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 15, 2001

TABLE OF CONTENTS

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
01P-0354 Immediately ban the sale of human cadaveric dura mater *
01P-0355 ANDA suitability for hydrocortisone acetate lotion, 2.5% *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 2 Alicia Casilli Vol#: 28

EMC 3 Maura O'Connor Vol#: 28

EMC 4 Richard Wehrman Vol#: 28

EMC 5 Keith Kunz Vol#: 28

EMC 6 David Landskov Vol#: 28

EMC 7 Donna Vilardi Vol#: 28

EMC 8 Cheryl Costigan Vol#: 28

EMC 9 Kathleen & Tom Washburn Vol#: 28

EMC 10 Brian Henderlong Vol#: 28

EMC 11 William Luthy Vol#: 28

EMC 12 number not used Vol#: 28

EMC 13 Keith Kunz Vol#: 28

EMC 14 Richard Wehrman Vol#: 28

EMC 15 Maura O'Connor Vol#: 28

EMC 16 Alicia Casilli Vol#: 28

EMC 17 Donald Mower Vol#: 28

EMC 18 Theodore Venet Vol#: 28

EMC 19 Gerald Foreman Vol#: 28

EMC 20 Dane Nance Vol#: 28

EMC 21 number not used Vol#: 28

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11530 unsigned Vol#: 422

EMC 11531 Reid Erickson Vol#: 422

EMC 11532 Sarina Grosswald Vol#: 422

EMC 11533 Ron Krinock Vol#: 422

EMC 11534 Wiep de Vries, registered nurse Vol#: 422

EMC 11535 Karen Long Vol#: 422

EMC 11536 Lizbeth Ryan Vol#: 422

EMC 11537 Mary Ann Merville Vol#: 422

EMC 11538 Marion Dawson Vol#: 422

EMC 11539 Susan Tucker Vol#: 422

EMC 11540 Craig Shepherd Vol#: 422

EMC 11541 Mark Denny Vol#: 422

EMC 11542 Judy Steele Vol#: 422

EMC 11543 Susan Milliner Vol#: 422

EMC 11544 Maria AB Acevedo Vol#: 422

EMC 11545 Linda Fritts Vol#: 422

EMC 11546 Nancy E. Wilcox Vol#: 422

EMC 11547 Kay Ryan Biondo Vol#: 422

EMC 11548 Terry Spencer-Smith Vol#: 422

EMC 11549 Loren Clive Vol#: 422

EMC 11550 Lillian Turner Vol#: 422

EMC 11551 Carol Denton-Smith Vol#: 422

EMC 11552 David Calvani Vol#: 422

EMC 11553 China Niemann Vol#: 422

EMC 11554 Lsa Lebo Vol#: 422

EMC 11555 Ronald Ward Vol#: 422

EMC 11556 Toni Sorrentino Vol#: 422

EMC 11557 Thelma Curtis Vol#: 422

EMC 11558 Betty Gardner Vol#: 422

EMC 11559 Marilyn Dinger Vol#: 422

EMC 11560 Scott Wiro Vol#: 422

EMC 11561 Dana Sherrell Vol#: 422

EMC 11562 Sharon Letts Vol#: 422

EMC 11563 Brenda Martin Vol#: 422

EMC 11564 Pauline Herrmann Vol#: 422

EMC 11565 David Gerke Vol#: 422

EMC 11566 William Zinne Vol#: 422

EMC 11567 Donna Covington Vol#: 422

EMC 11568 Monika Louderback Vol#: 422

EMC 11569 Richard Stimson Vol#: 422

EMC 11570 Joey Chang Vol#: 422

EMC 11571 Ken Woodward Vol#: 422

EMC 11572 Debra Rogers Vol#: 422

EMC 11573 Kim Merville Vol#: 422

EMC 11574 Susan Drake Vol#: 422

EMC 11575 John McAbery Vol#: 422

EMC 11576 Carla Valente Vol#: 422

EMC 11577 Carla Valente Vol#: 422

EMC 11578 number not used Vol#: 422

EMC 11579 number not used Vol#: 422

EMC 11580 number not used Vol#: 422

EMC 11581 number not used Vol#: 422

EMC 11582 Sharon Kerley Vol#: 422

EMC 11583 L. Falcioni Vol#: 422

EMC 11584 Bard Sullenger Vol#: 422

EMC 11585 Sheri Vail Vol#: 422

EMC 11586 Kristofer Young, DC Vol#: 422

EMC 11587 Mary Garroutte Vol#: 422

EMC 11588 Bev Doran Vol#: 422

EMC 11589 Sharon Vadas Vol#: 422

EMC 11590 Laurel Saltzman Vol#: 422

EMC 11591 Irene Bensinger Vol#: 422

EMC 11592 Linda Neale Vol#: 422

EMC 11593 Lane Utley Vol#: 422

EMC 11594 Mark Preston Vol#: 422

EMC 11595 Carolyn Yakaboski Vol#: 422

EMC 11596 Susannah Frishman-Phillips Vol#: 422

EMC 11597 Marguerite Bunyan Vol#: 422

EMC 11598 Carrie Stubbs Vol#: 422

EMC 11599 Bonnie Chiara Vol#: 422

EMC 11600 Harvey Wheeler Vol#: 422

EMC 11601 Skye Weintraub Vol#: 425

EMC 11602 Natasha and Noah Brenner Vol#: 425

EMC 11603 Mary McMahon Vol#: 425

EMC 11604 Pat Bily Vol#: 425

EMC 11605 Clifford S. Garner, PhD (Holistic Health Vol#: 425

EMC 11606 Laura McKee Vol#: 425

EMC 11607 Jo & Al Mitchell Vol#: 425

EMC 11608 Richard Pyle Vol#: 425

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 7921 Joyce M. Poudrier Vol#: 285

C 7922 Laura Buchite Vol#: 285

C 7923 Nancy Margaret Lyons Vol#: 285

C 7924 Mrs. Joan McCullough Vol#: 285

C 7925 Mary Heikes Vol#: 285

C 7926 MaryLou Begnaud Vol#: 285

C 7927 Robert C. Herhold, Sr. Vol#: 285

C 7928 Nila J. Reineke Vol#: 285

C 7929 Michael Alexander Vol#: 285

C 7930 Nancy Pernell Vol#: 285

C 7931 P. Westbrook Vol#: 285

C 7932 Betsy Walker Vol#: 285

C 7933 Kathy Gerard Friedlander Vol#: 285

C 7934 Gerald Leigh Vol#: 285

C 7935 Mrs. Mary D. McHenry Vol#: 285

C 7936 Cheryl R. Cromer Vol#: 285

C 7937 Bernard Petley Vol#: 285

C 7938 no signature Vol#: 285

C 7939 Karen Scheel Vol#: 285

C 7940 Nancy A. Sica Vol#:

