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 18, 2000

DOCKETS ENTERED on February 19, 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 ]

 
78N-0038 Sunscreen Drug Products*
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97N-0068 Regulation of Cellular & Tissue-Based Products Data *
97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood *
97P-0350 Reclassify Home Uterine Activity Monitors from III to II *
98D-0388 Dermatological Drug Product NDA's and ANDA's *
98P-0683 Soy Protein Containing Products*
98P-1075 Ticlopidine Hydrochloride Tablets (250 mg) *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-4487 Conducting Stability Testing to Support an Expiration Date *
99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma *
99N-1852 Status reports/postmarketing studies-human drugs&biological *
99N-4491 Reuse of Single Use Devices proposal*
99P-2148 Label or Labeling of food ingredients and regulation *
00P-0685 Revocation of Yogurt Standards*
99D-5347 Transmission of Zoonoses By Blood and Blood Products *

78N-0038 Sunscreen Drug Products

C 557 CTFA Vol#: 131

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 59 PharmaSe Inc Vol#: 37

RPT 60 Lucas Meyer Inc Vol#: 39

SUP 6 PharmaSe Inc Vol#: 39

97N-0068 Regulation of Cellular & Tissue-Based Products Data

C 42 ThermoGenesis Corp. Vol#: 4

97N-0074 President's National Food Safety Initiative

C 234 Kraft Foods Vol#: 20

C 235 Am College of Obstetricians & Gynecologi Vol#: 20

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

C 2 American Association of Blood Banks Vol#: 1

C 3 Viacord Inc Vol#: 1

C 4 T Breeders Inc Vol#: 1

C 5 National Marrow Donor Program Vol#: 1

EXT 1 Foundation for the Accreditation of Hema Vol#: 1

97P-0350 Reclassify Home Uterine Activity Monitors from III to II

C 5 Am College of Obstetricians & Gynecologi Vol#: 5

C 6 Am College of Obstetricians & Gynecologi Vol#: 5

C 7 Am College of Obstetricians & Gynecologi Vol#: 5

C 8 Univesity of Texas, Houston Vol#: 5

98D-0388 Dermatological Drug Product NDA's and ANDA's

ANS 1 HFD-6 to Dermik Laboratories Inc Vol#: 1

ANS 2 HFD-6 to Connectics Corporation Vol#: 1

C 17 Connectics Corporation Vol#: 1

98P-0683 Soy Protein Containing Products

EMC 1 Joyce E Joyce Vol#: 25

98P-1075 Ticlopidine Hydrochloride Tablets (250 mg)

LET 4 Hoffmann-LaRoche Inc. Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

ANS 3 HFV-12 to Heather Johnston Vol#: 24

C 759 Heather Johnston Vol#: 24

99D-4487 Conducting Stability Testing to Support an Expiration Date

C 1 Tillotson Healthcare Corporation Vol#: 1

99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma

C 1 Bayer Pharmaceutical Division Vol#: 1

C 2 ZLB Central Laboratory Vol#: 1

C 3 National Hemophilia Foundation Vol#: 1

EXT 1 Aventis Behring LLC Vol#: 1

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

C 7 GlaxoWellcome Research & Development Vol#: 1

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

C 1570 Joanne Morgan Vol#: 199

C 1571 Constance M DeMarse Vol#: 199

C 1572 Cheryl Michel Vol#: 199

C 1573 Leo Duroche Vol#: 199

C 1574 D James Vol#: 199

C 1575 Suzanne J Real Vol#: 199

C 1576 Mary Jane Heinricks Vol#: 199

C 1577 K Lynn Geosits Vol#: 199

C 1578 Barbara Gehring Vol#: 199

C 1579 Betty M John Vol#: 199

C 1580 Christopher S Shiner Vol#: 199

C 1581 Eileen Lavery Vol#: 199

C 1582 Brian Altman Vol#: 199

C 1583 Suzie Null Vol#: 199

C 1584 Turaj Zaimi Vol#: 199

C 1585 Amitteinrich Vol#: 199

C 1586 J Curein Vol#: 199

C 1587 Michael L Rogers Vol#: 199

C 1588 J Garcia Vol#: 199

C 1589 Faith H Gowan Vol#: 199

C 1590 Shawn F Ackerman Vol#: 199

C 1591 Rebecca Dickson Vol#: 199

C 1592 Jane Isbistes Vol#: 199

C 1593 Mariah Simonton Vol#: 199

C 1594 Christie Baryames Vol#: 199

C 1595 Amie Fries Vol#: 199

C 1596 Joan Bodewes Vol#: 199

C 1597 Clare Schoolmaster Vol#: 199

C 1598 Marlys Cave Vol#: 199

C 1599 Sally Nurney Vol#: 199

C 1600 Delano R Freeberg Vol#: 199

C 1601 Rebekah Dak Vol#: 199

C 1602 You Vol#: 199

C 1603 Ruth Blackmore Vol#: 199

C 1604 Herberto Pugh Vol#: 199

C 1605 Don Barshay Vol#: 199

C 1606 Jeanna Dolegal Vol#: 199

C 1607 Jon High Vol#: 199

C 1608 Jacey Tramutt Vol#: 199

C 1609 Francesca Woollser Vol#: 199

C 1610 Jeff Jayne-Anteau Vol#: 199

C 1611 D C Vol#: 199

C 1612 Lisa Dowers Vol#: 199

C 1613 Brett A Graf Vol#: 199

C 1614 Charles Welles Vol#: 199

C 1615 Richard Bevan Vol#: 199

C 1616 Kreg Viesselman Vol#: 199

C 1617 Amy Dustin Vol#: 199

C 1618 Mary Burns Vol#: 199

C 1619 Trish Flanders Vol#: 199

C 1620 Marolyn Masterson Vol#: 199

C 1621 Bertina Houghland Vol#: 199

C 1622 Soren McCarty Vol#: 199

C 1623 Darius Victor Vol#: 199

C 1624 Tom Lagos Vol#: 199

C 1625 John Daigle Vol#: 199

C 1626 L Burie Vol#: 199

C 1627 Kim Guerriero Vol#: 199

C 1628 Michael McGory Vol#: 199

C 1629 Curtine Metcalf Vol#: 199

EMC 1498 Peter Roth Vol#: 200

EMC 1499 Raymond W Bricknell Jr Vol#: 200

EMC 1500 Kelly Ensell Jr Vol#: 200

EMC 1501 Daniel Davids Vol#: 200

EMC 1502 Kevin Hogue Vol#: 200

EMC 1503 Cristina Meirelles Vol#: 200

EMC 1504 Cynthia Connolly Vol#: 200

EMC 1505 Shoshana Weiner Vol#: 200

EMC 1506 Mindy Whitacre Vol#: 200

EMC 1507 Bret H Mitchell Vol#: 200

EMC 1508 Kent Richards Vol#: 200

EMC 1509 Elizabeth A W Steward Vol#: 200

EMC 1510 Richard Layman Vol#: 200

EMC 1511 Cindy M Krapft Vol#: 200

EMC 1512 Rosemary A Kot Vol#: 200

EMC 1513 Hope M Hagan Vol#: 200

EMC 1514 J-Sin Keebler Vol#: 200

EMC 1515 Kate Lucas Vol#: 200

EMC 1516 Dann P Gravett Vol#: 200

EMC 1517 Michael Mezzanotte Vol#: 200

EMC 1518 M Zimmerman Vol#: 200

EMC 1519 Bernard Walsh Vol#: 200

EMC 1520 Margaret Clark Vol#: 200

EMC 1521 Thomas Ballantyne Vol#: 200

EMC 1522 Robbin Kelly Vol#: 200

EMC 1523 Nancy Woodward Vol#: 200

EMC 1524 Brandie Haigler Vol#: 200

EMC 1525 Kim M Bond Vol#: 200

EMC 1526 Tracy Jose Vol#: 200

EMC 1527 Ann Robinson Vol#: 200

EMC 1528 Martin Thurman Vol#: 200

EMC 1529 Nicole C O'Brien Vol#: 200

EMC 1530 Harriet Behar Vol#: 200

EMC 1531 Walter Sorensen Vol#: 200

EMC 1532 Roland Vollmann Vol#: 200

