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 September 17, 2001

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1355 Labeling requirements for dietary supplements/St.John's wort *
01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA
01P-0068 Revoke the ban set on implementation of prosthetic hair fibe *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0406 To reqiure Telephone Contact Information on label of bottled *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

ACK 8 HFA-305 Vol#: 107

CP 9 Ciba Specialty Chemicals Corporation Vol#: 107

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

SUP 46 Bristol-Myers Squibb Company Vol#: 235

98N-0337 Over the counter human drugs labeling requirements

LET 8 HFD-560 to Nat. Reye's Syndrome Foundati Vol#: 8

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 59 Association for Dressings and Sauces Vol#: 6

C 60 International Jelly & Preserve Assoc. Vol#: 6

C 61 Association of Food & Drug Officials Vol#: 6

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

C 5210 Pamela A. Smith Vol#: 169

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9428 Rachel Chaput, MPH Vol#: 476

C 9429 Manuel Mayer Vol#: 476

C 9430 Joanne Kennedy Vol#: 476

C 9431 John Kennedy Vol#: 476

C 9432 Eligible Vol#: 476

C 9433 Madalene Eckstein Vol#: 476

C 9434 Janet Hoffman Vol#: 476

C 9435 Laure Edwards Vol#: 476

C 9436 Sam Clarkson Vol#: 476

C 9437 Grace Blankenberger Vol#: 476

C 9438 Organic Material Revie Institute Vol#: 476

C 9439 Janet Hill Strom Vol#: 476

C 9440 S&S Produce & natural Foods Vol#: 476

C 9441 Erin Pearce Vol#: 476

C 9442 Dorothy Boyer Vol#: 476

C 9443 R.J. Haw Vol#: 476

C 9444 Michael L. Rilla Vol#: 476

C 9445 Ralf Brand Vol#: 476

C 9446 Freddie Hart Vol#: 476

C 9447 Eligible Vol#: 476

C 9448 John I. Hungerford Vol#: 476

C 9449 Susan Jarrett Vol#: 476

C 9450 Rena Stahr Vol#: 476

C 9451 Ruth Prinz Vol#: 476

C 9452 Rena Stahr Vol#: 476

C 9453 John Pandolfo Vol#: 476

C 9454 Karen Neill Vol#: 476

C 9455 Marilyn R. Parks Vol#: 476

C 9456 Michelle Stuckey Vol#: 476

C 9457 Angela Medbery Vol#: 476

C 9458 Richie Brown Vol#: 476

C 9459 A. Ling Vol#: 476

C 9460 Susan Anderson Vol#: 476

C 9461 J. Walls Vol#: 476

C 9462 Julie L. Rand Vol#: 476

C 9463 Eligible Vol#: 476

C 9464 Eligible Vol#: 476

C 9465 Eligible Vol#: 476

C 9466 Robin L. Swanson Vol#: 476

C 9467 Weinda Simpson Vol#: 476

C 9468 Barbara S. Evans Vol#: 476

C 9469 Groffrey Tudor Vol#: 476

C 9470 C. Appel Vol#: 476

C 9471 Lydia Blanchard Vol#: 476

C 9472 John E. Tanner Vol#: 476

C 9473 James Marley Vol#: 476

C 9474 E. Boom Vol#: 476

C 9475 Tina Moody Vol#: 476

C 9476 Ruth Prinz Vol#: 476

C 9477 David McLean Vol#: 476

C 9478 Janet Glass Vol#: 476

C 9479 Christine Gyovai Vol#: 476

C 9480 Kathleen Jones Vol#: 476

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

C 12322 Charles Carroll Vol#: 770

C 12323 Robert Martin Vol#: 770

C 12324 Sam Zollman Vol#: 770

C 12325 Jodi Rothermund Vol#: 770

C 12326 Laura Margasian Vol#: 770

C 12327 G Wells Vol#: 770

C 12328 Andrea Zollman Vol#: 770

C 12329 Liisz Mayosian Vol#: 770

C 12330 Eric Love Vol#: 770

C 12331 Linda K Margosian Vol#: 770

C 12332 J Stevenson Vol#: 770

C 12333 Rosalie Gardiner Vol#: 770

C 12334 Christian Melgard Vol#: 770

C 12335 John Hawkes Vol#: 770

