DOCKETS ENTERED on 04/16/99

FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 16, 1999

Updated as of 1:55 pm, April 22, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

78N-0038 Sunscreen Drug Products
90P-0201 Optimum size & Style of print to be used to label OTC Drugs
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
95N-0259 Over the Counter Drug Labeling; Public Hearing
96E-0270 Etopophos, Patent Extension Application No. 4,904,768
96E-0314 GEMZAR, Patent Extension request #4,808,614
96N-0420 OTC Human Drugs; Proposed Labeling Requirements
97E-0152 Dostinex; Patent Extension Application No. 4,526,892
97E-0168 Coagulation Factor;Patent Extension App No. 5,171,569
97E-0271 Taisho Pharmaceutical Co. Ltd /PANDEL Cream # 4,290,962
97E-0290 Aqueous Aryl Fluorophosphite Suspension, No. 4,912,155
97E-0292 Aqueous Aryl Fluorophosphite Suspension, No. 4,867,907
97E-0338 Patent Extension, Anipryl (Selegiline Hydrochloride)
97E-0357 Patent Extension; Fareston (toremifene citrate)
97E-0461 Patent Extension; Cook Incorporated Cook Grii Coronary Stent
97E-0462 Patent Extension; Hoffman-LaRoche Inc. Posicor
97E-0464 Patent Extension; Boehringer Ingelheim Intl GmbH / Mirapex
98D-0362 Stability Testing of Drug Substances and Drug Products
98D-1267 Impurities in Drug Substances
98N-0044 Effect of dietary supplement on structure/function of body
98N-0337 Over the counter human drugs labeling requirements
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
98P-0509 Refrain from Destroying Dietary Supp. Co Publications
99N-0235 Premarket Notification for Food Contact Substances
99V-1009 Variance for Band W Teks BWD-800 Laser Diode and Driver

77N-0085 Saccharin and Its Salts

CA 27137 G Bryans Vol#: 426

CA 27138 D E Polk Vol#: 426

CA 27139 L Andrews Vol#:

CA 27140 C Bauer Vol#: 426

CA 27141 R Farrington, D.D.S. Vol#: 426

CA 27142 W E Goble Vol#: 426

CA 27143 M Liston Vol#: 426

CA 27144 J B McCloskey Vol#: 426

CA 27145 H Eitner Vol#: 426

CA 27146 J R Speer Vol#: 426

CA 27147 P McKeeny Vol#: 426

CA 27148 A T Kolman Vol#: 426

CA 27149 J D Szczotkowski Vol#: 426

CA 27150 J W Woodson Vol#: 426

CA 27151 G Lucchesi Vol#: 426

CA 27152 S O'Kennedy Vol#: 426

CA 27153 C Beneventi Vol#: 426

CA 27154 A Fehring Vol#: 426

CA 27155 K White Vol#: 426

CA 27156 C T Newton Vol#: 426

CA 27157 J VanOmen Vol#: 426

CA 27158 D P Eubanks Vol#: 426

CA 27159 J Abe Vol#: 426

CA 27160 V W Hunter Vol#: 426

CA 27161 K Nimblett Vol#: 426

CA 27162 A V Myers Vol#: 426

CA 27163 I N & R H Chiecerel Vol#: 426

CA 27164 W J Pare Vol#: 426

CA 27165 G H Hunt Vol#: 426

CA 27166 D Bryson et al Vol#: 426

CA 27167 J D Freederson Vol#: 426

CA 27168 S D Klein Vol#: 426

CA 27169 E Payne Vol#: 426

CA 27170 L Engquist Vol#: 426

CA 27171 R S Hodgekinsen Vol#: 426

CA 27172 G C Moist Vol#: 426

CA 27174 F D Gardner Vol#: 426

CA 27175 L Morris Vol#: 426

CA 27176 K McGovern Vol#: 426

CA 27177 J Cederholm Vol#: 426

CA 27178 S J Clayton Vol#: 426

CA 27179 G M & M J Colvin Vol#: 426

CA 27180 E W & N M Brogren Vol#: 426

CA 27181 P L Taylor Vol#: 426

CA 27182 C L Bard Vol#: 426

CA 27183 V T Wynn Vol#: 426

78N-0038 Sunscreen Drug Products

ACK 3 HFA-305 Vol#: 111

CP 11 CTFA Vol#: 111

SUP 23 Morgan, Lewis & Bockius LLP Vol#: 122
(Attachments are available for review in the Dockets Management Branch

