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Dockets Management
Dockets Entered On October 20, 2004
Docket # Title
1999P-2630 Establish a Daily Value for "added sugars"
1999P-5106 Identify Sources of Natural Flavorings
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004D-0414 FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2004D-0431 Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
2004D-0440 Guidance for Industry on Computerized Systems Used in Clinical Trials
2004D-0443 Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0267 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
2004P-0464 Vitamin D and Calcium and Reduced Risk of Osteoporosis
1999P-2630 Establish a Daily Value for "added sugars"
EMC 799 B. Combest Vol #: 33
1999P-5106 Identify Sources of Natural Flavorings
EMC 208 D. Sellers Vol #: 3
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12740 Tammy Moppin Vol #: 789
C 12741 Athanasia Gregoriades Vol #: 789
EMC 5839 vnskar@aol.com Vol #: 789
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 10668 K. Benitez Vol #: 294
EMC 10669 A. Snider Vol #: 294
EMC 10670 T. Quinn Vol #: 294
EMC 10671 A. Mantey Vol #: 294
EMC 10672 A. Boland Vol #: 294
EMC 10673 H. Drain Vol #: 294
EMC 10674 D. Thomas Vol #: 294
EMC 10675 L. Brognano Vol #: 294
EMC 10676 M. Leee Vol #: 294
EMC 10677 D. Thomas Vol #: 294
EMC 10678 R. Henry Vol #: 294
EMC 10679 K. Dahl Vol #: 294
EMC 10680 T. Bettinson Vol #: 294
EMC 10681 M. Johnson Vol #: 294
EMC 10682 S. Roberts Vol #: 294
EMC 10683 C. Cafferty Vol #: 294
EMC 10684 A. Nickelson Vol #: 294
EMC 10685 A. Abrosimova Vol #: 294
EMC 10686 K. Gomez Vol #: 294
EMC 10687 B. Collazo Vol #: 294
EMC 10688 J. Gordon Vol #: 294
EMC 10689 A. Hauptstein Vol #: 294
EMC 10690 E. Edenfield Vol #: 294
EMC 10691 M. Quinones Vol #: 294
EMC 10692 J. Goussot Vol #: 294
EMC 10693 C. Surovey Vol #: 294
EMC 10694 D. Crozier Vol #: 294
EMC 10695 J. Kutney Vol #: 294
EMC 10696 G. Grappone Vol #: 294
EMC 10697 N. Swiatek Vol #: 294
EMC 10698 R. Hutchinson Vol #: 294
EMC 10699 A. Hall Vol #: 294
EMC 10700 A. Froese Vol #: 294
EMC 10701 C. Bates Vol #: 294
EMC 10702 M and C Becker Vol #: 294
EMC 10703 D. Jenkins Vol #: 294
EMC 10704 M. Dunn Vol #: 294
EMC 10705 J. Lauzon Vol #: 294
EMC 10706 C. Court Vol #: 294
EMC 10707 K. Kirk Vol #: 294
EMC 10708 C. Nolley Vol #: 294
EMC 10709 S. Windsor Vol #: 294
EMC 10710 C. Showden Vol #: 294
EMC 10711 J. Shematek Vol #: 294
EMC 10712 A. Bresnahan Vol #: 294
EMC 10713 B. Stebleton Vol #: 294
EMC 10714 V. Zeitner Vol #: 294
EMC 10715 D. Sewing Vol #: 294
EMC 10716 T. Fisher Vol #: 294
EMC 10717 L. Hoff Vol #: 294
EMC 10718 S. Straus Vol #: 294
EMC 10719 G. NeSmith Vol #: 294
EMC 10720 M. Waimon Vol #: 294
EMC 10721 J. Foss Vol #: 294
EMC 10722 R. Little Vol #: 294
EMC 10723 K. Buchanan Vol #: 294
EMC 10724 M. Burwell Vol #: 294
EMC 10725 N. Ritter Vol #: 294
EMC 10726 J. Malyn Vol #: 294
EMC 10727 H. Orn Vol #: 294
EMC 10728 R. Devos Vol #: 294
EMC 10729 K. Marrison Vol #: 294
EMC 10730 B. Morgan Vol #: 294
EMC 10731 J. Howell Vol #: 294
EMC 10732 E. Massimini Vol #: 294
