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  1. Anesthetic and Analgesic Drug Products Advisory Committee

Anesthetic and Analgesic Drug Products Advisory Committee Charter

Advisory Committee's Official Designation

Anesthetic and Analgesic Drug Products Advisory Committee (the Committee)

Authority

The Anesthetic and Analgesic Drug Products Advisory Committee is established under 15 U.S.C. §1451 et seq.; 21 U.S.C. §321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 355h, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. §217a, 241, 242, 242a, 262, 264; 21 CFR Part 14; and is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. §1001 et seq).

Objectives and Scope of Activities

The Committee advises and informs the Commissioner of Food and Drugs (the Commissioner) or designee(s) about the existing and relevant evidence of benefits and risks of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, issues related to opioid abuse, and drug products for use in anesthesiology. The goal of this Committee is to convene experts to provide recommendations based on their interpretation of evidence, informed by their scientific, clinical, or other relevant expertise. The recommendations of this Committee will help FDA make informed decisions about the product(s) or issues under consideration. For clarity, the Committee provides advice and recommendations, but FDA retains full regulatory decision-making authority on the issues associated with the product(s) or issues under consideration.

Description of Duties

The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, issues related to opioid abuse, and drug products for use in anesthesiology. The Committee may consider the quality and relevance of FDA’s research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

Agency or Federal Officer Receiving the Advisory Committee's Advice/Recommendations

The Committee provides advice to the Commissioner of Food and Drugs.

Support

Management and support services shall be provided by the Office of the Commissioner, Principal Deputy Commissioner, and / or the relevant Centers, Offices, and Programs.

Estimated Annual Operating Costs and Staff Years

FDA estimates the following annual operating costs and staff years associated with this Committee.

(1) Annual budget and expected costs: $126,950.
(i) The estimated person years of Federal staff support required is 0.25 at an estimated annual cost of $50,875.
(ii) The estimated annual payments to Committee members are $8,473 for a total of six members, and
(iii) The estimated annual reimbursable costs, including travel and related expenses for members, is $45,902.

Estimated Number and Frequency of Meetings

FDA will convene the Committee as needed consistent with the Agency’s needs and applicable legal and regulatory authorities.

The frequency of meetings will vary from year to year, depending on the specific issues upon which Committee’s advice and recommendations are sought. FDA is not required to convene the committee each calendar year.

Except where legally required to conduct a closed meeting, the committee meetings will be open to the public, consistent with 5 U.S.C. §1009 and in the interest of scientific innovation, education, and transparency.

Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. §552b(c)) and the Federal Advisory Committee Act. Notice of all such meetings shall be given to the public.

Duration

The duration of the advisory committee is continuing, subject to the Termination section below.

Termination

Unless renewed by appropriate action, the Anesthetic and Analgesic Drug Products Advisory Committee will terminate two years from the date the charter is filed.

Membership and Designation

The Committee shall consist of a core of at least six voting members including the Chair. Subject to legal and regulatory requirements, members and the Chair are selected by and serve at the discretion of the Commissioner or designee. Each member, including the Chair, will be selected from among authorities knowledgeable in the fields of anesthesiology, analgesics (e.g., abuse deterrent opioids, novel analgesics, and issues related to opioid abuse), epidemiology or statistics, and related specialties.

Members will be invited to serve for terms of up to four years, or for less time in the discretion of the Commissioner or designee. 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.

In addition to the voting members, the Commissioner or designee may identify consumer and/or industry representatives to join the Committee (or serve as alternate representatives) as non-voting representative member(s), via a process consistent with legal and regulatory requirements. Individuals currently employed at FDA-regulated companies, such as pharmaceutical and medical device manufacturers, shall not be selected to serve as members of the Committee unless this Committee is expected to address issues for which inclusion of an industry representative is required by statute. If this Committee includes an industry representative, the Commissioner or designee will determine whether to invite them to participate in meetings on a case-by-case basis, according to applicable legal and regulatory requirements.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees to serve temporarily as voting members and to designate Special Government Employees 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.

A quorum for the Committee is a majority of the current voting members present at the time, provided that FDA may specify a quorum that is less than a majority of the current voting members because of the size of the Committee and the variety in the types of issues that it will consider, or other reason determined appropriate in accordance with legal and regulatory requirements. 21 CFR §14.22(d).

Members appointed to an advisory committee serve for the duration of the committee, or until their terms expire, they resign, or they are removed from membership by the Commissioner or designee. Committee members’ terms may be ended prior to their date of expiration, for reasons determined to be good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interferes with the ability to render objective advice, failure to abide by established procedures, or violation of other applicable rules and regulations.

Subcommittee

Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.

If requested, subcommittees may make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee. Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency or any other Federal officer.

Filing Date

May 1, 2026

Approved:

Date: April 23, 2026

Dr. Sara Brenner, M.D., M.P.H.
Principal Deputy Commissioner

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