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Dockets Management
Dockets Entered On May 12, 2006
Docket # Title
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005Q-0297 Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
2006E-0025 Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
2006M-0193 P040033 - Birmingham Hip Resurfacing (BHR) System, Approved 5/9/06
2006M-0199 P030008/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System, Approved 4/19/06
2006M-0200 P050012 - DexCom STS Continuous Glucose Monitoring System, Approved 3/24/06
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
RPT 766 Statistical Report - Month of April 2006 Vol #: 55
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17592 Market America, Inc. Vol #: 162
LET 17593 Market of America, Inc. Vol #: 162
LET 17594 Market Americal, Inc. Vol #: 162
LET 17595 Body Innoventions, LLC Vol #: 162
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 9051 B. Hanskins-McElfvin Vol #: 132
C 9052 J. Brokken Vol #: 132
C 9053 unreadable Vol #: 132
C 9054 Unreadabe Vol #: 132
C 9055 K. Prench Vol #: 132
C 9056 J. M eier Vol #: 132
C 9057 S. Melchiore Vol #: 132
C 9058 Kathy Abbo, MD Vol #: 132
C 9059 R. M. Shoemaker Vol #: 132
C 9060 R. H. Rons Vol #: 132
C 9061 L. Brar Vol #: 132
C 9062 J. Jaynes Vol #: 132
C 9063 P. Rider Vol #: 132
C 9064 K. Jobe Vol #: 132
C 9065 P. Chernack Vol #: 132
C 9066 J. O'Shea Vol #: 132
C 9067 J. Hoffart Vol #: 132
C 9068 K. McMurray Vol #: 132
C 9069 L. Hart Vol #: 132
C 9070 M. J. Hull Vol #: 132
C 9071 J. L. Anderson Vol #: 132
C 9072 J. LeMay Vol #: 132
C 9073 G. Kennedy Vol #: 132
C 9074 K. Allen Vol #: 132
C 9075 D. Sondergard Vol #: 132
C 9076 M. Scott Vol #: 132
C 9077 K. Ricci Vol #: 132
C 9078 S. Moore Vol #: 132
C 9079 F. McQueen Vol #: 132
C 9080 K. Harris Vol #: 132
C 9081 C. Sullivan Vol #: 132
C 9082 L. Williams Vol #: 132
C 9083 H. J. Delgado Vol #: 132
C 9084 S. E. Ellen Vol #: 132
C 9085 J. A. Ferrier Vol #: 132
C 9086 M. Schillroth Vol #: 132
C 9087 A. A. Hupfel Vol #: 132
C 9088 L. Mumford Vol #: 132
C 9089 F. Selman Vol #: 132
C 9090 E. Patton Vol #: 132
C 9091 S. Klinkers Vol #: 132
C 9092 R. M. Jaccaud Vol #: 132
C 9093 C. Olmsted Vol #: 132
C 9094 K. Carr Vol #: 132
C 9095 P. Konyk Vol #: 132
C 9096 N. Morgan Vol #: 132
C 9097 L. D. Barill Vol #: 132
C 9098 K. Scholter Vol #: 132
C 9099 K. Lindquist Vol #: 132
C 9100 C. Payne Vol #: 132
C 9101 Ms. C. Small Vol #: 132
C 9102 P. Neos Vol #: 132
C 9103 C. Quann Vol #: 132
C 9104 S. Lewis Vol #: 132
C 9105 L. Rhoden Vol #: 132
C 9106 C. Gerardi Vol #: 132
C 9107 J. Filosa Vol #: 132
C 9108 S. Greene Vol #: 132
C 9109 V. Bentley Vol #: 132
C 9110 C. Norman Vol #: 132
C 9111 C. Nissly Vol #: 132
C 9112 K. Farrington Vol #: 132
C 9113 E. Nunley Vol #: 132
C 9114 S. Paez Vol #: 132
C 9115 P. Potrin Vol #: 132
C 9116 S. J. Feraco Vol #: 132
C 9117 M. Erwin Vol #: 132
