[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18412-18413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07816]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-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 May 13, 2015, from 8
a.m. to 5:30 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 Web cast. The Web cast will be available at the following
link: https://collaboration.fda.gov/bpac2015/. When accessing the Web
cast 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 Joanne Lipkind, 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 240-402-8129, 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 May 13, 2015, the Blood Products Advisory Committee will
meet in open session to discuss strategies for implementation of
serological and nucleic acid testing for Babesia microti in blood
donors. In the afternoon, the committee will hear update presentations
on the following topics: (1) FDA considerations for Hemoglobin S
Testing in blood donors; and (2) FDA considerations for a revised blood
donor deferral policy for men who have sex with men. Following the
update presentations, the committee will hear presentations on the
research programs of the Laboratory of Cellular Hematology, Division of
Hematology Research and Review, 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 May 13, 2015, from 8:30 a.m. to approximately 5 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 May 6, 2015. Oral presentations from the public on May 13,
2015, will be scheduled between approximately 11:15 a.m. and 12:15 p.m.
and 4:30 p.m. until 5 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 April 28, 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 April 29, 2015.
Closed Committee Deliberations: On May 13, 2015, from approximately
5 p.m. to 5:30 p.m., the meeting will be closed to the public 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 of
the Laboratory of Cellular Hematology 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 8:30 a.m. on May 13, 2015, 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.
[[Page 18413]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07816 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P