DOCKETS ENTERED on May 11, 1999
TABLE OF CONTENTS
(ONLY FOR HYBERLINKED
ITEMS)
92N-0139
Statement Policy: Foods Derived from New Plant Varieties
98D-0785
Medical imaging drugs and biologics
98D-1168
Industry on ANDA Impurities in Drug Products;
98E-0474 TAZORAC
(TAZAROTENE) U.S.Patent #5,089,509
98E-0612
TROVAN (trovafloxacin mesylate) Patent #5,164,402
98E-0615
Interleukin-11 (Neumega, oprelvekin) Patent # 5,215,895
98E-0754
Patent Term Extension Omnicef (cefdinir) #4,559,334
98E-0779
Patent Ext MONOSTRUT CARDIAC VALVE PROSTHESIS No. 4,343,049
98E-0789
Patent Extension LOTEMAX and ALREX No. 4,996,335
98E-0840
Patent Extension OMNICEF (cefdinir) 4,935,507
98N-0044 Effect
of dietary supplement on structure/function of body
98N-1038 Irradiation
in the production, processing, &handling of food
98N-1170
Sunlamp Products Performance Standard
98N-1265
Distribution of Compounded Drug Products
98P-0203
Eliminate Forced Molting of Laying Birds
98P-0968
Guidance regarding Surimi Ingredient Labeling
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
99M-1306
PMA Medtronic Interstim System for Urinary Control
99N-0554
Public meeting/health & nutrient content claims in food lab
99P-0485
Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1340 Declared
Eternity eau de Parfum Misbranded
99V-1341
Laser Light Show X-29 Lite/ Cambridge Scanner, Beamscan
99V-1342 Laser
Light Show K.E.S. Laser
77N-0085 Saccharin and Its Salts
CA 27399 T L Rhom, Jr., D.D.S. Vol#: 429
CA 27400 B Carrier Vol#: 429
CA 27401 J M Crooms Vol#: 429
CA 27402 G Cantrell Vol#: 429
CA 27403 C H Lynch Vol#: 429
CA 27404 R D House Vol#: 429
CA 27405 R R Knutson Vol#: 429
CA 27406 J Biggerstaff Vol#: 429
CA 27407 C Gray Vol#: 429
CA 27408 L S Maddox Vol#: 429
CA 27409 R S Moore Vol#: 429
CA 27410 M D Snider Vol#: 429
CA 27411 J L Tutterou Vol#: 429
CA 27412 D H Orr Vol#: 429
CA 27413 M S Rauer Vol#: 429
CA 27414 G H Edwards Vol#: 429
CA 27415 K B Rheinlander Vol#: 429
CA 27416 T S Turner Vol#: 429
CA 27417 C E Bergeron Vol#: 429
CA 27418 E L Sutton Vol#: 429
CA 27419 D L Roulston Vol#: 429
CA 27420 W W Whitesides Vol#: 429
CA 27421 E Dahl Jr. Vol#: 429
CA 27422 J W Deslatti Vol#: 429
CA 27423 C Kephart Vol#: 429
CA 27424 R W Eaton Vol#: 429
CA 27425 E Kovalehick Vol#: 429
CA 27426 V D Able Vol#: 429
CA 27427 B M Harrison Vol#: 429
CA 27428 J A Schubert Vol#: 429
CA 27429 G Wortham Vol#: 429
CA 27430 W Schultz Vol#: 429
CA 27431 H F Lemoine Vol#: 429
CA 27432 A B Bulla Vol#: 429
CA 27433 S Stanley Vol#: 429
CA 27434 G E Baker Vol#: 429
CA 27435 W & J Mott Vol#: 429
CA 27436 F Rypka Vol#: 429
CA 27437 W J Gaston Vol#: 429
CA 27438 R G Swinnea Vol#: 429
CA 27439 O E Vellenoweth Vol#: 429
CA 27440 R McCormick Vol#: 429
CA 27441 G A Smyth Vol#: 429
CA 27442 J Peterson Vol#: 429
CA 27443 D Haynes Vol#: 429
CA 27444 H E Rivers Vol#: 429
CA 27445 J Chandler Vol#: 429
CA 27446 A Ardoin Vol#: 429
