Notice2024-01585
Advisory Committee; Vaccines and Related Biological Products Advisory Committee, Renewal
Primary source
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Published
January 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) 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 the December 31, 2025, expiration date.
Full Text
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<title>Federal Register, Volume 89 Issue 18 (Friday, January 26, 2024)</title>
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[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5243-5244]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01585]
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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 Federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 the December 31, 2025,
expiration date.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2025, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Sussan Paydar, Division of Scientific
Advisors and Consultants, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 202-657-8533,
<a href="/cdn-cgi/l/email-protection#da89afa9a9bbb4f48abba3bebba89abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="5102242222303f7f013028353023113735307f3939227f363e27">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services 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.
Pursuant to its charter, 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, hypersensitivity reactions to the vaccines,
preventive medicine, infectious diseases, pediatrics, microbiology, and
biochemistry. Members will be invited
[[Page 5244]]
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 nonvoting 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, an additional nonvoting
representative of consumer interests and a nonvoting 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 <a href="https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee">https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee</a> 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 notice 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01585 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P
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