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] 

DOCKETS ENTERED on February 9, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]
 
97N-484S Human Cellular and Tissue-Based Products *
97P-0350 Reclassify Home Uterine Activity Monitors from III to II *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-4617 Extend the Implementation Dates of the OTC Drug Labeling Rul *
97N-0074 President's National Food Safety Initiative

C 213 Crystal Wooldridge Vol#: 20

C 214 Margie & Vince Mortimer Vol#: 20

C 215 Arizona Dept of Agriculature Vol#: 20

C 216 Leonore Conacher Vol#: 20

TR 3 Transcript of the 1/19/00 meeting Vol#: 21

97N-484S Human Cellular and Tissue-Based Products

C 450 Bascom Palmer Eye Institute Vol#: 24

97P-0350 Reclassify Home Uterine Activity Monitors from III to II

C 4 CPOP, Coalition for Positive Outcomes in Vol#: 5

98H-1080 Civil Money Penalties;Larry W Denley,d/b/a Coffeeville Groce

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1085 Civil Money Penalties;Stephen D Underwood,d/b/a Underwood's

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1086 Civil Money Penalties;Walgreen Co Inc,d/b/a Walgreen Drug

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1087 Civil Money Penalties; Robert J Watts, d/b/a Robert Watts

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1089 Civil Money Penalties; Citizens Fuel Co

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1090 Civil Money Penalties; Jordan R L oil Co of NC,d/b/a Ashelan

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1092 Civil Money Penalties; CVS Corp,d/b/a CVS Pharmacy

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1093 Civil Money Penalties; Phar Mor Inc,d/b/a Phar Mor Store 207

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1095 Civil Mooney Penalties;Dare Venture Ltd,d/b/a Nags Head Shel

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1097 Civil Money Penalties;The Southland Corp,d/b/a 7 Eleven Stor

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1098 Civil Money Penalties; S.S.S.Development Inc,d/b/a Jiffi Sto

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1099 Civil Money Penalties;Hector Contreras,d/b/a H & B Grocery

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1101 Civil Money Penalties;Walgreen Co,d/b/a Walgreens Drug Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1103 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #742

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1104 Civil Money Penalties;Wayne Peters,d/b/a Oleander Exxon

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1105 Civil Money Penalties;CVS Revco D.S. Inc,d/b/a CVS Pharmacy

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1106 Civil Money Penalties;Wal-Mart Store Inc,d/b/a Wal-Mart 1761

CR 1 GCF-1 Vol#:

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1107 Civil Money Penalties;Worsley Operating Corp;d/b/a Scotchman

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1108 Civil Money Penalties;Worsley Operating Corp,d/b/a Scotchman

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1112 Civil Money Penalties;Bob Jack Corp,d/b/a Lakeside Texaco

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

LET 4 HF-11 to CHPA Vol#: 5

LET 5 Consumer Healthcare Products Association Vol#: 5

PAV 2 HF-11 to CHPA Vol#: 5

99H-2275 Civil Money Penalty;Anthony E Jones,dba Anthony's Amoco

ANS 1 Anthonys Amoco Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

ANS 2 Zamiri's Arco Inc Vol#: 1

99H-5123 Civil Money Penalty;Michael Masaitis;dba County Line Conveni

LET 2 Office of Tobacco Programs Vol#: 1

99H-5465 Civil Money Penalty;Cooperative Supply Inc;dba Cenex Coopera

ANS 1 Cooperative Supply Inc Vol#: 1

99H-5533 Civil Money Penalty;Jim & Dorothy,Inc;dba Bay Shore Food Mar

ANS 1 Jim & Dorothy Inc Vol#: 1

99H-5586 Civil Money Penalty;Phillip's Sub Shop,Inc;dba Corner Carry

ANS 1 Phillip's Sub Shop Inc Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EC 1347 Mr. Duncan Greene Vol#: 167

