Food and Drug Administration

DOCKETS ENTERED on June 30, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
93N-0044 Intent to Amend Performance Standard; Laser Products *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-0923 ANADA Suitability Petition for Miconazole Nitrate Cream 2% *
99P-1340 Declared Eternity eau de Parfum Misbranded *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties

ANS 3 HF-40 to Denise Frizzell Vol#: 101

C 5580 Constance F Griffith Vol#: 101

C 5581 Herbert C Mendel Vol#: 101

C 5582 Dr & Mrs Stuart L Cohn Vol#: 101

C 5583 Neil Davis & Family Vol#: 101

C 5584 J Michael Oxley Vol#: 101

C 5585 L Morgan Holbrook Vol#: 101

C 5586 Dorothy Geisler Vol#: 101

C 5587 William Ahlers Vol#: 101

C 5588 Cynthia Fischers Vol#: 101

C 5589 Alan & Jan Marie Rushforth Vol#: 101

C 5590 Mrs Lillian Vingoe Vol#: 101

C 5591 Ms Wendy K Beikin Vol#: 101

C 5592 Larry Horvath Vol#: 101

C 5593 Gail Runk Vol#: 101

C 5594 Dr & Mrs Peter Rynders Vol#: 101

C 5595 Kathleen Whitefield Vol#: 101

C 5596 Sharon Vadas Vol#: 101

C 5597 Dan & Debbie Bergmann Vol#: 101

C 5598 Dristina Pico Vol#: 101

C 5599 Mary Vrabec Vol#: 101

C 5600 Sody Marashisa Vol#: 101

C 5601 Brian Maniere Vol#: 101

C 5602 Sabine Toussaint Vol#: 101

C 5603 Kristina M Pico Vol#: 101

C 5604 Mark Dolce Vol#: 101

C 5605 Kelly Reed Vol#: 101

C 5606 Anne L Lazarurs Vol#: 101

C 5607 Theodora W Grab Vol#: 133

C 5608 Gary Harrold Vol#: 133

C 5609 Leslie & Merrill Glustrom Vol#: 133

C 5610 Jeanette B Noline Vol#: 133

C 5611 Ms Valerie Salice Vol#: 133

C 5612 Ken Schmidt Vol#: 133

C 5613 James Barker Vol#: 133

C 5614 Joseph D'Angelo Vol#: 133

C 5615 Monica Forgnoni Vol#: 133

C 5616 John C Harrington Vol#: 133

C 5617 Dennis Plank Vol#: 133

C 5618 Janice R Dowling Vol#: 133

C 5619 Sarah Jane Fuller et al Vol#: 133

C 5620 Anne S Watson Vol#: 133

C 5621 Joy Cruise Vol#: 133

C 5622 James A Hall III Vol#: 133

C 5623 Devon E Jercinovic Vol#: 133

C 5624 Michael C Lesser Vol#: 133

C 5625 Genoa Bliven & 40 signatures Vol#: 133

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

EXT 1 Picker International, Inc Vol#: 2

98H-0949 Civil Money Penalties;Mims Oil Co Inc,d/b/a Shellgo 502

ANS 1 Mims Enterprises Vol#: 1

98H-1013 Civil Money Penalties;Mims Convenience Stores Inc,d/b/a Juni

ANS 1 Mims Enterprises Vol#: 1

98H-1045 Civil Money Penalties;Talat M Khan,d/b/a Lil Short Stop #4

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1049 Civil Money Penalties;Cosmo Mignosa, d/b/a Fruit Basket

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1072 Civil Money Penalties; Rite Aid Corp,d/b/a Rite Aid #7211

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1079 Civil Money Penalties; CVS Corp,d/b/a CVS Pharmacy

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-1082 Civil Money Penalties;Ocean Springs Biloxi Koa Inc,d/b/a Oce

SET 1 GCF-1 Vol#: 1

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

C 3049 J Michael Oxley Vol#: 85

C 3050 Kathleen Whitefield Vol#: 85

C 3051 Machiko Yasukohchi (Japan) Vol#: 85

C 3052 Beth Ellen DiLuglio, MS, RD, CNSD, LD/N Vol#: 85

C 3053 Nelson Maxwell Vol#: 85

C 3054 Gustav A. Pohlig Vol#: 85

C 3055 James Barker Vol#: 85

C 3056 Kay M. Yeuell Vol#: 85

C 3057 Michael C Lesser Vol#: 85

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 157 Theodora W Grab Vol#: 3

