Antiviral Drugs Advisory Committee Charter
The Antiviral 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(f), 355, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.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 Antiviral 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 available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections, and makes 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 $163.691. The estimated person years of staff support required is 1.10, at an estimated annual cost of $128,257.
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 four 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. A report will be prepared which will contain, as a minimum, a list of members and their business addresses, the Committee’s functions, the dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of this report will be provided to the Department Committee Management Officer.
Unless renewed by appropriate action prior to its expiration, the Antiviral 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 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical pharmacology, internal medicine, infectious diseases, microbiology, virology, psychiatry, statistics, epidemiology, ophthalmology, immunology, pediatrics, hematology, and related specialties. 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; there also may be alternate industry representative.
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, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum 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 a quorum 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.
Members shall be invited to serve for overlapping four-year terms. Terms of more than two years are contingent upon the renewal of the Committee by appropriate action prior to its expiration.
Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed 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, and estimated 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. The records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
February 15, 2013
|Date||Jill Hartzler Warner, J.D.|
Associate Commissioner for Special Medical Programs (Acting), FDA