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Dockets Management
Dockets Entered On February 20, 2007
Docket # Title
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
1996V-0210 Variance for Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1997V-0088 Laser Light Show
2001D-0221 Biological Product Deviation Reporting for Licensed Manufact
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
2002P-0426 Andrx in its currently pending ANDA 76-159 Glipizide product
2004D-0002 Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
2004V-0272 Projector for a Laser Light Show
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0226 Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
2006M-0384 Premarket Approval: BP050009 / 0 SURE CHECK HIV 1/2 ASSAY
2006M-0385 Premarket Approval: BP050010 / 0 HIV 1/2 STAT-PAKT ASSAY
2006M-0386 Premarket Approval: BP050030 / 0 ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
2006N-0277 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0464 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
2006P-0052 Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
2006P-0415 Petition Seeking Regulation of Cloned Animals
2007P-0059 Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
2007P-0060 ANDA Suitability for Hydrocortisone Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn for Safety or Efficacy Reasons
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
RPT 774 Statistical Report - Month of January 2007 Vol #: 56
1996V-0210 Variance for Laser Light Show
VRA 6 FDA/CDRH to LaserSmith Light Show Systems Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18668 NBTY Inc. Vol #: 169
LET 18669 NBTY Inc. Vol #: 169
LET 18670 NBTY Inc. Vol #: 169
LET 18671 NBTY Inc. Vol #: 169
LET 18672 NBTY Inc. Vol #: 169
LET 18673 Enzymatic Theraphy, Inc. Vol #: 169
LET 18674 Enzymatic Theraphy, Inc. Vol #: 169
LET 18675 Enzymatic Therapy, Inc. Vol #: 169
LET 18676 Enzymatic Therapy, Inc. Vol #: 169
LET 18677 Enzymatic Therapy, Inc. Vol #: 169
LET 18678 New Chapter, Inc. Vol #: 169
LET 18679 New Chapter, Inc. Vol #: 169
LET 18680 New Chapter, Inc. Vol #: 169
LET 18681 New Chapter, Inc. Vol #: 169
LET 18682 New Chapter, Inc. Vol #: 169
LET 18683 New Chapter, Inc. Vol #: 169
LET 18684 New Chapter, Inc. Vol #: 169
LET 18685 Perrigo Company of South Carolina Vol #: 169
LET 18686 NBTY Inc. Vol #: 169
LET 18687 NBTY Inc. Vol #: 169
LET 18688 NBTY Inc. Vol #: 169
LET 18689 Enzymatic Therapy, Inc. Vol #: 169
LET 18690 Enzymatic Therapy, Inc. Vol #: 169
LET 18691 Enzymatic Therapy, Inc. Vol #: 169
LET 18692 Enzymatic Therapy, Inc. Vol #: 169
LET 18693 New Century Company Vol #: 169
LET 18694 PuraPharm Corporation Vol #: 169
LET 18695 PuraPharm Corporation Vol #: 169
LET 18696 PuraPharm Corporation Vol #: 169
LET 18697 PuraPharm Corporation Vol #: 169
LET 18698 PuraPharm Corporation Vol #: 169
LET 18699 PuraPharm Corporation Vol #: 169
LET 18700 PuraPharm Corporation Vol #: 169
LET 18701 PuraPharm Corporation Vol #: 169
