Food and Drug Administration

DOCKETS ENTERED on June 10, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

92N-0139 Statement Policy: Foods Derived from New Plant Varieties
98D-0362 Stability Testing of Drug Substances and Drug Products*
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0254 product name placement,size, & prominence in advertising*
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99N-0035 Medical Devices; Reclassification of 38 Preamendments*
99N-0438 Contamination ready-to-eat foods associated food prepartion*
99N-1174 Development of Strategy for Dietary Supplements *
99P-0033 Combat the spread of transmissible spongiform encephalopathy*
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91F-0228 Safe Use of Sucrose Acetate Isobutyrate As A Stabilizer

BKG 1 Vol#: 2

NFR 1 Vol#: 1

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5504 Don Williams Vol#: 99

C 5505 Debbie Ortman & Family Vol#: 99

C 5506 Helene Asmis Clifford Vol#: 99

C 5507 Campaign for Food Safety/Organic Consumr Vol#: 99

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98D-0362 Stability Testing of Drug Substances and Drug Products

C 62 Zeneca Pharmaceuticals Vol#: 5

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98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 55 National Center for Infectious Diseases Vol#: 2

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

CR 1 GCF-1 Vol#: 1

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

C 2631 Elaine J. Attwood (Australia) Vol#: 60

C 2632 Linda Helgeson Vol#: 60

C 2633 Bob Stabach Vol#: 60

C 2634 Melanie Griffith Vol#: 60

C 2635 R. Chambers Vol#: 60

C 2636 Mary C. Russell Vol#: 60

C 2637 Susan Wise Vol#: 60

C 2638 Jacob & Muriel Small Vol#: 60

C 2639 Dino Pauletto Vol#: 60

C 2640 People's Food Co-Op Vol#: 60

C 2641 Susan Wiedman Vol#: 60

C 2642 Karen K. McKinney Vol#: 60

C 2643 Wendy de Martini Vol#: 60

C 2644 Bette Kent Vol#: 60

C 2645 Ray E. Funk Vol#: 60

C 2646 Cerena Mary Lauren Vol#: 60

C 2647 Wendy de Martini Vol#: 60

C 2648 Frederick Woeckener Vol#: 60

C 2649 Joan Payne Kincaid Vol#: 60

C 2650 Marty Jabara Vol#: 60

C 2651 Kim Woo Vol#: 60

C 2652 Barbara & Robert M. Goldberg Vol#: 60

C 2653 Lisa Fishbein Vol#: 60

C 2654 James Vol#: 60

C 2655 Julia Maceda-Willebrand, Ed.D. Vol#: 60

C 2656 Sarah R. Buehhelz Vol#: 60

C 2657 Leisa Hammett-Goad Vol#: 60

C 2658 Lois Amacher Vol#: 60

C 2659 Rebecca Wood Vol#: 60

C 2660 Lillian Polak Vol#: 60

C 2661 Karen Robin, Fujita Vol#: 60

C 2662 Nancy E. Curran Vol#: 60

C 2663 William Cleek Vol#: 60

C 2664 Beryl Schwartz Vol#: 60

C 2665 David Burress Vol#: 60

C 2666 Christine Bish Vol#: 60

C 2667 Ulana L. Mackay Vol#: 60

C 2668 Catharine Gunderson Vol#: 60

C 2669 L. Alixx Noonan Vol#: 60

C 2670 Patricia J. Smith Vol#: 60

C 2671 Heike-Marie Eubanks Vol#: 60

C 2672 James Smith Vol#: 60

C 2673 Antonette Thomson Vol#: 60

C 2674 Alfredo Urso Vol#: 60

C 2675 Wendy de Martini Vol#: 60

C 2676 Barbara McGovern Vol#: 60

C 2677 Rose Hiffenan Vol#: 60

