Daily FOI Log Control No: 98001821 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A GRAY Requester: LESTER SCHWAB KATZ & DWYER Subject: DKT 94N-0078 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES Control No: 98001822 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: R SANTOS Requester: FOIA GROUP INC Subject: DKT 97N-0218 - COMMENTS Control No: 98001823 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: R SANTOS Requester: FOIA GROUP INC Subject: DKT 97S-0162 - STATEMENTS Control No: 98001824 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 HFM48 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: BIOLOGICAL PRODUCTS - CLEARED 510K & APRVD PMA'S Control No: 98001825 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: B MARDAMBEY Requester: REICHLER MILTON & MEDEL Subject: DKT 97N-0218 - COMMENTS 11 & 16 Control No: 98001826 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: R SANTOS Requester: FOIA GROUP INC Subject: DKT 97S-0316 - NEW DIETARY INGREDIENT Control No: 98001827 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: Requester: BASS A Subject: DKT 78N-0124 - DMB VOL. 5, 181, 211, ETC Control No: 98001828 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: K MARTELLO Requester: MORGAN LEWIS & BOCKIUS LLP Subject: DKT 97P-0441 - COMMENTS C3 Control No: 98001829 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFS22 Signature: B WALDMAN Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: ALOE VERA - ADR ASSOCIATED W/CONSUMPTION OF FOOD Control No: 98001830 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFS22 Signature: M HENSEL Requester: BLEAKLEY & MCKEEN PC Subject: ETHYLENE GLYCOL MONOBUTYL ETHER; 2-BUTOXYETHANOL & BUTYLACETATE - DOCS Control No: 98001831 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 HFS22 Signature: S BRIENZA Requester: PATTON BOGGS LLP Subject: DIETARY SUPPLEMENT HEALTH & EDUCATION ACT 1994 - ADMINISTRATION RECS, WARNING LTRS, CONSENT AGREEMENT, ETC Control No: 98001832 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFS22 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: SHANK - MINS 12/15,16,17/97 & 1/5/98 Control No: 98001833 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFS22 Signature: Requester: MALOTKE E Subject: ANTI-PERSPIRANTS - RECALL LTRS, ADR, SAFETY STUDIES, ETC Control No: 98001834 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFS22 HFV12 Signature: Requester: JORDAN C Subject: CURRENTS CONCEPTS IN FOOD PROTECTION - DOCS Control No: 98001835 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: N FRETZ Requester: SCANTIBODIES LABORATORY INC Subject: BLOOD BANKS & BLOOD CENTERS - LIST OF LICENCED Control No: 98001836 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: A AUSTIN Requester: VENABLE BAETJER HOWARD ET AL Subject: CHIMERIC - CORRS Control No: 98001837 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: A AUSTIN Requester: VENABLE BAETJER HOWARD ET AL Subject: IDEC & FDA - RITUXAN CORR, LBLG, SBA, ETC Control No: 98001838 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: A AUSTIN Requester: VENABLE BAETJER HOWARD ET AL Subject: GENENTECH & FDA - RITUXAN CORRS, LBLG, SBA, ETC Control No: 98001839 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: E DAMIANO Requester: US BIOSCIENCE Subject: NEUMEGA - MEDICAL OFFICER REVIEW Control No: 98001840 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: V SCHAFFNER Requester: DENALI CENTER FAIRBANKS MEMORIAL Subject: HUMAN BLOOD DERIVATIVE - LTR DTD 12/11/97 Control No: 98001841 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: Requester: HENZEL M ATTY AT LAW Subject: INT'L WORKSHOP - POLIOVIRUS 12/9-10/91 Control No: 98001842 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: R LEMMON Requester: PASTEUR MERIEUX CONNAUGHT Subject: A/C TSE - SUMMARY MINS 10/6-7/97 Control No: 98001843 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA306 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: RAMSEY R, LEANDER M, KORB N, ETC - MEMBERS OF MEDICAL IMAGING DRUGS C/V Control No: 98001844 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: G PARADISE Requester: KENYON & KENYON Subject: RESEARCH DIVISION OF BACTERIAL PRODUCTS - ANNUAL RPTS 1983-1987; ACELLULAR PERTUSSIS VACCINE COMPOSITIONS - ANALYSIS OF SAMPLES FROM 1982-1990 Control No: 98001845 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 Signature: M DEROSE Requester: ROBERT B PATTERSON LTD Subject: DIVISION OF BLOOD & BLOOD PRODUCTS - MEMORANDUM, LTRS, RECOMMENDATIONS, ETC FROM 1/93 TO 3/85 Control No: 98001846 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & SCHERING - VANCENASE, VANCERIL, PROVENTIL, ETC CORRS 1/97 TO PRESENT Control No: 98001847 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & ASTRA - RHINOCORT & PULMICORT CORR 1/1/97 TO PRESENT Control No: 98001848 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & FOREST LABS - AEROBID CORR 1/1/97 TO PRESENT Control No: 98001849 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: DEBTOR HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & RHONE POULENC RORER - NASCORT/AZMACORT CORR 1/1/97 TO PRESENT Control No: 98001850 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & ZENECA - ACCOLATE CORR 1/97 TO PRESENT Control No: 98001851 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & PFIZER - ZYRTEC CORR 1/1/97 TO PRESENT Control No: 98001852 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: CARNRICK LABS - MIDRIN CISOMETHEPTENE MUCATE, DICHLORALPHENAZONE ACETAMINOPHEN SBA, LBLG, PI, ETC Control No: 98001853 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: CARNRICK LABS - SKELAXIN SBA, APRVL LTR, LBLG, PI, ETC Control No: 98001854 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: ASPIRIN - ADR Control No: 98001855 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: DDMAC & HOECHST MARION ROUSSEL - ALLEGRA CORR 1/1/97 TO PRESENT Control No: 98001856 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: JOHNSON & JOHNSON CORP - OTC CONTRACEPTIVE PRODUCTS DOCS Control No: 98001857 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSW340 Signature: G INCORVIA Requester: PROTIVA Subject: SHERWOOD MEDICAL PRODUCTS, NORFOLK, NE - FOI SUMMARY 7/28-8/1/97 Control No: 98001858 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 77N-0094 VOLS 159-167 Control No: 98001859 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HF40 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: HENNEY J - TRAN, REMARKS & SPEECHES Control No: 98001860 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFC300 Signature: Requester: PHILIPSON C Subject: ALL DOCUMENTS RE OIG CMPLNT #112212 Control No: 98001861 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: FOI DAILY LOG ON DISK & WARNING LTRS ISSUED WEEK OF 1/20/98 Control No: 98001862 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: Z STEELE Requester: STEELE COMMUNICATIONS Subject: DKT 91P-0009 VOL 2 WDL1, 91N-384H VOL 5 LET5, LET4, ETC Control No: 98001863 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: J KENT Requester: DATEX ENGSTROM Subject: PROTOCOL SYSTEMS INC - PROPAG ENCORE 200 SERIES MONITOR K951246 Control No: 98001864 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97N-0296 C74, 94P-0036 984, 91N-384H LET4 & LET5, ETC Control No: 98001865 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: S MUSGNUNG Requester: SYNTHES USA Subject: ORTHOLOGIC 1000 BONE GROWTH STIMULATOR - P910066000; ORTHOFIX PHYSIO-STIM LITE - P850007/S018 Control No: 98001866 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 77N-0094 CP13 & LET36, 98P-0031 CP1 Control No: 98001867 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: S BUTCHOCK Requester: MEDICAL DEVICE REPORT Subject: DKT 97N-0517 APE1, C1; 97N-0477; 97P-0363 PAV1; ETC Control No: 98001868 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: F LEE Requester: INFORMATION ACCESS Subject: DKT 78N-036L VOL 82 LET118, LET117, LET113, ETC Control No: 98001869 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P MITCHELL Requester: FOOD REGULATION WEEKLY Subject: DKT 91P-0009 VOL 2 WDL1, 91N-384H VOL 5 LET5, 92P-0441 VOL 10 C100, ETC Control No: 98001870 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A KURIEN Requester: HANNOCH WEISMAN PC Subject: DKT 98P-0008, 98P-0011 Control No: 98001871 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: J HAUSHEER Requester: STERI-OSS INC Subject: ATRIX LABS - ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION K955838 SUMMARY Control No: 98001872 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: G FISHER Requester: KETCHUM PUBLIC RELATIONS Subject: A/C GASTRO & NON-RX - TRANS 7/13-14/95 Control No: 98001873 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97S-0163 VOL 2 Control No: 98001874 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 97N-0325 C59-C61 Control No: 98001875 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: K CHANG Requester: KENYON & KENYON Subject: RESPIRONICS INC - SLEEP THERAPY DEVICES WARNING LTRS, CORR, CO RESPONSE Control No: 98001876 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: DKT 77N-094W VOL 1 EXT1, 80N-0295 VOL 3 CR60, ETC Control No: 98001877 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: Requester: HERKLOTZ G Subject: IMPLANTABLE RADIO FREQUENCY ID DEVICES - RECALLS, COMPLAINTS Control No: 98001878 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: CARDIO-DYNAMICS - BIO Z SYSTEM K963183 & SS&E Control No: 98001879 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 97S-0162 LET808-814 Control No: 98001880 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 90S-0308 M384 Control No: 98001881 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: Requester: DEWEERDT J Subject: TRUQUANT BR RIA RADIOIMMUNOASSAY TEST KIT - APRVL RECS Control No: 98001882 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: K GEORGE Requester: SOFTWARE QUALITY MANAGEMENT INC Subject: DKT 98P-0022 CP1, 97N-0477 C1, 97D-0525 C1, 97D-0282 C21 Control No: 98001883 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: M JOHNSON Requester: JOHNSON & ASSOCS Subject: INDIGO MEDICAL SYSTEMS - PORTABLE LASER SYSTEM W/TEMPERATURE FEEDBACK K963969 SS&E Control No: 98001884 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: J MCKENNA Requester: FDC REPORTS INC Subject: DKT 77N-094W VOL 1 C1, 96N-0420 VOL 19 C1011, ETC Control No: 98001885 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFM48 HFRSW140 HFZ82 Signature: Requester: MAAS M Subject: LIFECELL CORP - ALLODERM APPLICATIONS FOR APRVL/LICENSING, CORR, MEMOS, ETC Control No: 98001886 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: ANADA 200-140 - FOI SUMMARY Control No: 98001887 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: PROCYTE CORP - OSMOCYTE ISLAND WOUND DRESSING K972150 SS&E Control No: 98001888 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 90S-0308 M581-583 Control No: 98001889 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: M AQUINALDO Requester: BAXTER HEALTHCARE CORP Subject: GLYCARTISSUE REPAIR PATCH - K963368 Control No: 98001890 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: DKT 97P-0354 VOL 3 PAV1, 97P-0363 VOL 2 PAV1 Control No: 98001891 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: M AQUINALDO Requester: BAXTER HEALTHCARE CORP Subject: SLYCAR PERICARDIAL PATCH - K963967 Control No: 98001892 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: L GILUEST Requester: WASHINGTON BUSINESS INFORMATION Subject: DKT 95D-0349 C2, 77N-094W C1 Control No: 98001893 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: DKT 97D-0261 NAD1 TOBACCO REGULATIONS, 97D-0411 VOL 1 C2 & C10 Control No: 98001894 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: Requester: BILSKY D Subject: VARIAN ASSOCIATES INC - LINEAR ACCELERATOR CLINAC 6X, 6/80, 6/100 510K Control No: 98001895 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: CHRON LIST OF CP PGS 428-429, DKT 97M-0254 VOL 2 C10 Control No: 98001896 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: T SCHWALENBERG Requester: NORLAND MEDICAL SYSTEMS INC Subject: LUNAR CORP - EXPERT ORTHOPEDIC HIP ANALYSIS K972517 Control No: 98001897 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R GAUDOIN Requester: HERNDON MORTON HERNDON & YAEGER Subject: PFIZER HOSPITAL PRODUCTS GROUP/AMERICAN MEDICAL SYSTEMS - AMS 700 ULTREX PLUS (TM) PENILE PROSTHESIS/AMS 700 INFLATABLE PENILE PROSTHESIS - COMPLAINTS, MDR, ETC Control No: 98001898 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: J DICKINSON Requester: FERDIC INC Subject: DKT 78N-036L MM14, 96N-0108 0B1, 98P-0022 CP1, ETC Control No: 98001899 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: PROCYTE CORP - OSMOCYTE RA WOUND DRESSING K972329 SS&E Control No: 98001900 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: PROCYTE CORP - OSMOCYTE ISLAND WOUND DRESSING K972150 Control No: 98001901 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: STRYKER INSTRUMENTS - CONSTAVAC BLOOD CONSERVATION SYSTEM II K970714 SS&E Control No: 98001902 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A FENWICK Requester: ALDERSON REPORTING Subject: DKT 94N-0304 VOLS 1-3, 88P-0407 VOLS 1-3, ETC Control No: 98001903 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: IMMUNO-U S INC - DUPLOJECT K973510 SS&E Control No: 98001904 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R LARIVIERE Requester: HARVEST TECHNOLOGIES Subject: MEDLOGIC GLOBAL CORP - SUPERSKIN K972081 SS&E Control No: 98001905 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P MITCHELL Requester: FOOD REGULATION WEEKLY Subject: DKT 97N-0217 VOL 2 C38-C43 Control No: 98001906 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRP140 Signature: Requester: FOI SERVICES INC Subject: GENCORP AEROJET, SACRAMENTO, CA - EIRS, 483S 1/96 TO 12/97 Control No: 98001907 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSW340 Signature: Requester: FOI SERVICES INC Subject: OREAD LABS, LAWRENCE, KS - EIRS, 483S 1/95 TO 12/97 Control No: 98001908 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: C.A. BLOCKERS INC - REG LTR 1989 Control No: 98001909 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: ACS DOBFAR, MILAN, ITALY - CORR RE: WARNING LTR 10/15/96, CO RESP 10/31/96, FDA LTR DTD 1/9/97 & CO RESP Control No: 98001910 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: BEDFORD - ETOMIDATE/ETOMIDATE/ANDA 74-593 APRVL LTR, LABELING, RVWS ETC Control No: 98001911 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: E DCELANEY Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - AMIDATE/ETOMIDATE/N18-227 APRVL LTR, LABELING, RVWS ETC Control No: 98001912 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSE140 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: GRANUTEK INC, WILSON, NC - EIRS, 483S, CO RESPS 9/16/97 Control No: 98001913 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRMA140 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: FMC CORP, NEWARK, DE - EIRS, 483S, CO RESPS 11/13/97 Control No: 98001914 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRNE340 Signature: P BARRETT Requester: AMBER FOODS LTD Subject: SPL #112-3052637-6 - TEST RESULTS Control No: 98001915 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFC230 Signature: R HULL Requester: HULL & CO Subject: LIST OF PLANTS IN U.S. AND PUERTO RICO REGISTERED AND APPROVED TO MANUFACTURE TABS, CAPS OR POWDERS FOR FOOD AND DRUG USE Control No: 98001916 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSW340 Signature: W ALBRECHT Requester: IMMUNO-RX INC Subject: NOVA-TECH INC, GRAND ISLAND, NE - EIRS, 483S, CO RESPS 2 MOST RECENT Control No: 98001917 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 HFRMW240 HFRNE340 Signature: R HAMER Requester: RICHARD HAMER ASSOCIATES INC Subject: NYCOMED INC, RENSSELAER, NY; TORCAN CHEMICALS INC, ONTARIO, CANADA; ZEELAND CHE-MICALS INC, ZEELAND, MI - EIRS, 483S 1994 TO 1997 Control No: 98001918 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: W SANDERS Requester: OREAD LABORATORIES INC Subject: MERCK - MEVACOR/LOVASTATIN 10, 20 & 40MG TABS SBA, APRVL PACKAGE Control No: 98001919 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: B ROSENBERG Requester: PAREXEL INTERNATIONAL CORP Subject: PHARMA HAMELN, HAMELN, GERMANY - EIR 10/97 Control No: 98001920 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRMA340 Signature: J PRYLL Requester: WEGMANS FOOD MARKETS INC Subject: G&W LABS INC, S PLAINFIELD, NY - EIRS, CMPLNTS, CO RESPS PAST 2 YRS Control No: 98001921 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: R BAHIBLA Requester: BUC & BEARDSLEY Subject: DKT 94P-0144, PETITION & ADVISORY OPINIONS VOL 2 Control No: 98001922 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: M PHELAN Requester: CANTOR ARKEMA & EDMONDS Subject: FLUMADINE/RIMANTADINE - ADRS Control No: 98001923 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: L MCGINNIS Requester: PERRIGO CO Subject: MCNEIL CONSUMER PRODS CO - CHILDRENS MOTRIN IBUPROFEN ORAL SUSPENSION/N20-516 APRVD LABELING Control No: 98001924 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: C AGNOLUTTO Requester: KING & SPALDING Subject: DKT 97P-0324 VOL 1 Control No: 98001925 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFIDR Signature: H HEDMAN Requester: Q I MEDICAL INC Subject: IMED CORP - IV FILTERSET 5 MICROMETER K813445; NATIONAL PATENT DEVELOPMENT CO - LARGE VOL 5 MICRON CONICAL K792021 Control No: 98001926 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: L MCGINNIS Requester: PERRIGO CO Subject: BRISTOL-MYERS PRODS - EXCEDRIN MIGRAINE TABS, CAPS & GELTABS/N20-802 ARPVL RECS Control No: 98001927 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P KENISTON Requester: KING & SPALDING Subject: DKT 97P-0441 VOL 4 C1, LET2; VOL 6 C2, LET6, LET10; INDEX OF PETITIONS Control No: 98001928 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 97P-0441 VOL 8 MM1 Control No: 98001929 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 97P-0441 VOL 8 C132-C138, N1 Control No: 98001930 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: Requester: PRICE L Subject: ULTRASOUND, MAMMOGRAPHY, MAGNETIC RESONANCE - APRVL DATES, LIST OF COS & MFRS Control No: 98001931 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: J DICKINSON Requester: FERDIC INC Subject: WARNING LTRS WEEK OF 1/20/98; FOI DAILY LOG 12/12, 12/19, 12/30, 1/13 & 1/14 Control No: 98001932 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: C AGNOLUTTO Requester: KING & SPALDING Subject: DKT 97N-0314 Control No: 98001933 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: WARNING LTRS WEEK OF 1/20/98; IMPORT ALERTS WEEK OF 1/12/98 Control No: 98001934 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: K GEORGE Requester: SOFTWARE QUALITY MANAGEMENT INC Subject: WARNING LTRS WEEK OF 1/20/98 Control No: 98001935 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: S LINGANE Requester: O'CONNOR COHN DILLON & BARR Subject: MEDTRONIC; BAXTER HEALTHCARE - TWO STAGE CANNULA RECS Control No: 98001936 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: I LOSS Requester: WASHINGTON ANALYSIS Subject: WARNING LTRS WEEK OF 1/20/98 Control No: 98001937 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: A/C OB/GYN - TRANS 4/22/77 CERTIFIED RECS Control No: 98001938 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: B HOLLER Requester: FOOD CHEMICAL NEWS Subject: WARNING LTRS WEEK OF 1/20/98; IMPORT ALERTS WEEK OF 1/12/98 Control No: 98001939 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: A SILVESTRI Requester: SYNTHES USA Subject: CORIN USA - CORIFIX DYNAMIC HIP SCREW SYSTEM K973231 SS&E; CORIFIX LIGAMENT ANCHOR K973005 SS&E; ETC Control No: 98001940 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRNE140 Signature: G PAPAZIAN Requester: FDC REPORTS INC Subject: ESTEE LAUDER, MELVILLE, NY - 483 9/17-23/97, CO RESP, CORR Control No: 98001941 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFA305 Signature: A LAVENDER Requester: LAVENDER CONSULTING SERVICES Subject: DKT 97N-0314 VOLS 1 & 2 Control No: 98001942 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: G PAPAZIAN Requester: FDC REPORTS INC Subject: GLUCOPHAGE PHASE IV TRIAL PROTOCOL Control No: 98001943 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: A SILVESTRI Requester: SYNTHES USA Subject: ARCAN ORTHOPAEDIC - BRYAN POSTERION SPINAL FIXATOR K971457 SS&E; ARTHREX INC - BIO-INTERFERENCE SCREW K971358 SS&E; ETC Control No: 98001944 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: S SCHNEIDERMAN Requester: FDC REPORTS INC Subject: WYETH-AYERST - REDUX PHASE 4 PROTOCOLS Control No: 98001945 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: DEBTOR HFA305 Signature: T MACK Requester: WASHINGTON DOCUMENT SERVICE INC Subject: DKT 95N-0228/TR, 97D-0525 REFERENCES 2, 11, 14 Control No: 98001946 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: A SILVESTRI Requester: SYNTHES USA Subject: BIOMEDICA INC - BIOPLATE RIGID FIXATION BONE PLATING SYSTEM K972463 SS&E; DEPUY INC - MOTECH MOSS-MIAMI SPINAL SYSTEM K972568 SS&E; ETC Control No: 98001947 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: A SILVESTRI Requester: SYNTHES USA Subject: ACE MEDICAL CO - DEPUY ACE A I M TITANIUM TIBIAL NAIL K972183 SS&E; BIOMET INC - LACTOSORB TRAUMA PLATING SYSTEM K971870 SS&E; RECOVERY PROTRUSION CAGE K971890 SS&E; ETC Control No: 98001948 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: N DUNNING Requester: NEAL DUNNING ASSOC INC Subject: ACE