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 October 25, 2000

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
78P-0173 LASERIUM CONCERT SYSTEM *
90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
98D-0785 Medical imaging drugs and biologics *
98N-1038 Irradiation in the production, processing, &handling of food *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-4375 Health Claim: Vitamin E and Heart Disease *
00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1322 Food Labeling and Allergen Contamination Control *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 18 The Soap & Detergent Association Vol#: 60

78P-0173 LASERIUM CONCERT SYSTEM

EXP 8 Laser Images, Inc. Vol#: 1

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 686 HFD-611 Vol#: 48

M 687 HFD-600 Vol#: 48

M 688 HFD-600 Vol#: 48

M 689 HFD-600 Vol#: 48

M 690 HFD-600 Vol#: 48

M 691 HFD-600 Vol#: 48

95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr

C 19 Korsch American Inc Vol#: 3

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

ACK 2 HFA-305 Vol#: 293

CP 2 American Herbal Products Assn et al Vol#: 293

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

C 317 J. Pittman Vol#: 7

EMC 82 Bruce Magnuson Vol#: 7

98D-0785 Medical imaging drugs and biologics

C 22 Committee On Health Care Vol#: 1

EMC 1 Robert E. Wittes, MD Vol#: 1

EMC 2 Carmen Allegra, MD Vol#: 1

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

C 5208 Julia Bayha Vol#: 151

C 5209 Jody Grage Haug Vol#: 151

C 5210 G. Boyce Vol#: 151

C 5211 Mary Heid Vol#: 151

C 5212 Margaret R. McGinnis Vol#: 151

C 5213 Joan H. Brady Vol#: 151

C 5214 Kalen Hammann Ph.D. Vol#: 151

EMC 235 Terry Whalen Vol#: 151

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2623 S. A. Tatsumi Vol#: 188

C 2624 Ms. Perrie'Lee Prouty Vol#: 188

C 2625 Mana Iluna, MSW Vol#: 188

C 2626 AHI, Animal Health Institute Vol#: 188

C 2627 Judith Deck Vol#: 188

C 2628 Fred & Helen Burger et al Vol#: 188

C 2629 Rich Maxfield Vol#: 188

C 2630 Patricia Winer Vol#: 188

C 2631 Mary Lyon Vol#: 188

C 2632 Gina Clifford Vol#: 188

C 2633 Jerri Brandt Vol#: 188

EMC 58 Justyn Wolf Vol#: 188

99P-4375 Health Claim: Vitamin E and Heart Disease

SUP 5 Emord & Associates & others Vol#: 5

00D-1418 Q7A ICH Good Manufacturing Practice Guide for Active Pharmac

ECT 1 Number Not Used Vol#: 1

ECT 2 PDA Vol#: 1

ECT 3 Pfizer Inc Vol#: 1

ECT 4 Novo Nordisk Vol#: 1

ECT 5 Glaxo Wellcome Vol#: 1

00D-1492 Mutual Recognition Agreement,Medical Device Annex Confidence

GDL 1 GUIDANCE Vol#: 1

GDL 2 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

00N-1224 Responses to Clinical Holds;Agency Information Collection

NAL 1 Vol#: 1

S 1 Supporting Statement Vol#: 1

00N-1256 Over-the-Counter Drug Products;Public Hearing

C 1 June M. Ford Vol#: 24

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 22 State of Washington Dept. of Health Vol#: 1

00N-1521 Agency Information Collection Act: Food Labeling Regulations

N 1 Vol#: 1

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

C 6842 Leland C Warren Vol#: 300

C 6843 Warren Lewis Vol#: 300

C 6844 Waltraud Raninger Vol#: 300

C 6845 Robert Bliss Vol#: 300

C 6846 Emil Bartok Vol#: 300

C 6847 Eric Johnson Vol#: 300

C 6848 Ester Winsjansen Vol#: 300

C 6849 Richard Kavanaugh Vol#: 300

C 6850 Jonathan Janssen Vol#: 300

C 6851 Felice D Swalla Vol#: 300

C 6852 Joy Alexander Vol#: 300

C 6853 Lorraine White Vol#: 300

C 6854 Nancy M Davison Vol#: 300

C 6855 Linda Fielden Vol#: 300

C 6856 J R Stanley Vol#: 300

C 6857 Michelle Rodriguez Vol#: 300

C 6858 Andre' Longpre' Vol#: 300

C 6859 Myrtle Johnston Vol#: 300

C 6860 Angie Chaos-Peters Vol#: 300

C 6861 Barbara Quist Vol#: 300

C 6862 Bruce Linnell Vol#: 300

C 6863 Tony Greenberg Vol#: 300

C 6864 Tara Brelinsky Vol#: 300

C 6865 Kathleen McIntosh Vol#: 300

C 6866 Susan W Gittler Vol#: 300

C 6867 Cat Fribley Vol#: 300

C 6868 Allen J Oh Vol#: 300

C 6869 Christine Walker Vol#: 300

C 6870 Alissa Gloor Vol#: 300

C 6871 AO c/o JHD 2/9 I Corp Vol#: 300

C 6872 Lynne Cownie Vol#: 300

C 6873 Leslie Castanha Vol#: 300

C 6874 Richard John Mann Vol#: 300

C 6875 Esther P Webb Vol#: 300

C 6876 Mary E Lenox Vol#: 300

C 6877 Christine E Ramsey Vol#: 300

C 6878 Angela Goston Vol#: 300

C 6879 Pamela Garber Vol#: 300

C 6880 Elizabeth Ruf Vol#: 300

C 6881 Annie Hawkins Vol#: 300

C 6882 Jeri Behrmans Vol#: 300

C 6883 Barbara Marsheille Vol#: 300

C 6884 Mr & Mrs Bryan Vetch Vol#: 300

C 6885 Emily Ann Gatsby Vol#: 300

C 6886 Karl Hargrave Vol#: 300

C 6887 Sandra Meatze Vol#: 300

C 6888 Bill Combs Vol#: 300

C 6889 Kathy Radford Vol#: 300

C 6890 Sonja Severson Vol#: 300

C 6891 Marion Rawson Vol#: 300

C 6892 Karem Eppard Vol#: 300

C 6893 John Hinman Vol#: 300

C 6894 Gerald Eysaman Vol#: 300

C 6895 Neil Harrington Vol#: 300

C 6896 Jennifer Wood Vol#: 300

C 6897 Virginia Brain Vol#: 300

C 6898 Michael Hamilton Vol#: 3003

C 6899 C J Wolford Vol#: 300

C 6900 Betty S Roberts Vol#: 300

C 6901 Trudy Mason Vol#: 300

C 6902 Pat King Vol#: 300

C 6903 Tanya Tope Vol#: 300

C 6904 Joan Beldin Vol#: 300

C 6905 Liz Graham Vol#: 300

C 6906 Jay Shafer Vol#: 300

C 6907 Karen Horne Vol#: 300

C 6908 Troy A Billings Vol#: 300

C 6909 Janet Franklin Vol#: 300

C 6910 Norman Prussack Vol#: 300

C 6911 Aldo Jan Eysaman Vol#: 300

C 6912 Michele Friedlander Vol#: 300

C 6913 Drashell Schmidt Vol#: 300

C 6914 Diana Lorenzo Vol#: 300

C 6915 David J Turner Vol#: 300

C 6916 Heather Parrish Vol#: 300

C 6917 Cari Kraudt Vol#: 300

C 6918 Betty Rubens Vol#: 300

C 6919 Beth Taylor Vol#: 300

C 6920 Jean Hertchison Vol#: 300

C 6921 Deane Anderson Vol#: 300

C 6922 Jeanette Cheney Vol#: 300

C 6923 R A Clayville Vol#: 300

EMC 3567 Sam Haschert Vol#: 300

00P-1322 Food Labeling and Allergen Contamination Control

ANS 1 HFS-1 Vol#: 2

C 3 The Food Allergy Network Vol#: 2