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 October 12, 2000

TABLE OF CONTENTS

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93N-0372 Medical Devices; Hearing Aid Requirements *
97N-0289 Pregnancy Labeling; Content & Format Requirements *
99D-0392 Seafood HACCP transition guidance *
00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac *
00N-1257 International Drug Scheduling;Convention on Psychotropic *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
93N-0372 Medical Devices; Hearing Aid Requirements

C 4598 Midwest Hearing Aids Inc Vol#: 86

C 4599 Sears Hearing Aid Center Vol#: 86

C 4600 Wilson Hearing Aid Center Vol#: 86

C 4601 Lowry Hearing Aid Center Vol#: 86

97N-0289 Pregnancy Labeling; Content & Format Requirements

C 6 R Zisa CPA Vol#: 6

LET 1 HFD-104 to R Zisa CPA Vol#: 6

99D-0392 Seafood HACCP transition guidance

C 4 CSPI Vol#: 1

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

C 15375 E Mullis Vol#: 460

C 15376 L Pruzan Vol#: 460

C 15377 M Perry Vol#: 460

C 15378 R LaFleur Vol#: 460

C 15379 M Salus Vol#: 460

C 15380 V Olson Vol#: 460

C 15381 B Lemmie Vol#: 460

C 15382 J Koenigs Vol#: 460

C 15383 B Saffle Vol#: 460

C 15384 J Wood Vol#: 460

C 15385 F Rodrigues Vol#: 460

C 15386 J Sultz Vol#: 460

C 15387 R Dowdle Vol#: 460

C 15388 D Devereaux Vol#: 460

C 15389 L Baehr Vol#: 460

C 15390 C Leeson Vol#: 460

C 15391 M Ball Vol#: 460

C 15392 C Hackett Vol#: 460

C 15393 N Kramer Vol#: 460

C 15394 M Zarndt Vol#: 460

C 15395 M Huhnke Vol#: 460

C 15396 R Carnevale Vol#: 460

C 15397 Dr. R Nibley Vol#: 460

C 15398 P Scott Vol#: 460

C 15399 D Pavich Vol#: 460

C 15400 B McMahon Vol#: 460

C 15401 A Ahrens Vol#: 460

C 15402 L Scarborough Vol#: 460

C 15403 C Bachmuth Vol#: 460

C 15404 J Coleman Vol#: 460

C 15405 D Johnson Vol#: 460

C 15406 R Trask Vol#: 460

C 15407 D Flores Vol#: 460

C 15408 J Gustafson Vol#: 460

C 15409 D Bushey Vol#: 460

C 15410 T Umland Vol#: 460

C 15411 S Findlay Vol#: 460

C 15412 A Dill Vol#: 460

C 15413 D Castagna Vol#: 460

C 15414 J Marien Vol#: 460

C 15415 S Coatts Vol#: 460

C 15416 P Nechvatal Vol#: 460

C 15417 R Brennan Vol#: 460

C 15418 J Pocsi Vol#: 460

C 15419 P McKnight Vol#: 460

C 15420 R Nichols Vol#: 460

C 15421 D Hebert Vol#: 460

C 15422 N Kinsey Vol#: 460

C 15423 A Taylor Vol#: 460

C 15424 B Richey Vol#: 460

C 15425 W White Vol#: 460

C 15426 B Mock Vol#: 460

C 15427 P Eicher Vol#: 460

C 15428 C DeRouer Vol#: 460

C 15429 P Getz Vol#: 460

C 15430 H Stetter Vol#: 460

C 15431 no signature Vol#: 460

C 15432 M Froner Vol#: 460

C 15433 H Depuy Vol#: 460

C 15434 K McWhorter Vol#: 460

C 15435 D Katz Vol#: 460

C 15436 E Bruner Vol#: 460

C 15437 D Sloan Vol#: 460

C 15438 M Lewis Vol#: 460

C 15439 T Thompson Vol#: 460

C 15440 M Pool Vol#: 460

C 15441 F Sheehan Vol#: 460

C 15442 B Matthys Vol#: 460

C 15443 S Woolington Vol#: 460

C 15444 C Mello Vol#: 460

C 15445 C Baldwin Vol#: 460

C 15446 K Wick Vol#: 460

C 15447 D McCulloh Vol#: 460

C 15448 R Chumbley Vol#: 460

C 15449 G Bouse Vol#: 460

C 15450 Earth Mother Health Foods Vol#: 460

C 15451 G Godley Vol#: 460

C 15452 J Lycans Vol#: 460

C 15453 M Ban Vol#: 460

C 15454 V White Vol#: 460

C 15455 O Folda Vol#: 460

C 15456 G Harris Vol#: 460

C 15457 D Fagan Vol#: 460

C 15458 T Marlow Vol#: 460

C 15459 T Rawley Vol#: 460

C 15460 C Austin Vol#: 460

C 15461 K Judd Vol#: 460

C 15462 R Jackson Vol#: 460

