83 FR 49101 - 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 189 (September 28, 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 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49101-49102]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3424]


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 November 8, 2018, from 11 a.m. to 
2:45 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/vrbpac1118/.

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 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 November 8, 2018, the Center for Biologics Evaluation 
and Research's (CBER) VRBPAC committee will meet in open session to 
hear an overview of the research program in the Laboratory of DNA 
Viruses (LDV), Division of Viral Products (DVP), Office of Vaccines 
Research and Review (OVRR), CBER, FDA. 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 November 8, 2018, from 11 a.m. to 1:50 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

[[Page 49102]]

person on or before November 1, 2018. Oral presentations from the 
public will be scheduled between approximately 12:45 p.m. to 1:45 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 
October 24, 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 October 25, 
2018.
    Closed Committee Deliberations: On November 8, 2018, from 1:50 p.m. 
to 2:45 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 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: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21137 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P