[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8298-8299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


Request for Nominations of Individuals and Industry Organizations 
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) is requesting that 
industry organizations interested in participating in the selection of 
a pool of nonvoting industry representatives to serve as temporary 
nonvoting members on the Patient Engagement Advisory Committee (the 
Committee) in the Center for Devices and Radiological Health notify FDA 
in writing. FDA is also requesting nominations for temporary nonvoting 
industry representatives to be included in a pool of individuals to 
serve on the Committee. Nominees recommended to serve as a temporary 
nonvoting industry representative may either be self-nominated or 
nominated by an industry organization. This position may be filled by 
representatives from different medical device areas based on expertise 
relevant to the topics being considered by the Committee. Nominations 
will be accepted for upcoming vacancies effective with this notice.
    FDA seeks to include the views of women and men, 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: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest must send a letter stating that interest to the FDA by March 
16, 2020 (see sections I and II of this document for details).

[[Page 8299]]

Concurrently, nomination materials for prospective candidates should be 
sent to FDA by March 16, 2020.

ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of a pool of 
nonvoting industry representatives should be sent electronically to 
Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations 
for nonvoting industry representatives should be submitted 
electronically by accessing the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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: Margaret Ames, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993-0002, 301-796-5960, 
email: margaret.ames@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of 
nonvoting industry representatives for the Committee. The list of 
needed expertise on May 1, 2020, is identified below:

(1) Cybersecurity
(2) Communication of Benefit and Risk Information to Patients; 
Medical Device Labeling
(3) Digital Health Technology/Artificial Intelligence
(4) Health of Women/Pediatrics (Vulnerable Population Groups)
(5) Patient Engagement
(6) Patient Preference Elicitation
(7) Patient-reported Outcomes Development, Validation, and Use in 
Regulatory Studies or Clinical Practice
(8) Postmarket Studies, including Observational and Registry-based 
Studies
    FDA is publishing separate documents regarding:
1. Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee
2. Request for Nominations for Consumer Representative for the 
Patient Engagement Advisory Committee

I. General Description of the Committee's Duties

    The Committee provides advice 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. Members 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. The Commissioner of Food and Drugs (the 
Commissioner), or designee, shall 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(s).

II. Qualifications

    Persons nominated for the Patient Engagement Advisory Committee 
should be full-time employees of firms that manufacture medical device 
products, or consulting firms that represent manufacturers or have 
similar appropriate ties to industry.

III. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest must send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations, and a list of all nominees 
along with their current resumes or curriculum vitae. The letter will 
also state that it is the responsibility of the interested 
organizations to confer with one another and to select a candidate or 
candidates (to serve in a pool of individuals with varying areas of 
expertise) to represent industry interest for the Committee, within 60 
days after the receipt of the FDA letter. The interested organizations 
are not bound by the list of nominees in selecting a candidate or 
candidates. However, if no individual is selected within 60 days, the 
Commissioner will select temporary nonvoting members (or pool of 
individuals) to represent industry interests.

IV. Nomination Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a temporary nonvoting industry 
representative. Nominations must include a cover letter and a current, 
complete resume 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 Committee Membership Nomination Portal 
(see ADDRESSES). Nominations should specify the advisory committee for 
which the nominee is recommended within 30 days of publication of this 
document (see DATES). In addition, nominations should acknowledge that 
the nominee is aware of the nomination, unless self-nominated. FDA will 
forward all nominations to the organizations expressing interest in 
participating in the selection process for the Committee. Only 
interested industry organizations participate in the selection process. 
Persons who nominate themselves as nonvoting industry representatives 
will not participate in the selection process.
    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 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02872 Filed 2-12-20; 8:45 am]
 BILLING CODE 4164-01-P