C 9118 L. L. Pier Vol #: 132
C 9119 J. L. Stimach Vol #: 132
C 9120 N. Tuakli Vol #: 132
C 9121 N. Reeder Vol #: 132
C 9122 C. Birka Vol #: 132
C 9123 B. Hauskins-McElyunn Vol #: 132
C 9124 N. Chrzanowski Vol #: 132
EMC 1658 S. Kopcha Vol #: 121
EMC 1659 A. Giardiniand Vol #: 121
EMC 1660 A. Giardini Vol #: 121
EMC 1661 Dr. R. Whipps Vol #: 121
EMC 1662 S. Schinzinger Vol #: 121
EMC 1663 E. Lemings Vol #: 121
EMC 1664 E. Kraushaar Vol #: 121
EMC 1665 S. Adams Vol #: 121
EMC 1666 G. Hull Vol #: 121
EMC 1667 M. Olesen Vol #: 121
EMC 1668 K. Allums Vol #: 121
EMC 1669 L. Talley Vol #: 121
EMC 1670 S. Moore Vol #: 121
EMC 1671 R. Bolton Vol #: 121
EMC 1672 A. White Vol #: 121
EMC 1673 B. Feely Vol #: 121
EMC 1674 P. Mulligan Vol #: 121
EMC 1675 P. Chestnutt Vol #: 121
EMC 1676 L. Hamaguchi Vol #: 121
EMC 1677 D. Brower Vol #: 121
EMC 1678 P. Gerhardt Vol #: 121
EMC 1679 Dr. D. Barry Vol #: 121
EMC 1680 N. Buroff Vol #: 121
EMC 1681 J. Jones Vol #: 121
EMC 1682 C. Troedson Vol #: 121
EMC 1683 S. Simmons Vol #: 121
EMC 1684 L. Solberg Vol #: 121
EMC 1685 C. Fleuriel Vol #: 121
EMC 1686 R. Torelli Vol #: 121
EMC 1687 Dr. J. McCullough Vol #: 121
EMC 1688 J. Ward Vol #: 121
EMC 1689 M. Leach Vol #: 121
EMC 1690 M. Robinson Vol #: 121
EMC 1691 D. Cross Vol #: 121
EMC 1692 B. Spivey Vol #: 121
EMC 1693 J. Schaefer Vol #: 121
EMC 1694 C. Persina Vol #: 121
EMC 1695 P. Thielking Vol #: 121
EMC 1696 J. Tassillo Vol #: 121
EMC 1697 K. Swisher Vol #: 121
EMC 1698 B. Pavlic Vol #: 121
EMC 1699 C. Victor Vol #: 121
EMC 1700 L. Lubben Vol #: 123
EMC 1701 L. Taylor Vol #: 123
EMC 1702 M. McFatridge Vol #: 123
EMC 1703 T. Snyder Vol #: 123
EMC 1704 R. Collins Vol #: 123
EMC 1705 E. Vaughan Vol #: 123
EMC 1706 B. Schroer Vol #: 123
EMC 1707 M. Aspinwall Vol #: 123
EMC 1708 M. Hitchins Vol #: 123
EMC 1709 L. Abercrombie Vol #: 123
EMC 1710 K. Krumpoch Vol #: 123
EMC 1711 J. Busch Vol #: 123
EMC 1712 M. Schmitt Vol #: 123
EMC 1713 D. Mauro Vol #: 123
EMC 1714 G. Bakst Vol #: 123
EMC 1715 V. Jones Vol #: 123
EMC 1716 C. Barry Vol #: 123
EMC 1717 J. Rueckhaus Vol #: 123
EMC 1718 J. Seldon Vol #: 123
EMC 1719 S. Ferraro Vol #: 123
EMC 1720 R. Mays Vol #: 123
EMC 1721 A. Morgn Vol #: 123
EMC 1722 K. Zirbel Vol #: 123
EMC 1723 Dr. C. Conkell Vol #: 123
EMC 1724 K. Brouillette Vol #: 123
EMC 1725 D. Bivens Vol #: 123
EMC 1726 V. Hufnagel Vol #: 123
EMC 1727 V. Hufnagel Vol #: 123
EMC 1728 V. Hufnagel Vol #: 123
EMC 1729 C. Stockwell Vol #: 123
EMC 1730 V. Hufnagel Vol #: 123
EMC 1731 V. Hufnagel Vol #: 123
EMC 1732 M. McCarthy Vol #: 123
EMC 1733 B. Lott Vol #: 123
EMC 1734 L. Simpson Vol #: 123
EMC 1735 T. Burnett Vol #: 123
EMC 1736 T. Roeder Vol #: 123
EMC 1737 J. Brower Vol #: 123
EMC 1738 N. Call Vol #: 123
EMC 1739 M. StLouis Vol #: 123
EMC 1740 L. Levin Vol #: 123
EMC 1741 D. Owen Vol #: 123
EMC 1742 J. Plesnicher Vol #: 123
EMC 1743 A. Roselle Vol #: 123
