Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 55016-55017 [2020-19482]
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Federal Register / Vol. 85, No. 172 / Thursday, September 3, 2020 / Notices
ANNUAL BURDEN ESTIMATES: URM PROVIDER AGENCIES
Total number
of respondents
Instrument
ORR–3 Unaccompanied Refugee Minors Placement
Report .........................................................................
ORR–4 Unaccompanied Refugee Minors Outcomes
Report .........................................................................
Total number
of responses
per respondent
Average
burden hours
per response
Total
burden hours
Annual
burden hours
24
270
0.50
3,240
1,080
24
162
1.0
3,888
1,296
Estimated Total Annual Burden Hours (Provider Agencies): 2,376.
ANNUAL BURDEN ESTIMATES: YOUTH PARTICIPANTS
Total number
of respondents
Instrument
ORR–4 Unaccompanied Refugee Minors Outcomes
Report .........................................................................
Total number
of responses
per respondent
1032
Average
burden hours
per response
3
0.50
Total
burden hours
1,548
Annual
burden hours
516
Estimated Total Annual Burden Hours (Youth Participants): 516.
Total Estimated Annual Burden
Hours: 4,137.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522(d).
[FR Doc. 2020–19466 Filed 9–2–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Ophthalmic Devices
SUMMARY:
VerDate Sep<11>2014
16:51 Sep 02, 2020
Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
AGENCY:
Panel of the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will take place
virtually on November 9, 2020, from 8
a.m. Eastern Time to 6 p.m. Eastern
Time.
Jkt 250001
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver Spring,
MD 20993–0002, James.Swink@
fda.hhs.gov; 301–796–6313, 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/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 the meeting.
SUPPLEMENTARY INFORMATION:
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Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On
November 9, 2020, the committee will
discuss, make recommendations and
vote on information regarding the
premarket application (PMA) for the
VisAbility Micro Insert sponsored by
Refocus Group, Inc. The proposed
Indication for Use for the VisAbility
Micro Insert, as stated in the PMA, is as
follows:
The VisAbility Micro Insert is
indicated for bilateral scleral
implantation to improve unaided near
vision in phakic, presbyopic patients
between the ages of 45 and 60 years of
age, who have a manifest spherical
equivalent between –0.75D and +0.50 D
with less than or equal to 1.00D of
refractive cylinder in both eyes, and
require a minimum near correction of at
least +1.25 D reading add.
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 made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/medical-devicesadvisory-committee/ophthalmicdevices-panel. (Select the link for the
2020 Meeting Materials.) The meeting
will include slide presentations with
audio components to allow the
presentation of materials in a manner
E:\FR\FM\03SEN1.SGM
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 172 / Thursday, September 3, 2020 / Notices
that most closely resembles an in-person
advisory committee meeting.
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 20, 2020.
Oral presentations from the public will
be scheduled on November 9, 2020,
between approximately 1 p.m. Eastern
Time and 2 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person (see FOR FURTHER
INFORMATION CONTACT). The notification
should include 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
13, 2020. 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 14, 2020.
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 Mallet
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/
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: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–19482 Filed 9–2–20; 8:45 am]
BILLING CODE 4164–01–P
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16:51 Sep 02, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1530]
Control of Nitrosamine Impurities in
Human Drugs; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
final guidance for industry, entitled
‘‘Control of Nitrosamine Impurities in
Human Drugs.’’ This guidance
recommends steps manufacturers of
active pharmaceutical ingredients and
drug products should take to detect and
prevent objectionable levels of
nitrosamine impurities in
pharmaceutical products. The guidance
also describes conditions that may
introduce nitrosamine impurities. The
recent unexpected finding of
nitrosamine impurities, which are
probable human carcinogens, in drugs
such as angiotensin II receptor blockers,
ranitidine, nizatidine, and metformin,
has made clear the need for a risk
assessment strategy to identify and
minimize nitrosamines in any
pharmaceutical product at risk for their
presence.
DATES: The announcement of the
guidance is published in the Federal
Register on September 3, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
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55017
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
Submissions’’ 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–
2020–D–1530 for ‘‘Control of
Nitrosamine Impurities in Human
Drugs.’’ Received comments 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, 240–402–7500.
• 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
Agency 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
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]]>Agencies
[Federal Register Volume 85, Number 172 (Thursday, September 3, 2020)]
[Notices]
[Pages 55016-55017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19482]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Ophthalmic Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Ophthalmic Devices Panel of
the Medical Devices Advisory Committee. The general function of the
committee is to provide advice and recommendations to the Agency on
FDA's regulatory issues. The meeting will be open to the public.
DATES: The meeting will take place virtually on November 9, 2020, from
8 a.m. Eastern Time to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002,
[email protected]; 301-796-6313, 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/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 the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On November
9, 2020, the committee will discuss, make recommendations and vote on
information regarding the premarket application (PMA) for the
VisAbility Micro Insert sponsored by Refocus Group, Inc. The proposed
Indication for Use for the VisAbility Micro Insert, as stated in the
PMA, is as follows:
The VisAbility Micro Insert is indicated for bilateral scleral
implantation to improve unaided near vision in phakic, presbyopic
patients between the ages of 45 and 60 years of age, who have a
manifest spherical equivalent between -0.75D and +0.50 D with less than
or equal to 1.00D of refractive cylinder in both eyes, and require a
minimum near correction of at least +1.25 D reading add.
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 made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/ophthalmic-devices-panel. (Select the link for the
2020 Meeting Materials.) The meeting will include slide presentations
with audio components to allow the presentation of materials in a
manner
[[Page 55017]]
that most closely resembles an in-person advisory committee meeting.
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 20, 2020. Oral presentations from the public will be scheduled
on November 9, 2020, between approximately 1 p.m. Eastern Time and 2
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include 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 13, 2020. 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
14, 2020.
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 Mallet 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/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: August 26, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19482 Filed 9-2-20; 8:45 am]
BILLING CODE 4164-01-P
