
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57007-57008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23521]



[[Page 57007]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3166]


Establishment of the Patient Engagement Advisory Committee; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of the Patient Engagement Advisory Committee (the 
Committee). The Committee will provide advice to the Commissioner of 
Food and Drugs (the Commissioner) or designee, on complex issues 
relating to medical devices, regulation of devices, and their use by 
patients. The Committee may consider topics such as 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, and other patient-
related topics. The Agency is also announcing the establishment of a 
public docket for comments on the potential topics.

DATES: Comments received by November 20, 2015, will be provided to the 
Agency.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Comments are to be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510.

SUPPLEMENTARY INFORMATION:

I. Background

    The Committee will provide advice to the Commissioner or designee, 
on complex issues relating to medical devices, the regulation of 
devices, and their use by patients. The Committee may consider topics 
such as: 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, and other patient-related topics. The Committee will provide 
relevant skills and perspectives, in order to improve communication of 
benefits, risks, clinical outcomes, and increase integration of patient 
perspectives into the regulatory process for medical devices. It will 
perform its duties by discussing and providing advice and 
recommendation in ways such as: Identifying new approaches, promoting 
innovation, recognizing unforeseen risks or barriers, and identifying 
unintended consequences that could result from FDA policy.

A. Composition of the Committee

    The Committee will consist of a core of nine voting members, 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from experts who are knowledgeable in areas 
such as clinical research, primary care patient experience, and health 
care needs of patient groups in the United States. Selected Committee 
members may also be 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 voting members may include one consumer representative 
who is a technically qualified member, selected by the Commissioner or 
designee, identified with consumer interests, and is recommended by 
either a consortium of consumer oriented organizations or other 
interested persons.
    The Commissioner or designee will 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 non-voting members selected for a particular 
meeting will depend on the meeting topic.

B. Topics

    FDA is also soliciting public feedback on potential topics for this 
Committee to discuss and advise the Agency. The following topics may 
include, but are not limited to:
     Where can patients provide input across the medical device 
total product lifecycle? What should be the focus of that input (e.g., 
input on unmet medical needs; input on endpoints of interest for 
particular diseases/conditions; input on feasibility of clinical study 
plans and protocols to reduce barriers to patient participation and 
retention; input on draft patient labeling; postmarket data reported 
directly from patients; input on potential risk communication related 
to products already on the market)? How should the process of 
soliciting patient input for various purposes work?
     How should FDA directly engage patients for input related 
to medical device premarket considerations (e.g., in considering public 
health impact criterion for eligibility for Expedited Access Program)?
     How should FDA engage patients for input related to 
medical device performance once products are available on the market?
     Under what conditions should health care professional or 
patient labeling include information about patient preference studies 
or patient reported outcomes (PROs)?
     How should sponsors present patient preference information 
or PROs in the health care professional and patient labeling?
     How should labeling indicate that only a portion of 
patients in a patient preference study were willing to accept certain 
risks in order to achieve probable benefits?
     How should sponsors and the FDA ensure that patients 
receive and understand patient preference information?
     How can patient preferences be obtained in an unbiased 
manner if the device study has already enrolled and/or been published?
     How do patients view clinical study informed consent 
forms?
    Elsewhere in this issue of the Federal Register, FDA is publishing 
separate documents regarding:
    1. Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee
    2. Request for Nominations of Individuals and Consumer 
Organizations for the Patient Engagement Advisory Committee
    3. Request for Nominations of Individuals and Industry 
Organizations for the Patient Engagement Advisory Committee
    FDA intends to publish a final rule in the Federal Register, adding 
the Patient Engagement Advisory Committee to 21 CFR part 14.100.

[[Page 57008]]

II. Comments

    FDA is opening a docket for 60 days to provide an opportunity for 
public comment on the potential topics. Interested persons may submit 
either electronic comments regarding the potential topics to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23521 Filed 9-18-15; 8:45 am]
 BILLING CODE 4164-01-P


