Document ID: FDA-2015-N-0001-0038
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2015-04-06T04:00Z

[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18412-18413]
From the Federal Register Online via the Government Printing 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