MEDICAL CO - ACE CERVICAL TRACTION HALOZA, TONGS/PINS K954069 SUMMARY Control No: 98001949 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R GRECO Requester: REGULATORY ASSOCIATES INC Subject: LIFE MEDICAL SCIENCES, PRINCETON, NJ - SKAR KARE SILICONE-BASED SCAR MANAGEMENT DEVICE APRVL, CLAIMS Control No: 98001950 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFZ82 Signature: R GRECO Requester: REGULATORY ASSOCIATES INC Subject: RE JUVENESS - PROMOTIONAL CLAIMS, REGULATORY ACTIONS Control No: 98001951 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: Requester: INFORMATION ACCESS Subject: 97-39759 Control No: 98001952 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: Requester: INFORMATION ACCESS Subject: 97-38264 Control No: 98001953 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: G PAPAZIAN Requester: FDC REPORTS INC Subject: WARNING LTRS - 1/20/98 Control No: 98001954 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: G PAPAZIAN Requester: FDC REPORTS INC Subject: ESTEE LAUDER, NEW YORK, NY - WARNING LTR 12/15/97 Control No: 98001955 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: T GUARINO Requester: COLLIER SHANNON RILL & SCOTT Subject: WARNING LTRS - 1/20/98 Control No: 98001956 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: W ANDERSON Requester: VENABLE BAETJER HOWARD ET AL Subject: WARNING LTRS - 1/20/98 Control No: 98001957 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FOI LOGS - 1/16/98, 1/15/98, 1/20/98 Control No: 98001958 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: Requester: INFORMATION ACCESS Subject: MARKET DRUG PRODS - SPONSORS CURRENT Control No: 98001959 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: D AUKNAVAGE Requester: HOGAN & HARTSON Subject: K940322 Control No: 98001960 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: D AUKNAVAGE Requester: HOGAN & HARTSON Subject: WARNING LTRS; IMPORT ALERTS - 1/20/98 Control No: 98001961 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFI35 Signature: J KIM Requester: BUC & BEARDSLEY Subject: WARNING LTRS; IMPORT ALERTS Control No: 98001962 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: SUMIKA FINE CHEMICALS INC, OSAKA, JAPAN - EIRS, 483S 4/94, 6/93 & 4/97 Control No: 98001963 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: SUMIKA FINE CHEMICALS CO, FIFU, JAPAN - EIR, 483 7/91 Control No: 98001964 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: ZITHROMAX - SBA, APRVL LTR, LABELING ETC Control No: 98001965 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: BIAXIN - SBQA, APRVL LTR, LABELING ETC Control No: 98001966 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: FLOVENT DISKHALER/FLUTICASONE - SBA, APRVL LTR, LABELING ETC Control No: 98001967 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: GLAXO WELLCOME - RAXAR/N20-695 SBA, APRVL LTR, LABELING ETC Control No: 98001968 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: SCHERING - CLARITIN CORR 8/19/97 TO PRESENT Control No: 98001969 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: F LEE Requester: INFORMATION ACCESS Subject: FOREST LABS - AEROBID/AEROBID-M CORR 10/30/97 TO PRESENT Control No: 98001970 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSE240 Signature: J IRVIN Requester: SMITH & NEPHEW UNITED INC Subject: SWISS AMERICAN PRODS INC, DALLAS, TX - EIR, 483 MOST RECENT Control No: 98001971 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRMA340 Signature: C LASSITER Requester: DOMINION GROUP Subject: BIOCRAFT LABS, PATTERSON, NJ - EIRS, 483S, CO RESPS 1/1/97 TO PRESENT Control No: 98001972 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSE240 Signature: L MICHAELS Requester: SUGEN INC Subject: RP SCHERER, ST PETERSBURG, FL - EIRS, 483S, CO RESPS ETC 1/94 TO PRESENT Control No: 98001973 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRSE240 Signature: L MICHAELS Requester: SUGEN INC Subject: BANNER PHARMACAPS, HIGH POINT, NC - EIRS, 483S, CO RESPS ETC 1/96 TO PRESENT Control No: 98001974 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFIGC Signature: A LUGINBUHL Requester: LIBRAIRIE LUGINBUHL Subject: APPLICATION OF MEDICAL DEVICE GMPS TO COMPUTERIZED DEVICES AND MANUFACTURING PROCESSES: MEDICAL DEVICE GMP GUIDANCE FOR FDA INVESTIGATORS Control No: 98001975 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: G LASH Requester: MAYER & BEAL Subject: A.H. ROBINS CO; AMERICAN HOME PROD CORP; WYETH-AYERST LABS OR ANY AFFILIATES - PONDIMIN AND/OR DEXFENFLURAMINE PRODS INCLUDING REDUX MARKETING, ADVERTISING, LABELING ETC Control No: 98001976 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFD205 Signature: G LASH Requester: MAYER & BEAL Subject: MEDEVA PHARM INC; FISONS CORP; RUGBY GROUP INC; PENNWALT PHARM OR AFFILIATES - PHENTERMINE PRODS INCLUDING IONAMIN MARKETING, ADVERTISING, LABELING ETC Control No: 98001977 Received Date: 01/22/98 Due Date: 02/20/98 Action Offices: HFRMW240 Signature: D BIELENDA Requester: MORGAN LEWIS & BOCKIUS Subject: NORTH AMERICAN BIOLOGICALS INC (NABI) - RECS AFTER 1995 Control No: 98001978 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: SMITHKLINE - TIMENTIN INJ (CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM) APRVL LTR, PKG CIRC, RVWS, SUPPL-030, NDA 50-530 Control No: 98001979 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: PFIZER - TROVAN INJ (ALATROFLOXACIN MESYLATE) APRVL LTR, PKG CIR, RVWS, NDA 20-759 Control No: 98001980 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: MERCK - PROPECIA TABS (FINASTERIDE) APRVL LTR, PKG CIRC, RVWS, NDA 20-788 Control No: 98001981 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: HOFFMANN LAROCHE - ROCEPHIN INJ (CEFTRIAZONE) APRVL LTR, PKG CIRC, RVWS, SUPPL- 046, NDA 50-585 Control No: 98001982 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: MERCK - PROSCAR TABS (FINASTERIDE) APRVL LTR, PKG CIRC, RVWS, SUPPL-017 NDA 20-180 Control No: 98001983 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: D GOLDSTEIN Requester: AKIN GUMP STRAUSS HAUER & FELD Subject: DRUG SCALE-UP AND POST APPRVAL CHANGES (SUPAC) - CORR Control No: 98001984 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: M SMITH Requester: FENWICK & WEST Subject: ROCH - BACTRIM APRVL PKG FROM 6/81 & 6/94 Control No: 98001985 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: M SMITH Requester: FENWICK & WEST Subject: ASTRA - FOSCAVIR APRVL PKG 9/91 Control No: 98001986 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: M SMITH Requester: FENWICK & WEST Subject: ADRIA - ANSAMYCIN APRVL PKG 12/92 Control No: 98001987 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: NEULAND LABS, HYDERABAD, INDIA - EIR 3/13-15/97 Control No: 98001988 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: FABRICA ITALIANA SINTETICI, VINCEZA, ITALY - EIR 4/11, 14-17/97 Control No: 98001989 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: ROUSSEL UCLAF, FRANCE - EIR 11/27-29/95 Control No: 98001990 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: SOREBIO, MARTILLAC, FRANCE - EIR 12/4-8/95 Control No: 98001991 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: TEIKOKU SEIYAKU, JAPAN - EIR 1/21-24/97 Control No: 98001992 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: L FITZGERALD Requester: XOMA CORP Subject: A/C ANTIVIRAL DRUG - TRAN 1/14/98 Control No: 98001993 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFW1 Signature: T BERNS Requester: THERMO ELECTRON Subject: HOLSTON S - LTR & ATTACHMENTS DTD 6/7/96 TO HONORABLE J BARTON Control No: 98001994 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 HFS22 Signature: C SCHWEITZER Requester: HENKEL CORP Subject: SOY ISOFLAVONES, PHYTOESTROGENS OR GENISTEIN - ADVERSE EFFECT RPTS Control No: 98001995 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: S MACNAB Requester: NOVARTIS PHARMACEUTICALS CORP Subject: A/C PHYCOHOPHARMACOLOGIC - TRAN & SUMMARY 7/14/97 Control No: 98001996 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA306 Signature: M TALLAS Requester: BOEHRINGER MANNHEIM DIAGNOSTICS Subject: MICROBIOLOGY DEVICES ADVISORY PANEL, CLINICAL CHEMISTRY & CLINICAL TOXICOLOGY DEVICES PANEL MTG, HEMOTOLAY & PATHOLOGY DEVICES PANEL MTG, ETC - MEMBERS Control No: 98001997 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA306 Signature: M TALLAS Requester: BOEHRINGER MANNHEIM DIAGNOSTICS Subject: MICROBIOLOGY DEVICES ADVISORY PANEL MTG - MEMBERS Control No: 98001998 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFIGC Signature: S ELLIS Requester: SHAMAN PHARMACEUTICALS INC Subject: SUMMARY FOR NEW DRUG & ANTIBIOTIC APPLICATIONS, HUMAN PHARMACOKINETIC & BIOAVAILABILITY & CHEMISTRY, MANUFACTURING & CONTROLS - FORMAT & CONTENT Control No: 98001999 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: C EVANS Requester: PHASE FIVE COMMUNICATIONS Subject: CELLCEPT MTG - TRANS 1/14/98 Control No: 98002000 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: C STUPAK Requester: MCGHAN MEDICAL CORP Subject: DKT 97M-0499 Control No: 98002001 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: DYNAMIC HEALTHCARE TECHNOLOGIES INC, MAITLAND, FL - TRANSFUSION SERVICE MANAGER BK960041 SBA Control No: 98002002 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: SHARED MEDICAL SYSTEMS, MALVERN, PA - SMS BLOOD BANK TRANFUSION SYSTEM BK960036 510K SUMMARY Control No: 98002003 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: COMMUNITY BLOOD CENTER OF GREATER KANSAS CITY, KANSAS CITY, MO - CBC BLOOD SYSTEM BK960060 SBA Control No: 98002004 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: BLOOD BANK COMPUTER SYSTEMS INC, AUBURN, WA - BLOOD BANK CONTROL SYSTEM BK960044 510K SUMMARY Control No: 98002005 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: C STUPAK Requester: MCGHAN MEDICAL CORP Subject: DKT 97M-0521 Control No: 98002006 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: BLOOD BANK COMPUTER SYSTEMS INC, AUBURN, WA - BLOOD BANK CONTROL SYSTEM BK960044 SBA Control No: 98002007 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: COMMUNITY BLOOD CTR OF GREATER KANSAS CITY, KANSAS CITY, MO - CBC BLOOD SYSTEM BK960060 510K SUMMARY Control No: 98002008 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: SHARED MEDICAL SYSTEMS, MALVERN, PA - SMS BLOOD BANK TRANSFUSION SYSTEM BK960036 SBA Control No: 98002009 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: DYNAMIC HEALTHCARE TECHNOLOGIES INC, MAITLAND, FL - TRANSFUSION SERVICE MANAGER BK960041 510K SUMMARY Control No: 98002010 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: DEPARTMENT OF DEFENSE, FALLS CHURCH, VA - DEFENSE BLOOD STANDARD SYSTEM BK960004 510K SUMMARY Control No: 98002011 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: E JONES Requester: INFORMEDICS INC Subject: DEPARTMENT OF DEFENSE, FALLS CHURCH, VA - DEFENSE BLOOD STANDARD SYSTEM BK960004 SBA Control No: 98002012 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: Requester: LANGER B Subject: DENTAL IMPLNATS MTG - TRANS 1/13/98 Control No: 98002013 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: E SOAREC Requester: LAB PHARMCOLOGICAL RESEARCH INT'L Subject: LAB PHARMACOLOGICAL RESEARCH INT'L INC, QUEBEC, CANADA - EIR 8/14-15/96 Control No: 98002014 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: C GRIFFITH Requester: CIGNA PROPERTY & CASUALTY Subject: VANCARE INC, AURORA, NE - VANDER-LIFT MEDWATCH RPTS 1993 TO PRESENT Control No: 98002015 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: E SOAREC Requester: LAB PHARMCOLOGICAL RESEARCH INT'L Subject: LAB PHARMACOLOGICAL RESEARCH INT'L INC, QUEBEC, CANADA - EIR 8/96 Control No: 98002016 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: E SOAREC Requester: LAB PHARMCOLOGICAL RESEARCH INT'L Subject: LAB PHARMACOLOGICAL RESEARCH INT'L INC, QUEBEC, CANADA - EIR 7/24-8/4/95 Control No: 98002017 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: BRISTOL MYERS SQUIBB - EXCEDRIN APRVL DOCS NDA 20802 Control No: 98002018 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HOFFMAN-LA ROCHE - CLONOPIN APRVL RECS Control No: 98002019 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: RISPERIDONE - ADR Control No: 98002020 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SERTINDOLE - ADR Control No: 98002021 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: EMADINE - APRVL DOCS NDA 20706 Control No: 98002022 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SCHERER DDS, SWINDOW WILTSHIRE, UK - EIR & 483 11/10-14/97 Control No: 98002023 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: N BEILENSON Requester: SUSMAN SCHERMER RIMMEL & SHIFRIN Subject: PREPIDIL GEL & PROSTAGLANDIN E2 - DOCS Control No: 98002024 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: C MILLER Requester: BIOCRYST PHARMACEUTICALS INC Subject: NEORAL - SBA Control No: 98002025 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: A LAVENDER Requester: LAVENDER CONSULTING SERVICES Subject: SUCRALFATE - DMF Control No: 98002026 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: L MCGINNIS Requester: PERRIGO CO Subject: NDA 20310 - FINAL PRINTING LBLG Control No: 98002027 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: L MCGINNIS Requester: PERRIGO CO Subject: DELSYM ORAL SUSPENSION - APRVL DOCS NDA 18658 Control No: 98002028 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFICD Signature: M HMRELL Requester: MORIAH CONSULTANTS Subject: OTC ACTIVE INGREDIENT LIST Control No: 98002029 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: R HANDREN Requester: HANDREN ASSOCIATES INC Subject: K872313, K884448, K810208, K820332, K915119 Control No: 98002030 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: DEPUY, WARSAW, IN - CO RESPONSE TO UNTITLED LTR ISSED BY CDRH Control No: 98002031 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: CONVATEC, PRINCETON, NJ - CO RESPONSE TO UNTITLED LTR FROM CDRH Control No: 98002032 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: INTEGRA LIFE SCIENCES - MED/TOX RVWS PMA P900033 Control No: 98002033 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: J BROWN Requester: AMERICAN COLLEGE OF CARDIOLOGY Subject: CHANGES IN MEDICAL DEVICE TRACKING & POSTMARKET SURVEILLANCE UNDER FDA MODERNIZATION ACT OF 1997 - SUMMARY/MINS 1/15/98 MTG Control No: 98002034 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFIDR HFZ82 Signature: M EVANS Requester: MED INSTITUTE INC Subject: ADVANCED CARDIOVASCULAR - ACS HI-TORQUE IRON MAN GUIDE WIRE K963702, ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE K950156, ETC Control No: 98002035 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: COEUR LABS INC, RALEIGH, NC - FRONT LOAD INJECTOR TURRENT MODEL 859-0001/200 ML FRONT LOAD K960965, FRONT LOAD INJECTOR RETROFIT KIT K965214 Control No: 98002036 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: BIORESORBABLE FIXATION TACK - K972480 510K SUMMARY Control No: 98002037 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: GORE RESOLUT XT REGENERATIVE MATERIAL - K973594 510K SUMMARY Control No: 98002038 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: T SCHWALENBERG Requester: NORLAND MEDICAL SYSTEMS INC Subject: LUNAR CORP - EXPERT MORPHOMETRY REFERENCE K961007 Control No: 98002039 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: Requester: FADEN J Subject: MATRIX ELECTROMEDICAL INC - MATARIX PRO-ELECDT K930263, SCHAD MEDICAL INSTRUMENTS K931261 510K, 510K SUMMARY Control No: 98002040 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HF35 Signature: R SANTOS Requester: FOIA GROUP INC Subject: ORPHAN PRODS DEVELOPMENT PROGRAM - MINS OF MTG & POST MTG 11/4/97 W/ERICA MCNEILLY, SAM SPARKS, JOE HALL, PETER VACCARI, DR MARTIN ROSE, ETC Control No: 98002041 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: J KRAUSER Requester: EMERGING TECHNOLOGIES GROUP INC Subject: K961385 Control No: 98002042 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: GLYCAR INC - GLYCAR PERICARDIAL PATCH K963967 Control No: 98002043 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: GLYCAR INC - GLYCARTISSUE REPAIR PATCH K963368 Control No: 98002044 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: INSTROMEDIX - LIFESIGNS CARDIAC MONITORING SYSTEM K964408 Control No: 98002045 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: K973911 - 510K SUMMARY Control No: 98002046 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: J AKERSON Requester: AKERSON ASSOCS Subject: DIAL ULTRA SKIN CARE ANTIBACTERIAL BODY WASH - DRUG LISTING REGISTRATION, SS&E TESTING, CORR Control No: 98002047 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: PSEUDOEPHEDRINE - ADR Control No: 98002048 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: WARNING LTRS WEEK OF 1/20/98; IMPORT ALERTS WEEK OF 1/12/98; K801057 - 510K Control No: 98002049 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: S BECH Requester: IPSEN SCANDINAVIA A/S Subject: IPSEN & HENRI BEAUFOUR INSTITUTE - EIR 10/9-10/95, 10/17-18/95, 10/19-24/95 Control No: 98002050 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: J GROSS Requester: ZENITH GOLDLINE PHARMACUTICALS Subject: LECITHIN - PRODUCTS Control No: 98002051 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW240 Signature: Requester: FOI SERVICES INC Subject: HYCLONE LABS, LOGAN, UT - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002052 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW440 Signature: Requester: FOI SERVICES INC Subject: SIGMA CHEMICAL CO, ST LOUIS, MO - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002053 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 HFICD Signature: J GROSS Requester: ZENITH GOLDLINE PHARMACUTICALS Subject: INACTIVE INGREDIENT GUIDE 1998 Control No: 98002054 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: B ELLIN Requester: ELLIN'S DIAMONDS INC Subject: INTAL (CROMOLYN SODIUM) - RPTD SIDE EFFECTS Control No: 98002055 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE140 Signature: Requester: FOI SERVICES INC Subject: APPLIED ANALYTICAL INDUSTRIES INC, WILMINGTON, NC - EIR, 483 7/97 Control No: 98002056 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: GEORGETOWN PAREXEL CLINICAL PHARMACOLOGY RESEARCH UNIT, WASHINGTON, DC - EIR, 483 MOST RECENT Control No: 98002057 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: A LAVENDER Requester: LAVENDER CONSULTING SERVICES Subject: MEDEVA EVANS - FLUVIRON; WYETH - FLU SHIELD; PARKE-DAVIS - FLUOGEN; CONNAUGHT - FLUZONE P/O OF VAERS 7/1/96 TO PRESENT Control No: 98002058 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMW340 Signature: Requester: FOI SERVICES INC Subject: TOTAL RENAL RESEARCH INC, MINNEAPOLIS, MN - EIR, 483 MOST RECENT Control No: 98002059 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: M NEILSON Requester: BANKERS TRUST Subject: MOLECULAR ENTITY APRVLS - DRUG NAME, APPLICATION NUMBER, SPONSORING FIRM, ETC Control No: 98002060 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: E HERRICK Requester: CHIRON CORP Subject: DKT 92N-0434 Control No: 98002061 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE540 Signature: Requester: FOI SERVICES INC Subject: PARKE-DAVIS, FAJARDO, PR - EIRS, 483S, WARNING LTRS ETC 1/92 TO 12/95 Control No: 98002062 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: PHOENIX INTL, CINCINNATI, OH - EIRS, 483S 1/95 TO PRESENT Control No: 98002063 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: R FRANKS Requester: MEDICAL DEVICE CONSULTANTS INC Subject: DKT 97M-0520 Control No: 98002064 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW340 Signature: Requester: FOI SERVICES INC Subject: JRH BIOSCIENCES, LENEXA, KS - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002065 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: V CARMAN Requester: ALTANA INC Subject: TOBRADEX OPHTHALMIC OINTMENT (NDA 50616) & SUSPENSION (NDA 50592) - SBA Control No: 98002066 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW340 Signature: Requester: FOI SERVICES INC Subject: MDS HARRIS, LINCOLN, NE - EIR, 483 MOST RECENT Control No: 98002067 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: INTRALIPID - APRVL RECS NDA 20248 Control No: 98002068 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMW340 Signature: Requester: FOI SERVICES INC Subject: COVANCE CLINICAL RESEARCH UNIT, MADISON, WI - EIR, 483 MOST RECENT Control No: 98002069 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: L JOHNSON Requester: ATHINA NEUROSCIENCES Subject: ARVL DRUG LIST Control No: 98002070 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRP140 Signature: Requester: FOI SERVICES INC Subject: JRH BIOSCIENCES, WOODLAND, CA - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002071 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMA140 Signature: Requester: FOI SERVICES INC Subject: JRH BIOSCIENCES, DENVER, PA - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002072 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFIGC Signature: Y BEN-ZAKAI Requester: KAV HABRIUT Subject: MEDICINES - LIST, ADVERTISEMENTS W/CONNECTION TO MEDICINE'S INSURANCE Control No: 98002073 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: FOI LOG 1/21/98 Control No: 98002074 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: W MCVICKER Requester: RECALL REGULATORY ANALYSIS Subject: WARNING LTRS & IMPORT ALERTS Control No: 98002075 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DUKE UNIV CLINICAL RESEARCH INSTITUTE, DURHAM, NC - EIRS, 483S, CO RESPS MOST RECENT Control No: 