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Dockets Management
Dockets Entered On December 30, 2003
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2000N-1449 Changes to an Approved NDA or ANDA; Agency Information Collection
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002D-0525 Medical Devices; Chemical Indicators Premarket Notification
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0549 Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
2003D-0562 Compliance Policy Guide Sec.110.300 b
2003N-0528 Revision of the Requirements for Spore-Forming Microorganisms
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 12065 Bioneurix Corporation Vol #: 97
LET 12066 Enzymatic Therapy Natural Medicines Vol #: 97
LET 12067 Pharmavite LLC Vol #: 97
LET 12068 Pharmavite LLC Vol #: 97
LET 12069 Integrative Therapeutics Inc. Vol #: 97
LET 12070 Integrative Therapeutics Inc. Vol #: 97
LET 12071 Integrative Therapeutics Inc. Vol #: 97
2000N-1449 Changes to an Approved NDA or ANDA; Agency Information Collection
N 3 FDA Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 1744 L. McGinnis Vol #: 127
EMC 1745 K. Berra Vol #: 127
EMC 1746 D. Durica Vol #: 127
EMC 1747 R. Subbian Vol #: 127
EMC 1748 S. Chase Vol #: 127
EMC 1749 N. Keefer Vol #: 127
EMC 1750 M. Meister Vol #: 127
EMC 1751 M. Jotter Vol #: 127
EMC 1752 S. Keen Vol #: 127
EMC 1753 J. Farber Vol #: 127
EMC 1754 J. Loo Vol #: 127
EMC 1755 D. Cavaleri Vol #: 127
EMC 1756 P. E. Frawley Vol #: 127
EMC 1757 M.P. Franklin Vol #: 127
EMC 1758 V. Taylor Vol #: 127
EMC 1759 S. Robertson Vol #: 127
EMC 1760 C. Nattrass Vol #: 127
EMC 1761 D. Jr. Vol #: 127
EMC 1762 L. Fuqua Vol #: 127
EMC 1763 E. Bingham Vol #: 127
EMC 1764 B.M. Shapero Vol #: 127
EMC 1765 D. Thorp Vol #: 127
EMC 1766 M. Heminger Vol #: 127
EMC 1767 C. Talbeck Vol #: 127
EMC 1768 E. Doerr Vol #: 127
EMC 1769 A. Miralia Vol #: 127
EMC 1770 A. Ziegler Vol #: 127
EMC 1771 L. Wright Vol #: 127
EMC 1772 L. Seidel Vol #: 127
EMC 1773 G. Roberson Vol #: 127
EMC 1774 B. Telfare Vol #: 127
EMC 1775 T. Knierim Vol #: 127
EMC 1776 J. Greenleaf Vol #: 127
EMC 1777 K. Beckman Vol #: 127
EMC 1778 M.J. Mosher Vol #: 127
EMC 1779 K. Smith Vol #: 127
EMC 1780 D. Dimon Vol #: 127
EMC 1781 R.E. Pratt Vol #: 127
EMC 1782 K. Fergason Vol #: 127
EMC 1783 P. Sagerson Vol #: 127
EMC 1784 S. Thotz Vol #: 127
EMC 1785 S. Allen Vol #: 127
EMC 1786 L. Wade Vol #: 127
EMC 1787 K. Larkin Vol #: 127
EMC 1788 D. Jackson Vol #: 127
EMC 1789 P. Yaverbaum Vol #: 127
EMC 1790 A. Garcia Vol #: 127
EMC 1791 F. Perlman Vol #: 127
EMC 1792 M. McPherson Vol #: 127
EMC 1793 C. Gauthier Vol #: 127
EMC 1794 P.B. Isle Vol #: 127
EMC 1795 D. Torres Vol #: 127
EMC 1796 K. Stiegler Vol #: 127
EMC 1797 D. Couch Vol #: 127
EMC 1798 D. Canby Vol #: 127
EMC 1799 J. Boyd Vol #: 127
EMC 1800 E. Elman Vol #: 127
EMC 1801 S. Sandell Vol #: 127
EMC 1802 K. Sharpe Vol #: 127
EMC 1803 V. Copestakes Vol #: 127
EMC 1804 S. Johnston Vol #: 127
EMC 1805 A. Shah Vol #: 127
EMC 1806 R. Foss Vol #: 127
EMC 1807 S. Grieff Vol #: 127
EMC 1808 J. Gaddis Vol #: 127
EMC 1809 J.C. Eberle Vol #: 127
EMC 1810 R. Criswell Vol #: 127
EMC 1811 E. Cadenas Vol #: 127
EMC 1812 P. Funch Vol #: 127
EMC 1813 M. Thibault Vol #: 127
EMC 1814 L. Vinson Vol #: 127
EMC 1815 S.B. Seldin Vol #: 127
EMC 1816 L. Lahr Vol #: 127
EMC 1817 C. Northrup Vol #: 127
EMC 1818 T. Gerrodette Vol #: 127
EMC 1819 J. Wolff Vol #: 127
EMC 1820 N. Solzman Vol #: 127
EMC 1821 C. Danielson Vol #: 127
EMC 1822 R. Scott Vol #: 127
EMC 1823 H. Ivy Vol #: 127
EMC 1824 B. Luckenbach Vol #: 127
EMC 1825 R. Nowak Vol #: 127
EMC 1826 P. Staight Vol #: 127
EMC 1827 M. Martin Vol #: 127
EMC 1828 S. Brace Vol #: 127
EMC 1829 L. Hamilton Vol #: 127
EMC 1830 B. Hill Vol #: 127
EMC 1831 N. Garrett Vol #: 127
EMC 1832 R. Quintal Vol #: 127
EMC 1833 P. Marriott Vol #: 127
EMC 1834 K. Powers Vol #: 127
EMC 1835 J. Warren Vol #: 127
EMC 1836 P. Hough Vol #: 127
EMC 1837 B. Laffey Vol #: 127
EMC 1838 R. Soenneker Vol #: 127
EMC 1839 S. Behn Vol #: 127
EMC 1840 K. Maccorkle Vol #: 127
EMC 1841 R. Hurlbert Vol #: 127
EMC 1842 A. Ebner Vol #: 127
EMC 1843 G. Frohnsdorff Vol #: 127
EMC 1844 T.L.G. Shostack Vol #: 127
EMC 1845 S.Q. Wagner Vol #: 127
EMC 1846 A. Thobae Vol #: 127
EMC 1847 L. Batway Vol #: 127
EMC 1848 P. Faughender Vol #: 127
EMC 1849 K. Murphy Vol #: 127
EMC 1850 A. Oesterle Vol #: 127
EMC 1851 C. Collins Vol #: 127
EMC 1852 A. Burrows Vol #: 127
EMC 1853 K. Tuzinkiewicz Vol #: 127
EMC 1854 L. Pfaffmann Vol #: 127
EMC 1855 A. Page Vol #: 127
EMC 1856 C.A. Kowalewski Vol #: 127
EMC 1857 K. Troyan Vol #: 127
EMC 1858 J. Jean Vol #: 127
EMC 1859 C. Kucsera Vol #: 127
EMC 1860 J. Jones Vol #: 127
EMC 1861 M. Doherty Vol #: 127
EMC 1862 E. Daerr Vol #: 127
EMC 1863 L. Darin Vol #: 127
EMC 1864 S. Gallentine Vol #: 127
EMC 1865 S.S. Smith Vol #: 127
