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 4, 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 ]

 
84N-0102 Orphan Product Designations *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00P-0442 Variance from Perf Std for Electrode Lead Wires & Patient Ca *
00P-0443 Exempt Model 4220 Sterile Disposable Surgical Extension Cabe *
00P-0444 ANADA Suitability for spectinomycin sterile solution *

84N-0102 Orphan Product Designations

LST 93 January 2000 Vol#: 2

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 1196 Karen Finnegan Vol#: 40

C 1197 Teresa B Sheehan Vol#: 40

C 1198 Pat Hansen Vol#: 40

C 1199 Kathryn Durrill Vol#: 40

C 1200 E C Vol#: 40

C 1201 Noah O Clayton Vol#: 40

C 1202 Gloria D Pond, Tony Pond Vol#: 40

C 1203 Walter Lee Bennett Vol#: 40

C 1204 Joan Cox Vol#: 40

C 1205 Marshall Kayser Vol#: 40

C 1206 Eldonea Owens Vol#: 40

C 1207 Steve Jones Vol#: 40

C 1208 Mrs C W Grant Vol#: 40

C 1209 Karen Reynolds MS Vol#: 40

C 1210 Wesley H Wells Vol#: 40

C 1211 Robert C Franz Vol#: 40

C 1212 Jennie Fox MBA RD Vol#: 40

C 1213 Keith Padgett Vol#: 40

C 1214 Pamela C Smith Vol#: 40

C 1215 Dennis Donoghue, Maureen Donoghue Vol#: 40

C 1216 Frank W Quillin Jr DDS PA Vol#: 40

C 1217 Sanford Levy MD Vol#: 40

C 1218 Wells Goodrich MD Vol#: 40

C 1219 Hildegard Hannum Vol#: 40

C 1220 Iva Wilmoth Vol#: 40

C 1221 Sharolyn Sherman Vol#: 40

C 1222 Bruce Inkman Vol#: 40

C 1223 Alice Vankley Vol#: 40

EMC 64 Jolene Lemelin Vol#: 40

EMC 65 Dean Mandiloff Vol#: 40

EMC 66 Carcat Vol#: 40

EMC 67 Loraine Rieken Vol#: 40

EMC 68 Rosalie Jordan Vol#: 40

EMC 69 DOROTHY GALLOWAY Vol#: 40

EMC 70 Hank Fales Vol#: 40

EMC 71 Carolyn E. Levy Vol#: 40

EMC 72 University of Minnesota Vol#: 40

EMC 73 Arthur Meyer Vol#: 40

EMC 74 Gerald E Colado Vol#: 40

EMC 75 Harold Brake Vol#: 40

EMC 76 William R Randolph Vol#: 40

EMC 77 Ray Chu Vol#: 40

EMC 78 Phyllis Andreoni Vol#: 40

EMC 79 Marv Keckhut Vol#: 40

EMC 80 Sue Allmart Vol#: 40

EMC 81 Eileen and Robert Hirsch Vol#: 40

EMC 82 Marilyn McGowan Grobler Vol#: 40

EMC 83 Cathy Husted Vol#: 40

EMC 84 Teresa A.Granelli Vol#: 40

EMC 85 LFilczer Vol#: 40

EMC 86 Melvin Shapiro Vol#: 40

EMC 87 Loriene J. Dohring Vol#: 40

EMC 88 Adrienne Woestendiek Vol#: 40

EMC 89 New York University Vol#: 40

EMC 90 Gloria Pasternak Vol#: 40

EMC 91 John P. Wheeler Vol#: 40

EMC 92 Harvey Feder Vol#: 40

EMC 93 Rod Johnson Vol#: 40

EMC 94 Chris Raypole Vol#: 40

EMC 95 Indonesian Palm Oil Producers Associatio Vol#: 40

EMC 96 Hallie L. Huttash Vol#: 40

EMC 97 Shahid A. Buttar Vol#: 40

EMC 98 Melovlo Vol#: 40

EMC 99 Chair of Learner Affairs Vol#: 40

EMC 100 John K.D. Lazier Vol#: 40

EMC 101 William Umiker, M.D. Vol#: 40

