[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.

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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, 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


