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Dockets Management
Dockets Entered On January 4, 2005
Table of Contents
Docket # Title
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001D-0059 Submitting Clinical Data for Purposes of Assessing User Fees
2003D-0117 Implementation of Inspection by Accredited Persons Program
2003P-0564 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
2004D-0377 International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
2004D-0385 Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
2004D-0440 Guidance for Industry on Computerized Systems Used in Clinical Trials
2004D-0459 Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
2004D-0493 Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
2004D-0494 Guidance for Industry on Changes to an Approved NDA or ANDA; Specifications Use of Enforcement Discretion for Compendial Changes
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
2004N-0296 Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
2004N-0416 Beverages: Bottled Water
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0458 Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
2004N-0461 Amendment to 25.34; Categorical Exclusions Environmental Assessment
2004N-0480 The Minor Use & Minor Species (MUMS) Animal Health Act
2004N-0503 Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
2004N-0516 Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
2004N-0526 Agency Information Collection Activities; Proposed Collection; Comment Request;
2004N-0534 Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
2004N-0539 Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
2004N-0554 Agency Information Collection Activities: Proposed Collection; Comment Request; Irradiation in the Production, Processing and Handling of Food
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
EC 1 CHF patients Vol #: 9
EC 3 American Bakers Association Vol #: 9
EC 4 Grocery Manufacturers of America Vol #: 9
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 255 Antanais Corp. (Suisse) SA Vol #: 174
RPT 256 Natursol Vol #: 187
RPT 257 Natursol Vol #: 188
RPT 258 Syntech (SSPF) International Inc Vol #: 174
RPT 259 MTC Industries Inc Vol #: 174
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15130 NBTY Inc. Vol #: 133
LET 15131 NBTY Inc. Vol #: 133
LET 15132 NBTY Inc. Vol #: 133
LET 15133 NBTY Inc. Vol #: 133
LET 15134 NBTY Inc. Vol #: 133
LET 15135 NBTY Inc. Vol #: 133
LET 15136 NBTY Inc. Vol #: 134
LET 15137 NBTY Inc. Vol #: 134
LET 15138 NBTY Inc. Vol #: 134
LET 15139 NBTY Inc. Vol #: 134
LET 15140 NBTY Inc. Vol #: 134
LET 15141 NBTY Inc. Vol #: 134
LET 15142 NBTY, Inc. Vol #: 134
LET 15143 NBTY Inc. Vol #: 134
LET 15144 NBTY Inc. Vol #: 134
LET 15145 NBTY Inc. Vol #: 134
LET 15146 NBTY Inc. Vol #: 134
LET 15147 NBTY Inc. Vol #: 134
LET 15148 NBTY Inc. Vol #: 134
LET 15149 NBTY Inc. Vol #: 134
LET 15150 NBTY Inc. Vol #: 134
LET 15151 NBTY Inc. Vol #: 134
LET 15152 NBTY Inc. Vol #: 134
LET 15153 NBTY Inc. Vol #: 134
LET 15154 NBTY Inc. Vol #: 134
LET 15155 NBTY Inc. Vol #: 134
LET 15156 NBTY Inc. Vol #: 134
LET 15157 NBTY Inc. Vol #: 134
LET 15158 NBTY Inc. Vol #: 134
LET 15159 NBTY Inc. Vol #: 134
LET 15160 NBTY Inc. Vol #: 134
LET 15161 NBTY Inc. Vol #: 134
LET 15162 NBTY Inc. Vol #: 134
LET 15163 NBTY Inc. Vol #: 134
LET 15164 NBTY Inc. Vol #: 134
LET 15165 NBTY Inc. Vol #: 134
LET 15166 NBTY Inc. Vol #: 134
LET 15167 NBTY Inc. Vol #: 134
LET 15168 NBTY Inc. Vol #: 134
2001D-0059 Submitting Clinical Data for Purposes of Assessing User Fees
GDL 2 Guideline Vol #: 1
NAD 2 FDA Vol #: 1
2003D-0117 Implementation of Inspection by Accredited Persons Program
EC 3 Ms. Loretta Tennant Vol #: 3
2003P-0564 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
EC 1 AdvaMed Vol #: 1
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
EC 6 Mrs. Sally Williams Vol #: 10
EC 7 Mr. Eric Norman Vol #: 10
EC 8 Mr. Graham Lingley Vol #: 10
EC 9 Mrs. Darcia Helle Vol #: 10
EC 10 Mr. Mark Schneider Vol #: 10
EC 11 Ms. Sandra Williamson Vol #: 10
EC 12 Ms. Hannah Dominguez Vol #: 10
EC 13 Mr. Paul Borgerson Vol #: 10
EC 14 Ms. Ellen-Cathryn Nash Vol #: 10
EC 15 Mr. Peter Muskus Vol #: 10
EC 16 Ms. Marian Steiskal Vol #: 10
EC 17 Mr. Jan-Erik Knudsen Vol #: 10
EC 18 Mrs. Crystal Daugherty Vol #: 10
EC 19 Concerned Voters Vol #: 10
EC 20 Ms. Jenn Gunder Vol #: 10
EC 21 Mr. Kurt Bell Vol #: 10
EC 22 Dr. Laura Galligan Vol #: 10
EC 23 SE Essex Organic Gardeners Vol #: 10
EC 24 Mr. David Kollen Vol #: 10
EC 25 none Vol #: 10
EMC 126 L. Benson Vol #: 7
EMC 127 M. Quitiquit Vol #: 7
EMC 128 E. Cox Vol #: 7
EMC 129 F. Tierney Vol #: 7
EMC 130 S. Nelson Vol #: 7
EMC 131 A. Sainsbury Vol #: 7
EMC 132 S. Overstreet Vol #: 7
EMC 133 J. Eyrich Vol #: 7
EMC 134 L. Hernandez Vol #: 7
EMC 135 T. Kovach Vol #: 7
EMC 136 E. Perez Vol #: 7
EMC 137 C. Crusha Vol #: 7
EMC 138 J. Peck Vol #: 7
EMC 139 C. Thom Vol #: 7
EMC 140 D. Moyer Vol #: 7
EMC 141 High Sun Engineering Vol #: 7
EMC 142 B. Mancuso Vol #: 7
EMC 143 Straus Family Creamery Vol #: 7
EMC 144 C. Every Vol #: 7
EMC 145 L. Milks Vol #: 7
EMC 146 S. Blake Vol #: 7
EMC 147 S. Leon Vol #: 7
EMC 148 F. Wyatt Vol #: 7
EMC 149 N. Greene Vol #: 7
EMC 150 E. Feinblatt Vol #: 7
EMC 151 F. Kirsch Vol #: 7
EMC 152 F. Kirsch Vol #: 7
EMC 153 J. Poss Vol #: 7
EMC 154 E. O'Reilly Vol #: 7
EMC 155 A. Bryant Vol #: 7
EMC 156 M. Fordham, Esq Vol #: 7
EMC 157 B and W Hough Vol #: 7
EMC 158 N. Price Vol #: 7
EMC 159 J. Williams Vol #: 7
EMC 160 M. Castaline Vol #: 7
EMC 161 L. Larsen, RN Vol #: 7
EMC 162 R. Roy Vol #: 7
EMC 163 S. Wuerstle Vol #: 7
EMC 164 H. Ennes Vol #: 7
EMC 165 J. Spitz Vol #: 7
EMC 166 M. Pallie Vol #: 7
EMC 167 M. Barclay Vol #: 7
EMC 168 Ryan L. Vol #: 7
EMC 169 C. Marchand Vol #: 7
EMC 170 M. Wonsidler Vol #: 7
EMC 171 M. Letourneau Vol #: 7
EMC 172 C. Ristad Vol #: 7
EMC 173 M. Kessler Vol #: 7
EMC 174 W. Seifert Vol #: 7
EMC 175 T. Urani Vol #: 7
EMC 176 P. Rousselot Vol #: 7
EMC 177 J. Eveland Vol #: 7
EMC 178 A. Sutphin Vol #: 7
EMC 179 C. Rios Vol #: 7
EMC 180 N. Fajardo Vol #: 7
EMC 181 S. Harter Vol #: 7
EMC 182 K. Williams Vol #: 7
