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DOCKETS ENTERED on August 2, 2001

TABLE OF CONTENTS

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97N-0314 Prescription Drug Products; Levothyroxine Sodium *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
01N-0191 Medical Devices Classification/GHTF Study Group 1 *
01N-0205 Applications for FDA Approval to Market a New Drug *
01N-0249 Consumer and Producer Surveys on Economic Issues *
01N-0267 Agency Information Collection: Medical Device Labeling Reg *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
97N-0314 Prescription Drug Products; Levothyroxine Sodium

EC 5 Mr. Richard Vitale Vol#: 9

EC 6 Ms. Jane La Barbera Vol#: 9

EC 7 Mr. Fredric Baumann Vol#: 9

EC 8 Private Citizen Vol#: 9

EC 9 Mrs. Bonnie Leister Vol#: 9

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

C 5100 Lucinda Meehan Vol#: 159

C 5101 Marian Carter Vol#: 159

C 5102 Jason Allen Vol#: 159

C 5103 Mrs. Dorothy Finger Vol#: 159

C 5104 AnnMarie Miller Vol#: 159

C 5105 Jyllian Smolev Vol#: 159

C 5106 Soul Journ Vol#: 159

C 5107 Cindy Sunley Vol#: 160

C 5108 Ms. Joyce Frohn Vol#: 160

C 5109 Ms. Roberta A. Claypool Vol#: 160

C 5110 Jennifer Goolsby Vol#: 160

C 5111 Ginger Leilani Chapin Vol#: 160

C 5112 Mart Bono Vol#: 160

C 5113 Bergen Regional Medical Center Vol#: 160

C 5114 Amy Loudermilk Vol#: 160

C 5115 Candee Hett & Paul Goldsmith Vol#: 160

C 5116 Ellen Dillinger Vol#: 160

C 5117 Linda de Soto Vol#: 160

C 5118 Tiffany Kurish Vol#: 160

C 5119 Tatiana Gelfand Vol#: 160

C 5120 Susan I. Lowe Vol#: 160

C 5121 Eugene Trott Vol#: 160

C 5122 Marisa Hayes & Ainslie Heilich Vol#: 160

C 5123 Rebecca Mardula Vol#: 160

C 5124 Nora Kramer Vol#: 160

C 5125 Colleen A. Patrick Vol#: 160

C 5126 Denise Dimino Vol#: 160

C 5127 Mr. & Mrs. Larry W. Phillips Vol#: 160

C 5128 Lee Mahavier Vol#: 160

C 5129 Norma J. Bartko Vol#: 160

C 5130 Beth Laurer Vol#: 160

C 5131 Ms. Martine Sankari Vol#: 160

C 5132 Patricia Brant Vol#: 160

99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices

EC 2 Ms. BIVIRIN O'REGGIO Vol#: 1

00D-1541 Electronic Signatures: Audit Trails

MM 14 HFC-240 & Industry Coalition (5/30/2001) Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 10359 Christine Young Vol#: 411

EMC 10360 Martin Geller, MD Vol#:

