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 14, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97N-0314 Prescription Drug Products; Levothyroxine Sodium *
97P-0197 Require that warning labels about risks of salmonella *
97P-0498 Label foods & beverages containing greater than 5mg caffeine *
98N-1038 Irradiation in the production, processing, &handling of food
98N-1215 Foreign Establishment Registration and Listing *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-2013 Cooperative Manufacturing Arrangements for Licensed *
99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis *
99D-2636 Guidance for Industry on Levothyroxine Sodium *
99D-2638 Use of Medicated Feeds for Minor Species *
99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy *
99N-4063 Positron emmission tomography drug products *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-4375 Health Claim: Vitamin E and Heart Disease *

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6019 Melira B D Vol#: 151

C 6020 Kirsten Firdell Vol#: 151

C 6021 Ian Rutkowski Vol#: 151

C 6022 Ms Erin McMahon Vol#: 151

C 6023 Kyle McDerrith Vol#: 151

C 6024 Brian Pine Vol#: 151

C 6025 Kathy Keating Vol#: 151

C 6026 Carol Fitzgerald Vol#: 151

C 6027 Ann Pearce Vol#: 151

C 6028 B C Keith Vol#: 151

C 6029 Melissa Arioli Vol#: 151

C 6030 Cynthia Henning Vol#: 151

C 6031 Russell Amincade Vol#: 151

C 6032 Tim Jennings Vol#: 151

C 6033 George Thabault Vol#: 151

C 6034 Anne & David Eishon Vol#: 151

C 6035 Jo R Haijherle PhD Vol#: 151

C 6036 Jeanne Pender Vol#: 151

C 6037 Mary Alexander Vol#: 151

C 6038 Molly Maslin Vol#: 151

C 6039 Melira B Vol#: 151

C 6040 M Russin Vol#: 151

C 6041 Toni Kastner Vol#: 151

C 6042 Heather Whitney Vol#: 151

C 6043 C Massey Vol#: 151

C 6044 Koralie Hill Vol#: 151

C 6045 Laurel Herendreen Vol#: 151

C 6046 Ann Warnecke Vol#: 151

C 6047 Maria Karpfinger Vol#: 151

C 6048 Amanda-Jayne Ross Vol#: 151

C 6049 D W MacDonald & 16 signatures Vol#: 151

C 6050 Frankie Lind Vol#: 151

C 6051 None C Redmond Vol#: 151

C 6052 Michael J Paquet Vol#: 152

C 6053 Michelle Sprague Vol#: 152

C 6054 Floyd Rohde Vol#: 152

C 6055 Pamela Doherty Vol#: 152

C 6056 Frances Campbell Vol#: 152

C 6057 Laurel M Sturt Vol#: 152

C 6058 D Schonfield Vol#: 152

C 6059 Priscilla Reynolds Vol#: 152

C 6060 Richard Fuller Vol#: 152

C 6061 Beverly B Ferguson Vol#: 152

C 6062 Sue Rhineheimer Vol#: 152

C 6063 Randal J Watkins Vol#: 152

