Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on February 27, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99N-3088 Mktg Exclusivity & Patent Provisions for Certain Antibioitic *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1618 Blood collection/persons with Hereditary Hemochromatosis *
00D-1681 Potassium Iodide as a Thyroid Blocking Agent *
00N-0989 Human Gene Therapy *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m *
01P-0085 ANDA Suitable for topical cream containing 2% Hyrocortisone *
01P-0087 Request Classification for Dulbecco's Modified Eagle Tissue *

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 3930 Margaret McGinnis Vol#: 124

C 3931 Bill & Carleen Boehl Vol#: 124

C 3932 Kellie Cremer Vol#: 124

C 3933 Bob & Nancy Breslin Vol#: 124

C 3934 Ellen Waggoner Vol#: 124

C 3935 Frances Morris Vol#: 124

C 3936 Mary Angilly Vol#: 124

C 3937 Margia Dean Alvarez Vol#: 124

C 3938 Kate Neilson Vol#: 124

C 3939 Sarah Schwandt Vol#: 124

C 3940 Audrey Scussell Vol#: 124

C 3941 Patti Morris Vol#: 124

C 3942 Richard Mc Colley Vol#: 124

C 3943 Eloise Senyan Vol#: 124

C 3944 Marilyn E. Murphy Vol#: 124

C 3945 Robert H. Lumbra Vol#: 124

C 3946 J. B. Neall Vol#: 124

C 3947 Kate Lemery Vol#: 124

C 3948 Jennifer Martin Vol#: 124

EMC 1157 Mindy Canter Vol#: 123

EMC 1158 Mary Ann Naples Vol#: 123

EMC 1159 Deborah Pageau (Canada) Vol#: 123

EMC 1160 Heather & Nathan Sugioka Vol#: 123

EMC 1161 Jennifer Hillman Vol#: 123

EMC 1162 Tracy Huddleson Vol#: 123

EMC 1163 Maria Lopes (Portugal) Vol#: 123

EMC 1164 Colleen Smith Vol#: 123

EMC 1165 Shirley J. Cofresi Vol#: 123

EMC 1166 Gary W. McLaughlin Vol#: 123

EMC 1167 Kelly Bradford Vol#: 123

EMC 1168 Betty Jean Herner Vol#: 123

EMC 1169 Laura Saxton Vol#: 123

EMC 1170 Loretta Morgan Vol#: 123

EMC 1171 Dan Burbank & Dawn James Vol#: 123

EMC 1172 Cindy Raven Vol#: 123

EMC 1173 Dan Burbank Vol#: 123

EMC 1174 Dulcy Jenkins Vol#: 123

EMC 1175 Kristina Munz Vol#: 123

EMC 1176 Ellen Barnett Vol#: 123

EMC 1177 Patrick Holderfield Vol#: 123

EMC 1178 Glenda T. Berg, Ph.D. Vol#: 124

99N-3088 Mktg Exclusivity & Patent Provisions for Certain Antibioitic

C 6 AstraZeneca Pharmaceuticals Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16943 Patricia A Barton Vol#: 488

C 16944 Barbara A Sullivan Vol#: 488

C 16945 Gilbert & Marjorie Lay Vol#: 488

C 16946 Kathleen Rudaitis Vol#: 488

C 16947 Eugene Hackert Vol#: 488

C 16948 Charlotte Nightlinger Vol#: 488

C 16949 Ronald K & Susan J Mengel Vol#: 488

C 16950 Rhonda Jennings Vol#: 488

C 16951 Joan R Okeefe Vol#: 488

C 16952 Brenda Mullins Vol#: 488

C 16953 Carylyn Later Vol#: 488

C 16954 Tom & Anne Laundrie Vol#: 488

C 16955 Barbara E Lawrence Vol#: 488

C 16956 Ginger L German Vol#: 488

C 16957 Eric Smalley Vol#: 488

C 16958 Geraldine Vathne Vol#: 488

C 16959 Amethyst Amico Vol#: 488

C 16960 Dorothy Scott Vol#: 488

C 16961 Robert J Lessard Vol#: 488

C 16962 Jacqueline Howes Vol#: 488

C 16963 Teresa Johnson Vol#: 488

C 16964 Alan H Brewer Vol#: 488

C 16965 Virginia Randolph Vol#: 488

C 16966 Jacqueline A Goohs Vol#: 488

C 16967 Laurence Pollette Vol#: 488

C 16968 Roger L Slakey Vol#: 488

EMC 3386 Gail Napell Vol#: 488

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 13 Family Planning Council Vol#: 1


00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays

C 3 Abbott Laboratories Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

C 380 Form Letter Count 69 Vol#: 7

C 381 Form Letter Count 5 Vol#: 8

C 382 Form Letter Count 3 Vol#: 32

EC 155 Ms. Sigrid Hafstrom Vol#: 31

EC 156 Mr. Brandon Miller Vol#: 31

EC 157 Miss Sachiko Neumann Vol#: 31

EC 158 Mr. Geoff Brown Vol#: 31

EC 159 Ms. Anne McKenna Vol#: 31

EC 160 individual Vol#: 31

EC 161 Ms. Collette Mattingly Vol#: 31

EC 162 Consultant Vol#: 31

EC 163 pomona college Vol#: 31

EC 164 Miss T Moore Vol#: 31

EC 165 Mr. Steve Brauneis Vol#: 31

EC 166 Ms. Miriam Landman Vol#: 31

EC 167 Mr. Kevin Brown Vol#: 31

EC 168 MCS Vol#: 31

EC 169 Ms. Morgan Herron Vol#: 31

EC 170 Ms. J.A. Coxey Vol#: 31

EC 171 Mr. Charles Griemsman Vol#: 31

EC 172 Mr. Public Citizen Vol#: 31

EC 173 Ms. Rebecca Bramer Vol#: 31

EC 174 Mrs. Cole Thompson Vol#: 31

EC 175 Mr. anthony phillipson Vol#: 31

EC 176 concerned citizins Vol#: 31

EC 177 Mrs. Christine Clark Vol#: 31

EC 178 Mr. Luke Deasy Vol#: 31

EC 179 Mr. Jon Thomas Vol#: 31

EC 180 citizen Vol#: 31

EC 181 Dr. Judith Robinson Vol#: 31

EC 182 Mrs. Elisa Mohrmann Vol#: 31

00D-1618 Blood collection/persons with Hereditary Hemochromatosis

C 2 Bill Sides Vol#: 1

C 3 Victor Herbert MD Vol#: 1

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

C 2 P Meisse Vol#: 1

C 3 Duck Power Company Vol#: 1

EMC 1 Steven H Lamm MD Vol#: 1

00N-0989 Human Gene Therapy

EMC 4 Lesley Parker-Rollins Vol#: 1

EMC 5 Lesley Parker-Rollins Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EC 86 Ms. D. Weynand Vol#: 17

EC 87 individual Vol#: 17

EC 88 Mr. Lorn Kay Vol#: 17

EC 89 Franciscan Justice and Peace Office Vol#: 17

EC 90 Ms. Kristin Homme Vol#: 17

EC 91 Mr. Bruce Summers Vol#: 17

EC 92 Ms. J.A. Coxey Vol#: 17

EC 93 greater taunton greens Vol#: 17

EC 94 Ms. Helen McGreary Vol#: 17

EC 95 Ms. Rosemary Wood Vol#: 17

EC 96 Mr. Jon Thomas Vol#: 17

EC 97 citizen Vol#: 17

EMC 311 E Rose Vol#: 18

EMC 312 P Waterstone Vol#: 18

EMC 313 C Richards, MA Vol#: 18

EMC 314 H Crocker Vol#: 18

EMC 315 M Salisbury Vol#: 18

EMC 316 A C Payne Vol#: 18

EMC 317 C Ferkenhoff Vol#: 18

EMC 318 S Walters Vol#: 18

EMC 319 J Matras Vol#: 18

EMC 320 M Barrantes Vol#: 18

EMC 321 M J Dorsey Vol#: 18

EMC 322 C O'Brien Vol#: 18

EMC 323 M Palmer Vol#: 18

EMC 324 L Thurston Vol#: 18

EMC 325 P Rasmussen Vol#: 18

EMC 326 P Scilipote Vol#: 18

EMC 327 Rev. Dr. A H Feldman Vol#: 18

EMC 328 L Zobin Vol#: 18

EMC 329 SRL Vol#: 18

EMC 330 C Yaeger Vol#: 18

EMC 331 A Manghan Vol#: 18

EMC 332 M & N Vlasaty Vol#: 18

EMC 333 J McConnell Vol#: 18

EMC 334 R E Reynolds Vol#: 18

EMC 335 D Morris Vol#: 18

EMC 336 R Swadener Vol#: 18

EMC 337 K Button Vol#: 18

EMC 338 M Pesa Vol#: 18

EMC 339 R Wheeler Vol#: 18

EMC 340 G Levy Vol#: 18

EMC 341 A Lindsey Vol#: 18

EMC 342 A W Vol#: 18

EMC 343 E Smith Vol#: 18

EMC 344 J Sillars Vol#: 18

EMC 345 B Kessler Vol#: 18

EMC 346 A Jamison Vol#: 18

EMC 347 G Scagnetti Vol#: 18

EMC 348 M Gordon Vol#: 18

EMC 349 Pesticide Free Environment Now Vol#: 18

EMC 350 D Buckley Vol#: 18

EMC 351 K Brady Vol#: 18

EMC 352 M Gordon Vol#: 18

EMC 353 S G Robinson Vol#: 18

EMC 354 N Olson Vol#: 18

EMC 355 C Mandelbaum Vol#: 18

EMC 356 J Wood Vol#: 18

EMC 357 R Gordon Vol#: 18

EMC 358 S Hunter Vol#: 18

EMC 359 J A Kinberg Vol#: 18

EMC 360 C Ball Vol#: 18

EMC 361 G McMahon Vol#: 18

EMC 362 W Bardsley Vol#: 18

EMC 363 P Nigrini Vol#: 18

EMC 364 P Friedman Vol#: 18

EMC 365 W B Winget Vol#: 18

EMC 366 W Porter Vol#: 18

EMC 367 L McGauhey Vol#: 18

EMC 368 G McCallister Vol#: 18

EMC 369 N Heffron Vol#: 19

EMC 370 T E Welch Vol#: 19

EMC 371 H Willson Vol#: 19

EMC 372 S Wanat Vol#: 19

EMC 373 J Cleer Vol#: 19

EMC 374 D Friedman Vol#: 19

EMC 375 N Mueller Vol#: 19

EMC 376 J Detert-Moriarty Vol#: 19

EMC 377 S Friesen, RD, CDE Vol#: 19

EMC 378 K Girardin Vol#: 19

EMC 379 M Worthington Vol#: 19

EMC 380 M KirkWagner Vol#: 19

EMC 381 G & M McGaughey Vol#: 19

EMC 382 M Sipe Vol#: 19

EMC 383 M Schulman Vol#: 19

EMC 384 E Berger Vol#: 19

EMC 385 S & L Suggs Vol#: 19

EMC 386 R E Long Vol#: 19

EMC 387 A Koransky Vol#: 19

EMC 388 M Logan Vol#: 19

EMC 389 S Emmack Vol#: 19

EMC 390 H Hill Vol#: 19

EMC 391 R Ghia Vol#: 19

EMC 392 D MacCannell Vol#: 19

EMC 393 Appalachia--Science in the Public Intere Vol#: 19

EMC 394 K Laible Vol#: 19

EMC 395 R E Rutkowski. Esq. Vol#: 19

EMC 396 R Bogolub Vol#: 19

EMC 397 S Karbiner Vol#: 19

EMC 398 A Walker Vol#: 19

EMC 399 A Aptekar Vol#: 19

