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Dockets Management

Dockets Entered On January 10, 2007
Docket # Title
1978N-0065 Skin Bleaching Drug Products
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2002E-0100 Patent Application for Dutrasteride
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003E-0254 Patent Extension for Inspra (eplerenone), 4,559,332
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0573 Draft Animal Cloning Risk Assessment
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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-0515 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
2006E-0022 Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
2006E-0026 Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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-0061 Charging for Investigational Drugs
2006N-0517 Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0462 Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
2006P-0498 Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
2007P-0004 Take steps to insure the safey of Americans regarding th misues of Lasik
1978N-0065 Skin Bleaching Drug Products
EC 566 Ms. Simi Bakshi Vol #: 19
EC 567 CDM Corp Vol #: 19
EMC 4 T. Dailey Vol #: 15
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
EMC 3420 Number Not Used Vol #: 297
2002E-0100 Patent Application for Dutrasteride
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
EMC 1 Hyman, Phelps & McNamara, P. C. Vol #: 2
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 753 Calorie Control Council Vol #: 10
2003E-0254 Patent Extension for Inspra (eplerenone), 4,559,332
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1421 S. Rush Vol #: 12
EMC 1422 M. Taylor Vol #: 12
EMC 1423 J. Lathan Vol #: 12
EMC 1424 A. F. N. I. Vol #: 12
EMC 1425 J. Perry Vol #: 12
2003N-0573 Draft Animal Cloning Risk Assessment
EMC 38 J. Atkins Vol #: 5
EMC 39 G. Stout Vol #: 5
EMC 40 M. North Vol #: 5
EMC 41 J. Williams Vol #: 5
EMC 42 G. Ambrosio Vol #: 5
EMC 43 K. Cubala Vol #: 5
EMC 44 B. Sachau Vol #: 5
EMC 45 L. Gazzaola Vol #: 5
EMC 46 L. Jorgenson Vol #: 5
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
LET 5 FDA/CDER to U.S. Patent and Trademark Office Vol #: 1
2004P-0464 Vitamin D & Calcium & Reduced Risk of Osteoporosis
EC 1 Mr. Robert Zaremba Vol #: 9
EC 2 Director, Sports Medicine North Osteoporosis Cente Vol #: 9
EREG 1 B. Sachau Vol #: 9
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
EC 9 Mr. mike Cook Vol #: 1
EC 10 Ms. Laura Wuest Vol #: 10
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 490 E. Lernmer Vol #: 33
C 491 T. Bailey Vol #: 33
C 492 B. Hansen Vol #: 33
C 493 P and E Karls Vol #: 33
C 494 J and N Ball Vol #: 33
C 495 S and L Martelli Vol #: 33
C 496 G. Demars Vol #: 33
C 497 R. Mayer Vol #: 33
C 498 M. Grist Vol #: 33
C 499 J and B Griffin Vol #: 33
C 500 M. Clark Vol #: 33
C 501 M. Sherry Vol #: 33
C 502 M. Jordan Vol #: 33
C 503 A and R Christman Vol #: 33
C 504 E. Hill Vol #: 33
C 505 J and M Feldman Vol #: 33
C 506 M. Kennedy Vol #: 33
C 507 F. Gunten, OD, FAAO Vol #: 33
C 508 Illinois Right to Life Committee Vol #: 33
C 509 C and D Lopez Vol #: 33
C 510 A. Gaddini Vol #: 33
