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 September 15, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products*
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98N-0331 Medical Devices;Implementation third party review under FDA *
98N-1038 Irradiation in the production, processing, &handling of food *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4053 Sympathominetic Amine Phentermine *
99P-4613 Revoke the Regulation That Approved Posilac *
00N-0504 Egg Safety Action Plan *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1077 Amend Current Reg Banning Sale of Small Turtles *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1518 ANDA Suitability for Leucovorin Calcium Injection 5mg/ML *
00P-1519 ANADA for a generic new animal drug/Heartgard chewable tblts *

78N-0038 Sunscreen Drug Products

C 586 C. P. Hall & Co % Steinberg & Associates Vol#: 145
 

94G-0267 Triglyceride Containing Behenic & Oleic Acids

WDL 1 HFS-200 to Fuji Oil Co., LTD Vol#: 1

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 297 Sheila Costello Vol#: 5

C 298 Susan Ziccardi Vol#: 5

EMC 58 University of Wisconsin-Eau Claire Vol#: 5

EMC 59 Gregory Eastham Vol#: 5

EMC 60 University of Wisconsin-Eau Claire Vol#: 5

EMC 61 Carla Kostka Vol#: 5

EMC 62 Patricia I. Chenier, R.N. Vol#: 5

EMC 63 Wayne Kostka Vol#: 5

EMC 64 Karen Platt Vol#: 5

EMC 65 Cortney Patrow Vol#: 5

EMC 66 Ryan Patrow Vol#: 5

EMC 67 Sr. Judie Wagener SSND Vol#: 5

EMC 68 Maridean I. Hagens Vol#: 5

EMC 69 Lawrence A. Hagens Vol#: 5

EMC 70 Wayne Laufenberg Vol#: 5

98F-0165 safe use of ionizing radition for reduction of salmonella

OB 20 Frank Hartmann & Lisa Rocheleau Vol#: 1

OB 21 Hava Dennenberg Vol#: 1

OB 22 Ursula Emmens Vol#: 1

OB 23 Nancy Zierenberg Vol#: 1

98N-0331 Medical Devices;Implementation third party review under FDA

C 10 ITS, Intertek Testing Services NA, Inc. Vol#: 1

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

C 5190 Mrs. Mary H. Shaud Vol#: 151

C 5191 Dawn Wright Vol#: 151

C 5192 Ruth R. Stober Vol#: 151

C 5193 Iris Freelander Vol#: 151

C 5194 Mr. & Mrs. Robert Scholz Vol#: 151

C 5195 Elizabeth C. North Vol#: 151

C 5196 Elsie Fisher Vol#: 151

99P-1340 Declared Eternity eau de Parfum Misbranded

C 665 Blanche Greenfield Vol#: 16

C 666 Beth A. Baron Vol#: 16

C 667 Juniper Brighidsdottir Vol#: 16

EMC 169 Sharon Stillson Vol#: 16

EMC 170 Loyce Tucker Vol#: 16
 

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

C 338 Truitt Ingram Vol#: 17

C 339 Sydney Friedman Vol#: 17

C 340 Ann Somers Vol#: 17

C 341 Margaret L Elliott Vol#: 17

C 342 Gerhard Blombach Vol#: 17

C 343 Amedee J Maserjian Vol#: 17

C 344 Dee Palombo Vol#: 17

C 345 Donnal Lee Herold Vol#: 17

C 346 Wisconsin Cheeseman Vol#: 17

C 347 American Academy Of Pediatric Dentistry Vol#: 17

C 348 Glenn Compton Vol#: 17

C 349 George Trefethern Vol#: 17

C 350 Wellspring Healthcare Assoc Vol#: 17

C 351 Celeste A Smith Vol#: 17

C 352 Ursula C Fechek Vol#: 17

C 353 Ryan Brankovich Vol#: 17

C 354 Lorita Whitehead Vol#: 17

C 355 Daniel Brostoff Vol#: 17

C 356 Janette V Arenz Vol#: 17

C 357 Gilbert Veceoni Vol#: 17

C 358 S Fink Vol#: 17

C 359 Mary Louise Culver Vol#: 17

C 360 Mr & Mrs R Vigeant Vol#: 17

C 361 Allan B Packman Vol#: 17

C 362 V W Moore Vol#: 17

C 363 Frances H Thomas Vol#: 17

C 364 Christopher S Hursh Vol#: 17

C 365 Marian S Sargent Vol#: 17

C 366 Dr & Mrs Robert W Read Vol#: 17

C 367 Genevieve Monaghan Vol#: 17

C 368 Dr A Artemis Vol#: 17

C 369 Annelle Durham Vol#: 17

C 370 M A McDaniel Vol#: 17

C 371 Kenneth E Mangione Vol#: 17

C 372 Pearl Wong Vol#: 17

C 373 E J Vol#: 17

C 374 H N Weller Vol#: 17

C 375 S P Richardson Vol#: 17

C 376 Edna R Lea Vol#: 17

C 377 Kenneth Klaas Vol#: 17

C 378 Anne Fuller Vol#: 17

C 379 Mr & Mrs R Schumann Vol#: 17

C 380 C L Vol#: 17

C 381 W H Rosenberg Vol#: 17

C 382 Renna Giuntoli Vol#: 17

C 383 Suzi Segal Vol#: 17

C 384 Betty Harasyn Vol#: 17

C 385 Barbara A Thacker Vol#: 17

C 386 Pat Hudson Vol#: 17

C 387 M P Mack Vol#: 17

C 388 Lisa Vivori Vol#: 17

C 389 G M Jean Vol#: 17

C 390 Kathleen S Victores Vol#: 17

C 391 Heidi Yin Vol#: 17

C 392 Gladys A Ahle Vol#: 17

C 393 Pauline Feingold Vol#: 17

C 394 Shirley Baer Vol#: 17

C 395 Gean R Griffith Vol#: 17

C 396 Guy De Primo Vol#: 17

C 397 M Joyce Schick Vol#: 17

C 398 John Rankin Vol#: 17

C 399 Nora Rubinstein Vol#: 17

C 400 Carol MacLennan Vol#: 17

C 401 Claire Meirowitz & Joseph Spiegel Vol#: 17

C 402 Stanley & Lata Goldbert Vol#: 17

EMC 291 Form letter count 23 Vol#: 16

EMC 292 J Spiker Vol#: 17

EMC 293 Christopher Meinen Vol#: 17

EMC 294 Barbara Zimmerman Vol#: 17

EMC 295 C T Wells Vol#: 17

EMC 296 B Martin Hurley Vol#: 17

EMC 297 Veronica Wade Vol#: 17

EMC 298 Susan Murphy Vol#: 17

EMC 299 Jo Landefeld Vol#: 17

EMC 300 Jill Adams Vol#: 17

EMC 301 Carolyn Howard Vol#: 17

EMC 302 Lynn Davis Vol#: 17

EMC 303 Don J Buscher Vol#: 17

99P-4053 Sympathominetic Amine Phentermine

PDN 1 HFD-1 to Mark P McGrath Esq Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2333 Lucinda Hall Vol#: 43

00N-0504 Egg Safety Action Plan

EMC 292 Ericka Vol#: 8

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 25 Sulzer Spine-Tech Vol#: 1

00P-1077 Amend Current Reg Banning Sale of Small Turtles

LET 1 HFS-600 to The Humane Soc. of United Sta Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 5921 Jennifer Kupp Vol#: 246

