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 16, 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 *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99N-0391 International Guidelines on Vitamin and Mineral supplements *
99N-1852 Status reports/postmarketing studies-human drugs&biological *
00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso *
00V-0654 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5 *

92F-0443 Dow Corning Corp.; Filing of Food Additive Petition

BKG 1 Vol#: 1

NFR 2 Vol#: 1

93P-0277 Reclassify Nd:YAG Laser Peripheral Iridotomy

NFR 1 Vol#: 3

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

NEC 1 Vol#: 40

97N-0074 President's National Food Safety Initiative

C 231 American Dietetic Association Vol#: 20

C 232 CSPI Vol#: 20

C 233 American College of Preventie Medicine Vol#: 20

97N-0511 Procedures the safe and sanitary processing/importing juice

C 512 Vicky Johnson Vol#: 25

C 513 Bonnie Platt Vol#: 25

C 514 Kathleen Ross Vol#: 25

C 515 R. P. Barley Vol#: 25

C 516 Heidi Ware Vol#: 25

C 517 Irene Cooper Vol#: 25

C 518 Marin Buelling Vol#: 25

C 519 J. Hall Vol#: 25

C 520 illegible Vol#: 25

C 521 Lainu Castette Vol#: 25

C 522 L. Dut Vol#: 25

C 523 Allan Henwood Vol#: 25

C 524 illegible Vol#: 25

C 525 Shammon Sherman Vol#: 25

C 526 Emma Stevens Vol#: 25

C 527 Shaun B. Tister Vol#: 25

C 528 S. H. Vol#: 25

C 529 Marcia D. Hardy Vol#: 25

C 530 Joy Doverspike Vol#: 25

C 531 Sonia Ann Murphy Vol#: 25

C 532 Nancy Pfoff Vol#: 25

C 533 Edgar N. Vol#: 25

C 534 Kathy Lancaster Vol#: 25

C 535 R. L. D. Vol#: 25

C 536 Jo Ann Cox Vol#: 25

C 537 Allene Moorehead Vol#: 25

C 538 Sis Liverance Vol#: 25

C 539 Joan Blomberg Vol#: 25

C 540 Lindall Jones Vol#: 25

C 541 Laurie Campbell Vol#: 25

C 542 Lindsay B. Vol#: 25

C 543 M. C. Vol#: 25

C 544 David Cassidy Vol#: 25

C 545 W. Vol#: 25

C 546 Tianna de la Cruz Vol#: 25

C 547 Gregory L. Martin Vol#: 25

C 548 Edward Vol#: 25

C 549 Jason S. Vol#: 25

C 550 Solomac R. Harris, Jr. Vol#: 25

C 551 Colleen K. Mills Vol#: 25

C 552 S. Gigil Vol#: 25

C 553 T. K. Vol#: 25

C 554 R. B. Vol#: 25

C 555 John D. Fuz, Jr. Vol#: 25

C 556 Dr. Don Wilkins Vol#: 25

C 557 illegible Vol#: 25

C 558 Gail Keefer Vol#: 25

C 559 Anthony P. Keefer Vol#: 25

C 560 Robin Tiddy Vol#: 25

C 561 illegible Vol#: 25

C 562 illegible Vol#: 25

C 563 illegible Vol#: 25

C 564 Ellen P. Geyde Vol#: 25

C 565 illegible Vol#: 25

C 566 Lamont Parkinson Vol#: 25

C 567 John Vol#: 25

C 568 illegible Vol#: 25

C 569 Genia Bradwell Vol#: 25

C 570 Clara Bradwell Vol#: 25

C 571 Glenn F. Bradwell Vol#: 25

C 572 Frank Hahn Vol#: 25

C 573 Lisa Hahn Vol#: 25

C 574 illegible Vol#: 25

C 575 Julie R. McLeod Vol#: 25

C 576 Ann M. Watkins Vol#: 25

C 577 illegible Vol#: 25

C 578 R. Vol#: 25

C 579 Form letters count 14 Vol#: 26

C 580 Robert Vol#: 27

C 581 illegible Vol#: 27

C 582 Laura Cassidy Vol#: 27

C 583 T. Pastor Vol#: 27

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

C 451 Boston Spine Group Vol#: 24

C 452 Mid-America Transplant Services (MTS) Vol#: 24

C 453 Neurosurgeons LTD Vol#: 24

C 454 Eye Bank Association of America Vol#: 24

C 455 California Cryobank Vol#: 24

C 456 Byron J Russell Vol#: 24

C 457 Form letter count 9 Vol#: 25

LET 2 HFM-305 to University of Texas Vol#: 24

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

C 15 Conti Group Companies Inc Vol#: 4

C 16 American Association of Bovine Practitio Vol#: 4

C 17 Allen's Hatchery Inc Vol#: 4

