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 May 18, 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 ]

 
76N-052N OTC Nasal Decongestants*
81N-0022 OTC Weight Control Drug Products for Human Use *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
93D-0139 Stability Testing of Biotechnological/Biological Products *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98N-0419 Omega-3 Fatty Acids/Risk in Adults Cardiovascular Disease *
98N-1038 Irradiation in the production, processing, &handling of food *
98S-1064 The Implementation (MRA) between the United States & Europea *
99N-4783 Administrative Practices & Procedures;Good Guidance Practice *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-4053 Sympathominetic Amine Phentermine *
99P-5106 Identify Sources of Natural Flavorings *
00D-0087 IND meetings for human drugs/biologics,chemistry,mfging *
00N-0504 Egg Safety Action Plan *
00N-1257 International Drug Scheduling;Convention on Psychotropic *
00N-1262 Improving Premarket Review/Approval of Food/Color Additives *
00P-0219 Verapamil Hydrochloride Extended-Release Tablets *
00P-0596 ANADA consisting of different physical form of drug product *
00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone*
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1297 Permit an OTC drug mfg to include "may contain" in label *
00V-1301 Laser Light Show*
00V-1302 *
76N-052N OTC Nasal Decongestants

C 230 Yale University School of Medical Vol#: 73

81N-0022 OTC Weight Control Drug Products for Human Use

RPT 14 Yale University School of Med Vol#: 93

81N-0106 OTC Digestive Aid Drug Products for Human Use

WDL 1 Blistex, Inc Vol#: 26

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

THE LINKED COMMENTS BELOW DUPLICATE THOSE FOR 92N-0297, ALSO BELOW

C 73 Bell Medical Services, Inc Vol#: 2

C 74 Park Surgical Co., Inc Vol#: 2

C 75 Mohawk Medical Vol#: 2

C 76 UltraCare Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 60 Bell Medical Services, Inc Vol#: 3

C 61 Park Surgical Co., Inc. Vol#: 3

C 62 Mohawk Medical Vol#: 3

C 63 Ultra Care Vol#: 3

92P-0408 Safety & Efficacy of Lactase Enzyme/Fungal Sources

WDL 1 Blistex Inc Vol#: 1

93D-0139 Stability Testing of Biotechnological/Biological Products

C 48 Alcon Research, Ltd. Vol#: 2

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 3 Amy F. Olive Vol#: 4

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 225 Martha Chambers Vol#: 6

C 226 Melissa Iacino Vol#: 6

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

C 13 Sondra and Alex Rosiewicz Vol#: 1

C 14 Jeffrey Friedman Vol#: 1

C 15 Dennis Sichner Vol#: 1

C 16 Jami Tolpin Vol#: 1

C 17 Joyce Bloom Vol#: 1

C 18 Stephanie Gipson Vol#: 1

C 19 Michael Showliakowsky Vol#: 1

C 20 J.A. Hyra Vol#: 1

C 21 Diedre Peterson Vol#: 1

C 22 Bernard Cooley Vol#: 1

C 23 Donald Trump Vol#: 1

C 24 Kerry Holliday Vol#: 1

C 25 Ralph Regalado Vol#: 1

C 26 Robert Sanoff Vol#: 1

C 27 Frank Evans Vol#: 1

C 28 Dorothy Finger Vol#: 1

C 29 Elizabeth Pallesen Vol#: 1

C 30 No signature Vol#: 1

C 31 Darilyn Aranero Vol#: 1

C 32 No signature Vol#: 1

C 33 L. Johnsen Vol#: 1

C 34 Dennis Taylor Vol#: 1

C 35 Jan Kemmers Vol#: 1

C 36 Pat Curnow Vol#: 1

C 37 Judy Calandra Vol#: 1

C 38 Deborah Skillsky Vol#: 1

C 39 Lori Dority Vol#: 1

C 40 Betsy Welch Vol#: 1

C 41 Paul Nahay Vol#: 1

C 42 Robert Buczek Vol#: 1

C 43 David Frisk Vol#: 1

C 44 Sally Klinke Vol#: 1

C 45 Judy Jones Vol#: 1

C 46 Virginia Langston Vol#: 1

C 47 Kip Bellairs Vol#: 1

C 48 Jenny Collins Vol#: 1

C 49 Christina Weaver Vol#: 1

C 50 Gina Shatas Vol#: 1

C 51 Marjorie Hass Vol#: 1

C 52 Cathy Zimmerman Vol#: 1

C 53 Michelle Lukasiewicz Vol#: 1

C 54 Mary Peterson Vol#: 1

C 55 AnnMarie Miller Vol#: 1

C 56 Marc Hoffman Vol#: 1

C 57 Jessica Rogers Vol#: 1

C 58 Hettie Whatley Vol#: 1

C 59 Thomas Curry Vol#: 1

C 60 Patricia Sterner Vol#: 1

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 21 American Health Institute Vol#: 4

