DOCKETS ENTERED on 04/27/99

FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 27, 1999

Updated as of 9:30 am, May 6, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

NOTE: Starting July 1, 1999, documents on public display, such as this listing and the Federal Register - Public Inspection Listing, will be available primarily in electronic format. There will be no physical (hard copy) display.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

77N-0240 Single-Entity Coronary Vasodilators
96E-0043 EPIVIR, Patent Term Extension, 5,047,407
96E-0362 Differin Topical Gel, 0.1%, Patent Term Ext. No. Re. 34,440
96E-0363 Differin Solution, 0.1%, Patent Term Ext. App. No. 4,717,720
97E-0012 Rimadyl; Patent Extension Application No. 4,264,500
97E-0087 RAY THREADED FUSION CAGE; PATENT EXT APP NO.
97E-0269 Riker Laboratories Inc Tradename ALDARA US Patent
97E-0270 Riker Laboratories, Inc Trade name ALDARA Patent
97E-0293 Skelid, Patent Extension Number 4,876,248
97E-0294 Silvacote K, Patent Extension No. 4,209,430
97E-0367 Patent Extension; NORMIFLO (ardeparin sodium)
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
98E-0230 Witcor Prime Coronary Stent System;U.S.Patent App
98E-0489 Corlopam (fenoldopam mesylate);U. S. Patent Ext # 4,197,297
98N-0182 Bulk Drug Substances To Be Used in Pharmacy
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
98P-0968 Guidance regarding Surimi Ingredient Labeling
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99N-0386 Talking with Stakeholders About FDA Modernization
99P-0033 Combat the spread of transmissible spongiform
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1149 Label of Mintezol be Amended
99P-1150 Permit ANDA for Norethindrone & Ethinyl Estradiol chewable
99V-1151 Variance for laser-lexell 88 Water Cooled Scanner

77N-0240 Single-Entity Coronary Vasodilators

SUP 23 Hercon Laboratories Corporation Vol#: 27

96E-0043 EPIVIR, Patent Term Extension, 5,047,407

LET 5 HFY-20 Vol#: 1

96E-0362 Differin Topical Gel, 0.1%, Patent Term Ext. No. Re. 34,440

LET 5 HFY-20 Vol#: 1

96E-0363 Differin Solution, 0.1%, Patent Term Ext. App. No. 4,717,720

LET 5 HFY-20 Vol#: 1

97E-0012 Rimadyl; Patent Extension Application No. 4,264,500

LET 4 HFY-20 Vol#: 1

97E-0087 RAY THREADED FUSION CAGE; PATENT EXT APP NO. 4,961,740

LET 4 HFY-20 Vol#: 1

97E-0269 Riker Laboratories Inc Tradename ALDARA US Patent #5,238,944

LET 4 HFY-20 Vol#: 1

97E-0270 Riker Laboratories, Inc Trade name ALDARA Patent #4,689,338

LET 4 HFY-20 Vol#: 1

97E-0293 Skelid, Patent Extension Number 4,876,248

LET 4 HFY-20 Vol#: 1

97E-0294 Silvacote K, Patent Extension No. 4,209,430

LET 4 HFY-20 Vol#: 1

97E-0367 Patent Extension; NORMIFLO (ardeparin sodium)

LET 3 HFY-020 Vol#: 1

97P-0327 Premarin Conjugated Estrogens must identify active ingredien

WDL 1 Duramed Pharmaceuticals, Inc. Vol#: 1

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 265 HFS-456 to Boston Univ School of Medicin Vol#: 5

LET 266 HFS-456 to NBTY Inc Vol#: 5

LET 267 HFS-456 to Nutrition Professionals Inc Vol#: 5

LET 268 HFS-456 to Melaleuca Inc Vol#: 5

98E-0230 Witcor Prime Coronary Stent System;U.S.Patent App #4,886,062

LET 4 HFY-20 Vol#: 1

98E-0489 Corlopam (fenoldopam mesylate);U. S. Patent Ext # 4,197,297

LET 4 HFY-20 Vol#: 1

98H-0763 Civil Money Penalties;Gul Faraz,d/b/a Houston Corner Store

LET 5 HFA-305 to DAB Vol#: 1

98HRSA01 Organ Procurement and Transplantation Network

C 2683 Arlene B McWhorter Vol#: 214

C 2684 Patricia P Douglas Vol#: 214

C 2685 William C Cato Vol#: 214

C 2686 Mary B Capka RN Vol#: 214

C 2687 Ramsey Williams Vol#: 214

C 2688 Estelle Pennington Vol#: 214

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 124 Wayne B. Mahy Vol#: 19

C 125 Angela J. Salazar Vol#: 19

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

C 772 Jeanne M. Pitts Vol#: 16

C 773 Mary C. Ryan Vol#: 16

C 774 Jennifer Baumann Vol#: 16

C 775 Franklin County Cooperative Extension Vol#: 16

C 776 C.C. Lantz Vol#: 16

C 777 Jean E. Fox Tree Vol#: 16

C 778 Ron Cowit Vol#: 16

C 779 Nancy Mattheiss Vol#: 16

C 780 Alia Clary Vol#: 16

C 781 Sue Lovas Vol#: 16

C 782 Darrin King Vol#: 16

C 783 John Reinhardt Vol#: 16

C 784 Don Schrader Vol#: 16

C 785 Kathleen M. Lyons Vol#: 16

C 786 Raymond J. Niemi Vol#: 16

C 787 Linda Odom, Ph.D. Vol#: 16

C 788 Steven K. Thomas Vol#: 16

C 789 Pamela Morrissey Vol#: 16

C 790 Victor M. Kane Vol#: 16

C 791 Flo Teters Vol#: 16

C 792 Russell Ferriday Vol#: 16

C 793 Citizens For Health Vol#: 16

98N-1265 Distribution of Compounded Drug Products

C 1301 United States House of Representatives Vol#: 71

C 1302 Ms. Marilyn L. Powers Vol#: 71

C 1303 Enid Brodsky Vol#: 71

C 1304 Judy Ann Ohlsen Vol#: 71

C 1305 Ann Schumacher Vol#: 71

C 1306 Nancy Wilson Vol#: 71

C 1307 Anne Buchman Vol#: 71

C 1308 Jeri Green Vol#: 71

C 1309 Desert Resorts School of Somatherapy Vol#: 71

C 1310 Ruth B. Johns Vol#: 71

C 1311 George Heller, DDS Vol#: 71

C 1312 Ms. Flo Hunke Vol#: 71

C 1313 Debra A. Dill-Bergmann Vol#: 71

C 1314 Erminia Tucker Vol#: 71

C 1315 Peggy Herren Vol#: 71

C 1316 Elaine M. Ross Vol#: 71

C 1317 Carol Haring Vol#: 71

C 1318 Lila A. Smick Vol#: 71

C 1319 Linda Schonfeld Vol#: 71

C 1320 Deborah Schallon Vol#: 71

C 1321 Vicki L. Margaritis Vol#: 71

C 1322 Mirta E. Vidal Vol#: 71

C 1323 Elaine D'Lys McClurkan Vol#: 71

C 1324 Illegible Vol#: 71

C 1325 Sally J. Rychly Vol#: 71

C 1326 William A. & Evelyn L. Jacobi Vol#: 71

C 1327 Nicole Sandperl Vol#: 71

C 1328 Linda Lucas Vol#: 71

C 1329 Patricia G. Griffeth Vol#: 71

C 1330 Rose Norman Vol#: 71

C 1331 Judy Wilkins Vol#: 71

C 1332 Marrie Butler Vol#: 71

C 1333 Donna R. Thompson Vol#: 71

C 1334 Christine Reed Vol#: 71

C 1335 Dorcas F. Toney Vol#: 71

C 1336 Barbara J. H. Higgins Vol#: 71

C 1337 Alice Jane Weems Vol#: 71

C 1338 Ann B. Brown Vol#: 71

C 1339 John Stuber Vol#: 71

C 1340 Cynthia Lewin Vol#: 71

C 1341 Tina Ganch Vol#: 71

C 1342 Nancy G. Bauer Vol#: 71

C 1343 L. Rita Herzfeld Vol#: 71

C 1344 Christine Watters Vol#: 71

C 1345 Pamela Beedle-Gee Vol#: 71

C 1346 Carol Reiner Vol#: 71

C 1347 Diana Duque Vol#: 71

C 1348 S. M. Menegar Vol#: 71

C 1349 Elizabeth Hester Vol#: 71

C 1350 Sarah M. Koher Vol#: 71

C 1351 Ken T. Wand Vol#: 71

C 1352 Barbara Laudel Vol#: 71

C 1353 Felicea Deuscher Vol#: 71

C 1354 Kathleen Interess Vol#: 71

C 1355 Cheryl S. Gordan Vol#: 71

C 1356 Kimberly Trepton Vol#: 71

C 1357 Illegible Vol#: 71

C 1358 F. Gaye Lucher Vol#: 71

C 1359 Nancy Benguerel Vol#: 71

C 1360 Sally R. Bermudes Vol#: 71

C 1361 Jeanne & Jim Manning Vol#: 71

C 1362 Elizabeth Watts Vol#: 71

C 1363 Sally A. Polyer Vol#: 71

C 1364 Laura Lee Vol#: 71

C 1365 Mary Drone Vol#: 71

C 1366 Clara Cupery Vol#: 71

C 1367 Kay C. Ward Vol#: 71

C 1368 Janice Mlekush Vol#: 71

C 1369 Suzanne Drese Vol#: 71

C 1370 Rita Vahling Vol#: 71

C 1371 Casandra M. Campbell Vol#: 71

C 1372 Susan Portmann Vol#: 71

C 1373 Loretta C. Norris Vol#: 71

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2095 Luke M. O'Brien Vol#: 52

C 2096 Dana Leota Vol#: 52

C 2097 Arthur Fleyenheomer Vol#: 52

C 2098 Joanne Reid Vol#: 52

C 2099 Kendra Diehl Vol#: 52

C 2100 Sally Nichols Vol#: 52

C 2101 Marlan Smith Vol#: 52

C 2102 Annette C. Scharl Vol#: 52

C 2103 Susan Caleader Vol#: 52

C 2104 Lorrie M. Foreman Vol#: 52

C 2105 Carmine Borie Vol#: 52

98P-0203 Eliminate Forced Molting of Laying Birds

C 1138 P Strand Vol#: 29

C 1139 Katherine & Keith Zumbrunnen Vol#: 29

C 1140 Linda Stein Vol#: 29

C 1141 Diane Green Vol#: 29

C 1142 Mr & Mrs Edgar H Brown Vol#: 29

C 1143 Sophia B McAskill Vol#: 29

C 1144 The Weintraubs Vol#: 29

C 1145 Ruth W Pappelis Vol#: 29

C 1146 Virginia Hart Vol#: 29

C 1147 Anna Wilson Vol#: 29

C 1148 Louise Mariana Vol#: 29

C 1149 Ms Constance Andrews Vol#: 29

C 1150 Martha J Brown Ph D Vol#: 29

C 1151 Gloria Holtz & Family Vol#: 29

C 1152 Margaret F Binkowski Vol#: 29

C 1153 Melissa Wheelock Vol#: 29

C 1154 Helen Scott Vol#: 29

C 1155 Carmela Turi Vol#: 29

C 1156 Diana Petrella Vol#: 29

C 1157 Ms A Campbell Vol#: 29

C 1158 Cathy Emmanull Vol#: 29

C 1159 Dr. Kristin K Howell Vol#: 29

C 1160 Kathy Tanis Vol#: 29

C 1161 M Conley Vol#: 29

C 1162 Miranda Grizio Vol#: 29

C 1163 Kathleen L Ciacchi Vol#: 29

C 1164 Linda L Hawkins Vol#: 29

C 1165 Karen S LaRocci Vol#: 29

C 1166 Jennifer Jones Vol#: 29

C 1167 Jeffrey D Gordon Vol#: 29

C 1168 Miss Crystal Petrowich Vol#: 29

C 1169 Maria J Balboa Vol#: 29

C 1170 Jeanne & Norman Purcell Vol#: 29

C 1171 Stacey Murrow Vol#: 29

C 1172 Marjorie Nelson Vol#: 29

C 1173 Peggy J Phillips Vol#: 29

C 1174 Judith J Durham Vol#: 29

C 1175 Denise M Hanusek Vol#: 29

C 1176 Heather Silvio Vol#: 29

C 1177 Jeanne Barker Vol#: 29

C 1178 Mrs Suzanne Weinstein Vol#: 29

C 1179 unsigned Vol#: 29

C 1180 Larry A Temin Vol#: 29

C 1181 Ms Kristina Blaylock Vol#: 29

C 1182 Heather Heuer Vol#: 29

C 1183 Susan J Tabor Vol#: 29

C 1184 Lana Gersman Vol#: 29

C 1185 Ms AnnMarie L Miller Vol#: 29

C 1186 Nick Generalovich Vol#: 29

C 1187 Elaine Holpuch Vol#: 29

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 160 Olsen & Son Oyster Co. Vol#: 15

C 161 United Shellfish Co., Inc. Vol#: 15

C 162 Kevin Sidelinger Vol#: 15

C 163 The County of Chambers, Texas Vol#: 15

C 164 Clifford LeBouef Sr. Vol#: 15

C 165 IMP, Ipswich Maritime Products Vol#: 15

C 166 Massachusetts Shellfish Dealers & Produc Vol#: 15

C 167 New Zealand Embassy Vol#: 15

C 168 The Gulf Oyster Industry Council Vol#: 15

C 169 Molluscan Shellfish Institute Vol#: 15

C 170 State of MD Dept of Hlth & Mental Hygien Vol#: 15

C 171 Tulane Medical Center Vol#: 15

C 172 Bon Secour Fisheries, Inc. Vol#: 15

C 173 The Tulalip Tribes Shellfish Program Vol#: 15

C 174 Pacific Coast Oyster Growers Assn. Vol#: 15

C 175 Taylor Shellfish, Co. Vol#: 15

C 176 Aquaculture Technology, Inc. Vol#: 15

C 177 Nisqually Indian Tribe Vol#: 15

98P-0968 Guidance regarding Surimi Ingredient Labeling

C 1 Public Voice For Food & Health Policy Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 1 Robert L. Trimble Vol#: 1