EMC 1744 M. Beauchamp Vol #: 123
EMC 1745 J. Samuels Vol #: 123
EMC 1746 S. Ferraro Vol #: 123
EMC 1747 Dr. C. Randolph Vol #: 123
EMC 1748 G. James Vol #: 123
EMC 1749 D. Boardman Vol #: 123
EMC 1750 B. Brock Vol #: 123
EMC 1751 Dr. Angelle Vol #: 123
EMC 1752 C. Clearaters Vol #: 123
EMC 1753 P. Dean Vol #: 123
EMC 1754 J. Lysen Vol #: 123
EMC 1755 S. Emersen Vol #: 123
EMC 1756 C. Vaughn Vol #: 123
EMC 1757 J. Concino Vol #: 123
EMC 1758 C. BEach Vol #: 123
EMC 1759 E. Dirks Vol #: 123
EMC 1760 C. Stringfellow Vol #: 123
EMC 1761 M. Perel Vol #: 123
EMC 1762 L. Halvorson Vol #: 123
EMC 1763 M. Mallett Vol #: 123
EMC 1764 S. Johannes Vol #: 123
EMC 1765 R. Petersen Vol #: 123
EMC 1766 S. Johannes Vol #: 123
EMC 1767 S. Bridenbaugh Vol #: 123
EMC 1768 D. Johannes Vol #: 123
EMC 1769 D. Johannes Vol #: 123
EMC 1770 M. Mulhollan Vol #: 123
EMC 1771 B. Gardner Vol #: 123
EMC 1772 M. Geddy Vol #: 123
EMC 1773 C. Geist Vol #: 123
EMC 1774 L. Mitzenmacher Vol #: 123
EMC 1775 J. Ditzler Vol #: 123
EMC 1776 S. Keenum Vol #: 123
EMC 1777 W. Stretten Vol #: 123
EMC 1778 M. Lair Vol #: 123
EMC 1779 G. McCarter Vol #: 123
EMC 1780 D. Hofflinger Vol #: 123
EMC 1781 Dr. J. Lawler Vol #: 123
EMC 1782 P. Antginopoulos Vol #: 123
EMC 1783 J. Murphy Vol #: 123
EMC 1784 No signature Vol #: 123
EMC 1785 Dr. Bailey Vol #: 123
EMC 1786 W. Marek Vol #: 123
EMC 1787 A. Jackson Vol #: 123
EMC 1788 L. Childs Vol #: 123
EMC 1789 K. Bergman Vol #: 123
EMC 1790 C. Reynolds Vol #: 123
EMC 1791 Dr. E. Plourde Vol #: 123
EMC 1792 Dr. E. Plourde Vol #: 123
EMC 1793 K. Johns Vol #: 123
EMC 1794 Dr. Jurovich Vol #: 123
EMC 1795 J. Johns Vol #: 123
EMC 1796 B. Stetler Vol #: 123
EMC 1797 L. Lister Vol #: 123
EMC 1798 C. Thornton Vol #: 123
EMC 1799 V. Billings Vol #: 123
EMC 1800 Dr. C. Buxton Vol #: 123
EMC 1801 J. Pradetto Vol #: 123
EMC 1802 D. Noffsinger Vol #: 123
EMC 1803 S. Savela Vol #: 123
EMC 1804 K. Winter Vol #: 123
EMC 1805 T. Jones Vol #: 123
EMC 1806 S. Chase Vol #: 123
EMC 1807 I. Boyens Vol #: 123
EMC 1808 Dr. A. Elliott Vol #: 123
EMC 1809 G. Carr Vol #: 123
EMC 1810 Dr. D. Olsen Vol #: 123
EMC 1811 C. Duncan Vol #: 123
EMC 1812 G. Kegley Vol #: 123
EMC 1813 S. BArnett Vol #: 123
EMC 1814 P. Perry Vol #: 123
EMC 1815 S. Kafka Vol #: 123
EMC 1816 J. Lont Vol #: 123
EMC 1817 A. Guillory Vol #: 123
EMC 1818 S. Stovall Vol #: 123
EMC 1819 P. Carrion Vol #: 123
EMC 1820 B. Foster Vol #: 123
EMC 1821 R. Henry Vol #: 123
EMC 1822 S. Shackelford Vol #: 123
EMC 1823 M. Grave Vol #: 123
EMC 1824 H. Zelinsky Vol #: 123
EMC 1825 T. Turner Vol #: 123
EMC 1826 Dr. C. Fallwell Vol #: 123
EMC 1827 S. Parker Vol #: 123
EMC 1828 E. Seyda Vol #: 123
EMC 1829 K. Hjelm Vol #: 123
EMC 1830 L. Reid Vol #: 123
EMC 1831 N. Fitzgerald Vol #: 123
EMC 1832 Dr. T. Kabisch, DO Vol #: 123
EMC 1833 Dr. R. Braun Vol #: 123
EMC 1834 E. Lerman Vol #: 123
EMC 1835 S. Kopel Vol #: 123
