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Dockets Management
Dockets Entered On April 13, 2005
Table of Contents
Docket # Title
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998D-0514 Industry on ANDA's: Impurities in Drug Substances
1998N-0046 Comprehensive List of Current Guidance Documents at FDA
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2003D-0112 Independent Consultants for Biotechnology Clinical Trias
2003D-0554 Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
2004D-0453 Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
2004N-0463 Food Labeling: Prominence of Calories
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005M-0117 P040020 - Acrysof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3, Approved 3/21/05
2005M-0118 P040024 - Restylane Injectable Gel, Approved 3/25/05
2005M-0129 P040018 - ADVIA Centaur HAV IgM ReadyPack Reagents; ADVIA Centaur HAV IgM Quality Control Materials
2005M-0130 P030052 - UroVysion Bladder Cancer Kit
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
2005N-0059 Withdrawal of Approval of a New Animal Drug Application; Dichlorophene and Toluene Capsules
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
EC 39 Mrs. jamillah gonzalez Vol #: 140
EC 40
Attachment 		US Army Medical Research Institute of Inf Dis Vol #: 140
EC 41 Mr. Lawrence Rizzo Vol #: 140
EC 42 Mrs. Cheryl Reinertsen Vol #: 140
EC 43 Mr. David Panzera Vol #: 140
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15889 NOW Foods Vol #: 140
LET 15890 NOW Foods Vol #: 140
LET 15891 NOW Foods Vol #: 140
LET 15892 Enzymatic Therapy Vol #: 140
LET 15893 Enzymatic Therapy Vol #: 140
LET 15894 Enzymatic Therapy Vol #: 140
LET 15895 Enzymatic Therapy Vol #: 140
LET 15896 Enzymatic Therapy Vol #: 140
LET 15897 Enzymatic Therapy Vol #: 140
LET 15898 Enzymatic Therapy Vol #: 140
LET 15899 Enzymatic Therapy Vol #: 140
LET 15900 Enzymatic Therapy Vol #: 140
LET 15901 Enzymatic Therapy Vol #: 140
LET 15902 Enzymatic Therapy Vol #: 140
LET 15903 Enzymatic Therapy Vol #: 140
LET 15904 Enzymatic Therapy Vol #: 140
LET 15905 Purdue Products L.P. Vol #: 140
LET 15906 Enzymatic Therapy Vol #: 140
LET 15907 Enzymatic Therapy Vol #: 140
LET 15908 North American Pharmacal Inc. Vol #: 140
LET 15909 North American Pharmacal Inc. Vol #: 140
1998D-0514 Industry on ANDA's: Impurities in Drug Substances
EC 1 Teva Pharmaceutical Industries Ltd. Vol #: 1
1998N-0046 Comprehensive List of Current Guidance Documents at FDA
EC 5 Olympus America Inc Diagnostic Systems Group Vol #: 2
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 1178 Animal Health Institute Vol #: 478
EXB 1179 Animal Health Institute Vol #: 478
EXB 1180 Animal Health Institute Vol #: 478
EXB 1181 Animal Health Institute Vol #: 478
EXB 1182 Animal Health Institute Vol #: 478
EXB 1183 Animal Health Institute Vol #: 478
EXB 1184 Animal Health Institute Vol #: 478
EXB 1185 Animal Health Institute Vol #: 478
EXB 1186 Animal Health Institute Vol #: 478
EXB 1187 Animal Health Institute Vol #: 478
