DOCKETS ENTERED on May 20, 1999
TABLE OF CONTENTS
(ONLY FOR HYBERLINKED
ITEMS)
77N-0240
Single-Entity Coronary Vasodilators
92N-0139
Statement Policy: Foods Derived from New Plant Varieties
96N-0135
Protein Derived from Ruminants Prohibited in Ruminant Feed
98D-1146
Microbial effects of antimicrobial new animal drugs/human sa
98D-1195
Bioanalytical Methods Validation for Human Studies
98E-1222 Vitravene
Injection; Patent Term Extension Application
98N-0044 Effect
of dietary supplement on structure/function of body
98N-0966 Transmissible
spongiform encephalopathies/bovine
98N-1038 Irradiation
in the production, processing, &handling of food
98N-1109
Mercury Compounds in Drugs and Food
98N-1110 CGMP
Regulations for Finished Pharmaceuticals
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-1194
Withdrawal NADA Approval for Posilac - rBGH
99E-0118
Patent Extension ARAVA, #4,284,786
99N-0554
Public meeting/health & nutrient content claims in food lab
77N-0240 Single-Entity Coronary Vasodilators
HER 39 KV Pharmaceutical Company Vol#: 32
HER 40 Eon Labs Manufacturing Inc Vol#: 32
91F-0399 Antioxidants and/or Stabilizers for Polymers
NFR 1 Vol#: 1
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 5328 Geraldine Freedman Vol#: 90
C 5329 Ingelore Weinberg Vol#: 90
C 5331 Kathryn & Tim Kosse Vol#: 90
C 5333 Evelyn De Buks Vol#: 90
C 5334 Mr & Mrs Joel Hunter Vol#: 90
C 5335 Ms Carol Tresner Vol#: 90
C 5337 Mr Vincent M Belovich Vol#: 90
C 5338 David McMullen Vol#: 90
C 5340 DiAnne Joy Legendre Vol#: 90
C 5342 Janice Lubbock Vol#: 90
C 5343 Michelle Bosomworth Vol#: 90
C 5346 G Jeannette Lawrence Vol#: 90
C 5347 Scott & Sylvia Schneider Vol#: 90
95F-0191 Safe Use of Polyestercarbonate resins
NFR 1 HFS-215 Vol#: 1
96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed
C 1693 Gregory Wilcox Vol#: 86
97D-0389 Guidance of Animal Drugs for Minor Uses & Minor Species
GDL 2 Vol#: 1
NAD 2 Vol#: 1
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98D-1195 Bioanalytical Methods Validation for Human Studies
98E-0612 TROVAN (trovafloxacin mesylate) Patent #5,164,402
N 1 HFY-20 Vol#: 1
98E-0615 Interleukin-11 (Neumega, oprelvekin) Patent # 5,215,895
N 1 HFY-20 Vol#: 1
98E-0779 Patent Ext MONOSTRUT CARDIAC VALVE PROSTHESIS No. 4,343,049
N 1 HFY-20 Vol#: 1
98E-1222 Vitravene Injection; Patent Term Extension Application
98H-0882 Civil Money Penalty; CVS Corp. d/b/a CVS Pharmacy
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0887 Civil Money Penalty; J & E Pantry & Liquors, Inc
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0900 Civil Money Penalties;Ingles Markets Inc.,d/b/a Ingles #5
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0902 Civil Money Penalties; Ingles Markets Inc,d/b/a Ingles #31
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0903 Civil Money Penalties;Kmart Corp,d/b/a Smart Sore #3669
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0904 Civil Money Penalties;Kmart Corp,d/b/a Kmart Store 4112
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0916 Civil Money Penalties;Robert Defreitas, d/b/a G.V.Mini Mart
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98H-0917 Civil Money Penalties;Endicott Pharmacy Inc,d/b/a Endicott
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 HHS/FDA/CDER Vol#: 1
98N-0044 Effect of dietary supplement on structure/function of body
C 22317 John Sherman Vol#: 771
CR 1 Small Business Administration D. C. Vol#: 771
98N-0966 Transmissible spongiform encephalopathies/bovine
98N-1038 Irradiation in the production, processing, &handling of food
C 1688 Steve & Sandy Caster Vol#: 38
C 1689 Richard Wiegel Vol#: 38
C 1691 Jennifer Scoville Vol#: 38
C 1695 Debra Morrison & Joseph Szwaja Vol#: 38
C 1696 Trina Fentriss Vol#: 38
C 1698 Mary Burton Riseley Vol#: 38
