Dockets Entered on November 17, 2006

Dockets Management



Dockets Entered On November 17,2006



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

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

2005P-0402	Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

2006P-0394	Revise the labeling requirements for eggs sold in the United States

1978N-0065	Skin Bleaching Drug Products

EC 50	Dr. Robert Bader	Vol #:	4

EC 51	Dr. Iris Gin	Vol #:	4

EC 52	Dr. wendy Long	Vol #:	4

EC 53	Dr. William Long	Vol #:	4

EC 54	Dr. Robert Benson	Vol #:	4

EC 55	Marshfield Clinic	Vol #:	4

EC 56	Dr. Nicole Hayre	Vol #:	4

EC 57	SkinCare Physicians, Inc.	Vol #:	4

EC 58	Dr. zheng qian	Vol #:	4

EC 59	Dr. Ellen de Coninck	Vol #:	4

EC 60	Grossman Dermatology	Vol #:	4

EC 61	Dr. Douglas Woseth	Vol #:	4

EC 62	SkinCare Physicians	Vol #:	4

EC 63	skin cancer specialists, p.c.	Vol #:	4

EC 64	SkinCare Physicians	Vol #:	4

EC 65	Dr. Margaret Weiss	Vol #:	4

EC 66	Penn State Medical Center Dept of Dermatology	Vol #:	4

EC 67	American Society of Dermatologic Surgery	Vol #:	4

EC 68	Dermatology	Vol #:	4

EC 69	University of Alabama - Dept of Dermology	Vol #:	4

EC 70	Dr. Darlene Sampson	Vol #:	4

EC 71	Dr. Robert Haber	Vol #:	4

EC 72	Dr. Eleanor Ford	Vol #:	4

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

RPT 359	DOX LLC	Vol #:	270

RPT 360	Ajinomoto USA Inc	Vol #:	281



RPT 361	Center fro Lifestyle Disease	Vol #:	270

2005P-0402	Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."