C 6064 Lynn Martin Vol#: 152

C 6065 Barbara Kennedy Vol#: 152

C 6066 C Roberts Vol#: 152

C 6067 O Stockert Vol#: 152

C 6068 Pamela S Cotheg Vol#: 152

C 6069 Corinne McGrail Vol#: 152

C 6070 Sally Connelly Vol#: 152

C 6071 Kyle Wilson Vol#: 152

C 6072 Carrie Puiia Vol#: 152

C 6073 Patrick Kiley Vol#: 152

C 6074 Mari Krajec Vol#: 152

C 6075 Betty Stewart Vol#: 152

C 6076 Catherine Basciano Vol#: 152

C 6077 Sarah L Trepanier Vol#: 152

C 6078 Deborah Young Vol#: 152

C 6079 Heather Schamanek Vol#: 152

C 6080 Form letter count 73 Vol#: 153

C 6081 Sandra Dann Vol#: 152

C 6082 Mr Samuel Ranish Vol#: 152

C 6083 Susan Zimmerman Vol#: 152

C 6084 Julia Linnell Vol#: 152

C 6085 Valerie L Williams Vol#: 152

C 6086 Shirley & Milton Paul Vol#: 152

C 6087 Peter Ramanow Vol#: 152

C 6088 Charlotte Hobday Vol#: 152

C 6089 Alfred S Fuller Vol#: 152

C 6090 Carol Ward Vol#: 152

C 6091 Jennifer W Clark Vol#: 152

C 6092 Andrea Hornbein Vol#: 152

C 6093 Laura Ticciati Vol#: 152

C 6094 Charles E Lincoln III Vol#: 152

C 6095 Debbie Triff Vol#: 152

C 6096 Billy Bramblett Vol#: 152

C 6097 Joseph Byrne Vol#: 152

C 6098 Bill Derau Vol#: 152

C 6099 Sheila Lamb Vol#: 152

C 6100 Audra Ruyle Vol#: 152

C 6101 Mari Guarino Vol#: 152

C 6102 Alicia Gomer Vol#: 152

C 6103 Sandy Mitchell Vol#: 152

C 6104 Monica Wesolowska Vol#: 152

C 6105 Mrs Robert C Stevens Vol#: 152

C 6106 Margaret E Jones Vol#: 152

C 6107 William Kauffman Vol#: 152

C 6108 GM/SOS COMMITTEE Vol#: 152

EC 42 Jane Blake Vol#: 152

EC 43 Lindy Tucker Vol#: 152

EC 44 Heather McKean Vol#: 152

EC 45 SDAI LABS Vol#: 152

EC 46 J Detert-Moriaty Vol#:

EC 47 Avi Bortnick Vol#: 152

EC 48 E F Johnson Vol#: 152

EC 49 Sonja Bruce Vol#: 152

EC 50 Anita A Cardenas Vol#: 152

EC 51 Linda Verdonk Vol#: 152

EC 52 Judi Boehner Vol#: 152

EC 53 Conrad Miller MD Vol#: 152

EC 54 Jill Topley Vol#: 152

EC 55 Lesley Holdom Vol#: 152

EC 56 Steven McKay Vol#: 152

EC 57 Tracey Savage Vol#: 152

EC 58 Adele Sue Boies Vol#: 152

EC 59 Maria Novotny Vol#: 152

EC 60 Laura Hale Vol#: 152

EC 61 Rita A Rogers Vol#: 152

EC 62 Arleen S Henry Vol#: 152

EC 63 Barbara Francis Vol#: 152

EC 64 Michelle Golf Vol#: 152

EC 65 Heather Dear Vol#: 152

EC 66 Keith, Beth, & Eric Johns Vol#: 152

EC 67 Malia Damon Vol#: 1522

EC 68 Lindy Tucker Vol#: 152

EC 69 Jill Mistretta-Bruno Vol#: 152

EC 70 H Elizabeth Belletti Vol#: 152

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 995 Cheryl Mendonsa Vol#: 21

