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Dockets Management
Dockets Entered On January 26, 2006
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2000P-1491 Amend Definition & Standard of Identy for Parmesan Cheese
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
2004P-0223 Whole Grain Descriptive Claims
2005N-0457 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
2005P-0273 Add Calcium to the Mandatory List
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0420 Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
2006N-0010 Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications
2006P-0049 reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities
2006P-0054 513(f) Petition for the SCRAM Bracelet (and Collectively, the SCRAM System) as a Class I Medical Device
2006V-0053 Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17174 Enzymatic Therapy Vol #: 157
LET 17175 Enzymatic Therapy Vol #: 157
LET 17176 Enzymatic Therapy Vol #: 157
LET 17177 Immunotec Research Ltd. Vol #: 157
LET 17178 NBTY Inc. Vol #: 157
LET 17179 NBTY Inc. Vol #: 157
LET 17180 NBTY Inc. Vol #: 157
LET 17181 NBTY Inc. Vol #: 157
LET 17182 NBTY Inc. Vol #: 157
LET 17183 NBTY Inc. Vol #: 157
LET 17184 NBTY Inc. Vol #: 157
LET 17185 Enzymatic Therapy Vol #: 157
LET 17186 NBTY Inc. Vol #: 157
LET 17187 The Vitamin Shoppe Industries, inc. Vol #: 157
2000P-1491 Amend Definition & Standard of Identy for Parmesan Cheese
C 9 European Communities Vol #: 1
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1365 M. Jones Vol #: 259
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
C 48 European Communities Vol #: 2
2004P-0223 Whole Grain Descriptive Claims
C 28 Grain Foods Foundation Vol #: 5
LET 3 HFS-820 to Grain Foods Foundation Vol #: 5
2005N-0457 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
C 1 Center for Science in the Public Interest (CSPI) Vol #: 1
2005P-0273 Add Calcium to the Mandatory List
LET 1 HFS-800 to Rutgers, The State University of New Jersey Vol #: 2
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 425 J. Guilz Vol #: 6
C 426 M. Colombo Vol #: 6
C 427 S. McCarty Vol #: 6
C 428 N. Vermamo Vol #: 6
C 429 S. Goodwin Vol #: 6
C 430 T. Brenna Vol #: 6
C 431 M. Curry Vol #: 6
C 432 L. Charouleau Vol #: 6
C 433 A. Couch Vol #: 6
C 434 M. Jamec Vol #: 6
C 435 Y. Smith Vol #: 6
C 436 S. Given Vol #: 6
C 437 J. Carter Vol #: 6
C 438 R. Fisher Vol #: 6
C 439 M. Koppe Vol #: 6
C 440 S. Stratton Vol #: 6
C 441 S. Coatney Vol #: 6
C 442 M. Fullbright Vol #: 6
C 443 Eligible Vol #: 6
C 444 Eligible Vol #: 6
C 445 G. Kramer Vol #: 6
C 446 C. Reid Vol #: 6
C 447 A. Vining Vol #: 6
C 448 R. Lane Vol #: 6
