DOCKETS ENTERED on 03/07/00

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 March 7, 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*
90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
95S-0117 Human Drugs Patent Term Extension & New Patents *
99P-4613 Revoke the Regulation That Approved Posilac *
00M-0811 PMA Kremer Excimer Laser System (Serial # KEA940202) *
00M-0901 PMA SpinalPak Bone Growth Stimulator P850022/S9 *
00P-0788 Totally Implanted Spinal Cord Stimulator *

84N-0102 Orphan Product Designations

LST 95 February 2000 Vol#: 3

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

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

C 1968 Andrew Messiceh Vol#: 52

C 1969 Osiris Gomez Vol#: 52

C 1970 Joe Premens Vol#: 52

C 1971 Rebecca Jamicik Vol#: 52

C 1972 LeighAnn Vol#: 52

C 1973 Jean W & William F Donaldson Jr Vol#: 52

C 1974 Phyllis A. Hamilton Vol#: 52

C 1975 S. J. Hagens Vol#: 52

C 1976 Gary M. Russell Vol#: 52

C 1977 PT. Perkebunan Nusantara XIII Vol#: 52

C 1978 Becky Young Vol#: 52

C 1979 Jacquelyn Gibson Vol#: 52

C 1980 Ana W. Parramore Vol#: 52

C 1981 Mary Beth Salisbury Vol#: 52

C 1982 Joy E. Chamber Vol#: 52

C 1983 Nancy Feit Vol#: 52

C 1984 Rebecca Schleman Vol#: 52

C 1985 Rosanne Walker Vol#: 52

C 1986 Tonia R. Docker Vol#: 52

C 1987 No Signature Vol#: 52

C 1988 Marlene Brewster Vol#: 52

C 1989 Theresa Harrell Vol#: 52

C 1990 Sabrina S. Hernandez Vol#: 52

C 1991 Jamie Moore Vol#: 52

C 1992 Michelle Shilts Vol#: 52

C 1993 Cristina Scally Vol#: 52

C 1994 Sonia Ruiz Vol#: 52

C 1995 Christina Fernandez Vol#: 52

C 1996 Stephanie Jennings Vol#: 52

C 1997 Rocio Y. Klunk Vol#: 52

C 1998 Kathleen T. Cartier-Whorley Vol#: 52

C 1999 Gina Stoner Smith Vol#: 52

C 2000 Stephanie J. Blanks Vol#: 52

C 2001 Elin Mathewson Vol#: 52

C 2002 Catherine Christine Vol#: 52

C 2003 Cynthia C. D. Marco Vol#: 52

C 2004 Edie Ryan Johnson Vol#: 52

C 2005 Dara Whittle Vol#: 52

C 2006 Zazda V. Gutterrez Vol#: 52

C 2007 Peggy Cooper Vol#: 52

C 2008 Terrie McDaniel Vol#: 52

C 2009 Larry J. Langston Vol#: 52

C 2010 Mindy Benedict Vol#: 52

C 2011 Kirsten Coffey Vol#: 52

C 2012 Delores James Vol#: 52

C 2013 Grace Lau Vol#: 52

C 2014 Mary A. Keith Vol#: 52