C 12336 Barbara Hudson Vol#: 770

C 12337 Mary Jane Wagle Vol#: 770

C 12338 D Patterson Vol#: 770

C 12339 Barbara Lee Patrick Vol#: 770

C 12340 Cheryl Dent Vol#: 770

C 12341 John A Carley Vol#: 770

C 12342 Tina Pretsch Vol#: 770

C 12343 Oly C Mogollon Vol#: 770

C 12344 Amy Krieg Vol#: 770

C 12345 Kriston Fischer Vol#: 770

C 12346 Becki M Moore Vol#: 770

C 12347 Frederick N Martin Vol#: 770

C 12348 Penny Johnson Vol#: 770

C 12349 Rachael Elliott Vol#: 770

C 12350 Christine Roberts Vol#: 770

C 12351 Edward N Royalty Vol#: 770

C 12352 Daniel F Paulsons Vol#: 770

C 12353 Diane M Williams Vol#: 770

C 12354 Sister Virginia Fabilli Vol#: 770

C 12355 Matthew F Margulies Vol#: 770

C 12356 Trudi Aitkens Vol#: 770

C 12357 William Craig, MD Vol#: 770

C 12358 Kirsten Edey Vol#: 770

C 12359 Edward Triska Vol#: 770

C 12360 Robert Roethig Vol#: 770

C 12361 Patricia Molfese Pastor Vol#: 770

C 12362 Kristyne Zaworsler Vol#: 770

C 12363 Jules Goeke Vol#: 770

C 12364 Thomas W Patterson Vol#: 770

C 12365 Gladys Streek Vol#: 770

C 12366 Deb MacLeod Vol#: 770

C 12367 Barbara Troutman Vol#: 770

C 12368 Wendy Schauer Vol#: 770

C 12369 Jennifer Dunn Vol#: 770

C 12370 Michael Chase Brock Vol#: 770

C 12371 Nadeen L Roake Vol#: 770

C 12372 Lasa Home Vol#: 770

C 12373 Mary A Matthaei Vol#: 770

C 12374 F C Matthaei Vol#: 770

C 12375 Cheryl L Drumm Vol#: 770

C 12376 Marilee J Armstrong Vol#: 770

C 12377 Therese fontanini Vol#: 770

C 12378 Nancy Stephens Vol#: 770

C 12379 Joaquin Patting Vol#: 770

C 12380 Lili Jackson Vol#: 770

C 12381 Bill Brimijoin Vol#: 770

C 12382 Bob Plunkett Vol#: 770

C 12383 Emily Donat Vol#: 770

C 12384 Ron Adams Vol#: 770

C 12385 Donna Brockmann Vol#: 770

C 12386 Lin de Carel Vol#: 770

C 12387 G Hawkins Vol#: 770

C 12388 Miss Ann Blackburn Vol#: 770

00P-1322 Food Labeling and Allergen Contamination Control

C 378 Pamela S. Cusmano Vol#: 25

C 379 Audrey Klegman Vol#: 25

00P-1355 Labeling requirements for dietary supplements/St.John's wort

C 2 T. Wind Vol#: 1

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

C 182 Eli D. Ehrenpreis, MD Vol#: 5

01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic

C 11 Society of Toxicologic Pathology Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

C 2 Novartis Concumer health, Inc. Vol#: 1

C 3 Schering-Plough Healthcare Products Vol#: 1

01P-0068 Revoke the ban set on implementation of prosthetic hair fibe

PDN 1 HFZ-1 to Medicap Ltd. (Italy) Vol#: 3

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 223 Friend of ZPG Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 170 Sherryl McBride Vol#: 9

C 171 Chrisley V. Pickens/Greg Bernucca Vol#: 9

C 172 Betty J. Fowler Vol#: 23

C 173 Virginia Barber Vol#: 23

C 174 Dan Norris Vol#: 23

C 175 Susan J. Murphy/Peter A. Poccia Vol#: 23

C 176 Liz Haenel Vol#: 23

C 177 Mercedes Chavez Vol#: 23

01P-0349 Sterile Injectable Compressed Rod

WDL 1 Smart Drug Systems, Inc. Vol#: 1

01P-0406 To reqiure Telephone Contact Information on label of bottled

ACK 1 HFA-305 Vol#: 1

CP 1 International Bottle Water Ass. Vol#: 1

01V-0408 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Shooters 21-Kansa City Vol#: 1

01V-0409

ACK 1 HFA-305 Vol#: 1

VAR 1 Sonny U. Llyod Enterprises Vol#: 1

01V-0410

ACK 1 HFA-305 Vol#: 1

VAR 1 Shooters 21-Warrenburg Vol#: 1