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 Us]

DOCKETS ENTERED on March 26, 2001

TABLE OF CONTENTS

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78N-036L OTC Laxative *
91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1595 Recommendations for Complying with the Pediatric Rule *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
78N-036L OTC Laxative

ANS 6 HFD-560 to Purdue Pharma L.P. Vol#: 107


91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

LET 3 HFS-800 to Emord & Associates, P.C. Vol#: 46

LET 4 HFS-800 to Emord & Associates, P.C. Vol#: 46

LET 5 HFS-800 to Emord & Associates, P.C. Vol#: 46


98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 4259 M Luce Vol#: 135

C 4260 W Coleman Vol#: 135

C 4261 J Beckhan Vol#: 135

C 4262 G Giorno Vol#: 136

C 4263 J Berry Vol#: 136

C 4264 K Sprague Vol#: 136

C 4265 C Holt Vol#: 136

C 4266 F Obaid Vol#: 136

C 4267 A Dios Vol#: 136

C 4268 Pam Vol#: 136

C 4269 E Levin Vol#: 136

C 4270 R Lehrman Vol#: 136

C 4271 J Dadds Vol#: 136

C 4272 O Boothman Vol#: 136

C 4273 M Engebretson Vol#: 136

C 4274 M Pastacaldi Vol#: 136

C 4275 N Lowell Vol#: 136

C 4276 C Magni Vol#: 136

C 4277 M Vander Heyden Vol#: 136

C 4278 J Mangine Vol#: 136

C 4279 M Seeburg Vol#: 136

C 4280 G Bourque Vol#: 136

C 4281 D Wood Vol#: 136

C 4282 P Tice Vol#: 136

C 4283 B Apanaitis, Ph.D. Vol#: 136

C 4284 V Wilder Vol#: 136

C 4285 K Angus Vol#: 136

C 4286 J Villars Vol#: 136

C 4287 A B Vol#: 136

C 4288 B Williams Vol#: 136

C 4289 K Erwin Vol#: 136

C 4290 B Bonsignone Vol#: 136

C 4291 J Spragg Vol#: 136

C 4292 B Drabek & E Clustian Vol#: 136

C 4293 V Blewer Vol#: 136

C 4294 L Nielsen Vol#: 136

EMC 1543 N Wong Vol#: 135

EMC 1544 S Schultz Vol#: 135

EMC 1545 J Yindra Vol#: 135

EMC 1546 C Stewart Vol#: 135

EMC 1547 EarthSave Inland Empire Vol#: 135

EMC 1548 R Buddle Vol#: 135

EMC 1549 G Brief Vol#: 135

EMC 1550 S Mercier Vol#: 135

EMC 1551 J Sivey Vol#: 135

EMC 1552 W Huynh Vol#: 135

EMC 1553 L Maddock Vol#: 135

EMC 1554 T Whitham Vol#: 135

EMC 1555 A Mikina Vol#: 135

EMC 1556 Lee's Carpet staff Vol#: 135

EMC 1557 K McBride Vol#: 135

EMC 1558 D Reinsma Vol#: 135

EMC 1559 M McCauley & J Munson Vol#: 135

EMC 1560 B Maddaloni Vol#: 135

EMC 1561 D Maddock Vol#: 135

EMC 1562 number not used Vol#: 135

EMC 1563 J Daniels Vol#: 135

EMC 1564 E Fay Vol#: 135

EMC 1565 N Klockner Vol#: 135

EMC 1566 S. Blythe Vol#: 135

EMC 1567 S Mandal Vol#: 135