C 2015 John Ferrante Vol#: 52

C 2016 Linda Mills Vol#: 52

C 2017 Alastair Riach Vol#: 52

C 2018 Ministry of Hlth Republic of Indonesia Vol#: 52

C 2019 International Dairy Foods Assn Vol#: 52

C 2020 Marilyn Pistel Vol#: 52

C 2021 Maxine Bellamy Vol#: 52

C 2022 PTPP London Sumatra Indonesia (Lonsum) Vol#: 52

C 2023 The Popcorn Institute Vol#: 52

C 2024 Williard Kasga Vol#: 52

C 2025 Stuart Katsh Vol#: 52

C 2026 The Popcorn Board Vol#: 52

C 2027 American Public Health Assn Vol#: 52

C 2028 Johanna Ohrmundt Vol#: 52

C 2029 Debbie Ings Vol#: 52

C 2030 Phyllis L. Glackman Vol#: 52

C 2031 Theodore E. Glackman Vol#: 52

C 2032 Keller Communications Vol#: 52

C 2033 Richard M. Manski Vol#: 52

C 2034 Minister of Hlth Republic of Indonesia Vol#: 52

C 2035 Louise Tierce Vol#: 52

C 2036 University of California Vol#: 52

C 2037 Barbara Morel Vol#: 52

C 2038 Brigham & Women's Hospital Vol#: 52

C 2039 Regina F. McClellan Vol#: 52

C 2040 Margaret Lienhardt Vol#: 52

C 2041 Form Letter Count 94 Vol#: 56

C 2042 Preventive Cardiology of Victoria Vol#: 57

C 2043 Preventive Cardiology of Victoria Vol#: 57

C 2044 Rae Heiner Vol#: 57

C 2045 John M. Johnsrud Vol#: 57

EMC 440 Ruth Sievert Vol#: 52

EMC 441 Harley MMM Vol#: 52

EMC 442 Form Letter Count 11 Vol#: 55

EMC 443 Katherine B. Gibbons Vol#: 57

EMC 444 Olive N. Woodard Vol#: 57

EMC 445 Anne Angermeyr Vol#: 57

EMC 446 Patti Steinmuller Vol#: 57

EMC 447 Karl Weissmann Vol#: 57

EMC 448 Hilary Boyd Vol#: 57

EMC 449 Lynn B. Bachenberg Vol#: 57

EMC 450 Josephine S. Carroll Vol#: 57

EMC 451 Danielle Taylor Vol#: 57

EMC 452 Lori Fischer Vol#: 57

EMC 453 Juanita Anderson Vol#: 57

EMC 454 Lynn Martin Vol#: 57

EMC 455 Dora Woods Vol#: 57

EMC 456 Joanne McBrayer Vol#: 57

EMC 457 Lisa A. Tomovitch Vol#: 57

EMC 458 David J. Popovich Vol#: 57

LET 7 United States Senate Vol#: 52

LET 8 United States Senate Vol#: 52

LET 9 The Quaker Oats Company Vol#: 52

LET 10 Kellogg's Vol#: 52

LET 11 Kellogg's Vol#: 52

LET 12 Kellogg's Vol#: 52

LET 13 David Lawrence Dewey Author/Columnist Vol#: 52

LET 14 Congress of the United States Vol#: 52

M 1 United States Senate Vol#: 52

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 51 List as of February 11, 2000 Vol#: 3

