[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23685-23686]
[FR Doc No: 2018-10848]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1787]

Advisory Committee; Blood Products Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Blood Products Advisory Committee by the Commissioner of
Food and Drugs (the Commissioner). The Commissioner has determined that
it is in the public interest to renew the Blood Products Advisory
Committee for an additional 2 years beyond the charter expiration date.
The new charter will be in effect until May 13, 2020.

DATES: Authority for the Blood Products Advisory Committee will expire
on May 13, 2020, unless the Commissioner formally determines that
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm.
6268, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Blood Products Advisory Committee. The committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner.
    The Blood Products Advisory Committee advises the Commissioner or
designee in discharging responsibilities as they relate to helping to
ensure safe and effective drugs for human use and, as required, any
other product for which FDA has regulatory responsibility.
    The Committee shall consist of a core of 17 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of clinical and administrative medicine, hematology, immunology,
blood banking, surgery, internal medicine, biochemistry, engineering,
biological and physical sciences, biotechnology, computer technology,
statistics, epidemiology, sociology/ethics, and other related
professions. Members will be invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal members of this committee serve
as Special Government Employees. The core of voting members may include
one technically qualified member, selected by the Commissioner or
designee, who is identified with consumer interests and is recommended
by either a consortium of consumer-oriented organizations or other
interested persons. In addition to the voting members, the Committee
may include one non-voting member who is identified with industry
interests.
    The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) Expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current

voting members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
    If functioning as a medical device panel, a non-voting
representative of consumer interests and a non-voting representative of
industry interests will be included in addition to the voting members.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm121602.htm or by contacting the
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In
light of the fact that no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10848 Filed 5-21-18; 8:45 am]
 BILLING CODE 4164-01-P