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] 

DOCKETS ENTERED on February 3, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]
 
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems *
99D-4396 Financial Disclosure By Clinical Investigators *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00P-0425 To amend 21 CFR 107 Subpart B,labeling of infant formulas *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EMC 41 Jenkins Vol#: 40

EMC 42 Pam Scott Vol#: 40

EMC 43 Elizabeth and Howard Kinslinger Vol#: 40

EMC 44 Marilyn Wykoff Vol#: 40

EMC 45 Barbara Mattocks Vol#: 40

EMC 46 Holly Rothkopf Vol#: 40

EMC 47 J.E.H. Vol#: 40

EMC 48 Beverly Archibald Vol#: 40

EMC 49 Molly Bundy Vol#: 40

EMC 50 Paul & Sandy Berman Vol#: 40

EMC 51 John D. Bruen Vol#: 40

EMC 52 R.C. Van Essendelft Vol#: 40

EMC 53 G J CAMPBELL JR Vol#: 40

EMC 54 Nancy F Johnston Vol#: 40

EMC 55 RICHARD D. JACOBS Vol#: 40

EMC 56 Ohbettyio Vol#: 40

EMC 57 Robert W. Romberg, Ph.D. Vol#: 40

EMC 58 Dorothy Welsh Vol#: 40

EMC 59 North Dakota State University Vol#: 40

EMC 60 Patricia Niego Vol#: 40

EMC 61 Larry G. Lankford Vol#: 40

EMC 62 William Shapiro, Ed.D. Vol#: 40

EMC 63 Margo Sailor Vol#: 40

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 219 Sheila M Wight Vol#: 6

97N-0451 Microbial Safety of Produce; Public Meeting

SUP 4 Denise Denkinger Vol#: 17

SUP 5 Denise Denkinger Vol#: 17

97N-0481 Reclassification of the Penile Rigidty Implant

NFR 1 HFZ-470 Vol#: 1

98E-0854 Patent Extension 4,485,088 BAPTEN (beta-aminopropionitrile f

N 1 Vol#: 1

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

LET 2 Andrx Pharmaceuticals, Inc. Vol#: 6

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

C 2290 Form Letter Count 17 Vol#: 66

C 2291 Paulette Green Vol#: 67

C 2292 Michael Leo Vol#: 67

C 2293 J Scott Doyle Vol#: 67

C 2294 J M Barringer & G R Barringer Vol#: 67

C 2295 Margie Lazor Vol#: 67

C 2296 Katie Lozito Vol#: 67

C 2297 Charlene Gruen Vol#: 67

C 2298 Kimberly Wampole Vol#: 67

C 2299 Kevin Dickens Vol#: 67

C 2300 Linda Hoyt Vol#: 67

C 2301 Bonnie England Vol#: 67

99D-0186 Testing Orthopedic Implants with Metallic Plasma Sprayed

GDL 2 Guideline Vol#: 1

NAD 2 HFZ-220 Vol#: 1

99D-0392 Seafood HACCP transition guidance

GDL 1 Guideline Vol#: 1

NAD 1 HFS-400 Vol#: 1

99D-4003 Preclinical and Clinical Data and Labeling Breast Prostheses

C 2 Mentor Corporation Vol#: 1

99D-4130 Manufacturers to assemblers for Diagnostic X-Ray Systems

C 3 Siemens Medical Engineering Group Vol#: 1

99D-4396 Financial Disclosure By Clinical Investigators

C 12 Abbott Laboratories Vol#: 1

99E-0116 Patent Extension Rotashield, #4,704,275

N 1 HFD-7 Vol#: 1

99H-1366 Civil Money Penalties;Richard Carbaugh,d/b/a Waverly Grocery

CS 2 HFA-305 Vol#: 1

99H-5068 Civil Money Penalty;Haymarket Inc,dba Kennedyville Market

ANS 1 Haymarket Inc Vol#: 1

99H-5167 Civil Money Penalty;Frank Faulkner;dba Crossroad Grocery

ANS 1 Crossroads Grocery Vol#: 1

99H-5244 Civil Money Penalty;Air Host,Inc;dba Air Host Bentonville

ANS 2 Air Host Inc Vol#: 1

99H-5460 Civil Money Penalty;Beaver Park Investments, Inc;dba Kwik St

ANS 1 Kwik Stop Food Stores Vol#: 1

99H-5565 Civil Money Penalty;Henicle's Market, Inc;dba Henicle's Mark

ANS 1 Henicle's Market Inc Vol#: 1

99H-5580 Civil Money Penalty;Donovan Woodburn, Jr;dba Hop & Sack #22

ANS 1 Donovan Woodburn Jr,dba Hop & Sack #22 Vol#: 1

99N-4202 Market New Drug, Biologic, Antibiotic Drug for human Use

N 2 HFA-250 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 1045 James H Harnden Vol#: 111

