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U.S. Department of Health and Human Services

Advisory Committees

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October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Announcement

Center

Date

Time

Location

CBER

October 28-29, 2010

October 28 from 8:30 a.m. to approximately 5 p.m.
October 29 from 8:30 a.m. to approximately 12:30 p.m.

Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD

 

 

 

 

 

Agenda

On October 28, 2010 the Committee will discuss: (1) FDA’s risk assessment for potential exposure to the variant Creutzfeldt - Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII and (2) labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD. On October 29, 2010, the Committee will hear informational presentations related to FDA’s geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, tissue and cellular and tissue based products. The Committee will also hear updates on the following topics: The development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

Meeting Materials

Materials for this meeting will be available on the 2010 Meeting Materials, Transmissible Spongiform Encephalopathies Advisory Committee 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 October 21, 2010
  • Oral presentations from the public will be scheduled between approximate 11 a.m. and 11:45 a.m. and between 3:30 p.m. and 4 p.m. on October 28 and between approximately 10:30 a.m. and 11 a.m. on October 29. Those desiring to make 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 October 13, 2010. 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 October 14 , 2010.

Contact Information

  • Bryan Emery or Rosanna Harvey
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    301-827-0314
    FAX: 301-827-0294
    e-mail: bryan.emery@fda.hhs.govrosanna.harvey@fda.hhs.gov
    FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington, DC, area)
    code 3014512391. 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. 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 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 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).