DOCKETS ENTERED on June 5, 2001

TABLE OF CONTENTS

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92N-0489 Taxol; Enviromental Assessments and Fonsi

EA 3 Paclitaxel Injection ANDA 75-184/S002 Vol#: 1

00D-0087 IND meetings for human drugs/biologics,chemistry,mfging

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 3507 Hans Schweiger Vol#: 293

C 3508 Amanda Husberg Vol#: 293

C 3509 Corinna M. Johnson Vol#: 293

C 3510 illegible Vol#: 293

C 3511 Gina M. Mercurio Vol#: 293

C 3512 Mary R. Currier Vol#: 293

C 3513 Christine Boyd Vol#: 293

C 3514 Victoria L. Pellinen Vol#: 293

C 3515 Lisa Dunn Vol#: 293

C 3516 Charles Payne Vol#: 293

C 3517 Brenda Mahoney Vol#: 293

C 3518 Lauretta Clowes Vol#: 293

C 3519 Steven McFadden Vol#: 293

C 3520 Chandelle Vuolo Vol#: 293

C 3521 Patricia Heather-Lea Vol#: 293

C 3522 Martha A. Carroll Vol#: 293

C 3523 illegible Vol#: 293

C 3524 illegible Vol#: 293

C 3525 Claudia M. Doege Vol#: 293

C 3526 Joan Margaret Vol#: 293

C 3527 illegible Vol#: 293

C 3528 Claire L. Schosser Vol#: 293

C 3529 Sky Swett Vol#: 293

C 3530 Virgil/Dee Ciabattoni Vol#: 293

C 3531 Margaret Chatelain Vol#: 293

C 3532 Jean Rosenberg Vol#: 293

C 3533 Olemara Peters Vol#: 293

C 3534 Charlotte & Clark Mahoney Vol#: 293

C 3535 Ann Veneman, Sec. of Agriculture, USDA Vol#: 293

C 3536 Angela Holt Vol#: 293

C 3537 Joseph D. Johnson Vol#: 293

C 3538 Peter F. Mennis Vol#: 293

C 3539 Kay McDonough Vol#: 293

C 3540 David Haynes Vol#: 293

C 3541 Jacqueline Whitehorn Vol#: 293

C 3542 Donald L. Merrick Vol#: 293

C 3543 Margaret O'Brien Vol#: 293

C 3544 James Ramsay Vol#: 293

C 3545 Charli Vogt Vol#: 293

C 3546 Frances A. Day Vol#: 293

C 3547 J L Colby Vol#: 294

C 3548 Mary H Panzera Vol#: 294

C 3549 Dr. Kristin Swenson-Mendez Vol#: 294

C 3550 Manny Mendez Vol#: 294

C 3551 Rita Ann Petit Vol#: 294

C 3552 Michael Gardos Reid Vol#: 294

C 3553 Gary Kleaman Vol#: 294

C 3554 Michael Ortega Vol#: 294

C 3555 Susan Eakins Vol#: 294

C 3556 Michael E. Bialas Vol#: 294

C 3557 Michelle Xuereb Vol#: 294

C 3558 Mareka Ohison Vol#: 294

C 3559 Norm Haight Vol#: 294

C 3560 John W. Thompson Vol#: 294

C 3561 Washington Legal Foundation Vol#: 294

C 3562 Gary Germany Vol#: 294

C 3563 Rita Parise Vol#: 294

C 3564 illegible Vol#: 294

C 3565 Claire Meirowitz & Joseph Spiegel Vol#: 294

C 3566 Martin Petroski Vol#: 294

C 3567 Gaudry Normand Vol#: 294

C 3568 Dennis & Barbara Kendall Vol#: 294

C 3569 Shawn Winkelman Vol#: 294

C 3570 Megan Weary Vol#: 294

C 3571 James W. Conrad Vol#: 294

C 3572 illegible Vol#: 294

C 3573 Benjamin Pink Vol#: 294

C 3574 M. Z. Sendek Vol#: 294

C 3575 Elizabeth T. Sendek Vol#: 294

C 3576 Elizabeth T. Robinson Vol#: 294

C 3577 Adrianne Allen Vol#: 294

C 3578 Don Limbaugh Vol#: 294

C 3579 Gisela S. Ray Vol#: 294

C 3580 Gordon Leon Vol#: 294

C 3581 Todd Hildebrand Vol#: 294

C 3582 A. S. Hill Vol#: 294

C 3583 Karen Thomas Vol#: 294

C 3584 Sonia Bellini Vol#: 294

C 3585 Edna Rix Vol#: 294

C 3586 James J. Hill & Arlene P. Hill Vol#: 294

C 3587 Russel Ness Vol#: 294

C 3588 Kristina Berkeley Vol#: 294

C 3589 Steve Wegner Vol#: 294

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 2061 Ryan J. Naylor Vol#: 203

