[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Page 27010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1725]
Advisory Committee; Peripheral and Central Nervous System Drugs
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Peripheral and Central Nervous System Drugs 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 Peripheral and Central Nervous System Drugs Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until June 4, 2020.
DATES: Authority for the Peripheral and Central Nervous System Drugs
Advisory Committee will expire on June 4, 2020, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Yinghua Wang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-
796-9001, email: [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 Peripheral and Central Nervous System Drugs Advisory
Committee. The committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner.
The Peripheral and Central Nervous System Drugs Advisory Committee
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 Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of neurology, neuropharmacology, neuropathology, otolaryngology,
epidemiology or statistics, and related specialties. 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. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/default.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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12443 Filed 6-8-18; 8:45 am]
BILLING CODE 4164-01-P