EMC 1866 G. Kingsley Vol #: 127
EMC 1867 W. Parker Vol #: 127
EMC 1868 P. Burkhardt Vol #: 127
EMC 1869 A. Long Vol #: 127
EMC 1870 N. Bauman Vol #: 127
EMC 1871 Molly Brewton Vol #: 127
EMC 1872 R. Ries Vol #: 127
EMC 1873 J. Widmer Vol #: 127
EMC 1874 R. Rankin Vol #: 127
EMC 1875 J.A. Bowie Vol #: 127
EMC 1876 N. Wilson Vol #: 127
EMC 1877 J. Brewton Vol #: 127
EMC 1878 W. Yeager Vol #: 127
EMC 1879 D.D. Minney Vol #: 127
EMC 1880 P. Steinmann Vol #: 127
EMC 1881 A. Entler Vol #: 127
EMC 1882 A.P. Cawley Vol #: 127
EMC 1883 A. Hurst Vol #: 127
EMC 1884 H. Gordon Vol #: 127
EMC 1885 B. Snyder Vol #: 127
EMC 1886 B. Young Vol #: 127
EMC 1887 M.C. Niblack, MD Vol #: 127
EMC 1888 A. Valle Vol #: 127
EMC 1889 M.J. Chalmers Vol #: 127
EMC 1890 N.C. Hirshhorn Vol #: 127
EMC 1891 A. Dodge Vol #: 127
EMC 1892 E. Hastings Vol #: 127
EMC 1893 K. Miller Vol #: 127
EMC 1894 J. Madden Vol #: 127
EMC 1895 J. Royal Vol #: 127
EMC 1896 E.M. Coombs Vol #: 127
EMC 1897 P. Loonan Vol #: 127
EMC 1898 N. Bouvier Vol #: 127
EMC 1899 A. West Vol #: 127
EMC 1900 G.M. Butrica Vol #: 127
EMC 1901 M. Macinnes Vol #: 127
EMC 1902 R. Brust Vol #: 127
EMC 1903 A. Calvert Vol #: 127
EMC 1904 H. McGee Vol #: 127
EMC 1905 C. Castle Vol #: 127
EMC 1906 M. Cunningham Vol #: 127
EMC 1907 S. Davis Vol #: 127
EMC 1908 M. Serrano Vol #: 127
EMC 1909 Amy Carlson Vol #: 127
EMC 1910 J. Dinkmeyer Vol #: 127
EMC 1911 S. Chynoweth Vol #: 127
EMC 1912 E. Newsom Vol #: 127
EMC 1913 S. Lambert Vol #: 127
EMC 1914 J. Kasabach Vol #: 127
EMC 1915 J. Pepper Vol #: 127
EMC 1916 B. Roeth Vol #: 127
EMC 1917 J. Kester Vol #: 127
EMC 1918 J.E. Simpson Vol #: 127
EMC 1919 L. Castiglioni Vol #: 127
EMC 1920 K. A. Weaver Vol #: 127
EMC 1921 K.E. Nahigian Vol #: 127
EMC 1922 B. Buchholz Vol #: 127
EMC 1923 Rev A. Krug, DM Vol #: 127
EMC 1924 S. Levin Vol #: 127
EMC 1925 V. Joshi Vol #: 127
EMC 1926 J. Bowhers Vol #: 127
EMC 1927 S. Siebold Vol #: 127
EMC 1928 A. Sheridan Vol #: 127
EMC 1929 K. Maguire Vol #: 127
EMC 1930 M. Patt Vol #: 120
EMC 1931 C.B. Hagler Vol #: 127
EMC 1932 M. Taylor Vol #: 127
EMC 1933 N. Strand Vol #: 127
EMC 1934 S. Krieckhaus Vol #: 127
EMC 1935 J. Cook Vol #: 127
EMC 1936 K. Stell Vol #: 127
EMC 1937 J. McDaniel Vol #: 127
EMC 1938 C. Jacobs Vol #: 127
EMC 1939 K. Sabatini Vol #: 127
EMC 1940 W. Krueger Vol #: 127
EMC 1941 L. Shipp Vol #: 127
EMC 1942 S. Settle Vol #: 127
EMC 1943 D. Artley Vol #: 127
