Document ID: FDA-2010-N-0001-0104
Agency: fda
Document Type: Notice
Title: Transmissible Spongiform Encephalopathies Advisory Committee
Posted Date: 2010-09-14T04:00Z

[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Notices]               
[Page 55803-55804]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se10-79]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Transmissible Spongiform Encephalopathies Advisory Committee; 
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee

[[Page 55804]]

of the Food and Drug Administration (FDA). The meeting will be open to 
the public.
    Name of Committee: Transmissible Spongiform Encephalopathies 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 28, 2010, from 
8:30 a.m. to approximately 5 p.m. and on October 29, 2010, from 8:30 
a.m. to approximately 12:30 p.m.
    Location: Holiday Inn, Gaithersburg, 2 Montgomery Village Ave., 
Gaithersburg, MD, 20879.
    Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512392. Please call the Information Line 
for up-to-date information on this 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.
    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, and 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.
    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. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: 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 
on October 28, 2010, between approximately 11 a.m. and 11:45 a.m. and 
between approximately 3:30 p.m. and 4 p.m. and on October 29, 2010, 
between approximately 10:30 a.m. and 11 a.m. 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.
    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 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).

    Dated: September 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22805 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S