LET 18	FDA to the Honorable Rush D. Holt	Vol #:	5

2006D-0331	Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

EC 55	OHSU	Vol #:	3

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases


EC 1830	Mrs. Cecilia Reising	Vol #:	8

EC 1831	Nurturing Touch	Vol #:	8

EC 1832	Miss. Kira Haluszczak	Vol #:	8

EC 1833	Ms. Carol Craik	Vol #:	8

EC 1834	Mr. Michael Greco	Vol #:	8

EC 1835	Mr. Bruce Birge	Vol #:	8

EC 1836	Mr. Brian du Quesnay	Vol #:	8

EC 1837	Mrs. Carol Preiss	Vol #:	8

EC 1838	Mrs. Angela Pennisi	Vol #:	8

EC 1839	Mrs. jeanne wonio	Vol #:	8

EC 1840	Mrs. Kerry Parlor	Vol #:	8

EC 1841	Mr. Tom Heinold	Vol #:	8

EC 1842	Mr. Martin Cameron	Vol #:	8

EC 1843	Mrs. Patricia Creel	Vol #:	8

EC 1844	Mrs. Carmela Benjamin	Vol #:	8

EC 1845	Mrs. Marguerite Sumeraj	Vol #:	8

EC 1846	Mr. Bruce Benjamin	Vol #:	8

EC 1847	Mr. Leon Gallagher	Vol #:	8

EC 1848	Mrs. Cindy Winkles	Vol #:	8

EC 1849	Dr. Joseph Evers	Vol #:	8

EC 1850	Mrs. Paula Brown	Vol #:	8

EC 1851	Mrs. Karan Bowerman	Vol #:	8

EC 1852	Mrs. Dawn Beck	Vol #:	8

EC 1853	Dr. Kirk Wonio	Vol #:	8

EC 1854	Trausch Enterprises	Vol #:	8

EC 1855	Dr. Teresa Menart	Vol #:	8

EC 1856	Mrs. Anne Outarsingh	Vol #:	8



EC 1857	Tyler Diocesan Council of Catholic Women	Vol #:	8

EC 1858	Mrs. Carol Hager	Vol #:	8

EC 1859	Mrs. Paula Terrazas	Vol #:	8

EC 1860	Mr. Adam Ziegler	Vol #:	8

EC 1861	Dr. Thomas Zabiega	Vol #:	8

EC 1862	Mr. Robert W. H. Jones	Vol #:	8

EC 1863	Mr. Brendan Cronin	Vol #:	8

EC 1864	Ms. JENNIFER CHAPLIN	Vol #:	8

EC 1865	Mrs. Meghan Kelly	Vol #:	8

EC 1866	Dr. Michael Price	Vol #:	8

EC 1867	John Jay College, City University of New York	Vol #:	8

EC 1868	Mr. Rowland Hoslet	Vol #:	8

EC 1869	private citizen	Vol #:	8

EC 1870	Mr. Sean Hurley	Vol #:	8

EC 1871	Mrs. Bridget Swoger	Vol #:	8

EC 1872	Mr. Benjamin Clay	Vol #:	8

EC 1873	Mr. William Murphy	Vol #:	8

EC 1874	Mrs. renee johnson	Vol #:	8

EC 1875	Mrs. Peggy Santarpia	Vol #:	8

EC 1876	Mrs. Marsha Feingold	Vol #:	8

EC 1877	Mr. Raymond Marsh	Vol #:	8

EC 1878	Mrs. Mary Hathaway	Vol #:	8

EC 1879	Mr. Andrew Fournier	Vol #:	8

EC 1880	Dr. walter johnson	Vol #:	8

EC 1881	Sacred Heart Parish	Vol #:	8

EC 1882	Mount Carmel West Hospital	Vol #:	8

EC 1883	Mrs. sandy harlander	Vol #:	8

EC 1884	Mrs. Liliana Barkes	Vol #:	8

EC 1885	Mrs. Mary Quinn	Vol #:	8

EC 1886	Mrs. Kathryn Carter	Vol #:	8

EC 1887	Mrs. priscilla mccaffrey	Vol #:	8

EC 1888	Mrs. Jennifer Tutwiler	Vol #:	8

EC 1889	Mrs. Rose Anna Nelson	Vol #:	8

EC 1890	Mrs. Sherry Cleveland	Vol #:	8

2006N-0352	Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam

C 114	A. Siess, Jr.	Vol #:	25



C 115	Y. Mattox	Vol #:	25

C 116	J. Burghorn	Vol #:	25

C 117	P. Wellin	Vol #:	25

C 118	A. Gorg	Vol #:	25

C 119	K. Johnson	Vol #:	25

C 120	R. Levine	Vol #:	25

C 121	L. Eterian, D.C.	Vol #:	25

C 122	T. Jennings	Vol #:	25

C 123	J. Mundall, M.D.	Vol #:	25

C 124	Consumers for Dental Choice	Vol #:	25

C 125	D. Massingill	Vol #:	25

C 126	C. Rees	Vol #:	25

C 127	A. Whaley	Vol #:	25

C 128	P. Jordan	Vol #:	25

C 129	A. Tibau	Vol #:	25

C 130	No signature	Vol #:	25

C 131	A. Tibau	Vol #:	25

C 132	K. Daubenmier	Vol #:	25

C 133	G. Ivey	Vol #:	25

C 134	R. Harrison	Vol #:	25

C 135	Dr. B. McNeil	Vol #:	25

C 136	I. Potter, L.Ac	Vol #:	25

C 137	A. Summer, PhD	Vol #:	25

C 138	D. Hanisch	Vol #:	25

C 139	R. Fecteau, PhD	Vol #:	25

C 140	R. Burrows	Vol #:	25

C 141	N. Frezados	Vol #:	25

C 142	Consumers for Dental Choice	Vol #:	25

C 143	H. Garlinger	Vol #:	25

C 144	Consumers for Dental Choice	Vol #:	25

C 145	B. Rider	Vol #:	25

C 146	R. Bucher	Vol #:	25

C 147	E. Connett	Vol #:	25

C 148	F and I Beaumont	Vol #:	25

C 149	M. Hearn	Vol #:	25

C 150	S. Berkun	Vol #:	25

C 151	K. Blackett	Vol #:	25



C 152	C. KAye	Vol #:	25

C 153	T. Rodgers	Vol #:	25

C 154	S. O'Neil	Vol #:	25

C 155	A. MAtthei	Vol #:	25

C 156	J. Nielsen, MD	Vol #:	25

C 157	R. Ferron	Vol #:	25

C 158	C. Zimmerman	Vol #:	25

C 159	No signature	Vol #:	25

2006P-0394	Revise the labeling requirements for eggs sold in the United States

EC 409	Mr. George Mizia	Vol #:	7

EC 410	Ms. Jennifer Warner	Vol #:	7

EC 411	Mr. Kamesh Bulusu	Vol #:	7

EC 412	Ms. Melanie Henley	Vol #:	7

EC 413	Miss. Cortney Sdao	Vol #:	7

EC 414	Ms. Teresa Parcell	Vol #:	7

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FDA/Dockets Management