C 15463 K Reynolds Vol#: 460

C 15464 G Chance Vol#: 460

C 15465 J Baker Vol#: 460

C 15466 R Haase Vol#: 460

C 15467 D Lewis Vol#: 460

C 15468 M Uphoff Vol#: 460

C 15469 Rev. J Fishburn Vol#: 460

C 15470 S Foster Vol#: 460

C 15471 C Grove Vol#: 460

C 15472 O Hendrickson Vol#: 460

C 15473 M Payne Vol#: 460

C 15474 A Korzyniowski Vol#: 460

C 15475 D Davis Vol#: 460

C 15476 S Frigon Vol#: 460

C 15477 L White Vol#: 461

C 15478 M Nyakoni Vol#: 461

C 15479 R Downs + 2 signatures Vol#: 461

C 15480 D Armenia Vol#: 461

C 15481 T Scheffer Vol#: 461

C 15482 M Peritz Vol#: 461

C 15483 S Zubaedi Vol#: 461

C 15484 T Berry Vol#: 461

C 15485 W Osterman Vol#: 461

C 15486 S Martinear Vol#: 461

C 15487 J McDonald Vol#: 461

00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac

C 4 Agvar Chemicals Inc Vol#: 1

C 5 Merck Research Labs Vol#: 1

C 6 Otsuka America Pharm Inc Vol#: 1

00N-1257 International Drug Scheduling;Convention on Psychotropic

C 6 PhRMA Vol#: 1

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 14 D Painter Vol#: 2

C 15 E Armstrong Vol#: 2

C 16 Addison Livingston Pharm D Vol#: 2

C 17 D Hook Vol#: 2

C 18 R Abbott Sr Vol#: 2

00P-1210 Restrict Sale of Coal Tar-Containing Products

C 5 Whitehall-Robins Healthcare Vol#: 2

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 6467 M Allen Vol#: 279

C 6468 D Taylor Vol#: 279

C 6469 V Wallace Vol#: 279

C 6470 K Balsley Vol#: 279

C 6471 J Deeley Vol#: 279

C 6472 L Pruzan Vol#: 279

C 6473 S Schmitt Vol#: 279

C 6474 B Gasteiger Vol#: 279

C 6475 D Staggs Vol#: 279

C 6476 M Bella Vol#: 279

C 6477 M mcConnell Vol#: 279

C 6478 W Moore Vol#: 279

C 6479 L Pruzan Vol#: 279

C 6480 K Farrell Vol#: 279

C 6481 J Narozny Vol#: 279

C 6482 K Flynn Vol#: 279

C 6483 M Harper Vol#: 279

C 6484 S Brown Vol#: 279

C 6485 Organic Comsumers Association Vol#: 283

C 6486 M Bryson Vol#: 279

C 6487 D Swadbolt Vol#: 279

C 6488 Unsigned Vol#: 279

C 6489 J T Vol#: 279

C 6490 J Ranchhand Vol#: 279

C 6491 M Ard-Kelly Vol#: 279

C 6492 S Ard-Kelly Vol#: 279

C 6493 F Krueger Vol#: 279

C 6494 M Corteza Vol#: 279

C 6495 M Sandweiss Vol#: 279

C 6496 K Killops Vol#: 279

C 6497 J Crane Vol#: 279

C 6498 B Rohier Vol#: 279

C 6499 M Lazor Vol#: 279

C 6500 C Carlson Vol#: 279

C 6501 C Cox Vol#: 279

C 6502 M Abraham Vol#: 279

C 6503 P Johnson Vol#: 279

C 6504 P Sluka Vol#: 279

C 6505 G Heoker Vol#: 279

C 6506 C Campbell Vol#: 279

C 6507 R Smith Vol#: 279

C 6508 V Scarpelli Vol#: 279

C 6509 I Slater Vol#: 279

C 6510 M Scarpelli Vol#: 279

C 6511 M Scarpelli Vol#: 279

C 6512 J Williamson Vol#: 279

C 6513 F Kinzel Vol#: 279

C 6514 S Swanson Vol#: 279

C 6515 T Jochum Vol#: 279

C 6516 D St Perre Vol#: 279

C 6517 F Zinno Vol#: 279

C 6518 I Brown Vol#: 279

C 6519 H Hurwitz Vol#: 279

C 6520 T Biel Jr Vol#: 279

C 6521 L Scharwz Vol#: 279

C 6522 D Bradley Vol#: 279

C 6523 M Fogg Vol#: 279

C 6524 G Ewall Vol#: 279

C 6525 J Gropp Vol#: 279

C 6526 Unsigned Vol#: 279

C 6527 A Hernday Vol#: 279

EMC 3218 B McClintock Vol#: 279

EMC 3219 C Lewis Vol#: 279

EMC 3220 E Couture Vol#: 279

EMC 3221 L Harrison Vol#: 279

EMC 3222 R Creighton Vol#: 279

EMC 3223 R Petrik Vol#: 279

EMC 3224 D Nyzio Vol#: 279

EMC 3225 D Curry Vol#: 279

EMC 3226 L Pazzaglia Vol#: 279

EMC 3227 L Pazzaglia Vol#: 279

EMC 3228 P Thompson Vol#: 279

EMC 3229 A Blum Vol#: 279

EMC 3230 E UDell Vol#:

EMC 3231 H Crupe Vol#: 279