Dockets Entered on July 18, 2007

Dockets Management



Dockets Entered On July 18, 2007



Docket #	Title

1998N-0359	Program priorities/Center for Food Safety & Applied Nutrition

2003N-0573	Draft Animal Cloning Risk Assessment

2005N-0272	Irradiation in the Production, Processing & Handling of Food

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006P-0218	To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension

2007D-0106	Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

2007N-0208	Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability

2007P-0023	Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute

2007P-0028	Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

1998N-0359	Program priorities/Center for Food Safety & Applied Nutrition

C 126	National Alliance for Breastfeeding Advocacy (NABA)	Vol #:	10

2003N-0573	Draft Animal Cloning Risk Assessment

C 4059	M. Jonas	Vol #:	238

C 4060	D. Roth	Vol #:	238

C 4061	I. Armos	Vol #:	238

C 4062	O. Smith	Vol #:	238

C 4063	A. Morris	Vol #:	238

2005N-0272	Irradiation in the Production, Processing & Handling of Food

C 1725	J. Novack	Vol #:	19

C 1726	S. Grannell	Vol #:	19

C 1727	A. Hernandez	Vol #:	19

C 1728	C. J. Hayes	Vol #:	19

C 1729	C. Moschopulos	Vol #:	19

C 1730	T. Wiebe	Vol #:	19

C 1731	L. Parham	Vol #:	19

C 1732	B. Cornelius	Vol #:	19

C 1733	D. O'neill	Vol #:	19

C 1734	T. Reed	Vol #:	19

C 1735	V. & J. Volmensky	Vol #:	19

C 1736	K. Lott	Vol #:	19

C 1737	T. W. Sanchez	Vol #:	19



C 1738	D. Mccaslin	Vol #:	19

C 1739	T. Lovdal	Vol #:	19

C 1740	M. Henderson	Vol #:	19

C 1741	B. And J. Tache	Vol #:	19

C 1742	M. Ward	Vol #:	19

C 1743	M. Thompson	Vol #:	19

C 1744	S. Wax	Vol #:	19

C 1745	F. Cangialosi	Vol #:	19

C 1746	J. Gowdy	Vol #:	19

C 1747	R. Coones	Vol #:	19

C 1748	B. Kilbourne	Vol #:	19

C 1749	E. Stogner	Vol #:	19

C 1750	L. Braley	Vol #:	19

C 1751	D. Ingram	Vol #:	19

C 1752	D. Williams	Vol #:	19

C 1753	S. Savage	Vol #:	19

C 1754	L. Wall	Vol #:	19

C 1755	S. Book-lover	Vol #:	19

C 1756	N. Garvin	Vol #:	19

C 1757	A. Katahira	Vol #:	19

C 1758	S. Hildeman	Vol #:	19

C 1759	C. Dobson	Vol #:	19

C 1760	G. Raucher	Vol #:	19

C 1761	R. Robey	Vol #:	19

C 1762	C. Blackwell	Vol #:	19

C 1763	J. Acton	Vol #:	19

C 1764	W. Hardy	Vol #:	19

C 1765	D. Bell	Vol #:	19

C 1766	S. Gridley	Vol #:	19

C 1767	B. L. Melton	Vol #:	19

C 1768	J. Steitz	Vol #:	19

C 1769	S. Younger	Vol #:	19

C 1770	L. Sorensen	Vol #:	19

C 1771	J. Keltner	Vol #:	19

C 1772	A. Schutz	Vol #:	19

C 1773	K. Tenerowicz	Vol #:	19

C 1774	G. Bp	Vol #:	19



C 1775	G. Camhi	Vol #:	19

C 1776	M. Montes	Vol #:	19

