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 January 27, 2000

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 ]

 
80N-0042 Anticaries Drug Products for OTC Human Use *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
98N-1038 Irradiation in the production, processing, &handling of food *
99N-2550 Technical data in hearing aid labeling *
80N-0042 Anticaries Drug Products for OTC Human Use

C 108 CHPA, Consumer Healthcare Products Assn Vol#: 34

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 802 Jan Martin Vol#: 31

C 803 Gloria & Harvey Welch Vol#: 31

C 804 Christine Burton Vol#: 31

C 805 Kristel Poelz-Giga Vol#: 31

C 806 Brenda Price Vol#: 31

C 807 USDA/FSIS Vol#: 31

C 808 John Mark Smeenk Vol#: 31

C 809 Marilyn Dugger Vol#: 31

97P-0197 Require that warning labels about risks of salmonella enteri

C 803 Jan Martin Vol#: 30

C 804 Gloria & Harvey Welch Vol#: 30

C 805 Christine Burton Vol#: 30

C 806 Kristel Poelz-Giga Vol#: 30

C 807 Brenda Price Vol#: 30

C 808 USDA/FSIS Vol#: 30

C 809 John Mark Smeenk Vol#: 30

C 810 Marilyn Dugger Vol#: 30

98D-0132 Medical device tracking

DL 3 Guidance Vol#: 1

NAD 3 Guidance Vol#: 1

98N-0144 Elimination of establishment license/product license

NAL 1 Vol#: 1

S 1 Supporting Statement Vol#: 1

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

C 5019 form letter count 17 Vol#: 144

C 5020 Joseph Gross Vol#: 143

C 5021 P. Sladek Vol#: 143

C 5022 AIM Associates Vol#: 143

C 5023 Joan Linney Vol#: 143

C 5024 Mrs. Joan Botwinick Vol#: 143

C 5025 Judy Shull Vol#: 145

C 5026 H. Nona Hungate Vol#: 145

C 5027 Ron Kramer Vol#: 145

C 5028 Barbara Wynroth Vol#: 145

C 5029 M. L. Cruikshank Vol#: 145

C 5030 Erin Snow Vol#: 145

C 5031 Ellen Loch Vol#: 145

C 5032 Dolores G. Meck Vol#: 145

C 5033 Ruth E. Long Vol#: 145

C 5034 Arthur B. Eliot Vol#: 145

C 5035 Mary J. Chrisulis Vol#: 145

C 5036 Mary P. Pierce Vol#: 145

C 5037 Ms. Laurel Leslie Vol#: 145

C 5038 Gay Vol#: 145

C 5039 Robert A. Jenkins, Ph.D. Vol#: 145

C 5040 Lura B. Irish Vol#: 145

C 5041 Janice Erdman et al Vol#: 145

C 5042 Bob DeBolt Vol#: 145

C 5043 Lillian Nurmela Vol#: 145

C 5044 Bernice Mueller Vol#: 145

C 5045 Jody Grage Haug Vol#: 145

C 5046 Joan De Groot Vol#: 145

C 5047 Committee For Children Vol#: 145

C 5048 Mrs. Ann Peries Vol#: 145

C 5049 Mr. & Mrs. Arthur Kulosa, Jr. Vol#: 145

EC 26 Lorraine Lemire Vol#: 145

EC 27 Linda Steen Vol#: 145

EC 28 Susan Schwartz Vol#: 145

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 802 Jan Martin Vol#: 32

C 803 Gloria & Harvey Welch Vol#: 32

C 804 Christine Burton Vol#: 32

C 805 Kristel Poelz-Giga Vol#: 32

C 806 Brenda Price Vol#: 32

C 807 USDA/FSIS Vol#: 32

C 808 John Mark Smeenk Vol#: 32

C 809 Marilyn Dugger Vol#: 32

99D-5297 Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer

GDL 1 Guidance Vol#: 1

NAL 1 Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

EXB 2 Zamiri's Arco Inc Vol#: 1

99H-3061 Civil Money Penalty;Eads News Inc,dba Eads News & Smoke Shop

LET 2 Office of Tobacco Programs Vol#: 1

99H-4010 Civil Money Penalty;Route 3A Shell,dba Route 3A Shell

MO 1 GCF-1 Vol#: 1

99H-4570 Civil Money Penalty;Victor Aguiar,dba Silver Dollar Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-4687 Civil Money Penalty;Oakland Variety Inc,dba Oakland Variety

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-4691 Civil Money Penalty;Daniel Walsh,dba Eagan's Package Store

LET 2 Office of Tobacco Programs Vol#: 1

99H-4899 Civil Money Penalty;Mt Carmel Medical Inc,dba Mt Carmel Phar

LET 2 Office of Tobacco Programs Vol#: 1

99H-4919 Civil Money Penalty;Coborn's Incorporated,dba Little Dukes

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-4991 Civil Money Penalty;David L. Palensky;dba 7-Eleven #11707

