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) |
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
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 1199 Kathryn Durrill 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 1205 Marshall Kayser 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 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 1221 Sharolyn Sherman Vol#: 40
EMC 64 Jolene Lemelin Vol#: 40
EMC 65 Dean Mandiloff Vol#: 40
EMC 67 Loraine Rieken Vol#: 40
EMC 68 Rosalie Jordan Vol#: 40
EMC 69 DOROTHY GALLOWAY Vol#: 40
EMC 71 Carolyn E. Levy Vol#: 40
EMC 72 University of Minnesota Vol#: 40
EMC 74 Gerald E Colado Vol#: 40
EMC 76 William R Randolph Vol#: 40
EMC 78 Phyllis Andreoni Vol#: 40
EMC 81 Eileen and Robert Hirsch Vol#: 40
EMC 82 Marilyn McGowan Grobler Vol#: 40
EMC 84 Teresa A.Granelli 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 95 Indonesian Palm Oil Producers Associatio Vol#: 40
EMC 96 Hallie L. Huttash Vol#: 40
EMC 97 Shahid A. Buttar 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 105 Alvin & Lois Arzt 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 114 Barbara Gregorio 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 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 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 302 Cathy Zaranek et al Vol#: 8
C 305 Jessica R. Merauik Vol#: 8
C 307 Monika Zaranek et al Vol#: 8
C 308 Vanessa Gaglione Vol#: 8
C 310 Lorraine Pelosof Vol#: 8
C 311 Monika Zaranek et al Vol#:
C 316 Samuel J. Anderson Vol#: 8
C 317 Kay Henderson Rasmussen Vol#: 8
C 320 Ellen S. Whitaker Vol#: 8
C 322 Alice B. Bartholomew Vol#: 8
C 323 Charlotte Marchese Vol#: 8
C 324 Margaret Pennewell Vol#: 8
C 328 Kathryn A. Watkins Vol#: 8
C 331 Barbara Yorganjian Vol#: 8
C 333 Joellen Gilchrist Vol#: 8
C 335 Mr & Mrs Ed Searcy Vol#: 8
C 336 Christine Sherren Vol#: 8
C 338 Michelle Lieberman Vol#: 8
C 339 Michelle Lieberman Vol#: 8
C 341 Mr & Mrs H Evans Vol#: 8
C 342 Lyndell Pritchett Vol#: 8
C 344 William L. Duffey Vol#: 8
C 348 Catherine Ramsey 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 1900 Ms. Dorothy S. Smith 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 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 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 1938 Maria Sanchez Steenberger Vol#: 173
C 1940 Deralde Carewile Vol#: 173
00P-0442 Variance from Perf Std for Electrode Lead Wires & Patient Ca
CP 1 Ludlow Technical Products Vol#: 1
00P-0443 Exempt Model 4220 Sterile Disposable Surgical Extension Cabe
00P-0444 ANADA Suitability for spectinomycin sterile solution