[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Pages 9909-9910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 March 18, 2014, from 
8:30 a.m. to 4:30 p.m. and March 19, 2014, from 9 a.m. to 11:30 a.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1. For those unable to attend in person, the meeting 
will also be Webcast. The Webcast will be available at the following 
link: https://collaboration.fda.gov/bpac2014/. On link please enter as 
a guest to the site.
    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 the morning of March 18, 2014, the committee will meet 
in open session to discuss the evaluation of the safety and 
effectiveness of the Immucor PreciseTypeTM HEA Molecular 
BeadChip Assay, manufactured by BioArray Solutions Limited. In the 
afternoon, the committee will hear update presentations on the 
following topics: (1) Report from the Presidential Commission for the 
Study of Bioethical Issues on the ethical implications of incidental 
findings in clinical, research, and direct-to-consumer contexts; (2) 
summary of the January 28-29, 2014, FDA public workshop on immune 
globulin-associated hemolysis; and (3) a summary of the December 4-5, 
2013, HHS Advisory Committee on Blood and Tissue Safety and 
Availability. On the morning of March 19, 2014, the committee will meet 
in open session to

[[Page 9910]]

hear presentations on the research programs of the Laboratory 
Hemostasis, 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 March 18, 2014, from 8:30 a.m. to approximately 4:30 
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 March 11, 2014. Oral presentations from the public 
on March 18, 2014, will be scheduled between approximately 1:30 p.m. 
and 2 p.m. On March 19, 2014, from 9 a.m. to approximately 11 a.m., the 
meeting is open to the public. Oral presentations from the public on 
March 19, 2014, will be scheduled between approximately 10:30 a.m. and 
11 a.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 March 3, 2014. 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 March 4, 
2014.
    Closed Committee Deliberations: On March 19, 2014, from 
approximately 11 a.m. to 11:30 a.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 Webcast if unable to attend. The Webcast 
will be available at 8:30 a.m. on March 18, 2014, and on March 19, 
2014, at 9 a.m. 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 meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03703 Filed 2-20-14; 8:45 am]
BILLING CODE 4160-01-P