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Thread: Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED

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    Exclamation Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED

    Tuesday, April 21, 2015

    Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

    http://tseac.blogspot.com/2015/04/tr...halopathy.html



    kind regards, terry

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    June 1, 2015: Transmissible Spongiform Encephalopathies Advisory Committee
    Meeting Announcement

    Center

    Date

    Time

    Location

    CBER June 1, 2015 June 1, 2015 from 8:00 a.m. to approximately 5:00 p.m.
    10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room,
    room 1503 Silver Spring, MD 20993-0002

    Agenda

    On June 1, 2015, the Transmissible Spongiform Encephalopathies Advisory
    Committee will meet in open session to hear update presentations on the
    following topics: 1) the variant Creutzfeldt-Jakob Disease (vCJD) situation
    worldwide and an update on the United Kingdom’s Transfusion Medicine
    Epidemiological Review; 2) vCJD in the United States; and 3) the bovine
    spongiform encephalopathy (BSE) situation worldwide and the United States
    Department of Agriculture’s regulatory approaches to reduce the risk of
    food-borne exposure of BSE. Following the update presentations, in open
    session, the committee will hear presentations from FDA on current measures
    to reduce risk of vCJD from transfusion in the US, and a mathematical model
    of the risk reduction achievable under the current and alternative
    geographically based donor deferral policies in conjunction with leukocyte
    reduction of blood components. The Committee will then discuss FDA’s
    geographically based donor deferral policies and other strategies, including
    leukocyte reduction of blood components, to reduce the risk of
    transfusion-transmitted vCJD.

    Meeting Materials

    Materials for this meeting will be available on the 2015 Meeting Materials,
    Transmissible Spongiform Encephalopthies Advisory Commitee page.

    Public Participation Information

    Interested persons may present data, information, or views, orally or in
    writing, on issues pending before the committee. •Written submissions may be
    made to the contact person on or before May 25, 2015 •Oral presentations on
    June 1, 2015 from the public will be scheduled between approximately 2:30
    p.m. and 3:30 p.m. •Those individuals interested in making formal oral
    presentations should notify the contact person and submit a brief statement
    of the general nature of the evidence or arguments they wish to present, the
    names and addresses of proposed participants, and an indication of the
    approximate time requested to make their presentation on or before May 15,
    2015. Time allotted for each presentation may be limited. If the number of
    registrants requesting to speak is greater than can be reasonably
    accommodated during the scheduled open public hearing session, FDA may
    conduct a lottery to determine the speakers for the scheduled open public
    hearing session. The contact person will notify interested persons regarding
    their request to speak by May 18, 2015. •For those unable to attend in
    person, the meeting will also be Web cast. The Web cast will be available at
    the following link. Transmissible Spongiform Encephalopathies Advisory
    Committee meeting June 1, 2015: https://collaboration.fda.gov/cbertseac/

    Contact Information •Bryan Emery or Rosanna Harvey 10903 New Hampshire Ave.,
    Bldg. 71, rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054 e-mail:
    Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov •FDA Advisory
    Committee Information Line 1-800-741-8138 (301-443-0572 in the Washington,
    DC, area). Please call the Information Line for up-to-date information on
    this meeting.

    FDA intends to make background material available to the public no later
    than 2 business days before the meeting. If FDA is unable to post the
    background material on its Web site prior to the meeting, the background
    material will be made publicly available at the location of the advisory
    committee meeting, and the background material will be posted on FDA’s Web
    site after the meeting.

    A notice in the Federal Register about last minute modifications that impact
    a previously announced advisory committee meeting cannot always be published
    quickly enough to provide timely notice. Therefore, you should always check
    the agency’s Web site and call the appropriate advisory committee hot
    line/phone line to learn about possible modifications before coming to the
    meeting.

    Persons attending FDA’s advisory committee meetings are advised that the
    agency is not responsible for providing access to electrical outlets.
    Seating for this meeting may be limited, so the public is encouraged to
    watch the free webcast if you are unable to attend. The link for the webcast
    will be available at 8 a.m. June 1, 2015 at the links above. FDA welcomes
    the attendance of the public at its advisory committee meetings and will
    make every effort to accommodate persons with physical disabilities or
    special needs. If you require special accommodations due to a disability,
    please contact Bryan Emery or Rosanna Harvey at least 7 days in advance of
    the meeting. FDA is committed to the orderly conduct of its advisory
    committee meetings. Please visit our Web site at
    http://www.fda.gov/AdvisoryCommittee.../ucm111462.htm
    for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5
    U.S.C. app. 2). Official FR Notice

    http://www.fda.gov/AdvisoryCommittee...ce=govdelivery


    Tuesday, April 21, 2015

    Transmissible Spongiform Encephalopathy Advisory Committee TSEAC MEETING SCHEDULED FOR June 1, 2015

    http://tseac.blogspot.com/2015/04/tr...halopathy.html

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