[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69063-69064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24100]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for nominations.
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SUMMARY: The Food and Drug Administration's (FDA) is requesting
additional nominations for members to serve on the Center for Devices
and
[[Page 69064]]
Radiological Health's (CDRH) Patient Engagement Advisory Committee (the
PEAC or Committee). The Committee provides relevant skills and
perspectives in order to improve communication of benefits, risks and
clinical outcomes, and increase integration of patient perspectives
into the regulatory process for medical devices. It performs its duties
by identifying new approaches, promoting innovation, recognizing
unforeseen risks or barriers, and identifying unintended consequences
that could result from FDA policy.
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, particularly encourages
nominations of appropriately qualified candidates from these groups.
DATES: Nominations received by November 21, 2016, will be given first
consideration for membership on the Committee. Nominations received
after November 21, 2016, will be considered for nomination to the
Committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm please select Academician/Practitioner in the drop down menu,
to apply for membership, 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, or by FAX: 301-
847-8640. Information about becoming a member on 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: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for the Committee. 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.
I. General Description of the Committee's Duties
The PEAC provides relevant skills and perspectives in order to
improve communication of benefits, risks, and clinical outcomes and
increase integration of patient perspectives into the regulatory
process for medical devices.
The PEAC provides advice on issues relating to medical devices, the
regulation of devices, and their use by patients. A variety of topics
may be considered by the PEAC, including Agency guidance and policies,
clinical trial or registry design, patient preference study design,
benefit-risk determinations, device labeling, unmet clinical needs,
available alternatives, patient reported outcomes and device-related
quality of life or health status issues.
II. Criteria for Voting Members
The Committee consists of a core of nine voting members including
the Chair. Members and the Chair are selected by the Commissioner of
Food and Drugs or designee from candidates who are knowledgeable in
areas such as clinical research, primary care patient experience,
healthcare needs of patient groups in the United States, or are
experienced in the work of patient and health professional
organizations, methodologies for eliciting patient preferences, and
strategies for communicating benefits, risks, and clinical outcomes to
patients and research participants. Prospective members should also
have an understanding of the broad spectrum of patients in a particular
disease area.
Members will be invited to serve for overlapping terms of up to 4
years. Non-Federal members of this Committee serve as Special
Government Employees, with the exception of the representatives from
Industry.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the Committee. Self-nominations are also
accepted.
Nominations should include a cover letter; a current, complete
resume or curriculum vitae for each nominee, including a current
business and/or home address, telephone number, and email address if
available; and should specify the advisory committee for which the
nominee is recommended.
Nominations should also acknowledge that the nominee is aware of
the nomination, unless self-nominated. FDA will ask potential
candidates to provide detailed information concerning such matters
related to financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflicts of
interest.
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: September 28, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24100 Filed 10-4-16; 8:45 am]
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