FDA Logo links to FDA home page
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On January 25, 2007
Docket # Title
1999E-0116 Patent Extension Rotashield, #4,704,275
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0573 Draft Animal Cloning Risk Assessment
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
2005E-0236 Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,916,246
2005E-0245 Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
2006E-0034 Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
2006E-0046 Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
2006E-0240 Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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
2006N-0416 Use of Ozone-Depleting Substances; Removal of Essential Use Designations
2006P-0415 Petition Seeking Regulation of Cloned Animals
1999E-0116 Patent Extension Rotashield, #4,704,275
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 756 L. Abbey Vol #: 10
2003N-0573 Draft Animal Cloning Risk Assessment
EMC 85 H. Delaney Vol #: 5
EMC 86 X. Legault Vol #: 5
EMC 87 J. Gerdes Vol #: 5
EMC 88 G. Higby Vol #: 5
EMC 89 E. Tetens Vol #: 5
EMC 90 B. Romero Vol #: 5
EMC 91 B. Joosse Vol #: 5
EMC 92 D. Mather Vol #: 5
EMC 93 B. Lindtner Vol #: 5
EMC 94 B. Foose Vol #: 5
EMC 95 R. Bratman Vol #: 5
EMC 96 W. Phillips Vol #: 5
EMC 97 R. Vosburg Vol #: 5
EMC 98 P. Blochowiak Vol #: 5
EMC 99 T. Fisk Vol #: 5
EMC 100 A. Laguna Vol #: 5
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
EMC 794 G. Ocasio Vol #: 9
2005E-0236 Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,916,246
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2005E-0245 Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2005E-0259 Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
LET 4 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
BKG 2 Background Material Vol #: 24
EMC 306 S. Wickersham Vol #: 23
EREG 1 Celiac Support Group of Vermont Vol #: 23
EREG 2 J. Greer-Carney Vol #: 23
EREG 3 School Sisters of Notre Dame/Celiac Sprue Association Vol #: 23
EREG 4 A. Tyler Vol #: 23
EREG 5 J. Akre Vol #: 23
EREG 6 Hampton & Associates Vol #: 23
EREG 7 V. Lee Vol #: 23
EREG 8 M. Adams Vol #: 23
EREG 9 K. Scott Vol #: 23
EREG 10 Celiac Support Group Vol #: 23
EREG 11 R. Germain Vol #: 23
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
EMC 591 C. Brownell Vol #: 12
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
EMC 5 B. M. T. Processing Laboratories Vol #: 6
EREG 2 National Council for Prescription Drug Programs Vol #: 3
EREG 3 Academy of Managed Care Pharmacy Vol #: 3
EREG 4 American Association of Exporters & Importers Vol #: 3
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EMC 4196 M. Abshier Vol #: 199
EMC 4197 M. Driscoll Vol #: 199
EMC 4198 J. Bouldin Vol #: 199
EMC 4199 R. Disselkoen Vol #: 199
EMC 4200 C. McRae Vol #: 199
EMC 4201 N. Morris-Farber Vol #: 199
EMC 4202 D. Schwalb Vol #: 199
EMC 4203 A. Lobdell Vol #: 199
EMC 4204 N. Gee Vol #: 199
EMC 4205 J. Johnson Vol #: 199
EMC 4206 P. Troia Vol #: 199
EMC 4207 M. Medlen Vol #: 199
EMC 4208 D. Bellerue Vol #: 199
EMC 4209 D. Kemmerle Vol #: 199
EMC 4210 J. Kenyon Vol #: 199
EMC 4211 P. Wingate Vol #: 199
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 1387 T. Robinson Vol #: 44
C 1388 Illigible Vol #: 44
C 1389 Illigible Vol #: 44
C 1390 Illigible Vol #: 44
C 1391 A. Nichols Vol #: 44
C 1392 O. Lopez Vol #: 44
C 1393 J. Nemec Vol #: 44
C 1394 M. Kharouf Vol #: 44
C 1395 F. Hansmary Vol #: 44
C 1396 Dr and Mrs A. Pomitto, III Vol #: 44
C 1397 J. Cherplei Vol #: 44
C 1398 M. Brewton Vol #: 44
C 1399 M. Ryan Vol #: 44
C 1400 J. Kirchner Vol #: 44
C 1401 M. Kirchner Vol #: 44
C 1402 S. Bailey Vol #: 44
C 1403 L. Murphy Vol #: 44
C 1404 L. Wright Vol #: 44
C 1405 E and J O'Donnell Vol #: 44
C 1406 E. Voss Vol #: 44
C 1407 A. Voss Vol #: 44
C 1408 M. Polizzi Vol #: 44
C 1409 M. Kling Vol #: 44
C 1410 R and R Dufour Vol #: 44
C 1411 Illigible Vol #: 44
C 1412 Illigible Vol #: 44
C 1413 Illigible Vol #: 44
C 1414 Illigible Vol #: 44
C 1415 M. Leporte Vol #: 44
C 1416 A. Reileen Vol #: 44
C 1417 C. Luckow Vol #: 44
C 1418 E. Drake Vol #: 44
C 1419 R. Jare Vol #: 44
C 1420 C. Cavenagh Vol #: 44
C 1421 Illigible Vol #: 44
C 1422 A. Munor Vol #: 44
C 1423 J. Reiheir Vol #: 44
C 1424 M. Ming Vol #: 44
C 1425 S. Felton Vol #: 44
C 1426 M. Tharense Vol #: 45
C 1427 J. Jacobson Vol #: 45
C 1428 Illigible Vol #: 45
C 1429 R. Wilson Vol #: 45
C 1430 Illigible Vol #: 45
C 1431 G. Ruckow Vol #: 45
C 1432 T. Conlin Vol #: 45
C 1433 A. Brocato Vol #: 45
C 1434 R and L Bloom Vol #: 45
C 1435 B. Kelly Vol #: 45
C 1436 T. Dake Vol #: 45
C 1437 P. Kirkman Vol #: 45
C 1438 C. Shannon Vol #: 45
C 1439 J. Shannon Vol #: 45
C 1440 A and M Caldieraro Vol #: 45
C 1441 A. Bruchalski Vol #: 45
C 1442 M. Blackburn Vol #: 45
C 1443 M. Bria Vol #: 45
C 1444 L. Pieper Vol #: 45
C 1445 R. Schafer Vol #: 45
C 1446 M. Cortney Vol #: 45
C 1447 J. Liston Vol #: 45
C 1448 P. Berry Vol #: 45
C 1449 J. Olson Vol #: 45
C 1450 R. Petschauer Vol #: 45
C 1451 E. Berger Vol #: 45
C 1452 D. Kulbartz Vol #: 45
C 1453 J. Fixmur Vol #: 45
C 1454 S. Reilly Vol #: 45
C 1455 C. and S Hill Vol #: 45
C 1456 R. Martin Vol #: 45
C 1457 S. MAxley Vol #: 45
C 1458 M. LaPorta Vol #: 45
C 1459 K. Ford Vol #: 45
C 1460 B. Meier Vol #: 45
C 1461 E. Croce Vol #: 45
C 1462 V. Kasper Vol #: 45
C 1463 N. Weiss Vol #: 45
C 1464 D and R Marsala Vol #: 45
C 1465 M. McGinty Vol #: 45
C 1466 M. Iannitello Vol #: 45
C 1467 C. Riesterer Vol #: 45
C 1468 K. Riesterer Vol #: 45
C 1469 J. Riesterer Vol #: 45
C 1470 E. Riesterer Vol #: 45
C 1471 B. Riesterer Vol #: 45
C 1472 N. Riesterer Vol #: 45
C 1473 E. Stephens Vol #: 45
C 1474 D. Harte Vol #: 45
C 1475 H. Meany Vol #: 45
C 1476 H. Petullo Vol #: 45
C 1477 D. Arbogast Vol #: 45
C 1478 S. Marincel Vol #: 45
C 1479 M. Klein Vol #: 45
C 1480 B. Moran Vol #: 45
C 1481 R. Puhalla Vol #: 45
C 1482 M. Cronauer Vol #: 45
C 1483 V. Davies Vol #: 45
C 1484 B. Kearney, RN Vol #: 45
C 1485 M. Kimes, RN Vol #: 45
C 1486 L. Maurizio Vol #: 45
C 1487 J. Moran Vol #: 45
C 1488 F. McHale Vol #: 45
C 1489 B. Sitar Vol #: 45
C 1490 M. LaLonde Vol #: 45
C 1491 M. Bonnell Vol #: 45
C 1492 R. Sparks Vol #: 45
C 1493 A. Schuck Vol #: 45
C 1494 T. Giannotti Vol #: 45
C 1495 E. Race Vol #: 45
C 1496 D. Pogor Vol #: 45
C 1497 N. Anderton Vol #: 45
C 1498 A. McNichol et al. Vol #: 45
C 1499 A. Clift Vol #: 45
C 1500 M. Good Vol #: 45
C 1501 S. Clemens Vol #: 45
C 1502 A. Drost Vol #: 45
C 1503 T. Sears Vol #: 45
C 1504 D. Foley Vol #: 45
C 1505 J. Murray Vol #: 45
C 1506 A. Bourek Vol #: 45
C 1507 C. MArtin Vol #: 45
C 1508 E. Berrodin Vol #: 45
C 1509 F. Roloff Vol #: 45
C 1510 M. Harmon Vol #: 45
C 1511 R. Korenkiewicz Vol #: 45
C 1512 A. Lindberg Vol #: 45
C 1513 L. Jennings Vol #: 45
C 1514 T. Fullenkemf Vol #: 45
C 1515 J. Feldpausch Vol #: 45
C 1516 E. Metzler Vol #: 45
C 1517 J and A Meis Vol #: 45
C 1518 J. Nicholson Vol #: 45
C 1519 No signature Vol #: 45
C 1520 C. Serafin Vol #: 45
C 1521 S. NAseman Vol #: 45
C 1522 P. Brown Vol #: 45
C 1523 M. Tritz Vol #: 45
C 1524 J and J Donahoe Vol #: 45
C 1525 J. McCarty Vol #: 45
C 1526 A. Durkin Vol #: 46
C 1527 M. Eisele Vol #: 46
C 1528 E. Terwilliger Vol #: 46
C 1529 M. Christman Vol #: 46
C 1530 L. Benz Vol #: 46
C 1531 Mr and Mrs J. Holschuh Vol #: 46
C 1532 J. Kettunen Vol #: 46
C 1533 J. Silverberg Vol #: 46
C 1534 E. Rocks Vol #: 46
C 1535 R. Cowles Vol #: 46
C 1536 C. Lavallee Vol #: 46
C 1537 R. Bowen Vol #: 46
C 1538 J. Hart, Jr. Vol #: 46
C 1539 L. Mitoraj Vol #: 46
C 1540 L. Kozlowski, MD Vol #: 46
C 1541 M. Pauwels Vol #: 46
C 1542 G. Korman Vol #: 46
C 1543 S. Vrazel Vol #: 46
C 1544 M. George Vol #: 46
C 1545 No siganture Vol #: 46
C 1546 M. Klueiner Vol #: 46
C 1547 A. Kraengel Vol #: 46
C 1548 J. Carey Vol #: 46
C 1549 A. Kraengel Vol #: 46
C 1550 Children of God for Life Vol #: 46
C 1551 Children of God for Life Vol #: 46
C 1552 Children of God for Life Vol #: 47
C 1553 J. Kettunen Vol #: 46
C 1554 C. Stensvad Vol #: 46
C 1555 G. Ziccardi Vol #: 46
C 1556 H. Mack Vol #: 46
C 1557 J. Jalbert Vol #: 46
C 1558 N. Blind Vol #: 46
C 1559 H and S Reilly Vol #: 46
C 1560 Form Letters Vol #: 50
C 1561 Form Letters Vol #: 51
C 1562 Form Letters Vol #: 52
C 1563 Form Letters Vol #: 53
C 1564 Form Letters Vol #: 54
C 1565 Form Letters Vol #: 55
C 1566 Form Letters Vol #: 56
C 1567 Form Letters Vol #: 57
C 1568 Form Letters Vol #: 58
C 1569 Form Letters Vol #: 59
C 1570 Form Letters Vol #: 60
C 1571 Form Letters Vol #: 61
C 1572 Form Letters Vol #: 62
C 1573 Form Letters Vol #: 63
C 1574 Form Letters Vol #: 64
C 1575 Form Letters Vol #: 65
C 1576 Form Letters Vol #: 66
C 1577 Form Letters Vol #: 67
C 1578 Form Letters Vol #: 68
C 1579 Form Letters Vol #: 69
C 1580 Form Letters Vol #: 70
C 1581 Form Letters Vol #: 71
C 1582 Form Letters Vol #: 72
C 1583 Form Letters Vol #: 73
C 1584 Form Letters Vol #: 74
2006D-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
EMC 1 Merck & Co., Inc. Vol #: 1
2006E-0034 Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2006E-0046 Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2006E-0240 Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2006E-0478 Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
LET 4 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) 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 15 M. Bechtel Vol #: 1
EMC 16 B. Kimmel Vol #: 1
2006N-0416 Use of Ozone-Depleting Substances; Removal of Essential Use Designations
EA 1 Environmental Assessment Vol #: 1
FONS 1 Finding of No Significant Impact Vol #: 1
2006P-0415 Petition Seeking Regulation of Cloned Animals
EMC 38 Form Letters Vol #: 6
EMC 39 D. Nocita Vol #: 5
EMC 40 A. Woody Vol #: 5
EMC 41 M. Schrader Vol #: 5
EMC 42 R. Toomim Vol #: 5
EMC 43 T. Markovich Vol #: 5
EMC 44 R. Hyde Vol #: 5
EMC 45 San Jose State University-Soc. Department Vol #: 5
EMC 46 C. Shetterly Vol #: 5
EMC 47 G. Ruiz Vol #: 5
EMC 48 J. Courtney Vol #: 5
EMC 49 D. Morano Vol #: 5
EMC 50 B. Gorlach Vol #: 5
EMC 51 K. Justesen Vol #: 5
EMC 52 J. Goldsberry Vol #: 5
EMC 53 J. Lorraine Vol #: 5
EMC 54 M. Caprio Vol #: 5
EMC 55 L. Connor Vol #: 5
EMC 56 B. Centofante Vol #: 5
EMC 57 L. Stubbs Vol #: 5
EMC 58 E. Kearns Vol #: 5
EMC 59 K. Duke Vol #: 5
EMC 60 W. Teague Vol #: 5
EMC 61 J. Bushman Vol #: 5
EMC 62 S. Donnelly Vol #: 5
EMC 63 B. Brown Vol #: 5
EMC 64 T. Edminister Vol #: 5

Page created on February 6, 2007 ue

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management