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 November 17, 2000

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
76N-052N OTC Nasal Decongestants *
81N-0022 OTC Weight Control Drug Products for Human Use *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99F-2673 Irradiation in the Production, Processing & Handling of Food *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1424 Analytical procedures and methods validation; drug substance *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1494 Class/Reclass; Restricted Devices: Analyte Specific Reagent *
00N-1511 Petition for Administrative Reconsideration of Action *
00N-1521 Agency Information Collection Act: Food Labeling Regulations *
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt *

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

SUP 4 Intern'l Laboratory Technology Corp Vol#: 86

76N-052N OTC Nasal Decongestants

EC 1 Dr. JACK BARNES Vol#: 76

81N-0022 OTC Weight Control Drug Products for Human Use

EC 1 Dr. JACK BARNES Vol#: 95

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

RPT 82 Ocean Treasure Foods Inc Vol#: 41

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 413 HFS-456 to Cognis Corporation Vol#: 11

LET 414 HFS-456 to EFAsense Ltd Vol#: 11

LET 415 HFS-456 to E'OLA International Vol#: 11

LET 416 HFS-456 to Young Living Essential Oils Vol#: 11

LET 417 HFS-456 to Jarrow Formulas Inc Vol#: 11

LET 418 HFS-456 to The Cancer Wellness Institute Vol#: 11

LET 419 HFS-456 to SmithKline Beecham Consumer Vol#: 11

LET 420 HFS-456 to Chinese Herb Center Inc Vol#: 11

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

C 2828 Ms. Starr Rockhill Vol#: 84

C 2829 Ashley Fernandez Vol#: 84

C 2830 Cathy Polanco Vol#: 84

C 2831 Carol Kelly Vol#: 84

C 2832 Martine Flach-Aznar Vol#: 84

C 2833 Leslie Brito Vol#: 84

C 2834 Mrs. Robert Ballard Vol#: 84

C 2835 Deva Joy Gouss Vol#: 84

C 2836 Ms. Janet Scneider Vol#: 84

C 2837 L. Goughertz Vol#: 84

C 2838 Mary Ann Jazylo Vol#: 84

C 2839 Nancy Lee Tyler Vol#: 84

C 2840 Kathleen Finnegan Vol#: 84

C 2841 Pat Mehler Vol#: 84

C 2842 Doug L. Delassus Vol#: 84

C 2843 Janice Smith Vol#: 84

C 2844 Claudia Johnson Vol#: 84

C 2845 Ms. Doreen Tignanelli Vol#: 84

C 2846 Mrs. Rita Flygar Vol#: 84

C 2847 Paula Wylot Vol#: 84

C 2848 Phyllis White Vol#: 84

C 2849 Mark Goldberg Vol#: 84

C 2850 Sharon Cox Vol#: 84

C 2851 Juan Ortega Vol#: 85

C 2852 Peter Vargas Vol#: 85

C 2853 Lixmer Ventura Vol#:

C 2854 Migdalia Morel Vol#: 85

C 2855 Jane Monow Vol#: 85

C 2856 Rina M. Troy Vol#: 85

C 2857 Mrs. Jacqueline J. Kempinger Vol#: 85

C 2858 Betsy Welch Vol#: 85

C 2859 Ms. Ursula H. Schlichting Vol#: 85

C 2860 Glenda S. Brookins Vol#: 85

C 2861 Ms. Tammy Durante Vol#: 85

C 2862 K. M. Bowlin Vol#: 85

C 2863 Tammy Durante Vol#: 85

C 2864 Ann Fletcher + 13 signatures Vol#: 85

C 2865 Leona M. Kouba Vol#: 85

C 2866 Lisa Wurin Vol#: 85

C 2867 Ms. Ruth Schlossberg Vol#: 85

C 2868 Ms. Lois Wsetzel Vol#: 85

C 2869 Billie Forbus Vol#: 85

C 2870 Ralph Schiano Vol#: 85

C 2871 Don Baker, DDS Vol#: 85

C 2872 William Ross Vol#: 85

C 2873 Ms. Sarah Fiorillo Vol#: 85

C 2874 Jennifer A. Nichols Vol#: 85

C 2875 no signature Vol#: 85

C 2876 Ms. Evelyn Fenston Vol#: 85

C 2877 Ms. Vida U. Caslick Vol#: 85

C 2878 Ms. Elaine E. McClure Vol#: 85

C 2879 Someone Who Cares Vol#: 85

C 2880 Jill T. Bailey Vol#: 85

C 2881 W. Beabe Vol#: 85

C 2882 Ms. Carole Balala Vol#: 85

C 2883 Ms. Mary Fonda Vol#: 85

C 2884 Jerome Glassman Vol#: 85

C 2885 Ms. Tamara Jean Cornwell Vol#: 85

C 2886 Patricia Mace Vol#: 85

C 2887 Dorothy Savage Vol#: 85

EMC 358 Rita D. Gardner Vol#: 84

EMC 359 Corinne Ferraro Vol#: 84

EMC 360 Leonard I. Krimerman Vol#: 84

EMC 361 Jamie Durner Vol#: 84

EMC 362 Kirsten Svela Vol#: 84

EMC 363 Mary Gerber Vol#: 84

EMC 364 Kristine 712 Vol#: 84

EMC 365 Diane Trumbull Vol#: 84

EMC 366 Leanne Hodges Vol#: 84

EMC 367 Sandra Lee Steiner Vol#: 84

EMC 368 Alice Marin Vol#: 84

EMC 369 Matthew & Jodie Moehlenkamp Vol#: 84

EMC 370 Sherry Fudim Vol#: 84

99F-2673 Irradiation in the Production, Processing & Handling of Food

EC 1 Ms. Lynne mason Vol#: 1

EC 2 Mrs. Cassandra Woodin Vol#: 1

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

EC 3271 None Vol#: 479

EC 3272 Mr. Derek Greenwood Vol#: 479

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2636 illegible Vol#: 190

EMC 65 Gina Ward Vol#: 190

EMC 66 Rebecca Stack Vol#: 190

99P-2630 Establish a Daily Value for "added sugars"

EC 28 American Society for Nutritional Science Vol#: 29

EC 29 Ball State University Vol#: 29

EC 30 Mrs. Carla Brown Vol#: 28

99V-2974 Projector for Laser Light Show

SUP 1 L and L Productions Vol#: 1

00D-1424 Analytical procedures and methods validation; drug substance

C 3 SmithKline Beechman Pharmaceuticals Vol#: 1

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

MO 8 GCF-1 Vol#: 2

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 20 Yvonne B. Wolthuis-Olf Vol#: 68

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

EC 66 Mrs. Billie Schwarz Vol#: 15

EC 67 citizen Vol#: 15

EC 68 Ms. Jennifer Lilley Vol#: 15

EC 69 Mr. Ed Anderson Vol#: 15

EC 70 Ms. Marcia Hoodwin Vol#: 15

EC 71 Mrs. Marla Russell Vol#: 15

EC 72 n/a Vol#: 15

EC 73 Dr. Salah Badjou Vol#: 15

EC 74 University of Pennsylvania Vol#: 15

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EC 23 UNIVERSITY OF BALTIMORE LAW SHCOOL Vol#: 3

EC 24 CENTER FOR CLNICAL TRIALS, JOHNS HOPKINS Vol#: 3
 

00N-1449 Changes to an Approved NDA or ANDA;Agency Information Collec

EC 1 Number Not Used Vol#: 1

00N-1494 Class/Reclass; Restricted Devices: Analyte Specific Reagent

C 1 BD Biosciences Vol#: 1

00N-1501 Treshold of Regulation for Subances Used in Food-Contact

EC 1 Number Not Used Vol#: 1

00N-1511 Petition for Administrative Reconsideration of Action

EC 2 Number Not Used Vol#: 1

EC 3 Mr. John Linford Vol#: 1

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

EC 1 Mr. Mark Roth Vol#: 1

EC 2 Number Not Used Vol#: 1

EC 3 Number Not Used Vol#: 1

EC 4 Number Not Used Vol#: 1

EC 5 Number Not Used Vol#: 1

EC 6 Number Not Used Vol#: 1

EC 7 na Vol#: 1

EC 8 n/a Vol#: 1

EC 9 Number Not Used Vol#: 1

EC 10 Number Not Used Vol#: 1

EC 11 Number Not Used Vol#: 1

EC 12 Number Not Used Vol#: 1

EC 13 Number Not Used Vol#: 1

EC 14 Number Not Used Vol#: 1

EC 15 Bramble Light Nutritional Consulting LC Vol#: 1

00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt

C 1 NTEU Chapter 280 Vol#: 1

SUP 1 New Jersey General Assembly Vol#: 1
 

00Q-1582 Notification for Health Claims:Potassium Containing Foods

EC 1 Ms. Mary Jo Feeney Vol#: 1

00V-1626 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 S L V Vol#: 1

00V-1627 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Gear Connection Vol#: 1