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 March 8, 2001

TABLE OF CONTENTS

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78N-0301 OTC External Analgesic Drug Products *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00F-0789 Safe Use for X-radiation and Electron Beam Energy Sources *
01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked *
01N-0048 CGMP Regulations for Type A Medicated Articles *
01P-0122 To Remove False and Deceptive Labeling for Transderm Scop *

78N-0301 OTC External Analgesic Drug Products

PR 4 Chattem Inc Vol#: 102

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

C 2 Virginia Gross & 451 signatures Vol#: 49

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

C 1 Virginia Gross & 451 signatures Vol#: 11

98N-1038 Irradiation in the production, processing, &handling of food

EMC 242 Form letter count Vol#: 155

EMC 243 Public Citizen Vol#: 151

EMC 244 Renee McGarvie Vol#: 151

EMC 245 Paula Sherman Vol#: 151

EMC 246 Paul Rainosek Vol#: 151

EMC 247 Ruth Strmiska Vol#: 151

EMC 248 Gina Gilbert Vol#: 151

EMC 249 Carol Kuffner Vol#: 151

EMC 250 Helen Stayna Vol#: 151

EMC 251 David Landskov Vol#: 151

EMC 252 Alfred D. Washburn Vol#: 151

EMC 253 Bonnie Barnes Vol#: 151

EMC 254 Louise Collins Vol#: 151

EMC 255 Pacific Health Education Center Vol#: 151

EMC 256 Nicholas Gausling Vol#: 151

EMC 257 Mary Lodato Vol#: 151

EMC 258 Ecohaven Wellness Consulting Vol#: 156

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

EMC 1316 Paula Gregorowicz Vol#: 127

EMC 1317 M. G. Lind et al Vol#: 127

EMC 1318 Ron Binder Vol#: 127

EMC 1319 Darren Paul Strain Vol#: 127

EMC 1320 Rainforest Information Centre (Australia Vol#: 127

EMC 1321 Gary Gill Vol#: 127

EMC 1322 Gabriele Paul Vol#: 127

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 143 Susan Heckel Vol#: 40

EMC 144 Number Not Used Vol#: 40

EMC 145 Susan Heckel Vol#: 40

EMC 146 Judith Dunn Vol#: 40

EMC 147 Ellen Girt Vol#: 40

EMC 148 Laurel Robertson Vol#: 40

EMC 149 Ken Bonetti Vol#: 40

EMC 150 George Pinkel Vol#: 40

EMC 151 Lewis Green Vol#: 40

EMC 152 Ruth Sullivan Vol#: 40

EMC 153 Angela Heverling Vol#: 40

EMC 154 Bill & Marilyn Voorhies Vol#: 40

EMC 155 Pat Radin Vol#: 40

EMC 156 David McGraw Vol#: 40

EMC 157 Andy Radin Vol#: 40

EMC 158 Charles Liner Vol#: 40

EMC 159 Rick Browne Vol#: 40

EMC 160 Jeanine E Butler Vol#: 40

EMC 161 Anne O'Connell Vol#: 40

EMC 162 Debra Forman Vol#: 40

EMC 163 Rosemarie Goldstein Vol#: 40

EMC 164 Linda Moorcock Vol#: 40

99F-2081 Use of butanedioic acid,sulfo-1,4-diisodecyl ester, ammonium

NFR 1 Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 1 Kristy Moran Vol#: 1

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 1 Kristy Moran Vol#: 1

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 1 Kristy Moran Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

C 1384 Judith Teitelbaum Vol#: 44

C 1385 Anne Wolfley Vol#: 44

EMC 2374 Philip H. Coe Vol#: 44

EMC 2375 Sherry Melewsky Vol#: 44

EMC 2376 Pamela Ward Vol#: 44

EMC 2377 Dezum Vol#: 44

00D-1598 Voluntary Labeling for Bioengineered Foods

C 383 Brendan J. Curtin Vol#: 46

C 384 Natalie Dobie Vol#: 46

C 385 LaRue Christie Vol#: 46

C 386 John A. Watson Vol#: 46

C 387 Joel Hicks Vol#: 46

C 388 Julie M. Ahern Vol#: 46

C 389 David Steinhauner Vol#: 46

C 390 Deborah Coburn Vol#: 46

C 391 Avy Claire Vol#: 46

C 392 Kate Goldberg Vol#: 46

C 393 Linda S Vol#: 46

C 394 Janet R. Baltes Vol#: 46

C 395 Mr.& Mrs. Leslie Gavigan Vol#: 46

C 396 Jane Henney Vol#: 46

C 397 Kathleen Kluthe Vol#:

C 398 Mary McDonnell Vol#: 46

C 399 Dolores Dukes Vol#: 46

C 400 Barbara Murray-Lane Vol#: 46

C 401 Paul Lappen Vol#: 46

C 402 Jennifer McDonald Vol#: 46

C 403 From Letter Count 6 Vol#: 47

EMC 1301 Avalyn Pitts, Esq. Vol#: 43

EMC 1302 Gayle Simon Vol#: 43

EMC 1303 Steve Hamn Vol#: 43

EMC 1304 Rob Lewckyz Vol#: 43

EMC 1305 Jon Olson Vol#: 43

EMC 1306 Elisabeth Hoffman Vol#: 43

EMC 1307 Ivan Granger Vol#: 43

EMC 1308 Alice Bedout Vol#: 43

EMC 1309 Susan Phelan Vol#: 43

EMC 1310 Stephanie Charles Vol#: 43

EMC 1311 Binhita Halter Vol#: 43

EMC 1312 Joanne Cockerill Vol#: 43

EMC 1313 Michelle Jeske Vol#: 43

EMC 1314 Janice Cragnolin Vol#: 43

EMC 1315 Merrill Clark Vol#: 43

EMC 1316 Cindy Laramore Vol#: 43

EMC 1317 Alison Philbin Vol#: 43

EMC 1318 Isobel Contento Vol#: 43

EMC 1319 Robert Austin Vol#: 43

EMC 1320 Libby J. Goldstein Vol#: 43

EMC 1321 Jean Williams Vol#: 43

EMC 1322 Catherine Childers Vol#: 43

EMC 1323 Joanna Vargas-Vales Vol#: 43

EMC 1324 Brad Jeske Vol#: 43

EMC 1325 Lynn Johnson Vol#: 43

EMC 1326 Wendy Murdoch Vol#: 43

EMC 1327 Mike Brickey Vol#: 43

EMC 1328 Nicole Faaborg Vol#: 43

EMC 1329 Bob Flora Vol#: 43

EMC 1330 Daniel Strongin Vol#: 43

EMC 1331 Shawn McCracken Vol#: 43

EMC 1332 Anne E. Bocchini Vol#: 43

EMC 1333 Johanna Harman Vol#: 43

EMC 1334 Elinor Thomforde Vol#: 43

EMC 1335 Carol Elder Vol#: 43

EMC 1336 Shelby Flint Vol#: 43

EMC 1337 Cynthia Burke Vol#: 43

EMC 1338 Robert Michlin Vol#: 43

EMC 1339 Carla Remey Vol#: 43

EMC 1340 Bonnie Wagner Vol#: 43

EMC 1341 Jennifer LaRocco Vol#: 43

EMC 1342 Kate Hopkins Vol#: 43

EMC 1343 Lynn Asch Vol#: 43

EMC 1344 Chris Jacobs Vol#: 43

EMC 1345 Theresa Sal Vol#: 43

EMC 1346 Carolyn Gonglefski Vol#: 43

EMC 1347 Jeanne Prevett Vol#: 43

EMC 1348 Crystal Wooldridge Vol#: 43

EMC 1349 Khoi Nguyen Vol#: 43

EMC 1350 Eve Cruse Vol#: 43

EMC 1351 Valerie Traina Vol#: 43

EMC 1352 Carol Naughton Vol#: 43

EMC 1353 Lynn Rossiter Vol#: 43

EMC 1354 Francesca Rago Vol#: 43

EMC 1355 James Eldon Vol#: 43

EMC 1356 Jean-Paul LaCount Vol#: 43

EMC 1357 Jennifer Mollett Vol#: 43

EMC 1358 Donna Hodge Vol#: 43

EMC 1359 Kathryn Nance Vol#: 43

EMC 1360 Carol E. Landry Vol#: 43

EMC 1361 Ana Vertel Vol#: 43

EMC 1362 Nathan Flaherty Vol#: 43

EMC 1363 Bob Gregory Vol#: 43

EMC 1364 Noel Hribljan Vol#: 43

EMC 1365 Terry Huey Vol#: 43

EMC 1366 Lynn Curry Vol#: 43

EMC 1367 Eric Scheib Dahl Vol#: 43

EMC 1368 Elaine Knudson Vol#: 43

EMC 1369 Kathryn Jessica Manro Vol#: 43

EMC 1370 Mark Koplik Vol#: 43

EMC 1371 Mark Koplik Vol#: 43

EMC 1372 Scott Fry Vol#: 43

EMC 1373 Justine Silvey Vol#: 43

EMC 1374 Justine Silvey Vol#: 43

EMC 1375 Dr. D.K. & F.L. Cinquemani Vol#: 43

EMC 1376 Number Not Used Vol#: 43

EMC 1377 Richard Heckler Vol#: 43

EMC 1378 Allan Markman Vol#: 43

EMC 1379 Brian Turner Vol#: 43

EMC 1380 Natalie Dobie Vol#: 43

EMC 1381 Michael Collins Vol#: 43

EMC 1382 Tom Fugelsang Vol#: 43

EMC 1383 Ron Jacobs Vol#: 43

EMC 1384 Geoffrey Stone Vol#: 43

EMC 1385 James Nimmo Vol#: 43

EMC 1386 Chailly Clayton Vol#: 43

EMC 1387 Tom Athanasiou Vol#: 43

EMC 1388 Monte R. Vol#: 43

EMC 1389 Beverly Harlan Vol#: 43

EMC 1390 Beverly Harlan Vol#: 43

EMC 1391 Bryan P. Burns Vol#: 43

EMC 1392 Jeffrey P. Murray Vol#: 43

EMC 1393 Carrie Santulli Schudda Vol#: 43

EMC 1394 Carrie Santulli Schudda Vol#: 43

EMC 1395 David Galko Vol#: 43

EMC 1396 Stephen Machnowski Vol#: 43

EMC 1397 R. Bliss Vol#: 43

EMC 1398 Form Letter Count Vol#: 44

EMC 1399 Kathleen Pfoutz Vol#: 43

EMC 1400 Johnmark E. Larson Vol#: 45

EMC 1401 Rosemary Nicholas Vol#: 45

EMC 1402 Coy West Vol#: 45

EMC 1403 Brown University Vol#: 45

EMC 1404 Lindsay Wallace Vol#: 45

EMC 1405 Daniel Weiss Vol#: 45

EMC 1406 Kimberly Wood Bellemore Vol#: 45

EMC 1407 Ravi Grover Vol#: 45

EMC 1408 Ravi Grover Vol#: 45

EMC 1409 Shelby Smith Vol#: 45

EMC 1410 Margaret Almekinder Vol#: 45

EMC 1411 Margaret Almekinder Vol#: 45

EMC 1412 Jesus Pantel Vol#: 45

EMC 1413 Candice Guth Vol#: 45

EMC 1414 Thomas Lash Vol#: 45

EMC 1415 Arturo Andazola Vol#: 45

EMC 1416 Raymond T. Bissonnette Vol#: 45

EMC 1417 Edward M. Gish Vol#: 45

EMC 1418 Jonathan Simon Vol#: 45

EMC 1419 Mary A. Murphy Vol#: 45

EMC 1420 Mark Dawkins Vol#: 45

EMC 1421 Ann Didion Vol#: 45

EMC 1422 Dianna Sahhar Vol#: 45

EMC 1423 Brad Wolbert Vol#: 45

EMC 1424 Virginia Afentoulis Vol#: 45

EMC 1425 Bill Talsma Vol#: 45

EMC 1426 Michelle Hintz Vol#: 45

EMC 1427 Donald L. Anderson Vol#: 45

EMC 1428 John Keith Geiger Vol#: 45

EMC 1429 Martha Bartter Vol#: 45

EMC 1430 Jeffrey A. Schimpff Vol#: 45

EMC 1431 Patricia L. Giedrys Vol#: 45

EMC 1432 Richard Fox Vol#: 45

EMC 1433 Brandon J. Ross Vol#: 45

EMC 1434 Amy Chernoff-Itescu Vol#: 45

EMC 1435 Patricia Friedman Vol#: 45

EMC 1436 Jennifer Snelling Vol#: 45

EMC 1437 Mark Dubois Vol#: 45

EMC 1438 PJ John-Paul Vol#: 45

EMC 1439 PJ John-Paul Vol#: 45

EMC 1440 Eileen Fournier Vol#: 45

EMC 1441 Beverly Cohen Vol#: 45

EMC 1442 Arch McCulloch Vol#: 45

EMC 1443 Rose Metro Vol#: 45

EMC 1444 Patrick Flynn Vol#: 45

EMC 1445 Eric Rosenbloom Vol#: 45

EMC 1446 Christina Erickson Vol#: 45

EMC 1447 T L Ondrecek Vol#: 45

EMC 1448 BJ Middenorf Vol#: 45

EMC 1449 Philip H. Coe Vol#: 45

EMC 1450 Erin Anderson Vol#: 45

EMC 1451 Erin Anderson Vol#: 45

EMC 1452 Jamie Schwartz Vol#: 45

EMC 1453 Lisa Hastings Vol#: 45

EMC 1454 Jeanette Rodda Vol#: 45

EMC 1455 Deborah Woolston Vol#: 45

EMC 1456 Deborah Woolston Vol#: 45

EMC 1457 Dmitry Kushnirsky Vol#: 45

EMC 1458 Anarchist Vol#: 45

EMC 1459 Carola Dunn Vol#: 45

EMC 1460 Nick Pearson Vol#: 45

EMC 1461 Kind Regards Vol#: 45

EMC 1462 Dennis and Amy Whitworth Vol#: 45

EMC 1463 Kristina Filipovich Vol#: 45

EMC 1464 Jason Hardy Vol#: 45

EMC 1465 Bob Benson Vol#: 45

EMC 1466 J. Zane Vol#: 45

EMC 1467 William Gresham Vol#: 45

EMC 1468 Joe Queirolo Vol#: 45

EMC 1469 Sandra Stocke Vol#: 45

EMC 1470 Devon Ayers Vol#: 45

EMC 1471 Kathleen Stanley Vol#: 45

EMC 1472 Virginia Todd Vol#: 45

EMC 1473 Virginia Todd Vol#: 45

EMC 1474 Fred Fassberger Vol#: 45

EMC 1475 Fred Fassberger Vol#: 45

EMC 1476 M.B. Shahmehri Vol#: 45

EMC 1477 Timothy Gittings Vol#: 45

EMC 1478 Margaret Mahoney Vol#: 45

EMC 1479 Margaret Mahoney Vol#: 45

EMC 1480 C. Goodroe Vol#: 45

EMC 1481 Susanna King Vol#: 45

EMC 1482 Susie Sargent Vol#: 45

EMC 1483 Liana Forest, Ph.D. Vol#: 45

EMC 1484 Brad Allen Vol#: 45

EMC 1485 D R Vol#: 45

EMC 1486 D R Vol#: 45

EMC 1487 David Alban Vol#: 45

EMC 1488 Beth Hanley Vol#: 45

EMC 1489 Beth Hanley Vol#: 45

EMC 1490 Bill Greene Vol#: 45

EMC 1491 Dan Brook Vol#: 45

EMC 1492 Alistair Jackson Vol#: 45

EMC 1493 Martin Hippie Vol#: 45

EMC 1494 Meg Arnold Vol#: 45

EMC 1495 Sharon Krawczyk Vol#: 45

EMC 1496 Sharon Krawczyk Vol#: 45

EMC 1497 Andrew Cantino Vol#: 45

EMC 1498 John W. Hillman Vol#: 45

EMC 1499 Curt Larson Vol#: 45

EMC 1500 Scott Crawford Vol#: 45

EMC 1501 Terry Le Jeune Vol#: 46

EMC 1502 Bill Lord Vol#: 46

EMC 1503 Joe Sarno Vol#: 46

EMC 1504 Alan R. Seid Vol#: 46

EMC 1505 Daniel Paduano Vol#: 46

EMC 1506 Linsey Hudson Vol#: 46

EMC 1507 Linsey Hudson Vol#: 46

EMC 1508 J. R. Wallace Vol#: 46

EMC 1509 Barry Nelson Watson Vol#: 46

EMC 1510 Joanne Baek Vol#: 46

EMC 1511 Joanne Baek Vol#: 46

EMC 1512 Katie Bowen-Kosh Vol#: 46

EMC 1513 Colin Gary Dolinar Park Vol#: 46

EMC 1514 Ethan Hodek Vol#: 46

EMC 1515 Tony Samford Vol#: 46

EMC 1516 Adam Rabinowitz Vol#: 46

EMC 1517 Jose Viera Vol#: 46

EMC 1518 Daniel Lerch Vol#: 46

EMC 1519 Don Smith Vol#: 46

EMC 1520 Lura Trossello Vol#: 46

EMC 1521 Lura Trossello Vol#: 46

