[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4897-4898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01858]


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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.

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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, 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, 
[email protected].

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 https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01858 Filed 1-28-22; 8:45 am]
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