General Hospital and Personal Use Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 46546-46548 [2019-19079]
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46546
Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
information that are a usual and
customary part of businesses’ normal
activities. For example, the tagging and
labeling of molluscan shellfish (21 CFR
1240.60) is a customary and usual
practice among seafood processors.
information include processors and
importers of seafood.
We estimate the burden of this
collection of information as follows:
Consequently, the estimates in table 1
account only for information collection
and recording requirements attributable
to part 123.
Description of Respondents:
Respondents to this collection of
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
123.6(a), (b), and (c); Prepare hazard analysis and
HACCP plan. ..............................................................
123.6(c)(5); Undertake and prepare records of corrective actions. ................................................................
Total
annual
records
Number of
records per
recordkeeper 3
Number of
recordkeepers
21 CFR Section 2
Average
burden per
recordkeeping 4
Total
hours
50
1
50
16
800
15,000
4
60,000
0.30
(18 minutes)
18,000
15,000
1
15,000
4
60,000
4,100
80
328,000
0.20
(12 minutes)
65,600
123.6(c)(7); Document monitoring of critical control
points. .........................................................................
15,000
280
4,200,000
0.30
(18 minutes)
1,260,000
123.7(d); Undertake and prepare records of corrective
actions due to a deviation from a critical limit. ..........
6,000
4
24,000
0.10
(6 minutes)
2,400
123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of
any periodic end-product and in-process testing. ......
15,000
47
705,000
70,500
123.11(c); Maintain sanitation control records. .............
15,000
280
4,200,000
0.10
(6 minutes)
0.10
(6 minutes)
123.12(c); Maintain records that verify that the fish and
fishery products they offer for import into the United
States were processed in accordance with the
HACCP and sanitation provisions set forth in part
123. ............................................................................
4,100
80
328,000
0.10
(6 minutes)
32,800
123.12(a)(2); Prepare new written verification procedures to verify compliance of imports. .......................
41
1
41
4
164
Total ........................................................................
..............................
..............................
..................
..............................
1,930,264
123.8(a)(1) and (c); Reassess hazard analysis and
HACCP plan. ..............................................................
123.12(a)(2)(ii); Verify compliance of imports and prepare records of verification activities. .........................
420,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates include the information collection requirements in the following sections: § 123.16—Smoked Fish—process controls (see
§ 123.6(b)); § 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b)); § 123.28(c) and (d)—Records—molluscan shellfish (see
§ 123.6(c)(7).
3 Based on an estimated 280 working days per year.
4 Estimated average time per 8-hour work day unless one-time response.
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2 These
Based on a review of the information
collection since our last OMB approval,
we have made no adjustments to our
burden estimate. We base this hour
burden estimate on our experience with
the application of HACCP principles in
food processing. Further, the burdens
have been estimated using typical small
seafood processing firms as a model
because these firms represent a
significant proportion of the industry.
The hour burden of HACCP
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the size of the facility and
complexity of the HACCP control
scheme (i.e., the number of products
and the number of hazards controlled);
the daily frequency that control points
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19:08 Sep 03, 2019
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are monitored and values recorded; and
also on the extent that data recording
time and cost are minimized by the use
of automated data logging technology.
The burden estimate does not include
burden hours for activities that are a
usual and customary part of businesses’
normal activities. For example, the
tagging and labeling of molluscan
shellfish (§ 1240.60) is a customary and
usual practice among seafood
processors.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
HHS.
[FR Doc. 2019–18987 Filed 9–3–19; 8:45 am]
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[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,
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
SUMMARY:
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Food and Drug Administration
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Federal Register / Vol. 84, No. 171 / Wednesday, September 4, 2019 / Notices
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-hiltonwashington-dc-north-gaithersburgGAIGWDT/. 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-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. 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:
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• 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
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46547
‘‘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/201523389.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,
patricio.garcia@fda.hhs.gov, (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/advisorycommittees/advisory-committeecalendar. 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: https://
fda.yorkcast.com/webcast/Play/
eeed34f9b1f448f9a1f6ad05a4b
98d7d1d
November 7, 2019: https://
fda.yorkcast.com/webcast/Play/
49c5a76d5d1c422d8da028441ab
557de1d
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
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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 fdaoma@
fda.hhs.gov 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 Artair.Mallett@fda.hhs.gov 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/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Meeting of the Advisory Committee on
Training in Primary Care and Dentistry
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Training in Primary Care
SUMMARY:
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and Dentistry (ACTPCMD) has
scheduled a public meeting. Information
about ACTPCMD and the agenda for this
meeting can be found on the ACTPCMD
website at: https://www.hrsa.gov/
advisory-committees/primarycaredentist/.
DATES: October 31, 2019, 10:00 a.m.–
5:00 p.m. Eastern Time.
ADDRESSES: This meeting will be held
by webinar.
• Webinar link: https://
hrsa.connectsolutions.com/ACTPCMD.
• Conference Call in number: (888)
455–0640; Passcode: HRSA COUNCIL
(voice response).
FOR FURTHER INFORMATION CONTACT:
Kennita Carter, MD, Senior Advisor and
Designated Federal Official, Division of
Medicine and Dentistry, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; phone (301) 945–3505; or email
BHWACTPCMD@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ACTPCMD provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under section 747 of Title VII of the
Public Health Service (PHS) Act, as it
existed upon the enactment of Section
749 of the PHS Act in 1998.
At this meeting, ACTPCMD will
discuss matters concerning innovations
in training in primary care medicine
and dentistry as well as ACTPCMD’s
upcoming report and recommendations.
Agenda items are subject to change as
priorities dictate. Refer to the
ACTPCMD website for any updated
information concerning the meeting. An
agenda will be posted on the website at
least 14 calendar days before the
meeting. Members of the public will
have the opportunity to provide
comments. Public participants may
submit written statements in advance of
the scheduled meeting. Oral comments
will be honored in the order they are
requested and may be limited as time
allows. Requests to submit a written
statement or make oral comments to
ACTPCMD should be sent to Kennita
Carter using the contact information
above at least three business days prior
to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Kennita Carter at the address and
phone number listed above at least 10
business days before the meeting.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–19035 Filed 9–3–19; 8:45 am]
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee
[[Page 46547]]
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/. 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
[[Page 46548]]
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: https://fda.yorkcast.com/webcast/Play/eeed34f9b1f448f9a1f6ad05a4b98d7d1d
November 7, 2019: https://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