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Dockets Management

Dockets Entered On May 11, 2006
Table of Contents
Docket # Title
1994V-0448 Variance for L75 IR Laser Sight System
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2002V-0523 Laser Light Show
2005N-0437 Medical Gas Containers and Closures; Current Good Manufacturing
2005N-0467 Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
2005P-0325 Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005V-0222 Laser Light Show
2006D-0012 Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
2006N-0045 Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
2006P-0147 Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
2006P-0201 Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
2006V-0143 Laser Light Show
1994V-0448 Variance for L75 IR Laser Sight System
VRA 4 FDA/CDRH to Surefire, LLC Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17582 GNC Vol #: 162
LET 17583 Alan James Group, Inc. Vol #: 162
LET 17584 Miracle Breakthrough Lab, Inc. Vol #: 162
LET 17585 Miracle Breakthrough Lab, Inc. Vol #: 162
LET 17586 Anabolic Laboratories, Inc. Vol #: 162
LET 17587 Anabolic Laboratories, Inc. Vol #: 162
LET 17588 Anabolic Laboratories, Inc. Vol #: 162
LET 17589 Arbonne International, LLC Vol #: 162
LET 17590 Arbonne International, LLC Vol #: 162
LET 17591 Market America, Inc. Vol #: 162
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1386 L. Chamberlain, D.O. Vol #: 259
2002V-0523 Laser Light Show
VRA 2 FDA/CDRH to Louisiana Arts and Science Museum Vol #: 1
2005N-0437 Medical Gas Containers and Closures; Current Good Manufacturing
C 1 Compressed Gas Association (CGA) and Gases and Welding Distributors Association (GAWDA) Vol #: 1
2005N-0467 Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
C 1 Hologic, Inc. Vol #: 1
2005P-0325 Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
C 2 Corn Refiners Association (CRA) Vol #: 2
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 8890 J. Sudweeks Vol #: 131
C 8891 C.S.Inayatullha Vol #: 131
C 8892 D. Edmondson Vol #: 131
C 8893 M. Barker Vol #: 131
C 8894 M. Peckman Vol #: 131
C 8895 G. Helton Vol #: 131
C 8896 B. Hawskins-McElyum Vol #: 131
C 8897 D. August Vol #: 131
C 8898 L. Farran Vol #: 131
C 8899 N. Cannette Vol #: 131
C 8900 F. B. Cook Vol #: 131
C 8901 P. A. Carpenter, MD Vol #: 131
C 8902 E. Gutierrz Vol #: 131
C 8903 E. Gutierrz Vol #: 131
C 8904 L. Apatoff Vol #: 131
C 8905 F. Apatoff Vol #: 131
C 8906 V. Picciain Vol #: 131
C 8907 J. R. Whiffer, MD Vol #: 131
C 8908 L. Gruss Vol #: 131
C 8909 J. Strathman Petrarat Vol #: 131
C 8910 D. Chirells Vol #: 131
C 8911 T. Noxon Vol #: 131
C 8912 J. Cooke Vol #: 131
C 8913 S. Major Vol #: 131
C 8914 M Loudati Vol #: 131
C 8915 B. Hawskins McElyum Vol #: 131
C 8916 L. Robinsom Vol #: 131
C 8917 R. Marrocco Vol #: 131
C 8918 G. Morgan Vol #: 131
C 8919 B. Bass Vol #: 131
C 8920 J Stevens Vol #: 131
C 8921 R. M. Fortner Vol #: 131
C 8922 F. Keiman Vol #: 131
C 8923 L. Ann Vol #: 131
C 8924 K. Zeiner Vol #: 131
C 8925 J. Olsen Vol #: 131
C 8926 E. DelCastille Vol #: 131
C 8927 C. Martin Vol #: 131
C 8928 N. Gibson Vol #: 131
C 8929 B. Lohse Vol #: 131
C 8930 B. S. Harlan Vol #: 131
C 8931 K. Pityer Vol #: 131
C 8932 C. Huddless Vol #: 131
C 8933 L. Brown Vol #: 131
C 8934 M D. Rubi Vol #: 131
C 8935 F. C. Paul Vol #: 131
C 8936 P. Meyer Vol #: 131
C 8937 K. Vaughan Vol #: 131
C 8938 L. Kority Vol #: 131
C 8939 A. Binghan Vol #: 131
C 8940 D. Shue Vol #: 131
C 8941 M. Raeburn Vol #: 131
C 8942 M. Soriano Vol #: 131
C 8943 A. Lafferman Vol #: 131
C 8944 K Schmidi Vol #: 131
C 8945 E. Afpols Vol #: 131
C 8946 S. G. McBride Vol #: 131
C 8947 K. Siversor Vol #: 131
C 8948 J. Winzer Vol #: 131
C 8949 L. Brown Vol #: 131
C 8950 M. Krhsowski Vol #: 131
C 8951 L. Adler, MD Vol #: 131
C 8952 D. Keith Vol #: 131
C 8953 S. McCoy Vol #: 131
C 8954 J. H. Snyder Vol #: 131
C 8955 C. Denson-hamition Vol #: 131
C 8956 C. Byers Vol #: 132
C 8957 E. R. Marzbunk Vol #: 132
C 8958 C. Bistos Vol #: 132
C 8959 R. Chamberlin Vol #: 132
C 8960 L. Ortman Vol #: 132
C 8961 M. Hugha Vol #: 132
C 8962 S. Koch Vol #: 132
C 8964 J. D. Cranwell, MD Vol #: 132
C 8965 L. Steele Vol #: 132
C 8966 J. Petersen Vol #: 132
C 8967 s. Lewis Vol #: 132
C 8968 J. Praiswater Vol #: 132
C 8969 K. Brown Vol #: 132
C 8970 N. Chadlowen Vol #: 132
C 8971 C. Catellani, MD Vol #: 132
C 8972 S. J. Siloa Vol #: 132
C 8973 J. T. Anderson Vol #: 132
C 8974 N. Mantyn Vol #: 132
C 8975 L. Chamlers Vol #: 132
C 8976 C. Bomar Vol #: 132
C 8977 C. Mordgke Vol #: 132
C 8978 P. A/ Wilson Vol #: 132
C 8979 J. M. Pors Vol #: 132
C 8980 L. Yale Vol #: 132
C 8981 J. Stafford Vol #: 132
C 8982 S. Fullerton Vol #: 132
C 8983 P. Miller Vol #: 132
C 8984 P. Miller Vol #: 132
C 8985 V. P. Young Vol #: 132
C 8986 A. Lockard Vol #: 132
C 8987 S. Vol #: 132
C 8988 J. Homan Vol #: 132
C 8989 L. Palmer Vol #: 132
C 8990 D. Tharp Vol #: 132
C 8991 M. Simon Vol #: 132
C 8992 G. A. Francis Vol #: 132
C 8993 S. Myers Vol #: 132
C 8994 V. Turner Vol #: 132
C 8995 H. Peatross Vol #: 132
C 8996 B. Sherman Vol #: 132
C 8997 M. Kirnys Vol #: 132
C 8998 M. Golla Vol #: 132
C 8999 M. Bergl Vol #: 132
C 9000 D. Reed Vol #: 132
C 9001 P. J. Crawford Vol #: 132
C 9002 T. Wood Vol #: 132
C 9003 V. Payor Vol #: 132
C 9004 Jane H. Chamberlain Vol #: 132
C 9005 K. Wiesner Vol #: 132
C 9006 L. Santini Vol #: 132
C 9007 P. Admik Vol #: 132
C 9008 F. Perry Vol #: 132
C 9009 M. Frame Vol #: 132
C 9010 C. Smith Vol #: 132
C 9011 S.Soley Kery Vol #: 132
C 9012 P. Zito Vol #: 132
C 9013 M. Nieisen Vol #: 132
C 9014 M. Nieisen Vol #: 132
C 9015 R. Ortega Vol #: 132
C 9016 T. Lee Vol #: 132
C 9017 R. Banks Vol #: 132
C 9018 R. Banks Vol #: 132
C 9019 A. M. Toth Vol #: 132
C 9020 D. Harrary Vol #: 132
C 9021 D. A. Carter Vol #: 132
C 9022 L. Waugh Vol #: 132
C 9023 J. Lawitz Vol #: 132
C 9024 W. Durham Vol #: 132
C 9025 J. J. Callaway Vol #: 132
C 9026 T. Bauer Vol #: 132
C 9027 T. Bauer Vol #: 132
C 9028 D. Delgado Vol #: 132
C 9029 B. Smith Vol #: 132
C 9030 P. Chabrowe Vol #: 132
C 9031 P. Chabrowe Vol #: 132
C 9032 D. Deckert Vol #: 132
C 9033 P. Boucher Vol #: 132
C 9034 H. L. Elsen Vol #: 132
C 9035 B. L. Heiser Vol #: 132
C 9036 L. Fisher Vol #: 132
C 9037 M. Humer Vol #: 132
C 9038 J. Jacox Vol #: 132
C 9039 L. J. Carter Vol #: 132
C 9040 B. E. Raimond Vol #: 132
C 9041 N. Black Vol #: 132
C 9042 R. Black Vol #: 132
C 9043 D. A. Mitchell Vol #: 132
C 9044 M. Carina P. Kowalewski Vol #: 132
C 9045 D. Ballon Vol #: 132
C 9046 L. Houska Vol #: 132
C 9047 C. Chapman Vol #: 132
C 9048 R. M. Shoemaker Vol #: 132
C 9049 J. Simpson Vol #: 132
C 9050 P. A. Thurau Vol #: 132
2005V-0222 Laser Light Show
VRA 1 FDA/CDRH to Roper Mountain Science Center Vol #: 1
2006D-0012 Guidance for Industry and FDA Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers
C 4 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 1
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
C 8 Alphatec Spine, Inc. Vol #: 2
2006N-0045 Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
C 1 R. Seidenberg Vol #: 1
2006P-0147 Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
C 1 D. Lowe Vol #: 1
2006P-0201 Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
CP 1 B. Braun Medical Inc. Vol #: 1
2006V-0143 Laser Light Show
VRA 1 FDA/CDRH to Pro Video Solutions, Inc. Vol #: 1

Page created on June 30, 2006 kk

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