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Dockets Management
Dockets Entered On November 2, 2006
Docket # Title
2001E-0213 Angiomax, Patent Term Extension Application, No. 5,196,404
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2004P-0349 Action on Products containing added Mercury
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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-0107 FDA-Regulated Products Containing Nanotechnology Materials
2006N-0292 Unique Device Identification
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0430 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an
2006N-0431 Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0450 Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
2006V-0447 Laser Light Show
2006V-0448 Laser Light Show
2006V-0449 Laser Light Show
2001E-0213 Angiomax, Patent Term Extension Application, No. 5,196,404
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 732 Mission Possible International Vol #: 10
EMC 733 D. Voetee Vol #: 10
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
NM 1 FDA Vol #: 5
2004P-0349 Action on Products containing added Mercury
EC 25 Mrs. Janet Sheehan Vol #: 4
2005D-0490 Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 20 FDA/DDM Vol #: 6
MO 21 FDA/OGC Vol #: 6
OR 20 Administrative Law Judge Vol #: 6
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
EC 4 Eli Lilly and Company Vol #: 1
EMC 1 Novartis Pharmaceutical Corporation Vol #: 2
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 15 Mrs. michele kingsbury Vol #: 3
EC 16 Sarasota-Manatee Right to Life Vol #: 3
EC 17 Mrs. Diane Blevins Vol #: 3
EC 18 Ms. Mary Nord Vol #: 3
EC 19 Mrs. Jennifer Evans Vol #: 3
EC 20 Mr. donald roeder Vol #: 3
EC 21 Ms. Cheri Shelnutt Vol #: 3
EC 22 Mrs. gina walsh Vol #: 3
EC 23 Mr. Jeff Krinock Vol #: 3
EC 24 Mr. Jaye Baldwin Vol #: 3
EC 25 Ms. michelle quinn Vol #: 3
EC 26 Mrs. Laurie Young Vol #: 3
EC 27 Ms. Christine Posti Vol #: 3
EC 28 Mrs. Christine Pampo Vol #: 3
EC 29 Ms. Dianne Davis Vol #: 3
EC 30 Mrs. Rochelle Myers Vol #: 3
EC 31 Mr. Chris Hathaway, fssp Vol #: 3
EC 32 Mrs. Thresia Capano Vol #: 3
EC 33 Mrs. Christine Niles Vol #: 3
EC 34 Miss. Judith Krzebiot Vol #: 3
EC 35 Bon Secours Richmond Vol #: 3
EC 36 Mrs. Annmarie Fierek Vol #: 3
EC 37 Mrs. Terry Roessler Vol #: 3
EC 38 Mrs. Linda Strandt Vol #: 3
EC 39 Mrs. Catherine Heers Vol #: 3
EC 40 Dr. John Adams Vol #: 3
EC 41 Mrs. Lana Schexnayder Vol #: 3
EC 42 Ms. Janina Stepp Vol #: 3
EC 43 Ms. Lois Nunnally Vol #: 3
EC 44 Mrs. SUSAN MARTIN Vol #: 3
EC 45 Ms. Laura Randazzo Vol #: 3
EC 46 Mrs. Karen Hinnenkamp Vol #: 3
EC 47 Mr. Jason Engel Vol #: 3
EC 48 Mrs. Mary Griswold Vol #: 3
EC 49 Saint Louis University Medical Center Vol #: 3
EC 50 Pfizer, Inc. Vol #: 3
EC 51 Teacher Vol #: 3
EC 52 Mrs. Kristina Mancini Vol #: 3
EC 53 Mr. Robert D'Aurora Vol #: 3
EC 54 Mrs. Connie Chrane Vol #: 3
EC 55 Mrs. Meg Jalsevac Vol #: 3
EC 56 Ms. Pam Epstein Vol #: 3