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

LET 46 The Honorable Barbara Boxer Vol#: 291

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

Following duplicates linked comments in 97P-0197 below

C 667 Form letter count 75 Vol#: 25

C 668 Form letter count 57 Vol#: 26

C 669 Anne Sacilowski Vol#: 27

C 670 CSPI Vol#: 27

C 671 FMI, Food Marketing Institute Vol#: 27

C 672 Humanitarians of Florida, Inc. Vol#: 27

C 673 Dorothea Mueller Vol#: 27

C 674 Ms Sheila A. Rybak Vol#: 27

C 675 Ms Kari Nienstedt Vol#: 27

C 676 Susan Porto Vol#: 27

C 677 Ronda Styles Vol#: 27

C 678 Helene Schwartz Vol#: 27

C 679 Phil & Sue Ellin Vol#: 27

C 680 12 signatures Vol#: 27

C 681 10 signatures Vol#: 27

C 682 Margaret Murray Vol#: 27

C 683 Lori Thayer Vol#: 27

C 684 Susan M. Troutman Vol#: 27

C 685 E. Brien Vol#: 27

C 686 Lucille Kram Vol#: 27

C 687 no signature Vol#: 27

C 688 Mr. Pat Mezzullo Vol#: 27

C 689 Robin Kapien Vol#: 27

C 690 Linda Williams Vol#: 27

C 691 Joy M. Zakarian, M.P.H. Vol#: 27

C 692 Char Sakamoto Ishii Lum & Ching Vol#: 27

C 693 Lillian Shaver Vol#: 27

C 694 Ruth Kuzub Vol#: 27

C 695 Mary Gilbert Vol#: 27

C 696 Mary Picca Vol#: 27

C 697 Kelly Dovel Vol#: 27

C 698 Yasmin Aziz, Esq. Vol#: 28

C 699 Green Mountain Animal Defenders Vol#: 28

C 700 Sharon MacNair Vol#: 28

C 701 Mrs. Anne Fanelli Vol#: 28

C 702 Ellen Emerson Vol#: 28

C 703 Ruth Powell Vol#: 28

C 704 Desiree A. Passantino Vol#: 28

C 705 Jan Valois Vol#: 28

C 706 Meredith Erickson Vol#: 28

C 707 R. J. Bremier et al Vol#: 28

C 708 Painting Western & Native American Art Vol#: 28

C 709 Robin Lake Vol#: 28

C 710 Roderick D. White Vol#: 28

C 711 Evelyn Phillips Gutchell Vol#: 28

C 712 Mrs. Maria Tripp Vol#: 28

C 713 Suzanne Stufano Young Vol#: 28

C 714 Ayavalla Plantation/Ayavalla Land Co. Vol#: 28

C 715 Margie B. & James R. Kiser Vol#: 28

C 716 Ms. Allison Rivera Vol#: 28

C 717 Ms. Linda F. Hartge Vol#: 28

C 718 Ruta M. Klimas Vol#: 28

C 719 Jane Anne Remes Johnson Vol#: 28

C 720 Carolin Kweller Vol#: 28

C 721 B. R. Vol#: 28

C 722 Frances M. Sturim Vol#: 28

C 723 Raven Herron Vol#: 28

C 724 Jean Allison Thaler Vol#: 28

C 725 Karen Colterjohn Vol#: 28

C 726 Nikki L. Deane Vol#: 28

C 727 Elizabeth Guare Vol#: 28

C 728 Bruce Bennington Vol#: 29

C 729 Lynne Rayburn Vol#: 29

C 730 Gregory Haag Vol#: 29

C 731 Lorraine Nicotera Vol#: 29

C 732 Howardena Pindell Vol#: 29

C 733 Elaine Frances Livesey-Fassel, B.F.A.,MA Vol#: 29

C 734 Kady Lane Vol#: 29

C 735 Christine McQueary Vol#: 29

C 736 Kimberly Munroe Comentale Vol#: 29

C 737 Vivian V. Vetrano Vol#: 29

C 738 Tosca Haag Vol#: 29

C 739 Philip Ide Vol#: 29

C 740 Luater Potate Vol#: 29

C 741 Katrelya Angus Vol#: 29

C 742 Tenneco Packaging, Inc. Vol#: 29

97N-0074 President's National Food Safety Initiative

C 117 Cherie Bracewell Vol#: 10

C 118 Holly Reynolds & Others Vol#: 10

C 119 Jan Van Dyne Vol#: 10

C 120 Rhonda D. Wright, M.D. Vol#: 10

C 121 Voices for Animals Vol#: 10

97N-0314 Prescription Drug Products; Levothyroxine Sodium

C 2 King & Spalding Vol#: 1

97P-0197 Require that warning labels about risks of salmonella

C 668 Form letter count 75 Vol#: 24

C 669 Form letter count 57 Vol#: 25

C 670 Anne Sacilowski Vol#: 26

C 671 CSPI Vol#: 26

C 672 FMI, Food Marketing Institute Vol#: 26