C 449 A. Rhoney Vol #: 6
C 450 C. Flansburg Vol #: 6
C 451 D. Chambers Vol #: 6
C 452 B. Dickey Vol #: 6
C 453 A. Flanagan Vol #: 6
C 454 M. Lane Vol #: 6
EC 177 Mrs. E. Lynn Owen Vol #: 4
EC 178 Mrs. Anne Heath Vol #: 4
EC 179 Mrs. Carol Cronk Vol #: 4
EC 180 Mrs. Rosemary Panone Vol #: 4
EC 181 Ms. rochelle sirota Vol #: 4
EC 182 Mrs. Jody Stanage Vol #: 4
EC 183 Mrs. Alison O'Bryen Vol #: 4
EC 184 Mrs. Mary Lively Vol #: 4
EC 185 Mrs. Debra Branham Vol #: 4
EC 186 Mr. Jim Hunter Vol #: 4
EC 187 Mrs. Verdeen Stratton Vol #: 4
EC 188 Mrs. Mary Connolly Vol #: 4
EC 189 Ms. Shawn Yantis Vol #: 4
EC 190 Mrs. Bonnie Anderson Vol #: 4
EC 191 Ms. Lois Dornfeld Vol #: 4
EC 192 Ms. Darlene Zimmerman Vol #: 4
EC 193 Mrs. Linda Felske Vol #: 4
EC 194 Mrs. Theresa Domsher Vol #: 4
EC 195 Mrs. Rebecca Ritch Vol #: 4
EC 196 Mrs. Barbara Barlage Vol #: 4
EC 197 Ms. Debra Priest Vol #: 4
EC 198 Mrs. susanne miller Vol #: 4
EC 199 Miss. Irene Carrigan Vol #: 4
EC 200 Mrs. Carol Doolin Vol #: 4
EC 201 Mrs. Elizabeth West Vol #: 4
EC 202 S S Vol #: 4
EC 203 Mrs. Judith Bess Vol #: 4
EC 204 Patterson's Health Works Vol #: 4
EC 205 Ms. Patricia Smith Vol #: 4
EC 206 Ms. Linda Johnston Vol #: 4
EC 207 Mrs. KANDI KRAMER Vol #: 4
EC 208 Mrs. Beth Afonso Vol #: 4
EC 209 Ms. Virginia D. Gergen Vol #: 4
EC 210 Mrs. Cynthia Hohl Vol #: 4
EC 211 A H Vol #: 4
EC 212 Ms. Cynthia Streetz Vol #: 4
EC 213 Miss. Ann-Marie Fasciano Vol #: 4
EC 214 Mrs. Rosa Rector Vol #: 4
EC 215 Mrs. Beth Afonso Vol #: 4
EC 216 Mr. Daryl Duncan Vol #: 4
EC 217 Mrs. beth landes Vol #: 4
EC 218 none Vol #: 4
EC 219 Ms. Kathleen Reynolds Vol #: 4
EC 220 Mrs. Elizabeth Trout Vol #: 4
EC 221 Mrs. Sue DeVecka Vol #: 4
EC 222 Mrs. Denice Burger Vol #: 4
EC 223 Ms. Julie Cline Vol #: 4
EC 224 Mrs. Karen Davison Vol #: 4
EC 225 Dr. George Davis Vol #: 4
EC 226 Ms. FRAN GRANT Vol #: 4
EC 227 Mrs. Mary Beth Burrow Vol #: 4
EC 228 Ms. Myrna Roiser Vol #: 4
EC 229 Mrs. Courtney Vandiver Vol #: 4
EC 230 Mrs. Susan Schuessler Vol #: 4
EC 231 Dr. mila mcmanus Vol #: 4
EC 232 Ms. Darla Wanitschke Vol #: 4
EC 233 Mrs. Ingrid Allison Vol #: 4
EC 234 Mrs. Jana Mayberry Vol #: 4
EC 235 Mrs. Linda Hurley Vol #: 4
EC 236 Dr. B Lafferty Vol #: 4
EC 237 Mrs. Sally Mirabella Vol #: 4
EC 238 Mrs. Erin Godwin Vol #: 4
EC 239 Mrs. Margaret Sheldrick Vol #: 4
EC 240 Ms. Maat Andrews Vol #: 4
EC 241 Mrs. Beverly Barrett Vol #: 4
EC 242 Citizen Vol #: 4
EC 243 Mrs. Renee fitzpatrick Vol #: 4
EC 244 Ms. Sharlane Billman Vol #: 4
EC 245 Ms. Sally Lamkin Vol #: 4
EC 246 Ms. Debbie Horn Vol #: 4
EC 247 Mr. Paul Hotze Vol #: 4
EC 248 Mrs. Zoe Dodd Vol #: 4
EC 249 Mrs. Terri Coburn Vol #: 4
EC 250 Mrs. Tressa Knapp Vol #: 4
EC 251 Mrs. Julie Hewson Vol #: 4
EC 252 Mrs. S FRAAS Vol #: 4
EC 253 Mrs. Jeny Ewing Vol #: 4
EC 254 Ms. Heather Johnston Vol #: 4
EC 255 Mrs. Angela Trevino Vol #: 4
EC 256 Mrs. Elizabeth Chandler Vol #: 4
EC 257 Mrs. Sherry Good Vol #: 4
EC 258 Mrs. Karen Park Vol #: 4
EC 259 Mrs. Gayla Freeman Vol #: 4
EC 260 Mrs. Barbara Weigel Vol #: 4
EC 261 Mrs. Carol Almand Vol #: 4
EC 262 Mrs. Jenifer Nech Vol #: 4
EC 263 Mrs. Kimberly Haddock Vol #: 4
EC 264 Premier Pharmacy Vol #: 4
EC 265 Longhorn Medical Associates LLC Vol #: 4
EC 266 Dr. Thelma Jean Goodrich, Ph.D. Vol #: 4
EC 267 Mr. CHUCK WILSON Vol #: 4
EC 268 Mrs. GILENE WILSON Vol #: 4
EC 269 Mr. JOSHUA WILSON Vol #: 4
EC 270 Mr. LEE WILSON Vol #: 4
EC 271 Miss. CESSANY NOEL Vol #: 4
EC 272 Mr. CHAD WILSON Vol #: 4
EC 273 Mr. Larry Sanxter Vol #: 4
EC 274 Mrs. Vicki Price Vol #: 4
EC 275 Mr. Tim Phipps Vol #: 4
EC 276 Mrs. Anna Maire bettencourt Vol #: 4
EC 277 Mrs. kathleen tippit Vol #: 4
EC 278 Mrs. Linda Marcy Vol #: 4
EC 279 citizen of the united states Vol #: 4
EC 280 Mrs. Rena Walker Vol #: 4
EC 281 Ms. Sue Gleason Vol #: 4
EC 282 Mrs. Dana Klump Vol #: 4
EC 283 Ms. Barbara Bartus Vol #: 4
EC 284 Mr. William NeSmith Vol #: 4
EC 285 The King's Vol #: 4
EC 286 Miss. Dawn Cadenhead Vol #: 4
EC 287 Mrs. Carolyn J. Trites Vol #: 4
EC 288 Ms. Beva Gathje Vol #: 4
EC 289 Mrs. J. Johnson Vol #: 4
EC 290 Mrs. J. Johnson Vol #: 4
EC 291 Mrs. Penny Wright Vol #: 4
EC 292 Bikram's Yoga College Vol #: 4
EC 293 Mrs. Dolly Thomas Vol #: 4
EC 294 Mr. Andrew Northwall Vol #: 4
EC 295 Mrs. Martha Koslosky Vol #: 4
EC 296 Miss. Deborah Levy Vol #: 4
EC 297 Mr. Scott McEntyre Vol #: 4
EC 298 Mrs. Gina Teafatiller Vol #: 4
EC 299 Mrs. Aimee Harrington Vol #: 4
EC 300 Ms. Susan Coburn Vol #: 4
EC 301 Mrs. Heather Tripodo Vol #: 4
EC 302 Ms. Tammy Folsom Vol #: 4
EC 303 Mrs. Julie Menteer Vol #: 4
EC 304 Mr. Roy Ramirez Vol #: 4
EC 305 Mrs. Nancy Foley Vol #: 4
EC 306 Mrs. Monica Luedecke Vol #: 4
EC 307 Mrs. Shirley Steffens Vol #: 4
EC 308 Dr. Amaryllis Pascual Vol #: 4
EC 309 self Vol #: 4
EC 310 Ms. Donna Guthery Vol #: 4
EC 311 Ms. Lynn Whitlow Vol #: 4
EC 312 Mr. John Cantu Vol #: 4
EC 313 Ms. Jan Wiener Vol #: 4
EC 314 Mrs. Kristen McClung Vol #: 4
EC 315 Ms. Karen Winters Vol #: 4
EC 316 Ms. Suzanne Nye Vol #: 4
EC 317 Mrs. Anna Sweat Vol #: 4
EC 318 Ms. Beverly Richardson Vol #: 4
EC 319 Mrs. Diana Roberson Vol #: 4
EC 320 Ms. Nanette Noffsinger Vol #: 4
EC 321 Mrs. KeriAnn Reardon Vol #: 4
EC 322 Ms. Michelle Iglesias Vol #: 4
EC 323 Ms. DENISE ZIEHLKE Vol #: 4
EC 324 Ms. Edward Koslosky, Sr. Vol #: 4
EC 325 Mrs. Nell St. Cyr Vol #: 4