LET 18702 PuraPharm Corporation Vol #: 169
LET 18703 PuraPharm Corporation Vol #: 169
LET 18704 PuraPharm Corporation Vol #: 169
LET 18705 PuraPharm Corporation Vol #: 169
LET 18706 PuraPharm Corporation Vol #: 169
LET 18707 PuraPharm Corporation Vol #: 169
LET 18708 PuraPharm Corporation Vol #: 169
LET 18709 PuraPharm Corporation Vol #: 169
LET 18710 PuraPharm Corporation Vol #: 169
LET 18711 PuraPharm Corporation Vol #: 169
LET 18712 PuraPharm Corporation Vol #: 169
LET 18713 PuraPharm Corporation Vol #: 169
LET 18714 PuraPharm Corporation Vol #: 169
LET 18715 PuraPharm Corporation Vol #: 169
LET 18716 PuraPharm Corporation Vol #: 169
LET 18717 Enzymatic Therapy, Inc. Vol #: 169
LET 18718 Enzymatic Therapy, Inc. Vol #: 169
LET 18719 Enzymatic Therapy, Inc. Vol #: 169
LET 18720 Enzymatic Therapy, Inc. Vol #: 169
LET 18721 Enzymatic Therapy, Inc. Vol #: 169
LET 18722 Enzymatic Therapy, Inc. Vol #: 169
LET 18723 Enzymatic Therapy, Inc. Vol #: 169
LET 18724 Enzymatic Therapy, Inc. Vol #: 169
LET 18725 Enzymatic Therapy, Inc. Vol #: 169
LET 18726 New Chapter, Inc. Vol #: 169
LET 18727 New Chapter, Inc. Vol #: 169
LET 18728 New Chapter, Inc. Vol #: 169
LET 18729 New Chapter, Inc. Vol #: 169
LET 18730 NWM, Inc. Vol #: 169
1997V-0088 Laser Light Show
VRA 4 FDA/CDRH to Lantis Fireworks and Lasers Inc Vol #: 1
2001D-0221 Biological Product Deviation Reporting for Licensed Manufact
EC 1 L.C.C.life environment insitute Vol #: 1
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
C 3 Center for Science in the Public Interest Vol #: 2
2002P-0426 Andrx in its currently pending ANDA 76-159 Glipizide product
WDL 1 Watson Pharmaceutical Inc Vol #: 1
2004D-0002 Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
EC 19 Ms. B.A. McClintock Vol #: 2
2004V-0272 Projector for a Laser Light Show
EXP 1 Fan Yang, Science of Bubbles Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 1641 Celiac Sprue Association, Chptr. #14 Vol #: 31
EC 1642 Mrs. Kerry Cutright Vol #: 31
EC 1643 Mrs. Sonja Sanford Vol #: 31
EC 1644 Mrs. Nancy Candy Vol #: 31
EC 1645 Mrs. Marcey Cook Vol #: 31
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
C 139 P. Klemas Vol #: 7
C 140 P. Duffy Vol #: 7
C 141 K. Metcalf Vol #: 7
C 142 K. Klauda Vol #: 7
C 143 M. Fisher Vol #: 7
C 144 D. Roman Vol #: 7
C 145 D. Gamache Vol #: 7
C 146 M. Shaw Vol #: 7
C 147 K. Bendl Vol #: 7
C 148 J. Scmielewski Vol #: 7
C 149 L. Cronin Vol #: 7
C 150 M. Williams Vol #: 7
C 151 J. Azzolini Vol #: 7
C 152 S. Cooker Vol #: 7
C 153 L. Sherwood Vol #: 7
C 154 H. Marx-Heller Vol #: 7
C 155 G. Ivie Vol #: 7
C 156 J. Weitz Vol #: 7
C 157 M. Kaufman Vol #: 7
C 158 K. Cahill-Heiss Vol #: 7
C 159 N. Wells Vol #: 7
C 160 I. Slater Vol #: 7
C 161 J. Visintine Vol #: 7
C 162 R. Davis Vol #: 7
C 163 L. Taylor Vol #: 7
C 164 M. Echhardt Vol #: 7
C 165 C. Yeager Vol #: 7
C 166 C. Yedinak Vol #: 7
C 167 L. Wallace Vol #: 7
C 168 L. Cooke Vol #: 7
C 169 M. Randles Vol #: 7
C 170 R. MacKenzie Vol #: 7