EMC 1522 Robin Hessey Vol#: 46

EMC 1523 Aimee Waggoner Vol#: 46

EMC 1524 Anna Crosskill Vol#: 46

EMC 1525 True Laugh Vol#: 46

EMC 1526 Carol Stevenson Vol#: 46

EMC 1527 Candice Cooper-Greinke Vol#: 46

EMC 1528 Nita Alvarez Vol#: 46

EMC 1529 Stephanie Mertens, ASC Vol#: 46

EMC 1530 Chris Stevens Vol#: 46

EMC 1531 Devan Miller Vol#: 46

EMC 1532 Heather Allen Vol#: 46

EMC 1533 Donna Schauer Vol#: 46

EMC 1534 Jessica Robin Leach Vol#: 46

EMC 1535 Andy Austin Vol#: 46

EMC 1536 Alicia Meredith Vol#: 46

EMC 1537 Number Not Used Vol#: 46

EMC 1538 Craig Mazer Vol#: 46

EMC 1539 Robert Pandolfo Vol#: 46

EMC 1540 Annalee Letchinger Vol#: 46

EMC 1541 Jennifer Steiger Vol#: 46

EMC 1542 Bob Posey Vol#: 46

EMC 1543 Robert Posey Vol#: 46

EMC 1544 Chris Olson Vol#: 46

EMC 1545 Katy Harington Vol#: 46

EMC 1546 Kamala Asher Vol#: 46

EMC 1547 Kamala Asher Vol#: 46

EMC 1548 K R Vol#: 46

EMC 1549 Beverly Doran Vol#: 46

EMC 1550 Maria Luna Vol#: 46

EMC 1551 Aimee Noyes Vol#: 46

EMC 1552 Aimee Noyes Vol#: 46

EMC 1553 Carol Crossman Vol#: 46

EMC 1554 Joanne Osborn Vol#: 46

EMC 1555 Connie Cook Vol#: 46

EMC 1556 James Ward Vol#: 46

EMC 1557 Number Not Used Vol#: 46

EMC 1558 Karen Feeney Vol#: 46

EMC 1559 Kathryn Cuervo Vol#: 46

EMC 1560 Kathryn Cuervo Vol#: 46

EMC 1561 Rick & Joan Meierotto Vol#: 46

EMC 1562 Rick & Joan Meierotto Vol#: 46

EMC 1563 Cynthia Preston Vol#: 46

00E-1235 Patent Extension, Aciphex (rabeprazole)

N 1 Vol#: 1

00F-0789 Safe Use for X-radiation and Electron Beam Energy Sources

EMC 1 Kristy Moran Vol#: 1

00F-0812 "Inhibitor of yeast", for the safe of (DMDC)

NFR 1 Vol#: 1

00N-0505 Animals Protein Prohibited in Ruminant Feed

NAL 1 Vol#: 1

00N-1379 Safe processing/importing of fish & fishery products

NAL 1 Vol#: 1

00N-1426 Emergency Health Surveys;Agency Information Collection Acti

NAL 1 Vol#: 1

00N-1441 Infant Formula Requirements

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

00N-1501 Treshold of Regulation for Subances Used in Food-Contact

NAL 1 Vol#: 1

00N-1521 Agency Information Collection Act: Food Labeling Regulations

NAL 1 Vol#: 1

00N-1599 Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses

N 2 Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 2 Helaine Lerner Vol#: 1

EMC 3 Kristy Moran Vol#: 1

01N-0048 CGMP Regulations for Type A Medicated Articles

EC 1 Mr. william garver Vol#: 1

01P-0122 To Remove False and Deceptive Labeling for Transderm Scop

ACK 1 HFA-305 Vol#: 1

CP 1 Pharmacia Consumer Healthcare Inc. Vol#: 1