[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Page 2677]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00491]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Blood Products 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: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
DATES: Date and Time: The meeting will be held on February 12, 2013,
from 8:30 a.m. to 5 p.m.
Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville,
MD 20857. For those unable to attend in person, the meeting will also
be webcast. The webcast will be available at the following link: http://fda.yorkcast.com/webcast/Viewer/?peid=9e38bbbbc4ae4327ab895d98a845fdd11d.
Contact Person: Bryan Emery or Pearline Muckelvene, Center for
Biologics Evaluation and Research, HFM-71, Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1277
or 301-827-1281, 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 February 12, 2013, the Committee will meet in open
session to discuss Cangene's biologics license application for Botulism
Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) seeking licensure
under FDA's authority to approve a product based on evidence of safety
in humans and effectiveness from studies in animals when human efficacy
studies are not ethical or feasible.
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
February 5, 2013. On February 12, 2013, oral presentations 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
January 28, 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 January 29,
2013.
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. the morning of
February 12, 2013.
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: January 8, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-00491 Filed 1-11-13; 8:45 am]
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