[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Pages 33939-33940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15297]



Food and Drug Administration

[Docket No. FDA-2018-N-1324]

Advisory Committee; Science Board to the Food and Drug 
Administration; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.


SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the renewal of the Science Board to the Food and Drug Administration 
(Committee) by the Commissioner of Food and Drugs (Commissioner). The 
Commissioner has determined that it is in the public interest to renew 
the Science Board to the Food and Drug Administration for an additional 
2 years beyond the charter expiration date. The new charter will be in 
effect until June 26, 2020.

DATES: Authority for the Science Board to the Food and Drug 
Administration will expire on June 26, 2020, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, White Oak Building 1, Rm. 3309, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4769, 
[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 Science Board to the Food and Drug Administration. The 
Committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Science Board advises the 
Commissioner or designee in discharging responsibilities as they relate 
to helping to ensure safe and effective drugs for human use and, as 
required, any other product for which FDA has regulatory 
responsibility. The Science Board shall provide advice to the 
Commissioner and other appropriate officials on specific complex 
scientific and technical issues important to FDA and its mission, 
including emerging issues within the scientific community. 
Additionally, the Science Board will provide advice that supports the 
Agency in keeping pace with technical and scientific developments, 
including in

[[Page 33940]]

regulatory science; and input into the Agency's research agenda; and on 
upgrading its scientific and research facilities and training 
opportunities. It will also provide, where requested, expert review of 
Agency-sponsored intramural and extramural scientific research 
    The Committee shall consist of a core of 21 voting members 
including a Chair and Co-Chair. The members, Chair, and Co-Chair are 
selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of food science, safety, and nutrition; 
chemistry; pharmacology; translational and clinical medicine and 
research; toxicology; biostatistics; medical devices; imaging; 
robotics; cell and tissue based-products; regenerative medicine; public 
health and epidemiology; international health and regulation; product 
safety; product manufacturing sciences and quality; and other 
scientific areas relevant to FDA regulated products such as systems 
biology, informatics, nanotechnology, and combination products. 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. 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. The Committee may also include technically qualified Federal 
members. 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/ScienceBoardtotheFoodandDrugAdministration/ucm115356.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: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15297 Filed 7-17-18; 8:45 am]