Food and Drug Administration

DOCKETS ENTERED on June 29, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
93N-0044 Intent to Amend Performance Standard; Laser Products *
98N-1265 Distribution of Compounded Drug Products *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health *
99P-2119 Reclassify Constrained Hip Prosthesis *
99V-2120 Laser Light Show *
93N-0044 Intent to Amend Performance Standard; Laser Products

C 30 Weiner Associates Vol#: 2

C 31 Rockwell Laser Industries Vol#: 2

C 32 Sensor Physics Vol#: 2

98H-1030 Civil Money Penalties; The Southland Corp,d/b/a Christy's Ma

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1052 Civil Money Penalties;Walgreen Co Inc,d/b/a Walgreen Drug St

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1054 Civil Money Penalties;Wareco Service Inc,d/b/a Wareco Servic

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1056 Civil Money Penalties; Pak-A-Sak Food Stores Inc.

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1060 Civil Money Penalties;Taylor Oil Co,d/b/a Etna Self Serve

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1061 Civil Money Penalties;Enmark Stations Inc,d/b/a Enmark Stati

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1062 Civil Money Penalties;Eblen Short Stop Store,d/b/a Eblen Sho

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

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

C 22325 Form Letters Count Vol#: 867

98N-1265 Distribution of Compounded Drug Products

C 3311 Peter Halpern Vol#: 122

C 3312 Shari Nelson Vol#: 122

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 261 Gayle Murphy Vol#: 18

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 156 Paul Woods Vol#: 3

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 63 Alix Fano Vol#: 4

C 64 Ursula Ager Vol#: 4

C 65 K A Watson Vol#: 4

C 66 Liz Nicholas Vol#: 4

C 67 Elizabeth Valdovinos Vol#: 4

C 68 Matthew Cohen Vol#: 4

C 69 Valerie Morgan Vol#: 4

C 70 Kimberley Jones Vol#: 4

C 71 Dave Baker PhD Vol#: 4

C 72 Shelagh Smith Vol#: 4

C 73 Wendy Lochner Vol#: 4

C 74 Mark M Giese Vol#: 4

C 75 Chris Striegel Vol#: 4

C 76 Marian Spitzer Vol#: 4

C 77 Lori E Swanson Nemenz Vol#: 4

C 78 Jenni Maughan Vol#: 4

C 79 Mary Brownell Vol#: 4

C 80 Sherry Fudim Vol#: 4

C 81 Sandy R Watson Vol#: 4

C 82 Danielle Canonico Vol#: 4

C 83 Susan Gensinger Vol#: 4

C 84 Pamela Bowman Vol#: 4

C 85 Robyn Reichert Vol#: 4

C 86 Nancy L Harrison MD Vol#: 4

C 87 Barbara Hayes Vol#: 4

C 88 Marie Mackenzie Vol#: 4

C 89 Patrick Kent Vol#: 4

C 90 Ms Judy Alessio Vol#: 4

C 91 Gabrielle Koeferl Vol#: 4

C 92 Mr & Mrs Robert Anderlik Vol#: 4

C 93 Chandra Beal Vol#: 4

C 94 Monica Jankowski Vol#: 4

C 95 Linda Baumann Vol#: 4

C 96 Suzanna Hermans Vol#: 4

C 97 Robyn Riechert Vol#: 4

C 98 Mrs Betty Herner Vol#: 4

C 99 Gail Hale Vol#: 4

C 100 Scott VanValkenburg Vol#: 4

C 101 Marie Atake Vol#: 4

C 102 Elsie & Robert Steckel Vol#: 4

C 103 Dorothy C Ramsaier Vol#: 4

C 104 Bina Robinson Vol#: 4

C 105 Christine Weisheit Vol#: 4

C 106 William McMullin Vol#: 4

C 107 Barbara Warner Vol#: 4

C 108 Cynthia Schandi MD, PhD Vol#: 4

C 109 Ron Scheinberg Vol#: 4

C 110 Marc & Evelyn Gutchell Vol#: 4

C 111 Philip Glaser Vol#: 4

C 112 Melissa Wu Vol#: 4

C 113 Stella Grieco Vol#: 4

C 114 Nadja Mair Vol#: 4

99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor

LET 2 Office of Tobacco Programs Vol#: 1

99H-0689 Civil Money Penalty; Hugo Okonogi d/b/a Dark Side

ANS 1 Hugo Okonogi,dba Dark Side Vol#: 1

99H-0995 Civil Money Penalties;Joe Shamoun,d/b/a Shamoun Cardinal

LET 2 Office of Tobacco Programs Vol#: 1

99H-1179 Civil Money Penalties;Warner Ent Inc,d/b/a Alstead Village

ANS 1 Alstead Village Store Vol#: 1

99H-1524 Civil Money Penalties;Bauer Oil Co,d/b/a Bauer Amoco

ANS 1 Bauer Oil Co,dba Bauer Amoco Vol#: 1

99H-1545 Civil Money Penalties;Don Laughlin,d/b/a Riverside Resort &

CS 1 HFA-305 Vol#: 1

EXT 1 Don Laughlin,dba Riverside Resort & Casi Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1579 Civil Money Penalty; Casey's Marketing Co dba Casey's Genera

ANS 1 Casey's Marketing Co,dba Casey's General Vol#: 1

99H-1607 Civil Money Penalty;Rite Aid of Kentucky Inc dba Rite Aid Ph

ANS 1 Rite Aid Corporation Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1853 Civil Money Penalty;Eric Parker & Juanita Parker dba Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1854 Civil Money Penalty;Samuel Shoup & Nina Shoup dba Ashland Ch

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1855 Civil Money Penalty;James Kokosa & Jackie Kokosa dba Stan &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1856 Civil Money Penalty;The Handy Markets Inc dba Handy Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1857 Civil Money Penalty;Billy Breedlove & Janie Breedlove dba Br

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1858 Civil Money Penalty;James Havard dba Basin Shop Rite

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1859 Civil Money Penalty;Hill City Oil Co Inc dba Smoke Break

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1860 Civil Money Penalty;Jerry White dba Jerry's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1861 Civil Money Penalty;Mighty Mart Inc dba Mighty Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1862 Civil Money Penalty;Ronnie Waldrop & Kayla Waldrop dba Nola

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1863 Civil Money Penalty;Ralph E Myers dba Myers Market #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 GCF-1 Vol#: 1

99H-1880 Civil Money Penalty;Food Lion Inc,dba Food Lion Store #259

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1881 Civil Money Penalty;Kmart Corporation,dba Kmart Store #4158

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1882 Civil Money Penalty;Revco Discount Drug Ctrs Inc,dba CVS

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1883 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1884 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug Store #271

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1885 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug Store #432

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1886 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1887 Civil Money Penalty;Northland Cooperative,dba Tri Corner Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1888 Civil Money Penalty;City of Gilman,dba Gilman Municipal Liqu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1889 Civil Money Penalty;Autry Petroleum Co,dba Amoco Food Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1890 Civil Money Penalty;Autry Petroleum Co,dba Sunrise Pantry 32

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1891 Civil Money Penalty;Pine's Edge Grocery Inc,dba Pine's Edge

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1892 Civil Money Penalty;Crown Central Petroleum Co,dba Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1893 Civil Money Penalty;Duke & Long Distributing Co Inc,dba Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1894 Civil Money Penalty;Rapid Roberts Inc,dba Rapid Roberts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1895 Civil Money Penalty;Meadowbrook Resort Inc,dba Red Barn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1896 Civil Money Penalty;Petroleum World Inc,dba Maggie Valley

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1897 Civil Money Penalty;Tosco Marketing Co Inc,dba Circle K

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1898 Civil Money Penalty;Golden Pantry Food Stores Inc,dba Golden

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1899 Civil Money Penalty;Racetrac Petroleum Inc,dba Racetrac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1900 Civil Money Penalty;Ingles Markets Inc,dba Ingles #468

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1901 Civil Money Penalty;Kenneth Treblehorn,dba Amoco East

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1902 Civil Money Penalty;Robert Comeau,dba Ryezak Oil Co & One St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1903 Civil Money Penalty;Chris Toma,dba Thoma's Jack and Jill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1904 Civil Money Penalty;Jeff Nielsen,dba Total Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1905 Civil Money Penalty;Brad Erpelding & Bryan Erpelding & Mark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1906 Civil Money Penalty;Dennis Neihart & Pearl Neihart,dba Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1907 Civil Money Penalty;Paul Sommers & Rebecca Sommers,dba Swift

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1908 Civil Money Penalty;Patrick Hannigan & Paul Hannigan & Peggy

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1909 Civil Money Penalty;Mike O'Neil & Robin O'Neil,dba Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1937 Civil Money Penalty;Mims Oil Co Inc,dba Shell Go #514

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

C 1 Pacific Coast Shellfish Growers Vol#: 1

99P-2119 Reclassify Constrained Hip Prosthesis

ACK 1 HFA-305 Vol#: 1

CCP 1 Orthopedic Surgical Manufacturers Assn Vol#: 1

99V-2120 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 C-Systems Vol#: 1