C 2062 John Linse Vol#: 203

C 2063 Cindy Hendricks Vol#: 203

C 2064 Amanda Robinson Vol#: 203

C 2065 Unreadable Vol#: 203

C 2066 Sister Rose Mary O'Donnell Vol#: 203

C 2067 Gerda Alexander Vol#: 203

C 2068 Suzanne M. Plesha Vol#: 203

C 2069 Geoff Saavedra Vol#: 203

C 2070 Pelauria Havice Vol#: 203

C 2071 Ken Clark Vol#: 203

C 2072 Tara Sodergren Vol#: 203

C 2073 Loren Asreal Vol#: 203

C 2074 M. Jo Ann Erickson Vol#: 203

C 2075 Unsigned Vol#: 203

C 2076 Ron Milazzo Vol#: 203

C 2077 Margaret Birt Vol#: 203

C 2078 Joan Atchison Vol#: 203

C 2079 Mary Jane Vol#: 203

C 2080 Nancy M. Kennedy Vol#: 203

C 2081 Mrs. S. E. Vowles Vol#: 203

C 2082 Carole Clifton Tang Vol#: 203

C 2083 Martha Cablk Vol#: 203

C 2084 Dr. Julie Ann Allender Vol#: 203

C 2085 M. Camp Vol#: 203

C 2086 Jenny Clark Vol#: 203

C 2087 E. Nickel Vol#: 203

C 2088 Jeffrey Rosen Vol#: 203

C 2089 Joshua Levine Vol#: 203

C 2090 Chava Kaplan Vol#: 203

C 2091 Capt. H. M. Shay Vol#: 203

C 2092 Dr. Julie Ann Allender Vol#: 203

C 2093 D. Cooper Vol#: 203

C 2094 Paul Maimone Vol#: 203

C 2095 Unreadable Vol#: 203

C 2096 E. Randel Vol#: 203

C 2097 Mitzi Haggard Vol#: 203

C 2098 Henryka Roman Vol#: 203

C 2099 Abby Perl Vol#: 203

C 2100 Jim & Gera Cooper Vol#: 203

C 2101 Sue Clatter Vol#: 203

C 2102 C. Janis Chilmark Vol#: 203

C 2103 Bonnie Acker & John E. Davis Vol#: 203

C 2104 Denver & Eileen Barnes Vol#: 203

C 2105 Rosemary Jordan Nelsen Vol#: 203

C 2106 Henry Thomas Vol#: 203

C 2107 Patricia C. Baratta Vol#: 203

C 2108 Connie F. Springer Vol#: 203

C 2109 Unreadable Vol#: 203

C 2110 Honey Province Vol#: 203

C 2111 Lillie Anderson Vol#: 203

C 2112 Vincent G. Franze Vol#: 203

C 2113 Eugene Pompilio Vol#: 203

C 2114 Cie Margo Vol#: 203

C 2115 Jane Vose Vol#: 203

C 2116 Edwardine Panipinto Vol#: 203

C 2117 Betty Good Vol#: 203

C 2118 Winifred Johan Vol#: 203

C 2119 Lavena Howard Vol#: 203

C 2120 Mary Alderson Quinn Vol#: 203

C 2121 Edna C. Ball Vol#: 203

C 2122 Lila Sherman Vol#: 203

C 2123 Lynne Mulhall Vol#: 203

C 2124 Debrah Roemisch Vol#: 203

C 2125 Gary Davenport Vol#: 203

C 2126 Joan Davenport Vol#: 203

C 2127 Sarah K. Highland Vol#: 203

C 2128 Cynthia Kolbe Vol#: 203

C 2129 Unreadable Vol#: 203

C 2130 Victor Claycomb Vol#: 203

C 2131 Unreadable Vol#: 203

C 2132 Susan Rhett Vol#: 203

C 2133 Alvina M. Johnston Vol#: 203

C 2134 Elizabeth Walsh Vol#: 203

C 2135 Donald R. Williams Vol#: 203

C 2136 Clarence Durcholz Vol#: 203

C 2137 John Williams & Linda Moreno Vol#: 203

C 2138 Jennifer Aparisi Vol#: 203

C 2139 Lura B. Irish Vol#: 203

C 2140 Henry J. Kretkowski Vol#: 203

C 2141 Unreadable Vol#: 203

C 2142 Chaz L. Galvez Vol#: 203

C 2143 Eriq Keschuma Vol#: 203

C 2144 Robin Yost Vol#: 203

C 2145 Unreadable Vol#: 203

C 2146 Paula Zirgenbirm Vol#: 203

C 2147 Amy Beteller Vol#: 203

C 2148 Sister L. Calvillo & Sister B. Cavanaugh Vol#: 203

C 2149 Danelle Yost Vol#: 203

C 2150 Mayuri Bigno Vol#: 203

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 110502 Mary Lou Daniels Vol#: 760

