Dockets Entered on December 30, 2003

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2003D-0549	Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision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 #: