Committee's Official Designation
Fogarty International Center Advisory Board
Authority
Authorized by 42 U.S.C. 217a, section 222 of the Public Health Service (PHS) Act, as amended. The Fogarty International Center Advisory Board (Board) is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014).
Objectives and Scope of Activities
The Board will advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services (Secretary) and the Director, John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC, also referred to as Center) on matters related to the activities carried out by and through the Center and the policies respecting these activities.
Description of Duties
The Board may recommend to the Secretary, in accordance with section 231 of the PHS Act, as amended, acceptance of conditional gifts for study, investigation, or research into matters relating to health science internationally, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the Center.
The Board may review applications for grants and cooperative agreements for research and training and recommend approval of applications for projects which show promise of making valuable contributions to human knowledge; may review any grant, contract, or cooperative agreement proposed to be made or entered into by the Center; may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the Center was established and, with the approval of the Director, FIC, make available such information through appropriate publications for the benefit of public and private health entities, health professions personnel and scientists, and for the information of the general public.
The Board will prepare triennial reports describing the manner in which the Center has complied with section 492B of the PHS Act, as amended, which sets forth requirements addressing the inclusion of women and members of minority groups as subjects in clinical research conducted or supported by the National Institutes of Health (NIH). Each report shall be submitted to the Director, FIC, for inclusion in the triennial report submitted to Congress by the Director, NIH, pursuant to section 403 of the PHS Act, as amended. Each triennial report prepared by the Board shall include each of the following:
- The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies.
- The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies.
- For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that—
- have been completed during such reporting period; and
- are being carried out during such reporting period and have not been completed.
- The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with section 492B(c)(2)(A) of the PHS Act, as amended.
Agency or Official to Whom the Committee Reports
The Board will advise the Secretary and the Director, FIC.
Support
Management and support services will be provided by the Office of the Director, FIC.
Estimated Annual Operating Costs and Staff Years
The estimated annual cost for operating the Board, including compensation and travel expenses for members, but excluding staff support, is $29,669. The estimate of annual person-years of staff support required is 0.6, at an estimated annual cost of $102,763.
Designated Federal Officer
The Director, FIC, will assign a full-time or permanent part-time FIC, employee to serve as the Designated Federal Officer (DFO) of the Board (also known as Executive Secretary). In the event that the DFO cannot fulfill the assigned duties of the Board, one or more full-time or permanent part-time FIC employees will be assigned as DFO and carry out these duties on a temporary basis.
The DFO will approve all of the Board's and subcommittees' meetings, prepare and approve all meeting agendas, attend all Board and subcommittee meetings, adjourn any meeting when it is determined to be in the public interest, and chair meetings when directed to do so by the official to whom the committee submits its recommendations.
Estimated Number and Frequency of Meetings
Meetings of the full Board will be held at the call of the Chair (with the DFO's approval) or upon request of the Director, FIC, approximately three times within a fiscal year. Meetings will be open to the public except as determined by the Secretary at the request of the DFO in accordance with 5 U.S.C. 552b(c) and 41 C.F.R. 102-3.155 including specifying the specific exception(s) that justifies closure. Notice of all meetings will be given to the public. In the event a portion of a meeting is closed to the public, as determined by the Secretary, in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act, an annual report of closed or partially-closed meetings will be prepared which will contain, at minimum, a list of members and their business addresses, the Board's functions, dates and places of meetings, and a summary of the Board's activities and recommendations made during the fiscal year.
Duration
Continuing.
Termination
Unless renewed by appropriate action, the Fogarty International Center Advisory Board will terminate two years from the date the charter is filed.
Membership and Designation
The Board shall consist of not more than 13 members appointed by the Secretary (appointed members) and the following nonvoting ex officio members: the Directors of 2 NIH institutes or centers with active international programs and any additional officers or employees of the United States as the Secretary determines necessary for the Board to effectively carry out its functions. All appointed members must be eligible to serve as Special Government Employees (SGEs) and will serve as SGEs, as defined by 18 U.S.C. § 202. Of the 13 appointed members, 10 shall be selected from among the leading representatives of the health and scientific disciplines relevant to the activities of the FIC, particularly representatives of the biomedical and behavioral fields, such as molecular and cellular biology, neurosciences, basic physiology, epidemiology, immunology, nutrition, public health, economics, and demography. Three members shall be appointed by the Secretary from the general public and shall include leaders in the fields of health-related enterprises such as pharmaceutical or life insurance companies, voluntary organizations committed to betterment of public health, international health, and international health law. A quorum for the conduct of business by the full Board will consist of a majority of currently appointed members.
Appointed members will be invited to serve for overlapping four-year terms, except that any member appointed to fill a vacancy for an unexpired term will be appointed for the remainder of that term. The Secretary shall make appointments in such a manner as to ensure that the terms of the appointed members do not all expire in the same year. An appointed member may serve 180 days after the expiration of that member's term if a successor has not taken office. A member who has been appointed for a term of four years may not be reappointed to this Board before two years from the date of the expiration of that member's term of office.
The Chair of the Board will be selected by the Secretary from among the appointed members, except that the Secretary may select the Director, FIC, to be the Chair. The term of office of the Chair will be two years.
Subcommittees
As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Board's jurisdiction. The advice/recommendations of a subcommittee/working group must be deliberated by the parent advisory committee. A subcommittee/working group may not report directly to a Federal official unless there is statutory authority to do so.
Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. A quorum for a subcommittee will be three members. Ad hoc consultants are not members, do not count towards the quorum and may not vote. The Department Committee Management Officer will be notified upon establishment of each standing subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.
Recordkeeping
Meetings of the Board and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws, and Departmental policies. Board and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved agency records disposition schedule. These records will be available for public inspection and copying, subject to any applicable exemptions under the Freedom of Information Act, 5 U.S.C. 552(b) and 41 C.F.R. 102-3.170.
Filing Date
August 31, 2024.
Page updated September 5, 2024