98V-0657 Laser Lighting Effects

VRA 2 HFZ-340 to Viejas Casino & Turf Club Vol#: 1

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

C 1 Flow International Corp. Vol#: 1

00D-1595 Recommendations for Complying with the Pediatric Rule

C 5 Merck & Co Inc Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

C 587 The Braman Family Vol#: 77

C 588 D Taylor Vol#: 77

C 589 R Kuhlbars Vol#: 77

C 590 K Lamoche Vol#: 77

C 591 J Reves Vol#: 77

C 592 R Stirite Vol#: 77

C 593 M Jeschke Vol#: 77

C 594 O Nanopha Vol#: 77

C 595 C Schatzman Vol#: 77

C 596 K Kellogg Vol#: 77

C 597 M Barba Vol#: 77

C 598 N Whitmore Vol#: 77

C 599 J Contois Vol#: 77

C 600 J. Konopka Vol#: 77

C 601 A Marian Vol#: 77

C 602 E Dury Vol#: 77

C 603 R Sauve Vol#: 77

C 604 J Albrech, PhD Vol#: 77

C 605 L Lovas Vol#: 77

C 606 S Wolf Vol#: 77

C 607 B Evans Vol#: 77

C 608 M Sherman Vol#: 77

C 609 H Benjamin Vol#: 77

C 610 M Zacker Vol#: 77

C 611 I Fiering Vol#: 77

C 612 D Lee Vol#: 77

C 613 L Davis Vol#: 77

C 614 S Stein Vol#: 77

C 615 K Begeal Vol#: 77

C 616 M Ryan Vol#: 77

C 617 M Douglas Vol#: 77

C 618 M Santelli Vol#: 77

C 619 J Bowers Vol#: 77

C 620 K Murdock Vol#: 78

C 621 D. S. Devlin Vol#: 78

C 622 P Sloan Vol#: 78

C 623 T Rench Vol#: 78

C 624 Anderson Vol#: 78

C 625 A Health Vol#: 78

C 626 C Ponchlly Vol#: 78

C 627 L. Tuckman Vol#: 78

C 628 N McDaniel Vol#: 78

C 629 C Rogers Vol#: 78

C 630 M Geint Vol#: 78

C 631 M Skle Vol#: 78

C 632 J Neri Vol#: 78

C 633 J Nelson Vol#: 78

C 634 C Ward Vol#: 78

C 635 V Madison Vol#: 78

C 636 B Tetron Vol#: 78

C 637 H Thost Vol#: 78

C 638 M Campbell Vol#: 78

C 639 I Bernstein Vol#: 78

C 640 Dr. McLoughlin Vol#: 78

C 641 D Williams Vol#: 78

EMC 1616 A Neher Vol#: 76

EMC 1617 A Neher Vol#: 76

EMC 1618 E Cecil Vol#: 76

EMC 1619 E Cecil Vol#: 76

EMC 1620 T Mulligan Vol#: 76

EMC 1621 T Mulligan Vol#: 76

EMC 1622 M Fagan Vol#: 76

EMC 1623 S Wildschutte Vol#: 76

EMC 1624 S Wildschutte Vol#: 76

EMC 1625 S Wildschutte Vol#: 76

EMC 1626 P Gula Vol#: 76

EMC 1627 P Gula Vol#: 76

EMC 1628 B Voorhies Vol#: 76

EMC 1629 B Voorhies Vol#: 76

EMC 1630 G Miller Vol#: 76

EMC 1631 G Miller Vol#: 76

EMC 1632 Dr. J Saltman Vol#: 76

EMC 1633 Dr. J Saltman Vol#: 76

EMC 1634 Dr. J Saltman Vol#: 76

EMC 1635 E Volk Vol#: 76

EMC 1636 E Volk Vol#: 76

EMC 1637 A Ambler Vol#: 76

EMC 1638 A Ambler Vol#: 76

EMC 1639 K D Vol#: 76

EMC 1640 K D Vol#: 76

EMC 1641 P Martinez Vol#: 76

EMC 1642 P Martinez Vol#: 76

