 1252 tulane university Vol #: 7
EC 1253 variety veterinary Vol #: 7
EC 1254 Ms. Jennifer Logue Vol #: 7
EC 1255 Ms. Christine Grace Frances Vol #: 7
EC 1256 Mrs. KIM BLACK Vol #: 7
EC 1257 Mrs. Kay Milner Vol #: 7
EC 1258 Ms. elizabeth gray Vol #: 7
EC 1259 Mrs. Linda Smith Vol #: 7
EC 1260 Ms. Julie Tonkovich Vol #: 7
EC 1261 the mortar Vol #: 7
EC 1262 Mrs. sheila Grow Vol #: 7
EC 1263 Ms. Linda Nicholes Vol #: 7
EC 1264 Mrs. Kimberly Boerman Vol #: 7
EC 1265 Ms. Jan Simonis Vol #: 7
EC 1266 Miss. Mayra Lopez Vol #: 7
EC 1267 Mrs. elizabeth gray Vol #: 7
EC 1268 Ms. Stacie Dennison Vol #: 7
EC 1269 Mrs. Claire Ciccotelli Vol #: 7
EC 1270 Professional Pharmacy Associates Vol #: 7
EC 1271 Mrs. Sherry Shuman Vol #: 7
EC 1272 Mrs. Jennifer Mishler Vol #: 7
EC 1273 Ms. Lisa Nickel Vol #: 7
EC 1274 Mrs. sandra hinz Vol #: 7
EC 1275 Ms. Leigh Cochrane Vol #: 7
EC 1276 Mrs. Susan Babb Vol #: 7
EC 1277 Ms. Kathryn Rogers Vol #: 7
EC 1278 Mrs. Adrienne Cummings Vol #: 7
EC 1279 Ms. Letha Sullivan Vol #: 7
EC 1280 Mrs. Laura McEvoy Vol #: 7
EC 1281 Ms. Susan Derrick Vol #: 7
EC 1282 Dr. Lisa Hutchinson Vol #: 7
EC 1283 Mrs. Rhonda Stephan Vol #: 7
EC 1284 Ms. Cindy Rogers Vol #: 7
EC 1285 Ms. Kathryn Moczydlowski Vol #: 7
EC 1286 Mrs. renee helton Vol #: 7
EC 1287 Mrs. Cherrie Archer Vol #: 7
EC 1288 Mrs. Margaret Smith Vol #: 7
EC 1289 Ms. Patricia Hendrix Vol #: 7
EC 1290 Ms. COLLEEN HESELGRAVE Vol #: 7
EC 1291 Mrs. Rebekah McCabe Vol #: 7
EC 1292 Mrs. Lori Tieken Vol #: 7
EC 1293 Ms. Bobbi Holman Vol #: 7
EC 1294 Mrs. Angela Cortright Vol #: 7
EC 1295 Mrs. Anita Senskey Vol #: 7
EC 1296 Ms. Linda DeLaTorre Vol #: 7
EC 1297 Ms. Myra Bycher Vol #: 7
EC 1298 Dr. Valarie Wells Vol #: 7
EC 1299 Arbonne International Vol #: 7
EC 1300 Rema Z.Lichtenstein RN,BSN/Operating Room Nurse Vol #: 7
EC 1301 Mrs. cindy frank Vol #: 7
EC 1302 Mrs. Beth Esquivel Vol #: 7
EC 1303 Ms. Lynn Paulino Vol #: 7
EC 1304 Dr. Brian Vonk Vol #: 7
EC 1305 Mrs. Cathi Petramalo Vol #: 7
EC 1306 Mrs. Kathleen Pojeta Vol #: 7
EC 1307 Ms. Catlyn Loup Vol #: 7
EC 1308 Ms. shirley CLEVELAND Vol #: 7
EC 1309 Ms. M.K. OBrien Vol #: 7
EC 1310 Mrs. Nicole Reed Vol #: 7
EC 1311 Ms. Mia Perachiotti-Germack Vol #: 7
EC 1312 Ms. Veronica Allen Vol #: 7
EC 1313 Mrs. Liz arlak Vol #: 7
EC 1314 Mrs. Jeanette White Vol #: 7
EC 1315 Mr. G. Eric Morgan Vol #: 7
EC 1316 Mrs. Julie Moss Vol #: 7
EC 1317 Ms. cynthia bruce Vol #: 7
EC 1318 Mrs. Dana Holmstrom Vol #: 7
EC 1319 Mrs. billie coleman Vol #: 7
EC 1320 Mrs. Linda Milbrandt Vol #: 7
EC 1321 Ms. Mary Kopac Vol #: 7
EC 1322 Mrs. Miquelle Smith Vol #: 7
EC 1323 Ms. Janice Anderson Vol #: 7
EC 1324 Mrs. marion Robinson Vol #: 7
