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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 #: 18
EC 3833 Mrs. Laura Miller Vol #: 18
EC 3834 Mrs. Amanda Lang Vol #: 18
EC 3835 Mrs. carolyn walsh Vol #: 18
EC 3836 Mrs. Marisa Creaghan Vol #: 18
EC 3837 Mrs. Minette Paltz Vol #: 18
EC 3838 Mrs. Marilyn LaPorta Vol #: 18
EC 3839 Mrs. Beth Jareske Vol #: 18
EC 3840 Mrs. Maryjo Hepler Vol #: 18
EC 3841 St. Elizabeth Ann Seton Respect Life Committtee Vol #: 18
EC 3842 Interfaith Committe for Life Vol #: 18
EC 3843 Mrs. Denise McNair Vol #: 18
EC 3844 Mrs. RENEE DERRA Vol #: 18
EC 3845 Mrs. Bridgett Mihalski Vol #: 18
EC 3846 Mr. Greg Burrows Vol #: 18
EC 3847 Mr. Richard Mihalski Vol #: 18
EC 3848 Mr. Ted Langenfeld Vol #: 18
EC 3849 Mrs. Diane Mihalski Vol #: 18
EC 3850 Ms. Karen Mealey Vol #: 18
EC 3851 pro-life Vol #: 18
EC 3852 Mrs. Linda Koenigsfeld Vol #: 18
EC 3853 Mrs. Shelly Chloupek Vol #: 18
EC 3854 Mr. Mark McKay Vol #: 18
EC 3855 Mrs. Mary Harper Vol #: 18
EC 3856 Mrs. Deborah Martell Vol #: 18
EC 3857 none Vol #: 18
EC 3858 Mrs. Caroline Albrigo Vol #: 18
EC 3859 Retired Vol #: 18
EC 3860 Ms. Mary Leahy Vol #: 18
EC 3861 Mr. Leo Koenigsfeld Vol #: 18
EC 3862 Mrs. Donna Saavedra Vol #: 18
EC 3863 Miss. Karoline Kumke Vol #: 18
EC 3864 Knights of Columbus Vol #: 18
EC 3865 Miss. Joan Walsh Vol #: 18
EC 3866 Mrs. Deborah Martell Vol #: 18
EC 3867 Mrs. Susan Woerner Vol #: 18
EC 3868 Dr. Michael Dulac M.D. Vol #: 18
EC 3869 Mrs. Mary Glover Vol #: 18
EC 3870 Mrs. Christina Kleinschmidt RDH Vol #: 18
EC 3871 Mr. Justin Dziowgo Vol #: 18
EC 3872 Mr. eli king Vol #: 18
EC 3873 Dr. john Damiani Vol #: 18
EC 3874 Dr. John D'Orlando Vol #: 18
EC 3875 Ms. Sara Weeder Vol #: 18
EC 3876 Mr. Jimmy Polk Vol #: 18
EC 3877 Dr. Gertrude Murphy Vol #: 18
EC 3878 Mrs. Sheila Kumke Vol #: 18
EC 3879 ProLife Massachusetts Vol #: 18
EC 3880 Ms. Mary Jane Ziola Vol #: 18
EC 3881 Mrs. Kathleen Koenen Vol #: 18
EC 3882 Ms. Pamela Miller Vol #: 18
EC 3883 Mrs. Megan Schrieber Vol #: 18
EC 3884 Mrs. S Spewock Vol #: 18
EC 3885 Mrs. patrice9 thompson Vol #: 18
EC 3886 Ms. Linda Flynn Vol #: 18
EC 3887 Ms. cheryl Aden Vol #: 18
EC 3888 Precious Lives Ministry, Inc. Vol #: 18
EC 3889 Mrs. Natasia Kissinger Vol #: 18
EC 3890 Dr. Carolyn Manhart Vol #: 18
EC 3891 Lahey Clinic Medical Center Vol #: 18
EC 3892 Mrs. Regina Heywood Vol #: 18
EC 3893 Mrs. Tina Kaul Vol #: 18
EC 3894 Archdiocese of Omaha Vol #: 18
EC 3895 Sioux County Pro-Life Vol #: 18
EC 3896 Mr. Patrick Menconi Vol #: 18
EC 3897 Mrs. Alice DePompeo Vol #: 18
EC 3898 Dr. Mike Schleicher Vol #: 18
EC 3899 Mr. George McCauley Vol #: 18
EC 3900 Mrs. Pamela Dion Vol #: 18
EC 3901 Groene Chiropractic, P.C. Vol #: 18
EC 3902 Mrs. Michelle Sullivan Vol #: 18
EC 3903 Mrs. Chloe Osness Vol #: 18
EC 3904 Mr. Elwyn Draper Vol #: 18
EC 3905 Dr. John Tappel Vol #: 18
2006N-0067 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
C 3 National Aquaculture Association Vol #: 1
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
N 2 FDA Vol #: 1
2006N-0237 Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
N 2 FDA Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
LET 1 FDA to Honorable Patty Murray Vol #: 36
LET 2 FDA to Kathleen HArner Vol #: 36
LET 3 FDA to Honorable Rick Santorum Vol #: 36
LET 4 FDA to Honorable Evan Bayh Vol #: 36
LET 5 FDA to Honorable George Allen Vol #: 36
LET 6 FDA to Honorable John Warner Vol #: 36
LET 7 FDA to Honorable Richard G. Lugar Vol #: 36
LET 8 FDA to Kathleen HArner Vol #: 36
2006P-0245 Exclusivity Determination for Risperidone
LET 1 FDA/CDER to Mylan Pharmaceuticals, Inc. Vol #: 1
2006P-0524 Withdrawal of Approval of and recall all available stock of Ziana
ACK 1 FDA/DDM to Emil Tanghetti, MD Vol #: 1
CP 1 E. Tanghetti, MD Vol #: 1

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