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Dockets Management

Dockets Entered On September 24, 2007 - Corrected Copy
Docket # Title
1978N-0038 Sunscreen Drug Products
1992P-0250 Refrain from action against Genetic Systems HIV-1 test kits
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2002D-0081 Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005P-0405 Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007N-0264 Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
2007N-0330 Presidential Interagency Working Group on Import Safety; Public Meeting
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
2007P-0358 Ensure the Safe and Effective Use of Orally Administered Immunosuppressant Drugs That are Used in the Transplant Population and are Characterized by a Narrow Therapeutic Index
1978N-0038 Sunscreen Drug Products
EC 2424 Mrs. Lisa Jaeck-Fisher Vol #: 161
EC 2425 Ms. DAnae Kesel Vol #: 161
EC 2426 Randall International LP Vol #: 161
EC 2427 Mr. John Marin Vol #: 161
EC 2428 FDA Vol #: 161
EC 2429 Mr. Donald Kiesling Vol #: 161
EC 2430 Mrs. Jo McClure Vol #: 161
EC 2431 ASHTABULA COUNTY MEDICAL CENTER Vol #: 161
EC 2432 Mrs. Deborah Blacher Vol #: 161
EC 2433 Mrs. Alicia Laddin Vol #: 161
EC 2434 Mrs. Maureen Hetrick Vol #: 161
EC 2435 Miss. HEIDI BALDWIN Vol #: 161
EC 2436 Mrs. Yelena Petrova Vol #: 161
EC 2437 Mrs. Genesis DeLong Vol #: 161
EC 2438 KINeSYS Inc. Vol #: 161
EC 2439 Mrs. jennifer helsdingen Vol #: 161
EC 2440 Mr. Jason Dawson Vol #: 161
EC 2441 University of Pennsylvania Vol #: 161
EC 2442 Mr. A Briscoe Vol #: 161
EC 2443 Miss. Kelly Ryan Vol #: 161
EC 2444 Mr. Alex Ross Vol #: 161
1992P-0250 Refrain from action against Genetic Systems HIV-1 test kits
WDL 1 Bourget Laboratories Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 20876 NOW Foods Vol #: 181
2002D-0081 Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood
C 5 ZLB Plasma Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
RBF 1 TMJ Implants, Inc, and Robert W. Christensen and Maureen K. Mooney Vol #: 245
2005P-0405 Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components
LET 3 FDA/CDRH to Orhopedic Surgical Manufacturers Association Vol #: 4
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18337 G. Wright Vol #: 198
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 2625 P Ashton Vol #: 27
C 2626 P Colombo Vol #: 27
C 2627 W Fleming Vol #: 27
C 2628 M Eaton Vol #: 27
C 2629 H Moessner Vol #: 27
C 2630 C Chumbly Vol #: 27
C 2631 D Stafford Vol #: 27
C 2632 A Tyler Vol #: 27
C 2633 C DeLosa Vol #: 27
C 2634 R. Chrzanowski Vol #: 27
C 2635 L Dunaway Vol #: 27
C 2636 J Whidden Vol #: 27
C 2637 E Collinsworth Vol #: 27
C 2638 V Feagell Vol #: 27
C 2639 G Penick Vol #: 27
C 2640 V Collins Vol #: 27
C 2641 R Riegsecker Vol #: 27
C 2642 A Vamdergriff Vol #: 28
C 2643 O Gilley Jr Vol #: 28
C 2644 D Darling Vol #: 28
C 2645 R Knapp Vol #: 28
C 2646 J Rodriquez Vol #: 28
C 2647 D Messina Vol #: 28
C 2648 C Garrett Vol #: 28
C 2649 C Jones Vol #: 28
C 2650 S Turner Vol #: 28
C 2651 G Vesper Vol #: 28
C 2652 B Heidle Vol #: 28
C 2653 G Bronstein Vol #: 28
C 2654 C Fowler Vol #: 28
C 2655 C Lipman Vol #: 28
C 2656 M Morgan Vol #: 28
C 2657 D Hollinger Vol #: 28
C 2658 N Batson Vol #: 28
C 2659 J McDowell Vol #: 28
C 2660 J Raskin Vol #: 28
C 2661 M Devlin Vol #: 28
C 2662 A Roe Vol #: 28
C 2663 J Russell Jr Vol #: 28
C 2664 D Crawford Vol #: 28
C 2665 K Kalandros Vol #: 28
C 2666 M Morrison Vol #: 28
C 2667 K Batchelor Vol #: 28
C 2668 F Miller Vol #: 28
C 2669 D Cunningham Vol #: 28
C 2670 N Tanzini Vol #: 28
C 2671 M Finerman Vol #: 28
C 2672 G Bruchette Vol #: 28
C 2673 J Coleman Vol #: 28
C 2674 J Kinser Vol #: 28
C 2675 J Bergren Vol #: 28
C 2676 M Martin Vol #: 28
C 2677 H Rukusek Vol #: 28
C 2678 D Macleary Vol #: 28
C 2679 B Emme Vol #: 28
C 2680 U Sundaram Vol #: 28
