Notice2021-26264
Request for Nominations on the National Mammography Quality Assurance Advisory Committee
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
December 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Full Text
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<title>Federal Register, Volume 86 Issue 230 (Friday, December 3, 2021)</title>
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[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Page 68676]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26264]
[[Page 68676]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0417]
Request for Nominations on the National Mammography Quality
Assurance Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of nonvoting industry representatives to serve on the
National Mammography Quality Assurance Advisory Committee in the Center
for Devices and Radiological Health notify FDA in writing. FDA is also
requesting nominations for nonvoting industry representatives to serve
on the National Mammography Quality Assurance Advisory Committee. A
nominee may either be self-nominated or nominated by an organization to
serve as a nonvoting industry representative. Nominations will be
accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of appropriate nonvoting members to represent industry
interests must send a letter stating that interest to FDA by January 3,
2022 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by January 3, 2022.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent to Margaret Ames
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
<a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a> or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Management
Services, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver
Spring, MD 20993, 301-796-5960, email: <a href="/cdn-cgi/l/email-protection#703d110217110215045e311d1503301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="a3eec2d1c4c2d1c6d78de2cec6d0e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for
nonvoting industry representatives on the National Mammography Quality
Assurance Advisory Committee:
I. General Description of the Committee Duties
The National Mammography Quality Assurance Advisory Committee (the
committee) shall advise FDA 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 these 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.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner of Food and Drugs will select the nonvoting member to
represent industry interests.
III. Nomination Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must also specify the advisory committee for which the
nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for a nonvoting representative of industry
interests are encouraged from the mammography manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: November 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26264 Filed 12-2-21; 8:45 am]
BILLING CODE 4164-01-P
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