83 FR 6194 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 30 (February 13, 2018)

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.

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6194]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0536]


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. At least one portion of the meeting will be 
closed to the public.

DATES: The meeting will be held on March 1, 2018, from 8 a.m. to 5 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/vrbpac030118.

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. 6338, 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 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 1, 2018, 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 program in the Laboratory of Mucosal 
Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, 
Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research 
and Review (OVRR), CBER, FDA. Also on March 1, 2018, under Topic II, 
the committee 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 2018-2019 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 1, 2018, from 8 a.m. to 9:15 a.m., and 9:45 
a.m. to 5 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 22, 2018. Oral presentations 
from the public will be scheduled between approximately 9 a.m. to 9:15 
a.m. for the overview portion of the LMPCI Site Visit portion of the 
meeting, and 2:10 p.m. to 2:55 p.m. for the flu strain selection 
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 21, 2018. 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 
22, 2018.
    Closed Committee Deliberations: On March 1, 2018, from 9:15 a.m. to 
9:45 a.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 decisions regarding pay 
adjustments of service fellows or promotion and permanent staff 
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 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: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02853 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P