[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34344-34345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Psychopharmacologic Drugs 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 Psychopharmacologic Drugs 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
Psychopharmacologic Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the June 4, 2018.
DATES: Authority for the Psychopharmacologic Drugs Advisory Committee
will expire on June 4, 2016, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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, [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 Psychopharmacologic Drugs Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Psychopharmacologic Drugs
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 data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related fields and make
appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of psychopharmacology, psychiatry, epidemiology or statistics,
and related specialties. 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 one non-voting member who is
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/PsychopharmacologicDrugsAdvisoryCommittee/ucm107528.htm or by
[[Page 34345]]
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 http://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12637 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P