C 673 Humanitarians of Florida, Inc. Vol#: 26

C 674 Dorothea Mueller Vol#: 26

C 675 Ms Sheila A. Rybak Vol#: 26

C 676 Ms Kari Nienstedt Vol#: 26

C 677 Susan Porto Vol#: 26

C 678 Ronda Styles Vol#: 26

C 679 Helene Schwartz Vol#: 26

C 680 Phil & Sue Ellin Vol#: 26

C 681 12 signatures Vol#: 26

C 682 10 signatures Vol#: 26

C 683 Margaret Murray Vol#: 26

C 684 Lori Thayer Vol#: 26

C 685 Susan M. Troutman Vol#: 26

C 686 E. Brien Vol#: 26

C 687 Lucille Kram Vol#: 26

C 688 no signature Vol#: 26

C 689 Mr. Pat Mezzullo Vol#: 26

C 690 Robin Kapien Vol#: 26

C 691 Linda Williams Vol#: 26

C 692 Joy M. Zakarian, M.P.H. Vol#: 26

C 693 Char Sakamoto Ishii Lum & Ching Vol#: 26

C 694 Lillian Shaver Vol#: 26

C 695 Ruth Kuzub Vol#: 26

C 696 Mary Gilbert Vol#: 26

C 697 Mary Picca Vol#: 26

C 698 Kelly Dovel Vol#: 26

C 699 Yasmin Aziz, Esq. Vol#: 27

C 700 Green Mountain Animal Defenders Vol#: 27

C 701 Sharon MacNair Vol#: 27

C 702 Mrs. Anne Fanelli Vol#: 27

C 703 Ellen Emerson Vol#: 27

C 704 Ruth Powell Vol#: 27

C 705 Desiree A. Passantino Vol#: 27

C 706 Jan Valois Vol#: 27

C 707 Meredith Erickson Vol#: 27

C 708 R. J. Bremier et al Vol#: 27

C 709 Painting Western & Native American Art Vol#: 27

C 710 Robin Lake Vol#: 27

C 711 Roderick D. White Vol#: 27

C 712 Evelyn Phillips Gutchell Vol#: 27

C 713 Mrs. Maria Tripp Vol#: 27

C 714 Suzanne Stufano Young Vol#: 27

C 715 Ayavalla Plantation/Ayavalla Land Co. Vol#: 27

C 716 Margie B. & James R. Kiser Vol#: 27

C 717 Ms. Allison Rivera Vol#: 27

C 718 Ms. Linda F. Hartge Vol#: 27

C 719 Ruta M. Klimas Vol#: 27

C 720 Jane Anne Remes Johnson Vol#: 27

C 721 Carolin Kweller Vol#: 27

C 722 B. R. Vol#: 27

C 723 Frances M. Sturim Vol#: 27

C 724 Raven Herron Vol#: 27

C 725 Jean Allison Thaler Vol#: 27

C 726 Karen Colterjohn Vol#: 27

C 727 Nikki L. Deane Vol#: 27

C 728 Elizabeth Guare Vol#: 27

C 729 Bruce Bennington Vol#: 28

C 730 Lynne Rayburn Vol#: 28

C 731 Gregory Haag Vol#: 28

C 732 Lorraine Nicotera Vol#: 28

C 733 Howardena Pindell Vol#: 28

C 734 Elaine Frances Livesey-Fassel, B.F.A.,MA Vol#: 28

C 735 Kady Lane Vol#: 28

C 736 Christine McQueary Vol#: 28

C 737 Kimberly Munroe Comentale Vol#: 28

C 738 Vivian V. Vetrano Vol#: 28

C 739 Tosca Haag Vol#: 28

C 740 Philip Ide Vol#: 28

C 741 Luater Potate Vol#: 28

C 742 Katrelya Angus Vol#: 28

C 743 Tenneco Packaging, Inc. Vol#: 28

97P-0498 Label foods & beverages containing greater than 5mg caffeine

C 57 Avram Goldstein, M.D. Vol#: 1

98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

C 5 North Shore U Hosp - Cornell U Med Col Vol#: 1

98H-0368 Civil Money Penalties; Fourth Avenue Shell, LLC

SET 1 GCF-1 Vol#: 1

98H-0884 Civil Money Penalty; Demoulas Super Markets Inc d/b/a Market

SET 1 GCF-1 Vol#: 1

98H-0886 Civil Money Penalty; Gary R & Lorna L Hink d/b/a Jarrell's C

SET 1 GCF-1 Vol#: 1

98H-0899 Civil Money Penalties;Ice Service Inc,d/b/a Ice Service #1

SET 1 GCF-1 Vol#: 1

98H-0915 Civil Money Penalties;Robert R Ciaccio dba R&R Jackport Food

SET 1 GCF-1 Vol#: 1

98H-1043 Civil Money Penalties;E-Z Serve Corp,d/b/a E-Z Serve 4433-22

SET 1 GCF-1 Vol#: 1

98H-1066 Civil Money Penalties; Biloxi Casino Corp,d/b/a Casino Magic

SET 1 GCF-1 Vol#: 1

98H-1081 Civil Money Penalties;Davis Goon,d/b/a Goon's Grocery

SET 1 GCF-1 Vol#: 1

98H-1283 Civil Moneoy Penalties;Pace Oil Co Inc,d/b/a Pacesetter #4

