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 03/15/00

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 ]

 
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
97N-0068 Regulation of Cellular & Tissue-Based Products Data *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98D-0388 Dermatological Drug Product NDA's and ANDA's *
98P-0070 Refrain from Approving PMAs for Stem Cell Separation System *
98S-1064 The Implementation (MRA) between the United States & Europea *
99D-4396 Financial Disclosure By Clinical Investigators *
99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat *
99D-5424 Health claims for Conventional Foods & Dietary Supplements *
99N-4491 Reuse of Single Use Devices proposal *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-4649 Propoxyphene Napsylate/Acetaminophen Tablets/Capusles 50mg *
00N-0120 Safety of Imported Foods *
00N-0506 Safety Issues Associated With Dietary Supplements *
00P-0788 Totally Implanted Spinal Cord Stimulator *
00V-1118 Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,) *
00V-1125 Laser Light Show (Mobolazer ML10-200,ML10-300,ML10-300W, *
00V-1126 Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W, *
00V-1127 Laser Light Show*

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 70 McKenna & Cuneo (Attorneys at Law) Vol#: 26

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

C 2046 National Heart Savers Association Vol#: 57

96N-0277 Eligibility Criteria for Considering Additional Condition

EC 1 Number Not Used Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9628 The Honorable Christopher H. Smith (CI) Vol#: 197

C 9629 The Honorable Michael Billrakis (CI) Vol#: 197

C 9630 The Honorable Michael Bilirakis (CI) Vol#: 197

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

CR 2 ThermoGenesis Corp. Vol#: 4

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 4451 American Specialty Health & Wellness Vol#: 33