99H-5276 Civil Money Penalty;Waco Inc & Kelco Ltd;dba Stop `N Save

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

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

C 2236 Marvin & Stephanie Hughes Vol#: 221

C 2237 Dudley Carson Vol#: 221

C 2238 Bessie Sargent Vol#: 221

C 2239 George Lewis Brooks Vol#: 221

C 2240 Anthony Stone Vol#: 221

C 2241 P M DeSimone Vol#: 221

C 2242 Janyce Halligan Vol#: 221

C 2243 David Cooper Vol#: 221

C 2244 Carol A Vidole Vol#: 221

C 2245 Kathryn J Panks Vol#: 221

C 2246 Grover & Mary Ellen Bowers & Family Vol#: 221

C 2247 Carol Nix Vol#: 221

C 2248 Jean M Sommer Vol#: 221

C 2249 E M Morgan Vol#: 221

C 2250 Mary Campbell Vol#: 221

C 2251 May E Dorn Vol#: 221

C 2252 Dr M A Atkins Vol#: 221

C 2253 Walt Sonen Vol#: 221

C 2254 Donald McBride Vol#: 221

C 2255 Irene J Norton Vol#: 221

C 2256 Elena Leonard Vol#: 221

C 2257 Alice Ordway Vol#: 221

C 2258 Clifford Browder Vol#: 221

C 2259 Susan E Wilcock Vol#: 221

C 2260 Virginia Peterson Vol#: 221

C 2261 Emma Lou Stamislaw Vol#: 221

C 2262 J W Reginald Scurr Vol#: 221

C 2263 Roseanne Moulton Vol#: 221

C 2264 David & Kim Capicchioni Vol#: 221

C 2265 Donny J Bagley Vol#: 221

C 2266 J A Estill Vol#: 221

C 2267 Sarah Shaw Vol#: 221

C 2268 Thomas Kelly Vol#: 221

C 2269 Evelyn Koppel Vol#: 221

C 2270 Carol J Hay Vol#: 221

C 2271 John Klonowski Vol#: 221

C 2272 Khalk & Kay Ayoub Vol#: 221

C 2273 Patricia Bechett Vol#: 221

C 2274 Martin Arons Vol#: 221

C 2275 Genevieve Cornish Vol#: 221

C 2276 Judith H Keith Vol#: 221

C 2277 Bob Meinke Vol#: 221

C 2278 Christina R Knee Vol#: 221

C 2279 M W Scholoufer PhD Vol#: 221

C 2280 Mary E Duncan Vol#: 221

C 2281 Richard H Pierce Vol#: 221

C 2282 John R & Mary T Turner Vol#: 221

C 2283 William Schamerhorn Vol#: 221

C 2284 John Cotres Vol#: 221

C 2285 Rosemary C Parish Vol#: 221

C 2286 U Dehn-Wolfman PhD Vol#: 221

C 2287 Terry Foley Vol#: 221

C 2288 Cathy L Colbert Vol#: 221

C 2289 James M Taylor Vol#: 221

C 2290 Amy Van Buskirk Vol#: 221

C 2291 Ray Brilhart Vol#: 221

C 2292 Mike Tidwell Vol#: 221

C 2293 Ray Brilhart Vol#: 221

C 2294 Angela Torres Vol#: 221

C 2295 Joseph Vincze Vol#: 221

C 2296 Katharine Yares Vol#: 221

C 2297 Helen Farnlund Vol#: 221

C 2298 James K Dempsey Vol#: 221

C 2299 Forrest & Dorothy Gaul Vol#: 221

C 2300 Sue Nielson Vol#: 221

C 2301 Catharine L Sherrick Vol#: 221

C 2302 Barbara Entrees Vol#: 221

C 2303 Donna W Larson Vol#: 221

C 2304 Phyllis P Ford Vol#: 221

C 2305 Thomas Malloy Vol#: 221

C 2306 Harold Bourne Jr Vol#: 221

C 2307 Sandra S Munson Vol#: 221

C 2308 Elizabeth R MacKenzie PhD Vol#: 221

C 2309 Dorothy & Dante D Alessandro Vol#: 221

C 2310 Kristine R Treat Vol#: 221

C 2311 Anne Bloom Vol#: 221

C 2312 Mr & Mrs Jan Kuniholm Vol#: 221

C 2313 Tania Phillips Vol#: 221

C 2314 Lucy Nielsen Vol#: 221

C 2315 Francis J & Eva R Stokes Vol#: 221

C 2316 Oscar F Sensabaugh Jr Vol#: 221

C 2317 Margaret Christian Vol#: 221

C 2318 Christine K Moore Vol#: 221

C 2319 Dr & Mrs Wm Bager Vol#: 221

C 2320 Bette Small Vol#: 221

C 2321 Kent Hottinger Vol#: 221

