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 September 24, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
98N-1265 Distribution of Compounded Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA *
99N-0193 Supplements and Other Changes to an Approved Application *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
75N-0211 PRIVACY ACT OF 1974, SYSTEMS OF RECORDS

N 1 Vol#: 1

98H-0114 Civil Money Penalties; Mohammad Azim Khan d/b/a Food Corner

LET 5 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0577 Civil Money Penalties; Larry Schmidt,d/b/a Border Bar & Gril

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0596 Civil Money Penalties;Judith Corbeil,d/b/a Tobacco Treasure

CR 1 GCF-1 Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0631 Civil Money Penalties;Kathleen Plourde,d/b/a Bills Chestnut

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0652 Civil Money Penalties;Steven Rogall,d/b/a Rogall's Smoke Sho

CR 1 GCF-1 Vol#: 1

LET 4 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0690 Civil Money Penalties; Emily Onuzurui,d/b/a Jasrone Tropican

LET 4 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0959 Civil Money Penalties;Ro-Art Liquors Inc.

LET 4 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1014 Civil Money Penalties;Steve Smith, d/b/a/ Steves

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98N-0617 Treatment of Narcotic Dependence

C 9 Stat of CT, Office of Protection & Advoc Vol#: 1

C 10 Behavior & Stress Management Center Inc Vol#: 1

EC 4 Stephen D Anderson Vol#: 1

EC 5 Jay Hazelton Vol#: 1

EC 6 Robert Finkle Vol#: 1

EC 7 Brett A Shack Vol#: 1

EC 8 Jan Simonis Vol#: 1

EC 9 John Richmond Vol#: 1

EC 10 Jack Rice Vol#: 1

EC 11 Michael Myers Vol#: 1

REF 1 OMB Review Vol#: 6
 
 

98N-1265 Distribution of Compounded Drug Products

C 6110 Kathy Chavez Vol#: 171

C 6111 Elisabeth Czbart Vol#: 171

C 6112 Kimberly Dickerson Vol#: 171

C 6113 Anne Omara Vol#: 171
 
 

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

C 2240 Leslie Gougherty Vol#: 64

C 2241 M. Jones & Other signatures (14) Vol#: 64

C 2242 Ms Sue Young Vol#: 64

C 2243 Edward J. Blotzer, Jr Vol#: 64

C 2244 Rodney & Debbie DeGreenia Vol#: 64

C 2245 Jim Hopper Vol#: 64

C 2246 Sheila Hilton Hall Vol#: 64

C 2247 Katherine C. Parker Vol#: 64

C 2248 Thomas R. Parker Vol#: 64

C 2249 Keith Manigold Vol#: 64

C 2250 Barbara Beatly Vol#: 64

C 2251 Elizabeth Mather Vol#: 64

C 2252 Blue Ribbon Pony Club Vol#: 64

C 2253 Amy Shoemake Vol#: 64

C 2254 Alessandra Leal Vol#: 64

C 2255 S. Walsh Vol#: 64

C 2256 Otis White Vol#: 64

C 2257 Troy H. Seals Vol#: 64

C 2258 Dorothy Finger Vol#: 64

C 2259 Ursula Freymann Vol#: 64

C 2260 Eva F. Dayans Vol#: 64

C 2261 Mindy Rogovin Vol#: 64

C 2262 Kari C. Olsen Vol#: 64

C 2263 Tammy & Bruce Barney Vol#: 64

C 2264 Nadia King Vol#: 64

C 2265 Mr & Mrs Robert Neset Vol#: 64

C 2266 Alice Slaman Vol#: 64

C 2267 Zbigniew Stein Vol#: 64

C 2268 Christopher W. Glass Vol#: 64

C 2269 Andrew Liberante Vol#: 64

C 2270 Marlene S. Schmidt Vol#: 64

C 2271 Veronica Proksch Vol#: 64

C 2272 Joyce B. Breuer Vol#: 64

C 2273 Dr. Leah Olson Vol#: 64

C 2274 Iris Osier Vol#: 64

C 2275 Jason Calabrese Vol#: 64

C 2276 Isabel C. Alonso Vol#: 64

C 2277 Maryann C. Frambach Vol#: 64

C 2278 Sally Cannavo Vol#: 64

C 2279 Tom Abbott Vol#: 64

C 2280 Linda & Jim Yester Vol#: 64

C 2281 Lela Feedalonitz Vol#: 64

C 2282 Charisma J. Chadwick Vol#: 64

C 2283 Mrs. Doris A. Myers Vol#: 64
 
 