LET 4452 American Specialty Health & Wellness Vol#: 33

LET 4453 American Specialty Health & Wellness Vol#: 33

LET 4454 American Specialty Health & Wellness Vol#: 33

LET 4455 American Specialty Health & Wellness Vol#: 33

LET 4456 American Specialty Health & Wellness Vol#: 33

LET 4457 American Specialty Health & Wellness Vol#: 33

LET 4458 American Specialty Health & Wellness Vol#: 33

LET 4459 American Specialty Health & Wellness Vol#: 33

LET 4460 American Specialty Health & Wellness Vol#: 33

LET 4461 American Specialty Health & Wellness Vol#: 33

LET 4462 American Specialty Health & Wellness Vol#: 33

LET 4463 American Specialty Health & Wellness Vol#: 33

LET 4464 American Specialty Health & Wellness Vol#: 33

LET 4465 American Specialty Health & Wellness Vol#: 33

LET 4466 American Specialty Health & Wellness Vol#: 33

LET 4467 American Specialty Health & Wellness Vol#: 33

LET 4468 American Specialty Health & Wellness Vol#: 33

LET 4469 American Specialty Health & Wellness Vol#: 33

LET 4470 American Specialty Health & Wellness Vol#: 33

LET 4471 American Specialty Health & Wellness Vol#: 33

LET 4472 American Specialty Health & Wellness Vol#: 33

LET 4473 American Specialty Health & Wellness Vol#: 33

LET 4474 American Specialty Health & Wellness Vol#: 33

LET 4475 American Specialty Health & Wellness Vol#: 33

LET 4476 American Specialty Health & Wellness Vol#: 33

LET 4477 American Specialty Health & Wellness Vol#: 33

LET 4478 American Specialty Health & Wellness Vol#: 33

LET 4479 American Specialty Health & Wellness Vol#: 33

LET 4480 American Specialty Health & Wellness Vol#: 33

LET 4481 American Specialty Health & Wellness Vol#: 33

LET 4482 Standard Process Inc Vol#: 33

LET 4483 Standard Process Inc Vol#: 33

LET 4484 Standard Process Inc Vol#: 33

LET 4485 Standard Process Inc Vol#: 33

LET 4486 Pharmaton Natural Health Products Vol#: 33

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

C 20 Mr. Paul F. Manley Vol#: 3

98D-0548 Development of antimicrobial drug products/availability

REF 1 Technical University in Munich, Germany Vol#: 2

98P-0070 Refrain from Approving PMAs for Stem Cell Separation System

C 2 Joanny Moya Vol#: 1

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

C 1 The Honorable Jay Inslee (CI) Vol#: 1


99D-4396 Financial Disclosure By Clinical Investigators

C 13 W. L. Gore & Associates Vol#: 1

99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat

C 8 Berlex Laboratories, Inc Vol#: 1

C 9 Pharmacia & Upjohn Vol#: 1

99D-5424 Health claims for Conventional Foods & Dietary Supplements

C 1 Citizens for Health Vol#: 1

C 2 Julian M. Whitaker, M.D. et al Vol#: 1

99H-3014 Civil Money Penalty;Roswil Inc,dba Ramey's Supermarket

CS 2 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

99H-4748 Civil Money Penalty;Linson 2 Inc,dba 7-Eleven Store #26753

EXB 2 Linson 2 Inc Vol#: 1

99H-5251 Civil Money Penalty;Discount Smoke Shop,Inc;dba Discount Smo

CS 1 HFA-305 Vol#: 1

MO 2 GCF-1 Vol#: 1

OR 1 HF-3 Vol#: 1

RMO 1 GCF-1 Vol#: 1

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

RMO 1 GCF-1 Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

C 66 The Honorable Christopher Shays (CI) Vol#: 6

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

C 2823 Form letter count 333 Vol#: 245

C 2824 Caroline Berch Vol#: 247

C 2825 Sophey Thain Vol#: 247

C 2826 Lillian Cheely Vol#: 247

C 2827 Kathryn Lohrey Vol#: 247

C 2828 Ernest L Holmes Vol#: 247