EMC 1643 R Mowday Vol#: 76

EMC 1644 R Mowday Vol#: 76

EMC 1645 K. Theye Vol#: 76

EMC 1646 K Theye Vol#: 76

EMC 1647 J Moyer Vol#: 76

EMC 1648 U Stadler Vol#: 76

EMC 1649 M Sonnenfeld, MD Vol#: 76

EMC 1650 S Collins Vol#: 76

EMC 1651 K Parker Vol#: 76

EMC 1652 S Foster Vol#: 76

EMC 1653 C Logan Vol#: 76

EMC 1654 L Atoms Vol#: 76

EMC 1655 K Pfoutz Vol#: 76

EMC 1656 R Pfoutz Vol#: 77

EMC 1657 Z Davis Vol#: 76

EMC 1658 D Cooner Vol#: 77

EMC 1659 S Gilstrap Vol#: 77

EMC 1660 S Swartz Vol#: 77

EMC 1661 R Griffiths Vol#: 77

EMC 1662 C Cubillo Vol#: 77

EMC 1663 E Cubillo Vol#: 77

EMC 1664 J Wagner Vol#: 77

EMC 1665 M Crane Vol#: 77

EMC 1666 K McQuaite Vol#: 77

EMC 1667 K Daniels Vol#: 77

EMC 1668 D Goodin Vol#: 77

EMC 1669 C Sybert Vol#: 77

EMC 1670 F Starr Vol#: 77

EMC 1671 S Lambert Vol#: 77

EMC 1672 R O'Brien Vol#: 77

EMC 1673 J Fiebelkorn Vol#: 77

EMC 1674 D Fennell Vol#: 77

EMC 1675 G Fales Vol#: 77

EMC 1676 M Nicholas Vol#: 77

EMC 1677 X Sonnerat Vol#: 77

EMC 1678 J Raison Cain Vol#: 77

EMC 1679 D Britt Vol#: 77

EMC 1680 M Hodgson Vol#: 77

EMC 1681 D DiBiase Vol#: 77


00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 838 J Volkening Vol#: 30

EMC 839 B Ross Vol#: 30

EMC 840 R Williams Vol#: 30

EMC 841 R Warren Vol#: 30

EMC 842 G Berger Vol#: 30

EMC 843 R Brzustoski Vol#: 30

EMC 844 M Altman Vol#: 30

EMC 845 D Gardner Vol#: 30

EMC 846 R Weezer Vol#: 30

EMC 847 J Hillegas Vol#: 30

EMC 848 B Brown Vol#: 30

EMC 849 M Lopez Vol#: 30

EMC 850 R Cadigan Vol#: 30

EMC 851 M Becker Vol#: 30

EMC 852 K Meibert Vol#: 30

EMC 853 M Kelley Vol#: 30

EMC 854 R Fulweber Vol#: 30

EMC 855 C West Vol#: 30

EMC 856 N Guetti Vol#: 30

EMC 857 A Gadon Vol#: 30

EMC 858 C Milsom Vol#: 30

EMC 859 G Larson Vol#: 30

EMC 860 F Londres Vol#: 30

EMC 861 L Jensen Vol#: 30

EMC 862 C Knoxes Vol#: 30

EMC 863 P Johnson Vol#: 30

EMC 864 B Parten Vol#: 30

EMC 865 Consumer Vol#: 30

EMC 866 M Hackett Vol#: 30

EMC 867 T Sahs Vol#: 30

EMC 868 T Palin Vol#: 30

EMC 869 J. Koruba Vol#: 30

EMC 870 A. Pitts Vol#: 30

EMC 871 R Lewczyk Vol#: 30

EMC 872 S Charles Vol#: 30

EMC 873 J Cockerill Vol#: 30

EMC 874 A Bray Vol#: 30

EMC 875 R Austin Vol#: 30

EMC 876 L Johnson Vol#: 30

EMC 877 B Flora Vol#: 30

EMC 878 D Strongin Vol#: 30

EMC 879 S Flint Vol#: 30

EMC 880 R Michlin Vol#: 30

EMC 881 B Wagner Vol#: 30

EMC 882 C Jacobs Vol#: 30

EMC 883 T Sal Vol#: 30

EMC 884 C Gonglefski Vol#: 30

EMC 885 J Prevett Vol#: 30

EMC 886 E Cruse Vol#: 30

EMC 887 C Naughton Vol#: 30

EMC 888 L Rossiter Vol#: 30

EMC 889 F Rago Vol#: 30

EMC 890 J LaCount Vol#: 30

EMC 891 J Mollett Vol#: 30

EMC 892 K Nance Vol#: 30

EMC 893 C Grabarek Vol#: 30

EMC 894 N Flaherty Vol#: 30

EMC 895 B Gregory Vol#: 30

EMC 896 E Dahl Vol#: 30

EMC 897 E Knudson Vol#: 30

EMC 898 K Monro Vol#: 30

EMC 899 M Koplik Vol#: 30

EMC 900 M Koplik Vol#: 30

EMC 901 S Fry Vol#: 30

EMC 902 J Silvey Vol#: 30

EMC 903 J Silvey Vol#: 30

EMC 904 D. Cinquemani Vol#: 30

EMC 905 D Cinquemani Vol#: 30

EMC 906 R Heckler Vol#: 30

EMC 907 A Markman Vol#: 30

EMC 908 B Turner Vol#: 30

EMC 909 N Dobie Vol#: 30

EMC 910 M Collins Vol#: 30

EMC 911 T Fugelsang Vol#: 30

EMC 912 G Stone Vol#: 30

EMC 913 J Nimmo Vol#: 30

EMC 914 C Clayton Vol#: 30

EMC 915 T Athanasiou Vol#: 30

EMC 916 M Rolls Vol#: 30

EMC 917 B Harlan Vol#: 30

EMC 918 B Harlan Vol#: 30

EMC 919 B. Burns Vol#: 30

EMC 920 C. Farrell Vol#: 30

EMC 921 J Murray Vol#: 30

EMC 922 C Schudda Vol#: 30

EMC 923 D Galko Vol#: 30

EMC 924 S Machnowski Vol#: 30

EMC 925 M Beeler Vol#: 30

EMC 926 M Scaffidi Vol#: 30

EMC 927 K Pfoutz Vol#: 30

EMC 928 J. Larson Vol#: 30

EMC 929 D Weiss Vol#: 30

EMC 930 R Grover Vol#: 30

EMC 931 S Smith Vol#: 30

EMC 932 M Almekinder Vol#: 30

EMC 933 M Almekinder Vol#: 30

EMC 934 J Pantel Vol#: 30

EMC 935 C Guth Vol#: 30

EMC 936 T Lash Vol#: 30

EMC 937 A Andazola Vol#: 30

EMC 938 J Simon Vol#: 30

EMC 939 M. Murphy Vol#: 30

EMC 940 A Didion Vol#: 30

EMC 941 D Sahhar Vol#: 30

EMC 942 B Wolbert Vol#: 30

EMC 943 V Afentoulis Vol#: 30

EMC 944 M Hintz Vol#: 30

EMC 945 D Anderson Vol#: 30

EMC 946 J Schimpff Vol#: 30

EMC 947 R Fox Vol#: 30

EMC 948 J Ross Vol#: 30

EMC 949 P Friedman Vol#: 30

EMC 950 J Snelling Vol#: 30

EMC 951 M Dubois Vol#: 30

EMC 952 K Ross Vol#: 30

EMC 953 P Paul Vol#: 30

EMC 954 P Paul Vol#: 30

EMC 955 E Fournier Vol#: 30

EMC 956 A McCulloch Vol#: 30

EMC 957 R Metro Vol#: 30

EMC 958 E Anderson Vol#: 30

EMC 959 L Hastings Vol#: 30

EMC 960 J Rodda Vol#: 30

EMC 961 D Woolston Vol#: 30

EMC 962 D Kushnirsky Vol#: 30

EMC 963 C Dunn Vol#: 30

EMC 964 L Sutton Vol#: 30

EMC 965 D Whitworth Vol#: 30

EMC 966 K Filipovich Vol#: 30

EMC 967 B Benson Vol#: 30

EMC 968 J. Zane Vol#: 30

EMC 969 W Gresham Vol#: 30

EMC 970 J Queirolo Vol#: 30

EMC 971 K Stanley Vol#: 30

EMC 972 Virginia Todd Vol#: 30


00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 8997 Nancy Voorhees Vol#: 721