EC 57 Mrs. Jennifer McDevitt Vol #: 3
EC 58 Kansas Pro-Life Vol #: 3
EC 59 Mrs. Jane Keefe Vol #: 3
EC 60 Miss. Kera Foote Vol #: 3
EC 61 Mr. Thomas Cook Vol #: 3
EC 62 Dr. Gerald Kolf Vol #: 3
EC 63 Mrs. Faith Davy Vol #: 3
EC 64 Mr. mary arnold Vol #: 3
EC 65 Mrs. Janet Sheehan Vol #: 3
EC 66 Mrs. Kathleen Davis Vol #: 3
EC 67 Mrs. Joan Fasanello Vol #: 3
EC 68 Ms. Barbara Coscarello Vol #: 3
EC 69 Mrs. Patricia Kelly Vol #: 3
EC 70 Dr. Sandy Miles Vol #: 3
EC 71 Mrs. EILENE ROECKER Vol #: 3
EC 72 Mrs. Paulette Drozdowicz Drozdowicz Vol #: 3
EC 73 Mrs. DANIELLE FORD Vol #: 3
EC 74 Mrs. Suzanne Goldman Vol #: 3
EC 75 Mrs. Anne Caron Vol #: 3
EC 76 Mrs. Linda Stanley Vol #: 3
EC 77 Mr. Tom Brock Vol #: 3
EC 78 Mrs. Shirley Lewis Vol #: 3
EC 79 Mr. Peter Palumbo Vol #: 3
EC 80 .0 Vol #: 3
EC 81 Mrs. The Doane family Vol #: 3
EC 82 Ms. Stacey Ramon Vol #: 3
EC 83 Public University of Navarra Vol #: 3
EC 84 Mr. Craig First Vol #: 3
EC 85 Mr. Roland Mayer Vol #: 3
EC 86 Mrs. Dina Ellis Vol #: 3
EC 87 Mrs. Dawn Shuey Vol #: 3
EC 88 Dr. Anthony Yores N.D. Vol #: 3
EC 89 Mr. Alan Mehldau Vol #: 3
EC 90 Mr. Dale Brazil Vol #: 3
EC 91 AAA Women For Choice Vol #: 3
EC 92 Mrs. Rebecca Ferrell Vol #: 3
EC 93 California Right to Life Committee, Inc. Vol #: 3
EC 94 Mrs. Leslie Johnson Vol #: 3
EC 95 Mrs. Jennifer Arel Vol #: 3
EC 96 Mr. Donald Henke Vol #: 3
EC 97 Mr. John Young Vol #: 3
EC 98 Good Samaritan Food Bank Vol #: 3
EC 99 Miss. Myra Weakland Vol #: 3
EC 100 Ms. Jane Savko Vol #: 3
EC 101 Mr. Thomas Shaw Vol #: 3
EC 102 Mrs. Trina Abuan Vol #: 3
EC 103 Mrs. Helen Piquette, RN Vol #: 3
EC 104 Mrs. Barbara DiBella Vol #: 3
EC 105 Mrs. Ruth Lowe Vol #: 3
EC 106 Mr. Arthur and Maria Mullin Vol #: 3
EC 107 Mr. Frank Maroney Vol #: 3
EC 108 Mrs. Taryn Lamb Vol #: 3
EC 109 Ms. Victoria Evans Vol #: 3
EC 110 Mrs. Jennifer Williams Vol #: 3
EC 111 Mrs. Connie Mesco Vol #: 3
EC 112 Mrs. suzanne fitzsimmons Vol #: 3
EC 113 Ms. Lizann Prosser Vol #: 3
EC 114 Mrs. Amanda Conlan Vol #: 3
EC 115 Mrs. Monica Lenthe RN Vol #: 3
EC 116 Mrs. Dorothy Bartkiewicz Vol #: 3
EC 117 Mr. Steve Brock Vol #: 3
EC 118 Mr. Gerald Thibodeau Vol #: 3
EC 119 None Vol #: 3
EC 120 Ms. Crystal Ard Vol #: 3
EC 121 Mr. William Wells Vol #: 3
EC 122 Mrs. Mary Ann Kreitzer Vol #: 3
EC 123 Mrs. Jessica Ferrante Vol #: 3
EC 124 Mrs. Mary Loftus Vol #: 3
EC 125 Mrs. Marie Hosdil Vol #: 3
EC 126 Mrs. Jillian Davidsson Vol #: 3
EC 127 Mrs. Vicki Luciano Vol #: 3
EC 128 Mrs. Joyce Soos Vol #: 3
EC 129 Mrs. Joan Boulio R/N Vol #: 3
EC 130 Ms. Jane Spencer Vol #: 3
EC 131 Mrs. Rosanne Taibi Vol #: 3
EC 132 Mrs. Ann Fontenot Vol #: 3
EC 133 Mr. Joseph Lucia Vol #: 3
EC 134 Agape Family Medicine Vol #: 3
EC 135 Ms. Lynda Boulio Vol #: 3
EC 136 Mrs. Caroline O'Shea Vol #: 3
EC 137 Miss. Paula Templemeyer Vol #: 3
EC 138 Mr. Mark Lytell Vol #: 3
EC 139 Miss. Ellen Tietjen Vol #: 3
EC 140 Mrs. natasha pereira Vol #: 3
EC 141 Mrs. Jill Varnado Vol #: 3
EC 142 Mrs. jeanette fleming Vol #: 3
