Food and Drug Administration

DOCKETS ENTERED on June 11, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients
98E-0853 Patent Extension # 4,826,763, GlucaGen (glucagon (rDNA Origi
98N-1038 Irradiation in the production, processing, &handling of food
98N-1109 Mercury Compounds in Drugs and Food
98N-1170 Sunlamp Products Performance Standard
98N-1215 Foreign Establishment Registration and Listing
98N-1265 Distribution of Compounded Drug Products
99N-0391 International Guidelines on Vitamin and Mineral supplements
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1340 Declared Eternity eau de Parfum Misbranded
99P-1849 Exemption for Electrode Lead Wires & Patient cables
99P-1850 Exempt Electrode Lead Wires & Patient Cables, Model 6416

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

RPT 43 Chemtech Pharmics Inc Vol#: 23

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98E-0853 Patent Extension # 4,826,763, GlucaGen (glucagon (rDNA Origi

LET 2 HFY-20 Vol#: 1

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98H-0830 Civil Money Penalties;Sati Odeh Hasan,d/b/a Natl.Food Market

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

98H-0885 Civil Money Penalty; Friendly Shopping Inc d/b/a Scott's Gal

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

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

C 2694 Lisa Haglund, MD, FACP Vol#: 60

C 2695 Miriam Oppenheimer Vol#: 60

C 2696 Jackie Schirn Vol#: 60

C 2697 Gail Cooper Vol#: 60

C 2698 Rich Korn Vol#: 60

C 2699 Eugene & Abby Perl Vol#: 60

C 2700 Ruth Flanger Vol#: 60

C 2701 Vicki Madden et al Vol#: 61

C 2702 Marlin Vol#: 61

C 2703 M. C. Mass Vol#: 61

C 2704 Russell S. Buker, Jr. Vol#: 61

C 2705 Scott Grossman Vol#: 61

C 2706 Suzanne Carlstedt Vol#: 61

C 2707 Rendon Holloway Vol#: 61

C 2708 Paula Van Curen Vol#: 61

C 2709 Mark Dolce Vol#: 61

C 2710 Joanna Kirkpatrick Vol#: 61

C 2711 Janis Elaine Muir Vol#: 61

C 2712 Steve Self Vol#: 61

C 2713 Leonard E. Sienko, Jr. Vol#: 61

C 2714 Jonathan Jensen Vol#: 61

C 2715 Robin L. Sorrentino Vol#: 61

C 2716 John Pronchik Vol#: 61

C 2717 Daniel Read Vol#: 61

C 2718 Dr. Andrew C. Millard Vol#: 61

C 2719 Daniel, Sophia, Narayan & Byron Burke Vol#: 61

C 2720 L. Seaborg Vol#: 61

C 2721 Connie Gregory Vol#: 61

C 2722 Paul Sheridan Vol#: 61

C 2723 Dalia Carella Vol#: 61

C 2724 Leona Rea Vol#: 61

C 2725 Alice Chandleird Vol#: 61

C 2726 Bobby W. Ervin Vol#: 61

C 2727 Margaret Larrass Vol#: 61

C 2728 Diane McKay Vol#: 61

C 2729 Rachele Shaw Vol#: 61

C 2730 Barbara Zelwer Vol#: 61

C 2731 Gregory Palma Vol#: 61

C 2732 Majorie Shuman Vol#: 61

C 2733 Richard DeWid Vol#: 61

C 2734 Thatcher Forest Publishing Vol#: 61

C 2735 A. Simos Vol#: 61

C 2736 M. Paula McMinn Vol#: 61

C 2737 Cynthia Gabriel Vol#: 61

C 2738 Melissa Belvadi Vol#: 61