EC 326 Mrs. Joyce Cavanaugh Vol #: 4
EC 327 Mrs. Beverly Jones Vol #: 4
EC 328 Mrs. April Jones Vol #: 4
EC 329 Ms. Fonda Welch Vol #: 4
EC 330 Mrs. Sharon Applegate Vol #: 4
EC 331 Ms. Beth Calhoun Vol #: 4
EC 332 Mrs. Karen Meikle Vol #: 4
EC 333 APSI Vol #: 4
EC 334 Abernathy Longevity Systems Vol #: 4
EC 335 Dr. Jeffry Anderson Vol #: 4
EC 336 Mr. R. E. MERRIMAN Vol #: 4
EC 337 Dr. Jack Miller Vol #: 4
EC 338 Infinite Health Vol #: 4
EC 339 Mr. Randy Dunlap Vol #: 4
EC 340 Mrs. Stacey Upchurch Vol #: 4
EC 341 Mrs. Mindy Seymour Vol #: 4
EC 342 Pearson Wellness Center, Medical Corp. Vol #: 4
EC 343 Mrs. nancy pearson Vol #: 4
EC 344 Mrs. cindy krueger Vol #: 4
EC 345 Mrs. Stephanie Arthurs Vol #: 4
EC 346 Mrs. Melissa Weber Vol #: 4
EC 347 Ms. Christina Crawford Vol #: 4
EC 348 Dr. Scott Bertrand Vol #: 4
EC 349 Mr. Gordon Cook Vol #: 4
EC 350 Ms. Melanie Parker Vol #: 4
EC 351 Mrs. Silvia Oliva Vol #: 4
EC 352 AMitabha Medical clinic Vol #: 4
EC 353 www.hormonebalance.org Vol #: 4
EC 354 Mrs. Marilyn McFadgen Vol #: 4
EC 355 Dr. Eileen Wright Vol #: 4
EC 356 Mr. Thomas Cline Vol #: 4
EC 357 Dr. Darin Ingels Vol #: 4
EC 358 Mrs. Pamela Whitfield Vol #: 4
EC 359 Mrs. Samantha Dietz Vol #: 4
EC 360 Dr. Nancy McDonald Vol #: 4
EC 361 Mr. Brad Blum Vol #: 4
EC 362 Mr. Ron Sweet Vol #: 4
EC 363 Mrs. Judy Nye Vol #: 4
EC 364 Mrs. Sylvia Ellsworth Vol #: 4
EC 365 Mrs. Phyllis Vandegriff Vol #: 4
EC 366 Ms. Marisa Dolce Vol #: 4
EC 367 Dr. JOE WEZENSKY Vol #: 4
EC 368 Wellness Works Vol #: 4
EC 369 Mrs. Kara Baker Vol #: 4
EC 370 Dr. Dara Saghafi Vol #: 4
EC 371 Ultimate Living Medical Clinic Vol #: 4
EC 372 Ms. Cindy Norris Vol #: 4
EC 373 Mrs. Sara Harrison Vol #: 4
EC 374 Mrs. Josette Krause Vol #: 4
EC 375 Mrs. Tamara Boone Vol #: 4
EC 376 Mrs. Carolyn Miller Vol #: 4
EC 377 Ms. Donna Buchheit Vol #: 4
EC 378 Ms. Sherry Deutsch Vol #: 4
EC 379 Mr. Guy Evans Vol #: 4
EC 380 Mrs. Judie Lincks Vol #: 4
EC 381 N/A Vol #: 4
EC 382 Mrs. veronica lowry Vol #: 4
EC 383 Mrs. kimberly merrill Vol #: 4
EC 384 Ms. Stacy Hall Vol #: 4
EC 385 Mrs. Melissa Wagner Vol #: 4
EC 386 Mrs. Michele George Vol #: 4
EC 387 Concerned Citizen Vol #: 4
EC 388 Mrs. Terry Askew Vol #: 4
EC 389 Mrs. Tina Myers Vol #: 4
EC 390 Mrs. Kathryn Barton Vol #: 4
EC 391 Mrs. Dana Appiano Vol #: 4
EC 392 Ms. Debbie Baker Vol #: 4
EC 393 Mrs. J Erber Vol #: 4
EC 394 Ms. Sabrina Sonner Vol #: 4
EC 395 Ms. Alice fLAHERTY Vol #: 4
EC 396 Mr. Herman Roberts Vol #: 4
EC 397 Sheila Dean, MS, RD, LD/N, CDE Vol #: 4
EC 398 Mrs. Rebecca Harrison Vol #: 4
EC 399 Mr. brian smith Vol #: 4
EC 400 Ms. Jillian Mills Vol #: 4
EC 401 Dr. Walker Cunningham Vol #: 4
