Required by 42 U.S.C. 284a, section 406 of the Public Health Service (PHS) Act, as amended. The National Advisory Eye Council (Council) is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2).
Objectives and scope of activities
The Council will advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services (Secretary) and the Director, National Eye Institute (NEI, also referred to as Institute) on matters related to the activities carried out by and through the Institute and the policies respecting these activities.
Description of duties
The Council 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 on basic and clinical vision and eye diseases, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the Institute.
The Council 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 Institute; 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 Institute was established and, with the approval of the Director of NEI, 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 Council will prepare triennial reports describing the manner in which the Institute has complied with section 492B of the PHS Act, 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, NEI, for inclusion in the triennial report submitted to Congress by the Director, NIH, pursuant to section 403 of the PHS Act. Each triennial report prepared by the Council 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—
(a) have been completed during such reporting period; and
(b) 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.
Agency or official to whom the committee reports
The Council will advise the Secretary and the Director, NEI.
Management and support services will be provided by the Office of the Director, NEI.
Estimated annual operating costs and staff years
The estimated annual cost for operating the Council, including compensation and travel expenses for members, but excluding staff support, is $32,795. The estimated annual person-years of staff support required is 1.0 , at an estimated annual cost of $169,191.
Designated Federal Officer
The Director, NEI, will assign a full-time or permanent part-time NEI employee to serve as the Designated Federal Officer (DFO) of the Council. In the event that the DFO cannot fulfill the assigned duties of the Council, one or more full-time or permanent part-time NEI employees will be assigned as DFO and carry out these duties on a temporary basis.
The DFO will approve all of the Council’s and subcommittees’ meetings, prepare and approve all meeting agendas, attend all Council 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 Director, NIH or Director, NEI.
The Director, NEI shall designate a member of the staff of the Institute to serve as the Executive Secretary of the Council. The staff member assigned to serve as DFO will also be designated to serve as the Executive Secretary.
Estimated number and frequency of meetings
Meetings of the full Council will be held at the call of the Chair (with the DFO’s approval) or upon request of the Director, NEI not less than three times within a fiscal year. Meetings will be open to the public except as determined otherwise by the Secretary in accordance with subsection (c) of section 552b of Title 5 U.S.C. 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, a report will be prepared which will contain, as a minimum, a list of members and their business addresses, the Council’s functions, dates and places of meetings, and a summary of the Council’s activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.
Unless renewed by appropriate action, prior to its expiration, the Charter for the National Advisory Eye Council will expire two years from the date the charter is filed.
Membership and designation
The Council will consist of 12 members appointed by the Secretary (appointed members) and at least 5 nonvoting ex officio members. The nonvoting ex officio members will include the Secretary; the Director, NIH; the Director, NEI; the Under Secretary for Health of the Department of Veterans Affairs; the Assistant Secretary of Defense for Health Affairs (or their designees); and any additional officers or employees of the United States as the Secretary determines necessary for the Council to effectively carry out its functions. All appointed members must be eligible to serve as Special Government Employees (SGEs) and will serve as SGEs. Two-thirds of the appointed members will be selected from among the leading representatives of the health and scientific disciplines (including not less than 2 individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the NEI. One-third of the appointed members will be appointed by the Secretary from the general public and will include leaders in the fields of public policy, law, health policy, economics, and management. A quorum for the conduct of business by the full Council 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 Council before two years from the date of expiration of that member's term of office.
The Chair of the Council will be selected by the Secretary from among the appointed members, except that the Secretary may select the Director, NEI, to be the Chair. The term of office of the Chair will be two years.
As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Council’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.
Meetings of the Council and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws, and Departmental policies. Council 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 the Freedom of Information Act, 5 U.S.C. 552.
May 31, 2021
Approved: May 19, 2021
Lawrence A. Tabak, D.D.S., Ph.D.
Acting Director of the National Institutes of Health