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Dockets Entered On April 4, 2006
Table of Contents
Docket # Title
1997N-0484S Human Cellular and Tissue-Based Products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005N-0414 Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005Q-0298 Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
1997N-0484S Human Cellular and Tissue-Based Products
NCR 1 FDA Vol #: 44
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17476 Aboca USA Inc. Vol #: 160
LET 17477 Aboca USA Inc. Vol #: 160
LET 17478 Aboca USA Inc. Vol #: 160
LET 17479 Aboca USA Inc. Vol #: 160
LET 17480 Aboca USA Inc. Vol #: 160
LET 17481 Aboca USA Inc. Vol #: 160
LET 17482 RKS Inc. Vol #: 161
LET 17483 Source Naturals Vol #: 161
LET 17484 Natural Factors Nutritinal Products, inc. Vol #: 161
LET 17485 Source Naturals Vol #: 161
LET 17486 Natural Factors Nutritional Products, Ltd. Vol #: 161
LET 17487 Botanical Laboratories Vol #: 161
LET 17488 Livengood-Lifestyles Vol #: 161
LET 17489 Perrigo Company of South Carolina Vol #: 161
LET 17490 Perrigo Company of South Carolina Vol #: 161
LET 17491 Perrigo Company of South Carolina Vol #: 161
LET 17492 Perrigo Company of South Carolina Vol #: 161
LET 17493 Borba LLC Vol #: 161
LET 17494 Borba LLC Vol #: 161
LET 17495 AdvoCare International, L.P. Vol #: 161
LET 17496 AdoCare International, L.P. Vol #: 161
LET 17497 AdvoCare International, L.P. Vol #: 161
LET 17498 Bionorica LLC Vol #: 161
LET 17499 Bionorica LLC Vol #: 161
LET 17500 Bionorica LLC Vol #: 161
LET 17501 Bionorica LLC Vol #: 161
LET 17502 Bionorica LLC Vol #: 161
LET 17503 Alltech, Inc. Vol #: 161
LET 17504 Infinity2 Health Sciences, inc. Vol #: 161
LET 17505 Perrigo Company of South Carolina Vol #: 161
LET 17506 Perrigo Company of South Carolina Vol #: 161
LET 17507 Perrigo Company of South Carolina Vol #: 161
LET 17508 Perrigo Company of South Carolina Vol #: 161
LET 17509 Advanced Cardiac Life Sciences, LLC Vol #: 161
LET 17510 Advanced Cardiac Life Sciences, LLC Vol #: 161
LET 17511 Advanced Cardiac Life Sciences, LLC Vol #: 161
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
EMC 3 Sharon Vol #: 1
LST 1 Agenda for March 29, 2006 Meeting Vol #: 1
SUP 1 BabyBeat Inc Vol #: 1
TS 1 Babydater Co. Vol #: 1
TS 2 American Institute of Ultrasound in Medicine Vol #: 1
TS 3 BabyBeat Inc. Vol #: 1
TS 4 Summit Doppler Systems, Inc. Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 8 HF-3 to TMJ Implants and Robert W. Christensen and Maureen K. Mooney Vol #: 3
OR 8 HF-3 to TMJ Implants and Robert W. Christensen and Maureen K. Mooney Vol #: 3
2005N-0414 Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
N 2 FDA Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 4865 B. Kubarych Vol #: 80
C 4866 H. Pearson Vol #: 80
C 4867 S. Mossman Vol #: 80