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 35 Novartis Pharmaceutical Corporation Vol#: 3

C 36 Alcon Research Ltd Vol#: 3

C 37 Abbott Laboratories Vol#: 3

TR 1 transcript of August 19, 1999 meeting Vol#: 4

TS 2 Becton Dickinson & Company Vol#: 3

99H-0031 Civil Money Penalties;Gas Center Inc,d/b/a Gas Ctr #10

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0060 Civil Money Penalties; Boyette Texaco Inc

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0501 Civil Money Penalties;Eugene Redmond,d/b/a Redmond's Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0559 Civil Money Penalties;Shah Ahmad,d/b/a By Pass

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0588 Civil Money Penalties;Kim McCowen,d/b/a Kim's Total

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0597 Civil Money Penalties;Delchamps Inc,d/b/a Jitney Jungle #336

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0951 Civil Money Penalties;James Deady & Robert Deady,d/b/a Kwik

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1112 Civil Money Penalties;Ken Gallison,d/b/a Bridge Liquors

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1242 Civil Money Penalties;Zahoor Tariq,d/b/a Jayzi Mart

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1505 Civil Money Penalty;Carl Brown,dba Holiday BP West

LET 2 Office of Tobacco Programs Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

LET 2 Office of Tobacco Programs Vol#: 1

99H-1672 Civil Money Penalty;Steve Mogg & Connie Mogg,dba Hy Klas Foo

LET 2 Office of Tobacco Programs Vol#: 1

99H-1986 Civil Money Penalty;Tripo Inc,dba Fast Break Food Store

LET 2 Office of Tobacco Programs Vol#: 1

99H-2001 Civil Money Penalty;Bessie Owens Bell,dba Miss Bessie's

LET 2 Office of Tobacco Programs Vol#: 1

99H-2066 Civil Money Penalty;Kenneth Evans,dba Hill Top Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-2074 Civil Money Penalty;James Denne,dba Denne's Dog Haus

LET 2 Office of Tobacco Programs Vol#: 1

99H-2108 Civil Money Penalty;Doris Brown,dba The Food Bank

LET 2 Office of Tobacco Programs Vol#: 1

99H-2157 Civil Money Penalty;Emergency Fuel Station Inc,dba Emergency

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2253 Civil Money Penalty;Aultman Ent Inc,dba Super Valu #71804

LET 2 Office of Tobacco Programs Vol#: 1

99H-2261 Civil Money Penalty;Roy Gatlin,dba R & K Grocery & Grill

LET 2 Office of Tobacco Programs Vol#: 1

99H-2438 Civil Money Penalty;Rite Aid Corp;dba Rite Aid #2110

LET 2 Office of Tobacco Programs Vol#: 1

99H-2452 Civil Money Penalty;Robert Klepaida,dba Munich Hofbrau

LET 2 Office of Tobacco Programs Vol#: 1

99H-2518 Civil Money Penalty;Cheng Kwong Seafood Market Inc,dba Cheng

LET 2 Office of Tobacco Programs Vol#: 1

99H-2525 Civil Money Penalty;Jim Nassif,dba Tatnuck Square Getty Inc

LET 2 Office of Tobacco Programs Vol#: 1

99H-2540 Civil Money Penalty;Freeport Cooperative Creamery Associatio

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2566 Civil Money Penalty;Granite Super Market Inc,dba Almichs Sup

