[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13395-13396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0722]


Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Gastroenterology and Urology Devices Panel of 
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 14 and 15, 2015, 
from 8 a.m. to 6 p.m.
    Addresses: FDA is opening a docket for interested persons to submit 
electronic or written comments regarding this meeting. The Docket No. 
is FDA-2015-N-0722. Please see the Procedure section of the notice for 
further information.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1552, Silver Spring, MD 20993-0002, 301-796-5290, 
<a href="/cdn-cgi/l/email-protection#723c130613011a135c341311170b321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="6628071207150e0748200705031f26000207480e0e1548010910">[email protected]</span></a>, 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.
    Agenda: On May 14 and 15, 2015, the committee will discuss recent 
reports and epidemiologic investigations of transmission of infections 
associated with the use of duodenoscopes in endoscopic retrograde 
cholangiopancreatography (ERCP) procedures in hospitals in the United 
States.
    FDA is convening this committee to seek expert scientific and 
clinical opinion related to reprocessing of duodenoscopes and other 
endoscopes, as well as automated endoscope reprocessors, based on 
available scientific information. The committee will make 
recommendations on: (1) The effectiveness of cleaning, high level 
disinfection, and sterilization methods; (2) the amount and type of 
premarket validation data and information needed to support labeling 
claims and technical instructions; (3) the appropriate use of other 
risk mitigations, such as surveillance cultures; (4) best practices and 
guidelines for reprocessing duodenoscopes and endoscopes at user 
facilities to minimize the transmission of infections; and (5) 
recommended approaches for ensuring patient safety during ERCP 
procedures, including a discussion of appropriate patient selection.
    Recommendations on these issues will assist FDA in minimizing 
patient exposure to infectious agents that may result from reprocessed 
duodenoscopes and endoscopes.
    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.
    CDRH plans to provide a live Webcast of the May 14 and 15, 2015, 
meeting of the Gastroenterology and Urology Devices Panel. While CDRH 
is working to make Webcasts available to the public for all advisory 
committee meetings held at the White Oak campus, there are instances 
where the Webcast transmission is not successful; staff will work to 
re-establish the transmission as soon as possible. The link for the 
Webcast is available at: https://collaboration.fda.gov/gudpm052015/.

[[Page 13396]]

Further information regarding the Webcast, including the Web address 
for the Webcast, will be made available at least 2 days in advance of 
the meeting at the following Web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/default.htm. Select the link for 2015 Meeting Materials.
    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 
April 30, 2015. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on May 14 and between 
approximately 9 a.m. and 10 a.m. on May 15. 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 April 15, 2015. 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 April 20, 2015.
    FDA is opening a docket for public comment on this document. The 
Docket No. is FDA-2015-N-0722. The docket will close on May 28, 2015. 
Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Comments 
received on or before April 30, 2015, will be provided to the 
committee. Comments received after that date will be taken into 
consideration by the Agency. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Submit a single copy of electronic comments or two 
paper copies of any mailed comments. Comments are to be identified 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.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#87e1e3e6e8eae6c7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="f29496939d9f93b2949693dc9a9a81dc959d84">[email protected]</span></a> or 301-796-4540.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
at <a href="/cdn-cgi/l/email-protection#abeac5c5e6cad9c2ce85fcc2c7c7c2cac6d8ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="0a4b6464476b78636f245d636666636b67794a6c6e6b24626279246d657c">[email protected]</span></a> 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05710 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P


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