C 4868 H. Callin, CNP Vol #: 80
C 4869 L. Milliman Vol #: 80
C 4870 H. Tapp Vol #: 80
C 4871 G. Clarke Vol #: 80
C 4872 B. Holieton Vol #: 80
C 4873 C. Burgard Vol #: 80
C 4874 R. Sterling Vol #: 80
C 4875 B. O'Connor Vol #: 80
C 4876 M. Hanke Vol #: 80
C 4877 V. Oram, ND Vol #: 80
C 4878 S. Schultz, MD Vol #: 80
C 4879 F. Briancalana, MD Vol #: 80
C 4880 J. Taylor Vol #: 80
C 4881 B. Hunter Vol #: 80
C 4882 B. Hunter Vol #: 80
C 4883 E. Sellers Vol #: 80
C 4884 N. Camargo Vol #: 80
C 4885 A. Clegg Vol #: 80
C 4886 A. Cruz Vol #: 80
C 4887 J. Bach Vol #: 80
C 4888 B. Rosseland Vol #: 80
C 4889 Z. Arnold Vol #: 80
C 4890 J. Kaiser Vol #: 80
C 4891 P. Paine Vol #: 80
C 4892 W. Waggerby, DDS Vol #: 80
C 4893 A. Laughlin Vol #: 80
C 4894 P. Owen Vol #: 80
C 4895 P. Waggerby Vol #: 80
C 4896 B. Gowen Vol #: 80
C 4897 J. Goe Vol #: 80
C 4898 D. Webster Vol #: 80
C 4899 Dr. S. Cohen Vol #: 80
C 4900 V. Froehlich Vol #: 80
C 4901 J. Sikoski Vol #: 80
C 4902 T. Owens Vol #: 80
C 4903 S. Nitchals Vol #: 80
C 4904 T. Lawson, MD Vol #: 80
C 4905 D. Yates Vol #: 80
C 4906 C. Lamb Vol #: 80
C 4907 M. Blen Vol #: 80
C 4908 D. Russell Vol #: 80
C 4909 D. Wallace Vol #: 80
C 4910 A. Wirth Vol #: 80
C 4911 M. Blanchard Vol #: 80
C 4912 C. Richarden Vol #: 80
C 4913 J. Thein Vol #: 80
C 4914 J. Leith Vol #: 80
C 4915 L. Heyerdahl Vol #: 80
C 4916 S. Ryais Vol #: 80
C 4917 H. Kromat Vol #: 80
C 4918 N. Jardin Vol #: 80
C 4919 R. Rideout Vol #: 80
C 4920 K. Sullivan Vol #: 80
C 4921 S. Raiche Vol #: 80
C 4922 Dr. M. Emmer Vol #: 80
C 4923 C. Richardsen Vol #: 80
C 4924 Eligible Vol #: 80
C 4925 J. Reighley Vol #: 80
C 4926 D. Titus Vol #: 80
C 4927 F. Ratcliffe Vol #: 80
C 4928 B. Monacell Vol #: 80
C 4929 R. Reim Vol #: 80
C 4930 S. Novak Vol #: 80
C 4931 M. Kralic Vol #: 80
C 4932 H. Cochran Vol #: 80
C 4933 E. Benson Vol #: 80
C 4934 K. Powers Vol #: 80
C 4935 A. Matthews Vol #: 80
C 4936 F. Stiff Vol #: 80
C 4937 D. Nyborg Vol #: 80
C 4938 H. Fatkins Vol #: 80
C 4939 M. Tiner Vol #: 80
C 4940 L. Rauer Vol #: 80
C 4941 T. O'Brien Vol #: 80
C 4942 B. Murphy Vol #: 80
C 4943 L. Saunders Vol #: 80
C 4944 C. Rudolph Vol #: 80
C 4945 R. Zumbrunn Vol #: 80
C 4946 E. Burke Vol #: 80
C 4947 P. Ponte Vol #: 80
C 4948 M. Gunbjornsen Vol #: 80
C 4949 D. Gentry Vol #: 80
C 4950 C. Fowler Vol #: 80
C 4951 A. Garat Vol #: 80
C 4952 J. Giessinger Vol #: 80
C 4953 K. Litwand Vol #: 80
C 4954 Dr. J. Clark Vol #: 80
C 4955 A. Hart Vol #: 80
C 4956 M. Black Vol #: 80
C 4957 A. Johnson Vol #: 80
C 4958 A. Wood Vol #: 80
C 4959 S. Kaefe Vol #: 80
C 4960 Eligible Vol #: 80
C 4961 G. Aster, R.N., M.S., C.R.C. Vol #: 80
C 4962 N. Rich Vol #: 80
C 4963 M. Simpson Vol #: 80
C 4964 D. Moore Vol #: 80
C 4965 C. Clarke Vol #: 80
C 4966 K. Rabe Vol #: 80
C 4967 J. Waterman Vol #: 80
C 4968 E. Womack Vol #: 80