EC 143 Mrs. jessi lecker Vol #: 3
EC 144 Mrs. Anne Reynolds Vol #: 3
EC 145 Mrs. Michael Weber Vol #: 3
EC 146 Mr. Ronald Schmitt Vol #: 3
EC 147 Mrs. Sheila Parkhill Vol #: 3
EC 148 Mr. Christopher Cummings Vol #: 3
EC 149 Mr. Paul Vinnedge Vol #: 3
EC 150 Mr. Brian Coughlin Vol #: 3
EC 151 Mrs. Sara Lockwood Vol #: 3
EC 152 Ms. Sendy Andazola Vol #: 3
EC 153 Ms. Erin Griffith Vol #: 3
EC 154 Mr. James Basile Vol #: 3
EC 155 Mr. John Garvey Vol #: 3
EC 156 Dr. john hawboldt Vol #: 3
EC 157 Penn State University Vol #: 3
EC 158 Mr. Philip Lawler Vol #: 3
EC 159 Mrs. Mary Firth Vol #: 3
EC 160 St. Seraphim of Sarov Orthodox Church Vol #: 3
EC 161 Mr. James Fritz Vol #: 3
EC 162 Mr. John Duckett Vol #: 3
EC 163 Mr. Robert Seeley Vol #: 3
EC 164 Religious Sister Vol #: 3
EC 165 Miss. Alycia Hartley Vol #: 3
EC 166 Children of God for Life Vol #: 3
EC 167 Mr. John Dietrich Vol #: 3
EC 168 Mr. Fred Husak Vol #: 3
EC 169 none Vol #: 3
EC 170 Mrs. Margaret Plunkett Vol #: 3
EC 171 Retired Vol #: 3
EC 172 Mrs. Susy Stokes Vol #: 3
EC 173 Mr. Peter Drozdowicz Vol #: 3
EC 174 Mr. Tom Andersen Vol #: 3
EC 175 Catholic Parents OnLine Vol #: 3
EC 176 Mr. Andrew Witko Vol #: 3
EC 177 Mrs. pamela russell Vol #: 3
EC 178 Mrs. Melinda Lorenzen Vol #: 3
EC 179 Mr. Gerardo Gonzalez Vol #: 3
EC 180 Dr. Robert Peszynski Vol #: 3
EC 181 A CONCERN CITIZEN OF THIS US Vol #: 3
EC 182 Mrs. Rose Doane Vol #: 3
EC 183 Mrs. ROBERT NORTHWOOD Vol #: 3
EC 184 Dr. Darrin Muggli Vol #: 3
EC 185 Ms. Mary E. Decker RN MS Vol #: 3
EC 186 Mrs. Margaret O Duggan Vol #: 3
EC 187 Mr. Donald Lehrbaum Vol #: 3
EC 188 Kenrick School of Theology Vol #: 3
EC 189 Mr. Bruce Leehan Vol #: 3
EC 190 Mrs. Christine Atherley Vol #: 3
EC 191 Mr. Alan Clune Vol #: 3
EC 192 Miss. Jennifer Crothers Vol #: 3
EC 193 Mr. Terry and Jana Carlson Vol #: 3
EC 194 Mrs. Linda Marino Vol #: 3
EC 195 Mrs. Kath Hashimoto Vol #: 3
EC 196 Mrs. Joyce Cordaro Vol #: 3
EC 197 Mr. Connor Corkrin Vol #: 3
EC 198 Mrs. Linda Braschayko Vol #: 3
EC 199 Mr. Joseph Moran Vol #: 3
EC 200 Dr. James Atkins Vol #: 3
EC 201 Dr. Pamela Rohrmann Vol #: 3
EC 202 Mrs. Laura Leonard Vol #: 3
EC 203 Mrs. Lynn Jeffs Vol #: 3
EC 204 Mrs. Kristi Landis Vol #: 3
EC 205 Mrs. Jaroslava Lonchyna Vol #: 3
EC 206 Mr. Chris Mazza Vol #: 3
EC 207 Sandhills Pro Life Vol #: 3
EC 208 Miss. Tereza Becica Vol #: 3
EC 209 Mrs. Kathryn Hetrick Vol #: 3
EC 210 Mrs. betty peltier Vol #: 3
EC 211 Mrs. Marilyn Murphy, HT, ASCP Vol #: 3
EC 212 Mrs. Barbara Kemple Vol #: 3
EC 213 Mr. Gary Hejna Vol #: 3
EC 214 Mrs. Mary Provost Vol #: 3
EC 215 Mrs. Donna Mitchell Vol #: 3
EC 216 Mrs. Gloria Collins Vol #: 3
EC 217 Mrs. Erin Lewis Vol #: 3
EC 218 Mrs. Deborah Sullivan Vol #: 3
EC 219 Mrs. Sandra Bois Vol #: 3
EC 220 Dr. Tom Hudson Vol #: 3
EC 221 Mrs. K. Mathis Vol #: 3
EC 222 Mr. Owen Ward Vol #: 3
EC 223 Mrs. Gina Glenn Vol #: 3
EC 224 Ms. Eugenia Tsantinis Vol #: 3
EC 225 Mrs. liz Gilges Vol #: 3
EC 226 Dr. David Six Vol #: 3
EC 227 Philadelphia Catholic Medical Association Vol #: 3