EMC 183 C. Spake Vol #: 7
EMC 184 R. Keep Vol #: 7
EMC 185 H and K Askov Vol #: 7
EMC 186 B. Turnwald Vol #: 7
EMC 187 M. Thorsen Vol #: 7
EMC 188 D. Hamilton Vol #: 7
EMC 189 D. Trotta Vol #: 7
EMC 190 M. Every Vol #: 7
EMC 191 W. Juel Vol #: 7
EMC 192 D. Matthew Vol #: 7
EMC 193 N. Crawford Vol #: 7
EMC 194 A. Linton Vol #: 7
EMC 195 A. Quinn Vol #: 7
EMC 196 D. Pierce Vol #: 7
EMC 197 S. Nobriga Vol #: 7
EMC 198 K. Knoll Vol #: 7
EMC 199 J. Santesteban Vol #: 7
EMC 200 L. Callies Vol #: 7
EMC 201 J. Freeman Vol #: 7
EMC 202 T. Newmark Vol #: 7
EMC 203 H. Wu Vol #: 7
EMC 204 R. Browne Vol #: 7
EMC 205 R. Kaiser Vol #: 7
EMC 206 V. Rice Vol #: 7
EMC 207 R. Kaiser Vol #: 7
EMC 208 J. Polis Vol #: 7
EMC 209 L. Emerich Vol #: 7
EMC 210 D. Todd Vol #: 7
EMC 211 D. Palola Vol #: 7
EMC 212 B. Aleshnick Vol #: 7
EMC 213 G. Faust Vol #: 7
EMC 214 J and V Wagner Vol #: 7
EMC 215 J and V Wagner Vol #: 7
EMC 216 M. John Vol #: 7
EMC 217 E. Wood Vol #: 7
EMC 218 R. Green Vol #: 7
EMC 219 S. Naftaly Vol #: 7
EMC 220 R. Moser Vol #: 7
EMC 221 L. Swanson Vol #: 7
EMC 222 B. Flowers Vol #: 7
EMC 223 B. McClintock Vol #: 7
EMC 224 M. Morris Vol #: 7
EMC 225 K. Lim Vol #: 7
EMC 226 M. Bisheff Vol #: 7
EMC 227 A. Benedict Vol #: 7
EMC 228 L. Smith Vol #: 7
EMC 229 M. Flores Vol #: 7
EMC 230 D. Shoemaker Vol #: 7
EMC 231 P. Persons Vol #: 7
EMC 232 F. Moore Vol #: 7
EMC 233 T. Welsh Vol #: 7
EMC 234 C. Mone Vol #: 7
EMC 235 S. Greenberg Vol #: 7
EMC 236 J. Herrington Vol #: 7
EMC 237 M. Shunney Vol #: 7
EMC 238 I. Lodge Vol #: 7
EMC 239 A. Lamb Vol #: 7
EMC 240 P. Roth Vol #: 7
EMC 241 P. Martin Vol #: 7
EMC 242 K. Korten Vol #: 7
EMC 243 R. Smith Vol #: 7
EMC 244 S. Bidaure Vol #: 7
EMC 245 J. Kehret Vol #: 7
EMC 246 M. McMillen Vol #: 7
EMC 247 N. Gingrich Vol #: 7
EMC 248 S. Markell Vol #: 7
EMC 249 R. Wade Vol #: 7
EMC 250 H. Domenick Vol #: 7
EMC 251 W. Ballentine Vol #: 7
EMC 252 K. Kosup Vol #: 7
EMC 253 T. Taylor Vol #: 7
EMC 254 M. Phillips Vol #: 7
EMC 255 D. Russell Vol #: 7
EMC 256 S. Trexler Vol #: 7
EMC 257 L. Donaldson Vol #: 7
EMC 258 D. Morotz Vol #: 7
EMC 259 L. Lohan Vol #: 7
EMC 260 S. Whie Vol #: 7
EMC 261 E. Michielssen Vol #: 7
EMC 262 M. Leonard Vol #: 7
EMC 263 A. Hoy Vol #: 7
EMC 264 C. Angel Vol #: 7
EMC 265 B. Sachau Vol #: 7
EMC 266 R. Strochlic Vol #: 7
EMC 267 J. Levine Vol #: 7
EMC 268 K and A Tostado Vol #: 7
EMC 269 D. Rew Vol #: 7
EMC 270 S. Smith Vol #: 7
EMC 271 L. Vack Vol #: 7
EMC 272 V. Alvarez Vol #: 7
EMC 273 L. Ehrenfreund Vol #: 7
EMC 274 W. Matthew Vol #: 7
EMC 275 A. Budner Vol #: 7
EMC 276 S. Rosmarin Vol #: 7
EMC 277 B. McClintock Vol #: 7
EMC 278 C. Georgiou Vol #: 7
EMC 279 C. Fisher Vol #: 7
EMC 280 R. Fisher Vol #: 7
EMC 281 S. Stockton Vol #: 7
EMC 282 D. Sanor Vol #: 7
EMC 283 A. Hurley Vol #: 7
EMC 284 M. Gangemi Vol #: 7
EMC 285 C. Becker, PhD Vol #: 7
EMC 286 S. Schmidt Vol #: 7
EMC 287 M. Triplett Vol #: 7
EMC 288 L. Landis Vol #: 7
EMC 289 R. Chesrow Vol #: 7
EMC 290 D. McCauley Vol #: 7
EMC 291 B. Meyer Vol #: 7
EMC 292 A. Moomaw Vol #: 7