C 2322 James J Quint Vol#: 221

C 2323 Sebastian J DiMailolo Vol#: 221

C 2324 John & Paula Robinson Vol#: 221

C 2325 Harold L Baker Vol#: 221

C 2326 Steve Quitta Jr Vol#: 221

C 2327 Robin Skillern Vol#: 221

C 2328 Stanley Paul Eppley Vol#: 221

C 2329 Bob Rodgers Vol#: 221

C 2330 Patti Chenis Vol#: 221

C 2331 James Ray & Tina Dozauer Vol#: 221

C 2332 Bonnie J Fisher Vol#: 221

C 2333 Lois D Bowers Vol#: 221

C 2334 Caroline Berch Vol#: 221

C 2335 Summer Colella Vol#: 221

C 2336 L M John Vol#: 221

C 2337 Michael Dennis O'Meare Vol#: 221

C 2338 John G Hedden Vol#: 221

C 2339 Howard Posivo Vol#: 221

C 2340 Ann Wright Vol#: 221

C 2341 Marianne G Pferiffa Vol#: 221

C 2342 Edward P Pommer Vol#: 221

C 2343 Jean Satzer Vol#: 221

C 2344 Terry L Duenkel Vol#: 221

C 2345 Melissa Johns Vol#: 221

C 2346 Richard Kaufman Vol#: 221

C 2347 Virginia Heick Vol#: 221

C 2348 Diana K Taylor Vol#: 221

C 2349 Barbara Cross Vol#: 221

C 2350 Jim & Rickie Rachuy Vol#: 221

C 2351 Marianne Fieweger-Donch Vol#: 221

C 2352 John E & Patricia C Thomas Vol#: 221

C 2353 J C Mathews Vol#: 221

C 2354 Albert James & Iris Prine Vol#: 221

C 2355 Joel Burnett Vol#: 221

C 2356 Dr Jill Ammon-Wexler Vol#: 221

C 2357 Marian Malik Vol#: 221

C 2358 Carol Leone Vol#: 221

C 2359 Consuela O'Malley Vol#: 221

C 2360 Emerson R Rugh Vol#: 222

C 2361 Grace M Boas Vol#: 222

C 2362 Barbara P Gallagher Vol#: 222

C 2363 Sam Owens Vol#: 222

C 2364 Bettie Furuta Vol#: 222

C 2365 Linda Kadas Vol#: 222

C 2366 Rodney J Graham Vol#: 222

C 2367 Robert & Karen Boone Vol#: 222

C 2368 Laura M DeLanoy Vol#: 222

C 2369 Arlie Matthys Vol#: 222

C 2370 Patriciann C Sutton Vol#: 222

C 2371 Tamara Cronmiller Vol#: 222

C 2372 Ruth S Brennan Vol#: 222

C 2373 Judith Golden Vol#: 222

C 2374 Francine Rathe Vol#: 222

C 2375 Linda Marie Manning Vol#: 222

C 2376 John & Andrea Shaw Vol#: 222

C 2377 Marlyn Merchant Vol#: 222

C 2378 Shelly Avery Vol#: 222

C 2379 Carla Y Rogers Vol#: 222

C 2380 Steve Shapiro & Sharon Fridrick Vol#: 222

C 2381 Dwight W Taylor Vol#: 222

C 2382 Elaine Stout Vol#: 222

C 2383 Cynthia M Wolfe Vol#: 222

C 2384 Anne Alhadef-Caron Vol#: 222

C 2385 John E Nelson Vol#: 222

C 2386 Catherine Ann Foster Vol#: 222

C 2387 Jeanne Marie McCullough Vol#: 222

C 2388 Wayne Disbrow Vol#: 222

C 2389 Doris Wehunt Norris Vol#: 222

C 2390 Daniel E Chisholm Vol#: 222

C 2391 Sandra Hart Vol#: 222

C 2392 Dr Ann Sabin Vol#: 222

C 2393 Eileen M Craffey Vol#: 222

C 2394 Lisa Cummings Vol#: 222

C 2395 Leilani Stewart Vol#: 222

C 2396 Frances M Cooley Vol#: 222

C 2397 Laurie Beth Burg Vol#: 222

C 2398 Fatima M D'Oyen Vol#: 222

C 2399 Dennis L Nebel Vol#: 222

C 2400 Ron & Peg Marson Vol#: 222

C 2401 Douglas & Karen Kirk Vol#: 222

C 2402 Ruth Barker Vol#: 222

C 2403 Larry McKee Vol#: 222

C 2404 Roberta M Palmer Vol#: 222

C 2405 Abe Livchitz Vol#: 222

C 2406 John Maynard Vol#: 222

C 2407 Gael Ward Vol#: 222

C 2408 Susan E Fields Vol#: 222

C 2409 Elizabeth S Zvetina Vol#: 222

C 2410 Donna M Nicholson Vol#: 222

C 2411 Barbara E Fitzpatrick Vol#: 222

