FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 23, 1999

Updated as of 11:30 am, April 29, 1999.  The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

77N-0240 Single-Entity Coronary Vasodilators
96P-0023 Amend 101.12(b) Table 2 on Hard Candies
96P-0179 Establishes RACCs for various types of food products candies
98D-1195 Bioanalytical Methods Validation for Human Studies
98N-0044 Effect of dietary supplement on structure/function of body
98N-0826 Dietary Supplements of Health Claims
98N-1038 Irradiation in the production, processing, &handling of food
98N-1109 Mercury Compounds in Drugs and Food
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99E-1085 Pletal, Patent No. 4,277,479
99E-1086 Enbrel, Patent No. 5,712,155
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1087 ANDA Suitability for Omeprazole delayed-release tablets 40mg
99V-1072 Laser Fantasy International: 1-Rainbow 1 projector & 2-11000
99V-1088 Laser Light Show, LaserXpress

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77N-0240 Single-Entity Coronary Vasodilators

HER 37 Hercon Pharmaceutical Company, Inc Vol#: 27

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96P-0023 Amend 101.12(b) Table 2 on Hard Candies

CP 2 Brach and Brock Confections et al. Vol#: 3

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96P-0179 Establishes RACCs for various types of food products candies

CP 2 Brach and Brock Confections et al. Vol#: 3

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98D-1195 Bioanalytical Methods Validation for Human Studies

C 36 Organon Inc. Vol#: 2

98D-1266 Therapeutic Equivalence Code on Prescription Drug Labels

NEC 1 Vol#: 1

98H-0763 Civil Money Penalties;Gul Faraz,d/b/a Houston Corner Store

EXT 1 Gul Faraz,d/b/a Houston Corner Store Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

C 22305 Berlem L. Hooks Vol#: 771

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98N-0826 Dietary Supplements of Health Claims

C 18 NACDS, National Assn. of Chain Drug Stor Vol#: 1

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

C 742 Glen Mitchell Vol#: 16

C 743 E. Morrissett Vol#: 16

C 744 Betty Duffy Vol#: 16

C 745 John W. Emmert Vol#: 16

C 746 Fred & Mary Boshardt Vol#: 16

C 747 Sandra & John BeKolay Vol#: 16

C 748 Bonnie Clark Vol#: 16

C 749 Jennifer Barkan Vol#: 16

C 750 Meredith Coelho Vol#: 16

C 751 Kay Drache Vol#: 16

C 752 Donald Cortright Vol#: 16

C 753 Ralph Drayton Vol#: 16

C 754 Nancy Florsheim Vol#: 16

C 755 Gary Sanchez Vol#: 16

C 756 The Sloane Group Vol#: 16

C 757 Ed Rocks Vol#: 16

C 758 A. Kelley Vol#: 16

C 759 Karen Giles Vol#: 16

C 760 Elizabeth Coaules Vol#: 16

C 761 Rachel Samuels Vol#: 16

C 762 Richard Colbert Vol#: 16

C 763 Monica Emerich Vol#: 16

C 764 Emily F. Swan Vol#: 16

C 765 Craig S. Volland Vol#: 16

C 766 Linda Solaya Vol#: 16

C 767 Sandi Peaslee Vol#: 16

C 768 Dan O. Prussack Vol#: 16

C 769 Frederic Kent Vol#: 16

C 770 Fiora Starchild Vol#: 16

C 771 Brigitte Laing Vol#: 16

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98N-1109 Mercury Compounds in Drugs and Food

C 4 American Association Homeopathic Pharm Vol#: 2

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98N-1265 Distribution of Compounded Drug Products

C 1284 Lois Munson Vol#: 71

C 1285 Suzanne E. Gilbault-Bordens Vol#: 71

C 1286 Arlene Bernstein Vol#: 71

C 1287 Emily Hamlin Vol#: 71

C 1288 Shethar Itin Vol#: 71

C 1289 Mark Sherfey Vol#: 71

C 1290 Dr. Mary Jo Roseberry Vol#: 71

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

C 2092 Christina Menez Vol#: 52

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1102 Earleen Summitt Vol#: 26

