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 Us]

DOCKETS ENTERED on August 31, 2000

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
78P-0148 LASER MEDIA ENTERTAINMENT SYSTEM *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98N-1038 Irradiation in the production, processing, &handling of food *
00D-1267 Recommendations for Donor Questioning Regarding Malaria *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00N-0504 Egg Safety Action Plan *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 59 Steris Corporation Vol#: 60

LET 16 NIPA Hardwicke Inc Vol#: 60

LET 17 Lewis & Harrison/behalf of Lonza Inc Vol#: 60

PR 6 NIPA Hardwicke Inc Vol#: 60

PR 7 TRS/on behalf of Lonza Inc Vol#: 60

PR 8 NIPA Inc Vol#: 82

78P-0148 LASER MEDIA ENTERTAINMENT SYSTEM

AMD 6 Laser Media Inc Vol#: 1

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 15 R Fried Vol#: 4

EMC 16 J Spada Vol#: 4

EMC 17 K Rampspacher Vol#: 4

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 49 Bational Nutritional Foods Assn Vol#: 6

C 50 Council for Responsible Nutrition Vol#: 6

C 51 Food Marketing Institute Vol#: 6

C 52 The Cosmetic, Toiletry & Fragrance Assn Vol#: 6

C 53 National Food Processors Assn Vol#: 6

C 54 Grocery Manufacturers of America Vol#: 6

C 55 Consumer Healthcare Products Association Vol#: 6

EMC 1 Elizabeth Hayden Vol#: 6

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

EMC 223 A Caballero Vol#: 151
 

99P-2630 Establish a Daily Value for "added sugars"

C 134 G Hammerle Vol#: 8

C 135 S Goldberg Vol#: 8

C 136 S. Arkin Vol#: 8

C 137 A Currier Vol#: 8

C 138 F Williams Vol#: 8

C 139 C Cope Vol#: 8

C 140 I Weinberg Vol#: 8

C 141 E Dorfler Vol#: 8

C 142 G Lochhead Vol#: 8

C 143 R Riggles Vol#: 8

C 144 M Dearborn Vol#: 8

C 145 S Noel Vol#: 8

C 146 R Thompson Vol#: 8

C 147 J Friedman Vol#: 8

C 148 M Brown Vol#: 8

C 149 L Munger Vol#: 8

C 150 D Dickson Vol#: 8

C 151 no signature Vol#: 8

C 152 G Rohall Vol#: 8

C 153 V Hay Vol#: 8

C 154 C Else Vol#: 8

C 155 F Daly Vol#: 8

C 156 L Cser & Family Vol#: 8

C 157 Sayre Vol#: 8

C 158 C Ott Vol#: 8

C 159 A Conroy Vol#: 8

C 160 M Fein Vol#: 8

C 161 K Clegg Vol#: 8

C 162 D Bohart Vol#: 8

C 163 E Rogers Vol#: 8

C 164 M Crawford Vol#: 8

EMC 37 D Costanza Vol#: 8

EMC 38 J Skog Vol#: 8

EMC 39 G Sumi Vol#: 8

EMC 40 B Wall Vol#: 8

EMC 41 A Burdette Vol#: 8

EMC 42 R MacDonald Vol#: 8

EMC 43 R Jenkins Vol#: 8

EMC 44 J Fitko Vol#: 8

EMC 45 B Wall Vol#: 8

EMC 46 B Miner Vol#: 8

EMC 47 G Isaac Vol#: 8

EMC 48 J McLellan Vol#: 8

EMC 49 J Ross Vol#: 8

EMC 50 R Childree Vol#: 8

EMC 51 M Babcock Vol#: 8

EMC 52 L Smith Vol#: 8

EMC 53 G Reynolds Vol#: 8

EMC 54 J Tully Vol#: 8

EMC 55 E Hardy Vol#: 8

EMC 56 P Laibstain Vol#: 8

EMC 57 J Wood Vol#: 8

EMC 58 N Sybert Vol#: 8

EMC 59 M Dagar Vol#: 8

EMC 60 J Eagles Vol#: 8

EMC 61 E Rudolph Vol#: 8

EMC 62 D LaMelle Vol#: 8

EMC 63 J McLeer Vol#: 8

EMC 64 A Hallyburton Vol#: 8

EMC 65 F Lewis Vol#: 8

EMC 66 D Meggs Vol#: 8

EMC 67 J Rosenbalm Vol#: 8

EMC 68 R Brown Vol#: 8

EMC 69 E Nelson Vol#: 8

EMC 70 DeMill Vol#: 8

EMC 71 L Usack Vol#: 8

EMC 72 B Lyons Vol#: 8

EMC 73 L Hutchinson Vol#: 8

EMC 74 B. Hansen & Family Vol#: 8

EMC 75 H Heyman Vol#: 8

EMC 76 Georusselldc Vol#: 8

EMC 77 M Elliott Vol#: 8

EMC 78 J McNeeley Vol#: 8

EMC 79 B Stewart Vol#: 8

EMC 80 I Cohen Vol#: 8

EMC 81 J Bogle Vol#: 8

EMC 82 L Alan Vol#: 8

EMC 83 T Athan Vol#: 8

EMC 84 M Levee Vol#: 8

EMC 85 D Searcy Vol#: 8

EMC 86 S Peterfreund Vol#: 8

EMC 87 G Myers Vol#: 8

EMC 88 B Drumm Vol#: 8

EMC 89 E Holden Vol#: 8

EMC 90 O Steffey Vol#: 8

EMC 91 P Clayton Vol#: 8

EMC 92 S Morrell Vol#: 8

EMC 93 R Kahl Vol#: 8

EMC 94 S Planer Vol#: 8

EMC 95 K King Vol#: 8

EMC 96 B Wall Vol#: 8

EMC 97 P Bodjanac Vol#: 8

EMC 98 W Smith Vol#: 8

EMC 99 M Hanson Vol#: 8

EMC 100 D Chud Vol#: 8

EMC 101 D Campbell Vol#: 8

EMC 102 R Wise Vol#: 8

EMC 103 R Lott Vol#: 8

EMC 104 M Lynch Vol#: 8

EMC 105 L Anderson Vol#: 8

EMC 106 J Stauffer Vol#: 8

EMC 107 V Stillman Vol#: 8

EMC 108 L Jacobson Vol#: 8

EMC 109 W Mielke Vol#: 8

EMC 110 B Wilson Vol#: 8

EMC 111 R Van Essendelft Vol#: 8

EMC 112 J Rapczynski Vol#: 8

EMC 113 D Berne Vol#: 8

EMC 114 D Luck Vol#: 8

EMC 115 J Gerber Vol#: 8

EMC 116 L Figg Vol#: 8

EMC 117 A Herrick Vol#: 8

EMC 118 B Schwab Vol#: 8

EMC 119 J Sams Vol#: 8

EMC 120 C Eads Vol#: 8

EMC 121 G Newmark Vol#: 8

EMC 122 H Bartling Vol#: 8

EMC 123 F Bredell Vol#: 8

EMC 124 B Saxon Vol#: 8

EMC 125 J Barro Vol#: 8

EMC 126 J Amos Vol#: 8

EMC 127 J Udovch Vol#: 8

EMC 128 M Herlik Vol#: 8

EMC 129 D Knott Vol#: 8

EMC 130 M Crum Vol#: 8

EMC 131 E Wright Vol#: 8

EMC 132 M Gallatin Vol#: 8

EMC 133 H Brown Vol#: 8

EMC 134 D Matlock Vol#: 8

00D-1267 Recommendations for Donor Questioning Regarding Malaria

C 1 San Diego Blood Bank Vol#: 1

00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

C 3 3M Health Care Vol#: 1

C 4 Purdue Frederick Company Vol#: 1

C 5 Advanced Tissue Sciences Vol#: 1

C 6 Johnson & Johnson Medical/Ethicon Inc Vol#: 1

C 7 Smith & Nephew, Inc Wound Mngmt Div Vol#: 1

C 8 American Burn Association Vol#: 1

C 9 Cook Group Inc Vol#: 1

C 10 F.R.A.I.L.Board Members Vol#: 1

C 11 Novartis Pharmaceuticals Corp Vol#: 1

00D-1335 Allergic Rhinitis: Clinical Development Programs for Drug

C 1 Bristol-Myers Squibb Vol#: 1

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

EXT 1 R W Johnson Pharmaceutical Research Inst Vol#: 1
 

00M-1475 P990072; Horizon 55 EW & Horizon 55 EW Westint

AAV 1 Westcon Contact Lens Co., Inc. Vol#: 1

00N-0504 Egg Safety Action Plan

C 34 B Leonard Vol#: 8

C 35 J Cammer Vol#: 8

C 36 S Lustig Vol#: 8

C 37 Food Safety Consultant Services Vol#: 8

EMC 277 C Colavito Vol#: 8

EMC 278 G Benyk Vol#: 8

EMC 279 M Mackenzie Vol#: 8

EMC 280 Mieisch Vol#: 8

EMC 281 M Madden Vol#: 8

EMC 282 Dr. Kemmerer Vol#: 8

EMC 283 T Owre Vol#: 8

EMC 284 J Harrington Vol#: 8

EMC 285 A Jelen Vol#: 8

EMC 286 M Bonk Vol#: 8
 

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

NM 1 Meeting on 8/8/00 Vol#: 60

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 23 Institute of Food Technologists Vol#: 6

C 24 International Fresh-Cut Produce Assoc. Vol#: 6

C 25 D Caron Vol#: 6

C 26 Oldways Preservation & Exchange Trust Vol#: 6

C 27 Emerald Valley Kitchen Vol#: 6

C 28 G Schmitz Vol#: 6

C 29 A Blake Vol#: 6

C 30 M Rentas Vol#: 6

C 31 Kraft Foods Vol#: 6

EMC 40 B Molinare Vol#: 6

EMC 41 M Rentas Vol#: 6

EMC 42 B Behr Vol#: 6

EMC 43 B Golden Vol#: 6

EMC 44 R Lee Vol#: 6

EMC 45 P Porter Vol#: 6

EMC 46 N Miller Vol#: 6

EMC 47 S Hanrahan Vol#: 6

EMC 48 A Storbeck Vol#: 6

EMC 49 K Harris Vol#: 6

EMC 50 S. Grimson Vol#: 6

EMC 51 L Girand Vol#: 6

EMC 52 K Monsen Vol#: 6

EMC 53 D Denison Vol#: 6

EMC 54 D Zagory Vol#: 6

EMC 55 S Rekdal Vol#: 6

EMC 56 D Akel Vol#: 6

EMC 57 R Newsome Vol#: 6

EMC 58 T Moseley Vol#: 6

EMC 59 J de Smet Vol#: 6

EMC 60 E Gerson Vol#: 6

EMC 61 Ja West Vol#: 6

EMC 62 J Albrecht Vol#: 6

EMC 63 S Berlin Vol#: 6

EMC 64 B Bird Vol#: 6

EMC 65 A Rick Vol#: 6

EMC 66 K Franzen Vol#: 6
 
00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 12 Emory Healthcare Vol#: 1
 
00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EAPE57 Natl. Organization for Rare Disorders Vol#: 1

EAPE58 Pharmacia Vol#: 1

EAPE59 RxHealthValue Vol#: 1

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 12 Leadership in Clinical Systems Mgmt(CLIA Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 5348 R Miller Vol#: 200

C 5349 L Sander Vol#: 200

C 5350 A Samuelsen Vol#: 200

C 5351 T Ona Vol#: 200

C 5352 S Donahue Vol#: 200

C 5353 R Linehan Vol#: 200

C 5354 E Babich Vol#: 200

C 5355 L Mari Vol#: 200

C 5356 M Khalsa Vol#: 200

C 5357 G Bernardi Vol#: 200

C 5358 J Kappel Vol#: 200

C 5359 B Voegtlen Vol#: 200

C 5360 T Pozzi Vol#: 200

C 5361 B Zanet Vol#: 200

C 5362 D Royal Vol#: 200

C 5363 R Papy Vol#: 200

C 5364 J Martin Vol#: 200

C 5365 S Hopkins Vol#: 200

C 5366 Margaret Vol#: 200

C 5367 M Marshall Vol#: 200

C 5368 L Rollins Vol#: 200

C 5369 L Tuggle Vol#: 200

C 5370 N Kirkendall Vol#: 200

C 5371 B Emery Vol#: 200

C 5372 D Glenn Vol#: 200

C 5373 J Gosman Vol#: 200

C 5374 P Geroux Vol#: 200

C 5375 R Ketcham Vol#: 200

C 5376 G Tuerails Vol#: 200

C 5377 M Kidd Vol#: 200

C 5378 S Sokol Vol#: 200

C 5379 E Ross Vol#: 200

C 5380 S Marsh Vol#: 200

C 5381 J Drucker Vol#: 200

C 5382 I Martin Vol#: 200

C 5383 T Kelly Vol#: 200

C 5384 D Macpherson Vol#: 200

C 5385 B. Scudder Vol#: 200

C 5386 J Sanford Vol#: 200

C 5387 C Gleason Vol#: 200

C 5388 C Haas Vol#: 200

C 5389 P McRee Vol#: 200

C 5390 J Stover Vol#: 200

C 5391 E Geselle Vol#: 200

C 5392 S Pruitt Vol#: 200

C 5393 K Lang Vol#: 200

C 5394 I Marshall Vol#: 200

C 5395 Z Stafford Vol#: 200

C 5396 A Cavalier Vol#: 200

C 5397 R Garmenini Vol#: 200

C 5398 K Franzen Vol#: 200

C 5399 C Patnaude Vol#: 200

C 5400 B Young Vol#: 200

C 5401 F Schiavina Vol#: 200

C 5402 C Morton Vol#: 200

C 5403 S Pratek Vol#: 200

C 5404 G Parrish Vol#: 200

C 5405 M Deuel Vol#: 200

C 5406 P Larken Vol#: 200

C 5407 J Harrie Vol#: 200

C 5408 M Ritter Vol#: 200

C 5409 A Guerrie Vol#: 200

C 5410 C Gleason Vol#: 200

C 5411 M. Snyder Vol#: 200

C 5412 M O'Conner Vol#: 200

C 5413 J Romanski Vol#: 200

C 5414 M Kolasa Vol#: 200

C 5415 R Kolasa Vol#: 200

C 5416 W McClintock Vol#: 200

C 5417 D Abbott Vol#: 200

C 5418 S Goodale Vol#: 200

C 5419 C Donaldsen Vol#: 200

C 5420 Form Letter Count (1702) Vol#: 235

C 5421 Form Letter Count (40) Vol#: 236

C 5422 Form Letter Count (21) Vol#: 237