
[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56899-56900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22423]


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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). At least one 
portion of the meeting will be closed 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.
    Date and Time: The meeting will be held on November 1, 2013, 
from 8 a.m. to 4:30 p.m.
    Location: FDA Fishers Lane Building, 5630 Fishers Lane, rm. 
1066, Rockville, MD 20857. For those unable to attend in person, the 
meeting will also be Web cast. The Web cast will be available at the 
following link: http://fda.yorkcast.com/webcast/Viewer/?peid=18390c01dfff405681afa644b1837e5a1d.
    Contact Person: Bryan Emery or Pearline Muckelvene, Center for 
Biologics Evaluation

[[Page 56900]]

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 the morning of November 1, 2013, the committee will 
meet in open session to discuss MP Biomedicals' biologic license 
application for the MP Diagnostics HTLV Blot 2.4, a Western Blot 
intended for use as a confirmatory test for blood donors. In the 
afternoon, the committee will hear update presentations on the 
following topics: (1) The April 2013 FDA public workshop on 
multiplex detection of transfusion transmissible agents and blood 
cell antigens in blood donations and (2) FDA safety communications 
on new boxed warnings for immune globulin products and hydroxyethyl 
starch solutions. Following the update presentations, the committee 
will meet in open session to hear presentations on the research 
programs of the Laboratory of Biochemistry and Vascular Biology, 
Division of Hematology, Office of Blood Research and Review, Center 
for Biologics Evaluation and Research, FDA.
    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: On November 1, 2013, from 8 a.m. to approximately 4 
p.m., the meeting is open to the public. 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 24, 2013. Oral presentations 
from the public will be scheduled between approximately 11 a.m. and 
11:30 a.m. Afternoon presentations will be scheduled between 
approximately 3:30 p.m. and 4 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 October 16, 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 October 17, 
2013.
    Closed Committee Deliberations: On November 1, 2013, from 
approximately 4 p.m. to 4:30 p.m., the meeting will be closed to 
permit discussion where disclosure would constitute a clearly 
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The 
committee will discuss the site visit report of the intramural 
research programs and make recommendations regarding personnel 
staffing decisions.
    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 Web cast if you are unable to 
attend. The Web cast will be available at 8 a.m. on November 1, 
2013, at the link provided.
    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 meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 9, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-22423 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P


