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 23, 2002

TABLE OF CONTENTS

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NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

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93P-0310 White Chocolate Deviating From Identity Standard; TPMT *
98N-1215 Foreign Establishment Registration and Listing *
99P-2775 Refuse abbreviated new drug application for gabapentin tablt *
00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso *
01N-0464 Vaccine Adverse Event Reporting System *
01N-0496 Patient Profile Viewer *
01P-0207 Amend the final regulation on OTC drug labeling content & fo *
01P-0252 ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg *
01P-0495 Determine Ultram's safety or effectiveness reasons *
02P-0026 ANDA for Paclitaxel, ANDA 75-184 *

77N-0085 Saccharin and Its Salts

CA 32461 Caroline J Maupin Vol#: 555

CA 32462 Roscoe Fonucchi Vol#: 555

CA 32463 E R Fangman Vol#: 555

CA 32464 Hazel Bowin Vol#: 555

CA 32465 Whitney Fitch Vol#: 555

CA 32466 Peggy Allyn Vol#: 555

CA 32467 Elizabeth W Vogel Vol#: 555

CA 32468 A J Daumery Vol#: 555

CA 32469 Clarence A Roggensack Vol#: 555

CA 32470 Odette McIntyre Vol#: 555

CA 32471 Marshall B Johnson Vol#: 555

CA 32472 Margaret Scott Vol#: 555

CA 32473 Mrs. T Mayo Vol#: 555

CA 32474 Virgil H & Mabel L Bishop Vol#: 555

CA 32475 Mary Jane Gray Vol#: 555

CA 32476 James A Lancey Vol#: 555

CA 32477 Frances Kelley Vol#: 555

CA 32760 Dayna E. Burns & Gale L. Callaway Vol#: 558

CA 32762 Virginia Spiess Vol#: 558

CA 32763 Mrs. Edna M. Weaver Vol#: 558

CA 32764 Mrs. Alan (Barbara) Harris Vol#: 558

CA 32765 Mrs. Hazel M. Wilson Vol#: 558

CA 32766 Ed Madsen Vol#: 558

CA 32767 Paul Holsinger Vol#: 558

CA 32768 Don R. Conrad Vol#: 558

CA 32769 Mr. & Mrs. Olto Wegner Vol#: 558

CA 32770 Mrs. Eleanor Selzo Vol#: 558

CA 32771 Kathryn E. Moyer Vol#: 558

CA 32772 Dolores Menendez Vol#: 558

CA 32773 Mrs. Billie L. Hagan Vol#: 558

CA 32774 Brenda C. Meade Vol#: 558

CA 32775 Mrs. Frank Storey Vol#: 558

CA 32776 Mrs. Johnie (Lucille) Phillips Vol#: 558

CA 32777 Betty L. Hale Vol#: 558

CA 32779 Mrs. Clyde Peters Vol#: 558

CA 32780 Beverly J. Grogan Vol#: 558

CA 32781 Mrs. Agness Lawrence Vol#: 558

CA 32782 Mrs. Jack W. Pemberton Vol#: 558

CA 32784 Pauline F. Lehr Vol#: 558

CA 32785 Mrs. Roger (Marjorie) L. Thomas Vol#: 558

CA 32786 Jacqueline B. & Martin Kaufman Vol#: 558

CA 32787 Norma D. Theriot, R. N. Vol#: 558

CA 32788 Mrs. Gerald Kemp Vol#: 558

CA 32789 Joseph Merhige Vol#: 558

CA 32790 Linda Harner Vol#: 558

CA 32791 Mrs. James C. Rumple Vol#: 558

CA 32792 Mrs. C. M. Rifenberg Vol#: 558

CA 32793 Eunice Vosberg Vol#: 558

CA 32794 Rita Kearney Vol#: 558

CA 32795 James & Wanda Kurtz Vol#: 558