C 2739 Vivian Leven Vol#: 61

C 2740 P. James Powell Vol#: 61

C 2741 Mary Carney Vol#: 61

C 2742 Leslie Cerier Vol#: 61

C 2743 Joseph Rowe Vol#: 61

C 2744 Yosh Han Vol#: 61

C 2745 F. Strohman Vol#: 61

C 2746 Taran Singleton Vol#: 61

C 2747 Rebekah Feeser Vol#: 61

C 2748 Brandon Walters Vol#: 61

C 2749 Geddy Lee Vol#: 61

C 2750 Rose A. Jenkins Vol#: 61

C 2751 Gregor Robertson Vol#: 61

C 2752 Fergus O'Reilly Vol#: 61

C 2753 Cary Terrall Vol#: 61

C 2754 Vivien Richards, Ph.D. Vol#: 61

C 2755 Richard Caplan Vol#: 61

C 2756 Jonathan Elsberg Vol#: 61

C 2757 Richard DeWid Vol#: 61

C 2758 Ruth & Ron Omdalen Vol#: 61

C 2759 Cary Terrall Vol#: 61

C 2760 Arthur Schwartz Vol#: 61

C 2761 Sandra Schultz Vol#: 61

C 2762 Margie Bander Vol#: 61

C 2763 Patricia Ramey Vol#: 61

C 2764 D. Mead Vol#: 61

C 2765 Susan Brumbelow Vol#: 61

C 2766 Bryan Wilson Vol#: 61

C 2767 Henry F. Sant'Angelo Vol#: 61

C 2768 Joshua Forman Vol#: 61

C 2769 Ruth & Ron Omdalen Vol#: 61

C 2770 Fred Schmitt Vol#: 61

C 2771 Robert MacGrogan Vol#: 61

C 2772 Grace Brockway Vol#: 61

C 2773 Jan Ameen Vol#: 61

C 2774 Rhonda Bowden Vol#: 61

C 2775 Charles Pierson Vol#: 61

C 2776 Gregory Huang-Dale Vol#: 61

C 2777 Gene Leibson Vol#: 61

C 2778 Henry W. Luckower Vol#: 61

C 2779 Nada Pendic Vol#: 61

C 2780 Macon L. (Rusty) Bynum Vol#: 61

C 2781 W. Gertrude Josendal Vol#: 61

C 2782 American Preventive Medical Assn. Vol#: 61

C 2783 Leona Donian Vol#: 61

C 2784 Anne T. & Jack B. Lewis Vol#: 61

C 2785 Carol Van Steeter Vol#: 61

C 2786 Heath Davis Havlick Vol#: 61

C 2787 Susan Grybas Vol#: 61

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98N-1109 Mercury Compounds in Drugs and Food

C 8 Newton Laboratories, Inc Homeopatic Med Vol#: 2

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98N-1170 Sunlamp Products Performance Standard

C 11 Arizona Radiation Regulatory Agency Vol#: 1

C 12 Dept of Health State of Washington Vol#: 1

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98N-1215 Foreign Establishment Registration and Listing

C 1 Chem Werth Inc. Vol#: 1

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98N-1265 Distribution of Compounded Drug Products

C 3227 Marcia Kosowsky Vol#: 115

C 3228 Elizabeth King Vol#: 115

C 3229 Linda G. Hersey Vol#: 115

C 3230 Kathryn R. Setzer Vol#: 115

C 3231 Nancy K. Molander Vol#: 115

C 3232 Barbara Niels Vol#: 115

C 3233 Marion L. Drew Vol#: 115

C 3234 Phyllis Montierth Vol#: 115

C 3235 Virginia Hughes Vol#: 115

C 3236 Angela Bankston Vol#: 115

C 3237 Joan Montenegro Vol#: 115

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99H-1259 Civil Money Penalty; Duane J Clement d/b/a Henniker Pharmacy

ANS 1 Henniker Pharmcy Vol#: 1

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99N-0386 Talking with Stakeholders About FDA Modernization