EC 1348 Number Not Used Vol#: 167

EC 1349 Independent Organic Inspectors Assn. Vol#: 167

EC 1350 Mr. Brian Kennedy Vol#: 167

EC 1351 Number Not Used Vol#: 167

EC 1352 Number Not Used Vol#: 167

EC 1353 Mr. Gary Roth Vol#: 167

EC 1354 Number Not Used Vol#: 167

EC 1355 Number Not Used Vol#: 167

EC 1356 Mr. Gary Volz Vol#: 167

EC 1357 Number Not Used Vol#: 167

EC 1358 Mr. Daniel Newsome Vol#: 167

EC 1359 Ms. Joyce Lock Vol#: 167

EC 1360 self Vol#: 167

EC 1361 Aaron's Computer Works, Inc. Vol#: 167

EC 1362 Mrs. Alma Dorsey Vol#: 167

EC 1363 Number Not Used Vol#: 167

EC 1364 wing chun association Vol#: 167

EC 1365 Number Not Used Vol#: 167

EC 1366 Number Not Used Vol#: 167

EC 1367 Ms. wendy kolanz Vol#: 167

EC 1368 Farm Box Project Consulting Group Vol#: 167

EC 1369 Number Not Used Vol#: 167

EC 1370 Mrs. ELIZABETH HOECKER Vol#: 167

EC 1371 Dr. brooke london Vol#: 167

EC 1372 Mrs. Candy Hartman Vol#: 167

EC 1373 Ms. Teresa Clements Vol#: 167

EC 1374 Number Not Used Vol#: 167

EC 1375 Mr. Andrew Hayden Vol#: 167

EC 1376 Number Not Used Vol#: 167

EC 1377 Number Not Used Vol#: 167

EC 1378 Mr. Andrew Hayden Vol#: 167

EC 1379 Number Not Used Vol#: 167

EC 1380 Number Not Used Vol#: 167

EC 1381 Housewife Vol#: 167

EC 1382 Mr. Robert Ivie Vol#: 167

EC 1383 Mrs. Bonita Hay Vol#: 167

EC 1384 Number Not Used Vol#: 167

EC 1385 Ms. Candace Esslinger Vol#: 167

EC 1386 Ms. Keshini Ladduwahetty Vol#: 167

EC 1387 Ms. Alice Carin Vol#: 167

EC 1388 Mrs. Rhonda Stewart Vol#: 167

EC 1389 Number Not Used Vol#: 167

EC 1390 Mr. Rory Adams Vol#: 167

EC 1391 Number Not Used Vol#: 167

EC 1392 Honduran Foundation for Agricultural Res Vol#: 167

EC 1393 edge Vol#: 167

EC 1394 J C Ostrich Ranch Vol#: 167

EC 1395 Rio Grande Community Farms Vol#: 167

EC 1396 Private citizen Vol#: 167

EC 1397 Ms. Melissa Schulz Vol#: 167

EC 1398 Ms. Kristine Benishek Vol#: 167

EC 1399 Number Not Used Vol#: 167

EC 1400 Number Not Used Vol#: 167

EC 1401 Number Not Used Vol#: 167

EC 1402 Miss Marie Tedei Vol#: 167

EC 1403 Mr. Scott Stokoe Stokoe Vol#: 167

EC 1404 Mrs. jane butler Vol#: 167

EC 1405 Mrs. Linda Myers Vol#: 167

EC 1406 Number Not Used Vol#: 167

EC 1407 Mr. Burton Brush Vol#: 167

EC 1408 n/a Vol#: 167

EC 1409 Impact Assessment, Inc. Vol#: 167

EC 1410 Number Not Used Vol#: 167

EC 1411 Ms. Allison Sharkey Vol#: 167

EC 1412 Ms. Kay Stoltz Vol#: 167

EC 1413 Mr. Eric Dost Vol#: 167

EC 1414 Ms. Lorie Johnson Vol#: 167

EC 1415 Ms. Angela Sum Vol#: 167

EC 1416 City University of New York (ID purposes Vol#: 168

EC 1417 Mr. Chad Schmitz Vol#: 168

EC 1418 Pioneer Hi-Bred Int'l. Inc. Vol#: 168

EC 1419 consumer Vol#: 168

EC 1420 Number Not Used Vol#: 168

EC 1421 Number Not Used Vol#: 168

EC 1422 Northern Wind Recordings Vol#: 168

EC 1423 Ms. C. Liu Vol#: 168

EC 1424 Number Not Used Vol#: 168

EC 1425 Mrs. Barbara Baker Vol#: 168

EC 1426 Mr. Poh Yang Ming Vol#: 168

EC 1427 Number Not Used Vol#: 168

EC 1428 Number Not Used Vol#: 168

EC 1429 KWAB Vol#: 168

EC 1430 Number Not Used Vol#: 168

EC 1431 Concerned Citizen Vol#: 168

EC 1432 Ms. C. Liu Vol#: 168

EC 1433 Number Not Used Vol#: 168

EC 1434 Number Not Used Vol#: 168

EC 1435 Number Not Used Vol#: 168

EC 1436 Number Not Used Vol#: 168

EC 1437 Number Not Used Vol#: 168

EC 1438 Number Not Used Vol#: 168

EC 1439 none Vol#: 168

EC 1440 Ms. Sylvia Moestl Vol#: 168

EC 1441 Private Citizen Vol#: 168

EC 1442 Number Not Used Vol#: 168

EC 1443 Number Not Used Vol#: 168

EC 1444 Mr. Jack Smiley Vol#: 168

EC 1445 none Vol#: 168

EC 1446 Elem. teacher/farmer Vol#: 168

EC 1447 Number Not Used Vol#: 168

EC 1448 Health Information Services, Cornerstone Vol#: 168

EC 1449 Mr. Peter Stohn Vol#: 168

EC 1450 Number Not Used Vol#: 168

EC 1451 Number Not Used Vol#: 168

EC 1452 Number Not Used Vol#: 168

EC 1453 Number Not Used Vol#: 168

EC 1454 Number Not Used Vol#: 168

EC 1455 Number Not Used Vol#: 168

EC 1456 Number Not Used Vol#: 168

EC 1457 Ms. Valerie Ryan Vol#: 168

EC 1458 Mr. Jerry Edmondson Vol#: 168

EC 1459 Number Not Used Vol#: 168

EC 1460 Monsanto Vol#: 168

EC 1461 Monsanto Vol#: 168

EC 1462 Monsanto Vol#: 168

EC 1463 Mrs. Nancy Chatt Vol#: 168

EC 1464 Ford Associates Vol#: 168

EC 1465 Monsanto Vol#: 168

EC 1466 Mr. Douglas Rupp Vol#: 168

EC 1467 Mr. John Vietz Vol#: 168

EC 1468 Mr. SP Rudolph Vol#: 168

EC 1469 Ms. sue ogden Vol#: 168

EC 1470 Mr. Larry Desaire Vol#: 168

EC 1471 Mr. Walter Sorensen Vol#: 168

EC 1472 Mr. Eugene Coughlan Vol#: 168

EC 1473 Monsanto Vol#: 168

EC 1474 Number Not Used Vol#: 168

EC 1475 Monsanto Company Vol#: 168

EC 1476 Number Not Used Vol#: 168

EC 1477 Ms. Ann Kemler Vol#: 168

EC 1478 Number Not Used Vol#: 168

EC 1479 Number Not Used Vol#: 168

EC 1480 Number Not Used Vol#: 168

EC 1481 Number Not Used Vol#: 168

EC 1482 Ms. Johanna Black Vol#: 168

EC 1483 Prairie Woods Audubon Society Vol#: 168

EC 1484 Mr. Gregory Bergman Vol#: 168

EC 1485 Number Not Used Vol#: 168

EC 1486 Number Not Used Vol#: 168

EC 1487 Mr. Patrick Weston Vol#: 168

EC 1488 Mr. Patrick Dunkerley Vol#: 168

EC 1489 Mr. David Kelpe Vol#: 168

EC 1490 Mr. Ernie Taylor Vol#: 168

EC 1491 Mr. Patrick Wroblewski Vol#: 168

EC 1492 Mr. Wayne Brown Vol#: 168

EC 1493 Number Not Used Vol#: 168

EC 1494 Ms. Pamela Sisson Vol#: 168

EC 1495 Number Not Used Vol#: 168

EC 1496 Monsanto Co Vol#: 168

EC 1497 Number Not Used Vol#: 168

EC 1498 Mr. William Briner Vol#: 168

EC 1499 Number Not Used Vol#: 168

EC 1500 Number Not Used Vol#: 168

EC 1501 Number Not Used Vol#: 169

EC 1502 Mr. Ethan Cohen Vol#: 169

EC 1503 Mr. Thad Ekdahl Vol#: 169

EC 1504 Number Not Used Vol#: 169

EC 1505 Number Not Used Vol#: 169

EC 1506 Mr. Jimmie Cobb Vol#: 169

EC 1507 Mr. Edward Reid Vol#: 169

EC 1508 Mr. Gregory Branch Vol#: 169

EC 1509 Number Not Used Vol#: 169

EC 1510 Number Not Used Vol#: 169

EC 1511 Monsanto Vol#: 169

EC 1512 Number Not Used Vol#: 169

EC 1513 Department of Anthropology, UMass, Amher Vol#: 169

EC 1514 Mr. Nate Brogan Vol#: 169

EC 1515 Number Not Used Vol#: 169

EC 1516 Ms. Joan Levin Vol#: 169

EC 1517 N/A Vol#: 169

EC 1518 Dr. Walter Mayhew Vol#: 169

EC 1519 Number Not Used Vol#: 169

EC 1520 Number Not Used Vol#: 169

EC 1521 Soil Foodweb Inc. Vol#: 169

EC 1522 Mrs. Georgina Minto Vol#: 169

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2140 Karen B. Dantinne Vol#: 178

