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DOCKETS ENTERED on February 12, 2002

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
98N-1215 Foreign Establishment Registration and Listing *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01D-0514 Guidance on Labeling of Reprocessed Single Use Devices *
02P-0061 Modify the 2/14/02 deadline for Class II Reprocessed Devices *
02P-0067 All estrogen-containing products intended for oral use *
02P-0068 Determination of Chymopapain (Chymodiactin) *

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

ACK 11 HFA-305 Vol#: 123

CP 12 Ciba Specialty Chemicals Corporation Vol#: 123

77N-0085 Saccharin and Its Salts

CA 36291 Jean Klabunde Vol#: 596

CA 37195 Mrs. Woed Vol#: 605

CA 37437 Whitney Wise Vol#: 609

CA 37438 Leroy C. Corbin Vol#: 609

CA 37439 Eunice M. Johnstone Vol#: 609

CA 37440 Miss Donna Judy Vol#: 609

CA 37441 Virginia Garty Vol#: 609

CA 37442 Verne Garrett Vol#: 609

CA 37443 Mrs. C. J. Weber Vol#: 609

CA 37444 A. D. Cooke Vol#: 609

CA 37445 Mr. & Mrs. John Rukavina Vol#: 609

CA 37446 Mr. & Mrs. W. R. Anbrose Vol#: 609

CA 37447 Ms. Nicky Y. Schleider Vol#: 609

CA 37448 Rohen Bosman Vol#: 609

CA 37449 Mrs. John P. McCullin Vol#: 609

CA 37450 William M. Ferro Vol#: 609

CA 37451 Jean Short Vol#: 609

CA 37452 Mrs. Wayne Millar Vol#: 609

CA 37453 Margaret Marns Vol#: 609

CA 37454 Virginia A. Laylor Vol#: 609

CA 37455 Michael J. Austin Vol#: 609

CA 37456 John A. Rixse Vol#: 609

CA 37457 Joe Gross Vol#: 609

CA 37458 Marty Grosley Vol#: 609

CA 37459 Marvin H. Eckardt Vol#: 609

CA 37460 Mr. & Mrs. Joheph L. Rosenstein Vol#: 609

CA 37461 Mr. & Mrs. Elmer Maurer Vol#: 609

CA 37462 Mrs. I. Spreen Vol#: 609

CA 37463 Ralph H. Kroner Vol#: 609

CA 37464 Lyle B. Caldwell Vol#: 609

CA 37465 I. C. Spreen Jr. Vol#: 609

CA 37466 Marjorie G. Kelley Vol#: 609

CA 37467 Lou Eva Ingram Vol#: 609

CA 37468 Duane Burgett Vol#: 609

CA 37469 Walter S. hilsbos Jr. Vol#: 609

CA 37470 Bruce Wolf & Mrs. Ann Corro Vol#: 609

CA 37471 Mrs. S. C. Sorenson Vol#: 609

CA 37478 Eleanor Matano Vol#: 609

CA 37479 Mrs. Leroy Byrne Vol#: 609

CA 37480 Curtis A. Moore Vol#: 609

CA 37481 William K. Brogan Vol#: 609

CA 37482 Mrs. V. Ziegel Vol#: 609

CA 37483 Julian R. Story Vol#: 609

CA 37484 Richard Wilson Vol#: 609

CA 37485 Mrs. Doris M. McGowan Vol#: 609

CA 37486 Mrs. Robert E. Wenzel Vol#: 609

CA 37487 George L. Stumper Vol#: 609

CA 37488 Robert J. Herbert Vol#: 609

CA 37489 Mrs. S. K. Emery Vol#: 609

CA 37490 A. A. Gronberg Vol#: 609

CA 37491 John Spogle Vol#: 609

CA 37492 Mrs. Thomas M. Gevice Vol#: 609

CA 37493 Mike Duggins Vol#: 609

CA 37494 Carol Young Vol#: 609

CA 37495 A. M. Spinelli Vol#: 609

CA 37496 Barbara Held Vol#: 609