C 7941 Mrs. Phil Williams Vol#: 285

C 7942 Lauri Crossman Vol#: 285

C 7943 Todd Scott Vol#: 285

C 7944 Todd & Susan Menges Vol#: 285

C 7945 Julie Sabia Vol#: 285

C 7946 Mary E. Luksza Vol#: 285

C 7947 Sandra E. Mitchell Vol#: 285

C 7948 James A. Sanders Vol#: 285

C 7949 Tracy & Wm H. Foster Vol#: 285

C 7950 Judy A. Mink Vol#: 285

C 7951 Julia Sampietro Vol#: 285

C 7952 Elizabeth Anne Rennann Vol#: 285

C 7953 Cynthia Kobak Vol#: 285

C 7954 Sandee E. Beyerle Vol#: 285

C 7955 Ann M. Harness Vol#: 285

C 7956 Gail Reid Vol#: 285

C 7957 Joel & Marcee Musgrove Vol#: 285

C 7958 Sandra Kay Nevius Vol#: 285

C 7959 Paul & Bonnie Trowbridge Vol#: 285

C 7960 Ron Knapmiller Vol#: 285

C 7961 Velma J. Burkinshaw Vol#: 285

C 7962 Zach Castleman Vol#: 285

C 7963 Mrs. Susan Bradfield Vol#: 285

C 7964 Hyla Fetler Vol#: 285

C 7965 Hope Anwyll Vol#: 285

C 7966 Naidel Olsen Vol#: 286

C 7967 Beverly K. Happ Vol#: 286

C 7968 Cami J. Klingonsmith Vol#: 286

C 7969 Yoko Iusaki Vol#: 286

C 7970 Linda Carpenter Vol#: 286

C 7971 Julie Ann Brody Vol#: 286

C 7972 Deb Bell Vol#: 286

C 7973 Matthew G. Hall Vol#: 286

C 7974 Edmond Baudine Vol#: 286

C 7975 Sue Amerson Vol#: 286

C 7976 Ms. Ella J. Sontheimer Vol#: 286

C 7977 Joyce S. Daggett Vol#: 286

C 7978 Margaret Hyman Vol#: 286

C 7979 Betty D. Lucas Vol#: 286

C 7980 Rita Weintraub Vol#: 286

C 7981 Margaret A. Silverman Vol#: 286

C 7982 No Signature Vol#: 286

C 7983 Harriet H. King Vol#: 286

C 7984 William Cwik Vol#: 286

C 7985 Anna Landauer Vol#: 286

C 7986 Hazel Scheller Vol#: 286

C 7987 Melissa G. Lee Vol#: 286

C 7988 Aida S. Tallman Vol#: 286

C 7989 Marguerite Dunn Vol#: 286

C 7990 Kathleen Skoller Vol#: 286

C 7991 Greg Vogtritter Vol#: 286

C 7992 James Hedeen Vol#: 286

C 7993 Barbara A. Zink Vol#: 286

C 7994 Judith M. Currie Vol#: 286

C 7995 Andrea Ross Vol#: 286

C 7996 Sarah Rosenfield Vol#: 286

C 7997 Jean M. Moser Vol#: 286

C 7998 Marie V. Porter Vol#: 286

C 7999 Marie B. Bauer Jones Vol#: 286

C 8000 Mary Beth Hooper Vol#: 286

C 8001 J. Smith Vol#: 286

C 8002 Lisa Coplantz Vol#: 286

C 8003 Linda Hickok Vol#: 286

C 8004 Linda Stimson Vol#: 286

C 8005 Auria Gerhardt Vol#: 286

C 8006 Pat J. Piper Vol#: 286

C 8007 Willard G. Van Hoorn Vol#: 286

C 8008 Tyra Baker Vol#: 286

C 8009 Mary Grayson Vol#: 286

C 8010 Helen McGuigan-Kuperman Vol#: 286

C 8011 Illegible Vol#: 286

