
[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31642-31643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


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, 2018.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2016, 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. 
6132, Silver Spring, MD 20993-0002, 240-402-8054, 
Bryan.emery@fda.hhs.gov.

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

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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 http://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 http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11774 Filed 5-18-16; 8:45 am]
 BILLING CODE 4164-01-P


