Document ID: FDA-2023-N-2136-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
Posted Date: 2023-06-08T04:00Z

[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37548-37549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2136]

Advisory Committee; Antimicrobial Drugs 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 Antimicrobial Drugs 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 Antimicrobial 
Drugs Advisory Committee for an additional 2 years beyond the charter 
expiration date. The new charter will be in effect until the October 7, 
2024, expiration date.

[[Page 37549]]

DATES: Authority for the Antimicrobial Drugs Advisory Committee will 
expire on October 7, 2024, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: She-Chia Chen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services and by the General Services 
Administration, FDA is announcing the renewal of the Antimicrobial 
Drugs 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 available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders 
and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 13 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of infectious disease, internal medicine, microbiology, 
pediatrics, epidemiology or statistics, and related specialties. 
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/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-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. app.). For general information related to FDA advisory 
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12288 Filed 6-7-23; 8:45 am]
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