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Dockets Management
Dockets Entered On July 27, 2004
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998N-0359 Program priorities/Center for Food Safety & Applied Nutritin
1999P-5106 Identify Sources of Natural Flavorings
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
2002E-0342 Lea's Shield, U.S. Patent No. 4,703,752
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
2003E-0407 Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
2003N-0342 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
2003P-0574 Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
2004D-0187 Guidance for Industry on Premarketing Risk Assessment
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
2004D-0189 Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
2004N-0114 Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
2004N-0296 Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 14102 Northwest Natural Products, Inc. Vol #: 122
LET 14103 Northwest Natural Products, Inc. Vol #: 122
LET 14104 Arkopharma LLC Vol #: 122
LET 14105 Arkopharma LLC Vol #: 122
LET 14106 Arkopharma LLC Vol #: 122
LET 14107 Planetary Formulas Vol #: 122
LET 14108 Basic Organics, Inc. Vol #: 122
LET 14109 Bodyhealth.com Corporation Vol #: 122
LET 14110 The Hain Celestial Group Vol #: 122
1998N-0359 Program priorities/Center for Food Safety & Applied Nutritin
C 102 Public Citizen Vol #: 8
1999P-5106 Identify Sources of Natural Flavorings
C 36 G. Mayer Vol #: 2
C 37 Eligible Vol #: 2
C 38 L. Lessa Vol #: 2
C 39 D. Finger Vol #: 2
C 40 Eligible Vol #: 2
2000D-1392 Guidance for Industry on Botanical Drug Products
EC 2 Mr. will foster Vol #: 2
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
C 265 Gold Kist, Inc. Vol #: 99
EXB 338 Center for Veterinary Medicine Vol #: 423
EXB 339 Center for Veterinary Medicine Vol #: 423
EXB 340 Center for Veterinary Medicine Vol #: 423
EXB 341 Center for Veterinary Medicine Vol #: 423
EXB 342 Center for Veterinary Medicine Vol #: 423
EXB 343 Center for Veterinary Medicine Vol #: 423
EXB 344 Center for Veterinary Medicine Vol #: 423
EXB 345 Center for Veterinary Medicine Vol #: 423
EXB 346 Center for Veterinary Medicine Vol #: 423
EXB 347 Center for Veterinary Medicine Vol #: 423
EXB 348 Center for Veterinary Medicine Vol #: 423
EXB 349 Center for Veterinary Medicine Vol #: 423
EXB 350 Center for Veterinary Medicine Vol #: 423
EXB 351 Center for Veterinary Medicine Vol #: 423
EXB 352 Center for Veterinary Medicine Vol #: 423
EXB 353 Center for Veterinary Medicine Vol #: 423
EXB 354 Center for Veterinary Medicine Vol #: 423
EXB 355 Center for Veterinary Medicine Vol #: 423
EXB 356 Center for Veterinary Medicine Vol #: 423
EXB 357 Center for Veterinary Medicine Vol #: 423
EXB 358 Center for Veterinary Medicine Vol #: 423
EXB 359 Center for Veterinary Medicine Vol #: 423
EXB 360 Center for Veterinary Medicine Vol #: 423
EXB 361 Center for Veterinary Medicine Vol #: 423
EXB 362 Center for Veterinary Medicine Vol #: 423
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EC 811 N/A Vol #: 163
EMC 8654 H. Drossos Vol #: 283
EMC 8655 P. Prager Vol #: 283
EMC 8656 S. Drager Vol #: 283
EMC 8657 M. Countey Vol #: 283
EMC 8658 A. Wilson Vol #: 283
EMC 8659 K. Salmon Vol #: 283
EMC 8660 M. Schell Vol #: 283
EMC 8661 E. Pannell Vol #: 283
EMC 8662 R. Barba Vol #: 283
EMC 8663 K.T. Prager Vol #: 283
EMC 8664 T. McClean Vol #: 283
EMC 8665 D. Baik Vol #: 283
EMC 8666 J. Pannell Vol #: 283
EMC 8667 B. McBride Vol #: 283
EMC 8668 L. Curran Vol #: 283
EMC 8669 E. Meany Vol #: 283
EMC 8670 M. Joyner Vol #: 283
EMC 8671 J. Franken Vol #: 283
EMC 8672 C. Gabbay Vol #: 283
EMC 8673 S. Eygendaal Vol #: 283
EMC 8674 J. Winship Vol #: 283
EMC 8675 C. Tunkel Vol #: 283
EMC 8676 K. Spielberger Vol #: 283
EMC 8677 B. Sorensen Vol #: 283
EMC 8678 M. Simpson Vol #: 283
EMC 8679 K.M. Warner Vol #: 283
EMC 8680 W. E. Wallace Vol #: 283
EMC 8681 C. Scrafford Vol #: 283
EMC 8682 K. Noonan Vol #: 283
EMC 8683 M. Marucci Vol #: 283
EMC 8684 K. Stachnik Vol #: 283
EMC 8685 S. Trotman Vol #: 283
EMC 8686 T. Jodon Vol #: 283
EMC 8687 E. Jodon Vol #: 283
EMC 8688 S. Parker Vol #: 283
EMC 8689 C. P.R. Vol #: 283
EMC 8690 M. Batz Vol #: 283
EMC 8691 M. Roepe Vol #: 283
EMC 8692 A. Rissmiller Vol #: 283
EMC 8693 D. Camera Vol #: 283
EMC 8694 R. Scrafford Vol #: 283
EMC 8695 A. Rissmiller Vol #: 283
EMC 8696 L. Thompson Vol #: 283
EMC 8697 D. A. Stewart Vol #: 283
EMC 8698 D. Bennett Vol #: 283
EMC 8699 K. Keeling Vol #: 283
EMC 8700 G. Gomez Vol #: 283
EMC 8701 J. Swanson Vol #: 283
EMC 8702 E. Buckwalter Vol #: 283
EMC 8703 M. Leavell Vol #: 283
EMC 8704 W. Crispell Vol #: 283
EMC 8705 B. Rogers Vol #: 283
EMC 8706 S. Boone Vol #: 283
EMC 8707 P. Williams Rodoski Vol #: 283
EMC 8708 C. Absher Vol #: 283
EMC 8709 J. Peguero II Vol #: 283
EMC 8710 J. Solis Vol #: 283
EMC 8711 P. Wollum Vol #: 283
EMC 8712 A. Hall Vol #: 283
EMC 8713 P. Capocchi Vol #: 283
EMC 8714 S. Haugh Vol #: 283
EMC 8715 R. Angevine Vol #: 283
EMC 8716 S. Jodon Vol #: 283
EMC 8717 D. Kosup-Kennedy Vol #: 283
EMC 8718 E. Lyles Vol #: 283
EMC 8719 M. Kelson-Podolsky Vol #: 283
EMC 8720 P. Podolsky Vol #: 283
EMC 8721 J. Gialelis Vol #: 283
EMC 8722 T. Duffy Jr. Vol #: 283
EMC 8723 S. McKinley Vol #: 284
EMC 8724 M. J. Best Vol #: 284
EMC 8725 S. McClain Vol #: 284
EMC 8726 B. K. Kravec Vol #: 284
EMC 8727 R. J. Butler Vol #: 284
EMC 8728 L. Koen Vol #: 284
EMC 8729 P. Driscoll Vol #: 284
EMC 8730 S. G. Jones Vol #: 284
EMC 8731 K. O'Regan Vol #: 284
EMC 8732 N. James Vol #: 284
EMC 8733 J. Parker Vol #: 284
EMC 8734 J. W. Mack Vol #: 284
EMC 8735 D. Bare Vol #: 284
EMC 8736 C. Richardson Vol #: 284
EMC 8737 J. O'Connor Vol #: 284
EMC 8738 P. Mazzantiq Vol #: 284
EMC 8739 None Vol #: 284
EMC 8740 M. Czinski Vol #: 284
EMC 8741 K. M. Biener Vol #: 284
EMC 8742 M. V. Pereira Vol #: 284
EMC 8743 G. Floyd Vol #: 284
EMC 8744 S. Gordon Vol #: 284
EMC 8745 N. Palmatier Vol #: 284
EMC 8746 C. Dazey Vol #: 284
EMC 8747 K. Fix Vol #: 284
EMC 8748 E. Cardinal Hand Vol #: 284
EMC 8749 A. Sherwood Vol #: 284
EMC 8750 L. Fineson Vol #: 284
EMC 8751 L. Garren Vol #: 284
EMC 8752 P. Childs Vol #: 284
EMC 8753 E. S. Brody Vol #: 284
EMC 8754 E. Connor Vol #: 284
EMC 8755 M. Brechwald Vol #: 284
EMC 8756 A. Denholtz Vol #: 284
EMC 8757 B. Wicklund Vol #: 284
EMC 8758 M. Hayne Vol #: 284
EMC 8759 J. Purdue Vol #: 284
EMC 8760 S. Gourley Vol #: 284
EMC 8761 D. G. Mitchell Vol #: 284
EMC 8762 B. Muehlhausen Vol #: 284
EMC 8763 S. D. Noack Vol #: 284
EMC 8764 J. Inwood Vol #: 284
EMC 8765 M. Munday Vol #: 284
EMC 8766 M. Mauro Vol #: 284
EMC 8767 R. S. Allison Vol #: 284
EMC 8768 J. F. Adams Vol #: 284
EMC 8769 L. Friedkin Vol #: 284
EMC 8770 J. E. Marks Vol #: 284
EMC 8771 E. Falk Vol #: 284
EMC 8772 D. L. Masters Vol #: 284
EMC 8773 M. E. Buszek Vol #: 284
EMC 8774 F. Jones Vol #: 284
EMC 8775 S. Lewis Vol #: 284
EMC 8776 E. A. Hammad Vol #: 284
EMC 8777 J. Aten Vol #: 284
EMC 8778 A. s. Abernethy Vol #: 284
EMC 8779 A. Benefico Vol #: 284
EMC 8780 J. T. Gordon Vol #: 284
EMC 8781 B. Van Davis Vol #: 284
EMC 8782 J. Van Davis Vol #: 284
EMC 8783 R. Stull Vol #: 284
EMC 8784 E. Wickstrom Vol #: 284
EMC 8785 K. L. McKenna Vol #: 284
EMC 8786 K. Cafasso Vol #: 284
EMC 8787 N. Anderson Vol #: 284
EMC 8788 M. M. Drake Vol #: 284
EMC 8789 N. Friauf Vol #: 284
EMC 8790 B. Rauch Vol #: 284
EMC 8791 D. Federici Vol #: 284
EMC 8792 K. Gedge Vol #: 284
EMC 8793 B. Plummer Vol #: 284
EMC 8794 E. Rothstein Vol #: 284
EMC 8795 T. Masters Vol #: 284
EMC 8796 E. Fulton Vol #: 284
EMC 8797 R. Lavash Vol #: 284
EMC 8798 S. DeSimone Vol #: 284
EMC 8799 T. L. Felice Vol #: 284
EMC 8800 A. Roberts Vol #: 284
EMC 8801 K. Petronko Vol #: 284
EMC 8802 I. Griffiths Vol #: 284
EMC 8803 D. Wilson Vol #: 284
EMC 8804 J. Hamilton Vol #: 284
EMC 8805 S. Dolen Vol #: 284
EMC 8806 D. Binder Vol #: 284
EMC 8807 M. C. Ludwig-Crangle Vol #: 284
EMC 8808 S. M. Borches Vol #: 284
EMC 8809 W. Rothkopf Vol #: 284
EMC 8810 J. E. Allen Vol #: 284
EMC 8811 S. E. Morton Vol #: 284
EMC 8812 K. O'Malley Vol #: 284
EMC 8813 J. Bettinger Vol #: 284
EMC 8814 M. Bettencourt Vol #: 284
EMC 8815 A. Siracusa Vol #: 284
EMC 8816 P. Galvin Vol #: 284
EMC 8817 V. Burrows Vol #: 284
EMC 8818 D. A. Fair Vol #: 284
EMC 8819 B. Rosenthal Vol #: 284
EMC 8820 K. Manta Vol #: 284
EMC 8821 B. Bob Vol #: 284
EMC 8822 A. Grover Vol #: 284
EMC 8823 C. Fahey-Hunt Vol #: 284
EMC 8824 L. G. Homeyer Vol #: 284
EMC 8825 K. Beal Vol #: 284
EMC 8826 C. Maness Vol #: 284
EMC 8827 J. Ressinger Vol #: 284
EMC 8828 B. Bassett Vol #: 284
EMC 8829 S. Nicholas Vol #: 284
EMC 8830 S. Hilt Vol #: 284
EMC 8831 G. Maloney Lawrence Vol #: 284
EMC 8832 R. Banov Vol #: 284
EMC 8833 G. Longo Vol #: 284
EMC 8834 P. W. Crandall Vol #: 284
EMC 8835 B. W. Mosshart Vol #: 284
EMC 8836 D. K. Eckhardt Vol #: 284
EMC 8837 D. Martin Vol #: 284
EMC 8838 C. Roach Vol #: 284
EMC 8839 A. Rooney Vol #: 284
EMC 8840 B. Natamoros Vol #: 284
EMC 8841 I. Garin Vol #: 284
EMC 8842 S. Oakley Vol #: 284
EMC 8843 J. Marshall Vol #: 284
EMC 8844 E. Barger Vol #: 284
EMC 8845 B. Clague Vol #: 284
EMC 8846 B. Schwenkmeyer Vol #: 284
EMC 8847 H. & E. Haight Vol #: 284
EMC 8848 J. R. Butcher Vol #: 284
EMC 8849 K. Luke Vol #: 284
EMC 8850 L. Imhoff Vol #: 284
EMC 8851 S. Bender Vol #: 284
EMC 8852 C. Tilton-Jones Vol #: 284
EMC 8853 J. Hinze Vol #: 284
EMC 8854 P. E. Pierson Vol #: 284
EMC 8855 K. Bambrick Vol #: 284
EMC 8856 J. Barnard & M. Fain Vol #: 284
EMC 8857 P. J. Gogol Vol #: 284
EMC 8858 M. Thompson Vol #: 284
EMC 8859 B. Harley Vol #: 284
EMC 8860 R. Murphy Vol #: 284
EMC 8861 J. Altman Vol #: 284
EMC 8862 A. LaMonica Vol #: 284
EMC 8863 N. L. DeBlosi Vol #: 284
EMC 8864 T. Welser Vol #: 284
EMC 8865 N. Kahan Vol #: 284
EMC 8866 C. A. Loscalzo Vol #: 284
EMC 8867 M. Sturza Vol #: 284
EMC 8868 E. Best Vol #: 284
EMC 8869 C. A. Hill-Gant Vol #: 284
EMC 8870 M. MacCrae Vol #: 284
EMC 8871 E. Renner Vol #: 284
EMC 8872 J. Edwardson Vol #: 284
EMC 8873 T. R. Nichols Vol #: 284
EMC 8874 M. Hoffnung Vol #: 284
EMC 8875 J. Corbin Smith Vol #: 284
EMC 8876 P. N. Fonts Vol #: 284
EMC 8877 C. J. Adams Vol #: 284
EMC 8878 H. Wade Goolishian Vol #: 284
EMC 8879 C. Kuehl Vol #: 284
EMC 8880 J. Seibel Vol #: 284
EMC 8881 E. Pitt Vol #: 284
EMC 8882 K. Lee Vol #: 284
EMC 8883 S. M. Johnson Vol #: 284
EMC 8884 M. Ramjoue Vol #: 284
EMC 8885 K. Keifer-Boyd Vol #: 284
EMC 8886 K. M. Khan Vol #: 284
EMC 8887 M. G. Hoglund Vol #: 284
EMC 8888 C. Furey Vol #: 284
EMC 8889 S. Mozer Vol #: 284
EMC 8890 K. Harper Berkson Vol #: 284
EMC 8891 J. Holden Vol #: 284
EMC 8892 H. Silvert Newell Vol #: 284
EMC 8893 A. Young Vol #: 284
