[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]
 BILLING CODE 4164-01-P