Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on August 13, 2001

TABLE OF CONTENTS

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78N-036L OTC Laxative *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
96P-0001 Disclosure of Results of Statistical Studies re: INDs *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-0804 FD&C Yellow #5 & FD&C Blue #1 Labeling *
01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0350 Determine whether Sotradecol has been withdrawn from sale in *
01P-0351 ANDA for sodium tetradecyl sulfate inj. strenghts 0.5% & 0.2 *
78N-036L OTC Laxative

PAV 3 HFC-1 to C. B. Fleet Company Inc Vol#: 107

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

SUP 2 Pharmaceutical Distributors Assn. Vol#: 6

SUP 3 Pharmaceutical Distributors Assn. Vol#: 6

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 127 Branded Pharmaceutical Assn. Vol#: 8

SUP 2 Pharmaceutical Distributors Assn. Vol#: 8

SUP 3 Pharmaceutical Distributors Assn. Vol#: 8

96P-0001 Disclosure of Results of Statistical Studies re: INDs

LET 3 HFD-7 to Washington Legal Foundation Vol#: 1

M 1 HFD-7 to Washington Legal Foundation Vol#: 1

99D-4003 Preclinical and Clinical Data and Labeling Breast Prostheses

GDL 2 Final Guidance for Industry Vol#: 1

NAD 2 Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 41 Mayo Foundation et al Vol#: 7

00D-1598 Voluntary Labeling for Bioengineered Foods

C 6970 Beverly Bishop Vol#: 423

C 6971 Jeane Leete Vol#: 423

C 6972 Robin Oeint Vol#: 423

C 6973 Gen Barbour Vol#: 423

C 6974 Robynn Zinser Vol#: 423

C 6975 Samantha Brown Vol#: 423

C 6976 Mary Ann Lehma Vol#: 423

C 6977 Rachel Wift Vol#: 423

C 6978 Shannon Perna Vol#: 423

C 6979 Cynthia Van Bibber Vol#: 423

C 6980 Daniel J. Lysk Vol#: 423

C 6981 K. Arora Adney Vol#: 423

C 6982 Adam McMvoy Vol#: 423

C 6983 Jennifer Atkins Vol#: 423

C 6984 Jack Lloyd Vol#: 423

C 6985 Crystal Albares Vol#: 423

C 6986 M. Gonsales Vol#: 423

C 6987 Charles White Vol#: 423

C 6988 Anthony Sanchez Vol#: 423

C 6989 Scott Bilotta Vol#: 423

C 6990 Mary Maginnis Vol#: 423

C 6991 Paula DeGovia Vol#: 423

C 6992 Zaida Penton Vol#: 423

C 6993 Rogelio Penton Vol#: 423

C 6994 Jose Galvan Vol#: 423

C 6995 Alan Bayman Vol#: 423

C 6996 Mark Baldwin Vol#: 423

C 6997 Patricia Braatz Vol#: 423

C 6998 Miguel Ramos Vol#: 423

C 6999 Douglas L & Susan A. Ryan Vol#: 423

C 7000 Mike Kaplan Vol#: 423

C 7001 Betty LaPadula Vol#: 423

C 7002 Henry Sattonstall Vol#: 423

C 7003 No Signature Vol#: 423

C 7004 Pat Cramer Vol#: 423

C 7005 Patti Nicklaus Vol#: 423

C 7006 Susan L. Donnelly Vol#: 423

C 7007 Nancy Parent Vol#: 423

C 7008 Cesarie M. Simmons Vol#: 423

C 7009 Laurie E. Dills Vol#: 423

C 7010 Mabel Dash Vol#: 423

C 7011 John Paul Weigeous Vol#: 423

C 7012 Andrew Finney Vol#: 423

C 7013 Cherie Tamai Vol#: 423

C 7014 Kathleen Corr Vol#: 423

C 7015 Kevin Boyce Vol#: 423

C 7016 Roy Wegman Vol#: 423

C 7017 Jim Hollister Vol#: 423

C 7018 Coralie Lasalle Vol#: 423

C 7019 B.J. Oliver Vol#: 423

C 7020 Jordy Mark Vol#: 423

C 7021 Cathy Bauer Schuett Vol#: 423

C 7022 Mary Ziff Vol#: 423

C 7023 Eligible Vol#: 423

C 7024 Shannon Dawdy Vol#: 423

C 7025 Alice Minicus Vol#: 423

C 7026 Joellen Gilchrist Vol#: 423

C 7027 John Cabeldin Vol#: 423

C 7028 Cynthia Cane Vol#: 423

C 7029 Theresa Johnson Vol#: 423

C 7030 No Signature Vol#: 423

C 7031 G. Rennhack Vol#: 423

C 7032 C.A. Rains Vol#: 423

C 7033 Joan Huntley Vol#: 423

C 7034 P. Weedman Vol#: 423

C 7035 J. Wilson Vol#: 423

C 7036 Sharon Paltin, MD Vol#: 423

C 7037 Marion Yeager Vol#: 423

C 7038 Victor P. Randall Vol#: 423

C 7039 James H. Elder Vol#: 423

C 7040 Breast Cancer Action Vol#: 423

C 7041 George C. Wilbur Vol#: 423

C 7042 Ecology Action Vol#: 423

C 7043 Nikiya Lyles Vol#: 423

C 7044 Henrietta Quattrocchi Vol#: 423

C 7045 Gene S. Thomas Vol#: 423

C 7046 Caroline S. Fine Vol#: 423

C 7047 Patti Landres Vol#: 423

C 7048 Mary Steinkamp Vol#: 423

C 7049 Dianne Kaimann Vol#: 423

C 7050 Andy Stevensen Vol#: 423

C 7051 Dana Trattner Vol#: 423

C 7052 Jeff Stevensen Vol#: 423

C 7053 Dena Laycheck Vol#: 423

C 7054 Jane K. Van Dusen Vol#: 423

C 7055 Dr. Ariel Kerman Vol#: 423

C 7056 Malle Spratt Vol#: 423

C 7057 W. Krieger Vol#: 423

C 7058 Mary G. Daueufour Vol#: 423

C 7059 G. Gransette Lawrence Vol#: 423

C 7060 David E. Irvine Vol#: 423

C 7061 Helen Reske Vol#: 423

C 7062 Marisa Teter Vol#: 423

C 7063 Jan Aho Vol#: 423

C 7064 Pam Meadows Vol#: 423

C 7065 Paula Blum Vol#: 423

C 7066 Lee Purcell Vol#: 423

C 7067 A. Carl Vol#: 423

C 7068 Patricia Snouffer Vol#: 423

EMC 11406 Diana Lackner Vol#: 422

EMC 11407 Shirley Stieger and Lee R. Stieger Vol#: 422

EMC 11408 Natalia Morse Vol#: 422

EMC 11409 Louise Blumhorst Vol#: 422

EMC 11410 Maria Hughes Vol#: 422

EMC 11411 Randy P. Dandurand Vol#: 422

EMC 11412 Lauren Greene Vol#: 422

EMC 11413 Ruth Morita Vol#: 422

EMC 11414 Kellie Geldreich Vol#: 422

EMC 11415 Alex Kaplan Vol#: 422

EMC 11416 De Shell Vol#: 422

EMC 11417 Sarah Collins Vol#: 422

EMC 11418 Jerry Ellis Vol#: 422

EMC 11419 Steve Dean Vol#: 422

EMC 11420 Penelope Gedeon Vol#: 422

EMC 11421 Eliezer Erice Vol#: 422

EMC 11422 CJ Osburn Vol#: 422

EMC 11423 Amanda Woletz Vol#: 422

EMC 11424 Becky Ziny Vol#: 422

EMC 11425 Cecelia & Ron Noyes Vol#: 422

EMC 11426 Beth Lairson Vol#: 422

EMC 11427 Tatiana McProuty Vol#: 422

EMC 11428 John Jalkanen Vol#: 422

EMC 11429 Frank Carpenter Vol#: 422

EMC 11430 Louise Hillman Vol#: 422

EMC 11431 Ingrid Gordon Vol#: 422

EMC 11432 Ingrid Gordon Vol#: 422

EMC 11433 Jill Mayer Vol#: 422

EMC 11434 Kenneth Uchibori Vol#: 422

EMC 11435 Mike Gifford Vol#: 422

EMC 11436 Sandra Bruderer Vol#: 422

EMC 11437 Pat Williamson Vol#: 422

EMC 11438 J. Scaggs Vol#: 422

EMC 11439 Renee Underkoffler Vol#: 422

EMC 11440 Danell Cascio Vol#: 422

EMC 11441 Isaura Mendoza Vol#: 422

EMC 11442 Isaura Mendoza Vol#: 422

EMC 11443 Ann Adams Vol#: 422

EMC 11444 Michael Doll Vol#: 422

EMC 11445 Nadine E. Cummins Vol#: 422

EMC 11446 Linda Mathis Vol#: 422

EMC 11447 James Bash Vol#: 422

EMC 11448 Janison Roun Vol#: 422

EMC 11449 Gerry Gennoe Vol#: 422

EMC 11450 unsigned Vol#: 422

EMC 11451 Kevin Adams Vol#: 422

EMC 11452 Patricia Jones Vol#: 422

EMC 11453 Hally Baker Vol#: 422

EMC 11454 Carolee Carpenter Jandreau Vol#: 422

EMC 11455 Bradley Boe Vol#: 422

EMC 11456 Mary Bennett Vol#: 422

EMC 11457 Arriba Stature Vol#: 422

EMC 11458 Karen Carson Vol#: 422

EMC 11459 Melissa A. Brown Vol#: 422

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 7599 Form Letter Count 14 Vol#: 330

