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Dockets Management

Dockets Entered On January 24, 2007
Docket # Title
1978N-0065 Skin Bleaching Drug Products
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0573 Draft Animal Cloning Risk Assessment
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2006D-0353 Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
2006N-0036 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0511 Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
2007E-0035 Patent Extension Application for Vusion Ointment, U.S. Patent No. 4,911,932
2007M-0032 P050018 - AngioSculpt Scoring Balloon Catheter
2007P-0034 To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness
1978N-0065 Skin Bleaching Drug Products
EMC 5 SkinMedica Cosmeceuticals Vol #: 20
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4437 S. Hall Vol #: 320
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 755 M. Stangle Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1429 United Way of Washington County, Arkansas Vol #: 12
2003N-0573 Draft Animal Cloning Risk Assessment
EMC 56 No Submitter Vol #: 5
EMC 57 R. Martin Vol #: 5
EMC 58 A. Ruiz Vol #: 5
EMC 59 M. Johnson Vol #: 5
EMC 60 E. Henry Vol #: 5
EMC 61 L. John Vol #: 5
EMC 62 S. & D. Hesse Vol #: 5
EMC 63 P. Lalouken Vol #: 5
EMC 64 A. Pavelich Vol #: 5
EMC 65 A. Rami Vol #: 5
EMC 66 A. Berkson Vol #: 5
EMC 67 A. Judd Vol #: 5
EMC 68 A. Rosen Vol #: 5
EMC 69 B. Tokar Vol #: 5
EMC 70 B. Sutter Vol #: 5
EMC 71 M. Berk Vol #: 5
EMC 72 D. Wichar Vol #: 5
EMC 73 S. Sanders Vol #: 5
EMC 74 G. & B. Freeman Vol #: 5
EMC 75 M. Grappo Vol #: 5
EMC 76 K. O'Neil Vol #: 5
EMC 77 M. Dunne Vol #: 5
EMC 78 B. DeLancey Vol #: 5
EMC 79 K. Simon Vol #: 5
EMC 80 M. Hayman Vol #: 5
EMC 81 T. Biediger Vol #: 5
EMC 82 L. Frank Vol #: 5
EMC 83 S. Haley Vol #: 5
EMC 84 J. Webb Vol #: 5
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 29 Pharmion Coporation Vol #: 3
2006D-0353 Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
C 1 Abbott Laboratories Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 1248 T and A rave Vol #: 42
C 1249 J. Allen Vol #: 42
C 1250 Mr and Mrs R Andrews Vol #: 42
C 1251 R. Cacka Vol #: 42
C 1252 A. Collins Vol #: 42
C 1253 J. Wieber Vol #: 42
C 1254 Dr and M M. Spakovsky Vol #: 42
C 1255 J. House Vol #: 42
C 1256 C. Niedos Vol #: 42
C 1257 M. Harold Vol #: 42
C 1258 A. Synovic Vol #: 42
C 1259 M. Osborne Vol #: 42
C 1260 A. Thomas Vol #: 42
C 1261 F. Stout Vol #: 42
C 1262 M. Pauwels Vol #: 42
C 1263 M. Hutchinson Vol #: 42
C 1264 C. Leon Vol #: 42
C 1265 H. Vagley Vol #: 42
C 1266 E. Rome Vol #: 42
C 1267 M. Brunyansky Vol #: 42
C 1268 Association for World Peace, Justice and the Messianic-Charismatic Development of Peoples Vol #: 42
C 1269 J. Capozzelli Vol #: 42
C 1270 A. Nakamura et al. Vol #: 42
C 1271 L. Jennings Vol #: 42
C 1272 L. LeBlanc Vol #: 42
C 1273 J. Janhawski Vol #: 42
C 1274 F. Jackson Vol #: 42
C 1275 R and M Lindenfelser Vol #: 42
C 1276 C. Wright Vol #: 42
C 1277 M. Wright Vol #: 42
C 1278 C. Niedos Vol #: 42
C 1279 M and L Detera Vol #: 42
C 1280 K. Miller Vol #: 42
C 1281 J. Karlovitz Vol #: 42
C 1282 V. Walter Vol #: 42
C 1283 A. Ferraro Vol #: 42
C 1284 L. Harris Vol #: 42
C 1285 M. Kirchner Vol #: 42
C 1286 P. Griffith Vol #: 42
C 1287 J. DiMaggio, III Vol #: 42
C 1288 M. Vicente Vol #: 42
C 1289 B and J Bauer Vol #: 42
C 1290 D. Nugent Vol #: 42
C 1291 G and P Smith Vol #: 42
C 1292 F. Wheeler Vol #: 42
C 1293 R and K Meidl Vol #: 42
C 1294 W. Grossklas Vol #: 42
C 1295 F. Smith, M.D. Vol #: 42
C 1296 M. Griffith Vol #: 42
C 1297 R. Lewis Vol #: 42
C 1298 F and J Amy Vol #: 42
C 1299 M. Levings Vol #: 42
C 1300 S. Warrick Vol #: 42
C 1301 J. Pindell Vol #: 42
C 1302 R and L Feldpausch Vol #: 42
C 1303 B and M Kaiser Vol #: 42
C 1304 P and A Schafer Vol #: 42
C 1305 A. Petullo Vol #: 42