LET 2 Office of Tobacco Programs Vol#: 1

99H-2632 Civil Money Penalty;Camp Oil Company,dba Sav-A-Ton

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2863 Civil Money Penalty;Petro-Plus inc,dba petro Plus #103

LET 2 Office of Tobacco Programs Vol#: 1

99H-2976 Civil Money Penalty;BP Amoco plc,dba Amoco #2826

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2977 Civil Money Penalty;CBM Ventures LLC,dba Towson Park Exxon,d

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2978 Civil Money Penalty;Cedar Heights Service Center Inc,dba Fir

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2979 Civil Money Penalty;Cox Oil Company Inc,dba Little General #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2980

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2981 Civil Money Penalty;Ekelund Enterprises Inc,dba Trout Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2982 Civil Money Penalty;Ewing Oil Co inc,dba Williamsport Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2983 Civil Money Penalty;John Ioranidis,dba Trinity Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2984 Civil Money Penalty;katherine Lewellan,dba Lewellan's Food M

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2985 Civil Money Penalty;Kelly Bell,dba kelly's Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2986 Civil Money Penalty;Mazen Mutan,dba G&S Market

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2987 Civil Money Penalty;Meagher Inc,dba Scotty's Bar & Grill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2988 Civil Money Penalty;Patricia Gunn,dba North Highland Express

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2989 Civil Money Penalty;Paul Rulon,dba Rulon's Texaco Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1
 
 

99N-0193 Supplements and Other Changes to an Approved Application

C 13 Parke-Davis Pharmaceutical Research Vol#: 3

C 14 American Home Products, Wyeth-Ayerst Res Vol#: 3

C 15 Janssen Pharmaceutic Research Foundation Vol#: 3

C 16 Rhone-Poulenc Rorer Vol#: 3

C 17 Procter & Gamble Pharmaceuticals Vol#: 3

C 18 Gynzyme Corporation Vol#: 3

C 19 R W Johnson Pharmaceutical Research Inst Vol#: 3

C 20 Generic Pharmaceutical Industry Associat Vol#: 3

C 21 Animal Health Institute Vol#: 3

C 22 Coalition for Blood Safety Vol#: 3

C 23 National Pharmaceutical Alliance Vol#: 3

C 24 S S T Corporation Vol#: 3

C 25 Baxter Healthcare Corporation Vol#: 3

C 26 Novartis Pharmaceutical Corporation Vol#: 3

C 27 Hoffmann-La Roche Inc Vol#: 3

C 28 DuPont Pharmaceuticals Company Vol#: 3

C 29 Society of the Plastics Industry Inc Vol#: 3

C 30 Abbott Laboratories Vol#: 3

SUP 2 USP, United States Pharmacopeia Vol#: 3

TR 1 transcript of August 19, 1999 meeting Vol#: 4

TS 2 Becton Dickinson & Company Vol#: 3
 
 

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1573 Barbara Spruell Vol#: 25

