
[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, ACPS-CP@fda.hhs.gov.

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]
BILLING CODE 4164-01-P


