Notice2026-10410
Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal
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Published
May 26, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the renewal of the Pulmonary-Allergy 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 Pulmonary- Allergy Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 30, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 100 (Tuesday, May 26, 2026)</title>
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[Federal Register Volume 91, Number 100 (Tuesday, May 26, 2026)]
[Notices]
[Pages 30654-30656]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10410]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
Advisory Committee; Pulmonary-Allergy 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 Pulmonary-Allergy 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 Pulmonary-
Allergy Drugs Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
May 30, 2028, expiration date.
DATES: Authority for the Pulmonary-Allergy Drugs Advisory Committee
will expire on May 30, 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#68292b27253b3b1d0a05011b1b0107061b280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="9ddcded2d0cecee8fff0f4eeeef4f2f3eeddfbf9fcb3f5f5eeb3faf2eb">[email 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 Pulmonary-Allergy
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 pulmonary disease and diseases
with allergic and/or immunologic mechanisms 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 pulmonary medicine, allergy, clinical immunology, and
epidemiology or statistics.
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 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).
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/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-advisory-committee-charter">https://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-advisory-committee-charter</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 Pulmonary-Allergy 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 pulmonary disease and diseases
with allergic and/or immunologic mechanisms, 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 [filig]rst consult with the General Services
Administration's Committee Management Secretariat (the Secretariat)
and, as part of the consultation, provide a written public interest
determination
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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: Annual budget and expected costs: $123,187.
a. Federal personnel on a full-time equivalent (FTE) basis: The
estimate person years of Federal staff support required is 0.10 at an
estimated annual cost of $19,979.
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 $63,849.
c. Proposed payments to members: The estimated annual payment to
members is $7,447.
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 $24,466.
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 pulmonary disease,
diseases with allergic and/or immunologic mechanisms, 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 pulmonary medicine, allergy, clinical
immunology, and 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> 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> Gastrointestinal 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> Pharmacy Compounding Drugs AC
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical and Electronic Products Safety Standards Advisory
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 Pulmonary-Allergy 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
pulmonary disease and diseases with allergic and/or immunologic
mechanisms.
The topics considered by the Pulmonary-Allergy Drugs Advisory
Committee require specialized expertise in the practice of pulmonology,
allergy, immunology, 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 2023, the committee
discussed new drug application (NDA) 214697, for epinephrine nasal
spray, submitted by ARS Pharmaceuticals Inc., for the proposed
indication of emergency treatment of allergic reactions (Type I)
including anaphylaxis in adults and children >=30 kilograms. Their
recommendations informed FDA's decision to approve Neffy (epinephrine
nasal spray) as the first nasal spray for the treatment of anaphylaxis.
The PADAC did not meet in 2025, however the topics on which the
committee may be necessary are the following:
<bullet> Treatment for asthma
<bullet> Treatment for chronic obstructive pulmonary disease
<bullet> Pulmonary fibrosis
<bullet> Pulmonary hypertension
<bullet> Atopic Dermatitis/Eczema
<bullet> Food allergies
<bullet> Drug allergies
<bullet> Anaphylaxis
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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 Pulmonary-Allergy 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 pulmonary disease and diseases with allergic and/or
immunologic mechanisms 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/AdvisoryCommittees/default.htm">http://www.fda/AdvisoryCommittees/default.htm</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10410 Filed 5-22-26; 8:45 am]
BILLING CODE 4164-01-P
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