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Dockets Management
Dockets Entered On May 16, 2007
Docket # Title
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-1340 Declared Eternity eau de Parfum Misbranded
2000E-1253 Patent Extension Application for RAPLON (rapacuronium bromide), U.S. Patent No. 5,418,226
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2003E-0457 Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0573 Draft Animal Cloning Risk Assessment
2004N-0408 Regulatory Site Visit Training Program
2005D-0112 Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
2005E-0255 Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
2005N-0272 Irradiation in the Production, Processing, and Handling of Food
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0494 Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
2006D-0254 Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
2006E-0008 Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
2006E-0204 Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
2006E-0234 Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
2006E-0260 Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
2006E-0282 Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
2006P-0372 Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
2007D-0185 Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
2007E-0009 Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
2007E-0011 Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
2007E-0066 Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
2007E-0131 Patent Term Extension for OMNARIS (ciclesonide), U.S. Patent No. 5,482,934
2007E-0133 Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,395,716
2007E-0138 Patent Extension Application for ArteFill, U.S. Patent No. 5,344,452
2007E-0139 Patent Extension Application for Vectibix (panitumumab), U.S. Patent No. 6,235,883
2007E-0143 Patent Extension Application for Zolinza, U.S. Patent No. RE38506
2007M-0156 H060003, Onyx Liquid Embolic System (Onyx HD-500, Model 105-8101-500)
2007N-0041 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4444 K. Mason Vol #: 320
EMC 4445 D. & V. Frederick Vol #: 320
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 684 B. Wilkie Vol #: 24
EMC 685 World Wide Toxic Injury Awareness & Education Vol #: 24
EMC 686 J. Sverdlove Vol #: 24
EMC 687 A. Miller Vol #: 24
EMC 688 M. Bonogofsky Vol #: 24
EMC 689 J. Hix Vol #: 24
EMC 690 L. Lawson Vol #: 24
EMC 691 V. Wooding Vol #: 24
EMC 692 C. Pitts Vol #: 24
EMC 693 J. MacLeod Vol #: 24
2000E-1253 Patent Extension Application for RAPLON (rapacuronium bromide), U.S. Patent No. 5,418,226
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 259 G. Beall Vol #: 4
EMC 260 V. Massam Vol #: 4
2003E-0457 Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
LET 4 FDA/CDER to the U.S. Patent and Tradmark Office Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1488 C. Kearney Vol #: 12
EMC 1489 Planned Administrator's, Inc. Vol #: 12
2003N-0573 Draft Animal Cloning Risk Assessment
EC 8145 Union of Concerned Scientists Vol #: 94
EMC 377 L. Hammer Vol #: 5
EMC 378 W. Kelly Vol #: 5
EMC 379 P. Williford Vol #: 5
EMC 380 D. Stone Vol #: 5
EMC 381 J. Cleek Vol #: 5
EMC 382 D. Handel Vol #: 5
EMC 383 S. Nelson Vol #: 5
EMC 384 S. Singleton Vol #: 5
EMC 385 R. Moreno Vol #: 5
EMC 386 L. French Vol #: 5
EMC 387 C. Haddad Vol #: 5
EMC 388 K. Montague Vol #: 5
EMC 389 S. Gibson Vol #: 5
EMC 390 H. Reid Vol #: 5
EMC 391 S. Schoenewe Vol #: 5
EMC 392 R. Roback Vol #: 5
EMC 393 S. Raval Vol #: 5
EMC 394 L. Hill Vol #: 5
EMC 395 K. Doolan Vol #: 5
EMC 396 T. Landon Vol #: 5
EMC 397 A. Stature Vol #: 5
EMC 398 K. Doolan Vol #: 5
EMC 399 K. Holden Vol #: 5
EMC 400 M. Steinberg Vol #: 5
EMC 401 J. Eisemann Vol #: 5
EMC 402 R. Perez Vol #: 5
EMC 403 M. Ver Eecke Vol #: 5
2004N-0408 Regulatory Site Visit Training Program
EC 29 Cord Blood Registry (CBR Systems, Inc.) Vol #: 1
EC 30 Mayo Clinic Rochester Vol #: 1
EC 31 San Diego Eye Bank Vol #: 1
EC 32 Biomat USA, Inc. Vol #: 1
EC 33 Moffitt Cancer Center Vol #: 1
2005D-0112 Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005E-0255 Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2005N-0272 Irradiation in the Production, Processing, and Handling of Food
EREG 697 M. Rocka Vol #: 7
EREG 698 C. Barritt Vol #: 7
EREG 699 S. Sullivan Vol #: 7
EREG 700 D. Wickman Vol #: 7
EREG 701 L. Stillman Vol #: 7
EREG 702 A. Bockrath Vol #: 7
EREG 703 E. Robins Vol #: 7
EREG 704 L. Gayle Vol #: 7
EREG 705 D. Baum Vol #: 7
EREG 706 C. Barry Vol #: 7
EREG 707 S. Yao Vol #: 7
EREG 708 Healthy Focus Vol #: 7
EREG 709 M. McGuire Vol #: 7
EREG 710 L. Klanderman Vol #: 7
EREG 711 D. Ronnow Vol #: 7
EREG 712 J. Mudrak Vol #: 7
EREG 713 M. Webster Vol #: 7
EREG 714 D. Ehling Vol #: 7
EREG 715 Feldenkrais International Vol #: 7
EREG 716 Feldenkrais International Vol #: 7
EREG 717 P. Trochesset Vol #: 7
EREG 718 S. Scott Vol #: 7
EREG 719 Private Citizen Vol #: 7
EREG 720 T. Donaldson Vol #: 7
EREG 721 K. Dilts Vol #: 7
EREG 722 J. Rodgers-Phan Vol #: 7
EREG 723 D. Finkelstein Vol #: 7
EREG 724 R. May Vol #: 7
EREG 725 National College of Natural Medicine Vol #: 7
EREG 726 WestonAprice Foundation Vol #: 7
EREG 727 Samaritan Pacific Hospitals Vol #: 7
EREG 728 H. Holland Vol #: 7
EREG 729 J. Jordan Vol #: 7
EREG 730 H. Meisch Vol #: 7
EREG 731 B. Corriveau Vol #: 7
EREG 732 M. LeBaron Vol #: 7
EREG 733 P. Jaslove Vol #: 7
EREG 734 W. Gordon Vol #: 7
EREG 735 Harvard University Vol #: 7
EREG 736 Yale University Vol #: 7
EREG 737 A. Aymond Vol #: 7
EREG 738 S. Rifkin Vol #: 7
EREG 739 B. Slitkin Vol #: 7
EREG 740 J. Kovac Vol #: 7
EREG 741 Partners In Healing Vol #: 7
EREG 742 A. Wolff Vol #: 7
EREG 743 J. Shudde Vol #: 7
EREG 744 A. Stiver Vol #: 7
EREG 745 Pyramid Learning Concepts, L. L. C. Vol #: 7
EREG 746 S. Conti Vol #: 7
EREG 747 H. F. Hull & Associates, L. L. C. Vol #: 7
EREG 748 J. Denny Vol #: 7
EREG 749 A. Taft Vol #: 7
EREG 750 J. Johnson Vol #: 7
EREG 751 J. Holland Vol #: 7
EREG 752 S. Ferguson Vol #: 7
EREG 753 J. Tane Vol #: 7
EREG 754 Center for Food Safety Vol #: 7
EREG 755 P. Nussbaum Vol #: 7
EREG 756 H. McKay Vol #: 7
EREG 757 R. Windsor Vol #: 7
EREG 758 A. Kaplan Vol #: 7
EREG 759 A. Doran Vol #: 7
EREG 760 J. Pazmino Vol #: 7
EREG 761 D. Cohen Vol #: 7
EREG 762 R. McMahon Vol #: 7
EREG 763 J. Diessel Vol #: 7
EREG 764 S. Donegan Vol #: 7
EREG 765 C. W. Hawaii Pride, L. L. C. Vol #: 7
EREG 766 Weston A. Price Foundation Vol #: 7
EREG 767 M. McClaran Vol #: 7
EREG 768 L. Rowe Vol #: 7
EREG 769 J. S. C.-N. A. S. A. (Contractor) Vol #: 7
EREG 770 A. Brooks Vol #: 7
EREG 771 R. Fink-Winter Vol #: 7
EREG 772 V. Merz Vol #: 7
EREG 773 Floodgate Farm Vol #: 7
EREG 774 B. Richman Vol #: 7
EREG 775 Middlebury Natural Foods Co-op Vol #: 7
EREG 776 R. Jamieson Vol #: 7
EREG 777 S. Melton Vol #: 7
EREG 778 T. Earnest Vol #: 7
EREG 779 Weston A. Price Foundation Vol #: 7
EREG 780 Abington Nutrition Services Vol #: 7
EREG 781 S. Criscuolo Vol #: 7
EREG 782 C. Murrens Vol #: 7