C 110503 David Adomaitis Vol#: 760

C 110504 Yvonne M. Hart Vol#:

C 110505 Ronald L Griewe Vol#: 760

C 110506 Mr Kenneth Q Moore Vol#: 760

C 110507 Janelle Reiner Vol#: 760

C 110508 Kathy Culwell Vol#: 760

C 110509 Julia Kerl Vol#: 760

C 110510 Kim Heckman Vol#: 760

C 110511 Marilyn K Aber Vol#: 760

C 110512 Monica H Coffman Vol#: 760

C 110513 Jeanie Kufner Vol#: 760

C 110514 Kristal Forest Vol#: 760

C 110515 Julie Labey Vol#: 760

C 110516 Jane Levinson Vol#: 760

C 110517 Carmen White Vol#: 760

C 110518 I Meyer Pincus Vol#: 760

C 110519 Jennifer R Ong Vol#: 760

C 110520 Pierre Guesnon Vol#: 760

C 110521 Kevin Streitwirser Vol#: 760

C 110522 Kelly Carlson Vol#: 760

C 110523 Shana Cohen Vol#: 760

C 110524 Mrs Joan Seidel Vol#: 760

C 110525 Grace E Morehouse Vol#: 760

C 110526 Linda Hughes Vol#: 760

C 110527 Sally A Cannair Vol#: 760

C 110528 Judith M Schultz Vol#: 760

C 110529 Meg Candilore Vol#: 760

C 110530 Susan Cammer Vol#: 760

C 110531 Paula Tardge Vol#: 760

C 110532 Genie Coleman Vol#: 760

C 110533 Georgia Cole Vol#: 760

C 110534 Janet L Smith Vol#: 760

C 110535 Diane Abell-Chilton Vol#: 760

C 110536 Luisella Mazzone Vol#: 760

C 110537 Dennis, W, & Sylvia Thomas Vol#: 760

C 110538 Mary H Miller Vol#: 760

C 110539 Michelle Brown Vol#: 760

C 110540 Lillian M Nelson Vol#: 760

C 110541 Corrie Carlisle Vol#: 760

C 110542 Carl Puglisi Vol#: 760

C 110543 Lee Morgan Vol#: 760

C 110544 Sharon Gulseth Vol#: 760

C 110545 Sonia Allen Vol#: 760

C 110546 Victor Skorapa, Jr MD Vol#: 760

C 110547 Allen Sentinery Vol#: 760

C 110548 Ruth Seeliger Vol#: 760

C 110549 Roberta Radavich Vol#: 760

C 110550 Lauren Horican Vol#: 760

C 110551 Alexandra Honican Vol#: 760

C 110552 Virginia Cary Vol#: 760

C 110553 Brooke Honican Vol#: 760

C 110554 Tim Daulton Vol#: 760

C 110555 Betty Osmundson Vol#: 760

C 110556 Jude Lreissman Vol#: 760

C 110557 Joan Rutkowski Vol#: 760

C 110558 Margaret Ely Vol#: 760

C 110559 Howard & Ellan Parker Vol#: 760

C 110560 Margaret Katz Vol#: 760

C 110561 Diana Hillside Vol#: 760

C 110562 Debra Dunoplis-Zeller Vol#: 760

C 110563 Meg Chandler Vol#: 760

C 110564 No name Vol#: 760

C 110565 Corinna Gallardo Vol#: 760

C 110566 Emily Loeb Vol#: 760

C 110567 Carolyn Garwood Vol#: 760

C 110568 Marie H Zeller Vol#: 760

C 110569 Marie Wolf Vol#: 760

C 110570 D Major Vol#: 760

C 110571 Carol Medd Vol#: 760

C 110572 Cindy Hader Vol#: 760

C 110573 John Abernathy Vol#: 760

C 110574 Carla Mickael Vol#: 760

C 110575 Emily Nance Vol#: 760

C 110576 Annie Emmenegger Vol#: 760

C 110577 Linda Brady Vol#: 760

C 110578 Kerrie Byrne Vol#: 760

C 110579 John Dukes Vol#: 760

C 110580 Anne H Beck Vol#: 760

C 110581 Ethel M Rankin Vol#: 760

C 110582 Shirley Magder Vol#: 760

C 110583 Marva Dawson Jones Vol#: 760

