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

rooms/privacy-act-systems and at 73 FR 

33592, 33634 (June 12, 2008). 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

Pursuant to 5 U.S.C. 552a(k)(2), 

records in this system, which reflect 

records that are contained in other 

systems of records that are designated as 

exempt, are exempt from the 

requirements of subsections (c)(3), (d), 

(e)(1), (e)(4)(G), (H), (I), and (f) of 5 

U.S.C. 552a. See § 4.13(m) of the FTC 

Rules of Practice, 16 CFR 4.13(m). 

HISTORY: 

73 FR 33591–33634 (June 12, 2008). 

* * * * * 

David C. Shonka, 

Acting General Counsel. 

[FR Doc. 2017–23833 Filed 11–1–17; 8:45 am] 

BILLING CODE 6750–01–P 

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. 

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, 

Letise.Williams@fda.hhs.gov. 

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 devicerelated 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 


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