98002076 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-25896 Control No: 98002077 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: Z STEELE Requester: STEELE COMMUNICATIONS Subject: ISENNOCK L, FRAYSER A, POCHE J - WARNING LTRS Control No: 98002078 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMW140 Signature: V HENDRICKS Requester: OHMEDA INC Subject: TAYLOR PHARM, DECATUR, IL - EIRS, 483S, CO RESPS 1992 TO PRESENT Control No: 98002079 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-40178 Control No: 98002080 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-38567 Control No: 98002081 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMW140 Signature: V HENDRICKS Requester: OHMEDA INC Subject: TAYLOR PHARM, DECATUR, IL - EIRS, 483S, CO RESPS 1992 TO PRESENT Control No: 98002082 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFS22 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: M.K. HEALTH FOOD DISTRIBUTORS, GARDEN GROVE CA - COURTESY LTR 11/7/97 Control No: 98002083 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-38359 Control No: 98002084 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRP240 Signature: V HENDRICKS Requester: OHMEDA INC Subject: GENSIA LABS, IRVINE, CA - EIRS, 483S, CO RESPS 1994 TO PRESENT Control No: 98002085 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-40382 Control No: 98002086 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE540 Signature: V HENDRICKS Requester: OHMEDA INC Subject: FAULDING PUERTO RICO INC, AGUADILLA, PR - EIRS, 483S, CO RESPS 1994 TO PRESENT Control No: 98002087 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: 97-38670 Control No: 98002088 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE540 Signature: V HENDRICKS Requester: OHMEDA INC Subject: MOVA PHARM, CAGUAS, PR - EIRS, 483S, CO RESPS 1996 TO PRESENT Control No: 98002089 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-9210 Control No: 98002090 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 HFRNE240 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: ASSOCS OF CAPE COD, FALMOUTH, MA - EIR 11/18-21/96 Control No: 98002091 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW140 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: ALCON, FT WORTH, TX - EIR 8/14-9/27/96 Control No: 98002092 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-11989 Control No: 98002093 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRP140 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: CHIRON, EMERYVILLE, CA - EIR 6/6-30/97 Control No: 98002094 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: 98-698, 98-1128 REQUEST LTRS Control No: 98002095 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFI35 Signature: S BUTCHOCK Requester: MEDICAL DEVICE REPORT Subject: WARNING LTRS 1/20/98 Control No: 98002096 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: GCF1 HFRSW240 HFZ82 Signature: K STAUSS Requester: HALE AND DORR Subject: LEXICOR MEDICAL TECHNOLOGY INC - CIVIL PENALTY OR CONSENT AGREEMENT; PURITAN BENNETT - CIVIL PENALTY RECS Control No: 98002097 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRMA340 Signature: Requester: RAVNITZKY M Subject: 97-30448 DELETED MATERIAL Control No: 98002098 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW440 Signature: Requester: LOOS M Subject: COX MEDICAL CTRS HOME SUPPORT SYSTEMS, SPFD, MO; VICTOR MEDICAL, ST LOUIS, MO - EIR 12/30/97 Control No: 98002099 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW140 Signature: J IRVIN Requester: SMITH & NEPHEW UNITED INC Subject: SWISS AMERICAN PRODS INC, DALLAS, TX - EIR, 483 1/98 Control No: 98002100 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: R REIGLE Requester: COLGATE-PALMOLIVE CO Subject: COLGATE DENTAL CREAM/N15-148 Control No: 98002101 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSE140 Signature: R STILWELL Requester: NELSON MULLINS RILEY & SCARBOROUG Subject: SCARBOROUGH FARMS INC, GREENVILLE, SC - COLLECTION RPTS 10/96 Control No: 98002102 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ACCUTANE - MEDWATCH RPTS FOR CASE #1747358 Control No: 98002103 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SMITHKLINE BEECHAM - DIBENZYLINE CAPS ADRS Control No: 98002104 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFM48 Signature: S SMITH Requester: CHIRON DIAGNOSTICS CORP Subject: ABBOTT LABS SUPPLEMENT NO S009 & S010 - SS&E Control No: 98002105 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: KNOLL - RYTHMOL APRVL RECS Control No: 98002106 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PFIZER - TROVAN IV APRVL RECS Control No: 98002107 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFIGC Signature: B BALANA Requester: NABI Subject: ORPHAN DRUG & BIOLOGICAL DESIGNATIONS - CUMULATIVE LIST Control No: 98002108 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFA305 Signature: Requester: FOI SERVICES INC Subject: MINIMIZING MEDICAL PRODUCT ERRORS-A SYSTEMS APPROACH PUBLIC WORKSHOP MTG - TRANS1/9/98 Control No: 98002109 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: C SALMORIN Requester: PUREPAC PHARMACEUTICAL CO Subject: WYETH AYERST - LODINE XL TABS LABELING Control No: 98002110 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFICD Signature: B BATANA Requester: NABI Subject: LIST OF INVESTIGATORS INELIGIBLE TO RECEIVE INVESTIGATIONAL PRODS Control No: 98002111 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: D JOHNSON Requester: OSI PHARMACEUTICALS Subject: DERMATOLOGIC AND OPTHALMIC DRUGS A/C MTG - TRANS 11/11-12/97 Control No: 98002112 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: O GOUEDARD Requester: FOURNIER RESEARCH INC Subject: KNOLL - MERIDIA/SIBUTRAMINE HCL CAP/N20-632 APRVL RECS Control No: 98002113 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 HFRMA440 Signature: M KRAMER Requester: EPIHEALTH ASSOCS Subject: PROCTER & GAMBLE - HEAD & SHOULDERS SHAMPOO EIRS, REG LTRS ETC Control No: 98002114 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HF22 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: PHARMANEX - CHOLESTIN/MEVINOLIN LTR 9/30/97 Control No: 98002115 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: V THOMASEVICH Requester: UNION CORRECTIONAL INSTITUTION Subject: MANIC DEPRESSION DRUGS - TEST RESULTS, STUDIES ETC Control No: 98002116 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFD205 Signature: Requester: MAILENDER G Subject: VERSED - RECS Control No: 98002117 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRP340 HFRSW140 Signature: Requester: GREEN F Subject: IMMUNEX - LEUKINE/SARGRAMOSTIM CMPLNTS, RPTS ETC Control No: 98002118 Received Date: 01/23/98 Due Date: 02/23/98 Action Offices: HFRSW140 Signature: C WHELCHEL Requester: RIDGWAYS Subject: SCHOTTS BAKERY INC - RPT OF GLASS PURPORTED TO BE IN BREAD Control No: 98002119 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: O RASMUSSEN Requester: MADSEN ELECTRONICS A/S Subject: MADSEN ELECTRONICS, DENMARK - EIR 5/13-15/97 Control No: 98002120 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP240 Signature: R FRAMMOLINO Requester: LOS ANGELES TIMES Subject: DOHENY EYE & TISSUE TRANSPLANT BANK, LOS ANGELES, CA - EIR & 483 MOST RECENT Control No: 98002121 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRSE240 Signature: Requester: FOI SERVICES INC Subject: BACH M, BRADENTON, FL - EIRS, 483S, CORR 1/97 TO PRESENT Control No: 98002122 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRSE240 Signature: Requester: FOI SERVICES INC Subject: ST JOSEPH'S COMPREHENSIVE RESEARCH INSTITUTE, TAMPA, FL - EIRS, 483S, CORR ETC 1/97 TO PRESENT Control No: 98002123 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 HFRP240 Signature: Requester: FOI SERVICES INC Subject: GENENTECH, S SAN FRANCISCO, CA - EIR, 483 MOST RECENT Control No: 98002124 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRNE140 Signature: Requester: FOI SERVICES INC Subject: WILSON M, BUFFALO, NY - EIR, 483 11/23/93 Control No: 98002125 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: PUREPAC, ELIZABETH, NJ - 483, CO RESP 8/11-10/21/97 Control No: 98002126 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRSE240 Signature: Requester: FOI SERVICES INC Subject: PRIORITY HEALTHCARE CORP, ALTAMONTE SPRINGS, FL - EIRS, 483S 1/96 TO 12/97 Control No: 98002127 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: A AUSTIN Requester: VENABLE BAETJER HOWARD ET AL Subject: G.D. SEARLE & CO - COVERA-HS (VERAPAMIL HYDROCHLORIDE) DOCS, CORR CONCERNING WARNING LTR. Control No: 98002128 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 HFRP240 Signature: Requester: FOI SERVICES INC Subject: ALLERGAN, CAMPBELL, CA - EIR, 483 10/13/97 Control No: 98002129 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 Signature: Requester: FOI SERVICES INC Subject: IRVINE SCIENTIFIC, SANTA ANA, CA - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002130 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: MEDIATECH INC, HERNDON, VA - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002131 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: BIOWHITTAKER, WALKERSVILLE, MD - EIRS, 483S, WARNING LTRS ETC 1/97 TO 12/97 Control No: 98002132 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 HFRP240 Signature: D PARKIN Requester: SMITHKLINE BEECHAM Subject: ADVANCED POLYMER SYSTEMS INC, REDWOOD, CA - CO RESP, CORR RE:WARNING LTR 4/13/94 Control No: 98002133 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: RAPPAPORT N Subject: FARESTON (TOREMIFENE CITRATE) - DOCS, SIDE EFFECTS Control No: 98002134 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: DEBTOR Signature: A STEVENS Requester: MERIT PHARMACEUTICALS Subject: STERIS LABS, PHOENIX, AZ; AMERICAN REGENT LABS, SHIRLEY, NY - 483S, CO RESPS 2 MOST RECENT Control No: 98002135 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: SANOFI, WINTHROP PHARMACEUTICALS - TALWIN, ADVERSE EVENT REPORTS Control No: 98002136 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: DEBTOR Signature: B MULLENDORE Requester: ASTRA MERCK GROUP Subject: MCNEIL PHARM, LOS PIEDROS, PR - EIR 4/97 Control No: 98002137 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: FENFLURAMINE - ADVERSE EVENTS REPORTS Control No: 98002138 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMW240 Signature: B PURVIS Requester: SENECA FOODS CORP Subject: AMERICAN FINE FOODS, MILTON-FREEWATER, ID - EIRS PAST 3 YRS Control No: 98002139 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: B HEIL Requester: PLANTEX USA INC Subject: MERCK - TIMOPTIC-XE (TIMOLOL MALEATE) SBA OR EQUIVALENT PACKAGE NDA N020330 Control No: 98002140 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFM48 Signature: D MILLIRON Requester: GANNETT NEWS SERVICE Subject: VACCINE ADVERSE EVENT REPORTING SYSTEM DATABASE Control No: 98002141 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: N ISLAM Requester: MARSAM PHARMACEUTICALS INC Subject: DKT 97P-0227/CP1 Control No: 98002142 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: G PRICE Requester: OLYMPUS AMERICA INC Subject: DKT 97D-0530 Control No: 98002143 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: N MAVINKURVE Requester: MARSAM PHARMACEUTICALS INC Subject: DKT 97P-0058/CP1 Control No: 98002144 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: N MAVINKURVE Requester: MARSAM PHARMACEUTICALS INC Subject: DKT 95P-0360/CP Control No: 98002145 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: DKT 97S-0163 LET70-75 Control No: 98002146 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA210 Signature: J ESTRADA Requester: PROFESSIONAL CARPET SERVICE Subject: CARPET SERVICE & DRAPERY SERVICE - 3 MOST RECENT INVOICES Control No: 98002147 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: R LANIGAN Requester: COSMETIC INGREDIENT REVIEW Subject: EDTA, CALCIUM DISODIUM EDTA, DIAMMONIUM EDTA, ETC - STUDIES Control No: 98002148 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: J ZAWACKI Requester: BARD ACCESS SYSTEMS INC Subject: CORPAK INC - CRUZ CATHETER MDR 1996-PRESENT Control No: 98002149 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFW1 Signature: R JANKELSON Requester: MYO-TRONICS INC Subject: MYO-TRONICS INC - DOCS, RECS, CORR, ETC Control No: 98002150 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 HFD205 Signature: Requester: FOI SERVICES INC Subject: A/C ONCOLOGIC DRUGS MTG - MINS & SLIDES 12/18-19/97 Control No: 98002151 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: L MULET Requester: O'CONNOR & MEYERS Subject: KINETICOS MEDICAL INC - GREAT ATOE IMPLANT SYSTEM METATARSAL & PHALANGEAL COMPONENTS COMPLAINTS, RECALLS, MDR(S), ETC Control No: 98002152 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIMO Signature: Requester: SMITH L Subject: CPGM 7348.811, 7848.809 Control No: 98002153 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: A/C FERTILITY & MATERNAL DRUGS - MINS OF 1988 MTG Control No: 98002154 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DKT 98P-0022 CP1, 95P-0326 PAV1, 97M-0521 NAL1, ETC Control No: 98002155 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: D ALEKNAVAGE Requester: HOGAN & HARTSON Subject: DKT 97N-0436 INDEX PG 4, C51; 97P-0281 INDEX PG 1; ETC Control No: 98002156 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 97P-0441 C139, N1, LET13 Control No: 98002157 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: I KUO Requester: INDUSTRIAL TECHNOLOGY RESEARCH IN Subject: SONOQUICK ULTRASOUND GEL - K931908, SUMMARY Control No: 98002158 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: J MORRIS Requester: COOK BIOTECH INC Subject: XENOTRANSPLANTATION MTG - TRANS 12/17/97 Control No: 98002159 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: J WOOD Requester: MEDX COMMUNICATIONS INC Subject: METHYLPHENIDATE 20MG TABS - REVIEW OF BIOEQUIVALENCE STUDY Control No: 98002160 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: J BROWN Requester: ERGOSCIENCE Subject: LEK PHARMACEUTICALS, ROSEMONT PHARMMACEUTICAL - BROMOCRIPTINE MESYLATE, SBA & OTHER DOCS Control No: 98002161 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: M SERALY Requester: UNIVERSITY OF PITTSBURG Subject: PYRUVATE - TOXICITY STUDIES Control No: 98002162 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: R ROBERGE Requester: WEST PENN HOSPITAL EMERGENCY MEDI Subject: TRANSDERMAL DRUG DELIVERY SYSTEMS (CLONIDINE, SCOPOLAMINE, ESTRADIOL, FENTHAYL, NITROGLYCERIN, TESTOSTERONE, NICOTINE) ADVERSE OUTCOME DATA Control No: 98002163 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMW340 Signature: B PURVIS Requester: SENECA FOODS CORP Subject: STOKELY, SUN PRAIRIE, WI - EIRS PAST 3 YRS Control No: 98002164 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRSE240 Signature: E HALE Requester: RHEO LOGIX CORP OF AMERICA Subject: RHEOTHERAPY CTR OF TAMPA BAY, LARGO, FL - EIR 8/19/97 Control No: 98002165 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRNE240 Signature: G BROWN Requester: COBE BCT INC Subject: HAEMONETICS CORP, BRAINTREE, MA - EIRS 5/23-7/15/97 & 7/29-8/28/97 Control No: 98002166 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: D HUMAY Requester: SCHEIN PHARMACEUTICAL Subject: PHARMA COSMOS, DENMARK - EIR, ADDITIONAL DOCS OF RELECANCE TO MOST RECENT AUDIT OF 1996 Control No: 98002167 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: R ARIAN Requester: WORLD'S FINEST CHOCOLATE INC Subject: J M SMUCKER CO, NEW BETHLEHEM, PA - EIRS, EXHIBITS ETC 1993 TO PRESENT Control No: 98002168 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: T SMITH Requester: NAPP TECHNOLOGIES INC Subject: POWDERSIZE INC, QUAKERTOWN, PA; PARTICLE SIZE TECHNOLOGY INC, PLUMSTEADVILLE, PA- EIRS, 483S, CO RESPS MOST RECENT Control No: 98002169 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: T SMITH Requester: NAPP TECHNOLOGIES INC Subject: FINE GRINDING CORP, CONSHOHOCKEN, PA - EIR, 483 MOST RECENT Control No: 98002170 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA340 Signature: Requester: DOE J Subject: CMPLNT BUF-7609 Control No: 98002171 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: BOURGHOL A Subject: OTC INGREDIENT LIST Control No: 98002172 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP340 HFS22 Signature: T PAHL Requester: OLSSON FRANK & WEEDA PC Subject: CELL TECH, KLAMATH FALLS, OR - COMM ETC 1/1/96 TO PRESENT Control No: 98002173 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: P KOBYLSKI Requester: GOLDWELL COSMETICS INC Subject: CMPLNT PHI-8-0106 Control No: 98002174 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: F LEE Requester: INFORMATION ACCESS Subject: DKT 96N-0391 VOLS 3 C17, TS11, LET3, C11, TS10, ETC Control No: 98002175 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: HELLER R Subject: WYETH AYERST - DURACT, ADVRS Control No: 98002176 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 HFRMA240 HFRMA340 HFRNE140 HFRP240 Signature: R LUFT Requester: DIKE BRONSTEIN ET AL Subject: COLLATERAL THERAPEUTICS, SAN DIEGO, CA; BERLEX LABS INC, WAYNE, NJ - INDS; CORNELL UNIV MEDICAL COLLEGE, NEW YORK, NY - INDS Control No: 98002177 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DKT 87F-0179 INDEX Control No: 98002178 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: M HULL Requester: STERIS CORP Subject: STERIS CORP, ERIE, PA - EIRS 9/96 & 11/96 Control No: 98002179 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DKT 97D-0261 Control No: 98002180 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: M SZALKOWSKI Requester: AMARIC CORPORATION Subject: INDAPAMIDE - CASE REPORT M2025689 Control No: 98002181 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMA140 Signature: P DEMSKI Requester: NITTANY PHARMACEUTICALS INC Subject: NITTANY PHARM INC - EIRS 2/28/95 & 4/23/96 Control No: 98002182 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 98P-0032 CP1, 97D-0261 Control No: 98002183 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 HFRP240 Signature: P KLEIN Requester: ABC NEWS Subject: FANCY CUTT FARMS, HOLLISTER, CA - EIRS 3 MOST RECENT Control No: 98002184 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 98P-0032 VOL 1 CP1, 97M-0520 VOL 1 NAL1, ETC Control No: 98002185 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: D SCOTT Requester: PARKE DAVIS Subject: CEFTRIAXONE - APPRVL LTR & LBLG NDA 50-585 Control No: 98002186 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFM48 HFV12 Signature: K TURNER Requester: AIG CLAIM SERVICES INC Subject: BALL CLAY - IVESTIGATION INFORMATION Control No: 98002187 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRP140 Signature: Requester: GOODBEER G Subject: CONTRA COSTA COUNTY, CALIFORNIA HEALTH ASSOCS INC & BAY AREA ADDICTION RESEARCH & TREATMENT CLINICS - EIRS 2/83 TO 12/94 Control No: 98002188 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: Requester: SAUNDERS P Subject: DKT 78N-0064 C43 INDEX PG 5 Control No: 98002189 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: D LOISY Requester: LABORATOIRES FOURNIER SCA Subject: DKT 92S-0251 Control No: 98002190 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S BARLAS Requester: PACKAGING WORLD MAGAZINE Subject: DKT 97N-0436 C43, C39, C38, C34, C31, ETC Control No: 98002191 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFRMW340 HFRSW140 Signature: M GERSH Requester: GERSH & HELFRICH LLP Subject: MENTOR, MN - 483, CORR, CO RESP ETC 6/95 Control No: 98002192 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S BARLAS Requester: PACKAGING WORLD MAGAZINE Subject: DKT 97N-0296 VOL 2 C74, C71, C67, C49, C48, ETC Control No: 98002193 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFC230 Signature: C JOYCE Requester: NATIONAL PUBLIC RADIO Subject: COUNTERFEIT PHARMACEUTICALS OR BIOLOGICALS IDENTIFIED AND/OR SEIZED PAST 10 YRS Control No: 98002194 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 89N-0443 LET67, C2, ETC Control No: 98002195 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 HFM48 Signature: K KULLIYA Requester: MARY KAY ASH INSTITUTE FOR CANCER Subject: TRANSFER FACTOR/DIALYSABLE EXTRACTS - IND APPLICATION Control No: 98002196 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 77N-0094 VOL 152 HER1, 91N-0245 VOL 1 C1, 91N-0245 INDEX, ETC Control No: 98002197 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: C COLE Requester: PACIFIC RIM RESOURCES Subject: LIST OF WESTERN PHARMACUETICAL, TRADITIONAL CHINESE MEDICINE AND PHARMACUETICAL RAW MATERIAL MANUFACTURING FACILITIES IN CHINA APPROVED BY FDA Control No: 98002198 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFA305 Signature: S ECKEL Requester: FOI SERVICES INC Subject: DKT 97P-0441 VOLS 1-8 Control No: 98002199 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: GLASS C Subject: ORTHO-MCNEIL PHARM - REGRANEX/BECAPLERMIN STUDIES, CLINICAL RESULTS ETC Control No: 98002200 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIGC Signature: P MCMAHON Requester: BOEHRINGER INGELHEIM PHARMACEUTIC Subject: GOOD ACADEMIC RESEARCH PRACTICES - GUIDANCE Control No: 98002201 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: Requester: JAFARY A Subject: STARLIGHT INTERNATIONAL, MONTEREY, CA - EPHEDRA/MA HUANG/CHINESE EPHEDRA/ EPITONIN OWNER, DISTRIBUTOR, MFR, COMPLAINTS, ETC Control No: 98002202 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: GLASS C Subject: CHANGES FOR DATA REQUIREMENTS FOR DRUGS ACCORDING TO FDA ACT OF 1997 Control No: 98002203 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: G GANS Requester: TARGET HEALTH INC Subject: SYSOSSETT LABS -TOPICAL C SOLVE-2, N62751; TOPICAL LOTION E-SOLVE-2, N62467; GLAXO - EMGEL, N63107; SBA OR EQUIVALENT & OTHER DOCS Control No: 98002204 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIGC Signature: Requester: HAYES D Subject: IMMIGRATIONS ACT - COMMITTEE HEARINGS, TESTIMONY, RPTS, ETC Control No: 98002205 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: K YACOUB Requester: MCGHAN MEDICAL CORP Subject: SILICONE GEL BREAST IMPLANTS - IN-VITRO CHEMICAL ANALYSIS Control No: 98002206 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFI35 Signature: J BUKOWSKI Requester: WASHINGTON BUSINESS INFORMATION Subject: IMPORT ALERTS WEEK OF 1/12/98; WARNING LTRS WEEK OF 1/20/98; FOI DAILY LOG 1/14-15/98 Control No: 98002207 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIGC HFIMO Signature: A GOLDBERGER Requester: APOTEX INC Subject: CPGM 7348.809, .810, .811 Control No: 98002208 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: R SALSBURY Requester: INTEGRA LIFESCIENCES CORP Subject: W L GORE & ASSOC INC, FLAGSTAFF, AZ - PRECLUDE DURA SUBSTITUTE K953969 SUMMARY Control No: 98002209 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: R HEDGEPATH Requester: COLLINS HEDGEPATH LEE & YOUNG Subject: DANEK - EIR, 483 Control No: 98002210 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIGC Signature: T KRAUS Requester: IHS HEALTH INFORMATION Subject: DKT 97D-0153 Control No: 98002211 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: D KUTER Requester: REGULATORY ASSISTANCE CORP Subject: ALUMINUM POTASSIUM SULFATE - CHEMICAL APPRVD FOR USE IN PHARMACEUTICALS Control No: 98002212 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: T SCHWALENBERG Requester: NORLAND MEDICAL SYSTEMS INC Subject: LUNAR CORP - EXPERT MORPHOMETRY SOFTWARE K950611 Control No: 98002213 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: W OLSON Requester: CENTER FOR REGULATORY SERVICES Subject: KELLEGG - HEALTH CLAIMS FOR WHEAT BRAN PETITION RECS Control No: 98002214 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: W OLSON Requester: CENTER FOR REGULATORY SERVICES Subject: PERACETIC ACID - NO OBJECTION LTR, ADVISORY OPINION, RECS, ETC Control No: 98002215 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFIDR HFZ82 Signature: E NEMETH Requester: BRESSLER AMERY & ROSS Subject: HAEMOTRONIC INC/MEDIFLEX INTERNATIONAL INC - EXTENSION SET/BLOOD TUBING K852605; 500CC EVACUATION BAG K891077; ETC Control No: 98002216 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: B RUEFER Requester: BRIDGER BIOMED INC Subject: 935137 Control No: 98002217 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFS22 Signature: Requester: GUPTA S Subject: NON ALCOHOLIC CARBONATED & FRUIT BEVERAGES - FDA GUIDELINES Control No: 98002218 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: Requester: MURAD M Subject: BAUSCH & LOMB - SEEQUENCE I, STANDARD CORE LENSES 510K(S); CIBA VISION - CIBASOFT VISITINT, NEWVUES VISITINT 510K(S); ETC Control No: 98002219 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFM48 Signature: W JOHNSON Requester: CHURCH OF CHRIST'S PROMISES Subject: ANTHRAX VACCINE - PUBLISHED RECS ON PRIOR USE & VACCINE WAIVER OR FORMS Control No: 98002220 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: P MOUNTS Requester: MORGAN LEWIS & BOCKIUS LLP Subject: HEMODIALYSIS DEVICES - STANDARDS RPT #223-78-5046, INVESTIGATION OF RISKS & HAZARDS Control No: 98002221 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: S JENSEN Requester: BIOINTERVENTIONAL CORP Subject: GUIDANT CORP - ACS MULTI-LINK TM CORONARY STENT SYSTEM P970020 Control No: 98002222 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 HFIGC Signature: Requester: STAPEL C Subject: SHARK CARTILAGE - RECS Control No: 98002223 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: H HARRIS Requester: RP INTERANATIONAL Subject: BENZOPORPHYRIN DERIVATIVE - PHASE II OF CLINICAL FDA TRIALS -BPD Control No: 98002224 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: M PETTY Requester: FOX BENNETT & TURNER Subject: PACLITAXEL DRUG PRODUCTS - RECS AND/OR CORR, SUMMARIES OF ORAL COMMUNICATIONS FROM 1996 TO DATE, ETC. Control No: 98002225 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: Requester: NEWMAN M Subject: GUARDIAN GLOVE - K942313 SUMMARY Control No: 98002226 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: R KURKIEWICZ Requester: CARACO PHARMACEUTICAL LABS LTD Subject: STORZ OPTHALMICS - OCUCOAT SS&E Control No: 98002227 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: M DE LEONE Requester: MCINTYRE KAHN KRUSE & GILLOMBARDO Subject: PHENTERMINE - APPRVD LBLG Control No: 98002228 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFICD Signature: M MAREK Requester: SP PHARMACEUTICAL LLC Subject: INACTIVE INGREDIENT GUIDE Control No: 98002229 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: D PARKIN Requester: SMITHKLINE BEECHAM Subject: COLGATE PALMOLIVE - COLGATE TOTAL TOOTHPASTE, APPRVL LTR, LBLG, MORS, ETC. NDA 20-231 Control No: 98002230 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: M O'DONNELL Requester: GISH BIOMEDICAL INC Subject: BLOCK MEDICAL INC - VERIFUSE AMBULATORY PUMP K902891 Control No: 98002231 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: M O'DONNELL Requester: GISH BIOMEDICAL INC Subject: BLOCK MEDICAL INC - VERIFUSE AMBULATORY PUMP K934551 Control No: 98002232 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: M O'DONNELL Requester: GISH BIOMEDICAL INC Subject: SABRATEK CORP - 6060 HOMERUN VOLUMETRIC INFUSION PUMP K941984 Control No: 98002233 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: M O'DONNELL Requester: GISH BIOMEDICAL INC Subject: SIMS DELTEC INC - CADD-PRIZM MODEL 6100 PUMP K960826 Control No: 98002234 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: M NIELSON Requester: BANKERS TRUST Subject: ASCIII FORMAT - TRADE NAME, APPLICANT, REC'D DATE, ETC. FOR 1988 TO DATE Control No: 98002235 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: T LOUDON Requester: HUSCH & EPPENBERGER Subject: MEDICAL DEVICE & DIAGNOSTIC INDUSTRY - WARNING LTRS Control No: 98002236 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFZ82 Signature: N HUFF Requester: PLASTIC SURGERY OF TEXAS Subject: MENTOR/MCGHAN - SILICONE GEL IMPLANT IRB APRVL, FORMS 1572, 1571 Control No: 98002237 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFV12 Signature: Requester: FOI SERVICES INC Subject: PFIZER - STRONGID (5.66G) BANMINTH (5.66G), FOI SUMMARY Control No: 98002238 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PURDUE PHARMA - OXYCONTIN (80MG), CHEMISTRY/MANUF/CONTROL & BIOAVAILABILITY REVIEW NDA #20-553 Control No: 98002239 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPJOHN CO - XANAX APPRVL LTR DTD 1991/1992; SCHUMAN E. LTR DTD 10/19/81; FINKEL M. LTR DTD 10/15/91; ETC. Control No: 98002240 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: 3.5" HIGH DENSITY FLOPPY DISK LISTING OF NDA THRU CURRENT DATE INCLUDING DISCONTIUNED & WITHDRAWN DRUGS; ETC. Control No: 98002241 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: S JOHNSON Requester: GRADY HEALTH SYSTEM R Subject: ACYCLOVIR (ZOVIRAX) SPONTANEOUS ADVRS Control No: 98002242 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: N KUCERA Requester: AAI Subject: FEMSTAT ONE (BUTOCONAZOLE NITRATE) VAGINAL CREAM, 2% - FINAL PRINTED LBLG NDA 19-881 Control No: 98002243 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: B AYLSTOCK Requester: LEVIN MIDDLEBROOKS MABIE ET AL Subject: WYETH AYERST LABS - DEXFENFLURAMINE (REDUX), CASE REPORTS, CORR, STUDIES, CLINICAL TRIALS, COMPLAINTS Control No: 98002244 Received Date: 01/26/98 Due Date: 02/24/98 Action Offices: HFD205 Signature: E MANCHUR Requester: GILMAN AND PASTOR ET AL Subject: LABORATORIES SERVIER SA; INTERNEURON PHARMACEUTICALS INC; AMERICAN HOME PRODUCTS CORP; WYETH AYERST LABS - DEXFENFLURAMINE, FENFLURAMINE, PHENTERMINE, INFO RISKS OR INJURY TH THE HUMAN HEART, HEART VALVES AND/OR LUNGS ETC. Control No: 98002245 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: D BRUNO Requester: BP REPRO GRAPHICS Subject: PROPECIA - SBA Control No: 98002246 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: T JONES Requester: FLAHERTY SENSABAUGH & BONASSO Subject: SMITH KLINE BEECHAM - DEXEDRINE CASE RPTS, STUDIES, RECS, ETC Control No: 98002247 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: M ANTONIO Requester: UNIVERSITY OF CALIFORNIA LOS ANGE Subject: LOS ANGELOS AREA IRBS - INSPECTIONLIST Control No: 98002248 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: HOECHST MARION ROUSSEL - NILANDRON REGULATORY SUBMISSIONS/SUPPLEMENTS Control No: 98002249 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: ALCON- PATANOL SBA, APRVL LTR, LBLG, ETC Control No: 98002250 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: R HAMER Requester: RICHARD HAMER ASSOCIATES INC Subject: MS CONTIN NDA 19516 - SBA OR RVW SUMMARY Control No: 98002251 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: DKT 97S-0163 VOL 2 Control No: 98002252 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 97S-0163 VOL 2 LET76-94 Control No: 98002253 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: BUCHANAN B Subject: CRINONE - APRVL DOCS Control No: 98002254 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B WALDMAN Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: DKT 97P-0324 Control No: 98002255 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: MART RPTS 10/97-12/97 Control No: 98002256 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 271 C2647, C2648, C2649, ETC Control No: 98002257 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: RHONE RORER, FRANCE - EIR, 483 & CORR 4/1/96-5/31/96 Control No: 98002258 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: DKT 92P-0441 VOL 2 C1, C3, LET2, ETC Control No: 98002259 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: HARBISON J, RICHMOND, VA - EIR, 483 & CORR 7/1/97-9/30/97 Control No: 98002260 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 159 C1398, C1399, C1400, ETC Control No: 98002261 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: A/C CARDIOVASCULAR & RENAL DRUGS - MTG OF MINS 5/2-3/96, DKT 92P-0441 INDEX Control No: 98002262 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: BLAKELY J, CANADA - EIR, 483 & CORR 10/1/97-11/20/97 Control No: 98002263 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B GOODFELLOW Requester: FDC REPORTS INC Subject: DKT 96E-0263 VOL 1 Control No: 98002264 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: RHONE POULENC RORER, FRNACE - EIR, 483, CORR 4/1/96-5/31/96 Control No: 98002265 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: G GASKINS Requester: KLEINFELD KAPLAN & BECKER Subject: DKT 97D-0411 DC10, DC11, DC7, DC6, ETC Control No: 98002266 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: SANOFI - PLAVIX SBA, APRVL LTR, LBLG, ETC Control No: 98002267 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: MEININGER V, FRANCE - EIR, 483 & CORR 7/195-8/31/95 Control No: 98002268 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: PLEHN J, LEBANON, NH - EIR, 483 & CORR 5/1/97-7/31/97 Control No: 98002269 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: G GASKINS Requester: KLEINFELD KAPLAN & BECKER Subject: DKT 97D-0441 VOL 6 C3 & C4, VOL 7 C81 & ATTACHMENT A, ETC Control No: 98002270 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: HELGASON C, CHICAGO, IL - EIR, 483 & CORR 7/1/97-8/31/97 Control No: 98002271 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: D SHELTON Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: DKT 95S-0117 LST11 PGS 1 & 4, NOTICE OF AVAILABILITY, ETC Control No: 98002272 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: DKT 97D-0525 VOL 2 REFS 2 & 3, ETC Control No: 98002273 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: DKT 97P-0441 VOL 8 LET13, C139, C138, C136 Control No: 98002274 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 270 C2567, C2572; VOL 271 C2639, C2640, ETC Control No: 98002275 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: C BOAM Requester: CARTER LEDYARD & MILBURN Subject: DKT 97D-0411 C11, C10, TABS 1 & 2, C9, ETC Control No: 98002276 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: C BOAM Requester: CARTER LEDYARD & MILBURN Subject: DKT 97D-0411 C1-C3 Control No: 98002277 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B FROST Requester: CCH INC Subject: DKT 97P-0502, 97P-0518, 97V-0526, 97P-0527, ETC Control No: 98002278 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: DKT 95N-0228 INDEX Control No: 98002279 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 98P-0034 CP1 Control No: 98002280 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ACROS CHIMICA, BELGIUM - EIR, 483, WARNING LTRS, ETC Control No: 98002281 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PVP, BRAZIL - EIR, 483, WARNING LTRS, ETC Control No: 98002282 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: GLAXO WELLCOME - FLOVENT ROTA DISK APRVL LTR, LBLG, MEDICAL OFFICE RVW, ETC Control No: 98002283 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELSTE Requester: AAC CONSULTING GROUP INC Subject: DDAVP NDA 17922 - DECLARATION OF PATENT Control No: 98002284 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 95N-0230 C1-C5 Control No: 98002285 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRNE140 Signature: Requester: FOI SERVICES INC Subject: ESTEE LAUDER - CLINIQUE EXCEPTIONALLY SMOOTH SKIN CO RESP TO WARNING LTR 12/97 Control No: 98002286 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: DKT 97P-0441 Control No: 98002287 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ZENECA - MORPHINE SULFATE APRVL LTR, MEDICAL RVW, PHARMACOLOGY RVW, ETC Control No: 98002288 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRP240 Signature: Requester: FOI SERVICES INC Subject: POTKIN S, ORANGE, CA - EIR, 483 6/3/96 Control No: 98002289 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: F LEE Requester: INFORMATION ACCESS Subject: DKT 96N-0391 VOL 3 TS12, ETC Control No: 98002290 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFM48 HFRMA440 Signature: Requester: FOI SERVICES INC Subject: PHOENIX INTL LIFE SCIENCES INC, CINCINNATI, OH - EIRS, 483S 1/97 TO 12/97 Control No: 98002291 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: EXCEDRIN MIRGRAINE - APRVL LTR, MEDICAL RVW, CHEMISTRY RVW, ETC Control No: 98002292 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 HFRSE540 Signature: Requester: FOI SERVICES INC Subject: GLAXO WELLCOME IN EUROPE, UNITED KINGDOM & PR - LIST OF GMP INSPECTIONS 1/96 TO PRESENT Control No: 98002293 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: F LEE Requester: INFORMATION ACCESS Subject: DKT 90S-0308 VOL 35 M561 Control No: 98002294 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GIVAUDAN ROURE, SWITZERLAND - EIR 6/1-2/95 Control No: 98002295 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMW240 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: PHARMACIA & UPJOHN, KALAMAZOO, MI - EIR, 483, CORR MOST RECENT Control No: 98002296 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA440 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PROCTER & GAMBLE CHEMICAL, CINCINNATI, OH - EIRS, 483S, CO RESPS ETC Control No: 98002297 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FOREIGN API LIST 1/97 TO DATE Control No: 98002298 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: J T BAKER, PHILLIPSBURG, NJ - EIRS, 438S, CO RESPS ETC Control No: 98002299 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: DKT 97N-0325 C58-61, 97S-0162 LET802-814, ETC Control No: 98002300 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: BASF, PARSIPPANY, NJ - EIRS, 483S, CO RESPS ETC Control No: 98002301 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: S GOREY Requester: LAW OFFICES OF STEPHEN GOREY Subject: SEARLE - COPPER 7 IUD RECS Control No: 98002302 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA440 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: MALLINCKRODT, PARIS, KY - EIRS, 483S, CO RESPS ETC Control No: 98002303 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSE340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: WITCO CORP, MEMPHIS, TN - EIRS, 483S, CO RESPS ETC Control No: 98002304 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSE240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: FISHER, ORLANDO, FL - EIRS, 483S, CO RESPS ETC Control No: 98002305 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRP240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: SPECTRUM, GARDENA, CA - EIRS, 483S, CO RESPS ETC Control No: 98002306 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: GRAHAM D Subject: ESKALITH - DOCS Control No: 98002307 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: TEVETEN TABS NDA 20738 - APRVL LTR, PACKAGE CIRC & RVWS Control No: 98002308 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: DYNABAC TABS NDA 50678 - APRVL LTR, PACKAGE CIRC & RVW Control No: 98002309 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: LORABID NDA 50668 - APRVL LTR, PACKAGE CIRC & RVWS Control No: 98002310 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: RHONE POULENC BASIC CHEMICALS, CRANBERRY, NJ - EIRS, 483S, CO RESPS ETC Control No: 98002311 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PENTA, FAIRFIELD, NJ - EIRS, 483S, CO RESPS ETC Control No: 98002312 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: FEBRILE NEUTRONIA - APRVL LTR, PACKAGE CIRC, & RVWS Control No: 98002313 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRP240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: U.S. BORAX, VALENCIA, CA - EIRS, 483S, CO RESPS ETC Control No: 98002314 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: D LEININGER Requester: LEMON ARMEY HEARN LEININGER Subject: FDA DRUG BULLETIN 4/82 Control No: 98002315 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRNE140 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: EM INDUSTRIES, HAWTHORNE, NY - EIRS, 483S, CO RESPS ETC Control No: 98002316 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: B FAULKENBERG Requester: NEWBURGH PHARMACEUTICAL SYSTEMS Subject: APPLIED LABS INC - ALBUTEROL SOLUTION STATUS Control No: 98002317 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMW240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: AERCHEM INC, BLOOMINGTON, IN - EIRS, 483S, CO RESPS ETC Control No: 98002318 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSE240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: BAUSCH & LOMB PHARM, TAMPA, FL - EIR 4/22-27/94 Control No: 98002319 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: CAREY M Subject: RITALIN - ADVERSE REACTIONS Control No: 98002320 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSE240 Signature: Requester: INFORMATION ACCESS Subject: VOGEL C, MIAMI, FL - EIRS, 483S, CO RESPS ETC 1/1/90 TO PRESENT Control No: 98002321 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: CAREY M Subject: PROZAC - MICROFICHE Control No: 98002322 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: DKT 95C-0339 Control No: 98002323 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRNE140 Signature: Requester: INFORMATION ACCESS Subject: PFIZER INC, NEW YORK, NY - EIR, 483, WARNING LTR ETC 9/10/95 Control No: 98002324 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSW240 Signature: Requester: INFORMATION ACCESS Subject: TSCHEN E, ALBUQUERQUE, NM - EIR, 483, CO RESP ETC 6/24-7/3/97 Control No: 98002325 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: L DESIMIO Requester: FDC REPORTS INC Subject: A/C PHARM SCIENCES - TRANS 12/11-12/97 Control No: 98002326 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 97S-0163 VOL 2 Control No: 98002327 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA340 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: SOUTHERN NEW JERSEY MEDICAL INSTITUTE, STRATFORD, NJ - EIRS, 483S, CORR ETC 12/18-31/97 Control No: 98002328 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSW140 Signature: R KOCH Requester: SPYRIDON KOCH PSARELLIS ET AL Subject: EIRS OF HUMAN TISSUE BANKS IN HOUSTON, TX Control No: 98002329 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: S BUTCHOCK Requester: MEDICAL DEVICES REPORT Subject: 0KT 97D-0282 C17 & C18, 98P-0022 CP1 PGS 99-102, ETC R Control No: 98002330 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRP340 Signature: C JOHNSON Requester: CONTINENTAL MILLS INC Subject: CONTINENTAL MILLS INC, KENT, WA - EIR 1/6-7/98 Control No: 98002331 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA140 Signature: K DISTEFANO Requester: KOS PHARMACEUTICALS INC Subject: PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES INC, HORSHAM, PA - EIR, 483 MOST RECENT Control No: 98002332 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 77N-0094 CP13, 97N-0325 C54-C61, 97S-0162 LET807-814, ETC Control No: 98002333 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSW440 Signature: T JOHNSON Requester: QUAKER OATS CO Subject: SPL #98-073-477 & 478 - TEST RESULTS Control No: 98002334 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: A/C CLINICAL CHEM & CLINICAL TOX PANEL - TRANS 12/10/97, ETC Control No: 98002335 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: DRAFT GUIDANCE FOR INDUSTRY: EFFICACY STUDIES TO SUPPORT MKTG OF FIBRIN SEALANT PRODS MFG FOR COMMERCIAL USE, ETC Control No: 98002336 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSW440 Signature: M HULSELNS Requester: CARGILL INC Subject: SPL #98-073-641 & 471 - TEST RESULTS Control No: 98002337 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: B WALDMAN Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: DKT 97S-0163 Control No: 98002338 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: T KIRKPATRICK Requester: WILLIAMS MULLEN CHRISTIAN DOBBINS Subject: DKT 97N-0289 TR1 Control No: 98002339 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 170 C1720, C1721, C1722, C1723, ETC Control No: 98002340 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: D SHELTON Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: DKT 95S-0316 VOLS 7 & 6 Control No: 98002341 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: D ALEKNAVAGE Requester: HOGAN & HARTSON Subject: DKT 97D-0525 REFERENCES 1-15 Control No: 98002342 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: K962822 Control No: 98002343 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: K944866 Control No: 98002344 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: H GALLAS Requester: RICHARD WOLF MEDICAL INSTRUMENTS Subject: COMPUTER MOTION INC - ACSOP 3000 SYSTEM K972699; DAVOL INC - HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM K970078; ETC Control No: 98002345 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: E CONNER Requester: SOMNUS Subject: PM POSITIONER - K953293; ADJUSTABLE PM POSITIONER - K955503 Control No: 98002346 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: E CONNER Requester: SOMNUS Subject: SLEEP-IN BONE SCREW SYSTEM - K972023 Control No: 98002347 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: M NOLAN Requester: FULBRIGHT AND JAWORSKI Subject: DENTSPLY INT'L - LIQCRYLIC PRO DENTAL RESIN K972573 Control No: 98002348 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRP240 HFS22 Signature: L PESKO Requester: ST VINCENT MERCY MEDICAL CENTER Subject: VITATEK INTL & METAGENICS - REGISTRATION RECS Control No: 98002349 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: Requester: DAVID W BLANKENSHIP LAW OFCS Subject: TMJ IMPLANTS INC - DELETED RECS 1990-PRESENT Control No: 98002350 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: Requester: DOE J Subject: PER-CLOSE FEMEORAL ARTERY CLOSURE DEVICE - MDR Control No: 98002351 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: B LOEFFLER Requester: STEDIM INC Subject: SEDIM S A, AUBAGNE, FRANCE - EIR, 483, WARNING LTR 1996-1997 Control No: 98002352 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRMA140 Signature: R GOLDSMITH Requester: YANKOWITZ GOLDSMITH & SAYERS PA Subject: BOB O'LEARY HEALTH FOOD DISTRIBUTOR CO INC, TAYLOR, PA AND/OR SCRANTON, PA - ECLIPSE 2000 PRODUCT LINE RPTS, CMPLNTS, COMMS ETC Control No: 98002353 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: DEBTOR Signature: D LUCKING Requester: NOVEN PHARMACEUTICALS INC Subject: N20-501 - APRVL RECS; N17-874 - SUPPLEMENTS 025, 026 & 027 Control No: 98002354 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: F BRYSON Requester: BEIERSDORF-JOBST INC Subject: PHARMA HAMELN & CO, GERMANY - EIR 10/97-11/97 Control No: 98002355 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: A DE PASQUALE Requester: AKZO NOBEL Subject: COLUMBIA LABS - CRINONE VAGINAL GEL/N20-756 SBA, RVWS Control No: 98002356 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: A DE PASQUALE Requester: AKZO NOBEL Subject: COLUMBIA LABS - CRINONE VAGINAL GEL/N20-701 SBA, RVWS Control No: 98002357 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: A DE PASQUALE Requester: AKZO NOBEL Subject: HOECHST MERRYL PI - MIFEPRISTONE SBA, RVWS Control No: 98002358 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: A DE PASQUALE Requester: AKZO NOBEL Subject: ROUSSEL UNCLAF - MIFEPRISTONE SBA, RVWS Control No: 98002359 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: V DOANE Requester: PARKE DAVIS Subject: LIST OF INSPECTIONS PERFORMED ON A ROUTINE AND FOR CAUSE BASIS 1/1/77 TO PRESENT Control No: 98002360 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: A RUCHELMAN Requester: JANSSEN PHARMACEUTICA INC Subject: CDER'S NEW REVIEWERS' WORKSHOP MANUAL 10/27-31/97 WORKSHOP Control No: 98002361 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: A SILVESTRI Requester: SYNTHES USA Subject: BIO-VASCULAR INC - OCU-GUARD ORBITAL IMPLANT K973552 SUMMARY; HOWMEDICA INC - CHIN DISTRACTOR K973484 SUMMARY; ETC Control No: 98002362 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: A BURCH Requester: PALMIERI TYLER WIENER ET AL Subject: ALCON LABORATORIES INC - GEMINI OPHTHALMIC SURGERY SYSTEM K911808 LTR DTD 3/17/91; SERIES 20000 LEGACY PHACOEMULSIFIER K952213 LTR DTD 5/19/95 CERTIFIED Control No: 98002363 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: T CREAVEN Requester: ARTERIAL VASCULAR ENGINEERING INC Subject: GUIDANT - ACS MULTI-LINK(TM) CORONARY STENT SYSTEM MDR(S); JOHNSON & JOHNSON - CROWN STENT DELIVERY SYSTEM MDR(S) Control No: 98002364 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: R MURFITT Requester: VISUALIZATION TECHNOLOGY INC Subject: K961834, K970604, K961168, ETC Control No: 98002365 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIDR Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: CORDIS ENDOVASCULAR SYSTEMS INC - TRANSIT INFUSION CATHETER K936282 Control No: 98002366 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: CORDIS ENDOVASCULAR SYSTEMS INC - TRANSIT INFUSION CATHETER K936260; TRANSIT-2 INFUSION CATHETER K950910 Control No: 98002367 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIDR Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: TARGET THERAPEUTICS - DIAGNOSTIC INTRAVASCULAR CATHETER K925813 Control No: 98002368 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIDR HFZ82 Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: TARGET THERAPEUTICS - RETRIEVER 10 K921649; ANGIOGRAPHIC CATHETER K926243; BALT GUIDING CATHETER K925632 Control No: 98002369 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFZ82 Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: BOSTON SCIENTIFIC CORP - EVOLUTION MICROCATHETER K953114 Control No: 98002370 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFM48 Signature: R FRUTKIN Requester: SAVETT FRUTKIN PODELL & RYAN Subject: CENTOCOR INC - AVAKINE(TM)/CA2 RECS Control No: 98002371 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIMO Signature: T KRAUS Requester: INFORMATION HANDLING SERVICES Subject: WARNING LTRS; DAILY LOG - 2/2/98 Control No: 98002372 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: R LEBOYER Requester: BROWN BROTHERS HARRIMAN & CO Subject: A/C BIOLOGICAL RESPONSE MODIFIERS - TRANS; A/C PERIPHERAL & CENTRAL NERVOUS SYSTEM DRUG - MTG #46; ETC Control No: 98002373 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: FAP 6A3930, VOLS 1 & 2 Control No: 98002374 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFS22 Signature: C SCHWEITZER Requester: HENKEL CORP Subject: LUTEIN/LUTEIN OLEO RESIN, ETC - ADR(S) Control No: 98002375 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: IMMUNO, AUSTRIA - EIR, 483 1/96-1/98 Control No: 98002376 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIGC Signature: Requester: FOI SERVICES INC Subject: GUIDANCE FOR INDUSTRY ON AEROSOL STEROID PRODUCT SAFETY ETC Control No: 98002377 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFIMO Signature: K BLANKENSHIP Requester: TAP HOLDINGS INC Subject: CPGM 7346.832 - MOST RECENT Control No: 98002378 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: A DE PASQUALE Requester: AKZO NOBEL Subject: A/C ENDOCRINOLOGIC & METABOLIC DRUGS - TRANS 11/20/97 Control No: 98002379 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: J GANTENBERG Requester: FIRST EVALUTION INC Subject: DKT 97M-0459 - OSTEONICS CONSTRAINED ACETABULAR INSERT SS&E Control No: 98002380 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI35 Signature: L ELDER Requester: BAKER & BOTTS Subject: 96-31544 Control No: 98002381 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI35 Signature: D ALEKNAVAGE Requester: HOGAN & HARTSON Subject: 97-42593 Control No: 98002382 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI35 Signature: Requester: FOX BENNETT & TURNER Subject: 98-1357 - REQUEST LTR Control No: 98002383 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: FOI LOG - 1/22/98 Control No: 98002384 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: FOI LOG - 1/20-23/98 Control No: 98002385 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFA305 Signature: R PELLERIN Requester: CANADIAN BROADCASTING CORP Subject: A/C ENDOCRINOLOGIC & METABOLIC DRUGS - TRANS 2/20/97 Control No: 98002386 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: J WOOD Requester: MEDX COMMUNICATIONS INC Subject: UNIV OF TENN - METHYLPHENIDATE 20MG TABS RVW OF BIOEQUIVALENCE STUDY Control No: 98002387 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: G SIBLESZ Requester: MEDIPHARMA INC Subject: REQUIREMENTS FOR APRVL OF OVERSEAS UNIT-DOSE CONTRACT PACKAGING FACILITY, PACK- AGING PRESCRIPTION AND OTC TABS AND CAPS IN COSTA RICA Control No: 98002388 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: I WELLMAN Requester: ABELSON TAYLOR INC Subject: BAYER - BAYCOL/CERIVASTATIN SODIUM; MERCK - MEVACOR/IOVASTATIN & ZOCOR/SIMVAST- ATIN; BRISTOL-MYERS SQUIBB - PRAVACHOL/PRAVASTATIN; SANDOZ - LESCOL/FLUVASTATIN;PARKE-DAVIS - LIPITOR/ATORVASTATIN & Control No: 98002389 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: E GOODMAN Requester: STEVEN E NORTH PC Subject: GEVRAMYCIN/C1848976; GENTAMICIN SULFATE/C1864703; GENTAMICIN SULFATE/C1702730; GENTAMICIN SULFATE/C1567130 ETC Control No: 98002390 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: ATKINS J Subject: TOPIRAMATE/TOPAMAX - SBA, ADRS ETC Control No: 98002391 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: Requester: RAPPAPORT N Subject: FARESTON/TOREMIFENE CITRATE - RECS Control No: 98002392 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFD205 Signature: C AVARD-HICKS Requester: ASSOCIATES AND AVARD LAW OFFICES Subject: 97-39833 - DELETED MATERIAL Control No: 98002393 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFRSE240 Signature: Requester: TRAVELERS PROPERTY CASUALTY Subject: CMPLNT FLA9514 - TEST RESULTS Control No: 98002394 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: REXALL SHOWCASE INTL Subject: MEDICATION IMPORT Control No: 98002395 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: PUTNAM D Subject: MEDICATION IMPORT Control No: 98002396 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: TAYLOR G Subject: MEDICATION IMPORT Control No: 98002397 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: SONMORE S Subject: MEDICATION IMPORT Control No: 98002398 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: HARFORD R Subject: MEDICATION IMPORT Control No: 98002399 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: ROBERTS M Subject: MEDICATION IMPORT Control No: 98002400 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: RICE G Subject: MEDICATION IMPORT Control No: 98002401 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: SHELBY-LANE C Subject: MEDICATION IMPORT Control No: 98002402 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: COLEMAN B Subject: MEDICATION IMPORT Control No: 98002403 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: MYERS R Subject: MEDICATION IMPORT Control No: 98002404 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: MOODY L Subject: MEDICATION IMPORT Control No: 98002405 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: STEVENS H Subject: MEDICATION IMPORT Control No: 98002406 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: BARNETT J Subject: MEDICATION IMPORT Control No: 98002407 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: CASTLE L Subject: MEDICATION IMPORT Control No: 98002408 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: CRAIG N Subject: MEDICATION IMPORT Control No: 98002409 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: HARTMAN R Subject: MEDICATION IMPORT Control No: 98002410 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: ELLIOT R Subject: MEDICATION IMPORT Control No: 98002411 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: YEADON C Subject: MEDICATION IMPORT Control No: 98002412 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: WILHELM E Subject: MEDICATION IMPORT Control No: 98002413 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: RIZZO M Subject: MEDICATION IMPORT Control No: 98002414 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: PIERCE P Subject: MEDICATION IMPORT Control No: 98002415 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: PIERCE R Subject: MEDICATION IMPORT Control No: 98002416 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: MARGOLIS S Subject: FOOD SAFETY Control No: 98002417 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: VADNAIS G Subject: FOOD SAFETY Control No: 98002418 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: DONEY G Subject: FOOD SAFETY Control No: 98002419 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: MEYERS C Subject: FOOD SAFETY Control No: 98002420 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: MOORE C Subject: FOOD SAFETY Control No: 98002421 Received Date: 01/27/98 Due Date: 02/25/98 Action Offices: HFI30 Signature: Requester: GULLY H Subject: FOOD SAFETY Control No: 98002422 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: MCGAW LABS, IRVINE, CA - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002423 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: NORTH AMERICAN BIOLOGICALS INC, MIAMI, FL - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002424 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: PFIZER INC, GROTON, CT - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002425 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: PROCTOR & GAMBLE TOILET GOODS DIV, CINCINNATI, OH - EIR3, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002426 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: SHERWOOD, DAVIS & GECK, ARGYLE, NY - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002427 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: SOLOPAK LABS, ELK GROVE VILLAGE, IL - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002428 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: QUALITY BIOTECH INC, CAMDEN, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002429 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: HAZELTON LABS (CORNING), MADISON, WI - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002430 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: INTL. PROCESSING CORP (IPC), WINCHESTER, KY - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002431 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: ISOMEDIX INC, SPARTANBURG, SC - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002432 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: LINVATEC CORP, LARGO, FL - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002433 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: CIBA CORNING DIAGNOSTICS (CHIRON), OBERLIN, OH - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002434 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: DUPONT MERCK PHARM, GARDEN CITY, NY - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002435 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: ELAN PHARMA, SMITHFIELD, RI - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002436 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: FOOD SCIENCES CORP, MT LAUREL, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002437 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: GRIFFITH MICRO SCIENCE, SMYRNA, GA - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002438 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA240 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: BECTON DICKINSON, COCKEYSVILLE & SPARKS, MD - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002439 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: H REISMAN INC, ORANGE, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002440 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA240 HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: HAZELTON WASHINGTON LABS, VIENNA, VA - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002441 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: ISOMEDIX INC, COLUMBUS, MS - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002442 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: IVERS LEE, WEST CALDWELL, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002443 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: MALLINCKRODT INC, ST LOUIS, MO - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002444 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: MAPLE ISLAND, MEDFORD, WI - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002445 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: MERCK CHEMICAL DIC, RAHWAY, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002446 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: BAXTER, MARION, NC - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002447 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: AJINOMOTO, RALEIGH, NC - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002448 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA140 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: LANCASTER LABS, LANCASTER, PA - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002449 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW440 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: STORZ, ST LOUIS, MO - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002450 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: SHERWOOD MEDICAL INDUSTRIES, NORFOLK, NE - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002451 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: ROCHE DIAGNOSTICS, BELLVILLE, NJ - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002452 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW340 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: AMERICAN CRYSTAL, CROOKSTON, MN - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002453 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: L POOLS-BRUBAKER Requester: CAMERICAN Subject: ENTRY #E22-0040529-9 - LAB ANALYSIS RPT Control No: 98002454 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP340 Signature: M OSOTIO Requester: CI SEAFOODS INC Subject: ENTRY #112-9327010-2 - LAB RPT Control No: 98002455 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - AMIKACIN SULFATE ANDA 64-146 APRVL LTR, LBLG & REVIEWS Control No: 98002456 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - LEUCOVORIN CALCIUM ANDA 40-147 APRVL LTR, LBLG & REVIEWS Control No: 98002457 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - KETORLAC TROMETHAMINE ANDA 74-802 APRVL LTR, LBLG & REVIEWS Control No: 98002458 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - KETORLAC TROMETHAMINE ANDA 74-801 APRVL LTR, LBLG & REVIEWS Control No: 98002459 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - BUMETANIDE ANDA 74-160 APRVL LTR, LBLG & REVIEWS Control No: 98002460 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: BEDFORD - ACYCLOVIR SODIUM ANDA 74-596 APRVL LTR, LBLG & REVIEWS Control No: 98002461 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: BEDFORD - ATRACURIUM BESYLATE ANDA 74-901 APRVL LTR, LBLG & REVIEWS Control No: 98002462 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: BEDFORD - ATRACURIUM BESYLATE ANDA 74-900 APRVL LTR, LBLG & REVIEWS Control No: 98002463 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFIMO Signature: G DENNISON Requester: WISCONSIN AIDS RESEARCH CONSORTIU Subject: CPGM 7348.809 Control No: 98002464 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ELKINS SINN - ATRACURIUM BESYLATE ANDA 74-825 APRVL LTR, LBLG & REVIEWS Control No: 98002465 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ELKINS SINN - ATRACURIUM BESYLATE ANDA 74-824 APRVL LTR, LBLG & REVIEWS Control No: 98002466 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ELKINS SINN - ACYCLOVIR SODIUM ANDA 74-913 APRVL LTR, LBLG & REVIEWS Control No: 98002467 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FUJISAWA - IOPAMIDOL ANDA 74-679 APRVL LTR, LBLG & REVIEWS Control No: 98002468 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FAULDING - ATRACURIUM BESYLATE ANDA 74-741 APRVL LTR, LBLG & REVIEWS Control No: 98002469 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FAULDING - ATRACURIUM BESYLATE ANDA 74-740 APRVL LTR, LBLG & REVIEWS Control No: 98002470 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FAULDING - ACYCLOVIR SODIUM ANDA 74-720 APRVL LTR, LBLG & REVIEWS Control No: 98002471 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: SANOFI- WINTHROP - CIMETIDINE HCL ANDA 74-412 APRVL LTR, LBLG & REVIEWS Control No: 98002472 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFIMO Signature: G BELL Requester: AMREX ELECTROTHERAPY EQUIPMENT Subject: CHATTANOOGA GROUP INC - WARNING LTR 7/29/97 Control No: 98002473 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: SANOFI-WINTHROP - CIMETIDINE HCL ANDA 74-296, APRVL LTR, LBLG & REVIEWS Control No: 