Notice2022-09076
Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Renewal
Primary source
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Published
April 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25277-25278]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09076]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0620]
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) 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, 2024, expiration date.
DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2024, unless
the Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Rhea Bhatt, 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: <a href="/cdn-cgi/l/email-protection#12535142413f5142527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="d091938083fd938090b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
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 which such
[[Page 25278]]
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.
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. Non-
Federal members of this committee will serve as Special Government
Employees, representatives or Ex-Officio members. 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 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.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmaceutical-science-and-clinical-pharmacology-advisory-committee</a> 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 <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: April 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09076 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P
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