EMC 1944 C. Dan Vol #: 127
EMC 1945 D. Galbavy Vol #: 127
EMC 1946 L.G. Agnello Vol #: 127
EMC 1947 A. Marshall Vol #: 127
EMC 1948 S. Babcock Vol #: 127
EMC 1949 A. Vengel Vol #: 127
EMC 1950 L. Watts Vol #: 127
EMC 1951 T. Neely Vol #: 127
EMC 1952 P. Fleming Vol #: 127
EMC 1953 R. Samoska Vol #: 127
EMC 1954 E. Schmittdiel Vol #: 127
EMC 1955 M. McNeely Vol #: 127
EMC 1956 P. Shank Vol #: 127
EMC 1957 R.W. Wood Vol #: 127
EMC 1958 C. Sprowl Vol #: 127
EMC 1959 M. Catherine Sabatos Vol #: 127
EMC 1960 K. Miyauchi Vol #: 127
EMC 1961 C. Ross Vol #: 127
EMC 1962 J. Andrews Vol #: 127
EMC 1963 K.L. Freeman Vol #: 127
EMC 1964 R. Owens Vol #: 127
EMC 1965 B. Brockway Vol #: 127
EMC 1966 E. Avella Vol #: 127
EMC 1967 T. Marquette Vol #: 127
EMC 1968 M. Garcia Vol #: 127
EMC 1969 K. Reightler Vol #: 127
EMC 1970 C. Flynn Vol #: 127
EMC 1971 C. Hyre Vol #: 127
EMC 1972 D. Ottman Vol #: 127
EMC 1973 H. Cyr Vol #: 127
EMC 1974 M. Ralph Vol #: 127
EMC 1975 L. Wilcox Vol #: 127
EMC 1976 V. Ushakoff Vol #: 127
EMC 1977 B. Hoornbeek Vol #: 127
EMC 1978 C. Livesay Vol #: 127
EMC 1979 Rev M. Poulos Vol #: 127
EMC 1980 A. Gagnon Vol #: 127
EMC 1981 L.A. Johnson Vol #: 127
EMC 1982 D. Thompson Vol #: 127
EMC 1983 A. Hill Vol #: 127
EMC 1984 E. Spahn Vol #: 127
EMC 1985 L.L. Hulsebus Vol #: 127
EMC 1986 A. Blackman Vol #: 127
EMC 1987 R. Mandelcorn Vol #: 127
EMC 1988 W.T. Wells Vol #: 127
EMC 1989 J.T. Rolle Vol #: 127
EMC 1990 J. Reynolds Vol #: 127
EMC 1991 C. Moran Vol #: 127
EMC 1992 A. Brooks Vol #: 127
EMC 1993 H. King Vol #: 127
EMC 1994 C. Nacewicz Vol #: 127
EMC 1995 A. Battey Vol #: 127
EMC 1996 K. Cottrell Vol #: 127
EMC 1997 K. Tuley Vol #: 127
EMC 1998 C. Velazquez Vol #: 127
EMC 1999 P. Mastroianni Vol #: 127
EMC 2000 S. Nimmannit Vol #: 127
EMC 2001 H. Tani Vol #: 127
EMC 2002 C. Priest Vol #: 127
EMC 2003 A. Hobbs Vol #: 127
EMC 2004 P. R. Levy Vol #: 127
EMC 2005 L. Harrison Vol #: 127
EMC 2006 M. Wylie Vol #: 127
EMC 2007 C. Nugent Vol #: 127
EMC 2008 H. Logan Vol #: 127
EMC 2009 M. Casebourn Vol #: 127
EMC 2010 J. Nichols Vol #: 127
EMC 2011 P. Hock Vol #: 127
EMC 2012 S. Pelican Vol #: 127
EMC 2013 J. Williams Vol #: 127
EMC 2014 V. Shannon Vol #: 127
EMC 2015 J. Gamble Vol #: 127
EMC 2016 M. Pacific Vol #: 127
EMC 2017 B. Mclaughlin Vol #: 127
EMC 2018 J. Bennett Vol #: 127
EMC 2019 J. Dawes Vol #: 127
EMC 2020 A. Carnes Vol #: 127
EMC 2021 V. Bush Vol #: 127
EMC 2022 C. Jones Vol #: 127
