[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2219-2220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00675]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee: Vaccines and Related Biological 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 Vaccines and Related Biological 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 Vaccines and Related Biological Products Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until December 31, 2017.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2017, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 20993-0002, 240-402-7107,
[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
[[Page 2220]]
Vaccines and Related Biological Products Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Vaccines and Related Biological
Products Advisory Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective vaccines and related biological products for human use
and, as required, any other product for which the Food and Drug
Administration has regulatory responsibility.
The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other products for
which the Food and Drug Administration has regulatory responsibility.
The Committee also considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products and makes appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core of 15 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of immunology, molecular biology, rDNA, virology; bacteriology,
epidemiology or biostatistics, vaccine policy, vaccine safety science,
federal immunization activities, vaccine development including
translational and clinical evaluation programs, allergy, preventive
medicine, infectious diseases, pediatrics, microbiology, and
biochemistry. Members will be invited to serve for overlapping terms of
up to four years. Almost all non-Federal members of this committee
serve as Special Government Employees. Ex Officio voting members one
each from the Department of Health and Human Services, the Centers for
Disease Control and Prevention, and the National Institutes of Health
may be included. 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. There
may also be an alternate industry representative.
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 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.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: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-00675 Filed 1-14-16; 8:45 am]
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