LET 2 Office of Tobacco Programs Vol#: 1

99H-4996 Civil Money Penalty;So-Lo Foods, Inc;dba Valu Foods Supermar

LET 2 Office of Tobacco Programs Vol#: 1

99H-5003 Civil Money Penalty;Suk In Chung & Haeng Ja Chung,dba Vermon

ANS 1 Suk In Chung & Haeng Ja Chung Vol#: 1

99H-5049 Civil Money Penalty;Danny K. Moore,dba Sportsman's Crossing

LET 2 Office of Tobacco Programs Vol#: 1

99H-5068 Civil Money Penalty;Haymarket Inc,dba Kennedyville Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5203 Civil Money Penalty;Gary Sinkhorn & Eydie Sinkhorn;dba Sinkh

ANS 1 Sinkhorn Grocery Vol#: 1

99H-5284 Civil Money Penalty;Janak Enterprises,Inc;dba Mountair Liquo

LET 2 Office of Tobacco Programs Vol#: 1

NPH 2 HHS/CDER/FDA Vol#: 1

99H-5336 Civil Money Penalty;Deanna Curtain,dba Wewoka Baking Company

ANS 1 Wewoka Baking Co Vol#: 1

99H-5343 Civil Money Penalty;Lexington Business Ventures Inc,dba Lexi

LET 2 Office of Tobacco Programs Vol#: 1

99H-5383 Civil Money Penalty;South Minnesota Oil Co;dba Buffalo Super

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5437 Civil Money Penalty;Richard Cline;dba Richard's Quick Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-5497 Civil Money Penalty;John M. Snow;dba Corner Stop #1

ANS 1 Cornerstop Texaco Vol#: 1

99H-5520 Civil Money Penalty;Mississippi Department of Corrections

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

EC 9 American Herbal Pharmacopoeia Vol#: 6

99N-2549 Cosmetic Product Voluntary Reporting Program

NAL 1 Vol#: 1

S 1 Supporting Statment Vol#: 1

99N-2550 Technical data in hearing aid labeling

C 1 Academy of Rehabilitative Audiology Vol#: 1

C 2 Educational Audiology Association Vol#: 1

99N-3088 Mktg Exclusivity & Patent Provisions for Certain Antibioitic

NPR 1 Vol#: 1

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

C 926 form letter count 17 Vol#: 86

C 927 Joseph Gross Vol#: 87

C 928 P. Sladek Vol#: 87

C 929 AIM Associates Vol#: 87

C 930 Joan Linney Vol#: 87

C 931 Mrs. Joan Botwinick Vol#: 87

EMC 1061 Colleen T Bell Vol#: 87

EMC 1062 Laura Weaver Vol#: 87

EMC 1063 Ann Vugrin Vol#: 87

EMC 1064 Peter Merkle Vol#: 87

EMC 1065 David Divine Vol#: 87

EMC 1066 Charles E Steyer Vol#: 87

EMC 1067 Kerry Shen Vol#: 87

EMC 1068 Joel J Ronk Vol#: 87

EMC 1069 Roaslie Deri Vol#: 87

EMC 1070 Karen Nielsen Vol#: 87

EMC 1071 Pamela Feathers Vol#: 87

EMC 1072 Karen Zimmerman Vol#: 87

EMC 1073 Jacquelin Pegg Vol#: 87

EMC 1074 Michelle VanNatta Vol#: 87

EMC 1075 Kevin & Jennifer O'Malley Vol#: 87

EMC 1076 Terrie Lewine Vol#: 87

EMC 1077 Marie Rabideau Vol#:

EMC 1078 Bradley Burns Vol#: 87

EMC 1079 S M Vasich Vol#: 87

EMC 1080 Patricia Morgan Vol#: 87

EMC 1081 Alice Butler Vol#: 87

EMC 1082 Bobbye Middendorf Vol#: 87

EMC 1083 Shirley Freriks Vol#: 87

EMC 1084 Alissa Chadburn Vol#: 87

EMC 1085 Adrian Zeglin Vol#: 87

EMC 1086 Donnadine Miller Vol#: 87

EMC 1087 Angelo & Francine Militello Vol#: 87

EMC 1088 Jan Boudart Vol#: 87

EMC 1089 Amy Adamczak Vol#: 87

EMC 1090 Sue Brockman Zeigler Vol#: 87

EMC 1091 Linda E Hamilton Vol#: 87

EMC 1092 Larry A Smith Vol#: 87

EMC 1093 Allison Saturley Vol#: 87

EMC 1094 Renu Namjoshi Vol#: 87

EMC 1095 Melissa Sterne Vol#: 87

EMC 1096 Martha White Vol#: 87

EMC 1097 Barbara Berst Vol#: 87

EMC 1098 Leah Shafer Vol#: 87

EMC 1099 Eveline Chang Vol#: 87

EMC 1100 E R Bakwin Vol#: 87

EMC 1101 Janice M Olshesky Vol#: 87

EMC 1102 Elizabeth H Edgerly Vol#: 87

EMC 1103 Kathy Lorentz Vol#: 87

EMC 1104 Maida Genser Vol#: 87

EMC 1105 Joan Spear Vol#: 87

EMC 1106 Douglas Rappe Vol#: 87

EMC 1107 Erinn Greene Vol#: 87

EMC 1108 Charles M Hughes Vol#: 87

EMC 1109 Tom Des Brisay Vol#:

EMC 1110 M A Jyurovat Vol#: 87

EMC 1111 Carol Bennett Vol#: 87

EMC 1112 Barbara Hertel Vol#: 87

EMC 1113 Katherine Imislund-Clarke Vol#: 87

EMC 1114 Sarah Lee Vol#: 87

EMC 1115 Beth Elwood Vol#: 87

EMC 1116 Lewis E Westfall Jr Vol#: 87

EMC 1117 Mark A Horowitz Vol#: 87

EMC 1118 Arlene M Thompson Vol#: 87

EMC 1119 Jolyn Piercy Vol#: 87

EMC 1120 Catherine Nordstrom Vol#: 87

EMC 1121 Ramond Merolla-Di Sanza Vol#: 87

EMC 1122 Claudia Reinhardt Vol#: 87

EMC 1123 Patricia Cole Vol#: 87

EMC 1124 Rick Batten Vol#: 87

EMC 1125 Ronald P White Vol#: 87

EMC 1126 Kris Marohn Vol#: 87

EMC 1127 Renske van Staveren Vol#: 87

EMC 1128 Carol Muckleroy Vol#: 87

EMC 1129 Alex Katz Vol#: 87

EMC 1130 Stephen Taylor Vol#: 87

EMC 1131 Wendi Laing Vol#: 87

EMC 1132 Chris Hyland Vol#: 87

EMC 1133 Daved B Kerr Vol#: 87

EMC 1134 Ronald Hathcock Vol#: 87

EMC 1135 Rebecca A Cook PhD Vol#: 87

EMC 1136 Andrea Traber Vol#: 87

EMC 1137 Gloria Larkin Vol#: 87

EMC 1138 David Diamond Vol#: 87

EMC 1139 David A Lillie Vol#: 87

EMC 1140 Barbara Dufford Vol#: 87

EMC 1141 Mildred A Greenstreet Vol#: 87

EMC 1142 Dawn Anckarstrom-Bohm Vol#: 87

99N-4955 Amendment of Various Device Regulations

NFR 1 Vol#: 1

NPR 1 Vol#: 1

00F-0175 Filing of Food Additive Petition (FAP 0A4704)

NFL 1 Vol#: 1

00H-0220 Civil Money Penalty;Balco Inc,dba Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0221 Civil Money Penalty;Clargo Inc,dba Clarksburg Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0222 Civil Money Penalty;Equilon Enterprises LLC,dba Texaco Star

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0223 Civil Money Penalty;Mahmoud S. Ezmerli,dba Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0224 Civil Money Penalty;Fast Lane Discount Tobacco Outlet Inc,db

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0225 Civil Money Penalty;Houchens Industries Inc,dba Save-A-Lot #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0226 Civil Money Penalty;Veena Kumari,dba Apna Bazaar Indian Groc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0227 Civil Money Penalty;Larabi Company,dba Pic-Pac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0228 Civil Money Penalty;Med-X Corporation,dba Med-X Drug #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0229 Civil Money Penalty;Med-X Corporation,dba Med-X Drug #7

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0230 Civil Money Penalty;Safeway Inc,dba Safeway #764

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0231 Civil Money Penalty;Tedeschi Food Shops Inc,dba Tedeschi Foo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0232 Civil Money Penalty;Francis Thompson,dba Thompson's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0233 Civil Money Penalty;Tony's Cee Bee Inc,dba Tony's Cee Bee

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0234 Civil Money Penalty;Walgreen Co,dba Walgreen's Drug Store

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0235 Civil Money Penalty;James Webb,dba Joelton Valu-Plus

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0246 Civil Money Penalty,7-Eleven Inc,dba 7-Eleven Food Store

LET 1 Office of Tobacco Program Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0247 Civil Money Penalty,Mike Larson & Craig Stratman,dba MC's Du

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0248 Civil Money Penalty;Sunset Realty Inc,dba Sunset Wholesale

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0249 Civil Money Penalty;Creekside Market Inc,dba North Towanda D

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1