EMC 2023 C. Papke Vol #: 127
EMC 2024 M. Smith Vol #: 127
EMC 2025 A. Prado Vol #: 127
EMC 2026 J. King Vol #: 127
EMC 2027 A. Gunn Vol #: 127
EMC 2028 S. Gerken Vol #: 127
EMC 2029 Alyce Kalmer Vol #: 127
EMC 2030 J. Ness Vol #: 127
EMC 2031 C. Asmann Vol #: 127
EMC 2032 C. Phelps Vol #: 127
EMC 2033 A. Lebowitz Vol #: 127
EMC 2034 M. Delaney Vol #: 127
EMC 2035 T. Smith Vol #: 127
EMC 2036 S. Dollschnieder Vol #: 127
EMC 2037 E. Cattaneo Vol #: 127
EMC 2038 S. Rice Vol #: 127
EMC 2039 H. Rowe Vol #: 127
EMC 2040 S. Granger Vol #: 127
EMC 2041 Dr. R.S. Tannenbaum Vol #: 127
EMC 2042 K. Updegrove Vol #: 127
EMC 2043 J. Larson Vol #: 127
EMC 2044 C. Conley Vol #: 127
EMC 2045 R. Wilson Vol #: 127
EMC 2046 K. Breakstone Vol #: 127
EMC 2047 M. Benjamin Vol #: 127
EMC 2048 S. Camacho Vol #: 127
EMC 2049 R. Turrin Vol #: 127
EMC 2050 L. Eby Vol #: 127
EMC 2051 L. Marcato Vol #: 127
EMC 2052 J. Fisher Vol #: 127
EMC 2053 B. Kufalk Vol #: 127
EMC 2054 A. Dixon Vol #: 127
EMC 2055 R. Teasley Vol #: 127
EMC 2056 D. Corle Vol #: 127
EMC 2057 J.T. Schwob Vol #: 127
EMC 2058 A. Caldwell Vol #: 127
EMC 2059 S. Hodgins Vol #: 127
EMC 2060 E. Marom Vol #: 127
EMC 2061 M. Roeper Vol #: 127
EMC 2062 K. Anderson Vol #: 127
EMC 2063 M. Maxwell Vol #: 127
EMC 2064 A. Richards Vol #: 127
EMC 2065 S.R. Alpert Vol #: 127
EMC 2066 S. Chiarello Vol #: 127
EMC 2067 W. Ross Vol #: 127
EMC 2068 S. Walker Vol #: 127
EMC 2069 C. Anderson Vol #: 127
EMC 2070 J. Farmer Vol #: 127
EMC 2071 A. Lambert Vol #: 127
EMC 2072 E. DeCarlo Vol #: 127
EMC 2073 D. Meister Vol #: 127
EMC 2074 E. Smart Vol #: 127
EMC 2075 S. Birnbaum Vol #: 127
EMC 2076 C. James Vol #: 127
EMC 2077 K. Bermingham Vol #: 127
EMC 2078 S. Meyer Vol #: 127
EMC 2079 R. Rodin Vol #: 127
EMC 2080 D.J. Leblanc Vol #: 127
EMC 2081 S. French Vol #: 127
EMC 2082 C.A. Baier Vol #: 127
EMC 2083 S. Anderson Vol #: 127
EMC 2084 C. Dunwoody Vol #: 127
EMC 2085 J. Read Vol #: 127
EMC 2086 A. Heimburger Vol #: 127
EMC 2087 J.S. Warren Vol #: 127
EMC 2088 J. Nice Vol #: 127
EMC 2089 Rev. M. Miller Vol #: 127
EMC 2090 M. Sheldon Vol #: 127
EMC 2091 K. Ratynski Vol #: 127
EMC 2092 J. Pire Vol #: 127
EMC 2093 T. Blake Vol #: 127
EMC 2094 K. Rudd Vol #: 127
EMC 2095 J.C. Kenna Vol #: 127
EMC 2096 R. Bieniak Vol #: 127
EMC 2097 M. Pierre Vol #: 127
EMC 2098 Z. LaRosa Vol #: 127
EMC 2099 C. Scaglione Vol #: 127
EMC 2100 T. Winterhoff Vol #: 127