C 2678 Kevi Krause Vol#: 60

C 2679 Laura Jane Hilton, M.A., D.D. Vol#: 60

C 2680 Billy Ray Boyd Vol#: 60

C 2681 Gloria Upton Vol#: 60

C 2682 M. Harrison Vol#: 60

C 2683 Philip H. Carver Vol#: 60

C 2684 Arnoldo Garcia Vol#: 60

C 2685 Michael McPhail Vol#: 60

C 2686 Linda Rogers Vol#: 60

C 2687 Selwyn Polit Vol#: 60

C 2688 Gregor Gable Vol#: 60

C 2689 Val Willer Vol#: 60

C 2690 Patti Gandolfini Vol#: 60

C 2691 Kelly Lawson Vol#: 60

C 2692 Helene Asmis Clifford Vol#: 60

C 2693 Campaign fr Food Safety/Organic Consumes Vol#: 60

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98N-1265 Distribution of Compounded Drug Products

C 3210 Northwest Center for Environmental Med Vol#: 115

C 3211 Ruth E. Lewis Vol#: 115

C 3212 John B. Bonnett Vol#: 115

C 3213 Chemwerth Inc Vol#: 115

C 3214 Midge Miles Vol#: 115

C 3215 Sharon Rolzin Vol#: 115

C 3216 Kim A. Scare Vol#: 115

C 3217 Durin Andrew Vol#: 115

C 3218 Phyllis Mozilo Vol#: 115

C 3219 Monica McPherson Vol#: 115

C 3220 C. Chmielewski Vol#: 115

C 3221 Brenda Ponzani Vol#: 115

C 3222 Carolyn Degraffenreed Vol#: 115

C 3223 Anne Sidney Vol#: 115

C 3224 Jeannine Coiner Vol#: 115

C 3225 M. L. Ballmeg Vol#: 115

C 3226 Lucy Ann Arnold Vol#: 115

EXT 11 Arizona State Board of Pharmacy Vol#: 115

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1582 Maureen Ippolito Vol#: 35

C 1583 Animal Care & Welfare Inc Vol#: 35

C 1584 Bernard Coley Vol#: 35

C 1585 Mrs Carroll Soohoo Vol#: 35

C 1586 Mrs Eileen Adamec Vol#: 35

C 1587 Ida M Callan Vol#: 35

C 1588 Liliana Valk Vol#: 35

C 1589 Miss D Freeman Vol#: 35

C 1590 Barbara L Perimutter MD Vol#: 35

C 1591 Donna Taylor Vol#: 35

C 1592 Greg & Tay Gardner Vol#: 35

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 146 Illegible Vol#: 3

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99D-0254 product name placement,size, & prominence in advertising

C 6 Wyeth-Ayerst Research Vol#: 1

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99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 21 Dr & Mrs Steven Gross Vol#: 2

C 22 Stephanie Nickolan-Barron Vol#: 2

C 23 Cam Martinez Vol#:

C 24 Elizabeth P Vol#: 2

C 25 Lynn P Vol#: 2

C 26 John Montgomery Vol#: 2

C 27 Mark W Bunch Vol#: 2

C 28 Margery Glickman Vol#: 2

C 29 Mari Engert Vol#: 2

C 30 Arnold & Arielle Schechter Vol#: 2

C 31 Juli Falconer Vol#: 2

C 32 Evelyn B Kimber Vol#: 2

C 33 Lorraine Nicotera Vol#: 2

C 34 Behalf of BUAV (England) Vol#: 2

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99D-1540 Reviewers on Evaluation of Human Pregnancy Outcome Data

GDL 1 Vol#:

NAD 1 Vol#: 1

99D-1541 Establishing Pregnancy Registries Draft Guidance Industry

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-1193 Civil Money Penalties;Charles Lang,d/b/a Lang's Standard Ser

ANS 1 Lang's Towing Inc Vol#: 1

99H-1577 Civil Money Penalty; A L Prime Energy Consultant Inc dba A L

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1578 Civil Money Penalty; Billy's Seafood Inc dba T J's Gas & Gri

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1579 Civil Money Penalty; Casey's Marketing Co dba Casey's Genera

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1580 Civil Money Penalty; Colleen Gray dba Gray's Amoco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1582 Civil Money Penalty;Drug Emporium Inc dba Drug Emporium #313

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1583 Civil Money Penalty;Eckerd Corp dba Eckerd Drug #254

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1584 Civil Money Penalty; Little Five Points Pharmacy Inc dba Lit

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1585 Civil Money Penalty;Joseph A Knese dba Shell

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1586 Civil Money Penalty;Winks of Corolla Inc dba Wink's of Corol

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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99N-0035 Medical Devices; Reclassification of 38 Preamendments

LET 1 HFZ-001 to Health Industry Mfg Assoc Vol#: 1

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99N-0438 Contamination ready-to-eat foods associated food prepartion

C 11 Sloan Valve Company Vol#: 1

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99N-1174 Development of Strategy for Dietary Supplements

C 10 National Collegiate Athletic Assn Vol#: 1

C 11 Consumer Healthcare Products Assn Vol#: 1

C 12 University of Cincinnati College of Law Vol#: 1

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99N-1393 State Petitions for Exemption from Preemption

N 1 Vol#: 1

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99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 78 Seimi D. Shiba Vol#: 1

C 79 Lorrie Engleman Vol#: 1

C 80 Irene M. Gallipeau Vol#: 1

C 81 Binnie J. Walz Vol#: 1

C 82 Voices for Animals Vol#: 1

C 83 Danila B. Oder Vol#: 1

C 84 James & Gloria Zimmerman Vol#: 1

C 85 Karen Anderson Vol#: 1

C 86 Dianne T. Phillips Vol#: 1

C 87 Jennifer Johnson Vol#: 1

C 88 Suzanne Brennan Vol#: 1

C 89 Ruth D'Ambrosio Vol#: 1

C 90 Damon R. Phillips Vol#: 1

C 91 Mr & Mrs Joseph Austin Vol#: 1

C 92 Bruno F. Cilione Vol#: 1

C 93 Alice M. Brandofsky Vol#: 1

C 94 Craig Cline Vol#: 1

C 95 JoAnne Dunahee Vol#: 1

C 96 Roger Fagan Vol#: 1

C 97 Carolyn Barker Vol#: 1

C 98 David C. Fenimore Vol#: 1

C 99 Gail Camhi Vol#: 1

C 100 Diane Venberg Vol#: 1

C 101 Victoria George Vol#: 2

C 102 Jill Weyhrauch Vol#: 2

C 103 Lynn Hogan Vol#: 2

C 104 Wanda Horne Vol#: 2

C 105 Laura Williams Vol#: 2

C 106 JoAnne Dunahee Vol#: 2

C 107 Lynne E. Coppala, Esq Vol#: 2

C 108 Micheline Vincent Vol#: 2