EMC 102 Tom Sonnabend, Ph. D. Vol#: 40

EMC 103 Rich Shaffer Vol#: 40

EMC 104 Gail Silvers Vol#: 40

EMC 105 Alvin & Lois Arzt Vol#: 40

EMC 106 Janet Tilley Vol#: 40

EMC 107 Washtenaw Community College Vol#: 40

EMC 108 Joan Lyman and Hal Guilford Vol#: 40

EMC 109 Eloise Bender Vol#: 40

EMC 110 Harvard School of Public Health Vol#: 40

EMC 111 Jonathan Pray Vol#: 40

EMC 112 Gary Clement Vol#: 40

EMC 113 Roger Markle Vol#: 40

EMC 114 Barbara Gregorio Vol#: 40

EMC 115 Linda Beers Vol#: 40

EMC 116 Susie Vol#: 40

EMC 117 Mrs Enzo Conti Vol#: 40

EMC 118 Nancy J. Kinser Vol#: 40

EMC 119 Janet A. Doka Vol#: 40

EMC 120 Willard & Grace Mann Vol#: 40

EMC 121 John Grimes Vol#: 40

EMC 122 Thelen Larry Vol#: 40

EMC 123 texnolan Vol#: 40

EMC 124 Niko Theris Vol#: 40

EMC 125 Linda Kipper Vol#: 40

EMC 126 Peggy Handler Vol#: 40

EMC 127 Linda Eldredge Vol#: 40

EMC 128 Sheila Chawla Vol#: 40

EMC 129 Antone Holevas Vol#: 40

EMC 130 Terry Arkelian Vol#: 40

EMC 131 Joan Bennett Vol#: 40

EMC 132 Ellen K. Snyder Vol#: 40

98N-0044 Effect of dietary supplement on structure/function of body

ACK 2 HFA-305 Vol#: 1

PRC 1 Nutraceutical Corporation Vol#: 876

99D-0236 Skin Irritation/Sensitization testing of generic transdermal

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

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

C 1069 M Fountain Vol#: 114

C 1070 Cheryl V Murray Vol#: 114

C 1071 Regina Bennetts Vol#: 114

C 1072 L Jones Vol#: 114

C 1073 Katrinia Popin Vol#: 114

C 1074 Barbara Ann Reusch Vol#: 114

C 1075 Alyne M Webbs Vol#: 114

C 1076 Karya Kalyman Vol#: 114

C 1077 Crystal O'Connor Vol#: 114

C 1078 Beniyah Daniel Vol#: 114

C 1079 Illegible Vol#: 114

C 1080 Michelle Anne Reed Vol#: 114

C 1081 Linda G Thompson Vol#: 114

C 1082 Marjorie J Cala Vol#: 114

C 1083 Karl Liske Vol#: 114

C 1084 Illegible Vol#: 114

C 1085 Catherine Williams Vol#: 114

C 1086 Clark Herlirah Vol#: 114

C 1087 Annemarie Waterheart Vol#: 114

C 1088 Laura Bastrelli-Purran Vol#: 114

C 1089 JoAnn Kish Vol#: 114

C 1090 Jada Jackson Vol#: 114

C 1091 Eleanor Cochran Vol#: 114

C 1092 Raymond Berg Vol#: 114

C 1093 Colleen O Rourke Vol#: 114

C 1094 Laura Peskin Vol#: 114

C 1095 Neal Luoma Vol#: 114

C 1096 Sharon K Mesmild Vol#: 114

C 1097 Thomas H Srivluir Vol#: 114

C 1098 Charlotte Jackson Vol#: 114

C 1099 Joanne Griesinger Vol#: 114

C 1100 Barbara A Nicely Vol#: 114

EMC 1336 Marcus Williamson Vol#: 113

EMC 1337 Mark A Linett Vol#: 113

EMC 1338 Stephanie Roberts Vol#: 113

EMC 1339 Scott Stumbaugh Vol#: 113

EMC 1340 Nicholas Sammond PhD Vol#: 113

EMC 1341 Rachel Treichler Vol#: 113

EMC 1342 Michelle O'Brien Vol#: 113

EMC 1343 Amy Murphy Vol#: 113

EMC 1344 unsigned Vol#: 113