C 1306 K. Franklin Vol #: 42
C 1307 M. Wiedemer Vol #: 42
C 1308 Decatur Gastroenterology Associates, P.C. Vol #: 42
C 1309 M. Ridge Vol #: 42
C 1310 D. Watt Vol #: 42
C 1311 F. Alessio Vol #: 44
C 1312 L. Webb Vol #: 44
C 1313 L. Martinez Vol #: 44
C 1314 J. Factor Vol #: 44
C 1315 V. Danforth Vol #: 44
C 1316 R. Danforth Vol #: 44
C 1317 H. Ruffalo Vol #: 44
C 1318 M. Harrison Vol #: 44
C 1319 K. Surmont Vol #: 44
C 1320 J. Page Vol #: 44
C 1321 J. Donnelly Vol #: 44
C 1322 D. Detty Vol #: 44
C 1323 M. Niedospial Vol #: 44
C 1324 P. Menconi Vol #: 44
C 1325 R. Kohl Vol #: 44
C 1326 B and C McCarthy Vol #: 44
C 1327 E. Leaf Vol #: 44
C 1328 A. Trew Vol #: 44
C 1329 R. Trew Vol #: 44
C 1330 K. Maggio, MD Vol #: 44
C 1331 E. McGuirk Vol #: 44
C 1332 M. McGuirk Vol #: 44
C 1333 C. McGuirk Vol #: 44
C 1334 A. Swinson Vol #: 44
C 1335 E. Gaven Vol #: 44
C 1336 K. Simon Vol #: 44
C 1337 M. Wilson Vol #: 44
C 1338 L. Cahill, MD Vol #: 44
C 1339 R. Chamberlain Vol #: 44
C 1340 A. Nugent Vol #: 44
C 1341 L. Favreau Vol #: 44
C 1342 D. Brekalo Vol #: 44
C 1343 Illigible Vol #: 44
C 1344 M. Weed Vol #: 44
C 1345 M. Weltzer Vol #: 44
C 1346 D. Karano Vol #: 44
C 1347 K and C DeCeault Vol #: 44
C 1348 R. Brink Vol #: 44
C 1349 Dr and Mrs J. Calabro Vol #: 44
C 1350 J. Weaver Vol #: 44
C 1351 M. Hepler Vol #: 44
C 1352 T. Dygert Vol #: 44
C 1353 R. Tissot Vol #: 44
C 1354 No siganture Vol #: 44
C 1355 J. Hogan Vol #: 44
C 1356 J. Gentile Vol #: 44
C 1357 No signature Vol #: 44
C 1358 No signature Vol #: 44
C 1359 D. Gomolski Vol #: 44
C 1360 L. Pillar Vol #: 44
C 1361 S. Martensen Vol #: 44
C 1362 J. Wilson Vol #: 44
C 1363 D. Calderon Vol #: 44
C 1364 H. Walter Vol #: 44
C 1365 D. Opferman Vol #: 44
C 1366 P. Messina Vol #: 44
C 1367 A and R Mglatt Vol #: 44
C 1368 T. Huether Vol #: 44
C 1369 E. Roling et al. Vol #: 44
C 1370 M. Menez Vol #: 44
C 1371 B and C Glaser Vol #: 44
C 1372 P. Hoffman Vol #: 44
C 1373 A. Nugent Vol #: 44
C 1374 P. Kraemer Vol #: 44
C 1375 V. DeSomber, RN Vol #: 44
C 1376 K. Tuncy Vol #: 44
C 1377 D. Hoffman Vol #: 44
C 1378 A. Nugent Vol #: 44
C 1379 P. Moran Vol #: 44
C 1380 J. Glendening Vol #: 44
C 1381 C. Sowa Vol #: 44
C 1382 A. Reardon Vol #: 44
C 1383 J. Kirchner Vol #: 44
C 1384 G. Hoffner Vol #: 44
C 1385 P. Geczy Vol #: 44
C 1386 J and D Giallombardo Vol #: 44
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
C 1 Sanofi-aventis US LLC Vol #: 1
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
C 2 Ortho-Clinical Diagnostics, Inc. (OCD) Vol #: 1
C 3 St. Jude Medical (SJM) Vol #: 1
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
C 1 State of Washington Vol #: 1
2006N-0036 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
EMC 14 D. Miller Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 27 D. Luck Vol #: 6
C 28 Rose Acre Farms Vol #: 6
C 29 Daybreak Foods, Inc. Vol #: 6
C 30 J.S. West Milling Vol #: 6
C 31 K. McNulty Vol #: 6
C 32 Tampa Famr Service, Inc. Vol #: 6
C 33 Morning Fresh Farms Vol #: 6
C 34 No signature Vol #: 6
C 35 K. Welsh Vol #: 6
C 36 S. Jotoku Vol #: 6
C 37 S and H Wyck Vol #: 6
C 38 Pearl Valley Eggs Vol #: 6
C 39 K. Call Vol #: 6
C 40 Feather Crest Farms, Inc. Vol #: 6
2006P-0415 Petition Seeking Regulation of Cloned Animals
C 45 C. Kavina Vol #: 5
2006P-0511 Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
C 1 Mallinckrodt, Inc. Vol #: 1
2007E-0035 Patent Extension Application for Vusion Ointment, U.S. Patent No. 4,911,932
APP 1 Johnson & Johnson Consumer Companies, Inc. Vol #: 1
2007M-0032 P050018 - AngioSculpt Scoring Balloon Catheter
AAV 1 AngioScore, Inc. Vol #: 1
2007P-0034 To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness
ACK 1 FDA / DDM to JRRapoza Associates, Inc. Vol #: 1
ACK 2 Number not used Vol #: 1
CP 1 JRRapoza Associates, Inc. Vol #: 1

Page created on January 25, 2007 ue

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