EC 228 Mrs. J B Caroon Vol #: 3
EC 229 Mrs. Christina Crook Vol #: 3
EC 230 Mr. Robert O'Dowd Vol #: 3
EC 231 Mr. Edward Curtis Vol #: 3
EC 232 Mrs. Barbara Hildebrand Vol #: 3
EC 233 Mrs. veronica ross Vol #: 3
EC 234 Mrs. ILONA Sorensen Vol #: 3
EC 235 Mrs. Emily Jaminet Vol #: 3
EC 236 Ms. Christine Dudych Vol #: 3
EC 237 Registered Nurse Vol #: 3
EC 238 Mr. Mark Stromick Vol #: 3
EC 239 Father of Six Vol #: 3
EC 240 Mr. Martin Lobert Lobert Vol #: 3
EC 241 Dr. Susan Raybourne Vol #: 3
EC 242 Mr. Thomas Ullman Vol #: 3
EC 243 Ms. martha kruener Vol #: 3
EC 244 Mrs. Debra Amezcua-Gonzalez Vol #: 3
EC 245 Parent's Turf Vol #: 3
EC 246 Mrs. Kathryn DeBlanc Vol #: 3
EC 247 Mr. Raphael Whelan Vol #: 3
EC 248 Mr. Ronney Stovall Vol #: 3
EC 249 Mrs. Erin Talbot Vol #: 3
EC 250 Mrs. Kelly Futterer Vol #: 3
EC 251 Ms. Kathleen Seitz Vol #: 3
EC 252 Ms. Amber Arasmith Vol #: 3
EC 253 Dr. Leanne Sherburne Vol #: 3
EC 254 Mrs. Jennifer Arvin Vol #: 3
EC 255 Mr. Robert LaPlante Vol #: 3
EC 256 Mrs. Lee Ann LaPlante Vol #: 3
EC 257 Mrs. Pamela Lamo Vol #: 3
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
EC 23 Mr. Mark Preston Vol #: 12
TR 1 Transcript of the October 10, 2006 Public Meeting Vol #: 13
2006N-0292 Unique Device Identification
MM 1 Summary of October 25, 2006 Meeting Vol #: 1
TS 1 Eastern Research Group Inc Vol #: 1
TS 2 Cook Group Inc Vol #: 1
TS 3 Partners Health Care Vol #: 1
TS 4 DoD Vol #: 1
TS 5 Health Technology Evaluation and Safety Vol #: 1
TS 6 M Piper Vol #: 1
TS 7 Villanova School of Business Vol #: 1
TS 8 Novation Vol #: 1
TS 9 National Electrical Manufacturers Association (NEMA) Vol #: 1
TS 10 Fast Track Technologies Ltd Vol #: 1
TS 11 Dental Trade Alliance Vol #: 1
TS 12 NFD, HCA Vol #: 1
TS 13 Siemens Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
EC 154 Victory Center for Health and Healing Vol #: 3
EC 155 dentist Vol #: 3
EC 156 Ms. Desiree Starr DeJesus Vol #: 3
EC 157 UTHSCS Dental School Vol #: 3
EC 158 Mrs. Monica Thomas Vol #: 3
EC 159 Dental Care Vol #: 3
EC 160 Dental Care Vol #: 3
EC 161 Dental Care Vol #: 3
2006N-0430 Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an
N 1 FDA Vol #: 1
2006N-0431 Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs
N 1 FDA Vol #: 1
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
LET 3 Quaker Oats Company Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 380 Miss. ANS PERRAULT Vol #: 7
EC 381 Mrs. Arlene Patoray Vol #: 7
EMC 21 National Grocers Association Vol #: 3
2006P-0450 Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
ACK 1 FDA/DDM to Pfizer Inc Vol #: 1
CP 1 Pfizer Inc Vol #: 1
2006V-0447 Laser Light Show
ACK 1 FDA / DDM/ to Electric Cowboy Vol #: 1
VAR 1 Electric Cowboy Vol #: 1
2006V-0448 Laser Light Show
ACK 1 FDA / DDM to Zokku Vol #: 1
VAR 1 Zokku Vol #: 1
2006V-0449 Laser Light Show
ACK 1 FDA / DDM to Electric Cowboy Vol #: 1
VAR 1 Electric Cowboy Vol #: 1

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