Document ID: FDA-2019-N-1045-0001
Agency: fda
Document Type: Notice
Title: Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Posted Date: 2019-03-14T04:00Z

[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9344-9345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1045]

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. Consistent with FDA's regulations, notice 
is being published with less than 15 days prior to the date of the 
meeting based on a determination that an immediate meeting of the 
Vaccines and Related Biological Products Advisory Committee is needed. 
This Federal Register notice could not be published 15 days prior to 
the date of the meeting due to a delay by the World Health Organization 
(WHO) in recommending H3N2 strain for inclusion in the 2019-2020 
seasonal influenza vaccines.

DATES: The meeting will be held on March 22, 2019, from 8:30 a.m. to 
2:30 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. 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 those unable to attend in person, the meeting will also be 
webcast and will be available at the following link: https://collaboration.fda.gov/vrbpac032019.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 
240-402-5771, serina.hunter-thomas@fda.hhs.gov; or Monique Hill, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
0002, 301-796-4620, monique.hill@fda.hhs.gov; or the 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.

SUPPLEMENTARY INFORMATION:
    Agenda: On March 22, 2019, in followup to a delay by the World 
Health Organization (WHO) in recommending H3N2 strain for inclusion in 
the 2019-2020 seasonal influenza vaccines, the Center for Biologics 
Evaluation and Research will reconvene the VRBPAC to discuss and make 
recommendations specifically on the H3N2 strain. The VRBPAC previously 
met on March 6, 2019, and made recommendations on the selection of all 
other strains to be included in seasonal influenza virus vaccines for 
the 2019-2020 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 website 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 website 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: On March 22, 2019, from 8:30 a.m. to 2:30 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 March 15, 2019. On March 22, 2019, oral presentations from 
the public will be scheduled between

[[Page 9345]]

approximately 10:30 a.m. to 11:30 a.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 March 14, 2019. 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 March 15, 2019.
    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 (see FOR FURTHER INFORMATION CONTACT) 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: March 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04708 Filed 3-13-19; 8:45 am]
 BILLING CODE 4164-01-P