EXB 1188 Animal Health Institute Vol #: 479
EXB 1189 Animal Health Institute Vol #: 480
EXB 1190 Animal Health Institute Vol #: 480
EXB 1191 Animal Health Institute Vol #: 480
EXB 1192 Animal Health Institute Vol #: 480
EXB 1193 Animal Health Institute Vol #: 480
EXB 1194 Animal Health Institute Vol #: 480
EXB 1195 Animal Health Institute Vol #: 480
EXB 1196 Animal Health Institute Vol #: 480
EXB 1197 Animal Health Institute Vol #: 480
EXB 1198 Animal Health Institute Vol #: 480
EXB 1199 Animal Health Institute Vol #: 481
EXB 1200 Animal Health Institute Vol #: 480
2003D-0112 Independent Consultants for Biotechnology Clinical Trias
EC 3 INSTITUTO NACIONAL DE SALUD Vol #: 1
2003D-0554 Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
EC 9
Attachment 		Tracon Consultants Ltd. Vol #: 1
EC 10 Mr. Paul Haddow Vol #: 1
2003H-0432 Civil Money Penalty, Korangy Radiology Associates, PA
CS 15 HFA-305 to Henry E. Schwartz LLC Vol #: 8
OR 13 HF-3 Vol #: 8
OR 14 Number not used Vol #: 8
2004D-0453 Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
EMC 1 The University of Georgia Vol #: 3
EMC 2 J. Irwin Vol #: 3
EMC 3 T. Sadler Vol #: 3
EMC 4 Twinlab, An IdeaSphere Company Vol #: 3
EMC 5 B. O'Brien Vol #: 3
EMC 6 A. Atchison Vol #: 3
EMC 7 unsign Vol #: 3
EMC 8 Shawn Roberts Vol #: 3
EMC 9 Mirko Czentovic Vol #: 3
EMC 10 C. Kurtz Vol #: 3
EMC 11 G. Yazak Vol #: 3
EMC 12 M. Broumberg Vol #: 3
EMC 13 J. Blake Vol #: 3
EMC 14 C. Henrich Vol #: 3
EMC 15 W. Schiff Vol #: 1
EMC 16 L.Bundy Vol #: 3
EMC 17 P. Phelps Vol #: 3
EMC 18 J. Bowie Vol #: 3
EMC 19 A. Joy Vol #: 3
EMC 20 R. Schneider Vol #: 3
EMC 21 K. Vanmason Vol #: 3
EMC 22 A. Briggs Vol #: 3
EMC 23 B. Morse Vol #: 3
EMC 24 G. Powell Vol #: 3
EMC 25 E. Souza Vol #: 3
2004N-0463 Food Labeling: Prominence of Calories
EMC 135 V. Sparkman Vol #: 3
EMC 136 V. Sparkman Vol #: 3
EMC 137 D. Daniels Vol #: 3
EMC 138 J. Conley Vol #: 3
EMC 139 S. Wallace Vol #: 3
EMC 140 A. Krzywosinski Vol #: 3
EMC 141 B. Lobato Vol #: 3
EMC 142 no signature Vol #: 3
EMC 143 N. L. Thomas Vol #: 3
EMC 144 B. Gettler Vol #: 3
EMC 145 Barren River District Health Department Vol #: 3
EMC 146 S. Bebas Vol #: 3
EMC 147 K. Smith Vol #: 3
EMC 148 R. Baughman Vol #: 3
EMC 149 L. Cheek Vol #: 3
EMC 150 M. A. Shirley Vol #: 3
EMC 151 N. Mansuso Vol #: 3
EMC 152 B. Youmans Vol #: 3
EMC 153 W. Tremblay Vol #: 3
EMC 154 S. Baker Vol #: 3
EMC 155 D. Isbell Vol #: 3
EMC 156 J. Smolenski Vol #: 3
EMC 157 D. E. Bul Vol #: 3
EMC 158 T. Cayce Vol #: 3
EMC 159 R. Gault Vol #: 3
EMC 160 S. Meltzer, MPH Vol #: 3
EMC 161 L. Marin Vol #: 3
EMC 162 J. Heydt Vol #: 3
EMC 163 M. Howley Ryan, MS,RD Vol #: 3
EMC 164 T. Roth Vol #: 3
EMC 165 G. and K. Samaha Vol #: 3
EMC 166 G. T. Lynch Vol #: 3
EMC 167 A. L. Swarup Vol #: 3
EMC 168 R. Needham Vol #: 3
EMC 169 K. Payne, RN Vol #: 3
EMC 170 S. Cooper Vol #: 3
EMC 171 M. Hernandez Vol #: 3
EMC 172 T. Rice Vol #: 3
EMC 173 E. Frampton Vol #: 3
EMC 174 J. Kirk Vol #: 3
EMC 175 University of Illinois at Chicago Vol #: 3
EMC 176 E. DiPaolo Vol #: 3