EMC 8894 B. Brownlee Vol #: 284
EMC 8895 J. Christensen Vol #: 284
EMC 8896 A. Jaffe Vol #: 284
EMC 8897 K. W. Ames Vol #: 284
EMC 8898 L. Wilburn Vol #: 284
EMC 8899 T. Gheen Vol #: 284
EMC 8900 A. Gollakner Vol #: 284
EMC 8901 H. Antoine Vol #: 284
EMC 8902 N. Parsons Craft Vol #: 284
EMC 8903 D. Devonis Vol #: 284
EMC 8904 B. Burns Vol #: 284
EMC 8905 R. O'Meara-Costello Vol #: 284
EMC 8906 C. M. Nichols Vol #: 284
EMC 8907 C. M. Nichols Vol #: 284
EMC 8908 L. Berger Vol #: 284
EMC 8909 K. Carnabucci Vol #: 284
EMC 8910 M. Pelletier Vol #: 284
EMC 8911 N. Chapman Vol #: 284
EMC 8912 M. Shattuck Vol #: 284
EMC 8913 J. Ball Vol #: 284
EMC 8914 M. Roepe Vol #: 284
EMC 8915 E. Schneider Vol #: 284
EMC 8916 J. Watts Haresch Vol #: 284
EMC 8917 R. Rothman Vol #: 284
EMC 8918 L. H. Toole Vol #: 284
EMC 8919 A. Corrigan Vol #: 284
EMC 8920 K. A. Cowles Vol #: 284
EMC 8921 A. Terra Vol #: 284
EMC 8922 N. James Vol #: 284
EMC 8923 B. Kennedy Vol #: 284
EMC 8924 F. Burgess Vol #: 284
EMC 8925 C. Caporusso Vol #: 284
EMC 8926 A. Fulton-Cavett Vol #: 284
EMC 8927 M. Edwards Vol #: 284
EMC 8928 G. Floren Vol #: 284
EMC 8929 I. Innes Vol #: 284
EMC 8930 K. Gorosh Vol #: 284
EMC 8931 L. Lucchese Vol #: 284
EMC 8932 J. K. Obley Vol #: 284
EMC 8933 J. McGuire Vol #: 284
EMC 8934 W. Grigg Vol #: 284
EMC 8935 J. Bunning Vol #: 284
EMC 8936 H. S. Meyer Vol #: 284
EMC 8937 Dr. R. Klein Vol #: 284
EMC 8938 D. Couch Vol #: 284
EMC 8939 B.A. Greenwald Vol #: 284
EMC 8940 S. Parker Vol #: 284
EMC 8941 G. Holden Vol #: 284
EMC 8942 M. E. Roberts Vol #: 284
EMC 8943 A. Suarez Vol #: 284
EMC 8944 P. Self Vol #: 284
EMC 8945 D. Grabien Vol #: 284
EMC 8946 E. L. DeCoux Vol #: 284
EMC 8947 Dr. P. Hudson Vol #: 284
EMC 8948 E. Domagal Vol #: 284
EMC 8949 C. Ward Darby Vol #: 284
EMC 8950 N. O'Connell Vol #: 284
EMC 8951 D. Davis Vol #: 284
EMC 8952 M. Jack Vol #: 284
EMC 8953 C. Hardy Vol #: 284
EMC 8954 A. L. Katz Vol #: 284
EMC 8955 V. Jepson Vol #: 284
EMC 8956 C. Bercovitz Vol #: 284
EMC 8957 S. J. Lashley Vol #: 284
EMC 8958 L. Rinehart Vol #: 284
EMC 8959 A. Burgess Vol #: 284
EMC 8960 T. Miller Vol #: 284
EMC 8961 S. J. Weston Vol #: 284
EMC 8962 K. Doyle Vol #: 284
EMC 8963 N. M. Feltch I Vol #: 284
EMC 8964 R. Copeland Vol #: 284
EMC 8965 M. Richmond Vol #: 284
EMC 8966 J. Stapleton Vol #: 284
EMC 8967 T. Russo Vol #: 284
EMC 8968 G. Salgado Vol #: 284
EMC 8969 M. L. Kraft Vol #: 284
EMC 8970 K. Redfern Vol #: 284
EMC 8971 K. LaBonte Vol #: 284
EMC 8972 A. Calhoun Vol #: 284
EMC 8973 M. Garris Vol #: 284
EMC 8974 D. Vandeventer Vol #: 284
EMC 8975 R. Depart Vol #: 284
EMC 8976 T. Lusciatti Vol #: 284
EMC 8977 L. Breen Vol #: 284
EMC 8978 A. Hansen-Higa Vol #: 284
EMC 8979 A. Hasty Vol #: 284
EMC 8980 C. Gleason Vol #: 284
EMC 8981 K. Christensen Vol #: 284
EMC 8982 J. A. Rosenfeld Vol #: 284
EMC 8983 J. Dukovich Vol #: 284
EMC 8984 C. Miller Vol #: 284
EMC 8985 E. Katz Vol #: 284
EMC 8986 C. Arbit Vol #: 284
EMC 8987 D. Hoke Vol #: 284
EMC 8988 T. Connors Daniel Vol #: 284
EMC 8989 S. S. Pastin Vol #: 284
EMC 8990 L. Coakley Vol #: 284
EMC 8991 N. D. Bosma Vol #: 284
EMC 8992 D. Maughan Vol #: 284
EMC 8993 K. Virago Vol #: 284
EMC 8994 R. Cole Vol #: 284
EMC 8995 P. Gibbs Vol #: 284
EMC 8996 C. Mandile Vol #: 284
EMC 8997 M. Scharphie Vol #: 284
EMC 8998 K. Jurrus Vol #: 284
EMC 8999 E. Denzau Vol #: 284
EMC 9000 A. Sharrow Vol #: 284
EMC 9001 J. Rathwell Vol #: 284
EMC 9002 A. J. Williams Vol #: 284
EMC 9003 K. Burchett Vol #: 284
EMC 9004 N. Ryder Vol #: 284
EMC 9005 S. J. Christiansen Vol #: 284
EMC 9006 Dr. T. Bobo Vol #: 284
EMC 9007 J. Brodziak Vol #: 284
EMC 9008 R. Levin Vol #: 284
EMC 9009 S. Blank Vol #: 284
EMC 9010 R. Bartlein Vol #: 284
EMC 9011 L. Newcomer Vol #: 284
EMC 9012 A. Varga Vol #: 284
EMC 9013 E. Coutts Vol #: 284
EMC 9014 A. Sudeikis Vol #: 284
EMC 9015 K. Kendall-Holliday Vol #: 284
EMC 9016 Dr. C. & G. Alden Vol #: 284
EMC 9017 A. R. Wood Vol #: 284
EMC 9018 J. Fergus Vol #: 284
EMC 9019 A. Moser Vol #: 284
EMC 9020 R. W. Moser Jr. Vol #: 284
EMC 9021 S. L. Burley Vol #: 284
EMC 9022 E. Freed-Brown Vol #: 284
EMC 9023 D. R. Carra Vol #: 284
EMC 9024 C. Kurtz Vol #: 284
EMC 9025 A. Vazquez Vol #: 284
EMC 9026 A. M. Walczak Vol #: 284
EMC 9027 J. Behrman Vol #: 284
EMC 9028 K. Keegan Vol #: 284
EMC 9029 P. Rackowski Vol #: 284
EMC 9030 S. Betzer Vol #: 284
EMC 9031 E. Reilly Vol #: 284
EMC 9032 C. Kalemba Vol #: 284
EMC 9033 H. Bilheimer Vol #: 284
EMC 9034 K. Lems Vol #: 284
EMC 9035 J. Sayre Vol #: 284
EMC 9036 S. Parker Vol #: 284
EMC 9037 M. J. Bridge Vol #: 284
EMC 9038 M. Fine Vol #: 284
EMC 9039 K. R. Galler Vol #: 284
EMC 9040 S. Agar Vol #: 284
EMC 9041 E. Vigneault Vol #: 284
EMC 9042 E. Bloomenthal Vol #: 284
EMC 9043 M. Camardella Vol #: 284
EMC 9044 S. K. Blaney Vol #: 284
EMC 9045 A. Campitelli Vol #: 284
EMC 9046 M. Hardison Vol #: 284
EMC 9047 R. Nussbaum Vol #: 284
EMC 9048 P. D. Berger Vol #: 284
EMC 9049 B. Greenbert Vol #: 284
EMC 9050 R. Sell Vol #: 284
EMC 9051 J. A. Holbrook Vol #: 284
EMC 9052 J. Marriott Vol #: 284
EMC 9053 M. J. Tacheron Vol #: 284
EMC 9054 B. Bradford Vol #: 284
EMC 9055 J. E. Wissler Vol #: 284
EMC 9056 D. Foster Vol #: 284
EMC 9057 K. Heebink Vol #: 284
EMC 9058 R. Shield Vol #: 284
EMC 9059 M. Bia Vol #: 284
EMC 9060 W. W. Conhaim Vol #: 284
EMC 9061 A. Haselberger Vol #: 284
