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DOCKETS ENTERED on February 5, 2002

TABLE OF CONTENTS

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80N-0295 OTC drug review policy statement *
01D-0432 Evalution of the effects of Orally Inhaled and Intranasal *
01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01N-0464 Vaccine Adverse Event Reporting System *
01P-0353 ANDA for a generic albuterol inhalation aerosol *

77N-0085 Saccharin and Its Salts

CA 35425 Alex Nagy Vol#: 586

CA 35426 Mark L. Adams Vol#: 586

CA 35427 Bonnie Haziza Vol#: 586

CA 35428 Mr.& Mrs.Edward Greco Sr. Vol#: 586

CA 35429 Neol & Arla Lawson Vol#: 586

CA 35972 Sonja J. & Alvin D. Ankrum Vol#: 592

CA 35973 Shirley Fahrer & 5 other signatures Vol#: 592

CA 35974 Mae & John Hooten Vol#: 592

CA 35975 John G. Deitz Vol#: 592

CA 35976 Susan M. Hierlinger Vol#: 592

CA 35977 Betti L. Scott Vol#: 592

CA 35978 Jerry L. Lee Vol#: 592

CA 35979 Diana F. Moses & 15 other signatures Vol#: 592

CA 35980 Carolyn K. Anspach Vol#: 592

CA 35981 C. A. Pazman, Jr. Vol#: 592

CA 35982 Janet Sukup Vol#: 592

CA 35983 Mr. K. J. Laessig Vol#: 592

CA 35984 Barbara Armstrong Vol#: 592

CA 35985 C. William (Bill) Maxwell Vol#: 592

CA 35986 Mary K. Alstead Vol#: 592

CA 35987 Joseph A. Belluscio Vol#: 592

CA 35988 Rev. Thomas J. Calpin Vol#: 592

CA 35989 Sally Peters Vol#: 592

CA 35990 William J. Teague Vol#: 592

CA 36070 Palmer York, Jr. Vol#: 594

CA 36071 Aldona M. Deksnis Vol#: 594

CA 36072 Pamela S. Schindler Vol#: 594

CA 36073 Mrs. Glenn Hassler Vol#: 594

CA 36074 Joanie Schirm Vol#: 594

CA 36075 Pearl McKeehan Vol#: 594

CA 36076 Dorothy D. Light Vol#: 594

CA 36077 Thelbert D. Gupton, Jr. Vol#: 594

CA 36078 J. C. Thompson Vol#: 594

CA 36079 Leo Karas Vol#: 594

CA 36080 Gordon W. Moss Vol#: 594

CA 36081 Kim D. Forber Vol#: 594

CA 36082 Elaine Crafton Vol#: 594

CA 36083 Kay Bohnsack Vol#: 594

CA 36084 Mrs. M. E. Long Vol#: 594

CA 36085 Mrs. Marcia F. Wall Vol#: 594

CA 36086 Barbara J. Nearing Vol#: 594

CA 36087 Gordon H. Mynatt Vol#: 594

CA 36088 John W. Day Vol#: 594

CA 36089 Andrew J. Stefani Vol#: 594

CA 36090 Richard L. Sanderson Vol#: 594

CA 36091 Lynda Sabara Vol#: 594

CA 36092 John H. Evans Vol#: 594

CA 36093 Elaine Goolsby Vol#: 594

CA 36094 Elaine M. Salisbury & Edmund R. Thornton Vol#: 594

CA 36095 Rev. Edward L. Peet Vol#: 594

CA 36096 Harold B. Loeb Vol#: 594

CA 36097 Martin E. & Noel B. Taylor Vol#: 594

CA 36098 Geni Marino Vol#: 594

CA 36099 Roger Waller Vol#: 594

CA 36100 William S. Fredendall Vol#: 594

CA 36101 William Bentley Vol#: 594

CA 36102 Howard F. Kahn Vol#: 594

CA 36103 Dorothy Rhoades Vol#: 594

CA 36104 Kathleen S. O'Brien Vol#: 594

CA 36105 T. E. Duffy Vol#: 594

CA 36106 Mrs. Jerry F. Davis Vol#: 594

CA 36107 Burt J. Blustein Vol#: 594

CA 36108 Patricia A. Fellows Vol#: 594

CA 36109 Mel Jones Vol#: 594

CA 36110 Jon L. Wiseman Vol#: 594

CA 36111 Mrs. Jackie Thomas Vol#: 594

CA 36112 Pauline Tanenholz Vol#: 594

CA 36113 Mrs. E. L. Fennewald Vol#: 594

CA 36114 No Submitter Vol#: 594

