DOCKETS ENTERED on 04/12/01

Docket Title

Number

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.

THE DOCUMENTS IN THE FOLLOWING DOCKETS WILL BE LINKED AS SOON AS POSSIBLE. CLICK ON THE (*) TO SEE THE CONTENTS OF THE LISTED DOCKET. SOME DOCKETS, NOT LINKED TO THIS TABLE OF CONTENTS, WILL BE LINKED ELSEWHERE ON THE DOCKETS PAGE

90S-0308 Generic Drug Speeches & Policy and Procedure Guides *

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

00A-1635 Pharmacological Studies - Disability Antidiscrimination *

00D-1598 Voluntary Labeling for Bioengineered Foods *

00D-1662 Use of Xenotransplantation Products in Humans *

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals *

00N-0989 Human Gene Therapy *

00N-1269 Labeling for human prescription drug/Biologic Products *

00N-1396 Bioengineered Foods Consumed By Humans or Animals *

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

00P-1322 Food Labeling and Allergen Contamination Control *

00P-1560 Health Hazard of "Radial" Sunglasses *

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *

01D-0044 Clinical Laboratory Improvement Amendments of 1988 *

01N-0135 Radiation Disclosure Statement Options For Foods *

84N-0102 Orphan Product Designations

LST 97 January 2001 Vol#: 3

NAD 15 Vol#: 3

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 711 HFD-600 Vol#: 50

94F-0008 Safe use Machine Source High Energy X-Rays

EA 1 Environmental Assessment Vol#: 1

FONS1 Finding of no Significant Impact Vol#: 1

NFR 1 Vol#: 1

REF 1 Reference Vol#: 1

REF 2 Reference Vol#: 1

REF 3 Reference Vol#: 1

98N-0787 Parke-Davis Pharmaceutical withdrawal of 14 NDA/13 ANDA

NCR 1 Vol#: 1

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

C 4480 Miss Robin Tremblay Costello Vol#: 141

C 4481 Karla Bissell Vol#: 141

C 4482 Kasmah Kremmel Vol#: 141

C 4483 Roberta Bentz Letts RN Vol#: 141

C 4484 Pat Ballard Vol#: 141

C 4485 Mrs. Theresa Collins Vol#: 141

C 4486 H. Pelznichel Vol#: 141

C 4487 Diana Reese Vol#: 141

C 4488 Gretchen Donchecz Vol#: 141

C 4489 Jane Mowow Vol#: 141

C 4490 Corinda Toy Vol#: 141

C 4491 Suzanne Pease Vol#: 141

C 4492 The Johnson's Vol#: 141

C 4493 Gerald Lipa Vol#: 141

C 4494 William & Sandra Grunwell Vol#: 141

EMC 1671 Paisley Nash Vol#: 141

EMC 1672 Debra Lowry Vol#: 141

EMC 1673 Terry Lowry Vol#: 141

EMC 1674 Barbara Ressequie Vol#: 141

EMC 1675 Frances A. Gosson Vol#: 141

EMC 1676 Heather DeVault Vol#: 141

EMC 1677 Maryeileen S. Corcoran Vol#: 141

EMC 1678 Kathleen R. Tauro Vol#: 141

EMC 1679 Kari Rebecca Wouk Vol#: 141

EMC 1680 Rev. Wendy J. Taylor Vol#: 141

EMC 1681 Michelle Senne Vol#: 141

EMC 1682 Sarah Rudy Vol#: 141

EMC 1683 Elsbeth Louis (The Netherlands) Vol#: 141

EMC 1684 Robert Puca Vol#: 141

EMC 1685 Christine Tanana Vol#: 141

99F-2799 Irradiate animal feeds/feed ingredients for microbial contro

NFR 1 Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

NFR 2 Vol#: 2

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

C 2 Unilever Research Vlaardingen (Netherlan Vol#: 1

EXT 3 LM Working Group Vol#: 1

00A-1635 Pharmacological Studies - Disability Antidiscrimination

APA 1 HFD-40 to Advocacy, Incorporated Vol#: 1

M 1 HFD-7 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 1018 Brien Brennan Vol#: 87

C 1019 Amy Longo Vol#: 87

C 1020 Bev & Ernest Sherne Vol#: 87

C 1021 Amy Anderson Vol#: 87

C 1022 Alan Batie Vol#: 87

C 1023 Juliette Campbell Vol#: 87

C 1024 Lauren Panos Vol#: 87

C 1025 Raffaella Marcautonio Vol#: 87

C 1026 Vivian Larson Vol#: 87

C 1027 Fred Elmer Vol#: 87

C 1028 Christina DiMarco Vol#: 87

C 1029 Carol L. Derr-Breinig Vol#: 87

C 1030 Katharine Heed Vol#: 87

C 1031 Pelauria Havice Vol#: 87

C 1032 Kathleen Maio Vol#: 87

C 1033 Joel Gerwein Vol#: 87

C 1034 Janet Spite, PhD Vol#: 87

C 1035 Deborah Ginsburg Vol#: 87

C 1036 Adrienne Lubeau Vol#: 87

C 1037 D. Maieli Vol#: 87

C 1038 Elaine F. Bury Vol#: 87

C 1039 K. Whitlick Vol#: 87

C 1040 Philippa Crawford Vol#: 87

C 1041 Walter C. Diener Vol#: 87

C 1042 Carolyn S. Eisenmenger Vol#: 87

C 1043 Craig Allen Vol#: 87

C 1044 Margaret Kurta Vol#: 87

C 1045 Larry Jedlicka Vol#: 87

C 1046 Judy Jedlicka Vol#: 87

C 1047 David Burrow Vol#: 87

C 1048 Mike McCabe Vol#: 87

C 1049 Rosemary Love Vol#: 87

C 1050 Ernest J. Sherne Vol#: 87

C 1051 Gerard Bezzey Vol#: 87

C 1052 Elligible Vol#: 87

C 1053 Darryl Brandt Vol#: 88

C 1054 Jennifer Hix Vol#: 87

C 1055 C. Reid Vol#: 87

C 1056 No Signature Vol#: 88

C 1057 Luke Hale Vol#: 88

C 1058 David Robinson Vol#: 88

C 1059 Carol McGlauchlin Vol#: 88

C 1060 Bill Dalke Vol#: 88

C 1061 Kenneth G. Walton, PhD Vol#: 88

C 1062 Tatjana Jovancevic Vol#: 88

C 1063 Matthew B. Aljchuler Vol#: 88

C 1064 Jim Harbin Vol#: 88

C 1065 Bev & Ernest Sherne Vol#: 88

C 1066 Roberta King Vol#: 88

C 1067 Keizi Spencer Vol#: 88

C 1068 S. Cooke Vol#: 88

C 1069 Patricia Gooch Vol#: 88

C 1070 No Signature Vol#: 88

C 1071 Susan Bender Benjamin Vol#: 88

C 1072 Donald Briscoe Vol#: 88

C 1073 Chris Young Vol#: 88

C 1074 A. Monson Vol#: 88

C 1075 Anna Jeffries Vol#: 88

C 1076 Amy McGrace Vol#: 88

C 1077 Vern Grusdock Vol#: 88

C 1078 Joan Riech Vol#: 88

00D-1662 Use of Xenotransplantation Products in Humans

EMC 1 Bonnie M. West Vol#: 1

EMC 2 Nina Gentle Vol#: 1

EMC 3 Michelle Sullivan Vol#: 1

EMC 4 Randall Smith Vol#: 1

EMC 5 Ms. Dawn Masturzo Vol#: 1

EMC 6 AJ Solomon Vol#: 1

EMC 7 Corinne L. Thomas Vol#: 1

EMC 8 Barbara Biel Vol#: 1

EMC 9 Kerry-Ann Stanley (London) Vol#: 1

EMC 10 Anna Peries & Darren Edwards Vol#: 1

EMC 11 Gwendolyn Jorgens Vol#: 1

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals

C 7 Consumers Union Vol#: 1

C 8 Environmental Defense Vol#: 1

EMC 1 NUMBER NOT USED Vol#: 1

00N-0989 Human Gene Therapy

C 67 Marlene Cranmer Vol#: 4

C 68 Sheila Kandels Vol#: 4

C 69 Cheri A Gaspero Vol#: 4

C 70 Denise Dimino Vol#: 4

C 71 Dr Joyce Bloom Vol#: 4

C 72 Eve Balows Vol#: 4

C 73 Debbie Netardus Vol#: 4

C 74 Perrie' Lee Prouty Vol#: 4

C 75 P L McDaniel Jr Vol#: 4

EMC 134 Kevin M Crupi Vol#: 4

00N-1269 Labeling for human prescription drug/Biologic Products

EC 7 jennifer Vol#: 3

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 402 Kathy Burke Vol#: 60

C 403 unsigned Vol#: 60

C 404 Simm Chartinitz Vol#: 60

C 405 Eugene R. Brossman Vol#: 60

C 406 Katherine Gage Vol#: 60

C 407 V.M. Bianco Vol#: 60

C 408 Stella Wolf Vol#: 60

C 409 Brian Evans Vol#: 60

C 410 Marion Sherman Vol#: 60

C 411 Esther Benjamin Vol#: 60

C 412 M Zacker Vol#: 60

C 413 unsigned Vol#: 60

C 414 Doris Lee Vol#: 60

C 415 Georgia Davis Vol#: 60

C 416 Melissa Ryan Vol#: 60

C 417 Marie Douglas Vol#: 60

C 418 Maria Santelli Vol#: 60

C 419 unreadable Vol#: 60

C 420 Kathryn Murdock Vol#: 60

C 421 unreadable Vol#: 60

C 422 unreadable Vol#: 60

C 423 Kathy Begel Vol#: 60

C 424 unreadable Vol#: 60

C 425 Lori Anderson Vol#: 60

C 426 Aloh Health Vol#: 60

C 427 Christine Buckley Vol#: 60

C 428 unreadable Vol#: 60

C 429 Nancy McDaniel Vol#: 60

C 430 Carla Rogers Vol#: 60

EC 192 Miss Michelle Hoff Vol#: 23

EC 193 Mrs. Monserrate Corbett Vol#: 23

EC 194 Sunflower Vol#: 23

EC 195 Mill Hill Farm Vol#: 23

EC 196 Tandem Friends School Vol#: 23

EC 197 Ms. Betty Hanacek Vol#: 23

EC 198 Mrs. Pamela Janas Vol#: 23

EC 199 Ms. chrys hulbert Vol#: 23

EC 200 M.U.M. Information Systems Vol#: 23

EC 201 Ms. Lori Evesque Vol#: 23

EC 202 Mrs. Kathleen Edwards Vol#: 23

EC 203 Mr. Paul Simon Vol#: 23

EC 204 Self Vol#: 23

EC 205 Mrs. Vicki L. Gallagher Vol#: 23

EC 206 Mr. Kenneth Moore Vol#: 23

EC 207 citizen Vol#: 23

EC 208 Ms. Nancy Blaney Vol#: 23

EC 209 NA Vol#: 23

EC 210 Mrs. sarah hubbard Vol#: 23

EC 211 Dr. Karla Taylor Vol#: 23

EC 212 Mr. Ronald Schwertfeger Vol#: 23

EC 213 Mrs. Anna Izaguirre Vol#: 23

EC 214 Ms. Ruth Harris Vol#: 23

EC 215 Mr. Gary Buker Vol#: 23

EC 216 Mr. Duberly Mazuelos Vol#: 23

EC 217 Ms. Mary Jo Meteyer Vol#: 23

EC 218 Celo Community, Inc Vol#: 23

EC 219 Ms. Tisha Maraj Vol#: 23

EC 220 Ms. Margret Brillinger Vol#: 23

EC 221 Ms. Joyce Wilson Vol#: 23

EC 222 Miss corleen proulx Vol#: 23

EC 223 Mr. R caro Vol#: 23

EC 224 Ms. Melissa Snider Vol#: 23

EC 225 Mr. David Berman Vol#: 23

EC 226 Emanate Design Vol#: 23

EC 227 Ms. Nicole Lonner Vol#: 23

EC 228 Ms. Kathleen Hannigan Vol#: 23

EC 229 Ms. Jennifer Perry Vol#: 23

EC 230 Miss Amy Browne Vol#: 23

EC 231 Ms. Laurie Hessemer Vol#: 23

EC 232 New York University Vol#: 23

EC 233 Ms. SHARON SEHMANN Vol#: 23

EC 234 Ms. Heather Ogden Vol#: 23

EC 235 Private interest (concerned citizen) Vol#: 23

EC 236 Mr. Martin Webster Vol#: 23

EMC 1101 Shari Wildschutte Vol#: 60

EMC 1102 Shari Wildschutte Vol#: 60

EMC 1103 Patricia Gula Vol#: 60

EMC 1104 Patricia Gula Vol#: 60

EMC 1105 Bill & Marilyn Voorhies Vol#: 60

EMC 1106 number not used Vol#: 60

EMC 1107 Ginger Miller Vol#: 60

EMC 1108 number not used Vol#: 60

EMC 1109 Dr. Jason Saltman Vol#: 60

EMC 1110 number not used Vol#: 60

EMC 1111 number not used Vol#: 60

EMC 1112 Anne Ambler Vol#: 60

EMC 1113 number not used Vol#: 60

EMC 1114 Kris Debye Vol#: 60

EMC 1115 number not used Vol#: 60

EMC 1116 Patricia Martinez Vol#: 60

EMC 1117 number not used Vol#: 60

EMC 1118 Rhonda Mowday Vol#: 60

EMC 1119 number not used Vol#: 60

EMC 1120 Jeffrey W. Moyer Vol#: 60

EMC 1121 Ueli Stadler Vol#: 60

EMC 1122 Sue Collins Vol#: 60

EMC 1123 Kate Parker Vol#: 60

EMC 1124 Suzanne Foster Vol#: 60

EMC 1125 Carol Logan Vol#: 60

EMC 1126 Lindsey Atoms Vol#: 60

EMC 1127 kathleen & Bob Kirpfoutz Vol#: 60

EMC 1128 Zebel Davis Vol#: 60

EMC 1129 Sarah Gilstrap Vol#: 60

EMC 1130 Rachel Griffiths Vol#: 60

EMC 1131 Enrique G. Cubillo Vol#: 60

EMC 1132 Jim and Virginia Wagner Vol#: 60

EMC 1133 Kim McQuaite Vol#: 60

EMC 1134 Kyle Daniels Vol#: 60

EMC 1135 David Goodin Vol#: 60

EMC 1136 Chris Sybert Vol#: 60

EMC 1137 Frank Starr Vol#: 60

EMC 1138 Susan Lambert Vol#: 60

EMC 1139 Jon Fiebelkorn Vol#: 60

EMC 1140 Dana Fennell Vol#: 60

EMC 1141 Gaynol Fales Vol#: 60

EMC 1142 Mark Nicholas Vol#: 60

EMC 1143 Josiah Raison Cain Vol#: 60

EMC 1144 Deborah K. Britt Vol#: 60

EMC 1145 Robin Grae Vol#: 60

EMC 1146 Kalleen Henderson Vol#: 60

EMC 1147 Lynne Starrett Vol#: 60

EMC 1148 Kevin O'Dare Vol#: 60

EMC 1149 Annie Decker Vol#: 60

EMC 1150 Makyla Waters Vol#: 60

EMC 1151 B. Robin Dery Vol#: 60

EMC 1152 Anne Rossen Vol#: 60

EMC 1153 Todd Williams Vol#: 60

EMC 1154 Monique Harrison Vol#: 60

EMC 1155 D. Leonard Vol#: 60

EMC 1156 Heather Maria Johnson Vol#: 60

EMC 1157 John Thielking Vol#: 60

EMC 1158 Mary Roche Vol#: 60

EMC 1159 Erin Johnson Vol#: 60

EMC 1160 Anna Preble Vol#: 60

EMC 1161 Matt Hubin Vol#: 60

EMC 1162 Matthew Hubin Vol#: 60

EMC 1163 Stephanie Ferguson Vol#: 60

EMC 1164 Amy Kremen Vol#: 60

EMC 1165 Jack Ladwig Vol#: 60

EMC 1166 Shari Wildschutte Vol#: 60

EMC 1167 Laura M. Ohanian Vol#: 60

EMC 1168 Roy Gottlieb Vol#: 60

EMC 1169 Michelle Lee Vol#: 60

EMC 1170 Jeraldine Rosenthal Vol#: 60

EMC 1171 Oren Rosenthal Vol#: 60

EMC 1172 Emily Rosenthal Vol#: 60

EMC 1173 Donna Theall Vol#: 60

EMC 1174 Brien Brennan Vol#: 60

EMC 1175 Matt Meyers Vol#: 60

EMC 1176 Mariah Neary Vol#: 60

EMC 1177 Mike Simonet Vol#: 60

EMC 1178 Kim Marie Morris Vol#: 60

EMC 1179 Marlow Rodale Vol#: 60

EMC 1180 K Hedberg Vol#: 60

EMC 1181 Mary Rubach Vol#: 60

EMC 1182 Lisa Griffiths Vol#: 60

EMC 1183 Valerie Byxbe Vol#: 60

EMC 1184 Sandy Diller Vol#: 60

EMC 1185 Annette Weissbach Vol#: 60

EMC 1186 Norman Ben-Maor Vol#: 60

EMC 1187 Kurt Nilson Vol#: 60

EMC 1188 Ben Paulos Vol#: 60

EMC 1189 Karey Shawe Vol#: 60

EMC 1190 Cory Gassmann Vol#: 60

EMC 1191 Mark Lipsman Vol#: 60

EMC 1192 Tasha Harmon Vol#: 60

EMC 1193 Barbara Durfee Vol#: 60

EMC 1194 Robin Means Vol#: 60

EMC 1195 Cass Passmore Vol#: 60

EMC 1196 Jeff Derant Vol#: 60

EMC 1197 Cheyenne Hughes Vol#: 60

EMC 1198 Sandy Glassman Vol#: 60

EMC 1199 David Drinnan Vol#: 60

EMC 1200 Robert Hovey Vol#: 60

EMC 1201 Pat Crocker Vol#: 60

EMC 1202 Rachel diCerbo Vol#: 60

EMC 1203 Sara Queshi Vol#: 60

EMC 1204 Rob Means Vol#: 60

EMC 1205 Greg Cromwell Vol#: 60

EMC 1206 Ann Phillips Vol#: 60

EMC 1207 Priscilla Pedroza Vol#: 60

EMC 1208 Florence Fiaui-Davis Vol#: 60

EMC 1209 Karen Fordyce Vol#: 60

EMC 1210 Melinda Viren Vol#: 60

EMC 1211 Adam Pizer Vol#: 60

EMC 1212 Hayat Nancy Abuza Vol#: 60

EMC 1213 Dorothy Olinger Vol#: 60

EMC 1214 Susan Clarke Vol#: 60

EMC 1215 Elaine Marie Keene Vol#: 60

EMC 1216 Elizabeth Johnson Vol#: 60

EMC 1217 Kristen Liske Vol#: 60

EMC 1218 Sharon Dalton Vol#: 60

EMC 1219 Nicholai Matro Vol#: 60

EMC 1220 Scott McCandless Vol#: 60

EMC 1221 Stacey Gates Vol#: 60

EMC 1222 Louise Auerhahn Vol#: 60

EMC 1223 H Patton Vol#: 60

EMC 1224 Chris Wotton Vol#: 60

EMC 1225 John Schoenecker Vol#: 60

EMC 1226 Sherry Browne Vol#: 60

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

C 9818 Leland Acrey Vol#: 729

C 9819 Number not used Vol#: 729

C 9820 Carol McLaughlin Vol#: 729

EMC 4512 Kimberly Smith Vol#: 729

EMC 4513 Linda Castro Vol#: 729

EMC 4514 Stacey Spilman Vol#: 729

EMC 4515 Nicole Ozmina Vol#: 729

EMC 4516 Stella Maris Aleman de Gallardo Vol#: 729

EMC 4517 Jerome Pavlin Vol#: 729

EMC 4518 Jessica Phillips Vol#: 729

EMC 4519 Joshua Houdek Vol#: 729

EMC 4520 Ann McCandless Vol#: 729

EMC 4521 Norman Schwartz Vol#: 729

EMC 4522 C Simpson Vol#: 729

EMC 4523 Travis Smith Vol#: 729

EMC 4524 Isis Israel Vol#: 729

EMC 4525 Joanne Tredeau Vol#: 729

EMC 4526 Candice Gabrio Vol#: 729

EMC 4527 Thomas Ray Vol#: 729

EMC 4528 Steve Reed Vol#: 729

EMC 4529 Matija Trohar Vol#: 729

EMC 4530 Lorenn Leonard Vol#: 729

EMC 4531 Lopez Arteaga Vol#: 729

EMC 4532 Annie Banducci Vol#: 729

EMC 4533 Sarah Stratman Vol#: 729

EMC 4534 Monica Cady Vol#: 729

EMC 4535 Philip Geller Vol#: 729

EMC 4536 B Soltis Vol#: 729

EMC 4537 Cathy Ernst Vol#: 729

EMC 4538 Susie Stephens Vol#: 729

EMC 4539 Amanda Wiloner Vol#: 729

EMC 4540 Amanda McKenna Wiloner Vol#: 729

EMC 4541 Guillermo Saar Vol#: 729

EMC 4542 Shelley R Amdur Vol#: 729

00P-1322 Food Labeling and Allergen Contamination Control

C 7 B J Crippen Vol#: 3

C 8 M Coffey Vol#: 3

17

C 9 William F Crosby Vol#: 3

EMC 15 Nancy Mozgai Vol#: 3

EMC 16 W Tucker Vol#: 3

EMC 17 Lucas Vol#: 3

LET 3 HFS-800 to Grocery Manufacturers of Amer Vol#: 3

00P-1560 Health Hazard of "Radial" Sunglasses

PDN 1 HFZ-100 to Paul E. Knapp Vol#: 1

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

EMC 6 Lucile Beshearse Vol#: 1

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 2 ASCP, American Soc. of Clinical Patholog Vol#: 1

C 3 Roche Diagnostics Corp. Vol#: 1

01N-0135 Radiation Disclosure Statement Options For Foods

C 1 Nuclear Energy Ins (NEI) Vol#: 1

EMC 32 David Darin Vol#: 1

EMC 33 Ann Fonfa Vol#: 1

EMC 34 Aajonus Vonderplanitz & 3 signatures Vol#: 1

EMC 35 Mercedes Kirkel Vol#: 1

EMC 36 Ano Tarletz Vol#: 1

EMC 37 Val J Woodcock Vol#: 1

01V-0180 Laser light show and projectors

ACK 1 HFA-305 Vol#: 1

VAR 1 E3 Vol#: 1

01V-0181

ACK 1 HFA-305 Vol#: 1

VAR 1 Electric Cowboy Fayetteville Inc Vol#: 1

01V-0182

ACK 1 HFA-305 Vol#: 1

VAR 1 Valley Center Lanes Vol#: 1