Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal

Issuing agencies

Abstract

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, 2028, expiration date.

Full Text

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<title>Federal Register, Volume 91 Issue 189 (Thursday, October 1, 2026)</title>
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[Federal Register Volume 91, Number 189 (Thursday, October 1, 2026)]
[Notices]
[Pages 62520-62522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-0008]


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, 
2028, expiration date.

DATES: Authority for the Antimicrobial Drugs Advisory Committee will 
expire on October 7, 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#edacaea2a0bebe988f80849e9e8482839ead8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="c9888a86849a9abcaba4a0babaa0a6a7ba89afada8e7a1a1bae7aea6bf">[email&#160;protected]</span></a>.

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 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 infectious disease, internal medicine, microbiology, 
pediatrics, epidemiology or statistics, and related specialties.
    Members may 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

[[Page 62521]]

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).
    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.
    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/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee">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</a> or by contacting 
the Advisory Committee Oversight and Management Staff (see FOR FURTHER 
INFORMATION CONTACT). Because the committee's name and description of 
duties remain unchanged, 21 CFR 14.100 will not be amended.
    Renewal Requirements and Justification: The Commissioner has 
determined that renewal of the Antimicrobial Drugs Advisory Committee 
is in the public interest. This determination is based on the 
Committee's essential role in providing independent expert advice on 
the safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders, 
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 $87,827.
    a. Federal personnel on a full-time equivalent (FTE) basis: The 
estimated person years of Federal staff support is 0.25 at an estimated 
annual cost of $50,875.
    b. Other Federal internal costs: The anticipated total value in USD 
of other internal costs, such as cost associated with IT supplies for 
meetings is $20,269.
    c. Proposed payments to members: The estimated annual payments to 
members are $4,424.
    d. Proposed number of members: The anticipated number of members is 
six.
    e. Reimbursable costs: The estimated annual reimbursable costs, 
including travel and related expenses for members is $4,656.
    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 for use in 
the treatment of infectious diseases and disorders and related 
specialties. 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 infectious disease, internal medicine, 
microbiology, pediatrics, epidemiology or statistics, and related 
specialties, as well as needed consumer and industry representation. 
FDA also follows the requirements in section 505(n)(3) of the Federal 
Food, Drug & Cosmetic Act 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

[[Page 62522]]

maintains the following Federal advisory committees:

<bullet> Anesthetic and Analgesic Drug Products 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 Metabolic Diseases 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> Pediatric 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
<bullet> Vaccines and Related Biological Products 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 Antimicrobial Drugs Advisory Committee provides independent 
expert advice to FDA on the safety and effectiveness of marketed and 
investigational human drug products for use in the treatment of 
infectious diseases and disorders.
    The topics considered by the Antimicrobial Drugs Advisory Committee 
require specialized expertise in the fields of infectious disease, 
internal medicine, microbiology, pediatrics, epidemiology or 
statistics, and related specialties that is not within the primary 
scope of other FDA advisory committees. Potential topics that may need 
committee input include products related to the topics outlined in 
Section (6) below. These and other issues cannot be appropriately 
addressed by another standing committee without diminishing the depth 
and relevance of the expert input provided to the Agency.
    6. If the consultation is a committee renewal, a summary of the 
previous accomplishments of the committee and the reasons it needs to 
continue.
    Summary of Previous Accomplishments: In recent years, the 
Antimicrobial Drugs Advisory Committee met on four applications 
involving therapies and preventive interventions for infectious 
diseases. The Committee discussed benefit-risk evaluations for products 
addressing candidemia and invasive candidiasis, COVID-19, multidrug-
resistant bacterial pneumonia, and respiratory syncytial virus (RSV). 
All four applications reviewed by the Committee were approved by FDA. 
Renewal of the Committee is needed to ensure the continued availability 
of independent external expertise to advise the Agency on topics 
involving infectious diseases.
    7. Explanation of why the committee/subcommittee is essential to 
the conduct of agency business.
    Reasons for Continuation: The committee plays a critical role in 
enabling FDA to meet the requirements of sections 505(n)(1) and (s)(1) 
of the Federal Food, Drug, and Cosmetic Act by providing expert 
scientific advice and recommendations. Without the Antimicrobial Drugs 
Advisory Committee, FDA's ability to obtain external expert input on 
issues related to the approval and regulation of the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of infectious diseases and disorders 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 <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. 2026-20142 Filed 9-29-26; 4:15 pm]
BILLING CODE 4164-01-P


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