[Federal Register Volume 82, Number 174 (Monday, September 11, 2017)]
[Notices]
[Pages 42685-42686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4851]


Vaccines and Related Biological Products 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 Vaccines and Related 
Biological Products Advisory Committee (VRBPAC). 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. 
Members will participate via teleconference.

DATES: The meeting will be held on October 4, 2017, from 1 p.m. to 4:30 
p.m.

ADDRESSES: 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 
webcast and will be available at the following link: https://collaboration.fda.gov/cbervrbpac2017. 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: Serina Hunter-Thomas or Rosanna 
Harvey, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver 
Spring, MD 20993-0002, 240-402-5771 <a href="/cdn-cgi/l/email-protection#473422352e2926692f32293322356a332f282a263407212326692f2f3469202831"><span class="__cf_email__" data-cfemail="8cffe9fee5e2eda2e4f9e2f8e9fea1f8e4e3e1edffcceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a> 
and 240-402-8072, <a href="/cdn-cgi/l/email-protection#82f0edf1e3ecece3aceae3f0f4e7fbc2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="4d3f223e2c23232c63252c3f3b28340d2b292c6325253e632a223b">[email protected]</span></a>, 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On October 4, 2017, the VRBPAC will meet in an open session 
to discuss and make recommendations on the selection of strains to be 
included in an influenza virus vaccine for the 2018 southern hemisphere 
influenza season. 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 
September 27, 2017. Oral presentations from the public will be 
scheduled between approximately 1:15 p.m. and 2:15 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief

[[Page 42686]]

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 September 19, 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 September 20, 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 Serina Hunter-Thomas 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: 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: September 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19129 Filed 9-8-17; 8:45 am]
 BILLING CODE 4164-01-P


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