99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)

NCR 1 Vol#: 1

99H-0394 Civil Money Penalty; Paul Christie d/b/a Mechanic Street Get

ANS 1 Mechanic St Getty Vol#: 1

99H-0561 Civil Money Penalties;Crown Central Petroleum Corp,d/b/a

ANS 1 Crown Central Petroleum Corp Vol#: 1

99H-0605 Civil Money Penalties;Lynn McDonough,d/b/a Frank's Market

ANS 1 Isle Inc Vol#: 1

99H-0623 Civil Money Penalties;Michael Spears,d/b/a The Patriot II

ANS 1 The Patriot II Vol#: 1

99H-0676 Civil Money Penalties;Joseph Horkey,d/b/a Friend's Convenien

ANS 1 Joseph Horkey, d/b/a Friend's Convenienc Vol#: 1

99H-0757 Civil Money Penalty; DCM Enterprises Inc d/b/a McGloughlin's

ANS 1 DCM Enterprises Inc Vol#: 1

99H-0915 Civil Money Penalty; Thomas Investments Inc d/b/a Shell Food

ANS 1 Snows Cut Bait & Tackle Inc Vol#: 1

99H-0957 Civil Money Penalties;Brian Hammons & Gary Hammons,d/b/a Gai

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1042 Civil Money Penalties;Claudino Cardoso,d/b/a Hillside Deli

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1043 Civil Money Penalties;Home Service Oil Co,d/b/a DeSoto Citgo

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1044 Civil Money Penalties;Dung Huynh,d/b/a Quick Food Store #20

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1045 Civil Money Penalties;Kenyon Oil Co,d/b/a Exeter Xtra Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1046 Civil Money Penalties;Do Shook Kim,d/b/a William Village Liq

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

NPH 1 HHS/FDA/CDER Vol#:

99H-1047 Civil Money Penalties;Milan Mlakar,d/b/a 7-Eleven Food Store

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1048 Civil Money Penalties;Opped Inc,d/b/a Compare Supermarket

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1049 Civil Money Penalties;Paxton & Ball Inc,d/b/a Fast Way #11

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

NPH 1 HHS/FDA/CDER Vol#: 1

Peoples

99H-1050 Civil Money Penalties; Tropical Food Corp,d/b/a Peopl

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1051 Civil Money Penalties;Rogers Petroleum Services Inc,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1052 Civil Money Penalties;Sandy's Variety Store II,& Santo Baez

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1053 Civil Money Penalties;Service Station Mgt Inc,d/b/a Desert

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1054 Civil Money Penalties;Sudhi Ranjan Sood,d/b/a Key Food

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1055 Civil Money Penalties;Paul E St Martin,d/b/a Newport Mobil

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1056 Civil Money Penalties;Steven Jr Market Inc,d/b/a Steven Jr

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1057 Civil Money Penalties;James Stringer & Kerry Compton,d/b/a

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1058 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1059 Civil Money Penalties;Wetzel's Super Markets Inc,d/b/a Wetze

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

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1060 Civil Money Penalties;Wholesale Petroleum Inc,d/b/a Country

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

NPH 1 HHS/FDA/CDER Vol#: 1

99M-1073 PMA TransScan T-Scan 2000

AAV 1 TransScan Medical Inc Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

C 9 Consumer Healthcare Products Association Vol#: 1

C 10 Janet Pfister Vol#: 1

EC 5 P Davis Vol#: 1

99N-0672 Iatric Corp.; Revocation of U.S. License No. 0416

BKG 1 HFM-17 Vol#: 1

N 1 Vol#: 1

99N-0924 List of Documents that apply to Med Devs Regulated by CBER

N 1 Vol#: 1

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 43 Eleanor Lipschutz Vol#: 1

C 44 Laurie Loveman Vol#: 1

C 45 Alice Thomas Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 91 Elaine Holpuch Vol#: 1

99P-1149 Label of Mintezol be Amended

ACK 1 HFA-305 Vol#: 1

CP 1 Scott G. Beach Vol#: 1

99P-1150 Permit ANDA for Norethindrone & Ethinyl Estradiol chewable t

ACK 1 HFA-305 Vol#: 1

CP 1 Kirkland & Ellis Vol#: 1

99V-1151 Variance for laser-lexell 88 Water Cooled Scanner

ACK 1 HFA-305 Vol#: 1

VAR 1 Chaotic Laser Systems Vol#: 1