EMC 1345 Sandy Henschel Vol#: 113

EMC 1346 Jon Schmitz Vol#: 113

EMC 1347 Colin Johnson Vol#: 113

EMC 1348 Thomas Smith Vol#: 113

EMC 1349 Kristin Mercer Vol#: 113

EMC 1350 Colleen Robison Vol#: 113

EMC 1351 Ernest Goitein Vol#: 113

EMC 1352 Robert Gray Vol#: 113

EMC 1353 John DiZazzo Vol#: 113

EMC 1354 Matthew Metz Vol#: 113

EMC 1355 John & Julie Marquardt Vol#: 113

EMC 1356 Kim Wahl Vol#: 113

EMC 1357 Ann Steuemagel Vol#: 113

EMC 1358 Allen R Schmitt-Gordon PhD Vol#: 113

EMC 1359 Amy Goodwin Vol#: 113

EMC 1360 Amy Agigian Vol#: 113

EMC 1361 Ramola D Vol#: 113

EMC 1362 Jay Kammen Vol#: 113

EMC 1363 Dan Brunicardi Vol#: 113

EMC 1364 Gayle Lalich Vol#: 113

EMC 1365 Janet Brown Vol#: 113

EMC 1366 David Harde Vol#: 113

EMC 1367 Evan M Stajduhar Vol#: 113

EMC 1368 Richard Cicchetti Vol#: 113

EMC 1369 Deborah Innes Vol#: 113

EMC 1370 Linda L Maier Vol#: 113

EMC 1371 Candance Romig Vol#: 113

EMC 1372 Brian & Karina Zambreno Vol#: 113

EMC 1373 Geeta Aiyer Vol#: 113

EMC 1374 Linda Rosencranz Vol#: 113

EMC 1375 Eli B Moore Vol#: 113

EMC 1376 Zachary Kahn Vol#: 113

EMC 1377 David Harde Vol#: 113

EMC 1378 Sue Warren Vol#: 113

EMC 1379 Karen Cutler Vol#: 113

EMC 1380 Megan Vaught Vol#: 113

EMC 1381 David Stensby Vol#: 113

EMC 1382 Anne Roberts & Tim King Vol#: 113

EMC 1383 Mary Ellen Hunt Vol#: 113

EMC 1384 Susie Jennings Vol#: 113

EMC 1385 Paul Bauer Vol#: 113

EMC 1386 Karen Kruse Vol#: 113

EMC 1387 Raymond Traietti Vol#: 113

EMC 1388 Nora Swan-Foster Vol#: 113

EMC 1389 Andrea Wieland Vol#: 113

EMC 1390 Donald Haberstroh Vol#: 113

EMC 1391 Jan Davis Vol#: 113

EMC 1392 Dr Donald Richter Vol#: 113

EMC 1393 Susan Sherman Vol#: 113

EMC 1394 Deana McCauley Vol#: 113

EMC 1395 Ronald & Nettie Barca Vol#: 113

EMC 1396 Thomas J Hoban PhD Vol#: 113

EMC 1397 Paul De Marinis Vol#: 113

EMC 1398 Roger Sherron Vol#: 113

EMC 1399 Patricia Slama Vol#: 113

EMC 1400 Marda Kirn Vol#: 113

EMC 1401 Dharlys Fleharty Vol#: 113

EMC 1402 Nancy Allen Vol#: 113

EMC 1403 Robert Harrison Vol#: 113

EMC 1404 Joshua Jarman Vol#: 113

EMC 1405 Toby Y Landis Vol#: 113

EMC 1406 Mark Doyle Vol#: 113

EMC 1407 Joanne Tippett Vol#: 113

EMC 1408 Elizabeth Bell Vol#: 113

EMC 1409 Gregory S Diaz Vol#: 113

EMC 1410 Lawrence Gust Vol#: 113

EMC 1411 Mary England Vol#: 113

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 301 Linda O'Malley Vol#: 8

C 302 Cathy Zaranek et al Vol#: 8

C 303 Janet Eisberner Vol#: 8

C 304 April Hosty Vol#: 8

C 305 Jessica R. Merauik Vol#: 8

C 306 Mary Pollack Vol#: 8

C 307 Monika Zaranek et al Vol#: 8

C 308 Vanessa Gaglione Vol#: 8

C 309 Judith E. Embry Vol#: 8

C 310 Lorraine Pelosof Vol#: 8

C 311 Monika Zaranek et al Vol#:

C 312 Kathy Spurr Vol#: 8

C 313 Paula Tice Vol#: 8

C 314 Diane M. Marvin Vol#: 8

C 315 Nanette Potis Vol#: 8

C 316 Samuel J. Anderson Vol#: 8

C 317 Kay Henderson Rasmussen Vol#: 8

C 318 C C Lilley Vol#: 8

C 319 V June Hart Vol#: 8

C 320 Ellen S. Whitaker Vol#: 8

C 321 Maxine Jaffee Vol#: 8

C 322 Alice B. Bartholomew Vol#: 8

C 323 Charlotte Marchese Vol#: 8

C 324 Margaret Pennewell Vol#: 8

C 325 Eileen Varin Vol#: 8

C 326 Patricia Todes Vol#: 8

C 327 Jill Lim Vol#: 8

C 328 Kathryn A. Watkins Vol#: 8

C 329 Ann Bitting Vol#: 8

C 330 Cathy Baynar Vol#: 8

C 331 Barbara Yorganjian Vol#: 8

C 332 Jo Ann Herbert Vol#: 8

C 333 Joellen Gilchrist Vol#: 8

C 334 Enid L. Randall Vol#: 8

C 335 Mr & Mrs Ed Searcy Vol#: 8

C 336 Christine Sherren Vol#: 8

C 337 George Pelton Vol#: 8

C 338 Michelle Lieberman Vol#: 8

C 339 Michelle Lieberman Vol#: 8

C 340 June Faulk Vol#: 8

C 341 Mr & Mrs H Evans Vol#: 8

C 342 Lyndell Pritchett Vol#: 8

C 343 Vivian Gleeson Vol#: 8

C 344 William L. Duffey Vol#: 8

C 345 Cynthia Warren Vol#: 8

C 346 Vina Patel Vol#: 8

C 347 Seymour Folkman Vol#: 8

C 348 Catherine Ramsey Vol#: 8

C 349 Susan Greco Vol#: 8

C 350 Roberta Vullo Vol#: 8

C 351 Peggy Spiegel Vol#: 8

C 352 Mr & Mrs Ed Mettler Vol#: 8

C 353 Susan & Phil Kaye Vol#: 8

C 354 Alison Franklin-Stetler Vol#: 8

C 355 Dr. P. H. Polcyn Vol#: 8

C 356 Barbara Charlebois Vol#: 8

C 357 Margaret Gebhard Vol#: 8

C 358 Christina J. Felker Vol#: 8

C 359 Robert E. Kuehlwein Vol#: 8

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1897 R. M. Orum Vol#: 173

C 1898 Ray F. Smith Vol#: 173

C 1899 F. Phelps Vol#: 173

C 1900 Ms. Dorothy S. Smith Vol#: 173

C 1901 Dini Schut Vol#: 173

C 1902 Amanda Allen Vol#: 173

C 1903 Leah S. Feldman Vol#: 173

C 1904 Marilyn Serino Vol#: 173

C 1905 Constance Schulz Vol#: 173

C 1906 Mr. & Mrs. Byron D. Kaven Vol#: 173

C 1907 Marguerite Clark Vol#: 173

C 1908 John Belleville Vol#: 173

C 1909 Mr. Otto C. Chesnovsky Vol#: 173

C 1910 Sally J. Cohen Vol#: 173

C 1911 Mrs. D. M. Gall Vol#: 173

C 1912 Elaine Daly Vol#: 173

C 1913 Teresa A. Granelli Vol#: 173

C 1914 Nancy L. Becker RN Vol#: 173

C 1915 Rev. W. Thomas Engram Vol#: 173

C 1916 Paula J. Stober & W. K. Bucklen Vol#: 173

C 1917 Teresa L. Davis Vol#: 173

C 1918 Viola Sparagna Vol#: 173

C 1919 Mark B. Mikula Vol#: 173

C 1920 William Mason Vol#: 173

C 1921 Sally Galiste Vol#: 173

C 1922 Loretta Dunne Vol#: 173

C 1923 Michael E. Gordon Vol#: 173

C 1924 Violet J. Wiley Vol#: 173

C 1925 Virginia Mitchell Vol#: 173

C 1926 Faye Marie Pertuis Vol#: 173

C 1927 Bethia & Richard B. King Vol#: 173

C 1928 Tim House Vol#: 173

C 1929 Kara J. Haigler Vol#: 173

C 1930 Louise E. Zapp Vol#: 173

C 1931 Mary L. Ukleja Vol#: 173

C 1932 Darlene Buckley Vol#: 173

C 1933 Rosalind Dobkin Vol#: 173

C 1934 Mrs. Marie Casazza Vol#: 173

C 1935 R. McClelland Groben, Jr. Vol#: 173

C 1936 Mary Guger Smith Vol#: 173

C 1937 Alice Mikula Vol#: 173

C 1938 Maria Sanchez Steenberger Vol#: 173

C 1939 A. Bouche' Vol#: 173

C 1940 Deralde Carewile Vol#: 173

00P-0442 Variance from Perf Std for Electrode Lead Wires & Patient Ca

ACK 1 HFA-305 Vol#: 1

CP 1 Ludlow Technical Products Vol#: 1

00P-0443 Exempt Model 4220 Sterile Disposable Surgical Extension Cabe

ACK 1 HFA-305 Vol#: 1

CP 1 Pace Medical Inc Vol#: 1

00P-0444 ANADA Suitability for spectinomycin sterile solution

ACK 1 HFA-305 Vol#: 1

CP 1 Phoenix Scientific Inc Vol#: 1