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 19, 2002

TABLE OF CONTENTS

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00P-1550 Approve ANDA for Cefuroxime Axetil Products *
01P-0354 Immediately ban the sale of human cadaveric dura mater *
01P-0428 Generic Cefuroxime Axetil Products *

77N-0085 Saccharin and Its Salts

CA 38083 Number not used Vol#: 615

CA 38432 Robert B Gillis Vol#: 619

CA 38433 Mamie B Clark Vol#: 619

CA 38434 Karen Morrow Vol#: 619

CA 38435 F Gilbert Vol#: 619

CA 38436 Kate Bastien Vol#: 619

CA 38437 Estele Levitt Vol#: 619

CA 38438 Claire V & Eva McWilliams Vol#: 619

CA 38439 Hariet Klassen Vol#: 619

CA 38440 Mr & Mrs David Ackerman Vol#: 619

CA 38441 M A Smith Vol#: 619

CA 38442 Suniko Okubo Vol#: 619

CA 38443 Phylis E McCarty Vol#: 619

CA 38444 Carolyn Borus Vol#: 619

CA 38445 Farrell Copelin Vol#: 619

CA 38446 S Kawulok Vol#: 619

CA 38447 F D McKibbin Vol#: 619

CA 38448 Dorothy S Schmitt Vol#: 619

CA 38449 Elmer Ellis Vol#: 619

CA 38450 Robert McDaniel Vol#: 619

CA 38451 Elizabeth Schmitz Vol#: 619

CA 38452 Mrs. D Frudberg Vol#: 619

CA 38453 John & Elaine Walsh Vol#: 619

CA 38454 Cindy DeLong Vol#: 619

CA 38455 Teri Mosler Vol#: 619

CA 38456 Art Binkley Vol#: 619

CA 38457 Mrs. Linda S. Kaufman Vol#: 619

CA 38458 Virginia M. Posey, R. N. Vol#: 619

CA 38459 Diana McClain Vol#: 619

CA 38460 Bernard Kelly Vol#: 619

CA 38461 Doris Badue Vol#: 619

CA 38462 Louise McLeod Vol#: 619

CA 38463 Evelyn O. Price Vol#: 619

CA 38464 Edward W. Wing Vol#: 619

CA 38465 Alberta Dalton Vol#: 619

CA 38466 Maureen Freitas Vol#: 619

CA 38467 Mildred Knutson Vol#: 619

CA 38468 Dr. & Mrs. James Ceace Vol#: 619

CA 38469 Shirley A. Shamy Vol#: 619

CA 38470 Pat Endnew Vol#: 619

CA 38471 Selma Cohen Vol#: 619

CA 38472 Mrs. Alford B. Wise Vol#: 619

CA 38473 Mrs. Judy Maynard Vol#: 619

CA 38474 Marjorie Leftwich Vol#: 619

CA 38475 Linda J. Horton Vol#: 619

CA 38476 Nancy Evans Vol#: 619

CA 38477 Mrs. Alice G. Chance Vol#: 619

CA 38478 F. E. Munson Vol#: 619

CA 38479 Mrs. Fay E. McNiesh Vol#: 619

CA 38480 Pat Bianchi Vol#: 619

CA 38481 Harold Gleeck Vol#: 619

CA 38482 Mrs. Pat H. Munroe Vol#: 619

CA 38483 Anne Heimbrock Vol#: 619

CA 38484 Frances Turcotte Vol#: 619

CA 38485 Don Wolford & 3 other signatures Vol#: 619

CA 38486 Mrs. Leonard L. Smith Vol#: 619

CA 38487 Ruth Shanklin Vol#: 619

CA 38488 Ralph W. McDonald Vol#: 619

CA 38489 Mr. & Mrs. S. J. Cohen Vol#: 619

CA 38490 Paul Samaras Vol#: 619

CA 38491 Ronald L. Olson Vol#: 619

CA 38492 Barbara J. Brown Vol#: 619

CA 38493 Harriet Schwartz Vol#: 619

