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