C 4969 S. Miller Vol #: 80
C 4970 K. Marks, L.Ac. Vol #: 80
C 4971 K. Nelson Vol #: 81
C 4972 A. Angel Vol #: 81
C 4973 K. Roberts Vol #: 81
C 4974 E. Hudson Vol #: 81
C 4975 S. Wulff Vol #: 81
C 4976 J. Herding Vol #: 81
C 4977 M. Murray Vol #: 81
C 4978 V. Boyd Vol #: 81
C 4979 R. Polland Vol #: 81
C 4980 L. Gerlits Vol #: 81
C 4981 F. Strackbein Vol #: 81
C 4982 F. Ford Vol #: 81
C 4983 M. Lowery Vol #: 81
C 4984 J. Douglas Vol #: 81
C 4985 J. Corquepalmi Vol #: 81
C 4986 T. Pease Vol #: 81
C 4987 P. Frame Vol #: 81
C 4988 A. Nays Vol #: 81
C 4989 C. Loveil Vol #: 81
C 4990 D. Johnson Vol #: 81
C 4991 Dr. K. Fry Vol #: 81
C 4992 E. Fassio Vol #: 81
C 4993 J. Yaworski Vol #: 81
C 4994 Eligible Vol #: 81
C 4995 K. Hedden Vol #: 81
C 4996 D. Gilder Vol #: 81
C 4997 D. Clair Vol #: 81
C 4998 C. Hart Vol #: 81
C 4999 B. Drawbough Vol #: 81
C 5000 B. Gravesen Vol #: 81
C 5001 Eligible Vol #: 81
C 5002 J. Ellison Vol #: 81
C 5003 C. Rohan Vol #: 81
C 5004 C. Johnson Vol #: 81
C 5005 K. Canizaro Vol #: 81
C 5006 D. Dantyer Vol #: 81
C 5007 K. Brown Vol #: 81
C 5008 K. Mutschinski Vol #: 81
C 5009 L. York Vol #: 81
C 5010 T. Hupp Vol #: 81
C 5011 E. Beaman Vol #: 81
C 5012 M. Paredes Vol #: 81
C 5013 C. Kirby Vol #: 81
C 5014 D. Hickey Vol #: 81
C 5015 J. Smith Vol #: 81
C 5016 J. Ryan Vol #: 81
C 5017 M. Jackson Vol #: 81
C 5018 M. Jackson Vol #: 81
C 5019 I. Dukes Vol #: 81
C 5020 J. Thornberry Vol #: 81
C 5021 U. Brown Vol #: 81
C 5022 S. Glaser Vol #: 81
C 5023 M. King Vol #: 81
C 5024 D. Merryman Vol #: 81
C 5025 G. Laden Vol #: 81
C 5026 S. Kawashima Vol #: 81
C 5027 M. Williams Vol #: 81
C 5028 S. Walter Vol #: 81
C 5029 A. Sutcliffe Vol #: 81
C 5030 A. Bliss Vol #: 81
C 5031 A. Wiedower Vol #: 81
C 5032 E. Chen Vol #: 81
C 5033 E. Brown Vol #: 81
C 5034 E. Layton Vol #: 81
C 5035 J. Millman, MD Vol #: 81
C 5036 N. Ceurcea Vol #: 81
C 5037 D. Valdes Vol #: 81
C 5038 J. Sowa Vol #: 81
C 5039 Eligible Vol #: 81
C 5040 J. Eberhardt Vol #: 81
C 5041 L. Hulett Vol #: 81
C 5042 N. Holcomb Vol #: 81
C 5043 E. Mynatt Vol #: 81
C 5044 M. Runstuck Vol #: 81
C 5045 E. Griggs Vol #: 81
C 5046 S. Sloan Vol #: 81
C 5047 D. Edwards Vol #: 81
C 5048 B. McElyunn Vol #: 81
C 5049 L. Wilson Vol #: 81
C 5050 J. Wurtz Vol #: 81
C 5051 S. Levin Vol #: 81
C 5052 B. Crawford Vol #: 81
C 5053 M. Hoef Vol #: 81
C 5054 K. Stacey Vol #: 81
C 5055 M. Karpinski, RN Vol #: 81
C 5056 C. Allen Vol #: 81
C 5057 J. Kubat Vol #: 81
C 5058 M. Livingston Vol #: 81
C 5059 G. Leo Vol #: 81
C 5060 D. Bliff Vol #: 81
C 5061 A. Rivera Vol #: 81
C 5062 J. Griffith Vol #: 81
C 5063 D. Bliff Vol #: 81
C 5064 S. McCarty Vol #: 81
C 5065 S. Kottcamp Vol #: 81
C 5066 S. Jackson Vol #: 81
C 5067 G. Joyan Vol #: 81
C 5068 M. DiCarlo Vol #: 81
C 5069 D. Houtrijve Vol #: 81
C 5070 N. Allin Vol #: 81