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

ANS 2 HFV-12 to Ron Mann Vol#: 24

C 757 Ron Mann Vol#: 24

C 758 Mr Harold Altman Vol#: 24

EMC 4 Form letter count 21 Vol#: 25

99E-0241 Wallenstent Coronary Endoprosthesis, Pat. No. 4,954,126

N 1 Vol#: 1

99H-1352 Civil Money Penalty; Patrick L Malone d/b/a 7-Eleven #29627

CS 2 HFA-305 Vol#: 1

99H-1397 Civil Money Penalty; Emad Hussain d/b/a Mark Store

CS 2 HFA-305 Vol#: 1

99N-0391 International Guidelines on Vitamin and Mineral supplements

C 52 John L. Bolt Vol#: 1

C 53 Lyman Lampher Vol#: 1

C 54 Ralph M. Eisenmann Vol#: 1

C 55 Iva N. Pardo Vol#: 1

C 56 Donald Dyall Vol#: 1

C 57 Mark Putnam Vol#: 1

99N-1852 Status reports/postmarketing studies-human drugs&biological

C 1 Genzyme General Vol#: 1

C 2 Amgen Inc Vol#: 1

C 3 Eli Lilly and Company Vol#: 1

C 4 Merck & Co Inc Vol#: 1

C 5 PhRMA Vol#: 1

C 6 Baxter Healthcare Corporation Vol#: 1

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

C 1472 Stephanie Gooch Vol#: 197

C 1473 Ralph L Wilkinson Vol#: 197

C 1474 DNA Plant Technology Corporation Vol#: 197

C 1475 American Bakers Association Vol#: 197

C 1476 Grain Processing Corporation Vol#: 197

C 1477 US Chamber of Commerce Vol#: 197

C 1478 Donna Cunningham Vol#: 197

C 1479 Malcolm Fishman Vol#: 197

C 1480 International Dairy Foods Assoc Vol#: 197

C 1481 Virginia G Tibbetts Vol#: 197

C 1482 Amy Adamczak Vol#: 197

C 1483 Marvin E Baker Vol#: 197

C 1484 American Frozen Food Institute Vol#: 197

C 1485 CAST Vol#: 197

C 1486 National Restaurant Assoc Vol#: 197

C 1487 Edward J Bialozewski Vol#: 197

C 1488 Kathleen A Geary Vol#: 197

C 1489 Catherine R Geary Vol#: 197

C 1490 Elizabeth Tibbetts Vol#: 197

C 1491 Pat Scardina Vol#: 197

C 1492 John McMahon PhD & Felicia R McMahon PhD Vol#: 197

EMC 1412 Julie C Meadows Vol#: 197

EMC 1413 Patrik Rousselot Vol#: 197

EMC 1414 Charles L Tazzia Vol#: 197

EMC 1415 William L Nutter Vol#: 197

EMC 1416 Rebecca C Retzlaff Vol#: 197

EMC 1417 Bruce H Sielaff PhD Vol#: 197

EMC 1418 Cheryl Kojina Vol#: 197

EMC 1419 Travis B Keenan Vol#: 197

EMC 1420 Sharone M Farrar Vol#: 197

EMC 1421 Kristy Belton Vol#: 197

EMC 1422 Jonathan R Burk Vol#: 197

EMC 1423 Jamie L Scott Vol#: 197

EMC 1424 Nicole Vanoni Vol#: 197

EMC 1425 Mark A Kastel Vol#: 197

EMC 1426 Jessica L Parsley Vol#: 197

EMC 1427 Paula Meier Vol#: 197

EMC 1428 Katie M Earle Vol#: 197

EMC 1429 Lisa M Flick Vol#: 197

EMC 1430 Lowell J Zelinski PhD Vol#: 197

EMC 1431 Clay L Noe Vol#: 197

EMC 1432 Gerry Milliken Vol#: 197

EMC 1433 Barry B Bean Vol#: 197

EMC 1434 Steve McClure Vol#: 197

EMC 1435 Meghann Dallin Vol#: 197

EMC 1436 Jayne DeSesa Vol#: 197

EMC 1437 Odette H Lind Vol#: 197

EMC 1438 Angelo R Vol#: 197

EMC 1439 Jim Winter Vol#: 197

EMC 1440 Neil Mazman Vol#: 197

EMC 1441 Mike Green Vol#: 197

EMC 1442 Barry B Bean Vol#: 197

EMC 1443 Theresa A Bill Vol#: 197

EMC 1444 Aaron X Jette Vol#: 197

EMC 1445 Erik Lazdins Vol#: 197

EMC 1446 Annie Hoy Vol#: 197

EMC 1447 Debbie Kemp Vol#: 197

EMC 1448 Gail Closser Vol#: 197

EMC 1449 Leslie Patterson Vol#: 197

EMC 1450 Moreah Vestan Vol#: 197

EMC 1451 David Robinson Vol#: 197

EMC 1452 Deborah Grahame Vol#: 197

EMC 1453 Lucy Brukley Vol#: 197

EMC 1454 David J Bernstein Vol#: 197

EMC 1455 Adams Kirkpatrick Vol#: 197

EMC 1456 Mary Lyn Stoll Vol#: 197

EMC 1457 Pat Hawk Vol#: 197

EMC 1458 Joseph L Murray III Vol#: 197

EMC 1459 Anonymous Vol#: 197

EMC 1460 Phil G Schlotfeldt Vol#: 197

EMC 1461 Candy Marianos Vol#: 197

EMC 1462 Matthew M Keeler Vol#: 197

EMC 1463 Alfred S Fuller Vol#: 197

EMC 1464 Cynthia Paris Vol#: 197

EMC 1465 Pamela N B Gaines Vol#: 197

EMC 1466 Marian Jane Porter Vol#: 197

EMC 1467 Karilyn Beard Vol#: 197

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

GDL 2 GUIDANCE Vol#: 1

GDL 3 GUIDANCE Vol#: 1

NAL 1 Vol#: 1

00D-0186 M4 Common Technical Document

GDL 1 GUIDANCE Vol#: 1

NAL 1 Vol#: 1

00D-0218 Potency Limits for Standardized Dust Mite and Grass

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00H-0507 Civil Money Penalty;Milton Hoover,dba Hoover's Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0508 Civil Money Penalty;Willard Tillman and Edith Tillman,dba Pi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0509 Civil Money Penalty;Tomsec, Inc,dba DB Searle's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0510 Civil Money Penalty;The Old Cider Mill Wine & Spirits Inc,db

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0511 Civil Money Penalty;Kim Chhay & Seang Chhay,dba 7-Eleven Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0512 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store #10

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0513 Civil Money Penalty;Soon J Lee and Eun J Lee,dba Lee Food Ma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0514 Civil Money Penalty;Bob Oliver and Virginia Oliver,dba Cinci

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0515 Civil Money Penalty;Jimmy R Hales,dba Camden Supermarket

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0516 Civil Money Penalty;Jose M. Herrera,dba Jalisco Mexican Prod

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0517 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drugs #072

LET 1 Office of Tobacco Programs Vol#: 1

00H-0518 Civil Money Penalty;Emad Abdullah,dba Paradise Valley Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0519 Civil Money Penalty;Charles Mason,dba Raymond Como Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0520 Civil Money Penalty;Highway Service Ventures Inc,dba Petro S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0521 Civil Money Penalty;Vanis P Waugh and Pat Waugh,dba Circlev

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0522 Civil Money Penalty;Howe Enterprises Inc,dba Howe's Food Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 Office of Tobacco Programs Vol#: 1

00H-0554 Civil Money Penalty;Hammer - Williams Company,dba Jiffy Trip

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0555 Civil Money Penalty;W&W Foods Inc,dba Karl's Apple Market #4

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0556 Civil Money Penalty;Crowell's Village Store Inc,dba Crowell'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0557 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #534

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0558 Civil Money Penalty;Park Avenue Pharmacy Incorporated,dba P

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0559 Civil Money Penalty;Cleta Hulsey,dba Pond Creek Food Land

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00N-0352 Status of Useful written prescription drug info for Patients

NM 1 Vol#: 1

00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso

ACK 1 HFA-305 Vol#: 1

CP 1 The James Madison Project Vol#: 1

00V-0654 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5

ACK 1 HFA-305 Vol#: 1

VAR 1 Daddy Rocks, Inc Vol#: 1