[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48316-48317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3405]


Patient Engagement Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
forthcoming public advisory committee meeting of the Patient Engagement 
Advisory Committee (the Committee). The general function of the 
Committee is to provide advice to the Commissioner, or designee, on 
complex issues relating to medical devices, the regulation of devices, 
and their use by patients. The meeting will be open to the public.

DATES: The meeting will be held on November 15, 2018, from 8 a.m. to 5 
p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 
Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 
301-977-8900; additional information available online at: https://

[[Page 48317]]

www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-
gaithersburg-GAIGHHF/index.html. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

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, 
[email protected], 301-796-8398, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: Agenda: On November 15, 2018, the Committee 
will discuss and make recommendations on the topic ``Connected and 
Empowered Patients: E-Platforms Potentially Expanding the Definition of 
Scientific Evidence.'' The recommendations will address how FDA can 
leverage patient-driven platforms, such as social media and registries, 
to better engage patients and consumers as empowered partners in the 
work of protecting public health and promoting responsible innovation. 
Social media and other web platform enablers are facilitating the 
growth of virtual patient communities. Increasingly, patients and 
health care consumers are using these platforms to share their health 
experiences and seek information from other patients and consumers, 
rather than their health care providers alone. Novel approaches and 
methodologies are being used to tap into some of these platforms as 
potentially rich sources of patient-generated health data, which could 
be used as relevant and reliable real-world evidence (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm513027.pdf).
    This meeting will help advance FDA's objective to assure the needs, 
experiences, and perspectives of patients are included as part of FDA's 
deliberations involving the regulation of medical devices and their use 
by patients. For this meeting, FDA is seeking input from the Committee 
and the public on whether and how FDA can harness the emerging 
potential of these patient platforms to better engage patients and 
consumers as empowered partners in the work of protecting public health 
and promoting responsible innovation. In addition, FDA is seeking 
recommendations from the Committee on ways to leverage these platforms 
to disseminate as well as potentially collect and evaluate health 
information to and from patients and consumers.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee-meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the Committee. 
Oral presentations from the public will be scheduled between 
approximately 11:15 a.m. to 12:15 p.m. on November 15, 2018. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
October 15, 2018. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by October 17, 
2018. Individuals who do not wish to speak at the open public hearing 
session but would like their comments to be heard by the Committee may 
send written submissions to the contact person on or before October 23, 
2018.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected], or 301-796-
5966 at least 7 days in advance of the meeting.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings. Please be advised 
that, for the round table portion of the meeting, FDA will prepare a 
summary of the discussion in lieu of detailed transcripts.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20640 Filed 9-21-18; 8:45 am]
 BILLING CODE 4164-01-P