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

ACK 8 HFA-305 Vol#: 882

CP 2 Consumer Healthcare Products Assn Vol#: 882

98N-0419 Omega-3 Fatty Acids/Risk in Adults Cardiovascular Disease

C 12 Cochrane Heart Group Vol#: 1

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

EMC 105 Kfernholz Vol#: 149

EMC 106 Steve Guerreri Vol#: 149

EMC 107 Tygett Vol#: 149

EMC 108 Mitake Oyasin & Pejuta Kehuku Winyan Vol#: 149

EMC 109 Jones Vol#: 149

EMC 110 K. Brown Vol#: 149

EMC 111 Katharine Dalton Vol#: 149

EMC 112 J F R Nandz Vol#: 149

EMC 113 Patrick F. Vol#: 149

EMC 114 G. Wreum Vol#: 149

EMC 115 Charlene & Glen Vol#: 149

EMC 116 Aurora Borealis Vol#: 149

EMC 117 no signature Vol#: 149

EMC 118 Gloria Nelson Vol#: 149

EMC 119 Rebecca Gem Vol#: 149

EMC 120 V. Campbell Vol#: 149

EMC 121 Xenocide Vol#: 149

EMC 122 Eserval Vol#: 149

EMC 123 J. Jones Vol#: 149

EMC 124 Dave Fitz Vol#: 149

EMC 125 swnic Vol#: 149

EMC 126 stephmc Vol#: 149

EMC 127 Aggie Vol#: 149

EMC 128 Karen Colterman Vol#: 149

EMC 129 Delano Vol#: 149

EMC 130 Judy Lamar Vol#: 149

EMC 131 Renninger Vol#: 149

EMC 132 Ksanfrod Vol#: 149

EMC 133 Desiree Vol#: 149

98S-1064 The Implementation (MRA) between the United States & Europea

C 3 Public Citizen Vol#: 2

99H-2519 Civil Money Penalty;Pacific Sun Corp,dba Pacific Super Marke

LET 2 Office of Tobacco Programs Vol#: 1

M 1 GCF-1 Vol#: 1

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

C 12357 Teresa Judy Vol#: 381

C 12358 Mary Allison Vol#: 381

C 12359 Lois Richter Vol#: 381

C 12360 Carbone Vol#: 381

C 12361 Martha Baird Vol#: 381

C 12362 Joseph L. McGrave Vol#: 381

C 12363 Bertha C. Fulks Vol#: 381

C 12364 Therse Holderbaum Vol#: 381

C 12365 Ryta Pond Vol#: 381

C 12366 Gary Jones Vol#: 381

C 12367 Marcia Logwood Vol#: 381

C 12368 Jayne Miller Vol#: 381

C 12369 Laurel Yvonne Charette Vol#: 381

C 12370 Nancy V. Knight Vol#: 381

C 12371 Christine Martin Vol#: 381

C 12372 Donna Lewis Vol#: 381

C 12373 William T & R. Josephine Jordan Vol#: 381

C 12374 Eugene A. Malberg Vol#: 381

C 12375 J. H. Jackson Vol#: 381

C 12376 Julia Smith Vol#: 381

C 12377 Maureen Hooper Vol#: 381

C 12378 Liz Hart Vol#: 381

C 12379 Marianne Brettell Vol#: 381

C 12380 Mary Lou Long Vol#: 381

C 12381 Stuart James Butcher Vol#: 382

C 12382 Ajowa Nzinga Ifateyo Vol#: 382

C 12383 Marie B. Antonelli Vol#: 382

C 12384 Charles Wilson Vol#: 382

C 12385 Mona G. Morrison Vol#: 382

C 12386 Kathleen Schulik Vol#: 382

C 12387 Don B. Fanning Vol#: 382

C 12388 Monica Thompson Vol#: 382

C 12389 Joshua Goldman Vol#: 382

C 12390 Sharon R. DeLiso Vol#: 382

C 12391 Clay & Julie Otton Vol#: 382

C 12392 Christine Foster Vol#: 382

C 12393 Ralph Estevez Vol#: 382

C 12394 Sandra Benamassh Vol#: 382

C 12395 Kevin Stewart McKenzie Vol#: 382

C 12396 Nell S. G. Franklin Vol#: 382

C 12397 Violet Walker Vol#: 382

C 12398 James & Janet Getz Vol#: 382

C 12399 Nancy C. Pasquerilla Vol#: 382

C 12400 Trudy Biolic Vol#: 382

C 12401 Nancy L. Dallison Vol#: 382

C 12402 Jana Babcock Vol#: 382

C 12403 Catherine Roth Vol#: 382

C 12404 Barbara Love Vol#: 382

C 12405 Jennifer Benacci Vol#: 382

C 12406 Ismet Isman Vol#: 382

C 12407 Margaret T. Wieland Vol#: 382

C 12408 Joyce W. Sackett Vol#: 382

C 12409 Hannelore A. Bloom Vol#: 382

C 12410 Fred Chaloux Vol#: 382

C 12411 Mrs. Claire Wright Vol#: 382

C 12412 Heather S. Murphy Vol#: 382

C 12413 Sandra S. Munson Vol#: 382

C 12414 Mr & Mrs Raymond Clark Vol#: 382

C 12415 David B. Martin Vol#: 382

C 12416 Sheryl O'Crotter Vol#: 382

C 12417 Shirley M. Loomis Vol#: 382

C 12418 Jennifer Zur Vol#: 382

C 12419 Colette Fournier Vol#: 382

C 12420 Katherine A. Travis Vol#: 382

C 12421 Lawrence W. Riddle Vol#: 382

C 12422 Frances A. Bubolz Vol#: 382

C 12423 Nancy L. Spinella Vol#: 382

C 12424 Virginia McCelland Vol#: 382

C 12425 Mary K. Orlando Vol#: 382

C 12426 Travis Forte Vol#: 382

C 12427 Michelle D. Riggs Vol#: 382

C 12428 Teresa Davis Vol#: 382

C 12429 Elena P. Molina Vol#: 382

C 12430 Carolyn P. Schaper Vol#: 382

C 12431 Don & Judy Nelson Vol#: 382

C 12432 Barbara Ruf Vol#: 382

C 12433 Charles E. Karl Fisher Vol#: 382

C 12434 Fred & Karen Valentine Vol#: 382

C 12435 Frances M. McArdle Vol#: 382

C 12436 Sandra Tozier Vol#: 382

C 12437 V. Perschall Vol#: 382

C 12438 Maria Wikfors & Family Vol#: 382

C 12439 D. Scott Jensen Vol#: 382

C 12440 Miriam Boerm Vol#: 382

C 12441 Laura Carley Vol#: 382

C 12442 Victoria Crowe Vol#: 382

C 12443 Leslee Spencer Vol#: 382

C 12444 Melizan De E. Kunaus Vol#: 382

C 12445 Beth Salerno Vol#: 382

C 12446 Lester H. Vollmer Vol#: 382

C 12447 Robert Ratliff Vol#: 382

C 12448 Debra Lloyd Vol#: 382

C 12449 Vaughn, Roger & Julie Becker Vol#: 382

C 12450 Rose, Mike & Johanna Droubay Vol#: 382

C 12451 Michael Morrione Vol#: 382

C 12452 Michele Kierce Vol#: 382

C 12453 Sara Siebelski Vol#: 382

C 12454 Edith D. Verna Vol#: 382

C 12455 M. Leah Eshen Vol#: 382

C 12456 Elizabeth Jacobs Vol#: 382

C 12457 Brent Olson Vol#: 382

C 12458 Illegible Vol#: 382

C 12459 Dale M. Pederson Vol#: 382

C 12460 Tori Karpenko Vol#: 382

C 12461 no signature Vol#: 382

C 12462 Ben McDonald Coltvet Vol#: 382

C 12463 Rosaleen Dickinson Vol#: 382

C 12464 Richard Dickinson Vol#: 382

C 12465 Scott B. Olson Vol#: 382

C 12466 Bruce J. Moody Vol#: 382

C 12467 June Prange Vol#: 382

C 12468 Gerald Blecker Vol#: 382

C 12469 Matthew Armbrust Vol#: 382

C 12470 George L. Rogers Vol#: 382

C 12471 Ann Tolley Vol#: 382

C 12472 Peter Tolk Vol#: 382

