Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal, 27010 [2018-12443]
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. 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
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
members who are 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/
PharmacyCompounding
AdvisoryCommittee/ucm381305.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. 2018–12440 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
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.
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
Notice; renewal of advisory
committee.
ACTION:
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: PCNS@fda.hhs.gov.
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
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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/
PeripheralandCentralNervousSystem
DrugsAdvisoryCommittee/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–0327]
Determination That MUTAMYCIN
(Mitomycin) Injectable, 5 Milligrams/
Vial and 20 Milligrams/Vial, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that MUTAMYCIN
(mitomycin) injectable, 5 milligrams
(mg)/vial and 20 mg/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20
mg/vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
SUMMARY:
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[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
