Document ID: FDA-2015-N-0001-0045
Agency: fda
Document Type: Notice
Title: Transmissible Spongiform Encephalopathies Advisory
Committee; Notice of Meeting
Posted Date: 2015-04-29T04:00Z

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23797-23798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 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 June 1, 2015, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be 
available via Webcast. The Webcast will be available at the following 
link: https://collaboration.fda.gov/cbertseac/. When accessing the 
Webcast please enter as a guest. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 240-
402-8054 or 240-402-8072; or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    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 U.S., and a 
mathematical model of the risk reduction achievable under the current 
and alternative geographically based donor deferral policies when 
implemented in conjunction with the use of 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. FDA will seek advice from the committee in developing 
future recommendations to reduce this risk.
    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 meeting 
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 May 
25, 2015. Oral presentations from the public will be

[[Page 23798]]

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.
    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: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10026 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P