|CBER||March 14, 2013||March 14, 2013 from 8:00 a.m. to approximately 4:00 p.m.||5630 Fishers Lane, |
Rockville, MD 20857
On March 14, 2013, the Committee will meet in open session to discuss FDA’s draft risk assessment model for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in Red Blood Cells for transfusion in the United States.
Materials for this meeting will be available on the 2013 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 March 7, 2013
- Oral presentations on March 14, 2013 from the public will be scheduled between approximately 1:00 p.m. and 2:00 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 February 27, 2013. 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 February 28, 2013.
- 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 March 14, 2013:
- Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1297 or 301-827-1277
e-mail: email@example.com or email: firstname.lastname@example.org
- 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. March 14, 2013 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 Pearline Muckelvene 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