C 1777	L. Johns	Vol #:	19

C 1778	D. Wilson	Vol #:	19

C 1779	C. Henry	Vol #:	19

C 1780	D. Bernstein	Vol #:	19

C 1781	M. & M. Campbell	Vol #:	19

C 1782	S. Rittel-dunn	Vol #:	19

C 1783	J. Cali	Vol #:	19

C 1784	G. Young	Vol #:	19

C 1785	L. Quinn	Vol #:	19

C 1786	C. Hohman	Vol #:	19

C 1787	M. Alexander	Vol #:	19

C 1788	A. Martinez	Vol #:	19

C 1789	R. Handewith	Vol #:	19

C 1790	A. S. Namaste	Vol #:	19

C 1791	J. Wenzlow	Vol #:	19

C 1792	N. Dammann	Vol #:	19

C 1793	M. Drake	Vol #:	19

C 1794	D. Clancy	Vol #:	19

C 1795	A. P. Hart	Vol #:	19

C 1796	L. Weinberg	Vol #:	19

C 1797	J. Wilson	Vol #:	19

C 1798	M. (lartry D. Adams)	Vol #:	19

C 1799	S. R. Sullivan	Vol #:	19

C 1800	T. Scheinkman	Vol #:	19

C 1801	J. Hedge	Vol #:	19

C 1802	A. Favor	Vol #:	19

C 1803	S. Graham	Vol #:	19

C 1804	T. Wynn	Vol #:	19

C 1805	P. Peters	Vol #:	19

C 1806	C. Larsen	Vol #:	19

C 1807	M. Mccreary	Vol #:	19

C 1808	L. Gibson	Vol #:	19

C 1809	K. Cook	Vol #:	19

C 1810	M. Kasdan	Vol #:	19

C 1811	T. Wickstrom	Vol #:	19



C 1812	B. Lagraff	Vol #:	19

C 1813	D. Stevens	Vol #:	19

C 1814	E. White	Vol #:	19

C 1815	J. Mull	Vol #:	19

C 1816	B. Adkins	Vol #:	19

C 1817	J. Mcconkey	Vol #:	19

C 1818	M. Schille	Vol #:	19

C 1819	D. Jensen	Vol #:	19

C 1820	K. Roby	Vol #:	19

C 1821	A. Atwill	Vol #:	19

C 1822	P. Nelson	Vol #:	19

C 1823	B. Brostoski	Vol #:	19

C 1824	A. Craft	Vol #:	19

C 1825	J. Scarpa	Vol #:	19

C 1826	M. King	Vol #:	19

C 1827	V. Conner	Vol #:	19

C 1828	C. Walker	Vol #:	19

C 1829	A. Fulton	Vol #:	19

C 1830	C. Cline	Vol #:	19

C 1831	N. Mickevich	Vol #:	19

C 1832	C. Schave	Vol #:	19

C 1833	R. Lee	Vol #:	19

C 1834	E. J. Gendron	Vol #:	19

C 1835	M. Beilstein	Vol #:	19

C 1836	E. Mcgrath	Vol #:	19

C 1837	B. Grudzien	Vol #:	19

C 1838	R. L. Dennis	Vol #:	19

C 1839	V. Berg	Vol #:	19

C 1840	R. F. Kljucec	Vol #:	19

C 1841	R. A. Witt	Vol #:	19

C 1842	D. Allen	Vol #:	19

C 1843	P. Vanhorn	Vol #:	19

C 1844	R. Ungar	Vol #:	19

C 1845	K. Dodd	Vol #:	19

C 1846	B. Shiro	Vol #:	19

C 1847	D. Lackowitz	Vol #:	19

C 1848	S. Sullivan	Vol #:	19



C 1849	M. Johnson	Vol #:	19

C 1850	S. Seal	Vol #:	19

C 1851	A. Adams	Vol #:	19

C 1852	M. Boland	Vol #:	19

C 1853	D. Couchon	Vol #:	19

C 1854	E. H.	Vol #:	19

C 1855	L. Bagley	Vol #:	19

C 1856	B. Byrd	Vol #:	19

C 1857	T. Tarleton	Vol #:	19

C 1858	D. Patrick Jr.	Vol #:	19

C 1859	A. Wall	Vol #:	19

C 1860	R. Latham-ponneck	Vol #:	19

C 1861	M. Conley	Vol #:	19

C 1862	H. Babcock	Vol #:	19

C 1863	A. Hyde	Vol #:	19

C 1864	K. Gates	Vol #:	19

C 1865	K. Richards	Vol #:	19

C 1866	M. M. Balk	Vol #:	19

