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 January 8, 2001

TABLE OF CONTENTS

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95S-0117 Human Drugs Patent Term Extension & New Patents *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99F-1912 Ultraviolet Light for the Reduction of Microorganisms in Jui *
00D-1424 Analytical procedures and methods validation; drug substance *
00D-1562 Clinical Data In Marketing Applications*
00D-1681 Potassium Iodide as a Thyroid Blocking Agent *
00N-1567 Registration of Producers of Drugs & Listing of Drugs *
00N-1665 Consumer Roundtable; Notice of Meeting *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
00P-1623 WDL of letter issued regarding product Misoprostol *

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 59 List as of January 2, 2001 Vol#: 4

98N-0337 Over the counter human drugs labeling requirements

SUP 2 Block Drug Company, Inc. Vol#: 6

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

EMC 490 Cathryn Dodd Vol#: 100

EMC 491 Christine Buckley Vol#: 100

EMC 492 Stephanie Bell Vol#: 100

EMC 493 Steve Cooper Vol#: 100

EMC 494 Rosanne Tarantolo Vol#: 100

EMC 495 Dawn James Vol#: 100

EMC 496 Clint Wolf Vol#: 100

EMC 497 Angela Smith Vol#: 100

EMC 498 Anil K. Subramani, Ph.D. Vol#: 100

EMC 499 Amber J. Kewl Vol#: 100

EMC 500 Jerry Schupler Vol#: 100

EMC 501 Allison Sumrow Vol#: 100

EMC 502 Joe Haptas Vol#: 100

EMC 503 Margie Thompson Vol#: 100

EMC 504 Bernadette Serenari Vol#: 100

EMC 505 Stacy Swartz Vol#: 100

EMC 506 Chelsea C. Chilcoat Vol#: 100

EMC 507 Cara L. Campbell Vol#: 100

EMC 508 Jenny Braun Vol#: 100

EMC 509 Wendy Wolf Vol#: 100

EMC 510 Stephanie T. De Pue Vol#: 100

EMC 511 Cascade Designs, Inc Vol#: 100

EMC 512 Karen Felsted, CPA, DVM Vol#: 101

EMC 513 Molly Talbot-Metz Vol#: 101

EMC 514 Cam Martinez Vol#: 101

EMC 515 Jim Croop, Jr. Vol#: 101

EMC 516 Lori Madrid Vol#: 101

EMC 517 Janice Wickham Vol#: 101

EMC 518 Linda Gentille & Jan Knepper Vol#: 101

EMC 519 Jean Felsted Vol#: 101

EMC 520 Jennifer A. Goolsby Vol#: 101

EMC 521 Mr. & Mrs. Cutler Vol#: 101

EMC 522 Dana Gemer Vol#: 101

EMC 523 Jessica Dratler Vol#: 101

EMC 524 Priscilla D. Tello Vol#: 101

EMC 525 Wendy Lochner Vol#: 101

EMC 526 Form letters count 1 Vol#: 102

EMC 527 Holly Bander Vol#: 101

EMC 528 Hillary Hurst Vol#: 101

EMC 529 Friends of the Animals Intl. Vol#: 101

EMC 530 Maggie Ramirez Vol#: 101

EMC 531 Denise Steinkerchner Vol#: 101

EMC 532 Darren Edwards Vol#: 101

EMC 533 Jenny Carter & Francis X. Finigan Vol#: 101

EMC 534 Form letters count 1 Vol#: 103

EMC 535 Form letters count 1 Vol#: 104

99F-1912 Ultraviolet Light for the Reduction of Microorganisms in Jui

C 4 Bret Lutz Vol#: 1

C 5 FPE Inc. Vol#: 1

C 6 Community Office for Resources Efficieny Vol#: 1

EMC 65 Jeremy B. Vol#: 1

EMC 66 Anita Balodis, M.D. Vol#: 1

EMC 67 Michele M. Markucki Vol#: 1

EMC 68 Timothy Clark Vol#: 1

EMC 69 Nancy Arnold Vol#: 1

EMC 70 Elizabeth Shimberg Vol#: 1

EMC 71 Doug Wells Vol#: 1

EMC 72 Anna Harlowe Vol#: 1

EMC 73 Jeffrey Miller Vol#: 1

00D-1424 Analytical procedures and methods validation; drug substance

C 26 Roche Diagnostics GmbH Vol#: 2

C 27 Johnson & Johnson Vol#: 2

00D-1562 Clinical Data In Marketing Applications

C 1 Merck & Co Inc Vol#: 1

C 2 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 1

C 3 AstraZeneca Pharmaceuticals LP Vol#: 1

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

EXT 1 Kansas Department of Health & Environmen Vol#: 1

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

C 5 Jerome Mc Collom Vol#: 24

00N-1567 Registration of Producers of Drugs & Listing of Drugs

C 3 Merck & Co Inc Vol#: 1

EXT 1 Leiner Health Products Inc Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 31 Wampler Foods Vol#: 17

C 32 North Carolina State University Vol#: 17

C 33 George Tyndall Vol#: 17

C 34 Prestage Farms Inc. Vol#: 17

C 35 Richard Shooter Vol#: 17

C 36 Steven Clark Vol#: 17

C 37 Donna Thompson Vol#:

C 38 Carlton Wall Vol#: 17

C 39 Tillie Wall Vol#: 17

C 40 Ronald Bartlett Vol#: 17

C 41 Charles Horn Vol#: 17

C 42 Sietsema Farms Vol#: 17

C 43 Bill Sasser Vol#: 17

C 44 Prestage Farms, Inc Vol#: 17

C 45 Wood Lane Ent. Vol#:

C 46 Mooring Turkeys Inc. Vol#: 17

C 47 Cargill Inc. Vol#: 17

C 48 John D. Moore Vol#: 17

C 49 Kevin P. Reeves Vol#: 17

C 50 West Liberty Foods Vol#: 17

C 51 Prestage Farms Inc. Vol#: 17

C 52 Warne Farms Vol#: 17

C 53 Crockery Creek Turkey Farms Vol#: 17

C 54 Hoovon's Turkey Farm Vol#: 17

C 55 Rodney A. Branson Vol#: 17

C 56 American Asson. of Bovine Practitioners Vol#: 17

00N-1665 Consumer Roundtable; Notice of Meeting

TR 1 Transript 12/13/00 meeting Vol#: 2

00P-1499 Remove alosetron (Lotronex) from the market

C 63 Laurie Pokorny Vol#: 17

EMC 249 Chris Shields Vol#: 17

EMC 250 Sharyn Pohlman Vol#: 17

EMC 251 Barbara Yager Vol#: 17

EMC 252 Eric Carstensen Vol#: 17

EMC 253 Dr. Dina L. Stephens Vol#: 17

EMC 254 Mike Vander Wyden Vol#: 17

EMC 255 Liz Biss Vol#: 17

EMC 256 Jil Bane Vol#: 17

EMC 257 John D'Onofrio Vol#: 17

00P-1550 Approve ANDA for Cefuroxime Axetil Products

SUP 2 Glaxo Welcome Inc Vol#: 3

00P-1623 WDL of letter issued regarding product Misoprostol

EMC 2 Janette Strathy MD Vol#: 1

EMC 3 Laurie Scott Vol#: 1

01V-0007 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Miller-Vespoli Inc. Vol#: 1

01V-0008

ACK 1 HFA-305 Vol#: 1

VAR 1 Audio Associates Vol#: 1

01V-0009

ACK 1 HFA-305 Vol#: 1

VAR 1 Travis Hopkins Vol#: 1