Advisory Committees

Psychopharmacologic Drugs Advisory Committee Charter


The Psychopharmacologic Drugs Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321,341,342,343,343-1,344,345, 346,348,349,350,350a, 351,352,353(0, 355,360b, 360c-j, 371,375,376,378,379e, 381,393,394,881(b); 42U.S.C. 217a, 241,242, 242a, 262,264; 21 CFR Part 14,330.10(a); Pub. L.92-463 (5 U.S.C. App.), the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees.

Objectives and Scope of Activities

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.

Description of Duties

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.

Agency or Official to Whom the Committee Reports

The Committee provides advice to the Commissioner of Food and Drugs.


Management and support services shall be provided by the Center for Drug Evaluation and Research.

Estimated Annual Operating Costs and Staff Years

The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $64,366. The estimated person years of staff support required is 1.10, at an estimated annual cost of $133,200.

Designated Federal Officer

FDA will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration Manual directives. The DFO will approve and prepare all meeting agendas, call all of the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees.

Estimated Number and Frequency of Meetings

Meetings shall be held approximately 4 times a year. Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all meetings shall be given to the public.




Unless renewed by appropriate action the Psychopharmacologic Drugs Advisory Committee will terminate two years from the date the charter is filed.

Membership and Designation

The Committee shall consist of a core of 9 voting members including tiie Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable inthe fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms ofup to four 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.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, aquorum will be based on the combined total of regular and added members), or (2) to comprise aquorum when, because of unforeseen circumstances, aquorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular committee meeting, specify aquorum that is less than a majority of the current voting members. The Agency's regulations (21 CFR §14.22(d)) authorize a committee charter to specify quorum requirements.

If functioning as a medical device panel, a non-voting representative of consumer interests and a non-voting representative of industry interests will be included in addition to the voting members.


Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee asneeded to address specific issues within their respective areas of expertise.

Subcommittees make preliminary recommendations regarding specific issues for subsequent action by the full Committee. The Department Committee Management Officer shall be notified upon establishment of each subcommittee, and shall be provided information on its name, membership, function, andestimated frequency of meetings.


The records of the Committee, established subcommittees, or other subgroups of the committee, shall be handled in accordance with General Records Schedule 26, Item 2 or other approved agency records disposition schedule.

Filing Date

June 4, 2014


Date:  5/14/2014

Jill Hartzler Warner, J.D.
Associate Commissioner for Special Medical Programs (Acting), FDA


I determine that renewal of the Psychopharmacologic Drugs Advisory Committee beyond June 4,2014, is in the public interest in connection with the performance of duties imposed on the Food and Drug Administration by law, and that such duties can best be performed through the advice and counsel of such a group. Therefore, the Committee is continued until June 4, 2016.

I deem that this is not feasible for the Food and Drug Administration or any of its existing committees to perform these duties, and that a satisfactory plan for appropriate balance of the Committee membership exists.

Date: 5/14/2014

Jill Hartzler Warner, J.D.
Associate Commissioner for Special Medical Programs (Acting), FDA

Page Last Updated: 09/23/2014
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