C 171 S. Wells Vol #: 7
C 172 V. McGaughran Vol #: 7
C 173 L. Finkel Vol #: 7
C 174 G. McClain Vol #: 7
C 175 S. Freze Vol #: 7
C 176 D. McVay Vol #: 7
C 177 J. Sieler Vol #: 7
C 178 C.Benevides Vol #: 7
C 179 B. Wesp Vol #: 7
C 180 D. Helnley Vol #: 7
C 181 M. Elkis Vol #: 7
C 182 T. Harvey Vol #: 7
C 183 G. Shell Vol #: 7
C 184 F. Gasper Vol #: 7
C 185 J. Long Vol #: 7
C 186 D. Mis-Nash Vol #: 7
C 187 No signature Vol #: 7
C 188 E. O'Hare Vol #: 7
C 189 E. Alex Vol #: 7
C 190 M. Loyd Vol #: 7
C 191 H. Novacek Vol #: 7
C 192 M. Krueger Vol #: 7
C 193 J. Long Vol #: 7
C 194 S. Schoech Vol #: 7
C 195 R. Flygar Vol #: 7
C 196 E. Mainland Vol #: 7
C 197 J. Simone Vol #: 7
C 198 G. Mack Vol #: 7
C 199 C. Beckelheimer Vol #: 7
C 200 R. Lamp Vol #: 7
C 201 R. Avola Vol #: 8
C 202 K. Walker Vol #: 8
C 203 V. Lamb Vol #: 8
C 204 H. Levinson Vol #: 8
C 205 B. Zeichner Vol #: 8
C 206 L. Standridge Vol #: 8
C 207 A. Wilson Vol #: 8
C 208 A. Edwards Vol #: 8
C 209 F. Chetelat Vol #: 8
C 210 E. Hartem Vol #: 8
C 211 Cindy Vol #: 8
C 212 A. Lauer Vol #: 8
C 213 M. Lanford Vol #: 8
C 214 M. VanOrnneran Vol #: 8
C 215 J. Silverberg Vol #: 8
C 216 A. Sprague Vol #: 8
C 217 C. Bounds Vol #: 8
C 218 T. Higginbottom Vol #: 8
C 219 C. McCormick Vol #: 8
C 220 O. Sicking Vol #: 8
C 221 P. Tyler Vol #: 8
C 222 S. Edens Vol #: 8
C 223 W. Wilson Vol #: 8
C 224 J. Kemmer Vol #: 8
C 225 L. Vice Vol #: 8
C 226 C. Vanasselt Vol #: 8
C 227 L.Koch Vol #: 8
C 228 D. Keyser Vol #: 8
C 229 S. Schwartz Vol #: 8
C 230 R. McKee Vol #: 8
C 231 E. Perkins Vol #: 8
C 232 B. Conley Vol #: 8
C 233 W. Rush Vol #: 8
C 234 N. Carry Vol #: 8
C 235 C. Dial Vol #: 8
C 236 D. Seiz Vol #: 8
C 237 L. Carney Vol #: 8
C 238 G. Whittier Vol #: 8
C 239 Loucetta Vol #: 8
C 240 M. Bricchi Vol #: 8
C 241 no signature Vol #: 8
C 242 C. Ellis Vol #: 8
C 243 L. Masino Vol #: 8
C 244 D. De Mell Vol #: 8
C 245 L. Brown Vol #: 8
C 246 J. Scheuern Vol #: 8
C 247 J. Robins Vol #: 8
C 248 S. McRae Vol #: 8
C 249 D. Lenhart Vol #: 8
C 250 S. Delebois Vol #: 8
C 251 B. Moore Vol #: 8
C 252 L. Jackson Vol #: 8
C 253 F. Dippold Vol #: 8
C 254 M.Taney Vol #: 8
C 255 S. Sarros Vol #: 8
C 256 J. Coerr Vol #: 8
C 257 M. Roos Vol #: 8
C 258 M. Jaffee Vol #: 8
C 259 H. Fricke Vol #: 8
C 260 A. Cohen Vol #: 8
C 261 Adirondack Counseling Vol #: 8
C 262 D. Hirschfeld Vol #: 8
C 263 M. Wells-Jaskula Vol #: 8
C 264 J. Mayer Vol #: 8
C 265 N. Kraut Vol #: 8
C 266 M. Wolgin Vol #: 8
C 267 L. Goodwin Vol #: 8
C 268 A. Andrews Vol #: 8
C 269 K. Gulseth Vol #: 8
C 270 D. Herrold Vol #: 8
C 271 F. Elbert Vol #: 8
C 272 J. Foley Vol #: 8
C 273 F. Van Horn Vol #: 8
C 274 B. McMahon Vol #: 8
C 275 J. Azzolini Vol #: 8
C 276 J. Butcheron Vol #: 8
C 277 S. Gordon Vol #: 8
C 278 D.Harbin Vol #: 8
C 279 S. Wells Vol #: 8
C 280 C. Martin Vol #: 8
C 281 N. Dellamura Vol #: 8
C 282 E. DeStefano Vol #: 8
C 283 C. Gordon Vol #: 8
C 284 P. Ohman Vol #: 8
C 285 J. Specks Vol #: 8
C 286 T. Johnston Vol #: 8