C 2681 G Groover Vol #: 28
C 2682 M Bassford Vol #: 28
C 2683 P Stover Vol #: 28
C 2684 W James Vol #: 28
C 2685 L Cruse Vol #: 28
C 2686 M Blankers Vol #: 28
C 2687 M Venegas Vol #: 28
C 2688 S Sanders Vol #: 28
C 2689 A DeLaGarza Jr Vol #: 28
C 2690 S Melling Vol #: 28
C 2691 L Hodges Vol #: 28
C 2692 H Logsdon Vol #: 28
C 2693 D Fischer Vol #: 28
C 2694 M Koster Vol #: 28
C 2695 B Schroeder Vol #: 28
C 2696 S Tryba Vol #: 28
C 2697 J Zielinski Vol #: 28
C 2698 D Coursey Vol #: 28
C 2699 Z Walker Vol #: 28
C 2700 R Guilbeaux Vol #: 28
C 2701 E Lowe Vol #: 28
C 2702 J Reynolds Vol #: 28
C 2703 E Dzamka Vol #: 28
C 2704 A Murphy Vol #: 28
C 2705 I Browder Vol #: 28
C 2706 J Johns Vol #: 28
C 2707 R Cutler Vol #: 28
C 2708 A Ohneth Vol #: 28
C 2709 J Ballentine Vol #: 28
C 2710 K Price Vol #: 28
C 2711 J O'Laughlin Vol #: 28
C 2712 J Adams Vol #: 28
C 2713 F Dodge Vol #: 28
C 2714 B Jessin Vol #: 28
C 2715 M Mueller Vol #: 28
C 2716 L Goodman Vol #: 28
C 2717 A Keyler Vol #: 28
C 2718 L Kozlovich Vol #: 28
C 2719 R Becker Vol #: 28
C 2720 K George Vol #: 28
C 2721 C Smith Vol #: 28
C 2722 H Jones Vol #: 28
C 2723 J Bishop Vol #: 28
C 2724 D Paper Vol #: 28
C 2725 J Hamersly Vol #: 28
C 2726 G Connors Vol #: 28
C 2727 D Nicolini Vol #: 28
C 2728 P Evard Vol #: 28
C 2729 J Chiu Vol #: 28
C 2730 D Gray Vol #: 28
C 2731 R Greenwood Vol #: 28
C 2732 N Flon Vol #: 28
C 2733 K Stumpf Vol #: 28
C 2734 R Morris Vol #: 28
C 2735 W Green Vol #: 28
C 2736 M Clarke Vol #: 28
C 2737 M Hamilton Vol #: 28
C 2738 B Tondello Sr Vol #: 28
C 2739 G Carpenter Vol #: 28
C 2740 M Cortese Vol #: 28
C 2741 M Collins Vol #: 28
C 2742 T Ambron Vol #: 28
C 2743 F Brooks Vol #: 28
C 2744 A Firesteen Vol #: 28
C 2745 C Brenner Vol #: 28
C 2746 M Romano Vol #: 28
C 2747 W Sikes Vol #: 28
C 2748 J Casson Vol #: 28
C 2749 M Salyer Sr Vol #: 28
C 2750 R Elkins Vol #: 28
C 2751 B Baxter Vol #: 28
C 2752 C Abraham Vol #: 28
C 2753 P Travis Vol #: 28
C 2754 M Geer Vol #: 28
C 2755 R Donald Vol #: 28
C 2756 R Hagaman Vol #: 28
C 2757 C. Martin Vol #: 28
C 2758 S Beatty Vol #: 28
C 2759 J Higgins Vol #: 28
C 2760 M Jacobson Vol #: 28
C 2761 S Vaccaro Vol #: 28
C 2762 F Miller Vol #: 28
C 2763 H Bong Vol #: 28
C 2764 K Schilling Vol #: 28
C 2765 M Schaenzer Vol #: 28
C 2766 B Flores Vol #: 28
C 2767 L Tower Vol #: 28
C 2768 M Tiscus Vol #: 28
C 2769 L Jacobson Vol #: 28
C 2770 R Subria Vol #: 28
C 2771 R Twedt Vol #: 28
C 2772 D Richardson Vol #: 28
C 2773 R Schoeff Vol #: 28
C 2774 P Morgan Vol #: 28
C 2775 P Dewey Vol #: 28
C 2776 P Isonberg Vol #: 28
C 2777 C King Vol #: 28
C 2778 R Smith Vol #: 28
C 2779 D Lopshire Vol #: 28
C 2780 N Sterling Vol #: 28
C 2781 P Korsmo Vol #: 28
C 2782 J Jones Vol #: 28
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 146 Diane Stockman Vol #: 7
2007N-0264 Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
NCR 1 FDA Vol #: 1
NCR 2 FDA Vol #: 1
2007N-0330 Presidential Interagency Working Group on Import Safety; Public Meeting
EC 114 Association of Food and Drug Officials Vol #: 1
2007P-0097 Issue a new regulation wine product the composition of wine , water, sugar, with or without flavorings and an alcohol content of less than 75% can not be marketed or sold with a wine varietal designa
C 2 DEER RUN WINERY Vol #: 1
C 3 Ciccone Vineyard & Winery LLC Vol #: 1
C 4 OAKS RANCH Vol #: 1
C 5 OWENS & SULLIVANS WINERY Vol #: 1
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
EC 61 Mr. Yi Pan Vol #: 1
2007P-0358 Ensure the Safe and Effective Use of Orally Administered Immunosuppressant Drugs That are Used in the Transplant Population and are Characterized by a Narrow Therapeutic Index
CP 1 Astellas Pharma US, Inc. Vol #: 1
CP 2 FDA/DDM to Astellas Pharma US, Inc. Vol #: 1

Page created on October 2, 2007 ue

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