C 1103 Johanna L Nisley-Gil Vol#: 26

C 1104 June Sharp-Adkins Vol#: 26

C 1105 Betsy Welch Vol#: 26

C 1106 Darlene Dahl Vol#: 26

C 1107 Michelle Webb Vol#: 26

C 1108 Tracey Turcotte Vol#: 26

C 1109 Susan J Tabor Vol#: 26

C 1110 Debra G Slawter Vol#: 26

C 1111 Smadar Spector Vol#: 26

C 1112 Terry Malec Vol#: 26

C 1113 Constantina Economou Vol#: 26

C 1114 Donna Worthington Vol#: 26

C 1115 Roy C Rineer Vol#: 26

C 1116 Yuriko Gessell Vol#: 26

C 1117 Dr E Knowles Vol#: 26

C 1118 Diane Burket Vol#: 26

C 1119 Louise Perata Vol#: 26

C 1120 Ms Vicky Barbee Vol#: 26

C 1121 J Disbrow Vol#: 26

C 1122 Mr John S Crouch Vol#: 26

C 1123 Sandra Gray Vol#: 26

C 1124 Eleanor Massoth Vol#: 26

C 1125 Burton Kaplan Vol#: 26

C 1126 Milda Tatlow Vol#: 26

C 1127 Jo Ann Arcarese Vol#: 26

C 1128 Sherri Rothman Vol#: 26

C 1129 Marcia L Geyer Vol#: 26

C 1130 John Crinic Vol#: 26

C 1131 Barbara A Farr Vol#: 26

C 1132 Lara J Boeck Vol#: 26

C 1133 Luanne Fickett Vol#: 26

C 1134 JerriLyn Miller Vol#: 26

C 1135 Mrs Betty P Dale Vol#: 26

C 1136 Wyvone Harris Vol#: 26

C 1137 Judith Furnan Vol#: 26

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 111 Mississippi Dept. of Marine Resources Vol#: 12

C 112 Nautor's Swan Charters Vol#: 12

C 113 Leslie S. Demich Vol#: 12

C 114 Beth Rodriguez Vol#: 12

C 115 Mark C. Beuerman Vol#: 12

C 116 Rod Toups Vol#: 12

C 117 Alabama Restaurant Assn. Vol#: 12

C 118 French Quarter Business Assn. Vol#: 12

C 119 North Carolina Restaurant Assn. Vol#: 12

C 120 Texas Restaurant Assn. Vol#: 12

C 121 Betty Falton Vol#: 12

C 122 Edward M. Simmons Vol#: 12

C 123 Bevans Oyster Company, Inc. Vol#: 12

C 124 Probiotic Solutions Limited Vol#: 12

C 125 Bagala Oyster Company Southwest Pass, In Vol#: 12

C 126 Ward Tassin Vol#: 12

C 127 Ron Johansen Vol#: 12

C 128 Umited States Senate Vol#: 12

C 129 American Public Health Assn. Vol#: 12

C 130 County of Galveston Justice of the Peace Vol#: 12

C 131 Anahuac National Bank Vol#: 12

C 132 Acme Oyster House Vol#: 12

C 133 Michigan Restaurant Assn. Vol#: 12

C 134 National Consumers League Vol#: 12

C 135 Board of County Commissioners Franklin C Vol#: 12

C 136 Jamestown S'Klallam Tribe Vol#: 12

C 137 Squaxin Island Tribe Vol#: 12

C 138 Delaware Restaurant Assn. Vol#: 12

C 139 AmeriPure Oyster Companies Vol#: 13

EXT 1 Potomac River Fisheries Commission Vol#: 12

LET 2 City of Houma Parish of Terrebonne Vol#: 12

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99E-1085 Pletal, Patent No. 4,277,479

APP 1 Otsuka Pharmaceutical Co. Ltd. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

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99E-1086 Enbrel, Patent No. 5,712,155

APP 1 Immunex Corporation Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

99F-0925 Paper and Paperboard in Contact with Aqueous & Fatty Foods

NFL 1 The Dow Chemical Co. Vol#: 1

99H-0995 Civil Money Penalties;Joe Shamoun,d/b/a Shamoun Cardinal

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0996 Civil Money Penalties;E & R Sunflower Group Inc,d/b/a Sunflo

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0997 Civil Money Penalties;Shaw's Supermarkets Inc,d/b/a Shaw's

LET 1 Office of Tobacco Programs (HF-11) Vol#:

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0998 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug #2266

