DOCKETS ENTERED on 04/09/01
Docket Title
Number
Documents received by the Dockets Management Branch "MAY" be posted on the internet. PLEASE DO NOT INCLUDE personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.
THE DOCUMENTS IN THE FOLLOWING DOCKETS WILL BE LINKED AS SOON AS POSSIBLE. CLICK ON THE (*) TO SEE THE CONTENTS OF THE LISTED DOCKET. SOME DOCKETS, NOT LINKED TO THIS TABLE OF CONTENTS, WILL BE LINKED ELSEWHERE ON THE DOCKETS PAGE
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
78N-0038 Sunscreen Drug Products *
99P-4053 Sympathominetic Amine Phentermine *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1537 Discontinued Labeling for Listed Drugs in ANDA *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt *
00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants *
01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi *
01P-0169 Access & Safe Distribution of Alosetron
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
M 9 HFD-560 & CHPA Vol#: 235
78N-0038 Sunscreen Drug Products
C 594 CTFA Vol#: 146
RC 2 Playtex Products, Inc. Vol#: 146
87V-0388 Benedum natural science theater light show
VRA 6 HFZ-340 to Oglebay Park Vol#: 1
90V-0024 Laser Light Show
VRA 7 HFZ-340 to Sea World of Florida Vol#: 1
92V-0286 Variance Request for Mobilazer ML-10A Light Show
VRA 5 HFZ-340 to Mobolazer, Inc. Vol#: 1
95V-0312 Laser Light Show
VRA 5 HFZ-340 to Laseronics Northwest Vol#: 1
96V-0138
VRA 4 HFZ-340 to Strictly FX L.L.C. Vol#: 1
97N-0472 Petition for administrative stay of action
N 4 Vol#: 1
99P-4053 Sympathominetic Amine Phentermine
LET 2 HFD-1 to Mark P. McGrath, Esq. Vol#: 1
99P-4613 Revoke the Regulation That Approved Posilac
EMC 2382 Shannon Benckert Vol#: 44
EMC 2383 William DiMartino Vol#: 44
EMC 2384 Sharon Martin Howell Vol#: 44
00D-1537 Discontinued Labeling for Listed Drugs in ANDA
RC 1 GPhA, Generic Pharmaceutical Assn. Vol#: 1
00D-1598 Voluntary Labeling for Bioengineered Foods
C 891 G. Jenson Vol#: 83
C 892 Jean L. Ballon Vol#: 83
C 893 Leah Lee Vol#: 83
C 894 Judi Richardson Vol#: 83
C 895 Floy Barrett Vol#: 83
C 896 Flora Phillips Vol#: 83
C 897 Kenna Josephene Vol#: 83
C 898 Peter Nells Vol#: 83
C 899 Ken D. Brown Vol#: 83
C 900 Cynthia Gerzewski Vol#: 83
C 901 Cynthia Herwards Vol#: 83
C 902 A. Villar Vol#: 83
C 903 Andrea Hill Vol#: 83
C 904 Squidge Lilseblad Davis Vol#: 83
C 905 Melissa Carlson Vol#: 83
C 906 Debra Holzman Vol#: 83
C 907 Unsigned Vol#: 83
C 908 John Sumler Vol#: 83
C 909 Tim Smith, PhD Vol#: 83
C 910 Tom Bender Vol#: 83
C 911 Patrick Geaney Vol#: 83
C 912 Margaret Rankin Vol#: 83
C 913 Sabine Grob Vol#: 83
C 914 Norma Wojtczak Vol#: 83
C 915 Anthony Fox Vol#: 83
C 916 Robin Namney Vol#: 83
C 917 Bernard Demartini Vol#: 83
C 918 Theodore Kruzich Vol#: 83
C 919 Janice Zern Vol#: 83
C 920 Ms. D.R. Flynn Vol#: 83
C 921 Beverly Petiet Vol#: 83
C 922 Vivien Peirne Vol#: 83
C 923 B. Welch Vol#: 83
C 924 Ursula Wolf-Rottkay Vol#: 83
C 925 Betsy Gynn Vol#: 83
C 926 Stacey Emerick Vol#: 83
C 927 Z. Helene Noyer, MA Vol#: 83
C 928 Tracey Barnes Vol#: 83
C 929 Sue Ellen Davis Vol#: 83
C 930 Ray McCormick Vol#: 83
C 931 Catherine J. Schultz, PhD Vol#: 83
C 932 Philip H. Norris Vol#: 83
C 933 Sr. Constance Kozel, RSM, PhD Vol#: 83
C 934 Rosemary E. Gaskell Vol#: 83
C 935 Margreta Von Pein Vol#: 83
C 936 Louis Nicholas Vol#: 83
C 937 Jim Sluyter & Jo Meller Vol#: 83
C 938 Erica Siskind Vol#: 84
C 939 Hugh R. Putrain Vol#: 84
C 940 Paula James Vol#: 84
C 941 Elizabeth C. Parker Vol#: 84
C 942 Eric Perl Vol#: 84
C 943 Walter Epp Vol#: 84
C 944 Steven R. Gerrish Vol#: 84
C 945 Joy Wolff Vol#: 84
C 946 R. Aijik Vol#: 84
EMC 1890 Kathryn Kawazoe Vol#: 83
EMC 1891 Kristin Biehl Vol#: 84
EMC 1892 Larry Chernicoff Vol#: 84
EMC 1893 William Crafts Vol#: 84
EMC 1894 John Marchlik Vol#: 84
EMC 1895 Timothy Singh Vol#: 84
EMC 1896 Susan Lee Traft Vol#: 84
EMC 1897 Joel Feldman Vol#: 84
EMC 1898 Dr. Gloria Albrecht Vol#: 84
EMC 1899 D Z Vol#: 84
EMC 1900 Virginia McIver Vol#: 84
EMC 1901 Rosalie Fanshel Vol#: 84
EMC 1902 Johnny Combden Vol#: 84
EMC 1903 The Gordan Family Vol#: 84
EMC 1904 Qantara Langley Vol#: 84
EMC 1905 Walker Miller, PhD Vol#: 84
EMC 1906 Helga Wells Vol#: 84
EMC 1907 Samuel Ong Vol#: 84
EMC 1908 Thor Hemenway Vol#: 84
EMC 1909 Wee B. Guineapigs Vol#: 84
EMC 1910 Andrew Meyer Vol#: 84
EMC 1911 Karen Whitton Vol#: 84
EMC 1912 Rebecca Holroyd Vol#: 84
EMC 1913 Rebecca Holroyd Vol#: 84
EMC 1914 Gerrie DeVoe Vol#: 84
EMC 1915 Gene Poore Vol#: 84
EMC 1916 Nathaniel Minton Vol#: 84
EMC 1917 Brad Roseman Vol#: 84
EMC 1918 Lee Ann Kelly Vol#: 84
EMC 1919 Conald Miller Vol#: 84
EMC 1920 John D. Rachel Vol#: 84
EMC 1921 John D. Rachel Vol#: 84
EMC 1922 Dr. Judette M. Kolasny Vol#: 84
EMC 1923 Noelle Dobson Vol#: 84
EMC 1924 Caca Huate Vol#: 84
EMC 1925 Tami McQueen Vol#: 84
EMC 1926 Jada Hueber Vol#: 84
EMC 1927 Sara Idle Vol#: 84
EMC 1928 Kay McMullen Vol#: 84
EMC 1929 Ethan Rosenthal Vol#: 84
EMC 1930 Marian Buckner Vol#: 84
EMC 1931 Judy Flowers Vol#: 84
EMC 1932 Allison Vetter Vol#: 84
EMC 1933 Elizabeth Powanda Vol#: 84
EMC 1934 Mark Roth Vol#: 84
EMC 1935 D. Jennifer Hewitt Vol#: 84
EMC 1936 Selma Shelton Vol#: 84
EMC 1937 Colin R. Shelton Vol#: 84
EMC 1938 Rob D'Egidio Vol#: 84
EMC 1939 Hans Siegenthaler Vol#: 84
EMC 1940 Elly Benson Vol#: 84
EMC 1941 Peter J. Taylor, PhD Vol#: 84
EMC 1942 Allene Wahl, PhD Vol#: 84
EMC 1943 Daniel Kresmery Vol#: 84
EMC 1944 Linda D'Antonio Vol#: 84
EMC 1945 Steve Hays Vol#: 84
EMC 1946 Daniel E. Brannen Jr. Vol#: 84
EMC 1947 Erich Keefe Vol#: 84
EMC 1948 Kathleen Dobrzynski Vol#: 84
EMC 1949 Susan Williams Vol#: 84
EMC 1950 Yankee Gindoff Vol#: 84
EMC 1951 Margaret Simpson Vol#: 84
EMC 1952 Susan Beck Vol#: 84
EMC 1953 Susan Shankle Vol#: 84
EMC 1954 Andrew Hartley Vol#: 84
EMC 1955 Roger Glass Vol#: 84
EMC 1956 Trish Sage Vol#: 84
EMC 1957 Sarah Kotzamani Vol#: 84
EMC 1958 Todd Dufour Vol#: 84
EMC 1959 Matthew Jones Vol#: 84
EMC 1960 Derri Smith Vol#: 84
EMC 1961 Cynthia Hardin Vol#: 84
EMC 1962 Amy Land Vol#: 84
EMC 1963 Kathryn Monro Vol#: 84
EMC 1964 Gary Aitken Vol#: 84
EMC 1965 Debra DiLallo Vol#: 84
EMC 1966 Marian Sonnenfeld Vol#: 84
EMC 1967 Michael Rogen Vol#: 84
EMC 1968 Heather Wineteer Vol#: 84
EMC 1969 Margaret Weston Vol#: 84
EMC 1970 LeDonna Scalf Vol#: 84
EMC 1971 James R. Churchill Vol#: 84
EMC 1972 Linda Mahome Vol#: 84
EMC 1973 Bill Corbett Vol#: 84
EMC 1974 Daniel Goldberg Vol#: 84
EMC 1975 Debbie Stevens Vol#: 84
EMC 1976 Denise Smith Vol#: 84
EMC 1977 No Signature Vol#: 84
EMC 1978 S. Davis Vol#: 84
EMC 1979 Janice Larson Vol#: 84
EMC 1980 Ruth Haas Vol#: 84
EMC 1981 Samuel Justice Vol#: 84
EMC 1982 Patricia Lydy Vol#: 84
EMC 1983 Ruth Fike Vol#: 85
EMC 1984 Lori Butler Vol#: 85
EMC 1985 Jill Scobie Vol#: 85
EMC 1986 Loren Clift Vol#: 85
EMC 1987 Joan Patterson Vol#: 85
EMC 1988 Gary Hoffman Vol#: 85
EMC 1989 Israel David Fishman Vol#: 85
EMC 1990 No Signature Vol#: 85
EMC 1991 Sandy Arnold Vol#: 85
EMC 1992 Deidre Tracey Vol#: 85
00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals
C 2 M.E. Ginevan & Associates Vol#: 1
00N-1396 Bioengineered Foods Consumed By Humans or Animals
C 333 Carolyn Kmonia Vol#: 31
C 334 George W. Myer Vol#: 31
C 335 Thora Guinn Vol#: 31
C 336 Paul Levy Vol#: 31
C 337 P. Loomer Vol#: 31
C 338 Nathan,Joseph,Stephen Lever Vol#: 31
C 339 Dawn Sperby Vol#: 31
C 340 Mary E. Ricker Vol#: 31
C 341 Nora Fitzgerald Vol#: 31
C 342 Maira Gillen Vol#: 31
C 343 Karen Dewy Vol#: 31
C 344 Leslie Rayel-Coving Vol#: 31
C 345 katy Eagan Vol#: 31
C 346 Aatlon Citrin Vol#: 31
C 347 John Burr Vol#: 31
C 348 Ursula Wolf-Rottkay Vol#: 31
C 349 Harry Pylor Vol#: 31
C 350 Leigh Ow Vol#: 31
C 351 E. Ratign Vol#: 31
C 352 Patrick Ksaich Vol#: 31
C 353 Kim Savage Vol#: 31
C 354 Karen Serraino Vol#: 31
C 355 J. Oltmans Vol#: 31
C 356 David Sherman Vol#: 31
C 357 Greg Weave Vol#: 31
C 358 Barbara Banley Vol#: 31
C 359 Ann Kaff Vol#: 31
C 360 Sallie Wong Vol#: 31
C 361 Cynthie Bekke Vol#: 31
C 362 Justy Marie Vol#: 31
C 363 Emily Vogler Vol#: 31
C 364 Mary B McConnell Vol#: 31
C 365 unreadable Vol#: 31
C 366 I. Andalvz Vol#: 31
C 367 unreadable Vol#: 31
C 368 unreadable Vol#: 31
C 369 unreadable Vol#: 31
C 370 unreadable Vol#: 31
C 371 unreadable Vol#: 31
C 372 Jill Filbag Vol#: 31
C 373 unreadable Vol#: 31
C 374 unreadable Vol#: 31
C 375 Larry Kramer Vol#: 31
C 376 unreadable Vol#: 31
C 377 unsigned Vol#: 31
C 378 unreadable Vol#: 31
C 379 unsigned Vol#: 31
C 380 unreadable Vol#: 31
C 381 unreadable Vol#: 31
C 382 unreadable Vol#: 31
C 383 unreadable Vol#: 31
C 384 H. Cultin Vol#: 31
C 385 Nelson Sapod Vol#: 31
C 386 unreadable Vol#: 31
C 387 unreadable Vol#: 31
C 388 unreadable Vol#: 31
C 389 unreadable Vol#: 31
C 390 Karen Weisany Vol#: 31
C 391 Joan Spiering Vol#: 31
C 392 Laurel Ladwig Vol#: 31
C 393 Jeau O'Neile Vol#: 31
C 394 Beu Bronniuto Vol#: 31
C 395 Russell J. Bekins Vol#: 31
C 396 Linda Shepo Vol#: 31
C 397 unreadable Vol#: 31
C 398 unreadable Vol#: 31
C 399 unreadable Vol#: 31
C 400 Therese Cevant Vol#: 31
C 401 Form Letter Count 28 Vol#: 59
EMC 1039 Chris Olson Vol#: 31
EMC 1040 kamala Asher Vol#: 31
EMC 1041 K R Vol#: 31
EMC 1042 Beverly Doran Vol#: 31
EMC 1043 Aimee Noyes Vol#: 31
EMC 1044 Melissa Crandall Vol#: 31
EMC 1045 Carol Crossman Vol#: 31
EMC 1046 Joanne Osborn Vol#: 31
EMC 1047 Connie Cook Vol#: 31
EMC 1048 James Ward Vol#: 31
EMC 1049 number not used Vol#: 31
EMC 1050 karen Feeney Vol#: 31
EMC 1051 Kathryn Cuervo Vol#: 31
EMC 1052 Kathryn Cuervo Vol#: 31
EMC 1053 Rick and Joan Meierotto Vol#: 31
EMC 1054 Rick and Joan Meierotto Vol#: 31
EMC 1055 Cynthia Preston Vol#: 31
EMC 1056 Christine Jennis Vol#: 31
EMC 1057 Elizabeth Read Vol#: 31
EMC 1058 Amy Todisco Vol#: 31
EMC 1059 Meredith Arnow Love Vol#: 31
EMC 1060 C. Ralston Allen Vol#: 31
EMC 1061 C. Ralston Allen Vol#: 31
EMC 1062 Sienna Olin Vol#: 31
EMC 1063 Sienna Olin Vol#: 31
EMC 1064 Christine Pfeffer Vol#: 31
EMC 1065 number not used Vol#: 31
EMC 1066 Steve Torma Vol#: 31
EMC 1067 number not used Vol#: 31
EMC 1068 George Schroeder Vol#: 31
EMC 1069 number not used Vol#: 31
EMC 1070 Sara Scoles Vol#: 31
EMC 1071 Julia Sathler Vol#: 31
EMC 1072 Mary Sipple Vol#: 31
EMC 1073 David Charbonneau Vol#: 31
EMC 1074 Julia Olmstead Vol#: 31
EMC 1075 James C. Sweeton Vol#: 31
EMC 1076 Billie L. Lee Vol#: 31
EMC 1077 number not used Vol#: 31
EMC 1078 Hollis Watkins Vol#: 31
EMC 1079 Vanessa Boer Vol#: 31
EMC 1080 Thomas G. Kuzma, Jr. Vol#: 31
EMC 1081 Dana Davis Vol#: 31
EMC 1082 Cynthia Iberg Vol#: 31
EMC 1083 James & Andrea Thomas Vol#: 31
EMC 1084 Chel Christopher Vol#: 31
EMC 1085 Carolyn Vadala Vol#: 31
EMC 1086 Diane Denby Vol#: 31
EMC 1087 Beverly Rich Vol#: 31
EMC 1088 Daniel John Yakoubian, Esq. Vol#: 31
EMC 1089 number not used Vol#: 31
EMC 1090 Paul Harrison Vol#: 31
EMC 1091 Gary Hecker Vol#: 31
EMC 1092 Meryl R. Miller Vol#: 31
EMC 1093 Doug Hunt Vol#: 31
EMC 1094 Anya Neher Vol#: 31
EMC 1095 number not used Vol#: 31
EMC 1096 Emily Cecil Vol#: 31
EMC 1097 Emily Cecil Vol#: 31
EMC 1098 Trish Mulligan Vol#: 31
EMC 1099 Trish Mulligan Vol#: 31
EMC 1100 Shari Wildschutte Vol#: 31
00N-1666 Abbreviated New Drug Application Regulations; Patent & Exclu
N 2 Vol#: 1
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 9620 Form Letters count 123 Vol#: 726
C 9621 Ursula Perrin Vol#: 727
C 9622 Lynne Mitchell Vol#: 727
C 9623 Noel Ward Vol#: 727
C 9624 Gail Emily Roth Vol#: 727
C 9625 Dan Hughes Vol#: 727
C 9626 Denise Jameson Vol#: 727
C 9627 Christopher P Gronlund Vol#: 727
C 9628 Anthony Kostiner Vol#: 727
C 9629 a concerned citizen Vol#: 727
C 9630 Larry Pace Vol#: 727
C 9631 Ken Bireta Vol#: 727
C 9632 Cathy Burgoyne Vol#: 727
C 9633 Barbara Edmonds Vol#: 727
C 9634 Revis Pruette Vol#: 727
C 9635 Ed Trunck Vol#: 727
C 9636 George Riley Vol#: 727
C 9637 Jean Nordby Vol#: 727
C 9638 Sophia Suhu Vol#: 727
C 9639 Zita Frederic Vol#: 727
C 9640 Christopher Gronlund Vol#: 727
C 9641 Fumiko Futamura Vol#: 727
C 9642 Yolanda Villafana Vol#: 727
C 9643 toni Wiebe Vol#: 727
C 9644 Randall Hartman Vol#: 727
C 9645 Nancy Ward & Phil Hardy Vol#: 727
C 9646 Paul Fiscella Vol#: 727
C 9647 Frederick Chapman Vol#: 727
C 9648 Dennis Ritterholz Vol#: 727
C 9649 Christine Lavigna Vol#: 727
C 9650 Dusty Bunker Vol#: 727
C 9651 Andrew Hagen Vol#: 727
C 9652 Jenelda Dittrich Vol#: 727
C 9653 Desdea Dawning Vol#: 727
C 9654 Uri Strauss Vol#: 727
C 9655 Lisa lawrence Vol#: 727
C 9656 Julie Benyo Vol#: 727
C 9657 Sarah Jones Vol#: 727
C 9658 Arthur Dutton Vol#: 727
C 9659 Pinky Jane Pan Vol#: 727
C 9660 George Kaminsky Vol#: 727
C 9661 Laura Larkin Vol#: 727
C 9662 Hilary Delaney Vol#: 727
C 9663 Barbara Hensley Vol#: 727
C 9664 Deborah Jabs Vol#: 727
C 9665 Marcel Patrick Vol#: 727
C 9666 Renee Patti Vol#: 727
C 9667 David Dodds Vol#: 727
C 9668 Lynnette Ewoldt Vol#: 727
C 9669 Andre Beller Vol#: 727
C 9670 Caraleigh Holverson Vol#: 727
C 9671 Dabing Zhang Vol#: 727
C 9672 Anne Costello Vol#: 727
C 9673 Carrie Baker Vol#: 727
C 9674 Jonna K Slade Vol#: 727
C 9675 Jonna K Slade Vol#: 727
C 9676 Martha Austin Vol#: 727
C 9677 Penny Jacobs Vol#: 727
C 9678 Tamara English Vol#: 727
C 9679 Nicole Tami McNeill Vol#: 727
00P-1550 Approve ANDA for Cefuroxime Axetil Products
LET 2 HFD-1 to Glaxo Wellcome Vol#: 2
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt
C 9 Gerald E. Vermette, D.D.S., F.A.G.D. Vol#: 1
C 10 David S. Banks, D.D.S. Vol#: 1
C 11 Doris Robinson Vol#: 1
EMC 22 Diane Peterson Vol#: 1
EMC 23 Ann Lygas Vol#: 1
EMC 24 Dr. Catherine Saltzman Vol#: 1
EMC 25 Suzann Peters Vol#: 1
00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants
PDN 1 HFZ-1 to Associated Neurological Disorde Vol#: 1
01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi
C 3 Gambro BCT, Inc. Vol#: 1
C 4 University of Iowa Health Care Vol#: 1
C 5 University of Michian Hospitals Vol#: 1
C 6 Mayo Clinic Vol#: 1
C 7 Department of Defense Vol#: 1
C 8 The Blood Center of Central Iowa Vol#: 1
01P-0169 Access & Safe Distribution of Alosetron
ACK 1 HFA-305 Vol#: 1
CP 1 Lotronex Action Group Vol#: 1