[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Page 44900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18410]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3612]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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. At least one portion of the
meeting will be closed to the public. Members will participate via
teleconference.
DATES: The meeting will be held on October 9, 2019, from 8:30 a.m. to
3:30 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, 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/vrbpac100919/. 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: Capt. 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, [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 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 October 9, 2019, under topic I, the Center for Biologics
Evaluation and Research's (CBER) VRBPAC will meet in open session to
hear an overview of the research programs in the Laboratory of
Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral
Diseases (LVVD), Division of Viral Products, Office of Vaccines
Research and Review, CBER, FDA. Also, on October 9, 2019, under topic
II, the committee will meet in open session to discuss and make
recommendations on the selection of strains to be included in an
influenza virus vaccine for the 2020 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 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 October 9, 2019, from 8:30 a.m. to approximately 10
a.m. and from 11 a.m. to 3:30 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 October 2, 2019. Oral
presentations from the public will be scheduled between approximately
9:45 a.m. and 10 a.m. for the overview portion of the LHV/LVVD Site
Visit (topic I), and from 1:30 p.m. to 2:15 p.m. for the influenza
strain selection portion of the meeting (topic II). 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 September 24, 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 September 25, 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 Capt. 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 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: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18410 Filed 8-26-19; 8:45 am]
BILLING CODE 4164-01-P