Notice2024-16629
Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal
Primary source
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Published
July 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) 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, 2026, expiration date.
Full Text
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<title>Federal Register, Volume 89 Issue 145 (Monday, July 29, 2024)</title>
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[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60896-60897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16629]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0622]
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 or the Agency) 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, 2026, 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: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, <a href="/cdn-cgi/l/email-protection#bcecfdf8fdfffcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="114150555052517775703f7979623f767e67">[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 of Food and Drugs.
Pursuant to its Charter, the Committee shall consist of a core of
11 voting members, including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of pulmonary medicine, allergy, clinical
immunology, and epidemiology or statistics. Members will be invited to
serve for overlapping terms of up to 4 years. 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. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who is identified with consumer interests and is recommended by either
a consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
[[Page 60897]]
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) 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. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
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.
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 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.
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="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16629 Filed 7-26-24; 8:45 am]
BILLING CODE 4164-01-P
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