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 May 31, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu *
99F-5321 Food Safety & Inspection service safe use of ionizing radiai *
99F-5322 Ionizing Radiation for the Treatment of Food *
99F-5522 Ionizing radiation /control of Food-borne pathogens safe use *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1681 Potassium Iodide as a Thyroid Blocking Agent *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices *
01D-0044 Clinical Laboratory Improvement Amendments of 1988 *
01D-0058 Structure Function Rule *
01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0209 Prescription Drug Products list amendment&approve new dosage *

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

C 4834 Form letter count 5 Vol#: 153

C 4835 Abbott Vol#: 151


98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C 23 Pfizer Vol#: 3

C 24 American Association of Health Plans Vol#: 3

C 25 The Seniors Coalition (TSC) Vol#: 3

C 26 Washington Legal Foundation Vol#: 3

EMC 61 Markgraf Vol#: 2

EMC 62 Denney Vol#: 2

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

C 1 Public Citizen Vol#: 1


99F-5321 Food Safety & Inspection service safe use of ionizing radiai

C 1 Public Citizen Vol#: 1


99F-5322 Ionizing Radiation for the Treatment of Food

C 1 Public Citizen Vol#: 1


99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

C 1 Public Citizen Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

C 3142 Ramaekers Vol#: 268

C 3143 Long Vol#: 268

C 3144 Love Vol#: 268

C 3145 Fuchs Vol#: 268

C 3146 Kassowitz Vol#: 268

C 3147 du Pont Vol#: 268

C 3148 Meyer Vol#: 268

C 3149 Hartley Vol#: 268

C 3150 Danneker Vol#: 268

C 3151 Fox Vol#: 268

C 3152 Grogan, MA, MSW Vol#: 268

C 3153 Norman Vol#: 268

C 3154 DesMarais Vol#: 268

C 3155 Lyon Vol#: 268

C 3156 O'Reilly Vol#: 268

C 3157 Saad Vol#: 268

C 3158 Willinghby Vol#: 268

C 3159 Furth Vol#: 268

C 3160 Fraser Vol#: 268

C 3161 Smith Vol#: 268

C 3162 Wapner Vol#: 268

C 3163 Ilsley Vol#: 268

C 3164 Gavin Vol#: 268

C 3165 Wistar Vol#: 268

C 3166 Laughlin Vol#: 268

C 3167 Bultemn Vol#: 268

C 3168 Worland Vol#: 268

EMC 4894 Main Vol#: 266

EMC 4895 Paviour Vol#: 266

EMC 4896 Crosby Vol#: 266

EMC 4897 Foster Vol#: 266

EMC 4898 Solte Vol#: 266

EMC 4899 Magee Vol#: 266

EMC 4900 Fraley Vol#: 266

EMC 4901 Meyers Vol#: 269

EMC 4902 Ercegovich Vol#: 269

EMC 4903 Vought Vol#: 269

EMC 4904 Schneider Vol#: 269

EMC 4905 Wieland, BS, MA Vol#: 269

EMC 4906 Franz Vol#: 269

EMC 4907 unsigned Vol#: 269

EMC 4908 Karasek Vol#: 269

EMC 4909 unsigned Vol#: 269

EMC 4910 Kim Vol#: 269

EMC 4911 Waxman/Ste Vol#: 269

EMC 4912 Dillbeck, PhD Vol#: 269

EMC 4913 Malek Vol#: 269

EMC 4914 Unsigned Vol#: 269

EMC 4915 Hall Vol#: 269

EMC 4916 Wood Vol#: 269

EMC 4917 Brooks Vol#: 269

EMC 4918 Cooper Vol#: 269

EMC 4919 Blake Vol#: 269

EMC 4920 Brooks Vol#: 269

EMC 4921 Pritchard Vol#: 269

EMC 4922 Winningham Vol#: 269

EMC 4923 Levi Vol#: 269

EMC 4924 Lasher Vol#: 269

EMC 4925 Fox Vol#: 269

EMC 4926 Sereni Vol#: 269

EMC 4927 Vaughan Vol#: 269

EMC 4928 Martin Vol#: 269

EMC 4929 number not used Vol#: 269

EMC 4930 Allon Vol#: 269

EMC 4931 Stephens Vol#: 269

EMC 4932 Stimson Vol#: 269

EMC 4933 Ward Vol#: 269

EMC 4934 unsigned Vol#: 269

EMC 4935 Johnson Vol#: 269

EMC 4936 Benson-Gauss Vol#: 269

EMC 4937 Allen Vol#: 269

EMC 4938 Wolf Vol#: 269

EMC 4939 Vail Vol#: 269

EMC 4940 Chappell Vol#: 269

EMC 4941 Sutherland Vol#: 269

EMC 4942 Bety Beard Vol#: 269

EMC 4943 Butler Vol#: 269

EMC 4944 Unsigned Vol#: 269

EMC 4945 Unsigned Vol#: 269

EMC 4946 Nemeth Vol#: 269

EMC 4947 Trask Vol#: 269

EMC 4948 True Vol#: 269

EMC 4949 Sawyer Vol#: 269

EMC 4950 Carnes Vol#: 269

EMC 4951 Unsigned Vol#: 269

EMC 4952 Hawk Vol#: 269

EMC 4953 Lynch Vol#: 269

EMC 4954 Notestine Vol#: 269

EMC 4955 Schoof Vol#: 269

EMC 4956 Malone Vol#: 269

EMC 4957 Cannon Vol#: 269

EMC 4958 Breen Vol#: 269

EMC 4959 Unsigned Vol#: 269

EMC 4960 Ciaramitaro Vol#: 269

EMC 4961 Muehlman, PhD Vol#: 269

EMC 4962 Ehlert Vol#: 269

EMC 4963 Kerwin Vol#: 269

EMC 4964 Davis Vol#: 269

EMC 4965 Cussell Vol#: 269

EMC 4966 MacTavish Vol#: 269

EMC 4967 Crary Vol#: 269

EMC 4968 Carlisle & Estes Vol#: 269

EMC 4969 Wood Vol#: 269

EMC 4970 Amellia S Vol#: 269

EMC 4971 Nichols Vol#: 269

EMC 4972 Jaffe Vol#: 269

EMC 4973 Unsigned Vol#: 269

EMC 4974 Sheppard Vol#: 269

EMC 4975 Wiley Vol#: 269

EMC 4976 Rumke Vol#: 269

EMC 4977 Cullman Vol#: 269

EMC 4978 Vaughan Vol#: 269

EMC 4979 Fellmer Vol#: 269

EMC 4980 Boyd Vol#: 269

EMC 4981 Yearwood Vol#: 269

EMC 4982 Merkel Vol#: 269

EMC 4983 Yoo Vol#: 269

EMC 4984 Billings Vol#: 269

EMC 4985 Billings Vol#: 269

EMC 4986 Whiteside Vol#: 269

EMC 4987 Graetz Vol#: 269

EMC 4988 von Miller Vol#: 269

EMC 4989 Hughes, DPM Vol#: 269

EMC 4990 Robinson Vol#: 269

EMC 4991 Stevenson Vol#: 269

EMC 4992 Maria Vol#: 269

EMC 4993 Gebauer Vol#: 269

EMC 4994 Stevenson Vol#: 269

EMC 4995 Vincent Vol#: 269

EMC 4996 Wallace Vol#: 269

EMC 4997 Shore Vol#: 269

EMC 4998 Farver Vol#: 269

EMC 4999 Delaney Vol#: 269

EMC 5000 unsigned Vol#: 269

EMC 5001 Wulf Vol#: 269

EMC 5002 McCollum Vol#: 269

EMC 5003 Johnson Vol#: 269

EMC 5004 Freelander Vol#: 269

EMC 5005 NBS Vol#: 269

EMC 5006 Davis Vol#: 269

EMC 5007 Thorp / Thorp Design Vol#: 269

EMC 5008 Scheu Vol#: 269

EMC 5009 Unsigned Vol#: 269

EMC 5010 Town Vol#: 269

EMC 5011 Cushing Vol#: 269

EMC 5012 unsigned Vol#: 269

EMC 5013 Wing Vol#: 269

EMC 5014 Clark, Jr. Vol#: 269

EMC 5015 Smith Vol#: 269

EMC 5016 Unsigned Vol#: 269

EMC 5017 Boykin Vol#:

EMC 5018 Victor Vol#: 269

EMC 5019 Maxwell Vol#: 269

EMC 5020 Firzli Vol#: 269

EMC 5021 Burmeister Vol#: 269

EMC 5022 McElvy Vol#: 269

EMC 5023 Steifman Vol#: 269

EMC 5024 Hall Vol#: 269

EMC 5025 Pugh, PhD/Arvizu, RN Vol#: 269

EMC 5026 Jones Vol#: 269

EMC 5027 Siemsen Vol#: 269

EMC 5028 Christian Vol#: 269

EMC 5029 Hoopes Vol#: 269

EMC 5030 McMaster Vol#: 269

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

C 12 State of WI Dept of Health & Fam Serv Vol#: 1


00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 1828 Form Letter Count 7941 Vol#: 193

C 1829 Form Letter Count 2672 Vol#: 196

C 1830 Form Letter Count 86 Vol#: 197

C 1831 Form Letter Count 29 Vol#: 198

C 1832 Form Letter Count 352 Vol#: 199

C 1833 Form Letter Count 892 Vol#: 200

EMC 5911 Carmody Vol#: 192

EMC 5912 Miss Vol#: 192

EMC 5913 no signature Vol#: 192

EMC 5914 Smith Vol#: 192

EMC 5915 Tinkler Vol#: 192

EMC 5916 Unterbrink Vol#: 192

EMC 5917 LaRanger Vol#: 192

EMC 5918 Kimball Vol#: 192

EMC 5919 Hoal Vol#: 192

EMC 5920 Aardappel Vol#: 192

EMC 5921 Caito Vol#: 192

EMC 5922 Clark, Ph.D. Vol#: 192

EMC 5923 Smernoff Vol#: 192

EMC 5924 Shrubsole Vol#: 192

EMC 5925 Morpeth Smidt Vol#: 192

EMC 5926 Jamison Vol#: 192

EMC 5927 Steinkraus Vol#: 192

EMC 5928 Poterbin Vol#: 192

EMC 5929 Sadik Vol#: 192

EMC 5930 Deng Vol#: 192

EMC 5931 Miller Vol#: 192

EMC 5932 Everett, Jr. Vol#: 192

EMC 5933 Reynolds Vol#: 192

EMC 5934 Logsdon Vol#: 192

EMC 5935 Dreith Vol#: 192

EMC 5936 Stavans Vol#: 192

EMC 5937 number not used Vol#: 192

EMC 5938 Buchynski Vol#: 192

EMC 5939 Sterling Vol#: 192

EMC 5940 Schwartz Vol#: 192

EMC 5941 Britchey Vol#: 192

EMC 5942 Hawthorne Vol#: 192

EMC 5943 Naples Vol#: 192

EMC 5944 Pellegrino Vol#: 192

EMC 5945 Tucker Vol#: 192

EMC 5946 Sang Vol#: 192

EMC 5947 Flatt Vol#: 192

EMC 5948 Flatt Vol#: 192

EMC 5949 Bisbee Vol#: 192

EMC 5950 Kelso Vol#: 192

EMC 5951 Buck Vol#: 192

EMC 5952 Blood Vol#: 192

EMC 5953 Urban & Spears Vol#: 192

EMC 5954 Lindsay Vol#: 192

EMC 5955 Cuddehe Vol#: 192

EMC 5956 Pierce Vol#: 192

EMC 5957 Palmer Vol#: 192

EMC 5958 Norman Vol#: 192

EMC 5959 Miles Vol#: 192

EMC 5960 Kirschner Vol#: 192

EMC 5961 Fallis Vol#: 192

EMC 5962 Locke Vol#: 192

EMC 5963 Baker Vol#: 192

EMC 5964 Finkelstein Vol#: 192

EMC 5965 Pritt Vol#: 192

EMC 5966 Aird Vol#: 192

EMC 5967 Fields, Ph.D. Vol#: 192

EMC 5968 Reaser Vol#: 192

EMC 5969 Lahr Vol#: 201

EMC 5970 Boyer Vol#: 201

EMC 5971 Nuss Vol#: 201

EMC 5972 Erven Vol#: 201

EMC 5973 Marvin Tolson Vol#: 201

EMC 5974 Cornea Vol#: 201

EMC 5975 Estes Vol#: 201

EMC 5976 Connors Vol#: 201

EMC 5977 Taylor Vol#: 201

EMC 5978 Mathews Vol#: 201

EMC 5979 Dokas Vol#: 201

EMC 5980 Hewitt Vol#: 201

EMC 5981 Jacobson Vol#: 201

EMC 5982 Laurie Vol#: 201

EMC 5983 Hladky Vol#: 201

EMC 5984 Draper Vol#: 201

EMC 5985 DeLanghe Vol#: 201

EMC 5986 DeWit Vol#: 201

EMC 5987 Henning Vol#: 201

EMC 5988 number not used Vol#: 201

EMC 5989 Twintreess Vol#: 201

EMC 5990 Verzeano Vol#: 201

EMC 5991 Trio Vol#: 201

EMC 5992 Dawson Vol#: 201

EMC 5993 Field Vol#: 201

EMC 5994 O'Kiersey Vol#: 201

EMC 5995 Wheeler Vol#: 201

EMC 5996 Baltasi Vol#: 201

EMC 5997 number not used Vol#: 201

EMC 5998 Jarvis Vol#: 201

EMC 5999 Heart Vol#: 201

EMC 6000 Olsen Vol#: 201

EMC 6001 Lareau Vol#: 201

EMC 6002 Wheeler Vol#: 201

EMC 6003 Schneider Vol#: 201

EMC 6004 Johnson Vol#: 201

EMC 6005 Johnson Vol#: 201

EMC 6006 (privacy request) Vol#: 201

EMC 6007 Altmann Vol#: 201

EMC 6008 Brown MD Vol#: 201

EMC 6009 Evans Vol#: 201

EMC 6010 Cannone Vol#: 201

EMC 6011 DeVoe Vol#: 201

EMC 6012 Hoffman Vol#: 201

EMC 6013 Collen Marshall Vol#: 201

EMC 6014 Dick Vol#: 201

EMC 6015 Chae Vol#: 201

EMC 6016 Lord Vol#: 201

EMC 6017 Rachel Vol#: 201

EMC 6018 Schell Vol#: 201

EMC 6019 number not used Vol#: 201

EMC 6020 number not used Vol#: 201

EMC 6021Micheli Vol#: 201

EMC 6022 Lindsay Vol#: 201

EMC 6023 Vesalo Vol#: 201

EMC 6024 D'Agostino Vol#: 201

EMC 6025 Frownfelter Vol#: 201

EMC 6026 Borazack Vol#: 201

EMC 6027 Todd Vol#: 201

EMC 6028 Schaefer Vol#: 201

EMC 6029 Swanson Nemenz Vol#: 201

EMC 6030 Brott Vol#: 201

EMC 6031 no signature Vol#: 201

EMC 6032 Patten Vol#: 201

EMC 6033 Delaney Vol#: 201

EMC 6034 Collins Vol#: 201

EMC 6035 Law Vol#: 201

EMC 6036 Mozingo Vol#: 201

EMC 6037 Vol#: 201

EMC 6038 Rempe Vol#: 201

EMC 6039 Kinney Vol#: 201

EMC 6040 Read &Boyd Vol#: 201

EMC 6041 Manuel Vol#: 201

EMC 6042 Brown Vol#: 201

EMC 6043 Williams Vol#: 201

EMC 6044 Bolton Vol#: 201

EMC 6045 Sanders Vol#: 201

EMC 6046 Eck Vol#: 201

EMC 6047 Irwin Vol#: 201

EMC 6048 Leary Vol#: 201

EMC 6049 Sands, M.D. Vol#: 201

EMC 6050 R. Batten Vol#: 201

EMC 6051 Ford Vol#: 201

EMC 6052 Farm Vol#: 201

EMC 6053 Chernoff & Fernekes Vol#: 201

EMC 6054 Joie Vol#: 201

EMC 6055 Asakawa Vol#: 201

EMC 6056 Morrow Vol#: 201

EMC 6057 Scianna Vol#: 201

EMC 6058 Nelson Vol#: 201

EMC 6059 Van Cleave Vol#: 201

EMC 6060 Sardinha Vol#: 201

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 182 Cox Associates Vol#: 26

C 183 Wolf Vol#: 26

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

C 110325 Susan P Levine Vol#: 758

C 110326 Kathy Mandelas Vol#: 758

C 110327 Greg King Vol#: 758

C 110328 Constance G Weeks Vol#: 758

C 110329 Walter Grant Vol#: 758

C 110330 Robert LeBourdais Vol#: 758

C 110331 Josette M Badeaux Vol#: 758

C 110332 W J Rueger Vol#: 758

C 110333 Natalie Bleakney Vol#: 758

C 110334 Tamra Stallings Vol#: 758

C 110335 Antony Stefan Vol#: 758

C 110336 Toni Levi Vol#: 758

C 110337 Josef S Klus Vol#: 758

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

C 3 Boston Scientific Corp Vol#: 2


01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 6 Cholestech Corp Vol#: 2

C 7 College of American Pathologists (CAP) Vol#: 2

C 8 AdvaMed Assn Vol#: 2

C 9 ABRA Vol#: 2

C 10 Careside Inc Vol#: 2

C 11 LifePoint Inc Vol#: 2

C 12 Washington State Dept of Health Vol#: 2

C 13 ITC Clinic Vol#: 2

C 14 BD Diagnostic Systems Vol#: 2

C 15 American Soc for Clinical Lab Science Vol#: 2

C 16 Carter-Wallace Inc Vol#: 2

C 17 Abbott Laboratories Vol#: 2

C 18 American Soc for Microbiology Vol#: 2

C 19 Biosite Diagnostics Vol#: 2

C 20 Americian Assn for Clinical Chemistry Vol#: 2

C 21 Americian Clinical Lab Assn Vol#: 2

C 22 Pearson Vol#: 2

01D-0058 Structure Function Rule

C 2 CHPA Vol#: 1

C 3 Pure Encapsulations Inc & 9 other Co Vol#: 1

C 4 Council for Responsible Nutrition Vol#: 1

C 5 NEPA Vol#: 1

C 6 Nat'l Nutritional Foods Assn Vol#: 1

C 7 Tiedt PhD Vol#: 1


01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

C 1 Public Citizen Vol#: 1


01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 54 Costa Vol#: 5

C 55 Pianfetti Vol#: 5

C 56 Criscuolo Vol#: 5

C 57 Poniatowski Vol#: 5

C 58 Mogentale Vol#: 5

C 59 Catholic Diocese of Columbus Vol#: 5

C 60 Bourdon Vol#: 5

C 61 Van Vachal Vol#: 5

C 62 White Vol#: 5

C 63 Mackie Vol#: 5

EMC 206 Graham Vol#: 5

EMC 207 Kovach Vol#: 5

EMC 208 Rausch Vol#: 5

EMC 209 Prendergast Vol#: 5

EMC 210 Solanet MD. Vol#: 5

EMC 211 Elliott Vol#: 5

EMC 212 Bellavance Vol#: 5

EMC 213 Alexander, Jr. Vol#: 5

EMC 214 Vangeli Vol#: 5

EMC 215 Bell Vol#: 5

EMC 216 Meyer Vol#: 5

EMC 217 Schalk Vol#: 5

EMC 218 Houston Vol#: 5

EMC 219 Moran Vol#: 5

EMC 220 Horton Vol#: 5

EMC 221 Wilcox Vol#: 5

EMC 222 Gernstl Vol#: 5

EMC 223 Mulligan Vol#: 5

EMC 224 Network Training Services Vol#: 5

EMC 225 Shearer Vol#: 5

01P-0209 Prescription Drug Products list amendment&approve new dosage

SUP 1 Duramed Pharm Inc Vol#: 1