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 4, 2000

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked.

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
93N-0022 Debar Daphne Pai; Notice of Opportunity for Hearing *
93N-0372 Medical Devices; Hearing Aid Requirements *
00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat *
00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug *
00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac *
00N-0504 Egg Safety Action Plan *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1556 Policy regarding ANDA holder confidentiality *
93N-0022 Debar Daphne Pai; Notice of Opportunity for Hearing

LET 6 HFC-1 ORA Vol#: 1

93N-0372 Medical Devices; Hearing Aid Requirements

C 4541 Beltone Vol#: 85

C 4542 Beltone Hearing Aid Centers Vol#: 85

C 4543 Mid-West Hearing Aid Service, Inc. Vol#: 85

C 4544 Rainford Hearing Aid Service Vol#: 85

C 4545 Twin Cities Hearing Aid Center Vol#: 85

C 4546 Northwest Arkansas Hearing Aid Center Vol#: 85

C 4547 Auburn Hearing Aid Center Vol#: 85

C 4548 Rivers Group/Communicative Disorders Vol#: 85

C 4549 Miracle Ear Hearing Systems Vol#: 85

C 4550 Top Quality Hearing Aid Center, Inc. Vol#: 85

C 4551 Benson Hearing Aid Center Vol#: 85

C 4552 AVC Hearing Aid Center, Inc. Vol#: 85

C 4553 Hopmeier Hearing Centers Vol#: 85

C 4554 First Digital Hearing Aid Centers Vol#: 85

C 4555 Wisconsin Hearing Service Vol#: 85

C 4556 McGuire's All Brands Hearing Aid Service Vol#: 85

C 4557 AVC Hearing Aid Center Vol#: 85

C 4558 Fullerton Hearing Center Vol#: 85

C 4559 National Hearing Aid Center Vol#: 85

C 4560 Vallejo Hearing Aid Center Vol#: 85

C 4561 Madison Hearing Aid Center Vol#: 85

C 4562 Hopmeier Hearing Centers Vol#: 85

C 4563 Beltone Hearing Aid Center Vol#: 85

C 4564 Twin Cities Hearing Aid Center Vol#: 85

C 4565 Beltone Hearing Aid Service Vol#: 85

C 4566 Young's Hearing Aid Service Vol#: 85

C 4567 Therese L. Wolf-Hearing Consultants Vol#: 85

C 4568 Qual Hearing Aid Service Vol#: 85

C 4569 Advanced Hearing Services, Inc. Vol#: 85

C 4570 Beltone Hearing Aid Center Vol#: 85

C 4571 AVC Hearing Aid Center, Inc. Vol#: 85

C 4572 Beltone Hearing Aid Center Vol#: 85

C 4573 McGuire's All Brands Hearing Aid Service Vol#: 85

C 4574 McGuire's All Brands Hearing Aid Service Vol#: 85

C 4575 Bruce E. Mow Vol#: 85

C 4576 Sargon G. Yonan Hearing Aid Center Vol#: 85

C 4577 Miracle-Ear Vol#: 85

C 4578 Hopmeier Hearing Centers Vol#: 85

C 4579 Hopmeier Hearing Centers Vol#: 85

C 4580 ABC Hearing Aid Service Vol#: 85

C 4581 Advanced Instruments Vol#: 85

C 4582 Miracle-Ear Vol#: 85

C 4583 Beltone Hearing Aid Center Vol#: 85

C 4584 Beltone Hearing Aid Center Vol#: 85

C 4585 Beltone Hearing Aid Center Vol#: 85

C 4586 Conway Hearing Aid Center Vol#: 85

C 4587 Professional Hearing Aid Assoc. Vol#: 85

C 4588 Lowry Hearing Aid Centers Vol#: 85

C 4589 Advanced Hearing Systems Vol#: 85

C 4590 Center For Better Hearing Aids Vol#: 85

C 4591 Professional Hearing Aid Service Vol#: 85

C 4592 Hear & Now Hearing & Balance Center Vol#: 85

C 4593 Meadville Hearing Aids, Inc. Vol#: 85

C 4594 Professional Hearing Aid Service Vol#: 85

C 4595 Otolarnygology Vol#: 85

C 4596 Judy A. Deen Vol#: 85

C 4597 Hopmeier Hearing Centers Vol#: 85

00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat

C 9 Bristol-Myers Squibb Pharm. Res. Institu Vol#: 1

C 10 Lilly Research Labs. Vol#: 1

00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug

C 5 PhRMA Vol#: 1

C 6 Merck & Co., Inc. Vol#: 1

C 7 Pharmacia Vol#: 1

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

C 1 Abbott Laboratories Vol#: 1

C 2 Purdue Frederick Company Vol#: 1

C 3 Agvar Chemicals Inc Vol#: 1

EMC 1 Novo Nordisk Vol#: 1

EMC 2 Pfizer Inc Vol#: 1

EMC 3 Russell Madsen Vol#: 1

EMC 4 Glaxo Wellcome Vol#: 1

00N-0504 Egg Safety Action Plan

C 82 Winifred & Otto Reuter Vol#: 8

C 83 D'Anna Fortunato Vol#: 8

C 84 Liz Shepherd Vol#: 8

C 85 Dara's Canine Foundation, Inc. Vol#: 8

C 86 Ms Jan Van Dyne Vol#: 8

C 87 Ginger Leilani Chapin Vol#: 8

C 88 Margaret McGinnis Vol#: 8

C 89 Lyn Rosen Vol#: 8

C 90 B. Fenton Vol#: 8

C 91 E. M. Badger Vol#: 8

C 92 Marilyn Guathieri Vol#: 8

C 93 Ann Mazzer Vol#: 8

EMC 293 Rodolfo Ortega Paredes (Mexico) Vol#: 8

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 23 Council Responsible Nutrition Vol#: 65

C 24 CHPA, Consumer Healthcare Products Assn. Vol#: 65

EMC 15 Los Angeles Grassroots Regulatory Partne Vol#: 65

LET 9 Council Responsible Nutrition Vol#: 65

TS 48 Council for Responsible Nutrition Vol#: 65

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 658 Marilyn Hysen Vol#: 24

CH 659 Daniel Harper Vol#: 24

CH 660 Susan Kelly Vol#: 24

CH 661 Catherine Loredo Vol#: 24

CH 662 Stephen Graham Vol#: 24

CH 663 Academy of Managed Care Pharmacy Vol#: 24

CH 664 CMR International Vol#: 24

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

TR 1 Transcript of September 15, 2000 meeting Vol#: 2

00N-1516 Withdrawal of Approval of 76 ANDA's

NWL 1 Apothecon, Inc. et al Vol#: 1

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

C 6368 Marsha Jackson Vol#: 276

C 6369 Gloria Holtz Vol#: 276

C 6370 Nancy Barlow Vol#: 276

C 6371 Addie J. Bell Vol#: 276

C 6372 Julie Spear Vol#: 276

C 6373 Heather Ramirez Vol#: 276

C 6374 Patricia Seffens Vol#: 276

C 6375 David F. Gassman Vol#: 276

C 6376 Dirk Trenholm Vol#: 276

C 6377 Stanley C. Simon Vol#: 276

C 6378 N. E. C. Amord Vol#: 276

C 6379 G. Turubull Vol#: 276

C 6380 John Frazer Vol#: 276

C 6381 Mrs. Clayton Young Vol#: 276

C 6382 Lynn R. Horrocks Vol#: 276

C 6383 Tomascina Reaugh Vol#: 276

C 6384 Albine Guilianelli Vol#: 276

C 6385 Juliet Carr Vol#: 276

C 6386 Susan M. Hausen Vol#: 277

C 6387 Ann Weronhe Vol#: 277

C 6388 Meg Calderwood Vol#: 277

C 6389 Deborah Tweiti-Hull Vol#: 277

C 6390 Cliff Emery Vol#: 277

C 6391 Carlos Guerreiro Vol#: 277

C 6392 Elaine West Vol#: 277

C 6393 Hope Van Hollander Vol#: 277

C 6394 Eileen Friedman Vol#: 277

C 6395 Kathryn Palmer Vol#: 277

C 6396 Tana Jones Vol#: 277

C 6397 Aysel Marella Vol#: 277

C 6398 Reino Hakala Vol#: 277

C 6399 M. Abel Vol#: 277

C 6400 Miguel Merchado Vol#: 277

C 6401 Douglas C. Lawrence Vol#: 277

C 6402 Carol Simon Vol#: 277

C 6403 Mike Guerreriro Vol#: 277

C 6404 Brad Thacker Vol#: 277

C 6405 Phyllis Talbott Vol#: 277

C 6406 G. Griebaum Vol#: 277

C 6407 Robin Goepfert Vol#: 277

C 6408 A. G. Farnell Vol#: 277

C 6409 Margaret Stowe Vol#: 277

C 6410 Elizabeth T. Wolter Vol#: 277

C 6411 A. Joseph Ray Vol#: 277

C 6412 Louise Mingenbach Vol#: 277

C 6413 Pat Holland Vol#: 277

EMC 3061 David R. Paterson Vol#: 277

EMC 3062 Rebecca Rodgers Vol#: 277

EMC 3063 Ann L. White Vol#: 277

EMC 3064 Jennifer C. Sharon Vol#: 277

EMC 3065 Linnea Stonebraker Vol#: 277

00P-1556 Policy regarding ANDA holder confidentiality

ACK 1 HFA-305 Vol#: 1

CP 1 Hyman Phelps & McNamara PC Vol#: 1