Notice2026-03587
Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal
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Published
February 24, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal 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 Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 3, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 36 (Tuesday, February 24, 2026)</title>
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[Federal Register Volume 91, Number 36 (Tuesday, February 24, 2026)]
[Notices]
[Pages 8889-8891]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
Advisory Committee; Gastrointestinal 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 Gastrointestinal 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
Gastrointestinal Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the March 3, 2028, expiration date.
DATES: Authority for the Gastrointestinal Drugs Advisory Committee will
expire on March 3, 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. 31, Rm. 2417, Silver
Spring, MD 20993-0002, (301) 796-9001, <a href="/cdn-cgi/l/email-protection#d392909c9e8080a6b1bebaa0a0babcbda093b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="5415171b1907072136393d27273d3b3a27143230357a3c3c277a333b22">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 14 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 Gastrointestinal 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 on the safety and
effectiveness of marketed and investigational human drug and biologic
products for use in the treatment of gastrointestinal and liver
diseases. 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. Meetings are convened as appropriate consistent with the
Agency's needs and applicable legal and regulatory authorities.
The Committee shall consist of at least two 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
gastroenterology, hepatology, nutrition, surgery, clinical
pharmacology, physiology, pathology, and statistics.
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 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; or (3) when
[[Page 8890]]
considered appropriate in the discretion of the Commissioner or
designee.
A quorum for the Committee is a majority of the current voting
members present at the time, provided that FDA may, in connection with
a particular committee meeting, 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/gastrointestinal-drugs-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/gastrointestinal-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 Gastrointestinal Drugs Advisory
Committee 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 gastrointestinal
drug products, 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 U.S.C. 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 U.S.C. 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 $137,412.
a. Federal personnel (based on 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 associated with IT and supplies for meetings, is $32,457.
c. Proposed payments to members.
The estimated annual payment to members is $18,737.
d. Proposed number of members.
The anticipated number of members is 10.
e. Reimbursable costs.
The estimated annual reimbursable costs, including travel and
related expenses for members, is $35,480.
(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
gastrointestinal and liver diseases. 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
gastroenterology, hepatology, nutrition, surgery, clinical
pharmacology, physiology, pathology, and statistics 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.
Selection Process
A Federal Register Notice is published annually soliciting
nominations for vacancies. Agency Designated Federal Officers and
Office/Division Directors review and evaluate prospective members for
competence and suitability. Anyone may nominate an individual,
including themselves, for committee membership.
(4) List of all other Federal advisory committees of the agency.
FDA maintains the following Federal advisory committees:
<bullet> Anesthetic and Analgesic Drug Products Advisory Committee
<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
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<bullet> Pediatrics Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Pharmacy Compounding Drugs AC
<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 and Electronic Product Safety Standards AC
<bullet> Technical and Electronic Products Safety Standards Advisory
Committee
<bullet> Tobacco Products Advisory Committee
(5) Justification that the information or advice provided by the
Federal advisory committee is not available from another Federal
advisory committee, another Federal Government source, or any other
more cost-effective and less burdensome source.
The Gastrointestinal Drugs Advisory Committee provides independent
expert advice to FDA on the safety and effectiveness of marketed and
investigational human drug products for the treatment of
gastrointestinal and liver diseases.
The topics considered by the Gastrointestinal Drugs Advisory
Committee require specialized expertise in gastrointestinal physiology,
pathology, and clinical practice 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 justification relates to a renewal, a summary of the
previous accomplishments of the committee and the reasons it needs to
continue.
Summary of Previous Accomplishments
The Gastrointestinal Drugs Advisory Committee most recently met on
September 13, 2024, and May 19, 2023, to discuss applications related
to obeticholic acid for gastrointestinal indications. These meetings
supported FDA's evaluation of complex scientific and regulatory issues
associated with both marketed and investigational drug products.
(7) Explanation of why the committee/subcommittee is essential to
the conduct of agency businesses.
The Committee plays a critical role in enabling FDA to meet the
requirements of section 505(n)(1) of the Federal Food, Drug, and
Cosmetic Act by providing expert scientific advice and recommendations.
Without the Gastrointestinal Drugs Advisory Committee, FDA's ability to
obtain external expert input on issues related to the approval and
regulation of gastrointestinal drug products 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. 2026-03587 Filed 2-23-26; 8:45 am]
BILLING CODE 4164-01-P
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