[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Page 4311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
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) 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 (NMQAAC) for the Center for
Devices and Radiological Health (CDRH) notify FDA in writing. FDA is
also requesting nominations for nonvoting industry representatives to
serve on the NMQAAC. 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 and upcoming
vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by
February 25, 2016, (see sections I and II of this document for further
details). Concurrently, nomination materials for prospective candidates
should be sent to FDA by February 25, 2016.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives may be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 Web site at
http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993. 301-796-5960, FAX:
301-847-8505, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency request nominations for nonvoting
industry representatives to the following committee:
I. National Mammography Quality Assurance Advisory Committee
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 which 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.
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 resumes. 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 will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). 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 nonvoting representatives 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: January 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01487 Filed 1-25-16; 8:45 am]
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