[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Page 40069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17276]
[[Page 40069]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3402]
Advisory Committee; National Mammography Quality Assurance
Advisory Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the National Mammography Quality Assurance Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the National Mammography Quality Assurance Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until July 7, 2021.
DATES: Authority for the National Mammography Quality Assurance
Advisory Committee would have expired on July 7, 2019; however, the
Commissioner formally determined that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT: Sara Anderson, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver
Spring, MD 20993-0002, 301-796-7047, [email protected].
SUPPLEMENTARY INFORMATION: Under 41 CFR 102-3.65 and approval by the
Department of Health and Human Services under 45 CFR part 11 and by the
General Services Administration, FDA is announcing the renewal of the
National Mammography Quality Assurance Advisory Committee. The
committee is a non-discretionary Federal advisory committee established
to provide advice to the Commissioner. 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 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. The
Committee shall advise the Food and Drug Administration on:
(1) Developing appropriate quality standards and regulations for
mammography facilities;
(2) developing appropriate standards and regulations for bodies
accrediting mammography facilities under this program;
(3) developing regulations with respect to sanctions;
(4) developing procedures for monitoring compliance with standards;
(5) establishing a mechanism to investigate consumer complaints;
(6) reporting new developments concerning breast imaging that
should be considered in the oversight of mammography facilities;
(7) 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;
(8) determining whether there will exist a sufficient number of
medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.
The Committee shall consist of a core of 15 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 4
years. Almost all non-Federal members of this committee serve as
Special Government Employees. The core of voting members shall include
at least four individuals from among national breast cancer or consumer
health organizations with expertise in mammography, and at least two
practicing physicians who provide mammography services. In addition to
the voting members, the Committee shall include two 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.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/national-mammography-quality-assurance-advisory-committee/past-meeting-materials-national-mammography-quality-assurance-advisory-committee or
by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/advisory-committees.
Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17276 Filed 8-12-19; 8:45 am]
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