[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31871-31872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2809]


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 September 10, 2019, from 8 a.m. to 
5:30 p.m.

ADDRESSES: Holiday Inn Gaithersburg, Two Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900; 
additional information is available online at https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail. 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/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

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

[[Page 31872]]

enough to provide timely notice. Therefore, you should always check the 
Agency's website at https://www.fda.gov/advisory-committees 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 September 10, 2019, the Committee will discuss and make 
recommendations on the topic ``Cybersecurity in Medical Devices: 
Communication That Empowers Patients.'' Medical devices are 
increasingly connected to the internet, hospital networks, and other 
medical devices to provide features that improve healthcare and 
increase the ability of healthcare providers to treat patients. These 
same features may also increase cybersecurity risks. Preserving the 
benefit of these devices requires continuous vigilance as well as 
timely and effective communication to medical device users about 
evolving cybersecurity risks. The recommendations provided by the 
committee will address which factors should be considered by FDA and 
industry when communicating cybersecurity risks to patients and to the 
public, including but not limited to the content, phrasing, the methods 
used to disseminate the message and the timing of that communication. 
The recommendations will also address concerns patients have about 
changes to their devices to reduce cybersecurity risks as well as the 
role of other stakeholders such as healthcare providers in 
communicating cybersecurity risks to patients. Additional information 
about cybersecurity can be found at https://www.fda.gov/medical-devices/digital-health/cybersecurity.
    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/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. Select the 
link for the 2019 Meeting Materials.
    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 10:45 a.m. to 12:15 p.m. on September 10, 2019. 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 July 
22, 2019. 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 July 24, 2019. 
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 July 30, 2019.
    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 Artair Mallett at [email protected], or 301-796-9638 
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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during 
advisory committee meetings. Please be advised that, for the roundtable 
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: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14141 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P