Food and Drug Administration

DOCKETS ENTERED on July 7, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
76N-052N OTC Nasal Decongestants *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
93N-0044 Intent to Amend Performance Standard; Laser Products *
96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio *
97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0203 Eliminate Forced Molting of Laying Birds *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99M-2144 PMA, AutoCyte Prep System, P970018 *
99M-2168 PMA Biex, Inc., Salest *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
76N-052N OTC Nasal Decongestants

ACK 1 HFA-305 Vol#: 1

PSA 1 Leiner Health Products Vol#: 73

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

C 5636 Chad Dickerson Vol#: 133

C 5637 Julie Pearson Vol#: 133

C 5638 Lisa Hotchkiss Vol#: 133

C 5639 K Bandell Vol#: 133

C 5640 Mrs Patricia Cacioppo Vol#: 133

C 5641 Lynn Perpall Vol#: 133

C 5642 Kelly MacMichael Vol#: 133

C 5643 Stephanie Pezolan Vol#: 133

C 5644 Tommy Billman Vol#: 133

C 5645 Patricia Johnston Vol#: 133

C 5646 Giovanni Angello Vol#: 133

C 5647 Debra Schanilec Vol#: 133

C 5648 Kelley MacKinnon Vol#: 133

C 5649 Dr Timothy Riordan Vol#: 133

C 5650 Marilyn Lawrimore Vol#: 133

C 5651 Jessica Joseph Vol#: 133

C 5652 Henrik Langsdorf Vol#: 133

C 5653 David R Sokol Vol#: 133

C 5654 Lance & Linda Larkin Vol#: 133

C 5655 Florence Howling Vol#: 133

C 5656 Steve Henwood Vol#: 133

C 5657 Connie Blechle Vol#: 133

C 5658 Barbara Delgado Vol#: 133

C 5659 Debbie Dunbar Ortman Vol#: 133

93N-0044 Intent to Amend Performance Standard; Laser Products

C 33 Information Technology Industry Council Vol#: 2

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

C 164 Animal Protection Institute Vol#: 3

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

C 1 University of California, Los Angeles Vol#: 1

98C-0431 Synthetic Iron Oxide

NFL 2 EM Industries, Inc., Vol#: 1

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

C 3128 Susan V. Hubbard Vol#: 93

C 3129 Christine Ghezzo Vol#: 93

C 3130 Martie Whittekin Vol#: 93

C 3131 Frances Fuchs Vol#: 93

C 3132 Bryan M. Kopp & Kim M. Olson-Kopp Vol#: 93

C 3133 D. Lewit Vol#: 93

C 3134 Brian McNaughton Vol#: 93

C 3135 James Boschert Vol#: 93

C 3136 Gerald M. Bill Vol#: 93

C 3137 LeeAnne Tryon Vol#: 93

C 3138 Ned Ford Vol#: 93

C 3139 Joan O. King Vol#: 93

C 3140 Naomi Rachel Vol#: 93

C 3141 Russell P. Roe Vol#: 93

C 3142 Connie Pitts Vol#: 93

C 3143 Mrs. Julie Summey Vol#: 93

C 3144 Larry Kronen Vol#: 93

C 3145 American Botanical Council Vol#: 93

C 3146 Nancy Rader Vol#: 93

C 3147 Rand D. Vol#: 93

C 3148 Mk Campbell Vol#: 93

C 3149 Aquene Freechild Vol#: 93

C 3150 Construction Specifications Institute Vol#: 93

C 3151 Environmental Media Services Vol#: 93

C 3152 Ecological Villager's Alliance Vol#: 93

C 3153 Chris Malley Vol#: 93

C 3154 Balachander Krishnamurthy Vol#: 93

C 3155 Karen Egan Vol#: 93

C 3156 Jessica Prentice Vol#: 93

C 3157 Tara Treasurefield Vol#: 93

C 3158 Mark Ehrhardt Vol#: 93

C 3159 Ann Krohn Rick Vol#: 93

C 3160 Rick Wright Vol#: 93

C 3161 Chris Runyan Vol#: 93

C 3162 Scott Harris Vol#: 93

C 3163 Elizabeth Underwood Fahey Vol#: 93

C 3164 Lori Russo Vol#: 93

C 3165 Lori Russo Vol#: 93

C 3166 Sustainability Assocs. Vol#: 93

98N-1265 Distribution of Compounded Drug Products

C 3340 Sharlene Soulas Vol#: 122

C 3341 Joyce T Keenan Dwoush Vol#: 122

C 3342 Grace M Robinson Vol#: 122

C 3343 Peter J Winders Vol#: 122

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

C 2225 Carin Crews-Webb Vol#: 64

98P-0203 Eliminate Forced Molting of Laying Birds

C 1693 Deborah Sorensen Vol#: 43

C 1694 Yael Trock Esq Vol#: 43

C 1695 Marcia Bramson Guttler Vol#: 43

C 1696 Jennifer Arter Vol#: 43

C 1697 Marian Carter Vol#: 43

C 1698 Judy Sugg Vol#: 43

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 140 Ellen Rusten Vol#: 7

C 141 Nuria Querol Vinas Vol#: 7

C 142 Sandra Rosario Vol#: 7

C 143 Monica Engelretson Vol#: 7

C 144 Tovis Page Vol#: 7

C 145 Heather Parker Vol#: 7

C 146 Rochelle Goldman Vol#: 7

C 147 Mark Berman Vol#: 7

C 148 Doris Lin Vol#: 7

C 149 BWHBC Vol#: 7

C 150 Campaign for Responsible Transplantation Vol#: 7

C 151 Dr Jeffrey Elterman & A J Elterman Vol#: 7

C 152 Pet Birth Control Clinics Vol#: 7

C 153 Erika Montemayor Vol#: 7

