Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 2676-2677 [2021-00469]
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2676
Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices
Drug Administration Staff’’ 2 assists
FDA staff and regulated industry by
describing the user fees associated with
513(g) requests. The Medical Device
User Fee Cover Sheet (Form FDA 3601),
which accompanies the supplemental
material described in this information
collection is approved under OMB
control number 0910–0511.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Center for Devices and Radiological Health 513(g) requests ...............................................................................
Center for Biologics Evaluation and Research 513(g) requests ...............................................................................
Total ..............................................................................
1 There
Dated: January 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00470 Filed 1–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
response
Total annual
responses
Total hours
114
1
114
12
1,368
4
1
4
12
48
........................
........................
........................
........................
1,416
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Notice.
The Food and Drug
Administration (FDA or the 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 February 17, 2021, from 9
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.
SUMMARY:
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:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, aden.asefa@
fda.hhs.gov, 301–796–0400, 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 February
17, 2021, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
Lutonix 014 Drug Coated Balloon
Percutaneous Transluminal Angioplasty
(PTA) catheter. The proposed Indication
for Use for the Lutonix 014 Drug Coated
Balloon PTA catheter is indicated for
percutaneous transluminal angioplasty,
after appropriate vessel preparation, of
obstructive de novo or non-stented
restenotic lesions in native popliteal,
tibial, and peroneal arteries up to 320
mm in length and 2.0 to 4.0 mm in
diameter.
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/circulatory-systemdevices-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 February 10, 2021.
Oral presentations from the public will
be scheduled 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
2 https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/user-fees-513grequests-information.
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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices
requested to make their presentation on
or before February 2, 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
February 3, 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 AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov or 301–796–5966 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: January 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00469 Filed 1–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Scientific
Registry of Transplant Recipients
Information Collection Effort for
Potential Donors for Living Organ
Donation OMB No. 0906–0034—
Extension
Correction
In notice document 2020–28017
appearing on pages 83098–83099 in the
issue of Monday, December 21, 2020,
make the following correction:
(1) On page 83098, in the second
column, in the DATES section, change
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‘‘January 20, 2021’’ to read ‘‘January 21,
2021.’’
[FR Doc. C1–2020–28017 Filed 1–12–21; 8:45 am]
BILLING CODE 1301–00–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Privacy Act of 1974; System of
Records
National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Notice of a Modified System of
Records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, the Department of Health
and Human Services is updating and
renaming an existing system of records
maintained by the National Institutes of
Health (NIH), 09–25–0165, ‘‘National
Institutes of Health (NIH) Office of Loan
Repayment and Scholarship (OLRS)
Record System, HHS/NIH/OD’’ (to be
renamed ‘‘NIH Loan Repayment
Records’’). In a separate Notice of
Proposed Rulemaking (NPRM)
published elsewhere in today’s Federal
Register, HHS/NIH is proposing to
exempt a subset of records in the system
of records from certain requirements of
the Privacy Act, based on subsection
(k)(5) of the Privacy Act.
DATES: The comment period for this
modified System of Records Notice
(SORN) is co-extensive with the 60-day
comment period provided in the
companion NPRM also published in
today’s Federal Register. Written
comments on the SORN should be
submitted on or before March 15, 2021.
The modified SORN will be applicable
when the proposed exemptions are
made effective by publication of a Final
Rule, which will not occur until after
the 60-day comment period ends and
any comments received on the NPRM
(or on this SORN) have been addressed.
ADDRESSES: You may submit comments,
identified by the Privacy Act System of
Records Number (09–25–0165), by any
of the following methods: Email:
privacy@mail.nih.gov and include
Privacy Act System of Record (PA SOR)
number (09–25–0165) in the subject line
of the message. Phone: (301) 402–6201.
Fax: (301) 402–0169. Mail or handdelivery: NIH Privacy Act Officer, Office
of Management Assessment, National
Institutes of Health, 6011 Executive
Blvd., Suite 601, MSC 7669, Rockville,
MD 20852. Comments received will be
available for public inspection at this
same address from 9 a.m. to 3 p.m.,
Monday through Friday, except federal
SUMMARY:
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2677
holidays. Please call 301–496–4606 for
an appointment.
FOR FURTHER INFORMATION CONTACT:
General questions about the proposed
modified system of records may be
submitted to Celeste Dade-Vinson, NIH
Privacy Act Officer, Office of
Management Assessment, Office of the
Director, National Institutes of Health
(NIH), 6011 Executive Blvd., Suite 601,
MSC 7669, Rockville, MD 20852, or
telephone 301 402–6201.
SUPPLEMENTARY INFORMATION: This
system of records (hereafter referred to
as the ‘‘NIH Loan Repayment Records’’),
covers records maintained in a
particular NIH information technology
(IT) system managed by NIH’s Division
of Loan Repayment (DLR) that are used
to manage and evaluate the intramural
and extramural educational Loan
Repayment Programs (LRP) at NIH. As
of the date of this publication, there are
eight such programs that provide
student loan repayments for qualified
individuals who agree to conduct
biomedical and behavioral research;
recipients include NIH employee
researchers as well as scientists
conducting research at non-profit
organizations outside NIH. Scholarship
program records at NIH are now covered
by the following NIH SORNs, so are
omitted from modified SORN 09–25–
0165:
• 09–25–0014—Clinical Research:
Student Records, HHS/NIH/OD/OIR/
OE
• 09–25–0108—Personnel: Guest
Researchers, Special Volunteers, and
Scientists Emeriti, HHS/NIH/OHRM
• 09–25–0140—International Scientific
Researchers in Intramural
Laboratories, ORS/DIRS
• 09–25–0158—Administration Records
of Applicants and Awardees of the
Intramural Research Training Awards
Program, HHS/NIH/OD/OE
The System of Records Notice (SORN)
for System 09–25–0165 has been
reformatted in accordance with OMB
Circular A–108 and updated with these
changes:
• System name. The system name has
been changed from ‘‘National Institutes
of Health (NIH) Office of Loan
Repayment and Scholarship Records
system, HHS/NIH/OD’’ to ‘‘NIH Loan
Repayment Records.’’
• Throughout the SORN. References
to scholarship program records have
been omitted; for example, the
abbreviation ‘‘LRSPs’’ is now ‘‘LRPs.’’
• System Location and System
Manager. Office names and addresses
have been updated.
• Authority. This section has been
updated to remove all authorities
E:\FR\FM\13JAN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Pages 2676-2677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00469]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-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 the 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 February 17, 2021, from
9 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: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
[email protected], 301-796-0400, 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 February
17, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty
(PTA) catheter. The proposed Indication for Use for the Lutonix 014
Drug Coated Balloon PTA catheter is indicated for percutaneous
transluminal angioplasty, after appropriate vessel preparation, of
obstructive de novo or non-stented restenotic lesions in native
popliteal, tibial, and peroneal arteries up to 320 mm in length and 2.0
to 4.0 mm in diameter.
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/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
February 10, 2021. Oral presentations from the public will be scheduled
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
[[Page 2677]]
requested to make their presentation on or before February 2, 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 February 3, 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 AnnMarie Williams at [email protected] or 301-796-
5966 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: January 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00469 Filed 1-12-21; 8:45 am]
BILLING CODE 4164-01-P