C 5922 Rachel Claire Vol#: 246

C 5923 Jacob Lirtoff Vol#: 246

C 5924 Debra L. or William S. Clark Vol#: 246

C 5925 L. Kalnick Vol#: 246

C 5926 Jeffery Segal Vol#: 246

C 5927 Wiebke Bultmann Vol#: 246

C 5928 Debbie Bryam Vol#: 246

C 5929 Merril Kruger Vol#: 246

C 5930 T. Le Favor Vol#: 246

C 5931 Alison Lefavot Vol#: 246

C 5932 Miguenna Veras Vol#: 246

C 5933 Emily Lites Vol#: 246

C 5934 Audrey H. Vol#: 246

C 5935 Sarah Moldof Vol#: 246

C 5936 J. MacKenzie Vol#: 246

C 5937 N. Oaghton Vol#: 246

C 5938 Susan Ellis Vol#: 246

C 5939 Helen Slomovits Vol#: 246

C 5940 Debra Gregory Vol#: 246

C 5941 Elizabeth A. Robbins Vol#: 246

C 5942 Laura Hill Vol#: 246

C 5943 John & Dianna Miller Vol#: 246

C 5944 Ramon & Rachel Tamaran Vol#: 246

C 5945 Virginia Wren Cassidy Vol#: 246

C 5946 Darla H. Kay Vol#: 246

C 5947 M. V. Schumacher Vol#: 246

C 5948 Ruby Crowley Kocher Vol#: 246

C 5949 C. Roberts Vol#: 246

C 5950 Kathleen Corrao Vol#: 246

C 5951 Chis Bacehowski Vol#: 246

C 5952 Karen Arthur Vol#: 246

C 5953 Laura Lee Helfman Vol#: 246

C 5954 Diane Pearce Vol#: 246

C 5955 Robyn Autry Vol#: 246

C 5956 Max Pinto Vol#: 246

C 5957 Sherri Barbera Vol#: 246

C 5958 Kay Gibson Vol#: 246

C 5959 Karen Key Vol#: 246

C 5960 Cyndi Davis Vol#: 246

C 5961 Justin Remais Vol#: 246

C 5962 Deborah Hoffman Vol#: 246

C 5963 Michael Manoochechri Vol#: 246

C 5964 Shelley Simon Vol#: 246

C 5965 Valjean Harold Rehn Vol#: 246

C 5966 Adiran Bungh Vol#: 246

C 5967 Helena H. Grams Vol#: 246

C 5968 Mahvash Nazarian Vol#: 246

C 5969 Chris Jolly Vol#: 246

C 5970 Narvell Benning Vol#: 246

C 5971 Irene Kassionis Vol#: 246

C 5972 Melissa Heffernan Vol#: 246

C 5973 Michael & Gilda Spivak Vol#: 246

C 5974 Roy Ervin Vol#: 246

C 5975 Susan Maxwell Vol#: 246

C 5976 Lynn MacDonald Vol#: 246

C 5977 Margo Lee Sherman Vol#: 246

C 5978 Holly Holderer Vol#: 246

C 5979 Mr & Mrs Ralph Cavaliere Vol#: 246

C 5980 Joan E. Nelson Vol#: 246

C 5981 Gran Hagermaster Vol#: 246

C 5982 Bedi Hutchinson Vol#: 246

C 5983 Michael Goodson Vol#: 246

C 5984 Christopher Schnider Vol#: 246

C 5985 M. Christen Vol#: 246

C 5986 Liana McCroy Vol#: 246

C 5987 Susan Roese Vol#: 246

C 5988 Glenn Kleiman Vol#: 246

C 5989 Betty B. Vogel Vol#: 246

C 5990 Patricia Mancino Vol#: 246

C 5991 Morris Cohen Vol#: 246

C 5992 Joanne Tranonte Vol#: 246

C 5993 George Doolittle Vol#: 246

C 5994 Johanna Loeb Vol#: 246

C 5995 Doris Dubion Vol#: 246

C 5996 Cooley Ludtke Vol#: 246

C 5997 Nancy Hite Vol#: 246

C 5998 Renee C. Perreault Vol#: 246

C 5999 Kathleen Britton Vol#: 246

C 6000 Desiree & John Williams Vol#: 246

C 6001 Lori Jerman Vol#: 246

C 6002 Patrick J. Lang Vol#: 246

C 6003 K. Talbert Vol#: 246

C 6004 Robert L. Spicer Vol#: 246

