[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Page 12945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04169]



[[Page 12945]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-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 or Agency) is requesting 
nominations for voting members, excluding consumer and industry 
representatives, to serve on the Patient Engagement Advisory Committee 
(the Committee) in the Center for Devices and Radiological Health. 
Nominations will be accepted for upcoming vacancies effective with this 
notice. FDA seeks to include the views of members of all gender groups, 
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 May 1, 2023, will be given 
first consideration for membership on the Committee. Nominations 
received after May 1, 2023, 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) and selecting Academician/Practitioner from the 
dropdown menu (regardless of whether Academician/Practitioner 
accurately describes the nominee), or 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, Silver Spring, MD 20993-0002, 301-
796-8398, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to fill 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 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 related 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 measure or health 
status issues are among the topics that may be considered by the 
Committee.

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 or 
designee from among authorities who are knowledgeable in areas such as 
clinical research, patient or caregiver 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 other clinical outcome assessments, 
scientific methodologies for 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. Prospective members should also have 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 
r[eacute]sum[eacute] 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: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04169 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P


