Food and Drug AdministrationDockets 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 September 1, 2000

TABLE OF CONTENTS

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95P-0110 Request to amend regulation of the FDA *
98N-0046 Comprehensive List of Current Guidance Documents at FDA *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-1149 In Vivo Pharmacokinetics & Bioavail Levothyroxine Sodium Tab *
99D-2636 Guidance for Industry on Levothyroxine Sodium *
00N-0504 Egg Safety Action Plan *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1491 Amend Definition & Standard of Identy for Parmesan Cheese *
00P-1496 Gulucophage (Metformin HCI) Tablets, 625 mg and 750mg, *
00V-1490 Laser Light Show*
00V-1492 *

95P-0110 Request to amend regulation of the FDA

C 55 Buc & Beardsley Vol#: 4

98N-0046 Comprehensive List of Current Guidance Documents at FDA

C 2 Buc & Beardsley Vol#: 1

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

C 56 The United States Tuna Foundation Vol#: 6

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

C 2321 T Keene Vol#: 67

C 2322 C Lampman Vol#: 67

99D-1149 In Vivo Pharmacokinetics & Bioavail Levothyroxine Sodium Tab

C 4 Buc & Beardsley Vol#: 1

99D-2636 Guidance for Industry on Levothyroxine Sodium

C 6 Buc & Beardsley Vol#: 2
 

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 14790 Form letter count 56 Vol#: 449

C 14791 D Henderson Vol#: 447

C 14792 C Michel Vol#: 447

C 14793 S Unclebach Vol#: 447

C 14794 S Underwood Vol#: 447

C 14795 P Hughes Vol#: 447

C 14796 W Roberson Vol#: 447

C 14797 B Peavy Vol#: 447

C 14798 R Poe Vol#: 447

C 14799 J Acten Vol#: 447

C 14800 D Isaacson Vol#: 447

C 14801 H Clarkson Vol#: 447

C 14802 E Costin Vol#: 447

C 14803 G Knitter Vol#: 447

C 14804 P Connery Vol#: 447

C 14805 A Deviney Vol#: 447

C 14806 K Walters Vol#: 447

C 14807 E Naff Vol#: 447

C 14808 B Ballard Vol#: 447

C 14809 F Atkinson Vol#: 447

C 14810 K Askren Vol#: 447

C 14811 C Wack Vol#: 447

C 14812 C Horn Vol#: 447

C 14813 D Highman Vol#: 447

C 14814 S King Vol#: 447

C 14815 no signature Vol#: 447

C 14816 G Kuhns Vol#: 447

C 14817 E Marsh Vol#: 447

C 14818 S Schartzer Vol#: 447

C 14819 D Marion Vol#: 447

C 14820 L Magnuson Vol#: 447

C 14821 B Jacobs Vol#: 447

C 14822 J Bailey Vol#: 447

C 14823 D Dixon Vol#: 447

C 14824 J Tietjen Vol#: 447

C 14825 P Simpson Vol#: 447

C 14826 M Trachtenberg Vol#: 447

C 14827 E O'Brien Vol#: 447

C 14828 E Jacobs Vol#: 447

C 14829 H Speno Vol#: 447

C 14830 J Whalen Vol#: 447

C 14831 Sierra Club Vol#: 447

C 14832 T Ramsdell Vol#: 447

EMC 3063 K Winkelman Vol#: 447

EMC 3064 L Hymas Vol#: 447

EMC 3065 C Erb Vol#: 447

EMC 3066 L Mariorenzi Vol#: 447

EMC 3067 S Berkson Vol#: 447

EMC 3068 L Trost Vol#: 447

EMC 3069 H Charap Vol#: 447

EMC 3070 C Palmer Vol#: 447

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

C 165 M Ackley Vol#: 9

C 166 R Pettit Vol#: 9

C 167 S Lemberg Vol#: 9

C 168 A Hill Vol#: 9

C 169 G. Edzant Vol#: 9

C 170 C Latham Vol#: 9

C 171 M Kennedy Vol#: 9

C 172 H Flaccus Vol#: 9

C 173 R Stonecipher Vol#: 9

C 174 B. Sobey Vol#: 9

C 175 G Henderson Vol#: 9

C 176 G. Reidy Vol#: 9

C 177 M Paul Vol#: 9

C 178 M. Moll Vol#: 9

C 179 A. Dube Vol#: 9

C 180 E Stodolak Vol#: 9

C 181 P. Ferris Vol#: 9

C 182 H Duckett Vol#: 9

C 183 W. Stephens Vol#: 9

C 184 H Saunders Vol#: 9

C 185 S Bartle Vol#: 9

C 186 S. Alyea Vol#: 9

C 187 E. Coleman Vol#: 9

C 188 L Tylar Vol#: 9

C 189 E Force Vol#: 9

C 190 J. Mulgrew Vol#: 9

C 191 M Tohiver Vol#: 9

C 192 K Hickey Vol#: 9

C 193 M Musser Vol#: 9

C 194 L Valerio Vol#: 9

C 195 M Caskey Vol#: 9

C 196 American Public Health Association Vol#: 9

C 197 E Oxenberg Vol#: 9

C 198 E Cococcia Vol#: 9

C 199 M Wentworth Vol#: 9

C 200 B Glasgow Vol#: 9

C 201 M. Corioni Vol#: 9

C 202 N. Rush Vol#: 9

C 203 B Bruce Vol#: 9

C 204 C. Conklin Vol#: 9

C 205 F Relkin Vol#: 9

C 206 D Vinson Vol#: 9

C 207 D Marvin Vol#: 9

C 208 R Ross Vol#: 9

C 209 T Ray Vol#: 9

C 210 J LeBeau Vol#: 9

C 211 C Carter Vol#: 9

C 212 E Wilson Vol#: 9
 

00D-1424 Analytical procedures and methods validation; drug substance

GDL 1 Guideline Vol#: 1

NAD 1 HFD-210 & HFM-40 Vol#: 1

00N-0504 Egg Safety Action Plan

C 38 State of California Dept. of Food & Agr. Vol#: 8

C 39 Animal Welfare Institute Vol#: 8

C 40 B Basch Vol#: 8

C 41 PETA Vol#: 8

C 42 B. Frazer Vol#: 8

C 43 J Arcarese Vol#: 8

C 44 A Dolejs Vol#: 8

C 45 R Rechert Vol#: 8

C 46 WAGDOG, Williamsburg & Greenpoint Dog Ow Vol#: 8

C 47 C Repeta Vol#: 8

C 48 National Egg Regulatory Officals Vol#: 8

C 49 L Koester Vol#: 8

C 50 L Frisch Vol#: 8

C 51 no signature Vol#: 8

C 52 J Cammer Vol#: 8

C 53 P Fulda Vol#: 8

C 54 FARM, Farm Animal Reform Movement Vol#: 8

C 55 J Wells Vol#: 8

C 56 C Meier Vol#: 8

C 57 Georgia Poultry Laboratory Vol#: 8

C 58 S Brumbelow Vol#: 8

C 59 R Burrows Vol#: 8

C 60 D Damelio Vol#: 8

C 61 E Gordon Vol#: 8

C 62 L Devine Vol#: 8

C 63 E Ehrhardt Vol#: 8

C 64 A Wiley Vol#: 8

C 65 A Knight Vol#: 8

C 66 E Massoth Vol#: 8

C 67 R Gartner Vol#: 8

C 68 T Mohr Vol#: 8

C 69 G Cronick Vol#: 8

EMC 287 C Morris Vol#: 8

EMC 288 K Pow-Rich Vol#: 8

EMC 289 K Schroeder Vol#: 8
 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 607 National Assoc of Chain Drug Stores Vol#: 23

