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DOCKETS ENTERED on July 19, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1411 Set a regulatory limit for methylmercury in seafood *
01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed *
01D-0192 Forms for registation of producers of drugs and listing of *
01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic *

98N-0337 Over the counter human drugs labeling requirements

APP 17 BD Medical Systems Vol#: 8

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

EMC 2185 Linda Dale Rodriguez Vol#: 158

EMC 2186 Suzanne Godsted Vol#: 158

EMC 2187 Shellie Krabbe-Hendricks Vol#: 158

EMC 2188 Jennifer Richards Vol#: 158

EMC 2189 Susan Beattie Vol#: 158

EMC 2190 Caroline Slinn Vol#: 158

EMC 2191 Heidi Liebwein Vol#: 158

EMC 2192 Valerie Sydor Vol#: 158

EMC 2193 Corinne Ferraro Vol#: 158

EMC 2194 Suba Gunawardana Vol#: 158

EMC 2195 Jen Girgen, J.D. Vol#: 158

EMC 2196 MJ Stigliano Vol#: 158

EMC 2197 Kunal Mukherjee Vol#: 158

EMC 2198 Erin Juliana Marcus Vol#: 158

EMC 2199 Pwprovost Vol#: 158

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

C 10 National Fisheries Institute Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 5536 Form Letter Count 286 Vol#: 362

C 5537 Form Letter Count 77 Vol#: 363

C 5538 Form Letter Count 62 Vol#: 364

C 5539 Form Letter Count 101 Vol#: 397

C 5540 Form Letter Count 147 Vol#: 398

C 5541 Form Letter Count 78 Vol#: 399

C 5542 Form Letter Count 59 Vol#: 400

C 5543 Form Letter Count 51 Vol#: 401

C 5544 Form Letter Count 40 Vol#: 402

EMC 8901 Joan Sullivan Vol#: 368

EMC 8902 Brendan Tween Vol#: 368

EMC 8903 Brendan Tween Vol#: 368

EMC 8904 Nancy Savinelli Vol#: 368

EMC 8905 Nancy Savinelli Vol#: 368

EMC 8906 Barbara Anger Vol#: 368

EMC 8907 Barbara Anger Vol#: 368

EMC 8908 Dale & Sheree Kesler Vol#: 368

EMC 8909 Dale & Sheree Kesler Vol#: 368

EMC 8910 Wendy Fawcett Vol#: 368

EMC 8911 Wendy Fawcett Vol#: 368

EMC 8912 Linda Tagliaferro Vol#: 368

EMC 8913 Linda Tagliaferro Vol#: 368

EMC 8914 Rob Adams Vol#: 368

EMC 8915 Rob Adams Vol#: 368

EMC 8916 Kathleen Green Vol#: 368

EMC 8917 Kathleen Green Vol#: 368

EMC 8918 Bonnie Cosner Vol#: 368

EMC 8919 Lori A. Gauvin/Gary Gauvin Vol#: 368

EMC 8920 Elizabeth Medina Vol#: 368

EMC 8921 Elizabeth Medina Vol#: 368

EMC 8922 Richard Frisbie Vol#: 368

EMC 8923 Richard Frisbie Vol#: 368

EMC 8924 Jean Murphy Vol#: 368

EMC 8925 Jean Murphy Vol#: 368

EMC 8926 Stewart Guernsey Vol#: 368

EMC 8927 Paul Kendal Vol#: 368

EMC 8928 Clara Brand Vol#: 368

EMC 8929 Paul Murtha Vol#: 368

EMC 8930 Dan Begay Vol#: 368

EMC 8931 Johanna Schultz Vol#: 368

EMC 8932 Johanna Schultz Vol#: 368

EMC 8933 James Kenworthy Vol#: 368

EMC 8934 Marilyn Colson Vol#: 368

EMC 8935 Joeni Jones Vol#: 368

EMC 8936 Mary Bodde Vol#: 368

EMC 8937 Mary Bodde Vol#: 368

EMC 8938 Jeffery Jackson Vol#: 368

EMC 8939 Miryan Kenet Vol#: 368

EMC 8940 Roger Kliesh, Ph.D. & Marty Kliesh, Ph.D Vol#: 368

EMC 8941 Patrick Espinosa Vol#: 368

EMC 8942 Patrick Espinosa Vol#: 368

EMC 8943 Parma Yarkin Vol#: 368

EMC 8944 Parma Yarkin Vol#: 368

EMC 8945 William McMullin Vol#: 368

EMC 8946 Robert Mackie Vol#: 368

EMC 8947 Robert Mackie Vol#: 368

EMC 8948 Lorianne Nielsen-Pullon Vol#: 368

EMC 8949 Mary M. Neikirk Vol#: 368

EMC 8950 Joanne Husak Vol#: 368

EMC 8951 Joanne Husak Vol#: 368

EMC 8952 Jo Anne Pauli Vol#: 368

EMC 8953 Karen Mukherjee Vol#: 368

EMC 8954 Jared Dreyfus Vol#: 368

EMC 8955 Jared Dreyfus Vol#: 368

EMC 8956 Dr. Mha Atma S. Khalsa Vol#: 368

EMC 8957 Dr. Mha Atma S. Khalsa Vol#: 368

EMC 8958 Michael Parker Vol#: 368

EMC 8959 Michael Parker Vol#: 368

EMC 8960 Clifford Hickman Vol#: 368

EMC 8961 Clifford Hickman Vol#: 368

00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated

C 3 Jennifer Crow, MPH et al Vol#: 1

C 4 Lorraine S. DelGesso, RN, BS et al Vol#: 1

C 5 Charlotte Cione, BS, RN et al Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 6492 Kathleen Dudley Vol#: 248

