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 26, 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 *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0203 Eliminate Forced Molting of Laying Birds *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99P-0389 Abbreviated new drug application/topical dematological drug *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-4581 Add Triiodo-L-Thyronine, T3 SR to "Bulk Drug Substances" *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-4617 Extend the Implementation Dates of the OTC Drug Labeling
99V-4579 Laser Light Show *
99V-4580 Laser Light Show - Moblazer *
80N-0295 OTC drug review policy statement

MM 120 FDA/OTC & CTFA 10/26/99 Vol#: 3

MM 121 FDA/OTC & CTFA & SDA 11/3/99 Vol#: 3

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

C 6152 Emily J Bender Vol#: 156

C 6153 Illegible Vol#: 156

C 6154 Susan Werner Vol#: 156

EC 72 Suzanne La POinte-Brookes Vol#: 156

EC 73 Fannie Peczenik Vol#: 156

EC 74 Maverick Vol#: 156

EC 75 Heidi Pierce Vol#: 156

EC 76 Valarie Overton Vol#: 156

EC 77 Nicole J Ramsey Vol#: 156

EC 78 O'Neil Stetler Vol#: 156

EC 79 Donna Smith-Remick Vol#: 156

EC 80 Allie Kurtz Vol#: 156

EC 81 Elizabeth J Thompson Vol#: 156

EC 82 Christine M Migeot Vol#: 156

EC 83 Jessica McKenna Vol#: 156

EC 84 Bethany Larsen Vol#: 156

EC 85 Linda Seiler Vol#: 156

EC 86 Theresa Ann Moorehouse Vol#: 156

EC 87 Carla M Koykkari Vol#: 156

EC 88 John & Janice Dixon Vol#: 156

EC 89 Brenda Jayne MacKinnon-Gammon Vol#: 156

EC 90 Karen L Schloss Vol#: 156

EC 91 Amy Lynette Scott Vol#: 156

EC 92 Melody May Vol#: 156

EC 93 Tiffany Renee Enright Vol#: 156

EC 94 Ann Henry Vol#: 156

EC 95 Deborah A Corbin Vol#: 156

EC 96 Elizabeth Anderson Vol#: 156

EC 97 Jacque Dirskell Vol#: 156

EC 98 Patricia G Burkett Vol#: 156

EC 99 Sandy Gill Vol#: 156

EC 100 Joe Fillmer Vol#: 156

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 4001 Nature's Way Products Inc Vol#: 27

LET 4002 JDG Marketing Interst Inc Vol#: 27

LET 4003 Natures Answer Inc Vol#: 27

LET 4004 Premier Direct Inc Vol#: 27

LET 4005 Premier Direct Inc Vol#: 27

LET 4006 Premier Direct Inc Vol#: 27

LET 4007 Premier Direct Inc Vol#: 27

LET 4008 Premier Direct Inc Vol#: 27

LET 4009 Premier Direct Inc Vol#: 27

LET 4010 Premier Direct Inc Vol#: 27

LET 4011 Premier Direct Inc Vol#: 27

LET 4012 Premier Direct Inc Vol#: 27

LET 4013 Premier Direct Inc Vol#: 27

LET 4014 Premier Direct Inc Vol#: 27

LET 4015 Premier Direct Inc Vol#: 27

LET 4016 Premier Direct Inc Vol#: 27

LET 4017 Premier Direct Inc Vol#: 27

LET 4018 Premier Direct Inc Vol#: 27

LET 4019 Premier Direct Inc Vol#: 27

LET 4020 Premier Direct Inc Vol#: 27

LET 4021 Premier Direct Inc Vol#: 27

LET 4022 Premier Direct Inc Vol#: 27

LET 4023 Premier Direct Inc Vol#: 27

LET 4024 Premier Direct Inc Vol#: 27

LET 4025 Premier Direct Inc Vol#: 27

LET 4026 Premier Direct Inc Vol#: 27

LET 4027 Premier Direct Inc Vol#: 27

LET 4028 Premier Direct Inc Vol#: 27

LET 4029 Premier Direct Inc Vol#: 27

LET 4030 Premier Direct Inc Vol#: 27

LET 4031 Premier Direct Inc Vol#: 27

LET 4032 Premier Direct Inc Vol#: 27

LET 4033 Premier Direct Inc Vol#: 27

LET 4034 Premier Direct Inc Vol#: 27

LET 4035 Premier Direct Inc Vol#: 27

LET 4036 Feeling Fine Company LLC Vol#: 27

LET 4037 Feeling Fine Company LLC Vol#: 27

LET 4038 Herb Pharm Vol#: 27

LET 4039 Herb Pharm Vol#: 27

LET 4040 Uniweal Ltd Vol#: 27

LET 4041 Standard Process Inc Vol#: 27

LET 4042 Standard Process Inc Vol#: 27

LET 4043 Standard Process Inc Vol#: 27

LET 4044 Standard Process Inc Vol#: 27

LET 4045 Standard Process Inc Vol#: 27

LET 4046 Standard Process Inc Vol#: 27

LET 4047 Standard Process Inc Vol#: 27

LET 4048 Standard Process Inc Vol#: 27

LET 4049 Standard Process Inc Vol#: 27

LET 4050 Standard Process Inc Vol#: 27

LET 4051 Terra Life Health Products Co Inc Vol#: 27

LET 4052 Ricola USA Inc Vol#: 27

LET 4053 Ricola USA Inc Vol#: 27

LET 4054 Ricola USA Inc Vol#: 27

LET 4055 Ricola USA Inc Vol#: 27

LET 4056 Ricola USA Inc Vol#: 27

LET 4057 Ricola USA Inc Vol#: 27

LET 4058 Ricola USA Inc Vol#: 27

LET 4059 Ricola USA Inc Vol#: 27

LET 4060 USANA Vol#: 27

LET 4061 Nature's Way Products Inc Vol#: 27

LET 4062 NutriMed Inc Vol#: 27

LET 4063 Bayer Corporation Vol#: 27

LET 4064 Bayer Corporation Vol#: 27

LET 4065 Premier Direct Inc Vol#: 27

LET 4066 Kaire Nutraceuticals Inc Vol#: 27

LET 4067 M K Health Food Distributers d/a Nature Vol#: 27

LET 4068 Celestial Seasonings Inc Vol#: 27

LET 4069 Celestial Seasonings Inc Vol#: 27

LET 4070 Celestial Seasonings Inc Vol#: 27

LET 4071 Celestial Seasonings Inc Vol#: 27

LET 4072 Celestial Seasonings Inc Vol#: 27

LET 4073 Mason Vitamins Inc Vol#: 27

LET 4074 Celestial Seasonings Inc Vol#: 27

LET 4075 Celestial Seasonings Inc Vol#: 27

LET 4076 Celestial Seasonings Inc Vol#: 27

LET 4077 Celestial Seasonings Inc Vol#: 27

LET 4078 Celestial Seasonings Inc Vol#: 27

LET 4079 Celestial Seasonings Inc Vol#: 27

LET 4080 Celestial Seasonings Inc Vol#: 27

LET 4081 Celestial Seasonings Inc Vol#: 27

LET 4082 Celestial Seasonings Inc Vol#: 27

LET 4083 Celestial Seasonings Inc Vol#: 27

LET 4084 Celestial Seasonings Inc Vol#: 27

LET 4085 Celestial Seasonings Inc Vol#: 27

LET 4086 Celestial Seasonings Inc Vol#: 27

LET 4087 Celestial Seasonings Inc Vol#: 27

LET 4088 Celestial Seasonings Inc Vol#: 27

LET 4089 Naturalife Corporation Vol#: 27

LET 4090 Naturalife Corporation Vol#: 27

LET 4091 Naturalife Corporation Vol#: 27

LET 4092 Naturalife Corporation Vol#: 27

LET 4093 Naturalife Corporation Vol#: 27

LET 4094 Nature's Way Products Inc Vol#: 27

LET 4095 Nature's Herbs Vol#: 27

LET 4096 Nature's Herbs Vol#: 27

LET 4097 Nature's Herbs Vol#: 27

LET 4098 Nature's Herbs Vol#: 27

LET 4099 Nature's Herbs Vol#: 27

LET 4100 Kaire Nutraceuticals Inc Vol#: 27

98N-0337 Over the counter human drugs labeling requirements

APP 7 Johnson & Johnson Merck Vol#: 4

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

C 4736 Tom Minsel Vol#: 135

C 4737 Lynn Bishop Vol#: 135

C 4738 Patricia L Butler Vol#: 135

C 4739 Michael Reynolds Vol#: 135

C 4740 Kiplin D Chavis Vol#: 135

C 4741 Janice P Oliver Vol#: 135

C 4742 J Michael Oxley Vol#: 135

C 4743 Thomas Morley Vol#: 135

C 4744 Honorable Dennis J Kucinich (CI) Vol#: 135

C 4745 Dr Timothy Johnson Vol#: 135

C 4746 Barbara J Werdelin Vol#: 135

EC 10 Clay Olson Vol#: 135

EC 11 J T Graphix Vol#: 135

EC 12 Lonnie Ezati Vol#: 135

98P-0203 Eliminate Forced Molting of Laying Birds

C 1875 John W Cadek Vol#: 45

C 1876 M J Osborne-Wright & Family Vol#: 45

C 1877 Dr R Median Vol#: 45

C 1878 U K Nichols Vol#: 45

C 1879 J Scott Douglas Vol#: 45

C 1880 Mrs Chris Moyer Vol#: 45

C 1881 Madonna Niles Vol#: 45

C 1882 David Shalet Vol#: 45

C 1883 Theresa Ziadie Vol#: 45

C 1884 Linda Leeti Vol#: 45

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 332 Form letter count 15 Vol#: 48

