83 FR 3736 - Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

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 January 22, 2020.

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3736-3737]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01377]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6903]


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) is announcing the 
renewal of the Pharmaceutical Science

[[Page 3737]]

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, 2020.

DATES: Authority for the Pharmaceutical Science and Clinical 
Pharmacology Advisory Committee will expire on January 22, 2020, 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 Ave., 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 102-3.65 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). 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 drugs purport or are 
represented to have, and as required, any other product for which FDA 
has regulatory responsibility, and makes 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. 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/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/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 visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: January 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01377 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P