C 1046 Sandra Lilligren Vol#: 111

C 1047 Wanda T Karczynski Vol#: 111

C 1048 Debra L Diegoli Vol#: 111

C 1049 Ian D Lewis Vol#: 111

C 1050 Sister Barbara C Knight Vol#: 111

C 1051 Karen Norback Vol#: 111

C 1052 Daro Humphrey Vol#: 111

C 1053 Jay Humphrey Vol#: 111

C 1054 Monica Gilman Vol#: 111

C 1055 Jordan Endler & Amy Chesal Vol#: 111

C 1056 Karen Morrison Vol#: 111

C 1057 Mary Bradstock PhD Vol#: 111

C 1058 Frances Miriam Reed PhD Vol#: 111

C 1059 Philip Stevens Vol#: 111

C 1060 Samuel B Chirman MD Vol#: 111

C 1061 Sister Barbara Hubbard Vol#: 111

C 1062 Katharine G More Vol#: 111

C 1063 Lydia J Paxson Vol#: 111

C 1064 Betty C Crowell Vol#: 111

C 1065 Catherine Davenport Vol#: 111

C 1066 Mary E Alther Vol#: 111

C 1067 Kay Christopher Vol#: 111

C 1068 Form letter count 247 Vol#: 137

EMC 1264 Claire Pentecost Vol#: 112

EMC 1265 Roy Culver Vol#: 112

EMC 1266 Sally Kaiser Vol#: 112

EMC 1267 Paula Friedman Vol#: 112

EMC 1268 Sabine Stetson Vol#: 112

EMC 1269 Kezia Tenenbaum Vol#: 112

EMC 1270 Mark Hunerlach Vol#: 112

EMC 1271 Francesca Reitano Vol#: 112

EMC 1272 Elizabeth Whitton Vol#: 112

EMC 1273 Monika Crummett Vol#: 112

EMC 1274 Sharon S Owen Vol#: 112

EMC 1275 Cassandra March Vol#: 112

EMC 1276 Dr Rohit M Namjoshi Vol#: 112

EMC 1277 Irene Brown PhD Vol#: 112

EMC 1278 Sharon Hunter Vol#: 112

EMC 1279 Carole Lees Vol#: 112

EMC 1280 Lovel Pratt Vol#: 112

EMC 1281 Laura Bower Vol#: 112

EMC 1282 Nelson James Vol#: 112

EMC 1283 Larry McClaran Vol#: 112

EMC 1284 Mark Armantrout Vol#: 112

EMC 1285 Jessica Braginsky Vol#: 112

EMC 1286 Robyn Morgan Vol#: 112

EMC 1287 James P Knox Vol#: 112

EMC 1288 Randy Poole Vol#: 112

EMC 1289 Benita Whitman Vol#: 112

EMC 1290 Ruth Ossher Vol#: 112

EMC 1291 Carolyn Sellman Vol#: 112

EMC 1292 Amy Lint Vol#: 112

EMC 1293 Elizabeth Pike Vol#: 112

EMC 1294 Nina Sprecher Vol#: 112

EMC 1295 Bari Caine Vol#: 112

EMC 1296 Mary Tkach Vol#: 112

EMC 1297 Thomas Ferraro Vol#: 112

EMC 1298 Margaret L Hudson Vol#: 112

EMC 1299 Marie Rhodes Vol#: 112

EMC 1300 Glenneth Lambert Vol#: 112

EMC 1301 Andrew Sellman Vol#: 112

EMC 1302 Harold Ossher Vol#: 112

EMC 1303 Alexey Davies Vol#: 112

EMC 1304 Karen Edwards Vol#: 112

EMC 1305 Rocky Draughon Vol#: 112

EMC 1306 Kimberly Harris Vol#: 112

EMC 1307 Christine Falcon Vol#: 112

EMC 1308 Charles Cockey Vol#: 112

EMC 1309 Robert Schlesinger Vol#: 112

EMC 1310 Patricia Seyfarth Vol#: 112

EMC 1311 Sarah E Noulles Vol#: 112

EMC 1312 Terry Barnett Vol#: 112

EMC 1313 Gerard Gillespie Vol#: 112

EMC 1314 Elizabeth Berry Vol#: 112

EMC 1315 Jennifer Mollett Vol#: 112

EMC 1316 Brian Montgomery Vol#: 112

EMC 1317 Mark Frankel Vol#: 112

EMC 1318 Dana Birke Vol#: 112

EMC 1319 Galen Malicoat Vol#: 112

EMC 1320 Jeffrey Custer Vol#: 112

EMC 1321 Marcia Walker Vol#: 112

EMC 1322 Matricia Haigood Vol#: 112

EMC 1323 Edward B Gulick Vol#: 112

EMC 1324 Dolores Boogdanian Vol#: 112

EMC 1325 Christopher Plante Vol#: 112

EMC 1326 Vivien Straus Vol#: 112

EMC 1327 Laura C D Cobb Vol#: 112

EMC 1328 Miriam Therese MacGillis Vol#: 112

EMC 1329 Lynn Coangione Vol#: 112

EMC 1330 Eva LaRoche Vol#: 112

EMC 1331 James Yack Vol#: 112

EMC 1332 Cathy Zazueta Vol#: 112

EMC 1333 Joseph C Lacey Vol#: 112

EMC 1334 Deborah Stowe Vol#: 112

EMC 1335 Claudio Musajo Vol#: 112

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 294 Karina Tromberg Vol#: 8

C 295 Courtney Sisler Vol#: 8

C 296 Amy Zilka Vol#: 8

C 297 Danno Stirpe Vol#: 8

C 298 AnnMarie L. Miller Vol#: 8

C 299 Donna L. Johnson Vol#: 8

C 300 Angela M. Wilson Vol#: 8

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1846 Mr. & Mrs. Ralph H. Snyder Vol#: 170

