
[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Notices]
[Pages 45031-45032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20683]


-----------------------------------------------------------------------

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, Sara.Anderson@fda.hhs.gov.

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


