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 January 18, 2001

TABLE OF CONTENTS

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93N-0372 Medical Devices; Hearing Aid Requirements *
94S-0120 510K Substantially Equivalent List *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
00N-1665 Consumer Roundtable; Notice of Meeting *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

93N-0372 Medical Devices; Hearing Aid Requirements

C 4988 Jester's Hearing Aid Center Vol#: 113

C 4989 Julia Nettles Vol#: 113

C 4990 George Kingston Vol#: 113

C 4991 Area Hearing Center Vol#: 113

C 4992 Constance F. Park Vol#: 113

C 4993 Beltone Vol#: 113

C 4994 Beltone Vol#: 113

C 4995 Beltone Vol#: 113

C 4996 Larry Daffron Vol#: 113

C 4997 New Hearing-Aid Sales & Service Vol#: 113

C 4998 Keech Hearing Services Vol#: 113

C 4999 Keech Hearing Services Vol#: 113

C 5000 Virginia Cardone Vol#: 113

C 5001 Pat Finlayson Vol#: 113

C 5002 Sears Miracle Ear Vol#: 113

C 5003 Beltone Vol#: 113

C 5004 Kelso Jones Vol#: 113

C 5005 Danny & Jeffy Neuman Vol#: 113

C 5006 Frank Chrencik Vol#: 113

C 5007 Summit Hearing Aid Center Vol#: 113

C 5008 Harold L. Griffin, M.D., P.A. Vol#: 113

C 5009 Taylor's Advanced Hearing Systems Vol#: 113

94S-0120 510K Substantially Equivalent List

LST 102 Cumulative 510K, January - December 2000 Vol#: 24

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

C 3348 Karen J. Brown Vol#: 106

C 3349 Lori Sklar Vol#: 106

C 3350 Mrs. Dorothy Finger Vol#: 106

C 3351 Mr. & Mrs. Adolfo Lopez Vol#: 106

C 3352 Maryse Leland Vol#: 106

C 3353 Barbara Matthes Vol#: 106

C 3354 Mrs. Traude Buckland Vol#: 106

C 3355 Mrs. Roy Weintraub Vol#: 106

C 3356 Wyvone Harris Vol#: 106

C 3357 G. Cubillo Vol#: 106

C 3358 FARM, Farm Animal Reform Movement Vol#: 106

C 3359 Patricia E. Culver Vol#: 106

C 3360 Jennifer Shallow Vol#: 106

C 3361 S. M. (Sylvia) Bancroft Vol#: 106

C 3362 Janet Fajardo Vol#: 106

C 3363 Carrol McDonald Vol#: 106

C 3364 Envoy Entertainment Vol#: 106

C 3365 Lana J. Luhm Vol#: 106

C 3366 Shannon R. Robinson Vol#: 106

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 76 Seth Ackerman Vol#: 36

EMC 77 Lorie Kellog Vol#: 36

EMC 78 Rhiannon Thomas Vol#: 36

EMC 79 Gregg Ury Vol#: 36

EMC 80 Lynn Schmeidler Vol#: 36

EMC 81 Lucie Heisler Vol#: 36

EMC 82 Craig MacCorkle Vol#: 36

EMC 83 Amy Hutchinson Vol#: 36

EMC 84 Catherine Muller Vol#: 36

EMC 85 Anne Viebig Vol#: 36

EMC 86 Jarrett King Vol#: 36

98V-0682 Laser light show projection

VRA 2 HFZ-340 to The Planning Stage Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16878 Kristin Dwyer Vol#: 487