CA 27447 N Landry Vol#: 429
CA 27448 B R Owens Vol#: 429
CA 27449 H A Fisher Vol#: 429
CA 27450 G Upton Vol#: 429
CA 27451 F M Lindsey Vol#: 429
CA 27452 H Brinkley Vol#: 429
CA 27453 L Bennett Vol#: 429
CA 27454 R A Horracks Vol#: 429
CA 27455 J R Barton Vol#: 429
CA 27456 C Johnson Vol#: 429
CA 27457 L White Vol#: 429
CA 27458 J Pittam Vol#: 429
CA 27459 J A Hester Vol#: 429
CA 27460 J Scrudato Vol#: 429
CA 27461 C R Brown Vol#: 429
CA 27462 A R Mason Vol#: 429
CA 27463 I Sample Vol#: 429
CA 27464 H H Hurst Vol#: 429
CA 27465 E B Hill Vol#: 429
CA 27466 T Sanderford Vol#: 429
CA 27467 H F Kyer Vol#: 429
CA 27468 M A Brewer Vol#: 429
CA 27469 M Nakano Vol#: 429
CA 27470 M McAllister Vol#: 429
CA 27471 H Baker Vol#: 429
CA 27472 D L Gabele Vol#: 429
CA 27473 W C Stone Vol#: 429
CA 27474 B Adkins Vol#: 429
CA 27475 N Phillips Vol#: 429
CA 27476 K Buchwald Vol#: 429
CA 27477 R A Volk Vol#: 429
CA 27478 R E Feldman Vol#: 429
CA 27479 L Stevick Vol#: 429
CA 27480 H Zuege Vol#: 429
CA 27481 J Lunetta Vol#: 429
CA 27482 R E Miller Jr. Vol#: 429
CA 27483 F Richardson Vol#: 429
CA 27484 R B Hirst Vol#: 429
CA 27485 M W Olson Vol#: 429
CA 27486 R W Scherrer Vol#: 429
CA 27487 M R Stables Vol#: 429
CA 27488 C Shafer Vol#: 429
CA 27489 D W Griffith Vol#: 429
CA 27490 R E Rinda Vol#: 429
CA 27491 G Johns Vol#: 429
CA 27492 R E Price Vol#: 429
CA 27493 L Kadin Vol#: 429
CA 27494 R Maccaulay Vol#: 429
CA 27495 C O'Donnell Vol#: 429
CA 27496 M L Barasch Vol#: 429
CA 27497 P & J Lorsbach Vol#: 429
CA 27498 R A Wooley Vol#: 429
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 5254 Gertrude C Coad Vol#: 90
C 5255 Ester Johansson Murray Vol#: 90
C 5256 Thomas Marc futter Vol#: 90
C 5257 Anne Pondelick Vol#: 90
C 5259 Mrs Ann Elizabeth Silverman Vol#: 90
C 5260 Carolyn Gibson Vol#: 90
C 5261 Charlotte M Kenzie Vol#: 90
C 5262 Vera E Burnett Vol#: 90
C 5263 Marilin Engelman Vol#: 90
C 5264 Corinth W Carson Vol#: 90
C 5265 Donna Schwartz Vol#: 90
C 5266 Edith Stephan & Family Vol#: 90
C 5270 John L Scripp III Vol#: 90
C 5271 Professor M Kimbrell Vol#: 90
C 5272 Laurie P Oates Vol#: 90
C 5273 Cynthia M & Corry Knudson Vol#: 90
C 5275 Eunice A Riblinger Vol#: 90
C 5278 Alice Siegfried Vol#: 90
C 5282 Gail J McIntosh Vol#: 90
C 5284 Bette Jane Wogen Vol#: 90
C 5285 Madeline Swain Vol#: 90
C 5288 Richard L Costner Vol#: 90
C 5289 John a Harriott Jr Vol#: 90
C 5290 Ruth Gray Philips Vol#: 90
C 5291 Evelyn V Knazek Vol#: 90
C 5294 Linden A Schatzbert & Family Vol#: 90
C 5299 Barbara A Hoegh Vol#: 90
C 5301 Susan J Lambert Vol#: 90
C 5303 Ms Marilyn L Merchant Vol#: 90
C 5304 Benjamin Schlav Vol#: 90
C 5305 Robert J Duffy Vol#: 90
C 5306 Robert Marquez Vol#: 90
C 5307 Dr Hugh H Iltis Vol#: 90
C 5309 James Marshall Vol#: 90
C 5310 Martha Logan-Pearl Vol#: 90
98D-0785 Medical imaging drugs and biologics
C 19 Hyman, Phelps & McNamara, P.C. Vol#: 2
98D-1168 Industry on ANDA Impurities in Drug Products;
