Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail]

DOCKETS ENTERED on September 2, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE] [FDA HOME PAGE]
 
86V-0194 Rainbow Hene Serial #3050*
96P-0215 Withdrawal Norplant's approval for sale in the United States *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
98P-1147 Prohibit use of xenotransplantation*
99D-0236 Skin Irriation/Sensitization testing of generic transdermal *
99D-2145 VICH GL11 on Impurities in New Veterinary Medicinal Products *
99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat *
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
86V-0194 Rainbow Hene Serial #3050

EXP 5 Lasertainment Productions International Vol#: 1

94F-0283 Safe Use Of Menadione Nicotinamide Bisulfite

NFR 2 Vol#: 1

95F-0130 Safe Use of Polyethylene Terephthalate Polymers

EA 2 Shell Chemical Company Vol#: 2

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 209 Melissa Bryce Vol#: 5

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLCATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 131 Tammy Wolfanger Vol#: 6

C 132 Sylvia L. & Raymond W. Brown Vol#: 6

C 133 Eugenia Torricelli Vol#: 6

C 134 Carolyn Repeta Vol#: 6

C 135 Bruno Repeta Vol#: 6

C 136 Timothy P. McMahon Vol#: 6

C 137 Donna J. Stevens Vol#: 6

C 138 B.B. Burroughs Vol#: 6

C 139 Nancy Keeler Vol#: 6

C 140 Jean Lauren Vol#: 6

C 141 Darren Wolfanger Vol#: 6

C 142 Anna L. Moretto Vol#: 6

C 143 Bernard Caley Vol#: 6

C 144 Susan Repeta Vol#: 6

C 145 Kirk Blaisdell Vol#: 6

C 146 Lavinia T. Severeyn Vol#: 6

C 147 Marion Grodin Vol#: 6

97P-0197 Require that warning labels about risks of salmonella enteri

C 132 Tammy Wolfanger Vol#: 5

C 133 Sylvia L. & Raymond W. Brown Vol#: 5

C 134 Eugenia Torricelli Vol#: 5

C 135 Carolyn Repeta Vol#: 5

C 136 Bruno Repeta Vol#: 5

C 137 Timothy P. McMahon Vol#: 5

C 138 Donna J. Stevens Vol#: 5

C 139 B.B. Burroughs Vol#: 5

C 140 Nancy Keeler Vol#: 5

C 141 Jean Lauren Vol#: 5

C 142 Darren Wolfanger Vol#: 5

C 143 Anna L. Moretto Vol#: 5

C 144 Bernard Caley Vol#: 5

C 145 Susan Repeta Vol#: 5

C 146 Kirk Blaisdell Vol#: 5

C 147 Lavinia T. Severeyn Vol#: 5

C 148 Marion Grodin Vol#: 5

98F-0195 Food Additives Permitted in the Feed and Drinking Water of n

NFR 1 Vol#: 1

98N-0495 Prescription Drug User Fee Act,Pdufa II Five-Year Plan

BKG 2 Vol#: 1

NAD 2 Vol#: 1

98N-0617 Treatment of Narcotic Dependence

C 8 New Directions Treatment Services Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 131 Tammy Wolfanger Vol#: 9

C 132 Sylvia L. & Raymond W. Brown Vol#: 9

C 133 Eugenia Torricelli Vol#: 9

C 134 Carolyn Repeta Vol#: 9

C 135 Bruno Repeta Vol#: 9

C 136 Timothy P. McMahon Vol#: 9

C 137 Donna J. Stevens Vol#: 9

C 138 B.B. Burroughs Vol#: 9

C 139 Nancy Keeler Vol#: 9

C 140 Jean Lauren Vol#: 9

C 141 Darren Wolfanger Vol#: 9

C 142 Anna L. Moretto Vol#: 9

C 143 Bernard Caley Vol#: 9

C 144 Susan Repeta Vol#: 9

C 145 Kirk Blaisdell Vol#: 9

C 146 Lavinia T. Severeyn Vol#: 9

C 147 Marion Grodin Vol#: 9

98P-1147 Prohibit use of xenotransplantation

LET 2 International Ctr for Technology Assessm Vol#: 2

99D-0236 Skin Irriation/Sensitization testing of generic transdermal

C 8 National Association of Pharm Manuf Vol#: 1

99D-2145 VICH GL11 on Impurities in New Veterinary Medicinal Products

THIS LINKED COMMENT DUPLCATES THOSE FOR 99d-2215 AND 99D-2249, ALSO BELOW

C 1 Animal Health Institute Vol#: 1

99D-2215 Impurities in New Veterinary Drug Substances

C 1 Animal Health Institute Vol#: 1

99D-2249 Technical Requirements for VICH

C 1 Animal Health Institute Vol#: 1

99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99D-2777 Possible Dioxin/PCB Contamination in Drugs/Biological Produc

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-2514 Civil Money Penalty;Steven Johnson,dba Papa Joe's

ANS 1 Steven Johnson Vol#: 1

99H-2689 Civil Money Penalty;Breezy Hill Enterprises Inc,dba Breezy

ANS 1 Buzzy Hill Enterprises Vol#: 1

99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat

C 2 Tim Krauskopf, R. A. C Vol#: 1

C 3 Baxter Healthcare Corporation Vol#: 1

C 4 Nat Organization for Rare Disorders, Inc Vol#: 1

C 5 Medtronic, Inc. Vol#: 1

C 6 Cook Group Inc Vol#: 1

C 7 Health Industry Manufacturers Assn Vol#: 1

C 8 Aids Project Los Angeles Vol#: 1

C 9 Medical Device Manufacturers Assn Vol#: 1

C 10 Abbott Laboratories Vol#: 1

C 11 The Innovation Factory Vol#: 1

99N-2100 Computer-controlled potentially high risk medical devices

N 2 Vol#: 1

S 1 Vol#: 1

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

RC 2 Purdue Pharma L. P. ("Purdue") Vol#: 1