FDA - Food and Drug Administration |
DOCKETS ENTERED on May 3, 1999
Updated as of 6:45 am, May 12, 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.
98E-0854 Patent Extension 4,485,088 BAPTEN (beta-aminopropionitrile
98H-0799 Civil Money Penalties; CVS Corp, d/ba/ CVS Pharmacy #4290
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0800 Civil Money Penalties; CVS Corp, d/b/a CVS Pharmacy #4391
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0801 Civil Money Penalties; Eckerd Corp, d/b/a Eckerd Drugs 1100
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0803 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion Store 57
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0804 Civil Money Penalties; Lucky's Liquors Inc,d/b/a Lucky's Liq
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0806 Civil Money Penalties;Joe Phouthavong,d/b/a Joe's Auto Servi
LET 3 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0807 Civil Money Penalties; Safeway Inc.
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0808 Civil Money Penalties; Total Petroleum Inc,d/b/a Total 2740
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0809 Civil Money Penalties; Tranco Food Mart Inc.
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
C 126 Baylor College of Medicine Vol#: 19
98N-1038 Irradiation in the production, processing, &handling of food
C 841 Joan Fraser, MD Vol#: 18
C 843 Elizabeth A. Pfaft Vol#: 18
C 844 Diana Anthony-Avers Vol#: 18
C 848 Michele Friedrich Vol#: 18
C 849 LeRoy & Shirley Waszak Vol#: 18
C 852 Bernadette Glenski Vol#: 18
C 853 Kimberley Makela Vol#: 18
C 854 Kathryn A. & Jerry B. Thompson Vol#: 18
C 855 Frankie Lee Slater Vol#: 18
C 857 Michael Mazzetti Vol#: 18
C 859 Celebration of Health Center Vol#: 18
C 860 Anne Millhollen Vol#: 18
C 862 State Board of Animal Hlth North Dakota Vol#: 18
C 863 Robert W. Lincoln Vol#: 19
C 864 Eileen M. & Paul LaFort Vol#: 19
C 865 Phyllis Underwood Vol#: 19
C 866 Helen V. Karlsen Vol#: 19
C 868 Jeanne F. Harper Vol#: 19
C 870 Seigfreid, Bingham, Levy, Selzer & Gee Vol#: 19
C 871 Margaret A. Ross Vol#: 19
C 872 Robert Lorenzini Vol#: 19
C 874 Form Letters 96 Vol#: 20
C 875 Harvest Co-op Markets Vol#: 19
C 876 Harvest Co-op Markets Vol#: 19
C 877 form Letters 66 Vol#: 21
C 878 form Letters 12 Vol#: 22
C 880 Joyce & Richard Rouse Vol#: 19
C 883 Nelson M. Feldman Vol#: 19
C 886 Silvermoon Pamela Johnson Vol#: 19
C 888 Dorothy J. LeGeyt Vol#: 19
C 889 A. Isabel Mease Vol#: 19
C 892 William F. Shertzer Vol#: 19
C 893 Gladys Schmitz et al Vol#: 19
C 894 Charles G. McDougal Vol#: 19
C 895 Christine M. Williams Vol#: 19
C 896 Sally Barrett-Page Vol#: 19
C 897 Anne Marie Connor Vol#: 19
98N-1170 Sunlamp Products Performance Standard
C 3 Untraviolet Medical Systems Vol#: 1
98N-1265 Distribution of Compounded Drug Products
C 1535 Teresa H. Stephenson Vol#: 73
C 1536 Jean Schoellerman Vol#: 73
C 1539 Kathleen Johns Vol#: 73
C 1541 Shellie K. Nixon Vol#: 73
C 1542 Elizabeth Larsen Vol#: 73
C 1543 Dorothy G. Anderson Vol#: 73
C 1544 Gregory Dickey Vol#: 73
C 1545 Jean C. Dickey Vol#: 73
C 1546 Beatrice Garner Vol#: 73
C 1547 Helen V. Klein Vol#: 73
C 1549 Ani Ertel Magid Vol#: 73
C 1550 Marilyn Stolove Vol#: 73
C 1551 Nancy E. Miller Vol#: 73
C 1553 Nanny B. Marvel Vol#: 73
C 1554 Barbara L. Laurance Vol#: 73
C 1555 Ruth M. Ritters Vol#: 73
C 1556 Great Smokies Medical Center, P.A. Vol#: 73
C 1557 Barbara Dimsdale Vol#: 73
C 1560 Joy Richardson Vol#: 73
C 1561 Renee M. Kuerbis Vol#: 73
C 1562 Susan A. Divorak Vol#: 73
C 1563 Margaret M. Vella Vol#: 73
C 1565 Judith Marienthal Vol#: 73
C 1566 Penelope Abrecht Vol#: 73
C 1567 Yvonne A. Hilden Vol#: 73
C 1568 Leonard & Katherine Neglia Vol#: 73
C 1569 Kathryn W. Wood Vol#: 73
C 1571 Jeanne Ketcham Vol#: 73
C 1572 Rachael Z. Buck Vol#: 73
C 1574 Iris S. McNalley Vol#: 73
C 1576 Linda Sprecher Vol#: 73
C 1577 Sharon Catanzaro Vol#: 73
C 1579 Tamara L. Trattner Vol#: 73
C 1580 Elizabeth Wakeman Vol#: 73
C 1582 Phyllis Mangano Vol#: 73
C 1584 Mr & Mrs Bruce Hanson Vol#: 73
C 1588 Barbara Bonnett Vol#: 73
C 1589 Marlene J. Moon Vol#: 73
C 1591 Susanna Felder Vol#: 73
C 1592 Donna Batterson Vol#: 73
C 1593 Julie A. Dawson Vol#: 73
C 1594 Leslie Ellen Tohar Vol#: 73
C 1595 Barbara E. French Vol#: 73
C 1596 Muriel J. Horton Vol#: 73
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2135 Jeanette L. Stauffer Vol#: 52
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 236 Deamer Design Grp. Architecture & Planni Vol#: 17
C 237 Bos Smoked Fish, Inc. Vol#: 17