C 511 L and R Borelli Vol #: 33
C 512 D. and M Massa Vol #: 33
C 513 M. Barth Vol #: 33
C 514 T. Mayer Vol #: 33
C 515 M and R Spaeth Vol #: 33
C 516 J. Wieber Vol #: 33
C 517 A. Jordan Vol #: 33
C 518 E. Thomas Vol #: 33
C 519 K. Hill Vol #: 33
C 520 J. McSweeney and E. Sinnott Vol #: 33
C 521 E. Ludwig Vol #: 33
C 522 N and U Malwitz Vol #: 33
C 523 J and M Rohde Vol #: 34
C 524 E. Waldon Vol #: 34
C 525 M. Brennan Vol #: 33
C 526 Catholic Medical Association (CMA) Vol #: 34
C 527 San Francisco Guild of the Catholic Medical Association Vol #: 34
C 528 R. McClone Vol #: 34
C 529 S. Costanzo Vol #: 34
C 530 S. Costanzo Vol #: 34
C 531 D. Tripi Vol #: 34
C 532 S. Placek Vol #: 33
C 533 J and D Giallombardo Vol #: 34
C 534 D Hjelstrom et al. Vol #: 34
C 535 P. Kraemer Vol #: 34
C 536 T. Phelan III Vol #: 34
C 537 P. McClone Vol #: 34
C 538 G. Borgeson Vol #: 34
C 539 M. Zawoysky Vol #: 34
C 540 D. Jones Vol #: 34
C 541 M. Cates Vol #: 34
C 542 E. Romo Vol #: 34
C 543 B. Sitar Vol #: 34
C 544 J. McDermott Vol #: 34
C 545 M. Walter Vol #: 34
C 546 J. Higgins Vol #: 34
C 547 T. Guillette Vol #: 34
C 548 E. Timmerman Vol #: 34
C 549 C and P Mohler Vol #: 34
C 550 L. Caslavka Vol #: 34
C 551 D. Guillotte Vol #: 34
C 552 J. Cosentino Vol #: 34
C 553 D and J Feasel Vol #: 34
C 554 E. Biance Vol #: 34
C 555 M. Christman Vol #: 34
C 556 M. Anstoetter Vol #: 34
C 557 M. Holiday Vol #: 34
C 558 D. Butten Vol #: 34
C 559 C. Steyer Vol #: 34
C 560 J. Munoz Vol #: 34
C 561 G. Lodzinski Vol #: 34
C 562 S. Command Vol #: 34
C 563 Illigible Vol #: 34
C 564 M. Simon Vol #: 34
C 565 T. Sheehy Vol #: 34
C 566 R. Howell Vol #: 34
C 567 R and M Weiden Vol #: 34
C 568 J. Moran Vol #: 34
C 569 J. Ksiojdk Vol #: 34
C 570 B. Roggay Vol #: 34
C 571 E. Neubaum Vol #: 34
C 572 D. Curl Vol #: 34
C 573 F. Vangeli Vol #: 34
C 574 M. Zucearo Vol #: 34
C 575 S. Kendall Vol #: 34
C 576 M. Falconio Vol #: 34
C 577 J. Rohr Vol #: 34
C 578 N. Roberts Vol #: 34
C 579 V and C Oukrop Vol #: 34
C 580 J. Daly Vol #: 34
C 581 E. Dagit Vol #: 34
C 582 R. Reicher Vol #: 34
C 583 M. Kunick Vol #: 34
C 584 S. Barron Vol #: 34
C 585 E. Sava Vol #: 34
C 586 J. Locke Vol #: 34
C 587 B. Drapiewski Vol #: 34
C 588 M. Biel Vol #: 34
C 589 P. Hayes Vol #: 34
C 590 B. Toth Vol #: 34
C 591 C. Maffey Vol #: 34
C 592 Illigible Vol #: 34
C 593 10 signatures Vol #: 34
C 594 J. Kammer Vol #: 34
C 595 K. Crouch Vol #: 34
C 596 D. Bidey Vol #: 34
C 597 M. McLauchlin Vol #: 34
C 598 D. Horning Vol #: 34
C 599 J. Byrne Vol #: 34
C 600 R. Trudell Vol #: 34
C 601 F. Dantzman Vol #: 34
C 602 J and Alexander Sasso Vol #: 34
C 603 D. Hottman Vol #: 34
C 604 M. Dunne Vol #: 34
C 605 P. Moran Vol #: 34
C 606 V. Daum Vol #: 34
C 607 A. Reardon Vol #: 34
C 608 P. Hoffman Vol #: 34
C 609 A. Nugent Vol #: 34
C 610 M. LaLonde Vol #: 34
C 611 J. Sitar Vol #: 34
C 612 B. Rastenis Vol #: 34
C 613 A. Langlois Vol #: 34
C 614 M. Clos Vol #: 34
C 615 C. Sayegh Vol #: 34
C 616 Illigible Vol #: 34
C 617 J. Lynch Vol #: 34
C 618 J. Thomas Vol #: 34
C 619 National Catholic Bioethics Center Vol #: 34
C 620 Wyeth Pharmaceuticals Inc. (Wyeth) Vol #: 34
C 621 10193 signatures Vol #: 35
C 622 D. Devillers Vol #: 36
C 623 J. Factor Vol #: 36
C 624 D. Pogor Vol #: 36
