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.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

98E-0854 Patent Extension 4,485,088 BAPTEN (beta-aminopropionitrile 
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;
98N-1038 Irradiation in the production, processing, &handling of food
98N-1170 Sunlamp Products Performance Standard
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99D-0121 Waiver of in vivo biavailability & bioequivalence studies
99M-1167 PMA Keravision Intacs, P980031
99P-0033 Combat the spread of transmissible spongiform

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98E-0854 Patent Extension 4,485,088 BAPTEN (beta-aminopropionitrile

LET 2 HFY-20 Vol#: 1

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

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98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 126 Baylor College of Medicine Vol#: 19

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

C 839 Jack Stuart Vol#: 18

C 840 Betsy Cashen Vol#: 18

C 841 Joan Fraser, MD Vol#: 18

C 842 Rhonda Fields Vol#: 18

C 843 Elizabeth A. Pfaft Vol#: 18

C 844 Diana Anthony-Avers Vol#: 18

C 845 Joyce Sabella Vol#: 18

C 846 Erik N. Guss Vol#: 18

C 847 Alinda Worley Vol#: 18

C 848 Michele Friedrich Vol#: 18

C 849 LeRoy & Shirley Waszak Vol#: 18

C 850 Alicia Amaral Vol#: 18

C 851 Anne Lindholm 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 856 Elaine Dutton Vol#: 18

C 857 Michael Mazzetti Vol#: 18

C 858 Chris Worden Vol#: 18

C 859 Celebration of Health Center Vol#: 18

C 860 Anne Millhollen Vol#: 18

C 861 Lynne Russell 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 867 C. Kent Vol#: 19

C 868 Jeanne F. Harper Vol#: 19

C 869 Wendy K. Moss 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 873 Donna Cassata 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 879 Linda Haight Vol#: 19

C 880 Joyce & Richard Rouse Vol#: 19

C 881 E. Orndorf Vol#: 19

C 882 Anne Shermon Vol#: 19

C 883 Nelson M. Feldman Vol#: 19

C 884 Sharon Cody Vol#: 19

C 885 Donna J. Young Vol#: 19

C 886 Silvermoon Pamela Johnson Vol#: 19

C 887 Jan Spencer Vol#: 19

C 888 Dorothy J. LeGeyt Vol#: 19

C 889 A. Isabel Mease Vol#: 19

C 890 Donna Kessler Vol#: 19

C 891 Dorothy Feder 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

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98N-1170 Sunlamp Products Performance Standard

C 3 Untraviolet Medical Systems Vol#: 1

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98N-1265 Distribution of Compounded Drug Products

C 1535 Teresa H. Stephenson Vol#: 73

C 1536 Jean Schoellerman Vol#: 73

C 1537 Ruth Frey Vol#: 73

C 1538 Peggy Hinders Vol#: 73

C 1539 Kathleen Johns Vol#: 73

C 1540 Lynn Harvey 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 1548 Dan Norman Vol#: 73

C 1549 Ani Ertel Magid Vol#: 73

C 1550 Marilyn Stolove Vol#: 73

C 1551 Nancy E. Miller Vol#: 73

C 1552 Karla VanDyke 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 1558 Ruth Heyes Vol#: 73

C 1559 Joel Lehrer 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 1564 R. Gieber 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 1570 Jean Kerr Vol#: 73

C 1571 Jeanne Ketcham Vol#: 73

C 1572 Rachael Z. Buck Vol#: 73

C 1573 Toni Bagliani Vol#: 73

C 1574 Iris S. McNalley Vol#: 73

C 1575 Bonnie Shaw Vol#: 73

C 1576 Linda Sprecher Vol#: 73

C 1577 Sharon Catanzaro Vol#: 73

C 1578 M. J. Lazarus Vol#: 73

C 1579 Tamara L. Trattner Vol#: 73

C 1580 Elizabeth Wakeman Vol#: 73

C 1581 Mary Hurst Vol#: 73

C 1582 Phyllis Mangano Vol#: 73

C 1583 Marilyn Dahm Vol#: 73

C 1584 Mr & Mrs Bruce Hanson Vol#: 73

C 1585 Maryann Waite Vol#: 73

C 1586 Susan Puga Vol#: 73

C 1587 Joan Heineman Vol#: 73

C 1588 Barbara Bonnett Vol#: 73

C 1589 Marlene J. Moon Vol#: 73

C 1590 Polly Tuggle 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

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

C 2135 Jeanette L. Stauffer Vol#: 52

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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

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99D-0121 Waiver of in vivo biavailability & bioequivalence studies

C 11 Bristol-Myers Squibb Pharm Res Institute Vol#: 1

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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

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99M-1167 PMA Keravision Intacs, P980031

AAV 1 KeraVision, Inc Vol#: 1

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99P-0033 Combat the spread of transmissible spongiform

C 51 Janice F. Kargus Vol#: 1

C 52 Lisa Montmarquet Vol#: 1

C 53 Sharon W. Reich Vol#: 1

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