[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25277-25278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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 http://www.fda.gov/AdvisoryCommittees/default.htm.

    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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