[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46546-46548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3793]


General Hospital and Personal Use Panel of the Medical Devices 
Advisory Committee; Notice of Meeting; Establishment of a Public 
Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee

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meeting of the General Hospital and Personal Use Devices Panel of the 
Medical Devices Advisory Committee (the Committee). The general 
function of the Committee is to provide advice and recommendations to 
FDA on regulatory issues. The meeting will be open to the public. FDA 
is establishing a docket for public comment on this document.

DATES: The meeting will be held on November 6 and 7, 2019, from 8 a.m. 
to 6 p.m.

ADDRESSES: DoubleTree by Hilton, Washington DC North/Gaithersburg, 
Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's 
telephone number is 301-977-8900. https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-washington-dc-north-gaithersburg-GAIGWDT/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/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. You may 
submit comments as follows:
    FDA is establishing a docket for public comments on this meeting. 
The docket number is FDA-2019-N-3793. The docket will close on December 
6, 2019. Submit either electronic or written comments on this public 
meeting to the docket by December 6, 2019. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 6, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submission) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.
    Comments received on or before October 21, 2019, will be provided 
to the Committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is cancelled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submission'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-3793 for ``The General Hospital and Personal Use Devices 
Panel of the Medical Devices Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments.'' Received 
comments those filed in a timely manner (see ADDRESSES), will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The FDA will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or or go to the Dockets Management Staff, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66 Rm. G610, Silver Spring, MD 20993-0002, 
[email protected], (301) 796-6875, 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/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 November 6 and 7, 2019, the committee will discuss the 
topic of industrial ethylene oxide (EtO) sterilization of medical 
devices and its role in maintaining public health as

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well as the risks of infection with reprocessed duodenoscopes. Subject 
matter of the panel meeting will include potential methods and expert 
assessment of how to reduce EtO emissions to the environment from 
medical device sterilization processes without compromising assurance 
of sterility or effective processing of medical devices. The panel will 
also discuss recommendations to reduce the risk of infection from 
reprocessed duodenoscopes.
    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 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 will be 
available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll down to the appropriate advisory committee 
meeting link.
    FDA plans to provide a live webcast of the November 6 and 7, 2019, 
meeting of the General Hospital and Personal Use Devices Panel of the 
Medical Devices Advisory Committee. While CDRH is working to make 
webcasts available to the public for all advisory committee meetings, 
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. Webcast information, including the website 
address for the webcast, are the following, for their respective days:

November 6, 2019: http://fda.yorkcast.com/webcast/Play/eeed34f9b1f448f9a1f6ad05a4b98d7d1d
November 7, 2019: http://fda.yorkcast.com/webcast/Play/49c5a76d5d1c422d8da028441ab557de1d
    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 
October 22, 2019. Oral presentations from the public will be scheduled 
on November 6, 2019, between approximately 1:30 p.m. and 2 p.m. and 
from 3:50 p.m. to 4:20 p.m. and on November 7, 2019, between 
approximately 1:20 p.m. and 1:50 p.m. 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 16, 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 October 17, 2019.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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.
    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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19079 Filed 9-3-19; 8:45 am]
 BILLING CODE 4164-01-P