C 1574 Mr & Mrs G R Deering Vol#: 25

C 1575 Thomas Zoline Vol#: 25

C 1576 Robert Delgadillo Vol#: 25

C 1577 Robert Weiss MD Vol#: 25

C 1578 Jean M Brewer Vol#: 25

C 1579 John Yackel & 3 signatures Vol#: 25

C 1580 Alan McCann-Sayles Vol#: 25

C 1581 Susan Anderson Vol#: 25

C 1582 Joan Brandon Vol#: 25

C 1583 Juli Neander & Gordon Leppig Vol#: 25

C 1584 Jackie Wright Vol#: 25

C 1585 Joe Mateer Vol#: 25

C 1586 Nicole Sault Vol#: 25

C 1587 Dave Keniston Vol#: 25

C 1588 Lisa Bauer Vol#: 25

C 1589 Thomas E Stockert Vol#: 25

C 1590 Virginia Hallock Vol#: 25

C 1591 Peter Betts Vol#: 25

C 1592 Anne C Highland PhD Vol#: 25

C 1593 Frances M Goodman Vol#: 25

C 1594 Joan Daugirda Vol#: 25

C 1595 Heidi Baruch Vol#: 25

C 1596 Jackie Elhausen Vol#: 25

C 1597 Sophia Sutherland Vol#: 25

C 1598 Sue C Nishino Vol#: 25

C 1599 Alene O Smith Vol#: 25

C 1600 James A Pemble Vol#: 25

C 1601 Sarah Brokenshire Vol#: 25

C 1602 Jacqueline Rankin Vol#: 25

C 1603 Suzanne Smith Vol#: 25

C 1604 Carol Colip Vol#: 25

C 1605 Marian Gyr Vol#: 25

C 1606 Susan Hennies Vol#: 25

C 1607 Louis Tenenbaum Vol#: 25

C 1608 Irwin Gooen Vol#: 25

C 1609 Nature Conservancy Vol#: 25

EC 114 Sandra M Leiby Vol#: 25

EC 115 Gwen A Crist Vol#: 25

EC 116 Edie Herrold Vol#: 25

EC 117 Gary L Arkoff Vol#: 25

EC 118 Sarah L Bushnell Vol#: 25

EC 119 Cheryl Purvis Vol#: 25

EC 120 Phillip, Janet & Adam Hascall Vol#: 25

EC 121 Christine Hall Vol#: 25

EC 122 Sandra Linabury Vol#: 25

EC 123 John O Bevard Vol#: 25

EC 124 Wat Stearns Vol#: 25

EC 125 Nancy Stiefel Vol#: 25

EC 126 Paul & Joan Waller Vol#: 25

EC 127 Marjorie Vol#: 25

EC 128 Gloria Mattingly Vol#: 25

EC 129 P M Diana Vol#: 25

EC 130 Chris Gilbert Vol#: 25

EC 131 Celine Grenier Vol#: 25

EC 132 Ianthe Zevos Vol#: 25

EC 133 Rosanne Bane Vol#: 25

EC 134 Jonathan Weinstock Vol#: 25

EC 135 Dumford Vol#: 25

EC 136 Lori Phelps Vol#: 25

EC 137 Cindy Connor Vol#: 25

EC 138 Slaskoo Vol#: 25

EC 139 Joan Allen Vol#: 25

EC 140 Phyllis Swackhamer Vol#: 25

EC 141 Tim Olsen Vol#: 25

EC 142 Roslyn Fuerman Vol#: 25

EC 143 John Bratten Vol#: 25

EC 144 Mrs Daniel J Schlesinger Vol#: 25

EC 145 Deirdre Ruth Murano Vol#: 25

EC 146 Pat Simon Vol#: 25

EC 147 Steve Lyons Vol#: 25

EC 148 Laura Cluff Vol#:

EC 149 Clear Englebert Vol#: 25

EC 150 Shari Mosier Vol#: 25

EC 151 Robert E Sullivan MD Vol#: 25

EC 152 Jim Christopher Vol#: 25

EC 153 Doug Fischer Vol#: 25

EC 154 Gordon Thomas Vol#: 25

EC 155 Paul Jablon PhD Vol#: 25

EC 156 Beverly Harlan Vol#: 25

EC 157 Betsy Wolf-Graves Vol#: 25

EC 158 Laura Lyons Vol#: 25

EC 159 Peggy Koteen Vol#: 25

EC 160 Anna M Lyles PhD Vol#: 25

EC 161 Vicky Turner Vol#: 25
 
 

99P-1340 Declared Eternity eau de Parfum Misbranded

C 324 Carey A. E. Ryan Vol#: 6

C 325 Joseph L. Bauman Vol#: 6

C 326 No Signature Vol#: 6

C 327 Peggy L. Troiano Vol#: 6

C 328 Leon Lietzlee Vol#: 6

C 329 Barbara Post Vol#: 6

C 330 ABIL Vol#: 6

EC 35 Kathy Reilly, MS, RN Vol#: 6

EC 36 No Signature Vol#: 6

EC 37 Norbert Dichter Vol#: 6

EC 38 Lynn Penner Vol#: 6