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

ACK 1 HFA-305 Vol#: 3

CP 2 CTFA Vol#: 3

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

C 5002 Jane Monow Vol#: 78

C 5003 Paula J. Stober Vol#: 78

C 5004 Margaret Perina Vol#: 78

C 5005 Warren & Olive Wilson Vol#: 78

C 5006 Michael A. Banak Vol#: 78

C 5007 Alexandra Stochwell Vol#: 78

C 5008 Jenny Lind Vol#: 78

C 5009 Dorothy A. Boime Vol#: 78

C 5010 Concepts in Nutrition Vol#: 78

C 5011 EcoLaw Institute, Inc. Vol#: 78

95N-0259 Over the Counter Drug Labeling; Public Hearing

ACK 1 HFA-305 Vol#: 11

CP 1 CTFA Vol#: 11

96E-0270 Etopophos, Patent Extension Application No. 4,904,768

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

96E-0314 GEMZAR, Patent Extension request #4,808,614

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

ACK 1 HFA-305 Vol#: 23

CP 1 CTFA Vol#: 23

97E-0152 Dostinex; Patent Extension Application No. 4,526,892

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0168 Coagulation Factor;Patent Extension App No. 5,171,569

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0271 Taisho Pharmaceutical Co. Ltd /PANDEL Cream # 4,290,962

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0290 Aqueous Aryl Fluorophosphite Suspension, No. 4,912,155

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0292 Aqueous Aryl Fluorophosphite Suspension, No. 4,867,907

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0338 Patent Extension, Anipryl (Selegiline Hydrochloride)

LET 4 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0357 Patent Extension; Fareston (toremifene citrate)

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0461 Patent Extension; Cook Incorporated Cook Grii Coronary Stent

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0462 Patent Extension; Hoffman-LaRoche Inc. Posicor

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

97E-0464 Patent Extension; Boehringer Ingelheim Intl GmbH / Mirapex

LET 3 HFY-20 to U.S. Patent & Trademark Office Vol#: 1

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

SUP 1 Agenda & slides for mtg March 31, 1999 Vol#: 7

TR 1 Public Meeting March 31, 1999 Vol#: 6

98D-1267 Impurities in Drug Substances

C 2 Bristol-Myers Squibb Vol#: 1

98H-1261 Civil Money Penalties;Timothy Terrell,d/b/a Twin Roads Foodm

MO 1 GCF-1 Vol#: 1

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

C 22302 Judy Dean Vol#: 771

C 22303 Melvin J. Hesse Vol#: 771

98N-0337 Over the counter human drugs labeling requirements

ACK 1 HFA-305 Vol#: 1

CP 1 CTFA Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 1121 Janiene C. Y. Platzek Vol#: 58

