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Dockets Management
Dockets Entered On August 23, 2005
Table of Contents
Docket # Title
1995N-0294 Quality/fill container; common or unusual name regulations
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999P-1340 Declared Eternity eau de Parfum Misbranded
1999P-5106 Identify Sources of Natural Flavorings
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2004D-0333 Emergency Use Authorization of Medical Products
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0469 Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
2004N-0545 Nonclinical and Clinical Datasets; Notice of Pilot Project
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005D-0183 Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
2005D-0203 Guidance for Industry on Safety Testing of Drug Metabolites
2005D-0310 Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
2005N-0029 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
2005N-0153 Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring
2005N-0231 Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
2005N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
2005P-0139 withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
1995N-0294 Quality/fill container; common or unusual name regulations
C 105 Chocolate Manufacturers Association (CMA) Vol #: 5
EMC 4 Hormel Foods Corporation (Hormel) Vol #: 5
EMC 5 Juice Products Association (JPA) Vol #: 5
EMC 6 United Egg Asociation (UEA) Vol #: 5
EMC 7 United Egg Asociation (UEA) Vol #: 5
EMC 8 MarlerClark, LLP Vol #: 5
EMC 9 California Farmers Union Vol #: 5
EMC 10 The Solae Company Vol #: 5
EMC 11 Nestle USA, Inc (Nestle) Vol #: 5
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 16506 Laboratories Garden House S.A. Vol #: 148
LET 16507 Laboratories Garden House S.A. Vol #: 148
LET 16508 Laboratories Garden House S.A. Vol #: 148
LET 16509 Laboratories Garden House S.A. Vol #: 148
LET 16510 Laboratories Garden House S.A. Vol #: 148
LET 16511 Laboratories Garden House S.A. Vol #: 148
LET 16512 Pharmavite LLC Vol #: 148
LET 16513 Pharmavite LLC Vol #: 148
LET 16514 Traditional Medicinals, Inc. Vol #: 148
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7503 E. Marcus Vol #: 319
C 7504 American Farm Bureau Federation (AFBF) Vol #: 319
C 7505 S. Prasad Vol #: 319
EMC 4364 C. Santos Vol #: 320
EMC 4365 H. McDonnell Vol #: 320
EMC 4366 K. Hall Vol #: 320
EMC 4367 K. Murphy Vol #: 320
EMC 4368 K. Robbins Vol #: 320
EMC 4369 J. Jasper Vol #: 320
EMC 4370 G. Schonholz Vol #: 320
EMC 4371 S. Prasad Vol #: 320
EMC 4372 D. Godin Vol #: 320
EMC 4373 R and E Jackson Vol #: 320
EMC 4374 M. Edwards Vol #: 320
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18236 Karen Kenning Vol #: 516
EMC 4219 I. Holte Vol #: 515
EMC 4220 M. Perkins Vol #: 515
EMC 4221 K. Woods Vol #: 515
EMC 4222 S. Ford Vol #: 515
EMC 4223 V. Zachary Vol #: 515
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 608 J. Flowers Vol #: 24
1999P-5106 Identify Sources of Natural Flavorings
EMC 212 A. Chamandy Vol #: 3
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 2091 S. Adams, MD Vol #: 300
C 2092 Juridic Embassy - Micro ICU Project Vol #: 300
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1277 B. Wickes Vol #: 6
EMC 1278 K. Jeter Vol #: 6
EMC 1279 P. Klicin Vol #: 6
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 502 Mission Possible International Vol #: 8
EMC 503 Calorie Control Council Vol #: 8
EMC 504 Calorie Control Council Vol #: 8
2004D-0333 Emergency Use Authorization of Medical Products
C 2 Advanced Medical Technology Association (AdvaMed) Vol #: 1
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EMC 1168 R. Marsh Vol #: 29
EMC 1169 C. Blake Vol #: 29
EMC 1170 R. Copeland Vol #: 29
EMC 1171 L. Alldrin Vol #: 29
EMC 1172 J. Poehlman Vol #: 29
2004N-0469 Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2004N-0545 Nonclinical and Clinical Datasets; Notice of Pilot Project
