[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36796-36797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


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 or the Agency) 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.

DATES: The meeting will be held on September 13, 2017, from 8:30 a.m. 
to 5 p.m.

[[Page 36797]]


ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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: 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, [email protected] 
and 240-402-8072, [email protected]; 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 September 13, 2017, the VRBPAC will meet in an open 
session to discuss and make recommendations on the safety and 
effectiveness of Zoster Vaccine Recombinant, Adjuvanted, manufactured 
by GlaxoSmithKline Biologicals. 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 6, 2017. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 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 August 29, 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 August 30, 2017.
    Web cast: For those unable to attend in person, the meeting will 
also be web cast and will be available at the following link: https://collaboration.fda.gov/vrbpac0917/.
    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: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16519 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P