CA 37497 Carol Dye Vol#: 609

CA 37498 L. E. Kenney Vol#: 609

CA 37499 Debbie Skeens Vol#: 609

CA 37500 Lisa G. Chapnick Vol#: 609

CA 37626 Carlos A. Hernandez Vol#: 611

CA 37627 E. Javier Vol#: 611

CA 37628 Mrs. Robert Notz Vol#: 611

CA 37629 W. A. Hall Vol#: 611

CA 37630 Susan A. Schroeder Vol#: 611

CA 37631 James Neher Vol#: 611

CA 37632 R. E. Danskin, D. D. S. Vol#: 611

CA 37633 Richard M. Greene Vol#: 611

CA 37634 Henry J. Schleider Vol#: 611

CA 37635 Mrs. Pat Vicker Vol#: 611

CA 37636 Mary Lawniczak Vol#: 611

CA 37637 Mrs. Lindsey Barrett Vol#: 611

CA 37638 Daniel E. McPherson, Jr. Vol#: 611

CA 37639 Raymond W. Kittelberger Vol#: 611

CA 37640 N. B. McLarew Vol#: 611

CA 37641 Helen L. Auvil Vol#: 611

CA 37642 Kurt Willis Vol#: 611

CA 37643 Marion A. Roberts Vol#: 611

CA 37644 John M. Klopper Vol#: 611

CA 37645 Patricia G. Sweeney Vol#: 611

CA 37646 Diana Balint Vol#: 611

CA 37647 Susan M. McCarty Vol#: 611

CA 37648 C. F. Michels Vol#: 611

CA 37649 Don C. Branca Vol#: 611

CA 37650 Leland S. Johnson Vol#: 611

CA 37651 Noel Nuzun Vol#: 611

CA 37652 A. A. Wiley, Sr. Vol#: 611

CA 37653 Arthur L. Booth Vol#: 611

CA 37654 Earl L. Carpenter Vol#: 611

CA 37655 Suzanne Allen & 31 other signatures Vol#: 611

CA 37656 Betty A. Whiting Vol#: 611

CA 37657 Mrs. R. L. Eash Vol#: 611

CA 37658 Howard W. Ziegler Vol#: 611

CA 37659 Mrs. H. A. Thiemich Vol#: 611

CA 37660 Lovina Kinsley Vol#: 611

CA 37661 Marie Hardman Vol#: 611

CA 37662 Roxie Keller Vol#: 611

CA 37663 Vera Gamet Vol#: 611

CA 37665 John C. Allain Vol#: 611

CA 37666 Vida L. Clark Vol#: 611

CA 37667 V. L. Tobler, Jr. Vol#: 611

CA 37668 Dennis J. Hayes Vol#: 611

CA 37669 John G. Nelson Vol#: 611

CA 37670 John M. Anderson Vol#: 611

CA 37671 Steve Copas Vol#: 611

CA 37672 John M. DeBoer Vol#: 611

CA 37673 Estelle Darian Vol#: 611

CA 37674 Bonnie Nobriga Vol#: 611

CA 37675 Martha Fray Vol#: 611

CA 37676 Mr. & Mrs. Harold Peintner Vol#: 611

CA 37677 Mr. & Mrs. Theodore M. Johnson Vol#: 611

CA 37678 Mrs. E. J. Bielefeld, Jr. Vol#: 611

CA 37679 Noreen Schneider Vol#: 611

CA 37680 Linda S. Rozycki Vol#: 611

CA 37681 Douglas C. O'Brien Vol#: 611

CA 37682 Rudolf F. Nolte Vol#: 611

CA 37683 Number Not Used Vol#: 611

CA 37684 William T. C. Hunt Vol#: 611

CA 37685 Dennis M. Gray Vol#: 611

CA 37686 Lela S. Post Vol#: 611

CA 37687 Betty Jane York Vol#: 611

CA 37688 Leo A. Grenier Vol#: 611

CA 37689 Gerald M. Reynolds, M. S., D. D. S. Vol#: 611

CA 37690 Richard November Vol#: 611

CA 37691 Mrs. Roy W. Getchel, Jr. Vol#: 611

CA 37692 Herbert L. Gray Vol#: 611

CA 37693 David D. Garfinkle Vol#: 611

CA 37694 John C. Weaver, Ph. D. Vol#: 611

CA 37695 Sharon Alvarado & 11 other signatures Vol#: 611

CA 37696 Linda Barnes & 94 other signatures Vol#: 611

CA 37697 Roy Kuhn Vol#: 611

CA 37698 Marilyn Edelbleem Vol#: 611

CA 37699 Richard E. Jensen Vol#: 611

CA 37700 Heidi Buxton Vol#: 611

CA 37701 Andrew S. Ladd Vol#: 611

CA 37702 Lida G. Picton Vol#: 611

CA 37703 Dr. A. Albert Fox Vol#: 611

CA 37704 Walter J. Selton Vol#: 611

CA 37705 Mrs. Vernon Bailey Vol#: 611

CA 37706 W. Richard Kuball, D. D. S. Vol#: 611

CA 37707 Sam C. Sebree Vol#: 611

CA 37708 Mrs. W. H. Pearre Vol#: 611

CA 37709 Dr. Joseph F. Frantz Vol#: 611

CA 37710 Simon Schmidt Vol#: 611

CA 37711 Cleve A. I. Goring Vol#: 611

CA 37712 Frances Perry & 22 other signatures Vol#: 611

CA 37713 Debbie Holmes Vol#: 611

CA 37714 David Olken Vol#: 611

CA 37715 Patience Buchanan Vol#: 611

CA 37716 Mike McIntyre Vol#: 611

CA 37717 James R. & Louise K. West Vol#: 611

CA 37718 Virginia Tiemann Vol#: 611

CA 37719 Edward St. Claire Vol#: 611

CA 37720 Mrs. Linda Richert Vol#: 611

CA 37721 Joseph Nelson Vol#: 611

CA 37722 Kevin McDennon Vol#: 611

CA 37723 William J. Gill, Ph. D. Vol#: 611

CA 37724 Mrs. Robert H. Davis, Jr. Vol#: 611

CA 37725 W. L. Vanderweil Vol#: 611

CA 37726 Mrs. A. M. Pryor Vol#: 611

CA 37727 Rosemary Kellium Vol#: 611

CA 37728 K. Alfred Aho Vol#: 611

CA 37729 Mrs. Gloria Schmalstig Vol#: 611

CA 37730 Mr. Joseph L. LaRosa Vol#: 612

CA 37731 Mrs. Ann Premo Vol#: 612

CA 37732 W. H. Brough Vol#: 612

CA 37733 John Meriden Vol#: 612

CA 37734 Mrs. Dan Brooks Vol#: 612

CA 37735 Memorial Hospital Vol#: 612

CA 37736 Wendell C. Davis Vol#: 612

CA 37737 Pamela L. Norton Vol#: 612

CA 37738 Billie Dobyns Vol#: 612

CA 37739 S. Grant Vol#: 612

CA 37740 Mrs. Ray Emerson Vol#: 612

CA 37741 Mrs. Robert Marple Vol#: 612

CA 37742 J. L. Lindberg Vol#: 612

CA 37743 Kimberly J. Smith Vol#: 612

CA 37744 Mary Vaillancourt Vol#: 612

CA 37745 Mrs. Shirley Brown Vol#: 612

CA 37746 Mrs. W. J. Matteson Vol#: 612

CA 37747 Ginger Lavin Vol#: 612

CA 37748 Mrs. A. N. McCallum, Jr. Vol#: 612

CA 37830 James K. Draper Vol#: 613

CA 37831 Lori Sandler Vol#: 613

CA 37832 Ronald R. Palmer Vol#: 613

CA 37833 Mrs. Jean M. Vanderberry Vol#: 613

CA 37834 Bobbie R. North Vol#: 613

CA 37835 Edwin E. Bailey Vol#: 613

CA 37836 Mrs. Phyllis E. Rall Vol#: 613

CA 37837 Robert D. Kemp Vol#: 613

CA 37838 A. C. MacDonald Vol#: 613

CA 37839 Marci Heintz Vol#: 613

CA 37840 Laura Watkins Vol#: 613

CA 37841 Janet Marie Fleck Vol#: 613

CA 37842 Audrey E. Beers Vol#: 613

CA 37843 Mrs. J. Nathan (Connie) Grimes Vol#: 613

CA 37844 Bette Morrissey Vol#: 613

CA 37845 Mr. & Mrs. George E. King Vol#: 613

CA 37846 Mrs. Ralph W. Graves Vol#: 613

CA 37847 W. L. Hibbard Vol#: 613

CA 37848 Mrs. Charlotte Parks Vol#: 613

CA 37849 Mrs. Robert Brookshire Vol#: 613

CA 37850 Pat Helder Vol#: 613

78N-0301 OTC External Analgesic Drug Products

WDL 7 Winston Laboratories, Inc. Vol#: 102

92S-0251 Electronic Submissions; Establishment of Public Docket

M 17 CDER Advertisements & Promotional Labeli Vol#: 1

96V-0167 Variance for OxyMet Model 9910 Beam Attenuator

EXT 1 Nonin Medical, Inc. Vol#: 1

98D-0814 Good manufacturing practice for blood and blood components

EC 1 SELF GAY ADVOCATE Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

EC 6 MERIDIAN CO., LTD. Vol#: 1

EC 7 Medizintechnik Vol#: 2

EC 8 VITALITEC INTERNATIONAL Vol#: 2

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

C 5562 Florence Delfino Vol#: 203

C 5563 Donna DeVries Vol#: 203

C 5564 Ellen Donahue Vol#: 203

C 5565 Sandra Sterling R.N. Vol#: 203

C 5566 Rosalie Lesser Vol#: 203

C 5567 Bud & Nancy Wakeland Vol#: 203

C 5568 Carol Privitera Vol#: 203

C 5569 Gina M. Tubertini-DeMaria Vol#: 203

C 5570 Karin Fischer Vol#: 203

C 5571 Johanna Coxeter Vol#: 203

C 5572 Ms. Lois Shane Vol#: 203

C 5573 Ingrid Casas Vol#: 203

C 5574 B. R. Vol#: 203

C 5575 Pete & Pamela Subatina Vol#: 203

99N-4063 Positron emmission tomography drug products

NFR 1 Vol#: 1

00D-1562 Clinical Data In Marketing Applications

EC 1 Mr. James Adams Vol#: 1

EC 2 home/R.N./multiple family members with c Vol#: 1

00N-1034 Cost Assessment of Medical Device Tracking

NFR 1 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9232 Walt Socha Vol#: 404

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

C 7 Genentech, Inc. Vol#: 1

C 8 National Cancer Institute Vol#: 1

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

EC 4 St. John's Hospital Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

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

EC 229 Mr. Jack Segler Vol#: 4

EC 230 Ms. meredith loy Vol#: 4

EC 231 Ms. Cheri Stine Vol#: 4

EC 232 care giver for wife Vol#: 4

01N-0308 Agency Information Collection; Financial Disclosure

N 2 Vol#: 1

01N-0587 Changes to an approved application labeling forms 356h&2567

N 1 Vol#: 1

01N-0589 Extralabel Drug Use in Animals

EC 1 Veterinarian Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EC 3 None Vol#: 141

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

GDL 1 Vol#: 1

NAD 1 Vol#: 1

02P-0061 Modify the 2/14/02 deadline for Class II Reprocessed Devices

ACK 3 HFA-305 Vol#: 1

CP 3 Alliance Medical Corp. Vol#: 1

02P-0067 All estrogen-containing products intended for oral use

ACK 1 HFA-305 Vol#: 1

CP 1 PCRM Vol#: 1

02P-0068 Determination of Chymopapain (Chymodiactin)

ACK 1 HFA-305 Vol#: 1

CP 1 ChymoCorp Vol#: 1

02V-0069 A projector for a laser light show.

AMD 1 HFA-305 Vol#: 1

VAR 1 AREA 54 DJ, Co. Vol#: 1