[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Notices]
[Pages 63435-63436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17243]


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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 or the Agency) 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, 2026, expiration date.

DATES: Authority for the Drug Safety and Risk Management Advisory 
Committee will expire on May 31, 2026, unless the Commissioner formally 
determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (240) 743-8319, 
[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.
    Pursuant to its Charter, 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 or 
representatives. 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.

[[Page 63436]]

    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to exceed 10 members) to serve temporarily as voting 
members and to designate consultants to serve temporarily as voting 
members when: (1) expertise is required that is not available among 
current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members), or (2) to comprise a quorum when, because of unforeseen 
circumstances, a quorum is or will be lacking. Because of the size of 
the Committee and the variety in the types of issues that it will 
consider, FDA may, in connection with a particular committee meeting, 
specify a quorum that is less than a majority of the current voting 
members. The Agency's regulations (21 CFR 14.22(d)) authorize a 
committee charter to specify quorum requirements.
    If functioning as a medical device panel, an additional non-voting 
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in 
addition to the voting members.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/drug-safety-and-risk-management-advisory-committee 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. 1001 et seq.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17243 Filed 8-2-24; 8:45 am]
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