C 5071 D. Storm Vol #: 81
C 5072 M. Barnett Vol #: 81
C 5073 G. Barnett Vol #: 81
C 5074 V. Harshall Vol #: 81
C 5075 E. Weinlander Vol #: 81
C 5076 D. Jamison Vol #: 81
C 5077 S. Thomas Vol #: 81
C 5078 K. Jackson Vol #: 81
C 5079 V. Curtis Vol #: 81
C 5080 G. Lewis Vol #: 81
C 5081 A. Bliss Vol #: 81
C 5082 K. Canizaro Vol #: 81
C 5083 C. Duckwiley Vol #: 81
C 5084 S. Kowalski Vol #: 81
C 5085 C. Vincent Vol #: 81
C 5086 D. VanNess Vol #: 81
C 5087 L. Maas Vol #: 81
C 5088 S. Meeker Vol #: 81
C 5089 B. Richards Vol #: 81
C 5090 A. Horton Vol #: 81
C 5091 A. Horton Vol #: 81
C 5092 C. Gandler Vol #: 81
C 5093 P. Stern Vol #: 81
C 5094 J. Scott Vol #: 81
C 5095 L. Haynes Vol #: 81
C 5096 J. Steel Vol #: 81
C 5097 J. Bucholtz Vol #: 81
C 5098 R. Maldonado Vol #: 81
C 5099 Z. Germaine Vol #: 81
C 5100 K. Melton Vol #: 81
C 5101 R. Malter Vol #: 81
C 5102 B. Klann Vol #: 81
C 5103 S. Wittenberg Vol #: 81
C 5104 S. Wittenberg Vol #: 81
C 5105 S. Spiker Vol #: 81
C 5106 S. Roberts, MD Vol #: 81
C 5107 B. Dodson, PhD Vol #: 81
C 5108 K. Goerke Vol #: 81
C 5109 S. Storm, MD Vol #: 81
C 5110 K. Powers Vol #: 81
C 5111 K. Crocker Vol #: 81
C 5112 C. Flandecau Vol #: 81
C 5113 G. Beauchamp Vol #: 81
C 5114 N. Williams Vol #: 81
C 5115 I. Karushisa Vol #: 81
C 5116 P. Durkin Vol #: 81
C 5117 J. Munson Vol #: 81
C 5118 L. Brod Vol #: 81
C 5119 T. Wester Vol #: 81
C 5120 C. Faffel Vol #: 81
C 5121 C. Ponesa Vol #: 81
C 5122 P. Sales Vol #: 81
C 5123 S. Festa Vol #: 81
C 5124 M. Klock Vol #: 81
C 5125 S. Vickers Vol #: 81
C 5126 C. Biondi Vol #: 81
C 5127 C. Schneider Vol #: 81
C 5128 H. Schneider Vol #: 81
C 5129 A. Pemberton Vol #: 81
C 5130 D. Maha Vol #: 81
C 5131 N. Masullo Vol #: 81
C 5132 D. Rubens, PhD Vol #: 81
C 5133 J. Douglas Vol #: 81
C 5134 B. Allen Vol #: 81
C 5135 C. Stockton Vol #: 81
C 5136 D. Rubens, PhD Vol #: 81
C 5137 E. Sherman Vol #: 81
C 5138 G. Martin Vol #: 81
C 5139 J. White Vol #: 81
C 5140 J. Hamby Vol #: 81
C 5141 J. Quinnell Vol #: 81
C 5142 S. Raphael Vol #: 81
C 5143 K. Culbertson Vol #: 81
C 5144 J. Bey Vol #: 81
C 5145 S. Goodwin Vol #: 81
C 5146 T. Thompson Vol #: 81
C 5147 D. Nelson Vol #: 81
C 5148 J. Shepler Vol #: 81
C 5149 B. Trentler Vol #: 81
C 5150 J. Jones Vol #: 81
C 5151 L. Chuba Vol #: 81
C 5152 M. Ellsworth Vol #: 81
C 5153 C. Dix Vol #: 81
C 5154 M. Pippin Vol #: 81
C 5155 L. Ecclesine Vol #: 81
C 5156 B. McEljunn Vol #: 81
C 5157 L. Russell Vol #: 81
C 5158 S. Roach Vol #: 81
C 5159 J. Allione Vol #: 81
C 5160 M. Katz Vol #: 81
C 5161 M. Berardine Vol #: 81
C 5162 D. Heck Vol #: 81
C 5163 N. Kroening Vol #: 81
C 5164 G. Yost Vol #: 81
C 5165 J. Kayn Vol #: 81
C 5166 C. Clark Vol #: 81
C 5167 J. Reason Vol #: 81
C 5168 B. Schwarting Vol #: 81
C 5169 M. Herman Vol #: 81
       

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