C 1847 Mary & Bob Clark Vol#: 170

C 1848 Ann Schulze Vol#: 170

C 1849 Edith B. Morales Vol#: 170

C 1850 J. J. Vol#: 170

C 1851 Hildegarde Hannum Vol#: 170

C 1852 Sandra Littell Vol#: 170

C 1853 Giovanna Davis Vol#: 170

C 1854 Mary White Vol#: 172

C 1855 Mona & Barry Fansher Vol#: 172

C 1856 Mr. & Mrs. Ervey P. Shelley Vol#: 172

C 1857 Bonnie R. Vol#: 172

C 1858 M. Ruth Niswander Vol#: 172

C 1859 Ms. Lynne Bloom Vol#: 172

C 1860 Athena Hrevatis Vol#: 172

C 1861 J. Scott Douglas Vol#: 172

C 1862 Linda Boulos Vol#: 172

C 1863 Ms. Jan Van Dyne Vol#: 172

C 1864 Susan & Colin Crawford Vol#: 172

C 1865 Ms. Barbara Crall Vol#: 172

C 1866 Virginia Doster Vol#: 172

C 1867 Mr. & Mrs. J. L. Denison Vol#: 172

C 1868 Ms. Susan Johnson Vol#: 172

C 1869 Barbara Seiger Vol#: 172

C 1870 Ms. Jheri Zimmer Vol#: 172

C 1871 Karen Malley Vol#: 172

C 1872 Grace Naccarato Vol#: 172

C 1873 Joe Del Azzo Vol#: 172

C 1874 T. E. Vol#: 172

C 1875 Martha Gwyn Vol#: 172

C 1876 Debra Kratzenberg Vol#: 172

C 1877 Nicole S. Sweeney Vol#: 172

C 1878 Don Schrader Vol#: 172

C 1879 Heidi Knost Vol#: 172

C 1880 Lois Montalbano Vol#: 172

C 1881 Joseph & Christine Tessitore Vol#: 172

C 1882 R. Tyner Vol#: 172

C 1883 Nancy Farell Vol#: 172

C 1884 Edward J. Allard Vol#: 172

C 1885 Patricia Pope Vol#: 172

C 1886 Wendy Glass Vol#: 172

C 1887 Barbara Kann Vol#: 172

C 1888 Mr. Sam Calaby Vol#: 172

C 1889 Diane Ensign Vol#: 172

C 1890 Mr. Clark Vogel Vol#: 172

C 1891 Betty & Paul Rondell Vol#: 172

C 1892 Mrs. Angela Marvin Vol#: 172

C 1893 Michael F. Jacobson Vol#: 172

C 1894 Natalie D. Brecher Vol#: 172

C 1895 Mr. Albert W. Klein, M.D. Vol#: 172

C 1896 Liza F. & Melvin Meister Vol#: 172

EMC 41 Elaine Barnartt-Goldstein Vol#: 172

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

00H-0027 Civil Money Penalty;Ibrahim Mustafa;dba Lena Super Valu

ANS 1 Lena Super Valu Vol#: 1

00H-0149 Civil Money Penalty;Evergreen Drug Co,dba Evergreen Discount

ANS 1 Evergreen Drug Co Vol#: 1

00H-0169 Civil Money Penalty;Pride Convenience, Inc;dba Pride

ANS 1 Pride Convenience Inc Vol#: 1

00H-0216 Civil Money Penalty;Orvil Sheets;dba Hermitage Exxon

ANS 1 Hermitage Exxon Vol#: 1

00H-0250 Civil Money Penalty;Dean Bacon and Ann Bacon,dba Maurie's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0251 Civil Money Penalty;Brewer's Oil Co Inc,dba Brewer's Auto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0252 Civil Money Penalty;CVS Revco D S Inc,dba CVS Pharmacy #6446

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0253 Civil Money Penalty;Dash In Inc,dba Dash In #7

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0254 Civil Money Penalty;Jack Dungan,dba Jack's Quick Serve

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0255 Civil Money Penalty;E&S Oil Co,An Oklahoma Limited Parnershi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0256 Civil Money Penalty;Wanda East,dba Wanda's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0257 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug #6294

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0258 Civil Money Penalty;E-Z Mart Stores Inc,dba E-Z Mart #551

