Food and Drug Administration

DOCKETS ENTERED on July 14, 1999

Table of Contents

(Hyper links are at the part of the Docket  title)

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99N-0193 Supplements and Other Changes to an Approved Application *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5660 Ruth M Seksinsky Vol#: 133

C 5661 Patrick De Semma Vol#: 133

C 5662 Deborah L Shearer Vol#: 133

C 5663 W Christopher Zany & Family Vol#: 133

C 5664 Sharolyn W Sherman Vol#: 133

C 5665 R Charles Forrester Vol#: 133

C 5666 B Heinrich Vol#: 133

C 5667 Harry Pownall Vol#: 133

C 5668 M Delano Vol#: 133

C 5669 Julie Laramie Vol#: 133

C 5670 Sister Dorothy Briggs Vol#: 133

C 5671 Sister Bernadine M Egleston Vol#: 133

C 5672 Lourdette Gangemi Vol#: 133

C 5673 Bill Hemelhoch Vol#: 133

C 5674 Sister Mary Lou Sullin Vol#: 133

C 5675 William Hosford Vol#: 133

C 5676 Sister Barbara Rapp Vol#: 133

C 5677 Caroline Cavalier Vol#: 133

C 5678 Julie Reid Vol#: 133

C 5679 Neva Anderson Vol#: 133

C 5680 Kimberly Ann Bart Vol#: 133

C 5681 Marjorie Fisher Vol#: 133

98H-0949 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo 502

LET 2 Office of Tobacco Programs Vol#: 1

98H-1013 Civil Money Penalties;Mims Convenience Stores Inc,d/b/a Juni

LET 2 Office of Tobacco Programs Vol#: 1

98H-1078 Civil Money Penalties;Craddock Oil Co Inc, d/b/a The C Store

LET 2 Office of Tobacco Programs Vol#: 1

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

EXB 2 Milo Jackson,dba MJ's Corner Store Vol#: 1

98H-1163 Civil Money Penalties;Terry Wendt,d/b/a White hen Pantry

LET 4 Office of Policy Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

CS 1 HFA-305 Vol#: 1

LET 3 GCF-1 Vol#: 1

MO 1 GCF-1 Vol#: 1

OR 1 HF-3 Vol#: 1

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

C 3311 Katherine Forrest, M.D., MPH Vol#: 95

C 3312 Karen Thomas Vol#: 95

C 3313 Gail Blum Vol#: 95

C 3314 Dorothy Sucharski Vol#: 95

C 3315 John Draper Vol#: 95

C 3316 Gail Rose Vol#: 95

C 3317 Jeff Allen Vol#: 95

C 3318 Linda Beane Vol#: 95

C 3319 Debra & Scott Lee Vol#: 95

C 3320 Luther L. Rozar, Jr. Vol#: 95

C 3321 Loretta Morgan Vol#: 95

C 3322 Robert (Bob) F. Heltman Vol#: 95

C 3323 Darius Victor Vol#: 95

C 3324 Laragh Neelin Vol#: 95

C 3325 David E. Suycott Vol#: 95

C 3326 Jason Foster Vol#: 95

C 3327 Mrs. Loretta J. Forrest Vol#: 95

C 3328 Elise & Tom Murray Vol#: 95

C 3329 Melinda L. Bretthauer Vol#: 95

C 3330 Nancy E. Pike Vol#: 95

C 3331 Linda May McCann Vol#: 95

C 3332 Maggie Anderson Vol#: 95

C 3333 Doris E. Bouwensch Vol#: 95

C 3334 John Scott Vol#: 95

C 3335 Astrid & Joseph Kennedy Vol#: 95

C 3336 Isabel A. Leonard Vol#: 95

C 3337 Naziha Bashshur Vol#: 95

C 3338 Susan Trischman Vol#: 95

C 3339 Sarah Shaw Vol#: 95

C 3340 Kathleen H. & John E. Johnson Vol#: 95

C 3341 Steve Chase Vol#: 95

C 3342 Marsha Carter Vol#: 95

C 3343 Marvin Lewis Vol#: 95

C 3344 Thomas Rumyon Vol#: 95

C 3345 Cynthia & Gustavo Vazquez Vol#: 95

C 3346 Esther C. Leon R.N. Vol#: 95

C 3347 Eileen Hasday Vol#: 95

C 3348 August Leppelmeier Vol#: 95

