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 October 12, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
93P-0310 White Chocolate Deviating From Identity Standard; TPMT * 96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs * 97P-0197 Require that warning labels about risks of salmonella * 99D-2013 Cooperative Manufacturing Arrangements for Licensed * 99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis * 99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone * 99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast * 99V-4371 Laser Light Show, Laserium CSLP Projector Manufactured |
LET 9 Seneca Foods Corporation Vol#: 1
LET 10 HFS-165 to Virginia L. Wilkening Vol#: 1
LET 11 Seneca Foods Corporation Vol#: 1
LST 4 HFS-158 to Catalina Ferre-Hockensmith Vol#: 1
93P-0310 White Chocolate Deviating From Identity Standard; TPMT
LET 84 Parmalat Canada Bakery Division Vol#: 2
LET 85 Parmalat Canada Bakery Division Vol#: 2
LET 86 Parmalat Canada Bakery Division Vol#: 2
LET 87 Parmalat Canada Bakery Division Vol#: 2
LET 88 Parmalat Canada Bakery Division Vol#: 2
LET 89 HFS-151 to Gerad L. McCowin Vol#: 2
LET 90 HFS-151 to Gerad L. McCowin Vol#: 2
LST 15 HFS-158 - Catalina Ferre-Hockensmith Vol#: 2
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
C 544 Lindsey A. Davis Vol#: 20
C 547 Levanah Bartens Vol#: 20
C 548 Charles Rosenbloom, M.D. Vol#: 20
C 551 Nicole D. Grossman Vol#: 20
C 553 Flannery O'Bourke Vol#: 20
C 555 Jennifer Keever & Lisa Williams Vol#: 20
C 556 Ronald Wingrove Vol#: 20
C 557 Emily J. Crement Vol#: 20
C 558 Kristin Zimmerman Vol#: 20
C 560 Allison M. Babin Vol#: 20
C 563 Matthew Fleming Vol#: 20
C 564 Barbara E. Bingnear Vol#: 20
C 567 Mrs. Douglas Long Vol#: 21
C 569 Christine Weisheit Vol#: 21
C 571 Joan & Baxter Dow & Family Vol#: 21
C 572 Kenneth G. DeNeal, Sr., R.Ph. Vol#: 21
C 575 Inherit the Earth Vol#: 21
C 577 Howard & Arleen Wiley Vol#: 21
C 578 For the Sake of Animals Vol#: 21
C 579 Margaret H. Thompson Vol#: 21
C 580 Atake & Associates Vol#: 21
C 583 Linda M. Matthews Vol#: 21
C 585 Ms. Davy Davidson Vol#: 21
C 587 Pasteurized Eggs, L.P. Vol#: 21
C 588 United Poultry Concerns, Inc. Vol#: 21
C 591 AnnMarie L. Miller Vol#: 21
C 592 Mr. Caspar Sacco Vol#: 21
C 593 Caridad Polanco Vol#: 21
C 597 Pamela Wasserman Vol#: 21
97P-0197 Require that warning labels about risks of salmonella
Following duplicates linked comments in 96P-0418 above
C 540 Breen Casey Vol#: 19
C 541 Brian Gruetze Vol#: 19
C 542 Rob Cullen Vol#: 19
C 543 Kevin Robinson Vol#: 19
C 544 Sara Fusco Vol#: 19
C 545 Lindsey A. Davis Vol#: 19
C 546 Sean Hanery Vol#: 19
C 547 Lauren Burkurt Vol#: 19
C 548 Levanah Bartens Vol#: 19
C 549 Charles Rosenbloom, M.D. Vol#: 19
C 550 June Anna-Fey Vol#: 19
C 551 CSPI Vol#: 19
C 552 Nicole D. Grossman Vol#: 19
C 553 Brian Watson Vol#: 19
C 554 Flannery O'Bourke Vol#: 19
C 555 Jeany Oh Vol#: 19
C 556 Jennifer Keever & Lisa Williams Vol#: 19
C 557 Ronald Wingrove Vol#: 19
C 558 Emily J. Crement Vol#: 19
C 559 Kristin Zimmerman Vol#: 19
C 560 Derek Sorg Vol#: 19
C 561 Allison M. Babin Vol#: 19
C 562 Cliff Chion Vol#: 19
C 563 Barbara Kunze Vol#: 19
C 564 Matthew Fleming Vol#: 19
C 565 Barbara E. Bingnear Vol#: 19
C 566 Richard Brown Vol#: 20
C 567 Susan Lindsay Vol#: 20
C 568 Mrs. Douglas Long Vol#: 20
C 569 Debbie Casey Vol#: 20
C 570 Christine Weisheit Vol#: 20
C 571 Ilona Auth Vol#: 20
C 572 Joan & Baxter Dow & Family Vol#: 20
C 573 Kenneth G. DeNeal, Sr., R.Ph. Vol#: 20
C 574 Gwen Woodard Vol#: 20
C 575 Eva Sprouse Vol#: 20
C 576 Inherit the Earth Vol#: 20
C 577 21 signatures Vol#: 20
C 578 Howard & Arleen Wiley Vol#: 20
C 579 For the Sake of Animals Vol#: 20
C 580 Margaret H. Thompson Vol#: 20
C 581 Atake & Associates Vol#: 20
C 582 Lina M. Alta Vol#: 20
C 583 Heidi C. Lopez Vol#: 20
C 584 Linda M. Matthews Vol#: 20
C 585 Sharon Oscar Vol#: 20
C 586 Ms. Davy Davidson Vol#: 20
C 587 Luater Potate Vol#: 20
C 588 Pasteurized Eggs, L.P. Vol#: 20
C 589 United Poultry Concerns, Inc. Vol#: 20
C 590 Polly Strand Vol#: 20
C 591 HAVE, Inc. Vol#: 20
C 592 AnnMarie L. Miller Vol#: 20
C 593 Mr. Caspar Sacco Vol#: 20
C 594 Caridad Polanco Vol#: 20
C 595 Claire Manber Vol#: 20
C 596 Paul J. Alix Vol#: 20
C 597 Lauren Devine Vol#: 20
C 598 Pamela Wasserman Vol#: 20
C 599 Daniel Polana Vol#: 20
98H-0368 Civil Money Penalties; Fourth Avenue Shell, LLC
LET 2 Office of Tobacco Programs Vol#: 1
98H-0884 Civil Money Penalty; Demoulas Super Markets Inc d/b/a Market
LET 2 Office of Tobacco Programs Vol#: 1
98H-0886 Civil Money Penalty; Gary R & Lorna L Hink d/b/a Jarrell's C
LET 3 Office of Tobacco Programs Vol#: 1
98H-0899 Civil Money Penalties;Ice Service Inc,d/b/a Ice Service #1
LET 3 Office of Tobacco Programs Vol#: 1
98H-0915 Civil Money Penalties;Robert R Ciaccio dba R&R Jackport Food
CR 1 GCF-1 Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
98H-1043 Civil Money Penalties;E-Z Serve Corp,d/b/a E-Z Serve 4433-22
LET 2 Office of Tobacco Programs Vol#: 1
98H-1066 Civil Money Penalties; Biloxi Casino Corp,d/b/a Casino Magic
LET 2 Office of Tobacco Programs Vol#: 1
98H-1081 Civil Money Penalties;Davis Goon,d/b/a Goon's Grocery
LET 2 Office of Tobacco Programs Vol#: 1
98H-1283 Civil Moneoy Penalties;Pace Oil Co Inc,d/b/a Pacesetter #4
LET 2 Office of Tobacco Programs Vol#: 1
98H-1289 Civil Money Penalties; Triple V Inc,d/b/a Sunflower Food
LET 2 Office of Tobacco Programs Vol#: 1
99D-2013 Cooperative Manufacturing Arrangements for Licensed
C 6 Lilly Research Laboratories Vol#: 1
C 7 Lonza Biologics Plc Vol#: 1
C 8 Zeneca Pharmaceuticals Vol#: 1
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis
C 1 Edward Lau, Ph.D. Vol#: 1
99H-0074 Civil Money Penalties; Bi-Lo Inc
LET 2 Office of Tobacco Programs Vol#: 1
99H-1035 Civil Money Penalties;Gil Sullivan,d/b/a Sullivan Amoco
LET 2 Office of Tobacco Programs Vol#: 1
99H-2133 Civil Money Penalty;Harbour Investments Inc,dba Korner Store
LET 2 Office of Tobacco Programs Vol#: 1
99H-2632 Civil Money Penalty;Camp Oil Company,dba Sav-A-Ton
ANS 1 Camp Oil Co, dba Sav-A-Ton Vol#: 1
99H-2749 Civil Money Penalty;Andlar Ent Inc,dba Fast Break Food Mart
LET 2 Office of Tobacco Programs Vol#: 1
99H-3036 Civil Money Penalty;Detroit Auto Service Inc,dba Frederick
LET 2 Office of Tobacco Programs Vol#: 1
99H-3062 Civil Money Penalty;Billy L. Eckstine,dba Myersville Exxon
LET 2 Office of Tobacco Programs Vol#: 1
99H-3095 Civil Money Penalty;Holiday Food Stores Inc,dba Holiday Food
ANS 1 Holiday Food stores Inc Vol#: 1
99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market
ANS 1 Ingram's Market Inc Vol#: 1
99H-4023 Civil Money Penalty;VAS Inc,dba Augusta Liquor
LET 2 Office of Tobacco Programs Vol#: 1
99H-4031 Civil Money Penalty;Fareway Stores Inc,dba Fareway Store #55
ANS 1 Fareway Stores Inc Vol#: 1
99H-4072 Civil Money Penalty;Bell Ent Inc & Colais Foodstore Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
99H-4073 Civil Money Penalty;Broadway Ent Inc,dba Broadway Catering
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4074 Civil Money Penalty;Donald E Brutlkeutz,dba Doc's Conoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
NPH 2 HHS/FDA/CDER Vol#: 1
99H-4075 Civil Money Penalty;Casey's General Store Inc,dba Casey's Ge
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4076 Civil Money Penalty;Cliff Brice Stations Inc,dba Cliff Brice