EMC 10361 Martin Geller, MD Vol#: 411

EMC 10362 Beatriz Valdellon Vol#: 411

EMC 10363 Beatriz Valdellon Vol#: 411

EMC 10364 unsigned Vol#: 411

EMC 10365 John R. Drenth Vol#: 411

EMC 10366 unsigned Vol#: 411

EMC 10367 Kristin Lyon Vol#: 411

EMC 10368 Paul Palmer Vol#: 411

EMC 10369 Paul Palmer Vol#: 411

EMC 10370 Scott D. Randolph Vol#: 411

EMC 10371 Tina Thornton Wrasse Vol#: 411

EMC 10372 Liz Eastwood Vol#: 411

EMC 10373 Sarah Thornton Vol#: 411

EMC 10374 Natalie Hudson Vol#: 411

EMC 10375 Paul Wiley (small family farmer) Vol#: 411

EMC 10376 Francesca Perez Vol#: 411

EMC 10377 Francesca Perez Vol#: 411

EMC 10378 Delight Craft Vol#: 411

EMC 10379 Mary Ann Keefer Vol#: 411

EMC 10380 Dr & Mrs John Lally Vol#: 411

EMC 10381 Dr & Mrs John Lally Vol#: 411

EMC 10382 Bonnie Kreitler Vol#: 411

EMC 10383 Linda and Gene Sentz Vol#: 411

EMC 10384 Jack Downhill Vol#: 411

EMC 10385 Joanne Brown Vol#: 411

EMC 10386 Karen Green Stone Vol#: 411

EMC 10387 James Thomson Vol#: 411

EMC 10388 James Thomson Vol#: 411

EMC 10389 Marina Quinn-Benitt Vol#: 411

EMC 10390 Marina Quinn-Benitt Vol#: 411

EMC 10391 Barbara S. Tufts Vol#: 411

EMC 10392 Erinne Vol#: 411

EMC 10393 Erinne Vol#: 411

EMC 10394 unsigned Vol#: 411

EMC 10395 Dan Inglis Vol#: 411

EMC 10396 Susan G. Cox Vol#: 411

EMC 10397 Sherry Szabo Vol#: 411

EMC 10398 John Szabo, M.D. Vol#: 411

EMC 10399 Randy Nowell Vol#: 411

EMC 10400 John Serop Simonian Vol#: 411

EMC 10401 Miguel A. Conty Vol#: 411

EMC 10402 Meri Reinhold Vol#: 411

EMC 10403 Eric Brooks Vol#: 411

EMC 10404 Barbara Peress Vol#: 411

EMC 10405 Kourosh Razban Vol#: 411

EMC 10406 Kourosh Razban Vol#: 411

EMC 10407 Teresa Birkeland Vol#: 411

EMC 10408 Teresa Birkeland Vol#: 411

EMC 10409 Marcia Bourne Vol#: 411

EMC 10410 Marcia Bourne Vol#: 411

EMC 10411 Carrie Newcomer Vol#: 411

EMC 10412 Bina Robinson, Dir. Vol#: 411

EMC 10413 Pat Wahl Vol#: 411

EMC 10414 Karemah Alhark Vol#: 411

EMC 10415 Lynn Bechtold Vol#: 411

EMC 10416 Lorraine Deuel Vol#: 411

EMC 10417 Barbara Rietberg Vol#: 411

EMC 10418 Diane L. Sheldon Vol#: 411

EMC 10419 Sarah Thornton Vol#: 411

EMC 10420 Kathleen Martin Vol#: 411

EMC 10421 Nicola Coddington Vol#: 411

EMC 10422 Nicola Coddington Vol#: 411

EMC 10423 Audhild Skancke Vol#: 411

EMC 10424 Earth Duarte-Trattner Vol#: 411

EMC 10425 Mark Swartz Vol#: 411

EMC 10426 Mark Swartz Vol#: 411

EMC 10427 Marguerite Shreve Vol#: 411

EMC 10428 Connie J. Ova Vol#: 411

EMC 10429 Robyn Holt Vol#: 411

EMC 10430 Robyn Holt Vol#: 411

EMC 10431 Monica Lucas Vol#: 411

EMC 10432 unsigned Vol#: 411

EMC 10433 Jane Trautman Vol#: 411

00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated

C 12 Pharmacia Corp. Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 10051 Susan G. Cox Vol#: 265

