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 February 6, 2002

TABLE OF CONTENTS

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01P-0323 Not rely on non-public filings to approve an innovator NDA; *
02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products *

77N-0085 Saccharin and Its Salts

CA 35430 Sue A.Moore Vol#: 586

CA 35431 Roland P. Vukic Vol#: 586

CA 35432 W.H.Coleman Vol#: 586

CA 35433 Frederic C. Cowden Vol#: 586

CA 35434 Patricia L. Dittfurth Vol#: 586

CA 35435 S.F. Zenner Vol#: 586

CA 35436 Kenneth J. Tannen Vol#: 586

CA 35437 Joseph F. Kunz Vol#: 586

CA 35439 Mrs.John P.Crain Vol#: 586

CA 35440 Ms.Frances Elson Vol#: 586

CA 35441 Annis M. Cuppet Vol#: 586

CA 35442 Jerome Sokolski Vol#: 586

CA 35443 David Hugh Birley Vol#: 586

CA 35444 Carolyn and Janet White Vol#: 586

CA 35445 Sandra and Ronald Reese Vol#: 586

CA 35446 Miss Leslie F.Lefton Vol#: 586

CA 35447 Debora L. Stone Vol#: 586

CA 35448 R.A.Shiffer Vol#: 586

CA 35449 Karen Samuelsohn Vol#: 586

CA 35450 Beth Cullom Vol#: 586

CA 35451 Mrs. Donna R. Creekmore Vol#: 586

CA 35452 Annette M.Stramesi Vol#: 586

CA 35453 Philip Pollak Vol#: 586

CA 35454 Richard J.Michalcik Vol#: 586

CA 35455 Mr.J.Nichol Vol#: 586

CA 35456 John F. Pullo JR. Vol#: 586

CA 35457 Gloria F.Kane Vol#: 586

CA 35458 Laura Mossing Vol#: 586

CA 35459 Marlene Lever Vol#: 586

CA 35460 Daniele D. Costantini Vol#: 586

CA 35461 Seymour Sheldon Vol#: 586

CA 35462 George A.Davis Vol#: 586

CA 35463 Mrs.Diane Bruggeman Vol#: 586

CA 35464 David Lee Rubin Vol#: 586

CA 35465 Kathy Mullinax Vol#: 586

CA 35466 Leslie H.Killgore & Ernestine I.McCoy Vol#: 586

CA 35467 Albert K.Smith Vol#: 586

CA 35468 Myrle B.Gallops Vol#: 586

CA 35730 Stanley H. Love Vol#: 590

CA 35731 Corinne Levenburg Vol#: 590

CA 35732 M. K. Prives Vol#: 590

CA 35733 Mrs. T. R. Books Vol#: 590

CA 35734 Mrs. Shirley de Coup-Crank Vol#: 590

CA 35735 William A. Ferro Vol#: 590

CA 35736 Elaine Luppescu Vol#: 590

CA 35737 Natalie A. Tobin Vol#: 590

CA 35738 Fran Lee Vol#: 590

CA 35739 Fred Gervasoni Vol#: 590

CA 35740 William Dickey Vol#: 590

CA 35741 Mr. & Mrs. David Finkelstein Vol#: 590

CA 35742 Judith V. Parker Vol#: 590

CA 35743 Nelma J. Scott Vol#: 590

CA 35744 Norma Klorjene Vol#: 590

CA 35745 Selma & Daniel Weiss Vol#: 590

CA 35746 Bess S. Posner Vol#: 590

CA 35747 Edward M. Cowan Vol#: 590

CA 35748 George C. Seymour Vol#: 590

CA 35749 Jean M. Melia Vol#: 590

CA 35750 Mrs. Kathleen Dowling Vol#: 590

CA 35752 Don P. Walling Vol#: 590

CA 35753 Eugene R. & Winifred A. Farneti Vol#: 590

CA 35754 Priscilla Dugan Vol#: 590

CA 35755 Carol A. Knoles Vol#: 590

CA 35756 Robert C. Regan Vol#: 590

CA 35757 Bunni Berman Vol#: 590

CA 35758 Susan Reynolds Vol#: 590

CA 35759 Melissa Kaye Lawrence Vol#: 590

CA 35760 Dale Bendig Vol#: 590

CA 35761 Kevin Few Vol#: 590

CA 35762 Andy Hood Vol#: 590

CA 35763 Bobby Lookingbill Vol#: 590

CA 35764 Tom Lambert Vol#: 590

CA 35765 Paul Robert Raezer Vol#: 590

CA 35766 Doug Honeycutt Vol#: 590

CA 35767 Jim Hewitt Vol#: 590

CA 35768 Kelly Bowers Vol#: 590

CA 35769 Tina Rill Vol#: 590

CA 35770 Charles I. Barish Vol#: 590

CA 35772 Alexander C. McLeod, M. D. Vol#: 590

CA 35773 J. D. Bryant Vol#: 590

CA 35774 Beverly R. Kimzey Vol#: 590

CA 35775 Carl Muchnick, M. D. Vol#: 590

CA 35776 Phyllis Bielanski Vol#: 590

CA 35777 Mrs. H. N. Edwards Vol#: 590

CA 35778 Janice Myers Vol#: 590

CA 35779 Edward J. Gill & 12 other signatures Vol#: 590

CA 35780 Raymond Scalettar, M. D. Vol#: 590

CA 35781 Lynne A. Wedel Vol#: 590

CA 35782 Lori Siepelmeyer Vol#: 590

CA 35783 Karen Fisher Vol#: 590

CA 35784 Mrs. D. Jane Bair Vol#: 590

CA 35785 Judith K. Brandenburg Vol#: 590

CA 35786 Dick M. Jacobs Vol#: 590

CA 35787 Philip Pollak Vol#: 590

CA 35788 Samuel Mancher Vol#: 590

CA 35789 Mrs. Donna L. Butler Vol#: 590

CA 35790 Stuart A. Cowan Vol#: 590

CA 35791 Evelyn A. Russ Vol#: 590

CA 35793 Mrs. Anne S. Cohen Vol#: 590

CA 35794 Howard E. Yule Vol#: 590

CA 35795 Frank G. Fanning Vol#: 590

CA 35796 J. Dohal Earl Vol#: 590

CA 35797 Glenna Hoagland-Matthews Vol#: 590

CA 35798 A. J. Galvin Vol#: 590

CA 35799 Judith K. Brandenburg Vol#: 590

CA 35800 Linda Lebovitz Vol#: 590

CA 35801 John C. Whitwell Vol#: 590

CA 35802 Deborah A. Meyer Vol#: 590

CA 35803 Evelyn Schwanke Vol#: 590

CA 35804 Edward A. Laird Vol#: 590

CA 35805 Harry Bogatch Vol#: 590

CA 35806 Francine Holzer Vol#: 590

CA 36175 Linda Day Vol#: 595

CA 36176 Judith Hutchinson & 7 other signatures Vol#: 595

CA 36177 Julian D. Hendrix Vol#: 595

CA 36178 Lloyd Kester Vol#: 595

CA 36179 Jenard M. Gross Vol#: 595

CA 36180 Mrs. William E. Sellars Vol#: 595

CA 36181 Mary Lou Geldigan Vol#: 595

CA 36182 Judith Hutchinson & 7 other signatures Vol#: 595

CA 36183 Mrs. Douglas L. Williams Vol#: 595

CA 36184 Kay R. Maltbie Vol#: 595

CA 36185 Phyllis A. Giardino Vol#: 595

CA 36186 Sharon L. Ewing Vol#: 595

CA 36187 Dwight L. Young, M. S. Vol#: 595

CA 36188 Sherrie C. Bossie Vol#: 595

CA 36189 Walter W. Hayes Vol#: 595

CA 36190 R. Keith Campbell Vol#: 595

CA 36191 Marvin Weinberg Vol#: 595

CA 36192 Kenneth J. Tannen Vol#: 595

CA 36193 Anne Niederman Vol#: 595

CA 36194 Barbara J. Engel Vol#: 595

CA 36195 Dale W. Engel Vol#: 595

CA 36196 Richard F. Duckwall Vol#: 595

CA 36197 Richard F. Duckwall Vol#: 595

CA 36198 Mrs. Margaret S. Dudley Vol#: 595

CA 36199 David Hugh Birley Vol#: 595

CA 36200 Mrs. John B. Bystricky Vol#: 595

CA 36201 Mrs. William E. Sellars Vol#: 595

CA 36202 Joseph F. Kunz Vol#: 595

CA 36203 Marita E. Paparelli Vol#: 595

CA 36204 Donal S. Sharp Vol#: 595

CA 36205 Joseph G. Meyck Vol#: 595

CA 36206 Lois Singer & 59 other signatures Vol#: 595

CA 36207 Patricia A. & William J. Puhl Vol#: 595

CA 36208 Warren Allen Smith Vol#: 595

CA 36209 Mrs. W. A. Turner Vol#: 595

CA 36210 Anthony V. Kulis Vol#: 595

CA 36211 Frank A. Augsbury, Jr. Vol#: 595

CA 36212 Mrs. Hugh H. Howell, III Vol#: 595

CA 36213 Number Not Used Vol#: 595

CA 36214 Richard M. & Jane P. Lieberman Vol#: 595

CA 36215 Marcy Wright Vol#: 595

CA 36216 Jacquelyn Friedlander Vol#: 595

CA 36217 Mrs. Henry P. (Vivian) DeGooyer Vol#: 595

CA 36218 Ms. Helen Schaffer Vol#: 595

CA 36219 Mrs. Rita Ballas Vol#: 595

CA 36220 J. J. & Barbara D. Casey Vol#: 595

CA 36221 Joe R. McFarlane, Jr., M. D. Vol#: 595

CA 36222 Mrs. Virginia Best Vol#: 595

CA 36223 Eli Becker Vol#: 595

CA 36224 Charlotte Randall & 5 other signatures Vol#: 595

CA 36225 Richard L. Schmalz Vol#: 595

CA 36226 Jack P. Taylor Vol#: 595

CA 36227 George W. Gray Vol#: 595

CA 36228 J. W. Morrison Vol#: 595

CA 36229 Richard L. Nagle, Jr. Vol#: 595

CA 36230 Samuel A. Clark, Jr. Vol#: 595

CA 36231 William Golub Vol#: 595

CA 36232 Mrs. Judy Fonville Vol#: 595

CA 36233 Mrs. Sarah Owings Vol#: 595

CA 36234 Mary Elizabeth Joiner Vol#: 595

CA 36235 Pierre J. Karrari Vol#: 595

CA 36236 W. L. Vanderweil Vol#: 595

CA 36237 Nancy Castleman Vol#: 595

CA 36238 Delight E. Buness Vol#: 595

CA 36239 Anthony V. Kunis Vol#: 595

CA 36240 Lennart A. Sundquist Vol#: 595

CA 36241 Joe P. Adams Vol#: 595

CA 36242 Jean Jordan Vol#: 595

CA 36243 Mrs. John B. Bystricky Vol#: 595

CA 36244 James R. Bailey Vol#: 595

CA 36245 Annis M. Cuppett Vol#: 595

CA 36246 Richard A. & Lois M. Sandberg Vol#: 595

CA 36247 Kenneth D. Hebner Vol#: 595

CA 36248 Joe P. Adams Vol#: 595

CA 36249 Alice P. Butler Vol#: 595

CA 36250 David R. Steindorf, Ph. D. Vol#: 595

CA 36251 Anna Greene Vol#: 595

CA 36276 Harry C. Eggleston Vol#: 596

CA 36277 Mrs. Peter P. Drunen Vol#: 596

CA 36278 Arlene M. Armes Vol#: 596

CA 36279 R. Miller Vol#: 596

CA 36280 P. P. Vandrunen Vol#: 596

CA 36281 D. A. Hardison Vol#: 596

CA 36282 John B. Gravelle Vol#: 596

CA 36283 Mrs. Howard I. Goodman Vol#: 596

CA 36284 Kim R. Meyers Vol#: 596

CA 36285 elizabeth Burch Vol#: 596

CA 36286 Mary K. Myers Vol#: 596

CA 36287 Mrs. Carla Blair Vol#: 596

CA 36288 Flora Lawrence Vol#: 596

CA 36289 Mrs. Minnie Breed Vol#: 596

CA 36290 Mrs. Sam W. Bourland Vol#: 596

CA 36292 The Mosura Family Vol#: 596

CA 36293 Mrs. Jean klabunde Vol#: 596

CA 36294 Richard S. Reade Vol#: 596

CA 36295 Charles J. Vukotich Jr. Vol#: 596

CA 36296 Mrs. Jerry jones Vol#: 596

CA 36297 Robert C. McIntyre Vol#: 596

CA 36298 Paul M. Capdevielle Vol#: 596

CA 36299 Mrs. Marjorie Kastel Vol#: 596

CA 36300 Avery Concernid Citigen Vol#: 596

CA 36301 Mrs. B. W. Vick Vol#: 596

CA 36302 Pierce McDonnell Vol#: 596

CA 36303 Daniel Arbegast Vol#: 596

CA 36304 Jeffrey A. Gordon Vol#: 596

CA 36305 Charlotte M. Roth & Mrs. James P. Roth Vol#: 596

CA 36306 Mrs. Karen Ann Eagle Vol#: 596

CA 36307 Susan Cline & Ann Arbor Mich Vol#: 596

CA 36308 Mrs. Earl. Hodgins Vol#: 596

CA 36309 Mildred McCallester Vol#: 596

CA 36310 George S. Kinkey Vineyard Vol#: 596

CA 36311 Mrs. Melvin Meyer Vol#: 596

CA 36312 Ruth lay Vol#: 596

CA 36313 No Signatures Vol#: 596

CA 36314 Ronald H. Smith Vol#: 596

CA 36315 Lorene Porter Vol#:

CA 36316 Roy E Welduey Vol#: 596

CA 36317 Joan Kaumeyer Vol#: 596

CA 36318 Mrs. C. Parker Vol#: 596

CA 36319 Mr. & Mrs C. L. Hawk Vol#: 596

CA 36320 Roger F. Schlink Vol#: 596

CA 36321 Howard Baum Vol#: 596

CA 36322 Robert W. Hogan Vol#: 596

CA 36324 Christine Moore Vol#: 596

CA 36325 Mrs. Marion Borman Vol#: 596

CA 36326 Dan & Erline Lorkins Vol#: 596

CA 36327 Mrs. harold Edge Vol#: 596

CA 36328 Lillie M. Muller Vol#: 596

CA 36329 Mrs. Max Parker Vol#: 596

CA 36330 Barbara Navarro Vol#: 596

CA 36331 No Signature Vol#: 596

CA 36332 Helga Moles Vol#: 596

CA 36333 Mrs. Louise C. Cleaver Vol#: 596

CA 36334 J. H. Dasdory Vol#: 596

CA 36335 Deborah Truly Vol#: 596

CA 36336 Catherine Pizza Vol#: 596

CA 36338 Trish cottrell Vol#: 596

CA 36339 J. B. Greer Vol#: 596

CA 36341 William H. Spohn Vol#: 596

CA 36342 Mrs. Charles M. Camden Vol#: 596

CA 36343 Aneta H. Carrigan & Harry G. Corrigan Vol#: 596

CA 36344 Mrs Ralph Raetzel Vol#: 596

CA 36345 Ruth Beeler White, Ph.D. Vol#: 597

CA 36346 Judith L. Celeste Vol#: 597

CA 36347 Mrs. Harold Booth Vol#: 597

CA 36348 Nettie & Harold Knarr Vol#: 597

CA 36349 C. Harter Vol#: 597

CA 36350 Mrs. Chester E. Blanton Vol#: 597

CA 36351 Mrs. Don Gross Vol#: 597

CA 36352 Mrs. Mildred T. Schelat Vol#: 597

CA 36353 Mrs. Edna Arnsberg Vol#: 597

CA 36354 Milton Snow Vol#: 597

CA 36355 Bertha Stahlheber Vol#: 597

CA 36356 F. M. Hacunda Vol#: 597

CA 36357 A. B. Joffe Vol#: 597

CA 36358 Mrs. Hudson C. Miller, Jr. Vol#: 597

CA 36359 Lowell Lykins Vol#: 597

CA 36360 Mrs. Edsel M. Lowe Vol#: 597

CA 36361 Mrs. Eugene Yanko Vol#: 597

CA 36362 Harold C. Riley Vol#: 597

CA 36363 Carl G. Ross Vol#: 597

CA 36364 William L. McIntyre II Vol#: 597

CA 36365 Helen Hacunda Vol#: 597

CA 36366 Geo A. Mattison, Jr. Vol#: 597

CA 36367 Mrs. Dorothy H. Parker Vol#: 597

CA 36368 Paul & Margaret Berry Vol#: 597

CA 36369 Carolyn Chapin Vol#: 597

CA 36370 Mr. & Mrs. Joseph D. Gallery Vol#: 597

CA 36371 Mrs. E. L. Palliser Vol#: 597

CA 36373 Susan Young Vol#: 597

CA 36374 Carma Brewer Vol#: 597

CA 36375 Mr. & Mrs. Autura Underwood Vol#: 597

CA 36376 Lee Jensen Vol#: 597

CA 36377 Mrs. William Treadwell Vol#: 598

CA 36378 Mrs. Clyde Tucker Vol#: 598

CA 36379 Mrs. Wm. Sparks Vol#: 598

CA 36380 Delbert & Naomi J. Conley Vol#: 598

CA 36381 Mrs. Jimmy Stevens Vol#: 598

CA 36382 Lorna Jean McLeod Vol#: 598

CA 36383 Edith Serbin Vol#: 598

CA 36384 Homer H. Bryan Vol#: 598

CA 36385 Wilbur Palmer Vol#: 598

CA 36386 James Hedge Vol#: 598

CA 36387 Louis A. Baum Vol#: 598

CA 36388 Mrs. P. Fontenot Vol#: 598

CA 36389 Larry A. Salstrom Vol#: 598

CA 36390 Robert S. Gunter Vol#: 598

CA 36391 Thelma Brady Vol#: 598

CA 36392 Beverly DeVore Vol#: 598

CA 36393 George Harman Vol#: 598

CA 36394 Lois J. Hiett Vol#: 598

CA 36395 Mrs. William F. See Vol#: 598

CA 36396 Warner D. McKinnon Vol#: 598

CA 36397 Kate Ferriter Vol#: 598

CA 36398 Mrs. Roxie Martin Vol#: 598

CA 36399 James Porterfield Vol#: 598

CA 36400 Mrs. Harold E. Ray Vol#: 598

CA 36401 Jack Wulfmeyer Vol#: 598

CA 36402 Caroline N. Delsanter Vol#: 598

CA 36403 Atcheson, Cartwright & Associates Vol#: 598

CA 36404 Kathleen E. Multhauf Vol#: 598

CA 36405 Norman F. Stone, Ph.D. Vol#: 598

CA 36406 Mrs. Gerald L. Houstons Vol#: 598

CA 36408 Albert Bean Jr. Vol#: 598

CA 36409 Akron Speech and Reading Center Vol#: 598

CA 36410 Loren & Eunice Anderson Vol#: 598

CA 36411 Randall J. Dicks Vol#: 598

CA 36412 Johnny Miles Vol#: 598

CA 36413 Marilyn Pasierb Vol#: 598

CA 36414 Diana J. Hough Vol#: 598

CA 36415 Leon Segal Vol#: 598

CA 36416 Sanna E. Obermiller Vol#: 598

CA 36417 Ohio Poultry Association Vol#: 598

CA 36418 Norma L. Cucci Vol#: 598

CA 36419 Susan Coats Vol#: 598

CA 36420 Sam L. Davies Vol#: 598

CA 36421 Mrs. Janet E. Hamilton Vol#: 598

CA 36422 Beverly Edwards Vol#: 598

CA 36423 Joseph L. Massett Vol#: 598

CA 36424 Mrs. Bill G. Mauldin Vol#: 598

CA 36425 Joseph H. & Sybil S. Dilkes Vol#: 598

CA 36426 Margaret A. Norman Vol#: 598

CA 36427 Richard R. DeGregorio Vol#: 598

CA 36428 Susan Crone Vol#: 598

CA 36429 Mr. John Hennessy Vol#: 598

CA 36430 Mr. & Mrs. J. R. Krabbenhoft Vol#: 598

CA 36431 Ms. Maidie Waller Vol#: 598

CA 36432 Sheila Crone Vol#: 598

CA 36433 E. Famok Vol#: 598

CA 36434 F. A. Kolder Vol#: 598

CA 36437 William M. Glasgow Vol#: 598

CA 36438 Miss Linda Drumm Vol#: 598

CA 36439 Mrs. Marie Srour Vol#: 598

CA 36440 Mrs. Julia L. Krapfl Vol#: 598

CA 36441 Mrs. Wayne Calloway Vol#: 598

CA 36442 Gary Oldnettle Vol#: 598

CA 36443 Lorraine Hall Vol#: 598

CA 36444 Jim Trotter Vol#: 598

CA 36446 Paul A. Runge Vol#: 598

CA 36447 C. W. Nance Vol#: 598

CA 36449 Mrs. Zela Patterson Vol#: 598

CA 36450 Leslie McIntyre Vol#: 598

CA 36451 Harold H. Hall Vol#: 598

CA 36452 Ruth Boyle Vol#: 598

CA 36453 Claudia J. Miller Vol#: 598

CA 36454 Paul J. Riley Vol#: 598

CA 36455 Toni Shover Vol#: 598

CA 36456 Susan A. Boolukos Vol#: 598

CA 36457 Mr. & Mrs. T. S. Gapen Vol#: 598

CA 36458 Kathy McNay Vol#: 598

CA 36459 Andrew J. Price Vol#: 598

CA 36460 Marion Knoblauch-Franc Vol#: 598

CA 36461 B. Evans Vol#: 598

CA 36462 Ruth Stoker Vol#: 598

CA 36463 Patricia Lawyer Vol#: 598

CA 36464 Mrs. Tracy Barr Vol#: 598

CA 36465 Karen Barneo Vol#: 598

CA 36466 Robert C. McIntyre, Jr. Vol#: 598

CA 36467 Mrs. Robert Strine Vol#: 598

CA 36468 Mary Rapone Vol#: 598

CA 36469 Mrs. Linda Wozniak Vol#: 598

CA 36470 T. A. Alder Vol#: 598

CA 36472 James C. Breeden Vol#: 599

CA 36473 Bob Bourdene, C. L. U. Vol#: 599

CA 36474 Phil Spector Vol#: 599

CA 36475 Mrs. A. J. Peschke Vol#: 599

CA 36476 Joseph P. Campione Vol#: 599

CA 36477 Mary Davis Vol#: 599

CA 36478 Mr. & Mrs. (Nicki) Anthony Sacco Vol#: 599

CA 36479 Frederick S. Shaffer Vol#: 599

CA 36480 Dana Knight Vol#: 599

CA 36481 Mrs. Judith Broyles Vol#: 599

CA 36482 Gail A. Vancil Vol#: 599

CA 36483 Mrs. Marjorie Weber Vol#: 599

CA 36484 Mrs. Lena Curtin Vol#: 599

CA 36485 No Submitter Vol#: 599

CA 36486 W. E. Hammack Vol#: 599

CA 36487 Mrs. George Stille Vol#: 599

CA 36488 Janice M. Stuessi Vol#: 599

CA 36489 Carole Tomter Vol#: 599

CA 36490 Rev. Eugene M. Higney Vol#: 599

CA 36491 William K. Viertel Vol#: 599

CA 36492 Janet Lecompte Vol#: 599

CA 36493 Peter Bassi Vol#: 599

CA 36495 Mrs. Verna D. Mikelonis Vol#: 599

CA 36496 Linda Bagg Vol#: 599

CA 36497 Elise Cheney & Jason W. Guy Vol#: 599

CA 36498 Janet Englefield Vol#: 599

CA 36499 D. G. Peterson Vol#: 599

CA 36500 Mrs. Harold I. Fanth Vol#: 599

CA 36501 Barbara Hyde, R. N. Vol#: 599

CA 36502 Ruth B. Kimball Vol#: 599

CA 36503 Mrs. Evelyn Brown, R. N. Vol#: 599

CA 36504 Mrs. Arthur F. Prodell Vol#: 599

CA 36505 Harold Hammond Vol#: 599

CA 36506 Gloria D. Roby Vol#: 599

CA 36507 Clayton H. Jaster Vol#: 599

CA 36508 Mrs. Peggy Dale Vol#: 599

CA 36509 Lee V. Leneker Vol#: 599

CA 36510 John R. Stedham Vol#: 599

CA 36511 Mrs. Lawrence E. Mawn Vol#: 599

CA 36512 Peggy V. Steir Vol#: 599

CA 36513 Cathryn Tepe Vol#: 599

CA 36514 Mrs. A. M. Rawlings Vol#: 599

CA 36515 Florence Whessel Vol#: 599

CA 36516 Mr. & Mrs. Pete Zilke Vol#: 599

CA 36517 Leona M. Wandschneider Vol#: 599

CA 36518 Debra M. Bubeault Vol#: 599

CA 36519 Robert G. Dent Vol#: 599

CA 36520 Carol P. & Howard J. Colier, M. D. Vol#: 599

CA 36521 Mrs. Marie Jean Weld Vol#: 599

CA 36522 Jan Stephens Vol#: 599

CA 36523 Helen F. Jones Vol#: 599

CA 36524 Joseph & Jacqueline Kennedy & 1 other Vol#: 599

CA 36525 Connie Sweeney Vol#: 599

CA 36526 Donna Liston Vol#: 599

CA 36527 Mattie Gustin Vol#: 599

CA 36528 Mary Kersnick Vol#: 599

CA 36529 Carol Kahn Vol#: 599

CA 36530 Betty Cohlie Vol#: 599

CA 36531 Barbara McCarter Vol#: 599

CA 36532 Irene F. Ficarra Vol#: 599

CA 36533 Mrs. Diana Brustrom Vol#: 599

CA 36534 Marjorie M. Hilton Vol#: 599

CA 36535 Dan Ferry Vol#: 599

CA 36536 Paulette Milligan Vol#: 599

CA 36537 Mrs. Katharine N. Hubbard Vol#: 599

CA 36538 Mrs. Paul Lehn Vol#: 599

CA 36539 Lois Lauber Vol#: 599

CA 36540 Norman H. Hobson Vol#: 599

CA 36541 Mrs. Fred P. Fariss Vol#: 599

CA 36542 Mrs. K. Bechter Vol#: 599

CA 36543 Harry A. Delgado Vol#: 599

CA 36544 L. A. Enkema Vol#: 599

CA 36545 Lou B. Brannon Vol#: 599

CA 36546 Mrs. Lester T. Piner Vol#: 599

CA 36547 C. B. Kelley Vol#: 599

CA 36548 Guy Tarrance, Jr. Vol#: 599

CA 36549 Vicki Hawkins Vol#: 599

CA 36550 Mrs. Dorothy Capron Vol#: 599

CA 36551 Mrs. Glenn C. Hamilton Vol#: 599

CA 36552 Mr. & Mrs. James A. Burbidge Vol#: 599

CA 36553 L. A. Enkema Vol#: 599

CA 36554 Philip Cohen Vol#: 599

CA 36555 Virginia Pierson & 19 other signatures Vol#: 599

CA 36556 Lesley D. Gray Vol#: 599

CA 36557 William J. Gill, Ph. D. Vol#: 599

CA 36558 Estelle Darian Vol#: 599

CA 36559 Curtis E. Pickens Vol#: 599

CA 36560 Debbie Rupp Vol#: 599

CA 36561 Harry A. Delgado Vol#: 599

CA 36562 Robert J. Crone Vol#: 599

CA 36563 Richard Rosenberg Vol#: 599

CA 36564 Mrs. E. J. Corcoran Vol#: 599

CA 36565 Ray & Margaret White Vol#: 599

CA 36566 Mrs. Betty N. Lonis Vol#: 599

CA 36567 Irma Pigott Vol#: 599

CA 36568 Marion Hawkins Vol#: 599

CA 36570 Mr. & Mrs. Warren Kracke Vol#: 599

CA 36571 Rev. Harold Wright Vol#: 600

CA 36572 Richard F. Corwin Vol#: 600

CA 36573 Beverly Baer Vol#: 600

CA 36574 William R. Kenney Vol#: 600

CA 36575 Candy Speer Vol#: 600

CA 36671 Mrs. K. W. Clemens & Family Vol#: 601

CA 36672 Bruce Mills Vol#: 601

CA 36673 Peter F. Maunoir Vol#: 601

CA 36674 Frank M. Vierra Vol#: 601

CA 36675 Cason Rucker Vol#: 601

CA 36676 Jackie Coleman Vol#: 601

CA 36677 Robert B. McNamara Vol#: 601

CA 36678 Hudson Metals Vol#: 601

CA 36679 N. Ray Tipton Vol#: 601

CA 36680 Mr. John K. & Mrs. Bettye Jan Adair Vol#: 601

CA 36681 Schrock Bros., Inc. Vol#: 601

CA 36683 Joan Dunn Vol#: 601

CA 36684 Patricia L. Shore Vol#: 601

CA 36685 Dr. Krystyna Lemieszek Vol#: 601

CA 36686 Marilyn J. Dexter Vol#: 601

CA 36687 F. J. McIntyre Vol#: 601

CA 36688 Thomas E. Ohm Vol#: 601

CA 36689 Kathy Beal Vol#: 601

CA 36690 Geraldine Sweeney Vol#: 601

CA 36691 Stephanie L. Rice Vol#: 601

88N-0038 Records & Reports concerning experience w/ new animal drugs

NIR 1 Vol#: 1

94S-0120 510K Substantially Equivalent List

LST 111 List of January 2002 Vol#: 27

98N-1038 Irradiation in the production, processing, &handling of food

EMC 651 Katherine L. Krupka Vol#: 185

EMC 652 John Kesich Vol#: 185

EMC 653 Paul B. Stewart Vol#: 185

EMC 654 Stacy Buckles Vol#: 185

EMC 655 Philip Stadelman Vol#: 185

EMC 656 Amy Biskovich Vol#: 185

EMC 657 Elena Pinto Vol#: 185

EMC 658 Naomi Hospodarsky Vol#: 185

EMC 659 Elizabeth Kline Vol#: 185

EMC 660 Melissa Gaines Vol#: 185

EMC 661 Carli Gaskill Vol#: 185

EMC 662 Celia Ramirez Vol#: 185

EMC 663 Rosemarie Sawdon Vol#: 185

EMC 664 Nina Silver Vol#: 185

EMC 665 Ruth Bryant Vol#: 185

EMC 666 Ruth Bryant Vol#: 185

EMC 667 Charles Mies Vol#: 185

EMC 668 Janet Hitt Vol#: 185

EMC 669 James Moffitt Vol#: 185

EMC 670 Thomas O' Grady Vol#: 185

EMC 671 Lisa Garcia Vol#: 185

EMC 672 Karen Kinsman Vol#: 185

EMC 673 Janet Hitt Vol#: 185

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

C 5514 Petros Tzavellas Vol#: 203

C 5515 Patricia E. Culver Vol#: 203

C 5516 Janice Emich Vol#: 203

C 5517 Walter M. Desher Vol#: 203

C 5518 Jane Levy Vol#: 203

C 5519 Mrs. Trent Meacham Vol#: 203

C 5520 Sondra Cannon Vol#: 203

C 5521 The Boyd Family Vol#: 203

C 5522 Wells Keddie & Mary Gibson Vol#: 203

C 5523 Kathryn Lezenby Vol#: 203

C 5524 Donald L. Wert Vol#: 203

C 5525 Kathleen Gillman Vol#: 203

C 5526 Janine Marre Vol#: 203

C 5527 Patricia Aufdenberg Vol#: 203

C 5528 RoseMarie J. Tubertini Vol#: 203

C 5529 Jacqueline Morgan Sharkey Vol#: 203

C 5530 Maxine B. Gates Vol#: 203

C 5531 Richard A. Compagni Vol#: 203

C 5532 Nancy Sailor Vol#: 203

C 5533 Linda V. Vol#: 203

C 5534 Anastasia Thermos Vol#: 203

C 5535 Mr. Mark Blackburn Vol#: 203

C 5536 Joy Wilder Vol#: 203

C 5537 Carol Nelson Vol#: 203

C 5538 Linda Cannon-Huffman Vol#: 203

C 5539 Margery Hall Vol#: 203

C 5540 Karen Ide Vol#: 203

C 5541 Edythe Zimmerman Vol#: 203

C 5542 Pamela Stones Vol#: 203

C 5543 Frank & Faye Evans Vol#: 203

C 5544 Rena Powell Vol#: 203

C 5545 Enrieo Praesepio Vol#: 203

C 5546 Carrol McDonald Vol#: 203

C 5547 Kathy Sellers Vol#: 203

C 5548 Nancy Nagel Vol#: 203

C 5549 Lynn F. Wallace Vol#: 203

C 5550 Caryn F. Ginsberg Vol#: 203

C 5551 Marilynn M. Cafrurey Vol#: 203

C 5552 Ms. Patricia Sawyer Vol#: 203

C 5553 Kathrin Kraft Vol#: 203

C 5554 Kirsti B. Gholson Vol#: 203

C 5555 Joy Kamer Vol#: 203

C 5556 Beth Brogle Vol#: 203

C 5557 Ingrid Casas Vol#: 203

C 5558 Farm Sanctuary Vol#: 203

C 5559 Elizabeth Muellers Vol#: 203

C 5560 Bonnie Bennett Vol#: 203

C 5561 William C. Kerr Vol#: 203

99P-1340 Declared Eternity eau de Parfum Misbranded

C 738 Ariel F. Barfield, Ph.D. Vol#: 18

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9667 Riedia Zielke Vol#: 476

C 9668 No signature Vol#: 476

C 9669 Tim Diehlman Vol#: 476

C 9670 Lois L. Gardner Vol#: 476

C 9671 Patricia Evans Vol#: 476

C 9672 Mary Hunter Vol#: 476

C 9673 Avis M. Fisher Vol#: 476

C 9674 Larry Mikkelson Vol#: 476

C 9675 Sharon R. Thornah Vol#: 476

C 9676 Anastasia Thermos Vol#: 476

C 9677 LaCretia Dickerson Vol#: 476

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9218 Larry Mikkelson Vol#: 404

C 9219 Avis M. Fisher Vol#: 404

C 9220 Mary Hunter Vol#: 404

C 9221 Patricia Evans Vol#: 404

C 9222 Lois Laznik Gardner Vol#: 404

C 9223 Jim Diehlman Vol#: 404

C 9224 Unsigned Vol#: 404

C 9225 Riedia Zielke Vol#: 404

C 9226 LaCretia Dickerson Vol#: 404

C 9227 Anastasia Thermos & Petros Tzowellas Vol#: 404

C 9228 Kevin Uehlinger Vol#: 404

C 9229 Janet Hitt Vol#: 404

C 9230 Debra R. Deninger Vol#: 404

C 9231 Veronica Corea Vol#: 404

01P-0323 Not rely on non-public filings to approve an innovator NDA;

LET 1 HFD-1 to Pfizer Inc. & Pharmacia Corp. Vol#: 1

02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products

ACK 1 HFA-305 Vol#: 1

CP 1 Hoffmann-La Roche Inc. Vol#: 1