C 110584 Alan Wiig Vol#: 760

C 110585 Lisa Kaufman Vol#: 760

C 110586 Norma Kaline Vol#: 760

C 110587 Emily Maloney Vol#: 760

C 110588 Kevin Nicolls Vol#: 760

C 110589 Laurie Rubin Vol#: 760

C 110590 F D Carter Vol#: 769

C 110591 L Edmonds Vol#: 760

C 110592 Delight Craft Vol#: 760

C 110593 Myrtle Nix Vol#: 760

C 110594 Natasha Gorgziano Vol#: 760

C 110595 K M Smith Vol#: 760

C 110596 B McGain Vol#: 760

C 110597 David M Hansen & Opus Hansen Vol#: 760

C 110598 Anne L Perry Vol#: 760

C 110599 Connie Scheunemann Vol#: 760

C 110600 Mary A Sewell Vol#: 760

01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

NEC 1 Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 80 Mr. & Mrs. Louis De Vizia Vol#: 5

C 81 Robert R. Allard Vol#: 5

C 82 Kay P. West Vol#: 5

C 83 C. Heerey Vol#: 5

C 84 Ruth Holweger Vol#: 5

C 85 Carolyn B. Wischerth Vol#: 5

C 86 Linda Lizotte Vol#: 5

C 87 Paul G. Perkins Vol#: 6

C 88 Herbert & Jane Thoma Vol#: 6

C 89 Vernon G. Gladu Vol#: 6

C 90 Mrs. Clem Becker Vol#: 6

C 91 Patrick D. Kennedy Vol#: 6

C 92 Mary L. Temmink Vol#: 6

C 93 Stanley Weiner Vol#: 6

C 94 Lee Gillman Vol#: 6

C 95 Thelma Knapp Vol#: 6

C 96 Orie Vander Boon Vol#: 6

C 97 Joe Ardizzone Vol#: 6

C 98 Patricia C. Caron Vol#: 6

C 99 Thomas A. Podraza Vol#: 6

C 100 Mr. & Mrs. George Pester Vol#: 6

C 101 Josefina R. & Juan I. Guerra Vol#: 6

C 102 James R. Blum Vol#: 6

C 103 Florence Mooney Vol#: 6

C 104 Donald H. & Ramona C. Trousil Vol#: 6

C 105 John Hayes Vol#: 6

C 106 Dorothy M. Scherer Vol#: 6

C 107 Carol Mosses Vol#: 6

C 108 Rosella Kaiser Vol#: 6

C 109 Marion L. High Vol#: 6

C 110 Rachel Kennel, R.N. Vol#: 6

C 111 Dolores D. Giosaffatte Vol#: 6

C 112 Mr. & Mrs. Ted Nied Vol#: 6

C 113 Mildred Johnson Vol#: 6

C 114 James C. Bowe Vol#: 6

C 115 Mrs. Dennis Malleck Vol#: 6

EMC 238 Susan Mazzone Vol#: 5

EMC 239 Michael R. Brooks Vol#: 5

EMC 240 Peggyann Vol#: 5

EMC 241 number not used Vol#: 5

EMC 242 L. Bruening Vol#: 5

EMC 243 number not used Vol#: 5

EMC 244 Harold & Joyce Nelsen Vol#: 5

EMC 245 number not used Vol#: 5

EMC 246 Donald Konwinski Vol#: 5

EMC 247 number not used Vol#: 5

EMC 248 Louis Ruggeri Vol#: 5

EMC 249 Katie Bayford Vol#: 5

EMC 250 number not used Vol#: 5

EMC 251 Mrs. Victoria L. Resurreccion Vol#: 5

EMC 252 number not used Vol#: 5

EMC 253 Arnie Dowd III Vol#: 5

EMC 254 number not used Vol#: 5

EMC 255 Marie Carlson Vol#: 5

EMC 256 Elisabeth Olden Vol#: 5

01P-0258 Request to revoke approal of Suitability Petitions 01P-0045,

ACK 1 HFA-305 Vol#: 1

01P-0259 Refuse to approve tegaserod (Zelmac)

ACK 1 HFA-305 to Public Citizen Vol#: 1

C 1 Novartis Pharmaceuticals Corporation Vol#: 2

CP 1 Public Citizen Vol#: 1

LET 1 Novartis Pharmaceuticals Corporation Vol#: 1