[Federal Register Volume 85, Number 3 (Monday, January 6, 2020)]
[Notices]
[Page 509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5888]


Advisory Committee; Pharmaceutical Science and Clinical 
Pharmacology Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA or 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 January 22, 
2022.

DATES: Authority for the Pharmaceutical Science and Clinical 
Pharmacology Advisory Committee will expire on January 22, 2022, unless 
the Commissioner formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Division of Advisory 
Committee and Consultant Management, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Avenue, 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 
301-847-8533, email: ACPS-CP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing 
the renewal of the Pharmaceutical Science and Clinical Pharmacology 
Advisory Committee. The committee is a discretionary Federal advisory 
committee established to provide advice to the Commissioner.
    The Pharmaceutical Science and Clinical Pharmacology Advisory 
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 which such drugs purport or are 
represented to have, and as required, any other product for which FDA 
has regulatory responsibility, and make 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 Pharmaceutical Science and Clinical 
Pharmacology Advisory Committee shall consist of a core of 14 voting 
members including two 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. Almost all non-Federal members of this committee 
serve as Special Government Employees. 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 up to three non-voting members who are identified 
with industry interests.
    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 document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28530 Filed 1-3-20; 8:45 am]
BILLING CODE 4164-01-P


