Dockets Entered on July 19, 2007

Dockets Management



Dockets Entered On July 19, 2007



Docket #	Title

1994D-0025	Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

1994N-0355	Quinine treatment/prevention of Malaria for OTC Human Use

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

2004P-0448	DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)

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

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006P-0428	Combivent (ipratropium bromide and albuterol sulfate)

2007D-0212	Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis

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

2007N-0155	Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop

2007N-0186	Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary


2007P-0004	Take steps to insure the safety of Americans regarding the misuses of Lasik

1994D-0025	Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8590	Dennis R. Mahoney & Alicia J. Mahoney	Vol #:	116

1994N-0355	Quinine treatment/prevention of Malaria for OTC Human Use

C 2	Joseph K. Kiraly MD	Vol #:	1

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

C 252	Russell Walker	Vol #:	43

C 253	Wendy Wilson	Vol #:	43

C 254	Phil Whitehead	Vol #:	43

C 255	Loydelle McElyea	Vol #:	43

2004P-0448	DERMA-SMOOTHE/FS(fluocinolone acetonide 0.01% topical oil)

LET 6	Hill Dermaceuticals, Inc.	Vol #:	1

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

C 1995	J. Ly	Vol #:	27

C 1996	L. Leibowitz	Vol #:	27

C 1997	L. Romano	Vol #:	27

C 1998	P. Hostetler	Vol #:	27

C 1999	M. Daitzman	Vol #:	27

C 2000	I. J. Barzak	Vol #:	27

C 2001	D. Esposito	Vol #:	27

C 2002	G. Smay	Vol #:	27



C 2003	H. Lewis	Vol #:	27

C 2004	R. Graham	Vol #:	27

C 2005	L. Bariga	Vol #:	27

C 2006	C. Jallits	Vol #:	27

C 2007	R. Malone	Vol #:	27

C 2008	S. Gioia	Vol #:	27

C 2009	T. Bryant	Vol #:	27

C 2010	C. Bolden	Vol #:	27

C 2011	J. Soucie	Vol #:	27

C 2012	T. Huey	Vol #:	27

C 2013	R. Sobel	Vol #:	27

C 2014	V. Giganti	Vol #:	27

C 2015	S. Walters	Vol #:	27

C 2016	J. Moore	Vol #:	27

C 2017	D. Robertson	Vol #:	27

C 2018	R. Marr	Vol #:	27

C 2019	D. Skolnik	Vol #:	27

C 2020	J. Partridge	Vol #:	27

C 2021	F. Ingram	Vol #:	27

C 2022	J. Flint	Vol #:	27

C 2023	C. Degner	Vol #:	27

C 2024	K. Reitz	Vol #:	27

C 2025	L. Schiller	Vol #:	27

C 2026	J. Henriques	Vol #:	27

C 2027	C. Singer	Vol #:	27

C 2028	C. Riggs	Vol #:	27

C 2029	S. Huskey	Vol #:	27

C 2030	C. Kobierowski	Vol #:	27

C 2031	D. Dungan	Vol #:	27

C 2032	M. Bentley-deloria	Vol #:	27

C 2033	A. Zariski	Vol #:	27

C 2034	P. Avila	Vol #:	27

C 2035	W. Romatowski	Vol #:	27

C 2036	P. Pugliani	Vol #:	27

C 2037	M. Huntley	Vol #:	27

C 2038	G. Madaras	Vol #:	27

C 2039	E. Bobbitt	Vol #:	27



C 2040	D. Eades	Vol #:	27

C 2041	P. Wells	Vol #:	27

C 2042	G. Simmons	Vol #:	27

C 2043	C. Martin	Vol #:	27

C 2044	F. K. Moore	Vol #:	27

C 2045	K. Makarewicz	Vol #:	27

C 2046	V. Wilt	Vol #:	27

C 2047	J. Soos	Vol #:	27

C 2048	J. Nirenberg	Vol #:	27

C 2049	M. Neddermeyer	Vol #:	27

C 2050	C. Platts	Vol #:	27

C 2051	P. True	Vol #:	27

C 2052	E. Garvey	Vol #:	27

C 2053	M. Kren	Vol #:	27