2002D-0525 Medical Devices; Chemical Indicators Premarket Notification
GDL 2 GUIDANCE Vol #: 1
NAD 2 FDA Vol #: 1
2002N-0276 Bioterrorism Preparedness; Registration of Food Facilities
EC 332 Kinter, Marcia Vol #: 20
EC 333 Bown, Leman Vol #: 20
EC 334 Kettel, James Vol #: 20
EC 335 Rice, Martin Vol #: 20
EC 336 Maxwell, Robert Vol #: 20
EC 337 Maxwell, Robert Vol #: 20
EC 338 McDonald, Ann Vol #: 20
EC 339 Yoo, Dong Hee Vol #: 20
EC 340 Andrus, Katherine Vol #: 20
EC 341 Sidaway-Wolf, Daphne Vol #: 20
EC 342 Gorny, James Vol #: 20
EC 343 Gorny, James Vol #: 20
EC 344 Gorny, James Vol #: 20
EC 345 Fortin, Carole Vol #: 20
EC 346 Nagle, Nancy Vol #: 20
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
EC 352 Kjaer, Poul Vol #: 21
EC 353 Halligan, David Vol #: 21
EC 354 Johnston, Ted Vol #: 21
EC 355 Menkes, Paul Vol #: 21
EC 356 Lubeskie, David Vol #: 21
EC 357 Bown, Leman Vol #: 21
EC 358 Lubeskie, David Vol #: 21
EC 359 Hutchinson, Colin Vol #: 21
EC 360 Lubeskie, David Vol #: 21
EC 361 Kettel, James Vol #: 21
EC 362 Briggs, Barrie Vol #: 21
EC 363 Rice, Martin Vol #: 21
EC 364 Maxwell, Robert Vol #: 21
EC 365 Maxwell, Robert Vol #: 21
EC 366 Yoo, Dong Hee Vol #: 21
EC 367 Tepoorten, Mark Vol #: 21
EC 368 Hamid-Hardenberg, Inge Vol #: 21
EC 369 Barzelay, Douglas Vol #: 21
EC 370 Andrus, Katherine Vol #: 21
EC 371 Reyes, Carlos Vol #: 21
EC 372 Cohen, Dennis Vol #: 21
EC 373 Lubeskie, David Vol #: 21
EC 374 Lubeskie, David Vol #: 21
EC 375 Traner, Norman Vol #: 21
EC 376 Reinauer, Greg Vol #: 21
EC 377 Sidaway-Wolf, Daphne Vol #: 21
EC 378 Bengard, Karen Vol #: 21
EC 379 Sidaway-Wolf, Daphne Vol #: 21
EC 380 Richards, Bruce Vol #: 21
EMC 153 Canadian Trucking Allinace (CTA) Vol #: 21
EMC 154 London Agricultural Commodities, Inc. Vol #: 21
EMC 155 American Association of Exporters and Importers Vol #: 21
EMC 156 Seminis Inc. Vol #: 21
EMC 157
Enclosure
Australian Government Vol #: 21
EMC 158 J & K Fresh, LLC Vol #: 21
EMC 159 Sirva Inc. Vol #: 21
EMC 160 Canadian Courier & Messenger Association Vol #: 21
2003D-0549 Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2003D-0562 Compliance Policy Guide Sec.110.300 b
GDL 1 GUIDANCE Vol #: 1
NAD 1 FDA Vol #: 1
2003N-0528 Revision of the Requirements for Spore-Forming Microorganisms
NFR 1 FDA Vol #: 1
NPR 1 FDA Vol #: 1

Page created on December 31, 2003 dp
Page updated by January 23, 2004 jb

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