[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]
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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.
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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
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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]
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