C 158 Michael C Lesser Vol#: 3

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

GDL 1 HFD-357 Vol#: 1

NAD 1 Vol#: 1

99H-0046 Civil Money Penalties;Mims Convenience Stores,d/b/a Shell

ANS 1 Mims Enterprises Vol#: 1

99H-0620 Civil Money Penalties;Sos Truck Stop Inc,d/b/a Sos Food Stop

ANS 1 SOS Truck Stop Inc Vol#: 1

99H-0957 Civil Money Penalties;Brian Hammons & Gary Hammons,d/b/a Gai

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1007 Civil Money Penalties;Store Express Inc,d/b/a Store Express

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1082 Civil Money Penalties;Stringers Inc,d/b/a Exxon at the Glen

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1110 Civil Money Penalties;James McInnis,d/b/a The Village Market

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1395 Civil Money Penalty;Crestwood Amoco Inc d/b/a South County A

ANS 1 Crestwood Amoco Inc Vol#: 1

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

EXT 1 Donald German, dba The alibi Vol#: 1

99H-1515 Civil Money Penalties;Phung Truong,d/b/a Bellrock Market

ANS 1 Bellrock Market Vol#: 1

99H-1584 Civil Money Penalty; Little Five Points Pharmacy Inc dba Lit

ANS 1 Little Five Points Pharmacy Inc Vol#: 1

99H-1603 Civil Money Penalty; Jere Co dba Village Texaco

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

99H-1677 Civil Money Penalty;Waverly Square Service Inc,dba Waverley

ANS 1 Waverley Square Service Inc Vol#: 1

99H-1954 Civil Money Penalty;Kenneth Trebelhorn,dba Amoco North on 37

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1955 Civil Money Penalty;Camellia Food Stores Inc,dba Be-Lo #121

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1956 Civil Money Penalty;A & H Services Inc,dba Belmont Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1957 Civil Money Penalty;Tip Top Convenience Stores Inc,dba Big K

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1958 Civil Money Penalty;Cape Cod Gas Co Inc,dba Cape Cod Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1959 Civil Money Penalty;Casey's Marketing Co,dba Casey's General

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1960 Civil Money Penalty;Na Tran,dba Dan's Convenient Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1961 Civil Money Penalty;Kenneth Estes,dba Estes General Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1962 Civil Money Penalty;Fast Lane Inc,dba Fast Lane

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1963 Civil Money Penalty;Naegler Brothers Inc,dba Fast-N-Friendly

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1964 Civil Money Penalty;FS Energy Fuel 24,LLC,dba FS Fast Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1965 Civil Money Penalty;Food Lion Inc,dba Food Lion #406

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1966 Civil Money Penalty;Fred's Inc,dba Fred's Super Dollar Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1967 Civil Money Penalty;Grafton Liquors Inc,dba Grafton Discount

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1968 Civil Money Penalty;J & B Handy Mart Inc,dba Handy Mart #3

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1969 Civil Money Penalty;Patty Bess,dba Highland Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1970 Civil Money Penalty;Kmart Corp,dba Kmart #3726

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1971 Civil Money Penalty;Stefal Inc,dba Main Street Mobil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1972 Civil Money Penalty;The Old #3 Restaurant Inc,dba Old #3

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1973 Civil Money Penalty;Charles Russell Baughman,dba R & J Count

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1975 Civil Money Penalty;Bridget Whisman,dba Rogers General Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1976 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven #19676

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1977 Civil Money Penalty;Don Colcord,dba The Apothecary Shoppe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1978 Civil Money Penalty;Tim Gardner,dba The Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

NPR 1 Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

EC 23 Carol Clarke Vol#: 3

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1090 Brian Maniere Vol#: 16

99P-0923 ANADA Suitability Petition for Miconazole Nitrate Cream 2%

PAV 1 HFV-100 to Pharmaderm, Veterinary Div. Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 130 John Cailleau Vol#: 3

C 131 Robin Sweeney Vol#: 3

C 132 Harold Glickman Vol#: 3

C 133 Renee' Amico - Taback Vol#: 3

C 134 Rowena Caldwell       Vol#: 3

C 135 Joanna Jones Vol#: 3

C 136 Ruth C Shannon Vol#: 3

C 137 Ruth C Shannon Vol#: 3

C 138 Harvard Medical School Vol#: 3

C 139 Karen Harkins-Cowgill Vol#: 3

C 140 Rae L. Chappell Vol#: 3

C 141 Donna Hoaglin Vol#: 3

C 142 Patricia M. Williams Vol#: 3

C 143 Lori Claude Vol#: 3

C 144 Kelly Seibert, RN Vol#: 3

C 145 Barbara Wilkie Vol#: 3

C 146 Patricia Rentz Vol#: 3

C 147 Doris & Emanuel Wachsler Vol#: 3

C 148 Gisela Morgenstern Vol#: 3

C 149 M J Penner Vol#: 3

C 150 Catherine Warneski Vol#: 3