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 September 20, 2001

TABLE OF CONTENTS

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98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
99D-5046 Human Blood & Blood Components Intended for Transfusion *
00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1199 Approval of ANDAs for Extended-Release *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures *
01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s] *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0083 Disclosure Source of Premarin *
01P-0425 ANADA Suitability for Heartgard 30 Chewables *
01P-0426 Determine Status of Oxycontin Extended-Release Tabs. 160 mg *
01P-0427 ANADA Suitability for Eqvalan Paste 1.87% to Liquid *
01P-0428 Generic Cefuroxime Axetil Products *
01P-0430 Propofol Injectable Emulsion 1%,10mg/mL Formulation 0.025% *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 67 Kraft Foods, Inc. Vol#: 6

C 68 Central Soya Company, Inc. Vol#: 6

C 69 Food Marketing Institute Vol#: 6

C 70 National Food Processors Assn Vol#: 6

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

C 5212 Hildegarde Eberhardt Vol#: 169

C 5213 Nancy Dumas Vol#: 169

C 5214 Dona J. Mellott Vol#: 169

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

C 41 Sharrell Blakeley Vol#: 5

C 42 United Rentals, Inc. Vol#: 5

99D-5046 Human Blood & Blood Components Intended for Transfusion

EC 1 Mr. Mark Jander Vol#: 4

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 8 Biomira Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9484 Alison Krishnadas Vol#: 476

00P-1199 Approval of ANDAs for Extended-Release

SUP 1 Biovail Corporation Vol#: 2

00P-1322 Food Labeling and Allergen Contamination Control

C 381 Shirley A. Murphy Vol#: 25

C 382 Hilari Moore Vol#: 25

C 383 J. Kirk Vol#: 25

C 384 International Dairy Foods Assn Vol#: 25

C 385 Matthew Chase Maxwell Vol#: 25

C 386 Irving Morof Vol#: 25

C 387 Edith Gingras Vol#: 25

EC 9 Mrs. Teri Carabello Vol#: 17

EC 10 Mr. Chuck Norris Vol#: 17

EC 11 Mrs. Amy Raymond Vol#: 17

01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures

C 2 National Electrical Manufacturers Assn Vol#: 1

01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

C 1 ViroLogic, Inc. Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 149 Mr. James Cotter Vol#: 4

EC 150 Mr. Garnet Hanson Vol#: 4

EC 151 University of Florida, West Oaks Family Vol#: 4

EC 152 Indian River Memorial Hospital Vol#: 4

EC 153 Miss Janet Karam Vol#: 4

EC 154 Nebraska Medicaid Drug Utilization Revie Vol#: 4

EC 155 National Consumers League Vol#: 4

EC 156 Dr. Gerald Goldberg Vol#: 4

EC 157 Mrs. Susan Rachford Vol#: 4

EC 158 The CFIDS Association of America Vol#: 4

EC 159 Ms. Melissa Pilar Vol#: 4

EC 160 Mrs. Fran Rolfsen Vol#: 4

EC 161 Ms. Jacqulyn Perfetto Vol#: 4

EC 162 Ms. Rose Tomlin Vol#: 4

EC 163 Mrs. Simone Meeker Vol#: 4

EC 164 Mrs. Sherry-Lynn Ciangiola Vol#: 4

EC 165 Mrs. Marianne Howell Vol#: 4

EC 166 Mrs. jj jj Vol#: 4

EC 167 Dr. Kay Sherman Vol#: 4

EC 168 Ms. Bridget Brown Vol#: 4

EC 169 Mrs. Grace Ward Vol#: 4

EC 170 Ms. S L Schindlbeck Vol#: 4

EC 171 private citizen Vol#: 4

EC 172 Ms. Virginia Waters Vol#: 4

EC 173 none Vol#: 4

EC 174 Lyme Disease Support Group Vol#: 4

EC 175 Ms. Lee McLean Vol#: 4

EC 176 Miss Cindy DeMarco Vol#: 4

EC 177 Ms. Nancy Carmack Vol#: 4

EC 178 Mr. David Barton Vol#: 4

EC 179 Mrs. Maurine Stevens Vol#: 4

EC 180 Ms. Tammie Fulcher Vol#: 4

EC 181 Ms. Holly Brzeczek Vol#: 4

EC 182 Mr. James Lesperance Vol#: 4

EC 183 Mr. Timothy Haupt Vol#: 4

EC 184 Ms. LJ Fidler Vol#: 4

EC 185 Ms. C. Damon Vol#: 4

EC 186 Fibromyalgia and Chroic Myofascial Pain Vol#: 4

EC 187 Ms. Judith Stover Vol#: 4

EC 188 FMS/CFS Empowerment Group at Memorial Ho Vol#: 4

EC 189 Ms. Dawn Hughes Vol#: 4

EC 190 N/A Vol#: 4

EC 191 chronic fatigue immune defiency syndrome Vol#: 4

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

C 224 Mr. Robert L. Montague, III Vol#: 10

C 225 Mr. Herbert Klepper Vol#: 10

C 226 Dr. Kenneth Elkington Vol#: 10

C 227 Jon Young Vol#: 10

C 228 Reva Wheatcraft Vol#: 10

C 229 Jon Young Vol#: 10

C 230 Reva Wheatcraft Vol#: 10

C 231 Jon Young Vol#: 10

C 232 Reva Wheatcraft Vol#: 10

C 233 Pat Hessler Vol#: 10

01P-0083 Disclosure Source of Premarin

C 3 D. Abbott Vol#: 1

C 4 Linda Barizone Vol#: 1

C 5 Linda Grace et al. Vol#: 1

01P-0425 ANADA Suitability for Heartgard 30 Chewables

ACK 1 HFA-305 Vol#: 1

CP 1 First Priority, Inc. Vol#: 1

01P-0426 Determine Status of Oxycontin Extended-Release Tabs. 160 mg

ACK 1 HFA-305 Vol#: 1

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

01P-0427 ANADA Suitability for Eqvalan Paste 1.87% to Liquid

ACK 1 HFA-305 Vol#: 1

CP 1 Karen A. Sisson Vol#: 1

01P-0428 Generic Cefuroxime Axetil Products

ACK 1 HFA-305 Vol#: 1

CP 1 Professional Detailing, Inc. Vol#: 1

01P-0430 Propofol Injectable Emulsion 1%,10mg/mL Formulation 0.025%

ACK 1 HFA-305 Vol#: 1

CP 1 GensiaSicor Pharmaceuticals Vol#: 1

01V-0424 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Chilewig Vol#: 1

01V-0429

ACK 1 HFA-305 Vol#: 1

VAR 1 Light America Vol#: 1