CH 608 M NARAL Vol#: 23

CH 609 N Gumm Vol#: 23

CH 610 C Schneider Vol#: 23

CH 611 M Belair Vol#: 23

CH 612 T Golomb Vol#: 23

CH 613 T. Monihan Vol#: 23

CH 614 R Johnson Vol#: 23

CH 615 The National Council on the Aging Vol#: 23

CH 616 P Hall Vol#: 23

CH 617 M Aveni Vol#: 23

EC 521 T Sonnier Vol#: 14

SUP 11 National Comsumers League Vol#: 23

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

CR 1 Consumer Federation of American Vol#: 6
 

00N-1409 Revision of the Identification of the Ionotophoresis

NPR 1 Vol#: 1

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

C 5423 M Conna Vol#: 233

C 5424 H Kennedy Vol#: 233

C 5425 R Ziel Vol#: 233

C 5426 K Larsen Vol#: 233

C 5427 F Ruzek Vol#: 233

C 5428 M Galt Vol#: 233

C 5429 M Pronio Vol#: 233

C 5430 D Goshell Vol#: 233

C 5431 L Hardesty Vol#: 233

C 5432 L Will Vol#: 233

C 5433 L Hash Vol#: 233

C 5434 M Schwartz Vol#: 233

C 5435 J Embry Vol#: 233

C 5436 L Masino Vol#: 233

C 5437 J Wolfe Vol#: 233

C 5438 J Van Dyne Vol#: 233

C 5439 D. Long Vol#: 233

C 5440 L Garvey Vol#: 233

C 5441 S Xuereb Vol#: 233

C 5442 J Ryan Vol#: 233

C 5443 K Rohla Vol#: 233

C 5444 S Pease Vol#: 233

C 5445 E Calhoun Vol#: 233

EMC 1980 L Longstreet Vol#: 233

EMC 1981 S Sikes Vol#: 233

EMC 1982 J Nimmo Vol#: 233

EMC 1983 S Williamson Vol#: 233

EMC 1984 K McCallum Vol#: 233

EMC 1985 M Cozens Vol#: 233

EMC 1986 J Corbitt Vol#: 233

EMC 1987 J Cleer Vol#: 233

EMC 1988 K Sanderbeck Vol#: 233

EMC 1989 G Anderson Vol#: 233

EMC 1990 T Rogers Vol#: 233

EMC 1991 R Scovil Vol#: 233

EMC 1992 L Wakerman Vol#: 233

EMC 1993 D Mantell Vol#: 233

EMC 1994 D Baumann Vol#: 233

EMC 1995 J Hodges Vol#: 233

EMC 1996 E Aquil Vol#: 233

EMC 1997 R Muccianti Vol#: 233

EMC 1998 R Jenkins Vol#: 233

EMC 1999 S Stout Vol#: 233

EMC 2000 D Blockston Vol#: 233

EMC 2001 W Talaro Vol#: 233

EMC 2002 J Kelly Vol#: 233

EMC 2003 B Abernathy Vol#: 233

EMC 2004 J Alvarado Vol#: 233

EMC 2005 E Meidenbauer Vol#: 233

EMC 2006 E Barr Vol#: 233

EMC 2007 J Worthy Vol#: 233

EMC 2008 M Costello Vol#: 233

EMC 2009 L Lessa Vol#: 233

EMC 2010 D Perkins Vol#: 233

EMC 2011 T Tarrivonna Vol#: 233

EMC 2012 S Mazur Vol#: 233

EMC 2013 P Menke Vol#: 233

EMC 2014 D Peters Vol#: 233

EMC 2015 L Bonanova Vol#: 233

EMC 2016 M Altman Vol#: 233

EMC 2017 F O'Brien Vol#: 233

EMC 2018 M Toenniessen Vol#: 233

EMC 2019 M Giese Vol#: 233

EMC 2020 K Donnelly Vol#: 233

EMC 2021 K Stranc Vol#: 233

EMC 2022 L Hymas Vol#: 233

EMC 2023 K Winkleman Vol#: 233

EMC 2024 A Trattner Vol#: 233

EMC 2025 N Deckha Vol#: 233

EMC 2026 H Price Vol#: 233

EMC 2027 D Vorolieff Vol#: 233

EMC 2028 S Danbom Vol#: 233

EMC 2029 J Sherman Vol#: 233

EMC 2030 R Young Vol#: 233

EMC 2031 D Darling Vol#: 233

EMC 2032 M Newcombe Vol#: 233

EMC 2033 J Dearner Vol#: 233

EMC 2034 S DeFazio Vol#: 233

EMC 2035 H Plowe Vol#: 233

EMC 2036 N Tucker Vol#: 233

EMC 2037 K Telfer Vol#: 233

EMC 2038 R Dunkel Vol#: 233

EMC 2039 D Pilgrim Vol#: 233

EMC 2040 T Flores Vol#: 233

EMC 2041 N Langer Vol#: 233

EMC 2042 E Hartley Vol#: 233

EMC 2043 M Calabrese Vol#: 233

EMC 2044 L Heming Vol#: 233

EMC 2045 B Cutsforth Vol#: 233

EMC 2046 L Hymas Vol#: 233

EMC 2047 C Leslie Vol#: 233

EMC 2048 C Johnson Vol#: 233

EMC 2049 C Pierson Vol#: 233

EMC 2050 A Green Vol#: 233

EMC 2051 A Markowitz Vol#: 233

00P-1491 Amend Definition & Standard of Identy for Parmesan Cheese

ACK 1 HFA-305 Vol#: 1

CP 1 Kraft Foods, Inc. Vol#: 1

00P-1496 Gulucophage (Metformin HCI) Tablets, 625 mg and 750mg,

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services,Inc. Vol#: 1

00V-1490 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 The Mens Club of Dallas Vol#: 1

00V-1492

ACK 1 HFA-305 Vol#: 1

VAR 1 Red Line Inc. Vol#: 1