C 109 Bernard Kalus Vol#: 2

C 110 No Signature Vol#: 2

C 111 U. K. Nichols Vol#: 2

C 112 Thelma Cabaniss Vol#: 2

C 113 Janet Glass Vol#: 2

C 114 Eugene Martin Vol#: 2

C 115 Jennifer Vock Vol#: 2

C 116 Kenneth G. DeNeal, Sr Vol#: 2

C 117 Joan M. Bennett Vol#: 2

C 118 Elizabeth Gingery Vol#: 2

C 119 George H. Estes Vol#: 2

C 120 Chris Lucy Vol#: 2

C 121 Leona Grimes Vol#: 2

C 122 Marcia D. Anneke Vol#: 2

C 123 No Signature Vol#: 2

C 124 Ann Blowers Vol#: 2

C 125 James N. Broshears Vol#: 2

C 126 Peggy Chantler-Dick Vol#: 2

C 127 Armando G. Rosa Vol#: 2

C 128 Emily Fabiano Vol#: 2

C 129 Mary Wicks Vol#: 2

C 130 Louise Barva Vol#: 2

C 131 No Signature Vol#: 2

C 132 Gerd Schubert Vol#: 2

C 133 Jean Edlefsen Vol#: 2

C 134 Helen Harvey Vol#: 2

C 135 No Signature Vol#: 2

C 136 Ann Markham Vol#: 2

C 137 Marcie Vol#: 2

C 138 Karen & Everett Raasch Vol#: 2

C 139 Ashworth, Blanchet & Raya Vol#: 2

C 140 Arneta Crossman Vol#: 2

C 141 Holmhaven Vol#: 2

C 142 L. Baer Vol#: 2

C 143 Marion Thomas Vol#: 2

C 144 Linda Nicholas Vol#: 2

C 145 Allison Burgess Vol#: 2

C 146 Madge Rubsam Vol#: 2

C 147 Virginia Catlin Vol#: 2

C 148 Danila B. Order Vol#: 2

C 149 Bernice A. White Vol#: 2

C 150 Christine Pistor Vol#: 2

C 151 Linda C. Cherp Vol#: 2

C 152 Leonard Lechner Vol#: 2

C 153 Kristy L. Boettler Vol#: 2

C 154 Mark Peppercorn Vol#: 2

C 155 Robert L. Carpenter Vol#: 2

C 156 Joann Dublin Vol#: 2

C 157 Shirley Kovar Vol#: 2

C 158 Ruth Berard Vol#: 2

C 159 Adelaide Mosca Vol#: 2

C 160 Elena Reed Vol#: 2

C 161 Martine Sankari Vol#: 2

C 162 Brenda Frey Vol#: 2

C 163 Florrie Goldman Vol#: 2

C 164 Marilyn Evenson Vol#: 2

C 165 Beth Wheeler Vol#: 2

C 166 Christine Nassikas Vol#: 2

C 167 Dorothea J. S. Goetz Vol#: 2

C 168 David Lynch Vol#: 2

C 169 Marikay Gruen Vol#: 2

C 170 Valerie Gilbert Vol#: 2

C 171 William Maxfield Vol#: 2

C 172 Rebecca Mitchell Vol#: 2

C 173 Peggy Toll Vol#: 2

C 174 Mary S. Mc Elroy Vol#: 2

C 175 Lois Shane Vol#: 2

C 176 Sandra Davis Vol#: 2

C 177 Eleanor Glaser Vol#: 2

C 178 Arlene Hundrieser Vol#: 2

C 179 Rober Van Dyke Vol#: 2

C 180 Irene M. Slater Vol#: 2

C 181 Thomas B. Coyle Vol#: 2

C 182 Anita Leblanc Vol#: 2

C 183 Lanette Rapp Vol#: 2

C 184 Jill Hopper Vol#: 2

C 185 Gloria Hafner-Allee Vol#: 2

C 186 Angela Critelli Vol#: 2

C 187 Florence Negherbon Vol#: 2

C 188 Joanne Parry Vol#: 2

C 189 J. L. Brown Vol#: 2

C 190 Pamela V. Maulfair Vol#: 2

C 191 Henry Casas Vol#: 2

C 192 Norma Wissick Vol#: 2

C 193 Franclose J. Navarro Vol#: 2

C 194 Thomas C. Jane Vol#: 2

C 195 Valerie Lyles Vol#: 2

