Charter National Mammography Quality Assurance Advisory Committee
The National Mammography Quality Assurance Advisory Committee is established pursuant to 42 USC 217a, 241, 263b, 21 USC 394; the committee is governed by the provisions of Public Law 92-463 (5 USC App.2), the Federal Advisory Committee Act which sets forth standards for the formation and use of advisory committees.
Objectives and Scope of Activities
The Secretary and, by delegation, the Assistant Secretary for the Office of Public Health and Science, and the Commissioner of Food and Drugs are charged with the administration of the Federal Food, Drug and Cosmetic Act and various provisions of the Public Health Service Act. The Mammography Quality Standards Act of 1992 (MQSA) amends the Public Health Service Act to establish national uniform quality and safety standards for mammography facilities. The National Mammography Quality Assurance Advisory Committee advises the Secretary and, by delegation, the Commissioner of Food and Drugs in discharging their responsibilities with respect to establishing a mammography facilities certification program.
Description of Duties
The Committee shall advise the Food and Drug Administration on: (A) developing appropriate quality standards and regulations for mammography facilities; (B) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (C) developing regulations with respect to sanctions; (D) developing procedures for monitoring compliance with standards; (E) establishing a mechanism to investigate consumer complaints; (F) reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities; (G) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (H) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (I) determining the costs and benefits of compliance with these requirements.
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 Devices and Radiological Health.
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 $ 47,300. The estimated person years of staff support required is 0.30, at an estimated annual cost of $ 39,379.
Designated Federal Officer
FDA will select a fulltime 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 annually. 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 National Mammography Quality Assurance Advisory Committee will terminate two years from the date the charter is filed.
Membership and Designation
The Committee shall consist of a core of 19 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members shall include at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography, and at least 2 practicing physicians who provide mammography services. In addition to the voting members, the Committee shall include 2 nonvoting industry representatives who have expertise in mammography equipment. The Committee may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests.
The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed four 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.
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. 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.
July 6, 2013
Jill Hartzler Warner, J.D.
Associate Commissioner for Special Medical Programs (Acting)