Dockets Entered on December 20, 2006

Dockets Management



Dockets Entered On December 20, 2006 Table of Contents



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

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-0067	Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

2006N-0202	Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002


2006N-0237	Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

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

2006P-0245	Exclusivity Determination for Risperidone

2006P-0524	Withdrawal of Approval of and recall all available stock of Ziana

1978N-0065	Skin Bleaching Drug Products

C 57	Washington DC Dermatological Society	Vol #:	15

C 58	Van Dam Dermatology	Vol #:	15

C 59	Southern Illinois University	Vol #:	15

C 60	Center for Dermatology & Cosmetic Surgery	Vol #:	15

EC 159	Assoc Prof Derm, Wake Forest Univ Sch of Med	Vol #:	14

EC 160	Ms. Lynn Hennessy	Vol #:	14

EC 161	Lovley Skin .com	Vol #:	14

EC 162	Ms. Christine Fairchild	Vol #:	14

EC 163	Mrs. PAULA RIVERA	Vol #:	14

EC 164	Ms. reggie griner	Vol #:	14

EC 165	Ms. Shirley Rayer	Vol #:	14

EC 166	Ms. Patricia Herford	Vol #:	14

EC 167	Ms. MARY ADAIR	Vol #:	14

EC 168	Ms. laurie pape	Vol #:	14

EC 169	Ms. Jacyntha Billingsley	Vol #:	14

EC 170	Mrs. Janet Wilson	Vol #:	14

EC 171	Mrs. Melissa Pares	Vol #:	14

EC 172	NA	Vol #:	14

EC 173	Mrs. Janet Pry	Vol #:	14

EC 174	Mrs. Susie Roy	Vol #:	14

EC 175	Ms. Carol Franklin	Vol #:	14

EC 176	Mrs. Karen King	Vol #:	14

EC 177	Mrs. Pat Bickford	Vol #:	14

EC 178	Mrs. mel olson	Vol #:	14



EC 179	Miss. Kim Santy	Vol #:	14

EC 180	Lakeview Medical Center	Vol #:	14

EC 181	Ms. Maureen Jackson	Vol #:	14

EC 182	Mrs. Janet Roush	Vol #:	14

EC 183	Ms. Harriet Smartt	Vol #:	14

EC 184	Mrs. Corazon Quintana	Vol #:	14

EC 185	Ms. ANDREA FITZGERALD	Vol #:	14

EC 186	Mrs. Barbara Sheridan	Vol #:	14

EC 187	Mrs. Leslie Adams	Vol #:	14

EC 188	Ms. Rosemary Barnhart	Vol #:	14

EC 189	Mrs. marion ghidella/McKeag	Vol #:	14

EC 190	Mrs. Michele Gillette	Vol #:	14

EC 191	Ms. Sharon McDermott	Vol #:	14

EC 192	Mrs. Wendy Kurihara-Wong	Vol #:	14

EC 193	Ms. Carolyn Hallinan	Vol #:	14

EC 194	Ms. susan kemp	Vol #:	14

EC 195	Mr. Kent Cochran	Vol #:	14

EC 196	Mrs. M Frances Samet	Vol #:	14

EC 197	Mrs. Jennifer Howard	Vol #:	14

EC 198	Ms. linda medling	Vol #:	14

EC 199	Ms. d n	Vol #:	14

EC 200	Ms. Diane Tew	Vol #:	14

EC 201	Ms. Joy Poochigian	Vol #:	14

EC 202	Ms. Janet Raggi	Vol #:	14

EC 203	Ms. Shari Bromley	Vol #:	14

EC 204	personal	Vol #:	14

EC 205	Mrs. jeanette takenishi	Vol #:	14

EC 206	Individual Consumer	Vol #:	14

EC 207	Ms. Robin Gower	Vol #:	14

EC 208	Ms. Vicki Wright	Vol #:	14

EC 209	Ms. Karrie Oertli	Vol #:	14

EC 210	Ms. Karen Loftis	Vol #:	14

EC 211	PSI Seafoods	Vol #:	14

EC 212	Mrs. susan ritchie	Vol #:	14