EMC 1836 M. Lauber Vol #: 123
EMC 1837 M. Lauber Vol #: 123
EMC 1838 B. Jansen Vol #: 123
EMC 1839 A. Esch Vol #: 123
EMC 1840 K. Olson Vol #: 123
EMC 1841 G. Christ Vol #: 123
EMC 1842 L. Devlin Vol #: 123
EMC 1843 S. Glassow Vol #: 123
EMC 1844 D. Church Vol #: 123
EMC 1845 B. Sloofman Vol #: 123
EMC 1846 D. Kraft Vol #: 123
EMC 1847 A. Shaw Vol #: 123
EMC 1848 S. Davis Vol #: 123
EMC 1849 V. Edwards Vol #: 123
EMC 1850 L. Harrison Vol #: 123
EMC 1851 J. Schilling, RN, PhD Vol #: 123
EMC 1852 Dr. H. Rotar Vol #: 123
EMC 1853 P. Fay Vol #: 123
EMC 1854 J. Goodman Vol #: 123
EMC 1855 C. Chuzi Vol #: 123
EMC 1856 M. Vincent Vol #: 123
EMC 1857 S. Zistatsis Vol #: 123
EMC 1858 N. Chadick Vol #: 123
EMC 1859 T. Collier Vol #: 123
EMC 1860 R. Cushman Vol #: 123
EMC 1861 J. Stinebaugh Vol #: 123
EMC 1862 Dr. S. Croteau Vol #: 123
EMC 1863 C. Mingus Vol #: 123
EMC 1864 P. Collins Vol #: 123
EMC 1865 L. Bovard Vol #: 123
EMC 1866 C. Lee Vol #: 123
EMC 1867 J. Nichols Vol #: 123
EMC 1868 J. Reynolds Vol #: 123
EMC 1869 P. Greenberg Vol #: 123
EMC 1870 E. Barrett Vol #: 123
EMC 1871 C. Biggs Vol #: 123
EMC 1872 K. Reiner Vol #: 123
EMC 1873 L. Francis Vol #: 123
EMC 1874 S. Iderstein Vol #: 123
EMC 1875 K. Vyzral Vol #: 123
EMC 1876 C. Wood Vol #: 123
EMC 1877 E. Wood Vol #: 123
EMC 1878 Erline Furrow Vol #: 123
EMC 1879 J. Smith Vol #: 123
EMC 1880 C. Ayers Vol #: 123
EMC 1881 C. Simpson Vol #: 123
EMC 1882 M. Humphrey Vol #: 123
EMC 1883 Dr. A. Patton Vol #: 123
EMC 1884 Dr. Mitchell Vol #: 123
EMC 1885 L. Rogers Vol #: 123
EMC 1886 M. Benke Vol #: 123
EMC 1887 K. Rausch Vol #: 123
EMC 1888 P. Dylan Vol #: 123
EMC 1889 E. Day Vol #: 123
EMC 1890 J. Papenfus Vol #: 123
EMC 1891 J. Jackson Vol #: 123
EMC 1892 D. Souders Vol #: 123
EMC 1893 S. Blue Vol #: 123
EMC 1894 M. Wright Vol #: 123
EMC 1895 B. Marciante Vol #: 123
EMC 1896 N. Jackson Vol #: 123
EMC 1897 J. Plank Vol #: 123
EMC 1898 A. Jackson Vol #: 123
EMC 1899 E. Wilcox Vol #: 123
EMC 1900 J. Jackson Vol #: 123
EMC 1901 I. Blum Vol #: 123
EMC 1902 L. Curtis Vol #: 123
EMC 1903 S. Chamberlaine Vol #: 123
EMC 1904 M. Cody Vol #: 123
EMC 1905 J. Breslkow Vol #: 123
EMC 1906 P. Souders Vol #: 123
EMC 1907 M. Wiggs Vol #: 123
2005Q-0297 Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
PDN 1 FDA/CFSAN to AAC Consulting Group Vol #: 6
2006E-0025 Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
LET 3 U.S. Patent and Trademark Office Vol #: 1
2006M-0193 P040033 - Birmingham Hip Resurfacing (BHR) System, Approved 5/9/06
AAV 1 Smith & Nephew Orthopaedics Vol #: 1
2006M-0199 P030008/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System, Approved 4/19/06
AAV 1 SurgiVision Refractive Consultants, Inc. Vol #: 1
2006M-0200 P050012 - DexCom STS Continuous Glucose Monitoring System, Approved 3/24/06
AAV 1 DexCom, Inc. Vol #: 1

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