C 196 J. Elens Vol#: 2

C 197 Chris Salamon Vol#: 2

C 198 M. Mc Ginnis Vol#: 2

C 199 Evelyn Murphy Vol#: 2

C 200 Jovette Levine Vol#: 2

C 201 Mary Cummini Vol#: 3

C 202 Joe D'Angelo Vol#: 3

C 203 Mary L. Cordes Vol#: 3

C 204 Evelyn V. Knazek Vol#: 3

C 205 Yolanda Hardman Vol#: 3

C 206 Megan Geer Alsop Vol#: 3

C 207 Arezoo Rahmim Vol#: 3

C 208 Susan & Hubert Van Wyck Vol#: 3

C 209 Karen Curcio Vol#: 3

C 210 Shari Krueger Vol#: 3

C 211 Susan Williams Vol#: 3

C 212 Margaret Waters Vol#: 3

C 213 Beth Bantz Vol#: 3

C 214 Julie Fenix Vol#: 3

C 215 Alexandra Fingesten Vol#: 3

C 216 Eunice Anderson Vol#: 3

C 217 Lisa Doell Vol#: 3

C 218 Marion Dennis Vol#: 3

C 219 Teresia E. LaFleur Vol#: 3

C 220 Dennis W. Campbell, Jr Vol#: 3

C 221 Maudie Lopez Vol#: 3

C 222 Helen Karlow Vol#: 3

C 223 Carolyn Repeta Vol#: 3

C 224 Kevin M. Crupi Vol#: 3

C 225 Philip H. Coe Vol#: 3

C 226 Gloria R. Aubuchon Vol#: 3

C 227 Pamela Wade Vol#: 3

C 228 Dennis J. Lenz Vol#: 3

C 229 Paula N. Tice Vol#: 3

C 230 Sylvia Wakley Vol#: 3

C 231 Jill Cresko Vol#: 3

C 232 V. Cunningham Vol#: 3

C 233 Grace Ertel Vol#: 3

C 234 Elsie F. Blumberg Vol#: 3

C 235 Ted Haack Vol#: 3

C 236 Donna E. Thomason Vol#: 3

C 237 Diane Riel Vol#: 3

C 238 Rozalyn Sherman Vol#: 3

C 239 Gaby S. Robey Vol#: 3

C 240 Irene Maud Lopez Vol#: 3

C 241 Theresa Gregg Vol#: 3

C 242 Kenneth S. Gregg Vol#: 3

C 243 Linda Dills Vol#: 3

C 244 D. K. Cinquemani Vol#: 3

C 245 Lorraine Hertel Vol#: 3

C 246 Sally Roche Vol#: 3

C 247 Sherlyn M. Kistner Vol#: 3

C 248 Jean Lauren Vol#: 3

C 249 June E. Cummings Vol#: 3

C 250 Bernard Caley Vol#: 3

C 251 Robert DeWolfe Vol#: 3

C 252 Linda C. Cherp Vol#: 3

C 253 Kathy Tanis Vol#: 3

C 254 Donald & Janis Hruby Vol#: 3

C 255 Jerome Sanders Vol#: 3

C 256 Joan Schuch Vol#: 3

C 257 Dorothy Nowotny Vol#: 3

C 258 Debra Lindsey Vol#: 3

C 259 Jo Ann Arcarese Vol#: 3

C 260 Frances C. Bargmann Vol#: 3

C 261 Jean L. McCoy Vol#: 3

C 262 Frank Evans Vol#: 3

C 263 Katherine A. Lander Vol#: 3

C 264 Carol Anderson Vol#: 3

C 265 Barbara Bonsignore Vol#: 3

C 266 Peter O'Kane Vol#: 3

C 267 Betty Rand Vol#: 3

C 268 Victoria Holzendorf Vol#: 3

C 269 Florence Blust Vol#: 3

C 270 Mari Engert Vol#: 3

C 271 Carol A. Lawson Vol#: 3

C 272 Neill Whitman Vol#: 3

C 273 David J. Minton Vol#: 3

C 274 Stacey Murrow Vol#: 3

C 275 Dawn Sullivan Vol#: 3

C 276 Holly J. Wells Vol#: 3

C 277 Craig S. Volland Vol#: 3

C 278 Rosita A. Smith Vol#: 3

C 279 Aimee Lykes Vol#: 3

C 280 Jill M. Heins Vol#: 3

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