82 FR 45031 - Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 186 (September 27, 2017)

Page Range		45031-45032
FR Document		2017-20683

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, 2019.

Federal Register, Volume 82 Issue 186 (Wednesday, September 27, 2017)

[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Notices]
[Pages 45031-45032]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


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, 2019.

DATES: Authority for the National Mammography Quality Assurance 
Advisory Committee will expire on July 7, 2017, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Sara Anderson, Office of Device 
Evaluation, 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: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services (HHS) 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 (Committee). The Committee is a non-discretionary Federal 
advisory committee established to provide advice to the Commissioner. 
The HHS Secretary and, by delegation, the Assistant Secretary for the 
Office of Public Health and Science and the Commissioner 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 Committee advises the HHS Secretary and, by delegation, 
the Commissioner in discharging their responsibilities with respect to 
establishing a mammography facilities certification program. The 
Committee shall advise FDA on:
     Developing appropriate quality standards and regulations 
for mammography facilities;
     Developing appropriate standards and regulations for 
bodies accrediting mammography facilities under this program;
     Developing regulations with respect to sanctions;
     Developing procedures for monitoring compliance with 
standards;
     Establishing a mechanism to investigate consumer 
complaints;
     Reporting new developments concerning breast imaging which 
should be considered in the oversight of mammography facilities;
     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;
     Determining whether there will exist a sufficient number 
of medical physicists after October 1, 1999; and
     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/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/ucm520365.htm 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,

[[Page 45032]]

please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20683 Filed 9-26-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Notices 45031

Comments in Response to the 60 Day Annual Burden Estimates estimated burden of 2 hours per grantee
Federal Register Notice for a total of 112 hours per submission.
ACL estimates the burden of this
A 60-day notice was published in the collection of information as follows: 56 The proposed data collection tool may
Federal Register in Vol. 82, No. 117, pg. be found on the ACL Web site for
State Units on Aging (SUA) respond
28068 on June 20, 2017. No comments review at: https://www.acl.gov/about-
semi-annually which have an average
were received. acl/public-input.

Responses
Number of Hours per Total annual
Respondent/data collection activity per
respondents response burden hours
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Title III Supplemental Form to the Financial Status Report ............................ 56 2/yr 2 224

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Dated: September 19, 2017. Services (HHS) pursuant to 45 CFR part • Determining whether there will
Mary Lazare, 11 and by the General Services exist a sufficient number of medical
Principal Deputy Administrator. Administration, FDA is announcing the physicists after October 1, 1999; and
[FR Doc. 2017–20666 Filed 9–26–17; 8:45 am] renewal of the National Mammography • Determining the costs and benefits
BILLING CODE 4154–01–P
Quality Assurance Advisory Committee of compliance with these requirements.
(Committee). The Committee is a non- The Committee shall consist of a core
discretionary Federal advisory of 15 members, including the Chair.
DEPARTMENT OF HEALTH AND committee established to provide advice Members and the Chair are selected by
HUMAN SERVICES to the Commissioner. The HHS the Commissioner or designee from
Secretary and, by delegation, the among physicians, practitioners, and
Food and Drug Administration Assistant Secretary for the Office of other health professionals, whose
Public Health and Science and the clinical practice, research
[Docket No. FDA–2017–N–0001] specialization, or professional expertise
Commissioner are charged with the
administration of the Federal Food, includes a significant focus on
Advisory Committee; National
Drug, and Cosmetic Act and various mammography. Members will be invited
Mammography Quality Assurance
provisions of the Public Health Service to serve for overlapping terms of up to
Advisory Committee; Renewal
Act. The Mammography Quality 4 years. Almost all non-Federal
AGENCY: Food and Drug Administration, Standards Act of 1992 amends the members of this Committee serve as
HHS. Public Health Service Act to establish Special Government Employees. The
ACTION:Notice; renewal of advisory national uniform quality and safety core of voting members shall include at
committee. standards for mammography facilities. least four individuals from among
The Committee advises the HHS national breast cancer or consumer
SUMMARY: The Food and Drug Secretary and, by delegation, the health organizations with expertise in
Administration (FDA) is announcing the Commissioner in discharging their mammography, and at least two
renewal of the National Mammography responsibilities with respect to practicing physicians who provide
Quality Assurance Advisory Committee establishing a mammography facilities mammography services. In addition to
by the Commissioner of Food and Drugs certification program. The Committee the voting members, the Committee
(the Commissioner). The Commissioner shall advise FDA on: shall include two nonvoting industry
has determined that it is in the public representatives who have expertise in
• Developing appropriate quality
interest to renew the National mammography equipment. The
standards and regulations for
Mammography Quality Assurance Committee may include one technically
mammography facilities;
Advisory Committee for an additional 2 qualified member, selected by the
years beyond the charter expiration • Developing appropriate standards Commissioner or designee, who is
date. The new charter will be in effect and regulations for bodies accrediting identified with consumer interests.
until July 7, 2019. mammography facilities under this Further information regarding the
program; most recent charter and other
DATES: Authority for the National
Mammography Quality Assurance • Developing regulations with respect information can be found at https://
Advisory Committee will expire on July to sanctions; www.fda.gov/AdvisoryCommittees/
7, 2017, unless the Commissioner • Developing procedures for CommitteesMeetingMaterials/Radiation-
formally determines that renewal is in monitoring compliance with standards; EmittingProducts/National
MammographyQualityAssurance
the public interest. • Establishing a mechanism to
AdvisoryCommittee/ucm520365.htm or
FOR FURTHER INFORMATION CONTACT: Sara investigate consumer complaints;
by contacting the Designated Federal
Anderson, Office of Device Evaluation, • Reporting new developments Officer (see FOR FURTHER INFORMATION
Center for Devices and Radiological concerning breast imaging which should
asabaliauskas on DSKBBXCHB2PROD with NOTICES

CONTACT). In light of the fact that no
Health, Food and Drug Administration, be considered in the oversight of change has been made to the Committee
10903 New Hampshire Ave., Bldg. 66, mammography facilities; name or description of duties, no
Rm. G616, Silver Spring, MD 20993– • Determining whether there exists a amendment will be made to 21 CFR
0002, 301–796–7047, Sara.Anderson@ shortage of mammography facilities in 14.100.
fda.hhs.gov. rural and health professional shortage This document is issued under the
SUPPLEMENTARY INFORMATION: Pursuant areas and determining the effects of Federal Advisory Committee Act (5
to 41 CFR 102–3.65 and approval by the personnel on access to the services of U.S.C. app.). For general information
Department of Health and Human such facilities in such areas; related to FDA advisory committees,

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Document Created: 2018-10-24 14:46:44
Document Modified: 2018-10-24 14:46:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
Dates		Authority for the National Mammography Quality Assurance Advisory Committee will expire on July 7, 2017, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Sara Anderson, Office of Device Evaluation, 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]
FR Citation		82 FR 45031

82 FR 45031 - Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 186 (September 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration