[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23466-23467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10734]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1708]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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. At least 
one portion of the meeting will be closed to the public.

DATES: The meeting will be held on June 22, 2018, from 11 a.m. to 4:20 
p.m.

ADDRESSES: Great Room A, Building 31, FDA White Oak Campus, 10903 New 
Hampshire Ave., Silver Spring, MD 20993. 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, 
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 Rm. 6270, at 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 website 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: https://collaboration.fda.gov/bpac0618/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 22, 2018, in the morning open session, under Topic 
1, the Committee will hear presentations on the research programs in 
the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and 
TSE Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) 
in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), 
Office of Blood Research and Review (OBRR), Center for Biologics 
Evaluation and Research (CBER), FDA. After the conclusion of the open 
session, the meeting will be closed to permit discussion where 
disclosure would constitute an unwarranted invasion of personal privacy 
in accordance with 5 U.S.C. 552b(c)(6).
    In the afternoon, in open session, under Topic II, the Committee 
will hear presentations on the research program in the Hemostasis 
Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), 
Office of Tissues and Advanced Therapies (OTAT), Center for Biologics 
Evaluation and Research (CBER), FDA. After the open session, the 
meeting will be closed to the public to permit discussion where 
disclosure would constitute an unwarranted invasion of personal privacy 
in accordance with 5 U.S.C. 552.b(c)(6).
    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 website prior to the meeting, the 
background material will

[[Page 23467]]

be made publicly available at the venue of the advisory committee 
meeting, and the background material will be posted on FDA's website 
after the meeting. Background material will be available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee meeting link.
    Procedure: On June 22, 2018, from 11 a.m. to 12:55 p.m. and 2:20 
p.m. to 3:45 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 June 15, 2018. Oral presentations 
from the public will be scheduled between approximately 12:25 p.m. to 
12:55 p.m. and from 3:15 p.m. to 3:45 p.m. on June 22, 2018. 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 June 
7, 2018. 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 June 8, 2018.
    Closed Committee Deliberations: On June 22, 2018 between 12:55 p.m. 
and 1:40 p.m. and between 3:45 p.m. and 4:20 p.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)). During 
the closed sessions, the Committee will discuss the research progress 
made by staff involved in the intramural research programs and make 
recommendations regarding personnel actions and staffing.
    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 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10734 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P


