Notice2026-08125
Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal
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Published
April 27, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 80 (Monday, April 27, 2026)</title>
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[Federal Register Volume 91, Number 80 (Monday, April 27, 2026)]
[Notices]
[Pages 22539-22542]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08125]
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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) 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
[[Page 22540]]
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, 2028, 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: Advisory Committee Oversight and
Management Staff, Office of the Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#f2b3b1bdbfa1a187909f9b81819b9d9c81b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="3d7c7e72706e6e485f50544e4e5452534e7d5b595c1355554e135a524b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 21 CFR 14.40(b) and 41 CFR 102-
3.65, and following approval by the Department of Health and Human
Services and review 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 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, and makes appropriate recommendations to the
Commissioner.
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.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/anesthetic-and-analgesic-drug-products-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/anesthetic-and-analgesic-drug-products-advisory-committee</a> 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.
Renewal Requirements and Justification: The Commissioner has
determined that renewal of the AADPAC is in the public interest. This
determination is based on the Committee's essential role in providing
independent expert advice on complex scientific and regulatory matters
related to anesthesiology, analgesics, and related specialties, the
continued need for specialized expertise in this therapeutic area, and
the Committee's demonstrated value in supporting FDA's regulatory
mission. The following information supports this determination in
accordance with applicable legal and regulatory requirements.
Public Interest Determination
Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish,
or merge a discretionary (agency discretion) advisory committee, an
agency must first consult with the General Services Administration's
Committee Management Secretariat (the Secretariat) and, as part of the
consultation, provide a written public interest determination approved
by the head of the agency to the Secretariat with a copy to the Office
of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an
agency shall follow the same consultation process and document in
writing the same determination of need before creating a subcommittee
under a discretionary committee that is not made up entirely of members
of a parent advisory committee.
Information on the following factors for the committee is provided
to the Secretariat to demonstrate that renewing the committee is in the
public interest:
1. Annual budget.
The overall budget for this committee is $126,950.
a. Federal personnel on a full-time equivalent (FTE) basis.
The estimated person years of Federal staff support required is
0.25.
b. Other Federal internal costs.
The anticipated total value in dollars of other internal costs,
such as costs
[[Page 22541]]
associated with IT and supplies for meetings, is $21,700.
c. Proposed payments to members.
The estimated annual payment to members is $8,473.
d. Proposed number of members.
The anticipated number of members is 6.
e. Reimbursable costs.
The estimated annual reimbursable costs, including travel and
related expenses for members, is $45,902.
2. If applicable, the total dollar value of grants expected to be
recommended during the fiscal year.
N/A.
3. Criteria for selecting members to ensure the committee has the
necessary expertise and fairly balanced membership.
Ensuring Necessary Expertise: Members must have background,
education, and experience commensurate with the committee's function of
advising FDA on 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.
Scientific and technical competence is critical. Nominees should be
acknowledged experts with demonstrated skills in critical evaluation of
data and effective communication. As outlined in the committee charter,
the membership should include 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, as well as needed consumer and
industry representation. FDA also follows the requirements in section
505(n)(3) regarding membership of drug product advisory committees. (21
U.S.C. 355(n)(3)). Ensuring Fair Balance: Appointments are made without
discrimination. The committee is reviewed in totality for balance,
characterized by inclusion of necessary knowledge, insight, and
scientific perspective from the relevant community or expertise area.
Nominations are sought from all geographic locations within the United
States and its territories, and from diverse sources including
professional and scientific societies, academia, government agencies,
industry and trade associations, consumer and patient organizations,
and current Agency staff.
4. List of all other Federal advisory committees of the agency FDA
maintains the following Federal advisory committees:
<bullet> Antimicrobial Drugs Advisory Committee
<bullet> Blood Products Advisory Committee
<bullet> Cardiovascular and Renal Drugs Advisory Committee
<bullet> Cellular, Tissue and Gene Therapies Advisory Committee
<bullet> Dermatologic and Ophthalmic Drugs Advisory Committee
<bullet> Device Good Manufacturing Practice Advisory Committee
<bullet> Digital Health Advisory Committee
<bullet> Drug Safety and Risk Management Advisory Committee
<bullet> Endocrinologic and Metabolic Drugs Advisory Committee
<bullet> Genetic and Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Obstetrics, Reproductive and Urologic Drugs Advisory Committee
<bullet> Oncologic Drugs Advisory Committee
<bullet> Patient Engagement Advisory Committee
<bullet> Pediatrics Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Pulmonary-Allergy Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical Electronic Product Radiation Safety Standards
Committee
<bullet> Tobacco Products Scientific Advisory Committee
5. Justification that the information or advice provided by the
Federal advisory committee or subcommittee is not available from
another Federal advisory committee, another Federal Government source,
or any other more cost-effective and less burdensome source.
The Anesthetic and Analgesic Drug Products Advisory Committee is
the only FDA advisory committee that provides specialized expertise in
anesthesiology, addiction medicine, and analgesics (e.g., abuse
deterrent opioids, novel analgesics, and issues related to opioid
abuse). The complexity of technical, clinical, and regulatory
considerations in this therapeutic area exceeds the expertise of other
advisory committees, necessitating the continuation of this dedicated
committee.
6. If the consultation is a committee renewal, a summary of the
previous accomplishments of the committee and the reasons it needs to
continue.
Patients benefit from this committee's review and evaluation of
anesthetics and analgesic drugs. For example, in 2025, the committee
met jointly with the Drug Safety and Risk Management Advisory Committee
and discussed the findings of the completed extended-release/long-
acting opioid analgesic (ER/LA OA) post marketing requirements (PMRs)
3033-1 and 3033-2. These PMRs were prospective (3033-1) and
retrospective (3033-2) epidemiologic studies that examined the serious
risks and predictors of misuse, abuse, addiction, and fatal and non-
fatal opioid overdose in patients with long-term use of opioid
analgesics for management of chronic pain, including patients
prescribed ER/LA OAs. The Committees discussed their interpretation of
the findings from these PMRs on the incidence and prevalence of misuse,
abuse, Opioid Use Disorder (OUD), and fatal and nonfatal overdose in
patients using OAs long-term, their thoughts on the most important
findings, as well as any novel findings they believed FDA should
communicate to healthcare providers, patients, and other members of the
public.
7. Explanation of why the committee/subcommittee is essential to
the conduct of agency business.
The Committee plays a critical role in enabling FDA to meet the
requirements of section 505(n)(1) and (s)(1) of the Federal Food, Drug,
and Cosmetic Act by providing expert scientific advice and
recommendations. The Anesthetic and Analgesic Drug Products Advisory
Committee is the only FDA advisory committee that provides specialized
expertise in anesthesiology, addiction medicine, and analgesics.
Without the Anesthetic and Analgesic Drug Products Advisory Committee,
FDA's ability to obtain external input on issues related to the
approval and regulation of anesthetics, addiction medicine and
analgesics would be significantly limited.
In conclusion, this public interest determination documents that
renewing the Committee is in the public interest, essential to the
conduct of agency business, and that the information to be obtained is
not already available through another advisory committee or source
within the Federal Government
This notice is issued under the Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For general information related to FDA
advisory committees, please visit us at
[[Page 22542]]
<a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08125 Filed 4-24-26; 8:45 am]
BILLING CODE 4164-01-P
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