82 FR 50882 - Advisory Committee; Patient Engagement Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 211 (November 2, 2017)

Page Range		50882-50882
FR Document		2017-23884

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.

Federal Register, Volume 82 Issue 211 (Thursday, November 2, 2017)

[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Notices]
[Page 50882]
From the Federal Register Online  [www.thefederalregister.org]
[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

50882 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices

rooms/privacy-act-systems and at 73 FR Patient Engagement Advisory nonvoting members who are identified
33592, 33634 (June 12, 2008). Committee. The committee is a with industry interests. The number of
discretionary Federal advisory temporary members selected for a
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
committee established to provide advice particular meeting will depend on the
Pursuant to 5 U.S.C. 552a(k)(2), to the Commissioner. The Patient meeting topic.
records in this system, which reflect Engagement Advisory Committee
records that are contained in other The Commissioner or designee shall
advises the Commissioner or designee
systems of records that are designated as also have the authority to select
in discharging responsibilities as they
exempt, are exempt from the relate to helping to ensure safe and members of other scientific and
requirements of subsections (c)(3), (d), effective devices for human use and, as technical FDA advisory committees
(e)(1), (e)(4)(G), (H), (I), and (f) of 5 required, any other product for which (normally not to exceed 10 members) to
U.S.C. 552a. See § 4.13(m) of the FTC FDA has regulatory responsibility. The serve temporarily as voting members
Rules of Practice, 16 CFR 4.13(m). Committee provides advice to the and to designate consultants to serve
HISTORY: Commissioner on complex issues temporarily as voting members when:
relating to medical devices, the (1) Expertise is required that is not
73 FR 33591–33634 (June 12, 2008).
regulation of devices, and their use by available among current voting standing
* * * * * members of the Committee (when
patients. Agency guidance and policies,
David C. Shonka, clinical trial or registry design, patient additional voting members are added to
Acting General Counsel. preference study design, benefit-risk the Committee to provide needed
[FR Doc. 2017–23833 Filed 11–1–17; 8:45 am] determinations, device labeling, unmet expertise, a quorum will be based on the
BILLING CODE 6750–01–P
clinical needs, available alternatives, combined total of regular and added
patient reported outcomes, and device- members) or (2) to comprise a quorum
related quality of life or health status when, because of unforeseen
DEPARTMENT OF HEALTH AND issues are among the topics that may be circumstances, a quorum is or will be
HUMAN SERVICES considered by the Committee. The lacking. Because of the size of the
Committee provides relevant skills and Committee and the variety in the types
Food and Drug Administration perspectives in order to improve of issues that it will consider, FDA may,
communication of benefits, risks and in connection with a particular
[Docket No. FDA–2015–N–3224] clinical outcomes, and increase committee meeting, specify a quorum
integration of patient perspectives into that is less than a majority of the current
Advisory Committee; Patient
the regulatory process for medical voting members. The Agency’s
Engagement Advisory Committee,
devices. It performs its duties by
Renewal regulations (21 CFR 14.22(d)) authorize
identifying new approaches, promoting
a committee charter to specify quorum
AGENCY: Food and Drug Administration, innovation, recognizing unforeseen risks
HHS. or barriers, and identifying unintended requirements.
ACTION:Notice; renewal of advisory consequences that could result from Further information regarding the
committee. FDA policy. most recent charter and other
The Committee shall consist of a core information can be found at https://
SUMMARY: The Food and Drug of nine voting members including the www.fda.gov/AdvisoryCommittees/
Administration (FDA) is announcing the Chair. Members and the Chair are CommitteesMeetingMaterials/
renewal of the Patient Engagement selected by the Commissioner or PatientEngagementAdvisoryCommittee/
Advisory Committee by the designee from among authorities who default.htm or by contacting the
Commissioner of Food and Drugs (the are knowledgeable in areas such as Designated Federal Officer (see FOR
Commissioner). The Commissioner has clinical research, primary care patient FURTHER INFORMATION CONTACT). In light
determined that it is in the public experience, health care needs of patient of the fact that no change has been made
interest to renew the Patient groups in the United States, or are to the committee name or description of
Engagement Advisory Committee for an experienced in the work of patient and duties, no amendment will be made to
additional 2 years beyond the charter health professional organizations,
expiration date. The new charter will be 21 CFR 14.100.
methodologies for eliciting patient
in effect until October 6, 2019. This document is issued under the
preferences, and strategies for
DATES: Authority for the Patient Federal Advisory Committee Act (5
communicating benefits, risks, and
Engagement Advisory Committee will clinical outcomes to patients and U.S.C. app.). For general information
expire on October 6, 2017, unless the research subjects. Members will be related to FDA advisory committees,
Commissioner formally determines that invited to serve for overlapping terms of please check https://www.fda.gov/
renewal is in the public interest. up to 4 years. Almost all non-Federal AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: members of this committee serve as Dated: October 30, 2017.
Letise Williams, Center for Devices and Special Government Employees. The Anna K. Abram,
Radiological Health, Food and Drug core of voting members may include one Deputy Commissioner for Policy, Planning,
Administration, 10903 New Hampshire technically qualified member, selected Legislation, and Analysis.
Ave., Bldg. 66, Rm. 5441, Silver Spring,
asabaliauskas on DSKBBXCHB2PROD with NOTICES

by the Commissioner or designee, who
[FR Doc. 2017–23884 Filed 11–1–17; 8:45 am]
MD 20993–0002, 301–796–8398, is identified with consumer interests
Letise.Williams@fda.hhs.gov. and is recommended by either a BILLING CODE 4164–01–P

SUPPLEMENTARY INFORMATION: Pursuant consortium of consumer-oriented
to 41 CFR 102–3.65 and approval by the organizations or other interested
Department of Health and Human persons. The Commissioner or designee
Services pursuant to 45 CFR part 11 and shall also have the authority to select
by the General Services Administration, from a group of individuals nominated
FDA is announcing the renewal of the by industry to serve temporarily as

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Document Created: 2017-11-02 02:41:02
Document Modified: 2017-11-02 02:41:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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]
FR Citation		82 FR 50882

82 FR 50882 - Advisory Committee; Patient Engagement Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 211 (November 2, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration