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 1, 2002

TABLE OF CONTENTS

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77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
78N-0038 Sunscreen Drug Products *
80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use *
95S-0117 Human Drugs Patent Term Extension & New Patents *
99P-5198 Request amendment of the definition of milk *
01D-0432 Evalution of the effects of Orally Inhaled and Intranasal *
01D-0488 Food-Effect Bioavailability & Fed Bioequivalence Studies *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01P-0117 Rescind Approval of Solid Oral Dosage form of Metaxalone *
01P-0333 Non-lyophilized Cytoxan *
01P-0356 Amend approved drug products with "Orange Book" 21st list *
01P-0396 Request that FDA ban the production and sale of all ephedra *
01P-0585 Requirement of ANDA for Mixed Salts of Single Entity Amphet *
01P-0586 New and/or Amended Regulations for BPCA *
02P-0057 ANDA Suitability Ventolin Albuterol Sulfate Inhalation *

77N-0085 Saccharin and Its Salts

CA 34663 Nancy M. Ketola Vol#: 578

CA 34664 Maraline Parr Vol#: 578

CA 34665 Lynn Stalter Vol#: 578

CA 34666 Mya Gans Vol#: 578

CA 34667 Mrs. J. J. McCormick Vol#: 578

CA 34668 John Pozzo Vol#: 578

CA 34669 William D. Hanna Vol#: 578

CA 34670 A. L. Kiser Vol#: 578

CA 34671 Donald A. Perry Vol#: 578

CA 34672 Carolyn A. Neyhard Vol#: 578

CA 34673 Craig Lazinsky Vol#: 578

CA 34674 Mrs. Thelma B Revelle Vol#: 578

CA 34675 Thomas R. Rath & Elaine S. Rath Vol#: 578

CA 34676 N. C. Spangler Vol#: 578

CA 34677 Mr. & Mrs. Mel Marks Vol#: 578

CA 34678 Mrs. Olive J. Wilson Vol#: 578

CA 34679 John M. little Vol#: 578

CA 34680 Mrs Robert M. Blitz Vol#: 578

CA 34681 Dotty Wilson Vol#: 578

CA 34682 Mr. & Mrs. John T. Alston Vol#: 578

CA 34683 Mr. 7 Mrs. Marion B. jett Vol#: 578

CA 34684 Mrs. Gerald Roseland Vol#: 578

CA 34685 Christine Landan Vol#: 578

CA 34686 Mrs. Margaret Edmancgyh Vol#: 578

CA 34687 Mr. & Mrs. Bernard J. Maas Vol#: 578

CA 34688 Mrs. Thomas Murphy Vol#: 578

CA 34689 Donna Olson Vol#: 578

CA 34690 Alexander Marble Vol#: 578

CA 34691 David T. Hastings Vol#: 578

CA 34692 Mrs. Claggett Martin Vol#: 578

CA 34693 Edward J. Brickhouse Vol#: 578

CA 34694 Virgil H. & Mabel L. bishop Vol#: 578

CA 34695 Mrs. John R. Gee Vol#: 578

CA 34696 Joanne Holzknecht Vol#: 578

CA 34697 Mrs. Arthur Webber Vol#: 578

CA 34698 Mrs. Ruth Broods Vol#: 578

CA 34699 No Signature Vol#: 578

CA 34700 Larry Sharyl & Meija Boatman Vol#: 578

CA 35242 Harold Hazel Vol#: 584

CA 35243 Joanne S. & Donald R. Haines Vol#: 584

CA 35244 R. L. Lewis Vol#: 584

CA 35245 Tonda M. McComas Vol#: 584

CA 35246 Douglas Darlington Vol#: 584

CA 35247 Leslie C. & Thelda H. Rowe Vol#: 584

CA 35248 Philip Blume, M. D. Vol#: 584

CA 35249 Mrs. Beverly M. Miller Vol#: 584

CA 35250 Betty Lou & Paul W. Moore Vol#: 584

CA 35251 Lynne A. Wedel Vol#: 584

CA 35252 Lynne A. Wedel Vol#: 584

CA 35253 Sol Weil Vol#: 584

CA 35254 Janice M. & John D. Shaw Vol#: 584

CA 35255 Theresa Richardson Vol#: 584

CA 35256 Charles E. Lind Vol#: 584

CA 35257 Helen Lovell Vol#: 584

CA 35258 Margaret Ferman Vol#: 584

CA 35259 Myrtle A. Hutchins Vol#: 584

CA 35260 Lloyd E. Skinner Vol#: 584

CA 35261 Ruth Rosenfelder Vol#: 584

CA 35262 Mrs. Colon A. Brown Vol#: 584

CA 35263 Mildred Coulter Vol#: 584

CA 35264 E. J. Tucker, M. D. Vol#: 584

CA 35265 Marie O. Buckels Vol#: 584

CA 35266 Marjorie M. Blanchard Vol#: 584

CA 35267 John W. Turner Vol#: 584

CA 35268 John Burger Vol#: 584

CA 35269 Rosemary Stabeno Vol#: 584

CA 35270 Marion D. Lovora Vol#: 584

CA 35271 H. Becker Vol#: 584

CA 35272 Sara B. Clark Vol#: 584

CA 35273 Thomas Howe Vol#: 584

CA 35274 Norman Beidler Vol#: 584

CA 35275 Mrs. Jill Caraway Vol#: 584

CA 35276 Karen Tish & 8 other signatures Vol#: 584

CA 35277 Helen & Sterling Brandt Vol#: 584

CA 35278 Christine F. Turrentine Vol#: 584

CA 35279 Sharon Jaeger Vol#: 584

CA 35280 Mrs. Linda K. Key Vol#: 584

CA 35281 Margaret & Paul Hamer Vol#: 584

CA 35282 Harry R. & Inez E. Langley Vol#: 584

CA 35283 Daniel W. Nightingale Vol#: 584

CA 35284 Warren Mandlin Vol#: 584

CA 35285 Minnie A. Deutsch Vol#: 584

CA 35286 Richard A. Van Winkle Vol#: 584

CA 35287 Mr. & Mrs. Edward G. Wright Vol#: 584

CA 35288 Mrs. John N. Oglesby Vol#: 584

CA 35289 William A. Shoemaker, Jr., D. D. S. Vol#: 584

CA 35290 Charles E. Lind Vol#: 584

CA 35291 The Chandler Family Vol#: 584

CA 35292 Mr. & Mrs. T. C. Griscom Vol#: 584

CA 35293 Margaret Keller Vol#: 584

CA 35294 Mr. & Mrs. Robert Galloway Vol#: 584

CA 35295 Mrs. Olivia Spencer Vol#: 584

CA 35296 Farren B. & Winifred R. G. Jensen Vol#: 584

CA 35297 Yvonne L. Smith Vol#: 584

CA 35298 Mrs. Edward Kastl Vol#: 584

CA 35299 Reuben A. Jacoby Vol#: 584

CA 35300 Dolores Kehler Vol#: 584

CA 35301 Ivan Offilkoff & Robert Aykens Vol#: 584

CA 35302 Dan Paul Gilbert Vol#: 584

CA 35303 Gene Chapman Vol#: 584

CA 35304 John S. Helling Vol#: 584

CA 35305 Nancy J. Klingensmith & 15 other sign. Vol#: 584

CA 35306 Joseph J. Newman Vol#: 584

CA 35307 David Neill Vol#: 584

CA 35308 E. G. Scheiber Vol#: 584

CA 35309 Ruth E. Dewey Vol#: 584

CA 35310 Karen Fisher & 37 other signatures Vol#: 584

CA 35311 George E. Curtis Vol#: 584

CA 35312 Ms. Sandra A. Gardner Vol#: 584

CA 35313 Milanne Bancroft Vol#: 584

CA 35314 Mrs. R. E. Burgamy, Jr. Vol#: 584

CA 35315 Patricia M. Cutkomp Vol#: 584

CA 35316 Elizabeth K. Bates Vol#: 584

CA 35317 Janice A. Vanbinder Vol#: 584

CA 35318 C. Thomas Gavin Vol#: 584

CA 35319 Mr. & Mrs. M. G. Stark Vol#: 585

CA 35320 Wilbur F. Garber Vol#: 585

CA 35321 Cheryl L. Mendonsa & 27 other signatures Vol#: 585

CA 35322 Meriam S. Treadwell Vol#: 585

CA 35323 Linda J. Barnes Vol#: 585

CA 35324 James E. Floyd Vol#: 585

CA 35325 Jim & Lisa Carnevale Vol#: 585

CA 35326 Didi Tarne Vol#: 585

CA 35327 Mrs. Patricia D. Weed Vol#: 585

CA 35328 Shannon M. Lewis Vol#: 585

CA 35330 Jane Edgerton Vol#: 585

CA 35333 Mr. & Mrs. L. C. Hinton Vol#: 585

CA 35334 Charles P. Storrs Vol#: 585

CA 35335 Daniel M. & Mary-Ellen Hrisak Vol#: 585

CA 35336 E. Kathleen Ligon Vol#: 585

CA 35337 Julia Ann Breidenstein Vol#: 585

CA 35338 Stella L. Dumm Vol#: 585

CA 35339 John K. Nelson Vol#: 585

CA 35340 Lorraine Ostler Vol#: 585

CA 35341 John Fiscocoski Vol#: 585

CA 35342 Dana T. Johnson Vol#: 585

CA 35343 Billy Weathington Vol#: 585

CA 35344 P. E. Pothier Vol#: 585

CA 35345 Mrs. Sheila B. Pineda Vol#: 585

CA 35346 John G. Fleckenstein Vol#: 585

CA 35347 Steven J. Schwartz Vol#: 585

CA 35348 Mrs. Martha O. Benton Vol#: 585

CA 35349 Otto E. Spokas Vol#: 585

CA 35350 John Gex Vol#: 585

CA 35351 John E. Geschwindt Vol#: 585

CA 35352 Mrs. Virginia Wyatt Vol#: 585

CA 35353 Nancy Petschek Vol#: 585

CA 35354 Steve Owens Vol#: 585

CA 35355 Frank K. Bosworth, Jr. Vol#: 585

CA 35357 Ms. Patricia Pollock Vol#: 585

CA 35358 Linda Wilshusen Vol#: 585

CA 35359 Herbert D. Pearlson Vol#: 585

CA 35360 J. Richard & Susan E. Horner Vol#: 585

CA 35361 Kathryn J. Axe & 19 other signatures Vol#: 585

CA 35362 Conni Boughan Vol#: 585

CA 35363 Stuart H. Lane Vol#: 585

CA 35364 Number Not Used Vol#: 585

CA 35365 Robert J. Kalupa Vol#: 585

CA 35366 Linda Bourgeois Austin Vol#: 585

CA 35367 Mrs. Debra J. Matteucci Vol#: 585

CA 35368 Shirley J. Arbini Vol#: 585

CA 35369 John A. Heldman Vol#: 586

CA 35370 Mr. & Mrs. W. Cucura Vol#: 586

CA 35371 Carolyn and Janet White Vol#: 586

CA 35372 Barbara J. Engel Vol#: 586

CA 35373 Marguerite Irwin Vol#: 586

CA 35374 Ralph E. Mason Vol#: 586

CA 35375 Ms. Leigh Hicks Vol#: 586

CA 35376 Ms.Janice S. Friedland+21 Signatures Vol#: 586

CA 35377 Mrs. Connie S. Clark Vol#: 586

CA 35378 Kathleen P.Hoffman Vol#: 586

CA 35379 Nancy Butler Francis Vol#: 586

CA 35380 Michael Rouse Vol#: 586

CA 35381 Martin R. Shainen Vol#: 586

CA 35382 John E.Cherrix Vol#: 586

CA 35384 Robert Kamerschen Vol#: 586

CA 35385 Kenneth C.Becker Vol#: 586

CA 35386 Miss Jackie Needham Vol#: 586

CA 35387 Mrs.Patricia A.Puhl Vol#: 586

CA 35388 Byron H. Brown Vol#: 586

CA 35389 Mrs. Bea Baker Vol#: 586

CA 35390 Norma Ann Cole Vol#: 586

CA 35391 Jennifer Goldfinger Vol#: 586

CA 35392 Mr. & Mrs. Douglas B. Kenney Vol#: 586

CA 35393 Wallace F. and Loraine Blackburn Vol#: 586

CA 35394 George H. Batchelder Vol#: 586

CA 35395 Ernestine Tye Vol#: 586

CA 35396 Fred Weiss Vol#: 586

CA 35397 Mrs. Dixie Weems Vol#: 586

CA 35398 Gerald F. Marine Vol#: 586

CA 35399 Jill M. Da Via Vol#: 586

CA 35400 Esther A. Middlewood Vol#: 586

CA 35401 Marjorie Shields Vol#: 586

CA 35402 James A.Robertson Vol#: 586

CA 35403 Mrs. Sandra Louise Johnson Vol#: 586

CA 35404 Mrs. Florence L. Parman Vol#: 586

CA 35405 Cynthia Clinger Vol#: 586

CA 35406 John W. Purvis Vol#: 586

CA 35407 Linda Hughes Vol#: 586

CA 35408 Linda Lebovitz Vol#: 586

CA 35409 John K. Nelson Vol#: 586

CA 35410 Martyl J. Pollak Vol#: 586

CA 35411 Dorothy A. Schmit Vol#: 586

CA 35412 George W.Jenkins Vol#: 586

CA 35413 Barbara Armstrong Vol#: 586

CA 35414 P.J.Brammer Vol#: 586

CA 35415 Mr. David Orr Vol#: 586

CA 35469 Richard A. Abeles Vol#: 587

CA 35470 Barry Beeson Vol#: 587

CA 35471 Judith K. Brandenburg Vol#: 587

CA 35472 Maurice L. & Eva E. Bullard Vol#: 587

CA 35473 Mae Duty Vol#: 587

CA 35474 Mrs. Don Williams, Jr. Vol#: 587

CA 35475 Gerald S. Michuda Vol#: 587

CA 35476 William & Ellen Reinke Vol#: 587

CA 35477 Nedra K. Fischer Vol#: 587

CA 35478 Allan L. Burdick Vol#: 587

CA 35479 Judi Grivna Vol#: 587

CA 35481 Mrs. Don Williams, Jr. Vol#: 587

CA 35482 Rose Walcoff Vol#: 587

CA 35483 Patricia L. Kraus Vol#: 587

CA 35484 Sunnie Bates Vol#: 587

CA 35485 May E. Sand Vol#: 587

CA 35486 Elizabeth J. Edwards Vol#: 587

CA 35487 Mrs. Gertrude C. Bosowski Vol#: 587

CA 35488 Mary Womack Vol#: 587

CA 35489 Wena Dows Vol#: 587

CA 35490 Ruth B. Hoerdt Vol#: 587

CA 35491 Ruth M. Taylor Vol#: 587

CA 35492 J. W. Morrison Vol#: 587

CA 35493 Helen Lemak Vol#: 587

CA 35494 Verla Southcombe Vol#: 587

CA 35495 Joan Hancock & 11 other signatures Vol#: 587

CA 35496 Barbara J. Garry Vol#: 587

CA 35497 Robert B. Mauterstock, Jr. Vol#: 587

CA 35498 Arthur G. Gruner Vol#: 587

CA 35499 George A. Davis Vol#: 587

CA 35500 Raymond F. Stokes Vol#: 587

CA 35501 Mrs. William S. Wilkinson Vol#: 587

CA 35502 Carol A. Knoles Vol#: 587

CA 35503 J. W. Morrison Vol#: 587

CA 35504 Ruth B. Hoerdt Vol#: 587

CA 35505 Mr. & Mrs. W. D. Hartmann Vol#: 587

CA 35506 Mattland B. Knox Vol#: 587

CA 35507 Robert F. Peterson Vol#: 587

CA 35508 Coralie M. Knight Vol#: 587

CA 35509 Philip Pollak Vol#: 587

CA 35511 Pauline Cruciano Vol#: 587

CA 35512 T. Dale Neuendorf Vol#: 587

CA 35513 Fred Weiss Vol#: 587

CA 35514 Ms. Barbara Schafale Vol#: 587

CA 35515 Julia Ann Flanigan Vol#: 587

CA 35516 Ralph W. Gibbs Vol#: 587

CA 35517 Joan Hancock & 9 other signatures Vol#: 587

CA 35518 Shirley J. Arbini Vol#: 587

CA 35519 William S. Bush Vol#: 587

CA 35520 Jeannie Benetti Vol#: 587

CA 35521 Margie L. Bolen Vol#: 587

CA 35522 N. C. Walton Vol#: 587

CA 35523 Helen J. Richardson Vol#: 587

CA 35524 Francis R. Campbell Vol#: 587

CA 35525 Sarah F. Smith, R. N. Vol#: 587

CA 35526 Rosalie I. Ruse Vol#: 587

CA 35527 Dr. William Frank Vol#: 587

CA 35528 Charles C. Moats Vol#: 587

CA 35529 Sidney Witzer Vol#: 587

CA 35530 June Padgett Vol#: 587

CA 35531 Mrs. Paul Von Moos Vol#: 587

CA 35532 David A. Johnson Vol#: 587

CA 35533 Sandra J. Roupp Vol#: 587

CA 35535 Barbara Scherer Vol#: 587

CA 35536 Cynthia Shawley Vol#: 587

CA 35538 Clifton S. Merkert Vol#: 587

CA 35539 Jack M. Turner Vol#: 587

CA 35540 Margaret A. Guenther Vol#: 587

CA 35541 Rebecca Blum Vol#: 587

CA 35542 Mrs. Hugh N. Howell, III Vol#: 587

CA 35543 Micheal Shanik Vol#: 587

CA 35544 Jack P. Taylor Vol#: 587

CA 35545 Jean Short Vol#: 587

CA 35546 Lynda Jackson Vol#: 587

CA 35547 Carolyn Wolf Vol#: 587

CA 35548 Mr. Henry H. Kurtz, Jr. Vol#: 587

CA 35549 Beverly C. Wamble Vol#: 587

CA 35550 Mrs. Frank M. Littleton Vol#: 587

CA 35551 Number Not Used Vol#: 587

CA 35552 Mary C. Tice Vol#: 587

CA 35553 Marsha L. Overstreet & 78 other sign. Vol#: 587

CA 35554 Mrs. Verlan K. Klassen Vol#: 587

CA 35555 Donna Core Vol#: 587

CA 35556 Lorraine Ostler Vol#: 587

CA 35557 Number Not Used Vol#: 587

CA 35558 Number Not Used Vol#: 587

CA 35559 Elaine Salcido Vol#: 587

CA 35560 Betty A. Cichoski Vol#: 587

CA 35561 Carroll V. Springer Vol#: 587

CA 35562 Harold H. Zirkel Vol#: 587

CA 35563 Janet Houston Vol#: 587

CA 35564 Andrea Eason Vol#: 587

CA 35565 Number Not Used Vol#: 587

CA 35566 James A. Phillips, M. D. Vol#: 587

CA 35567 Mrs. Sarah Owings Vol#: 587

CA 35568 Patricia L. Shore Vol#: 587

CA 35569 Valerie Friedman Vol#: 588

CA 35570 Shirley J. Reichman Vol#: 588

CA 35571 Bunni Bermman Vol#: 588

CA 35572 Mr. jackson S. Kiser Vol#: 588

CA 35573 John S. Helling Vol#: 588

CA 35574 Rosalie I. Reese Vol#: 588

CA 35575 Susane V. Hulme Vol#: 588

CA 35576 Gloria F. Kane Vol#: 588

CA 35577 Lynn Bradley Vol#: 588

CA 35578 W. Sherman Pederson Vol#: 588

CA 35579 Mrs. Sheryl A. Orr Vol#: 588

CA 35580 Irvin M. cederlind Vol#: 588

CA 35581 Ruth Dowell Vol#: 5878

CA 35582 Mrs. Joseph L. Cuddy Vol#: 588

CA 35583 Mr. David Orr Vol#: 588

CA 35584 Mrs. Lilyan Stewart Vol#: 588

CA 35585 Barbara A. Davis Vol#: 588

CA 35586 Wynnelle H. Felt Vol#: 588

CA 35587 Mrs. Joan H. Moberly Vol#: 588

CA 35588 William J. Teague Vol#: 588

CA 35589 Virginia K. burns Vol#: 588

CA 35590 W. Sherman Pederson Vol#: 588

CA 35591 Jack H. Lindheimer Vol#: 588

CA 35592 Laura Stanley Vol#: 588

CA 35593 Marion E. Vaughn Vol#: 588

CA 35594 Frank E. McLaughlin Vol#: 588

CA 35595 George Magnus Johnson Vol#: 588

CA 35596 Mrs. Ralph N. Hamilton Vol#: 588

CA 35597 Helen W. Whitley Vol#: 588

CA 35598 Dan S. Alexander Vol#: 588

CA 35599 Mrs. Wilma Anglemyer Vol#: 588

CA 35600 A. L. Weaver Vol#: 588

CA 35601 Aum Rankin & 2 Signatures Vol#: 588

CA 35602 Larry Lash Vol#: 588

CA 35603 J. Cecil Sharp Vol#: 588

CA 35604 Mrs. Marsha L. Overstreet Vol#: 588

CA 35605 A. L. Weaver Vol#: 588

CA 35606 Mrs. George Stafford Vol#: 588

CA 35607 Mrs Vivian Stevens Vol#: 588

CA 35608 Joan Floyd & 2 Signatures Vol#: 588

CA 35609 Emery C. Swanson Vol#: 588

CA 35610 Mayone B. Morse Vol#: 588

CA 35611 Mrs. James Wolfe Vol#: 588

CA 35612 George Strobel Vol#: 588

CA 35613 Mary E. Salenburger Vol#: 588

CA 35614 Parker O. Willson Vol#: 588

CA 35615 Shiela C. murphy Vol#: 588

CA 35616 Seymour Sheldon Vol#: 588

CA 35617 Mrs. Sharon L. Rossell Vol#: 588

CA 35619 Veleta J. Brockman Vol#: 588

CA 35620 Jan R. Skinner Vol#: 588

CA 35621 John G. Williams Vol#: 588

CA 35622 Mrs. D. P. Epperson Vol#: 588

CA 35623 Mr. & Mrs. James Vanostembridge Vol#: 588

CA 35624 Mrs. Wayne York Vol#: 588

CA 35625 Ira A. Jacobs Vol#: 588

CA 35626 Paul D. Cowden Vol#: 588

CA 35627 Mrs. Adrianna Byers Vol#: 588

CA 35628 rs. Sarah Giametto Vol#: 588

CA 35629 V. W. Hamby Vol#: 588

CA 35630 Mrs. Wanda Mortensen Vol#: 588

CA 35631 Mildred Coulter Vol#: 588

CA 35632 Mrs. Margaret M. Hawes Vol#: 588

CA 35633 Marian B. Crowley Vol#: 588

CA 35634 Glen D. Rixen Vol#: 588

CA 35635 George W. Gray Vol#: 588

CA 35636 Jim bates Family Vol#: 588

CA 35637 Nancy Apple Vol#: 588

CA 35639 Mrs. Joseph A. De Marco Vol#: 588

CA 35640 Floy A. Beecher Vol#: 588

CA 35641 Billy J. Meldrum Vol#: 588

CA 35642 L. A. Riddell Vol#: 588

CA 35643 Bonnie Bjorkmman Vol#: 588

CA 35644 Mrs. Susanne S. Robb Vol#: 588

CA 35645 victoria Gould Pryor Vol#: 588

CA 35646 Ted D. ayres Vol#: 588

CA 35647 Stanley Schwartz Vol#: 588

CA 35650 S. Steven Karalekas Vol#: 589

CA 35651 Norman S. Knee, D. O. Vol#: 589

CA 35652 Micheal C. Slotnick Vol#: 589

CA 35653 Jesse Laslav Vol#: 589

CA 35654 W. D. Van Amburg & 2 other signatures Vol#: 589

CA 35655 Harold Vincent Gleason Vol#: 589

CA 35656 James A. Webb, M. D. Vol#: 589

CA 35657 Mel R. Gray Vol#: 589

CA 35658 Peter J. Bobrek Vol#: 589

CA 35659 Lawrence E. Rapoport Vol#: 589

CA 35660 The Kohn Family Vol#: 589

CA 35661 Herbert D. Pearlson Vol#: 589

CA 35662 Chris E. Carstenson Vol#: 589

CA 35663 Harold N. Lieber Vol#: 589

CA 35664 John Flannery Vol#: 589

CA 35665 Charles H. Stewart Vol#: 589

CA 35666 Frank Leach Vol#: 589

CA 35667 Joseph A. Reich, Jr. Vol#: 589

CA 35668 Margaret B. Ellis Vol#: 589

CA 35669 Vance J. Hardy, Jr. Vol#: 589

CA 35670 Robert S. Gunter Vol#: 589

CA 35671 Harriet I. Godbee & 30 other signatures Vol#: 589

CA 35672 Micheal P. Mehr, M. D., F. A. C. P. Vol#: 589

CA 35673 R. Lynn Bradley Vol#: 589

CA 35674 Thomas E. Hatch Vol#: 589

CA 35675 Lori Siepelmeyer Vol#: 589

CA 35676 Patricia A. Geithman Vol#: 589

CA 35677 Richard J. Stringer Vol#: 589

CA 35678 Jack E. Ayers Vol#: 589

CA 35679 Barbara McIntyre Vol#: 589

CA 35680 S. H. Bowring Vol#: 589

CA 35681 Carrie M. Godfrey Vol#: 589

CA 35682 John Erikson Vol#: 589

CA 35683 Harold L. Smith Vol#: 589

CA 35684 Steven M. Fecik Vol#: 589

CA 35685 Harry T. Herdman Vol#: 589

CA 35686 James Groves & 2 other signatures Vol#: 589

CA 35687 Dick M. Jacobs Vol#: 589

CA 35688 Marilyn Van Pelt Vol#: 589

CA 35689 Theodore E. Burke Vol#: 589

CA 35690 Irvin M. Cederlind, M. D. Vol#: 589

CA 35691 Floy A. Beecher Vol#: 589

CA 35692 David C. Logan Vol#: 589

CA 35693 Russell K. Smith Vol#: 589

CA 35694 Robert Allen Vol#: 589

CA 35695 Sergio Luis Lopez & 7 other signatures Vol#: 589

CA 35696 William M. Burnett Vol#: 589

CA 35697 John G. Stratman Vol#: 589

CA 35698 Vickie Adams Vol#: 589

CA 35699 H. L. Treni Vol#: 589

CA 35700 H. Paul Jacobi, D. D. S. Vol#: 589

CA 35701 Loren A. Mintz Vol#: 589

CA 35702 Mr. David Orr Vol#: 589

CA 35703 Joan Duffy Vol#: 589

CA 35704 Number Not Used Vol#: 589

CA 35705 Warren Maudlin Vol#: 589

CA 35706 Marijane Stalland Vol#: 589

CA 35707 Betsy Brown Vol#: 589

CA 35708 Ellen A. Moore Vol#: 589

CA 35709 Lorraine Powel Vol#: 589

CA 35710 Helen Owens Vol#: 589

CA 35711 Mr. & Mrs. John Nalls Vol#: 589

CA 35712 Alex Nagy Vol#: 589

CA 35713 Thomas B. Crews Vol#: 589

CA 35714 J. Norman Berry, M. D. Vol#: 589

CA 35715 Dalice B. Preston Vol#: 589

CA 35716 Warren N. Kerber Vol#: 589

CA 35717 Milton Nevrenchan Vol#: 589

CA 35718 Richard Ellington Vol#: 589

CA 35719 L. Jay Labe Vol#: 589

CA 35720 Max P. Blaylock Vol#: 589

CA 35721 Nancy Butler Francis Vol#: 589

CA 35722 Micheal H. Lott Vol#: 589

CA 35723 Philip N. Hutmacher Vol#: 589

CA 35724 Betsy Brown Vol#: 589

CA 35725 Number Not Used Vol#: 589

CA 35726 Frederick C. Stakel, Sr. Vol#: 589

CA 35727 Margery Wilson Vol#: 589

CA 35728 Norma Davis Smith Vol#: 589

CA 35729 Lois C. Rocchio Vol#: 589

CA 35807 Abraham Blucher Vol#: 590

CA 35808 Dan Bagley Jr. Vol#: 590

CA 35809 Sandra J. Roupp Vol#: 590

CA 35810 Julie Reed Vol#: 590

CA 35811 Larry burton Vol#: 590

CA 35812 nicholis Terebey Vol#: 590

CA 35814 Marie L. Gregory Vol#: 590

CA 35815 Sandra Patti & 17 Signatures Vol#: 590

CA 35816 Sarah Setton Vol#: 590

CA 35817 Sarah Howell & R. Rodney Howell Vol#: 590

CA 35818 Frank McCarthy Vol#: 590

CA 35819 Robert J. & Diane Huffeling Vol#: 590

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

LET 140 Whitehall-Robins Healthcare Vol#: 235

MM 24 HFD-560 & Whitehall-Robins Healthcare Vol#: 235

78N-0038 Sunscreen Drug Products

PDN 1 HFC-1 To Morgan lewis & Bockius LLP Vol#: 146

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use

MT 1 HFD-560 & Gary Yingling Vol#: 8

94V-0328 Laser Light Show

VRA 5 HFZ-300 to Laser Fascinations Vol#: 1

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 70 List as of January 25, 2002 Vol#: 4

98N-0337 Over the counter human drugs labeling requirements

ANS 13 HFD-560 to Generi Tech Corp Vol#: 8

LET 13 Consumer Healthcare Products Association Vol#: 8

MM 6 HFD-560 & CHPA Vol#: 8

99P-5106 Identify Sources of Natural Flavorings

C 14 Deanna Edgar Vol#: 2

99P-5198 Request amendment of the definition of milk

C 7 National Milk Producers Federation Vol#: 1

C 8 National Milk Producers Federation Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 26 National Food Producessors Association Vol#: 6

00D-1543 Electronic Signatures: Glossary of Terms

C 20 National Food Producessors Association Vol#: 7

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 32 National Milk Producers Federation Vol#: 2

C 33 National Milk Producers Federation Vol#: 2

01D-0432 Evalution of the effects of Orally Inhaled and Intranasal

C 2 AstraZeneca LP Vol#: 1

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

C 11 PhRMA Vol#: 1

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

C 6 Johns Hopkins University, Center for Cli Vol#: 1

01P-0117 Rescind Approval of Solid Oral Dosage form of Metaxalone

PAV 1 HFD-1 to Mutual Pharmaceutical Company Vol#: 1

01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola

C 1 Marianne E Payton Vol#: 1

01P-0333 Non-lyophilized Cytoxan

LET 1 HFD-1 to ASTA Medica, Inc. Vol#: 1

01P-0356 Amend approved drug products with "Orange Book" 21st list

LET 1 HFD-1 to Lachman Consultant Services Inc Vol#: 1

01P-0396 Request that FDA ban the production and sale of all ephedra

SUP 1 Public Citizen Vol#: 1

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

SUP 1 Arnall Golden Gregory, LLP Vol#: 2

01P-0586 New and/or Amended Regulations for BPCA

C 2 Washington Legal Foundation Vol#: 1

01V-0115 Laser Light Show

VRA 2 HFZ-300 to Thomas Michael Hagan II Vol#: 1

01V-0544

CR 1 SF Productions Vol#: 1

02P-0057 ANDA Suitability Ventolin Albuterol Sulfate Inhalation

ACK 1 HFA-305 Vol#: 1

CP 1 Nephron Pharmaceuticals Corp. Vol#: 1