Food and Drug Administration

DOCKETS ENTERED on July 2, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
84N-0102 Orphan Product Designations *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1265 Distribution of Compounded Drug Products *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99P-1271 Stay of Action Regarding Approval of Cisplatin Injection *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2147 Ban the use of silicone gel-filled breast implants *
99P-2148 Label or Labeling of food ingredients and regulation *
99P-2149 ANDA butalbital, acetaminophen & caffeine 50mg/500mg/20mg *
99P-2150 ANDA butalbital, acetaminophen & caffeine 50mg/750mg/40mg *
84N-0102 Orphan Product Designations

LST 86 June 1999 Vol#: 2

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

C 5635 Arthur Kamentz Vol#: 133

97D-0268 Container Closure Systems Used for Packaging of Human Drugs

GDL 1 HFD-180 HFM-676 Vol#: 1

97D-0444 Duration of Chronic Toxicity Testing in Animals.

NAD 2 Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 133 Karen B McHugh Vol#: 19

98N-0482 Adverse Experience Reporting for Licensed Biological Product

N 3 Vol#: 1

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

C 3083 Susan M. Hall Vol#: 85

C 3084 Mitch & Cathie Lamm Vol#: 85

C 3085 University of California, Berkeley Vol#: 85

C 3086 Mary E. Lothrop Vol#: 85

C 3087 Janice R. Scofield Vol#: 85

C 3088 Korey Hartwich Vol#: 85

C 3089 Charles Higley Vol#: 85

C 3090 Lilly Cooper Vol#: 85

C 3091 Margaret Verner Vol#: 85

C 3092 Joel Gallob Vol#: 85

C 3093 Donna McKenzie Vol#: 85

C 3094 Ms. Laura Lichtenstein Vol#: 85

C 3095 Kristin Knight & family Vol#: 85

C 3096 W. S. McKane Vol#: 85

C 3097 Ralph Anderson Vol#: 85

C 3098 Bill Stuber Vol#: 85

C 3099 Marvin I. Lewis Vol#: 85

98N-1265 Distribution of Compounded Drug Products

C 3327 Marguarite Richman Vol#: 122

C 3328 Marie J Peterson Vol#: 122

C 3329 Joan M Schultz Vol#: 122

C 3330 Katherine J Roth Vol#: 122

C 3331 Harriette Hopkins Vol#: 122

C 3332 Leslie Volker Vol#: 122

C 3333 Pamela Neary Vol#: 122

C 3334 Marguerite C Luthe Vol#: 122

C 3335 Nancy Currier Vol#: 122

C 3336 Judy Drouin Vol#: 122

C 3337 Laura Thompson Quinn Vol#: 122

98P-0203 Eliminate Forced Molting of Laying Birds

C 1686 Mary Radspinner Vol#: 43

C 1687 Betta Igel Vol#: 43

C 1688 Susan E Colvin Vol#: 43

C 1689 Michael Haines Vol#: 43

C 1690 Penny Hinkle Vol#: 43

C 1691 Corey Williams Vol#: 43

C 1692 Shirley Farabaugh Vol#: 43

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 162 Carol Zimmerman Vol#: 3

C 163 Douglas Rendall Vol#: 3

C 164 Deana Dennard Vol#: 3

C 165 Ms Elizabeth Austin Vol#: 3

C 166 Dr Robert Smith Vol#: 3

LET 4 HFV-1 to Joseph Mendelson III Vol#: 3

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 130 Russ Welti Vol#: 7

C 131 Kevin Bycroft Vol#: 7

C 132 Donna L Oliver Vol#: 7

C 133 William & Myriam Parham Vol#: 7

C 134 P Strand Vol#: 7

C 135 Cathy Kunkel Vol#: 7

C 136 Sarah Shaw Vol#: 7

C 137 Linda Genteel & Jan Knepper Vol#: 7

C 138 Cory Blaisdell Vol#: 7

C 139 Gail V Boterus Vol#: 7

99F-1912 ultraviolet light reduction of pathogens/microoganisms juice

NFL 1 California Day-Fresh Foods, Inc. Vol#: 1

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

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1928 Civil Money Penalty;Keith Raney,dba Busy Corner Truck Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1929 Civil Money Penalty;Ruth Taylor,dba R & W Variety

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1930 Civil Money Penalty;Tops Market Inc,dba Tops Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1931 Civil Money Penalty;Walgreen Co,dba Walgreens #2896

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1932 Civil Money Penalty;Walgreen Co,dba Walgreens Drug Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

NPH 2 HHS/FDA/CDER Vol#: 1

99H-1933 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #365

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1934 Civil Money Penalty;Waring Oil Co,dba Interstate Station

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1940 Civil Money Penalty;Amoco Oil co,dba Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1941 Civil Money Penalty;Astro Liquors Inc,dba Astro Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1942 Civil Money Penalty;Crosson OIl Co Inc,dba Crosson Oil Co

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1943 Civil Money Penalty;Del's Liquors Inc,dba Del's Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1944 Civil Money Penalty;Fast Lane Inc,dba Fast Lane Stores

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1945 Civil Money Penalty;Michael Gaughan & Jerry Herbst,dba Gold

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1946 Civil Money Penalty;Gornick's Inc,dba Jubilee Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1947 Civil Money Penalty;Value Mart Inc,dba Value Mart Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1948 Civil Money Penalty;Vicki Holloway,dba Heiskell Market & Del

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1949 Civil Money Penalty;Humboldt Foods Inc,dba Piggly Wiggly #44

LET 1 Office of Tobacco Programs Vol#: 1

99H-1950 Civil Money Penalty;Kari Inc,dba Duck In

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1951 Civil Money Penalty;Kiel Bros Oil Co Inc,dba BP

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1952 Civil Money Penalty;Mini Mart Inc,dba Loaf 'N Jug Inc,#39

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1953 Civil Money Penalty;Service Gas Co Inc,dba Sentry Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2041 Civil Money Penalty;Leotti Enterprises Co,dba Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0240 Extralabel Drug Use in Animals;Agency Information Collection

N 2 HFA-250 Vol#: 1

99N-1979 Apple Cider Food Safety Control

NM 1 Vol#: 1

99P-1271 Stay of Action Regarding Approval of Cisplatin Injection

LET 1 Olssol, Frank & Weeda, P.C. Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 154 Janice M Anderson DC Vol#: 4

99P-2147 Ban the use of silicone gel-filled breast implants

C 1 Form Letter Count 20 Vol#: 2

C 2 Mary Sapounakis Vol#: 3

C 3 Cali A Deming Vol#: 3

C 4 Nancy Korb Vol#: 3

99P-2148 Label or Labeling of food ingredients and regulation

ACK 1 HFA-305 Vol#: 1

99P-2149 ANDA butalbital, acetaminophen & caffeine 50mg/500mg/20mg

ACK 1 HFA-305 Vol#: 1

CP 1 Mikart, Inc. Vol#: 1

99P-2150 ANDA butalbital, acetaminophen & caffeine 50mg/750mg/40mg

ACK 1 HFA-305 Vol#: 1

CP 1 Mikart, Inc. Vol#: 1