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)

[FDA DOCKETS PAGE][FDA HOME PAGE]

86P-0510 Canned Green Beans Deviating From Identity Standard *
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99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *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
86P-0510 Canned Green Beans Deviating From Identity Standard

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 539 Breen Casey Vol#: 20

C 540 Brian Gruetze Vol#: 20

C 541 Rob Cullen Vol#: 20

C 542 Kevin Robinson Vol#: 20

C 543 Sara Fusco Vol#: 20

C 544 Lindsey A. Davis Vol#: 20

C 545 Sean Hanery Vol#: 20

C 546 Lauren Burkurt Vol#: 20

C 547 Levanah Bartens Vol#: 20

C 548 Charles Rosenbloom, M.D. Vol#: 20

C 549 June Anna-Fey Vol#: 20

C 550 CSPI Vol#: 20

C 551 Nicole D. Grossman Vol#: 20

C 552 Brian Watson Vol#: 20

C 553 Flannery O'Bourke Vol#: 20

C 554 Jeany Oh 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 559 Derek Sorg Vol#: 20

C 560 Allison M. Babin Vol#: 20

C 561 Cliff Chion Vol#: 20

C 562 Barbara Kunze Vol#: 20

C 563 Matthew Fleming Vol#: 20

C 564 Barbara E. Bingnear Vol#: 20

C 565 Richard Brown Vol#: 21

C 566 Susan Lindsay Vol#: 21

C 567 Mrs. Douglas Long Vol#: 21

C 568 Debbie Casey Vol#: 21

C 569 Christine Weisheit Vol#: 21

C 570 Ilona Auth Vol#: 21

C 571 Joan & Baxter Dow & Family Vol#: 21

C 572 Kenneth G. DeNeal, Sr., R.Ph. Vol#: 21

C 573 Gwen Woodard Vol#: 21

C 574 Eva Sprouse Vol#: 21

C 575 Inherit the Earth Vol#: 21

C 576 21 signatures 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 581 Lina M. Alta Vol#: 21

C 582 Heidi C. Lopez Vol#: 21

C 583 Linda M. Matthews Vol#: 21

C 584 Sharon Oscar Vol#: 21

C 585 Ms. Davy Davidson Vol#: 21

C 586 Luater Potate Vol#: 21

C 587 Pasteurized Eggs, L.P. Vol#: 21

C 588 United Poultry Concerns, Inc. Vol#: 21

C 589 Polly Strand Vol#: 21

C 590 HAVE, Inc. Vol#: 21

C 591 AnnMarie L. Miller Vol#: 21

C 592 Mr. Caspar Sacco Vol#: 21

C 593 Caridad Polanco Vol#: 21

C 594 Claire Manber Vol#: 21

C 595 Paul J. Alix Vol#: 21

C 596 Lauren Devine Vol#: 21

C 597 Pamela Wasserman Vol#: 21

C 598 Daniel Polana 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

EC 15 Thomas C. Brown Vol#: 3

EC 16 Betty Bridges Vol#: 3

EC 17 Rob Cedar Vol#: 3

EC 18 Tanya Hanton Vol#: 3

99V-4371 Laser Light Show, Laserium CSLP Projector Manufactured

ACK 1 HFA-305 Vol#: 1

VAR 1 Pepermill Hotel Casino Vol#: 1