[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3736-3737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01377]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6903]
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) is announcing the
renewal of the Pharmaceutical Science
[[Page 3737]]
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, 2020.
DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2020, 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 Ave., 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 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
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 which 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.
The 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, 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/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/default.htm 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 visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01377 Filed 1-25-18; 8:45 am]
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