CA 38494 Sandra Shefrin Vol#: 619

CA 38495 Mr. & Mrs. Paul C. Kaiser Vol#: 619

CA 38496 Mrs. Annette Carter Vol#: 619

CA 38497 Helen Johns Vol#: 619

CA 38498 Clara C. Rosekrans Vol#: 619

CA 38499 Dedie Rodriquez Vol#: 619

CA 38500 Nancy E. Sims Vol#: 619

CA 38501 Mrs. John S. Hurley Vol#: 619

CA 38502 Joycelyn M. Campbell Vol#: 619

CA 38503 38503-39299 Number not used Vol#: 619

CA 39300 Lee A. Sellers Vol#: 619

CA 39301 Karen T. Catlin Vol#: 619

CA 39302 Mrs. Vivian Spangler Vol#: 619

CA 39335 Rocky Mountain Marketing Services Vol#: 619

CA 39880 Richard John Zajkowski Vol#: 623

CA 39921 Mrs. William Sargent Vol#: 624

CA 39922 Lillian R. Magnuson Vol#: 624

CA 39923 Mr. & Mrs. W. B. Hervey Vol#: 624

CA 39924 Earnst Young Vol#: 624

CA 39925 Laura Beaucamp Vol#: 624

CA 39926 Mrs. Charles Foster Vol#: 624

CA 39927 Mrs. Kenneth Evers Vol#: 624

CA 39928 Elizabeth J. LeBlond Vol#: 624

CA 39929 Mr. & Mrs. Darrell Satker Vol#: 624

CA 39930 Mr. Thomas C. O'Connell Vol#: 624

CA 39931 Mrs. D. R. Hicks Vol#: 624

CA 39932 Reverend J. M. Prosser, D. D. Vol#: 624

CA 39933 Mrs. Katrine H. Wood Vol#: 624

CA 39934 Laura L. Osborne Vol#: 624

CA 39935 V. Ruth Creveling Vol#: 624

CA 39936 Imogene P. Russell Vol#: 624

CA 39937 Mr. & Mrs. Charles Dionese Vol#: 624

CA 39938 Mary A. McEniry Vol#: 624

CA 39939 Robert E. Nowak Vol#: 624

CA 39942 Dr. Kenneth L. Cox, D. P. M. Vol#: 624

CA 39943 Marian Blanchette Vol#: 624

CA 39944 Myron Stein Vol#: 624

CA 39946 Brenda Slade Vol#: 624

CA 39947 The Kiel Family Vol#: 624

CA 39948 Darlene Bullock Vol#: 624

CA 39949 Martin G. Brodwin Vol#: 624

CA 39950 Arthur A. Steiner Vol#: 624

CA 39952 Carita M. Culmer Vol#: 624

CA 39953 Carl E. Murray Vol#: 624

CA 39954 Lavanus Jackson Vol#: 624

CA 39955 Marjorie L. Moore, R. N. Vol#: 624

CA 39956 Carol J. Perkins Vol#: 624

CA 39957 Terry L. Glover Vol#: 624

CA 39958 Mrs. Betty D'Angelo Vol#: 624

CA 39959 Roy L. Ellison Vol#: 624

CA 39960 H. Paul Tracy Vol#: 624

CA 39961 Virginia A. Currey Vol#: 624

CA 39962 Robert S. Greenlee Vol#: 624

CA 39963 David W. & Evelyn J. Winn Vol#: 624

CA 39964 Joellen Quinn Vol#: 624

CA 39965 Raymond Fitzgerald Vol#: 624

CA 39966 Maurice Bourget Vol#: 624

CA 39967 Darla L. Jones Vol#: 624

CA 39968 Barbara Seifrid Vol#: 624

CA 39969 Janice Burke Vol#: 624

CA 39970 Arnold Shapiro Vol#: 624

CA 39971 Eleanor Copley Vol#: 624

CA 39972 Mrs. George R. Hedges Vol#: 624

CA 39973 Charlyne Chappelear Vol#: 624

CA 39974 Carl M. Dick Vol#: 624

CA 39975 John B. Nohiga Vol#: 624

CA 39977 Joyce E. Hawkins Vol#: 624

CA 39978 J. R. Hooker Vol#: 624