C 3349 Mary Ann & Robert S. Melvin Vol#: 95

C 3350 Howard H. Sargent Vol#: 95

C 3351 Sarah Malain Vol#: 95

C 3352 Mrs. H. Daschil Vol#: 95

C 3353 Christopher V. Malley Vol#: 95

C 3354 Tom Moore Vol#: 95

C 3355 Patricia R. Pierson Vol#: 95

C 3356 Virginia Robbins Vol#: 95

C 3357 Nansea Goldberg Vol#: 95

C 3358 Tara Treasurefield Vol#: 95

C 3359 Avis V. Farber Vol#: 95

C 3360 Ann J. Kremers Vol#: 95

C 3361 Sisters, Servants of the Immaculate Hear Vol#: 95

C 3362 Joan O. King Vol#: 95

C 3363 Kalustyan Corp. Vol#: 95

C 3364 Pauline L. Rabin, M.D. Vol#: 95

C 3365 Donald L. Merrick Vol#: 95

C 3366 Rachel Cahn Vol#: 95

C 3367 Candis S. Haley Vol#: 95

C 3368 Barbara Casey Vol#: 95

C 3369 Marjorie Fisher Vol#: 95

98N-1265 Distribution of Compounded Drug Products

C 3610 Roberta Barry Vol#: 136

C 3611 Mrs Linda J Boon Vol#: 136

C 3612 Mrs Shirley M Schultz Vol#: 136

C 3613 Paige Winkler Vol#: 136

C 3614 T L Zank Vol#: 136

C 3615 Barbara Steinweg Vol#: 136

C 3616 Linda Shuman Vol#: 136

C 3617 Serita Miner Vol#: 136

C 3618 Jeanne Manning Vol#: 136

C 3619 Juanita Davenport Vol#: 136

C 3620 Brenda Knowles Vol#: 136

C 3621 Illegible Vol#: 136

C 3622 Karen Mazos Vol#: 136

C 3623 Runell Vol#: 136

C 3624 Marie Ginel Vol#: 136

C 3625 Joan M McGee Vol#: 136

C 3626 Sharon Mezzina Vol#: 136

C 3627 Floyd Ahlers Vol#: 136

C 3628 Roxanne Roberts Vol#: 136

C 3629 Judith Meldrum Vol#: 136

C 3630 Eleanor Gabriel Vol#: 136

C 3631 Cheryl K Harris Vol#: 136

C 3632 Dawn Hawks Vol#: 136

C 3633 Cheryl Wilson Vol#: 136

C 3634 Ann D Lovely Vol#: 136

C 3635 Catherine A Meyer Vol#: 136

C 3636 Judith Ideker Vol#: 136

C 3637 Sharon Splinter Vol#: 136

C 3638 Raquei Halegua DDS Vol#: 136

C 3639 Penny Becker Vol#: 136

C 3640 Jessie L Abbott Vol#: 136

C 3641 Harriet Schloss Vol#: 136

C 3642 Ann Heisler Vol#: 136

C 3643 Jairre Lievand MD Vol#: 136

C 3644 L Goodrich Vol#: 136

C 3645 Glenda Mathews Vol#: 136

C 3646 John Malchow Vol#: 136

C 3647 Robert Green Vol#: 136

C 3648 Barbara Degregorio Vol#: 136

C 3649 Priscilla James Vol#: 136

C 3650 Frances Spano Vol#: 136

C 3651 Patricia Thompson Vol#: 136

C 3652 Mrs Betty Jane Prince Vol#: 136

C 3653 Carolyn Kesaven Vol#: 136

C 3654 Susan K Dorne Vol#: 136

C 3655 Patricia G Singeltary Vol#: 136

C 3656 Triska Drake Vol#: 136

C 3657 Ann R Deary Vol#: 136

C 3658 Sheila M Rielander Vol#: 136

C 3659 Linda Langstraat Vol#: 136

C 3660 Raylene T Larsen Vol#: 136

C 3661 Ava Olsen Vol#: 136

C 3662 Margot Richardson Vol#: 136

C 3663 Elaine Filose Vol#: 136

C 3664 Illegible Vol#: 136

C 3665 Renee Murphy Vol#: 136

C 3666 Sharon Gibson Vol#: 136

C 3667 Elizabeth A Schroeder Vol#: 136

C 3668 Barbara Bolton Vol#: 136

C 3669 Eleanor Lofaro Vol#: 136

C 3670 Sam W Wilder Vol#: 136

C 3671 Kathryn Suhaka Vol#: 136

C 3672 Mrs Ruth A Hecht Vol#: 136

C 3673 Elaine Bisbee Vol#: 136

C 3674 Monica Pineda Vol#: 136

C 3675 Harriet N Strong Vol#: 136

C 3676 Victoria Meredith Vol#: 136

C 3677 Lisa Mazurkewich Vol#: 136

C 3678 Virginia Fair Vol#: 136

