Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Renewal, 509 [2019-28530]
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Federal Register / Vol. 85, No. 3 / Monday, January 6, 2020 / Notices
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.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
PatientEngagementAdvisoryCommittee/
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 check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28518 Filed 1–3–20; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice; renewal of advisory
committee.
lotter on DSKBCFDHB2PROD with NOTICES
ACTION:
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
SUMMARY:
VerDate Sep<11>2014
17:53 Jan 03, 2020
Jkt 250001
(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
PO 00000
Frm 00017
Fmt 4703
Sfmt 9990
509
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-clinicalpharmacology-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
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
