[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Page 50882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23884]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3224]
Advisory Committee; Patient Engagement Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Patient Engagement Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Patient
Engagement Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until
October 6, 2019.
DATES: Authority for the Patient Engagement Advisory Committee will
expire on October 6, 2017, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002, 301-
796-8398, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Patient Engagement Advisory Committee. The committee is
a discretionary Federal advisory committee established to provide
advice to the Commissioner. The Patient Engagement Advisory Committee
advises the Commissioner or designee in discharging responsibilities as
they relate to helping to ensure safe and effective devices for human
use and, as required, any other product for which FDA has regulatory
responsibility. The Committee provides advice to the Commissioner on
complex 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 or health status issues are among the topics that may be
considered by the 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.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities who are knowledgeable
in areas such as clinical research, primary care patient experience,
health care 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. Almost all non-Federal members of
this committee serve as Special Government Employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. The Commissioner or
designee shall also have the authority to select from a group of
individuals nominated by industry to serve temporarily as nonvoting
members who are identified with industry interests. The number of
temporary members selected for a particular meeting will depend on the
meeting topic.
The Commissioner or designee shall also have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) Expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members) or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PatientEngagementAdvisoryCommittee/default.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: October 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23884 Filed 11-1-17; 8:45 am]
BILLING CODE 4164-01-P