Notice2022-12369
Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal
Primary source
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Published
June 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the May 31, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Page 34877]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12369]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0618]
Advisory Committee; Drug Safety and Risk Management Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal 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 the May 31, 2024, expiration date.
DATES: Authority for the Drug Safety and Risk Management Advisory
Committee will expire on May 31, 2024, 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, 240-
762-8729, <a href="/cdn-cgi/l/email-protection#17534476455a57717376397f7f6439707861"><span class="__cf_email__" data-cfemail="16524577445b56707277387e7e6538717960">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services (HHS) and by the General
Services Administration, FDA is announcing the renewal of the Drug
Safety and Risk Management Advisory Committee (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 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 information
gathered by HHS 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 HHS 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. Non-Federal members of this committee will serve as
Special Government Employees, representatives, or Ex-Officio members.
Federal members will serve as Regular Government Employees or Ex-
Officios. 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 representative member who is identified with industry
interests. There may also be an alternate industry representative.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/drug-safety-and-risk-management-advisory-committee/drug-safety-and-risk-management-advisory-committee-charter">https://www.fda.gov/advisory-committees/drug-safety-and-risk-management-advisory-committee/drug-safety-and-risk-management-advisory-committee-charter</a> 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 notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: June 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12369 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P
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