C 625 R. Agner Vol #: 36
C 626 B and C Glaser Vol #: 36
C 627 L. Cahill, MD Vol #: 36
C 628 G. Smith, MD and P. Smith, RN Vol #: 36
C 629 M. Jones Vol #: 36
C 630 D. Gomolski Vol #: 36
C 631 A. Guerrero Vol #: 36
C 632 M. Wiedemer Vol #: 36
C 633 K. Fastiggi Vol #: 36
C 634 K. Tuncy Vol #: 36
C 635 M. Ridge Vol #: 36
C 636 L. Harris Vol #: 36
C 637 R. Smith Vol #: 36
C 638 T. Brosh Vol #: 36
C 639 J. Stein Vol #: 36
C 640 D and D Williams Vol #: 36
C 641 T. Damaren Vol #: 36
C 642 Illigible Vol #: 36
C 643 GlaxoSmithKline (GSK) Vol #: 36
C 644 54 signatures Vol #: 36
C 645 63 signatures Vol #: 36
C 646 J. Pindell Vol #: 36
C 647 F. Wheeler Vol #: 36
C 648 R and K Meidl Vol #: 36
C 649 R and J Bauer Vol #: 36
C 650 J. Edliefson Vol #: 36
C 651 M. Kimes, RN Vol #: 36
C 652 C. Brien Vol #: 36
C 653 P. Laconto Vol #: 36
C 654 A. Clift Vol #: 36
C 655 J and M Nicholson Vol #: 36
C 656 S. Wharam Vol #: 36
C 657 M. Gigandet Vol #: 36
C 658 M and L Deters Vol #: 36
C 659 E and C Klaport Vol #: 36
C 660 S. Warrick Vol #: 36
C 661 T. Whalen Vol #: 36
C 662 L. Webb Vol #: 36
C 663 A and C Nicolosi Vol #: 36
C 664 C. Quinn Vol #: 36
C 665 E. Perona Vol #: 36
C 666 M. Klein Vol #: 36
C 667 Illigible Vol #: 36
C 668 M. Maley Vol #: 36
C 669 L. Hemmerly Vol #: 36
C 670 C. Serafin Vol #: 36
C 671 E. Cummings Vol #: 36
C 672 A and J McGawley Vol #: 36
C 673 J and A Meis Vol #: 36
C 674 I. Pastuszka Vol #: 36
C 675 M. Ceruzzi Vol #: 36
C 676 A. Glynn Vol #: 36
C 677 A and J Feldpausch Vol #: 36
C 678 Human Life International Vol #: 36
C 679 P and A Shafer Vol #: 36
C 680 S. Jennings Vol #: 36
C 681 R. Erb Vol #: 36
C 682 E. Race Vol #: 36
C 683 A. Porter Vol #: 36
C 684 B. Moran Vol #: 36
C 685 T. Short, MD Vol #: 36
C 686 A. Lindberg Vol #: 36
C 687 A. Schuck Vol #: 36
C 688 K. Miller Vol #: 36
C 689 J. Olson Vol #: 36
C 690 M. Iannitello Vol #: 36
C 691 R and L Feldpausch Vol #: 36
C 692 C. Niedos Vol #: 36
C 693 T. Cornell Vol #: 36
C 694 S. Costanzo Vol #: 36
C 695 S. Costanzo Vol #: 36
C 696 K. Hill Vol #: 36
C 697 P. McClone Vol #: 36
C 698 A. Jordan Vol #: 36
C 699 Church of Saint Patrick Vol #: 36
C 700 C. Litzelman Vol #: 36
C 701 C. Cunningham Vol #: 36
C 702 D and C Lopez Vol #: 36
C 703 T. Phelan III Vol #: 36
C 704 E. Thomas Vol #: 36
C 705 S. Placek Vol #: 36
C 706 D. Mordini Vol #: 36
C 707 M. Brennen Vol #: 36
C 708 D. Jones Vol #: 36
C 709 San Francisco Guild of the Catholic Medical Association Vol #: 36
C 710 R. McClone Vol #: 36
C 711 T. Brennan Vol #: 36
C 712 T. Huether Vol #: 36
C 713 P. Essig Vol #: 36
C 714 L. Curley Vol #: 36
C 715 A and M Caldieraro Vol #: 36
C 716 F. Smith, MD Vol #: 37
C 717 K. Simon Vol #: 36
C 718 M. Wilson Vol #: 37
C 719 National Catholic Bioethics Center Vol #: 36
C 720 A and R Malatt Vol #: 37
C 721 Illigible Vol #: 37
C 722 M. Vicente Vol #: 37
C 723 M. McGuirk Vol #: 37
C 724 A. Petullo Vol #: 37
C 725 J. Higgins Vol #: 37
C 726 R. Sibley Vol #: 37
C 727 M. Donnelley Vol #: 37
C 728 W. Rice, PhD Vol #: 37
C 729 G. Urban Vol #: 37
C 730 C. Knop Vol #: 37
C 731 F. Depman Vol #: 37
C 732 J and P O'Brien Vol #: 37
C 733 P. Contermarsh Vol #: 37
C 734 L. Courtney Vol #: 37
C 735 B. Fink Vol #: 37
C 736 D. Rosek Vol #: 37
C 737 A. Dina Vol #: 37
C 738 G. Nagasava Vol #: 37
C 739 L and F Schneider Vol #: 37
C 740 Concerned Women for America Vol #: 37
C 741 Mr and Mrs D. Hurley Vol #: 37
C 742 E. Roling et al Vol #: 37
C 743 D and M Arbogast Vol #: 37
C 744 D and P Glass Vol #: 37
C 745 K. Green Vol #: 37
C 746 E. Berger Vol #: 37
C 747 V. Kasper Vol #: 37
C 748 L. Martinez Vol #: 37
C 749 B. Meier Vol #: 37
C 750 12 signatures Vol #: 37
C 751 B and M Kaiser Vol #: 37
C 752 E. Stone Vol #: 37
C 753 K. Campbell Vol #: 37
C 754 R. Romo Vol #: 37
C 755 M. Cronauer Vol #: 37
C 756 M. Warren Vol #: 37
C 757 Illigible Vol #: 37
C 758 M. Trebon Vol #: 37
C 759 I Surmel Vol #: 37
C 760 F. Roloff Vol #: 37
C 761 J and J Donahoe Vol #: 37
C 762 G. Slyke Vol #: 37
C 763 L. Jennings Vol #: 37
C 764 S. Naseman Vol #: 37
2006D-0515 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2006E-0022 Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
LET 5 FDA/CDER to U.S. Patent and Trademark Office Vol #: 1
2006E-0026 Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
LET 6 FDA/CDER to U.S. Patent and Trademark Office 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 1 BanTransFats.com Vol #: 1
EMC 2 J. Maloof Vol #: 1
EMC 3 J. Pinard Vol #: 1
EMC 4 C. Sargent Vol #: 1
EMC 5 R. Maez Vol #: 1
EMC 6 T. Clayton Vol #: 1
EMC 7 K. Cole Vol #: 1
EMC 8 J. Stephens Vol #: 1
EMC 9 G. McCown Vol #: 1
EMC 10 J. Cihocki Vol #: 1
2006N-0061 Charging for Investigational Drugs
EC 2 UnitedHealth Group Vol #: 1
EC 3 Mrs. Melanie Lounds Vol #: 1
2006N-0517 Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays
NFR 1 FDA Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 473 Ms. Ashley Brotzge Vol #: 7
2006P-0415 Petition Seeking Regulation of Cloned Animals
EC 731 Mrs. Ginelle Edmondson Vol #: 4
EC 732 Mr. Gabriel Perkins Vol #: 4
EC 733 Dr. Philip Hurzeler Vol #: 4
EC 734 Mr. Gerald Miller Vol #: 4
EC 735 Mr. R Smith Vol #: 4
EC 736 DeStefano Architects Vol #: 4
EC 737 Mr. Kerry Lagueux Vol #: 4
EC 738 Mr. Duane Bruce Vol #: 4
EC 739 Ms. Amanda Moser Vol #: 4
EC 740 Mrs. Brenda Coman Vol #: 4
EC 741 Miss. Deborah Fenker Vol #: 4
EC 742 Mr. Walter Botich Vol #: 4
EC 743 Mr. Gabriel Churray Vol #: 4
EC 744 Mrs. Elisha Gray Vol #: 4
EC 745 Mr. Greg Reyna Vol #: 4
EC 746 Miss. Tracy Hall Vol #: 4
EC 747 Mrs. Gina Fields Vol #: 4
EC 748 Ms. Ella Elledge Vol #: 4
EC 749 ALBRECHT FARM Vol #: 4
EC 750 Mrs. Tina` Sporn Vol #: 4
EC 751 No affiliation Vol #: 4
EC 752 Mrs. Andre Christou Vol #: 4
EC 753 Mr. Pierre Avignon Vol #: 4
EC 754 Ms. Marie Begay Vol #: 4
EC 755 Mrs. jessica cole Vol #: 4
EC 756 Ms. Lisa Algarin Vol #: 4
EC 757 Mrs. Tearra Leger Vol #: 4
EC 758 Mrs. Nicole Saunders Vol #: 4
EC 759 Mrs. Michele Lee Vol #: 4
EMC 34 H. Lebed Vol #: 5
EMC 35 T. Rush Vol #: 5
2006P-0462 Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
EC 1 micheleleeclw@yahoo.com Vol #: 1
2006P-0498 Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods
EC 3 none Vol #: 1
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
EC 12 Mrs. stacy carney Vol #: 3
2007P-0004 Take steps to insure the safey of Americans regarding th misues of Lasik
EMC 2 Dean Kantis Vol #: 1
EMC 3 Dean Kantis Vol #: 1

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