LST 4 Agenda for 4/28/99 La Jolla, CA Vol#: 2

LST 5 Attendees for 4/28/99 La Jolla, CA Vol#: 2

SUM 3 Meeting Summary Boston, MA Site Vol#: 2

SUM 4 Meeting Summary San Francisco, CA Vol#: 2

SUM 5 Meeting Summary Chicago, IL Site Vol#: 2

TS 12 CryoGen Inc Vol#: 2

TS 13 Chemically Associated Neurological Disor Vol#: 2

TS 14 HIMA Vol#: 2

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99N-0391 International Guidelines on Vitamin and Mineral supplements

C 6 National Nutritional Foods Assn Vol#: 1

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99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 281 Form Letter Count 9 Vol#: 4

C 282 Form Letter Count 6 Vol#: 5

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 885 Pfizer Inc.'s Vol#: 10

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99P-1340 Declared Eternity eau de Parfum Misbranded

C 52 Rita D Gnap PhD Vol#: 2

C 53 Jacqueline F Colson Vol#: 2

C 54 Connie M Pitts Vol#: 2

C 55 Sherry Scott Vol#: 2

C 56 A R H Perceval Vol#: 2

C 57 Irene B Taylor Vol#: 2

C 58 R J Taylor Vol#: 2

C 59 Th C Willems Vol#: 2

C 60 A Hishmeh Vol#: 2

C 61 Michelle F Duval Vol#: 2

C 62 Madeline Chevalier Vol#: 2

C 63 Leona a Izzi Vol#: 2

C 64 Sharron M Pearce etc Vol#: 2

C 65 Gale R Laramie Vol#: 2

C 66 Debbie Jordan Vol#: 2

C 67 Sladjana Maksimovic Vol#: 2

C 68 Environmental Hlth Coalition of Western Vol#: 2

C 69 Lori S Greenleaf MA Vol#: 2

C 70 Marie Annette Vol#: 2

C 71 Robert Rhodes Vol#: 2

C 72 Jacki Barineau Vol#: 2

C 73 Theresa Janowski Vol#: 2

C 74 Norbert Dichter Vol#: 2

C 75 Katie Gordon Vol#: 2

C 76 sharon rooney Vol#: 2

C 77 E Renee Kole Vol#: 2

C 78 Pamela Marie Weishaupt Vol#: 2

C 79 Heidi Friedman MA Vol#: 2

C 80 Carol David Vol#: 2

C 81 Jacqueline F Colson Vol#: 2

C 82 Patricia Melrose Vol#: 2

C 83 Lorene Yacko Vol#: 2

C 84 Sharon Wachsler Vol#: 2

C 85 Catherine M. Warneski Vol#: 3

C 86 Sharon Bergida Vol#: 3

C 87 Cynthia Alison Norman Vol#: 3

C 88 Sandra Hughes Vol#: 3

C 89 Anthony Argandona Vol#: 3

C 90 Cornelia Jahn Vol#: 3

C 91 Irene Ruth Wilkenfeld Vol#: 3

C 92 Christine M Green Vol#: 3

C 93 Diane M Sohn Vol#: 3

C 94 Susan Stone Vol#: 3

C 95 Steven Lautermilch Vol#: 3

C 96 Loren Wieland Vol#: 3

C 97 Anderson Laboratories Inc Vol#: 3

C 98 Boston Women's Health Book Collective Vol#: 3

C 99 Leslie A Murchy Vol#: 3

C 100 Environmental Hlth Coalition of Western Vol#: 3

C 101 Carolyn Wilken Vol#: 3

C 102 Earle Phillips Vol#: 3

C 103 Donna Lee Vol#: 3

C 104 Fragranced Products Information Network Vol#: 3

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99P-1849 Exemption for Electrode Lead Wires & Patient cables

ACK 1 HFA-305 Vol#: 1

CP 1 Medtronic Inc Vol#: 1

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99P-1850 Exempt Electrode Lead Wires & Patient Cables, Model 6416

ACK 1 HFA-305 Vol#: 1

CP 1 Medtronic Inc Vol#: 1

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