C 12473 Marina Sobolensky Vol#: 382

C 12474 Catherine S. Jordan Vol#: 382

C 12475 Mike & Cheryl Kierce Vol#: 382

C 12476 J. Henson Vol#: 382

C 12477 Patricia R. Iafrate Vol#: 383

C 12478 R. Giddings Vol#: 383

C 12479 R. Giddings Vol#: 383

C 12480 Vivian Reidel Vol#: 383

C 12481 William J. Cook, Jr. Vol#: 383

C 12482 Rosamund Evans Vol#: 383

C 12483 Donald L. Hess Vol#: 383

C 12484 Sally Klinger Vol#: 383

C 12485 Lorittermann Vol#: 383

C 12486 Joseph & Susan Joshua Vol#: 383

C 12487 William G. Pickrel Vol#: 383

C 12488 Andrea Bertelli Vol#: 383

C 12489 Mrs. Robert J. Spence Vol#: 383

C 12490 Sharon J. Hicks Vol#: 383

C 12491 D. R. Flynn Vol#: 383

C 12492 Tony McFadden Vol#: 383

C 12493 Donna L. Johns Vol#: 383

C 12494 May D. Beard Vol#: 383

C 12495 David A. & Susan K. Buob Vol#: 383

C 12496 Prudence B. Barry Vol#: 383

C 12497 Marcey Rudolph Vol#: 383

C 12498 no signature Vol#: 383

C 12499 Dan M. Daly Vol#: 383

C 12500 Stephanie Stephens Vol#: 383

C 12501 Frances M. Reed Vol#: 383

C 12502 Mary M. McLellan Vol#: 383

C 12503 Eleanor Johnson Vol#: 383

C 12504 Christine K. Orcutt Vol#: 383

C 12505 Meg Sandell Vol#: 383

C 12506 Margaret B. Gose Vol#: 383

C 12507 Cheryl Berk Vol#: 383

C 12508 Josh James Vol#: 383

C 12509 Tara Greenwood Vol#: 383

C 12510 Shauna Clark Vol#: 383

C 12511 B. J. Amen Vol#: 383

C 12512 Jennifer Allbritton Vol#: 383

C 12513 Belinda Seville Vol#: 383

C 12514 Michael Meons Vol#: 383

C 12515 Kori White Vol#: 383

C 12516 Walter Zadam Vol#: 383

C 12517 Michael Prinz Vol#: 383

C 12518 Patricia Ann Brown Vol#: 383

C 12519 Jacqueline R. Smetak Vol#: 383

C 12520 Selma Goldberg Vol#: 383

EMC 2517 Brice Hereford Vol#: 383

EMC 2518 Pam Osborn Vol#: 383

EMC 2519 Kaybar Vol#: 383

EMC 2520 Vlietland Vol#: 383

EMC 2521 Maureen Hovermale Vol#: 383

EMC 2522 Melissa Faulconer Vol#: 383

EMC 2523 Jacqueline Duffy-Saenz Vol#: 383

EMC 2524 J. Carroll Vol#: 383

EMC 2525 Constance Pandelaras Vol#: 383

EMC 2526 no signature Vol#: 383

EMC 2527 Tamas Frajka Vol#: 383

EMC 2528 Kathy Spicer Vol#: 383

EMC 2529 Ben Parker Vol#: 383

EMC 2530 Brian Cieslar Vol#: 383

EMC 2531 no signature Vol#: 383

EMC 2532 W. Mosher Vol#: 383

EMC 2533 no signature Vol#: 383

EMC 2534 Dark Wolf Vol#: 383

EMC 2535 Lori Edwards Vol#: 383

EMC 2536 R. Thurston Vol#: 383

EMC 2537 Timothy Freundlich Vol#: 383

EMC 2538 Individual Consumer Vol#: 383

EMC 2539 Lisa Rogers Vol#: 383

EMC 2540 Jade Star Vol#: 383

EMC 2541 Frank Vol#: 383

EMC 2542 Ramlimo Vol#: 383

EMC 2543 Torrey Vol#: 383

EMC 2544 Orion 3322 Vol#: 383

EMC 2545 Marilu Vol#: 383

EMC 2546 no signature Vol#: 383

EMC 2547 Jgoorjian Vol#: 383

EMC 2548 Kris Webb Vol#: 383

EMC 2549 Mark Kraemer Vol#: 383

