Dockets Entered on September 12, 2007

Dockets Management



Dockets Entered On September 12, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

1995S-0158	Community Disclosure of Institutional Review Boards

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

2002D-0081	Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

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

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007N-0064	Electronic Case Report Form Submission; Notice of Pilot Project

2007N-0230	Agency Information Collection Activities; Proposed Collection; Comment Request; Information From U.S. Processors That Export to the European Community

2007P-0297	Request to reconsider the failure to approve Provenge

1978N-0038	Sunscreen Drug Products

EC 2380	Mrs. Sarah Tims	Vol #:	161

EC 2381	Ms. Danielle Sanches	Vol #:	161

EC 2382	Mr. Scott McKinnon	Vol #:	161

EC 2383	Ms. Louise Hersey	Vol #:	161

EC 2384	Mrs. cheryl farsalas	Vol #:	161

EC 2385	Mrs. Cathy Mac Intire	Vol #:	161

EC 2386	Ms. Eugenia Dillard	Vol #:	161

EC 2387	Mrs. maureen womack	Vol #:	161

1995S-0158	Community Disclosure of Institutional Review Boards

RPT 23	ROC	Vol #:	58

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

RPT 405	Sabinsa Corporation	Vol #:	320

RPT 406	TC Associates, Inc/Algatechnologies (1998) Ltd.	Vol #:	321

RPT 407	Kopali Organics, LLC	Vol #:	322

RPT 408	America Natural Herbs, LLC.	Vol #:	322

RPT 409	Kemin Health, LC	Vol #:	323

RPT 410	Nikken Sohonsha Corp	Vol #:	324

RPT 411	Choice USA International Corp.	Vol #:	325

RPT 412	Kemin Health, LC	Vol #:	326

2002D-0081	Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood

C 4	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010



N 9	FDA	Vol #:	1

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

C 2069	J. Medalen	Vol #:	25

C 2070	M Martiz	Vol #:	25

C 2071	M Newton	Vol #:	25

C 2072	J Garcia	Vol #:	25

C 2073	A Laurel	Vol #:	25

C 2074	J Harrold	Vol #:	25

C 2075	H Gomel	Vol #:	25

C 2076	J Mc Burney	Vol #:	25

C 2077	P Hamilton	Vol #:	25

C 2078	K Brady	Vol #:	25

C 2079	B Perry	Vol #:	25

C 2080	D Erickson	Vol #:	25

C 2081	W Clemes	Vol #:	25

C 2082	P Price	Vol #:	25

C 2083	M Whitlock	Vol #:	25

C 2084	J LaPointo	Vol #:	25

C 2085	M Brenzel Jr	Vol #:	25

C 2086	M Rogers	Vol #:	25

C 2087	D Jones	Vol #:	25

C 2088	G Kelly	Vol #:	25

C 2089	F Lloyd	Vol #:	25

C 2090	H Pingel	Vol #:	25

C 2091	F Inman	Vol #:	25

C 2092	B Waddle	Vol #:	25

C 2093	A Goodman	Vol #:	25

C 2094	A Pryse Jr	Vol #:	25

C 2095	R McCall	Vol #:	25

C 2096	A McIntosh	Vol #:	25

C 2097	D Trabue	Vol #:	25

C 2098	B Steven	Vol #:	25

C 2099	M Kelley	Vol #:	25

C 2100	E Littlefield	Vol #:	25

C 2101	E Miller	Vol #:	25

C 2102	C Griffin	Vol #:	25



C 2103	B Scott	Vol #:	25

