DOCKETS ENTERED on May 18, 1999
TABLE OF CONTENTS
(ONLY FOR HYBERLINKED
ITEMS)
77N-0240
Single-Entity Coronary Vasodilators
98D-0481
180-day Generic Drug Exclusivity under Hatch-Waxman Amendmen
98D-1146
Microbial effects of antimicrobial new animal drugs/human sa
98D-1168
Industry on ANDA Impurities in Drug Products;
98N-1038
Irradiation in the production, processing, &handling of food
98N-1170
Sunlamp Products Performance Standard
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-0434
Standards for Generic Transdermal Estradiol Patches
98P-0504
Raw Molluscan Shellfish of Undetectable Levels
99N-0554
Public meeting/health & nutrient content claims in food lab
99P-0485
Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1416
Methylphenidate Hydrochloride Oral Solution (5mg/mL&10mg/5mL
99P-1417
Methylphenidate Hydrochloride Chewable tablets 5mg & 10mg
99P-1418
Methylphenidate Hydrochloride Chewable Tablets, 2.5mg
77N-0240 Single-Entity Coronary Vasodilators
HER 38 King & Spalding Vol#: 32
98D-0481 180-day Generic Drug Exclusivity under Hatch-Waxman Amendmen
RC 1 Teva Pharmaceuticals USA Inc Vol#: 1
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
C 52 American Feed Industry Assoc Vol#: 2
98D-1168 Industry on ANDA Impurities in Drug Products;
C 15 R W Johnson Pharmaceutical Research Ins Vol#: 1
98F-0797 Antioxidants and/or Stabilizers for Polymers
NFR 1 HFS-215 Vol#: 1
98H-0982 Civil Money Penalties;Bullard Market & Package Store Inc.
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0983 Civil Money Penalties; Sixth Street Food Stores Inc d/b/a
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0984 Civil Money Penalties;The Southland Corp (7-Eleven #23935)
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0985 Civil Money Penalties;Texaco Refining & Marketing Inc,d/b/a
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0987 Civil Money Penalties;Walgreen Eastern Co Inc (NY) d/b/a
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-0989 Civil Money Penalties; Sanguk Chong,d/b/a Shop-N-Go
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1010 Civil Money Penalties;Double Quick Inc,d/b/a Double Quick 21
LET 3 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98H-1011 Civil Money Penalties; Down's Self Service Inc.
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 1531 Form Letters 541 Vol#: 32
C 1532 Wayne M. Deeter Vol#: 35
C 1533 Stuart Quimby & Cary Kittner Vol#: 35
C 1535 Bernard Heideman Vol#: 35
C 1536 Sunshine Coast Environment Council, Inc. Vol#: 35
C 1538 Susan L. Maddox Vol#: 35
C 1539 Ms. Carli Mareneck Vol#: 35
C 1540 Abigail Curkeet Vol#: 35
C 1542 Gray's Ice Cream, Inc. & General Store Vol#: 35
C 1543 Lynette Totans Vol#: 35
C 1545 Stephen M. Grochowski Vol#: 35
C 1546 Margaret Davenport Vol#: 35
C 1547 Katherine Whited Vol#: 35
C 1550 James N. Joseph Vol#: 35
C 1552 Richard Lowenthal Vol#: 35
C 1553 Willamette Valley Business Alliance Vol#: 35
C 1554 Leslie Goldstein Vol#: 35
C 1558 Mrs. Elizabeth Smid, B.S. Vol#: 35
C 1560 C. A. Heffernon Vol#: 35
C 1565 Arlyn Heideman Vol#: 35
C 1567 Sherri Detweiler Vol#: 35
C 1568 Mrs. Marian Buckner Vol#: 35
C 1569 Donna L. DeFiore Vol#: 35
C 1570 Judith Heideman Vol#: 35
C 1571 M. R. Eucalyptus Vol#: 35
C 1573 Wildtime Foods Vol#: 35
C 1574 Juliette Hanover Vol#: 35
C 1575 David Manary, D.D.S., M.S. Vol#: 35
C 1576 Ronald R. & Teresa K. Mead Vol#: 35
C 1578 Doug & Judy Bjork Vol#: 35
C 1579 Citizens Environmental Coalition Vol#: 35
C 1580 Betty J. Fowler Vol#: 35
C 1581 Marilyn A. Weinschreider Vol#: 35
C 1582 Lila M. Turner Vol#: 35
C 1583 Tom B. Younker Vol#: 35
C 1585 Bruce Campbell Vol#: 35
C 1588 Christine Stevens Vol#: 35
C 1589 Ruth D. Schiefen Vol#: 35
C 1590 Stephen H. Johnson Vol#: 35
C 1591 Rochelle & Steven Anderson Vol#: 35
EXT 21 Marjolein van der Veen Vol#: 35
98N-1170 Sunlamp Products Performance Standard
98N-1265 Distribution of Compounded Drug Products
C 2163 Phyllis Hofman Vol#: 84
C 2164 Bonnie K. Swenson Vol#: 84
C 2166 Margaret Rozyck Vol#: 84
C 2168 Gerald & Iris Westcott Vol#: 84
C 2171 Eleanore M. Nichols Vol#: 84
C 2175 Jeanne A. Woodruff Vol#: 84
C 2176 Patricia Knacbe Vol#: 84
C 2184 Rebel Elaena Plas Vol#: 84
C 2185 Delores M. Cranoe Vol#: 84
C 2187 Clara M. Forde Vol#: 84
C 2188 Claramcee Humphrey Vol#: 84
C 2189 North Carolina Board of Pharmacy Vol#: 84
C 2190 Virginia Davis Vol#: 84
C 2198 Joseph Henry Collins III Vol#: 84
C 2199 Barbara L. Chan Vol#: 84
C 2201 Shelly L. Docekal Vol#: 84
C 2205 Christine G. Greene Vol#: 84
C 2207 Mary Saunsberry Vol#: 84
C 2210 Sonia Roberson Vol#: 84
C 2211 Barbara Neller Vol#: 84
C 2214 Eleanore M. Nichols Vol#: 84
C 2215 Catherine Baden Vol#: 84
C 2219 Casandra M. Campbell Vol#: 84
C 2222 Shelly L. Docekal Vol#: 84
C 2223 Mary Joyce Hilton Vol#: 84
C 2224 Carol M. Henwood Vol#: 84
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2149 Joanne M. Seymour Vol#: 53
C 2151 Carol W. Morris Vol#: 53
C 2152 Evelyn I. Gutchell Vol#: 53
C 2154 Joan M. Weichmann Vol#: 53
C 2157 Dorothy Finger Vol#: 53
C 2158 Ellen P. Donahue Vol#: 53
C 2161 Gabrielle Untz Vol#: 53
C 2162 Peter Simonelli Vol#: 53
C 2163 Frank & Carol Eggers Vol#: 53
C 2166 John Dickinson Vol#: 53
C 2168 Patricia Purvin Vol#: 53
C 2169 Sherry Youngblood Vol#: 53
C 2170 Melanie Garcia Vol#: 53
C 2171 John S. Hand, Ph.D. Vol#: 53
C 2172 H. Sledge Morgan Vol#: 53
C 2173 Falguni P. Shah Vol#: 53
C 2174 Andrea Pettina Vol#: 53
C 2176 Loren A. Reynolds Vol#: 53
C 2177 Carol P. Cognito Vol#: 53
C 2179 Cassie R. Taylor Vol#: 53
C 2180 Andrea Schwinn Vol#: 53
C 2181 Michelle Davis Vol#: 53
C 2182 Asha Donongrat Vol#: 53
C 2183 Marta Dominguez Vol#: 53
98P-0203 Eliminate Forced Molting of Laying Birds
C 1374 Ms Mary Jo Nagy Vol#: 31
C 1375 Katharine Mancom et al Vol#: 31
C 1376 Melinda Davidson Vol#: 31
C 1378 Sally Smithern Vol#: 31
C 1379 Melinda Marshall Vol#: 31
C 1382 Stephanie Nickolan-Barron Vol#: 31
C 1383 Scott & May Sullivan Vol#: 31
C 1386 Elizabeth Augustine Vol#: 31
C 1390 Concetta Fisichella Vol#: 31
C 1391 Mr & Mrs T Washburn Vol#: 31
C 1392 Mildred Zimmerman Vol#: 31
C 1393 Lynn C Lehocky Vol#: 31
C 1397 Madeline Casey Vol#: 31
C 1398 Marily Sterling Vol#: 31
98P-0434 Standards for Generic Transdermal Estradiol Patches
SUP 7 Berlex Laboratories, Inc. Vol#: 2
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
C 252 Louisiana Pride Seafood Vol#: 18
C 253 Bluefin Seafoods Corp Vol#: 18
99H-0020 Civil Money Penalties;Mohammad Nemer,d/b/a Quick Shop
LET 2 Office of Tobacco Programs Vol#: 1
99H-0058 Civil Money Penalties;Montgomery Foods Inc,d/b/a Food King
LET 2 Office of Tobacco Programs Vol#: 1
99H-0071 Civil Money Penalties;Eastern Petroleum Corp,d/b/a E P Mart
LET 2 Office of Tobacco Programs Vol#: 1
99H-0769 Civil Money Penalty; Wheel City Mobile Homes Inc d/b/a Wheel
ANS 1 Wheel-In Grocery Vol#: 1
99H-0775 Civil Money Penalty; Highway 58 Grill Inc d/b/a Paps Grill &
ANS 1 Highway 58 Grill Inc Vol#: 1
99H-0919 Civil Money Penalty; Vettese Inc d/b/a Venient Food Mart
ANS 1 Vettese Inc, d/b/a Vanient Food Mart Vol#: 1
99H-0976 Civil Money Penalties;Rajiv Karua,d/b/a Kaka Food Mart
