Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal, 23467 [2018-10731]
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Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices
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Jkt 244001
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
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Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10734 Filed 5–18–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0001]
Advisory Committee; Anesthetic and
Analgesic Drug Products Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Anesthetic and Analgesic
Drug Products Advisory Committee (the
Committee) by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until May
1, 2020.
DATES: Authority for the Committee will
expire on May 1, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee Choi, 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: AADPAC@
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
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
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
23467
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products
including analgesics, e.g., abusedeterrent opioids, novel analgesics, and
issues related to opioid abuse, and those
for use in anesthesiology and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
anesthesiology, analgesics (such as:
abuse deterrent opioids, novel
analgesics, and issues related to opioid
abuse) 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/
AnestheticandAnalgesicDrugProducts
AdvisoryCommittee/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: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10731 Filed 5–18–18; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Page 23467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10731]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0001]
Advisory Committee; Anesthetic and Analgesic Drug Products
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 Anesthetic and Analgesic Drug Products Advisory
Committee (the Committee) by the Commissioner of Food and Drugs (the
Commissioner). The Commissioner has determined that it is in the public
interest to renew the Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until May 1,
2020.
DATES: Authority for the Committee will expire on May 1, 2020, unless
the Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, 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 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
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products including analgesics, e.g., abuse-deterrent opioids, novel
analgesics, and issues related to opioid abuse, and those for use in
anesthesiology and makes appropriate recommendations to the
Commissioner.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of anesthesiology, analgesics (such as: abuse deterrent opioids,
novel analgesics, and issues related to opioid abuse) 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/AnestheticandAnalgesicDrugProductsAdvisoryCommittee/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: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10731 Filed 5-18-18; 8:45 am]
BILLING CODE 4164-01-P