C 2104	J Grande	Vol #:	25

C 2105	B Reynolds	Vol #:	25

C 2106	A Garry	Vol #:	25

C 2107	M Swenson	Vol #:	25

C 2108	A Mahalitc	Vol #:	25

C 2109	H Jackin	Vol #:	25

C 2110	E Hauck	Vol #:	25

C 2111	W Carpenter	Vol #:	25

C 2112	D Smith	Vol #:	25

C 2113	B McAtee	Vol #:	25

C 2114	B East	Vol #:	25

C 2115	C Horwitz	Vol #:	25

C 2116	E Milton	Vol #:	25

C 2117	L Hahn	Vol #:	13

C 2118	H Bryant	Vol #:	25

C 2119	V Phipyir	Vol #:	25

C 2120	J Dodson	Vol #:	25

C 2121	R Roth	Vol #:	25

C 2122	G Allman	Vol #:	25

C 2123	M Craig	Vol #:	25

C 2124	P Gallaher	Vol #:	25

C 2125	H Hammond	Vol #:	25

C 2126	K Mickels	Vol #:	25

C 2127	B Nichols	Vol #:	25

C 2128	B Snodgrass	Vol #:	25

C 2129	B Bueno	Vol #:	25

C 2130	H Satterfield	Vol #:	25

C 2131	I Roth	Vol #:	25

C 2132	F Forren	Vol #:	25

C 2133	D Spindler	Vol #:	25

C 2134	F Raley	Vol #:	25

C 2135	E Branolt	Vol #:	25

C 2136	S Kasold	Vol #:	25

C 2137	R Slawson	Vol #:	28

C 2138	W Slaby	Vol #:	25

C 2139	E Kelly	Vol #:	25



C 2140	J Towey	Vol #:	25

C 2141	S Benoit	Vol #:	25

C 2142	B Carpenter	Vol #:	25

C 2143	L. Draves	Vol #:	25

C 2144	E Fuller	Vol #:	25

C 2145	E Lange	Vol #:	25

C 2146	T Ratterman	Vol #:	25

C 2147	J illegiible last name	Vol #:	25

C 2148	N Gibson	Vol #:	25

C 2149	S Einberger	Vol #:	25

C 2150	J Reisem	Vol #:	25

C 2151	M Crunk	Vol #:	25

C 2152	B Wannemacher	Vol #:	25

C 2153	J Budde	Vol #:	25

C 2154	A Scott	Vol #:	25

C 2155	R Hergenrether	Vol #:	25

C 2156	K Sass	Vol #:	25

C 2157	J Slaybaugh	Vol #:	25

C 2158	M Higgins	Vol #:	25

C 2159	A Brooks	Vol #:	25

C 2160	R Anderson	Vol #:	25

C 2161	G Ellerkainp	Vol #:	27

C 2162	H Rice	Vol #:	25

C 2163	J French	Vol #:	25

C 2164	P Jenkins	Vol #:	25

C 2165	C Madrazo	Vol #:	25

C 2166	R Gehriz	Vol #:	25

C 2167	N Barton	Vol #:	25

C 2168	P Davis	Vol #:	25

C 2169	R Jobe	Vol #:	25

C 2170	D Thompson	Vol #:	25

C 2171	I Jhamb	Vol #:	25

C 2172	F House	Vol #:	25

C 2173	K Nonweiler	Vol #:	25

C 2174	R Trouten	Vol #:	25

C 2175	M Conway	Vol #:	25

C 2176	V Anderley	Vol #:	25



C 2177	L Brott	Vol #:	25

C 2178	D Gilbert	Vol #:	25

C 2179	E Ramberg	Vol #:	25

C 2180	R Rawlings	Vol #:	25

C 2181	M Nelsen	Vol #:	25

C 2182	J Shinn	Vol #:	25

C 2183	W Larson	Vol #:	25

C 2184	C Hearox	Vol #:	25

C 2185	H Hall	Vol #:	25

C 2186	D Cunningham	Vol #:	25

C 2187	E Reynolds	Vol #:	25

C 2188	D Campbell	Vol #:	25

C 2189	P Brazier	Vol #:	25

C 2190	F Mundee	Vol #:	25

C 2191	P Kwiatkowski	Vol #:	25

C 2192	D Erickson	Vol #:	25

C 2193	W Calton	Vol #:	25

C 2194	N Sims	Vol #:	25

C 2195	E Bumashey	Vol #:	25

C 2196	R Shapiro	Vol #:	25

C 2197	L Hansen	Vol #:	25

C 2198	V Whybrew	Vol #:	25

C 2199	J Belzer	Vol #:	25

C 2200	L Hawthorne	Vol #:	25

C 2201	N Scalis	Vol #:	25

C 2202	R Zangrillo	Vol #:	25

C 2203	A Shaw	Vol #:	25

C 2204	S Goldstein	Vol #:	25

C 2205	W Young	Vol #:	25

C 2206	A Garfinkle	Vol #:	25

C 2207	W Wall	Vol #:	25

C 2208	D Roeth	Vol #:	25

C 2209	J Hawk	Vol #:	25

C 2210	E Harrison	Vol #:	25

C 2211	M Homsey	Vol #:	25

C 2212	M Rodon	Vol #:	25

C 2213	T LaValley	Vol #:	25



C 2214	C Warren	Vol #:	25

C 2215	D Brand	Vol #:	25

C 2216	L Thomas	Vol #:	25

C 2217	W Woodard	Vol #:	25

C 2218	T Boyer	Vol #:	25

C 2219	R Simpson	Vol #:	25

C 2220	D Skibel	Vol #:	25

C 2221	M Armstrrong	Vol #:	25

C 2222	I Villano	Vol #:	25

C 2223	S Taylor	Vol #:	25

C 2224	J Hovick	Vol #:	25

C 2225	G Holiwell	Vol #:	25

C 2226	G Shealy	Vol #:	25

C 2227	L Martin	Vol #:	25

C 2228	R Droz	Vol #:	25

C 2229	A Calabrese	Vol #:	25

C 2230	A Rucker	Vol #:	25

C 2231	H Cordillan	Vol #:	25

C 2232	P Remer	Vol #:	25

C 2233	K Wilson	Vol #:	25

C 2234	F McCormick	Vol #:	25

C 2235	D Riggenbach	Vol #:	25

C 2236	R Seeger	Vol #:	25

C 2237	C Brummett	Vol #:	25

C 2238	B Pelley	Vol #:	25

C 2239	I Ward	Vol #:	25

C 2240	B Burkett	Vol #:	25

C 2241	J Cohen	Vol #:	25

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

C 8	L. Donato	Vol #:	18

C 9	Jeanie Pisano	Vol #:	18

C 10	Terri Weiss	Vol #:	18

C 11	Robert Bruce Cruickshank	Vol #:	18

C 12	J.L. Cone	Vol #:	18

C 13	Shalin G. Gala	Vol #:	18

C 14	Michelle Eslinger	Vol #:	18



C 15	Mario Maraldo	Vol #:	18

C 16	Cherie Calbom	Vol #:	18

C 17	Christine Ghiglieri	Vol #:	18

M 1	Kennon M. Smith	Vol #:	18

MT 1	Louis Brock	Vol #:	18

2007N-0064	Electronic Case Report Form Submission; Notice of Pilot Project

LET 1	Bristol-Myers Squibb Pharmaceutical Research Institute	Vol #:	1

2007N-0230	Agency Information Collection Activities; Proposed Collection; Comment Request; Information From U.S. Processors That Export to the European Community

N 2	FDA	Vol #:	1

2007P-0297	Request to reconsider the failure to approve Provenge

EC 75	Mr. Sidney Eschenbach	Vol #:	1

EC 76	Mr. Hemang Parekh	Vol #:	1

EC 77	Pfizer, Inc.	Vol #:	1

EC 78	N/A	Vol #:	1

EC 79	Dr. Krzysztof Bienkowski	Vol #:	1

EC 80	Holmes Enterprises	Vol #:	1

EC 81	Mr. Greg Gilbert	Vol #:	1

EC 82	Mr. terry bole	Vol #:	1

EC 83	Mr. m rao	Vol #:	1

EC 84	Mr. Daniel Burnett	Vol #:	1

EC 85	Mr. Robert Oxenfeld	Vol #:	1

EC 86	Mr. George Krautter	Vol #:	1

EC 87	Mrs. Hilde Vander Stuyft	Vol #:	1

EC 88	Mr. jerome keyes	Vol #:	1

EC 89	Mr. Guy Greco	Vol #:	1

EC 90	Mr. J.J. McGrath	Vol #:	1

EC 91	Mr. Matthew Connolly	Vol #:	1

EC 92	Mr. Christopher P Devoy	Vol #:	1

EC 93	Mr. robert long	Vol #:	1

EC 94	Mr. Bernard Nagelvoort	Vol #:	1

EC 95	Mr. Paul Batchie	Vol #:	1

EC 96	Mr. Daniel McCarthy	Vol #:	1

EC 97	Mr. Kenneth Farrar	Vol #:	1

EC 98	Mr. Peter McGrath	Vol #:	1

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FDA/Dockets Management