C 2141 Ping Huang Vol#: 178

C 2142 Ms. Joyce Frohn Vol#: 178

C 2143 S. Kilheary Vol#: 178

C 2144 John & Deb Haynes Vol#: 178

C 2145 Paula & Norman Lesser Vol#: 178

C 2146 Peter Clark MD Vol#: 178

C 2147 Karen Andresen Vol#: 178

C 2148 Georgia L. Ferderber Vol#: 178

C 2149 Rebecca W. Neinan Vol#: 178

C 2150 Mr. & Mrs. Joseph R. Arinz Vol#: 178

C 2151 Ms. Thelma Segal Vol#: 178

C 2152 Mrs. Marilyn S. Mozenter Vol#: 178

C 2153 Irene Weiner Vol#: 178

C 2154 Robin Kajihara Vol#: 178

C 2155 J. R. Heffron Vol#: 178

C 2156 Shirley Kupferberg Vol#: 178

C 2157 Elisabeth B. Joshi Vol#: 178

C 2158 Donna Noonan Vol#: 178

C 2159 Mr. & Mrs. Paul A. Rossi Vol#: 178

C 2160 Lynn Engen Vol#: 178

C 2161 Edward & Nancy Weber Vol#: 178

C 2162 Annette Figatner Vol#: 178

C 2163 Walter & Jacqueline Gardner Vol#: 178

C 2164 Harriet E. Feder Vol#: 178

C 2165 Helen Rothstein Vol#: 178

C 2166 Sharon Grimm Vol#: 178

C 2167 Carol W. Guffey Vol#: 178

C 2168 Mr. & Mrs. Robert Wolf Vol#: 178

C 2169 Judy Skog Vol#: 178

C 2170 J. Abercombie Vol#: 178

C 2171 Lydia Miller Vol#: 179

C 2172 Carol Tallone Vol#: 179

C 2173 Judith & Walter Wormser Vol#: 179

C 2174 Sandra Groff Vol#: 179

C 2175 Richard Caldwell Vol#: 179

C 2176 Ruth Gabey Vol#: 179

C 2177 Laura Scholtz & Family Vol#: 179

C 2178 Jean Ostendorf Vol#: 179

C 2179 Harmon A. Baldwin Vol#: 179

C 2180 Caroline A. Williams Vol#: 179

C 2181 Dianne Kangisser Vol#: 179

C 2182 Agnes Eanes Vol#: 179

C 2183 Mrs. Arlene Wanamaker Vol#: 179

C 2184 Lorraine M. Wetherell Vol#: 179

C 2185 Angela Herring, MD Vol#: 179

C 2186 Molly V. MacGowan Vol#: 179

C 2187 Margaret P. Morrison Vol#: 179

C 2188 Sharon K. Olson Vol#: 179

C 2189 Dr. Douglas E. Wingeier Vol#: 179

C 2190 Barbara & Joe Cushner Vol#: 179

C 2191 Joanne M. Moore Vol#: 179

C 2192 OCM Boces Mid-State CSHW Center Vol#: 179

C 2193 D L. F Vol#: 179

C 2194 Mariann Schmitz Vol#: 179

C 2195 Bonnie Emlaw Vol#: 179

C 2196 Linda Padem Vol#: 179

C 2197 Mary A. Messmer et al Vol#: 179

C 2198 Mrs. E. J. Neher Vol#: 179

C 2199 James Roeder Vol#: 179

C 2200 Barbra McCandless Vol#: 179

C 2201 Ray Nassar Vol#: 179