EMC 293 C. Brown Vol #: 7
EMC 294 M. Eager Vol #: 7
EMC 295 S. Davatz Vol #: 7
EMC 296 K. Moore Vol #: 7
EMC 297 A. Kilborn Vol #: 7
EMC 298 B. Dean Vol #: 7
EMC 299 S. Thomas Vol #: 7
EMC 300 J. Lubarr Vol #: 7
EMC 301 B. Coberly Vol #: 7
EMC 302 T. Gabe Vol #: 7
EMC 303 R. Williams Vol #: 7
EMC 304 E. Nielsen Vol #: 7
EMC 305 J. Robbins Vol #: 7
EMC 306 N. Levin Vol #: 7
EMC 307 C. Williams Vol #: 7
EMC 308 P. Anderson Vol #: 7
EMC 309 B. Kreykes Vol #: 7
EMC 310 L. Carroll Vol #: 7
EMC 311 D. White Vol #: 7
EMC 312 S. Radtke Vol #: 7
EMC 313 C. Morris Vol #: 7
EMC 314 C. Wechsler Vol #: 7
EMC 315 K. Hellick Vol #: 7
EMC 316 D. Hoaglin Vol #: 7
EMC 317 D. Krystofiak Vol #: 7
EMC 318 A. White Vol #: 7
EMC 319 M. Olson Vol #: 7
EMC 320 D. Slack Vol #: 7
EMC 321 M. Drews Vol #: 7
EMC 322 E. Dinu Vol #: 7
EMC 323 S. Gee Vol #: 7
EMC 324 O. Green Vol #: 7
EMC 325 E. Rieber Vol #: 7
EMC 326 F. Vincent Vol #: 7
EMC 327 P. Williams Vol #: 7
EMC 328 J. Spilker Vol #: 7
EMC 329 K. Marcu Vol #: 7
EMC 330 H. Sudbury Vol #: 7
EMC 331 K. Lawler Vol #: 7
EMC 332 D. Whittaker Vol #: 7
EMC 333 M. Eiseman Vol #: 7
EMC 334 M. Greenberg Vol #: 7
EMC 335 K. Marohn Vol #: 7
EMC 336 H. Brown Vol #: 7
EMC 337 NWA, Inc. Vol #: 7
EMC 338 A. Rourke Vol #: 7
EMC 339 J. Gee Vol #: 7
EMC 340 C. Milano Vol #: 7
EMC 341 A. Bek Vol #: 7
EMC 342 D. Shelton Vol #: 7
EMC 343 J. Manganello Vol #: 7
EMC 344 W. Lill, Jr. Vol #: 7
EMC 345 G. Konecky Vol #: 7
EMC 346 W. Hershey Vol #: 7
EMC 347 C. Pliske Vol #: 7
EMC 348 S and L Wojno Vol #: 7
EMC 349 A. Bressler Vol #: 7
EMC 350 J. Wechsler Vol #: 7
EMC 351 R. Bauce Vol #: 7
EMC 352 P. Leverone Vol #: 7
EMC 353 K. Kuhn Vol #: 7
EMC 354 S. Haven Vol #: 7
EMC 355 K. Huttler Vol #: 7
EMC 356 M. Ambrose Vol #: 7
EMC 357 J. Gore Vol #: 7
EMC 358 E. Leonard Vol #: 7
EMC 359 R. McLaughlin Vol #: 7
EMC 360 M. Anderson Vol #: 7
EMC 361 M. Mills Vol #: 7
EMC 362 A. Linton Vol #: 7
EMC 363 M. Mills Vol #: 7
EMC 364 L. Whitlark Vol #: 4
EMC 365 C. Gradia Vol #: 7
EMC 366 M. Marohn Vol #: 7
EMC 367 M. Condon Vol #: 7
EMC 368 V. DellaVecchia Vol #: 7
EMC 369 L. Heard Vol #: 7
EMC 370 D. Strochlic Vol #: 7
EMC 371 W. Glover Vol #: 7
EMC 372 J. Mollett Vol #: 7
EMC 373 W. Hicks Vol #: 7
EMC 374 H. Sharp Vol #: 7
EMC 375 J. Sailing Vol #: 7
EMC 376 B. Trompen Vol #: 7
EMC 377 N. Confino Vol #: 7
EMC 378 C. Lippert Vol #: 7
EMC 379 C. Hicks Vol #: 7
EMC 380 U. Steinke Vol #: 7
EMC 381 E. Coombs Vol #: 7
EMC 382 J. Autrey Vol #: 7
EMC 383 B. Eddins Vol #: 7
EMC 384 M. Carrasco Vol #: 7
EMC 385 S. Katz Vol #: 7
EMC 386 K. Marshall Vol #: 7
EMC 387 S. Samuel Vol #: 7
EMC 388 E. Norman Vol #: 7
EMC 389 S. Gaffke Vol #: 7
EMC 390 B. Flowers Vol #: 7
EMC 391 M. Rajkowski Vol #: 7
EMC 392 E. Chung Vol #: 7
EMC 393 V. Hamilton Vol #: 7
EMC 394 A. Wright Vol #: 7
EMC 395 M. Hucek Vol #: 7
EMC 396 D. Crake Vol #: 7
EMC 397 L. Colson Vol #: 7
EMC 398 M. Chreptak Vol #: 7
EMC 399 A. Bartholomew Vol #: 7
EMC 400 G. Cronin Vol #: 7
EMC 401 L. York Vol #: 8
EMC 402 G. Turek Vol #: 8
EMC 403 D. Harnden Vol #: 8
EMC 404 J. Troy Vol #: 8
