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 29, 2002

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr *
98N-1215 Foreign Establishment Registration and Listing *
99D-2405 Information Request and Discipline Review Letter *
01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies *
01D-0514 Guidance on Labeling of Reprocessed Single Use Devices *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01N-0464 Vaccine Adverse Event Reporting System *
01P-0585 Requirement of ANDA for Mixed Salts of Single Entity Amphet *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 61 The Soap & Detergent & C.T.F.A Vol#: 60

77N-0085 Saccharin and Its Salts

CA 34063 Robert P. Wilson Vol#: 572

CA 34064 Bess Hirshberg Vol#: 572

CA 34065 Richard F. Grande Vol#: 572

CA 34066 Mrs. RICHARD l. BINDER Vol#: 572

CA 34067 Mrs. V. wentzel Vol#: 572

CA 34068 Connie Myers Vol#: 572

CA 34069 Frances Hordone Vol#: 572

CA 34070 jan Rogers Vol#: 572

CA 34071 Ruth milligan Vol#: 572

CA 34072 nancy Vargo Vol#: 572

CA 34073 Mrs. Edwin H. Season Vol#: 572

CA 34074 E. Dargan Cole Vol#: 572

CA 34075 Sarah Jane Paxton Vol#: 572

CA 34076 Hanna C. Aashh Vol#: 572

CA 34077 Mr. & Mrs. Don Rezac Vol#: 572

CA 34078 Mr. & Mrs. W. Kipp Vol#: 572

CA 34079 H. Blechman Vol#: 572

CA 34080 J. C. Buchanan Vol#: 572

CA 34081 Pat Sense Vol#: 572

CA 34082 Evelyn L. Rommer Vol#: 572

CA 34083 Susan W. Hannum Vol#: 572

CA 34084 Lillian V. Salsman Vol#: 572

CA 34085 Marie McDaniel Vol#: 572

CA 34086 Lillian A. Minnich Vol#: 572

CA 34087 JAMES p. kOCH Vol#: 572

CA 34088 Mrs. Elmer A. Anderson Vol#: 572

CA 34089 Mrs. Robert S. christie Vol#: 572

CA 34090 Mrs. Martha E. Katrichie Vol#: 572

CA 34091 Dixie D Dobyns Vol#: 572

CA 34092 Michael P. Statzer Vol#: 572

CA 34093 Mrs. Eleeanor S. Young Vol#: 572

CA 34094 Margaret Hauser Vol#: 572

CA 34095 S. Anna Mae Vol#: 572

CA 34096 Jean Bauckman & 11 Signatures Vol#: 572

CA 34097 Philip MeterParel Vol#: 572

CA 34098 D. C. Skiff Vol#: 572

CA 34099 Maureen Yourk Vol#: 572

CA 34100 Ray W. Harkins Vol#: 572

CA 34101 Lisa Gubler Vol#: 572

CA 34102 Mrs. Betty Hall Vol#: 572

CA 34103 Mr. Donald Kennedy Vol#: 572

CA 34104 Mrs. Earl Leasor Vol#: 572

CA 34105 Mrs. John Mayer Vol#: 572

CA 34106 George W. Hardy Vol#: 572

CA 34107 Warren B. Humes Vol#: 572

CA 34108 Alice G. Richie Vol#: 572

CA 34109 Mrs. Walter Harves Vol#: 572

CA 34110 Karen Haverson Vol#: 572

CA 34111 Robert C. Anderson & Barbara A. Anderson Vol#: 572

CA 34112 Paul Hirsch Vol#: 572

CA 34113 Richard C. Freed Vol#: 572

CA 34309 Carol Touchstone Vol#: 574

CA 34310 Sam Bloom Vol#: 574

CA 34311 Barbara M. Johansen Vol#: 574

CA 34312 Caroline Klas Vol#: 574

CA 34314 Mrs. Luana Bierlein Vol#: 574

CA 34315 George C. Hass, Jr. Vol#: 574

CA 34317 Mr. Edward N. Caras Vol#: 574

CA 34318 Ms. Susan Petitt Vol#: 574

CA 34320 Trey Auten Vol#: 574

CA 34322 Number Not Used Vol#: 574

CA 34323 Charles Zutes Vol#: 574

CA 34324 Mrs. Sandra Leitch Vol#: 574

CA 34325 Virginia H. Missman Vol#: 574

CA 34326 Paul L. Bengen Vol#: 574

CA 34327 Philip V. Nieder Vol#: 574

CA 34328 E. Harris Vol#: 574

CA 34329 Mrs. Mary Duell Vol#: 574

CA 34330 Mrs. Rose L. Sands Vol#: 574

CA 34331 Marjory A. Coveney Vol#: 574

CA 34332 Scott Stewart Vol#: 574

CA 34333 Angela French Vol#: 574

CA 34334 Harl Sandage Vol#: 574

CA 34336 Jean C. Schulte Vol#: 574

CA 34337 Sue Castle & 34 other signatures Vol#: 574

CA 34338 Maryann VandeYacht Vol#: 574

CA 34339 Ronald K. Wishart Vol#: 574

CA 34340 Joann Brawn Vol#: 574

CA 34341 Donna G. James Vol#: 574

CA 34343 Charles L. Hall Vol#: 574

CA 34344 Edward R. Bramlett Vol#: 574

CA 34345 J. Harvey Smith Vol#: 574

CA 34346 Alvie R. Livermore Vol#: 574

CA 34347 Nelson R. England Vol#: 574

CA 34348 A. G. Bittner Vol#: 574

CA 34349 Robert A. Patterson Vol#: 574

CA 34350 Beatrice M. Robins Vol#: 574

CA 34351 Mrs. Richard Swoffer Vol#: 574

CA 34352 Ann F. Karns Vol#: 574

CA 34353 K. Alfred Aho Vol#: 574

CA 34354 Josephine Cash Vol#: 574

CA 34356 Mrs. Florence Herkel Vol#: 574

CA 34357 Harriet Chad Vol#: 574

CA 34358 Catherine C. Jones Vol#: 574

CA 34359 F. R. Robberson Vol#: 574

CA 34360 Fred Sholty Vol#: 574

CA 34361 Mrs. George R. (Linda) Hines Vol#: 574

CA 34362 Mrs. Eliza Clark Vol#: 574

CA 34363 Gary O. McElfresh Vol#: 575

CA 34364 E. A. "Squatty" Lyons Vol#: 575

CA 34365 Billie R. Pugh Vol#: 575

CA 34366 Robert O. Fraley Vol#: 575

CA 34367 Patricia J. Skinner Vol#: 575

CA 34368 Betty Yanko Vol#: 575

CA 34369 Wilber W. Wilson Vol#: 575

CA 34372 Lilian S. Schindler Vol#: 575

CA 34373 Frank J. Engle Vol#: 575

CA 34374 Martin F. Fahey Vol#: 575

CA 34375 Harold Paxman Vol#: 575

CA 34376 Fifth Avenue Auto Supply (California) Vol#: 575

CA 34377 Robert L. Kaufman Vol#: 575

CA 34378 L. L. Johnson Vol#: 575

CA 34379 Howard C. Woodard Vol#: 575

CA 34380 Lewis H. Fast Vol#: 575

CA 34381 J. H. Eliasen, Jr. Vol#: 575

CA 34382 Loren Lemer Vol#: 575

CA 34383 Bill Brush Vol#: 575

CA 34384 M. Murphy Vol#: 575

CA 34385 Dr. J. A. Mowbray Vol#: 575

CA 34386 James B. Lipscomb, Jr. Vol#: 575

CA 34387 Pat L. Eitner Vol#: 575

CA 34388 H. R. Jensen Vol#: 575

CA 34389 Richard C. Kruse Vol#: 575

CA 34390 Richard M. Rhodes Vol#: 575

CA 34391 John H. Amrine Vol#: 575

CA 34392 Dennis D. Burbank Vol#: 575

CA 34393 W. June Bychinski Vol#: 575

CA 34394 P. T. Huffine Vol#: 575

CA 34395 William J. Mitchell Vol#: 575

CA 34396 King Rhiley, III Vol#: 575

CA 34397 Dannie Hefner Vol#: 575

CA 34398 Kas Majewski Vol#: 575

CA 34399 C. E. Townes Vol#: 575

CA 34400 L. Donald Winn Vol#: 575

CA 34401 Raywood J. Belanger Vol#: 575

CA 34402 Ron Chipman Vol#: 575

CA 34403 Robert Gricewich Vol#: 575

CA 34404 Blanche & Eric L. Taylor Vol#: 575

CA 34405 Jerry Davis Vol#: 575

CA 34406 C. Strickland Vol#: 575

CA 34407 Carl G. Park Vol#: 575

CA 34408 Steve Book Vol#: 575

CA 34409 Dale D. Ingalls Vol#: 575

CA 34410 Benjamin L. Harper, M. D. Vol#: 575

CA 34411 D. W. Chambers Vol#: 575

CA 34412 O. H. Jones Vol#: 575

CA 34413 Mrs. Robert T. Hart Vol#: 575

CA 34414 Joseph E. Fountain & 7 other signatures Vol#: 575

CA 34415 Linda S. Johnson Vol#: 575

CA 34416 Robert Lamishaw Vol#: 575

CA 34417 Tessie F. Hardin Vol#: 575

CA 34418 Patrick Ehrhart & 77 other signatures Vol#: 575

CA 34419 Fran Elson Vol#: 575

CA 34420 Betty J. & Phillip E. Culbert Vol#: 575

CA 34421 Marvin Weinberg Vol#: 575

CA 34422 Juanita Tucker Vol#: 575

CA 34423 Maria M. Marin & 6 other signatures Vol#: 575

CA 34424 Albert E. Martin, P. E. Vol#: 575

CA 34425 Lorraine C. Johnsen Vol#: 575

CA 34426 Conni Boughan Vol#: 575

CA 34427 Gary K. Himes Vol#: 575

CA 34428 Mrs. M. J. Walters Vol#: 575

CA 34429 Patricia L. Duttfurth Vol#: 575

CA 34430 E. Harold Ardahl Vol#: 575

CA 34431 M. J. Walters, Jr. Vol#: 575

CA 34432 Gene G. Fromentin Vol#: 575

CA 34434 Charlotte A. Nance & 18 other signatures Vol#: 575

CA 34435 John Walters Vol#: 575

CA 34436 Patricia Lytle Vol#: 575

CA 34437 Mary G. Fugua & 4 other signatures Vol#: 575

CA 34439 Patricia E. Vukovich Vol#: 575

CA 34440 William Easley Vol#: 575

CA 34441 Sheila Wales & 175 other signatures Vol#: 575

CA 34442 Charlaine Jones Vol#: 575

CA 34443 James D. Weinstein Vol#: 575

CA 34444 William Easley Vol#: 575

CA 34445 Anthony J. Trella Vol#: 575

CA 34447 Barbara Jacobi Vol#: 575

CA 34449 Mrs. Judith Zvereff Vol#: 575

CA 34450 Randall C. Rolfe Vol#: 575

CA 34451 James H. Johnson, M. D. Vol#: 575

CA 34452 John V. & Lynne P. Kozlowski Vol#: 575

CA 34453 Mr. & Mrs. George J. Schmidt Vol#: 575

CA 34454 Mrs. Robert T. Hart Vol#: 575

CA 34455 T. E. Duffy Vol#: 575

CA 34456 Lula O. Schmidt Vol#: 575

CA 34457 Mr. & Mrs. R. Peterson & 17 other sign. Vol#: 575

CA 34458 Joseph R. Neri Vol#: 575

CA 34459 Rosemary S. McElwain Vol#: 575

CA 34460 Suzanne Christoff Vol#: 575

CA 34461 Sharon L. Ewing Vol#: 575

CA 34462 Anne M. Stein Vol#: 575

CA 34463 Joseph R. Neri Vol#: 576

CA 34464 David A. Haymes, M. D. & 9 other sign. Vol#: 576

CA 34465 Mrs. Davideen L. Rowland Vol#: 576

CA 34466 James D. Weinstein Vol#: 576

CA 34467 Miss. Leslie F. Lefton Vol#: 576

CA 34468 L. E. Creel, III Vol#: 576

CA 34469 Mrs. Dorothy Fluallen Vol#: 575

CA 34470 John N. McManus Vol#: 576

CA 34471 Kathleen Moyer Vol#: 576

CA 34472 C. B. Halseth Vol#: 576

CA 34473 Paul W. O'Meara Vol#: 576

CA 34474 D. C. Keezer Vol#: 576

CA 34475 Suzanne Christoff Vol#: 576

CA 34476 Merritt W. Barnum Vol#: 576

CA 34477 Fred H. & Barbara M. Howey Vol#: 576

CA 34478 Richard W. Olson Vol#: 576

CA 34479 J. E. Johnson Vol#: 576

CA 34480 Patricia V. Echols Vol#: 576

CA 34481 Number Not Used Vol#: 576

CA 34482 (Mrs.) Lou Brewer Vol#: 576

CA 34483 Connie Upchurch & 18 other signatures Vol#: 576

CA 34484 Cathemae Cecchin Vol#: 576

CA 34485 Earl R. McMinn Vol#: 576

CA 34486 Barbara M. Byerly Vol#: 576

CA 34487 Elliott M. Welsh Vol#: 576

CA 34489 Mrs. Richard Scott Vol#: 576

CA 34490 Nancy Miller Vol#: 576

CA 34491 Mr. & Mrs. James B. Harvey Vol#: 576

CA 34492 Frank Sipos, Ph. D. Vol#: 576

CA 34493 Number Not Used Vol#: 576

CA 34494 Robert D. Johnson Vol#: 576

CA 34495 Donald R. Stewart Vol#: 576

CA 34497 Derwood Kennedy Vol#: 576

CA 34498 Frances Rang Vol#: 576

CA 34499 Connie S. Clark Vol#: 576

CA 34500 Fred H. Howey Vol#: 576

CA 34501 Phyllis A. Giardino Vol#: 576

CA 34502 Martin R. Shainen Vol#: 576

CA 34503 H. Ronald Harris Vol#: 576

CA 34504 Sue Fulks Vol#: 576

CA 34505 Gary Behle Vol#: 576

CA 34506 Dr. & Mrs. William T. Baldock Vol#: 576

CA 34507 John D. Hackworth Vol#: 576

CA 34508 J. Eitner Vol#: 576

CA 34509 Fred E. Ferguson Vol#: 576

CA 34510 T. W. Collier Vol#: 576

CA 34511 Edythe A. Nelson Vol#: 576

CA 34512 R. A. Giddens Vol#: 576

CA 34513 Lucy Singil Vol#: 576

CA 34514 R. Pool Vol#: 576

CA 34515 William E. Graham, Jr. Vol#: 576

CA 34516 John H. Connelly Vol#: 576

CA 34517 Rotha Anderson Vol#: 576

CA 34518 James E. Davis Vol#: 576

CA 34519 Dr. J. Leigh Beueridge Vol#: 576

CA 34520 Dennis D. McCloud Vol#: 576

CA 34521 Charles Pietro Vol#: 576

CA 34522 Ruby C. Kurek Vol#: 576

CA 34523 Hawley J. Gary Vol#: 576

CA 34524 Jeff Feaver Vol#: 576

CA 34525 Lillian Watkins Vol#: 576

CA 34526 Eugene M. Marsh Vol#: 576

CA 34527 Katherine M. Loughrey Vol#: 576

CA 34528 R. H. Beck Vol#: 576

CA 34529 J. E. McKillie Vol#: 576

CA 34530 Larry E. Holaway Vol#: 576

CA 34531 William A. Jasper Vol#: 576

CA 34532 H. O. T. Russell Vol#: 576

CA 34533 H. T. Young Vol#: 576

CA 34534 Wayne Darville Vol#: 576

CA 34535 Guy R. Crump Vol#: 576

CA 34536 Robert L. Doyle Vol#: 576

CA 34537 Valerie Graham Vol#: 576

CA 34538 Nellie May Barnett Vol#: 576

CA 34539 M. P. Frieday Vol#: 576

CA 34540 Mr. & Mrs. James C. Bulpitt, Sr. Vol#: 576

CA 34542 Philip B. Slatcher Vol#: 576

CA 34543 Mrs. Inez Harris Vol#: 576

CA 34544 Mrs. Linda Urbinati Vol#: 576

CA 34545 Royetta Stokes Vol#: 576

CA 34546 Mrs. Florence Bernstein Vol#: 576

CA 34547 Kathryn Evans Vol#: 576

CA 34548 Nancy L. O'Neill Vol#: 576

CA 34549 Mrs. Jewel Holzheimer Vol#: 576

CA 34550 Mrs. John Nicoll Vol#: 576

CA 34551 Dorothy & Charles A. Sanford Vol#: 576

CA 34552 Mrs. Frances Dunogon Vol#: 576

CA 34553 Mrs. Neal M. Roth Vol#: 576

CA 34554 Rosemary Schemmil Vol#: 576

CA 34555 Robert A. Couch Vol#: 576

CA 34556 Mrs. Richard D. Christie Vol#: 576

CA 34557 Katherine Brink Vol#: 576

CA 34558 Elizabeth Cohn Vol#: 576

CA 34559 Linda Jarvis Vol#: 576

CA 34560 Elizabeth A. Buyer Vol#: 576

CA 34561 Lisa Watkins Vol#: 576

CA 34562 Mrs. Liane Farber Vol#: 576

CA 34563 Mrs. Janet Vest Vol#: 577

CA 34564 Mrs. Earl Kohls Vol#: 577

CA 34565 Leslie B. McIntosh Vol#: 577

CA 34566 Alice E. Gerry Vol#: 577

CA 34567 Mrs. W. Stuart Goble Vol#: 577

CA 34568 Joan Keener Vol#: 577

CA 34569 Mrs. Morris E. Solod Vol#: 577

CA 34570 J. S. Sclaef Vol#: 577

CA 34571 James A. Hancock Vol#: 577

CA 34572 Karl Sharp Vol#: 577

CA 34573 Edgar Brown Vol#: 577

CA 34574 Elinor Albro Vol#: 577

CA 34575 Nan Allen Vol#: 577

CA 34576 Mrs. Frances Dunagan Vol#: 577

CA 34577 Dale F. Espen Vol#: 577

CA 34578 Mrs. Mabel H. Baker Vol#: 577

CA 34579 Mrs. J. E. Fraser Vol#: 577

CA 34580 Mrs. Rina DaTorre Vol#: 577

CA 34581 Doris Russell Vol#: 577

CA 34582 Joseph O. Belanger Vol#: 577

CA 34583 Terrie & Gary Schrader Vol#: 577

CA 34584 Susan Hemmendinger Vol#: 577

CA 34585 Lenore Tenowitz Vol#: 577

CA 34586 Bernard L. & Margaret B. Gleue Vol#: 577

CA 34587 Nancy Swann Vol#: 577

CA 34588 Reginald D. Manwell Vol#: 577

CA 34589 Dr. Frederick Occhino, D. O. & 4 others Vol#: 577

CA 34590 Sally Warren Vol#: 577

CA 34591 George G. Gellert Vol#: 577

CA 34593 Muriel S. Schleider Vol#: 577

CA 34594 Mrs. Charlotte M. Francis Vol#: 577

CA 34595 Mr. & Mrs. William S. Carmody Vol#: 577

CA 34596 Jerry U. Young Vol#: 577

CA 34597 The Selg Family Vol#: 577

CA 34598 Mary Anne Kinkade Vol#: 577

CA 34599 Mrs. William E. Kelley Vol#: 577

CA 34600 Gladys Miller Vol#: 577

CA 34601 Connie Galloway Vol#: 577

CA 34602 Suzanne & Edward D. Keefer Vol#: 577

CA 34603 Thomas J. Peterson Vol#: 577

CA 34604 James Kanikula Vol#: 577

CA 34605 Miss. Lydia Paula D'Isidori Vol#: 577

CA 34606 Helen Duncan Vol#: 577

CA 34607 Jane M. Horner Vol#: 577

CA 34608 Lynne F. Roche Vol#: 577

CA 34609 Catlin E. Tyler Vol#: 577

CA 34610 Eldon J. Metteer Vol#: 577

CA 34611 Frank Krug Vol#: 577

CA 34612 Harold F. Peterson Vol#: 577

CA 34613 Mrs. Juanita M. Green Vol#: 577

CA 34614 Florence M. Horn Vol#: 577

CA 34615 Gloria Phillips Vol#: 577

CA 34616 Leonard T. Brambley Vol#: 577

CA 34617 Florian T. Lampert Vol#: 577

CA 34618 Reuben Levin Vol#: 577

CA 34619 Jean L. Gordon Vol#: 577

CA 34620 Dinah Harrison Vol#: 577

CA 34621 Arthur Egelhofer Vol#: 577

CA 34622 Willard A. Thompson, Jr. Vol#: 577

CA 34623 Catherine Eberle Vol#: 577

CA 34624 Holly Kelly Kerns Vol#: 577

CA 34625 Mrs. Maurine West Vol#: 577

CA 34626 Allen R. Zeedyk Vol#: 577

CA 34627 Meleana Dorn Vol#: 577

CA 34628 Bruce D. & Michelle T. Walker Vol#: 577

CA 34629 Mrs. Ty Learn Zeigler Vol#: 577

CA 34630 Loretta Jones Vol#: 577

CA 34631 Guy A. Lucian Vol#: 577

CA 34632 Susan Marrash Vol#: 577

CA 34633 Marion Sheehan Vol#: 577

CA 34634 L. M. O'Kelley Vol#: 577

CA 34635 Sue B. Francis Vol#: 577

CA 34636 Linda L. Horn Vol#: 577

CA 34637 Mrs. Sheldon Anthony Vol#: 577

CA 34638 Charles P. Knight Vol#: 577

CA 34639 Loretta R. Garber Vol#: 577

CA 34640 T. W. Donovan Vol#: 577

CA 34641 Mary Ellen Jorkowski Vol#: 577

CA 34642 John E. Overton Vol#: 577

CA 34643 Dorothy G. Fraembs Vol#: 577

CA 34644 Mrs. Sherry Ronis Vol#: 577

CA 34645 Mrs. J. H. Thomas Vol#: 577

CA 34646 Henry S. Davidson Vol#: 577

CA 34648 Mr. & Mrs. Mike Grayson Vol#: 577

CA 34649 Cawline Ring Vol#: 577

CA 34650 Lucile Rich Vol#: 577

CA 34651 Ellen Tunkelrott Vol#: 577

CA 34652 Susan Marrash Vol#: 577

CA 34653 W. L. & Carol K. Howe Vol#: 577

CA 34654 Dorothy E. Holland & 47 other signatures Vol#: 577

CA 34655 Louis Rubin Vol#: 577

CA 34656 Anne J. McCouch Vol#: 577

CA 34657 Mrs. Paul E. (Evelyn) Nichols Vol#: 577

CA 34658 Miss. Janet M. Bretz Vol#: 577

CA 34659 Mr. & Mrs. John McGinnis Vol#: 577

CA 34660 Janie Urbanic Vol#: 577

CA 34661 Number Not Used Vol#: 577

CA 34662 M. Safianow Vol#: 577

CA 34744 William A. Kelly Jr. Vol#: 578

CA 34745 H. M. phyllys Dum Vol#: 578

CA 34746 Tim Viole Vol#: 578

CA 34747 D. L. Johnson Vol#: 578

CA 34748 Ron Matous Vol#: 578

CA 34749 Dick S. Simon Vol#: 578

CA 34750 R. N. Price Vol#: 578

CA 34751 Mr. & Mrs. Lee Roy Brehmer Vol#: 578

CA 34752 Clyden Chambliss Vol#: 578

CA 34753 Mrs. H. Malenke Vol#: 578

CA 34754 Wilma R. Noyse Vol#: 578

CA 34755 Carl Rosenstock Vol#: 578

CA 34756 John C. Alexander Vol#: 578

CA 34757 Robert T. deegan Vol#: 578

CA 34758 James Sperlazzo Vol#: 578

CA 34759 David Teas Vol#: 578

CA 34760 Leon H. Breuwear Vol#: 578

CA 34761 Bill Sinclair Vol#: 578

CA 34762 B. Reese Vol#: 578

CA 34764 Ferrell Yearwood Vol#: 579

CA 34765 R. Sterling Halladay Vol#: 579

CA 34766 Matt C. Mattson Vol#: 579

CA 34767 Cambridge Realty Vol#: 579

CA 34768 Ray Harp Vol#: 579

CA 34769 Wayne L. Moses Vol#: 579

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

LET 5 Emord & Associates, P.C. Vol#: 58

93D-0139 Stability Testing of Biotechnological/Biological Products

EC 2 Ms. jacqueline harding Vol#: 2

EC 3 self Vol#: 2

EC 4 Mr. Michael Reid Vol#: 2

95D-0349 Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr

C 22 Niro, Inc. Vol#: 3

98N-1215 Foreign Establishment Registration and Listing

EC 5 Considar Metal Marketing Inc. Vol#: 2

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

EMC 2627 Mike Butts Vol#: 188

EMC 2628 Elizabeth Lujambio Vol#: 188

EMC 2629 Tana Gullotta Vol#: 188

EMC 2630 Vivienne Handy Vol#: 188

EMC 2631 Robin Zeplin Vol#: 188

EMC 2632 Lori J. Korell Vol#: 188

EMC 2633 Traci Schmitt Vol#: 188

EMC 2634 R. Brinkman Vol#: 188

EMC 2635 Jesse Armaline Vol#: 188

EMC 2636 Deanne Foerster Vol#: 188

EMC 2637 Katherine S. Van Woert Vol#: 188

EMC 2638 Lindsay Kemper Vol#: 188

EMC 2639 Walter Desher Vol#: 188

EMC 2640 Tamara Brion Vol#: 188

EMC 2641 Lynn Powers Vol#: 188

EMC 2642 Peggy Schramm Vol#: 188

EMC 2643 Ana Young Vol#: 188

EMC 2644 Robert Sanders Vol#: 188

EMC 2645 Monique Harrison Vol#: 188

EMC 2646 Donna Cray Vol#: 188

EMC 2647 Susan Hughes Vol#: 188

EMC 2648 Emily Fabiano Vol#: 188

EMC 2649 Dennis Sichner Vol#: 188

99D-2405 Information Request and Discipline Review Letter

EC 1 med-facts inc. Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 145 Matthew Thompson Vol#: 3

EMC 146 Kristine Acevedo Vol#: 3

EMC 147 Beth Helm Vol#: 3

EMC 148 Cynthia Milutin Vol#: 3

EMC 149 Sheryl Loucks Vol#: 3

EMC 150 Janet Hitt Vol#: 3

EMC 151 Zachery Rodgers Vol#: 3

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 48 Matthew Thompsom Vol#: 3

EMC 49 Kristine Acevedo Vol#: 3

EMC 50 Beth Helm Vol#: 3

EMC 51 Cynthia Milutin Vol#: 3

EMC 52 Sheryl Loucks Vol#: 3

EMC 53 Janet Hitt Vol#: 3

EMC 54 Zachary Rodgers Vol#: 3

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 48 Matthew Thompson Vol#: 2

EMC 49 Kristine Acevedo Vol#: 2

EMC 50 Beth Helm Vol#: 2

EMC 51 Cynthia Milutin Vol#: 2

EMC 52 Sheryl Loucks Vol#: 2

EMC 53 Janet Witt Vol#: 2

EMC 54 Zachary Rodgers Vol#: 2

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 50 Matthew Thompson Vol#: 2

EMC 51 Kristine Acevedo Vol#: 2

EMC 52 Beth Helm Vol#: 2

EMC 53 Cynthia Milutin Vol#: 2

EMC 54 Sheryl Loucks Vol#: 2

EMC 55 Janet Hitt Vol#: 2

EMC 56 Zachary Rodgers Vol#: 2

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

EMC 3539 Janet Hitt Vol#: 505

EMC 3540 Robert Wood Vol#: 505

00E-1234 Patent Extension for SONATA (zalepon) #4,626,538

N 1 Vol#: 1

00E-1346 Patent Extension Keppra, No. 4,943,639

N 1 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 192 Form Letter Count 3,797 Vol#: 27

00P-1322 Food Labeling and Allergen Contamination Control

EMC 467 No signature Vol#: 20

01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies

C 10 Generic Pharmaceutical Assn Vol#: 1

01D-0514 Guidance on Labeling of Reprocessed Single Use Devices

EC 3 Med-Facts Inc. Vol#: 1

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

N 1 Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 226 none Vol#: 4

EC 227 Mrs. Amber Churchman Vol#: 4

01N-0284 Regulation for establishing import tolerances

EC 3 Dr. Lilly Kao Vol#: 1

01N-0399 Rapid Response Surveys;Agency Information Collection

N 2 Vol#: 1

01N-0450 Prescription Drug User Fee Act (PDUFA)

EC 8 Ms. teri wright Vol#: 2

EC 9 American Society of Health-System Pharma Vol#: 2


01N-0464 Vaccine Adverse Event Reporting System

EC 20 VAERS Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 987 Angela Minett Vol#: 4

EMC 988 T. Graham Vol#: 4

EMC 989 Diane Pracy Vol#: 4

EMC 990 Avril Peterson Vol#: 4

EMC 991 Helgi Stone Vol#: 4

EMC 992 Judithea Corr Vol#: 4

EMC 993 K. Bittler Vol#: 4

EMC 994 Caroline Hickerson Vol#: 4

EMC 995 Shannon A. Knight Vol#: 4

EMC 996 Paul Davis Vol#: 4

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 307 Ralph Bell Vol#: 2

EMC 308 Deborah & Mark Webb Vol#: 2

EMC 309 Eric Blackburn Vol#: 2

EMC 310 Thomas L. Rempfer Vol#: 2

EMC 311 Merle Jason Vol#: 2

EMC 312 Bruce Erney Vol#: 2

EMC 313 Tanya Marquette Vol#: 2

EMC 314 No signature Vol#: 2

EMC 315 Sarah Juntunen Vol#: 2

EMC 316 Glenn J. Asti Vol#: 2

01P-0585 Requirement of ANDA for Mixed Salts of Single Entity Amphet

C 1 Eon Labs Manufacturing, Inc. Vol#: 1