Document ID: FDA-2019-N-3402-0002
Agency: fda
Document Type: Notice
Title: Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal
Posted Date: 2021-09-03T04:00Z

[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49537-49538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: aden.asefa@fda.hhs.gov.

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 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 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19108 Filed 9-2-21; 8:45 am]
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