83 FR 27010 - Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 112 (June 11, 2018)

Page Range		27010-27010
FR Document		2018-12443

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.

Federal Register, Volume 83 Issue 112 (Monday, June 11, 2018)

[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Page 27010]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12443]


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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.

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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

27010 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices

pharmaceutical compounding, ACTION:Notice; renewal of advisory voting members may include one
pharmaceutical manufacturing, committee. technically qualified member, selected
pharmacy, medicine, and related by the Commissioner or designee, who
specialties. These members will include SUMMARY: The Food and Drug is identified with consumer interests
representatives from the National Administration (FDA) is announcing the and is recommended by either a
Association of Boards of Pharmacy, the renewal of the Peripheral and Central consortium of consumer-oriented
United States Pharmacopeia, Nervous System Drugs Advisory organizations or other interested
pharmacists with current experience Committee by the Commissioner of persons. In addition to the voting
and expertise in compounding, Food and Drugs (the Commissioner). members, the Committee may include
physicians with background and The Commissioner has determined that one non-voting member who is
knowledge in compounding, and patient it is in the public interest to renew the identified with industry interests.
and public health advocacy Peripheral and Central Nervous System Further information regarding the
organizations. Members will be invited Drugs Advisory Committee for an most recent charter and other
to serve for overlapping terms of up to additional 2 years beyond the charter information can be found at https://
4 years. Almost all non-Federal expiration date. The new charter will be www.fda.gov/AdvisoryCommittees/
members of this Committee serve as in effect until June 4, 2020. CommitteesMeetingMaterials/Drugs/
Special Government Employees. The DATES: Authority for the Peripheral and PeripheralandCentralNervousSystem
core of voting members may include one Central Nervous System Drugs Advisory DrugsAdvisoryCommittee/default.htm
or more technically qualified members, Committee will expire on June 4, 2020, or by contacting the Designated Federal
selected by the Commissioner or unless the Commissioner formally Officer (see FOR FURTHER INFORMATION
designee, who are identified with determines that renewal is in the public CONTACT). In light of the fact that no
consumer interests and are interest. change has been made to the committee
recommended by either a consortium of FOR FURTHER INFORMATION CONTACT: name or description of duties, no
consumer-oriented organizations or Yinghua Wang, Center for Drug amendment will be made to 21 CFR
other interested persons. In addition to Evaluation and Research, Food and 14.100.
the voting members, the Committee may This document is issued under the
Drug Administration, 10903 New
include one or more non-voting Federal Advisory Committee Act (5
Hampshire Ave., Bldg. 31, Rm. 2417,
members who are identified with U.S.C. app.). For general information
Silver Spring, MD 20993–0002; 301–
industry interests. related to FDA advisory committees,
796–9001, email: PCNS@fda.hhs.gov.
Further information regarding the please check https://www.fda.gov/
SUPPLEMENTARY INFORMATION: Pursuant AdvisoryCommittees/default.htm.
most recent charter and other to 41 CFR 102–3.65 and approval by the
information can be found at https:// Dated: June 5, 2018.
Department of Health and Human
www.fda.gov/AdvisoryCommittees/ Services pursuant to 45 CFR part 11 and Leslie Kux,
CommitteesMeetingMaterials/Drugs/ by the General Services Administration, Associate Commissioner for Policy.
PharmacyCompounding FDA is announcing the renewal of the [FR Doc. 2018–12443 Filed 6–8–18; 8:45 am]
AdvisoryCommittee/ucm381305.htm or Peripheral and Central Nervous System BILLING CODE 4164–01–P
by contacting the Designated Federal Drugs Advisory Committee. The
Officer (see FOR FURTHER INFORMATION committee is a discretionary Federal
CONTACT). In light of the fact that no advisory committee established to DEPARTMENT OF HEALTH AND
change has been made to the committee provide advice to the Commissioner. HUMAN SERVICES
name or description of duties, no The Peripheral and Central Nervous
amendment will be made to 21 CFR Food and Drug Administration
System Drugs Advisory Committee
14.100. advises the Commissioner or designee [Docket No. FDA–2018–P–0327]
This document is issued under the in discharging responsibilities as they
Federal Advisory Committee Act (5 relate to helping to ensure safe and Determination That MUTAMYCIN
U.S.C. app.). For general information effective drugs for human use and, as (Mitomycin) Injectable, 5 Milligrams/
related to FDA advisory committees, required, any other product for which Vial and 20 Milligrams/Vial, Was Not
please check https://www.fda.gov/ FDA has regulatory responsibility. Withdrawn From Sale for Reasons of
AdvisoryCommittees/default.htm. The Committee reviews and evaluates Safety or Effectiveness
Dated: June 5, 2018. data concerning the safety and AGENCY: Food and Drug Administration,
Leslie Kux, effectiveness of marketed and HHS.
Associate Commissioner for Policy. investigational human drug products for ACTION: Notice.
[FR Doc. 2018–12440 Filed 6–8–18; 8:45 am]
use in the treatment of neurologic
diseases. SUMMARY: The Food and Drug
BILLING CODE 4164–01–P
The Committee shall consist of a core Administration (FDA or Agency) has
of nine voting members including the determined that MUTAMYCIN
DEPARTMENT OF HEALTH AND Chair. Members and the Chair are (mitomycin) injectable, 5 milligrams
HUMAN SERVICES selected by the Commissioner or (mg)/vial and 20 mg/vial, was not
designee from among authorities withdrawn from sale for reasons of
Food and Drug Administration knowledgeable in the fields of safety or effectiveness. This
neurology, neuropharmacology, determination will allow FDA to
daltland on DSKBBV9HB2PROD with NOTICES

[Docket No. FDA–2018–N–1725] neuropathology, otolaryngology, approve abbreviated new drug
epidemiology or statistics, and related applications (ANDAs) for MUTAMYCIN
Advisory Committee; Peripheral and
specialties. Members will be invited to (mitomycin) injectable, 5 mg/vial and 20
Central Nervous System Drugs
serve for overlapping terms of up to 4 mg/vial, if all other legal and regulatory
Advisory Committee; Renewal
years. Almost all non-Federal members requirements are met.
AGENCY: Food and Drug Administration, of this committee serve as Special FOR FURTHER INFORMATION CONTACT:
HHS. Government Employees. The core of Stacy Kane, Center for Drug Evaluation

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Document Created: 2018-11-02 11:58:26
Document Modified: 2018-11-02 11:58:26

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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]
FR Citation		83 FR 27010

83 FR 27010 - Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 112 (June 11, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration