Document ID: FDA-2022-N-0618-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal
Posted Date: 2022-06-08T04:00Z

[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Page 34877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected].

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 https://www.fda.gov/advisory-committees/drug-safety-and-risk-management-advisory-committee/drug-safety-and-risk-management-advisory-committee-charter 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 http://www.fda.gov/AdvisoryCommittees/default.htm.

    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