Notice2024-05218
Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Renewal
Primary source
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Published
March 12, 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 Pharmaceutical Science and Clinical Pharmacology 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 Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the January 22, 2026, expiration date.
Full Text
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<title>Federal Register, Volume 89 Issue 49 (Tuesday, March 12, 2024)</title>
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[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17851-17852]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05218]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0869]
Advisory Committee; Pharmaceutical Science and Clinical
Pharmacology 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 Pharmaceutical Science and Clinical
Pharmacology 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 Pharmaceutical Science and Clinical
Pharmacology Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
January 22, 2026, expiration date.
DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2026, unless
the Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Yvette Waples, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993, 301-796-9001, <a href="/cdn-cgi/l/email-protection#77363427245a342737111316591f1f0459101801"><span class="__cf_email__" data-cfemail="aeefedfefd83edfeeec8cacf80c6c6dd80c9c1d8">[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 Pharmaceutical
Science and Clinical Pharmacology 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 scientific, clinical, and
technical issues related to the safety and effectiveness of drug
products for use in the treatment of a broad spectrum of human
diseases, the quality characteristics that such drugs purport or are
represented to have, and as required, any other product for which FDA
has regulatory responsibility, and makes appropriate recommendations to
the Commissioner. The Committee may also review Agency-sponsored
intramural and extramural biomedical research programs in support of
FDA's drug regulatory responsibilities and its critical path
initiatives related to improving the efficacy and safety of drugs and
improving the efficiency of drug development.
Pursuant to its charter, the Committee shall consist of a core of
14 voting members including 2 Chairpersons. Members and Chairpersons
are selected by the Commissioner or designee from among authorities
knowledgeable in the fields of pharmaceutical sciences (pharmaceutical
manufacturing, bioequivalence research, laboratory analytical
techniques, pharmaceutical chemistry, physiochemistry, biochemistry,
molecular biology, immunology, and microbiology) and clinical
pharmacology (dose-response, pharmacokinetics-pharmacodynamics,
modeling and simulation, pharmacogenomics, clinical trial design,
pediatrics and special populations, and innovative methods in drug
development), biostatistics, related biomedical and pharmacological
specialties, current good manufacturing practices, and quality systems
implementation. Members will be invited to serve for overlapping terms
of up to 4 years. Non-Federal members of this Committee will serve
either as Special Government Employees or non-voting 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
[[Page 17852]]
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
up to three non-voting representative members who are identified with
industry interests. There may also be an alternate industry
representative.
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/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee</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 (5
U.S.C. app.). 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: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05218 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
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