CA 36115 Charles T. Tillman Vol#: 594

CA 36116 Mr. & Mrs. Charles Murphy & 1 other sig. Vol#: 594

CA 36117 Mrs. Therese Bently Vol#: 594

CA 36118 Sybil Reizner Vol#: 594

CA 36119 J. R. Jordan, D. D. S. Vol#: 594

CA 36120 James R. Bailey Vol#: 594

CA 36121 Delight E. Buness Vol#: 594

CA 36122 Wayne T. Olson Vol#: 594

CA 36123 Judith Zvereff Vol#: 594

CA 36124 Anthony J. Trella Vol#: 594

CA 36125 Mrs. Barbara L. Aveni Vol#: 594

CA 36126 Dianne D. Schurke Vol#: 594

CA 36127 Laurence M. Olson Vol#: 594

CA 36128 Jim Brooks Vol#: 594

CA 36129 Mary A. Fugua & 4 other signatures Vol#: 594

CA 36130 Richard E. Campbell Vol#: 594

CA 36131 John & Lynne Kozlowski Vol#: 594

CA 36132 Maitland B. Knox Vol#: 594

CA 36133 Richard A. Schiffer Vol#: 594

CA 36134 Victoria Gould Pryor Vol#: 594

CA 36135 Carolyn H. Larsen Vol#: 594

CA 36136 Seymour Sheldon Vol#: 594

CA 36137 Lawrence E. Rapoport Vol#: 594

CA 36138 Dorothy Tarasoff & 43 other signatures Vol#: 594

CA 36139 Floyd F. Farley Vol#: 594

CA 36140 Marcy Wright Vol#: 594

CA 36141 John J. Welgos Vol#: 594

CA 36142 Marilyn Murray Vol#: 594

CA 36143 Virginia S. Heckman Vol#: 594

CA 36144 Mrs. Martha O. Benton Vol#: 594

CA 36145 Ms. Sarah Giannetto Vol#: 594

CA 36146 Dodie Thomas Vol#: 594

CA 36147 Charles S. Franklin Vol#: 594

CA 36148 Loyd R. Steelman Vol#: 594

CA 36149 Richard M. & Geraldine F. Pymn Vol#: 594

CA 36150 Pat L. Taylor Vol#: 594

CA 36151 Mrs. Richard Schumacker Vol#: 594

CA 36152 Dianne D. Schurke Vol#: 594

CA 36153 Lynette Sim Vol#: 594

CA 36154 Richard W. Foster Vol#: 594

CA 36155 Mrs. Linda Dempsey Vol#: 594

CA 36156 Richard M. & Jane P. Lieberman Vol#: 594

CA 36157 Loy R. Green Vol#: 594

CA 36158 Diane R. Grabhorn Vol#: 594

CA 36159 Anne Cason Vol#: 594

CA 36160 Estelle J. Shives Vol#: 594

CA 36161 Eleanor E. Harrison Vol#: 594

CA 36162 Mrs. Jane M. Sivert & 3 other signatures Vol#: 594

CA 36163 Mrs. Charlaine Jones Vol#: 594

CA 36164 Mrs. Barbara Maryott Vol#: 594

CA 36165 Cathi Cole Vol#: 594

CA 36166 Mrs. Jesse N. Johnson Vol#: 594

CA 36167 Jane Wellborn Vol#: 594

CA 36168 Father Malachi Vol#: 594

CA 36169 Charles A. Braak, M. D. Vol#: 594

CA 36170 Julian David Hendrix Vol#: 595

CA 36171 Harold C. Freedman, M. D. Vol#: 595

CA 36172 Marion L. Knudsen Vol#: 595

CA 36173 Anne M. Stein Vol#: 595

CA 36174 Frederic E. Cowden, M. D. Vol#: 595

80N-0295 OTC drug review policy statement

MM 126 FDA/OTC & Bayer Corporation Vol#: 3

98D-0016 Professional Flexible Labeling of Antimicrobial Drugs

NWL 1 Vol#: 1

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

EMC 637 Cora Fran Rotussney Vol#: 185

EMC 638 Thomas Klem Vol#: 185

EMC 639 Thomas Klem Vol#: 185

EMC 640 Ian S. Thompson Vol#: 185

EMC 641 Ryan A. Scott Vol#: 185

EMC 642 Malia Damon Vol#: 185

EMC 643 Caroline Carbone Vol#: 185

EMC 644 Stephen J. Dipresso Vol#: 185

EMC 645 Barbara Brown Vol#: 185

EMC 646 David R. Dunn Vol#: 185

EMC 647 Edgar Plum Vol#: 185

EMC 648 Kenneth A. Herren Vol#: 185

EMC 649 Jeff Evans Vol#: 185

EMC 650 Mary Moore Vol#: 185

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

C 5471 Mrs. Shirley L. Shepard Vol#: 202

C 5472 Mrs. Pat Curnow Vol#: 202

C 5473 Maria V. Barbee Vol#: 202

C 5474 Vivian Lynch & Lauren Lynch Schaefer Vol#: 202

C 5475 Donna J. Snyder & Sherwood R. Snyder Vol#: 202

C 5476 George Wortiska Vol#: 202

C 5477 Linda Johnson & Emily Arcolino Vol#: 202

C 5478 Linda Frost & Susan Mickiewicz Vol#: 202

C 5479 Julia Mallory Vol#: 202

C 5480 Mrs. Bonnie Taylor Vol#: 202

C 5481 Andrea Montlouis Vol#: 202

C 5482 Mr. & Mrs. Charles Jaris Vol#: 202

C 5483 Mrs. Robert Donner Vol#: 202

C 5484 J. Capozzelli Vol#: 202

C 5485 Winifred & Otto Rueter Vol#: 202

C 5486 Mrs. Nancy Pindisk Vol#: 202

C 5487 Mr. Charles Betcher Vol#: 202

C 5488 C. L. Mochert Vol#: 202

C 5489 Ms. Jean S. Sutherland Vol#: 202

C 5490 Marian Carter Vol#: 202

C 5491 Sandra Hrabowy Vol#: 202

C 5492 Ms. L. Seaman Vol#: 202

C 5493 Aline Johnson Vol#: 202

C 5494 Ann Fleming Vol#: 202

C 5495 Deborah R. Frame Vol#: 202

C 5496 James L. Gerardi Vol#: 202

C 5497 Patricia Joralemon Vol#: 202

C 5498 Professor Laura Seraso Vol#: 203

C 5499 Barbara A. Manaro Vol#: 203

C 5500 Rae S. Sabella Vol#: 203

C 5501 Ralph H. Regaalado Vol#: 203

C 5502 Mrs Patricia Rebhan et al Vol#: 203

C 5503 Susan A. Yacenda Vol#: 203

C 5504 John T Andrews, Ph.D. & Kathleen A Andre Vol#: 203

C 5505 Mr. & Mrs. Ross H. Dabney Vol#: 203

C 5506 Wilhelm Winter Vol#: 203

C 5507 Diana Vogt Vol#: 203

C 5508 Mary Lou Vanderburg Vol#: 203

C 5509 Simone G. Dennewill Vol#: 203

C 5510 Barbara A. Davis & Sandy K. Lingar Vol#: 203

C 5511 Marlene Cranmer Vol#: 203

C 5512 Janis Close Vol#: 203

C 5513 Elaine Nazzaro Vol#: 203

99P-1340 Declared Eternity eau de Parfum Misbranded

C 737 Loretta Carr, RNC Vol#: 18

00D-1538 Electronic Records; Electronic Signatures, Validation

C 27 Audit Repository Center Vol#: 6

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9661 Veronica Correa Vol#: 476

C 9662 M. Adams Vol#: 476

C 9663 Daniel Sackett Vol#: 476

C 9664 Kevin Uehlinger Vol#: 476

C 9665 Janet Hitt Vol#: 476

C 9666 D. Deringer Vol#: 476

00E-1251 Patent Extension Synercid #4,668,669

EC 1 Ms. Julie Hwa Vol#: 1

EC 2 Ms. Julie Hwa Vol#: 1

01D-0432 Evalution of the effects of Orally Inhaled and Intranasal

C 3 GlaxoSmithKline Vol#: 2


01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies

EC 1 Global Regulatory Affairs; Pharmacia Cor Vol#: 1

EC 2 Global Regulatory Affairs; Pharmacia Cor Vol#: 1

EC 3 Global Regulatory Affairs; Pharmacia Cor Vol#: 1

EC 4 Biovail Contract Research Organization Vol#: 1

EC 5 Barr Laboratories, Inc. Vol#: 1

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

EC 6 Genentech, Inc. Vol#: 1

01D-0584 Reduce the Risk of Transmission of HIV-1 & HCV

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 228 AS Life Support Groups Vol#: 4

01N-0464 Vaccine Adverse Event Reporting System

C 7 BioPort Corporation Vol#: 1


01P-0353 ANDA for a generic albuterol inhalation aerosol

LET 1 HFD-1 to Aspire Pharmaceuticals Inc Vol#: 1