EMC 1533 Alicia de Soto-Foley Vol#: 200

EMC 1534 Joe & Lanessa Machado Vol#: 200

EMC 1535 Emiko Ortega Vol#: 200

EMC 1536 Brad Belo Vol#: 200

EMC 1537 David Abraham Vol#: 200

EMC 1538 Nancy Brillault Vol#: 200

EMC 1539 KK cat Vol#: 200

EMC 1540 Marietta Larkin Vol#: 200

EMC 1541 James Fournier Vol#: 200

EMC 1542 Joel Weinberg Vol#: 200

EMC 1543 Gregory E Albertson Vol#: 200

EMC 1544 Karen Ellis Vol#: 200

EMC 1545 Barbara Gates Vol#: 200

EMC 1546 Kim Bourner Vol#: 200

EMC 1547 Trout Rogers Vol#: 200

EMC 1548 Nathan Batalion Vol#: 200

EMC 1549 Sally Osborne Vol#: 200

EMC 1550 Andrea Nichols Vol#: 200

EMC 1551 David Powelson Vol#: 200

EMC 1552 Catherine Witzling Vol#: 200

EMC 1553 Cheryl Fair Vol#: 200

EMC 1554 D Schwartz Vol#: 200

EMC 1555 Susan Plog Vol#: 200

EMC 1556 Brian Swartzbaugh Vol#: 200

EMC 1557 Carroll A Jackson Vol#: 200

EMC 1558 Hannah Burton Vol#: 200

EMC 1559 Stuart Shaw Vol#: 200

EMC 1560 Daniel Hunt Vol#: 200

EMC 1561 Nikki Freeburn Vol#: 200

EMC 1562 Karen Valiquette Vol#: 200

EMC 1563 Julie Reid Vol#: 200

EMC 1564 Alma Luz Villanueva Vol#: 200

EMC 1565 Joanne Moore Vol#: 200

EMC 1566 Ben Lipman Vol#: 200

EMC 1567 Elayne Jones Vol#: 200

EMC 1568 Le Mai Vol#: 200

EMC 1569 Erik Davis Vol#: 200

EMC 1570 Karin Boyd Vol#: 200

EMC 1571 Anna Sogliuzzo Vol#: 200

99N-4491 Reuse of Single Use Devices proposal

C 100 Vital Signs Inc Vol#: 7

C 101 Adven Medical Inc Vol#: 7

99P-2148 Label or Labeling of food ingredients and regulation

C 7 Martha Walton Vol#: 1

00H-0560 Civil Money Penalty;Edward Bourg Sr,dba Chevy Chase Citgo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0561 Civil Money Penalty;D&S Food Centers Inc,dba D&S Food Center

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0562 Civil Money Penalty;Christine Gorra & Darren Gorra,dba DG's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0563 Civil Money Penalty;Grunst Brothers Inc,dba Grunst Brothers

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0564 Civil Money Penalty;Sam McCollough,dba West End Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0565 Civil Money Penalty;Ed Montgomery,dba Halls Ferry Mobil Stat

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0566 Civil Money Penalty;Cynthia Nolan,dba Cindy's Country Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0567 Civil Money Penalty;Ohio Valley Supermarkets Inc,dba Twin Ri

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0568 Civil Money Penalty;Shur-Sav Inc,dba Shur-Sav Markets

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0569 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #128

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0571 Civil Money Penalty;DDT Package Liquor Inc,dba DDT Package L

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0572 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik C

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0573 Civil Money Penalty;Minnehaha Liquor Store Inc,dba Minnehaha

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0574 Civil Money Penalty;Persons Inc,dba Bayport Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0575 Civil Money Penalty;Storing-Curtis Inc,dba Wikieup Trading P

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0581 Civil Money Penalty;No 1 China Inc,dba No 1 China House

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0582 Civil Money Penalty;Sir Albert's RV Park & Country Store,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0583 Civil Money Penalty;Rita's Inc,dba Rita's Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0584 Civil Money Penalty;Doaba Oil Corporation,dba Doaba Oil Comp

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00N-0088 Psychiatric & Behavioral Disturbances associated w/Dementia