EREG 783 S. Colella Vol #: 7
EREG 784 L. Gibson Vol #: 7
EREG 785 J. Lara Vol #: 7
EREG 786 Homeland-Defense 4 U, Inc. Vol #: 7
EREG 787 T. Cooper Vol #: 7
EREG 788 M. Lamore Vol #: 7
EREG 789 M. Weingart Vol #: 7
EREG 790 C. Lindsey Vol #: 7
EREG 791 E. Yourtee Vol #: 7
EREG 792 J. Gillis Vol #: 7
EREG 793 N. Dawley Vol #: 7
EREG 794 Center for Food Safety Vol #: 7
EREG 795 M. Cardell Vol #: 7
EREG 796 B. LeGreca Vol #: 7
EREG 797 M. Landon Vol #: 7
EREG 798 N. O. Vol #: 7
EREG 799 M. Fine Vol #: 7
EREG 800 Y. Rice Vol #: 7
EREG 801 B. Jones Vol #: 7
EREG 802 F. D. A. Vol #: 7
EREG 803 M. Latino Vol #: 7
EREG 804 A. Ross Vol #: 7
EREG 805 White Buck Farm Vol #: 7
EREG 806 Actor Vol #: 7
EREG 807 J. Boal Vol #: 7
EREG 808 I. Rovira Vol #: 7
EREG 809 T. Parisi Vol #: 7
EREG 810 H. Carlock Vol #: 7
EREG 811 N. Savinelli Vol #: 7
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
SUP 1 A. A. C. C. International Vol #: 35
2005N-0494 Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006D-0254 Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
EMC 2 B. Sachau Vol #: 1
2006E-0008 Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0204 Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0234 Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0260 Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0282 Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006P-0372 Determine whether Mepron (atovaquone) Tablets, 250 mg, has been voluntarily withdrawn from sale for safety or efficacy reasons
N 1 FDA Vol #: 1
2007D-0027 Voluntary Self Inspection of Medicated Feed Manufacturing Facilities
EMC 1 B. Sachau Vol #: 1
2007D-0185 Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007E-0009 Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0011 Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0066 Patent Term Extension for NOXAFIL (posaconazole), U.S. Patent No. 5,661,151
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0131 Patent Term Extension for OMNARIS (ciclesonide), U.S. Patent No. 5,482,934
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0133 Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,395,716
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0138 Patent Extension Application for ArteFill, U.S. Patent No. 5,344,452
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0139 Patent Extension Application for Vectibix (panitumumab), U.S. Patent No. 6,235,883
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0143 Patent Extension Application for Zolinza, U.S. Patent No. RE38506
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007M-0156 H060003, Onyx Liquid Embolic System (Onyx HD-500, Model 105-8101-500)
AAV 1 Ev3 Neurovascular Vol #: 1
2007N-0041 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
N 2 FDA Vol #: 1
2007N-0121 Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
EMC 23 Rx Innovations Vol #: 2
EMC 24 Virginia Department of Corrections-Pharmacy Vol #: 2
EMC 25 C. Decker Vol #: 2
EMC 26 Central Virginia Health Services, Inc. Vol #: 2
EMC 27 B. Sigman Vol #: 2
EMC 28 S. Bounds Vol #: 2
EMC 29 Walgreens Vol #: 2
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
EMC 196 T. O'Connor Vol #: 2
EMC 197 C. Shipman Vol #: 2
EMC 198 J. Schlegel Vol #: 2
EMC 199 D. Leigh Vol #: 2
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
EMC 170 H. Nelson Vol #: 4
EMC 171 L. Baroni Vol #: 4
EMC 172 A. Ott Vol #: 4
EMC 173 R. Burns Vol #: 4
EMC 174 B. Nichols Vol #: 4

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