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0259 Civil Money Penalty;E-Z Mart Stores Inc,dba E-Z Mart #554

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0260 Civil Money Penalty;Forest City Foods Inc,dba Forest City Fo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0261 Civil Money Penalty;Goodner's Super Market No 2 Incorporated

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0262 Civil Money Penalty;Green Oil Co,dba Illiiopolis Citgo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0263 Civil Money Penalty;Jacinta Hernandez,dba Cesar's Drive In

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0264 Civil Money Penalty;Homeland Store Inc,dba Homeland Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0265 Civil Money Penalty;Hutchinson Oil Co Inc,dba E-Z Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0266 Civil Money Penalty;Karen Kabrud Inc,dba Coady's Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0267 Civil Money Penalty;Kishan Cards & Gifts Inc,dba Gateway Cig

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0268 Civil Money Penalty;Martin & Bayley Inc,dba Huck's Convenien

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0269 Civil Money Penalty;Minier Foods Inc,dba Minier Eisner #429

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0270 Civil Money Penalty;Claudio Montero Mora,dba Claudio's Liquo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0271 Civil Money Penalty;Ports Petroleum Co Inc,dba Fuel Mart 631

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0272 Civil Money Penalty;Joe Don Post,dba Post Exchange

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0273 Civil Money Penalty;Simons Petroleum Inc,dba Simons Oasis

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0274 Civil Money Penalty;W & J Dolch Inc,dba St Paul Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0298 Civil Money Penalty;Khaled M Ammar,dba Penny Saver Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0299 Civil Money Penalty;Town 7 Market Inc,dba Town 7 Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0301 Civil Money Penalty;Ramey & Sons Inc,dba Ramey's super Valu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0302 Civil Money Penalty;Wallis Oil Co & William Wallis, dba Mobi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0303 Civil Money Penalty;Edwards Food Fare Inc,dba Edwards Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00H-0304 Civil Money Penalty;Reid's Inc,dba Reid's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00H-0305 Civil Money Penalty;Farmland Ind Inc,dba Wynne Fast Lane 118

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00H-0306 Civil Money Penalty;Jack Weber,dba Pumpkin Center Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00H-0307 Civil Money Penalty;Charles Mayo,dba C J'S Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00H-0308 Civil Money Penalty;Bhavin Patel,dba Dixwell Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

00P-0425 To amend 21 CFR 107 Subpart B,labeling of infant formulas

ACK 1 HFA-305 Vol#: 1

CP 1 Mead Johnson Vol#: 1