Food and Drug Administration

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]

DOCKETS ENTERED on April 11, 2000

Table of Contents

(Hyper links are part of the Docket title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE] [ ITEM CODES ]

90P-0201 Optimum size & Style of print to be used to label OTC Drugs *
93N-0372 Medical Devices; Hearing Aid Requirements*
95N-0259 Over the Counter Drug Labeling; Public Hearing*
96N-0420 OTC Human Drugs; Proposed Labeling Requirements*
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1245 ANDA for Nizatidine Capsules, 75mg*
00V-1244 Laser Light Show*
00V-1247 *

90P-0201 Optimum size & Style of print to be used to label OTC Drugs
C 73 Consumer Healthcare Products Association Vol#: 7

93N-0372 Medical Devices; Hearing Aid Requirements

C 3986 Charles Warmkessel Vol#: 70

C 3987 Paul E. Hoey Vol#: 70

C 3988 Edra L. Spilman Vol#: 70

C 3989 Basil V. Deltour Vol#: 70

C 3990 Harry V. Ferster Vol#: 70

C 3991 R.H. Schweinfurth Vol#: 70

C 3992 John Campbell Vol#: 70

C 3993 M.F. Fisher Vol#: 70

C 3994 Elizabeth Hruska Vol#: 70

C 3995 John M. Barrett Vol#: 70

C 3996 Thomas Bates Vol#: 70

C 3997 Robert E. Frasier Vol#: 70

C 3998 Carrol Mitchell Vol#: 70

C 3999 Stanley J. Masson Vol#: 70

C 4000 Herbert R. Waltemath Vol#: 70

C 4001 Edward LT Nawoj Vol#: 70

C 4002 Gladys Washington Vol#: 70

C 4003 Laverne Linnert Vol#: 70

C 4004 William W. Siegel Vol#: 70

C 4005 Martha C. Baer Vol#: 70

C 4006 Jesse E. Daniel Vol#: 70

C 4007 W.E. McNulty Vol#: 70

C 4008 Oren Jones Vol#: 70

C 4009 Linwood Long Vol#: 70

C 4010 Forrest Robbins Vol#: 70

C 4011 Vonda Pyle Vol#: 70

C 4012 Ramona J. Cook Vol#: 70

C 4013 Walter F. Ellis Vol#: 70

C 4014 Gail L. Rominger Vol#: 70

C 4015 Milton H. Montgomery Vol#: 70

C 4016 Jack D. Maddox Vol#: 70

C 4017 Alex P. Leblanc Vol#: 70

C 4018 Roscoe S. Farmey, Jr. Vol#: 70

C 4019 John L. Haas Vol#: 70

C 4020 Fred Bathroy Vol#: 70

C 4021 Carolyn Dawson Vol#: 70

C 4022 Darrell K. Burdge Vol#: 70

C 4023 John McDonald Vol#: 70

C 4024 Bill Pfaff Vol#: 70

C 4025 Mary May Vol#: 70

C 4026 Unsigned Vol#: 70

C 4027 Joseph & Ragney Vol#: 70

C 4028 Ray W. Marshall Vol#: 70

C 4029 Jan R. Beaujon Vol#: 70

C 4030 James E. Shrod Vol#: 70

C 4031 Ruth Laucier Vol#: 70

C 4032 C.H. Overmyer Vol#: 70

C 4033 Pauline Harbolt Vol#: 70

C 4034 W.C. Johnson Vol#: 70

C 4035 Paul McNeill Vol#: 70

C 4036 John P. Wright Vol#: 70

C 4037 Emile Lachambre Vol#: 70

C 4038 Amelia Grether Vol#: 70

C 4039 John Ferry Vol#: 70

C 4040 Tensil Enzor Vol#: 70

C 4041 Carl Hoglin Vol#: 70

C 4042 Joan Stewart Vol#: 70

C 4043 Thomas Roberts Vol#: 70

C 4044 Harold McDonald Vol#: 70

C 4045 Daniel J. LaFon Vol#: 70

C 4046 June Lyons Vol#: 70

C 4047 Harold Wyatt Vol#: 70

C 4048 Robert L. Boaz Vol#: 70

C 4049 R.A. Diek Mader Vol#: 70

C 4050 J. Dalton Reece, Sr. Vol#: 70

C 4051 Vi Holmes Vol#: 70

C 4052 Wendell Litteral Vol#: 70

C 4053 Evelyn Truitt Vol#: 70

C 4054 Barbara A. Sommer Vol#: 70

C 4055 Louise H. Jones Vol#: 70

C 4056 V.L. Metcalf Vol#: 71

C 4057 Cabell F. Cobbs Vol#: 71

C 4058 E.B. Saurer Vol#: 71

C 4059 Leonard Bullis Vol#: 71

C 4060 Gene Liebeutritt Vol#: 71

C 4061 Roger Ingelson Vol#: 71

C 4062 Allen J. Havemeir Vol#: 71

C 4063 Margaret Halligan Vol#: 71

C 4064 Monte Previti Vol#: 71

C 4065 Frank R. Skimming Vol#: 71

C 4066 Neil I. Brohm Vol#: 71

C 4067 Stanley Waryas Vol#: 71

C 4068 Alfred McNamara Vol#: 71

C 4069 Edward Rawady Vol#: 71

C 4070 Kari V. Shawver, Jr. Vol#: 71

C 4071 Alfred D. Balsam Vol#: 71

C 4072 Alan Petrucci Vol#: 71

C 4073 Willard Cook Vol#: 71

C 4074 Carol Blount Vol#: 71

C 4075 Roy Fish Vol#: 71

C 4076 Stan Smith Vol#: 71

C 4077 L. Gordon Vol#: 71

C 4078 John Bartholomew Vol#: 71

C 4079 Donald Wilkinson Vol#: 71

C 4080 Wallace Hogan Vol#: 71

C 4081 Amos Higbee Vol#: 71

C 4082 Philip Dixey Vol#: 71

C 4083 Helen Glasby Vol#: 71

C 4084 Ada Faye Sargent Vol#: 71

C 4085 Bob McMahan Vol#: 71

C 4086 Henry A. Lovold Vol#: 71

C 4087 C.W. Bradock Vol#: 71

C 4088 Ray Cannon Vol#: 71

C 4089 Virgil Messer Vol#: 71

C 4090 Buelah Thompson Vol#: 71

C 4091 Ottis Rader Vol#: 71

C 4092 Carl Mills Vol#: 71

C 4093 Bob Lamb Vol#: 71

C 4094 J.B. Spegal Vol#: 71

C 4095 Zora Nell Hathcock Vol#: 71

C 4096 W.D. Harp Vol#: 71

C 4097 Omer Constant Vol#: 71

C 4098 Robert Garraffa Vol#: 71

C 4099 Otto Nelson Vol#: 71

C 4100 Roy E. Jones Vol#: 71

C 4101 James Weekly Vol#: 71

C 4102 Lacy L. Saunders Vol#: 71

C 4103 Ed Mastran Vol#: 71

C 4104 Paul E. Healy Vol#: 71

C 4105 Pearle Patterson Vol#: 71

C 4106 Dorothy Stangeland Vol#: 71

C 4107 Charles Gallo Vol#: 71

C 4108 Ruth Johnson Vol#: 71

C 4109 William G. Hockenberry Vol#: 71

C 4110 Delbert Smook Vol#: 71

C 4111 Arther Larsson Vol#: 71

C 4112 Richard Davis Vol#: 71

C 4113 Clarence A. Diem Vol#: 71

C 4114 D. McGill Vol#: 71

C 4115 Viva M. Piper Vol#: 71

C 4116 Marie Kauppila Vol#: 71

C 4117 Dale Martindale Vol#: 71

C 4118 Emma R. Twito Vol#: 71

C 4119 Orah W. Fry Vol#: 71

C 4120 Leaford Evans Vol#: 71

C 4121 Donald E. Franks, Sr. Vol#: 71

C 4122 John W. Fanning Vol#: 71

C 4123 Ray Tweedy Vol#: 71

C 4124 Sylvia A. Lewis Vol#: 71

C 4125 Gayle Romines Vol#: 71

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

NFR 2 Vol#: 4986

95N-0259 Over the Counter Drug Labeling; Public Hearing

C 20 Consumer Healthcare Products Association Vol#: 12

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

C 1026 CTFA Vol#: 24

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

THESE LINKED COMMENTS DUPLICATE SOME OF THOSE FOR 99D-2638, ALSO BELOW

C 18 The Coalition for Animal Health Vol#: 4

C 19 Clear Springs Foods, Inc Vol#: 4

M 1 NAA, Aquatic Animal Health Committee Vol#: 4

98N-0337 Over the counter human drugs labeling requirements

C 6 CTFA Vol#: 5

99D-2638 Use of Medicated Feeds for Minor Species

C 21 Clear Springs Foods, Inc Vol#: 1

M 1 NAA, Aquatic Animal Health Committe Vol#: 1

99N-2210 Reclassification of Cardiopulmonary Bypass Accessory Equipme

NFR 1 Vol#: 1

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

C 6464 Marilyn J. Henry Vol#: 308

C 6465 Nancy Sargent Vol#: 308

C 6466 Robert L. Manning Vol#: 308

C 6467 Patricia Kreg Vol#: 308

C 6468 David & Edna Weigel Vol#: 308

C 6469 James W. Lee Vol#: 308

C 6470 Sarah & John Petrovic Vol#: 308

C 6471 Tom Wilson Vol#: 308

C 6472 Richard D. Johnson Vol#: 308

C 6473 Mark-Allen Harmon Vol#: 308

C 6474 Emma Rose + 257 signatures Vol#: 308

C 6475 Kristin Pollock + 189 signatures Vol#: 308

C 6476 Peter Tolk Vol#: 308

C 6477 Britt Lord-Jacobsen Vol#: 308

C 6478 Robert L. Manning Vol#: 308

C 6479 Syed Towhid Vol#: 308

C 6480 Joan Tilke Vol#: 308

C 6481 Birute Tribys Vol#: 308

C 6482 Douglas G. Berg Vol#: 308

C 6483 Nancy Tam Vol#: 308

C 6484 LaRae Smith Vol#: 308

C 6485 Sr. Eleanor Uhl Vol#: 308

C 6486 Eva M. Smith Vol#: 308

C 6487 Chaz Schatzle Vol#: 308

C 6488 Claire B. Feder Vol#: 308

C 6489 Lillian Rhoden Vol#: 308

C 6490 Joan MacKeigan Vol#: 308

C 6491 William W. Atkins Vol#: 308

C 6492 Marie Nicholls Vol#: 308

C 6493 C. Matchett Vol#: 308

C 6494 Dr. Hugh H. Ilhs Vol#: 308

C 6495 Charles P. Fisk Vol#: 308

C 6496 Michael Merescere Vol#: 308

C 6497 Barbara W. Bacon Vol#: 308

C 6498 Marlin Engelman Vol#: 308

C 6499 Elizabeth Dodge Vol#: 308

C 6500 Jacqueline Pine Vol#: 308

C 6501 Shirley Oxarart Vol#: 308

C 6502 Marcie Clutter Vol#: 308

C 6503 Cheri Alderman Vol#: 308

C 6504 Susan Ernsdorff Vol#: 308

C 6505 Chicha Aglow Vol#: 308

C 6506 Jeff Voltz Vol#: 308

C 6507 Laura Ticciati Vol#: 308

C 6508 James Wl Lee Vol#: 308

C 6509 Brian Schuler Vol#: 308

C 6510 Alexander G. Schauss Vol#: 308

C 6511 Joan Linney Vol#:

C 6512 Hans Siegenthaler Vol#: 308

C 6513 Irl Stalcup Vol#: 308

C 6514 Christina Wulf Vol#: 309

C 6515 Dorothy Goldfarb Vol#: 309

C 6516 Elfriede Troia-Merchant Vol#: 309

C 6517 Michele Boning-Amy Vol#: 309

C 6518 M. Ann Tutwiler Vol#: 309

C 6519 Nancy Chuda Vol#: 309

C 6520 Anne Hudson Vol#: 309

C 6521 Esther J. Fillar Vol#: 309

C 6522 J. S. Garman Vol#: 309

C 6523 Marian R. Todd Vol#: 309

C 6524 Catherine C. Alexander Vol#: 309

C 6525 Kim Shakleee Vol#: 309

C 6526 Theo Garman Vol#: 309

C 6527 Dorothy Keenan Vol#: 309

C 6528 Mary Kay Brimeyer + 5 signatures Vol#: 309

C 6529 Vivian McQuoid Vol#: 309

C 6530 Oma L. Kortsch Vol#: 309

C 6531 Rick Seaman Vol#: 309

C 6532 Marilyn J. Miss Vol#: 309

C 6533 Dennis Denlinger Vol#: 309

C 6534 Angela J. Huey Vol#: 309

C 6535 Linda Lewis Vol#: 309

C 6536 Jean Jones Vol#: 309

C 6537 Beverly J. Stantial Vol#: 309

C 6538 Richard J. Cannon Vol#: 309

C 6539 Elise McMath Vol#: 309

C 6540 Andrea Wieland Vol#: 309

C 6541 Barbara-Jean Avery Vol#: 309

C 6542 Cynthia Camp Vol#: 308

C 6543 Warren Linney Vol#: 309

C 6544 Jeff Aldrich Vol#: 309

C 6545 no signature Vol#: 309

C 6546 Brad Smith Vol#: 309

C 6547 Melinda S. Walsh Vol#: 309

C 6548 Vivienne Lenk Vol#: 309

C 6549 Rowland M. Orum Vol#: 309

C 6550 Colette Corwin Vol#: 309

C 6551 Seana Lowe Vol#:

C 6552 Linda Walsh Vol#: 309

C 6553 Orli Loewenberg Vol#: 309

C 6554 Dr. Sally Haines Vol#: 309

C 6555 Jon Whitman Vol#: 309

C 6556 Garrett Jones Vol#: 309

C 6557 Sara Colburn Vol#: 309

C 6558 David Preis Vol#: 309

C 6559 Jody Slocum & Kurt Bicton Vol#: 309

C 6560 Laurie Bryant Vol#: 309

C 6561 Nick Bryant Vol#: 309

C 6562 Angela Tangnetti Vol#: 309

C 6563 Josie Pate Vol#: 309

C 6564 Judy Nachenky Vol#: 309

C 6565 Premena Vol#: 309

C 6566 Doris Compton Vol#: 309

C 6567 Kathleen King Vol#: 309

C 6568 Katrina Nazzal Vol#: 309

C 6569 Tracey B. Clarkson Vol#: 309

C 6570 M. Dodgers Vol#: 309

C 6571 Jean M. Tucker Vol#: 309

C 6572 G. Edsall Vol#: 309

C 6573 Dwight K. Harding Vol#: 309

C 6574 Claudie Cohan Vol#: 309

C 6575 Anne Fuller Vol#: 309

C 6576 Reni Roberts Vol#: 309

C 6577 Lea Dalton Vol#: 309

C 6578 Julie Dole Vol#: 309

C 6579 Barbara Tomlinson Vol#: 309

C 6580 Harry Millennium Vol#: 309

C 6581 Peter Byrne Vol#: 309

C 6582 Jennifer M. Zator Vol#: 309

C 6583 Edwin R. Wagner Vol#: 309

C 6584 Donald L. Bruestle Vol#: 309

C 6585 A. Brendel Vol#: 309

C 6586 Suzi Megles Vol#: 309

C 6587 Phyllis S. Brown Vol#: 309

C 6588 Claire B. Ludlow Vol#: 309

C 6589 D. Kirksey Vol#: 309

C 6590 Carol Boss Vol#: 309

C 6591 Patsy A. Kelley Vol#: 309

C 6592 Odaline Rowe Vol#: 309

C 6593 Robert A. Rhodes Vol#: 309

C 6594 Beverly A. Hicks Vol#: 309

C 6595 Leigh Dukas Vol#: 309

C 6596 Robert & Joann Ross Vol#: 309

C 6597 no signature Vol#: 309

C 6598 Kathleen Blake Vol#: 309

C 6599 G. A. Smith Vol#: 309

C 6600 Sylvia Shih Vol#: 309

C 6601 Andrea Lakeos Vol#: 309

C 6602 Connie Sloan Cathcart Vol#: 309

C 6603 Gorhard Georgi Vol#: 309

C 6604 Katherine Brewer Vol#: 310

C 6605 Judy Winzeler Vol#: 310

C 6606 Ruth Louise Granick Vol#: 310

C 6607 Stephanie Mulqueen Vol#: 310

C 6608 Adelaide M. Gallagher Vol#: 310

C 6609 Arden Buck Vol#: 310

C 6610 Virginia Robbins Vol#: 310

C 6611 Ron Peterson Vol#: 310

C 6612 Valerie Peters Vol#: 310

C 6613 Joan Driscoll-Kelly Vol#: 310

C 6614 Sister Ann Rutan Vol#: 310

C 6615 Kim A. Woodbridge Vol#: 310

C 6616 Stephen C. Evans Vol#: 310

C 6617 Anne Manvel Vol#: 310

C 6618 Marina Moevs Vol#: 310

C 6619 Delores Witkowski Vol#: 310

C 6620 Ken & Milane Corr Vol#: 310

C 6621 Daniel G. Tulenko Vol#: 310

C 6622 Louise Chestnut Vol#: 310

C 6623 Jeffrey Mear Vol#: 310

C 6624 Sue Mitrovic Vol#: 310

C 6625 Kevin M. McCarron Vol#: 310

C 6626 Jennifer D'Amato Vol#: 310

C 6627 Debora Rognosky Vol#: 310

C 6628 Deborah Westergreen Vol#: 310

C 6629 Stephanie J. Weigel Vol#: 310

C 6630 Marian Jane Porter Vol#: 310

C 6631 M. R. Fulks Vol#: 310

C 6632 Marya Zanders Vol#: 310

C 6633 Janeen Wheeler Vol#: 310

C 6634 James K. Hosley Vol#: 310

C 6635 William S. Heisler, Jr Vol#: 310

C 6636 Anthony Del Plato Vol#: 310

C 6637 Robert & Carol DeClue Vol#: 310

C 6638 Matthew Sweigart + 13 signatures Vol#: 310

C 6639 Shannon Nelson Vol#: 310

C 6640 Bruce Joitel Vol#: 310

C 6641 Cheryl Paulos Vol#: 310

C 6642 Jim & Rae Smith Vol#: 310

C 6643 Randy Moehn Vol#: 310

C 6644 Diane Parry Vol#: 310

C 6645 Barbara J. Martin Vol#: 310

C 6646 T. G. Barnhill Vol#: 310

C 6647 Joan F. Hertzberg Vol#: 310

C 6648 Stephanie R. Thompson Vol#: 310

C 6649 David Engel Vol#: 310

C 6650 Lou Pendleton Vol#: 310

C 6651 Jon F. Renner Vol#: 310

C 6652 Ben Gertner Vol#: 310

EMC 1953 Sal Caldrone Vol#: 308

EMC 1954 Marie H. Farrington Vol#: 308

EMC 1955 Brooke Cardin Vol#: 308

EMC 1956 Vicky Wolfhard Vol#: 308

EMC 1957 Camille Hall Vol#: 308

EMC 1958 Jody L. Logan Vol#: 308

EMC 1959 Julie du Bois Vol#: 308

EMC 1960 Myra Perala Vol#: 308

EMC 1961 Suzanne Weeldreyer Vol#: 308

EMC 1962 Deborah Johnson Vol#: 308

EMC 1963 Eleanor Mahood Vol#: 308

EMC 1964 Greg Makepeace Vol#: 308

EMC 1965 Kim Liu Vol#: 308

EMC 1966 James Adams Vol#: 308

EMC 1967 Derick Van Schoonhoven Vol#: 308

EMC 1968 Arthur Kennedy Vol#: 308

EMC 1969 Susan Fay Vol#: 308

EMC 1970 Helen Fogarty Vol#: 308

EMC 1971 Bob Rueckert Vol#: 308

EMC 1972 Sherry L. Berger Vol#: 308

EMC 1973 Kim Perl Vol#: 308

EMC 1974 Marlene Dick Vol#: 308

EMC 1975 Thomas A. Natiello Vol#: 308

EMC 1976 Evonne Herkert Vol#: 308

EMC 1978 Maureen Sperry Vol#: 308

EMC 1979 Rachel Gibson Vol#: 308

00H-0313 Civil Money Penalty;Lakehead Oil Company Inc,dba Lakehead Am