98E-0474 TAZORAC (TAZAROTENE) U.S.Patent #5,089,509
98E-0612 TROVAN (trovafloxacin mesylate) Patent #5,164,402
98E-0615 Interleukin-11 (Neumega, oprelvekin) Patent # 5,215,895
98E-0754 Patent Term Extension Omnicef (cefdinir) #4,559,334
98E-0779 Patent Ext MONOSTRUT CARDIAC VALVE PROSTHESIS No. 4,343,049
98E-0789 Patent Extension LOTEMAX and ALREX No. 4,996,335
98E-0840 Patent Extension OMNICEF (cefdinir) 4,935,507
98H-0558 Civil Money Penalties;Bill Reed & Steve Reed,d/b/a Reed's
EXB 1 GCF-1 Vol#: 1
98N-0044 Effect of dietary supplement on structure/function of body
C 22315 Dr. Allen M. Schoen Vol#: 771
C 22316 The Honorable Nancy L. Johnson (CI) Vol#: 771
98N-1038 Irradiation in the production, processing, &handling of food
C 1125 Ellen Lebowitz Vol#: 24
C 1126 Sally R. & Lamar Hoover Vol#: 24
C 1127 Marilynn B. Pope Vol#: 24
C 1128 David & Judy Savage Vol#: 24
C 1131 Virgil & Mary Renicker Vol#: 24
C 1132 Andelo Dispenzieri, Ph.D. Vol#: 24
C 1133 Scott & Sylvia Schneider Vol#: 24
C 1134 Rebecca-Grace Amer Vol#: 24
C 1135 Eileen Dispenzieri Vol#: 24
C 1136 Bonnie J. Rakowski Vol#: 24
C 1137 Glen E. Jackson & Susannah J. Kist Vol#: 24
C 1138 D. Marie Crooks Vol#: 24
C 1140 Mrs. Angela Marvin Vol#: 24
C 1142 Mr. & Mrs. W. L. Mackenzie Vol#: 26
C 1143 The Natural Gourmet Cookery School Vol#: 26
C 1144 R. Marguerite W. Ogden Vol#: 26
C 1145 Majorie M. Martin Vol#: 26
C 1146 Jerry Krueger, Sr. Vol#: 26
C 1147 Faye M. Mott Vol#: 26
C 1148 Florence Burghom Vol#: 26
C 1149 Gwytha C. Telotta Vol#: 26
C 1150 Aaron & Jeanne Money Vol#: 26
C 1151 Dorothy A. Spencer Vol#: 26
C 1152 Reba L. Kaprelian Vol#: 26
C 1153 Gary C. & Dorothy M. Savage Vol#: 26
C 1154 Dolores S. Kaufmann Vol#: 26
C 1155 Mrs. Leland Osterberg Vol#: 26
C 1156 Gerald Jongerius Vol#: 26
C 1157 Barry Fibel Vol#: 26
C 1158 Dixie Waldrip Vol#: 26
C 1159 Karin Smith Vol#: 26
C 1160 Bob Felt Vol#: 26
C 1161 Tamera Schlies Vol#: 26
C 1162 Jeffrey L. Hawkins Vol#: 26
C 1163 David Burdick Vol#: 26
C 1164 K. Kocher Vol#: 26
C 1165 Amy L. Lansky, Ph.D. Vol#: 26
C 1166 Philip Hypes Vol#: 26
C 1167 L4IKE Vol#: 26
C 1168 Bob Grobe Vol#: 26
C 1169 Debra & David Bokel Vol#: 26
C 1170 Lea Mathieu Vol#: 26
C 1171 Susan Moreau Vol#: 26
C 1172 Luis Fuentes Vol#: 26
C 1173 Penny Khaled Vol#: 26
C 1174 Toni & John Broderick Vol#: 26
C 1175 Ildiko Bartlett Vol#: 26
C 1176 Donna Ryan Vol#: 26
C 1177 Perry-Winkle Farm Vol#: 26
C 1178 Mark Lipsman Vol#: 26
C 1179 Connie Bigelow Vol#: 26
C 1180 Laura D. Cutler Vol#: 26
C 1181 Bruce Dickson Vol#: 26
C 1182 Dr. Elizabeth J. Mann Vol#: 26
C 1183 Gabrielle Dobronski Vol#: 26
C 1184 Bill Rosebrock Vol#: 26
C 1185 Amy M. Lechert Vol#: 26
C 1186 Lyle Otte Vol#: 26
C 1187 Susan Clark Vol#: 26
C 1188 Kathy Harris Vol#: 26
C 1189 Dennis Pottratz Vol#: 26
C 1190 Roger Briand & Carol Bergsma Vol#: 26
C 1191 Martha Feustel Vol#: 26
C 1192 Hugh M. S. Lovel Vol#: 26