EC 213	Mrs. Patricia Benak	Vol #:	14

EC 214	Mrs. Bonny Schley	Vol #:	14

EC 215	Mr. Barry Tonopolsky	Vol #:	14



EC 216	Ms. Mary Sousa	Vol #:	14

EC 217	Mrs. Christine McKinney	Vol #:	14

EC 218	Mrs. Zarah Celino	Vol #:	14

EC 219	Miss. Kim Campbell	Vol #:	14

EC 220	Ms. Patricia Parker	Vol #:	14

EC 221	Mrs. Sheila Culver	Vol #:	14

EC 222	Self	Vol #:	14

EC 223	Ms. Jo Tricia Lauberth	Vol #:	14

EC 224	Ms. Mary Pryor	Vol #:	14

EC 225	Ms. Cathy Bustamante	Vol #:	14

EC 226	Ms. Linda Young	Vol #:	14

EC 227	Ms. Lu Hsi McCoy	Vol #:	14

EC 228	Ms. lisa king	Vol #:	14

EC 229	Mrs. Maria Wittern	Vol #:	14

EC 230	Mrs. Dana Jirauch	Vol #:	14

EC 231	Mrs. Janie DeLaney	Vol #:	14

EC 232	Miss. Martina Cline	Vol #:	14

EC 233	Mrs. Maria Thorpe	Vol #:	14

EC 234	Mrs. Deborah Farner	Vol #:	14

EC 235	Ms. Lynda Smith	Vol #:	14

EC 236	Ms. Karen Shirley	Vol #:	14

EC 237	Ms. Joyce Ebel	Vol #:	14

EC 238	Miss. Aimee Black	Vol #:	14

EC 239	Mrs. Christine Laird	Vol #:	14

EC 240	Mrs. Kim Green	Vol #:	14

EC 241	Self	Vol #:	14

EC 242	Ms. T Chandler	Vol #:	14

EC 243	Ms. Lynette Marushige	Vol #:	14

EC 244	Mrs. Dawn Winnail	Vol #:	14

EC 245	self	Vol #:	14

EC 246	Mrs. vicki shields	Vol #:	14

EC 247	Ms. Nicole Hawkins	Vol #:	14

EC 248	Ms. Meryl Lynn Lombardi	Vol #:	14

EC 249	Mrs. raji good	Vol #:	14

EC 250	Ms. Kellie Mason	Vol #:	14

EC 251	Ms. Mary Cortner	Vol #:	14

EC 252	Ms. P. Alba	Vol #:	14



EC 253	Ms. M Taylor	Vol #:	14

EC 254	Ms. Lynne Hanson	Vol #:	14

EC 255	Ms. tammy mcgillen	Vol #:	14

EC 256	Mrs. Monica Knowles	Vol #:	14

EC 257	Ms. A Gregory	Vol #:	14

EC 258	Mrs. Jennie Twedt	Vol #:	14

EC 259	Mrs. brenda foster	Vol #:	14

EC 260	Ms. Nancy L Klein	Vol #:	14

EC 261	Ms. Sandra Moreno	Vol #:	14

EC 262	Ms. Sandy Amico	Vol #:	14

EC 263	Mr. Gary Schwartz	Vol #:	14

EC 264	Miss. Reena Iyer	Vol #:	14

M 1	FDA	Vol #:	15

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

EC 38	Mr. Bob Davis	Vol #:	5

N 1	FDA	Vol #:	1

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

MO 22	TMJ Implants, Inc.	Vol #:	9

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


C 286	D. McHenry	Vol #:	22

C 287	M. McLauchlin	Vol #:	22

C 288	M. Vreeland	Vol #:	22

C 289	K. Webken	Vol #:	22

C 290	P. Newman	Vol #:	22

C 291	H. Anderson	Vol #:	22

C 292	M. Connor	Vol #:	22

C 293	B. Connor	Vol #:	22

C 294	P. Armeli	Vol #:	22

C 295	H and T Barrett	Vol #:	22

C 296	A. Slattery	Vol #:	22

C 297	N. Roberts	Vol #:	22

C 298	K. Brune	Vol #:	22

C 299	C. Oukrop	Vol #:	22

C 300	W. Baumgartner	Vol #:	22



C 301	T. Winkle	Vol #:	22

C 302	V. Eicher	Vol #:	22

C 303	T. Clemens	Vol #:	22

C 304	M. Falconio	Vol #:	22

C 305	K. Groschadl	Vol #:	22

C 306	D. Blasland	Vol #:	22

C 307	7 signatures	Vol #:	22

C 308	A. Welk	Vol #:	22

C 309	M. Moes	Vol #:	22

C 310	M. Mauss	Vol #:	22

C 311	M. Coyle	Vol #:	22

C 312	D. McAllister	Vol #:	22