EMC 10401 Tere Carr Vol#: 281

EMC 10402 William H. and Jan Tache Vol#: 281

EMC 10403 Laura Pfeiff Vol#: 281

EMC 10404 Lori Linder Vol#: 281

EMC 10405 Katherine Brede Vol#: 281

EMC 10406 Anne Picard Vol#: 281

EMC 10407 Holly Randall Vol#: 281

EMC 10408 Richard Gardner Vol#: 281

EMC 10409 Joan Atkinson Vol#: 281

EMC 10410 David R. Genth Vol#: 281

EMC 10411 Malcolm Kenton Vol#: 281

EMC 10412 Malcolm Kenton Vol#: 281

EMC 10413 Robert and Cynthia Sonnenberg Vol#: 281

EMC 10414 Andrew McElroy Vol#: 281

EMC 10415 Kathy Mason Vol#: 281

EMC 10416 David Klein Vol#: 281

EMC 10417 Ruchi Kapur Vol#: 281

EMC 10418 Christopher Law Vol#: 281

EMC 10419 Bonnie Kaplan Vol#: 281

EMC 10420 Thomas Dinverno Vol#: 281

EMC 10421 Terri Liddon Vol#: 281

EMC 10422 Dr. Robert Klauber Vol#: 281

EMC 10423 Jenny Smith Vol#: 281

EMC 10424 Jenny Smith Vol#: 281

EMC 10425 Amy Russell Vol#: 281

EMC 10426 Bonnie Johnson Vol#: 281

EMC 10427 Joe Millon Vol#: 281

EMC 10428 Rachel Rowen Vol#: 281

EMC 10429 Maureen DeLaurell Vol#: 281

EMC 10430 Michael Finazzo Vol#: 281

EMC 10431 Joyce Vol#: 281

EMC 10432 Karen Stemann Vol#: 281

EMC 10433 Kris Abel-Helwig Vol#: 281

EMC 10434 Lisha Doucet Vol#: 281

EMC 10435 Margaret Fleming Vol#: 281

EMC 10436 Margaret Fleming Vol#: 281

EMC 10437 Drew Campbell Vol#: 281

EMC 10438 Drew Campbell Vol#: 281

EMC 10439 Susan Blankman Vol#: 281

EMC 10440 Jessi Krause Vol#: 281

EMC 10441 Boyer Ashley Vol#: 281

EMC 10442 Junko Boyd-Ritari Vol#: 281

EMC 10443 James Conroy Vol#: 281

EMC 10444 no signature Vol#: 281

EMC 10445 Mark Bennett Vol#: 281

EMC 10446 John Patsis Vol#: 281

EMC 10447 Linda Clarke Vol#: 281

EMC 10448 June Bodine Vol#: 281

EMC 10449 Michael Beifuss Vol#: 281

EMC 10450 Anastasia Serene Vol#: 281

EMC 10451 Aleythia Dolstad Vol#: 281

EMC 10452 Nicholas Night Vol#: 281

EMC 10453 Bobby Joe Vol#: 281

EMC 10454 Maryann Rader Vol#: 281

EMC 10455 Lauretta Lange Vol#: 281

EMC 10456 Lauretta Lange Vol#: 281

EMC 10457 Joe Bina Vol#: 281

EMC 10458 Joe Bina Vol#: 281

EMC 10459 Isabella Balkert Vol#: 281

EMC 10460 Elizabeth Bernsohn Vol#: 281

EMC 10461 Michael Sholas Vol#: 281

EMC 10462 Tina Landfried Vol#: 281

EMC 10463 Malysa Freeman Vol#: 281

EMC 10464 Steen Juhler Vol#: 281

EMC 10465 Julia Faulkner Vol#: 281

EMC 10466 Sandra Stinneford Vol#: 281

EMC 10467 Violet Cominski Vol#: 281

EMC 10468 Tara Lane Vol#: 281

EMC 10469 Margie Pasero Vol#: 281

EMC 10470 Stephen Birnbaum Vol#: 281

EMC 10471 Claire CdeBaca Vol#: 281

EMC 10472 Robert Richter Vol#: 281

EMC 10473 Stephanie Fairchild Vol#: 281

EMC 10474 Alex Herdman Vol#: 281

EMC 10475 Julia Bastianesi Vol#: 281

EMC 10476 Neta Noyd Vol#: 281

EMC 10477 Mr. & Mrs. Jesse Peterson Vol#: 281

EMC 10478 Olinda Lindsey Vol#: 281

EMC 10479 Sandra Strehlau Vol#: 281

EMC 10480 Rita Beine Vol#: 281

EMC 10481 Tania Gonzales Vol#: 281

EMC 10482 Paul Cooney Vol#: 281

EMC 10483 Magdolna Bury Vol#: 281

EMC 10484 Cliff Ward Vol#: 281

EMC 10485 Kelly Fleming Vol#: 281

EMC 10486 Chad Binder Vol#: 281

EMC 10487 Tim Vickey Vol#: 281

EMC 10488 number not used Vol#: 281

EMC 10489 Karen Jolliffe Vol#: 281

EMC 10490 Jason Long Vol#: 281

EMC 10491 Alena Daniel Vol#: 281

EMC 10492 Cliff Ward Vol#: 281

EMC 10493 Sharron Crocker Vol#: 281

EMC 10494 Roxanne Stapp Vol#: 281

EMC 10495 Mary Chandra Vol#: 281

EMC 10496 Ellie Evans Vol#: 281

EMC 10497 Maggie Schley Vol#: 281

EMC 10498 Phil Carmody Vol#: 281

EMC 10499 Charles Earnest Vol#: 281

EMC 10500 number not used Vol#: 281

EMC 10501 number not used Vol#: 281

EMC 10502 Dawn DuPey Vol#: 281

EMC 10503 Dawn DuPey Vol#: 281

EMC 10504 Linda Marcussen Vol#: 281

EMC 10505 Mary VanDyke Vol#: 281

EMC 10506 Deborah Marshall Vol#: 281

EMC 10507 Patrick Stine Vol#: 281

EMC 10508 Susan Stickney Vol#: 281

EMC 10509 Bonnie Mason Vol#: 281

EMC 10510 Marian Syrjamaki-Kuchta Vol#: 281

EMC 10511 Amy Jahn Vol#: 281

EMC 10512 Amy Jahn Vol#: 281

EMC 10513 Seraphina Tisch Vol#: 281

EMC 10514 Nan Lawler Vol#: 281

EMC 10515 Susan Dean Vol#: 281

EMC 10516 Clarie Houston Vol#: 281

EMC 10517 Elijah Road Vol#: 281

EMC 10518 Virginia Bolton Vol#: 281

EMC 10519 Kelly Coleman Vol#: 281

EMC 10520 Claire Cabeza de Baca Vol#: 281

EMC 10521 Claire Cabexa de Baca Vol#: 281

EMC 10522 Esther and Elliott Robbins Vol#: 281

EMC 10523 Jack Moss Vol#: 281

EMC 10524 Donna Brock Vol#: 281

EMC 10525 Sheila Fox Vol#: 281

EMC 10526 Marcie E. Delia Vol#: 281

EMC 10527 Badger Brock Vol#: 281

EMC 10528 Maureen Horowitz Vol#: 281

EMC 10529 Maureen Horowitz Vol#: 281

EMC 10530 Cheryl Frankfurth Vol#: 281

EMC 10531 Anne Moss Vol#: 281

EMC 10532 Michele Hughes Vol#: 281

EMC 10533 Sue Becker Vol#: 281

EMC 10534 Amy Zappia Vol#: 281

EMC 10535 John Smith Vol#: 281

EMC 10536 Nicole Matthews Vol#: 281

EMC 10537 Narayanan Krishnamurthy Vol#: 281

EMC 10538 Jana Pedemonte Vol#: 281

EMC 10539 Gabi Zois Vol#: 281

EMC 10540 Morris Zaltekoff Vol#: 281

EMC 10541 Marie Silva Vol#: 281

EMC 10542 Eric Jaquay Vol#: 281

EMC 10543 Jenny Smith Vol#: 281

EMC 10544 Jenny Smith Vol#: 281

EMC 10545 Mary Stafford Vol#: 281

EMC 10546 Charles Emory Vol#: 281

EMC 10547 Kim McBreen Vol#: 281

EMC 10548 Dorli T. Rainey Vol#:

EMC 10549 Janet Ashford Vol#: 281

EMC 10550 Shelly Bossert Vol#: 281

EMC 10551 Davina Hostetter Vol#: 281

EMC 10552 Lara Kaskabas Vol#: 281

EMC 10553 Sara Sparks Vol#: 281

EMC 10554 Warren Holmes Vol#: 281

EMC 10555 Yvonne Baker Vol#: 281

EMC 10556 Selene Mordue Vol#: 281

EMC 10557 Dianne Holmgren Vol#: 281

EMC 10558 Peggy-Lynn Boggs Vol#: 281

EMC 10559 Neeru Cerny Vol#: 281

EMC 10560 Karolina Maslanka Vol#: 281

EMC 10561 Shannon Hoffmann Vol#: 281

EMC 10562 Sandra Trinidad Vol#: 281

EMC 10563 Lynn Fogg Vol#: 281

EMC 10564 Gail Erickson Vol#: 281

EMC 10565 Ann Songayllo Vol#: 281

EMC 10566 Vicki Lane Vol#: 281

EMC 10567 Vicki Lane Vol#: 281

EMC 10568 Ronda Lynch Vol#: 281

EMC 10569 Ronda Lynch Vol#: 281

EMC 10570 Cori Huenink Vol#: 281

EMC 10571 Mary Neland Vol#: 281

EMC 10572 Natalie Mannering Vol#: 281

EMC 10573 Bren Leves Vol#: 281

EMC 10574 Lauren Bell Vol#: 281

EMC 10575 Melissa Lorentz Vol#: 281

EMC 10576 Melissa Lorentz Vol#: 281

EMC 10577 Deana Jewett Vol#: 281

EMC 10578 Rachel Kaiser Vol#: 281

EMC 10579 Dolores DeMarco Vol#: 281

EMC 10580 Kristy Moran Vol#: 281

EMC 10581 Joanne Sharpe Vol#: 281

EMC 10582 Charles & Mary Koenig Vol#: 281

EMC 10583 Angela Fishman Vol#: 281

EMC 10584 J. Swartz Vol#: 281

EMC 10585 Cai King-Young Vol#: 281

EMC 10586 Melinda Farrar Vol#: 281

EMC 10587 Cheryl Barr Vol#: 281

EMC 10588 Leonard Cole Vol#: 281

EMC 10589 John Sorflaten Vol#: 281

EMC 10590 Angela Devargas Vol#: 281

EMC 10591 Reyna Ambrose Vol#: 281

EMC 10592 Grace Ma Vol#: 281

EMC 10593 Don Giffin Vol#: 281

EMC 10594 J. Crotty Vol#: 281

EMC 10595 Laura Brackett Vol#: 281

EMC 10596 Frank Demeis Vol#: 281

EMC 10597 Anabellla Perez-Midence Vol#: 281

EMC 10598 M. J. Maroney Vol#: 281

EMC 10599 Lori Ankney Vol#: 281

EMC 10600 Jill Koenigsdorf Vol#: 281

EMC 10601 Frederick Pinard Vol#: 281

EMC 10602 Frederick Pinard Vol#: 281

EMC 10603 Ryan Warren Vol#: 281

EMC 10604 Ryan Warren Vol#: 281

EMC 10605 Dan Cherney Vol#: 281

EMC 10606 Dan Wilde Vol#: 281

EMC 10607 Debbie Burns Vol#: 281

EMC 10608 David Maple Vol#: 281

EMC 10609 number not used Vol#: 281

EMC 10610 number not used Vol#: 281

EMC 10611 Constance Sweitzer Vol#: 281

EMC 10612 Katrina Baker Vol#: 281

EMC 10613 Lynne Russillo Vol#: 281

EMC 10614 number not used Vol#: 281

EMC 10615 Vernon Jennings Vol#: 281

EMC 10616 Jonathan Kessler Vol#: 281

EMC 10617 Megan Milligan Vol#: 281

EMC 10618 Deborah Dlugos Vol#: 281

EMC 10619 Carolyn Johnson Vol#: 281

EMC 10620 Brian Skelton Vol#: 281

EMC 10621 Drew Lao Vol#: 281

EMC 10622 Drew Lao Vol#: 281

EMC 10623 Marilin Engelman Vol#: 281

EMC 10624 Suzanne Brown Vol#: 281

EMC 10625 Kelly Stechschulte Vol#: 281

EMC 10626 Julie Dean Vol#: 281

EMC 10627 Andrew Hartman Vol#: 281

EMC 10628 Joseph Pergolizzi Vol#: 281

EMC 10629 Mildred Weston Vol#: 281

EMC 10630 Irl Stalcup Vol#: 281

EMC 10631 Dr. Rodolfo Rodriguez Vol#: 281

EMC 10632 Edward Melendez Vol#: 281

EMC 10633 Penny Marquez Vol#: 282

EMC 10634 Sandra Baughman Vol#: 282

EMC 10635 Ted Quaday Vol#: 282

EMC 10636 Kathleen Donnelly Vol#: 282

EMC 10637 Jonathan Naimon Vol#: 282

EMC 10638 Santiago Edelmiro Vol#: 282

EMC 10639 M. Gregory Carbone Vol#: 282

EMC 10640 Traci Bryant Vol#: 282

EMC 10641 John Boucher Vol#: 282

EMC 10642 Linda Harmon Vol#: 282

EMC 10643 Robert Borchert Vol#: 282

EMC 10644 Christine Bruggemann Vol#: 282

EMC 10645 Robin Reed Vol#: 282

EMC 10646 Theresa Barke Vol#: 282

EMC 10647 Jina Wilson Vol#: 282

EMC 10648 Sharon DiPietro Vol#: 282

EMC 10649 Number not used Vol#: 282

EMC 10650 Christian Roth Vol#: 282

EMC 10651 Carole Riley Vol#: 282

EMC 10652 O. Mikosza Vol#: 282

EMC 10653 Donald S. Jacobs Vol#: 282

EMC 10654 Kay Garrity-Roth Vol#: 282

EMC 10655 Meat Eater Vol#: 282

EMC 10656 Christina Hyde Vol#: 282

EMC 10657 Christina Hyde Vol#: 282

EMC 10658 Alex Brunette Vol#: 282

EMC 10659 Sonshine Vol#: 282

EMC 10660 Time Traveler Vol#: 282

EMC 10661 Kathryn Hoover Vol#: 282

EMC 10662 Arlene Watters Vol#: 282

EMC 10663 Jessica Patton Vol#: 282

EMC 10664 Number not used Vol#: 282

EMC 10665 James Melton Vol#: 282

EMC 10666 Paul Shaia Vol#: 282

EMC 10667 John Sorflaten Vol#: 282

EMC 10668 Marty Plemmons Vol#: 282

EMC 10669 Lucas Suer Vol#: 282

EMC 10670 Pup Luck Vol#: 282

EMC 10671 Keith F. Zeitlin Vol#: 282

EMC 10672 Victoria R. Winfield Vol#: 282

EMC 10673 Ann Grimm Vol#: 282

EMC 10674 Margaret Draper Vol#: 282

EMC 10675 Jo Diane Main Vol#: 282

EMC 10676 Tom Devine Vol#: 282

EMC 10677 Joel Kimmel & Tanya Pozzi Vol#: 282

EMC 10678 Joel Kimmel & Tanya Pozzi Vol#: 282

EMC 10679 Dave Wesendunk Vol#: 282

EMC 10680 Mark Pruhenski Vol#: 282

EMC 10681 P. Marc Schwartz Vol#: 282

EMC 10682 Ahmed Jibril Vol#: 282

EMC 10683 Wendy Stowers Vol#: 282

EMC 10684 Sara Sandford Vol#: 282

EMC 10685 Tamara Quandt Vol#: 282

EMC 10686 Sven Lovegren Vol#: 282

EMC 10687 J. Snell Vol#: 282

EMC 10688 Camille Witten Vol#: 282

EMC 10689 Amy Sunderland Vol#: 282

EMC 10690 Kurt Schrader Vol#: 282

EMC 10691 Andrea Wentland Vol#: 282

EMC 10692 Cynthia Reardon Vol#: 282

EMC 10693 Theresa Williamson Vol#: 282

EMC 10694 Elizabeth Aldrich Vol#: 282

EMC 10695 Dinorah Rodriguez Vol#: 282

EMC 10696 Augustus Colangelo Vol#: 282

EMC 10697 Jonathan Markowitz Vol#: 282

EMC 10698 Susan Markowitz Vol#: 282

EMC 10699 Andrew Markowitz Vol#: 282

EMC 10700 Kay Garrity-Roth Vol#: 282

EMC 10701 Danna Gonzales Vol#: 282

EMC 10702 Laura Spencer Vol#: 282

EMC 10703 Elwood Richard Vol#: 282

EMC 10704 Dicron Meneshian Vol#: 282

EMC 10705 William Taylor Vol#: 282

EMC 10706 Muriel Rothenberg Vol#: 282

EMC 10707 Stephanie Antoni Vol#: 282

EMC 10708 Susanne LaBarge Vol#: 282

EMC 10709 Mark Stout Vol#: 282

EMC 10710 Andrew Frampton Vol#: 282

EMC 10711 E. Sam Arvizu Vol#: 282

EMC 10712 Lia Budd Vol#: 282

EMC 10713 Deirdre Quinn Vol#: 282

EMC 10714 Paul Williams Vol#: 282

EMC 10715 Jo Ingman Vol#: 282

EMC 10716 Jessica Bishop Vol#: 282

EMC 10717 Jessica Caron Vol#: 282

EMC 10718 Adeline Delia Vol#: 282

EMC 10719 Linda Paffel Vol#: 282

EMC 10720 David Haye Vol#: 282

EMC 10721 Angela Sansom Vol#: 282

EMC 10722 Lisa Dews Vol#: 282

EMC 10723 Martha Galan Vol#: 282

EMC 10724 Lynne Aldrich Vol#: 282

EMC 10725 Dharce Greenwald Vol#: 282

EMC 10726 Marilyn Morrison Vol#: 282

EMC 10727 Jeremiah Podleski Vol#: 282

EMC 10728 Kristin Wolinsky Vol#: 282

EMC 10729 Michelle Rich Vol#: 282

EMC 10730 Jill Lombardi Vol#: 282

EMC 10731 Kathleen Piet Vol#: 282

EMC 10732 Emily Heaton Vol#: 282

EMC 10733 Cindy Cutter Vol#: 282

EMC 10734 Candace Signor Vol#: 282

EMC 10735 Kenn Nickell Vol#: 282

EMC 10736 Beth K. Spangler Vol#: 282

EMC 10737 Edward Jerome Vol#: 282

EMC 10738 John Whiton Vol#: 282

EMC 10739 Helen Wilson Vol#: 282

EMC 10740 Cindy Lamberti Vol#: 282

EMC 10741 Jason Ball Vol#: 282

EMC 10742 Thomas Neal Vol#: 282

EMC 10743 Marty Friedman Vol#: 282

EMC 10744 John Advertical Vol#: 282

EMC 10745 Susanne Kurtz Vol#: 282

EMC 10746 Renee Crowell Vol#: 282

EMC 10747 Cat Talbot Vol#: 282

EMC 10748 Nadia N.S. Maczaj Vol#: 282

EMC 10749 Neil Levin Vol#: 282

EMC 10750 Lenora Hall Vol#: 282

EMC 10751 Laurie Powsner Vol#: 282

EMC 10752 Laurie Powsner Vol#: 282

EMC 10753 Carlyle Tom Vol#: 282

EMC 10754 David Hieatt Vol#: 282

EMC 10755 Gorus Bix Vol#: 282

EMC 10756 Michael Cullen Vol#: 282

EMC 10757 number not used Vol#: 282

EMC 10758 Cristobal Ramon Vol#: 282

EMC 10759 Cristobal Ramon Vol#: 282

EMC 10760 Dave Wright Vol#: 282

EMC 10761 Jan Brooks Vol#: 282

EMC 10762 Beth Shore Vol#: 282

EMC 10763 Beth Shore Vol#: 282

EMC 10764 Claire Jackson Vol#: 282

EMC 10765 Bobbi Smith Vol#: 282

EMC 10766 Janet Hunt Vol#: 282

EMC 10767 Bernadette Chapin Vol#: 282

EMC 10768 Madeleine Mulanix Vol#: 282

EMC 10769 Seth Christian Vol#: 282

EMC 10770 Marisa Jacobs Vol#: 282

EMC 10771 Kristi Welch Vol#: 282

EMC 10772 Frank Chisholm Vol#: 282

EMC 10773 Frank Chisholm Vol#: 282

EMC 10774 David Falk Vol#: 282

EMC 10775 Bill & Jan Tache' Vol#: 282

EMC 10776 Bill & Jan Tache' Vol#: 282

EMC 10777 Miroslay Suta Vol#: 282

EMC 10778 Miroslav Suta Vol#: 282

EMC 10779 Joanne Plank Vol#: 282

EMC 10780 Rick Freeman Vol#: 282

EMC 10781 Rick Freeman Vol#: 282

EMC 10782 Michael Black Vol#: 282

EMC 10783 Michael Black Vol#: 282

EMC 10784 Linda Lofgren Vol#: 282

EMC 10785 Linda Nelson Vol#: 282

EMC 10786 Francis Armstrong Vol#: 282

EMC 10787 Amber Jernigan Vol#: 282

EMC 10788 Spencer Agnew Vol#:

