[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1742-1743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00769]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0071]
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) 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.
DATES: The meeting will be held on March 6, 2019, from 8 a.m. to 4:30
p.m. and March 7, 2019, from 8:30 a.m. to 4:45 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, [email protected]; 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, [email protected]; 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
[[Page 1743]]
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 6, 2019, under Topic I, the Center for Biologics
Evaluation and Research's (CBER) VRBPAC will meet in open session to
discuss and make recommendations on the selection of strains to be
included in the influenza virus vaccines for the 2019 to 2020 influenza
season. Also on March 6, 2019, under Topic II, the committee will meet
in open session to hear an overview of the research programs in the
Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses
(LR), Division of Viral Products, Office of Vaccines Research and
Review, CBER, FDA.
On March 7, 2019, under Topic III, the committee will meet in open
session to discuss and make recommendations on the safety and
effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated)
(DENGVAXIA) manufactured by Sanofi Pasteur.
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 6, 2019, from 8 a.m. to 3:15 p.m., and on March
7, 2019, from 8:30 a.m. to 4:45 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 February 27,
2019. On March 6, 2019, oral presentations from the public will be
scheduled between approximately 11:10 a.m. to 11:55 a.m. for the
influenza strain selection portion of the meeting and 3 p.m. to 3:15
p.m. for the overview portion of the LIR/LR Site Visit. On March 7,
2019, oral presentations from the public will be scheduled between
approximately 1:15 p.m. to 2:15 p.m. for the Dengue Tetravalent Vaccine
(Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur portion
of the meeting. 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 February 19, 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 February
20, 2019.
Closed Committee Deliberations: On March 6, 2019, from 3:15 p.m. to
4:30 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)). The recommendations of the advisory
committee regarding the progress of the investigator's research will,
along with other information, be used in making personnel and staffing
decisions regarding individual scientists.
We believe that public discussion of these recommendations on
individual scientists would constitute an unwarranted invasion of
personal privacy.
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: January 15, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00769 Filed 2-4-19; 8:45 am]
BILLING CODE 4164-01-P