EMC 400 Number not used Vol#: 19

EMC 401 C Gish Vol#: 19

EMC 402 A Dufour Vol#: 19

EMC 403 J Smith Vol#: 19

EMC 404 E Lennert Vol#: 19

EMC 405 B Heltman Vol#: 19

EMC 406 C Voll Vol#: 19

EMC 407 W Leeman Vol#: 19

EMC 408 S Bulgier Vol#: 19

EMC 409 K Anderson Vol#: 19

EMC 410 S Y Lee & A S Mossman Vol#: 19

EMC 411 M/M R Anderlik Vol#: 19

EMC 412 S Hyer Vol#: 19

EMC 413 V Pelle Vol#: 19

EMC 414 P Plath Vol#: 19

EMC 415 L Wieland Vol#: 19

EMC 416 E Malone Vol#: 19

EMC 417 C Murck Vol#: 19

EMC 418 U of CA Vol#: 19

EMC 419 S Reed Vol#: 19

EMC 420 UC Davis Vol#: 19

EMC 421 G Anderson Vol#: 19

EMC 422 S Chase Vol#: 19

EMC 423 E Loomis Vol#: 19

EMC 424 mimisdad@lycos.com Eichenholtz Vol#: 19

EMC 425 M Bacigalupi Vol#: 19

EMC 426 A Ferguson Vol#: 19

EMC 427 J Pratt Vol#: 19

EMC 428 K Henrickson Vol#: 19

EMC 429 C Barnes & H Reeves Vol#: 19

EMC 430 C Eiermann Vol#: 19

EMC 431 G Quezada Vol#: 19

EMC 432 M Heister Vol#: 19

EMC 433 S Moore Vol#: 19

EMC 434 A Beckwith Vol#: 19

EMC 435 B S Wallace Vol#: 19

EMC 436 Number not used Vol#: 19

EMC 437 Number not used Vol#: 19

EMC 438 K Thompson Vol#: 19

EMC 439 M W Riley Vol#: 19

EMC 440 J Metzger Vol#: 19

EMC 441 D McCollum Vol#: 19

EMC 442 Dr. T Poland Vol#: 19

EMC 443 Dr. D L & F L Cinquemani Vol#: 19

EMC 444 Number not used Vol#: 19

EMC 445 Number not used Vol#: 19

EMC 446 C Hartman Vol#: 19

EMC 447 D Spangler Vol#: 19

EMC 448 L Foley Vol#: 19

EMC 449 S Clumpner Vol#: 19

EMC 450 T Burgin Vol#: 19

EMC 451 J Masucci Vol#: 19

EMC 452 Number not used Vol#: 19

EMC 453 C Wirt Vol#: 19

EMC 454 S Green Vol#: 19

EMC 455 D Perrett Vol#: 19

EMC 456 Number not used Vol#: 19

EMC 457 T Muehler Vol#: 19

EMC 458 H Cantino Vol#: 19

EMC 459 J DeWever Vol#: 19

EMC 460 J Hubbard Vol#: 19

EMC 461 M Kimaid Vol#: 19

EMC 462 North Olympic Youth Centers Vol#: 19

EMC 463 E B Socolar Vol#: 19

EMC 464 F Lefevre Vol#: 19

EMC 465 L M Pocquette Vol#: 19

EMC 466 J Spriggs Vol#: 19

EMC 467 L Raterman Vol#: 19

EMC 468 G Dutter Vol#: 19

EMC 469 L Martinez Vol#: 19

EMC 470 C Nelson Vol#: 19

EMC 471 A Handler Vol#: 19

EMC 472 J Hendrick Vol#: 19

EMC 473 P J Forsell Vol#: 19

EMC 474 R Liebman Vol#: 19

EMC 475 N Serpa Vol#: 19

EMC 476 L Prater Vol#: 19

EMC 477 R J Rooney Vol#: 19

EMC 478 L Schnick Vol#: 19

EMC 479 J Vered Vol#: 19

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 175 CSPI,et al Vol#: 25

C 176 Texas Turkey Federation Vol#: 25

C 177 Minnesota Turkey Growers Association Vol#: 25

00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m

C 2 Lachman Consultant Ser Inc Vol#: 1


01P-0085 ANDA Suitable for topical cream containing 2% Hyrocortisone

ACK 1 HFA-305 Vol#: 1

CP 1 Ferdale Laboratories Inc. Vol#: 1

01P-0087 Request Classification for Dulbecco's Modified Eagle Tissue

ACK 1 HFA-305 Vol#: 1

CCP 1 Life technologies, Inc. Vol#: 1

01V-0088 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Westwood Investment, LLC dba Club Vieux Vol#: 1