C 313	J. Lavauagh	Vol #:	22

C 314	E. Volkenburg	Vol #:	22

C 315	D. Canadeo	Vol #:	22

C 316	J. Byrne	Vol #:	22

C 317	E. Sava	Vol #:	22

C 318	E. Sheehan	Vol #:	22

C 319	E. Dagit	Vol #:	22

C 320	S.M. Watson	Vol #:	22

C 321	J. Tominez	Vol #:	22

C 322	M. and T. Eggers	Vol #:	22

C 323	E. Ryan	Vol #:	22

C 324	J. Daly	Vol #:	22

C 325	D. Karminski	Vol #:	22

C 326	J. Romandetti	Vol #:	22

C 327	7 signatures	Vol #:	22

C 328	K. Crouch	Vol #:	22

C 329	W. Kunick	Vol #:	22

C 330	R. Price	Vol #:	22

C 331	A. Becker	Vol #:	22

C 332	D. Farinholt	Vol #:	22

C 333	R. Farinholt	Vol #:	22

C 334	P. Dale	Vol #:	22

C 335	B. Alsup	Vol #:	22

C 336	L. Tetreault	Vol #:	22

C 337	J and H Field	Vol #:	22



C 338	A. Philip Bell	Vol #:	22

C 339	C. Defeo	Vol #:	22

C 340	T. Ehlinger	Vol #:	22

C 341	R. Culbertson	Vol #:	22

C 342	R. Stark	Vol #:	22

C 343	R. Weaver	Vol #:	22

C 344	M. Vreeland	Vol #:	22

C 345	D. Ross	Vol #:	22

C 346	D. Ward	Vol #:	22

C 347	D. McAllister	Vol #:	22

C 348	A. Ellis	Vol #:	22

C 349	D. Stewart	Vol #:	22

C 350	R. Sedlock	Vol #:	22

C 351	P. Pline	Vol #:	22

C 352	K. Pline	Vol #:	22

C 353	C. Gilbert	Vol #:	22

C 354	J. McLaughlin	Vol #:	22

C 355	J. Formica	Vol #:	22

C 356	E and D Maier	Vol #:	22

C 357	D. Holcomb	Vol #:	22

C 358	D. Canadeo	Vol #:	22

C 359	D. McAvoy	Vol #:	22

C 360	M. Burns	Vol #:	22

C 361	M. Hunt	Vol #:	22

C 362	J. Fetsko	Vol #:	22

C 363	A. Weaver, RN	Vol #:	22

C 364	P. Campbell	Vol #:	22

C 365	A. Eells	Vol #:	22

C 366	C. Perlock	Vol #:	22

C 367	J. Storms	Vol #:	22

EC 3727	Feminists for Life of New York	Vol #:	18

EC 3728	Mrs. Irina Bezik	Vol #:	18

EC 3729	Mrs. Gina Colau	Vol #:	18

EC 3730	Mr. Lawrence Roland	Vol #:	18

EC 3731	Mr. Gordon Dibler	Vol #:	18

EC 3732	Mr. Joe Ferreira	Vol #:	18

EC 3733	Mrs. Donna Dyer	Vol #:	18



EC 3734	Mrs. nancy stancato	Vol #:	18

EC 3735	Mrs. Mary Agrusa	Vol #:	18

EC 3736	Mrs. Pat Herbert	Vol #:	18

EC 3737	Mrs. Elaine Franco	Vol #:	18

EC 3738	Mrs. Kelly Powers	Vol #:	18

EC 3739	Mr. Cliff Price	Vol #:	18

EC 3740	Mr. Jamie Rohde	Vol #:	18

EC 3741	Pregnancy Aid, Inc.	Vol #:	18

EC 3742	Mr. Raymond Franco	Vol #:	18

EC 3743	Mrs. Elizabeth Roland	Vol #:	18

EC 3744	Mrs. Mary Ellen Satava	Vol #:	18

EC 3745	Mrs. Dolores Nevares	Vol #:	18

EC 3746	Ms. Connie Marshall	Vol #:	18

EC 3747	Milwaukee Guild of the Catholic Medical Assn.	Vol #:	18

EC 3748	Mrs. Kim Olson	Vol #:	18

EC 3749	Mr. Steven Criger	Vol #:	18

EC 3750	Mrs. Michele Gillett	Vol #:	18

EC 3751	Ms. sharon duskin	Vol #:	18

EC 3752	Mrs. Stephanie Meissner	Vol #:	18

EC 3753	Mrs. ruth caraher	Vol #:	18

EC 3754	St. Joseph Church	Vol #:	18

EC 3755	Mrs. Wendy-Irene Zepeda	Vol #:	18

EC 3756	Ms. Deborah Mattson	Vol #:	18

EC 3757	Mrs. Carole Wenzel	Vol #:	18

EC 3758	Ms. Rachel O'Keefe	Vol #:	18

EC 3759	Mrs. Monica Szabo	Vol #:	18

EC 3760	Mrs. Beverly Dutcher	Vol #:	18

EC 3761	American Dietetic Association	Vol #:	18

EC 3762	Mrs. Amanda DeLauter	Vol #:	18

EC 3763	Dr. Miguel Camara	Vol #:	18

EC 3764	ALL SAINTS CATHOLIC CHURCH	Vol #:	18

EC 3765	Mr. Jonathan Abbamonte	Vol #:	18

EC 3766	Mr. Gregory Schleppenbach	Vol #:	18

EC 3767	Mr. John Rogalski	Vol #:	18

EC 3768	Mrs. Sharon Lesniak	Vol #:	18

EC 3769	Mr. Robert Paige	Vol #:	18

EC 3770	Ms. Marisol Franco	Vol #:	18



EC 3771	Mr. Terence Maxwell	Vol #:	18

EC 3772	Ms. Cathy Kott	Vol #:	18

EC 3773	Mrs. Lila Martinez	Vol #:	18

EC 3774	Ms. Florence P. Saladino	Vol #:	18

EC 3775	Miss. Jessica Hayes	Vol #:	18

EC 3776	Mrs. Gail Besse	Vol #:	18

EC 3777	Mrs. Sharon Donaldson	Vol #:	18

EC 3778	Ms. Mary June Peterson	Vol #:	18

EC 3779	Mrs. Brenda Thorn	Vol #:	18

EC 3780	Mr. Ralph Desimone	Vol #:	18

EC 3781	Mr. John H Eberle	Vol #:	18

EC 3782	Ms. Mary Ann Lusk	Vol #:	18

EC 3783	Mrs. Amanda Norrish	Vol #:	18

EC 3784	Mr. William Ferguson	Vol #:	18

EC 3785	Mr. Thomas Held	Vol #:	18

EC 3786	Miss. Ann Horan	Vol #:	18

EC 3787	Mrs. Jacqueline Dalrymple	Vol #:	18

EC 3788	Mrs. Leslie Hazinski	Vol #:	18

EC 3789	Mr. william raiser	Vol #:	18

EC 3790	Human Life International	Vol #:	18

EC 3791	Mrs. Paula Wiseman	Vol #:	18

EC 3792	Mrs. Margaret M Connors	Vol #:	18

EC 3793	Mrs. Brigid O'Neill	Vol #:	18

EC 3794	Mrs. Maureen Conrad	Vol #:	18

EC 3795	Mrs. Deborah Haugen	Vol #:	18

EC 3796	Mr. Justin Schumacher	Vol #:	18

EC 3797	Ms. Cornelia Lathrop Murray	Vol #:	18

EC 3798	Mr. Robert Gerth	Vol #:	18

EC 3799	Diocese of San Diego	Vol #:	18

EC 3800	Mrs. Christina Dodge	Vol #:	18

EC 3801	Ms. Marilyn Peterson	Vol #:	18

EC 3802	Mrs. Rachel Yost	Vol #:	18

EC 3803	Our Lady of Consolation Church	Vol #:	18

EC 3804	Mrs. Melanie Gifford	Vol #:	18

EC 3805	Lepanto League	Vol #:	18

EC 3806	Mrs. H Day	Vol #:	18

EC 3807	Parenteral Drug Association	Vol #:	18



EC 3808	Mrs. Maria Mitchell, R.N.	Vol #:	18

EC 3809	Mercy Hospital	Vol #:	18

EC 3810	St. Boniface	Vol #:	18

EC 3811	St Lazare Retreat House	Vol #:	18

EC 3812	Central Nebraskans United for Life	Vol #:	18

EC 3813	Mr. Joseph Hejkal	Vol #:	18

EC 3814	Mrs. Michelle Paltz	Vol #:	18

EC 3815	Mr. Dale Cooper	Vol #:	18

EC 3816	Mrs. Sheila Fisher	Vol #:	18

EC 3817	Mrs. Yvonne Fernandez	Vol #:	18

EC 3818	Mrs. Susan Price	Vol #:	18

EC 3819	Mr. loras grell	Vol #:	18

EC 3820	Dr. Brad DeMark	Vol #:	18

EC 3821	Mrs. Jeanette Nedrig	Vol #:	18

EC 3822	Ms. Catrina Conway	Vol #:	18

EC 3823	Mr. Matt Smith	Vol #:	18

EC 3824	Mr. Matt Smith	Vol #:	18

EC 3825	Mr. Jonathan Flora	Vol #:	18

EC 3826	Mrs. Dorothy Buto	Vol #:	18

EC 3827	Mrs. BECKY ANDERSON	Vol #:	18

EC 3828	Mr. Glen Buto	Vol #:	18

EC 3829	Mrs. Carolyn Koepke	Vol #:	18

EC 3830	Mr. Matthew Koepke	Vol #:	18

EC 3831	Mrs. Eileen C. Young	Vol #:	18

EC 3832	Mr. Daniel Seiker	Vol #: <