[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34681-34682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


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) announces a forthcoming 
public advisory committee meeting of the Patient Engagement Advisory 
Committee (PEAC). The general function of the committee is to provide 
advice and recommendations to the Agency on complex issues relating to 
medical devices, the regulation of devices, and their use by patients. 
The meeting will be open to the public. This meeting will be the 
inaugural meeting of a new advisory committee.

DATES: The meeting will be held on October 11, 2017, from 1 p.m. to 5 
p.m. and October 12, 2017, 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. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://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, 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 Web site at http://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 October 11 and 12, 2017, the committee will discuss and 
make recommendations on the topic of patient input into medical device 
clinical trials. This meeting will provide the opportunity to bring 
patients, patient organization, FDA, industry, and other medical and 
scientific experts together for a broader discussion on this important 
patient-related issue.
    This meeting is a key part of FDA's goal to help assure the needs 
and experiences 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 PEAC and the public on 
topics such as to: (1) Better understand challenges for patients in 
medical device clinical trials, (2) better understand how patient input 
and engagement is being used to overcome these challenges (potential 
solutions), and (3) receive

[[Page 34682]]

recommendations from the PEAC on top areas for FDA to consider for 
action.
    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 Web site 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 Web site after the meeting. Background material is 
available at http://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. 
Written submissions may be made to the contact person on or before 
September 20, 2017. Oral presentations from the public will be 
scheduled between approximately 3:40 p.m. to 4:10 p.m. on October 11, 
2017, and approximately 9 a.m. to 9:30 a.m. and 2:30 p.m. to 3 p.m. on 
October 12, 2017. 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 September 12, 2017. 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 September 13, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://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 discussion instead of detailed transcripts.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 20, 2017.
Anna K. Abram,
Deputy Commiissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15657 Filed 7-25-17; 8:45 am]
BILLING CODE 4164-01-P