[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Notices]
[Pages 63434-63435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0621]


Advisory Committee; Anesthetic and Analgesic Drug Products 
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 Anesthetic and Analgesic Drug Products 
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 Anesthetic and Analgesic Drug Products Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until the May 1, 2026, expiration 
date.

DATES: Authority for the Anesthetic and Analgesic Drug Products 
Advisory Committee will expire on May 1, 2026, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, email: [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 Anesthetic and 
Analgesic Drug Products 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

[[Page 63435]]

investigational human drug products including analgesics; e.g., abuse-
deterrent opioids, novel analgesics, and issues related to opioid 
abuse, and those for use in anesthesiology and makes appropriate 
recommendations to the Commissioner of Food and Drugs.
    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 anesthesiology, analgesics (such as: 
abuse deterrent opioids, novel analgesics, and issues related to opioid 
abuse) 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 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.
    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/anesthetic-and-analgesic-drug-products-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. 2024-17248 Filed 8-2-24; 8:45 am]
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