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 November 2, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
96P-0215 Withdrawal Norplant's approval for sale in the United States * 96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs * 97P-0197 Require that warning labels about risks of salmonella enteri * 98N-0313 Surgeons's and Patient Examination Gloves Reclassification * 98N-1038 Irradiation in the production, processing, &handling of food * 98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell * 99D-2335 Guidance for Medical Gloves A workshop Manual * 99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis * 99D-2729 Industry on BA/BE studies orally administered drug products * 99P-1340 Declared Eternity eau de Parfum Misbranded * |
RPT 1 Ciba Specialty Chemicals Corporation Vol#: 9
96P-0215 Withdrawal Norplant's approval for sale in the United States
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
C 776 Cynthia A. Ward Vol#: 31
C 777 Anne E. Lynch Vol#: 31
C 778 Tracy M. Meadows Vol#: 31
C 779 Ed Pastor (CI) Vol#: 31
97P-0197 Require that warning labels about risks of salmonella enteri
Linked comments below duplicate those for 96P-0418, above, and 98N-1230, also below
C 777 Cynthia A. Ward Vol#: 30
C 779 Tracy M. Meadows Vol#: 30
98N-0313 Surgeons's and Patient Examination Gloves Reclassification
C 12 Magla Products Inc Vol#: 6
C 13 Medik Salalah Medical Supplies Mfg Co LL Vol#: 6
C 14 Emergency Nurses Association Vol#: 6
C 15 Custom Services International Vol#: 6
C 17 New York State Nurses Association Vol#: 6
C 18 Alan K Laufman JD MD Vol#: 6
C 19 Sumitomo Rubber Industries Ltd Vol#: 6
C 21 CHW Shared Business Services Vol#: 6
C 22 American College of Surgeons Vol#: 6
C 24 Allegiance Healthcare Corporation Vol#: 7
EXT 3 Custom Services International Vol#: 6
98N-1038 Irradiation in the production, processing, &handling of food
C 4768 The Mississippi 2020 Network Vol#: 135
C 4769 Terri Middleton Vol#: 135
C 4770 Thomas J. Kjolsing Vol#: 135
EMC 1 Kathy Van Dame Vol#: 135
EMC 2 Richard Alan Olson Vol#: 135
EMC 3 Jeff McCaffrey Vol#: 135
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell
C 776 Cynthia A. Ward Vol#: 32
C 777 Anne E. Lynch Vol#: 32
C 778 Tracy M. Meadows Vol#: 32
C 779 Ed Pastor (CI) Vol#: 32
99D-2335 Guidance for Medical Gloves A workshop Manual
C 2 CHW Shared Business Services Vol#: 1
C 3 Custom Services International Vol#: 1
C 4 American College of Surgeons Vol#: 1
C 6 Allegiance Healthcare Corporation Vol#: 2
EXT 1 Custom Services International Vol#: 1
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis
C 8 Mylan Pharmaceuticals Inc Vol#: 1
C 9 KV Pharmaceutical Company Vol#: 1
C 10 Knoll Pharmaceutical Company Vol#: 1
C 14 Bristol-Myers Squibb Pharmaceutical Res Vol#: 2
C 15 Zeneca Pharmaceuticals Vol#: 2
C 16 National Pharmaceutical Alliance Vol#: 2
C 18 Watson Laboratories Inc Vol#: 2
C 19 Lilly Research Laboratories Vol#: 2
C 20 Glaxo Wellcome Inc Vol#: 2
C 21 DuPont Pharmaceuticals Company Vol#: 2
LET 1 Schein Pharmaceutical Inc Vol#: 2
99D-2729 Industry on BA/BE studies orally administered drug products
C 1 Pharmacia & Upjohn Vol#: 1
99H-2982 Civil Money Penalty;Ewing Oil Co inc,dba Williamsport Shell
CS 1 HFA-305 Vol#: 1
OR 1 HF-3 Vol#: 1
99H-4258 Civil Money Penalty;Rite Aid Corporation,dba Rite Aid #7211
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4268 Civil Money Penalty;Family Foods of Gatesville Inc,dba Famil
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4269 Civil Money Penalty;James harper and Brenda Hawkins,dba Tayl
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4270 Civil Money Penalty;Jitney-Jungle Stores of America Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4271 Civil Money Penalty;S O S Truck Stop Inc,dba S O S Truck Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4272 Civil Money Penalty;Wal-Mart Stroes Inc,dba Wal-Mart #2065
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4273 Civil Money Penalty;Williams Express Inc,Williams Express
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4274 Civil Money Penalty;Williams Express Inc,dba Williams Expres
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDEr/FDA Vol#: 1
99H-4275 Civil Money penalty;Williams Express inc,dba Williams Expres
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4284 Civil Money Penalty;Carlisle's Big Star #53 Inc,dba Carlisle
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4285 Civil Money Penalty;A & A Perriodical Services,dba Hathaways
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4286 Civil Money Penalty;A H Schade Inc,dba Gem Stop #008
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4287 Civil Money Penalty;Eduardo Acosta,dba Longhill Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4288 Civil Money Penalty;Bill & Lisa Ent Inc,dba Billy Bobb Too
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4289 Civil Money Penalty;Bowden's II, Inc,dba Red Barn Food Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4290 Civil Money Penalty;Michael Brumbelow,dba Brumby Foods
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4291 Civil Money Penalty;Bruno's Inc,dba Bruno's
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4292 Civil Money Penalty;Cargo Oil Co Inc,dba Cargo Oil Co Inc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4293 Civil Money Penalty;Conrad & Bischoff Inc,dba Airport 66
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4294 Civil Money Penalty;Convenience Plus Partners Ltd,dba Conven
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4295 Civil Money Penalty;Judy Crews,dba Money Back Food Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4296 Civil Money Penalty;Druga Inc,dba Ramada Inn
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4297 Civil Money Penalty;Duckwall-Alco Stores Inc,dba Alco Discou
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4298 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug #8389
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4299 Civil Money Penalty;Falcon Hotel Corp,dba Sheraton Springfie
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4300 Civil Money Penalty;Gene's Place Inc,dba Gene's Place
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4301 Civil Money Penalty;Giant Food Stores Inc,dba Martins Food
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4302 Civil Money Penalty;Groggeries LTD, dba The Nickelodeon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4303 Civil Money Penalty;Mark Harold,dba Dawson Inland
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4304 Civil Money Penalty;L Roberts & Co Inc,dba BP Gas & Groceret
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4305 Civil Money Penalty;Lee O Ruwe Inc,dba Gas N Dash
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4306 Civil Money Penalty;Mini Mart Inc,dba All Bargain Cigarettes
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4307 Civil Money Penalty;Northern Lights Service Center Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4308 Civil Money Penalty;Paul F O'Connell & Linda K O'Connell,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4309 Civil Money Penalty;William Albert Oakes,dba Scuppernong Qui
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4310 Civil Money Penalty;Mala Patel,dba A to Z Convenience Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4311 Civil Money Penalty;James Kevin Phelps,dba Lou's Country Mar
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4312 Civil Money Penalty;Joel Quezada,dba El Mazmin
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4313 Civil Money Penalty;Rogers Petroleum Inc,dba Bearden Exxon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4314 Civil Money Penalty;Sowell & Sowell Inc,dba Bunky's
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4315 Civil Money Penalty;Street Oil Co,dba Ellenbecker Oil Co
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4316 Civil Money Penalty;T A Operating Corp,dba Travel Center of
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4317 Civil Money Penalty;Tenderfoot Inc,dba Tenderfoot
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4318 Civil Money Penalty;Terrible Herbst, Inc,dba Terrible Herbst
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4319 Civil Money Penalty;TPI Petroleum Inc,dba Total #2743
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4320 Civil Money Penalty;W A Kitchens Inc,dba Bovina Grocery &
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4321 Civil Money Penalty;William Kvidera Post No.6607 Veterans of
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
NPH 2 HHS/CDER/FDA Vol#: 1
99H-4333 Civil Money Penalty;Camp Oil Company,dba sunshine Truck Plaz
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4334 Civil Money Penalty;Cavetown Liquors Inc,dba Cavetown Liquor
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4335 Civil Money Penalty;CVS Revco DS Inc,dba Revco Drug Store #3
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4336 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug #446
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4337 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drug #2871
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4338 Civil Money Penalty;Ernest Bellew,dba Chicamauga Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4339 Civil Money Penalty;Food Lion Inc,dba Food Lion #901
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4340 Civil Money Penalty;Griffis Inc,dba Aden's Minit Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4341 Civil Money Penalty;Ingles Markets Incorporated,dba Ingles M
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4342 Civil Money Penalty;Jeff Hodge,dba Pride of the Southland Ma
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDE/FDA Vol#: 1
99H-4343 Civil Money Penalty;Jeff Hodge,dba Rocky Top Quick Stop #1
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4344 Civil Money Penalty;Kmart Corporation,dba Kmart Store #3154
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4345 Civil Money Penalty;Leach Enterprises Ltd,dba Your Country S
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4346 Civil Money Penalty;McDonald Oil Company,dba Money Back #45
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4347 Civil Money Penalty;Michael Sentell,dba Rite Stop #3
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4348 Civil Money Penalty;Racetrac Petroleum Inc,dba Racetrac Petr
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4349 Civil Money Penalty;Rite Aid of Georgia Inc,dba Rite Aid #32
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4350 Civil Money Penalty;Sung Park & Ae Park,dba Bob's Carryout
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4351 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store #
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4352 Civil Money Penalty;Wayne Blackwell,dba Blackwell Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4376 Civil Money Penalty; KCJS-FM Ent Inc & Kenneth Church,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4424 Civil Money Penalty;A/C Stores Oil Co Inc,dba A/C Stores #3
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4425 Civil Money Penalty;BSI Inc,dba H & M Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4426 Civil Money Penalty;Jeff Burton,dba The Out Post
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4427 Civil Money Penalty;Caladon Inc,dba Indianhead Exxon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4428 Civil Money Penalty;Colorado City Texaco Inc,dba Colorado Ci
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4429 Civil Money Penalty;Double Quick Inc,dba Double Quick #25
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4430 Civil Money Penalty;Double Quick Inc,dba Double Quick #20
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4431 Civil Money Penalty;P & M Ent Inc,dba Handy Andy
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4432 Civil Money Penalty;S & P Super Store Inc,dba S & P Supersto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4433 Civil Money Penalty;Tri-City Oil Co,dba Sun Mart #16
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4434 Civil Money Penalty;Sam Zeer,dba Shop 'N Save
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4466 Civil Money Penalty;Hyde Park Variety Food Mart Inc,dba Hyde
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99P-1340 Declared Eternity eau de Parfum Misbranded
C 373 Gwendolyn R Yagodich Vol#: 7
C 374 Debbie Joyce Phillips Vol#: 7
C 375 Barbara Alldredge Vol#: 7
C 378 Kenneth E Yagodich MD Vol#: 7
C 383 Beatrice H Clark Vol#: 7
C 384 Mrs Theodora S Apostolo Vol#: 7
C 385 Priscilla Stevens Vol#: 7
C 386 Marge June Miller Vol#: 7
C 394 Holly Hall Wilson Vol#: 7
C 399 Kingsley Hammett Vol#: 7
C 408 Katheryne Builne Vol#: 7
C 409 Ruth S Salkowski Vol#: 7
C 410 Astri L Lindberg Vol#: 7
C 411 Penny & Kayla Graves Vol#: 7
C 417 Form letter count 3 Vol#: 8
C 420 Teresa Nixon Smith Vol#: 7
C 421 Florence Ostroff Vol#: 7
C 423 Marie-Louise Bishop Vol#: 7
C 425 Elisabeth A Ullom Vol#: 7
EC 62 Vida Vakilotojar Vol#: 7