C 1867	V. Allison	Vol #:	19

C 1868	V. Shontell	Vol #:	19

C 1869	S. Simon	Vol #:	19

C 1870	H. Cespedes-zane	Vol #:	19

C 1871	T. Tillman	Vol #:	19

C 1872	K. Cohn	Vol #:	19

C 1873	M. Bernier	Vol #:	19

C 1874	D. Casner	Vol #:	19

C 1875	S. Parshall	Vol #:	19

C 1876	J. Abbott	Vol #:	19

C 1877	C. Fitzpatrick	Vol #:	19

C 1878	P. Nickles	Vol #:	19

C 1879	J. Wright	Vol #:	19

C 1880	J. Laskowski	Vol #:	19

C 1881	J. Gesang	Vol #:	19

C 1882	M. Stycos	Vol #:	19

C 1883	M. Schwanitz	Vol #:	19

C 1884	L. Conklin	Vol #:	19

C 1885	S. Idelshon	Vol #:	19



C 1886	E. Jaynes	Vol #:	19

C 1887	P. Warner	Vol #:	19

C 1888	A. Sauer	Vol #:	19

C 1889	S. Smith	Vol #:	19

C 1890	H. S. Decker	Vol #:	19

C 1891	I. Smith	Vol #:	19

C 1892	E. Jackson	Vol #:	19

C 1893	J. Goetinck	Vol #:	19

C 1894	Y. Maffud	Vol #:	19

C 1895	J. Herin	Vol #:	19

C 1896	M. Meadow	Vol #:	19

C 1897	W. Shufeldt	Vol #:	19

C 1898	B. Myles	Vol #:	19

C 1899	J. Kraus	Vol #:	19

C 1900	D. Sturges	Vol #:	19

C 1901	K. Young	Vol #:	19

C 1902	F. Horboychuk	Vol #:	19

C 1903	K. Marble	Vol #:	19

C 1904	C. W. Torkay, D.d., Ph.d.	Vol #:	19

C 1905	P. Deason	Vol #:	19

C 1906	G. H. Adcock	Vol #:	19

C 1907	C. Casey	Vol #:	19

C 1908	R. Nordland	Vol #:	19

C 1909	M. Riojas	Vol #:	19

C 1910	N. Banchik	Vol #:	19

C 1911	E. Gernert	Vol #:	19

C 1912	D. Lima	Vol #:	19

C 1913	J. Lachapelle	Vol #:	27

C 1914	A. Tracy	Vol #:	27

C 1915	K. Davis	Vol #:	27

C 1916	L. Gross	Vol #:	27

C 1917	J. Hartshorn	Vol #:	27

C 1918	T. Pierce	Vol #:	27

C 1919	R. J. Cornwell	Vol #:	27

C 1920	M. Free-phelps	Vol #:	27

C 1921	J. Whitley	Vol #:	27

C 1922	M. Howe	Vol #:	27



C 1923	H. Raemsch	Vol #:	27

C 1924	H. Yorty	Vol #:	27

C 1925	R. O. Guerin	Vol #:	27

C 1926	V. Cline	Vol #:	27

C 1927	H. Wilson	Vol #:	27

C 1928	R. Weber	Vol #:	27

C 1929	R. Drennan	Vol #:	27

C 1930	A. Tingley	Vol #:	27

C 1931	V. Wellman	Vol #:	27

C 1932	J. Schreiber	Vol #:	27

C 1933	A. Rosato	Vol #:	27

C 1934	S. Deutsch	Vol #:	27

C 1935	L. Amtower	Vol #:	27

C 1936	F. M. Rodriguez	Vol #:	27

C 1937	D. Cockrell	Vol #:	27

C 1938	S. J. Smith	Vol #:	27

C 1939	S. S. Tay	Vol #:	27

C 1940	E. Clemens-Ieblanc	Vol #:	27

C 1941	G. Gatts	Vol #:	27

C 1942	J. Sendrowski	Vol #:	27

C 1943	D. Creighton	Vol #:	27

C 1944	J. Megrail	Vol #:	27

C 1945	M. Mensing	Vol #:	27

C 1946	T. Bashore	Vol #:	27

C 1947	N. Villarreal	Vol #:	27

C 1948	J. Wyatt	Vol #:	27

C 1949	N. Williams	Vol #:	27

C 1950	C. Nonnenmacher	Vol #:	27

C 1951	D. Pina	Vol #:	27

C 1952	C. Lobert	Vol #:	27

C 1953	J. Gerstner	Vol #:	27

C 1954	J. Apone	Vol #:	27

C 1955	J. Rossi	Vol #:	27

