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 March 27, 2002

TABLE OF CONTENTS

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81N-0033 Oral Health Care Drug Products for OTC Human Use *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
01D-0584 Reduce the Risk of Transmission of HIV-1 & HCV *
02D-0049 Disclosure of Conflicts of Interest for Special Gov, Employe *

81N-0033 Oral Health Care Drug Products for OTC Human Use

LET 50 HFD-560 to Consumer Healthcare Products Vol#: 70

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

CA 295 Melissa LaBerre Vol#: 4990

CA 296 Rachelle Boudreau Vol#: 4990

CA 297 Dee Banta Vol#: 4990

CA 298 Pamela J. Burking Vol#: 4990

CA 299 Jacqueline Vidune Vol#: 4990

CA 300 Robert M. Harlian Vol#: 4990

CA 301 Ronald A. Marwitz Vol#: 4990

CA 302 Richard Messiz Vol#: 4990

CA 303 Travis A. Jacome Vol#: 4990

CA 304 Joel Schaffer Vol#: 4990

CA 305 Elizabeth Anne Ingram Vol#: 4990

CA 306 Kelly Drake Vol#: 4990

CA 307 Armand R. Boncal Vol#: 4990

CA 308 William L. Meadows Vol#: 4990

CA 309 Douglas K. Emmond Vol#: 4990

CA 310 Norah J. Keough Vol#: 4990

CA 311 Gary W. Slentz, II Vol#: 4990

CA 312 Gary W. Slentz Vol#: 4990

CA 313 Micheal P. Porter Vol#: 4990

CA 314 Patricia L. Porter Vol#: 4990

CA 315 Kevin F. Teer Vol#: 4990

CA 316 Linda L. Hobson Vol#: 4990

CA 317 Arnold Matthews Vol#: 4990

CA 318 Don R. Thomas Vol#: 4990

CA 319 James Moraco Vol#: 4990

CA 320 Albert L. Root, IV Vol#: 4990

CA 321 Pat Thomas Vol#: 4990

CA 322 Thomas F. Lefevre, Jr. Vol#: 4990

CA 323 Anthony J. Tucker Vol#: 4990

CA 324 Kerri A. Proulx Vol#: 4990

CA 325 Micheal L. Dules Vol#: 4990

CA 326 Pete Niblett Vol#: 4990

CA 327 Richard F. Saunders Vol#: 4990

CA 328 Elly Eshback Vol#: 4990

CA 329 Matt Campagna Vol#: 4990

CA 330 Albert Benjamin Vol#: 4990

CA 331 Kenneth Szwajda Vol#: 4990

CA 332 C. Fiske Campbell Vol#: 4990

CA 333 Dianne Detwiler Vol#: 4990

CA 334 Dave Richardson Vol#: 4990

CA 335 Jim Bennett Vol#: 4990

CA 336 Mary Ann Cope Vol#: 4990

CA 337 Thomas Lello Vol#: 4990

CA 338 Curtis Carmicheal Vol#: 4990

CA 339 Dorothy Hackett Vol#: 4990

CA 340 Sam Hackett Vol#: 4990

CA 341 James Pecrone Vol#: 4990

CA 342 Dale A. Imes Vol#: 4990

CA 343 Dave Wellain Vol#: 4990

CA 344 Ronald A. Zito Vol#: 4990

CA 345 Alan Salisbury Vol#: 4990

CA 346 Raymond G. Roeder Vol#: 4990

CA 347 Joan M. Reger Vol#: 4990

CA 348 Harry W. Cope, Jr. Vol#: 4990

CA 349 Micheal Cahill Vol#: 4990

CA 350 Fred Swanson Vol#: 4990

CA 351 Paul R. Hart Vol#: 4990

CA 352 Jerry W. Taylor Vol#: 4990

CA 353 Ginger C. Bauguss Vol#: 4990

CA 354 Andy Dickerson Vol#: 4990

CA 355 Forrest M. Zoslocki Vol#: 4990

CA 356 Andrea Diaz Vol#: 4990

CA 357 Sargon Yonan Vol#: 4990

CA 358 Melissa Dillon Vol#: 4990

CA 359 Peter Bonalez Vol#: 4990

CA 360 Nicole Orozco Vol#: 4990

CA 361 Jackie Sullivan Vol#: 4990

CA 362 Leonard R. Howard, M. D. Vol#: 4990

CA 363 Barrer Vol#: 4990

CA 364 April A. Baker Vol#: 4990

CA 365 Sandra S. Buck Vol#: 4990

CA 366 Dana Morgan Vol#: 4990

CA 367 Cecelia S. Rowden Vol#: 4990

CA 368 Susan A. Neely Vol#: 4990

CA 369 Margaret Seron Vol#: 4990

CA 370 Mike Coher Vol#: 4990

CA 371 Alice Cruikshank Vol#: 4990

CA 372 Frances Yanisch Vol#: 4990

CA 373 Leticia Camarena Vol#: 4990

CA 374 Becky Bravo Vol#: 4990

CA 375 Victor G. Grossman Vol#: 4990

CA 376 S. Bauer Bofram Vol#: 4990

CA 377 E. C. Rosenow Vol#: 4990

CA 378 Terry Sokoloff Vol#: 4990

CA 379 James Patrick Kiswan, Ph. D. Vol#: 4990

CA 380 Kristen Gucca Vol#: 4990

CA 381 Nancy M. Rhodes Vol#: 4990

CA 382 Bill Hannan Vol#: 4990

CA 383 Sterling W. McHarg Vol#: 4990

CA 384 Scott Z. Meyer Vol#: 4990

CA 385 Lynda F. Smith Vol#: 4990

CA 386 Bob Cullen Vol#: 4990

CA 387 Cheryl Petersen Vol#: 4990

CA 388 Alice Gold Vol#: 4990

CA 389 Karen Brodlen Vol#: 4990

CA 390 Mary J. McMurray Vol#: 4990

CA 391 S. O. Copa Vol#: 4990

CA 392 Jane J. Colver Vol#: 4990

CA 393 Edna Leake Vol#: 4990

CA 394 Robin Sloan Vol#: 4990

CA 395 Judy Roaf Vol#: 4990

97P-0130 Require Percentage Ingredient Labeling

C 162 Mary Morningstar Vol#: 5

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 8738 Indiana Botanic Gardens Inc Vol#: 66

LET 8739 Indiana Botanic Gardens Inc Vol#: 66

LET 8740 PhytoPharmica Natural Medicines Vol#: 66

LET 8741 PhytoPharmica Natural Medicines Vol#: 66

LET 8742 Enzymatic Therapy Natural Medicines Vol#: 66

LET 8743 Enzymatic Therapy Natural Medicines Vol#: 66

LET 8744 Enzymatic Therapy Natural Medicines Vol#: 66

LET 8745 PhytoPharmica Natural Medicines Vol#: 66

LET 8746 Earthrise Nutritionals Inc Vol#: 66

LET 8747 NBTY Inc Vol#: 66

LET 8748 NBTY Inc Vol#: 66

LET 8749 NBTY Inc Vol#: 66

LET 8750 NBTY Inc Vol#: 66

LET 8751 NBTY Inc Vol#: 66

LET 8752 NBTY Inc Vol#: 66

LET 8753 NBTY Inc Vol#: 66

LET 8754 NBTY Inc Vol#: 66

LET 8755 NBTY Inc Vol#: 66

LET 8756 NBTY Inc Vol#: 66

LET 8757 NBTY Inc Vol#: 66

LET 8758 NBTY Inc Vol#: 66

LET 8759 NBTY Inc Vol#: 66

LET 8760 NBTY Inc Vol#: 66

LET 8761 Mycology Research Laboratories Ltd Vol#: 66

LET 8762 Bayer Corporation, Consumer Care Divisio Vol#: 66

LET 8763 Arkion Life Sciences LLC Vol#: 66

LET 8764 Vital Basics Inc Vol#: 66

LET 8765 Earthrise Nutritionals Inc Vol#: 66

LET 8766 Jamieson Laboratories Vol#: 66

LET 8767 Rexall Sundown Inc Vol#: 66

LET 8768 Rexall Sundown Inc Vol#: 66

LET 8769 Rexall Sundown Inc Vol#: 66

LET 8770 Rexall Sundown Inc Vol#: 66

LET 8771 Rexall Sundown Inc Vol#: 66

LET 8772 Rexall Sundown Inc Vol#: 66

LET 8773 Rexall Sundown Inc Vol#: 66

LET 8774 Rexall Sundown Inc Vol#: 66

LET 8775 Rexall Sundown Inc Vol#: 66

LET 8776 Rexall Sundown Inc Vol#: 66

LET 8777 Rexall Sundown Inc Vol#: 66

LET 8778 Rexall Sundown Inc Vol#: 66

LET 8779 Rexall Sundown Inc Vol#: 66

LET 8780 Rexall Sundown Inc Vol#: 66

LET 8781 Rexall Sundown Inc Vol#: 66

LET 8782 Rexall Sundown Inc Vol#: 66

LET 8783 Rexall Sundown Inc Vol#: 66

LET 8784 Rexall Sundown Inc Vol#: 66

LET 8785 Rexall Sundown Inc Vol#: 66

LET 8786 Rexall Sundown Inc Vol#: 66

LET 8787 Rexall Sundown Inc Vol#: 66

LET 8788 Rexall Sundown Inc Vol#: 66

LET 8789 Rexall Sundown Inc Vol#: 66

LET 8790 Rexall Sundown Inc Vol#: 66

LET 8791 Rexall Sundown Inc Vol#: 66

LET 8792 Rexall Sundown Inc Vol#: 66

LET 8793 Rexall Sundown Inc Vol#: 66

LET 8794 Rexall Sundown Inc Vol#: 66

LET 8795 Rexall Sundown Inc Vol#: 66

LET 8796 Rexall Sundown Inc Vol#: 66

LET 8797 Rexall Sundown Inc Vol#: 66

LET 8798 Rexall Sundown Inc Vol#: 66

LET 8799 Rexall Sundown Inc Vol#: 66

LET 8800 Rexall Sundown Inc Vol#: 66

LET 8801 Rexall Sundown Inc Vol#: 66

LET 8802 Rexall Sundown Inc Vol#: 66

LET 8803 Rexall Sundown Inc Vol#: 66

LET 8804 Rexall Sundown Inc Vol#: 66

LET 8805 Rexall Sundown Inc Vol#: 66

LET 8806 Rexall Sundown Inc Vol#: 66

LET 8807 Rexall Sundown Inc Vol#: 66

LET 8808 Rexall Sundown Inc Vol#: 66

LET 8809 Rexall Sundown Inc Vol#: 66

LET 8810 Rexall Sundown Inc Vol#: 66

LET 8811 Rexall Sundown Inc Vol#: 66

LET 8812 Rexall Sundown Inc Vol#: 66

LET 8813 Rexall Sundown Inc Vol#: 66

LET 8814 Rexall Sundown Inc Vol#: 66

LET 8815 Rexall Sundown Inc Vol#: 66

LET 8816 Perrigo Company of South Carolina Vol#: 66

LET 8817 Perrigo Company of South Carolina Vol#: 66

LET 8818 Perrigo Company of South Carolina Vol#: 66

LET 8819 Perrigo Company of South Carolina Vol#: 66

LET 8820 Perrigo Company of South Carolina Vol#: 66

LET 8821 Perrigo Company of South Carolina Vol#: 66

LET 8822 Pharmanex Vol#: 66

LET 8823 Enzymatic Therapy Natural Medicines Vol#: 66

LET 8824 PhytoPharmica Natural Medicines Vol#: 66

LET 8825 Pharmanex Vol#: 66

LET 8826 Advitech Solutions Inc Vol#: 66

LET 8827 NBTY Inc Vol#: 66

LET 8828 NBTY Inc Vol#: 66

LET 8829 NBTY Inc Vol#: 66

LET 8830 NBTY Inc Vol#: 66

LET 8831 NBTY Inc Vol#: 66

LET 8832 NBTY Inc Vol#: 66

LET 8833 NBTY Inc Vol#: 66

LET 8834 NBTY Inc Vol#: 66

LET 8835 NBTY Inc Vol#: 66

LET 8836 NBTY Inc Vol#: 66

LET 8837 NBTY Inc Vol#: 66

LET 8838 NBTY Inc Vol#: 66

LET 8839 NBTY Inc Vol#: 66

LET 8840 NBTY Inc Vol#: 66

LET 8841 NBTY Inc Vol#: 66

LET 8842 NBTY Inc Vol#: 66

LET 8843 NBTY Inc Vol#: 66

LET 8844 NBTY Inc Vol#: 66

LET 8845 NBTY Inc Vol#: 66

LET 8846 NBTY Inc Vol#: 66

LET 8847 NBTY Inc Vol#: 66

LET 8848 NBTY Inc Vol#: 66

LET 8849 NBTY Inc Vol#: 66

LET 8850 NBTY Inc Vol#: 66

LET 8851 NBTY Inc Vol#: 66

LET 8852 NBTY Inc Vol#: 66

LET 8853 NBTY Inc Vol#: 66

LET 8854 NBTY Inc Vol#: 66

LET 8855 NBTY Inc Vol#: 66

LET 8856 NBTY Inc Vol#: 66

LET 8857 NBTY Inc Vol#: 66

LET 8858 NBTY Inc Vol#: 66

LET 8859 NBTY Inc Vol#: 66

LET 8860 NBTY Inc Vol#: 66

LET 8861 NBTY Inc Vol#: 66

LET 8862 NBTY Inc Vol#: 66

LET 8863 NBTY Inc Vol#: 66

LET 8864 NBTY Inc Vol#: 66

LET 8865 NBTY Inc Vol#: 66

LET 8866 NBTY Inc Vol#: 66

LET 8867 NBTY Inc Vol#: 66

LET 8868 NBTY Inc Vol#: 66

LET 8869 NBTY Inc Vol#: 66

LET 8870 NBTY Inc Vol#: 66

LET 8871 NBTY Inc Vol#: 66

LET 8872 Tobak's Health Products Vol#: 66

LET 8873 Perrigo Company of South Carolina Vol#: 66

LET 8874 Perrigo Company of South Carolina Vol#: 66

LET 8875 Perrigo Company of South Carolina Vol#: 66

LET 8876 Perrigo Company of South Carolina Vol#: 66

LET 8877 Perrigo Company of South Carolina Vol#: 66

LET 8878 Perrigo Company of South Carolina Vol#: 66

LET 8879 Perrigo Company of South Carolina Vol#: 66

LET 8880 Perrigo Company of South Carolina Vol#: 66

LET 8881 Perrigo Company of South Carolina Vol#: 66

LET 8882 Perrigo Company of South Carolina Vol#: 66

LET 8883 Perrigo Company of South Carolina Vol#: 66

LET 8884 Perrigo Company of South Carolina Vol#: 66

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

C 5688 Edward C. Hill Vol#: 233

C 5689 A. Heather Puddephat Vol#: 233

C 5690 Alita Popp Vol#: 233

C 5691 Janice Emich Vol#: 233

C 5692 M. Clouser Vol#: 233

C 5693 Mark Puddephat Vol#: 233

C 5694 Carole Leventhal & Richard West Vol#: 233

C 5695 Jill G. Radke Vol#: 233

C 5696 Janie Peto Vol#: 233

C 5697 Carole Benson Vol#: 233

C 5698 Whitney L. Boyd Vol#: 233

C 5699 Emil Heimtzelmann Vol#: 233

C 5700 Janet Waasdorp Vol#: 233

C 5701 Mary Wild-Roy Vol#: 233

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9269 Illegible Vol#: 404

C 9270 Richard Kyle Vol#: 404

C 9271 Barbara G. Schlein Vol#: 404

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CH 7 Dale Jacobson Vol#: 101

CH 8 Janet M. WestLee Vol#: 101

EMC 301 Sam E. Assef Jr. Vol#: 108

EMC 302 Lisa Tabor Vol#: 108

EMC 303 Norma D. Rodriguez Vol#: 108

EMC 304 Peter Roberts Vol#: 108

EMC 305 Martyn Williams Vol#: 108

EMC 306 Marsha Goldstine Vol#: 108

EMC 307 Shari Wildschutte Vol#: 108

EMC 308 Christopher Madden Vol#: 108

EMC 309 Mike Strawn Vol#: 108

EMC 310 Ella Hampton Vol#: 108

EMC 311 Lesia Mills Vol#: 108

EMC 312 Jennifer Keener Vol#: 108

EMC 313 Denyse Castle Vol#: 108

EMC 314 Britt Griswold Vol#: 108

EMC 315 Jason Koster Vol#: 108

EMC 316 Joel Potter Vol#: 108

EMC 317 Janet Damron Vol#: 108

EMC 318 Stewart Rosenkrantz Vol#: 108

EMC 319 Jimmy Irvin Vol#: 108

EMC 320 Laura Thomas-Marlow Vol#: 108

EMC 321 Debbie Hicks Vol#: 108

EMC 322 Christine Chandler Vol#: 108

EMC 323 Tamara Crowder Vol#: 108

EMC 324 James Geiser Vol#: 108

EMC 325 Richard Chapman Sr. Vol#: 108

EMC 326 Shonna Glen Vol#: 108

EMC 327 Curtis Goss Vol#: 108

EMC 328 Michael Thompson Vol#: 108

EMC 329 Geffrey & Alice Braun Vol#: 108

EMC 330 Randall Fry Vol#: 108

EMC 331 Robert Rutkowski Vol#: 108

EMC 332 Shirley Snider Vol#: 108

EMC 333 Rip Gough Vol#: 108

EMC 334 Scott Mullins Vol#: 108

EMC 335 Subir Trivedi Vol#: 108

EMC 336 Nancy Ross Vol#: 108

EMC 337 Serena Clayton Vol#: 108

EMC 338 Krista Kendall Vol#: 108

EMC 339 Sarah Durand Vol#: 108

EMC 340 Joan Siegwald Vol#: 108

EMC 341 Kenneth Koym Vol#: 108

EMC 342 David Beckham Vol#: 108

EMC 343 David Lynch Vol#: 108

EMC 344 Russ & Evelyne Fowler Vol#: 108

EMC 345 D. Bryan Vol#: 108

EMC 346 Jennifer Cure Vol#: 108

EMC 347 Abigail Wright Vol#: 108

EMC 348 Jessica Suter Vol#: 108

EMC 349 Rene Breier Vol#: 108

EMC 350 Alan Temes Vol#: 108

EMC 351 Sandra Merrell Vol#: 109

EMC 352 Gary & Dorothy Witteman Vol#: 109

EMC 353 Wm. Alobar Greywalker Vol#: 109

EMC 354 Dian Hardison Vol#: 109

EMC 355 Cherie Cray Vol#: 109

EMC 356 Fred Jakobcic Vol#: 109

EMC 357 Dale Wisler Vol#: 109

EMC 358 Sharon Van Der Wende Vol#: 109

EMC 359 Marilyn Short Vol#: 109

EMC 360 Jeremy Frazzell Vol#: 109

EMC 361 Virginia Simpson-Magruder Vol#: 109

EMC 362 Rick & Joan Meierotto Vol#: 109

EMC 363 Ryan Giusta Vol#: 109

EMC 364 Kerry Canfield Vol#: 109

EMC 365 Richard Shackelford Vol#: 109

EMC 366 Marcia Bruce Vol#: 109

EMC 367 Tracy Bowman Vol#: 109

EMC 368 Bill Abrams Vol#: 109

EMC 369 Geo Sindelar Vol#: 109

EMC 370 Natasha & Noah Brenner Vol#: 109

EMC 371 Arthur Sturgill Vol#: 109

EMC 372 Rachel Robson Vol#: 109

EMC 373 Anita Borton Vol#: 109

EMC 374 David Lapinski Vol#: 109

EMC 375 Scot Linkletter Vol#: 109

EMC 376 Karen Woytowich Vol#: 109

EMC 377 Jeanette Clancy Vol#: 109

EMC 378 Rosemary Bell Vol#: 109

EMC 379 Anne Milazzo Vol#: 109

EMC 380 Merrill Cole, Ph.D. Vol#: 109

EMC 381 Mike Sexton Vol#: 109

EMC 382 Marty Wilson Vol#: 109

EMC 383 Anne Whitefield Vol#: 109

EMC 384 Jerome Millay Vol#: 109

EMC 385 Eugene Fox Vol#: 109

EMC 386 Bonnie Gray Vol#: 109

EMC 387 Sandra Grubb Vol#: 109

EMC 388 Saret Tola Vol#: 109

EMC 389 Jorge Anderson Vol#: 109

EMC 390 Kiera Heiser Vol#: 109

EMC 391 Mariah Branch Vol#: 109

EMC 392 William Taylor Vol#: 109

EMC 393 Chris Jacobs Vol#: 109

EMC 394 Marie Murton Vol#: 109

EMC 395 Clayton Perry Vol#: 109

EMC 396 Jill Simon Vol#: 109

EMC 397 Ruth Dasche Vol#: 109

EMC 398 Bonnie MacBird Vol#: 109

EMC 399 Kristen Reilly Vol#: 109

EMC 400 Traci Spadorcia Vol#: 109

EMC 401 Julie Schoenstein Vol#: 109

EMC 402 Dave Thomas Vol#: 109

EMC 403 Diana Riddle Vol#: 109

EMC 404 Mari Nichols Vol#: 109

EMC 405 Clare Padfield Vol#: 109

EMC 406 Jeanette Alosi Vol#: 109

EMC 407 Vanesa Beauchamp Vol#: 109

EMC 408 Beverly Alexander Vol#: 109

EMC 409 Lorraine Buttner Vol#: 109

EMC 410 Adriane Dellorco Vol#: 109

EMC 411 Larry Trutter Vol#: 109

EMC 412 John van Arnold Vol#: 109

EMC 413 J. Sherratt Vol#: 109

EMC 414 Cynthia Hanna Vol#: 109

EMC 415 George Haws Vol#: 109

EMC 416 Deborah Rosier Vol#: 109

EMC 417 Faith Rawding Vol#: 109

EMC 418 Dr. Laura McIntosh Vol#: 109

EMC 419 Kara Bray Vol#: 109

EMC 420 Sherri Wright Vol#: 109

EMC 421 Rudolf Martin Vol#: 109

EMC 422 Ronald Radwin Vol#: 109

EMC 423 Marcelo Nasif, M.D. Vol#: 109

EMC 424 Robert Clarence Ziegler Vol#: 109

EMC 425 Elizabeth Fuller Vol#: 109

EMC 426 Corrinne Theodoru Vol#: 109

EMC 427 Charles Booher Vol#: 109

EMC 428 Laura Smith Vol#: 109

EMC 429 Janet Walker Vol#: 109

EMC 430 Judy Reed Vol#: 109

EMC 431 Jackie Pike Vol#: 109

EMC 432 Jody Reno Vol#: 109

EMC 433 Wayne & Barbara Covey Vol#: 109

EMC 434 Alexandra Lamb Vol#: 109

EMC 435 Bennett Konesni Vol#: 109

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

C 12609 Jeanne M Ancer Vol#: 783

C 12610 M Schwarzenbach Vol#: 783

C 12611 Donna Viola Vol#: 783

01D-0584 Reduce the Risk of Transmission of HIV-1 & HCV

C 3 Ortho-Clinical Diagnostics, Inc. Vol#: 1

01E-0363 Patent Term Extension Application, MIFEPREX No. 4,386,085

EXT 1 Buc & Beardsley Vol#: 1

01N-0458 Fast Track Drug Development Programs Designation,Development

N 2 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 858 Kathleen McCrossin Vol#: 190

02D-0049 Disclosure of Conflicts of Interest for Special Gov, Employe

C 3 CSPI Vol#: 1

02V-0130 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Astro Audio Video & Lighting, Inc. Vol#: 1

02V-0132 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Sound Dimensions Vol#: 1