[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: [email protected].
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]
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