Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal, 40069 [2019-17276]
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Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
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.
Notice; renewal of advisory
committee.
ACTION:
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, Sara.Anderson@
fda.hhs.gov.
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,
jspears on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:51 Aug 12, 2019
Jkt 247001
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-qualityassurance-advisory-committee/past-
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
40069
meeting-materials-nationalmammography-quality-assuranceadvisory-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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Q-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on requests for
feedback submitted under the QSubmission Program for medical
devices.
DATES: Submit either electronic or
written comments on the collection of
information by October 11, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 11,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 11, 2019.
Comments received by mail/hand
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