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0999 Civil Money Penalties;S P Petrol Inc,d/b/a S P Petrol Inc

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1000 Civil Money Penalties;Merl Phillip Kiper,d/b/a Village Markt

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1001 Civil Money Penalties;Ray Lawrence,d/b/a Lawrence Grocery

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1002 Civil Money Penalties;Ralph Dunning,d/b/a Corner Quick Stop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1003 Civil Money Penalties;Grog & Grist Market Inc,d/b/a Grog &

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1004 Civil Money Penalties;Peggy Propst,d/b/a Tobacco Discount

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1005 Civil Money Penalties;County Square Pharmacy Inc,d/b/a Count

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1006 Civil Money Penalties;K & R Automotive Inc,d/b/a Shell Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1007 Civil Money Penalties;Store Express Inc,d/b/a Store Express

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1008 Civil Money Penalties;Faye S Turpen,d/b/a Sparks Food Center

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1011 Civil Money Penalties;Carl White Oil Co Inc,d/b/a White Stat

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1012 Civil Money Penalties;Carl White Oil Co Inc,d/b/a General Ex

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1013 Civil Money Penalties;G & W Inc,d/b/a Delwood Inc,d/b/a Delw

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1014 Civil Money Penalties;A R J Inc,d/b/a Green Apple Liquor

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1015 Civil Money Penalties;Union-Page Drugs Inc,d/b/a Union-Page

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1016 Civil Money Penalties;Midwest Petroleum Co,d/b/a Citgo

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1017 Civil Money Penalties;Cherokee Food Market Inc,d/b/a Cheroke

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1018 Civil Money Penalties;P M Place Stores Co,d/b/a Place's Disc

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1019 Civil Money Penalties;Barnett's Market Inc,d/b/a Barnett's

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1020 Civil Money Penalties;Laclede Market Inc,d/b/a Laclede Marke

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1021 Civil Money Penalties;Nash-Finch Co,d/b/a Easter Foods

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1022 Civil Money Penalties;Kowalski Companies Inc,d/b/a Kowalski'

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1023 Civil Money Penalties;Krause Gentle Corp,d/b/a Kum & Go

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1024 Civil Money Penalties;Avanti Petroleum Inc,d/b/a Vickers

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1025 Civil Money Penalties;Supervalu Inc,d/b/a Shop N' Save

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1026 Civil Money Penalties;Quiktrip Corp,d/b/a Quiktrip #638

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1027 Civil Money Penalties;Discount Smoke Shop Inc,d/b/a Discount

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1028 Civil Money Penalties;Walgreen Co,d/b/a Walgreens #2142

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1029 Civil Money Penalties;Casey's Marketing Co,d/b/a Casey's

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1030 Civil Money Penalties;Jeff Imholte,d/b/a J & M Mini Mart

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1031 Civil Money Penalties;Amirali Jabrani,d/b/a Goodfellow Shell

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1033 Civil Money Penalties;Victor Tucci,d/b/a Victor Tucci Servic

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1034 Civil Money Penalties;Michael Rupe,d/b/a Mike's Liquors

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1035 Civil Money Penalties;Gil Sullivan,d/b/a Sullivan Amoco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1036 Civil Money Penalties;Ida Cannell,d/b/a 7-Eleven #13349

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1037 Civil Money Penalties;Maria Flora,d/b/a Lindell Amoco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1038 Civil Money Penalties;Amanda Venable,d/b/a Venable Grocery

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1039 Civil Money Penalties;Amir Sabri & Dan Danish,d/b/a Amir & D

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1040 Civil Money Penalties;Edwin J Marshall & Everett Marshall

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 72 Luanne Fickett Vol#: 1

C 73 Mrs Betty Dale Vol#: 1

C 74 Mrs Judith Furnan Vol#: 1

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99P-1087 ANDA Suitability for Omeprazole delayed-release tablets 40mg

ACK 1 HFA-305 Vol#: 1

CP 1 Andrx Pharmaceuitcals, Inc. Vol#: 1

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99V-1072 Laser Fantasy International: 1-Rainbow 1 projector & 2-11000

ACK 1 HFA-305 Vol#: 1

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99V-1088 Laser Light Show, LaserXpress

ACK 1 HFA-305 Vol#: 1

VAR 1 Splash Entertainment Vol#: 1

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