C 2202 Jenny Baker Vol#: 179

C 2203 Aimee Curtright Vol#: 179

C 2204 Victor Levin Vol#: 179

C 2205 Gary Geller, Ph.D. Vol#: 179

C 2206 Caitlin Williams, M.ED, LMHC Vol#: 179

C 2207 Joanne LaFreniere Vol#: 179

C 2208 Dave Momenee Vol#: 179

C 2209 Dorothy Matz Vol#: 179

C 2210 Claudette Schiratti, RSM Vol#: 179

C 2211 Professional Nutrition Services Vol#: 179

C 2212 Ms. Elizabeth Campuzano Vol#: 179

C 2213 William Estlick Vol#: 179

C 2214 Ralph C. Bailey Vol#: 179

C 2215 Lucia Coletta N.D. Vol#: 179

C 2216 Chuck Mitchell Vol#: 179

C 2217 T. L. Dix Vol#: 179

C 2218 Paul C. Szabo Vol#: 179

C 2219 G. M. DiLabio, Ph.D. Vol#: 179

C 2220 Robert Russell Vol#: 179

C 2221 Muriel J. King Vol#: 179

C 2222 Selma H. & Jerome Silverstein Vol#: 179

C 2223 Solar Energy Systems Vol#: 179

C 2224 Clarence Petty Vol#: 179

C 2225 Edith C. Whitson Vol#: 179

C 2226 Wheaton Franciscan Sisters Vol#: 180

C 2227 Julian Powers Vol#: 180

C 2228 New York Life Insurance Co. Vol#: 180

C 2229 Virginia Welsted Vol#: 180

C 2230 Fred T. Darvill, Jr. M.D., F.A.C.P. Vol#: 180

C 2231 Kathy Van Dame Vol#: 180

C 2232 Intercon Management Vol#: 180

C 2233 Eldon L. Ball Vol#: 180

C 2234 Adult & Pediatric Urology of Marshall Vol#: 180

C 2235 Rita Bonanera Vol#: 180

C 2236 Gloria Berman Vol#: 180

C 2237 Diana Rachel Lombardi Vol#: 180

C 2238 Dr. Douglas E. Wingeier Vol#: 180

99P-4617 Extend the Implementation Dates of the OTC Drug Labeling Rul

LET 2 HF-11 to CTFA Vol#: 1

PAV 1 HF-11 to CTFA Vol#: 1

00H-0143 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik C

ANS 1 Maverik Country Stores Inc Vol#: 1

00H-0156 Civil Money Penalty;Broadway Liquor,Inc;dba Broadway Liquors

ANS 1 Broadway Liquors Inc Vol#: 1

00H-0158 Civil Money Penalty;Casey's General Stores,Inc;dba Casey's

ANS 1 General Stores Inc,dba Casey's General Vol#: 1

00H-0159

ANS 1 General Stores Inc,dba Casey's General Vol#: 1

00H-0160 Civil Money Penalty;Casey's General Store,Inc;dba Casey's

ANS 1 General Stores Inc,dba Casey's General Vol#: 1

00H-0385 Civil Money Penalty;Traband Enterprises Inc,dba Victory Vill

ANS 1 Traband Enterprises Inc Vol#: 1