C 287 A. Bullyan Vol #: 8
C 288 J. Farrell Vol #: 8
C 289 F. Rao Vol #: 8
C 290 E. Kardash Vol #: 8
C 291 G. Lyssey Vol #: 8
C 292 M. Lange Vol #: 8
C 293 S. Higginbottam Vol #: 8
C 294 N. Currell Vol #: 8
C 295 D. Brumberg Vol #: 8
C 296 B. Hoffman Vol #: 8
C 297 R. Swain Vol #: 8
C 298 R. Obermeyer Vol #: 8
C 299 S. Day Vol #: 8
C 300 J. Batcheller Vol #: 8
C 301 M. Dailey Vol #: 8
C 302 E. Kelley Vol #: 8
C 303 C. Reiss Vol #: 8
C 304 M. Follmer Vol #: 8
C 305 M. Rostoker Vol #: 8
C 306 Linda Shanahan Vol #: 8
C 307 K. Merola Vol #: 8
C 308 M. Fay Vol #: 8
C 309 M. Rice Vol #: 8
C 310 M. Lazor Vol #: 8
C 311 B. Mangan Vol #: 8
C 312 D. Carpenter Vol #: 8
C 313 M. Dahl Vol #: 8
C 314 C. Bushell Vol #: 8
C 315 P. Donnelly Vol #: 8
C 316 Robinson Vol #: 8
C 317 M. Smith Vol #: 8
C 318 D. Savio Vol #: 8
C 319 G. Mulligan Vol #: 8
C 320 M. Elliot Vol #: 8
C 321 S. Mock Vol #: 8
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18257 D. Sheridan Vol #: 198
2006D-0226 Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
EC 18 Mrs. Anna Martin Vol #: 1
EC 19 Mrs. Veronica Coulston Vol #: 1
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
EC 14 N/A Vol #: 1
EC 15 Ms. Cheryl Gonzalez Vol #: 1
2006D-0336 Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
EC 11 College of American Pathologists Vol #: 1
2006M-0384 Premarket Approval: BP050009 / 0 SURE CHECK HIV 1/2 ASSAY
AAV 1 Chembio Diagnostic Systems, Inc. Vol #: 1
2006M-0385 Premarket Approval: BP050010 / 0 HIV 1/2 STAT-PAKT ASSAY
AAV 1 Chembio Diagnostic Systems, Inc. Vol #: 1
2006M-0386 Premarket Approval: BP050030 / 0 ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
AAV 1 Bayer HealthCare Vol #: 1
2006N-0277 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
SS 1 Supporting Statements Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
LET 9 FDA to Honorable Conrad Burns, United States Senator Vol #: 36
2006N-0464 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
EC 31 Tulane University Center for Gene Therapy Vol #: 2
EC 32 BD Biosciences Vol #: 2
EC 33 Pharm Res Vol #: 2
EC 34 The Society of the Plastics Industry, Inc. Vol #: 2
EC 35 Advanced Medical Technology Association (AdvaMed) Vol #: 2
EC 36 Generic Animal Drug Alliance Vol #: 2
EC 37 Animal Health Institute Vol #: 2
2006P-0052 Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
ANS 1 FDA/CDER to Lachman Consultant Services, Inc Vol #: 1
2006P-0415 Petition Seeking Regulation of Cloned Animals
C 51 I Carr Vol #: 6
2007P-0059 Withdrawal of New Animal Drug Application for Posilac - Rombinant Bovine Growth Hormone (rBGH)
ACK 1 FDA/DDM to Cancer Prevention Coalition et al Vol #: 1
CP 1 Cancer Prevention Coalition et al Vol #: 1
2007P-0060 ANDA Suitability for Hydrocortisone Tablets USP, 10 mg, (CORTEF) and Determine if CORTEF was Withdrawn for Safety or Efficacy Reasons
ACK 1 West-Ward Pharmaceutical Corp. Vol #: 1
CP 1 West-Ward Pharmaceutical Corp. Vol #: 1

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