EMC 2550 Alice Armen Vol#: 383

EMC 2551 Alexis Corbin Vol#: 383

EMC 2552 Tim Zazanis Vol#: 383

EMC 2553 Enigma Vol#: 383

EMC 2554 Andrew Thomson Vol#: 383

EMC 2555 no signature Vol#: 383

EMC 2556 Nathaniel Parsons Vol#: 383

EMC 2557 Seacmpr Vol#: 383

EMC 2558 Cgirlasky Vol#: 383

EMC 2559 Cgirlasky Vol#: 383

EMC 2560 no signature Vol#: 383

EMC 2561 Barbara Henderson Vol#: 383

EMC 2562 James F. Lombardo Vol#: 383

EMC 2563 Jeffery Smith Vol#: 383

EMC 2564 Parker Johnson Vol#: 383

EMC 2565 Jennifer Dow Vol#: 383

EMC 2566 Gina Goren Vol#: 383

EMC 2567 Nadigor Vol#: 383

EMC 2568 rlamartinabros Vol#: 383

EMC 2569 Tracey Hayes Vol#: 383

EMC 2570 Mike Vol#: 383

EMC 2571 E. Shore Vol#: 383

EMC 2572 Stewart Combs Vol#: 383

99N-4783 Administrative Practices & Procedures;Good Guidance Practice

C 16 Kraft Foods Vol#: 1

C 17 Indiana Med Device Mfg Council & Assn Vol#: 1

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 361 The Center for Food Safety Vol#: 9

99P-4053 Sympathominetic Amine Phentermine

C 3 Medeva Pharm, Inc & Medeva Pharm Manuf Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

C 4 Rose Deurloo Vol#: 1

00D-0087 IND meetings for human drugs/biologics,chemistry,mfging

C 9 Novartis Pharmaceuticals Corporation Vol#: 1

00H-0748 Civil Money Penalty;James B Lang,dba Crossroads Convenience

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00N-0504 Egg Safety Action Plan

C 22 The Honorable Mark E. Souder Vol#: 2

00N-1198 Proposal to withdraw approval of 158 (ANDA)

WDL 1 Zenith Goldline Pharmaceuticals Vol#: 1

00N-1257 International Drug Scheduling;Convention on Psychotropic

C 1 Hoffmann-La Roche Inc Vol#: 1

C 2 Pharmacetical Research & Manuf of Americ Vol#: 1

00N-1262 Improving Premarket Review/Approval of Food/Color Additives

C 1 Donna Gill Vol#: 1

00P-0219 Verapamil Hydrochloride Extended-Release Tablets

PAV 1 HFD-1 to Andrx Pharmaceuticals Inc. Vol#: 1

00P-0596 ANADA consisting of different physical form of drug product

ANS 1 HFV-100 to Phoenix Scientific, Inc, Vol#: 1

00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone

C 2 Sidney M. Wolfe Vol#: 1

00P-1243 ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen

WDL 1 Pharmaceutical Associates Inc. Vol#: 1

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

LET 1 Lipton Vol#: 4

LET 2 Lipton Vol#: 4

MM 1 HFS-832 & Thomas J. Lipton Company Vol#: 4

MT 1 HFS-832 & Nancy Schnell (Lipton) Vol#: 4

MT 2 HFS-832 & Dan Dwyer for Lipton Vol#: 4

00P-1297 Permit an OTC drug mfg to include "may contain" in label

ACK 1 HFA-305 Vol#: 1

CP 1 Arnall Golden & Gregory, LLP Vol#: 1

00V-1301 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 G World Productions Vol#: 1

00V-1302

ACK 1 HFA-305 Vol#: 1

VAR 1 Carnegis Science Center Vol#: 1