[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
[Notices]
[Pages 68261-68262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26118]


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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 Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 68262]]

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 the 
October 6, 2023, expiration date.

DATES: Authority for the Patient Engagement Advisory Committee would 
have expired on October 6, 2021, 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, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services and by the General Services 
Administration, FDA is announcing the renewal of the Patient Engagement 
Advisory Committee (the Committee). The Committee is a discretionary 
Federal advisory committee established to provide advice to the 
Commissioner. The 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 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, device-related 
quality of life measures, 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, 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 patient-reported outcomes and 
eliciting patient preferences, and strategies for communicating 
benefits, risks and clinical outcomes to patients and research 
subjects, as well as other relevant areas. Members will be invited to 
serve for overlapping terms of up to 4 years. Non-Federal members of 
this committee will serve as Special Government Employees, 
representative or Ex-Officio members. Federal members will serve as 
Regular Government Employees or Ex-Officios. 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 non-voting 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/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee 
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 notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26118 Filed 11-30-21; 8:45 am]
BILLING CODE 4164-01-P