C 1699 Sarah Hannigan Vol#: 38
C 1703 Small Things Considered Vol#: 38
C 1704 Jordan W. Dawn Vol#: 38
C 1705 Dr. Melanie Miller Vol#: 38
C 1707 Citizens Protecting Ohio Vol#: 38
C 1710 Libby M. Hazen Vol#: 38
C 1713 Russell D. Hoffman Vol#: 38
C 1716 Katherine Snooks Vol#: 38
C 1717 Ellen MacDonald Vol#: 38
C 1721 Jennifer Redwine Vol#: 38
C 1722 Roswitha & Bernard Lugauer Vol#: 38
C 1723 Howard W. Marsh Vol#: 38
C 1725 Konsumenter I Samverkan (Sweden) Vol#: 39
C 1727 Donald R. Rimmer Vol#: 39
C 1728 75 signaturers Vol#: 39
C 1729 Ann & Steve Pilcher Vol#: 39
C 1730 Margaret Rizzo Vol#: 39
C 1731 Judith L. Mathis Vol#: 39
C 1732 Helene Grazioso Vol#: 39
C 1733 Ms Dolores M. Timmons Vol#: 39
C 1734 Lynne C. Goldsand Vol#: 39
C 1736 Shelley Campbell Vol#: 39
C 1737 Heather T. Williams Vol#: 39
C 1738 Charles Muller Vol#: 39
C 1739 Cora Nell Abraham et al Vol#: 39
C 1740 Deanna Ireland, R.N. Vol#: 39
C 1741 Mary Lou Kinner Vol#: 39
C 1742 Karen S. Parker Vol#: 39
C 1743 Eleanor B. Brosius Vol#: 39
C 1744 Kata F. Orndorff Vol#: 39
C 1746 Jacqueline Benster Vol#: 39
C 1747 Jacqueline A. Alan Vol#: 39
C 1750 Beverly Kramer Vol#: 39
C 1751 Shelley Reavis Vol#: 39
C 1752 Russell E. Ruderman Vol#: 39
C 1754 Rhea & Armin Kuhlman Vol#: 39
C 1756 Eric Schilling Vol#: 39
C 1757 Coulette Westman Vol#: 39
C 1758 Audrey Dittberner Vol#: 39
C 1759 Carol Mathews Pimentel, M.S.W., M.F.C.C. Vol#: 39
C 1763 Dorothy J. Popp Vol#: 39
C 1764 Indico Technologies, Inc. Vol#: 39
C 1765 Ohio Citizen Action's Consumer Watch Vol#: 39
C 1766 Margaret C. Pierce Vol#: 39
C 1772 Richard & Ann Bush Vol#: 39
C 1775 Bridget Daly & John LeFerre Vol#: 39
C 1778 University of Illinois at Chicago Vol#: 39
C 1779 Mally Chrulski, RD, LD Vol#: 39
C 1780 State of Michigan Dept. of Agriculture Vol#: 39
C 1781 World Citizens Against Planetary Injusti Vol#: 39
EXT 31 M. Ruth Niswander Vol#: 39
EXT 32 Health & Energy Institute Vol#: 40
98N-1109 Mercury Compounds in Drugs and Food
C 6 Bristol-Myers Squibb Pharm Res Institute Vol#: 2
98N-1110 CGMP Regulations for Finished Pharmaceuticals
C 2 Merck Research Laboratories Vol#: 1
98N-1265 Distribution of Compounded Drug Products
C 2304 Georgia Fultin Vol#: 85
C 2308 Gail Eberhardt Vol#: 85
C 2311 Carolyn Allen Zeiger Vol#: 85
C 2315 Susan M. Knase Vol#: 85
C 2318 M. J. Vonderbruegge Vol#: 85
C 2319 Debbie McMillan Vol#: 85
C 2320 Verdis Overshiner Vol#: 85
C 2323 Geraldine Aftell Vol#: 85
C 2324 Arlette Hannan Vol#: 85
C 2326 Ann M. Barbati Vol#: 85
C 2330 Sharon L. Richmond Vol#: 85
C 2332 Sandra Stillwagon Vol#: 85
C 2334 Joanne F. Wright Vol#: 85
C 2335 Victoria Morgan Vol#: 85
C 2337 Mary Ann Ludwig Vol#: 85
C 2338 Linda R. Benedict Vol#: 85
C 2340 Betty Griffith Vol#: 85
C 2343 Mary E. Maselli Vol#: 85
C 2344 Louise G. Fisher Vol#: 85
C 2345 Marian E. Nichols Vol#: 85
C 2349 James D. Klein Vol#: 85
C 2350 Alberta S. Gunther Vol#: 85
C 2351 Marian Kirkham Vol#: 85
C 2353 Dale Trevillion Vol#: 85
C 2354 Gretchen Antil Vol#: 85
C 2356 Patricia L. Brooks Vol#: 85
C 2357 Pamela S. Orth Vol#: 85
C 2358 Marsha D. Durick Vol#: 85
C 2359 Jennifer Ginosky Vol#: 85
C 2362 Karen Schumacher Vol#: 85
C 2364 Lynette Richardson Vol#: 85
C 2365 Susan K. Ebery Vol#: 85
C 2369 Margaret Coble Vol#: 85
C 2371 Elizabeth C. Raff Vol#: 85
C 2372 Harold T. McKinney Vol#: 85
C 2373 Portia M. Cummings Vol#: 85
C 2376 Toby E. Louckes-Green Vol#: 85
C 2378 Sister Mary Jeannette Doran Vol#: 85
C 2379 Linda Netzloff Vol#: 85
C 2380 Sierra College Vol#: 85
C 2381 State of Wisconsin Dept of Hlth & Family Vol#: 85
C 2382 Frances Morgan Vol#: 85
C 2386 Patricia A. Marx Vol#: 85
C 2387 Catherine B. Tessier Vol#: 85
C 2389 Victoria Jean Muir Vol#: 85
C 2391 Sherry & Michael Nurmela Vol#: 85
C 2392 Leslie Monison Vol#: 85
C 2393 Flora Kawabata Vol#: 85
