81 FR 62504 - Blood Products Advisory Committee Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 175 (September 9, 2016)

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

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62504-62505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


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 general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. The 
meeting will be open to the public.

DATES: The meeting will be held on November 17, 2016, from 8 a.m. to 
5:30 p.m. and on November 18, 2016, from 8:30 a.m. to 1 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: LCDR Bryan Emery or Joanne Lipkind, 
Division of Scientific Advisors and Consultants, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., 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 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. 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/bpac1116/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On the morning of November 17, 2016, the Committee will 
meet in open session to discuss strategies to manage iron deficiency 
associated with blood donation. The Committee will also discuss 
proposed procedures for assuring donor safety for collections of blood 
from female donors with hemoglobin values of 12.0-12.4g/dL or a 
hematocrit value between 36 and 38. In the afternoon, the Committee 
will meet in open session to discuss adverse reactions related to blood 
donation in teenage (16 to 18 years) donors, and the effectiveness of 
several mitigation measures. On November 18, 2016, the Committee will 
meet in open session to hear an informational session on Zika virus and 
blood safety in the United States. Following the informational session, 
the Committee will hear presentations on the following topics: (1) The 
Transfusion Transmissible Infections Monitoring System; (2) a summary 
of the FDA workshop on new methods to predict the immunogenicity of 
therapeutic coagulation proteins; and (3) a summary of the FDA workshop 
on preclinical evaluation of red blood cells for transfusion.
    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: 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 4, 2016. Oral presentations from the public will be scheduled 
between approximately 11 a.m. to 11:45 a.m. and 4 p.m. to 4:30 p.m. on 
November 17, 2016. Oral presentations from the public will also be 
scheduled between approximately 10:30 a.m. and 11 a.m. and 12:30 p.m. 
to 1 p.m. on November 18, 2016. Those individuals interested in making 
formal oral presentations should notify the contact person and submit a 
brief

[[Page 62505]]

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 27, 2016. 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 
28, 2016.
    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.
    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: September 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21687 Filed 9-8-16; 8:45 am]
 BILLING CODE 4164-01-P