C 2054	R. Effa	Vol #:	27

C 2055	M. Gales	Vol #:	27

C 2056	R. Mcteer-ramirez	Vol #:	27

C 2057	C. Colburn	Vol #:	27

C 2058	K. Parcheta	Vol #:	27

C 2059	D. Barnhart	Vol #:	27

C 2060	P. Haynes	Vol #:	27

C 2061	K. Dalenberg	Vol #:	27

C 2062	L. Griswold	Vol #:	27

C 2063	K. Daddow	Vol #:	27

C 2064	A. Perez	Vol #:	27

C 2065	J. Matthai	Vol #:	27

C 2066	J. Crowley	Vol #:	27

C 2067	J. Longo	Vol #:	27

C 2068	S. Roulston-doty	Vol #:	27

C 2069	Reverend S. Wood	Vol #:	27

C 2070	K. Hegemann	Vol #:	27

C 2071	K. Sarnoff	Vol #:	27

C 2072	J. Decaria	Vol #:	27

C 2073	R. T.	Vol #:	27

C 2074	T. Feeko	Vol #:	27

C 2075	R. Schneider	Vol #:	27

C 2076	H. Noel	Vol #:	27



C 2077	J. M.	Vol #:	27

C 2078	V. Small	Vol #:	27

C 2079	R. Rose	Vol #:	27

C 2080	L. Granito	Vol #:	27

C 2081	M. Sinclair	Vol #:	27

C 2082	D. A. Amyx	Vol #:	27

C 2083	C. K. Davis	Vol #:	27

C 2084	R. Pasichnyk	Vol #:	27

C 2085	G. Sams	Vol #:	27

C 2086	D. Sinisi	Vol #:	27

C 2087	A. Sennish	Vol #:	27

C 2088	J. Davidson	Vol #:	27

C 2089	P. Jacquez	Vol #:	27

C 2090	P. Swank	Vol #:	27

C 2091	L. Sparks	Vol #:	27

C 2092	K. Pennell	Vol #:	27

C 2093	J. Doucet	Vol #:	27

C 2094	M. Funderbuck	Vol #:	27

C 2095	J. Larew	Vol #:	27

C 2096	D. Thoma	Vol #:	27

C 2097	N. Stevenson	Vol #:	27

C 2098	B. Burkett	Vol #:	27

C 2099	D. Rasmussen	Vol #:	27

C 2100	N. Cooper	Vol #:	27

C 2101	D. Douglas	Vol #:	27

C 2102	J. Fenner	Vol #:	27

C 2103	M. Devlin	Vol #:	27

C 2104	R. Harris	Vol #:	27

C 2105	P. Blum	Vol #:	27

C 2106	R. M. Hervey	Vol #:	27

C 2107	B. Burns	Vol #:	27

C 2108	M. Riley	Vol #:	27

C 2109	S. Gorenfeld	Vol #:	27

C 2110	M. Masucci	Vol #:	27

C 2111	G. Petty	Vol #:	27

C 2112	G. Crawford	Vol #:	27

C 2113	J. Rivard	Vol #:	27



C 2114	A. Apostolidis	Vol #:	27

C 2115	M. N. Bryan	Vol #:	27

C 2116	G. Miller	Vol #:	27

C 2117	L. Gudmundson	Vol #:	27

C 2118	R. Roberts	Vol #:	27

C 2119	J. Gall	Vol #:	27

C 2120	J. Mendoza	Vol #:	27

C 2121	M. A.	Vol #:	27

C 2122	R. Uhl	Vol #:	27

C 2123	D. Mckeag	Vol #:	27

C 2124	V. Raisola	Vol #:	27

C 2125	P. Desai	Vol #:	27

C 2126	P. Mixon	Vol #:	27

C 2127	A. Al-alaiwat	Vol #:	27

C 2128	L. Corbin	Vol #:	27

C 2129	C. Voit	Vol #:	27

C 2130	J. Wenzlaff	Vol #:	27

C 2131	A. R.	Vol #:	27

C 2132	D. Tourigny & R. Boudreau	Vol #:	27

C 2133	J. F. Shockley	Vol #:	27

C 2134	K. Svadlenak-gomez	Vol #:	27

C 2135	T. Cooke	Vol #:	27

C 2136	M. Farrell	Vol #:	27

C 2137	T. Marafiote	Vol #:	27

C 2138	L. Anderson	Vol #:	27

C 2139	V. Mullins	Vol #:	27

C 2140	S. Becotte	Vol #:	27

C 2141	R. Barrios	Vol #:	27

C 2142	W. Tanner	Vol #:	27

C 2143	C. P. Terrebonne	Vol #:	27

C 2144	S. Levy Ceren	Vol #:	27

C 2145	G. Hagy	Vol #:	27

C 2146	A. Duchene	Vol #:	27

C 2147	R. Cadman	Vol #:	27

C 2148	C. Eisterhold	Vol #:	27

C 2149	T. Baldridge	Vol #:	27

C 2150	M. Costello	Vol #:	27



C 2151	J. Rockwood	Vol #:	27

C 2152	C. Hunter	Vol #:	27

C 2153	M. J. Simmons	Vol #:	27

C 2154	R. Fessenbecker	Vol #:	27

C 2155	A. Albertson Murphy	Vol #:	27

C 2156	L. Ivey	Vol #:	27

C 2157	C. Bodnarchuk	Vol #:	27

C 2158	A. Rhodes	Vol #:	27

C 2159	M. Flowers	Vol #:	27

C 2160	J. Bronson	Vol #:	27

C 2161	C. Roberts	Vol #:	27

C 2162	J. Girardin	Vol #:	27

C 2163	H. Scott	Vol #:	27

C 2164	J. Gargiulo	Vol #:	27

C 2165	R. Lee	Vol #:	27

C 2166	S. Asher	Vol #:	27

C 2167	P. Lunn	Vol #:	28

C 2168	L. E. Cruze	Vol #:	28

C 2169	D. Pon	Vol #:	28

C 2170	S. Eanes	Vol #:	28

C 2171	K. Nelson	Vol #:	28

C 2172	J. Stone	Vol #:	28

C 2173	S. And B. Fisher	Vol #:	28

C 2174	J. Brady	Vol #:	28

C 2175	E. Steurer	Vol #:	28

C 2176	M. Snyder	Vol #:	28

C 2177	J. Ford	Vol #:	28

C 2178	N. Cox	Vol #:	28

C 2179	D. Kobylarz	Vol #:	28

C 2180	T. Anderson	Vol #:	28

C 2181	I. Lillien	Vol #:	28

C 2182	A. Rahhal	Vol #:	28

C 2183	S. Sewell	Vol #:	28

C 2184	M. Ribuffo	Vol #:	28

C 2185	S. Kipping	Vol #:	28

C 2186	K. B. Fisher	Vol #:	28

C 2187	K. Deamer	Vol #:	28



C 2188	A. Gorrell	Vol #:	28

C 2189	M. Adkison	Vol #:	28

C 2190	T. Banister	Vol #:	28

C 2191	P. Fisher	Vol #:	28

C 2192	L. Vickerman	Vol #:	28

C 2193	J. Kilpatrick	Vol #:	28

C 2194	J. Twombly	Vol #:	28

C 2195	C. Lamarr	Vol #:	28

C 2196	J. Berns	Vol #:	28

C 2197	B. Morrow	Vol #:	28

C 2198	T. Yunis	Vol #:	28

C 2199	S. Jobke	Vol #:	28

C 2200	M. Lord	Vol #:	28

C 2201	M. Erickson	Vol #:	28

C 2202	A. Gusty	Vol #:	28

C 2203	L. Mecham	Vol #:	28

C 2204	M. L. Dubay	Vol #:	28

C 2205	J. Peitavino	Vol #:	28

C 2206	L. Uzzell	Vol #:	28

C 2207	S. Higdon	Vol #:	28

C 2208	J. Wester	Vol #:	28

C 2209	S. Plenn	Vol #:	28

C 2210	R. Brown	Vol #:	28

C 2211	E. Howard	Vol #:	28

C 2212	A. Olsen	Vol #:	28

C 2213	C. Leonard	Vol #:	28

C 2214	P. Chubbuck	Vol #:	28

C 2215	B. Taylor	Vol #:	28

C 2216	I. Delvecchio	Vol #:	28

C 2217	A. Lefton	Vol #:	28

C 2218	R. Reed	Vol #:	28

C 2219	D. Enedot	Vol #:	28

C 2220	E. Brown	Vol #:	28

C 2221	J. Robles	Vol #:	28

C 2222	D. Cameron	Vol #:	28

C 2223	S. Lyle	Vol #:	28

C 2224	G. Aliberti	Vol #:	28



C 2225	D. Wilson	Vol #:	28

C 2226	D. Brooks	Vol #:	28

C 2227	S. Killay	Vol #:	28

C 2228	S. Hibshman	Vol #:	28

C 2229	L. G. Albano	Vol #:	28

C 2230	R. Parham	Vol #:	28

C 2231	B. Murphy	Vol #:	28

C 2232	J. A. Ishler	Vol #:	28

C 2233	R. Ang	Vol #:	28

C 2234	V. Fillingim	Vol #:	28

C 2235	D. Gregg	Vol #:	28

C 2236	B. Aldrich	Vol #:	28

C 2237	K. Reynolds	Vol #:	28

C 2238	S. Mcdermott	Vol #:	28

C 2239	D. Zwirtz	Vol #:	28

C 2240	C. Frey	Vol #:	288

C 2241	R. Boersema	Vol #:	28

C 2242	J. C. Melish	Vol #:	28

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 18327	A. Laster	Vol #:	198

C 18328	W. Sauls	Vol #:	198

2006P-0428	Combivent (ipratropium bromide and albuterol sulfate)

C 4	Alpha-1 Foundation	Vol #:	1

2007D-0212	Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis

C 1	World Health Organization	Vol #:	1

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

C 8	Medicine Shoppe International, Inc.	Vol #:	7

C 9	Mark de Bruin, R.Ph.	Vol #:	7

2007N-0155	Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop

C 1	AdvaMed	Vol #:	1

2007N-0186	Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary



C 1	Dona Offemaria	Vol #:	1



2007P-0004	Take steps to insure the safety of Americans regarding the misuses of Lasik

EMC 5	Dean Kantis	Vol #:	1

Page created on July 23, 2007 ue

FDA/Dockets Management