C 2412 Margaret L Brewer Vol#: 222

C 2413 Janette Westin Vol#: 222

C 2414 Margaret Mahan Vol#: 222

C 2415 Emily A Carpenter Vol#: 222

C 2416 Cynthia Wood Vol#: 222

C 2417 Lisa Peterson Vol#: 222

C 2418 Ms R Bollmeyer Vol#: 222

C 2419 Jeff Mathias Vol#: 222

C 2420 Nancy M Solyan Vol#: 222

C 2421 Roberta Racaniello Vol#: 222

C 2422 Janet Keethler Vol#: 222

C 2423 Bernice Mertz Vol#: 222

C 2424 Luna Lee Ray Vol#: 222

C 2425 Caralyn M Buehner Vol#: 222

C 2426 Nancy Hartley Vol#: 222

C 2427 Dr Margaret Owen Vol#: 222

C 2428 Lois Ann Grable Vol#: 222

C 2429 Linda L Mcfair Vol#: 222

C 2430 Ray & Dianne Domino Vol#: 222

C 2431 Earl Jensen Vol#: 222

C 2432 Roland & Laurie Heijn Vol#: 222

C 2433 Andrew & Marjorie Masse & Family Vol#: 222

C 2434 Scott Prost Demasky Vol#: 222

C 2435 Harry L Bauman Vol#: 222

C 2436 Louise Trickel Vol#: 222

C 2437 R B Crocker Vol#: 222

C 2438 Douglas Graig Gohr Vol#: 222

C 2439 Jennifer P Willis Vol#: 222

C 2440 M Jean McManus Vol#: 222

C 2441 Donna J & Dan F Barnes Vol#: 222

C 2442 Joanna Mae Kendall Vol#: 222

C 2443 Grace H Morris Vol#: 222

C 2444 Mae Kivkhride Vol#: 222

C 2445 William Lewis Breckner Vol#: 222

C 2446 Mr & Mrs Forest Yarger Vol#: 222

C 2447 Frances M Jones-Little Vol#: 222

C 2448 Joe Ferguson Vol#: 222

C 2449 Mark Allan Van Havcrbeke Vol#: 222

C 2450 Thomas C Ingram Vol#: 222

C 2451 Dora Claybourn Vol#: 222

99N-4329 Filing Objections & Requests for Hearing on Reg or Order

N 2 Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 1017 Mark Schoenfeld Vol#: 12

EMC 1018 Jane Langone Vol#: 12

EMC 1019 Nagi Natarajan Vol#: 12

EMC 1020 Brian Cupp Vol#: 12

EMC 1021 Brian Trautz Vol#: 12

EMC 1022 Art Boucher Vol#: 12

EMC 1023 Michael Busch, M.D., Ph.D. Vol#: 12

EMC 1024 Wisteria Haines Vol#: 12

EMC 1025 Lowell "Aman" Cable Vol#: 12

EMC 1026 Michelle Adams Vol#: 12

EMC 1027 Zuikiss Vol#: 12

EMC 1028 Law firm of Charles E. Bruzga Vol#: 12

EMC 1029 Martin Kandl Vol#: 12

EMC 1030 Morgen Goodroe Vol#: 12

EMC 1031 Jean Bailey Vol#: 12

EMC 1032 Timothy Homer Vol#: 12

EMC 1033 B. J. Pyle Vol#: 12

EMC 1034 Beth Ehrlich Vol#: 12

EMC 1035 Ellie Blake Vol#: 12

EMC 1036 Judy Boullosa Vol#: 12

EMC 1037 Ashley Brady Vol#: 12

EMC 1038 Buerk, Craig, Victor LLC Vol#: 12

EMC 1039 Joel M. Leskowitz Vol#: 12

EMC 1040 Brad Graef Vol#: 12

EMC 1041 Burton F. Goldberg Vol#: 12

EMC 1042 Dr. Steve Briggs Vol#: 12

EMC 1043 B. B. Glen Vol#: 12

EMC 1044 Jane Bialosky Vol#: 12

EMC 1045 Patrick E. D'Alessio Vol#: 12

EMC 1046 Weber's Leather Collection Vol#: 12

EMC 1047 Tallen Vol#: 12

EMC 1048 Deborah Parker Vol#: 12

EMC 1049 Steven F. Meyer Vol#: 12

EMC 1050 Terri & Brian Ellis Vol#: 12

EMC 1051 Wendy Fountain Vol#: 12

EMC 1052 Stephanie Hiller Vol#: 12

EMC 1053 Adam Strachan Vol#: 12

EMC 1054 Melinda Marrical Vol#: 12

EMC 1055 Robin Birdfeather Vol#: 12

EMC 1056 Carol Spooner Vol#: 12

EMC 1057 Martin Kroeze Vol#: 12

00H-0166 Civil Money Penalty;Harold Clabough;dba Clabough's Market

ANS 1 Clabough's Market Vol#: 1

00H-0534 Civil Money Penalty;Graves Oil & Butane Co Inc,dba Graves Oi