EC 402 None Vol #: 4
EC 403 Ms. Mary Tanton Vol #: 4
EC 404 Ms. Jocelyn Popovici Vol #: 4
EC 405 Dr. Hui Park Vol #: 4
EC 406 Mrs. Kimberly Heyart Vol #: 4
EC 407 Mrs. Joanne Bobal Vol #: 4
EC 408 Ms. Mary Stier Vol #: 4
EC 409 Mrs. Marcy Moorhead Vol #: 4
EC 410 Ms. Carla Stabley Vol #: 4
EC 411 Ms. Virginia Hopkins Vol #: 4
EC 412 Mrs. carolyn parsons Vol #: 4
EC 413 Mr. Roy Hamilton Vol #: 4
EC 414 Essential Nutrition Vol #: 4
EC 415 Ms. Eunice Rhonda Bastian Vol #: 4
EC 416 Mrs. Elizabeth Stevens Vol #: 4
EC 417 Mr. Chris Reynoso Vol #: 4
EC 418 Ms. Patricia Brown Vol #: 4
EC 419 Mrs. Debra Parker Vol #: 4
EC 420
Attachment
Ms. Tara Irwin Vol #: 4
EC 421 Mrs. Erin McRae Vol #: 4
EC 422 Mrs. Margo Lewis Vol #: 4
EC 423 Mrs. Tirsa Nel Vol #: 4
EC 424 Mrs. Maureen Gilmartin Vol #: 4
EC 425 Mrs. Diana Dillinger Vol #: 4
EC 426 Ms. Kathryn Carr Vol #: 4
EC 427 Mrs. Doris Hart Vol #: 4
EC 428 Mrs. Kathleen Barretto Vol #: 4
EC 429 Ms. Mary Elizabeth Peterson Vol #: 4
EC 430 Mrs. Susan Damanti Vol #: 4
EC 431 Mrs. Katherine Murray Vol #: 4
EC 432 Mrs. Susan Flynn Vol #: 4
EC 433 Ms. Sandy Griffith Vol #: 4
EC 434 Mrs. Shannon Vestal Vol #: 4
EC 435 Mrs. Wendy Bader Vol #: 4
EC 436 Dr. Wendy Churchill-Urrico Vol #: 4
EC 437 Mrs. Shannon Carducci Vol #: 4
EC 438 Ms. Denise Day Vol #: 4
EC 439 Mrs. Charlene Innerarity Vol #: 4
EC 440 NA Vol #: 4
EC 441 Mrs. Cindy Parker Vol #: 4
EC 442 Mrs. Barbara Miller Vol #: 4
EC 443 Mrs. Nancy Merritt Vol #: 4
EC 444 Ms. Ruth Alvarez Vol #: 4
EC 445 Ms. Julie Bowman Vol #: 4
EC 446 Mrs. Janet Miles-Maestas Vol #: 4
EC 447 Mrs. lisa elmer Vol #: 4
EC 448 Mrs. joanne ohlhausen Vol #: 4
EC 449 Ms. Diane Clagg Vol #: 4
EC 450 Dr. Helene Leonetti Vol #: 4
EC 451 Dr. V Borgmeyer Vol #: 4
EMC 10 M. Beam Vol #: 6
2005P-0420 Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
SUP 1
Exhibit A
Shire Pharmaceuticals Group Vol #: 3
2006N-0010 Able Laboratories, Inc.; Withdrawal of Approval of 43 Abbreviated New Drug Applications
LET 1 HFA-305 to Able Laboratories, Inc. Vol #: 1
2006P-0049 reduce the public health risks associated with the use of drugs manufactured or processed at foreign facilities
ACK 1 HFA-305 to Litron Laboratories Vol #: 1
2006P-0054 513(f) Petition for the SCRAM Bracelet (and Collectively, the SCRAM System) as a Class I Medical Device
ACK 1 HFA-305 to C. Humphrey & Associates, P.A. Vol #: 1
CCP 1 Alcohol Monitoring Systems Vol #: 1
2006V-0053 Laser Light Show
ACK 1 HFA-305 to Fascanition Laser Systems Vol #: 1
ACK 2 number not used Vol #: 1
VAR 1 Fascanition Laser Systems Vol #: 1

Page created on April 18, 2006 RSC

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