Document ID: FDA-2017-N-6358-0001
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee Advisory Committee; Notice of Meeting
Posted Date: 2017-11-09T05:00Z

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52060-52061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24408]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6358]

Blood Products Advisory Committee Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Blood Products Advisory 
Committee (the Committee). The general function of the committee is to 
provide advice and recommendations to the Agency on FDA's regulatory 
issues related to blood and products derived from blood. The meeting 
will be open to the public.

DATES: The meeting will be held on November 30, 2017, from 8 a.m. to 
5:45 p.m. and on December 1, 2017, from 8 a.m. to 3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Bldg. 71, Rm. 
6132, at 240-402-8054, [email protected] and 240-402-8106, 
[email protected] respectively, 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 https://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. For those unable to attend in person, the meeting will 
also be available via Webcast. The Webcast will be available at the 
following link for both days: https://collaboration.fda.gov/bpac2017.

SUPPLEMENTARY INFORMATION: 
    Agenda: On November 30, 2017, the Committee members will meet in 
open session to discuss bacterial risk control strategies for blood 
collection establishments and transfusion services to enhance the 
safety and availability of platelets for transfusion. In the afternoon, 
the Committee will be seated as a device classification panel. In open 
session, the panel will discuss the appropriate device classification 
of human leukocyte antigen, human platelet antigen, and human 
neutrophil antigen devices. On December 1, 2017, the committee members 
will meet in open session to discuss strategies to reduce the risk of 
transfusion-transmitted Zika virus. In the afternoon, an information 
session on the Transfusion Transmissible Infections Monitoring System 
will be presented to the Committee. Finally, the Committee will hear an 
update presentation on the April 6, 2017, FDA public workshop on 
emerging tick-borne diseases and blood safety.
    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 https://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 
November 22, 2017. Oral presentations from the public will be scheduled 
between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45 
p.m. on November 30, 2017. Oral presentations from the public will also 
be scheduled between approximately 10:45 a.m. and 11:30 a.m. and 3 p.m. 
to 3:30 p.m. on December 1, 2017. 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 November 14, 2017. 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 November 15, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Bryan Emery or Joanne Lipkind at least 7 days in advance of the 
meeting.

[[Page 52061]]

    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://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: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24408 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P