C 8012 Brenda Crandall Vol#: 286

C 8013 Patricia Snouffer Vol#: 286

C 8014 Meredith M. Lubenau Vol#: 286

C 8015 Mrs. Vivian Cornacchia Vol#: 286

C 8016 Erika A. Butts Vol#: 286

C 8017 Gloria S. Van Vliet Vol#: 286

C 8018 Donna Boozer Vol#: 286

C 8019 Dr. Jeannie Fennell Vol#: 286

C 8020 Ms. Rosemary Easley Vol#: 286

C 8021 Mary A. Morton Vol#: 286

C 8022 Angela Kim Gragg Vol#: 286

C 8023 Martin Mondrus Vol#: 286

C 8024 Nora Fisher Vol#: 286

C 8025 Jane Fairbanks Vol#: 286

C 8026 Gilbert H. Kirchner Vol#: 286

C 8027 Amy Anderson Vol#: 286

C 8028 Debra Meredith Vol#: 286

C 8029 Mrs. Louise Hoban Vol#: 286

C 8030 Rose H. Paret Vol#: 286

C 8031 Name doesn't matter Vol#: 286

C 8032 John & June Wilson Vol#: 286

C 8033 Margaret & Lynn Shelton Vol#: 286

C 8034 Robert Lee Rhodes Vol#: 286

C 8035 Myra Thornton Vol#: 286

C 8036 David E. & Julia M. Davis Vol#: 286

C 8037 Jo J. King Vol#: 286

C 8038 Leslie Law-Morstatt Vol#: 286

C 8039 Ruth E. Guilfoyle Vol#: 286

C 8040 Joseph S. Halapi Vol#: 286

C 8041 James Spaulding Vol#: 286

C 8042 Kathy A. Jabs Vol#: 286

C 8043 V. Bucko Vol#: 286

C 8044 Jude Milano Vol#: 286

C 8045 Jeanne Herner Vol#: 286

C 8046 Cynthia L. Gay Vol#: 286

C 8047 Ruth Van Acker Vol#: 286

C 8048 Loyd Campbell Vol#: 286

C 8049 Barbara Paul Vol#: 286

C 8050 Robert Hardy Trickey Vol#: 286

C 8051 Paula Krolikoski Vol#: 286

C 8052 Bhanu J. Harrison Vol#: 286

C 8053 B. Adams Vol#: 286

C 8054 Jo Edmisten Vol#: 286

C 8055 Mary Lou Wooten Vol#: 286

C 8056 Jackie G. Heronx Vol#: 286

C 8057 Charles R. Peterssen Vol#: 286

C 8058 Shirley Riley Vol#: 286

C 8059 Luella Gruchalla Vol#: 286

C 8060 Audra Macomber Vol#: 286

C 8061 Patrick Bretz Vol#: 286

C 8062 Bettina Voelk Vol#: 286

C 8063 Nancy Brokeig Vol#: 286

C 8064 Nancy Ostapovitch Vol#: 286

C 8065 Carol Dupuis Vol#: 286

C 8066 Pamela Ann Cabral Vol#: 286

C 8067 Mrs. Ronald M. Heard Vol#: 286

C 8068 Marsha Melder Vol#: 286

C 8069 Donald E. & Judith A. Hudgins Vol#: 286

C 8070 Thelma S. Taylor-Gayhart Vol#: 286

C 8071 Don & Sandra Runge Vol#: 286

C 8072 Don & Sandra Runge Vol#: 286

C 8073 Kathy Woodall Vol#: 286

C 8074 Merle Pieterse Vol#: 286

C 8075 Phyllis Diane Gibbs Vol#: 286

C 8076 Mrs. Robin Walter Vol#: 286

C 8077 Kathryn E. Mullis Vol#: 286

C 8078 Mary R. Hawkins Vol#: 286

C 8079 Catherine Abbott Vol#: 286

C 8080 Susan Pelakh Vol#: 286