C 238 Maryland House of Delegates Vol#: 17
99D-0121 Waiver of in vivo biavailability & bioequivalence studies
C 11 Bristol-Myers Squibb Pharm Res Institute Vol#: 1
99H-0625 Civil Money Penalties;Whitaker Oil Inc,d/b/a Diagonal Sincla
ANS 1 E-Z Variety Vol#: 1
99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor
ANS 1 Hamrick's Inc d/ba/ Carousel Liquor Vol#: 1
99H-0694 Civil Money Penalty; Rite Aid Corp d/b/a Rite Aid #7216
ANS 1 Rite Aid Corporation #7216 Vol#: 1
99H-0734 Civil Money Penalties;Bill Bueler,d/b/a H S B Tobacconist
ANS 1 Bill Bueler, d/b/a H.S.B Tobacconist Vol#: 1
99H-0896 Civil Money Penalties;Leroy Blanton & Derek Blanton,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1117 Civil Money Penalties;Pulse Petroleum co Inc,d/b/a Phillips
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1118 Civil Money Penalties;Wheeler's Service Station Inc,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1119 Civil Money Penalties;Energy Petroleum Co,d/b/a North Hanley
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1120 Civil Money Penalties;Walgreen Co,d/b/a Walgreens #3305
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1121 Civil Money Penalties;Paks Inc,d/b/a Paks West Convenience
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1122 Civil Money Penalties;Gary Johnson's Oil Corp,d/b/a Amoco
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1123 Civil Money Penalties;Grace Energy Corp,d/b/a Fastrip #1
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1124 Civil Money Penalties;Rapid Roberts Inc,d/b/a Rapid Roberts
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1125 Civil Money Penalties;Cumberland Farms Inc,d/b/a Cumberland
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1126 Civil Money Penalties;Hy-Vee Inc,d/b/a Hy-Vee Food Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1127 Civil Money Penalties;Maxi Drug Inc,d/b/a Brook Pharmacy 515
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1128 Civil Money Penalties;Delano Oil Co,d/b/a Delano Station Bre
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1129 Civil Money Penalties;H T Dunn Oil Co,d/b/a Richmond Height
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1130 Civil Money Penalties;Avanti Petroleum Inc,d/b/a Vickers
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1131 Civil Money Penalties;Hi-Vee Inc,d/b/a Regal Liquors
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1132 Civil Money Penalties;Krause Gentle Corp,d/b/a Kum & Go #407
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1133 Civil Money Penalties;Discount Smoke Shop Inc,d/b/a Discount
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1134 Civil Money Penalties;Vista Stores LLC,d/b/a C-Mart #20010
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1135 Civil Money Penalties;Frank Alosa,d/b/a Kimball's Market
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1136 Civil Money Penalties;Denny Redmon,d/b/a Quik-Stop
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1137 Civil Money Penalties;Harold Flora,d/b/a Harold Flora Amoco
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1138 Civil Money Penalties;Randy Muton,d/b/a 7-Eleven Food Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1139 Civil Money Penalties;Mike Foster,d/b/a 7-Eleven Food Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1140 Civil Money Penalties;Brenda Lawson,d/b/a Slaby's Bar & Gril
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99H-1141 Civil Money Penalties;The Cigarette Store Corp,d/b/a Cigaret
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1142 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1143 Civil Money Penalties;Ecker Corp,d/b/a Eckerd Drug Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1144 Civil Money Penalties;Kiki Grillis,d/b/a Lamar Restaurant
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1145 Civil Money Penalties;Morris Petroleum Inc,d/b/a McDowell Ex
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1146 Civil Money Penalties;Neupar Inc,d/b/a Lucky 7 Food Store #1
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1147 Civil Money Penalties;Spaceway Oil Co, Inc,d/b/a Spaceway
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1148 Civil Money Penalties;Waterville Family Grocery Inc,d/b/a
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1169 Civil Money Penalties;Restituto Catacutan & Juana Catacutan
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
99M-1167 PMA Keravision Intacs, P980031