EMC 9062 J. S. Jacobson Vol #: 284
EMC 9063 N. Belisle Vol #: 284
EMC 9064 B. Cobb Vol #: 284
EMC 9065 A. McMillan Vol #: 284
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
LET 4 HFD-005 to US Patent and Trademark Office Vol #: 1
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2002E-0342 Lea's Shield, U.S. Patent No. 4,703,752
LET 2 HFD-005 to US Patent and Trademark Office Vol #: 1
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
C 27 Introractive Consulting Associates GmBH Vol #: 3
C 28 Introractive Consulting Associates GmBH Vol #: 3
C 29 Introractive Consulting Associates GmBH Vol #: 3
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
LET 3 HFD-005 to US Patent and Trademark Office Vol #: 1
2003E-0407 Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
LET 2 HFD-005 to US Patent and Trademark Office Vol #: 1
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EC 11 Ms. Carole Waina Vol #: 4
2003N-0342 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
C 8 AARP Vol #: 2
C 9 National Council on Patient Information and Education (NCPIE) Vol #: 2
EC 2
Attachment
National Association of Chain Drug Stores Vol #: 2
2003P-0574 Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
C 1 Neese Country Sausage, Inc. Vol #: 2
2004D-0187 Guidance for Industry on Premarketing Risk Assessment
C 11 Johnson and Johson Pharmaceutical Research & Development, LLC Vol #: 1
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
C 11 Johnson and Johson Pharmaceutical Research & Development, LLC Vol #: 1
2004D-0189 Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
C 10 Johnson and Johson Pharmaceutical Research & Development, LLC Vol #: 1
2004N-0114 Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards--Part 56 (21 CFR Part 56.115)
N 2 FDA Vol #: 1
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
EXT 1 Grocery Manufacturers of America (GMA) Vol #: 1
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
C 3 Ohio Farm Bureau Federation Vol #: 1
C 4 Center for Science in the Public Interest (CSPI) Vol #: 1
C 5 Government of Canada Vol #: 1
C 6 Canadian Produce Marketing Assn (CPMA) Vol #: 1
C 7 Produce Marketing Assn (PMA) Vol #: 1
C 8 United Fresh Fruit and Vegetable Assn (United) Vol #: 1
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
EXT 12 SmithField Vol #: 1
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EXT 14 Valley Proteins, Inc. Vol #: 1
2004N-0296 Agency Information Collection Activities: Proposed Collection; Comment Request; Good Laboratory Practice (GLP) Regulations for Nonclinical Studies (21 CFR Part 58)
N 1 FDA Vol #: 1

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