[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17851-17852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [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 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 https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

    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