C 1122 Elody Rostzen Vol#: 58

C 1123 Frank E. Lewis Vol#: 58

C 1124 Sharon Stephens Vol#: 58

C 1125 Anita S. Manderville Vol#: 58

C 1126 Domingo Rodriguez Vol#: 58

C 1127 Jody L. Diorid Vol#: 69

C 1128 Gail Ambroz Vol#: 69

C 1129 Luella Fick Vol#: 69

C 1130 Karen Beehler Vol#: 69

C 1131 Marcia J. Kusse Vol#: 69

C 1132 Rosalie Barr Vol#: 69

C 1133 Deborah A. Taylor Vol#: 69

C 1134 Margo Jarrett Vol#: 69

C 1135 Saudi H. Bolding Vol#: 69

C 1136 Marsha Kidd Vol#: 69

C 1137 Elke Zuercher-White, Ph.D Vol#: 69

C 1138 Marilyn Segal Vol#: 69

C 1139 Esther Mae Ezan Vol#: 69

C 1140 Margaret K. Lincoln Vol#: 69

C 1141 Marigold Hill Vol#: 69

C 1142 S. Lee Mayfield Vol#: 69

C 1143 Karen Podvin Vol#: 69

C 1144 Joyce Moncella Kaye Vol#: 69

C 1145 Theresa E. Houston Vol#: 69

C 1146 Kathy Babincki Vol#: 69

C 1147 Nancy T. Jackson Vol#: 69

C 1148 Virginia Dullum Vol#: 69

C 1149 Jean M. Weeber Vol#: 69

C 1150 Lynn Elliott-Neaty Vol#: 69

C 1151 Gloria Bernardi Vol#: 69

C 1152 Clily Quist Vol#: 69

C 1153 Sheilah Moser Vol#: 69

C 1154 Dixie J. Mills Vol#: 69

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

C 2082 Barbara J. Bogner Vol#: 52

C 2083 Dee Hulsker Vol#: 52

98P-0203 Eliminate Forced Molting of Laying Birds

C 954 Mark S Kennedy Vol#: 24

C 955 Marjori E Thompson Vol#: 24

C 956 Iain Mc Garvie-Munn Vol#: 24

C 957 Patrice Harrington & other supporters Vol#: 24

C 958 Sarah Byrd Vol#: 24

C 959 Bill & Carleen Boehl Vol#: 24

C 960 E Mettler Vol#: 24

C 961 Jane Katz Vol#: 24

C 962 Amy Dykstra Vol#: 24

C 963 Mrs Alina Pizzitola Vol#: 24

C 964 Danna Nabors Vol#: 24

C 965 Kathie E Chipouvas Vol#: 24

C 966 Kevin M Crupi Vol#: 24

C 967 Chris & Susan Zimny Vol#: 24

C 968 Jessie Jordan Vol#: 24

C 969 Vicki Mayville Vol#: 24

C 970 Lori Dority Vol#: 24

C 971 Elizabeth Stawyczny Vol#: 24

C 972 Connie Kruichak Vol#: 24

C 973 Beverly Phillips Vol#: 24

C 974 Ernest Redeman Jr Vol#: 24

C 975 Linda Fager Vol#: 24

C 976 Lara Strazdin Vol#: 24

C 977 Barbara L Erdley Vol#: 24

C 978 Tina & Jordan Vol#: 24

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 30 Form letters 15 Vol#: 6

C 31 Form Letter 10 Vol#: 7

98P-0509 Refrain from Destroying Dietary Supp. Co Publications

M 1 HFC-1 Vol#: 5

PAV 1 HFC-1 to Emord & Associates Vol#: 5

99H-0115 Civil Money Penalties; Dwight Crawley Akins,d/b/a Sandtown

LET 2 Office of Tobacco Programs Vol#: 1

99H-0277 Civil Money Penalties; A-B Petroleum Inc,d/b/a Conoco

LET 2 Office of Tobacco Programs Vol#: 1

99H-0617 Civil Money Penalty; Saver Systems Inc d/b/a Save-a-Lot

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0897 Civil Money Penalty;Benny Shotts & Kathy Shotts d/b/a Shotts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0235 Premarket Notification for Food Contact Substances

C 5 Georgia-Pacific Corp. Vol#: 1

99N-0391 International Guidelines on Vitamin and Mineral supplements

BKG 1 Vol#: 1

N 1 Vol#: 1

99V-1009 Variance for Band W Teks BWD-800 Laser Diode and Driver

ACK 1 HFA-305 Vol#: 1

VAR 1 Phantom Productions Vol#: 1