Document ID: FDA-2013-N-0001-0001
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee Meeting
Posted Date: 2013-01-14T05:00Z

[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]
BILLING CODE 4160-01-P