C 154 M McCauley (6) signatures Vol#: 7

C 155 Karl J Novak Vol#: 7

C 156 Janet Hanan Vol#: 7

C 157 Evelyn Phillips Gutchell Vol#: 7

C 158 Animal Protection Institute Vol#: 7

C 159 James Pittard Vol#: 7

C 160 Mary J Mitchell Vol#: 7

C 161 Michelle Polefrone Vol#: 7

C 162 Susan M Gajewski Vol#: 7

C 163 Heather Miller Vol#: 7

C 164 Suzanne R Pattee JD Vol#: 7

C 165 P Grame Vol#: 7

99D-1878 Good Manufacturing Practice for Blood and Blood Components:

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99F-1910 The safe use 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2

NFL 1 Cytec Industries, Inc. Vol#: 1

99H-1377 Civil Money Penalty;David Umoh,dba Shop Fast

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1537 Civil Money Penalties;Lerbergs Inc,d/b/a Lerbergs Food & Clo

ANS 1 Lerbergs' Inc Vol#: 1

99H-1983 Civil Money Penalty;Kmart Corp,dba Kmart Store #7328

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1984 Civil Money Penalty;Waddill's Markets Inc,dba Express Lane 5

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1985 Civil Money Penalty;Express Lane Inc,dba Express Lane #56

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1986 Civil Money Penalty;Tripo Inc,dba Fast Break Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1987 Civil Money Penalty;Bruce Henderson Petroleum Co Inc,dba Fin

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1988 Civil Money Penalty;Winn-Dixie Stores Inc,dba Winn-Disie #22

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1989 Civil Money Penalty;Ingles Markets Inc,dba Ingles #443

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1990 Civil Money Penalty;Publix Super Markets Inc,dba Publix Supe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1991 Civil Money Penalty;Fred's Stores of Tennessee Inc,dba Freds

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1992 Civil Money Penalty;The Kroger Co,dba Kroger Store #386

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1993 Civil Money Penalty;H H White Oil Co,dba Amoco East

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1994 Civil Money Penalty;Town & Country Grocers of Fredericktown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1995 Civil Money Penalty;Bruno's Inc,dba Food Max

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1996 Civil Money Penalty;Crown Central Petroleum Corp,dba Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1997 Civil Money Penalty;Ken-Mart Inc,dba Ken-Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1998 Civil Money Penalty;Curt Wakefield,dba K C Outpost

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1999 Civil Money Penalty;Hope Seymour,dba Seymour's Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2000 Civil Money Penalty;James E Kendrick & Howard Guthrie,dba Fl

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2001 Civil Money Penalty;Bessie Owens Bell,dba Miss Bessie's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2002 Civil Money Penalty;Richard Corbin,dba JMS Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2003 Civil Money Penalty;Claude Embrey,dba Embrey's BP

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2004 Civil Money Penalty;Debbie Phillips,dba Dixie Package Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2005 Civil Money Penalty;Bobby Sheppard,dba Country Convenience

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2006 Civil Money Penalty;Mike Faulkner,dba Faulkner Grocery #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2007 Civil Money Penalty;Randy Crawford,dba Crawford's Amoco Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2008 Civil Money Penalty;Jim Morgan,dba Jiffy Jim's 1-Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2009 Civil Money Penalty;Sandy Melton,dba Sandy Girl's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2010 Civil Money Penalty;Richard Elfering,dba Sportsman's Bar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2011 Civil Money Penalty;Michael Pfeffer,dba Pfeffer's Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2012 Civil Money Penalty;Scott Wiehoff,dba Scooter's Tavern

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99M-2144 PMA, AutoCyte Prep System, P970018

AAV 1 AutoCyte Inc Vol#: 1

99M-2168 PMA Biex, Inc., Salest

AAV 1 Biex Inc Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1091 Charlene Aldrich Vol#: 16