Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 47648-47649 [2021-18403]
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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
made publicly available, submit your
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In the
Federal Register of June 15, 2021, FDA
published a request for comments with
a 90-day comment period to request
comments on the use of study data
exchange standards from persons
involved in study conduct, data
collection, data management, and
submission of animal study data
intended to support the approval of
NDAs, ANDAs, or applications for
conditional approval. Comments on the
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will help us evaluate the potential use
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animal studies submitted as part of the
new animal drug approval process
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:30 Aug 25, 2021
Jkt 253001
Interested persons were originally
given until September 13, 2021, to
comment on document. The Agency has
received a request for a 60-day
extension of the comment period. The
request conveyed concern that the
current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the request for comments. FDA has
considered the request and is extending
the comment period for the request for
comments for 60 days, until November
12, 2021. The Agency believes that a 60day extension allows adequate time for
interested persons to submit comments.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18395 Filed 8–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Circulatory System 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 2 and 3, 2021,
from 9 a.m. 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
including information regarding special
accommodations due to a disability may
be accessed at: https://www.fda.gov/
advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug
SUMMARY:
PO 00000
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Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring,
MD 20993–0002, Akinola.Awojope@
fda.hhs.gov, 301–636–0512, 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 2, 2021, the committee will
discuss and make recommendations on
information about the benefit-risk
profile of the Endologix AFX
endovascular graft system with regards
to the risk of Type III endoleaks. FDA
requests panel input regarding the
totality of data collected on AFX devices
and whether further actions are
necessary.
On November 3, 2021, the committee
will discuss and make
recommendations on the continued
safety and effectiveness of endovascular
stent grafts and how to strengthen realworld data collection on long-term
performance of the devices, both for
currently marketed devices and for
future technologies. FDA intends to
request panel input on the clinical
outcomes that are most relevant to
capture in the real world, along with
their frequency and duration.
Additionally, FDA intends to seek input
on data collection platforms, and how to
incentivize and optimize real world data
collection.
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/circulatory-systemdevices-panel/2021-meeting-materials-
E:\FR\FM\26AUN1.SGM
26AUN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices
circulatory-system-devices-panel. Select
the link for the 2021 Meeting Materials.
The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner 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 21, 2021.
Oral presentations from the public will
be scheduled on November 2 and
November 3, 2021, between
approximately 1 p.m. 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, the date which
they want to present, and an indication
of the approximate time requested to
make their presentation on or before
October 13, 2021. 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, 2021.
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 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).
VerDate Sep<11>2014
17:30 Aug 25, 2021
Jkt 253001
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18403 Filed 8–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0691]
Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing
Regimens of Programmed Cell Death
Receptor-1 or Programmed Cell DeathLigand 1 Blocking Antibodies for
Treatment of Patients With Cancer;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Pharmacokinetic-Based Criteria for
Supporting Alternative Dosing
Regimens of Programmed Cell Death
Receptor-1 (PD–1) or Programmed Cell
Death-Ligand 1 (PD–L1) Blocking
Antibodies for Treatment of Patients
with Cancer.’’ This draft guidance
provides recommendations for sponsors
of investigational new drug applications
(INDs) and biologics license
applications (BLAs) on the use of
pharmacokinetic (PK)-based criteria to
support the approval of alternative
dosing regimens for programmed cell
death receptor-1 (PD–1) or programmed
cell death-ligand 1 (PD–L1) blocking
antibodies. This draft guidance is based
on accumulated scientific and
regulatory experience for PD–1 and PD–
L1 drugs, and as such, does not address
development of alternative dosing
regimens for any other drugs or
biologics, changes in route of
administration, or novel formulations of
previously approved PD–1/PD–L1
products.
DATES: Submit either electronic or
written comments on the draft guidance
by October 25, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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47649
• 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
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–
2021–D–0691 for ‘‘PharmacokineticBased Criteria for Supporting
Alternative Dosing Regimens of
Programmed Cell Death Receptor-1 (PD–
1) or Programmed Cell Death-Ligand 1
(PD–L1) Blocking Antibodies for
Treatment of Patients with Cancer.’’
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
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47648-47649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Circulatory System 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 or Agency) announces a
forthcoming public advisory committee meeting of the Circulatory System
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 2 and 3, 2021,
from 9 a.m. 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 including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.
FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
[email protected], 301-636-0512, 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
2, 2021, the committee will discuss and make recommendations on
information about the benefit-risk profile of the Endologix AFX
endovascular graft system with regards to the risk of Type III
endoleaks. FDA requests panel input regarding the totality of data
collected on AFX devices and whether further actions are necessary.
On November 3, 2021, the committee will discuss and make
recommendations on the continued safety and effectiveness of
endovascular stent grafts and how to strengthen real-world data
collection on long-term performance of the devices, both for currently
marketed devices and for future technologies. FDA intends to request
panel input on the clinical outcomes that are most relevant to capture
in the real world, along with their frequency and duration.
Additionally, FDA intends to seek input on data collection platforms,
and how to incentivize and optimize real world data collection.
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/circulatory-
system-devices-panel/2021-meeting-materials-
[[Page 47649]]
circulatory-system-devices-panel. Select the link for the 2021 Meeting
Materials. The meeting will include slide presentations with audio
components to allow the presentation of materials in a manner 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 21, 2021. Oral presentations from the public will be scheduled
on November 2 and November 3, 2021, between approximately 1 p.m. 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, the date
which they want to present, and an indication of the approximate time
requested to make their presentation on or before October 13, 2021.
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, 2021.
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 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 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18403 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