C 2394 Kathleen L. Leer Vol#: 85
C 2396 Elizabeth Sipes Vol#: 85
C 2397 David W. Van Harn Vol#: 85
C 2398 Susan Stollsteimer Vol#: 85
C 2399 Mr & Mrs Edward G. Coyne Vol#: 85
C 2400 Cheryl M. Chevalier, Ph.D. Vol#: 85
C 2401 Darleen J. Magner Vol#: 85
C 2402 Linda Netzloff Vol#: 85
C 2403 Roberta Rhodes Vol#: 85
C 2405 Dorothy S. Joslin Vol#: 85
C 2406 Charles D. Kavalovski Vol#: 85
C 2411 Betty Henderson Vol#: 85
C 2412 Pauline Robertson Vol#: 85
C 2413 J. Sam Arnett, Ph.D Vol#: 85
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
C 1402 Abrecht Siebenfelder Vol#: 34
C 1404 Mr & Mrs Ed Mettler Vol#: 34
C 1407 Betty J Herner Vol#: 34
C 1408 Tatjana Morgan Vol#: 34
C 1410 Wanda R Forsythe Vol#: 34
C 1412 Joelle Von Finck Vol#: 34
C 1414 Carol RS Treacy Vol#: 34
C 1418 Candie J Binham Vol#: 34
C 1419 Debra McPherson Vol#: 34
C 1420 Dorothy Savage Vol#: 34
C 1421 Mrs Carol A Becker Vol#: 34
C 1422 Charles D Sisemore Vol#: 34
C 1424 Julie Van Horn Vol#: 34
C 1425 Sheri Avis & et al Vol#: 34
C 1426 Joseph Johnson Vol#: 34
C 1429 Laurra Maddock Vol#: 34
C 1430 Matthew Judd McGuire Vol#: 34
C 1431 Mrs Douglas Long Vol#: 34
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
C 106 DiAnne Joy Legendre Vol#: 3
99E-0118 Patent Extension ARAVA, #4,284,786
99H-0679 Civil Money Penalties;Stop & Shop Cos. Inc,d/b/a Stop & Shop
CR 1 HHS/FDA/CDER Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
99H-0757 Civil Money Penalty; DCM Enterprises Inc d/b/a McGloughlin's
LET 2 Office of Tobacco Programs Vol#: 1
99H-1365 Civil Money Penalties;7-Eleven Inc,d/b/a 7-Eleven
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1366 Civil Money Penalties;Richard Carbaugh,d/b/a Waverly Grocery
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1367 Civil Money Penalties;James Chung,d/b/a Tooele Texaco
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1368 Civil Money Penalties;Crown Central Petroleum Corporation
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1369 Civil Money Penalties;CVS Corp,d/b/a CVS Pharmacy #1840
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1370 Civil Money Penalties;Desrite Ent Ltd, and Desmond Johnson
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1371 Civil Money Penalties;Ecker Corp,d/b/a Eckerd Drug Store
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1372 Civil Money Penalties;Johnny Farmer,d/b/a Farmers Food
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1373 Civil Money Penalties;Merit Oil Corp,d/b/a Merit Oil Corp
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1374 Civil Money Penalties;M P G Corp,d/b/a Dean Street Texaco
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1375 Civil Money Penalties;Roy & Virginia Snavely,d/b/a Westview
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1376 Civil Money Penalties;Walgreen Co,d/b/a Walgreens
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1378 Civil Money Ppenalties;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-1380 Civil Money Penalties;Tosco Marketing Co,d/b/a Circle K Stor
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1381 Civil Money Penalties;Glenn Warner Jr,d/b/a Belle Haven Texa
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1383 Civil Money Penalties;Terrible Herbst Inc,d/b/a Terrible Her
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1384 Civil Money Penalties;Jim McGough's Mobil Inc,d/b/a Jim's
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1385 Civil Money Penalties;Rite Aid of Virginia,d/b/a Rite Aid
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1386 Civil Money Penalties;Joy Food Stores Inc,d/b/a Joy Food Sto
LET 1 Office of Tobacco Programs (HF-11) Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0554 Public meeting/health & nutrient content claims in food lab