[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