C 1194 Beatrice Vaygart Vol#: 26
C 1196 Patrice Linton Vol#: 26
C 1197 Mary & Fred Kremser Vol#: 26
C 1198 Paul R. Ovaitt Vol#: 26
C 1200 Patricia Linton Vol#: 26
C 1201 Judson Stern-Carusone Vol#: 26
C 1203 Michael Hofferbert Vol#: 26
C 1204 Sonoma Ecology Center Vol#: 26
C 1206 Alicia Kennedy Vol#: 26
C 1208 Yvonne Delamater Vol#: 26
C 1209 Connie Williams Vol#: 26
C 1212 Daniel Sackett Vol#: 26
C 1214 Sharon G. Jacobs Vol#: 26
C 1215 Andrew & Amber Getz Vol#: 26
C 1216 Marcus P. Bass Vol#: 26
98N-1170 Sunlamp Products Performance Standard
C 5 Michael Caswell, Ph.d Vol#: 1
98N-1265 Distribution of Compounded Drug Products
C 1872 Shirley Watson Vol#: 76
C 1873 Aracely Zamudice Vol#: 76
C 1875 Nancy J. Chase Vol#: 76
C 1876 Linda E. Tillmann-Page Vol#: 76
C 1877 Sandra Friedman Vol#: 76
C 1878 JoAnn Snelling Vol#: 76
C 1880 Tamara Sullivan Vol#: 76
C 1881 Dennis L. Martin Vol#: 76
C 1882 Melanie Brittain Vol#: 76
C 1883 Linda Deon Moore Vol#: 76
C 1884 Penny Friedman Vol#: 76
C 1885 Joe Totanelli & Tom Bader Vol#: 76
C 1886 Theresa Lawrence Vol#: 76
C 1890 Lucille Adamczyk Vol#: 76
C 1892 Sharon Usinger Vol#: 76
C 1893 Lynn Skaggs & Gayle Rowell Vol#: 76
C 1894 Laurie Capretta Vol#: 76
C 1895 Cognitive Enhancement Research Institute Vol#: 76
C 1896 Cheryl L. Ellis Vol#: 76
C 1897 Marjory Abbott Vol#: 76
C 1900 Annette Barath Vol#: 76
C 1902 Marjorie T. Blubaugh Vol#: 76
C 1903 Alison K. Hazelbaker Vol#: 76
C 1904 Sonya Hubenette Vol#: 76
C 1905 Carolyn Chapin Vol#: 76
C 1906 L. D. Remington Vol#: 76
C 1907 Odyssey Clinical Studies Vol#: 76
C 1909 Shirley C. Morgan Vol#: 76
C 1910 Judith K. Earley Vol#: 76
C 1912 Sarah E. Anheuser Vol#: 76
C 1913 Elaine Paolillo Vol#: 76
C 1915 Priscilla Devin Vol#: 76
C 1918 Charles Allred Vol#: 76
C 1919 Barbara Meadows Vol#: 76
C 1921 Karen F. Soumi Vol#: 76
C 1924 Valerie Nielsen Vol#: 76
C 1925 Marilyn Dobson Vol#: 76
C 1928 Juliet Moeckel Vol#: 76
C 1929 Elizabeth C. Riedel Vol#: 76
C 1930 Kathleen Miller Vol#: 76
C 1931 Giovanna Coppola Vol#: 76
C 1933 Marlene F. Wagner Vol#: 76
C 1935 Dr. Ralph Lewis Vol#: 76
C 1937 Steven Van Lopin Vol#: 76
98P-0203 Eliminate Forced Molting of Laying Birds
C 1327 Jennifer Stringer Vol#: 31
C 1331 Ms Li-Anne Kreeft Vol#:
C 1332 Dr Alyssa N Easton Vol#: 31
C 1334 Ms Lillian D McKinstry Vol#: 31
C 1337 Barbara J Bogner Vol#: 31
C 1339 Kathry A Watkins Vol#: 31
C 1341 Fredrick & Lynette Eliton Vol#: 31
C 1342 Arnold P Rubin Vol#: 31
C 1343 Erik Nebel et al Vol#: 31
C 1344 Dorothy Finger Vol#: 31
C 1346 Martha Bushnell PhD Vol#: 31
C 1347 Ms Frances Rosato Vol#: 31
C 1349 Veronica Proksch Vol#: 31
C 1352 Ms D McCormick Vol#: 31
C 1354 Ms Traci Hoelike Vol#: 31
C 1355 Leigh-Anne Dennison Vol#: 31
C 1356 Karen C Quigley Vol#: 31
C 1357 Ms Sydney Burrus Vol#: 31
C 1358 Ms Pauline Doyle Vol#: 31
C 1359 Suzanne Martin Vol#: 31
C 1360 Ms Lindsay Collins Vol#: 31
C 1361 Lizanne Bristol Vol#: 31
