[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Notices]
[Pages 3805-3806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01181]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Pharmaceutical Science and Clinical
Pharmacology Advisory Committee (Formerly Known as the Advisory
Committee for Pharmaceutical Science and Clinical Pharmacology),
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Pharmaceutical Science and Clinical Pharmacology
Advisory Committee (formerly known as the Advisory Committee for
Pharmaceutical Science and Clinical Pharmacology) 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, 2018.
DATES: Authority for the Pharmaceutical Science and Clinical
Pharmacology Advisory Committee will expire on January 22, 2018, unless
the Commissioner formally determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
[[Page 3806]]
Drug Administration, 10903 New Hampshire Avenue, Bldg. 31, Rm. 2417,
Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, [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 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 the Food and Drug
Administration 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 the
Food and Drug Administration has regulatory responsibility; and makes
appropriate recommendations to the Commissioner of Food and Drugs. 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); 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. 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: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm107524.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). Due to a change in the committee name,
FDA will publish a final rule will in the Federal Register amending 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 http://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: January 15, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Programs.
[FR Doc. 2016-01181 Filed 1-21-16; 8:45 am]
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