Food and Drug Administration

DOCKETS ENTERED on June 28, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
98N-0044 Effect of dietary supplement on structure/function of body *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0169 Labeling Standards for Botanicals, Homeopathics, etc. *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
98C-0158 D&C VIOLET NO.2 COLOR ABSORBABLE MENISCAL TASKS POLY(L-LACTC

BKG 1 Vol#: 1

NFR 1 Vol#: 1

98D-0362 Stability Testing of Drug Substances and Drug Products

C 70 Bristol-Myers Squibb Vol#: 5

98N-0044 Effect of dietary supplement on structure/function of body

C 22319 Gina D'Adamo Vol#: 771

C 22320 Mary Knoblich Vol#: 771

C 22321 Illegible Vol#: 771

C 22322 Mary L. Merlo Vol#: 771

C 22323 Illegible Vol#: 771

C 22324 Beverly F. Steinberg Vol#: 771

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

C 3026 Jim Farris Vol#: 80

C 3027 B. Y. Love Vol#: 85

C 3028 Julia Willebrand, Ed.D. Vol#: 85

C 3029 Earth Day Coalition Vol#: 85

C 3030 Esther M. Gateff Vol#: 85

C 3031 W. Roberts Vol#: 85

C 3032 Sylvia & Leo Wolf Vol#: 85

C 3033 Gay Gorden Vol#: 85

C 3034 Eli D. Gateff Vol#: 85

C 3035 Mark A. Bird Vol#: 85

C 3036 Ben Beal Vol#: 85

C 3037 Dave & Stephanie Reed Vol#: 85

C 3038 Willamarie Huelskamp Vol#: 85

C 3039 John Keeley Vol#: 85

C 3040 Sylvan Grey Vol#: 85

C 3041 Marcella Durand Vol#: 85

C 3042 Robert R. Cheeks Vol#: 85

C 3043 Janet Harvey Vol#: 85

C 3044 Miriam & Dan Fischman Vol#: 85

C 3045 Brenda Deese Vol#: 85

C 3046 David Gold et al Vol#: 85

C 3047 Robert Story Vol#: 85

C 3048 Form letter count 11 Vol#: 86

98N-1265 Distribution of Compounded Drug Products

C 3310 MaryAnne Hochadel Vol#: 122

98P-0169 Labeling Standards for Botanicals, Homeopathics, etc.

C 4 No Signature Vol#: 1

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 260 The Honorable Paul S. Sarbines (CI) Vol#: 18

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 155 Eric Patton Vol#: 3

99H-1608 Civil Money Penalty;William Eric Roberts dba City BP

ANS 1 William Eric Roberts,d/b/a City BP Vol#: 1

99H-1739 Civil Money Penalty;Cophers Service Center Inc dba Copher's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1740 Civil Money Penalty; Stephanie Edel dba Caseys Pizza Downtow

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1741 Civil Money Penalty;Calvin Greene & Danny Greene dba Town &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1742 Civil Money Penalty;Rosser Grocery Co dba Hillsboro Handi-Ma

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1743 Civil Money Penalty;Southeast Food Inc dba County Market #12

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1744 Civil Money Penalty;Basin Co-Op dba Ampride

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1745 Civil Money Penalty;Shirley Griffin, Jerry Smith, Tara Smith

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1746 Civil Money Penalty;Mario's Northtown Market Inc dba Mario's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1747 Civil Money Penalty;Red Hed Oil Co dba Red Hed Oil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1748 Civil Money Penalty;Walgreen Co dba Walgreens #2776

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1749 Civil Money Penalty;Richard Miller & Bobbie Miller dba Plaza

