
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57003-57004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3224]


Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on the Patient Engagement Advisory 
Committee (the Committee), Office of the Center Director, Center for 
Devices and Radiological Health.
    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.

DATES: Nominations received by November 20, 2015, will be given first 
consideration for membership on the Committee. Nominations received 
after November 20, 2015, 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, 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, 
Letise.Williams@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members for the Committee.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
separate documents regarding:
    1. Patient Engagement Advisory Committee; Notice of Establishment.
    2. Request for Nominations of Individuals and Industry 
Organizations for the Patient Engagement Advisory Committee.
    3. Request for Nominations of Individuals and Consumer 
Organizations for the Patient Engagement Advisory Committee.

I. General Description of the Committee's Duties

    The Committee provides advice on complex issues relating to medical 
devices, the regulation of devices, and their use by patients. Agency 
guidance

[[Page 57004]]

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 are among the 
topics that may be considered by the Committee. Members 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 subjects.

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 among authorities 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 subjects. Members will be invited to serve for 
overlapping terms of up to 4 years. Prospective members should also 
have an understanding of the broad spectrum of patients in a particular 
disease area. Almost all non-Federal members of this Committee serve as 
Special Government Employees.

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 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23524 Filed 9-18-15; 8:45 am]
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