C 8081 Dorothy C. Hatchett Vol#: 286

C 8082 Ruth M. Gordon Vol#: 286

C 8083 Valerie Weiss Vol#: 286

C 8084 Julie M. Emerson Vol#: 286

C 8085 Anne Marie Whitney Vol#: 286

C 8086 Shirley Geiser Vol#: 286

C 8087 Becki Kuhn Vol#: 286

C 8088 Heidi Freistone Vol#: 286

C 8089 Michelle Lieberman Vol#: 286

C 8090 Mona Christenson Vol#: 286

C 8091 William Baggins Vol#: 286

C 8092 Tracy Brown Vol#: 286

C 8093 Paul D. Konopelski Vol#: 286

C 8094 Martin Kellerman Vol#: 286

C 8095 Frances Peshkin Vol#: 286

C 8096 Dolores Tippett Vol#: 286

C 8097 Joanne Holbrook Vol#: 286

C 8098 Joyce Poudrier Vol#: 286

C 8099 Marilyn E. Logan Vol#: 286

C 8100 John Patsis Vol#: 286

C 8101 Elizabeth Patsis Vol#: 286

C 8102 Ms. H. R. Krugen Vol#: 286

C 8103 Orpha Hinkley Vol#: 286

C 8104 Kari Lemieux Vol#: 286

C 8105 Anne Adams Vol#: 286

C 8106 Dick, Beth, Ian, Andrew & Pearl Nesbitt Vol#: 286

C 8107 Lorraine Jackson Vol#: 286

C 8108 Sara Polgar Vol#: 286

C 8109 Jenny A. Cortina Vol#: 286

C 8110 Patrick Brown Vol#: 286

C 8111 Krista Sickler Vol#: 286

C 8112 Kathy & Geoffrey Adams Vol#: 286

C 8113 Barbara Green Vol#: 286

C 8114 Mark Davis Vol#: 286

C 8115 Claire Haddad Vol#: 286

C 8116 Ruth Beckner Vol#: 286

C 8117 Susan A. Junda Vol#: 286

C 8118 Henry Peck Vol#: 286

C 8119 Kendra Eneroth Vol#: 286

C 8120 C. Turner Vol#: 287

C 8121 Amy Davis Vol#: 287

C 8122 Deborah Lally Vol#: 287

C 8123 Rosemary Johnson Vol#: 287

C 8124 Kenneth Vannice Vol#: 287

C 8125 Ariel Bavekman Vol#: 287

C 8126 Anna M. Sinsigalli Vol#: 287

C 8127 Elinor Ramming Vol#: 287

C 8128 Susie Simen Vol#: 287

C 8129 B. Chaffee Vol#: 287

C 8130 Marilyn Bode Vol#: 287

C 8131 Michael J. Kawanagh Vol#: 287

C 8132 Hilary Franz Vol#: 287

C 8133 Marianne Brawley Vol#: 287

C 8134 Craig Jacobroxin Vol#: 287

C 8135 Patricia A. Glabach Vol#: 287

C 8136 Patricia A. Glabach Vol#: 287

C 8137 J. Salts Vol#: 287

C 8138 Nancy Drigotas Vol#: 287

C 8139 Penelope S. Anderson Vol#: 287

C 8140 Patricia Bass Vol#: 287

C 8141 Carolee Valentine Vol#: 287

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

MO 8 Worldwide Medical Corporation Vol#: 1

01P-0354 Immediately ban the sale of human cadaveric dura mater

ACK 1 HFA-305 Vol#: 1

CP 1 Public Citizen Vol#: 1

01P-0355 ANDA suitability for hydrocortisone acetate lotion, 2.5%

ACK 1 HFA-305 Vol#: 1

CP 1 Ferndale Labs., Inc. Vol#: 1