C 16879 Ruth M Palazzo Vol#: 487

C 16880 Norma Hubbard Vol#: 487

C 16881 Judy Cox Vol#: 487

C 16882 Joan H Groome Vol#: 487

C 16883 James D Williams Jr Vol#: 487

C 16884 Bob Gilbert Vol#: 487

C 16885 Judy Goodrobb Vol#: 487

C 16886 Mary S Ewan Vol#: 487

C 16887 Ellen Toderbach Vol#: 487

C 16888 Flavio & Tatjana Chamis Vol#: 487

C 16889 Judith Patrick Vol#: 487

C 16890 Frances Stevens Vol#: 487

C 16891 John & Sue Gremmer Vol#: 487

C 16892 Lynn R Thomas Vol#: 487

C 16893 Niki Thane Vol#: 487

C 16894 Nancy Thomas Vol#: 487

C 16895 Dee Yorke Vol#: 487

C 16896 Kathleen M Thompson Vol#: 487

C 16897 Hazel Minnich Vol#: 487

C 16898 Celia Grove Vol#: 487

C 16899 Norman Caulfield Vol#: 487

C 16900 Donna R Landis Vol#: 487

C 16901 Susan D Roberts Vol#: 487

C 16902 Johanna Rohde Vol#: 487

C 16903 Janet S Mayer Vol#: 487

C 16904 Marianne Anderson Vol#: 487

C 16905 Naomi T Hansen Vol#: 487

C 16906 Gena Paavola Vol#: 487

C 16907 Marianne Shea Vol#: 487

C 16908 Marie Martinez Vol#: 487

C 16909 Jean L Baker Vol#: 487

C 16910 Betty B Preston Vol#: 487

C 16911 Chris Forrest Vol#: 487

C 16912 Shirley A Burgess Vol#: 487

C 16913 Dale Morrow Vol#: 487

C 16914 Lynne Paul Vol#: 487

C 16915 Wendell Midkiff Vol#: 487

C 16916 Suzanne Claire Vol#: 487

C 16917 Clifford & Angela King Vol#: 487

C 16918 Bobby Ray Wood Vol#: 487

C 16919 Neita Blackmer Vol#: 487

C 16920 Anne McCourtie Vol#: 487

C 16921 Linda Riechel Vol#: 487

C 16922 Carmen L Skrine Vol#: 487

C 16923 Carol L Hanby Vol#: 487

C 16924 Anu Koiv Vol#: 487

C 16925 M J Tinges Vol#: 487

C 16926 Martha Pollack Velma Meeky & G Van Kirk Vol#: 487

C 16927 Alice Armitage Vol#: 487

C 16928 William M Seymour Vol#: 487

C 16929 Harry Boling Vol#: 487

C 16930 Jane M Frisch Vol#: 487

C 16931 Paul Mandell Vol#: 487

C 16932 Adair Delamater Vol#: 487

C 16933 Leslie Yuenger Vol#: 487

C 16934 Charles C Shuffield Vol#: 487

C 16935 Ann Lorimer Vol#: 487

00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

ANS 1 HFV-1 to Bayer Corporation Vol#: 18

C 96 Dewey F. Bensenhaver,M.D.,Becky C. Harma Vol#: 18

C 97 Randall O. Shipe Vol#: 18

C 98 Joe Huffman-Page Vol#: 18

C 99 Daniel Slater Vol#: 18

C 100 Billy W. Moore Vol#: 18

C 101 Bobby McCollum Vol#: 18

C 102 Sean Hildreth Vol#: 18

C 103 Lynn and Donna Housden Vol#: 18

C 104 Robert L. Moran Vol#: 18

C 105 Ronald W. Combs Vol#: 18

C 106 Charlie S. Mills Jr. & Laulitte Mills Vol#: 18

C 107 Christian E. Pate, III Vol#: 18

C 108 Ricard L. Cullers & Louis C. Page, Jr. Vol#: 18

C 109 Katie M. Fox Vol#: 18

C 110 Minnie J. Snyder Vol#: 18

C 111 David E. Turner Vol#: 18

LET 4 Bayer Corporation Vol#: 18

LET 5 Bayer Corporation Vol#: 18

00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio

NPR 1 Vol#: 1

00N-1665 Consumer Roundtable; Notice of Meeting

MM 1 Executive Summary of 12/13/00 meeting Vol#: 1

SP 1 Food Animal Concerns Truct (FACT) Vol#: 1

SP 2 Center for Medical Consumers Vol#: 1

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

C 7872 Emily Leon Vol#: 589

C 7873 Liz Tapia Vol#: 589

C 7874 Pam Learned Vol#: 589

C 7875 Angela Freeman Vol#: 589

C 7876 Bennie Updegroff Vol#: 589

C 7877 Donna Schrub Vol#: 589

C 7878 Paul M. Henderson Vol#: 589

C 7879 John Triplett Vol#: 589

C 7880 Kevin Zarazua Vol#: 589

C 7881 Harvey Castillo Vol#: 589

C 7882 Egor Guryev Vol#: 589

C 7883 Gaddiel Beleche Vol#: 589

C 7884 Nataly Osorio Vol#: 589

C 7885 Charles Brasher Vol#: 589

C 7886 Sebastian Ortego, Jr. Vol#: 589

C 7887 Jeffrey Castillo Vol#: 589

C 7888 Nicholas Lespinasse Vol#: 589

C 7889 Brian Valdez Vol#: 589

C 7890 Leslie Malina Vol#: 589

C 7891 Munezehan Cosic Vol#: 589

C 7892 Efren Jimenez Vol#: 589

C 7893 Natalie Aviles Vol#: 589

C 7894 Bianca Pascascio Vol#: 589

C 7895 Alicia Bradford Vol#: 589

C 7896 Sandie Alvarez Vol#: 589

C 7897 Craig Bell Vol#: 589

C 7898 Marvin Moran Vol#: 589

C 7899 Hadie Cuyan Vol#: 589

C 7900 Kevin Lopez Vol#: 589

C 7901 Alicia Arroyo Vol#: 589

C 7902 Chris Bilancouk Vol#: 589

C 7903 Sedrak Grigoyan Vol#: 589

C 7904 Edward Pineda Vol#: 589

C 7905 Daniel Slores Vol#: 589

C 7906 Katherine Dominguez Vol#: 589

C 7907 Nari Yi Vol#: 589

C 7908 Soo-Yeon Kim Vol#: 589

C 7909 Michael Bosch Vol#: 589

EMC 3886 Heather Spencer Vol#: 589

EMC 3887 Amberly Zijewski Brewer Vol#: 589

EMC 3888 Wanda Stone Vol#: 589

EMC 3889 Jonathan Orlando Vol#: 589

EMC 3890 Erica Gray Vol#: 589

EMC 3891 Marianna Aue Vol#: 589

EMC 3892 Christina Stork Vol#: 589

EMC 3893 David Bourke Vol#: 589

EMC 3894 Liz Bourret Vol#: 589

EMC 3895 Gabe Kircheimer Vol#: 589

EMC 3896 Rebecca Golden Vol#: 589

EMC 3897 Katie Pohmeier Vol#: 589

EMC 3898 Maren Mochizuki Vol#: 589

EMC 3899 Ben Tangalin Vol#: 589

EMC 3900 Heather Abbe Vol#: 589

EMC 3901 Sara Johnson Vol#: 589

EMC 3902 Stephanie Altom Vol#: 589

EMC 3903 Sonia Sola Vol#: 589

EMC 3904 Liz Martin Vol#: 589

EMC 3905 Julia Skinner Vol#: 589

EMC 3906 LaDonna Redmond Vol#: 589

EMC 3907 Barbara Crawford Vol#: 589

EMC 3908 Kathleen A. Bohde Vol#: 589

EMC 3909 Irving Pines Vol#: 589

EMC 3910 Brian Hayes Vol#: 589

EMC 3911 Paul Stitt Vol#: 589

EMC 3912 Roland Oehme Vol#: 589

EMC 3913 Tina Speck Vol#: 589

EMC 3914 Teuta Rexhepi Vol#: 589

EMC 3915 Patricia Weberman Vol#: 589

EMC 3916 Susan Collins Vol#: 589

EMC 3917 Mary Beth Monroe Vol#: 589

EMC 3918 Cassie Wyss Vol#: 589

EMC 3919 Anna Hoffman Vol#: 589

EMC 3920 Katherine Duerr Vol#: 589

EMC 3921 Cynthia Wegner Vol#: 589

EMC 3922 Judy Meyer Vol#: 589

EMC 3923 Lindsey Stevens Vol#: 589

EMC 3924 Barbara Crawford Vol#: 589

EMC 3925 Michael Macicoce Vol#: 589

EMC 3926 Carrie Taylor Vol#: 589

EMC 3927 Beth Logan Vol#: 589

EMC 3928 Catherine Conway Vol#: 589

EMC 3929 Sherry DeVries Vol#: 589

EMC 3930 Adeha Feustel Vol#: 589

EMC 3931 Nicholas Scavdis Vol#: 589

EMC 3932 Karl Sanchez Vol#: 589

EMC 3933 Kelly Arter Vol#: 589

EMC 3934 Alex Hall Vol#: 589

EMC 3935 John D. Clark Vol#: 589

EMC 3936 Judy Finch Vol#: 589

EMC 3937 Lauren Price Vol#: 589

EMC 3938 John Yunker Vol#: 589

EMC 3939 Scott Robertson Vol#: 589

EMC 3940 Marcia Guerrero Vol#: 589

EMC 3941 Barbara Sullivan Vol#: 589

EMC 3942 Eileen McDonough Foster Vol#: 589

EMC 3943 Diane Gordon Vol#: 589

EMC 3944 Mitchel Harper Vol#: 589

EMC 3945 Marshall Fox Vol#: 589

EMC 3946 Betty Taylor Vol#: 589

EMC 3947 Anna Bergmann Vol#: 589

EMC 3948 Kelly Hochendoner Vol#: 589

EMC 3949 Timothy Santoirre Vol#: 589

EMC 3950 Shawn Hebrank Vol#: 589

EMC 3951 Lee-Anne Karcher Vol#: 589

EMC 3952 Chris Trepal Vol#: 589

EMC 3953 Kenneth J. Kowalsky Vol#: 589

EMC 3954 Vijay Saxena Vol#: 589

EMC 3955 Jean Ferris Vol#: 589

EMC 3956 Kory Payne Vol#: 589

EMC 3957 Andrew Mount Vol#: 589

EMC 3958 Cathy Van Maren Vol#: 589

EMC 3959 Valerie Herman-Rodriguez Vol#: 589

EMC 3960 Carl Henderson Vol#: 589

EMC 3961 Michele Pereira Vol#: 589

EMC 3962 Max Wentworth Vol#: 589

EMC 3963 Ms Slepcev Brisbane Vol#: 589

EMC 3964 Jana Zawadzki Vol#: 589

EMC 3965 Dr. Jeffrey Hammersley Vol#: 589

EMC 3966 Kathy Pugh Vol#: 589

EMC 3967 Jenelda Dittrich Vol#: 589

EMC 3968 Joe Uzzle Vol#: 589

EMC 3969 Patrick Witherell Vol#: 589

EMC 3970 Adam S. Hunnicutt Vol#: 589

EMC 3971 Jennie Collingsworth Vol#: 589

EMC 3972 Diane Crowne Vol#: 589

EMC 3973 Eva Schachtl Vol#: 589

EMC 3974 G. Adams Vol#: 589

EMC 3975 Kendall Whelan Vol#: 589

EMC 3976 Gayleen Aguayo Vol#: 589

EMC 3977 Cailtin Irwin Vol#: 589

EMC 3978 Jerry Stogsdill Vol#: 589

EMC 3979 Thomas Grant Vol#: 589

EMC 3980 Chris Mobley Vol#: 589

EMC 3981 Diane Pinto Vol#: 589

EMC 3982 Christopher Howe Vol#: 589

EMC 3983 April Torzewski Vol#: 589

EMC 3984 James Smyth Vol#: 589

EMC 3985 Jennifer Stock Vol#: 589

EMC 3986 Maya Johnson Vol#: 589

EMC 3987 Michelle Forrest Vol#: 589

EMC 3988 K. Dover Vol#: 589

EMC 3989 Martin Wilson Vol#: 589

EMC 3990 Gene Brock Vol#: 589

EMC 3991 Daniel Nesson Vol#: 589

EMC 3992 Rebecca White Vol#: 589

EMC 3993 Christine Mosby Vol#: 589

EMC 3994 Leonard Buschel Vol#: 589

EMC 3995 Linda Kneeland Vol#: 589

EMC 3996 Mark Maynard Vol#: 589

EMC 3997 Organic Consumers Association Vol#: 589

EMC 3998 Shelly Avery Vol#: 589

EMC 3999 Veronica Johnson Vol#: 589

EMC 4000 Kristina M. Gabriel Vol#: 589

EMC 4001 Rosemary Woodruff Vol#: 589

EMC 4002 Judi Saunders Vol#: 589

EMC 4003 Britte Huddleston Vol#: 589

EMC 4004 Ben Yater Vol#: 589

EMC 4005 Cicero Joseph Gilreath Vol#: 589

EMC 4006 Ronald E. Voorhees, MD Vol#: 589

EMC 4007 Julie Rooney Vol#: 589

EMC 4008 Susan Ormelas Vol#: 589

EMC 4009 Typical Ignorant Man Vol#: 589

EMC 4010 M. Gorman Vol#: 589

EMC 4011 Robin Van Tassell Vol#: 589

00V-0791 Laser Light Show

VRA 1 HFZ-340 to Preston Productions, Inc. Vol#: 1

00V-1453 Laser Light Show (Golden Dreams Laser Special Effects)

VRA 1 HFZ-340 to Disneyland Resort Vol#: 1

00V-1590 Laser Light Show

VRA 1 HFZ-340 to Sound Advice Vol#: 1