C 4 American Assn for Geriatric Psychiatry Vol#: 1

C 5 Janssen Research Foundation Vol#: 1

C 6 Janssen Research Foundation Vol#: 1

C 7 International Psychogeriatric Associatio Vol#: 1

C 8 Eli Lilly and Company Vol#: 1

C 9 University of Pittsburgh Medical Center Vol#: 1

C 10 University of Southern California Vol#: 1

00P-0685 Revocation of Yogurt Standards

ACK 1 HFA-305 Vol#: 1

CP 1 National Yogurt Association Vol#: 1

DOCKETS ENTERED on 02/19/00

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

C 696 CLF, Conservation Law Foundation Vol#: 28

C 697 Wood's Cider Mill Vol#: 28

C 698 IDFA, International Dairy Foods Assn. Vol#: 28

C 699 CSPI, Center for Science in the Pub. Int Vol#: 28

C 700 NFPA, National Food Processors Assn. Vol#: 28

C 701 Thelma Jacobson Vol#: 28

C 702 Lyn K. Smith Vol#: 28

C 703 Carol Durn Drever Vol#: 28

C 704 Charlotte McArdun Vol#: 28

C 705 Monice Wellmeker Vol#: 28

C 706 L. Pap Vol#: 28

C 707 Joseph Gary Miller Vol#: 28

C 708 Grace Hanover Vol#: 28

C 709 Dee Kidonour Vol#: 28

C 710 Emma Renna Vol#: 28

C 711 Dorothy Mchesell Vol#: 28

C 712 Michell Jimnell Vol#: 28

C 713 Eric Needle Vol#: 28

C 714 Daniel A. Linsley Vol#: 28

C 715 Scott Wynn Vol#: 28

C 716 Lisa Chnupa Vol#: 28

C 717 Treva Chnupa Vol#: 28

C 718 Tom A. Walther Vol#: 28

C 719 Carl A. Elliott, Jr. Vol#: 28

C 720 Anthony Vilie Vol#: 28

C 721 Patience Vol#: 28

C 722 Jay C. Vol#: 28

C 723 Bill Morgan, Sr. Vol#: 28

C 724 James C. Gard, Jr. Vol#: 28

C 725 Ben Pauley Vol#: 28

C 726 Hua Heong Food Industries (Vietnam) Co.L Vol#: 29

C 727 U. S. Apple Assn. Vol#: 30

C 728 S.T.O.P., Safe Tables Our Priority Vol#: 30

C 729 Amos Newton Vol#: 30

C 730 Blake McClenachan Vol#: 30

C 731 Commonwealth of Massachusetts Dept. of F Vol#: 30

C 732 Dwight Miller & Son Orchards Vol#: 30

C 733 Arden's Garden Vol#: 30

C 734 Atherton's Apple Farm Vol#: 30

C 735 Morean Dolph Vol#: 30

C 736 Alecia Miller Vol#: 30

C 737 Chapin Orchard Vol#: 30

C 738 Purdue University Vol#: 30

C 739 S. Ogorkiewicz Vol#: 30

C 740 Pat Hopkins Vol#: 30

C 741 Loretta Atherton Vol#: 30

C 742 Denise & John Kelly Vol#: 30

C 743 Johanna Kaufman, DVM Vol#: 30

C 744 Carolina Food Concepts Vol#: 30

C 745 Richard Brigham Vol#: 30

C 746 Citrus Research Board Vol#: 30

C 747 County of El Dorado Dept. of Agr. Weight Vol#: 30

C 748 California Citrus Quality Council Vol#: 30

EMC 46 D. Ausband Vol#: 28

EMC 47 Mrs. Jay Fechtel Vol#: 28

EMC 48 Vazquez & Guillermo Vol#: 28

EMC 49 Eric Prestidge Vol#: 28

EMC 50 Eric Prestidge Vol#: 28

EMC 51 Emilio Biasucci Vol#: 30

EMC 52 Patrick Sheppard Vol#: 30

99D-5347 Transmission of Zoonoses By Blood and Blood Products

C 1 Andy Breslin Vol#: 3

C 2 Scott Plantier, Terry & Sophie Carlo Vol#: 3

EMC 5 Rachel Stine Vol#: 3

EMC 6 The Kifer-Borgen Family Vol#: 3

EMC 7 Dana Fillion Vol#: 3

EMC 8 Bina Robinson Vol#: 3

EMC 9 D. Horvath Vol#: 3

EMC 10 Mark Byers Vol#: 3

EMC 11 Suzanna Hermans Vol#: 3