EMC 10733 J. Howland Vol #: 294
EMC 10734 R. Safran Vol #: 294
EMC 10735 K. Forbes Vol #: 294
EMC 10736 R. Rogers Vol #: 294
EMC 10737 A. Curry Vol #: 294
EMC 10738 V. Johnson Vol #: 294
EMC 10739 K. Elias Vol #: 294
EMC 10740 S. Oakley Vol #: 294
EMC 10741 R. Barrett Vol #: 294
EMC 10742 J. Levin Vol #: 294
EMC 10743 M. Scharf Vol #: 294
EMC 10744 W. Robinette Vol #: 294
EMC 10745 J. Levin Vol #: 294
EMC 10746 R. Joos Vol #: 294
EMC 10747 B. Mylott Vol #: 294
EMC 10748 S. Swayze Vol #: 294
EMC 10749 D. Miller Vol #: 294
EMC 10750 T. Pier Vol #: 294
EMC 10751 E. Spielmann Vol #: 294
EMC 10752 J. Urrutia Vol #: 294
EMC 10753 R. Elliott Vol #: 294
EMC 10754 A. Martinez Vol #: 294
EMC 10755 J. Shelton Vol #: 294
EMC 10756 L. Janson Vol #: 294
EMC 10757 N. Fontenot Vol #: 294
EMC 10758 E. Braman Vol #: 294
EMC 10759 T. Smith Vol #: 294
EMC 10760 T. Wishart Vol #: 294
EMC 10761 G. Robinson Vol #: 294
EMC 10762 A. Whisnant Vol #: 294
EMC 10763 N. Wheeler Vol #: 294
EMC 10764 P. Goodwin Vol #: 294
EMC 10765 G. Pompa Grace Pompa Vol #: 294
EMC 10766 C. Nieto Vol #: 294
EMC 10767 R. Riggs Vol #: 294
EMC 10768 H. Polese Vol #: 294
EMC 10769 M. Casselman Vol #: 294
EMC 10770 C. Waltershausen Vol #: 294
EMC 10771 B. Bearden Vol #: 294
EMC 10772 P. Stapleton Vol #: 294
EMC 10773 J. Williamson Vol #: 294
EMC 10774 T. Guajardo Vol #: 294
EMC 10775 H. Norcross Vol #: 294
EMC 10776 R. Ulibarri Vol #: 294
EMC 10777 T. Vandergraff Vol #: 294
EMC 10778 T. Vandergraff Vol #: 294
EMC 10779 L. Fauss Vol #: 294
EMC 10780 M. Rotolo Vol #: 294
EMC 10781 M. Kaufman Vol #: 294
EMC 10782 N. Lively Vol #: 294
EMC 10783 V. Jackson Vol #: 294
EMC 10784 S. Rich Vol #: 294
EMC 10785 S. Sewell Vol #: 294
EMC 10786 E. Hodges Vol #: 294
EMC 10787 E. Franklin Vol #: 294
EMC 10788 A. Stone Vol #: 294
EMC 10789 L. Thornton Vol #: 294
EMC 10790 V. Lambert Vol #: 294
EMC 10791 L. Sheridan Vol #: 294
EMC 10792 H. Kapp Vol #: 294
EMC 10793 L. Eadline Vol #: 294
EMC 10794 B. Jalowiec Vol #: 294
EMC 10795 A. Mayrhofer Vol #: 294
EMC 10796 T. Perry Vol #: 294
EMC 10797 C. Rastaedt Vol #: 294
EMC 10798 V. Parks Vol #: 294
EMC 10799 E. Fillion Vol #: 294
EMC 10800 M. Moyer Vol #: 294
EMC 10801 R. Kuhn, PhD Vol #: 294
EMC 10802 J. Dawes Vol #: 294
EMC 10803 G. Rodabaugh Vol #: 294
EMC 10804 S. Salisbury Vol #: 294
EMC 10805 M. Quinones Vol #: 294
EMC 10806 B. Ewing Vol #: 294
EMC 10807 D. Parish Vol #: 294
EMC 10808 M. Johnston Vol #: 294
EMC 10809 E. Markovits Vol #: 294
EMC 10810 A. Lemmert Vol #: 294
EMC 10811 D. Stobaeus Vol #: 294
EMC 10812 R. Saunders Vol #: 294
EMC 10813 E. Fisher Vol #: 4
EMC 10814 B. Perkins Vol #: 294
EMC 10815 S. Carr Vol #: 294
EMC 10816 M. Scott Vol #: 294
EMC 10817 D. Purcell Vol #: 294
EMC 10818 A. Stegich Vol #: 294
EMC 10819 A. Agigian, PhD Vol #: 294
EMC 10820 A. Riggle Vol #: 294
EMC 10821 K. Jalowiec Vol #: 294
EMC 10822 P. Bacon Vol #: 294
EMC 10823 M. Batchelder Vol #: 294
EMC 10824 C. Larson Vol #: 294
EMC 10825 J. McCracken Vol #: 294
EMC 10826 A. Musall Vol #: 294
EMC 10827 L. Bailey Vol #: 294
EMC 10828 L. Evans Vol #: 294
EMC 10829 M. Quenzer Vol #: 294
EMC 10830 C. Lamm Vol #: 294
EMC 10831 L. Baldwin Vol #: 294
EMC 10832 A. LaBoo Vol #: 294
EMC 10833 W. Frederick Vol #: 294
EMC 10834 K. Walsh Vol #: 294
EMC 10835 K. Laird, RN, NP-C Vol #: 294
EMC 10836 A. Boxer Vol #: 294
EMC 10837 L. McFarland Vol #: 294
EMC 10838 J. Murray Vol #: 294
EMC 10839 G. Gautieri Vol #: 294
EMC 10840 S. Mohammadpour Vol #: 294
EMC 10841 B. Jacobs Vol #: 294
EMC 10842 E. Kachmar Vol #: 294
EMC 10843 A. Allred Vol #: 294
EMC 10844 Dr. V. Merlini Vol #: 4
EMC 10845 B. Haas Vol #: 294
EMC 10846 S. Edelstein Vol #: 294
EMC 10847 S. Edelstein Vol #: 294
EMC 10848 A. Houghton, MD Vol #: 294
EMC 10849 G. Parke Vol #: 294
EMC 10850 L. Johnston Vol #: 294
EMC 10851 M. Ewing Vol #: 294
EMC 10852 S. Tobin Vol #: 294
EMC 10853 L. Laing Vol #: 294
EMC 10854 P. Cohoon Vol #: 294
EMC 10855 P. Moessner Vol #: 294
EMC 10856 C. Kyles Vol #: 294
EMC 10857 Ms. Thomas Vol #: 294
EMC 10858 C. Elkins Vol #: 294
EMC 10859 J. Andrade Vol #: 294
EMC 10860 C. Gates Vol #: 294
EMC 10861 M. Molan Vol #: 294
EMC 10862 S. Edler Vol #: 294
EMC 10863 A. Hanson Vol #: 294
EMC 10864 K. McKnight Vol #: 294
EMC 10865 M. Hudson Vol #: 294
EMC 10866 K. Jackson Vol #: 294
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 379 Calorie Control Council Vol #: 6
EMC 380 Dr. B. Martini Vol #: 6
EMC 381 Dr. B. Martini Vol #: 6
EMC 382 Calorie Control Council Vol #: 6
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 423 A. Antonelli Vol #: 9
EMC 424 J. Hirsch Vol #: 9
EMC 425 V. Brimley Vol #: 9
EMC 426 R. Keller Vol #: 9
EMC 427 B and M Starks Vol #: 9
EMC 428 No signature Vol #: 9
EMC 429 No signature Vol #: 9
EMC 430 E. Pollard Vol #: 9
EMC 431 E. Pollard Vol #: 9
EMC 432 B. Coleman Vol #: 9
EMC 433 B. Coleman Vol #: 9
EMC 434 No signature Vol #: 9
EMC 435 H. Glynell Vol #: 9
2004D-0414 FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
EMC 1 B. Sachau Vol #: 1
2004D-0431 Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
EMC 1 B. Sachau Vol #: 1
2004D-0440 Guidance for Industry on Computerized Systems Used in Clinical Trials
EMC 1 B. Sachau Vol #: 1
EMC 2 B. Sachau Vol #: 1
2004D-0443 Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
EMC 1 B. Sachau Vol #: 1
2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 1124 R. Freedman Vol #: 11
EMC 1125 L. Freedman Vol #: 11
EMC 1126 T. Schwamb Vol #: 11
EMC 1127 S. Sududth Vol #: 11
EMC 1128 N and G Shinn Vol #: 11
EMC 1129 D and G Carson Vol #: 11
EMC 1130 D and G Carson Vol #: 11
EMC 1131 N and G Shinn Vol #: 11
EMC 1132 N and G Shinn et al. Vol #: 11
EMC 1133 Dr. L. Ugolik Vol #: 11
EMC 1134 D. Halsey Vol #: 11
EMC 1135 Chinese Goverment Vol #: 11
2004N-0267 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
EMC 2 Biotechnology Industry Organization (BIO) Vol #: 1
EMC 3 Merck & Co., Inc. Vol #: 1
EMC 4 Consumer Healthcare Products Assn (CHPA) Vol #: 1
2004P-0464 Vitamin D and Calcium and Reduced Risk of Osteoporosis
ACK 1 HFS-830 to Johnson Nutrition Solutions LLC Vol #: 1
CP 1 The Beverage Institute for Health & Wellness LLC Vol #: 1

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