EMC 10052 Lisa Pascual Vol#: 265

EMC 10053 Louis E. & Margaret Lee Lyles Vol#: 265

EMC 10054 Joe Cook Vol#: 265

EMC 10055 Felicia Lansbury Meyer Vol#: 265

EMC 10056 Number not used Vol#: 265

EMC 10057 Sherry Szabo Vol#: 265

EMC 10058 John Szabo Vol#: 265

EMC 10059 Adam Guberman Vol#: 265

EMC 10060 Randy Nowell Vol#: 265

EMC 10061 Marian Lanz Vol#: 265

EMC 10062 John Serop Simonian Vol#: 265

EMC 10063 Miguel A. Conty Vol#: 265

EMC 10064 Meri Reinhold Vol#: 265

EMC 10065 Eric Brooks Vol#: 265

EMC 10066 Barbara Peress Vol#: 265

EMC 10067 Norm Dutot Vol#: 265

EMC 10068 Kourosh Razban Vol#: 265

EMC 10069 Kourosh Razban Vol#: 265

EMC 10070 Teresa Birkeland Vol#: 265

EMC 10071 Teresa Birkeland Vol#: 265

EMC 10072 Marcia Bourne Vol#: 265

EMC 10073 Marcia Bourne Vol#: 265

EMC 10074 Carrie Newcomer Vol#: 265

EMC 10075 CIVITAS: Citizens for Planetary Health Vol#: 265

EMC 10076 Pat Wahl Vol#: 265

EMC 10077 Karemah Alahrk Vol#: 265

EMC 10078 Lynn Bechtold Vol#: 265

EMC 10079 Lorraine Deuel Vol#: 265

EMC 10080 Diane L. Sheldon Vol#: 265

EMC 10081 Sarah Thornton Vol#: 265

EMC 10082 Kathleen Martin Vol#: 265

EMC 10083 Brenda Cramer Vol#: 265

EMC 10084 Nicola Coddington Vol#: 265

EMC 10085 Nicola Coddington Vol#: 265

EMC 10086 Joni Dunn Vol#: 265

EMC 10087 Earth Duarte-Trattner Vol#: 265

EMC 10088 Mark Swartz Vol#: 265

EMC 10089 Mark Swartz Vol#: 265

EMC 10090 Marguerite Shreve Vol#: 265

EMC 10091 Celinas Ruth Vol#: 265

EMC 10092 Connie J. Ova Vol#: 265

EMC 10093 Robyn Holt Vol#: 265

EMC 10094 Robyn Holt Vol#: 265

EMC 10095 Monica Lucas Vol#: 265

EMC 10096 Jane Trautman Vol#: 265

EMC 10097 Brett Edelson Vol#: 265

EMC 10098 Anand Purushotham Vol#: 265

EMC 10099 Gerry & Chuck Jennings Vol#: 265

EMC 10100 Farah Fosse Vol#: 265

EMC 10101 Holly Lincoln Vol#: 265

00P-1322 Food Labeling and Allergen Contamination Control

APE 59 Wayne Amchin Vol#:

APE 60 Keebler Company Vol#: 15

APE 61 Keebler Company Vol#: 15

APE 62 FIS Flavor Specialist Vol#: 15

APE 63 FDA Vol#: 15

APE 64 Frito Lay Vol#: 15

APE 65 BNA's Food Safety Report Vol#: 15

APE 66 Andrea S Levario Vol#: 15

APE 67 Center for Celiac Research Vol#: 15

APE 68 Snock Food Association Vol#: 15

APE 69 Snock Food Association Vol#: 15

APE 70 The Kroger Company Vol#: 15

APE 71 USDA Vol#: 15

APE 72 The Long Company Vol#: 15

APE 73 Unilever US Inc Vol#: 15

C 209 Leland & Arleen Gjefle Vol#: 15

C 210 Diana Donaldson Vol#: 15

C 211 Susan G Ballard Vol#: 15

C 212 Cheryl H Brill Vol#: 15

C 213 Ann E Sims Vol#: 15

C 214 Ron Raleigh Vol#: 15

C 215 Celiac Disease Foundation Vol#: 15

C 216 Amy Hugon & Family Vol#: 15

C 217 Patricia A Ricci Vol#: 15

C 218 Sharon Rogers Vol#: 15

C 219 Lorelei Masseravy Vol#: 15

C 220 Patricia McGovern Vol#: 15

C 221 Carol Esbig Vol#: 15

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

C 169 Verna Eileen Radcliffe Vol#: 5

C 170 John D Bennett Vol#: 5

01F-0293 safe use of ethoxyquin Phosphate in animal feeds

EC 1 Number Not Used Vol#: 1

01N-0191 Medical Devices Classification/GHTF Study Group 1

C 8 Bundesfachverband Der Arzneimittel-Herst Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

EC 8 Ms. hope marcus Vol#: 1

01N-0249 Consumer and Producer Surveys on Economic Issues

EC 2 RSDHope Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 12 Evergreen Pharmacy Vol#: 3

EC 13 Omnicare, Inc. Vol#: 3

EC 14 RSDdysautohelp@Yahoogroups.com Vol#: 3

01N-0267 Agency Information Collection: Medical Device Labeling Reg

EC 1 Ms. Heather Kalachman Vol#: 1

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

C 210 Mr. Helmut V. Hirsch Vol#: 10

C 211 Ms. Theresa C. Arkley Vol#: 10

C 212 Mrs. Ellen Klawunn Vol#: 10

C 213 Mrs. Patricia A. Kelleher Vol#: 10

01P-0169 Access & Safe Distribution of Alosetron

C 103 Jennifer Frankel Vol#: 3

C 104 Vivian Kaye Vol#: 3

C 105 John D Bennett Vol#: 3

C 106 Mary M Polito Vol#: 3