DOCKETS ENTERED on APRIL 21, 1999

Updated as of 11:00 am, April 26, 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.

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77N-0240 Single-Entity Coronary Vasodilators

HER 35 Zeneca Pharmaceuticals Vol#: 27

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95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3692 Honorable Wayne T. Gilchrest (CI) Vol#: 291

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96P-0215 Withdrawal Norplant's approval for sale in the United States

C 203 Denise M. Miller Vol#: 5

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98D-0785 Medical imaging drugs and biologics

C 18 American College of Nuclear Physicians Vol#: 2

SUP 1 Bracco Diagnostics, Inc. Vol#: 2

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98D-0994 Draft Guidance for Industry on BACPAC I

C 33 Abbott Laboratories Vol#: 2

C 34 Astra Pharmaceuticals Vol#: 2

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98D-1195 Bioanalytical Methods Validation for Human Studies

C 35 Astra Pharmaceuticals Vol#: 2

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98D-1267 Impurities in Drug Substances

C 5 Merck Research Laboratories Vol#: 1

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98E-0851 Patent Extension #4,291,708, T-SCAN

AAV 1 US Dept of Commerce Patent & Trademark Vol#: 1

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98H-0558 Civil Money Penalties;Bill Reed & Steve Reed,d/b/a Reed's

MO 1 GCF-1 Vol#: 1

98H-0573 Civil Money Penalties; Olga Coclas, d/b/a Winthrop Shoppers

LET 3 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0575 Civil Money Penalties; K & G Stores Inc,d/b/a Conoco

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0589 Civil Money Penalties; Metro Mini Mart Inc

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0628 Civil Money Penalties;Eckerd Corp. d/b/a Eckerd Drugs #302

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0629 Civil Money Penalties;Eckerd Corp. d/b/a Eckerd Drugs #833

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0637 Civil Money Penalties;Ellison Enterprises,d/b/a Price Choppe

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0638 Civil Money Penalties;Cheng Kwong Seafood Market Inc

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0650 Civil Money Penalties;Pacific Sun Corp,d/b/a Pacific Super

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0684 Civil Money Penalties; Coastal Mart Inc.

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0687 Civil Money Penalties; Eckerd Corporation,d/b/a Eckerd Drug

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0691 Civil Money Penalties;Roundup Co Inc,d/b/a Fred Meyer

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0733 Civil Money Penalties;Moo Nam An and Pyung Ja An,d/b/a Don's

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0735 Civil Money Penalties; Camp Oil Co Inc,d/b/a Sav-A-Ton

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0738 Civil Money Penalties; Mansei 1 Inc.,d/b/a Fairway One Stop

LET 2 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

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

C 123 Susan Pendleton Vol#: 19

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98N-0970 Labeling for Menstrual Tampons

C 2 Personal Products Vol#: 1

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

C 699 Charles R. Robinson Vol#: 14

C 700 Joanne van der Vossen Vol#: 14

C 701 Peter Reardon-Anderson Vol#: 14

C 702 Sarah Anne Strup Vol#: 14

C 703 Alison Henck Vol#: 14

C 704 Ariel Werner Vol#: 14

C 705 Rebecca S. Robinson Vol#: 14

C 706 Konrad Schweitzer Vol#: 14

C 707 Erol Civan Vol#: 14

C 708 Andrew Roarty Vol#: 14

C 709 Julie Strawhorn Vol#: 14

C 710 Cindy Berger Vol#: 14

C 711 Beverly Stadiun Vol#: 14

C 712 John, Julie, Stella & Emma Brouson Vol#: 14

C 713 Naomi Zuckerman Vol#: 14

C 714 Form Letters 18 Vol#: 15

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98N-1109 Mercury Compounds in Drugs and Food

C 2 Boericke & Tafel Vol#: 2

C 3 Natural Pharmaceutical Manuf, Inc Vol#: 2

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98N-1265 Distribution of Compounded Drug Products

C 1202 Linda Benty Vol#: 69

C 1203 Shirley A. Oster Vol#: 69

C 1204 Joy Nugent Vol#: 69

C 1205 Tarea Catalano Vol#: 69

C 1206 Enid Portnoy Vol#: 69

C 1207 John W. Argabrite Vol#: 69

C 1208 Gloria Young Vol#: 69

C 1209 Celeste Callahan Vol#: 69

C 1210 Arlene Clotfelter Vol#: 69

C 1211 Katharine Rodriguez Vol#: 69

C 1212 Kathleen T. Cowperthwait Vol#: 69

C 1213 Diane Bozeman Vol#: 69

C 1214 Jeanne Morris Vol#: 69

C 1215 Julia Romagnoli Vol#: 69

C 1216 Georgiana Raco Vol#: 69

C 1217 Elizabeth Willis Vol#: 69

C 1218 Sandra M. Novak Vol#: 69

C 1219 Robin Stahlecher Vol#: 69

C 1220 Audrey Brown Vol#: 69

C 1221 Eileen O'Keefe Vol#: 69

C 1222 Rita Blake Vol#: 69

C 1223 Karen Rogers Vol#: 69

C 1224 Betty Dickerson Vol#: 69

C 1225 Sherry Diaz Vol#: 69

C 1226 Patricia Tobin Fein Vol#: 69

C 1227 Justin Pharmacy Vol#: 69

C 1228 Carolyn Geiser Vol#: 69

C 1229 Sharon Seebruck Vol#: 69

C 1230 Laura Murphy Vol#: 69

C 1231 Lillie M. Gill Vol#: 69

C 1232 Ellice Pinn Vol#: 69

C 1233 Carol Wilson Vol#: 69

C 1234 Margarete A. Fox Vol#: 69

C 1235 Ann Overschmidt Vol#: 69

C 1236 Jane Gold Vol#: 69

C 1237 Amy C. Salniker Vol#: 69

C 1238 Elizabeth Powell Vol#: 69

C 1239 Stacy Cruder Vol#: 69

C 1240 E. Kinyon Vol#: 69

C 1241 Judith Luger Vol#: 69

C 1242 Barbara Carver Zani Vol#: 69

C 1243 Jean C. Eads Vol#: 69

C 1244 Vicki Sommer Vol#: 69

C 1245 Catherine P. Kinchens Vol#: 69

C 1246 Vernon Lewis Vol#: 69

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

C 2089 Sheila Mclachlin Vol#: 52

C 2090 Air Resources Board Vol#: 52

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1067 Richard & Mary Hawran & Family Vol#: 26

C 1068 Emily S Vivitoe Vol#: 26

C 1069 Carole Thomas Vol#: 26

C 1070 Ms Holly Cowden Vol#: 26

C 1071 Harvey Topper Vol#: 26

C 1072 Pamela S Harders Vol#: 26

C 1073 Katy & Steve Brown Vol#: 26

C 1074 Daniel A Wilson Vol#: 26

C 1075 Blanche Sirmans Vol#: 26

C 1076 Phyllis Trostrud Vol#: 26

C 1077 Linda Van Den Bussche Vol#: 26

C 1078 Desiree J Childers Vol#: 26

C 1079 Anne-Marie Tustin Vol#: 26

C 1080 Theresa Keene Vol#: 26

C 1081 Laurel Harris & Andrew Marcopulos Vol#: 26

C 1082 Sheila Holbrook Vol#: 26

C 1083 Brittany Ottens Vol#: 26

C 1084 Kriston Nelson Vol#: 26

C 1085 Ms Anu Minocha Vol#: 26

C 1086 Ms Carmel G McPherson Vol#: 26

C 1087 Kathleen Joyce Vol#: 26

C 1088 Rory W Alden Vol#: 26

C 1089 Charlotte Purrington Vol#:

C 1090 Holly J Wells Vol#: 26

C 1091 Eve Barenholtz Vol#: 26

C 1092 Toni Schatz Vol#: 26

C 1093 Denise Trafforel Vol#: 26

C 1094 Marla Maleski Vol#: 26

C 1095 Carol l Clark Vol#: 26

C 1096 Jan Valies Vol#: 26

C 1097 James P Loughlin Vol#: 26

C 1098 Melanie Spear Vol#: 26

C 1099 Mr Booth K Bender Vol#: 26

C 1100 Chris Drumright Vol#: 26

C 1101 Angela Magnano Vol#: 26

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 57 Ford Sea Products. Inc. Vol#: 8

C 58 Umpqua Aquaculture, Inc. Vol#: 8

C 59 Houma Bearing Service, Inc. Vol#: 8

C 60 Collins Oyster Co. Inc. Vol#: 8

C 61 Baywater, Inc. Vol#: 8

C 62 Bon Secour Fisheries, Inc. Vol#: 8

C 63 Mary Etta Nelson Vol#: 8

C 64 Bruce K. Pollock Vol#: 8

C 65 Intersea Fisheries West, Inc. Vol#: 8

C 66 Dr. Custy Fernandes Vol#: 8

C 67 Pacific Oyster Company Vol#: 8

C 68 Scottcos of Dulac, Inc Vol#: 8

C 69 West Coast Seafood Processors Assn. Vol#: 8

C 70 Gulf States Marine Fishereies Commission Vol#: 8

C 71 Ann-Wallis White Charter Yacht Consultan Vol#: 8

C 72 Michael Parker Vol#: 8

C 73 Thompson Enterprises Vol#: 8

C 74 Harris Crab House Vol#: 8

C 75 Form Letter 6 Vol#: 11

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

C 3 Procter & Gamble Pharmaceuticals Vol#: 1

C 4 GlaxoWellcome Vol#: 1

C 5 Pharmacia & Upjohn Vol#: 1

C 6 Boehringer Ingelheim Pharmaceuticals Inc Vol#: 1

C 7 SmithKline Beecham Pharmaceuticals Vol#: 1

C 8 Eli Lilly & Company Vol#: 1

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99D-0296 Fortmal Meetings with Sponsors/Applicant for PDUFA Products

C 1 Merck Research Laboratories Vol#: 1

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99D-0297 Formal Dispute Resolution Appeals above the Division Level

C 1 Merck Research Laboratories Vol#: 1

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99E-1070 Reboxetine Mesylate, Patent No. 4,229,449

APP 1 Pharmacia & Upjohn S.p.A. Vol#: 1

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

99E-1071 Provigil, Patent No. 4,177,290

APP 1 Cephalon, Inc. Vol#: 1

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

99H-0177 Civil Money Penalties; Jayswal Ent Inc,d/b/a Hometown Pantry

EXB 2 Jayswall Enterprises Inc,d/b/a Hometown Vol#: 1

99H-0450 Civil Money Penalties;Mississippi Oil Inc,d/b/a Miss Amoco

ANS 1 Mississippi Oil Co. Vol#: 1

99H-0542 Civil Money Penalties;Holmes Oil Co Inc,d/b/a Starpoint Phil

ANS 1 Holmes Oil Co,d/b/a Starpoint Phillips Vol#: 1

99H-0577 Civil Money Penalties;Jaybar Inc,d/b/a Stinson's village

ANS 1 Jaybar Inc,d/b/a Stinson's Village Store Vol#: 1

99H-0679 Civil Money Penalties;Stop & Shop Cos. Inc,d/b/a Stop & Shop

ANS 1 Stop & Shop Companies, Inc. Vol#: 1

99H-0710 Civil Money Penalties;Moore Oil Co Inc,d/b/a Holiday Chevron

ANS 1 Moore Oil Co, d/b/a Holiday Chevron Vol#: 1

99H-0947 Civil Money Penalties;Bursaw Oil Corp,d/b/a Pump & Pantry

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0948 Civil Money Penalties;Cloverhill Country Store & Farmstand

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0949 Civil Money Penalties;Crosby's Markets Inc,d/b/a Crosby's

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0950 Civil Money Penalties;CVS Corp,d/b/a Pharmacy #1198

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0951 Civil Money Penalties;James Deady & Robert Deady,d/b/a Kwik

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0952 Civil Money Penalties;Honey Farms Inc,d/b/a Honey Farms

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0953 Civil Money Penalties;Jitney Jungle Stores of America Inc

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0954 Civil Money Penalties;Kimarnik Inc,d/b/a Center St Convenien

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0955 Civil Money Penalties;Kmart Corp Inc,d/b/a Kmart #9736

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0956 Civil Money Penalties;Lamountain Construction Inc,d/b/a Lamo

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0958 Civil Money Penalties;Marstep Inc,d/b/a Frost Sunoco

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0960 Civil Money Penalties;Charles Miller,d/b/a Miller Supply Co

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0961 Civil Money Penalties;Luong Nguyen,d/b/a Your Neighborhood

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0962 Civil Money Penalties;Phoug Nguyen,d/b/a Boston Street Varie

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0963 Civil Money Penalties;Smitten Oil & Tire Co Inc, & James Smi

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0964 Civil Money Penalties;Spaceway Oil Co Inc,d/b/a Spaceway Oil

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0965 Civil Money Penalties;Speedway Superamerica LLC,d/b/a Supera

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0966 Civil Money Penalties;Speedway Superamerica LLc,d/b/a Supera

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0967 Civil Money Penalties;Bay Tran,d/b/a Sunny Market

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0968 Civil Money Penalties;Transglobal Gas & Oil Co Inc,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0969 Civil Money Penalties;United Supermarkets Inc,d/b/a United

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0970 Civil Money Penalties;Walgreen Eastern Co Inc,d/b/a Walgreen

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0971 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart Sto

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

NPH 1 HHS/FDA/CDER Vol#: 1

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99N-0240 Extralabel Drug Use in Animals;Agency Information Collection

C 1 Fort Dodge Animal Health Vol#: 1

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99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 41 Mark Giese Vol#: 1

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99P-0233 Exemption for Lead Wires

PAV 1 GCF-1 to Terrebonne General Medical Ctr Vol#: 1

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99P-0343 Amiodarone Hydrochloride 400mg Tablets

LET 1 Wyeth-Ayerst Research Lab Vol#: 1

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