Notice2022-01858
Advisory Committee; Vaccines and Related Biological Products Advisory Committee; Renewal
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 31, 2022
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, 2023, expiration date.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 20 (Monday, January 31, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4897-4898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01858]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Advisory Committee; Vaccines and Related Biological Products
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
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, 2023,
expiration date.
DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2023, unless the
Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-402-8006,
<a href="/cdn-cgi/l/email-protection#b1e1c3d0d3d9d0dad0c3d09ff0c5c3d4c8d0f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="58082a393a303933392a3976192c2a3d2139183e3c397630302b763f372e">[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.
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
[[Page 4898]]
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 <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 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01858 Filed 1-28-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 31, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.