C 1366 Nicole C Baczkowski Vol#: 31
C 1367 Dr Margaret E Rooney Vol#: 31
98P-0968 Guidance regarding Surimi Ingredient Labeling
C 4 National Consumers League Vol#: 1
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
C 98 Proffesor M Kimbrell Vol#: 3
C 99 Eunice A Riblinger Vol#: 3
99D-0254 product name placement,size, & prominence in advertising
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99H-0199 Civil Money Penalties;Star Mart Inc,d/b/a Star Mart #2
LET 2 Office of Tobacco Programs Vol#: 1
99H-0525 Civil Money Penalties;Pump & Save Inc,d/b/a Pump & Save #702
ANS 1 Pump and Save Inc Vol#: 1
99H-0781 Civil Money Penalty; Wonder Foods Inc d/b/a Village Market
ANS 1 Wonder Foods Inc Vol#: 1
99H-0930 Civil Money Penalties;L & J's Country Store Inc,d/b/a L & J
ANS 1 L & J's Country Store Inc. Vol#: 1
99H-1000 Civil Money Penalties;Merl Phillip Kiper,d/b/a Village Markt
ANS 1 Merl Phillip Kiper Vol#: 1
99H-1221 Civil Money Penalty; CFJ Properties d/b/a Flying J
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99M-1306 PMA Medtronic Interstim System for Urinary Control
99N-0386 Talking with Stakeholders About FDA Modernization
C 11 Bayer Corporation Vol#: 2
C 12 STOP Safe Tables Our Priority Vol#: 2
C 13 UC Berkley Vol#: 2
C 14 Bio Merieux Inc Vol#: 2
C 15 Diacrin Inc Vol#: 2
C 16 Committee of Ten Thousand Vol#: 2
C 17 Genzyme Corporation Vol#: 2
C 18 International Pharmaceutical Excipiento Vol#: 2
C 19 Temple University School of Pharmacy Vol#: 2
C 20 Hoechst Roussel Vet Vol#: 2
C 21 unsigned Vol#: 2
C 22 Temple Un (Faculty) Vol#: 2
C 23 Jacobs Engineering Group Inc Vol#: 2
C 24 Baxter Vol#: 2
C 25 University of IL Vol#: 2
C 26 Valence Research LLC Vol#: 2
EC 8 William Ash Vol#: 2
LST 2 Agenda CDER Stakeholder Meeting, PA Vol#: 2
LST 3 Registration List CDER Meeting PA Vol#: 2
TR 1 Transcript April 28, 1999 Washington DC Vol#: 3
TR 2 Transcript April 28, 1999 Atlanta, GA Vol#: 4
TR 3 Transcript April 28, 1999 Overland Pk KS Vol#: 5
TR 4 Transcript April 28, 1999 Boston, MA Vol#: 6
TR 5 Transcript April 28, 1999 Phila., PA Vol#: 7
TR 6 Transcript April 28, 1999 Chicago, IL Vol#: 8
TR 7 Transcript 4/28/99 San Francisco, CA Vol#: 9
TS 1 Sacramento Medical Foundation Blood Ctr Vol#: 2
TS 2 Genentech Inc Vol#: 2
TS 3 Massachusetts Biotechnology Council Vol#: 2
TS 4 Haemonetics Corporation Vol#: 2
TS 5 Health Industry Manufacturers Associatio Vol#: 2
TS 6 Consumer Healthcare Products Association Vol#: 2
TS 7 Animal Health Institute Vol#: 2
99N-0554 Public meeting/health & nutrient content claims in food lab
C 1 American Preventive Med Assoc et al Vol#: 1
C 3 Association of Food&Drug (AFDO) Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1340 Declared Eternity eau de Parfum Misbranded
CP 1 Environmental Health Network (EHN) Vol#: 1
99V-1341 Laser Light Show X-29 Lite/ Cambridge Scanner, Beamscan
VAR 1 Central Caroline Commuity College Vol#: 1