CA 32796 Bobbie F. Wolf Vol#: 558

CA 32797 Mrs. Bruce E. Lewis Vol#: 558

CA 32798 Mrs. Inez C. LeJeune Vol#: 558

CA 32799 Mrs. Grace M. Templeton Vol#: 558

CA 32800 Minnie B. Cole Vol#: 558

CA 32801 Mrs. Harry H. Fisher Vol#: 558

CA 32802 Rachel B. Moseley Vol#: 558

CA 32803 Mrs. Edward Jones Vol#: 558

CA 32804 Terri Benincasa Vol#: 558

CA 32805 O. D. Clack Vol#: 558

CA 32806 Deanna Jo Knight Vol#: 558

CA 32807 Milton P. Riley Vol#: 558

CA 32808 Nancy P. Harriman Vol#: 558

CA 32809 Fay Bartlett Vol#: 558

CA 32810 Mrs. Leslie M. Johnson Vol#: 558

CA 32811 Julie D. Schuster Vol#: 558

CA 32812 Douglas A. Martin Vol#: 558

CA 32814 Mrs. L. Delant Vol#: 558

CA 32815 Marilyn & Jim Kline Vol#: 558

CA 32816 Elizabeth L. Huggins Vol#: 559

CA 32817 Mrs. Hugh E. Rodwell Vol#: 559

CA 32818 Mrs. Arlene Herrmann Vol#: 559

CA 32819 No Submitter Vol#: 559

CA 32820 James A. Pac Vol#: 559

CA 32821 Diane M. Rohrbaugh Vol#: 559

CA 32822 Mrs. Gordon Eaker Vol#: 559

CA 32823 Mr. & Mrs. Carl L. Eastman Vol#: 559

CA 32824 Dayla McDonald Vol#: 559

CA 32825 Mrs. Eva Graham Vol#: 559

CA 32826 Ann E. Bell Vol#: 559

CA 32827 Mr. & Mrs. M. Overmeyer Vol#: 559

CA 32828 Bertha Sartain Vol#: 559

CA 32829 Howard Snow Vol#: 559

CA 32830 Mrs. Guy Shiffer Vol#: 559

CA 32831 No Submitter Vol#: 559

CA 32832 Harry & Newell Seay Vol#: 559

CA 32833 Sarah J. Mayer Vol#: 559

CA 32834 Susan Lykins Vol#: 559

CA 32835 Harley L. Perry Vol#: 559

CA 32836 Anne V. Henderson Vol#: 559

CA 32837 Mr. & Mrs. John L. Gray Vol#: 559

CA 32838 Ruth L. Kaplan Vol#: 559

CA 32839 Mrs. Ted A. Graham Vol#: 559

CA 32841 Mrs. Mary Ley Vol#: 559

CA 32842 Elizabeth Mairtena Vol#: 559

CA 32843 B. J. Barnes Vol#: 559

CA 32844 Lois Gallaher Vol#: 559

CA 32845 Mr. & Mrs. R. W. Cagle Vol#: 559

CA 32846 Mrs. John Kliever Vol#: 559

CA 32847 Donald E. Williams Vol#: 559

CA 32848 Mrs. Raymond Eley Vol#: 559

CA 32849 C. Karlsen Vol#: 559

CA 32850 Marcie Janckila Vol#: 559

CA 32851 Rose Dawes Vol#: 559

CA 32852 Lorna D. Graham Vol#: 559

CA 32853 Sister Elizabeth Meyer Vol#: 559

CA 32854 Mrs. Ruby E. Osborne Vol#: 559

CA 32855 Milton Duell Vol#: 559

CA 32856 Sylvia Biscardi Vol#: 559

CA 32857 Gen. Maurice Hirsch Vol#: 559

CA 32858 Mrs. Jane A. Howorth, R. D. Vol#: 559

CA 32859 Linda R. Kempton Vol#: 559

CA 32860 Margaret H. Reavis Vol#: 559

CA 32861 Catherine C. Greenwood Vol#: 559

CA 32862 Katherine W. Pond Vol#: 559

CA 32863 Mrs. Sally L. Kurrasch Vol#: 559

CA 32864 Betty J. Briggs Vol#: 559

CA 32865 T. C. "Skip" Anderson Vol#: 559

CA 32866 William Burpitt Vol#: 559

CA 32867 Rosalie Eisenkramer Vol#: 559

CA 32868 Jeanette Shaffer Vol#: 559

CA 32869 Margaret Cribbs Vol#: 559

CA 32870 Mrs. Lester L. Ostrov Vol#: 559

CA 32871 Frank B. Davis Vol#: 559

CA 32872 Esther M. Rusk Vol#: 559

CA 32873 S. Baxter Sperry Vol#: 559

CA 32874 Terry Fraze Vol#: 559

CA 32875 Frank Schoeneman Vol#: 559

CA 32876 Mary Hillyard Vol#: 559

CA 32877 Eric Laner Vol#: 559

CA 32878 Marlene Shaw Vol#: 559

CA 32879 Mrs. Clarence Kruse Vol#: 559

CA 32880 Wanda McClure Vol#: 559

CA 32881 Eleanor E. Jungels Vol#: 559

CA 32882 William H. Kearns Vol#: 559

CA 32884 Jean E. Costales Vol#: 559

CA 32885 Rudolfs Krese Vol#: 559

CA 32886 Paula Device Vol#: 559

CA 32887 Peter A. Moles Vol#: 559

CA 32888 Louise Franklin Vol#: 559

CA 32889 Sylvia M. Isaac Vol#: 559

CA 32890 Mrs. Thomas Tait Vol#: 559

CA 32891 Ada Redington Vol#: 559

CA 32892 Charlotte & Margaret Bruegge Vol#: 559

CA 32893 Mrs. Carroll G. Rohrbaugh Vol#: 559

CA 32894 Ruth B. Brainard Vol#: 559

CA 32895 Audrey DeVries Vol#: 559

CA 32896 Mrs. Marion Wilson Vol#: 559

CA 32897 Virginia Feeser Vol#: 559

CA 32898 Mrs. Clyde Bridges Vol#: 559

CA 32899 August Lodato Vol#: 559

CA 32900 William A. Wockenfuss Vol#: 559

CA 32901 Mrs. Peggy Sisson Vol#: 559

CA 32902 Shirley Ockert Vol#: 559

CA 32903 John C. Collins Vol#: 559

CA 32904 Edna P. Slayton Vol#: 559

CA 32905 Marelia Hammock Vol#: 559

CA 32906 Mr. & Mrs. A. Tekavec Vol#: 559

CA 32907 E. R. Fulton Vol#: 559

CA 32908 S. Nowelski Vol#: 559

CA 32909 Marie & Jack Tettelbach Vol#: 559

CA 32910 Mrs. William R. Wright & Families Vol#: 559

CA 32911 Mrs. Hyman Cetel Vol#: 559

CA 32912 Reese N. Epstein Vol#: 559

CA 32913 Joseph L. LaRosa & 405 other signatures Vol#: 559

CA 32914 John E. Higgins & 39 other signatures Vol#: 559

CA 32915 Larry Tyler Vol#: 559

CA 32921 Leonard F. Watkinson, Jr. Vol#: 560

CA 32922 Helen McMahon Vol#: 560

CA 32923 Mrs. Lillian Day Vol#: 560

CA 32924 Robert F. Huddleston Vol#: 560

CA 32925 A. C. Schone Vol#: 560

CA 32926 Shelley Obler Vol#: 560

CA 32927 Mary L. Dell Vol#: 560

CA 32928 Clara E. Osterhoudt Vol#: 560

CA 32929 Paul E. Sischo Vol#: 560

CA 32931 Lyle Phillips Vol#: 560

CA 32932 Fred I. Morse, III Vol#: 560

CA 32933 Mr. & Mrs. Steve Johnson Vol#: 560

CA 32934 Mrs. Edna Willoughby Vol#: 560

CA 32935 Clare G. Miller Vol#: 560

CA 32936 John H. Williamson Vol#: 560

CA 32937 Mrs. Dan Gillespie Vol#: 560

CA 32938 Judy Smith & 24 other signatures Vol#: 560

CA 32939 Joe Baker Vol#: 560

CA 32941 Geneiveve Coleman Vol#: 560

CA 32942 William J. Rakers Vol#: 560

CA 32943 Mrs. Mark Hoffman Vol#: 560

CA 32944 Patricia A. Turk Vol#: 560

CA 32945 Tru' Blue Vol#: 560

CA 32946 Marian L. Mosser Vol#: 560

CA 32947 Debra G. Bratton Vol#: 560

CA 32948 Ms. Kris Joiner Vol#: 560

CA 32949 Mrs. Mary Fortune Vol#: 560

CA 32950 Merrilyn Webb Vol#: 560

CA 32951 Mrs. Ralph W. Fisher Vol#: 560

CA 32952 Dolores P. Gurney Vol#: 560

CA 32953 H. D. Korslund Vol#: 560

CA 32954 Illegible Vol#: 560

CA 32955 Virginia Warren Vol#: 560

CA 32956 Mrs. Rita A. Browne Vol#: 560

CA 32957 Marie E. & John S. Shemeld Vol#: 560

CA 32958 Donna Poole Vol#: 560

CA 32959 Charles T. Ellsworth, Jr. Vol#: 560

CA 32960 Don Warnke Vol#: 560

CA 32961 Bruce Carpenter, Jr. Vol#: 560

CA 32962 S. K. Bedenbaugh Vol#: 560

CA 32963 William P. Robinson Vol#: 560

CA 32964 Grace Carstens Vol#: 560

CA 32965 Judith Kirsner Vol#: 560

CA 32966 Robert L. Muis Vol#: 560

CA 32967 Mrs. Marie P. DiMaio Vol#: 560

CA 32968 Helen F. Miller Vol#: 560

CA 32969 Marlow Neher Vol#: 560

CA 32970 Norma J. Draves Vol#: 560

CA 32971 Harry T. Johnson Vol#: 560

CA 32972 Rena Rothchild Vol#: 560

CA 32973 Mrs. J. O. Garr Vol#: 560

CA 32974 Wilson Shindley Vol#: 560

CA 32975 Mrs. Stanley Levi Vol#: 560

CA 32976 M. Campbell Vol#: 560

CA 32977 Bobbie Anderson Vol#: 560

CA 32978 Mrs. Vivien E. Mastin Vol#: 560

CA 32979 G. Stewart Hoffman Vol#: 560

CA 32980 George Warren, Jr. Vol#: 560

CA 32981 Paula J. Glauz Vol#: 560

CA 32982 Robert L. Wade Vol#: 560

CA 32983 Janice McMillan Vol#: 560

CA 32984 Katherine S. Davis Vol#: 560

CA 32985 Benjamin W. Epps Vol#: 560

CA 32986 Jean A. Carl Vol#: 560

CA 32987 Pearl D. Hadley Vol#: 560

CA 32988 Darlene James Vol#: 560

CA 32989 V. H. Schlotterbeck Vol#: 560

CA 32990 Clara H. McKeand Vol#: 560

CA 32991 No Submitter Vol#: 560

CA 32992 Linda Hoff Vol#: 560

CA 32993 Mrs. Dale E. Janes Vol#: 560

CA 32994 George P. Phillips Vol#: 560

CA 32995 Ramona Wrobleski Vol#: 560

CA 32996 Mary K. Lemon Vol#: 560

CA 32997 Eugene H. Clavier Vol#: 560

CA 32998 R. A. Monreal Vol#: 560

CA 32999 Judith L. Daniels Vol#: 561

CA 33000 Margot M. Smith Vol#: 561

CA 33001 Julia T. Whitehead Vol#: 561

CA 33002 Gladys & Raymond Hulsey Vol#: 561

CA 33003 Christina Falls Vol#: 561

CA 33004 Mrs. A. R. Griffith Vol#: 561

CA 33005 Mrs. J. L. Munger Vol#: 561

CA 33006 K. L. McDonald Vol#: 561

CA 33007 Mrs. Rose A. Delphia Vol#: 561

CA 33008 Mrs. R. F. Gordon Vol#: 561

CA 33009 Martha Lutz Vol#: 561

CA 33010 Michelle Leverett Vol#: 561

CA 33011 Mr. Ken & Mrs. H. A. Petty Vol#: 561

CA 33012 Doris J. Miller Vol#: 561

CA 33013 Jerry G. & Claire R. Blake Vol#: 561

CA 33014 Kathleen A. Wilson Vol#: 561

CA 33015 Pat Collins Vol#: 561

CA 33016 Mrs. Jo Phillips Vol#: 561

CA 33017 Barbara Toppey Vol#: 561

CA 33018 Wallace White Vol#: 561

CA 33019 Irene Johnson Vol#: 561

CA 33020 Joan Plowden Vol#: 561

CA 33021 Mrs. John Breiner Vol#: 561

CA 33022 Margaret A. Lloyd Vol#: 561

CA 33023 Mrs. Mike Daire Vol#: 561

CA 33024 Shirley J. Wright Vol#: 561

CA 33025 Mrs. Nancy Hatfield Vol#: 561

CA 33026 Mrs. Bina B. Neher Vol#: 561

CA 33027 Louise M. Egnew Vol#: 561

CA 33028 Mrs. T. P. Ferguson Vol#: 561

CA 33029 Mrs. Judith Kotzbauer Vol#: 561

CA 33030 Karen A. Kral Vol#: 561

CA 33031 Mr. & Mrs. Joseph Bosse Vol#: 561

CA 33032 Gloria J. Harris Vol#: 561

CA 33033 Mr. Charles J. & Mrs. Isabel T. Haupt Vol#: 561

80N-0042 Anticaries Drug Products for OTC Human Use

C 110 William H. Bowen, B.D.S., PhD Vol#: 36

91V-0509 Las Vegas laser rental light shows.

LET 1 Number not used Vol#: 1

93P-0310 White Chocolate Deviating From Identity Standard; TPMT

LET 100 HFS-822 to Nestle Food Company Vol#: 2

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 67 Tammy VanPembrook Vol#: 9

98N-1215 Foreign Establishment Registration and Listing

EC 4 Visys AG Vol#: 2

99P-2630 Establish a Daily Value for "added sugars"

C 607 Helen J. Pero Vol#: 32

99P-2775 Refuse abbreviated new drug application for gabapentin tablt

PDN 1 HFD-1 to Palmer & Dodge Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9648 Lisa Waller Vol#: 476

C 9649 Carolyn Ziegler Vol#: 476

C 9650 James C. Keesey Vol#: 476

C 9651 Amy J. McClintock Vol#: 476

C 9652 Dolores Tippett Vol#: 476

C 9653 Sally Cumine Vol#: 476

C 9654 Barry E. Fansher Vol#: 476

C 9655 Suzanne Cunningham Vol#: 476

C 9656 Whitney Bowman Vol#: 476

C 9657 Randy Dawkins Vol#: 476

C 9658 Hilary Keever Vol#: 476

C 9659 Jeffrey Stera Vol#: 476

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9215 Jeffrey Stern Vol#: 401

00P-0653 Amend the product insert &/or label for Anthrax Vaccive adso

ANS 1 HF-11 to Mark S Zaid Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

C 492 William Spilka Vol#: 29

C 493 Jane Lee Vol#: 29

C 494 Susan Long Vol#: 29

C 495 Assunta A. Wigandt Vol#: 29

C 496 Katy Ganino Vol#: 29

C 497 John R. Reinhardt Vol#: 29

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

EC 220 Platinum Precision Software Inc. Vol#: 4

EC 221 Enhanced Marketing, Ltd Vol#: 4

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

EC 6 none / my email Vol#: 2

01N-0464 Vaccine Adverse Event Reporting System

C 2 Wyeth-Ayerst Pharmaceuticals Vol#: 1

C 3 Merck & Co., Inc. Vol#: 1

C 4 Aventis Pasteur Inc. Vol#: 1

C 5 Erma Breedlove Vol#: 1

01N-0496 Patient Profile Viewer

APE 9 Sanofi-Synthelabo Vol#: 1

01P-0207 Amend the final regulation on OTC drug labeling content & fo

LET 1 HFD-001 to Lil' Drug Store Prod Inc Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EC 2 Fundac?o Oswaldo Cruz Vol#: 141

01P-0252 ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg

LET 1 HFD-1 to Mallinckrodt Vol#: 1

01P-0495 Determine Ultram's safety or effectiveness reasons

C 1 R.W. Johnson Pharm & Ortho-McNeil Vol#: 1

02P-0026 ANDA for Paclitaxel, ANDA 75-184

WDL 1 Baker Norton Pharmaceuticals, Inc. Vol#: 1

02V-0038 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 The Underground Support Group Vol#: 1