EMC 405 S. Muzzey Vol #: 8
EMC 406 S. Jennings Vol #: 8
EMC 407 L. Tener Vol #: 8
EMC 408 W. Nichols Vol #: 8
EMC 409 R. Hopewell Vol #: 8
EMC 410 P. Buechler Vol #: 8
EMC 411 J. Nguyen Vol #: 8
EMC 412 H. Loring Vol #: 8
EMC 413 G. Fowler Vol #: 8
EMC 414 J and V Wagner Vol #: 8
EMC 415 D. Eisler Vol #: 8
EMC 416 S. Fletcher Vol #: 8
EMC 417 M. Anderson Vol #: 8
EMC 418 M. Hoffman Vol #: 8
EMC 419 L. Bouyea Vol #: 8
EMC 420 M. Bresner Vol #: 8
EMC 421 R. Gelcer Vol #: 8
EMC 422 D. Steinberg Vol #: 8
EMC 423 M. O'Neal Vol #: 8
EMC 424 M. Ravina Vol #: 8
EMC 425 S. Hannah Vol #: 8
EMC 426 G. Sindelar Vol #: 8
EMC 427 R. Caloggero Vol #: 8
EMC 428 P. Drew Vol #: 8
EMC 429 Form Letters Vol #: 9
2004D-0377 International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
EMC 1
Attachment 		Johnson & Johnson Pharmaceutical Research & Development, LLC Vol #: 1
2004D-0385 Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
EC 2 AdvaMed Vol #: 1
2004D-0440 Guidance for Industry on Computerized Systems Used in Clinical Trials
EC 5 ClinPhone Vol #: 1
EC 6 Data Quality Research Institute Vol #: 1
EC 7 PHT Corporation Vol #: 1
EMC 3 Merck & Co., Inc. Vol #: 1
2004D-0459 Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
EMC 1 Merck & Co., Inc. Vol #: 1
2004D-0493 Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
EMC 1 B. Sachau Vol #: 1
2004D-0494 Guidance for Industry on Changes to an Approved NDA or ANDA; Specifications Use of Enforcement Discretion for Compendial Changes
EMC 1 B. Sachau Vol #: 1
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
EC 2 Stavis Seafoods, Inc. Vol #: 1
2004N-0296 Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
N 2 FDA Vol #: 1
2004N-0416 Beverages: Bottled Water
EMC 1 B. Sachau Vol #: 2
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EMC 6 BASF Corporation Vol #: 3
2004N-0458 Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
EC 8 Dr. edmund copeland Vol #: 1
2004N-0461 Amendment to 25.34; Categorical Exclusions Environmental Assessment
EMC 1 B. Sachau Vol #: 1
2004N-0480 The Minor Use & Minor Species (MUMS) Animal Health Act
EC 1 Michigan State University - Sheep Extension Veteri Vol #: 1
2004N-0503 Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
EMC 1 B. Sachau Vol #: 1
2004N-0516 Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
EMC 1 B. Sachau Vol #: 1
2004N-0526 Agency Information Collection Activities; Proposed Collection; Comment Request;
EC 1 Ms. Barabara Sachau Vol #: 1
2004N-0534 Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-The Counter (OTC) Drug Product Labeling
N 1 FDA Vol #: 1
2004N-0539 Establishing a Docket for the Development of Plasma Standards Public Workshop; Availability
N 1 FDA Vol #: 1
2004N-0554 Agency Information Collection Activities: Proposed Collection; Comment Request; Irradiation in the Production, Processing and Handling of Food
N 1 FDA Vol #: 1
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
EMC 1 Noven Pharmaceuticals, Inc. (Noven) Vol #: 2

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