[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5450-5451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01659]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members, excluding consumer representative, to 
serve on the Patient Engagement Advisory Committee (the Committee) in 
the Center for Devices and Radiological Health. Nominations will be 
accepted for current and upcoming vacancies effective with this notice. 
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 on or before March 30, 2020, will be given 
first consideration for membership on the Committee. Nominations 
received after March 30, 2020, will be considered for nomination to the 
Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Select Academician/Practitioner in the drop menu to 
apply for membership, or apply 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 on an FDA advisory committee can also be 
obtained by visiting FDA's website at https://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. 5407, 301-796-8398, email: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to fill current and upcoming vacancies on the Patient 
Engagement Advisory Committee. This Notice does not include consumer 
and industry representative nominations. The Agency will publish two 
separate notices announcing the vacancy of a representative of consumer 
interests and vacancy of representatives of interests of the device 
manufacturing industry.

I. General Description of the Committee Duties

    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. The Committee provides advice on complex scientific 
issues relating to medical devices, the regulation of devices, and 
their use by patients. 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 measure 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, patient experience, healthcare 
needs of patient groups in the United States, or are experienced in the 
work of patient and health professional organizations, scientific 
methodologies for patient-reported outcomes and 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

[[Page 5451]]

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, 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 must include a cover letter; a current, complete 
resume or curriculum vitae for each nominee, including current business 
and/or home address, telephone number, and 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 
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 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: January 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01659 Filed 1-29-20; 8:45 am]
 BILLING CODE 4164-01-P