[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]
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