[Federal Register Volume 91, Number 103 (Friday, May 29, 2026)]
[Notices]
[Pages 32062-32064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-10674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
Advisory Committee; Psychopharmacologic 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 Psychopharmacologic 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
Psychopharmacologic Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the June 4, 2028, expiration date.
DATES: Authority for the Psychopharmacologic Drugs Advisory Committee
will expire on June 4, 2026, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Advisory Committee Oversight &
Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3215, Silver Spring, MD 20993-0002, 301-796-8220,
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
Psychopharmacologic 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 data concerning the safety and
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effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related specialties and makes
appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of at least 6 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 psychopharmacology,
psychiatry, epidemiology, statistics, and related specialties.
Members will be invited to serve for terms of up to four years, or
for less time at the discretion of the Commissioner or designee. Non-
Federal members of this committee will serve either 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 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.
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 https://www.fda.gov/advisory-committees/human-drug-advisory-committees/psychopharmacologic-drugs-advisory-committee or by contacting the Advisory Committee Oversight and
Management Staff (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 Psychopharmacologic Drugs Advisory
Committee is in the public interest. This determination is based on the
Committee's essential role in providing independent expert advice on
drug products for psychiatric indications for which the Food and Drug
Administration has regulatory responsibility, 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 $89,984.
a. Federal personnel on a full-time equivalent (FTE) basis:
The estimated person years of Federal staff support required is
0.25, at an estimated annual cost of $51,384.
b. Other Federal internal costs:
The anticipated total value in dollars of other internal costs,
such as costs associated with IT and supplies for meetings, is $20,396.
c. Proposed payments to members:
The estimated annual payment to members is $4,466.
d. Proposed number of members:
The anticipated number of members is six.
e. Reimbursable cost:
The estimated annual reimbursable costs, including travel and
related expenses for members, is $6,456.
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 practice of psychiatry 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
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psychopharmacology, psychiatry, epidemiology, 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:
[cir] Anesthetic and Analgesic Drug Products Advisory Committee
[cir] Antimicrobial Drugs Advisory Committee
[cir] Blood Products Advisory Committee
[cir] Cardiovascular and Renal Drugs Advisory Committee
[cir] Cellular Tissue and Gene Therapies Advisory Committee
[cir] Dermatologic and Ophthalmic Drugs Advisory Committee
[cir] Device Good Manufacturing Practice Advisory Committee
[cir] Digital Health Advisory Committee
[cir] Drug Safety and Risk Management Advisory Committee
[cir] Endocrinologic and Metabolic Drugs Advisory Committee
[cir] Gastrointestinal Drugs Advisory Committee
[cir] Genetic and Metabolic Disease Advisory Committee
[cir] Medical Devices Advisory Committee
[cir] National Mammography Quality Assurance Advisory Committee
(Administratively Inactive)
[cir] Nonprescription Drugs Advisory Committee
[cir] Obstetrics Reproductive and Urologic Drugs Advisory Committee
[cir] Oncologic Drugs Advisory Committee
[cir] Patient Engagement Advisory Committee
[cir] Pediatrics Advisory Committee
[cir] Peripheral and Central Nervous System Advisory Committee
[cir] Pharmacy Compounding Advisory Committee
[cir] Pulmonary-Allergy Drugs Advisory Committee
[cir] Risk Communication Advisory Committee (Administratively Inactive)
[cir] Science Board to the Food and Drug Administration
[cir] Technical Electronic Product Radiation Safety Standards Committee
[cir] 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 Committee advises and informs the Commissioner or designee(s)
about the existing and relevant evidence of benefits and risks of
marketed and investigational human drug products for use in the
practice of psychiatry and related specialties.
The topics considered by the Psychopharmacologic Drugs Advisory
Committee require specialized expertise in the practice of psychiatry
and related specialties that is not within the primary scope of other
FDA advisory committees. As such, these 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: The Psychopharmacologic Drugs
Advisory Committee serves the public interest by ensuring that patients
with psychiatric conditions have access to safe and effective
treatments through informed regulatory decision-making.
In 2024, the committee met jointly with the Drug Safety and Risk
Management Advisory Committee and discussed the reevaluation of the
Clozapine Risk Evaluation and Mitigation Strategy (REMS) and possible
changes to minimize burden on patients, pharmacies, and prescribers
while maintaining safe use of clozapine. The issues the Committees
discussed included whether clozapine healthcare providers have
sufficient knowledge and access to resources about the risk of
neutropenia and need for absolute neutrophil count (ANC) monitoring,
and whether ANC monitoring would be performed without the requirements
of the REMS.
Impact: The committee's recommendations informed the FDA's decision
to no longer expect prescribers, pharmacies, and patients to
participate in the REMS program for clozapine or to report results of
absolute neutrophil count (ANC) blood tests before pharmacies dispense
clozapine.
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 Psychopharmacologic Drugs Advisory Committee is
the only FDA advisory committee that provides specialized expertise in
the practice of psychiatry and related fields. Without the
Psychopharmacologic Drugs Advisory Committee, FDA's ability to obtain
external input on issues related to the approval and regulation of drug
products for psychiatric indications 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 http://www.fda.gov/AdvisoryCommittees/default.htm.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10674 Filed 5-28-26; 8:45 am]
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