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Advisory Committees

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

CenterDateTimeLocation
CBERJune 1, 2015June 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/AdvisoryCommittees/AboutAdvisoryCommittees/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

Page Last Updated: 06/09/2016
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