[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27011-27012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12442]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1728]
Advisory Committee; Drug Safety and Risk Management 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 Drug Safety and Risk Management 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 Drug
Safety and Risk Management Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until May 31, 2020.
DATES: Authority for the Drug Safety and Risk Management Advisory
Committee will expire on May 31, 2018, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Philip Bautista, 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 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 Drug Safety and Risk Management Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner.
The Drug Safety and Risk Management 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 information on risk management,
risk communication, and quantitative evaluation of spontaneous reports
for drugs for human use and for any other product for which FDA has
regulatory responsibility. The Committee also advises the Commissioner
regarding the scientific and medical evaluation of all
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information gathered by the Department of Health and Human Services and
the Department of Justice with regard to safety, efficacy, and abuse
potential of drugs or other substances, and recommends actions to be
taken by the Department of Health and Human Services with regard to the
marketing, investigation, and control of such drugs or other
substances.
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 risk communication, risk management, drug safety, medical,
behavioral, and biological sciences as they apply to risk management,
and drug abuse. 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/DrugSafetyandRiskManagementAdvisoryCommittee/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. 2018-12442 Filed 6-8-18; 8:45 am]
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