C 2829 William A Donze Vol#: 247

C 2830 Judith Turner Vol#: 247

C 2831 Jeffrey M Dickemann Vol#: 247

C 2832 Lynn Szanto Vol#: 247

C 2833 Jackson A Saxon MD Vol#: 247

C 2834 Debora Mandelbaum Vol#: 247

C 2835 David Chapman Vol#: 247

C 2836 Almida Meyer Vol#: 247

C 2837 Wendy de Forest Vol#: 247

C 2838 Lynette C Bryant Vol#: 247

C 2839 Sean P Villott Vol#: 247

C 2840 Lisa Bunch Vol#: 247

C 2841 JoAnne T Seaver Vol#: 247

C 2842 J Roffe Vol#: 247

C 2843 Miriam Saul Vol#: 247

C 2844 Patucu Bechett Vol#: 247

C 2845 Ed Block Vol#: 247

C 2846 Mark & Naomi Dambacher Vol#: 247

C 2847 Jeffrey A Williams Vol#: 247

C 2848 Andrew & Marjorie Masse & children Vol#: 247

C 2849 Roberta Plummer Vol#: 247

C 2850 Jeanni Lucy Meyer Vol#: 247

C 2851 Mr & Mrs McKay Vol#: 247

C 2852 Consuela O'Malley Vol#: 247

C 2853 Peter Colantonio Vol#: 247

C 2854 Arthur G Watrous Jr Vol#: 247

C 2855 JoAnn M McNeill Vol#: 247

C 2856 J Novotrua Vol#: 247

C 2857 Barbara Starre Vol#: 247

C 2858 Vincent Santangelo Vol#: 247

C 2859 Alicia Schick Vol#: 247

C 2860 Alan B Langrall Vol#: 247

C 2861 Louise N Kubista Vol#: 247

C 2862 Ola Studer Vol#: 247

C 2863 Mr & Mrs Richard Bachtold Vol#: 247

C 2864 Cheryl Perkosky Vol#: 247

C 2865 Marie J B Woodcock Vol#: 247

C 2866 Sam & Debbie Swearingen Vol#: 247

C 2867 James P Cassidy Vol#: 247

C 2868 Eileen Botty Vol#: 247

C 2869 Jeffrey Waingron Vol#: 247

C 2870 L M John Vol#: 247

C 2871 Ray McClelland Vol#: 247

C 2872 Patricia A Dowd Vol#: 247

C 2873 Linda K Tacci Vol#: 247

C 2874 Harriett F Nally Vol#: 247

C 2875 Isabel Allen Vol#: 247

C 2876 Robert A Floyd Vol#: 247

C 2877 Mehe Samano Vol#: 247

C 2878 Lila Culhane Vol#: 247

C 2879 Elizabeth Starzyk Vol#: 247

C 2880 Steven D Hudson Vol#: 247

C 2881 Cathy Barton Vol#: 247

C 2882 Leslie L Fornelius Vol#: 247

C 2883 Julie Craig Vol#: 247

C 2884 Ms Ann Senour Vol#: 247

C 2885 Robert Parmar Vol#: 247

C 2886 Caralyn M Buehner Vol#: 247

C 2887 Frances Greenlief Vol#: 247

C 2888 Samuel M Jenkins III Vol#: 247

C 2889 Dr Timona Pittman Vol#: 247

C 2890 Shamin B McClary Vol#: 247

C 2891 Susan Hartling Vol#: 247

C 2892 Glenn & Phyllis P Ford Vol#: 247

C 2893 Herbert W Yates Vol#: 247

C 2894 Cecilia Juliano Garvin Vol#: 247

C 2895 Fran Darling Vol#: 247

C 2896 Connie Patton Vol#: 247

C 2897 Genevieve Cornish Vol#: 247

C 2898 Harold C Baker Vol#: 247

C 2899 James J Quint Vol#: 247

C 2900 Gene Hopster Vol#: 247

C 2901 Thomas C Ingram Vol#: 247

C 2902 Elana Sifry Vol#: 247

C 2903 Cindy Irwin Vol#: 247

C 2904 Ann Marie Sereg Vol#: 247

C 2905 Kevin F Connell Vol#: 249

C 2906 Quinlan J Shea Jr Vol#: 249

C 2907 Joan C Steele Vol#: 249

C 2908 Lois E Baehr Vol#: 249

C 2909 Charles W Bruzee Vol#: 249

C 2910 Marianne G Pferiffer Vol#: 249

C 2911 Kristine R Treat Vol#: 249

C 2912 Cody Wheeler Vol#: 249

C 2913 Aaron Swarman Vol#: 249

C 2914 Rita O Hohenshell Vol#: 249

C 2915 Katri Santiago Vol#: 249

C 2916 Ann Veltr Vol#: 249

C 2917 Douglas Haussler Vol#: 249

C 2918 Gerald Carolyn Gibson Vol#: 249

C 2919 Eugene Charles Ryding Vol#: 249

C 2920 Erich Hering Vol#: 249

C 2921 Bunne Bright & Randal Pingrey Vol#: 249

C 2922 Ernest J Kiefer Vol#: 249

C 2923 Catherine Reimers Vol#: 249

C 2924 Douglas Craig Gohr Vol#: 249

C 2925 Louise Trickel Vol#: 249

C 2926 Coby Dietrick Vol#: 249

C 2927 Marlys Dietrick Vol#: 249

C 2928 Deborah Mills Vol#: 249

C 2929 Dennis Burtsfield Vol#: 249

C 2930 Robert Berman Vol#: 249

C 2931 Jane Johnson Vol#: 249

C 2932 Debbie Bench Vol#: 249

C 2933 Jonathan Coah Vol#: 249

C 2934 Pete Kvehn Vol#: 249

C 2935 Margaret N Durkan Vol#: 249

C 2936 Merolyn Graham Parker Vol#: 249

C 2937 Richard Flaherty Vol#: 249

C 2938 Ruth P Wicks Vol#: 249

C 2939 Yvonne Bruner Vol#: 249

C 2940 Norman C Kunkel Vol#: 249

C 2941 Mechteld Van Hardenbroek Vol#: 249

C 2942 Crosta Sumanik Vol#: 249

C 2943 Kathleen A Kaiser Vol#: 249

C 2944 William G Briggs Vol#: 249

C 2945 Randall Sieber Vol#: 249

C 2946 M Weiss Vol#: 249

C 2947 Jim Lane Vol#: 249

C 2948 M Prindiville Vol#: 249

C 2949 Jonathan Callet Vol#: 249

C 2950 Mary Body Vol#: 249

99N-4491 Reuse of Single Use Devices proposal

C 106 Chris Quigley Vol#: 7

99P-1340 Declared Eternity eau de Parfum Misbranded

C 591 Theodora Apostolo Vol#: 12

EMC 79 Juanita Anderson Vol#: 12

EMC 80 Helle Kongevang Vol#: 12

EMC 81 Dennis & Linda Kane Vol#: 12

EMC 82 Dr. Lorraine Parker Vol#: 12

EMC 83 Diane M. Kleinman Vol#: 12

99P-4613 Revoke the Regulation That Approved Posilac

EMC 1562 Monica Brady Vol#: 17

EMC 1563 Paula Wolfert Vol#: 17

EMC 1564 Claire Holzner Vol#: 17

EMC 1565 no signature Vol#: 17

EMC 1566 Rose Reina-Rosenbaum Vol#: 17

EMC 1567 Stuart B. Zimmerman Vol#: 17

EMC 1568 Susan Murphy Vol#: 17

EMC 1569 Joe Simone Vol#: 17

EMC 1570 John McGee Vol#: 17

EMC 1571 Paul & Susie Potter Vol#: 17

EMC 1572 Jimmie Young Vol#: 17

EMC 1573 Annie Copps Vol#: 17

EMC 1574 Kalonica McQuesten Vol#: 17

EMC 1575 Roy Finamore Vol#: 17

EMC 1576 Elizabeth Custer Vol#: 17

EMC 1577 Ali Meyer Vol#: 17

EMC 1578 General Vol#: 17

EMC 1579 New Union Work Systems Vol#: 17

EMC 1580 Howard Hesseman Vol#: 17

EMC 1581 Norm Clasen Vol#: 17

EMC 1582 Elizabeth Moule Vol#: 17

EMC 1583 Christopher Pavone Vol#: 17

EMC 1584 Katrina Martin Ryen Vol#: 17

EMC 1585 Flea St. Cafe & jZcool Eatery & Catering Vol#: 18

EMC 1586 Peter Morgan Vol#: 18

EMC 1587 Elizabeth Helman Minchilli Vol#: 18

EMC 1588 Judy Raymond Vol#: 18

EMC 1589 Julie Carney Vol#: 18

EMC 1590 Marian Melcher Vol#: 18

EMC 1591 Linda S. Luke Vol#: 18

EMC 1592 Steve Johnson Vol#: 18

EMC 1593 Laurie Harvey Vol#: 18

EMC 1594 W. Michael Fleming Vol#: 18

EMC 1595 Ben Long Vol#: 18

EMC 1596 Faith Willinger Vol#: 18

EMC 1597 Kate Warich Vol#: 18

EMC 1598 Gayle Kabaker & Peter Kitchell Vol#: 18

EMC 1599 Lee Halper Vol#: 18

EMC 1600 Joel D. Brezner Vol#: 18

EMC 1601 PulseWave Percussion Vol#: 18

EMC 1602 Donna Dean Vol#: 18

EMC 1603 Marian Melcher Vol#: 18

EMC 1604 Peter van Gorder Vol#: 18

EMC 1605 Sojeila Maria Silva Vol#: 18

EMC 1606 Tony Knickerbocker Vol#: 18

EMC 1607 Barry Nadler Vol#: 18

EMC 1608 Mary Reilly Vol#: 18

EMC 1609 Moraia Grau Vol#: 18

EMC 1610 Goodyear Technical Center Vol#: 18

EMC 1611 D. Bishop Vol#: 18

EMC 1612 PeterBread Consulting Vol#: 18

EMC 1613 Janet Fletcher Vol#: 18

EMC 1614 Francie King Vol#: 18

EMC 1615 Rachel Finson Vol#: 18

EMC 1616 Sasha Beltins Vol#: 18

EMC 1617 Julia Kolb Vol#: 18

EMC 1618 Dan Ringer-Barwick Vol#: 18

EMC 1619 Barbara McLeish Vol#: 18

EMC 1620 Jeff Milstead Vol#: 18

EMC 1621 Puffin Designs Vol#: 18

EMC 1622 Linda Cruz Nickell Vol#: 18

EMC 1623 Aurora Farm Vol#: 18

EMC 1624 Michael Boender Vol#: 18

EMC 1625 Suzanne Hamlin Vol#: 18

EMC 1626 Nancy Civetta Vol#: 18

EMC 1627 Rincon-Vitova Insectaries, Inc. Vol#: 18

EMC 1628 Jennifer Wyld Vol#: 18

