Notice2021-19108
Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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, 2023, expiration date.
Full Text
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<title>Federal Register, Volume 86 Issue 169 (Friday, September 3, 2021)</title>
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[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49537-49538]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19108]
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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, Health and Human Services (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, 2023, expiration date.
DATES: Authority for the National Mammography Quality Assurance
Advisory Committee will expire on July 7, 2023, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Aden Asefa, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver
Spring, MD 20993-0002, 301-796-0400, email: <a href="/cdn-cgi/l/email-protection#ed8c898883c38c9e888b8cad8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="076663626929667462616647616366296f6f7429606871">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 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). The committee is a non-discretionary Federal
advisory committee established to provide advice to the Commissioner.
The Commissioner is 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 or designee in discharging their
responsibilities with
[[Page 49538]]
respect to establishing a mammography facilities certification program.
The Committee shall advise the HHS Secretary and the Commissioner or
designee 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.
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 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
representative members 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 <a href="https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/ucm520365.htm">https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/ucm520365.htm</a> 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 notice 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19108 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P
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