C 3679 J Jean Herole Vol#: 136

C 3680 Fern M Skellings Vol#: 136

C 3681 Susan Emmit Vol#: 136

C 3682 Arlene Waltz Vol#: 136

C 3683 Lonelie Capell Vol#: 136

C 3684 Dina Linsk Vol#: 136

C 3685 Mary E Yoder Vol#: 136

C 3686 Marianne Plaisier Vol#: 136

C 3687 Jackie DeMicher Vol#: 136

C 3688 Gail Ann Lappala Vol#: 136

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 183 Eileen Hasday Vol#: 9

99H-0046 Civil Money Penalties;Mims Convenience Stores,d/b/a Shell

LET 2 Office of Tobacco Programs Vol#: 1

99H-0404 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo #524

LET 2 Office of Tobacco Programs Vol#: 1

99H-0497 Civil Money Penalties;Mims Oil Co Inc,d/b/a Jr Food Mart 611

LET 2 Office of Tobacco Programs Vol#: 1

99H-0498 Civil Money Penalties;Mims Oil Co Inc, d/b/a Shellgo #517

LET 2 Office of Tobacco Programs Vol#: 1

99H-0522 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo #20

LET 2 Office of Tobacco Programs Vol#: 1

99H-0607 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shell Go #515

LET 2 Office of Tobacco Programs Vol#: 1

99H-0660 Civil Money Penalty; Mims Oil Co Inc d/b/a Shell Go #519

LET 2 Office of Tobacco Programs Vol#: 1

99H-0919 Civil Money Penalty; Vettese Inc d/b/a Venient Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1144 Civil Money Penalties;Kiki Grillis,d/b/a Lamar Restaurant

LET 2 Office of Tobacco Programs Vol#: 1

99H-1169 Civil Money Penalties;Restituto Catacutan & Juana Catacutan

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-1246 Civil Money Penalty; Ahmad Mekkaoui d/b/a Athol Getty

LET 2 Office of Tobacco Programs Vol#: 1

99H-1305 Civil Money Penalties;William Bainbridge Sr & Lois Bainbridg

EXT 1 Wigg's Country Store Vol#: 1

99H-1395 Civil Money Penalty;Crestwood Amoco Inc d/b/a South County A

LET 2 Office of Tobacco Programs Vol#: 1

99H-1452 Civil Money Penalties;Bill Nicol & Lina Nicol,d/b/a Nicol's

LET 2 Office of Tobacco Programs Vol#: 1

99H-1524 Civil Money Penalties;Bauer Oil Co,d/b/a Bauer Amoco

LET 2 Office of Tobacco Programs Vol#: 1

99H-1537 Civil Money Penalties;Lerbergs Inc,d/b/a Lerbergs Food & Clo

LET 2 Office of Tobacco Programs Vol#: 1

99H-1603 Civil Money Penalty; Jere Co dba Village Texaco

ANS 1 Village Texaco Vol#: 1

99H-1660 Civil Money Penalty;Nemet Azad,dba Town Grocery

ANS 1 Nemat Azad,dba Town Grocery Vol#: 1

99H-1661 Civil Money Penalty;Leslie Burgett,dba Les' Mini Mart

ANS 1 Leslie Burgett Vol#: 1

99H-1712 Civil Money Penalties;Thomas Weinhandl,d/b/a Tom's Standard

LET 2 Office of Tobacco Programs Vol#: 1

99H-1723 Civil Money Penalty;Condor Capital Corp;dba Texaco Self Serv

ANS 1 Condor Capital Corp Vol#: 1

99H-1740 Civil Money Penalty; Stephanie Edel dba Caseys Pizza Downtow

ANS 1 EGC-ZTA, Inc Vol#: 1

99H-1755 Civil Money Penalty; Al's Corner Oil Co dba Sparky One Stop

ANS 1 Al's Corner Oil Co. Vol#: 1

99H-1763 Civil Money Penalty;South-Western Foods Inc dba Grocery Stor

ANS 1 southwestern Foods Inc Vol#: 1

99H-1790 Civil Money Penalty;Linda Downer d/b/a Linda's One Stop

ANS 1 Linda's One Stop Vol#:

99H-1804 Civil Money Penalty;Hines Inc,Angus I,dba Sentry Food Mart

ANS 1 Angus I Hines Inc,dba Sentry Food Mart Vol#: 1

99H-1806 Civil Money Penalty;Kroger Corporation,dba King Soopers

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1847 Civil Money Penalty;BJ Williams,dba Holcomb Gas Mart

WDL 1 GCF-1 Vol#: 1

99H-1861 Civil Money Penalty;Mighty Mart Inc dba Mighty Mart

ANS 1 Mighty Mart Inc,dba Mighty Mart Vol#: 1

99H-1892 Civil Money Penalty;Crown Central Petroleum Co,dba Crown

ANS 1 Crown Central Petroleum Corp Vol#: 1

99H-1972 Civil Money Penalty;The Old #3 Restaurant Inc,dba Old #3

ANS 1 The Old #3 Restaurant Inc,dba Old #3 Vol#: 1

99H-2011 Civil Money Penalty;Michael Pfeffer,dba Pfeffer's Country

ANS 1 Pfeffer's Country Market Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 1 DSM Anti-Infectives (The netherlands) Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1119 Virginia Netherton Vol#: 17

C 1120 Al Tappel Vol#: 17

C 1121 Eileen Hasday Vol#: 17

C 1122 Sara Atkinson Vol#: 17

C 1123 Amy Bush Vol#: 17

C 1124 Pauline M Perrin Vol#: 17

C 1125 Roslyn Dayan Vol#: 17

C 1126 Sue Speier Vol#: 17

C 1127 Philip H Coe Vol#: 17

C 1128 Leslie M Teeling Vol#: 17

C 1129 George Pelton Vol#: 17

C 1130 Charles & Janice Forman Vol#: 17

C 1131 Charles & Janice Forman Vol#: 17

C 1132 Joanne M robertson MD Vol#: 17

C 1133 Ruth M Jones Vol#: 17

C 1134 Marilyn G Knap Vol#: 17

C 1135 L Kosstrin Vol#: 17

C 1136 Lucio Chiaraviglio Vol#: 17

C 1137 Anne Peterson Vol#: 17

C 1138 Erna F Green Vol#: 17

C 1139 Elizabeth Hubbard Vol#: 17

C 1140 Dorothy Brooks Vol#: 17

C 1141 Phyllis Childs Vol#: 17

C 1142 Julien Wieland Vol#: 17

C 1143 Joseph & Carole Ledwith Vol#: 17

C 1144 Marcia E Keener Vol#: 17

C 1145 Georgia K Guida Vol#: 17

C 1146 David M Jackson MD Vol#: 17

C 1147 Linda Altenburger & 6 signatures Vol#: 17

C 1148 Kallyn Krash Vol#: 17

C 1149 Eileen Hoenig Vol#: 17

C 1150 Peter Smereka Vol#: 17

C 1151 Ken & Julie Maloney Vol#: 17

C 1152 Jennifer Kelly Vol#: 17

C 1153 Ruth Troetschler Vol#: 17

C 1154 Peggy B La Point Vol#: 17

C 1155 Norman & Susan Ewers Vol#: 17

C 1156 Illegible Vol#: 17

C 1157 Ms Maxine Manjos Vol#: 17

C 1158 Steven Plotnick Vol#: 17

C 1159 Maureen Rodgers Vol#: 17

C 1160 Sam Calaby Vol#: 17

C 1161 Alan A Katz Vol#: 17

C 1162 Ellen Eckels Vol#: 17

C 1163 James L Denison Vol#: 17

C 1164 Sandra Morrison Vol#: 17

C 1165 C Coleman Vol#: 17

C 1166 Edward & Virginia K Morey Vol#: 17

C 1167 Margaret Rusk Vol#: 17

C 1168 Dr Almut E Dettmers Vol#: 17

C 1169 Virginia Lyons Vol#: 17

C 1170 Ms Elizabeth Campuzano Vol#: 17

C 1171 Andrew Scott Vol#: 17

C 1172 June Cassidy Vol#: 17

C 1173 William Porter Vol#: 17

C 1174 Ruth Riggles Vol#: 17

C 1175 Carole R Keene Vol#: 17

99P-1340 Declared Eternity eau de Parfum Misbranded

C 165 Judy Stephenson Vol#: 4

C 166 Becky Slack Vol#: 4

99P-2252 Pamidronate Disodium Injection 3 mg/ml,6 mg/ml,9 mg/ml

ACK 1 HFA-305 Vol#: 1