    [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