[Federal Register Volume 85, Number 3 (Monday, January 6, 2020)]
[Notices]
[Pages 508-509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28518]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2809]


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, 2021.

DATES: Authority for the Patient Engagement Advisory Committee would 
have expired on October 6, 2019, unless the Commissioner had formally 
determined that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of the Center 
Director, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver 
Spring, MD 20993-0002, 301-796-8398, Letise.Williams@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3 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 the Food and Drug 
Administration has regulatory responsibility. The Committee provides 
advice to the Commissioner of Food and Drugs 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 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.
    Pursuant to its Charter 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, 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. 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

[[Page 509]]

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: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28518 Filed 1-3-20; 8:45 am]
 BILLING CODE 4164-01-P