C 1956	J. Ingersoll	Vol #:	27

C 1957	A. Spaltro	Vol #:	27

C 1958	R. Stephans	Vol #:	27

C 1959	M. Breit	Vol #:	27



C 1960	M. Martin	Vol #:	27

C 1961	E. Wilken	Vol #:	27

C 1962	J. Swanson	Vol #:	27

C 1963	S. Sayre	Vol #:	27

C 1964	D. Marriott	Vol #:	27

C 1965	W. Cicio	Vol #:	27

C 1966	D. Pierce	Vol #:	27

C 1967	G. Merritt	Vol #:	27

C 1968	P. Mottola	Vol #:	27

C 1969	M. M. Miller	Vol #:	27

C 1970	R. Wendland	Vol #:	27

C 1971	P. Berger	Vol #:	27

C 1972	J. W. Oman	Vol #:	27

C 1973	M. Justice	Vol #:	27

C 1974	D. Murphrey	Vol #:	27

C 1975	V. Grayson	Vol #:	27

C 1976	L. Romans	Vol #:	27

C 1977	M. Gardner	Vol #:	27

C 1978	A. O'connor	Vol #:	27

C 1979	B. S. Evans	Vol #:	27

C 1980	R. Archambault	Vol #:	27

C 1981	C. Kalmus	Vol #:	27

C 1982	K. Oblak	Vol #:	27

C 1983	E. Truskowski	Vol #:	27

C 1984	P. Norton	Vol #:	27

C 1985	C. Davis	Vol #:	27

C 1986	C. Day	Vol #:	27

C 1987	B. Savarise	Vol #:	27

C 1988	J. Fournier	Vol #:	27

C 1989	K. L. Creghan	Vol #:	27

C 1990	Mrs. J. Pavillard	Vol #:	27

C 1991	R. Estling	Vol #:	27

C 1992	H. Parnaby	Vol #:	27

C 1993	S. Branch	Vol #:	27

C 1994	C. Bartholomew	Vol #:	27

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration



C 1350	R. Walker	Vol #:	25

C 1351	E. Cleveland	Vol #:	25

C 1352	C. Getzyy	Vol #:	25

C 1353	K. Hoffman	Vol #:	25

C 1354	M. Lindic	Vol #:	25

C 1355	N. Lindic	Vol #:	25

C 1356	K. Goldberg	Vol #:	25

C 1357	I. Edmonds	Vol #:	25

C 1358	L. McElyea	Vol #:	25

C 1359	G. Weymouth	Vol #:	25

C 1360	D. Offemaria	Vol #:	25

C 1361	W. Wilson	Vol #:	25

C 1362	J. Schattel	Vol #:	25

C 1363	M. Frankel	Vol #:	25

C 1364	P. Whitehead	Vol #:	25

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

LET 1	University of Alabama at Birmingahm (UAB)	Vol #:	1

2006P-0218	To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension

LET 2	FDA	Vol #:	1

2007D-0106	Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection

C 8	Kendle	Vol #:	1

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

C 7	Pfizer Inc.	Vol #:	7

2007N-0208	Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability

EC 2	Ms. Rose Liss	Vol #:	1

EC 3	Mrs. Wendy Smuda	Vol #:	1

2007P-0023	Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute

LET 1	FDA	Vol #:	1

LET 2	FDA	Vol #:	1

2007P-0028	Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons

LET 1	FDA	Vol #:	1

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity



C 173	R. Stuurwold	Vol #:	6

C 174	K. Bentubo	Vol #:	6

C 175	M. Wilcoxson	Vol #:	6

C 176	D. Nathan	Vol #:	6

C 177	D. Casella	Vol #:	6

Page created on July 18, 2007 ue

FDA/Dockets Management