ANS 1 Rajiv Karua,d/b/a Kaka Food Mart Vol#: 1
99H-1003 Civil Money Penalties;Grog & Grist Market Inc,d/b/a Grog &
ANS 1 Grog & Grist Market Vol#: 1
99H-1007 Civil Money Penalties;Store Express Inc,d/b/a Store Express
ANS 1 Store Express Inc Vol#: 1
99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop
ANS 1 Bert Malone,d/b/a Lazy Lees One Stop Inc Vol#: 1
99H-1068 Civil Money Penalties;George S Smith & Dr Robert Smith,d/b/a
ANS 1 Smith Superette Vol#: 1
99H-1110 Civil Money Penalties;James McInnis,d/b/a The Village Market
ANS 1 The Village Market Vol#: 1
99H-1312 Civil Money Penalties;Charles Green & Annie Bell,d/b/a TCB
LET 1 Office of Tobacco Programs Vol#:
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1313 Civil Money Penalties;Debbie Ogieglo & Myra Ogieglo,d/b/a
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1314 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #409
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1315 Civil Money Penalties;Trade Oil Co,d/b/a Trade Mart #57
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1316 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1317 Civil Money Penalties;Four Star Ent Inc,d/b/a 13th St Mini
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1318 Civil Money Penalties;Walgreen Co,d/b/a Walgreens #3196
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1319 Civil Money Penalties;Nash-Finch Co,d/b/a Econofoods #439
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1320 Civil Money Penalties;Nash-Finch Co,d/b/a Food Folks
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1321 Civil Money Penalties;Nash-Finch Co,d/b/a Food Folks #971
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1322 Civil Money Penalties;Dahir Brothers Inc,d/b/a Lewis Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1323 Civil Money Penalties;Eblen Short Stop Stores Inc,d/b/a Eble
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1324 Civil Money Penalties;Stameys Ent Inc,d/b/a Stamey's Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1325 Civil Money Penalties;GFJ Ent Inc,d/b/a Jake's Kwik Stop #3
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1326 Civil Money Penalties;GFJ Ent Inc,d/b/a Jake's Kwik Stop #2
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1327 Civil Money Penalties;Krause Gentle Corp,d/b/a Kum & Go #701
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1328 Civil Money Penalties;Danlee Corp,d/b/a Jiffy
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1329 Civil Money Penalties;Wareco Service Inc,d/b/a Wareco #441
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1330 Civil Money Penalties;Caldwell's Inc,d/b/a Caldwell's Coasta
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1331 Civil Money Penalties;E & J Package Liquor Inc,d/b/a E & J
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1332 Civil Money Penalties;Glenn Lee Henry,d/b/a Oak Street Texac
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1333 Civil Money Penalties;Edward Eugene Armbruster,d/b/a Circle
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1334 Civil Money Penalties;Farouk Hamdan,d/b/a Regal Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1335 Civil Money Penalties;John Spurgeon,d/b/a Spurgeon's Phillip
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1336 Civil Money Penalties;Lowell Krewson,d/b/a Krewson's Conoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1337 Civil Money Penalties;Hamid Paracha,d/b/a 7-Eleven Food Stor
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1338 Civil Money Penalties;Jeff Lipe,d/b/a 7-Eleven Food Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1339 Civil Money Penalties;Cindy Callaway,d/b/a Centerville Quick
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1362 Civil Money Penalties;Shannon Hughes & Mary Hughes,d/b/a The
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0386 Talking with Stakeholders About FDA Modernization
EC 16 Peggy Davis Vol#: 2
EC 17 Peggy Davis Vol#: 2
EC 18 Connie Pitts Vol#: 2
EC 19 Susan Cooper Vol#: 2
EC 20 Betty Napier RN Vol#: 2
EC 21 HIMA Vol#: 2
TS 9 HIMA Vol#: 2
99N-0554 Public meeting/health & nutrient content claims in food lab
C 8 Ullman Shapiro & Ullman LLP Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
C 160 Joyce Van Sluyter Vol#: 2
C 163 Lorie R. Douglas Vol#: 2
C 164 Natalie M. Diehl Vol#: 2
C 165 Sandra T. Cutter Vol#: 2
C 166 Donald & Betty Sheaks Vol#: 2
C 167 Yvonne Nienstadt Vol#: 2
C 168 Bernice Schneider Vol#: 2
C 169 Barbara J. Stolz Vol#: 2
C 173 Mary C. Mazzotta Vol#: 2
C 176 Dorothy R. White Vol#: 2
C 177 Patricia Russell Vol#: 2
C 179 Alma Olivares-Oropeza Vol#: 2
C 183 Suzanne Fitzgerald Vol#: 2
C 184 William G. Moberly Vol#: 2
C 185 Florence Bevilacqua Vol#: 2
C 186 Daniel E. Ludlow Vol#: 2
C 187 Toni Wyatt Kirkeby Vol#: 2
C 188 B. Brooke Barrett Vol#: 2
C 190 William A. Donze Vol#: 2
C 192 Elizabeth Noerdlinger Vol#: 2
C 197 Mr & Mrs Robert Herro Vol#: 2
C 199 Thomas & Kathleen Washburn Vol#: 2
C 202 Jeanne Richardson Vol#: 3
C 208 Ann Marie Coleman Vol#: 3
C 209 Frank & Sandra Christhilf Vol#: 3
C 213 Nancy Lee Lawrence Vol#: 3
C 218 Mr & Mrs J. R. Whiteside Vol#: 3
C 220 Raiza Nicole Singh Vol#: 3
C 223 Alberta R. Gilbert Vol#: 3
C 224 Lee Federmeyer & Terry Thompson Vol#: 3
C 227 Ralph & Marilou Laudenslayer Vol#: 3
C 230 Mrs. Marjorie T. Pacino Vol#: 3
C 231 Patrick J. Reilly Vol#: 3
C 232 Frances Anderson Vol#: 3
C 234 Marjorie Carpenter Vol#: 3
C 235 Allan Stonecipher Vol#: 3
C 237 Madelyne W. Bennett Vol#: 3
C 238 Emily M. Kowalewski Vol#: 3
C 239 Mariana B. Buchanan Vol#: 3
C 244 Deborah G. Chamblee Vol#: 3
C 245 Dorothy F. Stauffer Vol#: 3
C 246 Sylvia K. Jankowski Vol#: 3
C 248 James F. Baruffi Vol#: 3
C 249 Karin J. Baruffi Vol#: 3
C 250 Robert E. Hansen Vol#: 3
C 251 Debbie & Paul O'Sullivan Vol#: 3
C 252 Maria S. Ragucci Vol#: 3
C 253 Harry & Gail Wolfe Vol#: 3
C 255 Carolyn Ferrentino Vol#: 3
C 259 Alfred L. Pellegrini Vol#: 3
C 266 Edmund L. Chipley Vol#: 3
C 274 Mr & Mrs R. E. Johnson Vol#: 3
C 276 Marvin C. Brunner Vol#: 3
C 277 Cecilia Wisniewski Vol#: 3
C 282 Carl & Jane Clay Vol#: 3
C 293 Elizabeth G. Haimson Vol#: 3
C 294 Herman J. Rabinowitz Vol#: 3
C 296 Gary & Dorothy Savage Vol#: 3
C 299 Angelo Dispenzieri Vol#: 3
C 301 Ann Tonia Silverio Vol#: 4
C 303 Hollis C. Polacek Vol#: 4
C 308 Albert Scarcello Vol#: 4
C 309 Marjorie M. Martin Vol#: 4
C 310 Jennifer H. Warning Vol#: 4
C 311 Muriel & Richard Mauer Vol#: 4
C 316 Phyllis E. Gerberding Vol#: 4
C 317 Clyde C. Jefferson Vol#: 4
C 318 Patricia O. Brown Vol#: 4
C 320 Lewis J. Dawkins Vol#: 4
C 322 Mr & Mrs Duane Hess Vol#: 4
C 323 Barbara A. Smith Vol#: 4
C 324 Annette Figatner Vol#: 4
C 326 Barbara Tomlinson Vol#: 4
C 327 Donald & Joyce Martin Vol#: 4
C 328 Ray & Ruth Croteao Vol#: 4
99P-1416 Methylphenidate Hydrochloride Oral Solution (5mg/mL&10mg/5mL
CP 1 Lachman Consultant Services, Inc. Vol#: 1
99P-1417 Methylphenidate Hydrochloride Chewable tablets 5mg & 10mg
CP 1 Lachman Consultant Services Inc. Vol#: 1
99P-1418 Methylphenidate Hydrochloride Chewable Tablets, 2.5mg