C 8998 Jane Richins Vol#: 721

C 8999 Carol Rudorf Vol#: 721

C 9000 Margerita Mees Vol#: 721

C 9001 Larry Norman Vol#: 721

C 9002 Victoria stoppiello Vol#: 721

C 9003 William J Grimes Vol#: 721

C 9004 Walter Johnson Vol#: 721

C 9005 Rebecca HrissiKopoubs Vol#: 721

C 9006 Mrs L H Topel Vol#: 721

C 9007 Penny King Vol#: 721

C 9008 Catherina de Carlo Vol#: 721

C 9009 Phyllis Hogue Vol#: 721

C 9010 Jesse Haag Vol#: 721

C 9011 Joseph P Sapp Vol#: 721

C 9012 Karen Ross Vol#: 721

C 9013 Brian Lawson Vol#: 721

C 9014 Linda Segura Vol#: 721

C 9015 Karena Hancock Vol#: 721

C 9016 Julie Waters-Baneme Vol#: 721

C 9017 Sharron Rudig Vol#: 721

C 9018 Karen D Lane Vol#: 721

C 9019 Sara Clark Vol#: 721

EMC 4421 Joi straaten Vol#: 721

EMC 4422 Patricia Brooks Vol#: 721

EMC 4423 Ary Bruno Vol#: 721

EMC 4424 Heather Tebbetts Vol#: 721

EMC 4425 Carolyn Miller Vol#: 721

EMC 4426 Willa VanHuizen Vol#: 721

EMC 4427 Gwen Curtis Vol#: 721

EMC 4428 Heidi Busse Vol#: 721

EMC 4429 Terry Huey Vol#: 721

EMC 4430 Lisa Buscho Vol#: 721

EMC 4431 Teddi Jensen Vol#: 721

EMC 4432 Clifford May Vol#: 721

EMC 4433 Dianna Bridges Vol#: 721

EMC 4434 Michael Kuehnert Vol#: 721

EMC 4435 Susanna Harrison Vol#: 721

EMC 4436 Lee Hudson Vol#: 721

EMC 4437 Lucy Schneid Vol#: 721

EMC 4438 Lisa Schrader Vol#: 721

EMC 4439 Andreu Pascual Vol#: 721

EMC 4440 Valerie Hunter Vol#: 721

EMC 4441 John LoBianco Vol#: 721

EMC 4442 Rodney Thomas Vol#: 721

EMC 4443 Irl Stalcup Vol#: 721

EMC 4444 Karel Luurtsema Vol#: 721

EMC 4445 Jennifer Mollett Vol#: 721

EMC 4446 HElga Ann Ruiterman Vol#: 721

EMC 4447 Terrence McGovern Jr Vol#: 721

EMC 4448 Joseph Groenke Vol#: 721

EMC 4449 Todd Davis Vol#: 721

EMC 4450 Elise Brown Vol#: 721

EMC 4451 Michael Shay Vol#: 721

EMC 4452 Judy & John Knoten Vol#: 721

EMC 4453 Jeff Deaon Vol#: 721

EMC 4454 Stella Salvo Vol#: 721

EMC 4455 Clay Turnbull Vol#: 721

EMC 4456 Kevin O'Riley Vol#: 721

EMC 4457 Gail Beeson Vol#: 721

EMC 4458 Steyn Pearson Vol#: 721

EMC 4459 Craig Peters Vol#: 721

EMC 4460 Syzanne O'Keeffe Vol#: 721

EMC 4461 Dr Terri Gibbs Vol#: 721

EMC 4462 HEather Fayhee Vol#: 7211

EMC 4463 John Luurtsema Vol#: 721

EMC 4464 Janice Joyce Patrick Vol#: 721

EMC 4465 Etta Simula Vol#: 721

EMC 4466 Kathleen O'Quinn Vol#: 721

EMC 4467 Robin Blier Vol#: 721

EMC 4468 Donna Andrews Vol#: 721

EMC 4469 JEff Watts Vol#: 721

EMC 4470 Amy Balkin Vol#: 721

EMC 4471 KEn Charuk Vol#: 721

EMC 4472 Elizabeth Wright Vol#: 721

EMC 4473 Andrew Tamburin Vol#: 721

EMC 4474 Nancy Osborn Vol#: 721

EMC 4475 Shirley Bossbach Vol#: 721

EMC 4476 Darcey Klein Vol#: 721

EMC 4477 Tamela MEder Vol#: 721

EMC 4478 Jane Lehr Vol#: 721

EMC 4479 Eli Curley Vol#: 721

EMC 4480 Caorl Smillie Vol#: 721

EMC 4481 Bita Shooshani Vol#: 721

EMC 4482 Diana Miller Vol#: 721

EMC 4483 J Faltas Vol#: 721

EMC 4484 Fran Hoef-Bouchard Vol#: 721

EMC 4485 Valerie Hunter-Bequette Vol#: 721

EMC 4486 Paul R Williams Vol#: 721

EMC 4487 Jennifer R Stock Vol#: 721

EMC 4488 Sal Quartuccio Vol#: 721

EMC 4489 Sal Quartuccio Vol#: 721

EMC 4490 Thad Cochran Vol#: 721

EMC 4491 Chris Serrano Vol#: 721

EMC 4492 Peg Sockalexis Vol#: 721

EMC 4493 Jesse Helms Vol#: 721

EMC 4494 Jean Bender Vol#: 721

EMC 4495 Robin Hobart Vol#: 721

EMC 4496 Christina Hoke Vol#: 721

EMC 4497 Carla Lanus Vol#: 721

01M-0149 PMA VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens

AAV 1 VISTAKON Div of Johnson & Johnson Vision Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 20 B McBride Vol#: 3

C 21 D Kristancil Vol#: 3

C 22 S Jenkins Vol#: 3

C 23 D Ray Vol#: 3

EMC 175 F Wagner Vol#: 3

EMC 176 J Cook Vol#: 3

EMC 177 J Bole Vol#: 3

EMC 178 M Dietz Vol#: 3

EMC 179 E Austin Vol#: 3

EMC 180 J Tindell Vol#: 3

01V-0004 Laser Light Show

VRA 1 HFZ-340 to Shephards Beach Resort Vol#: 1

01V-0007

VRA 1 HFZ-340 to Miller-Vespoli Inc. Vol#: 1

01V-0008

VRA 1 HFZ-340 Vol#: 1

01V-0040 Laser Light Show Mobolazer:ML8-20G,ML8-50RG,ML10-250

VRA 1 HFZ-340 to Pyradyne Vol#: 1

01V-0151 Laser Light Show ML8-20G,ML8-50RG,ML10-250,ML10-300

ACK 1 HFA-305 Vol#: 1

VAR 1 Phoenix Light Lab Vol#: 1