Food and Drug Administration

DOCKETS ENTERED on June 22, 1999

Table of Contents

(Hyper links are at the end of the Docket  title - click on * )
78N-0038 Sunscreen Drug Products *
90S-0308 Generic Drug Speeches & Policy and Procedure Guides *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
93N-0044 Intent to Amend Performance Standard; Laser Products *
98D-1266 Therapeutic Equivalence Code on Prescription Drug Labels *
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding; *
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-0911 ANDA Suitability for a Sublingual Tablet,Methylprednisolone *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99N-0035 Medical Devices; Reclassification of 38 Preamendments *
99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes *
99N-1174 Development of Strategy for Dietary Supplements *
99P-1271 Stay of Action Regarding Approval of Cisplatin Injection *

77N-0240 Single-Entity Coronary Vasodilators

LET 30 Eon Labs Manufacuring Inc Vol#: 32

78N-0038 Sunscreen Drug Products

CP 12 Rapid Precision Testing Laboratories Vol#: 130

90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 641 HFD-7 Vol#: 43

M 642 HFD-7 Vol#: 43

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

C 5562 R M Dexter Vol#: 101

C 5563 Mr & Mrs R M Zarnowitz Vol#: 101

C 5564 Tony Messent Vol#: 101

C 5565 Julie D Andrews Vol#: 101

C 5566 Rita Buthe Vol#: 101

C 5567 Diane Ciambrone Vol#: 101

C 5568 Eli A Scherr Vol#: 101

C 5569 Ruth Roberts Vol#: 101

C 5570 Virginia M B Luongo Vol#: 101

C 5571 Virginia Petersen Vol#: 101

C 5572 Dorothy Baker Vol#: 101

C 5573 Dolores Tippett Vol#: 101

C 5574 Mrs B Barras James Vol#: 101

C 5575 Andrew Bisset Vol#: 101

C 5576 Jean Marie Derderian Vol#: 101

C 5577 Tanya Bond Vol#: 101

C 5578 Stephanie & Travis Vol#: 101

C 5579 Denise Frizzell Vol#: 101

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

C 24 Welch Allyn, Inc. Vol#: 2

98D-1266 Therapeutic Equivalence Code on Prescription Drug Labels

C 21 American Pharmaceutical Association Vol#: 1

C 22 McKenna & Cuneo, L.L.P Vol#: 1

C 23 Pharmaceutical Res & Manuf of America Vol#: 1

C 24 National Coordinating Council for Medica Vol#: 1

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

C 131 The Healthy People / Healthy Planet Proj Vol#: 19

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

C 2964 Michael Chapin Vol#: 80

C 2965 Mrs. Hia Chapin Vol#: 80

C 2966 Bobbie D. Flowers Vol#: 80

C 2967 Marvin I. Lewis Vol#: 80

C 2968 John A. Stewart Vol#: 80

C 2969 Curtis Clark Vol#: 80

C 2970 Anne Totten Vol#: 80

C 2971 Carola Conle Vol#: 80

C 2972 Joanna Cezniak Vol#: 80

C 2973 Rebecca Hartman Vol#: 80

C 2974 Carolyn Doswell Vol#: 80

C 2975 Michael Fiorentino Vol#: 80

C 2976 Bill Hezel Vol#: 80

C 2977 Robin L. Stone Vol#: 80

C 2978 Kelley Wiley Vol#: 80

C 2979 Nancy Freeland Vol#: 80

C 2980 Richard Haynes Vol#: 80

C 2981 George Wiel Vol#: 80

98N-1265 Distribution of Compounded Drug Products

C 3282 Susan Michetti Vol#: 115

C 3283 Judith Birenbaun Vol#: 115

C 3284 Gertrude Rosensweig Vol#: 115

C 3285 Mandy Cohen Vol#: 115

C 3286 Elaine Masso Vol#: 115

C 3287 Lovell Ravita Vol#: 115

C 3288 Jill Kathryn Bunting Vol#: 115

C 3289 Ross F. Wandschneider Vol#: 115

C 3290 Kathleen Menter Vol#: 115

98P-0203 Eliminate Forced Molting of Laying Birds

C 1641 Henry Peck Vol#: 41

C 1642 Cynthia McNulty Vol#: 41

C 1643 Laurel Lyall Vol#: 41

C 1644 Karen Seiberlich Vol#: 41

C 1645 Jill Goldstein Vol#: 41

C 1646 Jessie & Garfield Wheeler Vol#: 41

C 1647 Pat Baldivia Vol#: 41

C 1648 Katrina Schlothauer Vol#: 41

C 1649 Carol Gardner Vol#: 41

C 1650 Linda Gagnier Vol#: 41

C 1651 Jessica Fomalont Vol#: 41

C 1652 Heather D Marshall Vol#: 41

C 1653 Steven Levin Vol#: 41

C 1654 Rachel Thompson Vol#: 41

C 1655 Sandra Thompkins Vol#: 41

C 1656 Laura Deitemeyer Vol#: 41

C 1657 Mr Neal Radke Vol#: 41

C 1658 Jeff Fessler Vol#: 41

C 1659 Chris Mandell Vol#: 41

C 1660 Keri Hejl Vol#: 41

98P-0911 ANDA Suitability for a Sublingual Tablet,Methylprednisolone

PDN 1 HFD-600 to Richard Hamer Associates, Inc Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 153 Intl Center for Technology Assessment Vol#: 3

C 154 Patricia A. Longoria Vol#: 3

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 49 Jane Hoffman Vol#: 4

C 50 Barbara Biel Vol#: 4

C 51 Donna Worthington Vol#: 4

C 52 Marilyn Rainville Vol#: 4

C 53 Trish Snouffer Vol#: 4

C 54 Brenda Shanks Vol#: 4

C 55 June Anna-Fey Vol#: 4

C 56 Barbara P Munves Vol#: 4

C 57 Sandy Hrabowy Vol#: 4

C 58 Linda Kifer-Borgen & Family Vol#: 4

C 59 Jennifer N Rangel Vol#: 4

C 60 Barbara J Bogner OD Vol#: 4

C 61 Nancie L Sailor Vol#: 4

C 62 Cam Martinez Vol#: 4

99H-1784 Civil Money Penalty;Amvets Home Inc dba Amvet Post 19

LET 1 Office of Tobacco Programs Vol#: 1

99M-1851 PMA Daig Livewire TC Steerable Electrophysiology Catheter

AAV 1 Daig Corp. Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

C 5 Ramus Medical Technologies Vol#: 1

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

TR 1 transcript of the May 27, 1999 meeting Vol#: 2

TS 1 NACMF Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

AMD 1 Emord & Associates, P.C. Vol#: 1

APE 1 Antonio C. Martinez, II. P.C. Vol#: 1

C 13 American Dietetic Assn Vol#: 1

C 14 Council for Responsible Nutrition Vol#: 1

C 15 Direct Access Alternative Infor Resource Vol#: 1

C 16 Patton Boggs LLP Vol#: 1

C 17 National Food Processors Association Vol#: 1

C 18 Society for Nutrition Education Vol#: 1

C 19 National Organization for Rare Disorders Vol#: 1

C 20 Phil Howry Vol#: 1

C 21 Consumer Healthcare Products Assn Vol#: 1

C 22 U.S. Pharmacopeia Vol#: 1

C 23 Center for Science in the Public Interes Vol#: 1

C 24 American Nutraceutical Assn Vol#: 1

TS 2 AARP Vol#: 1

TS 3 AARP Vol#: 1

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

CR 1 HFA-305 Vol#: 1

PSA 2 Pharmachemie B.V. Vol#: 1