[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Page 53385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18985]



[[Page 53385]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0001]


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 or Agency) announces a 
forthcoming public advisory committee meeting of the Vaccines and 
Related Biological Products Advisory Committee. The general function of 
the committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on October 22, 2020, from 10 a.m. 
Eastern Time to 5 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. 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. The online web conference 
meeting will be available at the following links: Main at https://collaboration.fda.gov/vrbpac102220/ and overflow at https://collaboration.fda.gov/vrbpac102220overflow/.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya or Monique Hill, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver 
Spring, MD 20993-0002, 240-506-4946, Prabhakara.Atreya@fda.hhs.gov, or 
301-796-4620, monique.hill@fda.hhs.gov, respectively, 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: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. In open 
session, the committee will discuss, in general, the development, 
authorization and/or licensure of vaccines to prevent COVID-19. No 
specific application will be discussed at this meeting.
    FDA intends to make any 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, any 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting. Any background material and 
the link to the online teleconference meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting.
    Procedure: 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 15, 2020. Oral presentations from the public will be scheduled 
between approximately 2:30 p.m. Eastern Time and 3:30 p.m. Eastern 
Time. 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 7, 2020. 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 8, 2020.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    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 Prabhakara Atreya (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: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18985 Filed 8-27-20; 8:45 am]
BILLING CODE 4164-01-P