EC 1325 Mrs. April Rice Vol #: 7
EC 1326 Arbonne International Vol #: 7
EC 1327 Mrs. Renee Boehnlein Vol #: 7
EC 1328 Ms. Brenda Markland Vol #: 7
EC 1329 Mrs. Cheryl Houser Vol #: 7
EC 1330 Ms. Kori Bowers Vol #: 7
EC 1331 Ms. Darlene McDonald Vol #: 7
EC 1332 Ms. Annie Ruth Carroll Vol #: 7
EC 1333 Ms. lav etheridge Vol #: 7
EC 1334 Mr. Nick kosmitis Vol #: 7
EC 1335 Mr. Francois Isabelle Vol #: 7
EC 1336 Dr. toby landis Vol #: 7
EC 1337 Mr. James Craswell Vol #: 7
EC 1338 Mrs. Judith Neill Vol #: 7
EC 1339 Mrs. martha halla Vol #: 7
EC 1340 Ms. Elaine Richards Vol #: 7
EC 1341 Ms. Sandra Heaton Vol #: 7
EC 1342 Miss. Robin Barton Vol #: 7
EC 1343 Ms. Deralyn Marlow Vol #: 7
EC 1344 Mrs. Kathy lynn Easterday Vol #: 7
EC 1345 Mrs. Tammy Dowty Vol #: 7
EC 1346 Ms. M L Ward Vol #: 7
EC 1347 Dr. moshe dekel Vol #: 7
EC 1348 Ms. Margaret Harkey Vol #: 7
EC 1349 Ms. Jami Wascko Vol #: 7
EC 1350 Mrs. LAURIE LOPEZ Vol #: 7
EC 1351 Mr. Kyle Zimmers Vol #: 7
EC 1352 Kirwin house project Vol #: 7
EC 1353 Ms. Kim Casteel Vol #: 7
EC 1354 Mrs. Suna Lester Vol #: 7
EC 1355 Ms. Peggie Peterson Vol #: 7
EC 1356 Jscam Vol #: 7
EC 1357 Ms. Terry Pennebaker Vol #: 7
EC 1358 Mrs. Janice Sweet Vol #: 7
EC 1359 Mrs. Zita Annen Vol #: 7
EC 1360 Mr. James Spears Vol #: 7
EC 1361 Ms. Lynne Madden Vol #: 7
EC 1362 Mrs. Kathy Araujo Vol #: 7
EC 1363 Mrs. SAUNDRA JOHNSTON Vol #: 7
EC 1364 Mrs. Sherry Scheidle Vol #: 7
EC 1365 Mrs. Jennifer Busbey Vol #: 7
EC 1366 Mrs. Robin Russo Vol #: 7
EC 1367 La Leva di Archimede Vol #: 7
EC 1368 Mrs. Wendy Swagerman Vol #: 7
EC 1369 Mrs. Eileen Landies Vol #: 7
EC 1370 Ms. Karen McLellan Vol #: 7
EC 1371 Ms. debra singho Vol #: 7
EC 1372 Arbonne International Vol #: 7
EC 1373 Mrs. Pamela Sherman Vol #: 7
EC 1374 Ms. Victoria Lorusso Vol #: 7
EC 1375 Ms. Mary Chadwick Vol #: 7
EC 1376 Ms. Mary Bonora Vol #: 7
EC 1377 Mrs. Melissa Karner Vol #: 7
EC 1378 Ms. Theresa Savich Vol #: 7
EC 1379 Mrs. Linda Dillow Vol #: 7
EC 1380 Mrs. Denise Galarneau Vol #: 7
EC 1381 Ms. Paula Barron Vol #: 7
EC 1382 Ms. Marge Marcil Vol #: 7
EC 1383 Ms. Maureen McCausland Vol #: 7
EC 1384 Ms. Michelle Marrs Vol #: 7
EC 1385 Mrs. Diane Antonitis Vol #: 7
EC 1386 Mrs. Deborah Leal Vol #: 7
EC 1387 Ms. Mary Lee Boyd Vol #: 7
EC 1388 Mr. Robert Danklefsen Vol #: 7
2006P-0068 Determine whether Syntocinon (oxytocin) Nasal Spray NDA 12-285, has been voluntarily withdrawn for safety or effectiveness reasons
ACK 1 HFA- 305 to Covington & Burling Vol #: 1
CP 1 Covington & Burling Vol #: 1
2006P-0070 Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
ACK 1 HFA-305 to Pfizer Inc. Vol #: 1
CP 1 Pfizer Inc. Vol #: 1

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