EMC 177 E. Jean (Kowan) Saltz Vol #: 3
EMC 178 M. L. Brown Vol #: 3
EMC 179 J. McMahon Vol #: 3
EMC 180 C. Harvey Vol #: 3
EMC 181 N. Corcodilos Vol #: 3
EMC 182 D. Schweikart Vol #: 3
EMC 183 Masterfoods USA, A Division of Mars Inc. Vol #: 3
EMC 184 no signature Vol #: 3
EMC 185 J. Tornquist Vol #: 3
EMC 186 J. Yamaguchi, RD Vol #: 3
EMC 187 S. McSilvers Vol #: 3
EMC 188 B. Belmonte Vol #: 3
EMC 189 B. G. Petit Vol #: 3
EMC 190 E. Richardson Vol #: 3
EMC 191 E. O'Dell Vol #: 3
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
EC 26 Mrs. Joan Borchers Vol #: 8
EC 27 Ms. Priscilla Reynolds Vol #: 8
EC 28 Ms. Courtney Bennett Vol #: 8
EC 29 Ms. Sherree Ross Vol #: 8
EC 30 Eat For Change Vol #: 8
EC 31 Ms. Kathryn Matsey Vol #: 8
EC 32 Mrs. Sammie Hahn Vol #: 8
EC 33 Ms. Jessica Ingersoll-Cope Vol #: 8
EC 34 Mr. Jeffrey Stoltzfus Vol #: 8
EC 35 Ms. Felicia Berryman Vol #: 8
EC 36 Ms. Sheril Rathke Vol #: 8
EC 37 Ms. danusia niklewicz Vol #: 8
EC 38 Mrs. Kellie Hicks Vol #: 8
EC 39 Ms. jill coyne Vol #: 8
EC 40 Ms. Luana Lindsey Vol #: 8
EC 41 Mrs. Jennifer Smock Vol #: 8
EC 42 Mr. Kelly Reed Vol #: 8
EC 43 Mr. Eugene Sinner Vol #: 8
EC 44 Mr. Richard Straub Vol #: 8
EC 45 Ms. Jeanette Noechel Vol #: 8
EC 46 Ms. Jill Nienhiser Vol #: 8
EC 47 Weston A Price Foundation Vol #: 8
EC 48 Miss. Amy Conaway Vol #: 8
EC 49 Ms. Ky Pauli Vol #: 8
EC 50 Miss. Kelly Finlaw Vol #: 8
EC 51 Mrs. Janice McLeod Vol #: 8
EC 52 Mrs. Elizabeth Tuttle Vol #: 8
EC 53 Mrs. Debbie Lambert Vol #: 8
EC 54 Mrs. Sherry Epps Vol #: 8
EC 55 Ms. Mary Morgan Vol #: 8
EC 56 Ms. Marianne Pendleton Vol #: 8
EC 57 Dr. Bob Willhite Vol #: 8
EC 58 Mrs. Wendy Wagner Vol #: 8
EC 59 Mr. Percy Mayeaux Vol #: 8
EC 60 Researcher Vol #: 8
EC 61 Mrs. Melissa DeVol Vol #: 8
EC 62 Mrs. Deana Smiel Vol #: 8
EC 63 Dr. Sherrill Sellman Vol #: 8
EC 64 Ms. Denise Rolen Vol #: 8
EC 65 Mrs. chaundra anderson Vol #: 8
EC 66 Ms. Ivana Kadija Vol #: 8
EC 67 Mrs. ALICIA DEARMIN Vol #: 8
EC 68 Mrs. Rebecca Bramlett Vol #: 8
EC 69 Mrs. Deborah Salls Vol #: 8
EC 70 Dr. Ken Taylor Vol #: 8
2005M-0117 P040020 - Acrysof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3, Approved 3/21/05
AAV 1 Alcon Research Ltd. Vol #: 1
2005M-0118 P040024 - Restylane Injectable Gel, Approved 3/25/05
AAV 1 Medicis Aesthetics Holdings, Inc. Vol #: 1
2005M-0129 P040018 - ADVIA Centaur HAV IgM ReadyPack Reagents; ADVIA Centaur HAV IgM Quality Control Materials
AAV 1 Bayer Healthcare, LLC Vol #: 1
2005M-0130 P030052 - UroVysion Bladder Cancer Kit
AAV 1 Vysis, Inc. Vol #: 1
2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
EC 16 Cancer Therapy Evaluation Program, NCI Vol #: 3
EC 17 South Georgia Medical Center Vol #: 3
EC 18 Univ Of Mississsippi MedCent.Clinical ResearchProg Vol #: 3
EC 19 University of Pittsburgh Vol #: 3
EC 20 UConn Health Center Vol #: 3
EC 21 Scripps Cancer Center IRB Vol #: 3
2005N-0059 Withdrawal of Approval of a New Animal Drug Application; Dichlorophene and Toluene Capsules
NWL 1 FDA Vol #: 1

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