C 6493 Sally Orr Vol#: 248

C 6494 Gene S. Thomas Vol#: 248

C 6495 Becky O'Brien Vol#: 248

C 6496 Rodney B. Turner Vol#: 248

C 6497 Gabe Richter Vol#: 248

C 6498 Crystal Albares Vol#: 248

C 6499 unreadable Vol#: 248

C 6500 Scott Bilotta Vol#: 248

C 6501 unreadable Vol#: 248

C 6502 Patricia Braatz Vol#: 248

C 6503 Mignel Ramos Vol#: 248

C 6504 Douglas L. & Susan A. Ryan Vol#: 248

C 6505 Mike Kaplan Vol#: 248

C 6506 Betty LaPadula Vol#: 248

C 6507 Henry Sattonstall Vol#: 248

C 6508 Jason Vol#: 248

C 6509 Pat Cramer Vol#: 248

C 6510 Patti Nicklaus Vol#: 248

C 6511 Susan L. Donnelly Vol#: 248

C 6512 Nancy Parent Vol#: 248

C 6513 Laurie E. Dills Vol#: 248

C 6514 Mabel Dash Vol#: 248

C 6515 John Paul Vol#: 248

C 6516 Andrey Finney Vol#: 248

C 6517 Cherie Tamai Vol#: 248

C 6518 Kathleen Corr Vol#: 248

C 6519 Kevin Boyce Vol#: 248

C 6520 Jim Hollister Vol#: 248

C 6521 Coralie LaSalle Vol#: 248

C 6522 Jordy Mark Vol#: 248

C 6523 no signature Vol#: 248

C 6524 Mary Ziff Vol#: 248

C 6525 unreadable Vol#: 248

C 6526 Shannon Dawdy Vol#: 248

C 6527 Ms. Alcie Minicus Vol#: 248

C 6528 Joellen Gilchrist Vol#: 248

C 6529 John Cabeldi Vol#: 248

C 6530 Cynthia Care Vol#: 248

C 6531 Theresa Johnson Vol#: 248

C 6532 no signature Vol#: 248

C 6533 Tom & Susan Spitzer & Family Vol#: 248

C 6534 Charles White Vol#: 248

C 6535 Anthony Sanchez Vol#: 248

C 6536 Cesarie M. Simmons Vol#: 248

C 6537 Roy Wegner Vol#: 248

C 6538 B. J. Oliver Vol#: 248

C 6539 J. Wilson Vol#: 248

C 6540 Sharon Paltin, M.D. Vol#: 248

C 6541 Victor P. Randall Vol#: 248

C 6542 James H. Elder Vol#: 248

C 6543 Barbara A. Brenner Vol#: 248

C 6544 George C. Wilbur Atty at Law Vol#: 248

C 6545 Vicci Warhol Vol#: 248

C 6546 Patti Landres Vol#: 248

C 6547 Mary Steinkamp Vol#: 248

C 6548 Dianne Kaimann Vol#: 248

C 6549 Andy Stevensen Vol#: 248

C 6550 Dena Laychock Vol#: 248

C 6551 Jane K. Van Dusen Vol#: 248

C 6552 Dr. Ariel Kerman Vol#: 248

C 6553 Malle Spratt Vol#: 248

C 6554 David E. Irvine Vol#: 248

C 6555 Helen H. Reske Vol#: 248

C 6556 Ms. Marisa Teter Vol#: 248

C 6557 Jan Aho Vol#: 248

C 6558 Pam Meadows Vol#: 248

C 6559 Lee Purcell Vol#: 248

C 6560 unreadable Vol#: 248

C 6561 Patricia Snouffer Vol#: 248

C 6562 Paula Blum Vol#: 248

C 6563 G. Rennhack Vol#: 248

C 6564 P. Weedman Vol#: 248

C 6565 Mary G. Davenport Vol#: 248

C 6566 Tina Clarke Vol#: 248

C 6567 unreadable Vol#: 248

C 6568 C. A. Rains Vol#: 248

C 6569 Denise Callahan Vol#: 248

C 6570 Amanda Stogner Vol#: 248

C 6571 Judith Conley Vol#: 248

C 6572 no signature Vol#: 248

C 6573 Rachel Heward Vol#: 248

C 6574 Toni Taylor Vol#: 248

C 6575 Skip McPherson Vol#: 248

C 6576 Dedee Mulenbury Vol#: 248

C 6577 Mavis B. Ricketts Vol#: 248

C 6578 Janet Monks Vol#: 248

C 6579 Aryag Leushe kalaki Vol#: 248

C 6580 unreadable Vol#: 248

C 6581 unreadable Vol#: 248

C 6582 The Ferrara's Family Vol#: 248

C 6583 Dorothy Boyer Vol#: 248

C 6584 Larry Eastlund Vol#: 248

C 6585 Jason Bulluck Vol#: 248

C 6586 Vera S. Cohen Vol#: 248

C 6587 Gray Panthers of San Francisco Vol#: 248

C 6588 Sister Rosemarie Robinson Vol#: 248

C 6589 Martha Ehrlich Vol#: 248

C 6590 Annie Yan Vol#: 248

C 6591 Timber Crest Farms Vol#: 248

C 6592 Alison Litchfield Vol#: 248

C 6593 Brian Nath Vol#: 248

C 6594 Vicky Ryan Vol#: 248

C 6595 Helen Heath Vol#: 248

C 6596 B. Lykes Vol#: 248

C 6597 David W. Barber Vol#: 248

C 6598 Sandra Suni Vol#: 248

C 6599 Coralie Cahill Vol#: 248

C 6600 Laurie Stewart Vol#: 248

C 6601 Beverly Abbe Vol#: 248

C 6602 Glenn M. Rukwin Vol#: 248

C 6603 Jason Langlois Vol#: 248

EMC 8840 Valerie Gilbert Vol#: 247

EMC 8841 RFLYGIRLROBYN@cs.com Vol#: 247

EMC 8842 Brian Norton Vol#: 247

EMC 8843 Jon & Theresa Jokiel Vol#: 247

EMC 8844 Sylvia Zitek Vol#: 247

EMC 8845 Sylvia Zitek Vol#: 247

EMC 8846 Vicki Leidner Vol#: 247

EMC 8847 Vicki Leidner Vol#: 247

EMC 8848 Sarah Smith Vol#: 247

EMC 8849 Sarah Smith Vol#: 247

EMC 8850 Carmaig de Forest Vol#: 247

EMC 8851 Carmaig de Forest Vol#: 247

EMC 8852 Richard Gardner Vol#: 247

EMC 8853 Anne (Nancy) Fleurat Vol#: 247

EMC 8854 Anne (Nancy) Fleurat Vol#: 247

EMC 8855 Jessie C. Grearson Vol#: 247

EMC 8856 Carol Dovel Vol#: 247

EMC 8857 Sandra Lebrun Vol#: 247

EMC 8858 Robin C. Crandall Vol#: 247

EMC 8859 Tony Black Vol#: 247

EMC 8860 AnnaJo Doerr Vol#: 247

EMC 8861 Karen Jones Vol#: 247

EMC 8862 Julie Matthaei Vol#: 247

EMC 8863 Rev. M. Blake Vol#: 247

EMC 8864 Virginia A. Bormann Vol#: 247

EMC 8865 Robert Danos Vol#: 247

EMC 8866 Albert Lewit Vol#: 247

EMC 8867 Kathleen Zaleski Vol#: 247

EMC 8868 Sarah Sellnow Vol#: 247

EMC 8869 Tammy Rainwater Vol#: 247

EMC 8870 Michael DeMornet Vol#: 247

EMC 8871 Michael DeMornet Vol#: 247

EMC 8872 Ann Rick Vol#: 247

EMC 8873 Holly Bowden Vol#: 247

EMC 8874 Holly Bowden Vol#: 247

EMC 8875 Marcia Sampson Vol#: 247

EMC 8876 Veronique Robert Vol#: 247

EMC 8877 Suzanne Krill Vol#: 247

EMC 8878 Suzanne Krill Vol#: 247

EMC 8879 T. J. McGivney Vol#: 247

EMC 8880 Val Nemcek Vol#: 247

EMC 8881 Val Nemcek Vol#: 247

EMC 8882 Larry Tommerdahl Vol#: 247

EMC 8883 Joyce Kehoe Vol#: 247

EMC 8884 Joyce Kehoe Vol#: 247

EMC 8885 Tuan Dinh Vol#: 247

EMC 8886 Jill Ainsworth Vol#: 247

EMC 8887 Claudio Fratarcangeli Vol#: 247

EMC 8888 Michael Mink Vol#: 247

EMC 8889 Bernadette Phelps Vol#: 247

EMC 8890 Ryan Klages Vol#: 247

EMC 8891 Janna S. Mintz Vol#: 247

EMC 8892 Lauretta Iaconetti Vol#: 247

EMC 8893 Janna Mintz Vol#: 247

EMC 8894 Fred Lefevre Vol#: 247

EMC 8895 David Swenson Vol#: 247

EMC 8896 Wolfgang Golser Vol#: 247

EMC 8897 Bianca Lozada Vol#: 247

EMC 8898 Bianca Lozada Vol#: 247

EMC 8899 Suzanne Halstead Vol#: 247

EMC 8900 Connie Gevock Vol#: 247

EMC 8901 David Dixon Vol#: 247

EMC 8902 Brett Pingree Vol#: 247

EMC 8903 Brett Pingree Vol#: 247

EMC 8904 Eva Cramer Vol#: 247

EMC 8905 Hope Titkin & Ray Cervenka Vol#: 247

EMC 8906 Nicola & Ruskin Whaley Vol#: 247

EMC 8907 Neil Parry Vol#: 247

EMC 8908 Leila Belhadjali Vol#: 247

EMC 8909 Leila Belhadjali Vol#: 247

EMC 8910 Gilbert Morrison Vol#: 247

EMC 8911 Marianne Masteller Vol#: 247

EMC 8912 Joan Clark Vol#: 247

EMC 8913 Joan Clark Vol#: 247

EMC 8914 Maureen Kelley Vol#: 247

EMC 8915 Peter Barozzi Vol#: 247

EMC 8916 Sybil Blazej-Yee Vol#: 247

EMC 8917 Marc Krimen, JD Vol#: 247

EMC 8918 Steven Rosstad Vol#: 247

EMC 8919 Lisa Kohn Vol#: 247

EMC 8920 Elaine Maibaum Vol#: 247

EMC 8921 Diana Gault Vol#: 247

EMC 8922 Lisa Gingras-Lamothe Vol#: 247

EMC 8923 Daken Ariel Vol#: 247

EMC 8924 Mary Beaty Vol#:

EMC 8925 Christina Jacobi Vol#: 247

EMC 8926 Heather Burns Vol#: 247

EMC 8927 Kori Haskell Vol#: 247

EMC 8928 Kay Brownfield Vol#: 247

EMC 8929 Randy L. Powers Vol#: 247

EMC 8930 Andy Cochran Vol#: 247

EMC 8931 Seren Wickson Vol#: 247

EMC 8932 Gian A. Morresi Vol#: 247

EMC 8933 Cynthia Hunter Vol#: 247

EMC 8934 David Kuhnert Vol#: 247

EMC 8935 Kassandra Maria de Feo Vol#: 247

EMC 8936 Amy A. Fischer Vol#: 247

EMC 8937 Jane Webb Vol#: 247

EMC 8938 daisyann1111 Vol#: 247

EMC 8939 Alciia White Vol#: 247

EMC 8940 Alciia White Vol#: 247

EMC 8941 Barbara Leonhard Vol#: 247

EMC 8942 Amy Conry Vol#: 247

EMC 8943 Gina Flores Vol#: 247

EMC 8944 Constance Bowencamp Vol#: 247

EMC 8945 Jeanne Murray-Hicks Vol#: 247

EMC 8946 James Leong Vol#: 247

EMC 8947 Candace Chase Vol#: 247

EMC 8948 Ronna Devincenzi Vol#: 247

EMC 8949 Claire Gendron Vol#: 247

EMC 8950 Doron Weisbarth Vol#: 247

EMC 8951 Judith Prager Vol#: 247

EMC 8952 Julia Standefer Vol#: 247

EMC 8953 Carrie Wernick Vol#: 247

EMC 8954 Sheila Seybolt Vol#: 247

EMC 8955 Sheila Seybolt Vol#: 247

EMC 8956 Kelly Bouey Vol#: 247

EMC 8957 Deborah Wolk Vol#: 247

EMC 8958 Carrie Hirsch Vol#: 247

EMC 8959 M. Huber Vol#: 247

EMC 8960 Sue Lindequist Vol#: 247

EMC 8961 Lauri Raymond Vol#: 247

EMC 8962 Phillip Raymond Vol#: 247

EMC 8963 Elayne Greenberg Vol#: 247

EMC 8964 Neill Gibson Vol#: 247

EMC 8965 Carol Kuhr Vol#: 247

EMC 8966 Paula Puhak Vol#: 247

EMC 8967 Paula Puhak Vol#: 247

EMC 8968 Gigi Kirk Vol#: 247

EMC 8969 Sandy Niemiec Vol#: 247

EMC 8970 Jayne Ollin Vol#: 247

EMC 8971 Jayne Ollin Vol#: 247

EMC 8972 Don White Vol#: 247

EMC 8973 Don White Vol#: 247

EMC 8974 Lyn Johnson Vol#: 247

EMC 8975 George Renfrey Vol#: 247

EMC 8976 Kent Don Vol#: 247

EMC 8977 Raymond Sowder Vol#: 247

EMC 8978 Raymond Sowder Vol#: 247

EMC 8979 Nicholas Night Vol#: 247

EMC 8980 Ramkumar Vol#: 247

EMC 8981 Judy A. Young Vol#: 247

EMC 8982 Terry Rosenberg Vol#: 247

EMC 8983 DDranikoff@aol.com Vol#: 247

EMC 8984 Jaak Panksepp Vol#: 247

EMC 8985 Lana O'Neil Vol#: 247

EMC 8986 Mike Dunton Vol#: 247

EMC 8987 Lindsay Wines Vol#: 247

EMC 8988 Peter Gross Vol#: 247

EMC 8989 Melissa Tyrrell Vol#: 247

EMC 8990 Clare Giroux Vol#: 247

EMC 8991 Denise Gibson Vol#: 247

EMC 8992 Robin Warne Vol#: 247

EMC 8993 Tim House Vol#: 247

EMC 8994 Tim House Vol#: 247

EMC 8995 Peter A. Cottell Vol#: 247

EMC 8996 Krista Serra Vol#: 247

EMC 8997 Krista Serra Vol#: 247

EMC 8998 William Witort Vol#: 247

EMC 8999 William Witort Vol#: 247

EMC 9000 Patrick Paine Vol#: 247

00P-1411 Set a regulatory limit for methylmercury in seafood

EMC 80 Sally Ebbert Vol#: 1

EMC 81 Robert Fort Vol#: 1

00P-1499 Remove alosetron (Lotronex) from the market

C 139 Maria A Zargo Vol#: 5

C 140 Bud Hodorowski Vol#: 5

C 141 Randi Deutsch Vol#: 5

C 142 Catherine Lewis Vol#: 5

C 143 Terri N Vol#: 5

C 144 Linda Sadek Vol#: 5

C 145 Anna Orjuela Vol#: 5

C 146 Michael D Kaiser Vol#: 5

C 147 D L Deegan Vol#: 5

C 148 Teri Vasso Vol#: 5

C 149 Debra H Benning Vol#: 5

C 150 Marilyn Schuller Vol#: 5

C 151 Karen A Pelner Vol#: 5

C 152 Sharyn S Davenport Vol#: 5

C 153 Tom Bell Vol#: 5

C 154 Lisa A Vol#: 5

C 155 Laura G Bell Vol#: 5

C 156 William W Brown Vol#: 5

C 157 Jenifer B Alzamora Vol#: 5

C 158 Jacqueline Becker Vol#: 5

C 159 NO SIGNATURE Vol#: 5

C 160 NO SIGNATURE Vol#: 5

C 161 Marissa Gangone Vol#: 5

C 162 Warren E Medina-Riutort Vol#: 5

C 163 Janet Sylvies Vol#: 5

C 164 Ruth E Roeder Vol#: 5

C 165 Melissa D Godwin Vol#: 5

C 166 Sally Read Vol#: 5

C 167 Lynne Mutz Vol#: 5

C 168 Michelle Vol#: 5

01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed

C 3 Aventis Pharmaceuticals, Inc. Vol#: 1

01D-0192 Forms for registation of producers of drugs and listing of

C 5 Procter & Gamble Vol#: 1

01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic

C 1 Novartis Pharmaceuticals Vol#: 1

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

C 100 William Piccirillo Vol#: 3