C 333 Milinda Spaner Vol#: 49

C 334 Frances Waters Vol#: 49

C 335 D Lenier Vol#: 49

C 336 Dennis Hewitt Vol#: 49

C 337 Helen Derevnuk Vol#: 49

C 338 Ruth Valva Vol#: 49

C 339 Anita Margolis Vol#: 49

99H-0105 Civil Money Penalties;Boris Sapozhnikov, d/b/a ABS Market

CR 1 GCF-1 Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

BRF 1 Lazy Lee's One Stop Inc Vol#: 1

99H-1448 Civil Money Penalties;Donald German,d/b/a The Alibi

MO 1 Donald German,dba The Alibi Vol#: 1

99H-2708 Civil Money Penalty;Fuhr Enterprises Inc dba Sunray Amoco

ANS 2 Fuhr Ent Inc. d/b/a Sunray Amoco Vol#: 1

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

BRF 1 GCF-1 Vol#: 1

99H-3002 Civil Money Penalty;Baker Energy Inc,dba Texaco Food Mart #2

ANS 1 Baker Energy Inc Vol#: 1

99H-3096 Civil Money Penalty;Honey Farms Inc,dba Honey Farms #31

ANS 1 Honey Farms Inc Vol#: 1

99H-4029 Civil Money Penalty;Balafas Enterprises Inc,dba Campus Liquo

ANS 1 Balafas Enterprises Inc Vol#: 1

99H-4123 Civil Money Penalty;L.S. Inc, dba Brunswick Citgo

ANS 1 L S Inc, dba Brunswick Citgo Vol#: 1

99H-4142 Civil Money Penalty;Daniel Chang & Karen Chang,dba Columbia

ANS 1 Daniel Chang & Karen Chang Vol#: 1

99H-4160 Civil Money Penalty;Catherine Sharp,dba Bob Sharp's Union

ANS 1 Bob Sharps Union Plaza Shell Vol#: 1

99H-4237 Civil Money Penalty;Calfee Co of Dalton Inc,dba Favorite Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#:

99H-4238 Civil Money Penalty;CRM Ent Inc,dba Longmeadow Liquors

ANS 1 CRM Ent Inc.,dba Longmeadow Liquors Vol#: 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4239 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #6366

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4240 Civil Money Penalty;E-Z Stop Food Marts Inc,dba E-Z Food Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4241 Civil Money Penalty;Food Lion Inc.,dba Food Lion #1147

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4242 Civil Money Penalty;Greenfield Management Inc,dba Chevron Pa

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4243 Civil Money Penalty;Honey Farms Inc,dba Honey Farms #77

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4244 Civil Money Penalty;Hy-Vee Inc,dba Hy-Vee #1353

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4245 Civil Money Penalty;J T K Corp,dba Akron Pronto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4246 Civil Money Penalty;Jerry Conley,dba Conley's Country Corne

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4247 Civil Money Penalty;Kmart Corp,dba Kmart Store #3189

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4248 Civil Money Penalty;Knicley Ent Inc,dba Washington Center Li

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4249 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4250 Civil Money Penalty;Norman Blaxon,dba Blaxton Grocery & Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4251 Civil Money Penalty;Peterborough Oil Co Inc, dba Mr Mike'Mob

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4252 Civil Money Penalty;Ray E Abbott,dba Abbott's Food Center

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4253 Civil Money Penalty;Sandy Foods Inc,dba Fod Pride

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4254 Civil Money Penalty;Tesoro Northstore Corp,dba Tesoro To Go

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4255 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-4256 Civil Money Penalty;Walgreen Co,dba Walgreens #522

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-0389 Abbreviated new drug application/topical dematological drug

ACK 2 HFA-305 Vol#: 1

CP 2 Pharmacia & Upjohn Inc. Vol#: 1

CR 1 HFA-305 Vol#: 1

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

C 6 Ellen DesMeules Vol#: 3

EC 27 Beth Israel Medical Center Vol#: 3

EC 28 unsigned Vol#: 3

EC 29 Tina Horowitz Vol#: 3

EC 30 Davis Baltz Vol#: 3

99P-4581 Add Triiodo-L-Thyronine, T3 SR to "Bulk Drug Substances"

ACK 1 HFA-305 Vol#: 1

CP 1 Beverly J. Warns Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

ACK 1 HFA-305 Vol#: 1

CP 1 Robert Cohen Vol#: 1

99P-4617 Extend the Implementation Dates of the OTC Drug Labeling Rul

ACK 1 HFA-305 Vol#: 1

CP 1 Cosmetic, Toiletry & Fragrance Assoc. Vol#: 1

99V-4579 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Kordis Sound, Inc. Vol#: 1

99V-4580 Laser Light Show - Moblazer

ACK 1 HFA-305 Vol#: 1

VAR 1 American Music Center Inc. Vol#: 1