    [Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
    [Notices]
    [Pages 53383-53384]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2020-18951]

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    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Food and Drug Administration

    [Docket No. FDA-2020-N-1767]

    Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
    and the Drug Safety and Risk Management Advisory Committee; Notice of
    Meeting; Establishment of a Public Docket; Request for Comments

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice; establishment of a public docket; request for comments.

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    SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
    public advisory committee meeting of the Joint Meeting of the
    Psychopharmacologic Drugs Advisory Committee and the Drug Safety and
    Risk Management Advisory Committee. The general function of the
    committee is to provide advice and recommendations to FDA on regulatory
    issues. The meeting will be open to the public. FDA is establishing a
    docket for public comment on this document.

    DATES: The meeting will be held on October 9, 2020, from 8 a.m. 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 about FDA advisory committee meetings may be
    accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
        FDA is establishing a docket for public comment on this meeting.
    The docket number is FDA-2020-N-1767. The docket will close on October
    8, 2020. Submit either electronic or written comments on this public
    meeting by October 8, 2020. Please note that late, untimely filed
    comments will not be considered. Electronic comments must be submitted
    on or before October 8, 2020. The https://www.regulations.gov
    electronic filing system will accept comments until 11:59 p.m. Eastern
    Time at the end of October 8, 2020. Comments received by mail/hand
    delivery/courier (for written/paper submissions) will be considered
    timely if they are postmarked or the delivery service acceptance
    receipt is on or before that date.
        Comments received on or before September 25, 2020, will be provided
    to the committees. Comments received after that date will be taken into
    consideration by FDA. In the event that the meeting is canceled, FDA
    will continue to evaluate any relevant applications or information, and
    consider any comments submitted to the docket, as appropriate. You may
    submit comments as follows:

    Electronic Submissions

        Submit electronic comments in the following way:
         Federal eRulemaking Portal: https://www.regulations.gov.
    Follow the instructions for submitting comments. Comments submitted
    electronically, including attachments, to https://www.regulations.gov
    will be posted to the docket unchanged. Because your comment will be
    made public, you are solely responsible for ensuring that your comment
    does not include any confidential information that you or a third party
    may not wish to be posted, such as medical information, your or anyone
    else's Social Security number, or confidential business information,
    such as a manufacturing process. Please note that if you include your
    name, contact information, or other information that identifies you in
    the body of your comments, that information will be posted on https://www.regulations.gov.
         If you want to submit a comment with confidential
    information that you

    [[Page 53384]]

    do not wish to be made available to the public, submit the comment as a
    written/paper submission and in the manner detailed (see ``Written/
    Paper Submissions'' and ``Instructions'').

    Written/Paper Submissions

        Submit written/paper submissions as follows:
         Mail/Hand delivery/Courier (for written/paper
    submissions): Dockets Management Staff (HFA-305), Food and Drug
    Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
         For written/paper comments submitted to the Dockets
    Management Staff, FDA will post your comment, as well as any
    attachments, except for information submitted, marked and identified,
    as confidential, if submitted as detailed in ``Instructions.''
        Instructions: All submissions received must include the Docket No.
    FDA-2020-N-1767 for ``Joint Meeting of the Psychopharmacologic Drugs
    Advisory Committee and the Drug Safety and Risk Management Advisory
    Committee; Notice of Meeting; Establishment of a Public Docket; Request
    for Comments.'' Received comments, those filed in a timely manner (see
    the ADDRESSES section), will be placed in the docket and, except for
    those submitted as ``Confidential Submissions,'' publicly viewable at
    https://www.regulations.gov or at the Dockets Management Staff between
    9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
         Confidential Submissions--To submit a comment with
    confidential information that you do not wish to be made publicly
    available, submit your comments only as a written/paper submission. You
    should submit two copies total. One copy will include the information
    you claim to be confidential with a heading or cover note that states
    ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
    this copy, including the claimed confidential information, in its
    consideration of comments. The second copy, which will have the claimed
    confidential information redacted/blacked out, will be available for
    public viewing and posted on https://www.regulations.gov. Submit both
    copies to the Dockets Management Staff. If you do not wish your name
    and contact information be made publicly available, you can provide
    this information on the cover sheet and not in the body of your
    comments and you must identify the information as ``confidential.'' Any
    information marked as ``confidential'' will not be disclosed except in
    accordance with 21 CFR 10.20 and other applicable disclosure law. For
    more information about FDA's posting of comments to public dockets, see
    80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
        Docket: For access to the docket to read background documents or
    the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
    the heading of this document, into the ``Search'' box and follow the
    prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
    Rm. 1061, Rockville, MD 20852, 240-402-7500.

    FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
    Evaluation and Research, Food and Drug Administration, 10903 New
    Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
    796-9001, Fax: 301-847-8533, email: PDAC@fda.hhs.gov, 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 FDA'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. The
    committees will discuss the efficacy, safety, and benefit-risk profile
    of new drug application (NDA) 213378, olanzapine and samidorphan oral
    tablets, submitted by Alkermes, Inc., for the proposed indications of
    schizophrenia and bipolar disorder.
        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 on FDA's website at
    the time of the advisory committee meeting. 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 committees.
    All electronic and written submissions submitted to the Docket (see the
    ADDRESSES section) on or before September 25, 2020, will be provided to
    the committees. Oral presentations from the public will be scheduled
    between approximately 1 p.m. and 2 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 September 16, 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 September 17, 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 LaToya Bonner (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.
    Lauren K. Roth,
    Associate Commissioner for Policy.
    [FR Doc. 2020-18951 Filed 8-27-20; 8:45 am]
    BILLING CODE 4164-01-P