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4077 Civil Money Penalty;David M Marsh Inc,dba Casey's General
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4078 Civil Money Penalty;Charles Domiano and Beverly Domiano,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4079 Civil Money Penalty; G L Fomby, dba Five Point Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4080 Civil Money Penalty;Gallatin Oil Co Inc,dba Southwater 66
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4081 Civil Money Penalty;Barbara Gourley,dba 411 S Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4082 Civil Money Penalty;Roger Harris,dba C & R Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4083 Civil Money Penalty;Jim Ignatius and Scott Ignatius,dba Gold
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4084 Civil Money Penalty;Keith Law,Ruth Law & Amy Law,dba Law's
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4085 Civil Money Penalty;Sang Thai Le-Teruya,dba Island Cigar Sho
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4086 Civil Money Penalty;Majed Massad,dba North 1st Phillips 66
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4087 Civil Money Penalty;McLain Grocery Co Inc,dba Piggly Wiggly
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4088 Civil Money Penalty;Mighty Mart Inc,dba Mighty Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4089 Civil Money Penalty;Delmar Mikelsen & Mave Estella Mickelsen
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4090 Civil Money Penalty;/Dustin Pfughaupt & Rebecca Pflughaupt,
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4091 Civil Money Penalty;Po-Boys & More Inc,dba Gluckstadt Mini
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4092 Civil Money Penalty;Reid Food Marts Inc,dba Reid Food Mart 2
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4093 Civil Money Penalty;Royal Farm Inc,dba Farm Crest Milk Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4094 Civil Money Penalty;Ammar Sabbagh,dba Bart's Market
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4095 Civil Money Penalty;Charles Schraeder & Sharon Schraeder
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4096 Civil Money Penalty;Ultramar Diamond Shamrock Corp,dba Total
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4097 Civil Money Penalty;Daniel L Willie,dba Oasis Stop N Go #2
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-4178 Civil Money Penalty;Dale & Jackie's Discount Liquors Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4181 Civil Money Penalty;Bearden Oil Company Inc,dba Shorty's Qui
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4263 Civil Money Penalty;E-Z Serve Corporation,dba E-Z Serve #207
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4264 Civil Money Penalty;Farmers Cooperative Elevator Co,dba Co-M
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4265 Civil Money Penalty;Git-N-Go Convenience Stores Inc,dba Git-
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4266 Civil Money Penalty;Pramod Handa,dba Acton Sunoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4267 Civil Money Penalty;Pedro Olmos and Mary Olmos,dba Zacatecas
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 Office of Tobacco Programs Vol#: 1
99N-4069 Notice of Participation; Extension Collection Agency
N 1 Vol#: 1
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone
LET 1 Purdue Pharma L.P. ("Purdue") Vol#: 1
RC 4 Purdue Pharma L.P. ("Purdue") Vol#: 1
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast
99V-4371 Laser Light Show, Laserium CSLP Projector Manufactured