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1750 Civil Money Penalty;Abraham Ogbamichael dba King's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1751 Civil Money Penalty;Husein Ahmad dba Chevron Quick Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1752 Civil Money Penalty;R & D Foods Inc dba Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1753 Civil Money Penalty;Tammy Rhoades dba TNT Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1754 Civil Money Penalty;Lewcor Inc dba Westside Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1755 Civil Money Penalty; Al's Corner Oil Co dba Sparky One Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1757 Civil Money Penalty;CVS Pharmacy Inc dba CVS Pharmacy #4457

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1758 Civil Money Penalty;Gaja Kim dba Equitable Cigar & Pipe Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1759 Civil Money Penalty; Myrna Costa dba Babes Tapp

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1796 Civil Money Penalty;B & K Foods Inc,dba Country Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1797 Civil Money Penalty;Leroy Bentler,dba Hillsboro Corner

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1798 Civil Money Penalty;Kelly Choi,d/b/a Denbigh Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1799 Civil Money Penalty;Cryder Ind Inc,d/b/a Greensprings Grocer

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1800 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1801 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug Store #8368

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1802 Civil Money Penalty;Michael M Gebremariam,dba King of Hill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1803 Civil Money Penalty;Golden Gallon Inc,dba Golden Garron #162

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1804 Civil Money Penalty;Hines Inc,Angus I,dba Sentry Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1805 Civil Money Penalty;Kyung Lim Hong,dba Bell Street Deli & Gr

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1806 Civil Money Penalty;Kroger Corporation,dba King Soopers

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1807 Civil Money Penalty;David Lynch,dba Dave's Quick-Chek

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1808 Civil Money Penalty;Miller Oil Co Inc,dba Miller Mart #15

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1809 Civil Money Penalty;Richard Dzvng Nguyen,dba Super Suds Coin

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1810 Civil Money Penalty;Phillips Petroleum Co,dba Wadsworth Plaz

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1811 Civil Money Penalty;Rite Aid of Virginia Inc,dba Rite Aid

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1812 Civil Money Penalty;RSI Supervalu Inc,dba Save-A-Lot

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1813 Civil Money Penalty;Service Oil Co,dba Bradley Petroleum Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1814 Civil Money Penalty;Roy B Stephens,dba Old Hebron Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1815 Civil Money Penalty;Terrible Herbst Inc,dba Terrible Herbst

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1816 Civil Money Penalty;Jim Wagner,dba Wagner's One Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1830 Civil Money Penalty;Bullards Market & Package Store Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1831 Civil Money Penalty;Robert Defreitas & Timothy Pitts,dba G V

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1834 Civil Money Penalty;49 Inc,dba Emerson's Fine Gifts & Tobacc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1835 Civil Money Penalty;Stanley Hobson Bezzo Sr,dba Ashland Disc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1836 Civil Money Penalty;Buffalo Services Inc,dba B-Kwik Food Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1837

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1838 Civil Money Penalty;Don Ricky Howard,dba Howard's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1839 Civil Money Penalty;McCarty's Chevron Food Mart LLC,dba Ms

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1840 Civil Money Penalty;Safeway Inc,dba Safeway #1040

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1841 Civil Money Penalty;24 Hour Markets Inc,dba 24 Hour Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1842 Civil Money Penalty;Smith Food & Drug Ctrs Inc,dba Price Rit

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1843 Civil Money Penalty;Vonc Stephens,dba Stephens Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1844 Civil Money Penalty;Tobacconist Ltd Inc,dba Tobacconist Ltd

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1845 Civil Money Penalty;Anselmo Trufel,dba Trufel Convenience St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1846 Civil Money Penalty;Ultramar Diamond Shamrock Corp

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1847 Civil Money Penalty;BJ Williams,dba Holcomb Gas Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1848 Civil Money Penalty;Darryl Williams & Jayneen Williams,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0791 Survey of Medical Device Mfg for Y2K Compliance of Mfg Syst

NAL 1 Vol#: 1

SS 1 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1087 Charlotte & Frank Marchese Vol#: 16

C 1088 Charles Ventura Vol#: 16

C 1089 Alan Hoffman, M.D. Vol#: 16