SET 1 GCF-1 Vol#: 1

98H-1289 Civil Money Penalties; Triple V Inc,d/b/a Sunflower Food

SET 1 GCF-1 Vol#: 1

98N-0337 Over the counter human drugs labeling requirements

ANS 5 HFD-560 to Automatic Liquid Packaging Vol#: 3

SUP 1 Automatic Liquid Packaging, Inc Vol#: 3

98N-1038 Irradiation in the production, processing, &handling of food

C 4731 Pamela S Cotheg Vol#: 135

98N-1215 Foreign Establishment Registration and Listing

C 28 Ontario Exports Inc Vol#: 1

C 29 Techlem Medical Systems Inc Vol#: 1

C 30 Medical Device Manufacturers Assn Vol#: 1

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

C 2284 Elaine & Maury Lawrence Vol#: 64

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 687 Barbara Kennedy Vol#: 23

99D-2013 Cooperative Manufacturing Arrangements for Licensed

C 9 Baxter Healthcare Corporation Vol#: 1

99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis

C 2 Janssen Pharmaceutical Res Foundation Vol#: 1

99D-2636 Guidance for Industry on Levothyroxine Sodium

C 1 Jones Pharma Inc Vol#: 1

99D-2638 Use of Medicated Feeds for Minor Species

C 3 Kimberly Birn Vol#: 1

99D-4052 Application for Processed Human Dura Mater

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

99D-4054 Intraocular Lens

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

99H-0056 Civil Money Penalties;Star Mart Inc,dba Star Mart

SET 1 GCF-1 Vol#: 1

99H-0074 Civil Money Penalties; Bi-Lo Inc

SET 1 GCF-1 Vol#: 1

99H-0608 Civil Money Penalties;Abdul Misrati,d/b/a Prime Service Ctr

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0736 Civil Money Penalites;Charles J Haun,d/b/a Haun's Grandview

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0778 Civil Money Penalty; Bledsoe-Starling Corp d/b/a Joe's Place

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0801 Civil Money Penalties;Kim Nguyn,d/b/a Rosemont Market

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0817 Civil Money Penalties;Mahmud Assad d/b/a Kelly Food & Liquor

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2756 Civil Money Penalty;Harden Oil Co Inc,dba Presto Food Store

CR 1 GCF-1 Vol#: 1

LET 2 GCF-1 Vol#: 1

99H-2825 Civil Money Penalty;The Health Effect Inc,dba Hall's Drug

CR 1 GCF-1 Vol#: 1

LET 2 GCF-1 Vol#: 1

99H-2939 Civil Money Penalty;Michael Seroy & Nancy E Seroy,dba Arco

ANS 1 Seroil Petroleum Marketers Vol#: 1

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

ANS 1 CBM Ventures LLC, Townson Park Exxon Vol#: 1

99H-4010 Civil Money Penalty;Hazaa El Fakih,dba Route 3A Shell

ANS 1 Rte. 3A Shell Inc Programs Vol#: 1

99H-4023 Civil Money Penalty;VAS Inc,dba Augusta Liquor

WDL 1 GCF-1 Vol#: 1

99H-4047 Civil Money Penalty;Saddika Mawla,dba 7-Eleven Food Store #2

ANS 1 7-Eleven Food Store #20448 Vol#: 1

99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy

C 4 Sherry Bozman Vol#: 1

99N-4063 Positron emmission tomography drug products

C 2 Mayo Clinic Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

EC 19 Denise Lee Vol#: 3

EC 20 William R. Picard Vol#: 3

EC 21 Joan Reinhardt Reiss Vol#: 3

99P-4375 Health Claim: Vitamin E and Heart Disease

ACK 1 HFS-465 to Emord & Associates PC Vol#: 5

CP 1 Julian M Whitaker, MD, Am Preventive etc Vol#: 1

LET 1 HFS-465 to Emord & Associates PC Vol#: 5

SUP 1 Julian M Whitaker, MD, Am Preventive etc Vol#: 5