98002474 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: SANOFI-WINTHROP - ACYCLOVIR SODIUM ANDA 74-663 APRVL LTR, LBLG & REVIEWS Control No: 98002475 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: SANOFI-WINTHROP - HYDROMORPHANE HCL ANDA 74-598 APRVL LTR, LBLG & REVIEWS Control No: 98002476 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: WHITEHALL LABORATORIES - AXID AR NDA 20-555 SUPPLEMENTS Control No: 98002477 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: NOVONORDISK - PRANDIN NDA 20-741 APRVL LTR, LBLG & REVIEWS Control No: 98002478 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: GLAXO WELLCOME OPERATION, UK - EIRS & 483S FROM 1/1/97 TO PRESENT Control No: 98002479 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: KETOPROFEN - ADR Control No: 98002480 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: WYETH-AYERST LABORATORIES INC - PREMPRO NDA 20527 APRVL LTR, LBLG & REVIEWS Control No: 98002481 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PHOTOFRIN NDA 20-451/S-002 - APRVL LTR & REVIEWS Control No: 98002482 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PREMPRO NDA 20-527/S006 - APRVL LTR & REVIEWS Control No: 98002483 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ETOPOSIDE NDA 74-968 - APRVL LTR & REVIEWS Control No: 98002484 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFIGC Signature: L MARTINEZ Requester: VALLEY DAY SCHOOL Subject: WATER FLOURIDATION - QUESIONNAIRE Control No: 98002485 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA430 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: SHROEDER A - SF 171 &/OR CIRRICULUM VITEA Control No: 98002486 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 HFZ82 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: GUILINI VHEMIE GMBH, LUDWIGSHAFEN, GERMANY - EIRS & 483S 1/1/95 TO PRESENT Control No: 98002487 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: BIOLOGICAL LABS EUROPE LTD, IRELAND - EIR, 483 & CO RESPONSE 3/2/92 & 6/13/96 Control No: 98002488 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: GLAXO WELLCOME OPERATIONS, UK - EIR, 483 & CO RESPONSE 1/1/97 TO DATE Control No: 98002489 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW140 Signature: S MATTERI Requester: CONTEMPORARY PRODUCTS INC Subject: CONTEMPORARY PRODUCTS INC, SPRINGDALE, AR - EIR IN YRS OF 1994, 1995, 1996, & 1997 Control No: 98002490 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: S MATTERI Requester: CONTEMPORARY PRODUCTS INC Subject: CONTEMPORARY PRODUCTS INC - ANALYSIS REPORT FROM PROFILE SAMPLE COLLECTED UNDER C/R 98-755-899 ON 10/7/97 THRU 10/9/97 Control No: 98002491 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW440 Signature: S MATTERI Requester: CONTEMPORARY PRODUCTS INC Subject: SCIENTIFIC ASSOCIATES DIV., ST. LOUIS, MO - EIR FOR YRS 1990, 1991, 1992, 1993 1994, 1995, 1996, & 1997 Control No: 98002492 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: IMMUNO, EUROPE - EIR, 483 & CO RESPONSE 1/1/96 TO DATE Control No: 98002493 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: S MATTERII Requester: CONTEMPORARY PRODUCTS INC Subject: LEBERCO DIVISION, EDISON, NJ - EIR FOR YRS 1990, 1991, 1992, 1993, 1994, 1995, 1996, & 1997 Control No: 98002494 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW140 Signature: S MATTERI Requester: CONTEMPORARY PRODUCTS INC Subject: ARKANSAS MICRO SPECIALTIES, LOWELL, AR - EIR FOR YRS 1994, 1995, 1996, 1997 Control No: 98002495 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: C GRAVEL Requester: PASTEUR MERIEUX CONNAUGHT Subject: MSD - PEDVAXHIB SBA Control No: 98002496 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW140 Signature: Requester: FOI SERVICES INC Subject: G.D. SEARLE & CO., CHICAGO, IL - EIRS & 483S FOR PERIODS 1/95 TO 6/97 & 11/97 TO DATE Control No: 98002497 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE540 Signature: Requester: FOI SERVICES INC Subject: MOVA PHARMACEUTICAL, CAGUAS, PR - EIRS & 483S FOR PERIOD 10/97 TO DATE Control No: 98002498 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA140 Signature: Requester: FOI SERVICES INC Subject: ENDO LABS, WILMINGTON, DE - EIRS & 483S PERIOD 1/95 TO DATE Control No: 98002499 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: DURAMED, CINCINNATI, OH - EIRS & 483S PERIOD 3/97 TO DATE Control No: 98002500 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: R WILLIAMS Requester: MCALOON & FRIEDMAN Subject: A/C BLOOD PRODUCTS - HEPATITIS B CORE ANTIBODY TESTING RPTS Control No: 98002501 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: TEVA PHARMACEUTICALS, FAIRLAWN, NJ - EIRS & 483S PERIOD 1/95 TO DATE Control No: 98002502 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: AMIDE PHARMACEUTICAL, LITTLE FALLS, NJ - EIRS & 483S PERIOD 6/97 TO DATE Control No: 98002503 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: INVAMED, DAYTON, NJ - EIRS & 483S PERIOD 5/97 TO DATE Control No: 98002504 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA240 HFRSE240 HFZ82 Signature: J HOVIS Requester: EXCEL HEARING SOLUTIONS Subject: CRYSTAL EAR HEARING AID (COMTRAD INDUSTRIES) - CORR Control No: 98002505 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: M PAI Requester: CHEDOKE MCMASTER HOSPITALS Subject: CHEDOKE MCMASTER HOSPITALS, CANADA - EIR Control No: 98002506 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFM48 Signature: Requester: MID-MICHIGAN EAR NOSE & THROAT Subject: FLU SHOT - HEARING LOSS Control No: 98002507 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE240 Signature: B BERGEN Requester: KREVSKY SILBER & BROWN Subject: SKIN-CAP - NAME, ADDRESS, OF DISTRIBUTOR AS WELL AS COMPANY, ETC. Control No: 98002508 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFV12 Signature: L STEDMAN Requester: PFIZER INC Subject: CVM P&P GUIDELINES Control No: 98002509 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFV12 Signature: Requester: TROJAK J Subject: PULVEX MULTI-PURPOSE WORM CAPSULES - FOI SUMMARY Control No: 98002510 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE240 Signature: V CABALLERO Requester: BRAINTREE LABORATORIES INC Subject: PURE ENCAPSULATIONS INC, SUDBURY, MA - 483 & EIR 1/92 TO DATE Control No: 98002511 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: WARNING LTRS, IMPORT ALERTS, FOI LOGS Control No: 98002512 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: S WRIGHT Requester: FDC REPORTS INC Subject: PARTICLE SIZE TECHNOLOGY INC & ELAN CORP - WARNING LTRS Control No: 98002513 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: WARNING LTRS 1/27/98 Control No: 98002514 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: REXAM, EVANSVILLE, IN - EIR & 483 MOST RECENT Control No: 98002515 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: FOI LOG 1/19-23/98 Control No: 98002516 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: S DICKERSON Requester: FOI SERVICES INC Subject: WARNING LTRS 1/27/98 Control No: 98002517 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: MORTON INTERNATIONAL, INC., MANISTEE, MI - EIRS, 483S FIRMS RESPONSES FROM 1/1/95 TO DATE Control No: 98002518 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: I LOSS Requester: WASHINGTON ANALYSIS Subject: WARNING LTRS 1/27/98 Control No: 98002519 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: J BUKAWSKI Requester: WASHINGTON BUSINESS INFORMATION Subject: IMPORT ALERTS, WARNING LTRS & FOI LOGS Control No: 98002520 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: WARNING LTRS, IMPORT ALERTS, FOI LOG, ETC Control No: 98002521 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: MARTIN MARIETTA MAGNESIA SPECIALTIES, BALTIMORE, MD - EIRS, 483S, FIRMS RESPONSES 1/1/95 TO DATE Control No: 98002522 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: K JENSEN Requester: BLOOMBERG BUSINESS NEWS Subject: WARNING LTRS & IMPORT ALERTS Control No: 98002523 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRNE240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ABELSON M, N ANDOVER, MA - EIR & 483 10/96 Control No: 98002524 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: M BAFFOUR Requester: SANDOZ/NOVARTIS Subject: WARNING LTRS 1/27/98 Control No: 98002525 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: GRAFCO, HANOVER, MD - EIR & 483 MOST RECENT Control No: 98002526 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW240 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: SILGAN, SEYMOUR, IN - EIR & 483 MOST RECENT Control No: 98002527 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE240 Signature: W WILLIAMS Requester: FOREST LABORATORIES INC Subject: WILLIAMS J, FT MYERS, FL - EIRS, 483S, & RESPONSES Control No: 98002528 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW140 Signature: W WILLIAMS Requester: FOREST LABORATORIES INC Subject: LESSER J, HOUSTON, TX - EIRS, 483S, & RESPONSE Control No: 98002529 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW240 Signature: W WILLIAMS Requester: FOREST LABORATORIES INC Subject: LEWITT P, WEST BLOOMFIELD, MI - EIRS, 483S, & RESPONSES Control No: 98002530 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE240 Signature: W WILLIAMS Requester: FOREST LABORATORIES INC Subject: KARP J, CLEARWATER, FL - EIRS, 483S, RESPONSES Control No: 98002531 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S WRIGHT Requester: FDC REPORTS INC Subject: ELANS GAINSVILLE, GA - EIR, CO RESP0NSE 8/25 - 9/17/97 Control No: 98002532 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE140 Signature: S WRIGHT Requester: FDC REPORTS INC Subject: ELANS, GAINSVILLE, GA - 483, CO RESPONSE TO 483 & WARNING LTR Control No: 98002533 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: F LEE Requester: INFORMATION ACCESS Subject: 98-1061 REQUEST LTR Control No: 98002534 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA140 Signature: S WRIGHT Requester: FDC REPORTS INC Subject: PARETICLE SIZE TECHNOLOGY'S, QUAKERTOWN, PA - 483, CO RESPONSE TO 483; CO RESPONSE TO WARNING LTR 11/12-20/97 Control No: 98002535 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: 98-1679 & 98-1680 REQUEST LTRS Control No: 98002536 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: 98-1679 & 98-1680 Control No: 98002537 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: WARNING LTR & IMPORT ALERTS Control No: 98002538 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: K GEORGE Requester: SOFTWARE QUALITY MANAGEMENT INC Subject: WARNING LTRS 1/27/98 Control No: 98002539 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: INTERNEURON PHARM - REDUX ADRS Control No: 98002540 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C MAYNARD Requester: FDC REPORTS INC Subject: WARNING LTRS WEEK OF 1/27/98; IMPORT ALERTS WEEK OF 1/16/98; WARNING LTRS ON DISK WEEK OF 1/27/98 Control No: 98002541 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: WARNING LTRS WEEK OF 1/26/98 Control No: 98002542 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: J DICKINSON Requester: FERDIC INC Subject: WARNING LTRS WEEK OF 1/27/98; FOI DAILY LOG 1/15-23/98 Control No: 98002543 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: WARNING LTRS WEEK OF 1/27/98; FOI DAILY LOG Control No: 98002544 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA140 Signature: S WRIGHT Requester: FDC REPORTS INC Subject: PARTICLE SIZE TECHNOLOGY'S, QUAKERTOWN, PA - EIR, CO RESPONSE, 11/12/97 Control No: 98002545 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: B THOMPSON Requester: U S SEAFOOD NEWS Subject: IMPORT ALERT #16-119, 16-120 & 16-121 Control No: 98002546 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: T GOREN Requester: FEDERAL FILINGS BUSINESS NEWSWIRE Subject: WARNING LTRS WEEK OF 1/20/98 & 1/27/98 Control No: 98002547 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: M PATTERSON Requester: ARNOLD & PORTER Subject: 98-1944, 98-1975 & 98-1976 REQUEST LTRS Control No: 98002548 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: W MCVICKER Requester: RECALL REGULATORY ANALYSIS Subject: WARNING LTRS WEEK OF 1/26/98; IMPORT ALERTS WEEK OF 1/16/98 Control No: 98002549 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: J BERLIN Requester: HYMAN PHELPS & MCNAMARA PC Subject: 96-42764 Control No: 98002550 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: J BERLIN Requester: HYMAN PHELPS & MCNAMARA PC Subject: 94-15982 Control No: 98002551 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: 98-1944, 98-1975 & 98-1976 Control No: 98002552 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-42162 Control No: 98002553 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: WYETH-AYERST - ANTI-VENIN APRVL LTR, LABELING ETC Control No: 98002554 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: WARNER-LAMBERT - PENETREX/ENOXACIN RVWS Control No: 98002555 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: 98-376 Control No: 98002556 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP240 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: GENSIA, IRVINE, CA - ERIS, 483S, CO RESPS 1/1/96 TO PRESENT Control No: 98002557 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: REHEIS CHEMICAL CO, BERKELEY HEIGHTS, NJ - EIRS, 483S, CO RESPS 1/95 TO PRESENT Control No: 98002558 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSE340 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: CHATTEM INC, CHATTANOOGA, TN - EIRS, 483S, CO RESPS 1/1/95 TO PRESENT Control No: 98002559 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - BUTOPHANOL/ANDA 74-626 APRVL LTR, LABELING, RVWS Control No: 98002560 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - BUTORPHANOL/ANDA 74-620 APRVL LTR, LABELING, RVWS ETC Control No: 98002561 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - ATRACURIUM BESYLATE/ANDA 74-639 APRVL LTR, LABELING, RVWS ETC Control No: 98002562 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - IOPAMIDOL/ANDA 74-638 APRVL LTR, LABELING, RVWS ETC Control No: 98002563 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - ACYCLOVIR SODIUM/ANDA 74-758 APRVL LTR, LABELING, RVWS ETC Control No: 98002564 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: INDUSTRIAS PENOLES, MEXICO - EIR, 483, CO RESPONSE(S) 1/95-PRESENT Control No: 98002565 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ABBOTT - IOPAMIDOL/ANDA 74-637 APRVL LTR, LABELING, RVWS ETC Control No: 98002566 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: K941984 Control No: 98002567 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW340 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: S.C. JOHNSON & SON INC - EIR 2/11/97 Control No: 98002568 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: SCHERING AG, BERGKAMEN, GERMANY - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002569 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: S.I.M.S., VALDARNO, ITALY - EIRS, 483S, CORR 7/1/96 TO 1/1/98 Control No: 98002570 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: BOEHRINGER INGELHEIM, THOMAE, GERMANY - EIRS, 483S, CORR 2 MOST RECENT Control No: 98002571 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW140 Signature: S EPSTEIN Requester: TEXAS INSTRUMENTS Subject: AIR LIQUIDE AMERICA - INVESTIGATION RECS Control No: 98002572 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFS22 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: RETINYL PROPIONATE - FREQUENCY OF USE RPT, LIST OF VOLUNTARY REGISTRATION OF INGREDIENTS Control No: 98002573 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFC230 Signature: R BLUM Requester: KAVANAGH MALONEY & OSNATO LLP Subject: CERTIFIED RECS Control No: 98002574 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: PROCTER & GAMBLE CO - OLESTRA ADR SUMMARY 7/23/97-10/22/97 Control No: 98002575 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP140 Signature: S MATTERI Requester: CONTEMPORARY PRODUCTS INC Subject: VETERINARY SERVICE INC, MODESTO, CA - EIR FOR YRS 1990, 1991, 1992, 1993, 1994 1995, 1996, & 1997 Control No: 98002576 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP140 HFRSE140 Signature: D TANKERSLEY Requester: PLASMA DERIVATIVES CONSULTING Subject: BAYER INC., BERKELEY, CA & CLAYTON, NC (LIC #008) - 483S, RESPONSE TO 483S & WARNING LTRS FOR 1997 Control No: 98002577 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP140 Signature: Requester: GOODBEER G Subject: METHADONE CLINIC, RICHMOND, CA - EIR FROM 2/83 - 12/94 Control No: 98002578 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: E MIRANDA Requester: UCB PHARMA INC Subject: 98-83 Control No: 98002579 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: R GORE Requester: SANTEN INCORPORATED Subject: DERMATOLOGIC & OPHTHALMIC A/C MTG - MINS OF MTG 11/14/97 Control No: 98002580 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HF22 HF40 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: HORTON L - MINS OR SUMMARY OF MTG HELD 1/14/98 Control No: 98002581 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: L SASICH Requester: PUBLIC CITIZEN Subject: KNOLL PHARM CO - MERIDIA/SIBUTRAMINE PHASE IV POSTMARKET STUDY PROTOCOLS Control No: 98002582 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: J DAVID Requester: DAIICHI PHARMACEUTICAL CORP Subject: FLOXIN OTIC/OFLOXACIN SOL/N20-799 - RVWS Control No: 98002583 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: J DAVID Requester: DAIICHI PHARMACEUTICAL CORP Subject: PFIZER - TROVAFLOXACIN/TROVAN RVWS Control No: 98002584 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C FLAMM Requester: TECHNOLOGY EVALUATION CENTER Subject: CYTOGEN - PROSTASCINT/CAPROMABPENDETIDE SBA Control No: 98002585 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: E BENJAMIN Requester: DEXCEL LTD Subject: IMDUR EXTENDED RELEASE TAB/ISOSORBIDE MONONITRATE; ISOPTIN SR SUSTAINED RELEASE ORAL TAB; VOLTAREN EXTENDED RELEASE TAB/DICOLOFENAC SODIUM - PACKAGE INSERTS, LABELING Control No: 98002586 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW340 Signature: L WREN Requester: MUSIC MOUNTAIN WATER COMPANY Subject: SAMPLE ANALYSIS DOCS, CORR, MEMO, COMPLAINT Control No: 98002587 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP140 Signature: L HILD Requester: UNION FISH CO Subject: LAB RESULTS # 40-0248195-0 Control No: 98002588 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRP140 Signature: J TOMSIC Requester: POINT BIOMEDICAL Subject: MATRIX PHARMACEUTICAL INC, SAN JOSE, CA - EIRS & 483S Control No: 98002589 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMW240 Signature: C DREYER Requester: LIPOSOME MANUFACTURING CO INC Subject: LIPOSOME CO INC, INDIANAPOLIS, IN - EIR, 483 DTD 4/21-4/29/97 Control No: 98002590 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: LIPTON TEA; OREGON STATE UNIVERSITY - MEMO OF MTG 8/19/97 Control No: 98002591 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: Z BILGRAMI Requester: ALLEGIANCE HEALTHCARE CORP Subject: BIOPSYS MEDICAL INC - MAMMATOME BIOPSY PROBE K963262 SS&E Control No: 98002592 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: S RUNFOLA Requester: USAA INSURANCE CO Subject: MATRIX PROELECT DT MACHINE - 510K, WARNING LTRS, ETC Control No: 98002593 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRSW340 Signature: Requester: DOE J Subject: SYNERGETIC INC, CHESTERFIELD, MO - 483S LATE 1997 (OCT - DEC) Control No: 98002594 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: J SURGEON Requester: DAVOL INC Subject: W L GORE & ASSOC INC - GORE RESOLUT XT REGENERATIVE MATERIAL K973594 SS&E; STRYKER INSTRUMENTS - CONSTAVAC BLOOD CONSERVATION SYSTEM II K970715 SS&E Control No: 98002595 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFRMA440 Signature: B RUSSELL Requester: UNIVERSITY OF CINCINNATI Subject: PHOENIX INTERNATIONAL LIFE SCIENCES INC, CIN - 483 & EIR FOR 7/19/96 & MOST RECENT MID 1997/NOV 1997 EIR Control No: 98002596 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: SHERWOOD DAVIS & GECK - DEXON VIOLET POLYGYCOLIC SUTURE K972566 Control No: 98002597 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 HFRMA140 Signature: H LEVINE Requester: COOPERS & LYBRAND LLP Subject: LEMMON-TEVA, PA - ANDA FILING RECS PAST 2 YRS Control No: 98002598 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: SPINNAKER - K965189 Control No: 98002599 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: N GENNELL Requester: C R BARD Subject: CORDIS - ATRIAL VASCULAR BRIDGE STENT SYSTEM #42106 Control No: 98002600 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: Requester: LENICK J ATTY Subject: AESTHETIC LASERS INC, ANNAPOLIS, MD - DERMOBRADER DMS-1000C K963204 Control No: 98002601 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: S ROUZER Requester: AARON MEDICAL INDUSTRIES INC Subject: SURG FLEX 5 SURGICAL LIGHT - K810018; SURG FLEX 15 SURGICAL LIGHT - K810019; ETC Control No: 98002602 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: HYMED GROUP - CHONDROPROTEC K961930 SUMMARY Control No: 98002603 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: R ANDERSEN Requester: SUNRISE MEDICAL Subject: WHEELCHAIRS - MDR(S), MALFUNCTIONS 1986-PRESENT Control No: 98002604 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: K REAGAN Requester: KLEINFELD KAPLAN & BECKER Subject: ABBOTT DIAGNOSTICS - ARCHITECT(TM) 510K Control No: 98002605 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFIDR HFZ82 Signature: A PETERSON Requester: INTRATHERAPEUTICS INC Subject: TARGET THERAPEUTICS - TRACKER INFUSION CATHETER K862177; ZEPHYR INFUSION CATHETER K911560; MAGIC INIFUSION CATHETER K923368 Control No: 98002606 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: L CANDELA Requester: BRYON CHEMICAL COMPANY INC Subject: MEHL A - FOREIGN EIR(S) 10/97-11/97 Control No: 98002607 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFZ82 Signature: S OZMUN Requester: WHITEHURST HARKNESS WATSON ET AL Subject: COBE - HEART BYPASS MACHINE MDR Control No: 98002608 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98002609 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: I BLANCH Requester: LABORATORIOS DR ESTEVE Subject: MCNEIL PHARM - HALDOL TABS/HALOPERIDOL TOXICOLOGICAL EVALUATION Control No: 98002610 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98002611 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98002612 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C COGG Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98002613 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 8 FOI REQUEST LTRS Control No: 98002614 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: L ROE Requester: KSTP CHANNEL 5 Subject: ABUZZAHAB F - CMPLNTS, DISCIPLINARY ACTIONS ETC Control No: 98002615 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA305 Signature: S LUKAS Requester: ABBOTT LABORATORIES Subject: DKT 97N-0362 - PARADIGM DRAFT COMMENTS Control No: 98002616 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: Requester: RUDAT J Subject: STADOL/BUTORPHANOL TARTRATE - CMPLNTS, ADRS ETC Control No: 98002617 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA305 Signature: D FREEMAN Requester: HALL DICKLER KENT FRIEDMAN & WOOD Subject: DKT 97S-0163 - COURTESY LTRS OF OBJECTION Control No: 98002618 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: Requester: BRICKEY J Subject: NORVASC/AMLODIPINE - ADRS Control No: 98002619 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA500 Signature: E STEPONKUS Requester: FEDERAL SOURCES INC Subject: CONTRACTS #223975511, 223975515 Control No: 98002620 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA500 Signature: P HUBBARD Requester: SHERIKON INC Subject: CONTRACT #223933000 Control No: 98002621 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFICD Signature: Requester: KATZ S Subject: PROPOSED RULES FOR EACH CATEGORY IN OTC MONOGRAPHS Control No: 98002622 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFS22 Signature: K KELLY Requester: MICROBAN PRODUCTS CO Subject: FAP 5B4468 Control No: 98002623 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA500 Signature: D GRAY Requester: DIGICON CORP Subject: ZIMMERMAN ASSOC - CONTRACT #223933000 Control No: 98002624 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFS22 Signature: Requester: JOHN H ERNSTER LAW OFCS Subject: EXCELPRO INC - CANNED TUNA CORR, TEST RESULTS, MEMOS, MINS OF MTGS, ETC Control No: 98002625 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: M BITONTI Requester: SPANGENBERG SHIBLEY & LIBER Subject: LEVOFLOXACIN INJ & TABS - ADRS Control No: 98002626 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: C DEFILLIPPO Requester: SHEA & ASSOCS Subject: GENZYME CORP - CEREDASE NDA OR ANDA Control No: 98002627 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFD205 Signature: Requester: SIEGLER R Subject: EPHEDRINE OR PSUEDO-EPHEDRINE - ADRS Control No: 98002628 Received Date: 01/28/98 Due Date: 02/26/98 Action Offices: HFA305 HFD205 Signature: T FAULKNER Requester: FAULKNER LAW OFFICES Subject: OTC A/C - TRANS 6/93; MCNEIL INC - TRANS 11/97 RE: WARNING LABELS FOR TYLENOL; MCNEIL INC - TYLENOL ADRS Control No: 98002629 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRNE240 Signature: Requester: FOI SERVICES INC Subject: ROCAP, WOBURN, MA - SERIOUS MFG & QA SYSTEMS PROBLEMS WARNING LTR 1/12/98 Control No: 98002630 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFA100 Signature: Requester: PUOPOLO M Subject: BOSTON DISTRICT AUDITED BUDGETS 526A 1994-1996 Control No: 98002631 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: MERIDIAN BIO-MEDICAL INC, ROUND ROCK, TX - EIRS, 483S 1/96-PRESENT Control No: 98002632 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: GENENTECH, S SAN FRANCISCO, CA - EIR, 483 1/5/98-1/13/98 Control No: 98002633 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRP240 Signature: Requester: FOI SERVICES INC Subject: IDEC, SAN DIEGO, CA - EIRS, 483S 4/97-PRESENT Control No: 98002634 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: BIOCHEMED, HUNTINGTON BEACH, CA - EIRS, 483S 1/90-PRESENT Control No: 98002635 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: QUETIAPINE OR QUETRAPINE - ADR Control No: 98002636 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HALOPERIDOL - ADR Control No: 98002637 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MOLINDONE HCL - ADR Control No: 98002638 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MESORIDAZINE BESYLATE - ADR Control No: 98002639 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PERPHENAZINE - ADR Control No: 98002640 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: MONOBIND, COSTA MESA, CA - EIRS, 483S 1/90-PRESENT Control No: 98002641 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE340 Signature: Requester: FOI SERVICES INC Subject: TENNESSEE BLOOD SERVICES, MEMPHIS, TN - EIRS, 483S 1/95-PRESENT Control No: 98002642 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE540 Signature: Requester: FOI SERVICES INC Subject: PHARMACEUTICAL PACKAGING SPECIALITIES, HUMACAO, PR - EIR, 483, WARNING LTR, CO RESP MOST RECENT Control No: 98002643 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFIMO Signature: Requester: COLLIER SHANNON RILL & SCOTT Subject: WARNING LTRS 1/27/98 Control No: 98002644 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: Requester: WHITAKER F Subject: AUTOMATED PLASMAPHERESIS EQUIPMENT - 510K, 510K SUMMARY, PMA Control No: 98002645 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: S BERGO Requester: WBBM TV Subject: PENILE IMPLANTS - RPTS OF ADVERSE INCIDENTS, ETC Control No: 98002646 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ULTRAM - ADR Control No: 98002647 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: K CONTI Requester: KMC SYSTEMS INC Subject: COHERENT - ULTRAPULSE CO2 SURGICAL LASER K912029 Control No: 98002648 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: HOECHST CORP; NUTRINOVA; PATTON BOGGS - ACESULFAME-K MEMO/MTG 12/16/97 Control No: 98002649 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: Requester: HAMAS R Subject: MENTOR CORP - SALINE-FILLED BREAST IMPLANTS, SILTEX SALINE-FILLED BREAST IMPLANT EIR, RECS Control No: 98002650 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE540 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: PFIZER PHARMACEUTICALS INC, PR - EIR, 483, CO RESP MOST RECENT Control No: 98002651 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE540 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: RHONE-PULENC RORER, PR - EIR, 483, CO RESP MOST RECENT Control No: 98002652 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFI35 Signature: ADMINSTRATOR Requester: RESPONSE Subject: 97-42802 Control No: 98002653 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFA305 Signature: A SCHWARTZ Requester: MDI CONSULTANTS INC Subject: DKT 97M-0520 Control No: 98002654 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: GOLDSTON J Subject: ZOLOFT - ADR Control No: 98002655 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 HFRMW140 Signature: R SIMON Requester: MARTEC GROUP Subject: ARCHER DANIELS MIDLAND, DECATUR, IL - XANTHAN GUM PERMITS OR DATA FILED Control No: 98002656 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: L JAHED Requester: CELL THERAPEUTICS INC Subject: PHARMACIA & UPJOHN CO, KALAMAZOO, MI - ADRIAMYCIN/DOXORUBICIN HCL SBA Control No: 98002657 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: SCHOENECK LABS, LITITZ, PA - EIR, 483 1/90 TO PRESENT Control No: 98002658 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 HFZ82 Signature: Requester: FOI SERVICES INC Subject: GEMINI BIO-PRODS, CALABASAS, CA - EIR, 483 1/90 TO PRESENT Control No: 98002659 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: ALLERGOLOGISK LABORATORIUM, HORSHOLM, DENMARK - EIR, 483 9/8-8-12/97 Control No: 98002660 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: PASTOR J Subject: IRBS - VOLUNTARY ACTION INDICATED/VAI AND/OR OFFICIAL ACTION INDICATED/OAI LTRS/WARNING LTRS THREE FOR EACH OF 17 DEFICIENCIES Control No: 98002661 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRP140 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: DEY LABS, CONCORD, CA & NAPA, CA - EIR, 483 1/1/96 TO PRESENT Control No: 98002662 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE540 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: PHARMACIA & UPJOHN CARIB INC, PR - EIR, 483, CO RESPONSE MOST RECENT Control No: 98002663 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA340 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: HIGHLAND PACKAGING LABS INC, SOMMERVILLE, NJ - EIR, 483, CO RESPONSE MOST RECENT Control No: 98002664 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE240 Signature: Requester: FOI SERVICES INC Subject: ROYCE LABS, MIAMI, FL - EIR, 483 11/96 TO PRESENT Control No: 98002665 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE340 Signature: Requester: FOI SERVICES INC Subject: DEIERHOI M, BIRMINGHAM, AL - EIR 2/7/95 Control No: 98002666 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: PUREPAC PHARM CO, ELIZABETH, NJ - EIR, WARNING LTR 8/11/97-10/21/97 Control No: 98002667 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: PACO, LAKEWOOD, NJ - EIR, 483, WARNING LTR, CO RESPONSE MOST RECENT Control No: 98002668 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSW140 Signature: Requester: FOI SERVICES INC Subject: ALLERGAN, WACO, TX - EIR, 483 Control No: 98002669 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA340 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: CP PACKAGING, JAMESBURG, NJ - EIR, 483, CO RESPONSE MOST RECENT Control No: 98002670 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: B RYAN Requester: GUIDELINES INC Subject: MCNEIL - IMODIUM A-D LOPERAMIDE CHEWABLE TABS NDA 20448 SBA/EQUIV Control No: 98002671 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: J RUBIN Requester: RUBIN & POOR INC Subject: SANGUIN INTL INC - MEDUSSA 2000 VERSION 3.2 BK940011; WYNDGATE TECHNOLOGIES - SAFE TRACE VERSION 1.0 BK950059 RECS Control No: 98002672 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSW140 Signature: S DOMBROFF Requester: AMERICAN FEDERATION OF LABOR AND Subject: WHOLE FOODS MARKET, AUSTIN, TX - WHOLE FOODS B-1, WHOLE FOODS VITAMIN C, WHOLE FOODS VEGETARIAN CHILDREN'S CHEWABLE, ETC NAME & ADDRESS, EIR 1996-1997 Control No: 98002673 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA340 HFRNE140 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: GEL SPICE INC, BROOKLY, NY & BAYONNE, NJ - EIR, 483, RELATED RECS BTWN 1977 & 1990 Control No: 98002674 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFV12 Signature: R STREMMING Requester: PFIZER INC Subject: ELANCO ANIMAL HEALTH - ESTRADIOL FOI SUMMARY, ENVIRONMENTAL ASSESSMENT, ETC NADA 118-123 Control No: 98002675 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFA305 Signature: A SCHWARTZ Requester: MDI CONSULTANTS INC Subject: DKT 97M-0519 Control No: 98002676 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFA305 Signature: A RUCHELMAN Requester: JANSSEN PHARMACEUTICA INC Subject: A/C BIOLOGICAL RESPONSE MODIFIERS - TRANS 10/21/96 Control No: 98002677 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: D SCOTT Requester: PARKE DAVIS Subject: ZAGAM (SPARFLOXACIN) TABS - RVW OF STUDY DESCRIBED IN PACKAGE INSERT Control No: 98002678 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: R OMAR Requester: CENTRE HOSPITALIER UNIVERSITE LAV Subject: PLURONIC F-127 (POLOXAMER 407) BLOCK COPOLYMER (NF GRADE) FROM BASF - DMF Control No: 98002679 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: ROSENBAUM G Subject: C1592040 & M1605672, C1793040 & M1818031, ETC - SPECIFIC CASES Control No: 98002680 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: KIRCHOFF J Subject: DURAVENT - ADVERSE EFFECTS Control No: 98002681 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CLNCL INVESTIGATOR EIR 3/97 TO PRESENT - LIST Control No: 98002682 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PROCHLORPERAZINE - ADR Control No: 98002683 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: THIORIDAZINE & THIORIDAZINE HYDROCHLORIDE - ADR Control No: 98002684 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FLUPHENAZINE DECANOATE & FLUPHENAZINE ENHANTHATE/FLUPHENAZINE HYDROCHLORIDE (ALL FORMS) - ADR Control No: 98002685 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CHLORPROMAZINE & CHLORPROMAZINE HYDROCHLORIDE (ALL FORMS) - ADR Control No: 98002686 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ROSEMONT - BROMOCRIPTINE MESYLATE 2.5MG TABS APRVL RECS, CORR Control No: 98002687 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFI35 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: FOI LOG 1/26,27/98 Control No: 98002688 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFM48 Signature: S MCQUOWN Requester: FRANK L BARNSON PC Subject: CONNAUGHT-FLUZONE/FLU SHOT OR LOT#6F71247 EXPIRATION 6/30/97 - ADR Control No: 98002689 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRNE340 Signature: C CREIGHTON Requester: ALDEN OPTICAL LABORATORIES Subject: ALDEN OPTICAL LABS, ALDEN, NY - EIR 12/16-30/97 Control No: 98002690 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRMA240 HFS22 Signature: L PATTERSON Requester: BOWEN ISLAND BREWING CO Subject: FREDERICK BREWING CO, FREDERICK, MD - HEMPEN ALE APRVL Control No: 98002691 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFIGC Signature: C CERVENKA Requester: LEGAL SUPPORT SERVICES Subject: STANLEY WORKS - STANLEY MAGIC DOOR/ELECTRIC INJURIES, RVWS, ANALYSIS, INCIDENT/ RPTS, ETC Control No: 98002692 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 Signature: M SZALKOWSKI Requester: AMARIC CORPORATION Subject: INDAPAMIDE - M2025689 CASE RPT Control No: 98002693 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: G THOMPSON Requester: HOME ACCESS HEALTH CORP Subject: CHEM TRAK - CHOLES TRAK HOME CHOLESTROL TEST RECS Control No: 98002694 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFZ82 Signature: G THOMPSON Requester: HOME ACCESS HEALTH CORP Subject: FERTILITY FORECASTER PREGNANCY PROGRAM - K880618 RECS Control No: 98002695 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFV12 Signature: R STREMMING Requester: PFIZER Subject: VETLIFE, WINTERSET, IA - ESTRADIOL/ENCORE IMPLANTS NADA 118-123 FOI SUMMARY, ENVIRONMENTAL ASSESSMENT, RECS, ETC Control No: 98002696 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFRSE240 Signature: Requester: GOLDBERG G Subject: XOMED INC, JACKSONVILLE, FL - XOMED DRILL INSTANCES Control No: 98002697 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFA305 Signature: M CROWE Requester: HOWMEDICA INC Subject: ORTHOPEDIC & REHABILITATION DEVICES PANEL MTG - TRANS 1/12-13/98 Control No: 98002698 Received Date: 01/29/98 Due Date: 02/27/98 Action Offices: HFD205 HFS22 Signature: M ROH Requester: DATELINE NBC NEWS Subject: DIETARY SUPPLEMENT HERBAL PHEN FEN - INVESTIGATIONS, MEDICAL STATISTIC, RPTS, MEMORANDA, ETC Control No: 98002699 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRMA440 Signature: S RICHEY Requester: THOMPSON HINE & FLORY LLP Subject: VALLEY NATIONAL GASSES, CINCINNATI, OH - EIRS 8/4-7/97 Control No: 98002700 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J HARTTEN Requester: AKIN GUMP STRAUSS HAUER & FELD Subject: DKT 75N-183H VOL 60 MM4, 87N-0056 VOL 2 C58, ETC Control No: 98002701 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97S-0162 808-814, 97S-0163 93 & 94, 98P-0043 CP1 & LTR, ETC Control No: 98002702 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MITCHELL Requester: FOOD REGULATION WEEKLY Subject: DKT 97N-0217 VOL 2 C43, C79 Control No: 98002703 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: N RUGGIERI Requester: SERONO LABS Subject: DKT 97P-0417 PAV1 Control No: 98002704 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: CITIZEN PETITION LOG PG 429 Control No: 98002705 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 96N-0249 VOL 1 C9, C4, INDEX, ETC Control No: 98002706 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 98P-0012 Control No: 98002707 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 97P-0441 VOL 8 C140-C144 Control No: 98002708 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DKT 91N-0245 VOL 2 INDEX Control No: 98002709 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 98P-0043 CP1, 95S-0117 LST34 Control No: 98002710 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: R BAHIBLA Requester: BUC & BEARDSLEY Subject: DKT 80N-0042 VOL 31 CP7 Control No: 98002711 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: R BAHIBLA Requester: BUC & BEARDSLEY Subject: DKT 97S-0163 VOL 2 Control No: 98002712 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 91N-0384 VOL 83 3 OF 4, REF 13 & 15, VOL 25 REF 1 Control No: 98002713 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: DKT 78N-036L VOL 93 C189, 95P-0326 VOL 1 PAV1, ETC Control No: 98002714 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 98H-0030 LET1 & NPH1, 98H-0029 LET1 & NPH1, ETC Control No: 98002715 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: R SHEPHERD Requester: FDC REPORTS INC Subject: DKT 98P-0043 CP1 Control No: 98002716 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: L GILUEST Requester: WASHINGTON BUSINESS INFORMATION Subject: DKT 95P-0326 PAV1, 77N-094W EXT1, 97D-0433 CEXT1, ETC Control No: 98002717 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A LAVENDER Requester: LAVENDER CONSULTING SERVICES Subject: DKT 97N-0217 C55, C57, C73, C77, C87 Control No: 98002718 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRNE240 Signature: Requester: FOI SERVICES INC Subject: ROCAP, WOBURN, MA - EIR, 483 8/97-9/97 Control No: 98002719 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSW140 Signature: Requester: FOI SERVICES INC Subject: HART R, SAN ANTONIO, TX - EIR 12/17/90 Control No: 98002720 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: AVITA GEL - NDA #20-400 APRVL Control No: 98002721 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ZENITH GOLDLINE - CLOZAAPINE ANDA #74-949 APRVL Control No: 98002722 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J DICKINSON Requester: FERDIC INC Subject: DKT 98P-0022 CP1 APPENDIX PGS 1-6, 24-31, 73-89, 99-103, ETC Control No: 98002723 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: K GEORGE Requester: SOFTWARE QUALITY MANAGEMENT INC Subject: DKT 98N-0015 N1 & FRN, 97D-0282 C22, 97N-0242 C97, ETC Control No: 98002724 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: NOVOPHARM, ONTARIO, CANADA - EIR, 483, WARNING LTR, CO RESPONSE, CORR Control No: 98002725 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ZUCLOPENITHIXOL - ADR Control No: 98002726 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DKT 77N-0094 VOL 156 LET67, 98P-0043 CP1, ETC Control No: 98002727 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LOXAPINE HYDROCHLORIDE; LOXAPINE SUCCINATE - ADR Control No: 98002728 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: S WENSTE Requester: GARDNER CARTON & DOUGLAS Subject: DKT 96N-0048 INDEX OF COMMENTS Control No: 98002729 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MITCHELL Requester: FOOD REGULATION WEEKLY Subject: DKT 97P-0441 VOL 8 LET13, C136, C140, MM1, ETC Control No: 98002730 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: THIOTHIXENE - ADR Control No: 98002731 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97N-0217 VOL 3 C80, C83, C84-C89, ETC Control No: 98002732 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: TRIFLUOPERAZINE HYDROCHLORIDE - ADR Control No: 98002733 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CLOZAPINE - ADR Control No: 98002734 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97P-0441 C140 LET13, C138, C136, ETC Control No: 98002735 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: EQUITECH-BIO INC, INGRAM, TX - EIR, 483 1/90-PRESENT Control No: 98002736 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: VALLEY BIOMEDICAL, WINCHESTER, VA - EIR, 483 1/95-PRESENT Control No: 98002737 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 96N-0249 VOL 20 AE 317, ATTACHMENT 3, ETC Control No: 98002738 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: BARR - ESTRACE APRVL Control No: 98002739 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFI35 Signature: J KIM Requester: BUC & BEARDSLEY Subject: WARNING LTRS; IMPORT ALERTS Control No: 98002740 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: TOPAMAX - ADR Control No: 98002741 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: CHOCOLATE MANUFACTURERS ASSOC - MEMO OF MTG 12/16/97 Control No: 98002742 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRMA340 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: ISO MEDIX, WHIPPANY, NJ - EIR, 483, CO RESPONSE MOST RECENT Control No: 98002743 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE540 