EMC 3 E. Ohri Vol #: 1
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
EMC 349 Weston A. Price Foundation Vol #: 9
2005D-0183 Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
C 3 Boehringer Ingelheim Pharmaceuticals Vol #: 1
2005D-0203 Guidance for Industry on Safety Testing of Drug Metabolites
C 12 D. McGee, PhD., DABT Vol #: 1
2005D-0310 Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events
BKG 1 Background Material Vol #: 2
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2005N-0029 Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2005N-0153 Agency Information Collection Activities: Proposed Collection; Comment Request; Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring
N 2 FDA Vol #: 1
2005N-0231 Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
C 2 Foodservice & Packaging Institute Vol #: 1
EMC 2 American Forest & Paper Association (AF&PA) Vol #: 1
EMC 3
Attachment
Fibre Box Association (FBA) Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
C 84 M. Bemboom Vol #: 3
C 85 No signature Vol #: 3
C 86 T. Avelina Vol #: 3
C 87 J. Scott Vol #: 3
C 88 R. Sutter Vol #: 3
C 89 M. Stewart Vol #: 3
C 90 D. Mussman Vol #: 3
C 91 B. Whittington Vol #: 3
C 92 Eligible Vol #: 3
C 93 No signature Vol #: 3
C 94 D. Kellaway Vol #: 3
C 95 M. Morse Vol #: 3
C 96 J. Mullen Vol #: 3
C 97 A. Weedin Vol #: 3
C 98 National Foundation for Celiac Awareness Vol #: 6
C 99 M. Fossedal Vol #: 6
C 100 G. Hudreck Vol #: 6
C 101 M. Steier Vol #: 6
C 102 S and R Phillips Vol #: 6
C 103 M. Ratliff Vol #: 6
EMC 90 F. Washburn Vol #: 5
EMC 91 C. Kennard Vol #: 5
EMC 92 No signature Vol #: 5
EMC 93 R. Kneile Vol #: 5
EMC 94 C. Axelrod Vol #: 5
EMC 95 S. Ciesla Vol #: 5
EMC 96 K. Light Vol #: 5
EMC 97 S. Jackson Vol #: 5
EMC 98 S. Fabrizio Vol #: 5
EMC 99 H. Palme Vol #: 5
EMC 100 V. Kuhn Vol #: 5
EMC 101 N. Kelly Vol #: 5
EMC 102 S. Milliner Vol #: 5
EMC 103 S. Warren Vol #: 5
EMC 104 L. Reilly Vol #: 5
EMC 105 D. Craig Vol #: 5
EMC 106 J. Behm Vol #: 5
EMC 107 J. Bertini Vol #: 5
EMC 108 J. Bertini Vol #: 5
EMC 109 J. Bertini Vol #: 5
EMC 110 M. Reed Vol #: 5
EMC 111 M. Sexton Vol #: 5
EMC 112 B. Zeller Vol #: 5
EMC 113 K. Juliano Vol #: 5
EMC 114 D. Rodman Vol #: 5
EMC 115 A. Smith Vol #: 5
EMC 116 W. Ward Vol #: 5
EMC 117 No signature Vol #: 5
EMC 118 N. Messinger Vol #: 5
EMC 119 J. Neisworth Vol #: 5
EMC 120 J. Diehl Vol #: 5
EMC 121 C. Sisson Vol #: 5
EMC 122 C. Elliott Vol #: 5
EMC 123 J. Thamsen Vol #: 5
EMC 124 J. Sladovich Vol #: 5
EMC 125 No signature Vol #: 5
EMC 126 D. Browne Vol #: 5
EMC 127 B. Dahl Vol #: 5
EMC 128 E. Skeen Vol #: 5
EMC 129 S. Kaur Vol #: 5
EMC 130 M. Shumate Vol #: 5
EMC 131 A. Wierema Vol #: 5
EMC 132 C. Lyall Vol #: 5
EMC 133 J. Bridgen Vol #: 5
EMC 134 T. Viles RD, LD Vol #: 5
EMC 135 D. Riccio Vol #: 5
EMC 136 C. Merrill Vol #: 5
EMC 137 T. Babbitt Vol #: 5
EMC 138 C. Lee Vol #: 5
EMC 139 Z. Ray Vol #: 5
EMC 140 J. Werkema Vol #: 5
EMC 141 No signature Vol #: 5
EMC 142 J. Chance Vol #: 5
EMC 143 L. Zephyr Vol #: 5
EMC 144 M. Evans Vol #: 5
EMC 145 S. Kufert Vol #: 5
EMC 146 No signature Vol #: 5
EMC 147 T. Voort Vol #: 5
EMC 148 A. Farris Vol #: 5
EMC 149 T. Kownacki Vol #: 5
EMC 150 Z. Abbott Vol #: 5
EMC 151 S. Miaskiewicz Vol #: 5
EMC 152 H. Hawkey Vol #: 5
EMC 153 B. Appel Vol #: 5
EMC 154 No signature Vol #: 5
EMC 155 L and J Larson Vol #: 5
EMC 156 P. Ballinger, PhD Vol #: 5
EMC 157 E. Prewitt Vol #: 5
EMC 158 No signature Vol #: 5
EMC 159 S. Soha Vol #: 5
EMC 160 J. McKinney Vol #: 5
EMC 161 No signature Vol #: 5
EMC 162 N. Debruin Vol #: 5
EMC 163 P. Zamora Vol #: 5
EMC 164 T. Duncan Vol #: 5
EMC 165 P. Kaempffer Vol #: 5
2005N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
N 1 FDA Vol #: 1
2005P-0139 withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
EMC 636 P. Lowe Vol #: 3

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