Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal, 1262 [2018-00239]
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Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6827]
Advisory Committee; Vaccines and
Related Biological Products Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
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, 2019.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2019, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6338, Silver Spring, MD 20993–0002,
240–402–5771, serina.hunter-thomas@
fda.hhs.gov.
SUMMARY:
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
Vaccines and Related Biological
Products Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The 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
FDA 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
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:23 Jan 09, 2018
Jkt 244001
other products for which FDA 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.
The Committee shall consist of a core
of 15 voting members, including the
Chairperson (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
4 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 consumeroriented 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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/Blood
VaccinesandOtherBiologics/
VaccinesandRelatedBiologicalProducts
AdvisoryCommittee/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 check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00239 Filed 1–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0312]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Extralabel Drug Use in Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February 9,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
SUMMARY:
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Page 1262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00239]
[[Page 1262]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6827]
Advisory Committee; Vaccines and Related Biological Products
Advisory Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
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, 2019.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2019, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6338, Silver Spring, MD 20993-
0002, 240-402-5771, [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 Vaccines and Related Biological Products Advisory
Committee (the Committee). The Committee is a discretionary Federal
advisory committee established to provide advice to the Commissioner.
The 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 FDA 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 FDA 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.
The Committee shall consist of a core of 15 voting members,
including the Chairperson (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 4 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: https://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 check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00239 Filed 1-9-18; 8:45 am]
BILLING CODE 4164-01-P