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: OMJ PHARMACEUTICALS, SAN GERMAN, PR - EIR, 483, CO RESPONSE MOST RECENT Control No: 98002744 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFI35 Signature: A KIERNAN Requester: THOMPSON PUBLISHING GROUP Subject: WARNING LTRS - 1/20, 1/27/98 Control No: 98002745 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST HIGH RESOLUTION SUPPL KIT HLA 510K 7/97 Control No: 98002746 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J VAN BUREN Requester: CANANDAIGUA WINE CO Subject: METHODS OF CONDUCTING RECALL EFFECTIVENESS CHECKS Control No: 98002747 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST HIGH RESOLUTION SUPPL KIT 510K SUMMARY 2/6/97 Control No: 98002748 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: ONE LAMBDA INC, CANOGA PARK, CA - MICRO SSP HLA CALSS II DNA TYPING KIT 510K 2/21/97 Control No: 98002749 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST DQB-ELPHA 510K 8/97 Control No: 98002750 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: J RUBIN Requester: RUBIN & POOR INC Subject: AMERICAN RED CROSS - NATIONAL BIOMEDICAL COMPUTER SYSTEM BK960040 Control No: 98002751 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST HIGH RESOLUTION SUPPL KIT 510K 2/6/97 Control No: 98002752 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST DQB-ELPHA 510K SUMMARY 8/97 Control No: 98002753 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: BIOTEST DIAGNOSTICS CORP, DENVILLE, NJ - BIOTEST HIGH RESOLUTION SUPPL KIT HLA 510K SUMMARY 7/97 Control No: 98002754 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 271 C2651, VOL 273 C2903, VOL 274 C2965 Control No: 98002755 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: E ROSSITER Requester: REGULATORY RESOURCES Subject: ONE LAMBDA INC,CANOGA PARK, CA - MICRO SSP HLA CLASS II DNA TYPING KIT 510K SUMMARY 2/21/97 Control No: 98002756 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 271 C2641, C2642, C2643, ETC Control No: 98002757 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J DICKINSON Requester: FERDIC INC Subject: DKT 97D-0433 EXT1, 97H-0379 MO2, 97P-0281 LET12, ETC Control No: 98002758 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 85N-0214 Control No: 98002759 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: DEBTOR Signature: A STEVENS Requester: MERIT PHARMACEUTICALS Subject: STERIS LABS, PHOENIX, AZ & AMERICAN REGENT LABS, SHIRLEY, NY - 483 & 2 MOST RECENT FORM & RESP Control No: 98002760 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 90S-0308 M585 Control No: 98002761 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P KENISTON Requester: KING & SPALDING Subject: DKT 97P-0314 VOLS 1-3 Control No: 98002762 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRMA340 Signature: K LENARCZYK Requester: LENCO INC Subject: KATO LABS INC, SUMMIT, NJ - EIR OR ANNUAL REGISTRATION OF DRUG ESTABLISHMENT Control No: 98002763 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 77N-0034 MT C0001, C0003, LET, C005ANS, LET005, ETC Control No: 98002764 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 85N-0214 C48, C43, ETC Control No: 98002765 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: DKT 97D-0282 VOL 3 C22, 97N-0242 VOL 3 C97, 97N-0477 VOL 1 C1& C2 Control No: 98002766 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 95S-0117 LST34 Control No: 98002767 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE240 Signature: R FILIPINA Requester: TECO DIAGNOSTICS Subject: HOME DIAGNOSTICS, FT LAUDERDALE, FL - EIR Control No: 98002768 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: DKT 98P-0032 VOL 1 CP1, 98P-0035 VOL 1 CP1, ETC Control No: 98002769 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 98P-0022 Control No: 98002770 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: DKT 97P-0343 Control No: 98002771 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE240 Signature: H MENENDEZ Requester: HOLLAND & KNIGHT Subject: ERWIN CHEMICAL LABS, MIAMI, FL - VIOLATIONS, CMPLNTS, RECS, ETC Control No: 98002772 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: F LEE Requester: INFORMATION ACCESS Subject: A/C ONCOLOGIC DRUGS - TRANS 12/18,19/97 Control No: 98002773 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 85N-0214 LET10 Control No: 98002774 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 98P-0042 CP1, 97N-0325 C62 Control No: 98002775 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 159 C1398/ANS, C1399, C1400, ETC Control No: 98002776 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: J STAMPER Requester: HYMAN PHELPS & MCNAMARA PC Subject: DKT 95N-0304 VOL 170 C1720-C1726, VOL 268 C2355, VOL 271 C2639, C2640 Control No: 98002777 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSW240 Signature: M ERICKSON Requester: MCGUINESS & HOLCH Subject: E EXCEL INTERNATIONAL, SPRINGVILLE, UT - EIR, CONTRACT PERSONNEL, DOCS, EVIDENCEOF ADULTERATION, ETC Control No: 98002778 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRMA140 Signature: W HAMPTON Requester: HAMPTON & MCCREARY Subject: BERKS COUNTY, PA - CYCLOSPORA OUTBREAK INVESTIGATION, RECS RE TELE CONVERSATION,TEST RESULTS, ETC 5/96 Control No: 98002779 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRP140 Signature: J DEMETROULAS Requester: TAN AMERICA Subject: CMPLNT EI 12-3-97 GLZ Control No: 98002780 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRP240 Signature: A RUCKELMAN Requester: JANSSEN PHARMACEUTICA INC Subject: SP PHARMACEUTICALS; GENSIA INC - EIR(S), WARNING LTRS Control No: 98002781 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: K CRAIG Requester: HYMAN PHELPS & MCNAMARA PC Subject: OMEGA-TECH INC - MINS OF MTS, MEMOS 12/16/97 Control No: 98002782 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFI35 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: 97-28739, 97-32856 Control No: 98002783 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFIGC Signature: Requester: MCCORMACK G Subject: PEROTONITIS OUTBREAK - RECALL, LOT NUMBERS, RPTS, ETC 1996-1997 Control No: 98002784 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFIGC Signature: Requester: KRUEGER N Subject: GEORGETOWN INSTITUTE OF ETHICS, WASHINGTON, DC - ASSISTED REPRODUCTION THERAPY IN-VITRO ETHICS, REGS Control No: 98002785 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: G PRESSINGER Requester: BRITISH AISLES LTD Subject: LACF INFO PROCESSES - 1992-PRESENT Control No: 98002786 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSW140 Signature: Requester: PATANE R Subject: KENMONT LABS INC - 483, WARNING LTRS, CO RESP, ETC 1995-1997; SOVEREIGN PHARM INC - 483S, WARNING LTRS, CO RESP, ETC 1997; ETC Control No: 98002787 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: C KUREK Requester: NORTHGATE TECHNOLOGIES INC Subject: ELECTRO MEDICAL SYSTEMS S A - EMS SWISS LITHOCLAST LITHOTRIPTER K963285; WOM GMBH - SURGIFLATOR-30 K973432 Control No: 98002788 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE340 Signature: V TATE Requester: SOUTHERN RESEARCH INSTITUTE Subject: GALBRAITH LABS INC, KNOXVILLE, TN - 482S, 483S, CORR, ETC 1993-PRESENT Control No: 98002789 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: D BARBER Requester: WAYNE GENERAL HOSPITAL Subject: COOK - MICROPUNCTURE INTRODUCER SET PROBLEMS, MDR Control No: 98002790 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE440 Signature: Requester: FARRIOR S Subject: RIVIANA MILLS, ABBEVILLE, LA - FEDERAL HEALTH INSPECTION RPTS 3/15/97 & 3/17/97 Control No: 98002791 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: W WILLIAMS Requester: FOREST LABORATORIES INC Subject: ZAMBRON CORP - MONUROL NDA #50-717 APRVL RECS Control No: 98002792 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSW140 Signature: S DOMBROFF Requester: AMERICAN FEDERATION OF LABOR AND Subject: WHOLE FOODS MARKET, AUSTIN, TX - EIR, COMPLAINTS, ETC 1996-1997 Control No: 98002793 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRMA340 Signature: Requester: FILIPPI M Subject: CAN OF VANILLA ENSURE PLUS - TEST RESULTS Control No: 98002794 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: A BUEHNER Requester: HAIR THERE & EVERY WEAR Subject: HOLLAND INTERNATIONAL TANNING BED - OWNER'S MANUAL Control No: 98002795 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRNE240 Signature: L QUASARANO Requester: BOSTON BAY BROKERS INC Subject: SMPL 530-0033875-5 ANALYTICAL WORKSHEETS Control No: 98002796 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFICD Signature: D ODINK Requester: ROCHE BIOSCIENCE Subject: INACTIVE INGREDIENT GUIDE Control No: 98002797 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Z DZIEWANOWSKA Requester: CYPROS PHARMACEUTICAL CORP Subject: ENQUAY PHARMACEUTICAL ASSOCS; CYPROS PHARMACEUTICAL CORP - SILDIMAC; DIMAC W/SILVER SULFADIAZINE NDA 19-608 TRANSFER OF OWNERSHIP, CERTIFICATION Control No: 98002798 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: C TRIOLO Requester: SPARTA PHARMACEUTICALS INC Subject: T-PA - SBA Control No: 98002799 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: T LURIA Requester: LEWIS & FINKELSTEIN Subject: TRAZODONE - ALL LINE LISTINGS FOR ADR(S) Control No: 98002800 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFRSE240 Signature: T MOTES Requester: SIROTE & PERMUTT Subject: LAKEVIEW CNTR INC, PENSACOLA, FL - EIRS, CORR, SUMMARIES, ETC LAST 5 YRS Control No: 98002801 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFIGC Signature: D DAVIS Requester: ADD CRUSADE INC Subject: THE STIMULANT MEDICATIONS (PRESCRIBED FOR ATTENTION DEFICIT DISORDER) - DATA Control No: 98002802 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: N DOWNEY Requester: SUN NUCLEAR CORP Subject: STANDARD IMAGING INC - IIDR 1000 ION CHAMBER/K922554 510K SUMMARY Control No: 98002803 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: R KURKIEWICZ Requester: CARACO PHARMACEUTICAL LABS LTD Subject: PHARMACIA INC - HEALON/SODIUM HYALURONATE SS&E Control No: 98002804 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: N KUMAR Requester: G PREMJEE (USA) INC Subject: POWDER FREE EXAMINATION GLOVES/K932550; STERILE SURGEONS GLOVES/K902449; PRE- POWDERED EXAMINATION GLOVES/K890872 - 510K Control No: 98002805 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: C HERNDON Requester: ALLIANCE PHARMACEUTICAL CORP Subject: HOWMEDICA - DEVICE GUN, EXETER CEMENT/K790275 510K Control No: 98002806 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: I WELLMAN Requester: ABELSON-TAYLOR INC Subject: PHARMACIA & UPJOHN - PROVERA/MEDROXYPROGESTERONE; WYETH-AYERST LABS - PREMPRO/ CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE NDA SAFETY DATA Control No: 98002807 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA20 HFD205 Signature: Requester: LAW OFFICE OF KEITH M JENSEN PC Subject: DEXFENFLURAMINE/REDUX & FENFLURAMINE/PONDOMIN - TRANS, ARPVL RECS ETC Control No: 98002808 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: D SIGELMAN Requester: KELLOGG SACCOCCIA & SIGELMAN Subject: LUTWAK L - INTEROFFICE MEMORANDUM 9/8/95 Control No: 98002809 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: R VARESE Requester: SHOTWELL & CARR INC Subject: INSTITUTE OF DRUG TECHNOLOGY, VICTORIA, AUSTRALIA - EIRS, 483S PAST 2 YRS Control No: 98002810 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFIDR HFZ82 Signature: Requester: ELLIOTT Subject: AMERICAN EDWARDS - XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES; BAXTER EDWARDS-IMAGECATH CORONARY ANGIOSCOPE/K926433; COOK UROLOGICAL INC - ILLUMINATED URETER-AL CATHETER/K923436 & 2 OTHER DEVICES - 510K Control No: 98002811 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: J TAN Requester: SORIN BIOMEDICAL INC Subject: BIOTREND OXYGEN SATRATION & HEMATOCRIT SYSTEM/K954501 - 510K Control No: 98002812 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: A MANNION Requester: IRISH MEDICINES BOARD Subject: ABBOTT PRISM SYSTEM - APRVL STATUS Control No: 98002813 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: DEBTOR Signature: M RENDELL Requester: CREIGHTON UNIVERSITY Subject: REPAGLINIDE - RECS Control No: 98002814 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: T GALLAGHER Requester: ALTA-G ENTERPRISES Subject: INDIUM - TOXICITY RECS; GRAS LIST Control No: 98002815 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: F STEARNS Requester: KELLER & HECKMAN LLP Subject: DENTAL PRODS PANEL MTG - TRANS 10/29-30/97 Control No: 98002816 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: J MOWE Requester: AMERICAN ASSOCIATION OF TISSUE Subject: LIST OF TISSUE BANKS OR OTHER ESTABLISHMENTS INSPECTED 1/1/97 TO 12/31/97 Control No: 98002817 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: JOHNSON & JOHNSON CORP - DRUG LISTING RECS RE: OTC CONTRACEPTIVE PRODS Control No: 98002818 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: C HERNDON Requester: ALLIANCE PHARMACEUTICAL CORP Subject: DEPUY INC - DEVICE GUN CEMENT/K781955 510K Control No: 98002819 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: K CONTI Requester: KMC SYSTEMS INC Subject: SHARPLAN MODEL 1020 CO2 SURGICAL LASER/K882180 - 51K Control No: 98002820 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFZ82 Signature: K CONTI Requester: KMC SYSTEMS INC Subject: SHARPLAN MODEL 1120 CO2 SURGICAL LASER/K936109 - 510K Control No: 98002821 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: S JOHN Requester: VIROPHARMA INC Subject: MASSACHUSETTS PUBLIC HEALTH BIOLOGIC LABORATORIES - RESPIGAM/RESPIRATORY SYNCT- IAL VIRUS IMMUNE GLOBULIN INTRAVENOUS SBA Control No: 98002822 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: B PETERSEN Requester: NOVIGEN SCIENCES INC Subject: TOTAL DIET STUDY Control No: 98002823 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: M SMITH Requester: FENWICK & WEST Subject: ARMOUR - ABLUMINAR 5% PACKAGING Control No: 98002824 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA306 Signature: K DELMONT Requester: PACE INC Subject: GASTROENTEROLOGY RVW BOARD - LIST OF A/C MEMBERS Control No: 98002825 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFM48 Signature: C GRAVEL Requester: PASTEUR MERIEUX CONNAUGHT Subject: SMITHKLINE - HEPATITIS A VACCINE; MERCK - HEPATITIS A VACCINE SBA Control No: 98002826 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HF35 Signature: R SANTOS Requester: FOIA GROUP INC Subject: ORPHAN PRODS DEVELOPMENT PROGRAM - MINS OF MTG 11/4-5/97 Control No: 98002827 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFICD Signature: M MAREK Requester: SP PHARMACEUTICAL LLC Subject: INACTIVE INGREDIENT GUIDE Control No: 98002828 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: A RAHMAN Requester: NORTHEAST LOUISIANA UNIVERSITY Subject: DKT 97D-0302 Control No: 98002829 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFI35 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: 98-381 Control No: 98002830 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: MAYERSON LAW OFFICES PC Subject: SERZONE - ASCI DISC Control No: 98002831 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: A MASTRAPA Requester: NEXTPHASE INTERNATIONAL Subject: NUMBER OF INVESTIGATORS IN 97 & EXPECTED GROWTH RATE; NUMBER OF CLINICAL TRIALS & PROJECTED GROWTH RATE; NUMBER OF INVESTIGATORS BROKEN DOWN BY THERAPEUTIC AREAS IN 1997 & 3 OTHER LISTS Control No: 98002832 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: L BLOCK Requester: GREY ADVERTISING Subject: ROCEPHIN IM - ADRS Control No: 98002833 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FLEISCHER N Subject: LEK - ACYCLOVIR TABS/ANDA 74-658 BIOEQUIVALENCE RVWS PG 2 ONLY Control No: 98002834 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: R YOUNG Requester: PHARMACEUTICAL UTILIZATION MANAGE Subject: REPACKAGING CO OF AMERICA - NDC #55306-0867-1 & NDC 54441-185-01;PHARMACEUTICAL TECHNOLOGIES - NDA 59415-038-01; PHARMACEUTICAL DISTRIBUTORS - NDC #57836-0867-1; DRUG DISTRIBUTORS - NDC #52985-0092-1 PREMARIN .625 MG LABELS Control No: 98002835 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FLEISCHER N Subject: SALAGEN TABS/N20-237 RVWS Control No: 98002836 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: GASIOROWSKI H Subject: JANSEN PHARM - SPORANOX SAFETY RECS Control No: 98002837 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: B YORGEY Requester: SANOFI WINTHROP INC Subject: PLAVIX/CLOPIDOGREL - SBA, RVWS Control No: 98002838 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: M CONEY Requester: SST CORP Subject: FABBRICA ITALIANA SINTETICI, VINCENZA, ITALY - EIR, 483, CO RESP 7/97 Control No: 98002839 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: B O'HALLORAN Requester: SANOFI WINTHROP INC Subject: SANOFI CHIMI, ARAMON, FRANCE - EIRS, 483S, CORR 1/1/93 TO 1/1/94 & 1/96 Control No: 98002840 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: B O'HALLORAN Requester: SANOFI WINTHROP INC Subject: SANOFI WINTHROP INDUSTRIE, DE BONDEVILLE, FRANCE - EIRS, 483S, CORR 1/96 Control No: 98002841 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: KANTOR K Subject: LUBELUZOLE - EIR 9/97-10/97 Control No: 98002842 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: S JOHN Requester: VIROPHARMA INC Subject: SMITHKLINE BEECHAM - FAMVIR/FAMCICLOVIR SBA Control No: 98002843 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: S JOHN Requester: VIROPHARMA INC Subject: GLAXO WELLCOME - ZOVIRAX/ACYCLOVIR SBA Control No: 98002844 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: MERCK - FAMOTIDINE POWDER/N19-527 SBA AND/OR EQUIVALENT Control No: 98002845 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: KNOLL - VICOPROFEN/ANDA 20-716 SBA AND/OR EQUIVALENT Control No: 98002846 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: M CONEY Requester: SST CORP Subject: LOFTUS BRYAN CHEMICALS LTD, WICKLOW, IRELAND - EIR, 483, CO RESP 7/97 Control No: 98002847 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: M CONEY Requester: SST CORP Subject: KOPRAN LTD, RAIGAD, INDIA - EIR, 483, CO RESP MOST RECENT Control No: 98002848 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: M CONEY Requester: SST CORP Subject: ORION CORP, OULO, FINLAND - EIR, 483, CO RESP MOST RECENT Control No: 98002849 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: S CINDRIC Requester: ANGIOTECH PHARMACEUTICALS INC Subject: CASE RPT FORMS FOR PHASE I/SAFETY CLINICAL STUDY IN RHEUMATOID ARTHRITIS Control No: 98002850 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: N ARMSTRONG Requester: GEM PHARMACEUTICALS INC Subject: SOMERSET PHARM INC - ELDEPRYL/L-DEPRENYL SBA Control No: 98002851 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: G REMPE Requester: SEATTLE INSTITUTE FOR WEIGHT-CONT Subject: FD&C BLUE #1 - TOXICOLOGICAL EFFECTS Control No: 98002852 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: G REMPE Requester: SEATTLE INSTITUTE FOR WEIGHT-CONT Subject: BROMINATEDS VEGETABLE OIL - TOXICOLOGICAL EFFECTS Control No: 98002853 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: G REMPE Requester: SEATTLE INSTITUTE FOR WEIGHT-CONT Subject: FD&C RED #40 - TOXICOLOGICAL EFFECTS Control No: 98002854 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: G REMPE Requester: SEATTLE INSTITUTE FOR WEIGHT-CONT Subject: FD&C YELLOW #5 - TOXICOLOGICAL EFFECTS Control No: 98002855 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFS22 Signature: W OLSON Requester: CENTER FOR REGULATORY SERVICES Subject: HOECHST CORP - MEMO OF MTG 12/16/97 Control No: 98002856 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: P THOMAS Requester: ZAMBON CORPORATION Subject: ZAMBON CORP - MONUROL/N50-717 APRVL RECS Control No: 98002857 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: S MACNAB Requester: NOVARTIS PHARMACEUTICALS CORP Subject: LILY - GEMZAR/GEMCITABINE A/C TRANS 7/24/95 Control No: 98002858 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: S MACNAB Requester: NOVARTIS PHARMACEUTICALS CORP Subject: XENOTRANSPLANTATION A/C MTG - TRANS 12/17/97 Control No: 98002859 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: M SMITH Requester: FENWICK & WEST Subject: BLOOD PRODS A/C MTG - TRANS 3/24/94 Control No: 98002860 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: B BRIMELOW Requester: PFIZER INC Subject: MALLINCKRODT VETERINARY INC - ZERANOL/RALGRO MAGNUM PACKAGE INSERT Control No: 98002861 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: B BRIMELOW Requester: PFIZER INC Subject: IVY LABS INC - IMPLUS-C/PROGESTERONE AND ESTRADIOL BENZOATE PACKAGE INSERT Control No: 98002862 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFA305 Signature: B BRIMELOW Requester: PFIZER INC Subject: ROUSSEL-UCLAF - FINAPLIX/TRENBOLONE ACETATE PACKAGE INSERT Control No: 98002863 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: ABEDRABBO M Subject: PONDEMIN AND SYNTHROID - ADRS Control No: 98002864 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: FARINELLA M Subject: ELAN CORP OR ELAN PHARM - ALL NDAS OR ANDAS 1997 & 1998 Control No: 98002865 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: A MOLGA Requester: ASTRA FRANCE Subject: LEXXEL/FELODIPINE & ENALAPRIL - SBA Control No: 98002866 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFD205 Signature: Requester: HUFF S Subject: LORAZEPAN - MYOCLONUR AND/OR FASCICULATIONS ASSOCIATED W/USE Control No: 98002867 Received Date: 01/30/98 Due Date: 03/02/98 Action Offices: HFI35 Signature: M RICHTER Requester: EPROVA AG Subject: 97-38620