CA 39979 Esther St. Germain Vol#: 624

CA 39980 Mrs. Clea Weber Vol#: 624

CA 39981 Helen M. & Marlin H. Shirley Vol#: 624

CA 39982 Edmund T. & Natalie Baines Vol#: 624

CA 39983 David A. Lundy, M. D. Vol#: 624

CA 39984 Jay A. Fields Vol#: 624

CA 39985 Rita M. Taylor Vol#: 624

CA 39986 Charles W. Fields Vol#: 624

CA 39987 Barry Bova, R. Ph. Vol#: 624

CA 39988 Mrs. Ed C. Kersh Vol#: 624

CA 39989 Richard D. Karr Vol#: 624

CA 39991 J. F. Darden Vol#: 624

CA 39992 Mrs. L. R. (Helen) Bilderback Vol#: 624

CA 39993 Peggy B. Johnson Vol#: 624

CA 39995 Evelyn E. Simmons & Elvis Reid Vol#: 624

CA 39996 John Ashbrook, M. C. Vol#: 624

CA 39998 Ralph Rustebakke Vol#: 624

CA 39999 Mrs. W. J. Beatty Vol#: 624

CA 40000 Joseph T. Grillo Vol#: 624

CA 40001 Eva B. Swenson Vol#: 624

CA 40002 Arleen Lorenz Vol#: 624

CA 40004 Jean Higbee Vol#: 624

CA 40005 Estelle Wetzel, R. N. Vol#: 624

CA 40006 L. L. Spellings Vol#: 624

CA 40008 James E. Mosa Vol#: 624

CA 40009 Mr. & Mrs. David Latter Vol#: 624

CA 40010 Virginia Curcio Vol#: 624

CA 40011 Mrs. Evelyn Spool Vol#: 625

CA 40013 Elva L. Best Vol#: 625

CA 40014 Vern M. Young Vol#: 625

CA 40015 Ronald S. Myhre Vol#: 625

CA 40016 D. A. Chioppetto Vol#: 625

CA 40017 Linda Opalinski Vol#: 625

CA 40018 Allen T. Hamner Vol#: 625

CA 40019 Albert E. Hansen Vol#: 625

CA 40020 Rolrya Heffelier Vol#: 625

CA 40021 J. A. McGowan Vol#: 625

CA 40022 Mrs. Buford B. Johnson Vol#: 625

CA 40023 Mrs. Frank Hunyadi Vol#: 625

CA 40024 Dorothy Slade Vol#: 625

CA 40025 Donald I. Krueger Vol#: 625

CA 40026 Robert L. Moore Vol#: 625

CA 40027 Mr. & Mrs. Charles T. Hill Vol#: 625

CA 40028 Robin Longway Vol#: 625

CA 40029 Calvin Hoehn Vol#: 625

CA 40030 Eleanor Bosey Vol#: 625

CA 40031 Ray AshMun Vol#: 625

CA 40032 Viola Lagas Vol#: 625

CA 40033 Carol D. Haykin Vol#: 625

CA 40034 Jim M. Donald Vol#: 625

CA 40035 Elizabeth H. Whitten Vol#: 625

CA 40036 John P. Higley Vol#: 625

CA 40037 Irving Sherman Vol#: 625

CA 40038 Florence SeDgwick Vol#: 625

CA 40041 Mrs. Lynette Weidner Vol#: 625

CA 40042 Patricia Forrest Vol#: 625

CA 40043 Joe Roberts Vol#: 625

CA 40044 Mrs. Stephen Chandler Vol#: 625

CA 40045 A. Durke Vol#: 625

CA 40046 Nancy Berger Vol#: 625

CA 40047 Ellen Davis Vol#: 625

CA 40048 Mildred Herbach Vol#: 625

CA 40049 Mrs. Bernard Lucier Vol#: 625

CA 40050 Barbara S. Strauss Vol#: 625

CA 40051 Barbara Allen Vol#: 625

CA 40052 Mrs. Elmer bratsch Vol#: 625

CA 40053 Mrs. Fletcher Vol#: 625

CA 40054 Donald Hays Vol#: 625

CA 40055 Mrs. W. H. Daughtry Vol#: 625

CA 40056 Carolyn Delaney Vol#: 625

CA 40057 Richard E. Knodel Jr. Vol#: 625

CA 40058 Lynne F. Roche Vol#: 625

CA 40059 Stephen A. Lison Vol#: 625

CA 40060 Mrs. Ruth Ledfor Vol#: 625

CA 40061 Lee A. Casey Vol#: 625

CA 40062 Warren R. Thomson Vol#: 625

CA 40063 Raymond & marjorie Doran Vol#: 625

CA 40064 Mrs. William Slas Vol#: 625

CA 40065 Ms. Margaret Widdicombe Vol#: 625

CA 40066 Bertha M. Beatty Vol#: 625

CA 40067 peggy J. Daley Vol#: 625

CA 40068 Harry P. Tolles & Robbyn L. Tolles Vol#: 625

CA 40069 Vito Turso Vol#: 625

CA 40070 Albert Joseph Kane Vol#: 625

CA 40071 Dennis W. Lanciani & Joan P. Lanciani Vol#: 625

CA 40072 John F. McHale Vol#: 625

CA 40073 Mr. & Mrs. Mark Sooemaker Vol#: 625

CA 40074 Norman L. Cucci Vol#: 625

CA 40075 John E. Lamparter Vol#: 625

CA 40076 Mrs. Alvin D. Oakes Vol#: 625

CA 40077 Donald A. McMachon Vol#: 625

CA 40078 George H. Brewer Vol#: 625

CA 40080 Mrs. Loismarie Smith Vol#: 625

CA 40081 Mrs. Ty Learn Ziegler Vol#: 625

CA 40082 Mrs. Janice S. Linden Vol#: 625

CA 40083 Joyce M. Gagnon Vol#: 625

CA 40086 Elizabeth K. Paterson Vol#: 625

CA 40087 R. S. Hayes Vol#: 625

CA 40088 Mrs. Julia E. Johnson Vol#: 625

CA 40089 Mrs. W. A. Black Vol#: 625

CA 40090 No Signature Vol#: 625

CA 40091 Elisa Cont Vol#: 625

CA 40092 Mrs. Dorothy Stoller Vol#: 625

CA 40093 Mary E. Laffey Vol#: 625

CA 40094 John M. Wick Vol#: 625

CA 40095 Vern lambert & ( Signatures Vol#: 625

CA 40097 M. O'Brien Vol#: 625

CA 40098 Mrs. Nancy Anderson Vol#: 625

CA 40099 David E. Hammer Vol#: 6725

CA 40100 Riy & Iogeid Gross Vol#: 625

CA 40101 Raymond E. Anderson Vol#: 625

CA 40102 A. Craig Vol#: 625

CA 40103 G. Michael Deem Vol#: 625

CA 40104 Mrs. Janice Dacesore Vol#: 625

CA 40105 Mrs. Elmer Fairchild Vol#: 625

CA 40106 Marion Buncher Vol#: 625

CA 40107 Ms. Harriet L, Hernandez Vol#: 625

CA 40108 Donald P. Reed Vol#: 625

CA 40109 Sandy Heieth Vol#: 625

CA 40110 Mrs. Carol Heinlerger Vol#: 625

CA 40111 Betty J. Elliott Vol#: 626

CA 40112 Jerrie G. Scholten & 15 other signatures Vol#: 626

CA 40113 Mrs. Maurice Block Vol#: 626

CA 40114 Eunice T. Scott Vol#: 626

CA 40115 Germaine C. Mousseau Vol#: 626

CA 40116 Diana Berrocoso & Doug Fogel Vol#: 626

CA 40117 Abigail Fritz Vol#: 626

CA 40118 Thomas J. Coad Vol#: 626

CA 40119 Eleanor Lumish Vol#: 626

CA 40120 Harvey C. Fleischmann Vol#: 626

CA 40121 Joan Heinzen Vol#: 626

CA 40122 Marvin L. Siniard Vol#: 626

CA 40123 The Lane Family Vol#: 626

CA 40124 Nancy J. Long Vol#: 626

CA 40125 William H. Sperber, Ph. D. Vol#: 626

CA 40126 Scott Palmer Vol#: 626

CA 40127 Lois Van Hoene Durant Vol#: 626

CA 40128 Lois C. Borst Vol#: 626

CA 40129 Robert D. Kingman, Jr. Vol#: 626

CA 40130 Sarah Hannon Vol#: 626

CA 40131 Ray BeVelle Vol#: 626

CA 40132 Jean V. Altman Vol#: 626

CA 40133 Markeeta L. McNatt Vol#: 626

CA 40134 Harold E. Schafer Vol#: 626

CA 40135 Don Ogilvie Vol#: 626

CA 40136 Philip M. Roberts Vol#: 626

CA 40137 Dianne Oklejas Vol#: 626

CA 40138 Deborah A. James Vol#: 626

CA 40139 David Stringer Vol#: 626

CA 40140 Edward P. Gallagher Vol#: 626

CA 40141 Diane Fritz Hunter Vol#: 626

CA 40142 Mrs. Mary Nell Johnson Vol#: 626

CA 40143 Lucille Harper Vol#: 626

CA 40144 Joe A. Fesperman Vol#: 626

CA 40145 Margaret Eager Vol#: 626

CA 40146 F. A. Kuhn Vol#: 626

CA 40147 Jill Mitchell Vol#: 626

CA 40148 Kenneth D. Harrington Vol#: 626

CA 40149 Mrs. Donna Despain Vol#: 626

CA 40150 Robert E. Rhue Vol#: 626

CA 40151 Thomas S. Dudick Vol#: 626

CA 40152 Mrs. June Sheehan Vol#: 626

CA 40153 C. Mervyn Downs Vol#: 626

CA 40154 Barbara M. Kommer Vol#: 626

CA 40155 Joyce Anderson Vol#: 626

CA 40156 Glenda J. Hite Vol#: 626

CA 40157 Alfred E. Richards, Sr. Vol#: 626

CA 40158 Micheal Dovsky Vol#: 626

CA 40159 Albert Mirsky Vol#: 626

CA 40160 Jack J. Keller Vol#: 626

CA 40161 Lee Ferrell Vol#: 626

CA 40162 Robert Mininger Vol#: 626

CA 40163 Mr. Henry J. Feeley, Jr. Vol#: 626

CA 40164 Annie Laurie A. Ball Vol#: 626

CA 40165 Mrs. Donald Devis Vol#: 626

CA 40167 Mr. & Mrs. Jack C. Carmichael Vol#: 626

CA 40168 Catherine S. & John R. Swanson Vol#: 626

CA 40169 Loretta Garher Vol#: 626

CA 40170 Gabe Meadows Vol#: 626

CA 40171 Carol Hedlund Vol#: 626

CA 40172 W. C. Kenyon Vol#: 626

CA 40173 Glenn Ross Lupton Vol#: 626

CA 40174 Evelyn Beeson Vol#: 626

CA 40175 Bernard Cohen Vol#: 626

CA 40176 Cora & Kamal A. Gamain Vol#: 626

CA 40177 John T. Spradling Vol#: 626

CA 40178 Jerry Ackerman Vol#: 626

CA 40179 Mr. W. A. Wiggins Vol#: 626

CA 40180 John Boros Vol#: 626

CA 40181 Clara Foske Vol#: 626

CA 40182 Mrs. Rose Smith Vol#: 626

CA 40183 Mr. & Mrs. Byron S. Kaopuiki Vol#: 626

CA 40184 Ann Woodmansee Vol#: 626

CA 40185 Jerrie J. Scholten & 14 other signatures Vol#: 626

CA 40186 Samuel J. Riegle Vol#: 626

CA 40187 Bruce Stevenson Vol#: 626

CA 40188 T. O. Stundahl Vol#: 626

CA 40189 Judith Longo Vol#: 626

CA 40190 Pat Junker Vol#: 626

CA 40191 Jim Chambers Vol#: 626

CA 40192 Bill Philpott Vol#: 626

CA 40193 Louis J. Drakos, A. I. A. Vol#: 626

CA 40194 Bernard L. & Margaret B. Gleue Vol#: 626

CA 40195 Dorothy L. Close Vol#: 626

CA 40196 Guida W. Dinsmore Vol#: 626

CA 40197 Lisa A. Baldwin & 125 other signatures Vol#: 626

CA 40198 Rodney W. Horner Vol#: 626

CA 40199 Mrs. Anthony J. Basile Vol#: 626

CA 40200 Mabel A. Wolford Vol#: 626

CA 40201 Ira Schectman Vol#: 626

CA 40202 Warren O. Dubell Vol#: 626

CA 40203 C. E. McCreless Vol#: 626

CA 40204 Bruce Connor Vol#: 626

CA 40205 Jerry & Jeanne States Vol#: 626

CA 40206 Mrs. Joseph Gentile Vol#: 626

CA 40207 Norman E. Shaw Vol#: 626

CA 40208 Eileen Wilcox Vol#: 626

CA 40209 Mr. & Mrs. Ronald Waitt Vol#: 626

CA 40210 Mrs. Josephine N. Arlak Vol#: 626

CA 40211 Goldie Tarvin Vol#: 627

CA 40311 L. W. Turoff Vol#: 628

CA 40312 George R. Roberts Vol#: 628

CA 40313 Mr. Leroy cheatham Vol#: 628

CA 40314 Walter B. moses Jr. Vol#: 628

CA 40315 Gerald F. Berglund Vol#: 628

CA 40316 Gordon M. Berger Vol#: 628

CA 40317 Renigio Valdey Vol#: 628

CA 40318 Frank Wylie Vol#: 628

CA 40319 Joyce Stephenson & @ Signatures Vol#: 628

CA 40320 Mrs. J. morton mathan & 9 Signatures Vol#: 628

CA 40321 Linda Wells Vol#: 628

CA 40322 John G. Magistrelli Vol#: 628

CA 40323 Helene Alley Vol#: 628

CA 40324 Elizabeth Perry Vol#: 628

CA 40325 Elizabeth H. Whitten Vol#: 628

CA 40326 Herman Cember Vol#: 628

CA 40327 Arnold O. Eacks Vol#: 628

CA 40328 Tod D. Skinner Vol#: 628

CA 40330 Mrs. Loretta J. nesbitt Vol#: 628

CA 400531 Mrs. Letcha Vol#: 625

96P-0460 Add Clotrimazole 1.0% for Treatment of Athlete's Foot etc.

NFR 1 Vol#: 1

97P-0130 Require Percentage Ingredient Labeling

C 157 Joan L. Frank Vol#: 5

C 158 Marilyn Buman Vol#: 5

C 159 Geraldine B. Carlson Vol#: 5

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

C 5638 Martha Bushnell, Ph.D. Vol#: 186

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

C 614 Sabrina Morell Vol#: 32

C 615 Lauren Garbie Vol#: 32

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9233 Unreadable Vol#: 404

C 9234 Sherry Magee Vol#: 404

00P-1550 Approve ANDA for Cefuroxime Axetil Products

PDN 1 HFC-1 to GlaxoSmithKline Vol#: 2

01D-0583 Food Security Guidance

NCR 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 806 Bill Kehler Vol#: 143

C 807 13 signatures Vol#: 143

C 808 A. M. Cohen Vol#: 143

01P-0354 Immediately ban the sale of human cadaveric dura mater

PDN 1 HFZ-1 to Public Citizen Vol#: 1

01P-0428 Generic Cefuroxime Axetil Products

PDN 1 HFC-1 to GlaxoSmithKline Vol#: 2

01V-0544 Laser Light Show

VRA 1 HFZ-300 to Scott Flaws/SF Productions Vol#: 1

01V-0568

VRA 1 HFZ-300 to Theatrix Inc. Vol#: 1

01V-0569

VRA 1 HFZ-300 to Klub Krush, Inc. Vol#: 1

01V-0575

VRA 1 HFZ-300 to High Output, Inc. Vol#: 1

02V-0016

VRA 1 HFZ-300 to Chase Chad, Inc. Vol#: 1

02V-0074

ACK 1 HFA-305 Vol#: 1

VAR 1 J Professional Inc, DBA Radio Interactiv Vol#: 1