EMC 10789 Spencer Agnew Vol#: 282

EMC 10790 Peter Dallman Vol#: 282

EMC 10791 Daveen Myers Vol#: 282

EMC 10792 Laura Lynn Vol#: 282

EMC 10793 Tom Moore Vol#: 282

EMC 10794 Jim Fiscella Vol#: 282

EMC 10795 Rose Fetchko Vol#: 282

EMC 10796 Rose Fetchko Vol#: 282

EMC 10797 Trevor Griles Vol#: 282

EMC 10798 Jimmie R. Markham Vol#: 282

EMC 10799 Roger & Sue Melton Vol#: 282

EMC 10800 Anne Wagner Vol#: 282

EMC 10801 Vella Lanz Vol#: 282

EMC 10802 Greg Willson Vol#: 282

EMC 10803 Dr. Rick Kirschner Vol#: 282

EMC 10804 Jyllian Smolev Vol#: 282

EMC 10805 Allan Taylor Vol#: 282

EMC 10806 Sam Johnston Vol#: 282

EMC 10807 Samuel DeFazio Vol#: 282

EMC 10808 Deborah Chambers Vol#: 282

EMC 10809 Bonnie Bates Vol#: 282

EMC 10810 Lindea Kirschner Vol#: 282

EMC 10811 L. M. Bruns Vol#: 282

EMC 10812 Bonnie Sperow Vol#: 282

EMC 10813 Autumn Campos Vol#: 282

EMC 10814 Constance Atwill Vol#: 282

EMC 10815 Shirley Emerson Vol#: 282

EMC 10816 Dave Bristol Vol#: 282

EMC 10817 Anita Beckwith Vol#: 282

EMC 10818 Jackie & Greg Guillory Vol#: 282

EMC 10819 Jonathan Hayes Vol#: 282

EMC 10820 Roxanne Hubbard Vol#: 282

EMC 10821 Petroso Tzavellas Vol#: 282

EMC 10822 Eric Bartok Vol#: 282

EMC 10823 Donna Ferguson Vol#: 282

EMC 10824 Luc Depiere Vol#: 282

EMC 10825 Janice VanDusen Vol#: 282

EMC 10826 Peter Di Pasqua Vol#: 282

EMC 10827 Anna Opalenik Vol#: 282

EMC 10828 Patrick Cancilla Vol#: 282

EMC 10829 William Hartranft Vol#: 282

EMC 10830 Jane McCloskeyh Vol#: 282

EMC 10831 Linda DeCramer Vol#: 282

EMC 10832 Doris Swenbeck Vol#: 282

EMC 10833 Kate Burroughs Vol#: 282

EMC 10834 Charles Fox Vol#: 282

EMC 10835 Mary Jo Walters Vol#: 282

EMC 10836 Chris Snedeker Vol#: 282

EMC 10837 Jim Wagner Vol#: 282

EMC 10838 Paul Fleischer Vol#: 282

EMC 10839 Samantha Perkins Vol#: 282

EMC 10840 Rosalie Jordan Vol#: 282

EMC 10841 Jason Ausmus Vol#: 282

EMC 10842 Mary C. Carras Vol#: 282

EMC 10843 Brenda Shaw Vol#: 282

EMC 10844 Brenda Shaw Vol#: 282

EMC 10845 Stephanie Denton Vol#: 282

EMC 10846 Mary Bielucki Vol#: 282

EMC 10847 Richard Beresford Vol#: 282

00P-0804 FD&C Yellow #5 & FD&C Blue #1 Labeling

LET 1 H.W. Witt, Jr.D.O., F.A.C.O.I, F.A.C.M.Q Vol#: 1

01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab

GDL 1 Draft Guidance Vol#: 1

NAD 1 Vol#: 1

01D-0221 Biological Product Deviation Reporting for Licensed Manufact

GDL 1 Draft Guidance Vol#: 1

NAD 1 Vol#: 1

01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures

C 1 Anil Bhalani Vol#: 1

01M-0342 P980044; SUPARTZ Dispo

AAV 1 Quintiles, Inc. Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

ACK 1 HFA-305 Vol#: 1

CP 1 Heather Brodie Perry Vol#: 1

01P-0350 Determine whether Sotradecol has been withdrawn from sale in

ACK 1 HFA-305 Vol#: 1

CP 1 Bennett & Company Vol#: 1

01P-0351 ANDA for sodium tetradecyl sulfate inj. strenghts 0.5% & 0.2

ACK 1 HFA-305 Vol#: 1

CP 1 Bennett & Company Vol#: 1