EMC 1629 Jeff Rast Vol#: 18

EMC 1630 David Bland Vol#: 18

EMC 1631 Maureen A. Boehm Vol#: 18

EMC 1632 Bob Carrau Vol#: 18

EMC 1633 Richard Swinehart Vol#: 18

EMC 1634 Goodyear Technical Center Vol#: 18

EMC 1635 Jodi Medlar Vol#: 18

EMC 1636 Moraia Grau Vol#: 18

EMC 1637 Richard Swinehart Vol#: 18

EMC 1638 Penina Finger Vol#: 18

EMC 1639 Samuel A. Abrash Vol#: 18

EMC 1640 Michael Shay Vol#: 18

EMC 1641 Sue Hecht Vol#: 18

EMC 1642 Jim King Vol#: 18

EMC 1643 Dr. Ben Eversage, D.C. Vol#: 18

EMC 1644 Thomas H. Makeig, P.C. Vol#: 18

EMC 1645 John Draper Vol#: 18

EMC 1646 Peggy Jones Vol#: 18

EMC 1647 Nancy Rosenthal Vol#: 18

EMC 1648 Kurt Hansen Vol#: 18

EMC 1649 Reeves Kilcollins Vol#: 18

EMC 1650 Tony Scheck Vol#: 18

EMC 1651 Michael S. Swink Vol#: 18

EMC 1652 Advanced Information Management, Inc. Vol#: 18

EMC 1653 Mark Cope Vol#: 18

EMC 1654 Steven Petusevsky Vol#: 18

EMC 1655 Green Development Services Rocky Mountai Vol#: 18

EMC 1656 Paul Rabalis Vol#: 18

EMC 1657 Kingsley Brooks Vol#: 18

EMC 1658 Mr. & Mrs. Kingsley & Leslie Brooks Vol#: 18

EMC 1659 Kathleen Bailey Vol#: 18

EMC 1660 Chris Barrett Vol#: 18

EMC 1661 R. L. Dawson Vol#: 18

99P-4649 Propoxyphene Napsylate/Acetaminophen Tablets/Capusles 50mg

CR 1 Mikart Vol#: 1

00H-0035 Civil Money Penalty;Beaudry Convenience, Inc;dba Beaudry Exp

MO 1 GCF-1 Vol#: 1

00H-0242 Civil Money Penalty;Charles Martin,dba Sugarloaf Mountain

ANS 1 Charles Martin Vol#: 1

00H-0251 Civil Money Penalty;Brewer's Oil Co Inc,dba Brewer's Auto

ANS 1 Brewer's Oil Co Inc Vol#: 1

00H-0261 Civil Money Penalty;Goodner's Super Market No 2 Incorporated

EXB 1 Goodner's Super Market Vol#: 1

00H-0307 Civil Money Penalty;Charles Mayo,dba C J'S Exxon

ANS 2 C J's Exxon Vol#: 1

00H-0320 Civil Money Penalty;Gilbert Bigby Terry Bigby and Mark Bigby

ANS 1 Big Food & Deli #2 Vol#: 1

00H-0321 Civil Money Penalty;Yin Yan Chen,dba Hing Wah

ANS 1 Yin Yan Chen Vol#: 1

00H-0386 Civil Money Penalty;William R Kerr,dba Ellicott General Stor

MO 1 Ellicott General Store Vol#: 1

00H-0439 Civil Money Penalty,Shaver's Inc,dba Shaver's Grocery Store

ANS 1 Shaver's Inc Vol#: 1

00H-0535 Civil Money Penalty;Linda Hayes,dba Linda's One Stop

ANS 1 Linda Hayes Vol#: 1

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

MO 1 Wawa Inc Vol#: 1

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

MO 1 Wawa Inc Vol#: 1

00H-0593 Civil Money Penalty;Samson Oil Company,dba Samson Oil

ANS 1 Samson Oil Co Vol#: 1

00N-0001 Leveraging - Collaborating with Stakeholders

EC 1 Number Not Used Vol#: 1

EC 2 Number Not Used Vol#: 1

EC 3 Plasmine Technology, Inc. Vol#: 1

EC 4 Breast Cancer Action Vol#: 1

00N-0120 Safety of Imported Foods

C 1 Dr.Jaime A. Alvarez/Dr.Felipe A Espinoza Vol#: 1

00N-0506 Safety Issues Associated With Dietary Supplements

EC 1 Number Not Used Vol#: 1

EC 2 Mr. Greg Elin Vol#: 1

00P-0788 Totally Implanted Spinal Cord Stimulator

CR 2 HFA-305 Vol#: 4

LET 1 Advanced Neuromodulation Systems, Inc. Vol#: 4

00V-1118 Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,)

ACK 1 HFA-305 Vol#: 1

00V-1125 Laser Light Show (Mobolazer ML10-200,ML10-300,ML10-300W,

ACK 1 HFA-305 Vol#: 1

VAR 1 New Pacific Inc. Vol#: 1

00V-1126 Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,

ACK 1 HFA-305 Vol#: 1

VAR 1 SSI Production Services, Inc. Vol#: 1

00V-1127 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 South Florida Science Museum Vol#: 1