C 6005 Janet Pauley Vol#: 246

C 6006 Mark Pauley Vol#: 246

C 6007 Gloria Monti Vol#: 246

C 6008 Marcie Caccamo Vol#: 246

C 6009 Nancy Rubin Vol#: 247

C 6010 Wayne Wentworth Vol#: 247

C 6011 Barbara Cleghorn Vol#: 247

C 6012 No Signature Vol#: 247

C 6013 Mary Jo Seward Vol#: 247

C 6014 Stacey Nazitto Vol#: 247

C 6015 Kathy Breitreiter Vol#: 247

C 6016 Deborah Heltzer Vol#: 247

C 6017 Gene Cleghorn Vol#: 247

C 6018 Kerrie B. Nancy Vol#: 247

C 6019 Betty Lee Alexander Vol#: 247

C 6020 Yvonne Hornbuckle Vol#: 247

C 6021 Virginia Karpovich Vol#: 247

C 6022 Jacquelyn Griffith Vol#: 247

C 6023 Richard O'Brien Vol#: 247

C 6024 Courtney Vantubbergen Vol#: 247

C 6025 DeAnn Wolf Vol#: 247

C 6026 Darius Pazihardon Vol#: 247

C 6027 G. K. Houser Vol#: 247

C 6028 Kathy Connair Vol#: 247

C 6029 Greg Douros Vol#: 247

C 6030 Lois Yuen Vol#: 247

C 6031 Phyllis Dantzler Vol#: 247

C 6032 Naomi Walker Vol#: 247

C 6033 C. Clover Vol#: 247

C 6034 Jacque Bieringer Vol#: 247

C 6035 Darcia Morgan Vol#: 247

C 6036 Najid Ham Vol#: 247

C 6037 Suzanne Oliver Vol#: 247

C 6038 Robin MacBride Vol#: 247

C 6039 Scott Daly Vol#: 247

C 6040 Scoff Price Vol#: 247

C 6041 Christine G. Alexanian Vol#: 247

C 6042 John C. Burdick Vol#: 247

C 6043 Joanna Juzwik McDonald Vol#: 247

C 6044 Lynn Springer Vol#: 247

C 6045 Doreen Delesha Vol#: 247

C 6046 Jay Fier Vol#: 247

C 6047 Jim Ruen Vol#: 247

C 6048 Glen Hansen Vol#: 247

C 6049 Diana Morgan-Hickey Vol#: 247

C 6050 D Dustin Vol#: 247

C 6051 Alice Wilson Vol#: 247

C 6052 Clara G. Lopez Vol#: 247

C 6053 Elmer Harr Vol#: 247

C 6054 Susan ConBoy Vol#: 247

C 6055 Linda Brewer Vol#: 247

C 6056 Marybeth Meli Vol#: 247

C 6057 Vernon Jackman Vol#: 247

C 6058 Mike Cotter Vol#: 247

C 6059 Jason Robinson Vol#: 247

C 6060 Carolyn Gutman-Dey Vol#: 247

C 6061 Mary Button Vol#: 247

C 6062 Kyle Tostenson Vol#: 247

C 6063 Barbara Kellum Vol#: 247

C 6064 Yvette Jordan Vol#: 247

C 6065 Canon Allen Vol#: 247

C 6066 Kathleen Cooke Vol#: 247

C 6067 Rhiannon Wells Vol#: 247

C 6068 Hollace Star Vol#: 247

C 6069 Sharen Haurl Vol#: 247

C 6070 Reza Safai Vol#: 247

C 6071 June Oliver Vol#: 247

C 6072 Stephanie Hogge Vol#: 247

C 6073 Sally Goodnight Vol#: 247

C 6074 Margo Glicksman Vol#: 247

C 6075 Phil Meehan Vol#: 247

C 6076 Barbara Walker Vol#: 247

C 6077 Lauren M. Tozzi Vol#: 247

C 6078 Mary E. Kimsey Vol#: 247

C 6079 Wendy Dann Vol#: 247

C 6080 Caroline Parris Vol#: 247

C 6081 Michele Kyzar Vol#: 247

C 6082 Brenda Aaronson Vol#: 247

0P-1518 ANDA Suitability for Leucovorin Calcium Injection 5mg/ML

CP 1 PD Regulaotry Services Inc Vol#: 1

00P-1519 ANADA for a generic new animal drug/Heartgard chewable tblts

ACK 1 HFA-305 Vol#: 1

CP 1 Smart Drug Systems Inc Vol#: 1